ALTERA INTERNATIONAL, LTD.Download PDFPatent Trials and Appeals BoardSep 14, 20212021000503 (P.T.A.B. Sep. 14, 2021) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 14/897,794 12/11/2015 Jay A. Altman 074408-509235 6179 27148 7590 09/14/2021 POLSINELLI PC PO Box 140310 KANSAS CITY, MO 64114-0310 EXAMINER CONIGLIO, AUDREA JUNE BUCKLEY ART UNIT PAPER NUMBER 1617 NOTIFICATION DATE DELIVERY MODE 09/14/2021 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): patentdocketing@polsinelli.com rendsley@polsinelli.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JAY A. ALTMAN Appeal 2021-000503 Application 14/897,794 Technology Center 1600 Before DONALD E. ADAMS, ULRIKE W. JENKS, and RACHEL H. TOWNSEND, Administrative Patent Judges. TOWNSEND, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims directed to a method for reducing chronic respiratory disease in an equid as being indefinite and as being obvious. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM the indefiniteness rejection but REVERSE the obviousness rejection. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as Altera International, LTD. (Appeal Br. 1.) Appeal 2021-000503 Application 14/897,794 2 STATEMENT OF THE CASE Appellant’s Specification indicates that “[c]hronic lower airway inflammatory diseases commonly occur in horses.” (Spec. ¶ 6.) When horses are afflicted with such disease they need long term or even lifelong management. (Id. ¶ 7.) Appellant’s Specification indicates that “there is a need in the art for methods of ameliorating chronic lower airway inflammatory disease.” (Id.) Appellant’s invention is directed to such a method. (Id. ¶ 50.) Claims 11, 12, 14, 17, and 18, are on appeal. Claim 11, reproduced below, is illustrative of the claimed subject matter: 11. A method for reducing chronic respiratory disease in an equid, the method comprising administering 2-4g per 110 lbs body weight for at least two weeks of a composition, wherein the composition comprises an all-vegetarian, fish oil-free source of DHA, methylsulfonylmethane (MSM), and between about 1000 and about 3000 mg per 30 g dose of a combination of Pleurotus eryngii mushrooms, Cordyceps militaris mushrooms, and Ganoderma lucidum mushrooms, wherein a portion of neutrophils in the lung mucus of the equid is reduced relative to the lung mucus of the equid prior to administration of the composition. (Appeal Br. iii–iv (“V. CLAIMS APPENDIX”).) Appeal 2021-000503 Application 14/897,794 3 The prior art relied upon by the Examiner is: Name Reference Date Chevis WO 2004/032918 A1 Apr. 22, 2004 Perrin et al. US 8,545896 B2 Oct. 1, 2013 Kim US 2009/0304827 A1 Dec. 10, 2009 Kevin G. Keegan et al.2 Effects of an Oral Nutraceutical on Clinical Aspects of Joint Disease in a Blinded, Controlled Clinical Trial: 39 Horses, 53 AAEP Proceedings, 252–55 2007 Nair US 2001/0206721 Aug. 25, 2011 Stamets US 2006/0171958 A1 Aug. 3, 2006 Ra WO 2007/126221 A1 Nov. 8, 2007 Lowell Observations on heaves. An asthma-like syndrome in the horse, 35 (4) J. Allergy, 322–30 1984 The following grounds of rejection by the Examiner are before us on review: Claims 11, 12, 14, 17, and 18 under 35 U.S.C. § 112(b) as being indefinite. Claims 11, 14, 17, and 18 under 35 U.S.C. § 103 as unpatentable over Chevis, Perrin, Kim, Downer, Nair, Stamets, and Ra. Claim 12 under 35 U.S.C. § 103 as unpatentable over Chevis, Perrin, Kim, Downer, Nair, Stamets, Ra, and Lowell. 2 The Examiner refers to this reference by the last named author, Judy Downer, rather than the first named author. We do the same to avoid confusion. Appeal 2021-000503 Application 14/897,794 4 DISCUSSION INDEFINITENESS The Examiner rejected claims 11, 12, 14, 17, and 18 as being indefinite because there is insufficient antecedent basis in claim 11 for the limitation “a portion of neutrophils in the lung mucus . . . relative to the lung mucus.” (Final Rejection 3.) In addition, the Examiner stated: It has not been stated what portion or neutrophils are under consideration in what lung mucus is being considered? What is the "portion" being claimed, and what "lung mucus" is considered a standard or control? Appropriate clarification is required. (Id.) Appellant did not respond to this rejection. We agree in part with the Examiner’s rejection. In particular, we agree that there is insufficient antecedent basis for “the lung mucus” in the phrase “a portion of neutrophils in the lung mucus.” However, we do not otherwise find the phrase the Examiner points to gives rise to uncertainty. We conclude that the claim limitation can be met where any portion of neutrophils in lung mucus of the equid administered the claimed composition is reduced as compared to the lung mucus of the equid prior to being administered the composition. Breadth does not equate to indefiniteness. In re Miller, 441 F.2d 689, 693 (CCPA 1971). OBVIOUSNESS In finding the method of claim 11 obvious, the Examiner relied on Chevis for its teaching of treating inflammation of the respiratory tract in a mammal through the administration of tuna fish oil, which oil has at least one omega-3 polyunsaturated fatty acid, e.g., docosahexanoic acid. (Final Action 4.) The Examiner relied on Kim for its teachings of using anti- Appeal 2021-000503 Application 14/897,794 5 inflammatory compositions of fish oil with edible mushrooms and other beta-glucan sources to treat “undesired respiratory and other inflammatory conditions in mammals.” (Id. at 6.) The Examiner relied on Downer for its teaching of treating osteoarthritis in horses using the product “Myristol,” which includes methylsulfonylmethane, glucosamine, hydrolyzed collagen, and cetyl myristoleate. (Id. at 7.) The Examiner found that from the foregoing, it would have been obvious to one of ordinary skill in the art “to add edible mushroom and other beta-glucan sources, a mushroom blend as taught by Kim” (id. at 6) and “to add methylsulfonylmethane as taught by Downer” (id. at 7) to the composition of Chevis with a reasonable expectation of success because “Chevis, Kim, and Downer are directed to anti-inflammatory compositions and methods including orally administered formulations” (id). The Examiner further explained that one of ordinary skill in the art would have been motivated to do so (1) because Kim teaches “dried powder of edible mushrooms and other beta-glucan sources and fish oil may be used in various combinations against inflammation disorders (see [0095])” (id. at 6) and (2) “to reduce known inflammatory and/or osteoarthritis conditions in horses based on Downer’s teaching” (id. at 7). The Examiner relied on Perrin for teaching that algae oil and fish oil are equivalently useful sources of DHA in nutritional supplements (id. at 5) and thus it would have been obvious to substitute algae oil DHA for Chevis’ tuna oil DHA (id. at 6). The Examiner relied on Nair, Stamets, and Ra to find that the claimed mushroom species would have been obvious to use together in the composition of Chevis as modified by Kim and Downer. (Final Action 7– 9.) In particular, the Examiner found that Nair teaches the use of various Appeal 2021-000503 Application 14/897,794 6 known medicinal mushrooms, including Ganoderma lucidum, in dietary formulations and in ranges of from 100 mg to 15000 mg (id. at 7–8), and that mushrooms are generally “included in dietary supplements for various purposes including inhibition of cancer, lowering lipids in serum, enhancing immunity to disease, inhibiting the aging processes, and preventing diseases.” (Ans. 4). The Examiner found that Stamets teaches Ganoderma lucidum and Plurotus eryngii “to be desirably included in mushroom blends giving desired benefits not limited to known antiviral and additional known nutraceutical benefits” (Final Action 8), whether as mycelium, extracts or derivatives (Ans. 3). The Examiner found that “Ra teaches anti- inflammatory drugs desirably further including Cordyceps Militaris extract (see abstract; page 9, line 8 and lines 12-15 in particular) for its known ‘health functional food’ effects having anti-inflammatory benefits (page 12, lines 1-12).” (Final Action 8.) The Examiner stated: “[i]n other words, Stamets and Ra provide teachings of particular mushroom components which may be used in combination in place of Kim and Nair’s generally disclosed mushroom component.” (Id. at 9.) According to the Examiner, it would have been prima facie obvious and one reasonably would have expected success from selecting the aforementioned mushrooms or mushroom components in particular for inclusion in a single benefit composition, with each reference above providing a specific rationale associated with each specific mushroom (i.e., anti-inflammatory benefit, anti-viral benefit, anti-cancer, anti-aging, anti-disease benefit). (Ans. 4.) In summary the Examiner’s position of obviousness is that it would have been obvious to combine Chevis and Perrin where both are directed to nutritional supplements including DHA; it is maintained that it would have been obvious to Appeal 2021-000503 Application 14/897,794 7 combine Chevis and Kim where both are directed to anti- inflammatory compositions and methods for treating undesired respiratory and other inflammatory conditions in mammals. It is maintained that it would have been obvious to combine Downer's MSM in an oral formulation for treating inflammatory conditions with the products and methods of Chevis and Kim. It is maintained that it would have been obvious to combine Kim and Nair and Ra where these are directed to the use of mushroom components in anti-inflammatory nutritional or dietary formulations, and further that one would have been motivated to do so based on Ra and Stamets' teaching of benefits of mushrooms. (Ans. 5.) The Examiner also found that the neutrophil limitation would have necessarily resulted when the composition of Chevis as modified by Kim, Downer, Perrin, Nair, Stamets and Ra was administered to equids “since the results of a method cannot be separated from performance of the method.” (Final Action 9.) We do not agree with the Examiner’s conclusion of obviousness. Appellant’s claim is directed a method of treatment by applying a particular composition. The rejection must establish a reason to combine all of the claimed ingredients of the composition and to administer that composition to equids with a reasonable expectation of treating chronic respiratory disease. We conclude that the Examiner has not set forth a persuasive reason that one of ordinary skill in the art would have found it obvious to include MSM in the composition of Chevis. Downer teaches that Myristol, which includes MSM, is a nutraceutical that can alleviate clinical signs of osteoarthritis in horses. (See, e.g., Downer abstr.) The Examiner has not provided any evidence that a horse that is suffering from inflammation of the lower respiratory tract or the gastrointestinal tract would also likely be suffering Appeal 2021-000503 Application 14/897,794 8 from osteoarthritis. Thus, there is insufficient evidence in the cited references to support inclusion of Myristol, much less MSM itself in the composition of Chevis for use in treating a horse with inflammation of the lower respiratory tract or gastrointestinal tract. Furthermore, we conclude, for similar reasons, that the Examiner has not set forth a persuasive reason that one of ordinary skill in the art would have found it obvious to include the three specific mushroom types set forth in Appellant’s claim 11 in the composition of Chevis as modified by Kim. It is true that Kim generally suggests that mushrooms which include beta glucan can be combined with fish oil which has omega-3 fatty acids such as DHA in a composition to treat inflammation-associated disorders. (Kim ¶¶ 45, 46, 73, 74, 95.) However, the Examiner has not provided sufficient evidence to establish that one of ordinary skill in the art would have selected the three specific mushrooms claimed for use in the composition to treat a horse that is suffering from inflammation of the lower respiratory tract or the gastrointestinal tract, because the Examiner has not established that such a horse would also likely be suffering from a proliferation of cancer cells, hypertension or peroxidized lipid, or a virus. Nair teaches that “the polysaccharide protein complex included in Ganoderma lucidum extract exhibits the inhibition of the proliferation of cancer cells, treatment of essential hypertension, inhibition of the formation of peroxidized lipid, etc.” (Nair ¶ 19.) Stamets teaches Ganoderma lucidum and Pleurotus eryngii mushrooms, among others, may be added to “[t]he mycelium, extracts and derivatives of Fomitopsis officinalis, Piptoporus betulinus and/or Ganoderma resinaceum.” (Stamets ¶ 45.) And Stamets teaches that the Fomitopsis, Piptoporus and Ganoderma resinaceum have Appeal 2021-000503 Application 14/897,794 9 antiviral activity. (Id. ¶ 37.) Stamets also states that “[t]he invention includes the combination of products from multiple mushroom species in a form to have the accumulated effect of restricting the growth, spread and survivability of viruses in animals.” (Id. ¶ 47.) It further states that “[s]uch forms may have the additional advantages of functioning as antibacterials, antiprotozoals, immunomodulators, nutraceuticals and/or probiotics as well as enhancing innate immunity defense mechanisms and host immune response.” (Stamets ¶ 47.) However, the foregoing does not indicate that Ganoderma lucidum and Pleurotus eryngii mushrooms are known to treat inflammation or that mammals suffering from inflammation of the lower respiratory tract or the gastrointestinal tract also have a viral infection, or a bacterial or protozoal infection. On the other hand, even if one were to consider that it would have been obvious to add Ganoderma lucidum and Pleurotus eryngii to the composition of Chevis as a general nutraceutical or probiotic or to enhance innate immunity defense mechanisms or host immune response as Stamets suggest certain forms of multiple mushroom species may function as,3 one must still find from the prior art, a reason to also include Cordyceps Militaris. Ra does not teach Cordyceps Militaris is known to treat inflammation or indicate any other benefit that is derived from the ingestion of Cordyceps Militaris. Ra teaches that Oldenlandia diffusa extract which includes ursolic acid and oleanolic acid “shows anti-inflammatory and analgesic effects.” (Ra 7, 8.) Ra further teaches that such an extract composition can also 3 In such a composition, according to Chevis, the DHA and EPA would treat the inflammation of the respiratory tract or gastrointestinal tract of the mammal. Appeal 2021-000503 Application 14/897,794 10 include an herbal extract of Cordyceps Militaris, among other mushrooms. (Id. at 9.) However, Ra does not indicate that any of the listed herbal extract components much less Cordyceps Militaris were known to have anti- inflammatory properties. Thus, we conclude that there is insufficient evidence in the cited references to support inclusion of Cordyceps Militaris in the composition of Chevis as modified by Kim and Stamets for use in treating a horse with inflammation of the lower respiratory tract or gastrointestinal tract. Moreover, the Examiner has not provided sufficient evidence that it would have been obvious to include the combination of Ganoderma lucidum, Pleurotus eryngii, and Cordyceps Militaris in an amount of about 1000 to 3000 mg per 30 g dose. The Examiner notes that Nair teaches a 20 gram powder total dosage and teaches embodiments of mushroom ranging from 100 mg to 150000 mg. (Final Action 8.) The Examiner then scales those teachings to a 30 gram dosage. (Id.) Even assuming such calculations were correct, Nair does not teach or suggest the combination of mushrooms claimed. Moreover, because we conclude that Nair does not provide a reason to include Ganoderma lucidum in the composition of Chevis, the teachings regarding that amount of mushroom to be included in the Nair composition does not provide one of ordinary skill in the art with a reason to include such an amount of even Ganoderma lucidum in the composition of Chevis much less a combination of Ganoderma lucidum, Pleurotus eryngii, and Cordyceps Militaris in such an amount. Thus, for the foregoing reasons we do not affirm the Examiner’s rejection of claims 11, 14, 17, and 18 as being obvious over Chevis, Perrin, Kim, Downer, Nair, Stamets, and Ra. Appeal 2021-000503 Application 14/897,794 11 The Examiner’s rejection of claim 12 incorporating the teachings of Lowell does not cure the defects noted above. Thus, we also do not affirm the Examiner’s rejection of claim 12 as being obvious over Chevis, Perrin, Kim, Downer, Nair, Stamets, Ra, and Lowell. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 11, 12, 14, 17, 18 112 Indefiniteness 11, 12, 14, 17, 18 11, 14, 17, 18 103 Chevis, Perrin, Kim, Downer, Nair, Stamets, Ra 11, 14, 17, 18 12 103 Chevis, Perrin, Kim, Downer, Nair, Stamets, Ra, Lowell 12 Overall Outcome 11, 12, 14, 17, 18 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation