Adel PENHASI

Patent Trials and Appeals Board

Jan 24, 2022

2021004704 (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. 13/345,783 01/09/2012 Adel PENHASI D111877 1020US.CP1 1130 26158 7590 01/24/2022 WOMBLE BOND DICKINSON (US) LLP ATTN: IP DOCKETING P.O. BOX 7037 ATLANTA, GA 30357-0037 EXAMINER DUBOIS, PHILIP A ART UNIT PAPER NUMBER 1791 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): 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 ADEL PENHASI ____________ Appeal 2021-004704 Application 13/345,783 Technology Center 1700 ____________ Before GEORGE C. BEST, CHRISTOPHER C. KENNEDY, and MERRELL C. CASHION, JR., Administrative Patent Judges. CASHION, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision finally rejecting claims 1-9 and 19-21. We have jurisdiction under 35 U.S.C. § 6(b). An oral hearing was held on January 11, 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 Degama Probiotics Ltd. Appeal Br. 1. Appeal 2021-004704 Application 13/345,783 2 2022.2 We REVERSE and enter a NEW GROUND OF REJECTION pursuant to 37 C.F.R. § 41.50(b). The invention generally “relates to health food products, particularly to heat resistant probiotic products, which are suitable for ingestion by humans, and a method of preparation thereof which features at least one heat treatment stage.” Spec. 1. Claim 1 illustrates the invention and is reproduced below from the Claims Appendix of the Appeal Brief: 1. A probiotic granule comprising a core and at least three layers comprising i) a core, said core comprising probiotic microorganisms, wherein said microorganisms are contained only in said core; ii) an inner oily layer coating said core containing an oil; and iii) a first outer layer and a second outer layer, wherein said second outer layer covers said first outer layer, said first outer layer coats said core and said inner layer, in which said first outer layer comprises an enteric coating layer comprising an anionic polymer selected from the group including alginic acid, animonia alginate, sodium alginate, potassium alginate, magnesium alginate and calcium alginate; and said second outer layer comprises, a water soluble gel forming polymer and a water insoluble polymer, in which the water insoluble polymer is embedded in the water soluble polymer; and wherein said second outer layer is adapted to provide heat resistance by forming a film in which said water insoluble polymer is embedded as particles, and, wherein said probiotic microorganisms are not found in any layer outside the core. Appellant requests review of the Examiner’s rejection of claims 1-9 and 19-21 rejected under pre-AIA 35 U.S.C. § 103(a) as unpatentable over 2 A transcript of the oral hearing will be entered into the record when available. Appeal 2021-004704 Application 13/345,783 3 Mattson (US 2007/0160589 A1, published July 12, 2007), Horgan (US 2008/0175949 A1, published July 24, 2008), and Zhang (US 6,251,430 B1, issued June 26, 2001). Appeal Br. 6; Final Act. 3.3 OPINION After review of the respective positions the Appellant provides in the Appeal and Reply Briefs and the Examiner provides in the Final Office Action and the Answer, we reverse the Examiner’s prior art rejection of claims 1-9 and 19-21 for the reasons the Appellant presents.4 We add the following for emphasis. Claim 1 recites a probiotic granule comprising a core including probiotic microorganisms only in the core and at least three layers that protect the viability of the probiotic microorganisms in the core. To give proper weight to the evidence of record and the respective positions of Appellant and the Examiner, we must first determine the meaning of the term “core” in claim 1. Thus, our review of the grounds of rejection of the appealed claims necessarily entails the interpretation of the scope of the appealed claims, giving the broadest reasonable interpretation to the terms thereof consistent with the written description provided in 3 The Examiner statement of rejection in the Final Office Action inadvertently omits claim 9 as one of the claims rejected. Final Act. 3. The Examiner addresses claim 9 in the body of the rejection. Id. at 7. Given that Appellant recognizes that the Examiner rejected claim 9, we consider this omission to be harmless error. Therefore, the rejection of claims 1-9 and 19-21 is before us for review on appeal. 4 We limit our discussion to independent claim 1, from which all other claims depend. Appeal 2021-004704 Application 13/345,783 4 Appellant’s Specification as it would be interpreted by one of ordinary skill in this art. See In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). While Appellants are free to redefine terms in their Specification, any such novel definitions must be clearly indicated. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). When the Specification does not contain an express definition, a reasonable, supported interpretation of the appealed claims that differs from that urged by Appellant can be used to determine the patentability of the claims. Morris, 127 F.3d at 1055-56 (“Absent an express definition in their specification, the fact that appellants can point to definitions or usages that conform to their interpretation does not make the PTO’s definition unreasonable when the PTO can point to other sources that support its interpretation.”). Indeed, “[i]t is the applicants’ burden to precisely define the invention, not the PTO’s. See 35 U.S.C. § 112 ¶ 2 [statute omitted].” Morris, 127 F.3d at 1056. We find no portion of the Specification expressly defining the term “core.” At best, Application Figure 1 shows a core as the component of the probiotic granule covered by successive coating layers. See Spec. 6. We find this figure is insufficient to define clearly what a core is. Therefore, we turn to other sources for a reasonable definition of the disputed term. Merriam-Webster defines “core” as “a central and often foundational part usually distinct from the enveloping part by a difference in nature.”5 We find this definition to be reasonable and consistent with Appellant’s 5 Core Definition & Meaning - Merriam-Webster, Merriam-Webster.com, https://www.merriam-webster.com/dictionary/core (accessed January 12, 2022) Appeal 2021-004704 Application 13/345,783 5 Specification and Application Figure 1. Therefore, using this definition, we interpret the term “core” as defining the central component of a probiotic granule that is distinct from the external coatings. Prior Art Rejection We refer to the Examiner’s Final Office Action for a complete statement of claim 1’s rejection. Final Act. 3-4. Briefly, the Examiner finds Mattson teaches a probiotic granule comprising a core surrounded by an oily layer coating. Final Act. 3; Mattson ¶ 9.6 In the Answer, the Examiner explains that a core only indicates that the structure is the central part of the composition. Ans. 13. The Examiner further explains that claim 1 does not limit the construction of “core” and that the probiotics added to Mattson’s oily coating are cores completely enveloped by the oily coating. Id. at 14. Appellant argues the Examiner fails to identify where Mattson teaches a probiotic where the probiotic is limited to the core. Appeal Br. 8. According to Appellant, the Examiner’s reliance on Mattson’s paragraph 9 is erroneous because a fair reading of that description would lead one skilled in the art to understand that Mattson’s “fully enveloping, substantially continuous fat-based coating” is analogous to claim l’s “inner oily layer coating said core” and not to the core itself. Appeal Br. 9 (emphasis omitted). Appellant’s argument identifies reversible error in the Examiner’s determination of obviousness. As we discuss above, the term “core” defines the central component 6 A discussion of Horgan and Zhang is unnecessary for disposition of this rejection because the Examiner does not rely on these references to address the claimed core component. Final Act. 3-4. Appeal 2021-004704 Application 13/345,783 6 of a probiotic granule that is distinct from the external coatings. As Appellant argues, Mattson discloses a fat-based coating comprising probiotics, where the fat-based coating fully envelops a food item, such as a compressed matrix of one or more of whole grains, nuts, rice crisps, puffed wheat, millet, soy, and dried fruit in the form of a bar. Mattson ¶¶ 9, 11. While Mattson does not use the term “core” in describing the food item, the noted disclosure does convey that Mattson’s food item, and not the probiotics in the fat-based coating, is a core that is distinct from the enveloping part (fat-based coating) by a difference in nature. In view of this, the Examiner fails to direct us to any disclosure in Mattson that teaches or suggests providing probiotics directly into the food item (core) instead of the fat-based coating. Nor does the Examiner provide a technical explanation of why a core containing probiotics would be suitable for Mattson’s purposes. Accordingly, we reverse the Examiner’s rejection of claims 1-9 and 19-21 under pre-AIA 35 U.S.C. § 103(a) for the reasons Appellant provides and we give above. New Ground of Rejection We enter the following NEW GROUNDS OF REJECTION pursuant to our authority under 37 C.F.R. § 41.50(b). Claims 1-9 and 19-21 are rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement.7 Appellant amended claim 1 to add the recitations “wherein said microorganisms are contained only in said core” and “wherein said probiotic 7 We again limit our discussion to independent claim 1, from which all other claims depend. Appeal 2021-004704 Application 13/345,783 7 microorganisms are not found in any layer outside the core.” See Amendments dated April 24, 2017 and June 28, 2018.8 The noted recitations added to claim 1 are negative limitations. The Specification, as originally filed, does not provide adequate written descriptive support for these added recitations. The test for determining whether claims satisfy the written description requirement involves “an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art. Based on that inquiry, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.” Inphi Corp. v. Netlist, Inc., 805 F.3d 1350, 1355 (Fed. Cir. 2015) (quoting Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc)). “Negative claim limitations are adequately supported when the specification describes a reason to exclude the relevant limitation.” Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344, 1351 (Fed. Cir. 2012). In Santarus, the court found that claims reciting the negative limitation “wherein the composition contains no sucralfate” satisfied the written description requirement, because the Specification described sucralfate as having adverse effects and described omeprazole as an advantageous alternative. Id. at 1350-51. In Inphi, the court found substantial evidence supported the Board’s finding that claims reciting the negative limitation “DDR chip selects that are not CAS, RAS, or bank 8 We note that when Appellant added these limitations, it stated that no new matter was added via these amendments. However, Appellant failed to identify portions of the Specification that provide adequate written descriptive support for the amendments made to claim 1. See Remarks dated April 24, 2017 and June 28, 2018. Appeal 2021-004704 Application 13/345,783 8 address signals” satisfied the written description requirement because the Specification incorporated by reference a JEDEC standard specifying that DDR signals (including CS, RAS, CAS, and bank address signals) are distinct from each other. Inphi Corp. 805 F.3d at 1353, 1357. The court held that “properly describing alternative features--without articulating advantages or disadvantages of each feature--can constitute a ‘reason to exclude’ under the standard articulated in Santarus.” Id. at 1355. After careful review of the Specification, we find no portion that expressly or impliedly describes a “reason to exclude” probiotics from the claimed inner oily layer and the first and second external layers. For example, the Specification describes the inventive probiotic granule as comprising a core including probiotic microorganisms, “an inner oily layer coating said core,” and “a first outer layer and a second outer layer.” Spec. 2. The Specification also describes the components used to form the inner layer and the first and second layers. Id. at 3-4. While these disclosures do not expressly list probiotics as components for these layers, the mere absence of a positive recitation in the originally filed description is not basis for an exclusion, i.e., a negative limitation. See MPEP § 2173.05(i). Nor does the Specification describe the use of probiotics in the claimed first and second layers as alternative embodiments or features. Such alternative embodiments or features must be positively recited in the written description. See Inphi 805 F.3d at 1357 (“[P]roperly described, alternative features are sufficient to satisfy the written description standard.” (emphasis added)), and id. at 1356 (quoting MPEP § 2173.05(i) (“If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims.”)). Appeal 2021-004704 Application 13/345,783 9 In light of these circumstances, on this record, the Specification, as originally filed, does not show that Appellants were in possession of the scope of the subject matter described in claims 1-9 and 19-21. CONCLUSION The Examiner’s prior art rejection of claims 1-9 and 19-21 is reversed. We enter a new ground of rejection for claims 1-9 and 19-21 under 35 U.S.C. § 112, first paragraph. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed New Ground 1-9, 19-21 103(a) Mattson, Horgan, Zhang 1-9, 19- 21 1-9, 19- 21 112 Written Description 1-9, 19-21 Overall Outcome 1-9, 19- 21 1-9, 19-21 TIME PERIOD FOR RESPONSE This decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b). Section 41.50(b) provides that “[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 Appeal 2021-004704 Application 13/345,783 10 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 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. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). REVERSED; 37 C.F.R. § 41.50(b)