Giorgis Isaac et al.

Patent Trials and Appeals Board

Feb 10, 2022

2021000666 (P.T.A.B. Feb. 10, 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. 14/122,140 08/12/2014 Giorgis Isaac W-755-US2 6337 13871 7590 02/10/2022 WOMBLE BOND DICKINSON (US) LLP / Waters ATTN: IP DOCKETING P.O. BOX 7037 ATLANTA, GA 30357-0037 EXAMINER PEO, KARA M ART UNIT PAPER NUMBER 1777 NOTIFICATION DATE DELIVERY MODE 02/10/2022 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): BostonDocket@wbd-us.com IPDocketing@wbd-us.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ______________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ______________ Ex parte GIORGIS ISAAC, STEPHEN McDONALD, ALAN MILLAR, KENNETH FOUNTAIN, and JOHN SHOCKCOR ______________ Appeal 2021-000666 Application 14/122,140 Technology Center 1700 ______________ Before GEORGE C. BEST, CHRISTOPHER C. KENNEDY, and BRIAN D. RANGE, Administrative Patent Judges. BEST, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1, 11, 15, 19, 20, 23-26, 30-36, 38, and 41-44 of Application 14/122,140.2 Final Act. (January 17, 2020). We have jurisdiction under 35 U.S.C. § 6. For the reasons set forth below, we affirm. 1 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies Waters Technology Corp. as the real party in interest. Appeal Br. 2. 2 After entry of the Final Action, Appellant canceled claim 28. Appeal Br. 4. Appeal 2021-000666 Application 14/122,140 2 I. BACKGROUND The ’140 Application describes methods for separating and analyzing liquid components of a biological sample comprising two lipids. Spec. 2, 12, 33-34. The biological sample is injected into a liquid chromatography device comprising a chromatographic material. Id. at 2, 35-36, 40. The chromatographic material includes a chromatographic medium comprising a hydrophobic surface group and one or more ionizable modifiers. Id. at 2, 35- 36, 39. The ionizable modifiers may not contain a zwitterion or a quaternary ammonium ion moiety. Id. As result of the liquid chromatography, the two lipids are separated and subsequently identified using mass spectrometry. Id. at 36-37. Claim 1 is representative of the ’140 Application’s claims and is reproduced below from the Appeal Brief’s Claims Appendix. 1. An analytical method of separating lipid components of a biological sample comprising: (a) injecting the biological sample containing at least two lipids onto a liquid chromatography device comprising a chromatographic material, the chromatographic material comprising a chromatographic surface wherein the chromatographic surface comprises a hydrophobic surface group and one or more ionizable modifiers with the proviso that when the ionizable modifier does not contain a Zwitterion, the ionizable modifier does not contain a quaternary ammonium ion moiety; (b) separating the at least two lipids; and (c) identifying the at least two lipids using mass spectrometry. Appeal Br. 18 (Claims App.). Appeal 2021-000666 Application 14/122,140 3 II. REJECTION On appeal, the Examiner maintains the following rejection: Claims 1, 11, 15, 19, 20, 23-26, 30-36, 38, and 41-44 are rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Dettmer3 and Jiang.4 Final Act. 4. III. DISCUSSION Appellant argues for reversal of the rejection of claims 1, 11, 15, 19, 20, 23-26, 30-36, 38, and 41-44 as a group. Appeal Br. 5-16. We choose claim 1-the only independent claim on appeal-to represent this group. 37 C.F.R. § 41.37(c)(1)(iv). Accordingly, we limit our discussion to claim 1. The Examiner rejected claim 1 as unpatentable over the combination of Dettmer and Jiang. Final Act. 4-6. In doing so, the Examiner found the Dettmer describes every limitation of claim 1 except for the use of a hydrophobic chromatographic surface comprising one or more ionizable modifiers that do not contain either a zwitterion or a quaternary ammonium ion. Id. at 5. The Examiner also found that Jiang describes or suggests a hydrophobic chromatographic surface that comprises one or more ionizable modifiers with the proviso that the modifiers do not contain a zwitterion or a quaternary ammonium. Id. The Examiner also found that a person having ordinary skill in the art would have been motivated to use Jiang’s modified 3 Katja Dettmer et al., Mass Spectrometry-Based Metabolomics, author manuscript available via NIH Pub Med Central, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1904337 (published June 28, 2007) (final edited version available at 26 Mass. Spectrom. Rev. 51-78 (2007)). 4 US 2001/0033931 A1, published October 25, 2001. Appeal 2021-000666 Application 14/122,140 4 hydrophobic chromatographic surface in Dettmer’s method because (1) Dettmer describes improvements in chromatographic performance-e.g., peak shape, resolution, and peak capacity-that are desirable and (2) Jiang describes its modified hydrophobic chromatographic surface is resulting in improved chromatographic performance. Id. at 4-6. Appellant argues that the rejection of claim 1 should be reversed for any of five reasons. We address each of these arguments in turn. For the reasons set forth below, we determine that Appellant has not identified reversible error in the rejection of claim 1. A. Dettmer’s disclosure is sufficiently detailed Appellant’s first argument is that Dettmer does not provide enough detail in its description of a liquid chromatography-mass spectroscopy (“LC- MS”) analysis. Appeal Br. 5-8. Specifically, Appellant argues that Dettmer is a review article that does not describe any specific analytical chemistry method in detail. Id. at 6. In particular, Appellant argues that the Examiner is improperly picking and choosing various portions of Dettmer’s disclosure is in claim 1 as a blueprint. Id. at 7. Appellant asserts that “there is nothing in Dettmer or in Jiang that links separating a biological sample containing two or more lipids with the claimed chromatographic surface.” Id. at 8. Appellant’s argument does not persuade us that the Examiner reversibly erred in rejecting claim 1. Appellant’s argument does not acknowledge the skill, experience, and knowledge of the person having ordinary skill in the art-i.e., the person through whose eyes the content of the prior art must be viewed. For this reason, we begin by considering the experience and education of a person having ordinary skill in the art. We can infer information about Appeal 2021-000666 Application 14/122,140 5 the training and experience such person from the ’140 Application’s Specification and the prior art. See, e.g., Ex parte Jud, No. 2006-1061, 2006 Wl 4080053 (BPAI Jan. 30, 2007) (informative) (inferring level of skill in the art from the specification); see also, Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art can reflect the level of skill in the art). Based on our review of these materials, we find that a person having ordinary skill in the art would have at least an undergraduate degree in chemistry and several years of experience in designing and performing chemical analyses of a variety of metabolites, including nonpolar metabolites such as lipids. See, e.g., Dettmer 33 (biographical information regarding authors). The content of prior art identified by the Examiner must be viewed through the eyes of such a person. Indeed, Dettmer is written for an audience largely made of persons having ordinary skill in the art. Thus, Dettmer can state, without citation to authority, that “[r]eversed phase chromatography is a standard tool for the separation of medium polar and nonpolar analytes.” Dettmer 12. A person having ordinary skill in the art would understand this to be a reference to the use of a hydrophobic chromatographic surface to separate lipid molecules. Similarly, the person having ordinary skill in also understand that mass spectroscopy can be used to separate and identify various chemical species. See, e.g., Dettmer 10 (discussing metabolic fingerprinting). In view of the foregoing, we are not persuaded that Dettmer’s disclosure lacks sufficient detail to teach the generic liquid chromatography process steps recited in claim 1. Appeal 2021-000666 Application 14/122,140 6 B. A person having ordinary skill in the art would have been motivated to combine Dettmer and Jiang Appellant argues that the rejection of claim 1 should be reversed because the Examiner improperly ignored discouraging statements in both Dettmer and Jiang. AB 8-11. Citing Polaris Industries, Inc. v. Arctic Cat, Inc., 882 F.3d 1056 (Fed. Cir. 2018), Appellant argues that these discouraging statements would fail to motivate a person having ordinary skill in the art to combine Dettmer and Jiang. Appeal Br. 10-11. This argument does not persuade us that the Examiner reversibly erred in rejecting claim 1. We agree with the Examiner that Dettmer and Jiang are properly combinable. Appellant’s arguments to the contrary are not persuasive for three reasons. First, Dettmer’s alleged discouraging statements appear in a section discussing a non-LC separation technique and, therefore, are not relevant to the rejection. See Answer 10-12. Second, Jiang’s alleged discouraging statements all concern problems with known hydrophobic chromatographic surfaces that led Jiang to create its modified hydrophobic chromatographic material. See id. at 12-13. Third, a person having ordinary skill in the art would have been motivated to combine Dettmer and Jiang because Jiang describes a modified chromatographic surface with improved properties. See id. at 13-15; see also Final Act. 5-6. Moreover, Polaris, the case relied upon by Appellant, is readily distinguished from the present situation. In Polaris, the Federal Circuit reversed the Board’s obviousness determination for three reasons. Polaris, 882 F.3d at 1068-69. None of these reasons is present in this case. First, the Federal Circuit found that the Board erred by regarding certain teachings in the prior art as “subjective preferences.” Id. at 1068. In this case, the Examiner has not disregarded or discount of the alleged Appeal 2021-000666 Application 14/122,140 7 “discouraging statements” identified by Appellant, let alone described them as mere “subjective preferences.” Rather, as demonstrated by the Answer, the Examiner has explained why the statements are not relevant to the obviousness analysis. See Answer 10-15. Second, the Federal Circuit found that the Board erred by focusing on what a skilled artisan would have been able to do rather than what the skilled artisan would have been motivated to do. Polaris, 882 F.3d at 1068-69. In the case at hand, however, the Examiner set forth persuasive reasoning explain why a person having ordinary skill in the art would have been motivated to combine Dettmer and Jiang. Answer 13-15. Third, the Federal Circuit found that the particular analysis used by the Board erroneously encouraged the factfinder to disregard evidence relevant to both the teaching away and motivation to combine inquiries. Polaris, 882 F.3d at 1069. In the instant case, however, the Examiner did not discard evidence. Instead the Examiner explains why the statements identified by Appellant are not relevant to the obviousness analysis. Answer 10-15. We, therefore, are not persuaded that the Examiner ignored “discouraging statements” in Dettmer and Jiang or reversibly erred by finding that a person having ordinary skill in the art would been motivated to combine Dettmer and Jiang to arrive at the claimed invention. C. The Examiner’s reliance on Boston Scientific is not reversible error In rejecting claim 1, the Examiner found that “[i]t would be readily apparent to one of ordinary skill in the art to incorporate a C18 bonded phase hydrophobic surface group into the chromatographic surface with a hydrophobic surface group and an ionizable modifier because C18 is a Appeal 2021-000666 Application 14/122,140 8 common bonded phase incorporated on chromatographic materials.” Final Act. 5 (citing Boston Scientific SciMed, Inc. v. Cordis Corp., 554 F.3d 982 (Fed. Cir. 2009)). Appellant argues that the Examiner has misapplied Boston Scientific. Appeal Br. 12-13. In particular, Appellant argues that [r]egardless of what two embodiments are allegedly combinable in either Dettmer or Jiang, the subject matter of the pending claims, an analytical method of separating liquid components, differs from the subject matter of the [Boston Scientific] case, a device directed to a polymer coated stent. Combining two adjacent physical embodiments is different than combining randomly selected portions of chemical methods. Id. at 12. We are not persuaded by this argument. The Examiner cites Boston Scientific in discussing the reasons why a person having ordinary skill in the art would have modified a C18 chromatographic surface with an ionizable modifier. See Final Act. 5. In the portion of the Final Action in question, the Examiner finds that Jiang teaches that C18 chromatographic materials are prepared by derivatizing the surface silanol groups on a silica particle. Id. Jiang notes that typically more than 50% of the silanol groups remain unreacted. Jiang ¶ 2. Jiang further explains that these silanol groups degrade the chromatographic medium’s performance. Id. The Examiner finds that Jiang teaches that a functional lysing the surface silanol groups improves performance of the chromatographic medium. Final Act. 5 (citing Jiang ¶¶ 2, 14, 30). Based on these findings, the Examiner further finds that a person having ordinary skill in the art would have been motivated to incorporate Jiang’s ionizable groups into the C18 chromatographic medium described by Dettmer to improve performance the medium’s performance. Final Act. 5-6. Appeal 2021-000666 Application 14/122,140 9 The Examiner also cites Boston Scientific as supporting the finding that a person having ordinary skill in the art would have been motivated to combine Jiang’s ionizable modifier with a C18 chromatographic medium. Final Act. 5. For the following reasons, we do not discern reversible error in the Examiner’s reliance on Boston Scientific. As an initial matter, the facts in this case resemble those in Boston Scientific. In that case, the obviousness rejection relied upon a combination of embodiments shown in Figures 3B and 4 of the same prior art patent. Boston Scientific, 554 F.3d at 991. The proximity of the two embodiments prompted the Federal Circuit to observe that “[c]ombining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness.” Id. Here, Jiang describes C18 chromatographic media is among the most commonly used HPLC techniques. Jiang ¶ 2. Jiang then describes its ionizable modifiers as reacting with free silanol groups on a silica gel support thereby reducing some of the problems created by the free silanol groups. Jiang ¶¶ 6-17. Thus, the facts here are similar to those in Boston Scientific-a single piece of prior art discloses, in close proximity, both embodiments that are combined to arrive at the claimed invention. Moreover, even if Boston Scientific does not stand for the proposition that it would always be obvious to combine adjacent embodiments, the Examiner’s citation of Boston Scientific is cumulative. As discussed above, the Examiner also provided a sufficient reasoned explanation for why a person having ordinary skill in the art would have been motivated to combine Dettmer and Jiang in the manner set forth in the rejection. Thus, the Examiner’s reliance on Boston Scientific is, at worst, harmless error. Appeal 2021-000666 Application 14/122,140 10 D. The Examiner correctly found that a person having ordinary skill in the art would have been motivated to combine Dettmer and Jiang Appellant argues that the Examiner erred by finding that a person having ordinary skill in the art would have had motivation to combine Dettmer and Jiang in the manner described in the rejection. Appeal Br. 13- 14. As we have discussed in § C, above, the Examiner has explained why such a person would have combined Jiang’s ionizable modifier with Dettmer’s C18 chromatographic medium. See also Final Act. 5-6 (“It would be obvious . . . to incorporate [Jiang’s] ionizable modifiers . . . in the method of Dettmer in order to increase separation efficiency, reduce band spreading, create overall good peak shape, and result in better hydrolytic stability.”). E. The Examiner has established a prima facie case of obviousness Appellant argues that the Examiner has not established a prima facie case of obviousness. Appeal Br. 14. In particular, Appellant argues that Dettmer’s disclosure is too generic and that a genus does not disclose a species. Id. We have already addressed these arguments in § A, above. For the reasons we have provided there, we determine that Dettmer’s disclosure, while generic, is no more generic than the LC-MS method recited in claim 1. For that reason, we are not persuaded that the Examiner has failed to establish a prima facie case of obviousness. IV. CONCLUSION The Examiner’s decision to reject claims 1, 11, 15, 19, 20, 23-26, 30- 36, 38, and 41-44 is affirmed. Appeal 2021-000666 Application 14/122,140 11 V. DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 11, 15, 19, 20, 23-26, 30-36, 38, 41-44 103 Dettmer, Jiang 1, 11, 15, 19, 20, 23-26, 30-36, 38, 41-44 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