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Gavrilova T.V. Berkasova N.L. Shilov Ju. I. Chereshneva M.V. Chereshnev V.A.
Myelopeptides in treatment for stress- and injury-induced changes in the immune response to a heterologous thymus-dependent antigen in rats with penetrating eye wounds // Doklady Biological Sciences. (Moscow), 2007. Volume 412, Issue 1. P. 8 - 10.
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Demakov V.A. Maksimov A.Ju. Kuznetsova M.V. Ovechkina G.V. Remezovskaya N.B. Maksimova Ju.G.
Biological diversity of nitrile metabolizing bacteria in anthropogenically modified soil of Perm Krai // Ecology. (Moscow), 2007. N3. P. 185-190.
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Carbon sorbent-based immobilization of Rhodococcus ruber gt1 possessing nitril hydrase activity // Applied Microbiology and Biochemistry. (Moscow), 2007. V.43.N2. P. 193-198.
Dependence of Protective Functions of Polyamines from Escherichia coli on the Intensity of Superoxide Stress // Biochemistry. Moscow, 2007. V. 72, N1. P. 109-116.
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Effect of myelopeptides on IFN-gamma and IL-4 production by peripheral blood lymphocytes // Proceedings of the Russian Academy of Sciences. (Moscow), 2007. V.413 N2. P. 1-3.
Effect of oil polluted soil on plants // Herald of Perm State University. Perm, 2007. N 5(10). P. 134-141.
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Home > 101 > What Do The IP Lawyers Have To Say In The Myriad Remand?
What Do The IP Lawyers Have To Say In The Myriad Remand?
Several associations and organizations of intellectual property lawyers submitted amicus briefs in the Federal Circuit remand of Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU “gene patenting”/BRCA1 case). While many make the same arguments, there are some points that may stand out enough to get the court’s attention.
Myriad’s isolated DNA claims raise different patent eligibility issues than the Prometheus method claims.
The Supreme Court has developed separate lines of precedent for analyzing the patent eligibility of compositions of matter (which must not claim “products of nature”) and methods (which must not preempt “laws of nature”).
The Supreme Court’s decision in Mayo v. Prometheus does not impact or undermine the panel decision that upheld the patent eligibility of Myriad’s isolated DNA claims, which is governed instead by Chakrabarty.
Even if Mayo somehow is relevant to the issues before the court in Myriad, the isolated DNA claims are patent eligible because isolated DNA is “markedly different” from naturally occurring DNA and so the claims relate to “significantly more” than anything found in nature.
A holding that isolated DNA claims are not patent eligible would upset investment-backed expectations and negatively impact research and innovation.
Myriad’s method claim 20 recites a specific transformative process using man-made materials and does not preempt any law of nature.
Some of the more unique points raised in the briefs are outlined below.
The AIPLA brief urges the court not to read Mayo as conflating the § 101 inquiry with the requirements of § 102 and § 103. The AIPLA points out that the Supreme Court relied on its 1981 decision in Diehr, and that Diehr itself states that novelty is “of no relevance in determining whether the subject matter of a claim” satisfies § 101.
The BIO brief raises the possibility that a patent eligibility assessment based on “whether the techniques used to make [the claimed subject matter] are ‘routine,’ ‘conventional,’ or ‘well-understood’ could render even new synthetic chemicals non-patentable.
Isolated DNA encoding erythropoietin, which underlies Amgen’s Epogen® product.
Sirolimus, a macrocyclic compound produced by a specific strain of bacteria that has antifungal and antibiotic activity, and that led to the development of RAPAMUNE® which is used to prevent organ rejection in kidney transplant patients.
Muromonab-CD3, a monoclonal antibody derived from mice that is used to prevent transplant rejection and that has been commercialized as Orthoclone OKT3®.
A phtyase enzyme produced by E. coli that is used to enhance the ability of livestock to digest phytate present in grain.
A glucoamylase enzyme produced by the fungus Trichoderma reseii that is useful in the field of biofuels.
[These examples] illustrate that the stakes of this case extend far beyond the diagnostic use of human DNA or the practices of a single company, and that any discussion of policy must consider the impact on new and emerging research regarding non-human DNA, therapeutic proteisn, agriculture, food safety, and industrial and environmental biotechnology.
BIO also argues that the sirolimus example demonstrates that the patent system can “speed the pace of innovation” because the disclosure of the original patent made the invention available to other researchers who developed the commercial product.
In manufacturing isolated DNA, an inventor must identify a cell that expresses a gene, isolate the mRNA and enzymatically convert the mRNA into DNA . . . [using an enzyme] that is absent from cells that have not been intentionally infected by a virus that produces the enzyme.
The IPO brief emphasizes that “[c]laims to isolated human DNA do not encompass the naturally occurring genes that are present in cells,” so “a patent claim on isolated human DNA does not implicate an individual’s right to her own genes.” The brief also explains that the claims are “limited to chemical compounds” and do not cover the “genetic information” itself.
The IPO brief asserts that “Myriad’s DNA claims have not had any negative effects on technological development.” In particular, the brief states that “a cursory scan of the medical and scientific literature reveals more than eight thousand articles and reports regarding human BRCA 1 and BRCA 2 genes since the patents-in-suit were granted.” Thus, according to IPO, there is “no policy basis” for excluding isolated DNA claims from patent eligibility.
The NYIPLA brief reads Supreme Court precedent as indicating that “human intervention is the key to this analysis.” The brief cites the discussion of the 1930 Plant Patent Act in the USPTO’s Manual of Patent Examining Procedure as distinguishing “a new plant found in the wild” from “the work of the plant breeder,” and analogizes isolated DNA to the latter.
The Federal Circuit has just under a month to review all of the briefs that have been filed in the Myriad remand, and prepare for the oral hearing scheduled for July 20. It will be interesting to see if the questions from the bench at this hearing are different from those the judges asked previously and whether prognosticators will be willing to predict the outcome now that there is a better understanding of just how much could be at stake.


REGISTRAR'S NOTICE: The Board of Housing and Community Development is claiming an exemption from the Administrative Process Act pursuant to § 2.2-4006 A 12 of the Code of Virginia, which excludes regulations adopted pursuant to § 36-98.3 of the Code of Virginia.
Title of Regulation: 13VAC5-31. Virginia Amusement Device Regulations (amending 13VAC5-31-20, 13VAC5-31-30, 13VAC5-31-40, 13VAC5-31-60, 13VAC5-31-75, 13VAC5-31-200, 13VAC5-31-210, 13VAC5-31-290; adding 13VAC5-31-217).
Statutory Authority: § 36-98.3 of the Code of Virginia.
Effective Date: July 14, 2014.
Agency Contact: Stephen W. Calhoun, Regulatory Coordinator, Department of Housing and Community Development, Main Street Centre, 600 East Main Street, Suite 300, Richmond, VA 23219, telephone (804) 371-7000, FAX (804) 371-7090, TTY (804) 371-7089, or email steve.calhoun@dhcd.virginia.gov.
a. In the definition of "amusement device," clarifies the phrase "open to the public" to facilitate a more uniform application of the VADR.
b. Adds a definition of the phrase "certificate of inspection" to mean the certificate or sticker for amusement devices distributed by the department, as referenced in 13VAC5-31-75 E. This amendment requires the use of the department sticker where previously a locality was permitted to use its own.
c. Changes the term "kiddie ride" to "small mechanical ride" and revises the criteria for what qualifies as a small mechanical ride. This amendment is in conjunction with new requirements for inspections in 13VAC5-31-75 D that limit the permit period to a maximum of six months for small mechanical rides.
2. 13VAC5-31-30 A: Adds this subsection to assist local building departments in determining whether certain devices are amusement devices and to achieve more uniformity in the application of the regulation.
3. 13VAC5-31-30 B: Expands the list of exempted equipment or devices.
4. 13VAC5-31-40 A: Updates the list of incorporated standards.
5. 13VAC5-31-75 A: Increases the amount a locality must reduce a permit fee when a private inspector is used, from 50% to 75%; increases permit fees for amusement rides; adds language permitting the increase of fees by a local building department for weekend or after-hour inspections; and adds language authorizing an additional fee for permits and inspections of generators and associated wiring for amusement device events.
6. 13VAC5-31-75 D: Adds language on (i) the minimum time frame for notifying local building departments prior to the operation of a small mechanical ride or an inflatable amusement device, (ii) the inspection fee that a local building department may charge per event where an inflatable amusement device is operating, and (iii) the inspection report required for such inspections.
7. 13VAC5-31-75 E: Clarifies that a local building department may authorize a third-party inspector to post the certification sticker and that permits for small mechanical rides are only valid for a maximum of six months.
8. 13VAC5-31-75 J: Adds this subsection to clarify the procedures for violations of the chapter.
9. 13VAC5-31-75 K: Adds this subsection to clarify that the Virginia Department of General Services functions as the local building department for amusement devices located on state-owned property.
10. 13VAC5-31-217: Adds this section to require that zip lines be operated, maintained, and inspected in accordance with incorporated standards.
"Amusement device" means (i) a device or structure open to the public by which persons are conveyed or moved in an unusual manner for diversion, but excluding snow tubing parks and rides, ski terrain parks, ski slopes, and ski trails, and (ii) passenger tramways. For the purpose of this definition, the phrase "open to the public" means that the public has full access to a device or structure at an event, irrespective of whether a fee is charged. The use of devices or structures at private events is not considered to be open to the public.
"Bungee cord" means the elastic rope to which the jumper is attached which lengthens and shortens to produce a bouncing action.
"Carabineer" means a shaped metal device with a gate used to connect sections of a bungee cord, jump rigging, equipment, or safety gear.
"Certificate of inspection" means the certificate or sticker for amusement devices distributed by DHCD.
"DHCD" means the Virginia Department of Housing and Community Development.
"Gravity ride" means a ride that is installed on an inclined surface, which depends on gravity for its operation to convey a passenger from the top of the incline to the bottom, and which conveys a passenger in or on a carrier tube, bag, bathing suit, or clothes.
"Ground operator" means a person who assists the jump master to prepare a jumper for jumping.
"Harness" means an assembly to be worn by a bungee jumper to be attached to a bungee cord. It is designed to prevent the wearer from becoming detached from the bungee system.
"Jump master" means a person who has responsibility for the bungee jumper and who takes the jumper through the final stages to the actual jump.
"Jump zone" means the space bounded by the maximum designed movements of the bungee jumper.
"Jumper" means the person who departs from a height attached to a bungee system.
"Kiddie ride" means an amusement device where the passenger or patron height is limited to 54 inches or less, the design capacity of passengers or patrons is 12 or less, and the assembly time for the device is two hours or less.
"Landing area" means the surface area of ground or water directly under the jump zone, the area where the lowering device moves the bungee jumper to be landed away from the jump space and the area covered by the movement of the lowering device.
"Local building department" means the agency or agencies of the governing body of any city, county or town in this Commonwealth charged with the enforcement of the USBC.
"Operating manual" means the document that contains the procedures and forms for the operation of bungee jumping equipment and activity at a site.
"Passenger tramway" means a device used to transport passengers uphill, and suspended in the air by the use of steel cables, chains or belts, or ropes, and usually supported by trestles or towers with one or more spans.
"Platform" means the equipment attached to the structure from which the bungee jumper departs.
"Private inspector" means a person performing inspections who is independent of the company, individual or organization owning, operating or having any vested interest in an amusement device being inspected.
"Small mechanical ride" means an amusement device, other than an inflatable amusement device, where (i) the assembly time for the device is two hours or less, (ii) the revolutions per minute of any rotation of the components of the device is not greater than seven, (iii) the device has a footprint of less than 500 square feet, and (iv) the device does not invert a patron or lift a patron more than three feet in the air, measured from the ground to the bottom of the patron's feet when the device is operating.
"Ultimate tensile strength" means the greatest amount of load applied to a bungee cord prior to failure.
"USBC" means the Virginia Uniform Statewide Building Code (13VAC5-63).
B. Words and terms used in this chapter which are defined in the USBC shall have the meaning ascribed to them in that regulation unless the context clearly indicates otherwise.
C. Words and terms used in this chapter which are defined in the standards incorporated by reference in this chapter shall have the meaning ascribed to them in those standards unless the context clearly indicates otherwise.
13VAC5-31-30. Exemptions Devices covered and exempt.
A. The following devices, identified by name or description, when open to the public shall be considered amusement devices subject to this chapter. The list is intended only to clarify questionable devices, while the definition of an "amusement device" in 13VAC5-31-20 is generally used to determine the applicability of this chapter.
6. Devices known as water walking balls, euro bubbles, or similar devices.
2. American Society for Testing and Materials (ASTM) Standard Nos. F698-94 (Reapproved 2000), F747-06, F770-06a F770-11, F846-92 (Reapproved 2003) (2009), F853-05, F893-05a, F1159-03a F893-10, F1159-11, F1193-06, F1305-94 (Reapproved 2002), F1950-99, F1957-99 (Reapproved 2004) (2011), F2007-06, F2137-09, F2291-09b, F2374-07a, F2376-06 [ F2007-11 F2007-12 ], F2137-11, F2291-11, F2374-10, F2375-09, F2376-08, [ and ] F2460-06 F2460-11 [ , and F2959-12 ] for the regulation of amusement devices.
B. The provisions of this chapter govern where they are in conflict with any provisions of the standards incorporated by reference in this chapter.
3. The operator of an amusement device shall not be (i) under the influence of any drugs which may affect the operator's judgment or ability to assure the safety of the public or (ii) under the influence of alcohol.
D. Where an amusement device was manufactured under previous editions of the standards incorporated by reference in this chapter, the previous editions shall apply to the extent that they are different from the current standards.
Appeals from the local building department concerning the application of this chapter shall be made to the local board of building code appeals established by the USBC. Application for appeal shall be filed with the local building department within 14 calendar days after receipt of the decision of the local building department. The board of appeals shall hear the appeal within seven calendar days after the application for appeal is filed. After final determination by the board, any person who was a party to the appeal may appeal to the State Building Code Technical Review Board, established under § 36-108 of the Code of Virginia, within 14 calendar days of receipt of the decision to be appealed. Such appeal shall be in accordance with the procedures established in the USBC, under the authority granted by § 36-98.3 of the Code of Virginia where the provisions of Chapter 6 (§ 36-97 et seq.) of Title 36 of the Code of Virginia and the USBC apply to amusement devices.
NOTE: Because of the short time frames normally associated with amusement device operations, DHCD staff will be available to assist in finding a timely resolution to disagreements between owners or operators and the local building department upon request by either party.
5. The local building department may charge an additional fee for permits and inspections of generators and associated wiring for amusement device events. Generators subject to these fees are those used exclusively with amusement devices and that are inspected by the local building department. The fee per event shall not exceed $165 and shall not exceed the actual cost to perform the inspection or inspections.
Notwithstanding the above, the local building department shall be permitted to increase the fees up to 50% when requested to perform weekend or after-hour inspections.
B. Notwithstanding the provisions of subsection A of this section, when an amusement device is constructed in whole or in part at a site for permanent operation at that site and is not intended to be disassembled and moved to another site, then the local building department may utilize permit and inspection fees established pursuant to the USBC to defray the cost of enforcement. This authorization does not apply to an amusement device that is only being reassembled, undergoing a major modification at a site or being moved to a site for operation.
C. A permit application shall be made to the local building department at least five days before the date in which the applicant intends to operate an amusement device. The application shall include the name of the owner, operator or other person assuming responsibility for the device or devices, a general description of the device or devices including any serial or identification numbers available, the location of the property on which the device or devices will be operated and the length of time of operation. The permit application shall indicate whether a private inspector will be utilized. If a private inspector is not utilized, the applicant shall give reasonable notice when an inspection is sought and may stipulate the day such inspection is requested provided it is during the normal operating hours of the local building department. In addition to the information required on the permit application, the applicant shall provide proof of liability insurance of an amount not less than $1,000,000 per occurrence or proof of equivalent financial responsibility. The local building department shall be notified of any change in the liability insurance or financial responsibility during the period covered by the permit.
D. Notwithstanding the provisions of subsection C of this section, a permit application is not required for a kiddie small mechanical ride or an inflatable amusement device that has an unexpired a certificate of inspection issued by any local building department in this Commonwealth within a one-year period prior to the dates the small mechanical ride or inflatable amusement device is to be used, regardless of whether the device has been disassembled and moved to a new site. In such cases, the local building department shall be notified at least three days prior to the operation of the kiddie small mechanical ride or the inflatable amusement device and the information required on a permit application as listed in subsection C of this section shall be provided to the local building department. In addition, and notwithstanding the provisions of subsection A of this section, the local building department shall be permitted to charge a $50 inspection fee per event to the person notifying the local building department of an event where an inflatable amusement device is operating, if the local building department chooses to inspect any or all of the inflatable amusement devices operating at that event. An inspection report shall be provided to the person notifying the local building department of the event if such an inspection is conducted.
E. Local building department personnel shall examine the permit application within five days and issue the permit if all requirements are met. A certificate of inspection for each amusement device shall be issued when the device has been found to comply with this chapter by a private inspector or by an inspector from the local building department. It shall be the responsibility of the local building department to verify that the private inspector possesses a valid certificate of competence as an amusement device inspector from the Virginia Board of Housing and Community Development. In addition, local building department personnel shall be responsible for assuring that the certificate of inspection is posted or affixed on or in the vicinity of the device in a location visible to the public. Local building department personnel shall post or affix such certificates or permit the certificates to be posted or affixed by the private inspector. Permits shall indicate the length of time the device or devices will be operated at the site, clearly identify the device or devices to which it applies and the date of expiration of the permit. Permits shall not be valid for longer than one year, except that permits for small mechanical rides shall not be valid for longer than six months.
F. In addition to obtaining a certificate of inspection in conjunction with a permit application for amusement devices permanently fixed to a site, a new certificate of inspection shall also be obtained prior to the operation of an amusement device following a major modification, prior to each seasonal operation of a device, at least once during the operating season and prior to resuming the operation of a device following an order from a local building department to cease operation. This requirement shall not apply to kiddie small mechanical rides meeting the conditions outlined in subsection D of this section.
G. For amusement devices manufactured prior to 1978, the owner or operator shall have the information required by §§ 2.1 through 2.6 of ASTM F698 available at the time of inspection. In addition, the operator of any amusement device shall be responsible for obtaining all manufacturer's notifications, service bulletins and safety alerts issued pursuant to ASTM F853 and the operator shall comply with all recommendations and requirements set out in those documents. A copy of all such documents shall be made available during an inspection.
H. In the enforcement of this chapter, local building department personnel shall have authority to conduct inspections at any time an amusement device would normally be open for operation or at any other time if permission is granted by the owner or operator, to issue an order to temporarily cease operation of an amusement device upon the determination that the device may be unsafe or may otherwise endanger the public and to accept and approve or deny requests for modifications of the rules of this chapter in accordance with the modification provisions of the USBC.
I. In accordance with subdivision 7 of § 36-137 of the Code of Virginia, the local building department shall collect a 2.0% levy of fees charged for permits under this chapter and transmit it quarterly to DHCD to support training programs of the Virginia Building Code Academy. Localities that maintain individual or regional training academies accredited by DHCD shall retain such levy.
J. In accordance with § 36-98.3 of the Code of Virginia and 13VAC5-31-10 B, the procedures for violations of this chapter shall be [ as ] prescribed in the USBC.
K. In accordance with § 36-98.1 of the Code of Virginia, the Virginia Department of General Services (DGS) shall function as the local building department for the application of this chapter to amusement devices located on state-owned property. In accordance with §§ 36-98.2 and 36-114 of the Code of Virginia, appeals of the application of this chapter by the DGS shall be made directly to the State Building Code Technical Review Board. Further, as a condition of this chapter, such appeals shall be filed within 14 calendar days after receipt of the decision of DGS.
In addition to other applicable requirements of this chapter, inflatable amusement devices shall be operated, maintained and inspected in accordance with ASTM F2374.
Notwithstanding any requirements of this chapter to the contrary, a permit to operate an inflatable amusement device that is less than 150 square feet and in which the height of the patron containment area is less than 10 feet need not be obtained if the device has an unexpired certificate of inspection issued by a local building department in this Commonwealth, regardless of whether the device has been disassembled or moved to a new site.
In addition to other applicable requirements of this chapter, artificial climbing walls shall be operated, maintained and inspected in accordance with ASTM F1159.
Notwithstanding any requirements of this chapter to the contrary, an artificial climbing wall may be moved, setup and operated without obtaining a permit provided the wall has a valid certificate of inspection issued by a local building department in this Commonwealth within the prior 90 days and the expiration date of the wire ropes used with the device does not expire within that 90-day period.
Amusement devices subject to this part shall comply with applicable requirements of 36 CFR Part 1191–Americans With Disabilities Act (ADA) Accessibility Guidelines for Buildings and Facilities and; Architectural Barriers Act (ABA) Accessibility Guidelines, (69 FR 44151-44455 (July 23, 2004)).
VA.R. Doc. No. R12-3160; Filed March 14, 2014, 9:53 a.m.


NOTICE: All slip opinions and orders are subject to formal revision and are superseded by the advance sheets and bound volumes of the Official Reports. If you find a typographical error or other formal error, please notify the Reporter of Decisions, Supreme Judicial Court, John Adams Courthouse, 1 Pemberton Square, Suite 2500, Boston, MA, 02108-1750; (617) 5571030; SJCReporter@sjc.state.ma.us SJC-11907 COMMONWEALTH vs. PAUL ROBINSON. May 25, 2017. Supreme Judicial Court, Superintendence of inferior courts. Practice, Criminal, Capital case. Along with a codefendant, Paul Robinson was convicted of two counts of murder in the first degree and two counts of assault with intent to rob in 1969. After plenary review, this court affirmed the convictions. Commonwealth v. McGrath, 358 Mass. 314 (1970), S.C., 408 Mass. 245 (1990) and 437 Mass. 1002, cert. denied, 537 U.S. 980 (2002). Robinson has since filed several motions for a new trial, all of which have been denied. After the denial of his most recent (seventh) such motion, Robinson sought leave to appeal pursuant to the gatekeeper provision of G. L. c. 278, § 33E. A single justice of this court concluded that the motion failed to present a "new and substantial question" and therefore denied such leave. Robinson filed a notice of appeal to the full court from the single justice's ruling, and the Commonwealth moved to dismiss. Robinson asserted in opposition that his appeal ought to be permitted to proceed despite the longstanding rule that the decision of the gatekeeper is "final and unreviewable." E.g., Commonwealth v. Vinnie, 475 Mass. 1011, 1011 (2016), and cases cited. We gave Robinson an opportunity to explain the basis for his position in a preliminary statement of no more than five pages. Robinson has responded with an eleven-page statement of issues, in which he argues essentially that the gatekeeper process leads to arbitrary results and, more particularly, that his appeal was not allowed to proceed whereas 2 other defendants' appeals were. 1 This is merely a recasting of the equal protection challenge we rejected in Napolitano v. Attorney Gen., 432 Mass. 240, 241-242 (2000). We reject it again here. Robinson received plenary review of his convictions under § 33E on direct appeal, and he has offered no reason to suppose that his seventh motion for a new trial raised any new and substantial issue that was not or could not have been presented in any of the previous six. There is no hint of arbitrariness in this case. He also has not offered any reason to believe that the "single justice erred by denying [his] gatekeeper petition on procedural grounds." Commonwealth v. Nassar, 454 Mass. 1008, 1009 n.2 (2009). Finally, we reject Robinson's argument that § 33E does not bar an appeal from the decision of the gatekeeper. "The special function of the single justice mandated by the statute would be futile and meaningless if his or her rulings were subject to appeal before the full court." Commonwealth v. Companiono, 472 Mass. 1004, 1005 (2015), quoting Leaster v. Commonwealth, 385 Mass. 547, 548 (1982). We see no reason to depart from our longstanding and well-established rule. See Companiono, supra, and cases cited. 2 Appeal dismissed. The case was submitted on briefs. David J. Nathanson for the defendant. Teresa K. Anderson, Assistant District Attorney, for the Commonwealth. 1 It appears that Robinson intended the memorandum to apply to both his own appeal and that of his codefendant, who similarly purports to appeal from a decision of the gatekeeper. See Commonwealth v. McGrath, 477 Mass. (2017). He incorrectly asserts that we issued identical orders to him and to his codefendant, affording each of them five pages. In fact, we issued one order, to Robinson alone. 2 Robinson's reliance on Commonwealth v. Grassie, 476 Mass. 202, 213-218 (2017), is misplaced. That case involved a direct appeal from a conviction of murder in the second degree and from an order denying a motion to reduce the verdict, not a final and unreviewable decision of the gatekeeper pursuant to G. L. c. 278, § 33.


Payment for emergency vaccination, etc.
§ 1. This notice applies to emergency vaccination of cattle, sheep and goats in the protection zone against bluetongue, serotype 8.
(2). After application can Food Agency under defined conditions allow vaccination against bluetongue serotype 8, within the protection zone of susceptible species other than bovine, ovine and caprine animals.
1) ' emergency vaccination ' means vaccination Compulsory of cattle, sheep and goats against bluetongue in the protection zone.
2) ' bovine animals ' means domestic animals of the species Bos Taurus:.
3) ' Bluetongue ': Bluetongue, serotype 8, there is a vector when illness caused by an orbivirus.
4) ' emergency vaccination ' means vaccination campaign against bluetongue in the period 23. July to 30. September 2008.
5) ' Herd ' means a collection of at least one animal, which is used for a particular purpose, are linked to a specific geographical location, and have an owner in the form of a natural or legal person.
6) ' protective zone ": Zone within the scope of section 10 of Decree No. 97 of 20. February 2002 on the fight against bluetongue.
7) ' the owner or the person responsible ' means any natural or legal person who owns cattle, sheep or goats or keeping these for others, regardless of whether it is a commercial activity or not.
8) ' bluetonguetekniker ': Authorized Person who is authorized to certify emergency vaccination and vaccination against bluetongue.
§ 3. Vaccine for use by emergency vaccination against bluetongue during vaccination campaign be obtained of the veterinary and Food Administration.
§ 4. The owner or the person responsible for cattle, sheep and goats in the protection zone shall ensure that animals are made for emergency vaccination against bluetongue in the context of the vaccination campaign. During the vaccination campaign should cattle be vaccinated twice with 25-35 days interval, while sheep and goats should be vaccinated once.
1) Offspring of bovine, ovine and caprine animals are less than 30 days, when the other animals in the herd for emergency vaccination.
2) Offspring of bovine, ovine and caprine animals born after the date of the emergency vaccination, unless it is done according to the rules laid down in section 11.
1) bovine, ovine and caprine animals, if they are slaughtered before the end of week 43 of 2008.
2) bovine animals afgræsser natural areas and covered by a derogation from section 2 of Executive Order No. 1066 by 10. November 2005 on marking, registration and movement of cattle, pigs, sheep and goats, issued by food region.
§ 5. Emergency vaccination of cattle, sheep and goats during the vaccination campaign shall be carried out and certified by a licensed veterinarian.
(2). The veterinarian may be assisted by persons who have passed the basic course on clinical veterinarian training or have equivalent training.
(2). Emergency vaccination in accordance with paragraph 1 shall be certified by a registered bluetonguetekniker of the basic regulation. § 8, paragraph 1, or by an authorised veterinarian.
1) owner or officer's name and address.
5) the name and address of the authorised veterinarian or bluetonguetekniker.
6) All animals in the herd, with an indication of the nature and CUS-number.
7) total number of animals in the herd at the time of emergency vaccination.
8) total number of nødvaccinerede animals.
9) list of each nødvaccineret animals, with an indication of the kind, CUS number and the used vaccines batch number.
10) should also be there for the animals concerned, indicate whether the animal is nødvaccineret first time bluetongue, see. § 4 (1), (2). PT.
12) hourly rate or fee.
(2). The record referred to in paragraph 1 must be signed both by the owner or the person responsible for the crew and by the veterinarian or the approved bluetonguetekniker. Veterinarian or authorized bluetonguetekniker must submit the record or a copy thereof to the local TWITCH-Department for registration.
(3). For herds of sheep and goats to the local advance section after registration return the original signed entry to the owner or the person responsible for the crew. The owner or the person responsible must keep the record in the crew for at least five years from the time of emergency vaccination.
§ 8. To emergency vaccination and certify that emergency vaccination has been carried out, see. section 6, paragraphs 1 and 2, the Food Agency firm bluetongueteknikere, who has completed a special course in order to emergency vaccination cattle, sheep and goats.
(2). Authorisations issued pursuant to paragraph 1 may at any time be withdrawn and cancelled by the vaccination campaign ended.
§ 9. Herds of cattle, sheep and goats, as if by the expiry of the vaccination campaign is not duly bluetongue, see nødvaccineret. section 4, paragraph 1, shall be placed under official supervision of the food the region.
(2). Food region can after application remove the public supervision, when the owner or the person responsible establishes that all animals in the herd have been duly vaccinated against bluetongue.
§ 10. There must not be placed on the use of living animals to or from a herd is under official supervision, in accordance with article 3. section 9, paragraph 1.
(2). However, the food the region allow the animals to live use transferred to and from the crew, if it has previously been documented, that the individual animal is duly nødvaccineret of the basic regulation. section 4, paragraph 1.
§ 11. After termination of the vaccination campaign can emergency vaccination of cattle, sheep and goats in the protection zone shall be carried out, if it is certified by an authorised veterinarian.
(2). The vaccine must be obtained by the veterinarian.
(3). The rules in § 7 shall apply mutatis mutandis.
§ 12. The costs of vaccination against bluetongue is DVFA extraneous.
2) violates conditions laid down pursuant to article 1, paragraph 2, and article 10, paragraph 2.
§ 14. The notice shall enter into force on the 24th. July 2008.


Laerdal, which manufactures and distributes medical devices, filed a complaint at the International Trade Commission asserting violations of 19 U.S.C. 1337 by infringement of Laerdal’s patents, trademarks, trade dress, and copyrights by importing, selling for importation, or selling within the U.S. certain medical devices. The Commission investigated Laerdal’s trade dress claims, one patent claim, two copyright claims, and one trademark claim, excluding all others. Despite being served with notice, no respondent responded. An ALJ issued the Order to Show Cause. Respondents did not respond. An ALJ issued an initial determination finding all respondents in default. Laerdal modified its requested relief to immediate entry of limited exclusion orders and cease and desist orders. The Commission requested briefing on remedies, the public interest, and bonding. The Commission's final determination granted Laerdal limited exclusion orders against three respondents and a cease and desist order against one, based on patent and trademark claims; it issued no relief on trade dress and copyright claims, finding Laerdal’s allegations inadequate. As to trade dress claims, the Commission found that Laerdal failed to plead sufficiently that it suffered the requisite harm, the specific elements that constitute its trade dresses, and that its trade dresses were not functional; despite approving the ALJ’s initial determination of default and despite requesting supplemental briefing solely related remedy, the Commission issued no relief on those claims. The Federal Circuit vacated. The Commission violated 19 U.S.C. 1337(g)(1) by terminating the investigation and issuing no relief for its trade dress claims against defaulting respondents.
United States Court of Appeals for the Federal Circuit ______________________ LAERDAL MEDICAL CORP., LAERDAL MEDICAL AS, Appellants v. INTERNATIONAL TRADE COMMISSION, Appellee ______________________ 2017-2445 ______________________ Appeal from the United States International Trade Commission in Investigation No. 337-TA-1008. ______________________ Decided: December 7, 2018 ______________________ JEFFREY I. KAPLAN, Kaplan, Breyer, Schwarz, LLP, Matawan, NJ, argued for appellants. Also represented by JOSEPH W. BAIN, Shutts & Bowen LLP, West Palm Beach, FL. ROBERT JOHN NEEDHAM, Office of the General Counsel, United States International Trade Commission, Washington, DC, argued for appellee. Also represented by DOMINIC L. BIANCHI, WAYNE W. HERRINGTON. ______________________ 2 LAERDAL MEDICAL CORP. v. ITC Before LOURIE, O’MALLEY, and STOLL, Circuit Judges. O’MALLEY, Circuit Judge. Laerdal Medical Corp. and Laerdal Medical AS (collectively, “Laerdal”) appeal from the U.S. International Trade Commission’s final determination denying Laerdal relief based on claims of trade dress infringement against defaulting respondents. Certain Carbon Spine Board, Cervical Collar, CPR Masks and Various Med. Training Manikin Devices, USITC Inv. No. 337-TA-1008 (June 14, 2017). After instituting an investigation during which the named parties failed to participate and were deemed to be in default, the Commission concluded that Laerdal’s trade dress allegations had not been adequately pleaded, and therefore, denied Laerdal any remedy against the named parties. We conclude that the Commission erred in reassessing the sufficiency of Laerdal’s complaint against defaulting respondents post-institution and in failing to assess the appropriate remedy to impose under the circumstances. We, therefore, reverse the Commission’s determination as to Laerdal’s trade dress claims and vacate and remand for the Commission to determine the proper remedy. I. BACKGROUND Laerdal is a manufacturer and distributor of medical devices, medical training products, and manikins. J.A. 2159, 2333. On March 21, 2016, Laerdal filed a complaint at the U.S. International Trade Commission (the “Commission”) asserting violations of 19 U.S.C. § 1337 by eleven respondents. Laerdal amended its complaint on May 18, 2016 and filed a supplement to the amended complaint on June 7, 2016. J.A. 2358. Laerdal’s complaint, as amended and supplemented, alleged that the respondents were infringing Laerdal’s patent, trademark, trade dress, and copyright rights by LAERDAL MEDICAL CORP. v. ITC 3 importing, selling for importation, or selling within the United States certain spine boards, cervical collars, CPR masks, training manikins, and accompanying product literature. J.A. 2140–261. Laerdal sought a general exclusion order covering the various infringing products, a limited exclusion order “as an addition, or in the alternative” to the general exclusion order, and a cease and desist order directed to each respondent. J.A. 2259–60. On June 2, 2016, in response to the complaint, the Commission’s Office of Unfair Import Investigations (“Staff”) requested supplemental information on certain of Laerdal’s allegations related to one asserted patent and three asserted trademarks. J.A. 2349–50. Laerdal provided the requested information on June 7, 2016 and requested that, if the additional evidence was insufficient, the Commission institute an investigation as to the remaining patent, trademark, trade dress, and copyright allegations. J.A. 2353–57. Thirteen days later, the Commission did exactly that, instituting an investigation on some, but not all, of Laerdal’s claims. Specifically, the Commission instituted an investigation on Laerdal’s trade dress claims, one patent claim, two copyright claims, and one trademark claim, excluding all others. J.A. 2358–62. Despite being served with the amended complaint and notice of investigation, no respondent submitted any response, appeared, or otherwise participated in any way in any of the proceedings. J.A. 2478–99. On October 20, 2016, therefore, Laerdal moved for an order requiring Respondents to show cause why they should not be found in default under § 1337(g)(1). J.A. 2550–59. The Administrative Law Judge (“ALJ”) granted Laerdal’s motion and issued the Order to Show Cause on November 7, 2016. J.A. 2584–86. Respondents again failed to respond to or acknowledge that order. Two weeks later, the ALJ issued an initial determination finding all respondents in default. J.A. 2589–95. 4 LAERDAL MEDICAL CORP. v. ITC On December 1, 2016, in response to the ALJ’s initial determination, Laerdal modified its requested relief from a general exclusion order to “immediate entry of limited exclusion orders (and cease and desist orders, where appropriate) against the defaulting Respondents.” J.A. 2599. The Commission ultimately determined not to review the ALJ’s initial determination finding all respondents in default and requested that Laerdal and the Staff provide briefing on remedy, the public interest, and bonding, and submit proposed remedial orders. J.A. 2609–12. The Commission did not request information on any other issue. Laerdal and the Staff each responded that public interest factors did not preclude relief and requested a 100 percent bond rate, a cease and desist order against the sole domestic respondent, and limited exclusion orders directed to all respondents. J.A. 2618–25, 2629–35, 2744– 52, 2778–86, 2789–95, 2796–804. Both Laerdal and the Staff, moreover, expressed that, because Laerdal satisfied the requirements of § 1337(g)(1), the Commission was required to presume the facts alleged in the complaint to be true and issue an exclusion order, cease and desist order, or both, unless such relief was precluded by public interest concerns. See J.A. 2621–22, 2780–81. On June 14, 2017, the Commission issued its final determination, granting Laerdal limited exclusion orders against three respondents and a cease and desist order against one respondent, all based on Laerdal’s patent and trademark claims. J.A. 1–13. The Commission issued no relief, however, on Laerdal’s trade dress and copyright claims, finding Laerdal’s allegations in those claims inadequate. J.A. 5–11. Specifically, the Commission concluded that, even when the pleaded facts were presumed true, Laerdal failed to show that any respondent LAERDAL MEDICAL CORP. v. ITC 5 violated § 1337 with respect to the alleged trade dresses and copyrights. J.A. 8, 11. As to Laerdal’s trade dress claims—the only claims at issue in this appeal—the Commission found that Laerdal failed to plead sufficiently (1) that it suffered the requisite harm, (2) the specific elements that constitute its trade dresses, and (3) that its trade dresses were not functional. J.A. 8–11. Thus, despite approving the ALJ’s initial determination finding all respondents in default and despite requesting supplemental briefing solely related to the appropriate remedy, the Commission issued Laerdal no relief on those claims or against any of the respondents named in those claims. Laerdal appeals the Commission’s termination of its trade dress claims, contending the Commission acted in violation of § 1337(g)(1) by terminating the investigation and issuing no relief for its trade dress claims against defaulting respondents. 1 We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(6). II. DISCUSSION Statutory interpretation is a question of law reviewed de novo. Belkin Int’l, Inc. v. Kappos, 696 F.3d 1379, 1381 (Fed. Cir. 2012); PS Chez Sidney, L.L.C. v. U.S. Int’l Trade Comm’n, 684 F.3d 1374, 1379 (Fed. Cir. 2012) (“[W]hether the ITC’s determination was based on a proper interpretation of the [law] is a question of law which we review de novo.”). Laerdal also appeals the Commission’s failure to provide it notice or an opportunity to amend before finding that Laerdal’s trade dress allegations were pleaded insufficiently. Because our conclusion regarding Laerdal’s argument under § 1337(g)(1) is dispositive, we do not reach these questions. 1 6 LAERDAL MEDICAL CORP. v. ITC Section 1337(g), titled “Exclusion from entry or cease and desist order; conditions and procedures applicable,” provides, in relevant part: If— (A) a complaint is filed against a person under this section; (B) the complaint and a notice of investigation are served on the person; (C) the person fails to respond to the complaint and notice or otherwise fails to appear to answer the complaint and notice; (D) the person fails to show good cause why the person should not be found in default; and (E) the complainant seeks relief limited solely to that person; the Commission shall presume the facts alleged in the complaint to be true and shall, upon request, issue an exclusion from entry or a cease and desist order, or both, limited to that person unless, after considering the effect of such exclusion or order upon the public health and welfare, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, and United States consumers, the Commission finds that such exclusion or order should not be issued. 19 U.S.C. § 1337(g)(1) (emphases added). According to Laerdal, the Commission acted outside of its statutory authority by sua sponte terminating Laerdal’s trade dress investigation at the final determination stage based on an assessment of the adequacy of its pleadings. Under § 1337(g)(1), Laerdal asserts, once the LAERDAL MEDICAL CORP. v. ITC 7 Commission found all respondents in default, it was required to accept all facts pleaded in the complaint as true and issue a remedy, subject only to the public interest concerns outlined above. Brief for Laerdal at 10. The Commission responds that, even in the case of defaulting respondents, where facts alleged in the complaint must be presumed true, it must still find unlawful activity before issuing relief. Brief for Commission at 18, 22–23. The decision to institute an investigation, it argues, is not substantive approval that the complaint established a § 1337 violation. Brief for Commission at 24–25. If a complaint does not adequately plead a § 1337 violation, it argues, no relief is warranted—even if its allegations are unopposed. We conclude that the statute, on its face, unambiguously requires the Commission to grant relief against defaulting respondents, subject only to public interest concerns, if all prerequisites of § 1337(g)(1) are satisfied. The statute’s plain text, surrounding context, purpose, and legislative history, as well as the Commission’s own prior decisions, support this conclusion. Through use of the word “shall,” the statute unambiguously requires the Commission to, upon finding that elements (A) through (E) are satisfied, (1) presume the facts alleged in the complaint to be true and (2) upon request, issue an exclusion order, cease and desist order, or both, subject to public interest concerns. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1354 (2018) (finding that the word “shall” means “must” because it “generally imposes a nondiscretionary duty”); Kingdomware Techs., Inc. v. United States, 136 S. Ct. 1969, 1977 (2016) (“Unlike the word ‘may,’ which implies discretion, the word ‘shall’ usually connotes a requirement.”); see also Converse, Inc. v. U.S. Int’l Trade Comm’n, — F.3d —, 2018 WL 6164571, at *14 (Fed. Cir. Oct. 30, 2018) (O’Malley, J., concurring in part and dissenting in part) (“This language 8 LAERDAL MEDICAL CORP. v. ITC requires the ITC to presume the facts alleged in the complaint to be true and to provide some form of relief against any parties found to be in default . . . .”). Granting the Commission discretion to issue relief under § 1337(g)(1), moreover, runs contrary to the surrounding statutory language. See King v. Burwell, 135 S. Ct. 2480, 2489 (2015) (“[W]e must read the words in their context and with a view to their place in the overall statutory scheme.” (internal quotation marks omitted)). In § 1337(g)(2), Congress granted the Commission discretion to issue a general exclusion order against defaulting respondents through use of the term “may.” By using “shall” in subsection (g)(1), though, Congress limited the Commission’s discretion in the case of petitioners seeking more limited relief—such as a limited exclusion order or cease and desist order or both—against defaulting respondents. And, while the Commission contends that it must find a § 1337 violation properly pleaded before it can issue relief under subsection (g)(1), only subsections (d)(1) and (g)(2)—neither of which are implicated here—require that additional layer of review post-institution. Subsection (g)(2) provides that relief “may be issued if . . . such a violation is established by substantial, reliable, and probative evidence.” And subsection (d)(1), which is implicated when respondents participate in the litigation, requires the Commission to determine “that there is a violation of this section” before it issues any relief. No such requirement is found in subsection (g)(1); instead, the Commission must “presume the facts alleged in the complaint to be true” and, upon request, issue relief after considering any relevant public interest concerns. See S. Rep. No. 100-71, at 132 (1987) (Subsection (g)(1) “authorizes the Commission to presume the facts alleged in the complaint to be true insofar as they involve a defaulting respondent, and to then issue relief limited to that respondent. . . . Relief in the form of a general exclusion LAERDAL MEDICAL CORP. v. ITC 9 order [under (g)(2)] must be supported by a Commission determination of violations of the Act based on substantial, reliable, and probative evidence.”); H.R. Rep. No. 100-576, at 636 (1988) (Conf. Rep.). To be sure, the Commission must find a violation of § 1337 before it can issue a remedy, but that analysis in the context of the defaulting respondent occurs, by statute and through the Commission’s regulatory regime, upon default. Through the pre-requisites of subsection (g)(1)— elements (A) through (E)—relief against defaulting respondents is only possible if the Commission has already determined, pre-institution, that the complaint was pleaded adequately and instituted an investigation thereof. After institution, the question of the adequacy of the pleadings is no longer a live one absent a challenge thereto by a responding party. The Commission’s rules are consistent with this understanding. Commission Rule 210.9, for example, requires that, prior to instituting an investigation, the Commission “shall examine the complaint for sufficiency and compliance with the applicable sections of this chapter.” 19 C.F.R. § 210.9 (emphases added). When a notice of investigation issues, therefore, the Commission must have already ensured that the complaint sufficiently pleaded a statutory violation. Under the pre-requisites to (g)(1), relief is both permitted and mandated only after, inter alia, a notice of investigation is served, implying that the Commission has completed its preliminary review and found the complaint sufficiently pleaded, and after the respondents are found to be in default. See 19 U.S.C. § 1337(g)(1)(B), (D). If a violation is not pleaded adequately in the complaint, the Commission can decline institution and dismiss the complaint, thereby never implicating relief under subsection (g)(1)—or any other subsection. See 19 C.F.R. § 210.10(c) (“If the Commission determines not to insti- 10 LAERDAL MEDICAL CORP. v. ITC tute an investigation on the basis of the complaint, the complaint shall be dismissed, and the complainant and all proposed respondents will receive written notice of the Commission’s action and the reason(s) therefor.”). But the Commission may not institute an investigation and then decide post-hoc that it is dissatisfied with an unchallenged complaint upon which the investigation was predicated. The purpose and legislative history of subsection (g)(1) confirm this conclusion. Prior to Congress’s 1988 Amendment to the Trade Act, the Commission was required to find a violation under § 1337 before issuing relief against a defaulting respondent, even if the facts of the complaint were uncontested. See Converse, 2018 WL 6164571, at *14; Certain Elec. Slow Cookers, USITC Inv. No. 337-TA-42, at 7 (Mar. 15, 1979) (relying on 19 C.F.R. § 210.21(d) (1976)). A complainant, therefore, faced essentially the same burden of proof regardless of the respondent’s participation. See Converse, 2018 WL 6164571, at *14; see also Certain Elec. Skin Care Devices, USITC Inv. No. 337-TA-959, 2017 WL 8683854, at *14 (Feb. 13, 2017). In 1988, however, Congress added § 1337(g) to the statute to address default judgments, acknowledging that, without the respondent’s participation, a complainant faced difficulties proving facts sufficient to establish a violation of § 1337. See Converse, 2018 WL 6164571, at *14; Certain Elec. Skin Care Devices, 2017 WL 8683854, at *14 (“The legislative history of Section 337(g) notes that the addition of the provision for ‘Default Judgments’ was motivated by the fact that discovery is usually difficult, if not impossible, to obtain from named respondents who have chosen not to participate in an investigation.”). Through the addition of subsection (g), therefore, Congress “require[d] the Commission, in cases involving defaulting respondents, to presume the facts alleged in the complaint to be true and, upon request, to issue relief LAERDAL MEDICAL CORP. v. ITC 11 against the defaulting respondents, unless the enumerated public interest factors . . . preclude[d] relief.” S. Rep. No. 100-71, at 132; H.R. Rep. No. 100-576, at 636 (Conf. Rep.) (“[W]hen a respondent fails to appear, the ITC shall presume the facts alleged in the complaint to be true and shall, upon request, issue appropriate relief solely against that person.”). The Commission contends that its approach of reviewing pleading sufficiency prior to a final determination is consistent with district court practice, which requires a court to review a plaintiff’s allegations to ensure the defaulter’s liability as a matter of law. Brief for Commission at 21. But the Commission overlooks an important distinction between district court and ITC practice—the Commission must conduct a preliminary review that district courts do not, and only then may institute an investigation. Rule 55, moreover, governing default judgment in district court litigation, is unlike § 1337(g)(1); it does not require the court to grant relief, it grants the court discretion to “conduct hearings or make referrals” in evaluating whether to “enter or effectuate judgment.” Fed. R. Civ. P. 55(b)(2). We presume that Congress was aware of the discretion granted to district courts under Rule 55 when it later drafted subsection (g) to § 1337. See Miles v. Apex Marine Corp., 498 U.S. 19, 32 (1990) (“We assume that Congress is aware of existing law when it passes legislation.”). Our interpretation is also supported by the Commission’s own prior application of the statute. In Certain Electric Skin Care Devices, the Commission—referring to the same legislative history addressed above—explained that it “distinguishes between default situations, in which the remedy is governed by Section 337(g), and contested situations, in which the remedy is governed by Sections 337(d) and (f).” Certain Elec. Skin Care Devices, 2017 WL 8683854, at *14 n.9. The Commission clarified that “the mandatory language of [subsection (g)(1),] (‘shall’), cou- 12 LAERDAL MEDICAL CORP. v. ITC pled with the use of the coordinating conjunction ‘or,’ requires the Commission to issue relief as to the defaulting respondent in the form of three alternative choices—an exclusion order, a cease and desist order, or both—when the conditions and applicable procedures of this provision are satisfied.” Id. at *14 (emphasis added). And the Commission acknowledged that “the grant of this appropriate relief can be overcome only by evidence pertaining to the statutory public interest factors.” Id. at *14 n.9. Recognizing that its discretion lay only in determining the appropriate remedy against defaulting respondents, not in deciding whether a remedy was warranted, the Commission concluded that, since the respondents were found in default, it did not need to “address whether there [wa]s a violation of Section 337” as the “claim [wa]s deemed established based on the allegations in the complaint.” Id. at *7. Here, it is undisputed that Laerdal met the prerequisites for § 1337(g)(1). The amended complaint and notice of investigation were served on all respondents, the respondents failed to respond or appear in any way and failed to show good cause why they should not be found in default, and Laerdal limited the relief it sought to exclusion orders and cease and desist orders against only the respondents. J.A. 2478–99, 2550–59, 2584–86, 2589–95, 2599, 2609–12. Subject only to public interest concerns, therefore, the Commission was required under § 1337(g)(1) to presume all facts alleged in the complaint as true and issue an exclusion order, cease and desist order, or both. While the Commission contends that Laerdal did not properly plead a § 1337 violation in the complaint, the time for that assessment was pre-institution. Had the Commission found Laerdal’s trade dress claims insufficient, it should have requested additional information or denied institution under Rules 210.9 and 210.10. In fact, that is precisely what the Commission did with respect to LAERDAL MEDICAL CORP. v. ITC 13 certain of Laerdal’s patent and trademark claims by not including them in the investigation. J.A. 2358–62. For those claims, the Staff highlighted pleading insufficiencies to Laerdal, Laerdal was provided an opportunity to supplement the complaint, and the Commission ultimately declined institution as to three of the four identified insufficiently pleaded allegations. J.A. 2349–50, 2353–57, 2358–60. As the Commission conceded during oral argument, “ideally that [same process] would have happened” with Laerdal’s trade dress claims as well. Oral Arg. at 25:00, http://oralarguments.cafc.uscourts.gov/default.aspx?fl=20 17-2445.mp3. Beyond improperly reaching the merits of Laerdal’s trade dress claims post-institution, the Commission also raised concerns about the adequacy of those trade dress claims that neither the Staff nor the ALJ— both of whom had previously considered the claims— shared. While we question the Commission’s actions in this regard, we do not reach the issue here. Having approved Laerdal’s trade dress claims without any additional questioning and instituted an investigation thereof, see J.A. 2358–62, the Commission cannot now, post-institution and without opposition or appearance from respondents, assert insufficient pleading as a basis for denying relief. After the respondents were found in default, the Commission was required to issue relief upon Laerdal’s request, unless precluded by public interest concerns. While both Laerdal and the Staff asserted that no public interest concerns precluded relief, J.A. 2618–25, 2778–86, we recognize that “the Commission has broad discretion in selecting the form, scope and extent of the remedy,” and therefore, remand for the Commission to determine the appropriate remedy. Viscofan, S.A. v. U.S. Int’l Trade Comm’n, 787 F.2d 544, 548 (Fed. Cir. 1986). 14 LAERDAL MEDICAL CORP. v. ITC III. CONCLUSION For the foregoing reasons, we reverse the Commission’s determination that Laerdal failed to plead its trade dress claims with adequate detail, vacate the Commission’s decision that no relief was warranted for those claims, and remand for the Commission to determine the appropriate remedy after consideration of public interest concerns, in light of Laerdal and the Staff’s submissions. REVERSED IN PART, VACATED IN PART, AND REMANDED COSTS No costs.
International Trade Commission violated 19 U.S.C. 1337(g)(1) by terminating an investigation and issuing no relief for trade dress claims against defaulting respondents.


text:
HERBERT L. CONNOLLY vs. SECRETARY OF THE COMMONWEALTH & others [Note 1] (and two companion cases [Note 2]).
Present: HENNESSEY, C.J., LIACOS, ABRAMS, & O'CONNOR, JJ.
CIVIL ACTION commenced in the Supreme Judicial Court for the county of Suffolk on October 3, 1988.
On transfer to the Superior Court Department the case was heard by Elbert Tuttle, J.
CIVIL ACTION commenced in the Superior Court Department on October 12, 1988.
The Supreme Judicial Court on its own initiative transferred both cases from the Appeals Court.
A separate action commenced in the Supreme Judicial Court for the county of Suffolk on November 22, 1988, was ordered dismissed after consideration by the full court.
Arthur C. Sullivan, Jr. (James C. Dragon with him) for Robert B. Kennedy.
William F. Galvin for Herbert L. Connolly.
Sanford A. Kowal for Jody Dow.
Ruth A. Bourquin, Assistant Attorney General, for Secretary of the Commonwealth & another.
HENNESSEY, C.J. We review here three actions concerning the Democratic primary election and the general election for the office of Governor's Councillor of the Third District of the Commonwealth. Jody Dow was the Republican candidate. Herbert L. Connolly and Robert B. Kennedy were the two candidates in the Democratic primary, which was held on September 15, 1988. After a recount of the results of the primary election, Kennedy was determined to be the winner by a margin of one vote.
general election between Dow and Connolly, and allowing the scheduled general election between Dow and Kennedy to proceed. Connolly filed a cross appeal. We transferred the appeals to this court on our own motion. A single justice of this court entered a preliminary injunction restraining the Secretary from transmitting the results of the November 8 general election for this office, in which Kennedy prevailed over Dow, to the Governor and the Executive Council for certification.
From the recount of the Democratic primary, it was determined that 14,691 uncontested votes were cast for Kennedy, and 14,690 uncontested votes were cast for Connolly. [Note 3] At issue before this court were 116 contested votes, of which fifty were absentee ballots and sixty-six were "punched" ballots submitted by voters at the polls. On December 23, 1988, this court entered an order declaring Kennedy the winner of the primary and the general election, and dismissing the actions of Dow. This opinion is pursuant to our order.
add that, if we had to reach the merits of the issues, we would decide that the commission properly overruled Dow's objections. See Wellesley College v. Attorney Gen., 313 Mass. 722, 731 (1943). The only residency requirement for the office of Governor's Councillor is that the candidate reside in the Commonwealth for five years. Art. 16 of the Amendments to the Massachusetts Constitution. There was no allegation that Connolly had not been a resident for that period. Therefore, even if Connolly did not live in Newton, he nonetheless would have been eligible for the office. Furthermore, even if Connolly's listed address was not his legal address, this fact alone did not make him a "fictitious or nonexisting person" within the meaning of G. L. c. 55B, Section 11. Connolly appeared before the commission and testified under oath that he was Herbert L. Connolly, and that he was the person who ran in the Democratic primary for Governor's Councillor. The commission stated, pursuant to G. L. c. 55B, Section 11, that it was satisfied that Connolly was a living person, that it was convinced of his identity, and that he was thus not a "fictitious or nonexisting person." We conclude that the commission's final determination in the matter was based on substantial evidence and contained no error of law. See G. L. c. 55B, Section 4 (c. 30A applies to decisions of the commission); Trustees of Forbes Library v. Labor Relations Comm'n, 384 Mass. 559, 569 (1981) (interpreting provisions of c. 30A).
unfairly prejudicial to her. She notes that the Superior Court judgment declaring the general election between herself and Kennedy null and void was entered on November 1, 1988. The order of the single justice of the Appeals Court granting a stay of this judgment and allowing the general election to go forward, she points out, was entered on November 7, 1988. Dow claims that the uncertainty as to whether the general election between herself and Kennedy would take place confused voters and harmed her candidacy. Consequently, she claims, her rights under the Massachusetts and Federal Constitutions were violated. We disagree. It is patently clear that her opponent, Kennedy, labored under the same difficulty which she asserts. It is also clear, therefore, that the special election she seeks as a remedy, which would merely be a repeat of the contest between herself and Kenendy, is not warranted.
We turn now to the controversy between Kennedy and Connolly. We make several preliminary observations. First, the determination of the legal effect of the ballots is a question of law. McCavitt v. Registrars of Voters of Brockton, 385 Mass. 833, 839 (1982). Morris v. Registrars of Voters of E. Bridgewater, 362 Mass. 48, 49 (1972). Second, this court must make a de novo determination of the voters' intent. DePetrillo v. Registrars of Voters of Rehoboth, 342 Mass. 13, 14 (1961). Finally, we point to a meaningful distinction between the contested absentee ballots and the contested "punched" ballots, in that all of the contested punched ballots are before us, but the only contested absentee ballots which are before us are those which were rejected by local election officials as not valid. The envelopes for all contested absentee ballots are before us for our consideration on the issue of validity, but it follows that the effect of any absentee ballots which we conclude were wrongfully counted is conjectural. Thus, in order to prevail, one of the candidates must show a winning margin of at least one vote more than the number of absentee ballots wrongfully counted.
We consider now the issue of the validity of fifty challenged absentee ballots. [Note 4] General Laws c. 54, Sections 86-103 (1986 ed.), regulate absentee voting. The challenged absentee ballots admittedly do not strictly comply with the technical requirements of the absentee voting laws. The Legislature, however, has not mandated strict compliance, and has directed courts not to reject a ballot for an "immaterial addition, omission, or irregularity." G. L. c. 54, Section 97. In keeping with this statement of legislative intent, we have reasoned that "an absentee voter should not be disenfranchised if he substantially complies with the election law." McCavitt v. Registrars of Voters of Brockton, supra at 844. To determine substantial compliance, we look to the purposes of the absentee voting laws, which we have determined to be (1) the enfranchisement of qualified voters, (2) the preservation of ballot secrecy, (3) the prevention of fraud, and (4) the achievement of a reasonably prompt determination of election results. Id. We note that there are no allegations of fraud in the present case. With these principles in mind, we review the fifty challenged absentee ballots. Most of these ballots can be classified into groups and accordingly we discuss them in this fashion.
the Marlborough voters), who failed to have their ballots properly witnessed. The ballots were held valid by election officials, and we agree with their rulings, because the voters substantially complied with the election laws. A voter who is within the United States and whose name is not on the list of permanently disabled voters is required by G. L. c. 54, Section 92, both to mark the ballot, and to execute an affidavit on the inner envelope in which the ballot is placed, in the presence of a witness. The section then requires the witness to sign the inner envelope, and provide his or her address. In contrast, a voter who is outside the United States, or whose name is on the list of permanently disabled voters, is not required to have a witness. G. L. c. 54, Section 92. The applications for absentee ballots by the Marlborough voters indicate that they fit neither exempt category and thus needed to comply with the witness requirement. These voters, however, received "C" inner envelopes, designed for absentee voters who do not need their ballots witnessed. These inner envelopes, therefore, did not contain a witness requirement, or a printed area to allow a witness to sign and swear as to the method the ballot was marked. Therefore, although none of the inner envelopes of the Marlborough voters was properly witnessed as required by Section 92, the Marlborough voters nonetheless fully complied with instructions on the inner envelopes.
and an affidavit signed by the voter. It is possible to compare this information, notably the signature, with information provided in each voter's application for an absentee ballot, and thereby to ensure that the person who applied for the ballot actually received and voted that ballot. The Marlborough votes were properly counted.
witness on each of the inner envelopes provides a sufficient safeguard against fraud. These eleven absentee ballots from Brighton were properly counted.
d. A group of five voters received absentee ballots without first filing applications requesting the ballots. All five ballots were counted by election officials. We agree with these decisions as to all but one voter, who we conclude failed to comply substantially with the election laws. Section 89 of c. 54 prohibits the delivery of an absentee ballot unless the voter has filed an application and has been certified by election officials. A voter, however, may appear in person before a city or town clerk, request an application, and, if the clerk is satisfied with the completed application, receive an absentee ballot immediately. G. L. c. 54, Section 91. The completed ballot will be valid if the voter, without removing the ballot from the office of the clerk, marks the ballot and signs it in the presence of the clerk. G. L. c. 54, Section 92 (b). Two voters in this group of five telephoned their town clerk, who brought the absentee ballots and necessary envelopes to their home. The clerk knew both voters personally. There was testimony that both voters were disabled. The voters marked the ballots and signed the inner envelopes in the clerk's presence. The clerk signed the envelopes as witness, and returned the completed ballot materials. Two other voters in this group appeared before town clerks who knew them personally, and, in their presence, completed the ballots and inner envelopes which the clerks witnessed. Although none of these four voters had first filed a satisfactory application, the fact that each was known personally by the town clerks, and that each fully completed a ballot and inner envelope in a clerk's presence provides, we believe, a "sufficient guaranty that these voters marked their own ballots." McCavitt, supra at 845. We therefore conclude that these four voters substantially complied with the requirements for voting an absentee ballot in person.
this ballot, we conclude that the vote is invalid, and should not have been counted.
e. We conclude that two voters from Newton whose signatures and addresses appear on their absentee ballots substantially complied with the election laws. The statute forbids a voter from placing "on a ballot any mark by which it may be identified." G. L. c. 54, Section 80 (1986 ed.). We have determined, however, that identifying marks do not necessarily invalidate a ballot unless they are "made intentionally and with dishonest purpose." Chamberlain v. Registrars of Voters of Harwich, 358 Mass. 536, 538 (1970). Hall v. Barton, 290 Mass. 476, 481 (1935). There was no suggestion that these voters had any dishonest purpose; rather, the marks appear to be an "inadvertent or careless irregularity." Chamberlain, supra at 540. Although some of our earlier decisions may appear to require a different conclusion, these decisions are distinguishable from the present case because they involved identifying marks which qualify the voter's position. See Chamberlain, supra; Munn v. Dabrowski, 335 Mass. 41, 46-47 (1956). The marks of the Newton voters do not impede the understanding of their ballots. These ballots were properly counted.
g. To summarize, we have concluded that, of the fifty absentee ballots, twenty-eight ballots were properly counted; nineteen ballots were properly not counted; one ballot which was not counted should have been; [Note 9] and two ballots which were counted should not have been included in the tally. As we stated early in our discussion of absentee ballots, we have no way of ascertaining for whom these two votes were cast. At this point, therefore, before we turn to the hand count of the punch cards, the validity of the primary election is conjectural to the extent of the two votes invalidly cast. If the "winning" candidate prevails by less than three votes, under our ruling in McCavitt, there must be a new primary election. McCavitt, supra at 848, 850.
We next review sixty-six contested votes which were recorded from "punched" ballots submitted by voters at the polls.
Voters of Fall River, 328 Mass. 511, 518 ) and any patterns that reveal intent (Morris v. Registrars of Voters of E. Bridgewater, 362 Mass. 48, 50, 51 ).
In sum, we conclude that Kennedy prevailed by a margin of five votes, and this, of course, exceeds the necessary minimum margin of three votes. Our starting point showed 14,691 uncontested ballots for Kennedy and 14,690 uncontested ballots for Connolly. We have added one vote which we have seen was inadvertently not counted, and which was cast for Kennedy. Kennedy prevailed by a margin of three votes (seventeen to fourteen) on the punched ballots. The ultimate totals are 14,709 for Kennedy and 14,704 for Connolly.
application (with an exception for voters who receive assistance in signing under Section 98), and (3) to ensure in general that the inner envelope complies with all of the requirements of Section 92, which include the witnessing requirements. If the inner envelope fails to meet any of these unambiguous requirements and is therefore facially invalid, see McCavitt, supra at 841-842, the official must mark the envelope, without removing the ballot it contains, "Rejected as Defective." G. L. c. 54, Section 94. Such envelopes are set aside, and are not further examined unless there is a recount. G. L. c. 54, Section 135. Even on recount, the ballots are not separated from the facially invalid inner envelopes, regardless of the registrars' opinion of the ballots' validity. Id. Because the ballots are not separated from their inner envelopes, cf. G. L. c. 54, Section 95 (inner envelopes not marked "Rejected as Defective" are separated irrevocably from ballots), the statutory procedure minimizes the potential for conjectural votes.
[Note 1] Robert B. Kennedy and Jody Dow.
[Note 2] Jody Dow vs. State Ballot Law Commission, Secretary of the Commonwealth, Robert B. Kennedy, and Herbert L. Connolly; and Jody Dow vs. Secretary of the Commonwealth, Robert B. Kennedy, and Herbert L. Connolly.
[Note 3] We arrive at the figure of 14,691 uncontested votes cast for Kennedy after we subtract the twenty-five challenged punched ballots from the 14,716 votes certified by the Secretary. We arrive at the figure of 14,690 uncontested votes cast for Connolly after we subtract the twenty-five challenged punched ballots from the 14,715 votes certified by the Secretary.
[Note 4] Connolly argues that the judge should not have admitted nineteen of these fifty absentee ballots because he claims that Kennedy waived any objections to the ballots by not filing a recount petition and by not objecting to these particular ballots during the recount. In McCavitt, we held that a candidate who challenges certain ballots in a judicial proceeding need not object to those specific ballots during a recount proceeding. McCavitt, supra at 840. Instead, we determined that a general allegation by a challenger that "`absentee ballots and the applications therefor are in error,' is sufficient to preserve the issue for judicial determination." Id., quoting Desjourdy v. Registrars of Voters of Uxbridge, 358 Mass. 664, 667 (1971). Connolly contends that McCavitt is distinguishable because there the challenger filed a recount petition and Kennedy did not file such a petition here. We do not think this is a meaningful distinction, especially in light of the fact that a court may order the production of ballots other than those specifically recorded as protested at the recount. G. L. c. 54, Section 135, twelfth par. We conclude that the judge properly admitted these ballots and considered the issues they raise.
[Note 5] Section 98, on its face, allows a voter to receive assistance only in preparing a ballot, and does not specifically allow for assistance in signing an application for an absentee ballot. We believe the Legislature intended to allow a voter to receive assistance, subject to requirements of Section 98, in completing a ballot, an application, or both. Cf. G. L. c. 54, Section 89A (allowing parent of specially qualified voter or voter attending institution of higher education to apply for absentee ballot on voter's behalf).
[Note 6] None of the inner envelopes or applications contains a printed space allowing a person who assists the voter to explain why the voter may be unable to write. Cf. G. L. c. 54, Section 103E. Adding this provision would clarify the duties of persons who assist voters.
A further revision of the inner envelopes is necessary. Section 92 (a) specifically allows a witness to communicate with a voter as to how the voter wishes to vote if the witness is assisting the voter under Section 98. The "R" inner envelopes which are designed for witnessed absentee ballots, however, do not appear to allow a witness to assist the voter in marking the ballot. Instead, the inner envelopes require the witness to swear, with no apparent exceptions, "I had no communication with the voter as to how he or she was to vote." These inner envelopes, therefore, should be revised to comply with the statute.
[Note 7] Chapter 54 provides a scheme to minimize the risk that ballots of nursing home residents will be invalidated because of improper witnessing or assistance. The statute provides for an election official to deliver ballots to residents of a "[d]esignated health care facility," to witness a voter's marking of the ballot and execution of the required affidavit, to provide assistance if necessary, and to return the ballot to the city or town clerk. G. L. c. 54, Sections 89 (a), 92 (c).
[Note 8] The judge ruled that one in-person ballot was properly counted. The judge found that, although the voter's name did not appear on the voting list for the ward and precinct in which she voted, evidence indicated that the voter had moved recently, and thus was properly allowed to vote by an election official. See G. L. c. 51, Section 1. We agree with the judge's ruling.
We have consistently referred to the total as fifty "absentee" ballots. The above makes it clear that there are actually forty-nine absentee ballots, and one in-person ballot.
[Note 9] This vote was cast for Kennedy and is added to his total in the tally included in part 5 of this opinion.
[Note 10] We determine that the exhibit numbers of the Kennedy votes are 18, 20, 24, 25, 30, 32, 33, 35, 37, 40, 42, 45, 48, 53, 54, 57, and 64.
[Note 11] We determine that the exhibit numbers of the Connolly votes are 3, 4, 9, 11, 26, 28, 31, 43, 44, 46, 50, 52, 66, and 69.
[Note 12] We determine that all of the exhibits from numbers 3 through 69, except those listed in nn. 10 and 11 above, were blanks. There was no ballot identified as exhibit 16.
[Note 13] See also our suggestions in note 6, supra, for necessary revision of the printed forms on envelopes and applications for absentee ballots.

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(1) An assignment for Educational Aide I is allowed with one of the following certificates.
(D) Valid Texas Classroom Teacher Certificate.
(2) The role description for an Educational Aide I is codified in §230.61(1) of this title (relating to Role Descriptions).
(1) An assignment for Educational Aide II is allowed with one of the following certificates.
(C) Valid Texas Classroom Teacher Certificate.
(2) The role description for an Educational Aide II is codified in §230.61(2) of this title.
(1) An assignment for Educational Aide III is allowed with one of the following certificates.
(B) Valid Texas Classroom Teacher Certificate.
(2) The role description of an Educational Aide III is codified in §230.61(3) of this title.
Statutory Authority: The provisions of this §231.641 issued under the Texas Education Code, §21.031(a) and §21.041(b)(1) and (2).
Source: The provisions of this §231.641 adopted to be effective August 15, 2013, 38 TexReg 5076.
§231.643. Administrators and Other Instructional and Professional Support Personnel.
(1) An assignment for Superintendent is allowed with one of the following certificates.
(2) An assignment for Principal is allowed with one of the following certificates.
(3) An assignment for Assistant Principal is allowed with one of the following certificates.
(b) School Counselor. An assignment for School Counselor is allowed with one of the following certificates.
(2) School Counselor (Early Childhood-Grade 12).
(c) Librarian. An assignment for Librarian is allowed with one of the following certificates.
(4) School Librarian (Early Childhood-Grade 12).
(d) Athletic Director. An assignment for Athletic Director is allowed with a teacher certificate.
Statutory Authority: The provisions of this §231.643 issued under the Texas Education Code, §§21.003(b), 21.031(a), and 21.041(b)(1) and (2), and the Texas Occupations Code, §401.054.
Source: The provisions of this §231.643 adopted to be effective August 15, 2013, 38 TexReg 5076; amended to be effective May 18, 2014, 39 TexReg 3707.
§231.645. Professional Support Personnel Requiring Other Professional License.
A person may not be employed by a school district to perform services within the following professions unless the person holds the appropriate credential or license from the appropriate state agency for that profession. Educator certification is not required for a school district assignment to provide services that are within the scope of that profession.
(4) Marriage and Family Therapist. As long as a person was employed by a school district before September 1, 2011, to perform marriage and family therapy, as defined by the Texas Occupations Code (TOC), §502.002, and remains employed by the same school district, the person is not required to hold a license as a marriage and family therapist to perform marriage and family therapy with that school district.
(11) Speech Language Pathologist. An assignment to provide Speech Therapy Services is allowed with a certificate authorized by the TOC, §401.054.
Statutory Authority: The provisions of this §231.645 issued under the Texas Education Code, §§21.003(b), 21.031(a), and 21.041(b)(1) and (2), and the Texas Occupations Code, §401.054.
Source: The provisions of this §231.645 adopted to be effective May 18, 2014, 39 TexReg 3707.