2019006406 (P.T.A.B. Jul. 23, 2020)

PROLACTA BIOSCIENCE, INC.

Patent Trials and Appeals BoardJul 23, 2020

2019006406 (P.T.A.B. Jul. 23, 2020)

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. 14/198,432 03/05/2014 SCOTT ELSTER PROL-023/01US 308366-2092 4532 150720 7590 07/23/2020 Cooley LLP/Prolacta Bioscience Inc. ATTN: Patent Group 1299 Pennsylvania Ave NW, Suite 700 Washington, DC 20004 EXAMINER WONG, LESLIE A ART UNIT PAPER NUMBER 1793 NOTIFICATION DATE DELIVERY MODE 07/23/2020 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): AFuller@prolacta.com Mamashruwala@prolacta.com zIPPatentDocketingMailboxUS@cooley.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte SCOTT ELSTER, JOSEPH FOURNELL, and SCOTT EAKER Appeal 2019-006406 Application 14/198,432 Technology Center 1700 ____________ Before ROMULO H. DELMENDO, MICHAEL P. COLAIANNI, and MICHAEL G. McMANUS, Administrative Patent Judges. McMANUS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 seeks review of the Examiner’s decision to reject claims 1, 3, and 4. We have jurisdiction under 35 U.S.C. § 6(b). A telephonic hearing was held on July 10, 2020. We reverse. 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 Prolacta Bioscience, Inc. Appeal Brief dated May 23, 2019 (“Appeal Br.”) 3. Appeal 2019-006406 Application 14/198,432 2 CLAIMED SUBJECT MATTER The present application generally relates to a pasteurized, high fat human milk product that can be administered enterally and increase the caloric content of human milk while not substantially increasing the overall volume fed to the infant. Specification filed Mar. 5, 2014 (“Spec.”) ¶ 5. Claim 1 is illustrative of the subject matter on appeal and is reproduced below with certain limitations bolded for emphasis: An enteral human milk cream composition comprising pasteurized human milk cream derived from pooled human milk, wherein the composition comprises about 2.5 kcal/ml and about 25% fat. Appeal Br. 24 (Claims App.). REFERENCES The Examiner relies upon the following prior art: Name Reference Date Medo ’430 US 2008/0124430 A1 May 29, 2008 Medo ’684 US 2011/0206684 Al Aug. 25, 2011 Appeal 2019-006406 Application 14/198,432 3 DISCUSSION Rejection The Examiner rejects claims 1, 3, and 4 under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Medo ’430 in view of Medo ’684. Final Action dated Feb. 20, 2018. (“Final Act.”) 2–4. In support of the rejection, the Examiner finds that “Medo ‘430 discloses a human milk cream composition comprising pasteurized cream derived from human milk.” Id. at 2. The Examiner further finds that the composition may include certain fortifiers that increase the caloric content of the composition to a value ranging from 1.7 kcal/ml to 2.7 kcal/ml. Id. The Examiner additionally finds that Medo ’430 includes an example “wherein cream contains 25 percent to 46 percent fat” thus satisfying the limitation requiring the composition be “about 25% fat.” Id. at 2–3. The Examiner relies on Medo ’684 as teaching the “enteral” limitation. Final Act. 3. Argument and Analysis Appellant alleges that the rejection is in error in several respects. First, Appellant argues that the cited art fails to teach a composition that comprises pasteurized human milk “cream.” Appeal Br. 9–11. Appellant asserts that Medo ’430, relied upon by the Examiner, teaches pasteurized human milk, not cream. Id. at 9. Appellant describes the process of Medo ’430 including that “[i]n step 4, the milk is transferred to a separator, e.g., a centrifuge, to separate the cream from the skim.” Medo ’430 ¶ 54. Medo ’430 then teaches that “skim is then blended with the cream” prior to pasteurization. Id. ¶ 56. Appeal 2019-006406 Application 14/198,432 4 Appellant argues that [w]hile the pasteurized compositions of Medo ’430 comprise a portion of the cream fraction that was added during the formulation (See paragraph [0057]), none of these could rationally be construed to be a cream composition within the meaning of the claims given the low amount of fat and large amounts of protein and carbohydrate present. Appeal Br. 10–11. We find the foregoing to be unpersuasive. The body of claim 1 requires only a composition “comprising pasteurized human milk cream.” Appellant concedes that the pasteurized compositions of Medo ’430 comprise a portion of the cream fraction. Accordingly, giving the claim its broadest reasonable interpretation, we determine that the “milk cream” limitation may encompass a composition as described in Medo ’430. Second, Appellant argues that Medo ’430 does not teach a composition comprising “about 2.5 kcal/mol.” Appeal Br. 11–13. Appellant asserts that there is a mathematical error in the Examiner’s calculation regarding the caloric content of the composition. In the Final Action, the Examiner describes the calculation to determine the caloric content of the composition as follows: human milk contains 24 cal/oz (0.811 kcal/ml) and added fortifiers of invention contain between 0.92 and 1.89 cal/ml (kcal/ml) leading to total caloric content of between 1.7 kcal/ml and 2.7 kcal/ml (2.5 kcal/ml); paragraphs [0005] and [0071]. Final Act. 2. That is, the Examiner cites to paragraph 5 of Medo ’430 as teaching a milk having 0.811 kcal/ml and paragraph 71 as teaching fortifiers having between 0.92 and 1.89 kcal/ml. Id. The Examiner then adds these numbers to achieve the claimed range of about 2.5 kcal/ml. Id. Appeal 2019-006406 Application 14/198,432 5 Appellant points out that “[t]hese values are concentrations and are not additive in the manner suggested by the Office.” Appeal Br. 12 (emphasis in original). Appellant further provides the following calculation: “1 ml having 0.811 kcal + 1 ml having 1.89 kcal= 2 ml having 2.7 total kcal” and “2 ml having 2. 7 kcal = 1.35 kcal/ml.” Id. (emphases in original). We find this analysis persuasive. Appellant additionally argues that Medo ’430 does not teach a composition comprising “about 25% fat.” Id. at 13–14. In the Final Action, the Examiner finds that Medo ’430 “discloses wherein the composition comprises about 25 percent fat (example 1 wherein cream contains 25 percent to 46 percent fat (about 25 percent fat); paragraph [0100]–[0102]).” Final Act. 2–3. The Examiner relies on the following portion of Medo ’430: 5. Milk was separated into in skim milk and cream, which had the following concentrations: a. Skim: 0.3%-0.69% Fat, 0.9%-1.2% Protein, 6%-10% Lactose b. Cream: 25%-46% Fat, 0.5%-2% Protein, 8-10% Lactose Medo ’430 ¶¶ 100–102 (emphasis added). The Medo ’430 specification further teaches the following: 6. The Cream can be, if desired, taken and run through the separator: a. This step produces more skim milk, which increases the yield because the more skim is produced, the more HMF can be produced. b. The product that comes out the non-skim side of the separator is currently considered waste. . . . 10. During the Bulk formulation, cream was added to the concentrated skim milk, after post wash was added. This step increased calories to the correct target. At this point, the product was at: Appeal 2019-006406 Application 14/198,432 6 a. Fat-8.5%–9.5%. Id. ¶¶ 103–105, 109, 110. Thus, Medo ’430 teaches that a portion of the cream is used to increase the fat content of the skim to a range of 8.5% to 9.5%. The remainder of the cream is “considered waste” and is discarded prior to pasteurization. Id. ¶¶ 105, 151. Accordingly, Appellant has shown error in the Examiner’s finding that Medo ’430 teaches a pasteurized composition comprising about 25% fat. CONCLUSION The Examiner’s rejection is reversed. In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 3, 4 103(a) Medo ’430, Medo ’684 1, 3, 4 REVERSED