Klaus SCHMIDT et al.

Patent Trials and Appeals Board

Jan 24, 2022

2022000163 (P.T.A.B. Jan. 24, 2022)

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. 14/912,657 02/18/2016 Klaus Michael SCHMIDT 25384-P44688US01 2743 93756 7590 01/24/2022 Adam R. Stephenson, LTD. 8350 E Raintree Dr., Ste 245 Scottsdale, AZ 85260 EXAMINER JUSTICE, GINA CHIEUN YU ART UNIT PAPER NUMBER 1617 NOTIFICATION DATE DELIVERY MODE 01/24/2022 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): adam@iptech.law ipdocket@iptech.law PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte KLAUS MICHAEL SCHMIDT and DAVID CECIL ROACH __________ Appeal 2022-000163 Application 14/912,657 Technology Center 1600 __________ Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and JOHN E. SCHNEIDER, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134(a) involving claims to a method of providing anesthesia sleep and torso organ-protection. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm but designate our affirmance as a new ground of rejection. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the Real Parties in Interest as the inventors, Klaus Schmidt and David Roach (see Appeal Br. 2). We have considered the Specification of Feb. 18, 2016 (“Spec.”); Non-Final Office Action of Dec. 15, 2020 (“Non-Final Action”); Appeal Brief of June 11, 2021 (“Appeal Br.”); Examiner’s Answer of Aug. 17, 2021 (“Ans.”); and Reply Brief of Oct. 14, 2021 (“Reply Br.”). An oral hearing was held on January 14, 2022. Appeal 2022-000163 Application 14/912,657 2 Statement of the Case Background “Delivering anesthesia is based on delivering at least one of sedation, sleep and pain control. Anesthetics can be gaseous (e.g.[,] xenon and/or nitrous oxide) or liquid (i.e.[,] buprenorphine, propofol, barbiturates, sevoflurane, isoflurane, desflurane)” (Spec. ¶ 7). Some “non-anesthetic protective gases may provide some protection against the side effects of the liquid anesthetic agents, and also against the harmful effects of oxygen deprivation” (id. ¶ 33). The present application relates to the synergistic application of protective gases that provide no anesthetic effects at atmospheric pressure (referred to herein as non-anesthetic protective gases), such as argon and hydrogen sulfide, and liquid anesthetic agents, where the organs are protected by the non-anesthetic protective gases, and the liquid anesthetic agents provide the anesthetic component absent in the non-anesthetic protective gases. (id. ¶ 8). The Claims Claims 1-4 and 10-23 are on appeal. Claim 1 is an independent claim, is representative and reads as follows: 1. A method of providing anesthesia sleep and torso organ- protection to an adult subject in need thereof, comprising co- administering to the subject a non-anesthetic protective gas by inhalation in an amount effective to provide torso organ protection, and a liquid anesthetic agent in an amount effective to provide anesthesia, at normobaric conditions. Appeal 2022-000163 Application 14/912,657 3 The Rejections A. The Examiner rejected claims 1-4, 10-12, and 16-23 under 35 U.S.C. § 103(a) as obvious over Franks,2 Simpkins,3 Irani,4 and Ryang5 (Non-Final Act. 3-5). B. The Examiner rejected claims 13-15 under 35 U.S.C. § 103(a) as obvious over Franks, Simpkins, Irani, Ryang, and Schmidt6 (Non-Final Act. 5-6). A. 35 U.S.C. § 103(a) over Franks, Simpkins, Irani, and Ryang The Examiner finds Franks teaches “co-administering xenon and volatile anesthetic agents such as isoflurane, sevoflurane and desflurane” and teaches “mixing the xenon with another inert gas, such as argon or krypton” (Non-Final Act. 3). The Examiner finds Simpkins teaches a “method of treating seizure, neuronal injuries, and/or brain ischemia in a subject comprising a pharmaceutical composition comprising xenon or argon and a volatile anesthetic such as sevoflurane” and teaches “that argon is shown neuroprotective properties in in vitro models of cerebral ischemia and traumatic brain injury” (id. at 3-4). The Examiner finds Irani teaches 2 Franks et al., US 2009/0311340 A1, published Dec. 17, 2009. 3 Simpkins, US 2012/0087956 A1, published Apr. 12, 2012. 4 Irani et al., Noble Gas (Argon and Xenon)-Saturated Cold Storage Solutions Reduce Ischemia-Reperfusion Injury in a Rat Model of Renal Transplantation, 1 Nephron Extra 272-82 (2011). 5 Ryang et al., Neuroprotective effects of argon in an in vivo model of transient middle cerebral artery occlusion in rats, 39 Critical Care Medicine 144853 (2011) Abstract only. 6 Schmidt, US 2010/0031961 A1, published Feb. 11, 2010. Appeal 2022-000163 Application 14/912,657 4 “Argon- or Xenon-saturated cold-storage solution preserve renal architecture and function following transplantation by reducing ischemia-reperfusion injury” and Ryang teaches “argon has neuroprotective effects in an in vivo experimental rat model of acute focal cerebral ischemia” (id. at 4). The Examiner finds it “obvious to substitute xenon with argon as 1) Simpkins and Irani teach in vitro and in vivo study showing neuroprotective effects of argon and 2) Irani also teaches that either argon or xenon reduces ischemia-reperfusion injury in renal transplantation in rat models” (Non- Final Act. 4). Appellant contends “the step of substituting xenon for argon is contrary to the intended purpose of Franks, and such a modification of Franks would render the reference inoperable for its intended purpose” (Appeal Br. 8). Appellant contends the “Examiner’s substitution theory is clearly based upon impermissible hindsight and not the teachings of the applied references” (id. at 8). Appellant contends “the Examiner’s ‘substitution’ of xenon with argon theory in regard to Franks is directly rebutted by Faure.7 Also, Faure is a direct rebuttal to the results set forth in Irani based upon a rat model that xenon and argon saturated cold storage solutions are similar in function” (id. at 10). The issue with respect to this rejection is: Does a preponderance of the evidence of record support the Examiner’s conclusion that the prior art 7 Faure et al., Effectiveness of pure argon for renal transplant preservation in a preclinical pig model of heterotopic autotransplantation, 14:40 J. Transl. Med. 1-11 (2016). Appeal 2022-000163 Application 14/912,657 5 suggests co-administering argon with a liquid anesthetic agent for neuroprotection during anesthesia? Findings of Fact 1. Franks teaches “the invention seeks to provide anesthetic combinations for use in neonates which comprise an agent capable of preventing or alleviating the adverse effects of known anesthetic agents such as isoflurane and/or sevoflurane, and/or desflurane” (Franks ¶ 11). 2. Franks teaches “the use of (i) xenon, and (ii) an anesthetic selected from isoflurane, sevoflurane and desflurane, in the preparation of a medicament for providing anesthesia in a subject, preferably a neonatal subject, wherein the amount of xenon is sufficient to alleviate or prevent anesthetic-induced injury” (Franks ¶ 63). 3. Franks teaches “the neonatal subject receives xenon indirectly as part of an anesthetic or analgesic regimen administered to the mother during labour, or during cesarean section. Preferably, the medicament is for preventing and/or alleviating one or more anesthetic-induced neurological deficits in a subject, preferably a neonatal subject. (Franks ¶¶ 25-26). 4. Franks teaches “[i]n another preferred embodiment, the xenon is mixed with another inert gas, such as argon or krypton” (Franks ¶ 82). 5. Simpkins teaches a “method for treating seizure or neuronal injury using xenon or argon . . . Xenon has been used as a general anaesthetic” (Simpkins ¶ 121). 6. Simpkins teaches that: “Argon (Ar) is another noble gas that has shown neuroprotective properties in in vitro models of cerebral ischemia and traumatic brain injury” (Simpkins ¶ 124). Appeal 2022-000163 Application 14/912,657 6 7. Simpkins teaches that in “another embodiment, xenon or argon is used in conjunction with another volatile anesthetic, such as sevoflurane” (Simpkins ¶ 125). 8. Irani teaches: “Argon- or xenon-saturated cold-storage solution preserved renal architecture and function following transplantation by reducing ischemia-reperfusion injury” (Irani 273, abstract). 9. Irani teaches the “biochemical results presented above demonstrate that storage of rat kidneys in an argon-saturated solution improved renal function after transplantation, compared to storage in solutions saturated with xenon, nitrogen, or air” (Irani 279). 10. Ryang teaches “argon’s neuroprotective effects in an in vivo experimental rat model of acute focal cerebral ischemia. Animals breathing spontaneously 50 vol% argon 1 hr after induction of transient middle cerebral artery occlusion for 1 hr by face mask showed significantly reduced infarct volumes and composite adverse outcomes” (Ryang, abstract). Principles of Law A prima facie case for obviousness “requires a suggestion of all limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) and “a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Analysis We adopt the Examiner’s findings of fact and conclusions of law (see Non-Final Act. 3-5; FF 1-10) and agree that the combination of prior art renders the claims obvious. We address Appellant’s arguments below. Appeal 2022-000163 Application 14/912,657 7 Appellant contends there is no factual or legal support for the Examiner’s proposed substitution of xenon as used in Franks with argon. Claim 1 provides for the coadministration of a nonanesthetic protective gas and a liquid anesthetic agent . . . . It would not have been obvious to substitute an anesthetic agent (xenon) with a non- anesthetic agent (argon). (Appeal Br. 7-8). We find this argument unpersuasive because Franks motivates an ordinary artisan to use “an agent capable of preventing or alleviating the adverse effects of known anesthetic agents” (FF 1) and Simpkins teaches “Argon (Ar) is another noble gas that has shown neuroprotective properties” (FF 6). Irani also teaches the use of argon protected organs during transplant and even “improved renal function after transplantation, compared to storage in solutions saturated with xenon” (FF 8). Ryang teaches that when breathing 50% argon, rats were protected from infarcts (FF 9). Simpkins, Irani, and Ryang therefore teach that argon is known as an organ protective agent (FF 4, 7-9). Thus, the prior art demonstrates that argon is equivalent to xenon as an neuroprotective agent that alleviates adverse effects of anesthetic agents motivated by Franks and teaches that in some instances, argon may be superior to xenon (FF 1, 3, 6, 8). We therefore agree with and affirm the Examiner on the substitution rationale. See KSR, 550 U.S. at 417 (“If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability” and finds obvious “the simple substitution of one known element for another.”) We also note that claim 1 uses the term “comprising.” See Georgia- Pacific Corp. v. US. Gypsum Co., 195 F.3d 1322, 1327 (Fed. Cir. 1999) Appeal 2022-000163 Application 14/912,657 8 (The transitional term “comprising” is “inclusive or open-ended and does not exclude additional, unrecited elements or method steps”). The broadest reasonable interpretation of the claims consistent with the Specification does not exclude the use of both xenon and argon. See In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000) (“[D]uring examination proceedings, claims are given their broadest reasonable interpretation consistent with the specification”). Franks teaches the use of xenon and argon together (FF 4) and none of Appellant’s claims currently exclude the use of anesthetics like sevoflurane with both argon and xenon as suggested by Franks (FF 4). We note that this reasoning does not apply to claims 20 and 23, which exclude the use of xenon. Because this “comprising” reasoning differs from that of the Examiner, we will designate this as a New Ground of Rejection. Appellant contends “the step of substituting xenon for argon is contrary to the intended purpose of Franks, and such a modification of Franks would render the reference inoperable for its intended purpose” (Appeal Br. 8). We find this argument unpersuasive because Franks teaches that “[p]referably, the [xenon] medicament is for preventing and/or alleviating one or more anesthetic-induced neurological deficits in a subject” (FF 3). Indeed, Franks teaches “the invention seeks to provide anesthetic combinations for use in neonates which comprise an agent capable of preventing or alleviating the adverse effects of known anesthetic agents such as isoflurane and/or sevoflurane, and/or desflurane” (FF 1). Thus, contrary to Appellant’s framing of the invention, Franks frames the invention as combining a known anesthetic such as sevoflurane with another agent that alleviates neurological deficits. Franks’ statement of invention is open to Appeal 2022-000163 Application 14/912,657 9 any known neuroprotective agent, and is not limited in any way to xenon (see FF 1). We therefore do not agree with Appellants that “any proposed substitute for xenon in Franks must possess both neuroprotective and anesthetic properties” (Reply Br. 2) because the primary purpose for using xenon in Franks is to preventing or alleviating the adverse effects of known anesthetic agents and Simpkins, Irani, and Ryang teach that argon is at least equivalent, if not better, than xenon at preventing such adverse effects (FF 5-10). As Franks discusses the invention, Franks teaches “the use of (i) xenon, and (ii) an anesthetic . . . wherein the amount of xenon is sufficient to alleviate or prevent anesthetic-induced injury” (FF 2). Franks does not require the amount of xenon to be sufficient to cause anesthesia, but rather to prevent adverse effects caused by anesthetic agents such as sevoflurane, which is clearly the role of xenon in the invention. Thus, argon would be entirely appropriate as a substitute and function for the central intended purpose of Franks of preventing or alleviating anesthetic adverse effects. Moreover, we note that “[n]othing in the prior art teaches that the proposed modification would have resulted in an ‘inoperable’ process.” In re Urbanksi, 809 F.3d 1237, 1244 (Fed. Cir. 2016). That is, Appellant provides no evidence that replacement of xenon with argon would not have allowed for the anesthetic to function or that argon would not have had the expected neuroprotective effect (FF 5-10). See In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s argument in a brief cannot take the place of evidence.”). Appeal 2022-000163 Application 14/912,657 10 Appellant contends the “Examiner’s substitution theory is clearly based upon impermissible hindsight and not the teachings of the applied references” (Appeal Br. 8). We are fully aware that hindsight bias may plague determinations of obviousness, Graham v. John Deere Co., 383 U.S. 1, 36 (1966). However, we are also mindful that the Supreme Court has clearly stated that the “combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR, 550 U.S. at 416. In this case, we agree with the Examiner that the ordinary artisan would have reasonably found it obvious to either add argon to the composition, or to substitute argon for xenon in the composition because argon was a known equivalent neuroprotective agent (FF 6) in anesthetic compositions. Specifically, Simpkins teaches that “xenon or argon is used in conjunction with another volatile anesthetic, such as sevoflurane” (FF 7) and “[a]rgon (Ar) is another noble gas that has shown neuroprotective properties” (FF 6). Thus, the use of argon with sevoflurane for anesthesia and neuroprotection was expressly suggested by the prior art, and would not have been hindsight. Appellant contends that “the Examiner’s ‘substitution’ of xenon with argon theory in regard to Franks is directly rebutted by Faure. Also, Faure is a direct rebuttal to the results set forth in Irani based upon a rat model that xenon and argon saturated cold storage solutions are similar in function” (Appeal Br. 10). Appellant contends “Faure concluded that ‘Xenon-Celsior was detrimental, no animal surviving by day-8 in a context where functional recovery, renal tissue properties and the antioxidant and inflammation Appeal 2022-000163 Application 14/912,657 11 responses were significantly altered. Thus, the positive effects of argon were not attributable to the noble gases as a group’” (id. at 12). We find Appellant’s reliance on Faure unpersuasive of non- obviousness. Faure teaches, consistent with the teachings of Simpkins, Irani, and Ryang, that “argon improved early functional recovery, graft quality and survival” (Faure 1, abstract). Indeed, Faure cites Ryang when stating: “While argon was found to exert a protective effect on myocardial/cerebral ischemia and traumatic brain injury [11, 20-23], the protective effect of this gas in renal transplantation is poorly documented” (Faure 7, col. 2; reference 21 is Ryang). Thus, Faure acknowledges that argon exerts a neuroprotective effect and would be desirable to use when such an effect is desired. We recognize that Faure finds, in the context of renal transplantation, that while “pure argon had beneficial effects . . . the use of xenon was dramatically detrimental” (Faure 8, col. 1). However, this certainly does not teach away from the use of argon, and does not address the teachings of the prior art that both xenon and argon protect the nervous system (FF 3, 5, 9, 10). Moreover, unlike Simpkins who teaches argon as neuroprotective when combined with anesthetics, Faure is drawn to organ preservation for transplant, and is therefore more distantly related to claim 1 which uses a non-anesthetic protective gas like argon in a method of anesthesia. Claims 20 and 23 We find Appellant’s asserted arguments for claims 20 and 23 unpersuasive as they do not overcome the Examiner’s rejection for the reasons already discussed. Claim 20 simply excludes the use of xenon and the Examiner’s rationale already replaces xenon with argon as an obvious Appeal 2022-000163 Application 14/912,657 12 substitute. As to claim 23, Appellant contends that “Claim 23 provides for the use of argon as the non-anesthetic protective gas” (Appeal. Br. 12). That is obvious consistent with the reasoning in the Examiner’s obviousness rejection. Conclusion of Law A preponderance of the evidence of record support the Examiner’s conclusion that the prior art suggests co-administering argon with a liquid anesthetic agent for neuroprotection during anesthesia. B. 35 U.S.C. § 103(a) Franks, Simpkins, Irani, Ryang, and Schmidt Having affirmed the obviousness rejection of claim 1 over Franks, Simpkins, Irani, and Ryang for the reasons given above, we also find that the further combination with Schmidt renders the rejected claims obvious for the reasons given by the Examiner (see Non-Final Act. 5-6). We note that the Examiner inadvertently omitted Irani, since we are designating the first rejection as a new ground of rejection, to ensure fairness, we will also designate this rejection as a new ground of rejection. Appeal 2022-000163 Application 14/912,657 13 DECISION SUMMARY We affirm the Examiner’s rejections based on the “substitution” rationale. We designate our “comprising” rationale as a new ground of rejection. In summary: Claims Rejected 35 U.S.C. § Basis Affirmed Reversed New Ground 1-4, 10- 12, 16- 23 103 Franks, Simpkins, Irani, Ryang 1-4, 10- 12, 16- 23 1-4, 10-12, 16-19, 21- 23 13-15 103 Franks, Simpkins, Irani, Ryang, Schmidt 13-15 13-15 Overall Outcome 1-4, 10- 23 1-4, 10-19, 21-23 This decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b). Section 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” Section 41.50(b) also provides: When the Board enters such a non-final decision, the appellant, within two months from the date of the decision, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new Evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the prosecution will be remanded to the examiner. The new ground of rejection is binding upon the examiner unless an amendment or new Appeal 2022-000163 Application 14/912,657 14 Evidence not previously of Record is made which, in the opinion of the examiner, overcomes the new ground of rejection designated in the decision. Should the examiner reject the claims, appellant may again appeal to the Board pursuant to this subpart. (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same Record. The request for rehearing must address any new ground of rejection and state with particularity the points believed to have been misapprehended or overlooked in entering the new ground of rejection and also state all other grounds upon which rehearing is sought. Further guidance on responding to a new ground of rejection can be found in the Manual of Patent Examining Procedure § 1214.01. AFFIRMED; 37 C.F.R. § 41.50(b)