JNC CORPORATION

Patent Trials and Appeals Board

Feb 8, 2022

2021002368 (P.T.A.B. Feb. 8, 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. 14/932,986 11/05/2015 Hajime TERAMURA 60312-US-599 6018 31561 7590 02/08/2022 JCIPRNET 8F-1, No. 100, Roosevelt Rd. Sec. 2, Taipei, 100404 TAIWAN EXAMINER TICHY, JENNIFER M.H. ART UNIT PAPER NUMBER 1653 NOTIFICATION DATE DELIVERY MODE 02/08/2022 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): Belinda@JCIPGROUP.COM USA@JCIPGROUP.COM PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte HAJIME TERAMURA Appeal 2021-002368 Application 14/932,986 Technology Center 1600 Before ERIC B. GRIMES, JOHN G. NEW, and JOHN E. SCHNEIDER, Administrative Patent Judges. Opinion for the Board filed by Administrative Patent Judge SCHNEIDER. Opinion Dissenting filed by Administrative Patent Judge GRIMES. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1-3.2 We have jurisdiction under 35 U.S.C. § 6(b). 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 JNC CORPORATION. Appeal Br. 1. 2 Claim 4 is pending in the application but has been withdrawn from consideration. Final Act. 1 Appeal 2021-002368 Application 14/932,986 2 We AFFIRM. CLAIMED SUBJECT MATTER The invention relates to culture media that can be used to detect bacteria of the genus Campylobacter. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A method for detecting Campylobacter bacteria, comprising: a step of inoculating a specimen to a culture medium comprising Cefoperazone and Cefoxitin, wherein the Cefoperazone and the Cefoxitin are mixed with each other in the culture medium, and a content of Cefoxitin in the culture medium is 1 to 10 mg/L; a step of culturing Campylobacter bacteria contained in the specimen; and a step of detecting colony of Campylobacter bacteria. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Line, et al. WO 00/75285 A1 Dec. 14, 2000 Karmali et al. Antimicrobial Susceptibility of Campylobacter jejuni and Campylobacter fetus subsp. fetus to Eight Cephalosporins with Special Reference to Species Differentiation, 18 Antimicrobial Agents and Chemotherapy 948 (1980) REJECTION The Examiner has rejected claims 1-3 under 35 U.S.C. § 103, as unpatentable over Line in view of Karmali. OPINION Issue Appeal 2021-002368 Application 14/932,986 3 The issue with respect to this rejection is whether a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 1-3 would have been obvious to one of ordinary skill in the art, at the time the invention was made, over Line combined with Karmali. The Examiner finds Line teaches a selective media for recovery and enumeration of Campylobacter comprising an indicator, nutrient medium, agar, a reducing agent and selective agents. Final Act. 3. The Examiner finds Line teaches the selective agent may comprise a mixture of agents selected from cycloheximide, cefoperazone, vancomycin, trimethoprim, polymyxin B, rifampicin, amphotericin, and nystatin. Id. The Examiner finds that Line teaches it was known that the selective medium may also comprise cephalothin. Id. The Examiner finds Line does not teach the use of cefoxitin or the concentration of cefoxitin recited in the claims. Id. at 4. The Examiner finds Karmali teaches Campylobacter susceptibility to cephalothin and cefoxitin. Id. The Examiner finds Karmali teaches that cefoxitin is only effective against Campylobacter at concentrations of 32 µg/ml or greater. Id. The Examiner concludes It would have been obvious to have also selected cefoxitin as a selective agent in the method of Line et al., because Karmali et al. teach that cefoxitin may also be considered for use particularly with certain strains of Campylobacter. See Karmali et al. at Table 1. Further, since the media of Line et al. may include cephalothin (e.g., a cephalosporin that has antibacterial activity against Campylobacters) and it is still included in media for isolation of Campylobacters, then it would be obvious to be able to substitute cefoxitin because Karmali et al. teach the antibiotic activity of at least those two antibiotics on two example strains of Campylobacter. Appeal 2021-002368 Application 14/932,986 4 A person of ordinary skill in the art would have motivation and a reasonable expectation of success in substituting cefoxitin for cephalothin, because Karmali et al. show there are minimum inhibitory concentrations for both agents which produce results effective for Campylobacter. See Karmali et al. at Table 1. Id. at 4-5. With respect to the concentration of cefoxitin, the Examiner concludes As each of the references indicate that the various proportions and amounts of the ingredients used in the claimed composition are result effective variables, it would have been customary for an artisan of ordinary skill to determine the optimal amount of the ingredient or relative ratio of each ingredient each one to the other in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, content of cefoxitin, would have been obvious at the time the invention was made. Id. at 6. Appellant contends Line does not teach the use of a second antibacterial compound. Appeal Br. 2. Appellant points to the examples of Line where the additional antimicrobial compounds are all antifungal agents, not antibacterial. Id. at 4-5. Appellant maintains that Line does not teach the use of two antibacterial agents. Id. Appellant contends that the references do not teach or suggest that cefoxitin is effective against bacteria other than Campylobacter. Id. at 5. Appellant contends that one skilled in the art would not be led to use cefoxitin in the method of Line. Id. Finally, Appellant contends there is no teaching or suggestion in the references that would have led one skilled in the art to optimize the concentration of cefoxitin to the amount recited in the claims. Id. at 6. Appeal 2021-002368 Application 14/932,986 5 Analysis We adopt the Examiner’s findings of fact, reasoning on scope and content of the prior art, and conclusions set out in the Final Action and Answer regarding this rejection. We find the Examiner has established a prima facie showing that the subject matter of the claims would have been obvious over the combined teachings of Line and Karmali to a person of ordinary skill in the art at the time the invention was made. Appellant has not produced evidence showing, or persuasively argued, that the Examiner’s determinations on obviousness are incorrect. Only those arguments made by Appellant in the Briefs have been considered in this Decision. Arguments not presented in the Briefs are waived. See 37 C.F.R. § 41.37(c)(1)(iv) (2015). We have identified claim 1 as representative; therefore, all claims fall with claim 1. We address Appellants’ arguments below. Appellant contends that Line does not teach or suggest the use of two antibacterial compounds. Appeal Br. 4-5, 6. Appellant points to the examples where an antibacterial compound is used with an antifungal compound. Id. We have considered Appellant’s argument and are not persuaded that the rejection is in error. While we agree that the examples of Line show the use of antifungal compounds, the teachings of Line are not limited to the examples. See In re Hedges, 783 F.2d 1038, 1041 (Fed. Cir. 1986) (When determining obviousness, “the prior art as a whole must be considered.”) Line teaches the use of mixtures of antibacterial agents such as vancomycin, trimethoprim, polymyxin B, and rifampicin in addition to cefoperazone. Line, Abst. Appeal 2021-002368 Application 14/932,986 6 Appellant contends that Karmali does not teach that cefoxitin would be useful against any bacteria other than Campylobacter. Appeal Br. 5, 7. Appellant contends that this would not have motivated on skilled in the art to use cefoxitin in the method of Line. Id. We remain unpersuaded. While Karmali does not specifically list species of bacteria that are susceptible to cefoxitin, Karmali does state that cefoxitin is an antibiotic. Karmali, 949. As the Examiner points out, the use of the cefoxitin as taught by Karmali et al. in the method of Line et al. amounts to the simple substitution of one known Campylobacter resistant cephalosporin for another. The use of cefoxitin in place of cephalothin would have been expected to predictably and successfully provide an alternative Campylobacter resistant cephalosporin for use in the culture medium for detecting Campylobacter bacteria as taught by Line et al. Ans. 9. Appellant contends that the teachings of Karmali would not lead one skilled in the art to use the concentration of cefoxitin recited in the claims. Appeal Br. 5, 7. Appellant contends that whereas Karmali at most teaches that below 32 µg, cefoxitin has little effect on Campylobacter, Karmali does not teach that a lower concentration would be effective against other bacteria. Id. Appellant contends that the references do not provide any motivation to optimize the amount of cefoxitin used. Id. Once again, we are not persuaded by Appellant’s arguments. As the Examiner points out, the references teach that the relative amount of the different ingredients used in the media, including the selection agents, are result effective variables. Final Act. 6. “[T]he discovery of an optimum value of a variable in a known process is normally obvious.” Exceptions to Appeal 2021-002368 Application 14/932,986 7 this rule include (1) the results of optimizing a variable were unexpectedly good and (2) the parameter optimized was not recognized in the prior art as one that would affect the results. In re Antonie, 559 F.2d 618, 620 (CCPA 1977). Here Appellant has not pointed to nor do we discern any evidence showing that the amount if cefoxitin produced unexpectedly good results or that the art did not recognize that optimization of the amount of selection agent would affect the results. Conclusion We conclude that a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 1-3 would have been obvious to one of ordinary skill in the art at the time the invention was made over Line combined with Karmali. CONCLUSION The Examiner’s rejection is affirmed. More specifically, The rejection of claims 1-3 under 35 U.S.C. § 103, as unpatentable over Line in view of Karmali is affirmed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1-3 103 Line, Karmali 1-3 Appeal 2021-002368 Application 14/932,986 8 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 Appeal 2021-002368 Application 14/932,986 9 GRIMES, Administrative Patent Judge, dissenting. I respectfully dissent. In my opinion, the Examiner has not persuasively shown that a person of ordinary skill in the art would have had a reason to modify Line’s Campylobacter-selective media by including 1-10 mg/L Cefoxitin, as required by Appellant’s claims. As the Examiner correctly found, Line discloses “selective media for recovery and enumeration of Campylobacters,” where the media include “selective agents [that] may be a mixture of agents selected from cycloheximide, cefoperazone, vancomycin, trimethoprim, polymyxin B, rifampicin, amphotericin, and nystatin.” Final Act. 3. Line also states that a different, prior art Campylobacter-selective media contains cephalothin. Id. However, neither Line’s media nor any prior art media described by Line includes both cefoperazone and cephalothin. See Line 2, last para. to 5, first para.; 8, last para. Thus, the Examiner’s finding that “the media of Line et al. may include cephalothin” (Final Act. 5) is not supported by the evidence of record. The Examiner concedes that Line does not teach including cefoxitin in its media, or specifically using cefoxitin at 1-10 mg/L. Final Act. 4. To meet this limitation of Appellant’s claims, the Examiner cites Karmali. Id. Karmali states that “[t]he differentiation of C. jejuni from C. fetus subsp. fetus (intestinalis) in clinical laboratories remains unsatisfactory.” Karmali 948, left col. Karmali therefore “compare[d] the susceptibility patterns of C. jejuni and C. fetus subsp. fetus (intestinalis) to seven cephalosporins and cefoxitin to determine which agents showed species differences in susceptibility patterns.” Id. at 948, right col. Appeal 2021-002368 Application 14/932,986 10 Karmali discloses that the minimum inhibitory concentration (MIC) of cefoxitin ranged from 32-64 μg/ml for 12 strains of C. fetus subsp. fetus, and ranged from 32 to ≥512 μg/ml for 60 strains of C. jejuni. Id. at 949, Table 1. Karmali does not disclose the susceptibility of any other microorganisms to cefoxitin and, in particular, does not disclose any microorganisms that are susceptible to 1-10 mg/L cefoxitin. The Examiner presents two reasons for modifying Line’s Campylobacter-selective media to include 1-10 mg/L cefoxitin. Final Act. 4-5. First, the Examiner posits that “[i]t would have been obvious to have also selected cefoxitin as a selective agent in the method of Line et al., because Karmali et al. teach that cefoxitin may also be considered for use particularly with certain strains of Campylobacter. See Karmali et al. at Table 1.” Id. I disagree with this reasoning. Karmali concluded that C. jejuni was significantly more resistant to three of the tested cephalosporins than C. fetus subsp. fetus, and that a less marked difference was observed with three other cephalosporins, but “no such difference occurred with cephalexin, cefotaxime, or cefoxitin.” Karmali 949, right col. (emphasis added). Thus, all Karmali discloses with regard to cefoxitin is that it is not particularly toxic to either C. jejuni or C. fetus subsp. fetus. Karmali does not disclose that cefoxitin is effective in killing or inhibiting the growth of any other microorganism at any concentration, and especially at 1-10 mg/L. I do not find Karmali’s description of cefoxitin as an “antibiotic[]” (id. at 949, paragraph bridging the columns) to be an adequate reason to include it in Line’s Campylobacter-selective media. Based on Karmali, a skilled artisan would reasonably conclude that adding cefoxitin would not harm Appeal 2021-002368 Application 14/932,986 11 Line’s media, because cefoxitin at less than 32 mg/L would not be expected to kill any Campylobacter present. But Karmali provides no basis for expecting that adding cefoxitin to Line’s media would provide any benefit to the combination of antibiotics already present. This is especially true because Line discloses that its “Campy-TTC agar”-containing trimethoprim, vancomycin, polymyxin B, cycloheximide, and cefoperazone-resulted in “no contaminants” for four tested strains of C. jejuni and four tested strains of C. coli. See Line 14-17 (Example 1). The Examiner also reasons that, since the media of Line et al. may include cephalothin . . . and it is still included in media for isolation of Campylobacters, then it would be obvious to be able to substitute cefoxitin because Karmali et al. teach the antibiotic activity of at least those two antibiotics on two example strains of Campylobacter. Id. at 5. However, as I pointed out above, neither the prior art media discussed by Line nor Line’s inventive media contain both cephalothin and cefoperazone. Thus no cefoxitin-for-cephalothin substitution in the media described in Line results in a culture medium comprising cefoperazone and cefoxitin, as required by Appellant’s claims. “Obviousness requires more than a mere showing that the prior art includes separate references covering each separate limitation in a claim under examination.” Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir. 2011). “Rather, obviousness requires the additional showing that a person of ordinary skill at the time of the invention would have selected and combined those prior art elements in the normal course of research and development to yield the claimed invention.” Id. Appeal 2021-002368 Application 14/932,986 12 In my view, the references cited by the Examiner in this case do not show that a skilled artisan would have selected 1-10 mg/L cefoxitin to combine with Line’s Campylobacter-selective media in the normal course of research and development. Therefore, in my view the references do not support a prima facie case of obviousness.