Kagaya, Shinji

Patent Trials and Appeals BoardJun 18, 2021

2020005092 (P.T.A.B. Jun. 18, 2021)

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. 14/783,295 10/08/2015 Junichi HIRAHASHI 10662-002US1 9567 96039 7590 06/18/2021 Meunier Carlin & Curfman LLC 999 Peachtree Street NE Suite 1300 Atlanta, GA 30309 EXAMINER REYNOLDS, FRED H ART UNIT PAPER NUMBER 1658 NOTIFICATION DATE DELIVERY MODE 06/18/2021 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): docketing@mcciplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte JUNICHI HIRAHASHI, YASUTERU URANO, KOUSHU OKUBO, MAKO KAMIYA, and SHINJI KAGAYA ____________ Appeal 2020-005092 Application 14/783,295 Technology Center 1600 ____________ Before DONALD E. ADAMS, ERIC B. GRIMES, and FRANCISCO C. PRATS, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s decision to reject claims 1–3, 6–9, and 14 (Appeal Br. 8). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as “Shinji Kagaya” (Appellant’s April 10, 2020, Appeal Brief (Appeal Br.) 4). Appeal 2020-005092 Application 14/783,295 2 STATEMENT OF THE CASE Appellant’s disclosure “relates to a composition for inhibiting formation of leukocyte extracellular traps containing lactoferrin as an active ingredient, and a composition for treating a disease associated with the formation of the leukocyte extracellular traps” (Spec. ¶ 1). “NETs (neutrophil extracellular traps) are extracellular structures that release mesh- like structures, capture bacteria, true fungi, parasitic worms and viruses, and exhibit an antibacterial action when neutrophils are activated by contamination with bacteria” (id. ¶ 2). Appellant’s claim 1 is reproduced below: 1. A method for treating a disease associated with formation of leukocyte extracellular traps, comprising administering a composition for inhibiting formation of leukocyte extracellular traps to a patient in need thereof, wherein said composition comprises lactoferrin and a pharmacologically acceptable carrier, and said disease is selected from the group consisting of microscopic polyangitis, allergic granulomatosis-angitis, local Shwartzman reaction, acute kidney injury (AKI) accompanied by ischemia reperfusion injury, and disseminated intravascular coagulation, wherein the composition inhibits the formation of leukocyte extracellular traps, and wherein the lactoferrin is a protein having the amino acid sequence of SEQ ID NOS: 1 to 5, wherein the leukocytes are selected from the group consisting of neutrophils, eosinophil granulocytes, basophil granulocytes, monocytes, macrophages, and mast cells. (Appeal Br. 23.) Appeal 2020-005092 Application 14/783,295 3 Claims 1–3, 6–9, and 14 stand rejected under 35 U.S.C. § 103 as unpatentable over the combination of Gregory2 and Scholzen.3,4 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 1. Gregory “relates to methods for modulating granulocyte, for example neutrophil, activation and migration, use of such methods in the treatment of inflammatory diseases and the treatment of cancer, and compositions which may be employed in such methods and uses” (Gregory ¶ 1; see Ans. 4). FF 2. Gregory discloses “that lactoferrin acts as a potent inhibitor of granulocyte migration,” which is “achieved by increasing the amount of lactoferrin in the vicinity of said cells and/or granulocytes,” by administration of lactoferrin . . . to said cells,” wherein “the granulocytes are neutrophils or eosinophils” (Gregory ¶¶ 5, 8–10; see generally Ans. 4). 2 Gregory et al., US 2011/0182914 A1, published July 28, 2011. 3 T. E. Scholzen et al., α-Melanocyte Stimulating Hormone Prevents Lipopolysaccharide-Induced Vasculitis by Down-Regulating Endothelial Cell Adhesion Molecule Expression, 144 Endocrinology 360–370 (2003). 4 Examiner entered Appellant’s December 10, 2019, After Final Amendment, which, inter alia, canceled Appellant’s claims 5 and 11 (see Examiner’s December 26, 2019, Advisory Action). Therefore, we do not include Appellant’s canceled claims 5 and 11 in our deliberations (cf. Examiner’s May 1, 2020 Examiner’s Answer (Ans.) 4 (Examiner’s statement of the rejection includes Appellant’s canceled claims 5 and 11)). Appeal 2020-005092 Application 14/783,295 4 FF 3. Gregory discloses that its invention may be used to treat any disease in which granulocytes contribute to the disease pathology. In one embodiment the disease is a disease in which granulocytes are principally responsible for the disease pathology. Such diseases include, but are not limited to those characterised by leukocytosis, neutrophilia, granulocytosis, or eosinophilia. Such conditions may result in symptoms such as inflammation, allergic reactions, drug reactions, cardiac abnormalities etc. Diseases for which the invention may find use include those mediated by neutrophils, eosinophils, basophils or two or more thereof. The invention may be used to treat diseases in which modulation of granulocyte, for example neutrophil, activation and/or infiltration may be therapeutically useful. In a particular embodiment of the invention, modulation of neutrophil activity may be used for the treatment of inflammatory diseases, such as chronic inflammatory diseases, associated with excessive neutrophil infiltration and neutrophil-mediated tissue damage and [remodeling]. . . . Examples of such chronic inflammatory disease include . . . vasculitis. (Gregory ¶¶ 70–71; see also id. ¶ 19 (Gregory discloses that vasculitis is an inflammatory disease that can be treated by its disclosed method); see Ans. 4.) FF 4. Gregory discloses: [L]actoferrin modulators . . . [that] are suitably administered to an individual in a “therapeutically effective amount”, this being sufficient to show benefit to the individual. The actual dosage regimen will depend on a number of factors including the condition being treated, its severity, the patient being treated, the agents being used, and will be at the discretion of the physician. (Gregory ¶ 85; see id. ¶ 33 (Gregory discloses that “a lactoferrin modulator may be a lactoferrin enhancer,” such as lactoferrin, which “specifically increase[s] lactoferrin concentration”); see Ans. 4.) Appeal 2020-005092 Application 14/783,295 5 FF 5. Gregory discloses pharmaceutical compositions comprising a lactoferrin modulator and a pharmaceutically acceptable excipient or carrier (Gregory ¶ 77). FF 6. Examiner finds that Gregory fails to disclose that the term vasculitis encompasses a genus that includes local Shwartzman reaction (see generally Ans. 5). FF 7. Scholzen discloses that cutaneous vasculitis is synonymous with local Shwartzman reaction (see Scholzen, Abstract; see Ans. 4–5). ANALYSIS Appellant’s claim 1 is reproduced above. The method of treating a local Shwartzman reaction, set forth in Appellant’s claim 1, comprises the administration of a composition comprising lactoferrin and a pharmacologically acceptable carrier to a patient in need thereof. Gregory discloses a method of treating vasculitis, which, as Scholzen explains, includes local Shwartzman reaction, by administering, to a patient in need thereof, a composition comprising lactoferrin and a pharmacologically acceptable carrier (see FF 1–5, 7). Therefore, we agree with Examiner’s conclusion that, at the time Appellant’s invention was made, it would have been prima facie obvious to use Gregory’s lactoferrin to treat vasculitis, such as a local Shwartzman reaction (see Ans. 5). Gregory further discloses that lactoferrin inhibits the migration of granulocytes, including neutrophils or eosinophils (FF 2). In addition, there is no dispute on this record that Gregory’s lactoferrin is a protein having the amino acid sequence of Appellant’s SEQ ID NOS: 1 to 5. Appeal 2020-005092 Application 14/783,295 6 We appreciate that the combination of Gregory and Scholzen does not address the inhibition of leukocyte extracellular trap formation. Gregory and Scholzen, however, disclose the treatment of vasculitis, which includes local Shwartzman reaction, which is a disease associated with formation of leukocyte extracellular traps and, thus, the composition and treatment method made obvious by the combination of Gregory and Scholzen would necessarily inhibit the formation of, and treat a disease associated with the formation of, leukocyte extracellular traps. “[I]t is elementary that the mere recitation of a newly discovered function or property, inherently possessed by things in the prior art, does not cause a claim drawn to those things to distinguish over the prior art.” In re Swinehart, 439 F.2d 210, 212–13 (CCPA 1971); see In re Dillon, 919 F.2d 688, 697 (Fed. Cir. 1990) (“[I]t is not required . . . that the prior art disclose or suggest the properties newly- discovered by an applicant in order for there to be a prima facie case of obviousness.”); Ex parte Obiaya, 227 USPQ 58, 60 (BPAI 1985) (“The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.”). For the foregoing reasons, we are not persuaded by Appellant’s contentions regarding “leukocyte extracellular trap formation” or the differences between various types of leukocytes (see e.g. Appeal Br. 9 (Appellant contends that “Gregory fails to teach or suggest any effects on leukocyte extracellular trap formation”)); id. at 10 (Appellant contends that “Scholzen fails to teach or suggest any effects on leukocyte extracellular trap formation”); id. at 14 (Appellant contends that “before the present application, no one else had shown lactoferrin as a ‘therapeutic drug for a Appeal 2020-005092 Application 14/783,295 7 disease caused by the formation of leukocyte extracellular traps’”); id. at 16 (Appellant contends that because leukocytes discussed in Gregory differ from those discussed in Scholzen “there is no motivation in Gregory or Scholzen, alone or in combination, for a person skilled in the art to use lactoferrin to treat Shwartzman reaction”); see also Reply Br. 3 (Appellant contends “there is no motivation in Gregory or Scholzen, alone or in combination, for a person skilled in the art to use lactoferrin to treat Schwartzman reaction”)). See In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s argument in a brief cannot take the place of evidence.”). We are not persuaded by Appellant’s contention that Bournazou5 and Legrand6 demonstrate unpredictability in this art and establish that “there was no reasonable expectation of success in combining Gregory and Scholzen to arrive at the present invention (Appeal Br. 18–19). Although Bournazou discloses that “lactoferrin is identified here as a promising therapeutic target for a range of chronic inflammatory conditions including vasculitis” (Bournazou 29), we do not find a disclosure in Bournazou of “merely speculative ‘metaphorical darts’” as asserted by Appellant (see Appeal Br. 18). In addition, Appellant recognizes that Legrand describes “lactoferrin as an anti-inflammatory agent” (see id. at 18–19 (citing Legrand 254)). It is not necessary for the combination of Gregory and Scholzen to disclose the precise mechanism through which lactoferrin acts to treat 5 Bournazou et al., Apoptotic human cells inhibit migration of granulocytes via release of lactoferrin, 119 The Journal of Clinical Investigation 20–32 (2009). 6 Legrand, Lactoferrin, a key molecule in immune and inflammatory processes, 90 Biochem. Cell Biol. 252–268 (2012). Appeal 2020-005092 Application 14/783,295 8 vasculitis, i.e. local Shwartzman reaction, in order to sustain an obviousness rejection. The discovery of the cause of a problem . . . does not always result in a patentable invention. Although there may be patentable invention where the solution is obvious after the discovery of the cause of the problem, . . . a different situation exists where the solution is obvious from prior art [w]hich contains the same solution for a similar problem. . . . [A] structure suggested by the prior art, and, hence, potentially in the possession of the public, is [not] patentable . . . because it also possesses an [i]nherent, but hitherto unknown, function which [Appellant claims] to have discovered. . . . A patent on such a structure would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Wiseman, 596 F.2d 1019, 1023 (CCPA 1979); see also In re Kubin, 561 F.3d 1351, 1357–58 (Fed. Cir. 2009) (If a process would have been obvious, reciting an inherent result does not make a claim to the process non-obvious.). Thus, we are not persuaded by Appellant’s contention that the field is unpredictable because although Legrand discloses that “[i]n regard to allergy, [lactoferrin] seems to play important anti-inflammatory roles,” “[t]he anti-inflammatory roles of [lactoferrin] in noninfectious pathologies, such as allergy, rheumatoid arthritis, and inflammatory bowel disorders, are not thoroughly elucidated” (see Legrand 255; see also Appeal Br. 19 (citing Legrand 255); see also id. (citing Legrand 256); Reply Br. 4– 5). As discussed above, Gregory discloses a method of treating vasculitis, which, as Scholzen explains, includes local Shwartzman reaction, by administering, to a patient in need thereof, a composition comprising lactoferrin and a pharmacologically acceptable carrier (see FF 1–5, 7). Prior Appeal 2020-005092 Application 14/783,295 9 art is presumed to be enabled. See In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012) (“[A] prior art printed publication cited by an examiner is presumptively enabling barring any showing to the contrary by a patent applicant or patentee.”). Therefore, we are not persuaded by Appellant’s contention that “Gregory fails to teach or suggest that lactoferrin will exert therapeutic effects upon application to humans” (Appeal Br. 9; see also id. at 17 (Appellant contends that “Gregory fails to teach or suggest that lactoferrin will exert therapeutic effects upon application to humans”); id. at 13 (Appellant contends that “neither of the prior art references (Gregory or Scholzen) provide a teaching or suggestion that lactoferrin would likely succeed in treating local Shwartzman reaction”); id. at 22 (Appellant contends that Examiner’s obviousness rejection provides only “a possibility that the therapy could work,” not a “reasonable expectation of success.”)). See also Pearson, 494 F.2d at 1405 (“Attorney’s argument in a brief cannot take the place of evidence.”). For the foregoing reasons, we are not persuaded by Appellant’s contention that “there is no direction or motivation provided to steer one of skill in the art to take lactoferrin as disclosed in Gregory and combine this reference with the additional cited reference Scholzen” (Appeal Br. 11). For the foregoing reasons, we are not persuaded by Appellant’s contention that “Gregory does not describe any experimental data indicating that lactoferrin can be used for the treatment of vasculitis” (Appeal Br. 12). We are not persuaded by Appellant’s contention that “the statement in Gregory that lactoferrin can be used for the treatment of vasculitis is merely a speculation” and “there was simply no reasonable expectation of success in arriving at the currently claimed invention” (Appeal Br. 12–13; see also Appeal 2020-005092 Application 14/783,295 10 Reply Br. 5 (Appellant contends that “[t]he effectiveness of the treatment of vasculitis by lactoferrin is not demonstrated in Gregory” and is instead, “a speculation”)). See Pearson, 494 F.2d at 1405 (“Attorney’s argument in a brief cannot take the place of evidence.”). For the foregoing reasons, we are not persuaded by Appellant’s contention that Examiner improperly combined Gregory with Scholzen because, although Scholzen discloses that local Shwartzman reaction is a type of vasculitis, Scholzen utilized an alternative to lactoferrin “for the treatment of vasculitis” and “does not specifically teach neutrophils, eosinophils, basophils, monocytes, macrophages or mast cells as recited in” Appellant’s claim 1 (Appeal Br. 14–15; see also Reply Br. 4). For the foregoing reasons, we are not persuaded by Appellant’s contention that “the state of the art was unpredictable, and thus there was no reasonable expectation of success” (Appeal Br. 16). For the foregoing reasons, we are not persuaded by Appellant’s contention that Examiner relied on improper hindsight reconstruction (see Appeal Br. 20–21; see also Reply Br. 5–6). CONCLUSION The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness. The rejection of claim 1 under 35 U.S.C. § 103 as unpatentable over the combination of Gregory and Scholzen is affirmed. Claims 2, 3, 6–9, and 14 are not separately argued and fall with claim 1. Appeal 2020-005092 Application 14/783,295 11 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–3, 6–9, 14 103 Gregory, Scholzen 1–3, 6–9, 14 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) (2019). AFFIRMED