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2016-03-16 First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=43065455&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=US10105473(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Methods and apparatuses are disclosed for applying negative pressure to a wound site. In some embodiments, the apparatus comprises a source of negative pressure, a processing element, and a memory comprising instructions configured to, when executed on the processing element, cause the apparatus to attempt to generate, via the source of negative pressure, a desired negative pressure at the wound site. If the desired negative pressure has not been generated after a first predetermined period of time, the instructions cause the apparatus to: deactivate the source of negative pressure for a second predetermined period of time, and subsequently attempt to generate the desired negative pressure at the wound site.
This application is a continuation of U.S. patent application Ser. No. 14/972,734, filed on Dec. 17, 2015, which is a continuation of U.S. patent application Ser. No. 14/256,658, filed on Apr. 18, 2014 and issued as U.S. Pat. No. 9,220,823, which is a continuation of U.S. patent application Ser. No. 13/824,982, filed on Jun. 26, 2013 and issued as U.S. Pat. No. 8,734,425, which is a U.S. National Phase application under 35 U.S.C. § 371 of International Application PCT/GB2011/051745, filed Sep. 16, 2011, which claims priority to Great Britain Patent Application No. 1015656.0, filed Sep. 20, 2010. The disclosures of these prior applications are incorporated by reference in their entireties.
The present invention relates to a method and apparatus for applying a negative pressure. In particular, but not exclusively, the present invention relates to the application of a negative pressure to a wound site in the application of topical negative pressure at the wound site.
There is much prior art available relating to the provision of apparatus and methods of use thereof for the application of topical negative pressure (TNP) therapy to wounds together with other therapeutic processes intended to enhance the effects of the TNP therapy. Examples of such prior art include those listed and briefly described below.
TNP therapy (sometimes referred to as Vacuum Assisted Closure or negative pressure wound therapy) assists in the closure and healing of wounds by reducing tissue oedema; encouraging blood flow and granulation of tissue; removing excess exudates and may reduce bacterial load and thus, infection to the wound. Furthermore, TNP therapy permits less outside disturbance of the wound and promotes more rapid healing.
In International patent application, WO 2004/037334, which is incorporated herein by reference, apparatus, a wound dressing and a method for aspirating, irrigating and cleansing wounds are described. In very general terms, the application describes the treatment of a wound by the application of TNP therapy for aspirating the wound together with the further provision of additional fluid for irrigating and/or cleansing the wound, which fluid, comprising both wound exudates and irrigation fluid, is then drawn off by the aspiration means and circulated through means for separating the beneficial materials therein from deleterious materials. The materials which are beneficial to wound healing are recirculated through the wound dressing and those materials deleterious to wound healing are discarded to a waste collection bag or vessel.
In International patent application, WO 2005/04670, which is incorporated herein by reference, apparatus, a wound dressing and a method for cleansing a wound using aspiration, irrigation and cleansing are described. Again, in very general terms, the invention described in this document utilises similar apparatus to that in WO 2004/037334 with regard to the aspiration, irrigation and cleansing of the wound, however, it further includes the important additional step of providing heating means to control the temperature of that beneficial material being returned to the wound site/dressing so that it is at an optimum temperature, for example, to have the most efficacious therapeutic effect on the wound.
However, the above described apparatus and methods are generally only applicable to a patient when hospitalised as the apparatus used is complex, needing people having specialist knowledge in how to operate and maintain the apparatus, and also relatively heavy and bulky, not being adapted for easy mobility outside of a hospital environment by a patient, for example.
Some patients having relatively less severe wounds which do not require continuous hospitalisation, for example, but whom nevertheless would benefit from the prolonged application of TNP therapy, could be treated at home or at work subject to the availability of an easily portable and maintainable TNP therapy apparatus. To this end GB-A-2 307 180 describes a portable TNP therapy unit which may be carried by a patient and clipped to belt or harness. A negative pressure can thus be applied at a wound site.
However, this portable apparatus is still relatively bulky, and may require monitoring of the patient by a trained caregiver. Furthermore, such portable therapy units commonly have reduced capacity to deal with fluid flow rates into a wound cavity caused by leaks. This leads to a greater number of alarms being raised due to an inability to maintain the desired negative pressure at the wound site in the presence of leaks.
Another problem associated with portable apparatus is that on occasion an onboard power source such as a battery pack is used rather than a continuous connection to a power source such as a mains power source. It will be appreciated that such a battery pack has only a limited power resource and therefore TNP therapy can on occasion be halted prior to a desired moment in time because of power failure.
Another problem associated with therapy units which can be utilised by a patient alone without the need for skilled technical assistants is that from time to time warning lights or warning alarms may be initiated when a desired therapy can not be maintained or initiated. This can be distressing for a patient who may not understand the meaning of the cues.
A still further problem associated with the apparatus used to provide TNP therapy is that from time to time a motor associated with a pump which generates a negative pressure will start up or stop. The change in volume coming from the therapy unit can be a cause of concern to a patient.
It is an aim of certain embodiments of the present invention to at least partly mitigate one or more of the above-mentioned problems.
It is an aim of certain embodiments of the present invention to provide a method for controlling the provision of a desired negative pressure at a wound site to aid in wound closure and healing.
It is an aim of certain embodiments of the present invention to provide a pressure control apparatus that avoids the generation of unnecessary alarms in the presence of transient leaks.
It is an aim of certain embodiments of the present invention to provide a pressure control apparatus that helps extend battery power lifetime.
It is an aim of certain embodiments of the present invention to provide a pressure control apparatus that reduces a number of pump motor start-up or power down operations.
subsequently attempting to generate the desired negative pressure at the wound site.
upon expiration of the second time interval, activate the source of negative pressure to generate the first desired negative pressure under the dressing.
In some embodiments, the controller is further configured to: deactivate the source of negative pressure when the first desired negative pressure has not been generated under the dressing after activating the source of negative pressure for a first number of times exceeding a first threshold.
In some embodiments, the controller is further configured to: when the first number of times exceeds the first threshold, deactivate the source of negative pressure for a third time interval.
In some embodiments, the apparatus further comprises: a switch configured to signal to the controller to activate or deactivate the source of negative pressure; and the controller is further configured to, upon expiration of the third time interval or upon receiving a signal to activate the source of negative pressure from the switch, activate the source of negative pressure to generate the first desired negative pressure under the dressing.
In some embodiments, the apparatus further comprises: an indicator, wherein the controller is further configured to activate the indicator when the first number of times exceeds the first threshold.
In some embodiments, the controller is further configured to: deactivate the indicator upon expiration of the third time interval or receiving a signal to activate the source of negative pressure from the switch.
In some embodiments, the indicator indicates a leak in the seal.
if the negative pressure under the dressing drops below a negative pressure threshold, activate the source of negative pressure to generate a second desired negative pressure under the dressing.
In some embodiments, the first and second desired negative pressure are the same.
In some embodiments, the second desired negative pressure is less than the first desired negative pressure.
In some embodiments, the controller is further configured: to deactivate the source of negative pressure if the negative pressure under the dressing has reached the second desired negative pressure or if the negative pressure under the dressing has not reached the second desired negative pressure upon expiration of a fourth time interval.
In some embodiments, if the negative pressure under the dressing has not reached the second desired negative pressure upon expiration of the fourth time interval, the controller is further configured to, upon expiration of the second time interval, activate the source of the negative pressure to generate the first desired negative pressure under the dressing.
In some embodiments, the controller is further configured to: activate the source of the negative pressure to generate the first desired negative pressure under the dressing if the controller has activated the source of negative pressure to reach the second desired negative pressure for a second number of times less than a second threshold.
upon expiration of the third time interval or upon receiving the signal from the switch to activate the source of negative pressure, activate the source of negative pressure to generate the first desired negative pressure under the dressing.
deactivate the source of negative pressure if the duty cycle exceeds a first duty cycle threshold without the negative pressure reaching the first or second desired negative pressure under the dressing.
In some embodiments, the duty cycle comprises an amount, proportion, or percentage of time the source of negative pressure is active over a period of time.
In some embodiments, the controller is further configured to: calculate a number of duty cycles that exceed the first duty cycle threshold and deactivate the source of negative pressure when the number of duty cycles that exceed the first duty cycle threshold exceeds a second duty cycle threshold.
In some embodiments, the controller is further configured to calculate a number of consecutive duty cycles that exceed the first duty cycle threshold.
In some embodiments, the second duty cycle threshold comprises 30 minutes.
In some embodiments, the controller is further configured: to upon expiration of the third time interval or upon receiving the signal from the switch to active the source of negative pressure, activate the source of negative pressure to generate the first desired negative pressure under the dressing.
In some embodiments, the source of negative pressure comprises a pump.
In some embodiments, the apparatus further comprises: a pressure sensor configured to sense pressure under the dressing and to communicate the sensed pressure to the controller.
In some embodiments, the apparatus further comprises: a one-way valve coupled between an inlet and the source of negative pressure, wherein the inlet is in fluid communication with the dressing.
In some embodiments, the source of negative pressure comprises: a valve configured to connect the port to an external source of negative pressure.
In some embodiments, the controller is further configured to: activate or deactivate the source of negative pressure by operating the valve.
upon expiration of the second time interval, activating the source of negative pressure to generate the first desired negative pressure under the dressing.
In some embodiments, the method further comprises: deactivating the source of negative pressure when the first desired negative pressure has not been generated under the dressing after activating the source of negative pressure for a first number of times exceeding a first threshold.
In some embodiments, the method further comprises: deactivating the source of negative pressure for a third time interval when the first number of times exceeds the first threshold.
In some embodiments, the method further comprises: activating the source of negative pressure to generate the first desired negative pressure under the dressing upon expiration of the third time interval or upon receiving a signal to activate the source of negative pressure from a switch.
In some embodiments, the method further comprises: indicating to a user when the first number of times exceeds the first threshold.
In some embodiments, the method further comprises: stopping the indication upon expiration of the third time interval or receiving a signal to activate the source of negative pressure from the switch.
In some embodiments, the indicating indicates a leak in the seal.
if the negative pressure under the dressing drops below a negative pressure threshold, activating the source of negative pressure to generate a second desired negative pressure under the dressing.
In some embodiments, the method further comprises: deactivating the source of negative pressure if the negative pressure under the dressing has reached the second desired negative pressure or if the negative pressure under the dressing has not reached the second desired negative pressure upon expiration of a fourth time interval.
In some embodiments, the method further comprises: if the negative pressure under the dressing has not reached the second desired negative pressure upon expiration of the fourth time interval, activating the source of the negative pressure to generate the first desired negative pressure under the dressing upon expiration of the second time interval.
In some embodiments, the method further comprises: activating the source of the negative pressure to generate the first desired negative pressure under the dressing if the source of negative pressure has been activated to reach the second desired negative pressure for a second number of times less than a second threshold.
upon expiration of the third time interval or upon receiving the signal from the switch to activate the source of negative pressure, activating the source of negative pressure to generate the first desired negative pressure under the dressing.
deactivating the source of negative pressure if the duty cycle exceeds a first duty cycle threshold without the negative pressure reaching the first or second desired negative pressure under the dressing.
In some embodiments, the method further comprises: calculating a number of duty cycles that exceed the first duty cycle threshold and deactivating the source of negative pressure when the number of duty cycles that exceed the first duty cycle threshold exceeds a second duty cycle threshold.
In some embodiments, the method further comprises: calculating a number of consecutive duty cycles that exceed the first duty cycle threshold.
In some embodiments, the method further comprises: upon expiration of the third time interval or upon receiving the signal from the switch to active the source of negative pressure, activating the source of negative pressure to generate the first desired negative pressure under the dressing.
In some embodiments, the method further comprises sensing pressure under the dressing.
In some embodiments, the method further comprises: activating or deactivating the source of negative pressure by operating a valve.
Certain embodiments of the present invention provide the advantage that the raising of alarms due to transient leaks into a wound chamber can be avoided, while also reducing the potential for drawing contaminants into a wound site through a leak into the wound chamber.
Certain embodiments of the present invention provide the advantage of extending the useful life of a battery powered source of negative pressure used to provide a desired negative pressure to a wound site.
FIG. 5 illustrates a controller.
FIG. 1 illustrates an arrangement for applying negative pressure wound therapy to a wound site 10. A packing material 12 is placed within a wound cavity, and then a drape 14 sealed to the surface of the skin around the wound site 10 forming a fluid tight seal around the perimeter of a wound chamber. A source of negative pressure, such as a pressure control apparatus 100 is coupled to the wound cavity via a tube 16. A fluid collection canister (not shown) may be coupled between the pressure control apparatus 100 and the wound chamber to collect any wound exudate drawn from the wound site 10. The use of the packing material 12 is optional, and it may be omitted in certain arrangements as appropriate.
Alternatively, a self contained wound dressing may be used in place of the drape, such a wound dressing absorbs wound exudate within the layers of the dressing removing the need for a separate fluid collection canister.
Further details regarding wound dressings that may be used in combination with the embodiments described herein are found in U.S. application Ser. No. 13/092,042, filed Apr. 21, 2011, the entirety of which is hereby incorporated by reference.
It is envisaged that the negative pressure range for the apparatus in certain embodiments of the present invention may be between about −50 mmHg and −200 mmHg (note that these pressures are relative to normal ambient atmospheric pressure thus, −200 mmHg would be about 560 mmHg in practical terms). Aptly, the pressure range may be between about −75 mmHg and −150 mmHg. Alternatively a pressure range of upto −75 mmHg, upto −80 mmHg or over −80 mmHg can be used. Also aptly a pressure range of below −75 mmHg could be used. Alternatively a pressure range of over −100 mmHg could be used or over −150 mmHg.
FIG. 2 illustrates a schematic representation of a pressure control apparatus 100 according to embodiments of the invention that can be used to apply negative pressure to a wound site 10. The pressure control apparatus includes an inlet 102 coupled to a pressure sensor 116, and also to an inlet of a pump 106 via a one-way check valve 104. The pump is operated by an electric motor 108, which draws power from a battery 114. A controller 112 is coupled to the pressure sensor 116 and provides control signals for controlling the operation of the electric motor 108. Indicators 110 are coupled to the controller 112 to allow audio and/or visual feedback of status signals to a user. An outlet of the pump 106 is coupled to an outlet 118 of the pressure control apparatus. A user can utilise a power button 120 to initiate or terminate operation.
The pump 106 shown is a diaphragm pump which may be highly efficient and capable of providing the required negative pressure. It will be appreciated that other types of pump such as peristaltic pumps, or the like can be used. In some arrangements, the one-way check valve 104 may form part of the pump 106, and may not exist as a separate element of the apparatus.
While the apparatus has been described as being battery powered, it will be understood that the apparatus could alternatively draw electrical power from a mains power supply and the battery power cell removed. In some arrangements, the apparatus may be capable of being powered from either a mains power supply or a rechargeable battery that may be recharged from the mains power supply.
In operation, the inlet 102 is coupled to a wound chamber formed over a wound site 10, for example via the length of tube 16. The electric motor 108 drives the pump 106 under the control of the controller 112 to provide a negative pressure at the inlet 102. The negative pressure can then be communicated to the wound chamber in order to provide a desired negative pressure at the wound site. The check valve 104 maintains the level of negative pressure at the inlet 102 when the pump 106 is not active and helps avoid leaks.
Upon initially connecting the pressure control apparatus 100 to the wound chamber, the pressure at the wound site will be equal to atmospheric pressure, and an initial pump-down must be performed to establish the desired negative pressure at the wound site. This may require the pump 106 to be operated for an extended period of time until the desired negative pressure is achieved.
The pressure at the inlet 102 is indicative of the pressure experienced at the wound site, and this pressure is measured by the pressure sensor 116. The controller 112 receives the pressure value measured at the pressure sensor 116, and once the measured pressure reaches the desired negative pressure, the controller deactivates the pump 106. The controller 112 then continues to monitor the pressure at the pressure sensor.
If during the initial pump-down phase, the controller 112 determines that the desired negative pressure has not been achieved within a certain time (for example 10 minutes or 20 minutes or 30 minutes or 40 minutes or the like), then leaks may be present into the wound chamber, and this condition is signalled via the indicators 110 to show that the wound chamber has not been correctly sealed, or some other error or fault is present.
Once the desired negative pressure has been established, the controller 112 monitors the pressure at the inlet of the pressure control apparatus. From time to time, leaks of fluid may occur into the wound chamber, reducing the level of negative pressure experienced at the wound site, or in other words increasing the absolute pressure at the wound site. The pressure value measured at the pressure sensor 116 and provided to the controller 112 will therefore increase as fluid leaks into the wound chamber. When the measured negative pressure value drops below a certain defined pressure level, the controller 112 will reactivate the pump 106 in order to re-establish the desired negative pressure at the wound site. The desired negative pressure and the defined pressure level at which the controller reactivates the pump provide hysteresis limits between which the pressure should be maintained to apply topical negative pressure to the wound site.
However, if a leak forms that allows fluid, for example air, to leak into the wound chamber with a flow rate greater than the maximum pump capacity 106, it will not be possible for the pressure control apparatus 100 to maintain the desired negative pressure at the wound site. If the pressure control apparatus 100 continued to attempt to re-establish the desired negative pressure in the presence of such a leak, the battery power cell 114 would become depleted. Furthermore, continued operation of the pump in the presence of a large leak can draw contaminants into the wound site, and lead to excessive drying of the wound site which is undesirable. Therefore, the controller 112 is configured to deactivate the pump 106 if the desired negative pressure is not re-established after operation of the pump 106 for a predetermined period of time. For example sometime between around 30 minutes and 4 hours.
The formation of leaks into the wound chamber may occur due to a range of factors. One common cause of such leaks is movement of a patient being treated with the pressure control apparatus 100. For example, a leak may form when a patient moves from a lying to a sitting position, or during the normal range of movement when walking. Such leaks may be transient, and have been found to regularly reseal as the patient continues to move or returns to their previous position. Thus, there is a risk that the pump 106 may be deactivated due to the detection of a leak that subsequently reseals. However, once the leak reseals, operation of the pressure control apparatus would be able to re-establish the desired negative pressure within the wound chamber.
According to embodiments of the invention, the controller 112 is configured to deactivate the pump 106 after the pump has operated for a certain period of time without the desired level of negative pressure being reached in the wound chamber. That is a timeout event occurs. The controller then waits for a further period of time before a retry attempt is made to re-establish the desired negative pressure at the wound site using the pump 106. If the leak has resealed while the pump has been temporarily deactivated, the retry attempt to re-establish the desired negative pressure will be successful, and operation of the pressure control apparatus 100 can continue as normal. However, if the leak is still present a further timeout event will occur and the pump will be deactivated for the further period of time.
This cycle of deactivating the pump 106 and then attempting to re-establish the desired negative pressure may be repeated a number of times in order to provide an opportunity for any leaks to reseal. However, once a timeout event occurs the negative pressure at the wound site will start to degrade, and therefore there will be a break in the negative pressure wound therapy applied to the wound site. While a short break in therapy may not be a concern, an extended period in which the negative pressure is not applied should preferably be avoided. Furthermore, if a leak path into the wound chamber exists for an extended period of time, the potential for contaminants reaching the wound site increases. Thus, if a number, N, of unsuccessful attempts are made to re-establish the desired negative pressure it can be assumed that the leak is permanent, and not transient, and the controller 112 disables operation of the pressure control apparatus 100 and provides a signal via an audio and/or visual cue to a user that attention is required. This allows a patient or caregiver to arrange for any dressings or drapes to be changed to thereby reform the wound chamber and allow the negative pressure wound therapy to be continued. Aptly N is an integer between 1 and 5 inclusive.
Alternatively, the pump 106 and motor 108 may be omitted, and the negative pressure may be provided via an external source of negative pressure, such as by connection to a vacuum line or vacuum reservoir. FIG. 3 provides a schematic representation of a further pressure control apparatus 200 for use with an external source of negative pressure, and which can be used to provide negative pressure to a wound site 10. Pressure control apparatus 200 includes a controllable valve 202 coupled between an inlet 102 and an outlet 118. The outlet 118 is coupled to the external source of negative pressure, Controller 212 provides control signals to the valve 202 to control the coupling of the external source of negative pressure to the inlet 102, and thereby to the wound chamber. The pressure at the inlet 102 is monitored by a pressure sensor 116, coupled to the inlet, and this monitored pressure is supplied to the controller 212.
The operation of the pressure control apparatus 200 of FIG. 3 is similar to that of the pressure control apparatus 100, except that pressure is controlled by operating the valve 202 to couple the wound chamber to the external source of negative pressure. Controller 112 is able to control the level of negative pressure at the inlet 102 by controlling the valve 202. By monitoring the pressure at the inlet via the pressure sensor 116, the controller 212 can control the valve to provide the desired negative pressure at the wound site.
Unlike the pressure control apparatus of FIG. 2, an extended attempt to provide the desired negative pressure in the presence of a leak will not lead to depletion of a battery power cell. However, longterm it is still undesirable to continue to apply a negative pressure in the presence of a leak due to the possibility of drawing contaminants into the wound chamber, and of drying out the wound site due to the flow of air through the chamber. Thus, the controller 212 of FIG. 3 implements the same control flow as described above with respect to the pressure control apparatus 100. That is, controller 212 is configured to de-couple the inlet 102 from the external source of negative pressure by closing the valve if the desired negative pressure is not established at the wound site within a predetermined period of time. A number of attempts may then be made to re-establish the desired negative pressure in order to provide the opportunity for transient leaks into the wound chamber to reseal.
Thus, the pressure control apparatus of FIGS. 2 and 3 are able to control the application of negative pressure to a wound site, and advantageously reduce the number of alarms due to transient leaks of fluid into the wound chamber. When a leak forms that allows air into the wound chamber at a flow rate above a certain level, the pressure control apparatus is configured to disable the provision of negative pressure to the wound chamber for a predetermined period of time, providing an opportunity for the leak to reseal. Then, if the leak is transient and reseals, the desired negative pressure may then be re-established at a subsequent attempt. This avoids the need to indicate an alarm condition for transient leaks, and also avoids the problem of drawing contaminants and excessive amounts of air into the wound chamber. This also avoids a pump motor being repeatedly energised and de-energised which avoids concerning noise level changes and helps improve pump motor longevity.
Controller 112, 212 may be implemented as a microcontroller, or an application specific integrated circuit, or the like, and may execute instructions to provide the above described control functions. For example, a suitable microcontroller would be one from the STM8L MCU family from ST Microelectronics, for example ST Microelectronics STM8L151G4U6, or one from the MC9S08QE4/8 series from Freescale, such as the Freescale MC9S08QE4CWJ.
The operation of the controller 112 may be described as a finite state machine. The operation of the controller is described below with reference to FIG. 4 which shows a state diagram 300 describing the operation of the controller 112 for the pressure control apparatus shown in FIG. 1.
FIG. 5 illustrates one embodiment of controller 112. The controller comprises a memory 502, which may hold program code for implementing the control functions. The memory is coupled to a microcontroller 504 able to execute the instructions. The microcontroller is coupled to inputs 506 and outputs 508 through which the microcontroller is able to monitor the operation of the system and provide control signals to other parts of the pressure control apparatus.
Referring again to FIG. 4 upon activation 310 of the pressure control apparatus 100 which may occur when an activation strip is pulled for the first time or a user button is pressed or the like, the controller 112 performs a power-on self test (POST) 302 to ensure that the pressure control apparatus is operating correctly. If the power-on self test is failed the pressure control apparatus should not be used. Therefore, after a failed POST, the controller transitions to a non-recoverable error state 304 and the error is signalled to the user via indicators 110. If the POST is passed, the controller 112 transitions to an operational state 308 via a standby state, and performs an initial pump down 312 when a user indicates via a button, in which the pump 106 is operated until a desired negative pressure is established in the wound chamber. Alternatively, the controller may wait on a user input before performing the initial pump-down in state 312.
Once the desired negative pressure has been successfully established, the controller transitions to the monitor pressure state 316. However, if after a predetermined period of time the desired pressure has not been established and the initial pump down state 312 is unable to establish the desired negative pressure (indicative of a leak), a timeout occurs. On the first timeout, the controller will transition to a wait state 314, in which the controller waits for a period of time before transitioning back to the initial pump down state 312. Further timeouts may occur from the initial pump-down state 312, and the controller maintains a count of the number of retry attempts made. Once the desired negative pressure has been established, the number of retry attempts may be reset.
If a timeout occurs and the number of retry cycles is greater than a predefined maximum number of retry attempts allowed, the controller transitions to a paused state 306. While in the paused state 306 the controller will transition from the paused state 306 to the initial pump down state 312 in response to a user input, or after a maximum pause time.
In the monitor pressure state 316, the controller monitors the pressure measured at the pressure sensor 116 and, if the pressure drops out of the desired pressure range, the controller transitions to a maintenance pump-down state 318. In the maintenance pump-down state 318, the suction pump is activated either for a predetermined period of time, for example between around 10 and 60 seconds, or until the desired negative pressure is re-established in the wound chamber, whichever occurs sooner.
It is noted that some hysteresis is built into the desired pressure range, such that the pressure value, a minimum desired negative pressure, that triggers a transition from the monitor pressure state 316 to the maintenance pump-down state 318 is lower than the desired negative pressure established in the wound chamber by operation of the pump during the maintenance pump-down state 318.
For example, taking the operating pressure ranges discussed above, the desired negative pressure may be −150 mmHg and the minimum desired negative pressure may be −75 mmHg. Alternatively, the controller may act to maintain the pressure within a certain percentage range of the desired negative pressure, for example a 5% hysteresis may be used.
If the desired negative pressure is reached before the suction pump has been operating for the predetermined period of time, the controller transitions back to the monitor pressure state 316.
However, if the pump operates for the predetermined period of time without the desired negative pressure being re-established in the wound chamber, normally due to a leak into the wound chamber, the pressure control apparatus will signal the presence of a leak. If the pressure is within the hysteresis limits, i.e. between the minimum desired negative pressure and the desired negative pressure, this signifies the presence of a high leak, having a flow rate similar to the capacity of the pump. In this situation, the pump continues to operate until the desired negative pressure is re-established, or until the pressure at the wound site is no longer held within the hysteresis limits.
If in the presence of a large leak, the desired negative pressure is restored before a maximum maintenance time is reached, the controller will transition back to the monitor pressure state 316, but will signal the presence of a leak. However, if the suction pump is operated for more than the maximum maintenance time to restore the desired negative pressure, the controller will transition to the paused state 306, while signalling the presence of a leak.
If during the maintenance pump-down state 318, the pressure in the wound chamber is not maintained within the hysteresis limits, a catastrophic leak has occurred, and the controller transitions to the wait state 314.
In some embodiments, if after a predetermined period of time, the desired pressure has not been established and the maintenance pump down state 318 is unable to establish the desired negative pressure before the maximum maintenance time is reached, a timeout occurs. On the first timeout, the controller will transition to the wait state 314, in which the controller waits for a period of time before transitioning back to the initial pump down state 312. Further timeouts may occur from the maintenance pump-down state 318, and the controller maintains a count of the number of retry attempts made. Once the desired negative pressure has been established in the maintenance pump down state 318, the number of retry attempts may be reset. If a timeout occurs and the number of retry attempts is greater than a predefined maximum number of retry attempts allowed, the controller transitions to the paused state 306, as described above.
Thus, if the leak is such that it is over a prescribed limit and the pump duty cycle (DC) as defined, in some embodiments, as pump on time divided by pump off time is over a predetermined limit then the pump shall continue to operate within the hysteresis limits for a particular time duration. For example, around 30 minutes as shown in FIG. 4. Thus, in the monitor pressure loop if the duty cycle is less than a predetermined limit then all is okay. If the duty cycle is greater than a particular limit but less than a time out time the pump continues to run for up to 30 minutes. If DC is greater than time out then a paused state 306 is entered.
At any time while in the operational state 308, the controller may be placed in the pause state 306 in response to a user input. Once the battery voltage reaches a low voltage cut off level or the lifetime of the pressure control apparatus has been reached, the controller de-activates the pressure control apparatus and an End of Life state is reached.
The controller 212 described with respect of the pressure control apparatus 200 of FIG. 3 operates in a similar manner as described above except that the initial pump-down and maintenance pump-down states are replaced with valve activation states in which the inlet 102 is coupled to the external source of negative pressure connected to the outlet 118 via controllable valve element 202.
Alternatively, the POST state 302 may be omitted.
The pressure control apparatus may be configured to be re-useable and be provided with a switch to allow the apparatus to be turned on and off as required. Such a re-usable apparatus may include rechargeable power cells, and may provide a low power indication in order to allow the power cells to be replaced/recharged.
In a disposable single use pressure control apparatus, activation may be provided by pulling an activation strip and it may not be possible to deactivate the apparatus once activated until the apparatus is to be discarded.
Throughout the description and claims of this specification, the words “comprise” and “contain” and variations of the words, for example “comprising” and “comprises”, means “including but not limited to”, and is not intended to (and does not) exclude other moieties, additives, components, integers or steps.
wherein the controller, the negative pressure source, and the wound dressing are configured to operate together to provide negative pressure wound therapy without use of a fluid collection canister.
2. The wound therapy apparatus of claim 1, wherein the controller is configured to deactivate the negative pressure source at the end of life state.
3. The wound therapy apparatus of claim 1, further comprising a housing configured to support the negative pressure source, the controller, and the button or the switch.
4. The wound therapy apparatus of claim 1, wherein the lifetime threshold is predetermined.
5. The wound therapy apparatus of claim 1, wherein the controller is configured to deactivate the negative pressure source once the first level of negative pressure under the wound dressing is generated.
6. The wound therapy apparatus of claim 5, the controller is configured to, subsequent to the first level of negative pressure under the wound dressing being generated, activate the negative pressure source once a second level of negative pressure under the wound dressing is reached, the second level of negative pressure being closer to an atmospheric pressure than the first level of negative pressure.
7. The wound therapy apparatus of claim 6, wherein the first level of negative pressure and the second level of negative pressure are between −20 mmHg and −200 mmHg.
8. The wound therapy apparatus of claim 1, wherein the controller is configured to maintain negative pressure under the wound dressing in a negative pressure range by repeatedly deactivating and activating the negative pressure source.
9. The wound therapy apparatus of claim 1, further comprising a battery configured to power the negative pressure source and the controller, the controller being configured to transition permanently to the end of life state when the battery still contains sufficient energy to continue to power the negative pressure source and the controller.
10. The wound therapy apparatus of claim 1, wherein once the negative pressure source is activated, the controller is configured to activate and deactivate the negative pressure source responsive to no inputs from the user other than the user inputs received with the button or the switch.
11. The wound therapy apparatus of claim 1, further comprising a plurality of visual indicators, the controller being configured to provide status indications about the negative pressure wound therapy with the plurality of visual indicators.
12. The wound therapy apparatus of claim 1, further comprising a plurality of visual indicators, the controller being configured to separately indicate a normal operating condition, a leak condition, and a remaining capacity or life of a power source with the plurality of visual indicators.
13. The wound therapy apparatus of claim 1, further comprising a one-way flow valve configured to be positioned in the fluid flow path between the negative pressure source and the wound dressing.
14. The wound therapy apparatus of claim 1, wherein the controller or the negative pressure source is configured to be activated for the first time responsive to a third user input of the user inputs.
15. The wound therapy apparatus of claim 1, wherein the wound dressing comprises a film that permits evaporation through the film.
16. The wound therapy apparatus of claim 1, wherein the controller is configured to, at the end of life state, no longer activate or deactivate operation of the negative pressure source responsive to the user inputs.
17. The wound therapy apparatus of claim 1, wherein the controller is configured to determine negative pressure under the wound dressing from pressure in the fluid flow path measured by the pressure sensor.
18. The wound therapy apparatus of claim 1, wherein the pressure sensor is configured to measure pressure in the fluid flow path at an input of the negative pressure source.
indicate the leak condition with one or more visual indicators.
wherein the method is performed without using a fluid collection canister.
subsequent to the first level of negative pressure under the wound dressing being generated, activating, with the controller, the negative pressure source once a second level of negative pressure under the wound dressing is reached, the second level of negative pressure being closer to an atmospheric pressure than the first level of negative pressure.
22. The method of claim 20, further comprising maintaining negative pressure under the wound dressing in a negative pressure range by repeatedly deactivating and activating the negative pressure source with the controller.
23. The method of claim 20, further comprising activating the controller or the negative pressure source for the first time responsive to a third user input with the button or the switch.
indicating the leak condition with one or more visual indicators.
Canadian Office Action, re CA Application No. 2,811,718, dated Apr. 28, 2017.
Chinese Office Action (Decision on Rejection), re CN Application No. 201180055731.0, dated Jul. 19, 2016.
Chinese Second Office Action for corresponding Chinese application No. 201180055731.0, dated Sep. 1, 2015, in 6 pages.
Diels, K. et al., "Leybold Vacuum Handbook", translated by Adam, H. et al, Pergamon Press, 1966, in 10 pages.
European Office Action and Extended Search Report, re EP Application No. 16193508.5, dated Feb. 14, 2017.
International Preliminary Report on Patentability, re PCT Application No. PCT/GB2011/051745, dated Mar. 26, 2013.
International Search Report and Written Opinion, re PCT Application No. PCT/IB2011/002943, dated Jan. 28, 2013.
International Search Report, re PCT Application No. PCT/GB2011/051745, dated Feb. 2, 2012.
Japanese Decision of Rection, re JP Application No. 2013-528768, dated Apr. 4, 2016.
Japanese First Office Action, re JP Application No. 2013-528768, dated Jul. 27, 2015.
Japanese Office Action (Appeal Decision), re JP Application No. 2013-528768, dated Jul. 14, 2017.
Japanese Office Action, re JP Application No. 2016-153604, dated Jul. 3, 2017.
KCI Inc., Acti V.A.C. Therapy System, User Manual, Sep. 2007, in 64 pages.
Martin, L.H. et al., "A Manual of Vacuum Practice", Melbourne University Press, first published 1947, reprinted 1948, in 12 pages.
Notice of Opposition to EP 2 618 860: Statement of Facts and Arguments (Patentee Response to Opposition to the EPO) dated Aug. 26, 2016, in 9 pages.
Notice of Opposition to EPO Patent No. EP 2 618 860, dated Mar. 16, 2016, in 5 pages.
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Preliminary Opinion of the Opposition Division re European Patent No. 2 618 860, dated Dec. 22, 2016, in 5 pages.
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Application No. 1015656
Application No. 2
Application No. 201180055731
application No. 201180055731
Application No. 16193508
Application No. 2013
Application No. 2013
Application No. 2013
Application No. 2016


In a decision filed December 4, 2018 and published December 20, 2018, the Sixth District Court of Appeal, in SummerHill Winchester LLC v. Campbell Union School District, __ Cal.App.5th __ (2018) (Case No. H043253), affirmed a trial court decision invalidating the Campbell Union School District’s fee on new residential development because the underlying fee study failed the leading test for ensuring school facilities fees are limited to the cost of increased services made necessary by the development.
The United States Supreme Court has had numerous opportunities in recent years to address an important and unsettled issue under the Takings Clause: whether heightened scrutiny under Nollan, Dolan, and Koontz applies in cases where an alleged taking arises from a legislatively imposed condition rather than an administrative one. The Court’s most recent denial of certiorari in such a case occurred on October 30, 2017, in 616 Croft Ave., LLC v. City of West Hollywood (Case No. 16-1137).
616 Croft Ave. concerned the City of West Hollywood’s imposition of a $540,000 “in-lieu” affordable housing fee, under the City’s inclusionary housing ordinance, in connection with the development of an 11-unit condominium project. The case addressed the California Supreme Court’s denial of a petition to review a Second District Court of Appeal decision that upheld the legality of the fee pursuant to the state Supreme Court’s decision in California Building Industry Association v. City of San Jose, 61 Cal. 4th 435 (2015).
On December 21, 2016, the California Supreme Court denied a petition to review 616 Croft Ave., LLC. A petition for writ of certiorari was filed on March 15, 2017 (Case No. 16-1137), giving SCOTUS its opportunity to consider the case.
The question of who should pay the cost of municipal services for new residential development is a vexing one. The answer is critically important to the developers and homebuilders who must finance and market their projects, the residents who will eventually foot the bills, and the communities seeking funds to ensure that new development pays for itself.
On October 13, 2016, the Court of Appeal for the First Appellate District addressed this issue in Building Industry Association of the Bay Area v. City of San Ramon, __ Cal.App.5th __ (2016) (Case No. A145575). The Court affirmed a trial court decision supporting the City of San Ramon’s formation of a community facilities district and a special tax levied on a 48-unit townhouse project under the Mello-Roos Community Facilities Act of 1982.
On September 23, 2016, the Court of Appeal for the Second Appellate District affirmed a trial court decision denying a petition for writ of mandate filed by a developer challenging various fees—totaling nearly $600,000—in connection with an 11-unit subdivision and condominium complex in West Hollywood. 616 Croft Ave., LLC v. City of West Hollywood, __ Cal.App.5th __ (2016) (Case No. BC498004).
The case is the first reported appellate decision to rely upon the broad holding of the California Supreme Court’s blockbuster 2015 affordable housing case, California Building Industry Assn. v. City of San Jose, and it boldly highlights the far reaching implications of that ruling. In my opinion, it also underscores the ongoing need for the United States Supreme Court to finally address whether the heightened scrutiny of the Nollan, Dolan, and Koontz Fifth Amendment takings cases applies to legislatively imposed permit conditions. We wrote about that issue earlier this year after the U.S. Supreme Court denied certiorari in the CBIA case, and we note that the Court will soon have another opportunity to grant certiorari on this important issue.
On May 26, 2016, the California Building Industry Association successful obtained a temporary restraining order from the Sacramento Superior Court preventing the State Allocation Board—and all others acting in concert with the SAB or under its direction—from implementing Level 3 school impact fees or sending notice to the Legislature that state funds for new school construction are not available. The TRO temporarily halted the ability of school districts statewide to impose Level 3 fees. We wrote about the California Building Industry Association v. State Allocation Board case on May 27, 2016.
The case proceeded to a preliminary injunction hearing on July 22, 2016, and exactly one month later the court denied the request and terminated the TRO.
The Mitigation Fee Act (Government Code § 66000 et seq.) provides the requirements for development impact fee programs. Most of the Act’s provisions were adopted in 1987 as AB 1600 and are sometimes referred to as “AB 1600 requirements.” In large part, the MFA codifies the requirements the U.S. Supreme Court established in its seminal decisions, Nollan v. California Coastal Commission, 483 U.S. 825 (1987) and Dolan v. City of Tigard, 512 U.S. 319 (1994). Those cases established the requirements that land use exactions must substantially advance the same government interest that would furnish a valid ground for denial of the permit and that such exactions must also be “roughly proportional” both in nature and extent to the impact of the proposed development.
The California Building Industry Association obtained a critical temporary restraining order against the State Allocation Board in connection with the Board’s 6-4 vote on May 25, 2016 finding, for the first time, that state funds for new school facility construction are not available. Upon making that finding, the Board is obligated to notify the Secretary of the Senate and the Chief Clerk of the Assembly and that notice must be published in the journal of each house. As soon as the notices are published, eligible school districts that already charge Level 2 fees may charge Level 3 school impact fees, which would immediately double the school fees in those districts.
CBIA filed suit the same day, seeking immediate injunctive and mandamus relief in the Sacramento Superior Court to prevent the SAB’s action from taking effect. California Building Industry Association v. State Allocation Board (Case No. 34-2016-80002356, May 25, 2016). The CBIA alleged, among other things, that Level 3 fees are not justified now because the SAB’s own records indicate that as of May 2016 the state has at least $150M available for new school facility construction.


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Reference: Zaitseva NA, Semenova LV, Larionova AA, Yumatov KV, Hamnaeva NI. The Role of Human Resource Capacity to Ensure the Competitiveness of the Cross-Border Cooperation Projects in the Tourism and Hospitality Industry. Int Elect J Math Ed. 2016;11(7), 1961-1970.
Reference: Zaitseva, N. A., Semenova, L. V., Larionova, A. A., Yumatov, K. V., & Hamnaeva, N. I. (2016). The Role of Human Resource Capacity to Ensure the Competitiveness of the Cross-Border Cooperation Projects in the Tourism and Hospitality Industry. International Electronic Journal of Mathematics Education, 11(7), 1961-1970.
Reference: Zaitseva, Natalia A., Lyudmila V. Semenova, Anna A. Larionova, Konstantin V. Yumatov, and Nina I. Hamnaeva. "The Role of Human Resource Capacity to Ensure the Competitiveness of the Cross-Border Cooperation Projects in the Tourism and Hospitality Industry". International Electronic Journal of Mathematics Education 2016 11 no. 7 (2016): 1961-1970.
Reference: Zaitseva, N. A., Semenova, L. V., Larionova, A. A., Yumatov, K. V., and Hamnaeva, N. I. (2016). The Role of Human Resource Capacity to Ensure the Competitiveness of the Cross-Border Cooperation Projects in the Tourism and Hospitality Industry. International Electronic Journal of Mathematics Education, 11(7), pp. 1961-1970.
Reference: Zaitseva, Natalia A. et al. "The Role of Human Resource Capacity to Ensure the Competitiveness of the Cross-Border Cooperation Projects in the Tourism and Hospitality Industry". International Electronic Journal of Mathematics Education, vol. 11, no. 7, 2016, pp. 1961-1970.
Reference: Zaitseva NA, Semenova LV, Larionova AA, Yumatov KV, Hamnaeva NI. The Role of Human Resource Capacity to Ensure the Competitiveness of the Cross-Border Cooperation Projects in the Tourism and Hospitality Industry. Int Elect J Math Ed. 2016;11(7):1961-70.
The importance and the relevance of research issues ensuring the competitiveness of cross-border cooperation projects in the tourism and hospitality industry by improving the human resources potential is obvious, because not only the success of the development and the implementation of management decisions depend on the human factor, but also the level of service in the tourism and hospitality industry. For this reason, this article aims to study the scientific approach to the definition of "competitiveness" and its features with respect to the cross-border cooperation projects. To conduct this study, the authors used methods of comparative, systematic, factorial and structure analysis, methods of ordering and generalization, SWOT-analysis, which allow addressing this issue comprehensively, taking into account many factors that affect the competitiveness of cross-border cooperation projects. The novelty of the results of the study is to develop a model to ensure the competitiveness of cross-border cooperation projects in the tourism and hospitality industry through the development of effective workforce capacity. The use of this model will contribute to the development of the tourism in the border areas. Article’s materials are of the theoretical value for scientific research in the field of cross-border cooperation as well as is of the practical value in the development of recommendations to improve the competitiveness of the cross-border cooperation projects in the tourism and hospitality industry due to the formation of an effective workforce capacity.
Bondarenko, O. (2006) Management of competitiveness of Russian industrial enterprises on the basis of the process approach: PhD Thesis. Krasnodar, 223 p.
Fatkhutdinov, R. A. (2005) Management of the competitiveness of the organization. Moscow. Exmo. 546р.
Ilina, I. E. (2013). Formation of competitiveness management system enterprises in the sphere of maintenance and transportation services: PhD Abstract. Kazan. 31p.
Kropinova, E. G., Zaitseva, N. A. & Moroz, M. (2015). Approaches to the assessment of the contribution of tourism into the regional surplus product. Mediterranean Journal of Social Sciences, 6(3), 75-282.
Larionova, A. A., Suslova, I. A., Povorina, E. V. & Vinogradova, M. V. (2015) Formation of Tourist Image of the Region. Mediterranean Journal of Social Sciences, 6(3), 261-266.
Ogneva, N. F. (2014). Organizational aspects of the development of cross-border cooperation: PhD Abstract. Kaliningrad. 22p.
Ponomarenko, T. (2013). Strategic management of competitiveness of integrated mining companies: PhD Abstract. St. Petersburg: Peter. 43p.
Porter, M. (1990). The Competitive Advantage of Nations. Harvard Business Review, 4, 73 - 74.
Úbeda-García, M, Cortés, C., Marco-Lajara, B., & Zaragoza-Sáez, P. (2014). Strategy, training and performance fit. International Journal of Hospitality Management, 42, 100-116.
Zaitseva N. A., Goncharova, I. V. Androsenko, M. E. (2016) Necessity of Changes in the System of Hospitality Industry and Tourism Training in Terms of Import Substitution. International Journal of Economics and Financial/ Issues, 6(1), 288-293.
Zaitseva, N. A., Larionova, A. A., Minervin, I. G., Yakimenko, R. V., Balitskaya, I. V. (2015). Foresight technologies usage in working out long term. Forecasts of service and tourism personnel training system development. Journal of Environmental Management and Tourism, 2(12), 411-418.
Zakharov, A. N. (2014). The competitiveness of the enterprise: the nature, methods, assessment and mechanisms to increase. Business and banks, 2, 3-11.
Zavyalov, P. S. (2001). Marketing schemes, diagrams, tables. Moscow: INFRA-M. 496р.

matches: V. V. V. V. V. V.


763 F.3d 273 (3rd Cir. 2014), 13-1615, VICI Racing, LLC v. T-Mobile USA, Inc.
§ 17.1 Foundations of . § 17.1.1 The Nature and Basis of . § 17.1.2 During the Original Natural Law Era: 1789-1873. § 17.1.2.1 Marbury v. Madison versus the Tripartite Theory of . § 17.1.2.2 Martin v. Hunter's Lessee and Federal Court Supremacy. § 17.1.3.1 During the Formalist Era: 1873-1937. § 17.1.3.2 During the Holmesian Era: 1937-1954. § 17.1.3.3 During the Instrumentalist Era: 1954-1986.
Constitutional avoidance as interpretation and as remedy.
Reg. B is no guaranty: Missouri courts' openly divergent views on the enforceability of coerced spousal guaranties in commercial lending.
IT'S ABOUT TIME: THE LONG OVERDUE DEMISE OF STATUTES OF REPOSE IN LATENT TOXIC TORT LITIGATION.
The federal common law of statutory interpretation: Erie for the age of statutes.
Brought back to life: Massachusetts Supreme Judicial Court resuscitates parole eligibility for juveniles convicted of first degree murder.


In the Federal Register Notice dated September 12, 2003, the U.S. Patent and Trademark Office requested public comments regarding the above identified Notice of Proposed Rulemaking. Presented herein are the comments of the Pennsylvania Intellectual Property Forum ("Pennsylvania IP Forum"). The Pennsylvania IP Forum is an organization of patent practitioners and intellectual property attorneys located principally in Southeastern Pennsylvania. While some of us represent large entities, all of us represent individual inventors and small entities. Large entities already have significant advocates in Washington. Our purpose in making these comments is to provide a voice to individual inventors and small entities that otherwise would not be heard.
The Pennsylvania IP Forum appreciates the opportunity to offer comments on the rule and practice changes proposed by the Office. We believe that several of the proposed changes would adversely affect the patent prosecution process in terms of time and cost and respectfully request consideration of the following issues presented below. In particular, as representatives of the majority of patent applicants, namely small inventive entities, there is particular concern with regard to the atmosphere of increasing inflexibility on the part of the Office, as well as the alarming sense of a shift in burden during prosecution review from examiners to applicants.
Everyone who works with the Patent and Trademark Office realizes that it is a large organization serving many constituencies. To administer the law fairly to all, uniform laws and rules are a must. However, a tension exists between the need to apply laws uniformly and the need to apply laws justly. The former requires rules, the latter requires sound discretion. We recommend that the Patent and Trademark Office avoid hard-and-fast rules where those rules are not absolutely required to make administration of the law uniform. Below, please find our comments with regard to specific proposed rule changes.
(1). Proposed Rule Change 37 C.F.R. §1.6 requires clarification.
The commentary in the PTO "Discussion of Specific Rules” at p. 53820 states that "drawings with detail" should not be submitted by fax. It would be helpful if the PTO could quantify what is meant by the term "detail" or alternatively, state what type of drawing is safe to be submitted by fax (e.g. simple block diagram or flow-chart).
(2). Proposed Rule Change 37 C.F.R. §1.17 requires further correction.
Rule 1.17 proposes expensive petition fees, all of which would be an increased hardship for small inventive entities. To cure this pernicious effect, we suggest that this rule be amended to provide that the petition fees shall apply only to large entities and that no petition fee shall be charged to any small entity.
(3). Proposed Rule Change 37 C.F.R. §1.53 should not be adopted as proposed.
In the absence of a timely (1.118(f)) petition pursuant to this paragraph, the filing date of an application in which the applicant was notified of a filing error pursuant to paragraph (e)(1) of this section will be the date the filing error is corrected.
Our difficulty with the proposed amendment stems from the situation where an error may appear in the specification; for example: a page may inadvertently omitted from the background section, a pagination error may make it appear that a page has been left out of the application, a figure may be omitted, or a numbering error may make it appear that a figure has been omitted. Current PTO practice is to notify the applicant of the apparent error and to provide the applicant with the opportunity to submit new information to correct the error. If the applicant chooses to submit, for example, new pages or new figures to correct the error, then the filing date becomes the date of correction. If the applicant chooses not to supplement the application, the applicant retains the original filing date and review proceeds on the application as filed. The applicant is required eventually to correct the application by removing references to the omitted pages, by correcting the pagination, or by correcting the figure references.
Under the proposal, the option to proceed with the application as filed and to retain the original filing date apparently is eliminated. This is a draconian result in, for example, the situation of a numbering error in the figures. We recommend that the option to proceed with the application as filed be retained consistent with current PTO policies.
We further recommend that the requirement for a petition and fee be required only if the applicant elects to submit new pages of the specification or new figures and thereby accepts a new filing date.
(4). Proposed Rule Change 37 C.F.R. §1.57 is rigid and inflexible; incorporation by reference should be liberal and open.
The number of pages in each patent application is creeping upward, with some applications reaching hundreds of pages. One cause of such massive patent applications was a series of Federal Circuit decisions effectively expanding the enablement requirement to include disclosure of prior art. The disclosure of the prior art in the patent application does nothing in itself to advance the art and is merely a regurgitation of what others have done before. Nonetheless, applicants believe that substantial prior art must be included in each patent application to satisfy the rulings of the Federal Circuit. Each massive application must be fully reviewed, eating up inordinate examiner time and adding to the PTO's backlog and costs of review. The need for ever-larger applications also renders the preparation of patent applications ever more expensive, putting the patent process out of reach for all but the richest of inventors and assignees.
(c). all disclosure in references included in an Information Disclosure Statement filed at the same time as the application in question.
The reasons given in PTO "Discussion of Specific Rules", p. 53827 for rejecting liberal incorporation by reference relate to § 112 paragraph 6 means-plus-function claims. The preamble indicates that the applicant may create means-plus-function claims that are unpatentably broad through inadvertent incorporation by reference.
In response, we believe that the benefit to the applicants and to the patent office of addressing the enablement problem through incorporation by reference outweighs any concern about inadvertent enlargement of means plus function claims. We also believe that a duly adopted regulation that provides specifically for incorporation by reference will overcome the reluctance of the Federal Circuit to look beyond the four corners of the patent application for means in a means plus function claim. Finally, we believe that means plus function claims coupled with the equivalents taught in the incorporated references may overcome some of the damage done by the Festo decisions.
In short, we recommend that each document should be presumed to be incorporated by reference unless the applicant states that it is not incorporated by reference. If an applicant is concerned that one or more references may render a means plus function claim too broad, then the applicant specifically can reject incorporation of the document.
Under the proposed rule as discussed in the preamble, defective incorporations by reference will incorporate nothing unless corrected during prosecution. Our problem with this approach is that if the teachings of a reference are not part of the application until a technically perfect incorporation is entered, then any post-filing correction to the incorporation by reference adds new matter. The original filing date therefore will be lost and the consequences for a technically imperfect incorporation by reference are very great. This is an unnecessary and overly technical result that adds nothing to the efficiency of the patent review process.
The PTO "Discussion of Specific Rules” at page 53828 states that the PTO is concerned that excess examiner resources will be used to correct defective incorporations by reference. The need to correct incorporations by reference, and hence the burden on examiners, is eliminated completely if all references are presumed incorporated and if mechanistic and rigid rules of incorporation are eliminated. We recommend that if a reference to an item of prior art is adequate to identify the item, the incorporation should be effective. For example, a reference to a U.S. or foreign patent number should be an effective incorporation by reference, whether or not the name of the inventor or the date of issuance is provided. Similarly, the name of the inventor and the issue date should adequately identify the incorporated reference, even if the patent number is omitted. For non-patent literature, a standard bibliographic reference should be sufficient.
(5). Proposed Rule Change 37 C.F.R. §1.105 should not be adopted in any form.
The changes to Rule 1.105 will have a detrimental impact on patent prosecution by creating confusion and additional burden on the part of both the Office and applicants, resulting in increased costs and time delays.
The PTO proposes to require applicants to provide the "technical information known to applicant concerning the interpretation of the related art, the disclosure, the claimed subject matter, other information pertinent to patentability, or the accuracy of the examiner's stated interpretation of such items". The format for this requirement is much more expansive than that currently in existence and would not only require the applicant to produce specific documents, but also to reply to interrogatories and stipulations in the form of statement with which the applicant may agree or disagree.
Interrogatories and stipulations are proposed to be used to elicit information as to numerous legally based categories of information.
As any litigator will attest, the crafting of interrogatory questions or statements for stipulation is one that requires a fair amount of time, training and skill in considering the formulation of such and the significance of the verbiage of both the questions and consequences of the answers. This expanded requirement for information places the examiner, who may not be legally trained, in the role of one presumed to be experienced in litigation.
The proposed amendment would further create the onerous task on the part of an applicant to formulate a carefully prepared reply which would anticipate all aspects of the potential impact of such a response in any later patent litigation which may arise. Calling for an applicant to stipulate to admissions or to respond to interrogatories as to his/her "interpretation", "intentions", "opinions", "rationale", "analysis" or "knowledge" as to, among other things, related art, examiner accuracy in his or her interpretations, evidentiary issues surrounding patentability conditions and technical attributes associated with the knowledge and skill of a person of ordinary skill in the art, shifts the burden of examination to the applicant. Further, the information requested may well require a legal conclusion, something a lay person is not qualified to provide, or revelation of trade secrets or other confidential business information.
The PTO "Discussion of Specific Rules" at page 53832 suggests that the Office believes this change to be necessary because the collection of such information is "highly burdensome" and "particularly wasteful" of examiner resources. However, such requirements for information place a substantial burden on the applicant and the threshold under which such discovery tactics may be employed, "to elicit information reasonably necessary to examination", is so low as to create a practice fraught with opportunity for abuse and regular use by examiners.
Presently a requirement for information in the form of production of specific documents under 1.105 accompanying an action on the merits has the same 3 month time period as the action on the merits, while a requirement separate from an action on the merits generally has a two month time period. Do these same time period requirements apply to interrogatory and stipulation responses as well? This is not clear in the present wording of the proposed change.
Also, there is no mechanism suggested in the proposed change to Rule 1.105 for requesting clarification from the examiner as to an interrogatory or stipulation which is vague, ambiguous or objectionable. Further, what is the consequential outcome if the examiner deems an applicant's answer to be incomplete or in some other manner inadequate? Is the answer then deemed to be untimely or a failure to reply resulting in the abandonment of the application? Can a supplemental answer be filed in response to the examiners indication as such? If this rule should be adopted, there needs to be a mechanism for an applicant to request clarification.
Further, is an answer by an applicant to an examiner's requirement for information under 37 CFR 1.105 in the form of interrogatories and/or stipulations deemed to be a "response" or is it deemed to be a "reply"? And would a supplemental answer be construed as a "supplemental reply" for purposes of the proposed changes to Rule 1.111?
Presently, MPEP 704.14 expressly sets forth that the examiner must consider the information submitted, and that it is never appropriate to deny considering information that is submitted, in response to a 37 CFR 1.105 requirement. How then do the proposed changes to Rule 1.111 prohibiting the consideration of supplemental replies as a matter of right except in certain limited circumstances, comport with MPEP 704.14 and affect responses to a 37 CFR 1.105 requirement? The new rule appears to be internally inconsistent with the present rules.
The proposed changes to 37 CFR 1.105 should not be adopted. In the alternative, if the rule changes are adopted, an answer to a 37 CFR 1.105 requirement should not be considered a reply for purposes of Rule 1.111. See below for further comments on 37 CFR 1.111.
(6). 37 C.F.R. §1.111 should remain as presently written and supplemental replies should be allowed.
First, as set forth above, if adopted, submissions under rule 1.105 should not be considered "replies." Applicants should be allowed to supplement these submissions.
Second, as proposed, Rule Change 37 C.F.R. 1. 1.111 is absolutely antithetical to the PTO's stated objective of improving patent quality because it prevents supplemental "filings" historically employed to provide key items such as new art (with distinctions), declarations and other information designed to assist the examiner in dealing with the application.
(7). 37 C.F.R. §1.213 is unduly cumbersome.
Rule 1.213 requires an actual inquiry consistent with 10.18(b) before filing a request for non-publication. Presumably, this would require the practitioner to write to the client and confirm that 1) no foreign application has been filed and 2) that the client does not intend to file any application and obtain a written response before filing a non-publication request. This is unduly cumbersome. There should be an exception where a single written statement from a client that, by default, all U.S. applications should be filed with a non-publication request and that the client understands that there are limitations on filing foreign applications.
The Rule 1.704 thirty (30) day safe harbor time period for filing an information disclosure statement after allowance for foreign search reports should be modified. Given mail delays and delays by foreign associates, many such search reports will not arrive until after the 30 days have elapsed. This requirement should be changed to 30 days after the U.S. practitioner or U.S. inventor has received the search report as long as it is within the three months in which the references may be filed.
In conclusion, the members of the Pennsylvania IP Forum appreciate the opportunity to comment on the proposed rules for implementing the 21st Century Strategic Plan in patent practice and would be pleased to further assist the Office in any manner necessary to consideration of the issues raised above . In advance of your courtesy and cooperation, we extend to you our appreciation.


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§ 220-4 Unreasonable noise prohibited.
§ 220-5 Specific acts constituting unreasonable noise.
§ 220-6 Exemption of certain horns and alarms.
§ 220-7 Permits for certain activities.
§ 220-8 Penalties for offenses.
Barking dogs — See Ch. 83, Art. I.
Boating and watercraft — See Ch. 104.
Peddling and soliciting — See Ch. 238.
Racetracks — See Ch. 249.
Snowmobiles and all-terrain vehicles — See Ch. 272.
Vehicles and traffic — See Ch. 325.
This chapter shall be known and may be cited as the "Town of Bethel Noise Law."
The Town Board finds that unreasonable noises, as that term is defined herein, degrade the environment of the Town to a degree which is harmful and detrimental to the public health, safety and welfare of its inhabitants. Such noises interfere with the comfortable enjoyment of life, property and recreation and with the conduct and operation of business and industry. Effective control and elimination of unreasonable noises is essential to the furtherance of the public health, safety and welfare of the Town's inhabitants and to the conduct of the normal pursuits of life, recreation, commerce and industrial activity.
Work made necessary to restore property to a safe condition following a public calamity or work necessary to protect persons or property from an imminent exposure to danger.
A sound of short duration, usually less than one second, and of high intensity, with an abrupt onset and rapid decay.
Includes the singular and plural and also any individual; any property owner and/or lessee; any firm; a corporation; a political subdivision; a government agency, including any agency of the Town of Bethel; an association or an organization, including but not limited to officers, directors, employees, agents and/or independent contractors thereof; or any legal entity whatsoever.
Any machine or device for the amplification of the human voice, instrumental music or any other sound. Sound-amplifying equipment shall not include warning devices on authorized emergency vehicles or horns or other warning devices on any vehicle or construction equipment used only for traffic safety purposes or authorized fire horns or other authorized emergency alarms.
Town of Bethel, Sullivan County, New York.
Any sound created or caused to be created by any person or an animal, machine, instrument or item owned, operated by or under such person's control which either annoys, disturbs, injures or endangers the comfort, repose, health, peace or safety of the public or which causes injury to animal life or damages to property or business.
No person shall intentionally cause public inconvenience, annoyance or alarm or recklessly create a risk thereof by making unreasonable noise or by causing unreasonable noise to be made unless otherwise permitted by the terms and conditions of this chapter.
The existence of complaints concerning the noise from persons living or working in different places or premises who are affected by the noise.
This section contains a list of specific acts constituting unreasonable noise. The provisions of this section complement and supplement § 220-4 hereof and are in addition to and not in lieu of that section. This list is not exclusive and any noise that meets the criteria set forth in § 220-4 may be deemed to be a violation of this chapter. Notwithstanding, a permit may be issued in accordance with this chapter to conditionally allow noise that may otherwise constitute an unreasonable noise.
The use of any sound-amplifying equipment or musical instrument outside a structure either on private property or on a public right-of-way or public space at any time within the Town which, by causing noise, annoys or disturbs the quiet, comfort or repose of a reasonable person of normal sensitivities.
The use of any sound-amplifying equipment or musical instrument inside a structure in such a manner as to result in the sound or any part thereof from such apparatus to be projected therefrom outside of the structure or out-of-doors at any time whereby the sound can be audibly heard more than 100 feet from the real property boundary line from which the noise emanates which would annoy or disturb the quiet, comfort or repose of a reasonable person of normal sensitivities.
The use of any sound-amplifying equipment or musical instrument within 500 feet of any school, church, hospital, clinic or courthouse while the same is in session or conducting business therein so as to interfere with the functions of such activities.
The use of any motor vehicle, including any automobile, motorcycle, trail bike, mini-bike, snowmobile, bus, vehicle, truck, all-terrain vehicle, motor-driven equipment or motor-driven vehicle, or water-going vessel, including all such vessels regulated under Chapter 104, Boating and Watercraft, hereof, in such a manner as to create noise which would annoy or disturb a reasonable person with normal sensitivities or if it injures or endangers the comfort, repose, health, hearing, peace or safety of another person.
The sounding of any horn, alarm or signal device on any automobile, motorcycle, bus, truck or other vehicle or water-going vessel, including all such vessels regulated under Chapter 104, Boating and Watercraft, hereof, except as a warning signal such as provided by § 15 of the Vehicle and Traffic Law of the State of New York.
Repeated or continuous yelling or shouting on or open to the public space or public right-of-way that either annoys or disturbs a reasonable person with normal sensitivities or if it injures or endangers the comfort, repose, health, hearing, peace or safety of another person.
Except as provided for in this section, no person shall engage in the erection, construction (including excavating), grading, dredging or pneumatic hammering, demolition, alteration or repair of any building or structure other than on weekdays between the hours of 7:00 a.m. and 6:00 p.m. or on Saturdays, Sundays or holidays between the hours of 10:00 a.m. and 4:00 p.m.
Any person desiring to engage in construction activity beyond the stated hours of limitation, based upon cases of urgent necessity or in the interests of public health, safety and convenience, may request the Building Department for authorization allowing such activity. The request shall include all of the information required by § 220-7D(1) through (3). No permit fee shall be charged. The authorization, if granted, shall be limited to a period of up to three days' duration but, at the sole discretion of the Code Enforcement Officer, may be renewed for additional periods of up to three days each, to a maximum of 15 days, if the emergency or need continues. The Building Department shall keep written records of all requests and their disposition. Permittees seeking more than a fifteen-day total period must make application to the Town Clerk in accordance with § 220-7E and pay the required permit fee.
The ability of the creator of the noise to minimize or reduce the amount of noise created or to otherwise minimize its adverse effects.
The operation of gasoline, electric or diesel power equipment or machinery in residential zones outdoors or covered structures with large openings, such as a carport or a garage with the garage door open, between the hours of 9:30 p.m. and 7:00 a.m. the following day, and on weekends between 9:30 p.m. and 8:00 a.m. the following day, is declared to be prima facie evidence of violation of this chapter.
Nothing contained in this section shall be construed to prevent the issuance of a permit pursuant to § 220-7 that will authorize particular sound sources.
The provisions of this chapter shall not apply to fire horns, sirens or other alarms authorized by any duly constituted fire department located in the Town or Sullivan County, or any Town of Bethel Constable, Sullivan County Sheriff's officer, or New York State police officer and operated in accord with that authorization.
The provisions of this chapter shall not apply to emergency warning devices, sirens, alarms or other devices being used in connection with the operation of emergency vehicles when performing emergency work.
The provisions of this chapter shall not apply to any warning device or alarm that is required to be sounded by applicable law.
Where a sound source is planned, installed or intended to be installed or modified by any person in a manner that such source will create or is likely to create unreasonable noise or otherwise fail to comply with the provisions of this chapter, such person must secure a permit pursuant to this § 220-7.
Where any person uses or plans to use any sound-amplifying equipment in such a way that such equipment is or will be heard outside of any building between 9:00 p.m. of any day and 7:30 a.m. the following day, such person must secure a permit pursuant to this § 220-7.
Where any person uses or plans to use a public-address system that will make sound outside of a building, such person must secure a permit pursuant to this § 220-7.
If the event is not a community-wide or public event, evidence that notification of the application for the permit has been given to each person reasonably expected to be affected by the noise, the content of such notification and the manner in which such notification has been given. The notification shall state that any person objecting to the granting of such permit may contact the Town Clerk to express his or her opposition to the granting of the permit.
The application for a permit shall be submitted at least 14 days in advance of an event.
Permit applications made pursuant to § 220-5G(2) shall be made to the Building Department. All other permit applications shall be made to the Town Clerk who shall forward each application to the Town Board for review and consideration. The issuance of a permit shall be discretionary and shall be issued only where the Town Board determines that i) the permit application is complete and ii) such permit is reasonable and necessary and will allow an activity that is consistent with the general findings of this chapter. For each permit application, the Town Board shall consider the volume of the noise, proximity of the noise to sleeping facilities, time of day or night the noise shall occur, time duration of the noise, and the impact of the noise on persons living or working in different places or premises who are affected by the noise. The Town Board may conduct a public hearing prior to any determination to issue or deny a permit. The Town Board may include any reasonable conditions in the permit and may limit the term of the permit to a fixed period of time, date, duration and location of the noise generation. In the absence of any express provision in the permit to the contrary, each permit shall expire on December 31 of the calendar year in which it was issued. If the Town Board fails to rule on a permit application within 30 days of its submission to the Town Clerk, the application shall be deemed denied.
A copy of any permit shall be provided to the Town Constables and the Building Department for use by the Code Enforcement Officers and inspectors.
Each permit applicant shall pay a nonrefundable application fee at the time of making the permit application in an amount established from time to time by resolution of the Town Board.
Notwithstanding anything herein to the contrary, public performances conducted in the Performing Arts Center Development Zoning District pursuant to a special use permit are exempt from the requirements of this chapter.
Persons who violate this chapter, or any permit issued under this chapter, shall be guilty of a violation and subject to punishment by a fine of not less than $50 nor more than $500, or by imprisonment of not more than 15 days, or by such fine or imprisonment or other penalties as may be available under the Town Law or the Penal Law. Each separate violation shall constitute a separate additional offense.
For any violation of this chapter that takes place on private property where the person or persons responsible for the violation cannot be determined, then all residents of the property from which the violation emanated shall be presumed to be responsible for said violation.
In addition to the foregoing, any permit issued under this chapter may be modified, suspended or revoked by the Town Board if the permit holder is found to be in violation of the permit or any applicable provision of this chapter. Violations include any material representations made in the permit application. Any actions taken by the Town Board shall be subject to a public hearing, notice of which must be served upon the permit holder either personally or by certified mail, return receipt requested, sent to the address listed on the permit application prior to the commencement of the public hearing.