SHARE-X CO., LTD. et al.Download PDFPatent Trials and Appeals BoardMay 28, 20202019005238 (P.T.A.B. May. 28, 2020) 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. 14/912,013 02/12/2016 Yoshiyuki Nasu 5703K-000008-US-NP 1043 28997 7590 05/28/2020 Harness Dickey (St. Louis) 7700 Bonhomme, Suite 400 St. Louis, MO 63105 EXAMINER YU, HONG ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 05/28/2020 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): bkamer@hdp.com stldocket@hdp.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte YOSHIYUKI NASU and SUSUMU FURUHASHI __________ Appeal 2019-005238 Application 14/912,013 Technology Center 1600 __________ Before DONALD E. ADAMS, FRANCISCO C. PRATS, and MICHAEL A. VALEK, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 52, 53, 69, 70, 72, and 73. 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 states that the real party in interest is Share-X Co., Ltd., having a place of business in 19, Nakasaiwaicho 2-Chome, Saiwai-Ku, Kawasaki-Shi Kanagawa, Japan 212-0012. Appeal Br. 3. Appeal 2019-005238 Application 14/912,013 2 STATEMENT OF THE CASE The following rejections are before us for review: (1) Claims 52, 53, and 69, under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over Huang2 and Matsuo3 (Final Act. 3–5 (entered Oct. 15 2018)); and (2) Claims 70, 72, and 73, under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over Huang, Matsuo, and Conceição4 (Final Act. 5–6). Appellant’s claim 52 is representative and reads as follows: 52. A method for preventing or managing infection of microorganism comprising: administering to a human subject in need thereof an effective amount of an antimicrobial agent comprising a hydrogen molecule, wherein the hydrogen molecule is adsorbed on a coral powder or coral calcium. Appeal Br. 13. DISCUSSION The Examiner’s Prima Facie Case In rejecting claims 52, 53, and 69, the Examiner cited Huang as disclosing that molecular hydrogen (H2) has a “therapeutic effect on infection and sepsis in human and the delivery including drinking H2 containing water (entire reference, especially abstract and the paragraph bridges left and right column on page 978).” Final Act. 3. 2 Chien-Sheng Huang et al., Recent advances in hydrogen research as a therapeutic medical gas, 44 FREE RADICAL RESEARCH 971–982 (2010). 3 US 8,168,245 B2 (issued May 1, 2012). 4 R.A. Conceição et al., Human sepsis-associated Escherichia coli (SEPEC) is able to adhere to and invade kidney epithelial cells in culture, 45 BRAZILIAN J. MED. BIOL. RES. 417–424 (2012). Appeal 2019-005238 Application 14/912,013 3 The Examiner found that Huang differs from the rejected claims in that Huang does not “specify the H2 being absorbed on coral powder.” Final Act. 4. As evidence that the claimed process would have been obvious despite this difference between Huang and the claims, the Examiner cited Matsuo, “who teach coral powder with H2 being adsorbed and retained in the micropores of coral powder as a supplementary food for H2 being gradually release and functioning in vivo (entire reference, especially abstract, the paragraph bridges column 2 and 3, and claim 1).” Id. Based on the references’ combined teachings, the Examiner reasoned that a skilled artisan would have considered it obvious to “combine the teachings in Huang et al. and Matsuo et al. to adsorb H2 in the teachings taught by Huang et al. into coral powder.” Final Act. 4. In particular, the Examiner reasoned, “[c]oral powder being suitable for adsorbing and retaining H2 was well known to a person of ordinary skill in the art at the time of the invention,” and the “motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose for human consumption with the advantage of being convenient for shipping, storing, and consuming anywhere.” Final Act. 4–5. Therefore, the Examiner concluded, “[a]bsent some demonstration of unexpected result it would have been obvious to one of ordinary skill in the art to adsorb H2 in the teachings taught by Huang et al. into coral powder with predictable results to one of ordinary skill in the art at the time of the invention.” Id. at 5. Appeal 2019-005238 Application 14/912,013 4 Analysis As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden . . . of presenting a prima facie case of unpatentability. . . . After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. In the present case, having carefully considered the evidence and arguments presented by Appellant and the Examiner, Appellant does not persuade us that the Examiner’s conclusion of obviousness is not supported by a preponderance of the evidence. Appellant’s representative claim 52 recites a method “for preventing or managing infection of microorganism.” Appeal Br 13. To prevent or manage infection, claim 52 requires performance of only a single process step: “administering to a human subject in need thereof an effective amount of an antimicrobial agent comprising a hydrogen molecule, wherein the hydrogen molecule is adsorbed on a coral powder or coral calcium.” Appeal Br. 13. Appellant does not persuade us that the Examiner erred in finding that that the combination of Huang and Matsuo would have suggested administering an effective amount of coral-bound molecular hydrogen to a human in need of prevention or management of an infection by a microorganism. Specifically, Huang discloses that molecular hydrogen, in the form of hydrogen gas, was found to have beneficial results in a mouse model of one type of human infection undisputedly caused by microorganisms, polymicrobial sepsis: Appeal 2019-005238 Application 14/912,013 5 Excessive production of ROS [(reactive oxygen species)] and reduced antioxidant defense systems play an important role in the pathogenesis of infection and sepsis. . . . Xie et al et al. in 2009 . . . demonstrated that hydrogen gas treatment ameliorated polymicrobial sepsis and sepsis-associated organ damage in mice through the ability of hydrogen gas to decrease the levels of oxidative products, increase the activities of antioxidant enzymes and reduce the levels of high-mobility group box 1 (HMGB1) in serum and tissue. Huang 978 (citations omitted). Based on this and similar findings in animal models of other diseases, Huang suggests administering molecular hydrogen to treat disorders, such as polymicrobial sepsis, in humans. See Huang 971 (“It is not an overstatement to say that hydrogen’s impact on therapeutic and preventive medicine could be enormous in the future.” (Abstract)); see also id. at 973 (“Hydrogen therapy may spare the innate immune system and allow phagocytosis of infecting organisms. It is not clear whether a similar reaction preferentially occurs under complex biological conditions. In fact, experimental studies have demonstrated that hydrogen has potent therapeutic efficacies on both parasite infection and polymicrobial sepsis.” (emphasis added; citations omitted)); id. at 979 (“Although further investigations are required, hydrogen may have a huge impact as a novel and innovative therapeutic tools for unmet medical needs that currently cause considerable health burdens.”). Huang discloses that oral administration is a suitable method of obtaining the therapeutic effects of molecular hydrogen: Although inhaled hydrogen gas may act more rapidly, this method of administration is not practical in daily life or suitable for continuous consumption for preventive or therapeutic use. In contrast, solubilized hydrogen may be beneficial since it is a Appeal 2019-005238 Application 14/912,013 6 portable, easily administered and safe means of delivering molecular hydrogen. Drinking hydrogen-rich water (HW) has a comparable effects to hydrogen inhalation. Huang 973 (emphasis added; citations omitted). Given these disclosures, we agree with the Examiner that Huang suggests orally administering, to a human suffering from an infection such as polymicrobial sepsis, molecular hydrogen in an amount effective to ameloriate the infection. We therefore also agree with the Examiner that Huang suggests administering molecular hydrogen, the therapeutic agent recited in representative claim 52, to a patient encompassed by claim 52, in an amount encompassed by claim 52. Although Huang does not describe administering the molecular hydrogen in the coral-bound form required by claim 52, Matsuo discloses that coral with hydrogen gas adsorbed thereon was known in the art to be useful as a food supplement: A large quantity of a hydrogen gas is adsorbed and retained in a coral powder obtained by the method of the present invention as compared with common coral powders, and therefore, when the coral powder is introduced into the body as a supplementary food, a hydrogen gas is taken up into the body, and a hydroxy radical (.OH), an active oxygen species that is very highly reactive and very toxic, is eliminated . . . so tissue damage by hydroxy radicals can be prevented in an organism. Matsuo 3:61–4:2. Thus, to summarize, Huang suggests orally administering, to a human suffering from polymicrobial sepsis, molecular hydrogen in an amount effective to ameliorate the infection, and Matsuo teaches that a useful method of orally administering hydrogen gas to humans was in the form of a coral powder to which the hydrogen has been adsorbed. We therefore agree Appeal 2019-005238 Application 14/912,013 7 with the Examiner that a skilled artisan had a good reason for, and a reasonable expectation of success in, orally administering Matsuo’s hydrogen-bearing coral powder to a human suffering from polymicrobial sepsis, in an amount effective to ameliorate the infection. We therefore also agree with the Examiner that the process recited in Appellant’s representative claim 52 would have been prima facie obvious to a skilled artisan. Appellant’s arguments do not persuade us to the contrary. In particular, Appellant does not persuade us that when representative claim 52 is given its broadest reasonable interpretation consistent with the Specification, claim 52 does not encompass the process suggested by Huang and Matsuo. See Appeal Br. 4–6; Reply Br. 2. As noted above, the preamble of claim 52 recites “[a] method for preventing or managing infection of microorganism.” Appeal Br. 13. We acknowledge the related disclosure in Appellant’s Specification, stating as follows: The term “prevention of infection with microorganisms” as used herein refers to enhancing the resistance of a subject against infection with microorganisms. The term “management of infection with microorganisms” as used herein refers to killing a microorganism or suppressing its expansion to thereby ameliorate the state of the subject as infected with the microorganism or inhibit the progress of the infection. Spec. ¶ 62. As also noted above, however, claim 52 requires performance of only a single action to achieve the preamble-recited result: “administering to a human subject in need thereof an effective amount of an antimicrobial agent Appeal 2019-005238 Application 14/912,013 8 comprising a hydrogen molecule, wherein the hydrogen molecule is adsorbed on a coral powder or coral calcium.” Appeal Br. 13. As discussed above Huang suggests orally administering, to a human suffering from polymicrobial sepsis, molecular hydrogen in an amount effective to ameliorate the infection (see Huang 973, 978), and Matsuo teaches that a useful method of orally administering hydrogen to humans was in the form of a coral powder to which the hydrogen has been adsorbed (see Matsuo 3:61–4:2). The combination of Huang and Matsuo, therefore, suggests administering the same therapeutic agent recited in claim 52, to the same patient recited in claim 52. That is, the combination of Huang and Matsuo suggests performing the exact process step that produces the preamble-recited result recited in claim 52. We are not persuaded, therefore, that any alleged misinterpretation of claim 52 on the part of the Examiner demonstrates error in the Examiner’s determination that Huang and Matsuo would have suggested performing a process having every step and feature required by claim 52. Appellant also does not persuade us that the Examiner misinterpreted the Huang reference in relation to treating infection-related inflammation, as opposed to killing infecting microorganisms, to an extent that the combination of Huang and Matsuo fail to suggest performing a process having all of the steps and features required by claim 52. See Appeal Br. 6– 8; 2–3. The fact that Huang and Matsuo’s reason for performing claim 52’s process might have been different than Appellant’s asserted rationale of killing microorganisms does not negate the fact that Huang and Matsuo, Appeal 2019-005238 Application 14/912,013 9 based on the disclosures noted above, suggest administering the same therapeutic agent as recited in claim 52, to the same patient recited in the claim. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007) (“In determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under § 103.”). Accordingly, even if Huang’s teaching of the desirability of administering hydrogen to treat an infection was for the purpose of ameliorating inflammation, that fact fails to demonstrate error in the Examiner’s determination that Huang and Matsuo provided motivation for, and a reasonable expectation of success in, orally administering Matsuo’s hydrogen-bearing coral powder to a human suffering from polymicrobial sepsis, in an amount effective to ameliorate the infection. We note, moreover, that in addition to the infection management argued by Appellant, claim 52 also recites preventing an infection by administering the coral-bound hydrogen to a human in need thereof. See Appeal Br. 13. Because essentially all humans need enhanced resistance against infection, claim 52 therefore encompasses virtually any administration of coral-bound hydrogen to a human, including the administration of coral-bound hydrogen as a food supplement described in Matsuo. Moreover, because the Examiner’s conclusion of obviousness is based on the express teachings discussed above in Huang and Matsuo, rather than some previously unknown property present in the prior art, we are not persuaded that the Examiner improperly relied on inherency in determining Appeal 2019-005238 Application 14/912,013 10 that the process of claim 52 would have been obvious. See Appeal Br. 8–9. In particular, even if it were true that Appellant was the first to demonstrate hydrogen’s antimicrobial effect, that does not negate the fact that the prior art cited by the Examiner provided good reason for, and a reasonable expectation of success in, performing a process having every step and feature required by representative claim 52. We are also unpersuaded that Appellant has advanced evidence of unexpected results sufficient to outweigh the prior art evidence of prima facie obviousness advanced by the Examiner. Appeal Br. 9–11; Reply Br. 3. It is well settled that, “when unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.” In re Baxter-Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). In the present case, we acknowledge Appellant’s experimental evidence that coral-bound hydrogen has antimicrobial properties. See Spec. ¶¶ 120–220 (Appellant’s Examples 1–9 testing several coral products (SUISO)). Appellant, however, does not identify what it considers to be the closest prior art. Nor does Appellant explain how or why the experimental evidence disclosed in the Specification represents the comparison to the closest prior art required by our reviewing court to show nonobviousness. See In re Baxter-Travenol Labs., 952 F.2d at 392. In particular, as the Examiner noted, Huang describes using hydrogen gas to treat sepsis, and discloses that hydrogen-rich water would be expected function equivalently to hydrogen gas. See Huang 973. Appellant does not identify any comparison on the current record between the infection-treating Appeal 2019-005238 Application 14/912,013 11 hydrogen preparations described in Huang and the coral-bound hydrogen preparations tested in Appellant’s Specification. In addition, it is well settled that, by themselves, assertions in briefing by counsel as to the unexpectedness of experimental results are of little probative value toward nonobviousness, absent some evidence, beyond the assertions in the briefs, that a skilled artisan actually would have considered the results unexpected. See In re Geisler, 116 F.3d 1465, 1470–71 (Fed. Cir. 1997) (finding arguments of unexpected results unpersuasive “naked attorney argument” because applicant “did not offer evidence of unexpected results in the form of a statement to that effect from the inventors or any third party, or any objective evidence from a respected source” nor did applicant make any statements of unexpectedness in its specification or in an affidavit under 37 C.F.R. § 1.132). In the present case, other than the assertions in briefs, Appellant does not identify, nor do we discern, any statements in the Specification, or elsewhere in the record, suggesting that the experimental results shown in the Specification actually would have been unexpected by a skilled artisan. Appellant’s assertions of unexpectedness, therefore, are of little probative value. Moreover, to the extent that Appellant has identified a naturally occurring result coming from the prior art’s administration of hydrogen, that recognition is insufficient to establish nonobviousness. See In re Baxter- Travenol Labs., 952 F.2d at 392 (“Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.”); see also In re Woodruff, 919 F.2d 1575, 1577−78 (Fed. Cir. 1990) (obviousness rejection affirmed where using claimed elements in the manner suggested by the prior art necessarily resulted in claim-recited effect). Appeal 2019-005238 Application 14/912,013 12 In sum, for the reasons discussed, Appellant does not persuade us that the Examiner erred in concluding that the process recited in representative claimed 52 would have been obvious to a skilled artisan. We therefore affirm the Examiner’s rejection of claim 52 over Huang and Matsuo. Claims 53 and 69 fall with claim 52. 37 C.F.R. § 41.37(c)(1)(iv). In rejecting claims 70, 72, and 73, all of which depend from claim 52 discussed above, the Examiner cited Huang and Matsuo for the teachings discussed above, and cited Conceição as evidence that the additional features recited in claims 70, 72, and 73 would have been obvious elements of the process suggested by Huang and Matsuo. See Final Act. 5–6. Because Appellant does not identify, nor do we discern, error in the Examiner’s rationale for combining Conceição with Huang and Matsuo, we affirm the Examiner’s rejection of claims 70, 72, and 73 over those references. CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/ Basis Affirmed Reversed 52, 53, 69 103(a) Huang, Matsuo 52, 53, 69 70, 72, 73 103(a) Huang, Matsuo, Conceição 70, 72, 73 Overall Outcome 52, 53, 69, 70, 72, 73 Appeal 2019-005238 Application 14/912,013 13 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