Miguel URIOL RIVERA

Patent Trials and Appeals Board

Mar 21, 2022

2021002478 (P.T.A.B. Mar. 21, 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. 15/117,896 08/10/2016 Miguel Giovanni URIOL RIVERA 631-86-UTIL 3263 79683 7590 03/21/2022 OLIVE LAW GROUP, PLLC BENTLEY J OLIVE 2500 Regency Parkway CARY, NC 27518 EXAMINER QAZI, SABIHA NAIM ART UNIT PAPER NUMBER 1628 NOTIFICATION DATE DELIVERY MODE 03/21/2022 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): bjolive@olivelawgroup.com docket@OLIVELAWGROUP.COM eofficeaction@appcoll.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte MIGUEL GIOVANNI URIOL RIVERA ____________ Appeal 2021-002478 Application 15/117,896 Technology Center 1600 ____________ Before DONALD E. ADAMS, ULRIKE W. JENKS, and JOHN E. SCHNEIDER, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s decision to reject claim 18. We have jurisdiction under 35 U.S.C. § 6(b). 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 “Miguel Giovanni URIOL RIVERA” (Appellant’s July 22, 2020, Appeal Brief (Appeal Br.) 5). Appeal 2021-002478 Application 15/117,896 2 STATEMENT OF THE CASE Appellant’s disclosure “describes the use of paricalcitol in the treatment of . . . [patients with inflammatory anaemia] associated with reduced . . . [erythropoiesis-stimulating agents (ESA)] requirements, optimised iron absorption, stabilisation of Hb levels, increased plasma [erythropoietin (EPO)] . . . levels and decrease in inflammatory markers in said patients” (Spec. 5:8-23). Appellant’s only pending claim, claim 18, is reproduced below: 18. A method of inducing an increase of endogenous erythropoietin synthesis in patients in dialysis, said method comprising administering paricalcitol to a subject, wherein the dose of paricalcitol to be administered is between 5-10 μg/week. (Appeal Br. 20.) Claim 18 stands rejected under 35 U.S.C. § 102(a)(1) as anticipated by Hamad.2 ISSUE Does the preponderance of evidence on this record support Examiner’s finding that Hamad teaches Appellant’s claimed invention? ANALYSIS “Anticipation requires a showing that each limitation of a claim is found in a single reference, either expressly or inherently.” Atofina v. Great 2 Hamad et al., Use of Intravenous Paricalcitol in Peritoneal Dialysis Patients Improved Control of Secondary Hyperparathyroidism, 27 Perit Dial. Int’l, Supp. 3 S16 (2007). Appeal 2021-002478 Application 15/117,896 3 Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006) (citing Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1369 (Fed. Cir. 2005)). It is well settled that, when Appellant’s claim recites a range that range is anticipated by a prior art reference if the reference discloses a point within the range. Titanium Metals Corp. v. Banner, 778 F.2d 775, 782 (Fed. Cir. 1985). It is important to note, however, that “the disclosure of a range[,] of[, for example] 150 to 350 ºC[,] does not constitute a specific disclosure of the endpoints of that range, i.e., 150 ºC and 350 ºC.” Atofina, 441 F.3d at 1000. Thus, when the prior art discloses its own range, rather than a specific point, . . . the prior art is only anticipatory if it describes the claimed range with sufficient specificity such that a reasonable fact finder could conclude that there is no reasonable difference in how the invention operates over the ranges. Ineos USA LLC v. Berry Plastics Corp., 783 F.3d 865, 869 (Fed. Cir. 2015) (citing Atofina, 441 F.3d at 999; ClearValue, Inc. v. Pearl River Polymers, Inc., 668 F.3d 1340, 1345 (Fed. Cir. 2012)). On this record, Examiner relies on, Hamad, a “Poster Presentation,” relating to the “Use of Intravenous Paricalcitol in Peritoneal Dialysis Patients Improved Control of Secondary Hyperparathyroidism” (Hamad, Title; see also Ans. 4). In particular, Hamad discloses a five month “study [of] the efficacy of intravenous (IV) paricalcitol in [five] peritoneal dialysis (PD) patients (pts) with secondary hyperparathyroidism (SHPT)” (Hamad §§ Objective, Results; see also Ans. 4-5). Hamad discloses that the IV paricalcitol “[d]ose at the end of the trial was 7-26 μg/week with a mean of 17.7 μg/week” (Hamad § Results; see also Ans. 4-5). Appeal 2021-002478 Application 15/117,896 4 Examiner finds that Appellant’s “[c]laimed dose overlaps with Hamad” and because the same compound pariclcitol was used in the same population (patients with dialysis) and . . . [Hamad’s] lower amount 7 μg/week . . . reads on [Appellant’s] claimed 5-10 μg/week . . . Hamad anticipates [Appellant’s] claimed method of “inducing an increase of endogenous erythropoietin synthesis” in patients in dialysis, said method comprising administering paricalcitol to a subject, wherein the dose of paricalcitol to be administered is between 5-10 μg/week. (Ans. 5.) Examiner further finds: The property of inducing an increase of endogenous erythropoietin synthesis in patients in dialysis, by administering paricalcitol to a subject, is considered inherent wherein the dose of paricalcitol to be administered to the same population is within the range (between 5-10 μg/week would be inherent as paricalcitol in amount 7 μg/week). (id. at 7.) We are not persuaded. Initially, we are not persuaded by Examiner’s emphasis on a dosage of 7 μg/week because the disclosure of a range, i.e. 7-26 μg/week, does not constitute a specific disclosure of the endpoints of that range, i.e., 7 μg/week and 26 μg/week. See Atofina, 441 F.3d at 1000. To the contrary, the only specific dosage amount disclosed in Hamad is 17.7 μg/week, which falls outside of Appellant’s claimed dosage range (see Hamad § Results; cf. Appeal Br. 14 (Appellant contends that “[t]he only thing from Hamad that is clear is a mean dosage of 17.7 micrograms/week.”)). For the foregoing reasons, we are not persuaded by Examiner’s finding that Appellant’s “claimed range [of] 5-10 μg/week dose is anticipated by 7 μg/week of Hamad . . . dosage” (Ans. 9). Therefore, we focus our attention on the slight, 7-10 μg/week, overlap between Appellant’s claimed range of 5-10 μg/week and Hamad’s disclosed Appeal 2021-002478 Application 15/117,896 5 range of 7-26 μg/week to determine whether Hamad described Appellant’s “claimed range with sufficient specificity such that a reasonable fact finder could conclude that there is no reasonable difference in how the invention operates over the ranges.” Ineos, 783 F.3d at 869. First, we note that the slightly overlapping range is not disclosed by Hamad as a species of its broader generic range of 7-26 μg/week. See Atofina, 441 F.3d at 1000 (A prior art’s disclosure of a range that “slightly overlaps” with a claimed range is not disclosed, in the prior art, as a species of the claimed range.). Next, the evidence on this record supports a finding that “doses higher than 10 μg/week are useful in the treatment of secondary hyperparathyroidism” and “[t]his finding is aligned with the teaching of Hamad that shows an average level of paricalcitol of 17.7 g/week for treating secondary hyperparathyroidism” (Third RIVERA Decl.3 ¶ 4; see also Appeal Br. 16- 17). In addition, Examiner does not dispute, RIVERA’s testimony that “only pariclcitol doses of 5 to 10 μg/week . . . are capable of maintaining erythropoietin plasma levels in the physiological normal range . . . whereas the administration of higher paricalcitol doses of 15-20 μg/week . . . resulted in levels of plasma erythropoietin that were too high,” thus, establishing the criticality of Appellant’s claimed range (Third RIVERA Decl. ¶ 7; cf. Ans. 8-9). See Atofina, 441 F.3d at 999-1000 (Reversing the lower courts finding of anticipation where the patent-in-suit claimed a temperature range that was critical to the operability of the invention and the broad range disclosed in the prior art was substantially different than the critical temperature range.). In sum, we find that the preponderance of evidence on 3 Third Declaration of Miguel Giovanni URIOL RIVERA, signed July 2, 2020. Appeal 2021-002478 Application 15/117,896 6 this record supports a finding that Hamad fails to describe Appellant’s “claimed range with sufficient specificity such that a reasonable fact finder could conclude that there is no reasonable difference in how the invention operates over the ranges.” Ineos USA LLC v. Berry Plastics Corp., 783 F.3d at 869. To be complete, we recognize Examiner’s citation to In re Boesch, 617 F.2d 272 (CCPA 1980) and In re Aller, 220 F.2d 454 to support a conclusion that “‘it is not inventive to discover the optimum or workable ranges by routine experimentation’” (Ans. 9). We note, however, that the rejection before this Panel is based on anticipation. Thus, although an overlapping or encompassing range in the prior art may “establish[] a prima facie case of obviousness” (see In re Peterson, 315 F. 3d 1325, 1329 (Fed. Cir. 2003)), such a disclosure does not necessarily constitute an anticipation (see e.g., In re Petering, 301 F.2d 676, 682 (CCPA 1962); Atofina, 441 F.3d at 999). In addition, although “picking and choosing may be entirely proper in the making of a 103, obviousness rejection . . . it has no place in the making of a 102, anticipation rejection.” In re Arkley, 455 F.2d 586, 587-88 (CCPA 1972). CONCLUSION The preponderance of evidence on this record fails to support Examiner’s finding that Hamad teaches Appellant’s claimed invention. The rejection of claim 18 under 35 U.S.C. § 102(a)(1) as being anticipated by Hamad is reversed. Appeal 2021-002478 Application 15/117,896 7 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 18 102(b)(1) Hamad 18 REVERSED