Heartbeet Ltd.

Patent Trials and Appeals Board

Jan 11, 2022

PGR2021-00094 (P.T.A.B. Jan. 11, 2022)

Trials@uspto.gov Paper 7 571-272-7822 Date: January 11, 2022 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD HUMAN POWER OF N COMPANY, Petitioner, v. HEARTBEET LTD., Patent Owner. PGR2021-00094 Patent 10,842,813 B2 Before SHERIDAN K. SNEDDEN, SUSAN L. C. MITCHELL, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. NEWMAN, Administrative Patent Judge. DECISION Denying Institution of Post-Grant Review 35 U.S.C. § 324 I. INTRODUCTION Human Power of N Company (“Petitioner”) filed a Petition requesting post-grant review of claims 1-24 of U.S. Patent No. 10,842,813 B2 (Ex. 1001, “the ’813 patent”). Paper 1 (“Pet.”). Heartbeet Ltd. (“Patent Owner”) filed a Preliminary Response to the Petition. Paper 6 (“Prelim. Resp.”). PGR2021-00094 Patent No. 10,842,813 B2 2 To institute a post-grant review, we must determine whether the information presented in the Petition, “if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). Upon consideration of the Petition and the Preliminary Response, for the reasons set forth below, we determine that Petitioner has not shown that the ’813 patent is eligible for post-grant review. Accordingly, we do not institute a post-grant review of the challenged claims of the ’813 patent. A. Real Parties-in-Interest In the Petition, Petitioner states it is the real party-in-interest. Pet. 1. Patent Owner identifies itself and an exclusive licensee, ThermoLife International, LLC, as real parties-in-interest. Paper 3, 1. B. Related Matters Both Petitioner and Patent Owner identify the following related case: Thermolife International, LLC v. Human Power of N Company, 6-21-cv- 00144-ADA (W.D. Tex.). Pet. 1; Paper 3, 2. Petitioner identifies the following as related matters: Pending U.S. Patent Application No. 17/061,321; U.S. Patent No. 10,406,118; U.S. Patent No. 10,555,968; U.S. Patent No. 9,180,140; and Reexamination No. 90/013,759, which is a reexamination of the ’140 Patent. Pet. 1. Patent Owner identifies the following as related matters: Pending U.S. Patent Application No. 17/061,321; Pending U.S. Patent Application No. 17/308,007; U.S. Patent No. 10,406,118; U.S. Patent No. 10,555,968; U.S. Patent No. 9,180,140; and Reexamination No. 90/013,759. Paper 3, 1- 2. PGR2021-00094 Patent No. 10,842,813 B2 3 We note that, subsequent to the filing of this Petition, PGR2021- 00110 was filed by Petitioner to challenge claims in U.S. Patent No. 10,835,555, also assigned to Heartbeet Ltd. C. The ’813 Patent The ’813 patent, titled “Compositions of Nitrates and Methods of Use Thereof,” issued November 24, 2020, from an application filed April 30, 2018. Ex. 1001, codes (54), (45), (22). It is a continuation of U.S. Application No. 12/528,794, filed as U.S. Application No. PCT/SE2008/050212 on February 26, 2008, and U.S. Application No. 15/966,508, which is a continuation of U.S. Application No. 14/830,937, filed on August 20, 2015, which is a continuation of U.S. Application No. 12/528,798, filed as U.S. Application No. PCT/SE2008/050211 on February 26, 2008. Id. at code (63). The parent application claims priority to U.S. Provisional application No. 60/919,709, filed March 22, 2007. Id. at code (60). Among the methods disclosed are “methods of decreasing systolic blood pressure, the method comprising administering inorganic nitrate (NO3- ) to a hypertensive human subject in need of reduced systolic blood pressure.” Id. at 4:45-48. The ’813 patent discloses that [t]he nitrite and nitrate salts may be of synthetic origin, but may also be isolated from natural sources, such as naturally nitrate containing plants, e.g., green leafy vegetables, examples include, but are not limited to spinach, lettuce, fennel, cabbage, Chinese cabbage and beetroot. Id. at 10:10-14. In some embodiments, the inorganic nitrate is administered in the form of beetroot juice given once a day in the amount of at least 3 deciliters. Id. at 4:64-67. The inorganic nitrate may also be in the form of a nitrate salt, such as “sodium nitrate, potassium nitrate, calcium nitrate, zinc PGR2021-00094 Patent No. 10,842,813 B2 4 nitrate, ammonium nitrate, or arginine nitrate.” Id. at 5:28-32. The specification discloses administration of various amounts of inorganic nitrate (id. at 4:57-63), in various forms (id. at 4:51-56), and with various additives (id. at 5:5-23) or additional compounds that may enhance the function of the inorganic nitrate (id. at 11:17-37; 12:51-57). The ’813 patent discloses an example titled “Effect of Ingestion of Beetroot on Blood Pressure,” detailing a study of “[a] 43-year old non- smoking subject with hypertension,” who “ingested fresh beetroot juice (300-400ml/day) for 14 days.” Id. at 27:37-39. The individual’s blood pressure when the experiment began (basal rate of systolic/diastolic pressure, in mmHg) was 142/99. Id. at 27:42-43. During the 14 days of the study, the subject experienced a mean reduction in systolic blood pressure of 15 mmHg and a mean reduction of 16mmHg in diastolic pressure. Id. at 27:45-49. Six days after stopping administration of beetroot juice, the subjects blood pressure had increased to 140/100 mmHg. Id. at 27:49-51. The measurements of the subject’s blood pressure in mmHg over the experiment are depicted in Figure 9: PGR2021-00094 Patent No. 10,842,813 B2 5 Figure 9 is a “graph showing the effect of a two-week intervention with [administration of] beetroot juice (fresh juice 3-4 dl/day) on systolic, diastolic, and mean arterial (MAP) blood pressure in a 43-year old male with hypertension.” Id. at 6:25-28. The ’813 patent discloses that similar results in reduction of blood pressure were achieved in nine volunteers administered inorganic nitrate as sodium nitrate. Id. at 24:3-18, 25:61-63, 26:20-21. The invention discloses use of inorganic nitrate administration in a number of applications, including as a pre-surgical treatment for patients, as a treatment for arterial insufficiency, and to “patients at risk of developing significant metabolic stress.” Id. at 17:1-19:24. D. Challenged Claims Petitioner challenges claims 1-24 of the ’813 patent. Pet. 3-4. Claim 1 is the sole independent claim. Ex. 1001, 28:48-30:29. Claim 1 is illustrative and reproduced below: 1. A method of decreasing systolic blood pressure, the method comprising administering inorganic nitrate (NO3 -) to an adult human subject requiring a reduction in systolic blood pressure. Id. at 28:48-51. E. Prior Art and Asserted Grounds Petitioner asserts that claims 1-24 would have been unpatentable on the following grounds (Pet. 3-4): PGR2021-00094 Patent No. 10,842,813 B2 6 Ground Claim(s) Challenged 35 U.S.C. § Reference(s)/Basis 1 1-2, 22, 23 102(a)(1) Brunton;1 EX1003 at ¶1022; EX1060; EX1061; EX1068 at ¶¶ 55-61 2 1-2, 14-18, 22, 23 103(a) Brunton 3 16-18 103(a) Brunton, Brunton 2;3 EX1003 at ¶ 124; EX1062; EX1063; EX1068 at ¶¶ 62-68 4 3-13, 24 103(a) Brunton, Shevach4 5 8-13, 24 103(a) Brunton, Shevach, Brunton 2 6 19-21 103(a) Brunton, Chevaux5 7 21 103(a) Brunton, Chevaux, Brunton 2 8 13 103(a) Brunton, Shevach, Chevaux 9 13 103(a) Brunton, Shevach, Chevaux, Brunton 2 10 1-7, 14-18, 22, 23 103(a) Webb;6 EX1068 at ¶¶ 110-116. 11 8-13, 24 103(a) Webb, Shevach 12 1-24 112(a) Lack of written description 13 1-15, 19-24 112(a) Nonenabled 14 21 112(b) Indefinite 1 Brunton, An Address on Blood Pressure in Man: Its estimation and indications for treatment, The British Medical Journal, pp. 64-67 (July 10, 1909) (Ex. 1032 “Brunton”). 2 This chart repeats the grounds as presented in Petitioner’s chart at Pet. 3-4. 3 Brunton et al., An Address on Longevity and the Means of Attaining It, The Lancet, Vol. 168, Issue 4342, pp. 1330-1355 (Nov. 17, 1906) (Ex. 1033 “Brunton 2”). 4 WO 2005/062713 A2, published July 14. 2005 (Ex. 1027 “Shevach”). 5 WO 99/45797, published Sept. 16, 1999 (Ex. 1043 “Chevaux”). 6 Webb et al., BHS Abstracts, Journal of Human Hypertension, Vol. 21, pp. 828-850 (Sept. 20, 2007) (Ex. 1042 “Webb”). PGR2021-00094 Patent No. 10,842,813 B2 7 Petitioner relies on the declaration testimony of Jeff Volek, Ph.D., (Ex. 1003) in support of these grounds. F. Person of Ordinary Skill in the Art Petitioner proposes that one of ordinary skill in the art would have had “an M.D. degree or a Ph.D. degree in biochemistry, pharmacology, nutrition chemistry, or kinesiology, and at least two years of post-doctoral research or clinical experience with physiology, biochemistry, or dietary supplements and formulation.” Pet. 13 (citing Ex. 1003 ¶ 21). Patent Owner does not challenge this definition at this time. Prelim. Resp. 7. For purposes of this decision, we apply Petitioner’s proposed definition as it is consistent with the level of skill presented in the ’813 patent and cited prior art. We also note that the level of ordinary skill in the art at the time of the invention may be reflected in the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). G. Claim Construction In a post-grant review, we apply the same claim construction standard as would be used by a district court to construe a claim in a civil action involving the validity or infringement of a patent. 37 C.F.R. § 42.200(b) (2021). Under that standard, claim terms are given their ordinary and customary meaning, as would have been understood by a person of ordinary skill in the art at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id.; Phillips PGR2021-00094 Patent No. 10,842,813 B2 8 v. AWH Corp., 415 F.3d 1303, 1312-19 (Fed. Cir. 2005) (en banc); Thorner v. Sony Comput. Entm’t Am. LLC, 669 F.3d 1362, 1365-66 (Fed. Cir. 2012). Petitioner proposes construction of two terms, “inorganic nitrate” and “requiring a reduction in systolic blood pressure.” Pet. 26-27. Of these terms, Patent Owner does not propose a construction for “inorganic nitrate” (Prelim Resp. 7). For purposes of determining whether to institute trial of the challenged claims, we determine it is not necessary to construe “inorganic nitrate.” Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in the context of an AIA proceeding). Petitioner proposes that “requiring a reduction in systolic blood pressure” should be defined in relation to “normal” systolic blood pressure, which the specification defines as “about 140.” Pet. 27 (citing Ex. 1001 at 11:64-66; Ex. 1003 ¶ 79). Petitioner next refers to the specification’s definition of “about”: The term “about” when used in the context of numeric values denotes an interval of accuracy, familiar and acceptable to a person skilled in the art. Said interval can be +/-2% of the given value, preferably +/-5%, and most preferably +/-10% of the numeric values, where applicable. Id. (citing Ex. 1001 at 6:54-59). Using this definition, Petitioner reasons that “the specification defines normal systolic BP as being up to 142.8 mmHg” and concludes that a subject “requiring a reduction in systolic blood pressure” would be a person “‘having a systolic blood pressure in excess of 142.8 mmHg.’” Id. (citing Ex. 1003 ¶ 80). PGR2021-00094 Patent No. 10,842,813 B2 9 Patent Owner responds that the term “requiring a reduction in systolic blood pressure” needs no construction and should be given its plain and ordinary meaning. Prelim. Resp. 7-12. Patent Owner argues that the specification discloses methods of administering inorganic nitrates to subjects needing reduced systolic pressure, including those who are hypertensive due to systolic-diastolic or isolated systolic hypertension. Id. at 8 (citing Ex. 1001 at 4:45-50). Patent Owner argues that the example provided in the specification at 27:38-43 (Ex. 1001) refers to “‘a 43-year- old non-smoking subject with hypertension’ whose ‘blood pressure was 142/99 on the day when the experiment started.’” Id. at 8-9. From this and other disclosures in the specification, Patent Owner concludes that “an individual requiring a reduction in systolic blood pressure is an individual that has elevated or high systolic blood pressure levels, as opposed to normal systolic blood pressure levels.” Id. at 8. Patent Owner argues that the term is “used in its ordinary sense” in the disclosure of the ’813 patent, but should, if construed, mean “includes at least individuals with a systolic blood pressure greater than 140 mmHg.” Id. at 9. Patent Owner argues that Petitioner’s construction is unduly restrictive, contrary to the testimony of its own expert that Stage I hypertension can include up to 159mmHg, applies only the positive portion of the indicated +/- interval, and is contrived to avoid the disclosed example at Ex. 1001, 27:37-54 of the 43-year-old with hypertension at 142/99mmHg. Id. at 9-12. We are persuaded that Petitioner’s proposed definition is unduly restrictive. The claims do not clarify the meaning of “requiring a reduction in systolic blood pressure”; hence, we rely on relevant disclosures in the specification and prosecution history. Phillips, 415 F.3d at 1312-19. The prosecution history adds no clarity to the meaning of this term. As noted by PGR2021-00094 Patent No. 10,842,813 B2 10 Patent Owner, the specification states that the claimed method seeks to lower the systolic blood pressure in a subject needing such a reduction “preferably to normal levels (about 140/80 mmHg”) and provides an example of a 43-year-old with hypertension whose “blood pressure was 142/99 on the day when the experiment started.” Prelim. Resp. 8-9. We agree with Patent Owner that these disclosures provide general guidance to the person of ordinary skill in the art that the upper bounds of normal systolic blood pressure is about 140 mmHg, and that a person “requiring a reduction in systolic blood pressure” is someone whose systolic blood pressure exceeds that general measurement. Moreover, as discussed above, Petitioner states that a person of ordinary skill in the art would have had a medical degree or equivalent study in fields such as “biochemistry, pharmacology, nutrition chemistry, or kinesiology” (Pet. 13) such that the term would have been interpreted by persons with a sophisticated understanding of human physiology according to the facts and circumstances presented and with the guidance of “about 140 mmHg” providing a general measurement guideline. We conclude that the plain and ordinary meaning of a person “requiring a reduction in systolic blood pressure” is a person having higher than about 140 mmHg systolic blood pressure. II. ELIGIBILITY FOR POST-GRANT REVIEW As a threshold matter, we must determine whether the ’813 patent is eligible for post-grant review. The post-grant review provisions set forth in section 6(d) of the Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (September 16, 2011) (“AIA”), apply only to patents subject to the first-inventor-to-file provisions of the AIA. See AIA § 6(f)(2)(A) (stating that the provisions of section 6(d) “shall apply only to patents described in section 3(n)(1)”). Patents subject to the first-inventor-to-file PGR2021-00094 Patent No. 10,842,813 B2 11 provisions are those that issue from applications that contain or contained at any time- (A) a claim to a claimed invention that has an effective filing date as defined in section 100(i) of title 35, United States Code, that is on or after [March 16, 2013]; or (B) a specific reference under section 120, 121, or 365(c) of title 35, United States Code, to any patent or application that contains or contained at any time such a claim. AIA § 3(n)(1). Our rules require that each petitioner for post-grant review certify that the challenged patent is available for post-grant review. 37 C.F.R. § 42.204(a) (“The petitioner must certify that the patent for which review is sought is available for post-grant review . . . .”). In addition, “[a] petition for a post-grant review may only be filed not later than the date that is 9 months after the date of the grant of the patent or of the issuance of a reissue patent (as the case may be).” 35 U.S.C. § 321(c). Determining whether a patent is subject to the first-inventor-to-file provisions of the AIA, and therefore eligible for post-grant review, is straightforward when the patentee filed the application from which the patent issued before March 16, 2013, or when the patentee filed the application on or after March 16, 2013, without any priority claim. The determination is more complex, however, for a patent that issues from a “transition application,” that is, an application filed on or after March 16, 2013, that claims the benefit of an earlier filing date. See MPEP § 2159.04 (9th ed. Rev. 10.2019, June 2020). Entitlement to the benefit of an earlier date under 35 U.S.C. §§ 119, 120, 121, or 365 is premised on disclosure of the claimed invention “in the manner provided by § 112(a) (other than the requirement to disclose the best mode)” in the earlier PGR2021-00094 Patent No. 10,842,813 B2 12 application. See 35 U.S.C. §§ 119(e), 120. Thus, a patent that issues from a transition application is not available for post-grant review if the claimed subject matter complies with the written description and enablement requirements of § 112(a) for an ancestor application filed prior to March 16, 2013. The application that matured into the ’813 patent is a transition application, as it claims priority to an application filed before March 16, 2013. Specifically, the ’813 patent issued November 24, 2020, from U.S. Application No. 15/966,508, filed April 30, 2018. Ex. 1001, codes (45), (21), (22). Petitioner provides, and Patent Owner adopts Chart 1, depicted below, to represent the two patent chains to which the ’813 patent claims priority: PGR2021-00094 Patent No. 10,842,813 B2 13 Chart 1 above is an excerpt from the Petition reflecting the familial relationships of the ’813 patent’s priority claim. Pet. 28; Prelim Resp. 5. For ease of reference, we adopt the naming conventions shown in the chart and used by the parties. As Patent Owner states: As shown in Chart 1, the ’813 patent has two priority chains. In what Petitioner labels as “Priority Chain 1,” the ’813 patent claims priority to U.S. Application No. 12/528,794 (“Parent1”), which issued as U.S. Patent No. 10,406,118 and is the national stage application of PCT/SE08/50212 (“PCT1”). PCT1 in turn claims priority to both U.S. Provisional Application No. 60/919,709 (“Provisional”) and SE 0700520-0 (“Swedish1”). And in what Petitioner labels as “Priority Chain 2,” the ’813 patent claims priority to U.S. Application No. 14/830,937 (“Parent3”), which issued as U.S. Patent No. 10,555,968 and is a continuation of U.S. Application No. 12/528,798 (“Parent 2”), which issued as U.S. Patent No. 9,180,140. The latter is the national stage application of PCT/SE08/050211 (“PCT2”), which claims priority to both Swedish1 and SE 0700729-7 (“Swedish2”). Prelim. Resp. 5-6. Petitioner does not raise any issue with respect to whether the priority applications enable the claims at issue. See, generally, Pet. Petitioner asserts that the ’813 patent is eligible for post-grant review under AIA § 3(n)(1)(B) because claims 5-18 and 24 “lack written description support in the applications in the ’813 Patent’s priority chain and thus have an effective filing date no earlier than that of the ’813 Patent.” Pet. 27-28. Petitioner asserts that certain limitations in claims 5-18 and 24 were disclosed for the first time in the ’508 application that led to the ’813 patent, which was filed after March 16, 2013. Id. at 27-32. PGR2021-00094 Patent No. 10,842,813 B2 14 Patent Owner disagrees and contends that Petitioner has failed to show that the ’813 patent is eligible for post-grant review. Prelim. Resp. 22-51. Patent Owner argues that claims 5-18 and 25 are each entitled an effective filing date “at least as early as February 26, 2008” and specifically, that “claims 5-7 are entitled to claim priority to PCT1, claim 24 is entitled to claim priority to PCT2, and claims 8-18 are entitled to claim priority to both PCT1 and PCT2.” Id. at 23, 51. The test for written description support is “whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date” based on an “objective inquiry into the four corners of the specification.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010) (en banc). If this test fails, the application is not entitled to the benefit of the earlier filing date. The written description requirement is satisfied when the specification “set[s] forth enough detail to allow a person of ordinary skill in the art to understand what is claimed and to recognize that the inventor invented what is claimed.” University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 928 (Fed. Cir. 2004). The specification does not have to provide exact or verbatim textual support for the claimed subject matter at issue. Fujikawa v. Wattanasin, 93 F.3d 1559, 1570 (Fed. Cir. 1996). The Federal Circuit has clarified that [a]lthough [the applicant] does not have to describe exactly the subject matter claimed, . . . the description must clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed . . . . The test for sufficiency of support . . . is whether the disclosure of the application relied upon “reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter.” PGR2021-00094 Patent No. 10,842,813 B2 15 Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991) (citations omitted). Moreover, “the written description requirement does not demand either examples or an actual reduction to practice.” Ariad Pharms., 589 F.3d at 1351. “[A]n applicant is not required to describe in the specification every conceivable and possible future embodiment of his invention.” Cordis Corp. v. Medtronic AVE, Inc., 339 F.3d 1352, 1365 (Fed. Cir. 2003). Furthermore, “[a] specification may . . . contain a written description of a broadly claimed invention without describing all species that [the] claim encompasses.” Id. Finally, the written description inquiry is a question of fact, is context specific, and must be determined on a case-by-case basis. Ariad Pharms., Inc., 598 F.3d at 1351 (citing Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F.2d 1570, 1575; Capon v. Eshhar, 418 F.3d 1349, 1357-1358 (Fed. Cir. 2005)); see also Vas-Cath, 935 F.2d at 1562 (“Precisely how close the [original] description must come to comply with [the description requirement of] § 112 must be [determined on a] case-by-case basis.”) (quoting In re Smith, 258 F.2d 1389, 1395 (CCPA 1972)). “[T]he level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.” Ariad Pharms at 1351 (citing Capon, 418 F.3d at 1357-1358). Factors used to evaluate the sufficiency of a disclosure include: 1) “the existing knowledge in the particular field”; 2) “the extent and content of the prior art”; 3) “the maturity of the science or technology”; and 4) “the predictability of the aspect at issue” (the “Ariad factors”). Id. (citing Capon, 418 F.3d at 1359). “Patent claims are awarded priority on a claim-by-claim basis based on the disclosure in the priority applications.” Lucent Techs., Inc., v. PGR2021-00094 Patent No. 10,842,813 B2 16 Gateway, Inc., 543 F.3d 710, 718 (Fed. Cir. 2008) (citations omitted). We address the claims in the same groupings applied by the parties, and limit our discussion to the alleged lack of written description argued by Petitioner for each claim or group of claims. A. Claims 5-7 Petitioner avers that claims 5-7 recite, through dependency, “administering inorganic nitrate … to an adult human subject requiring a reduction in systolic blood pressure” with the inorganic nitrate source being administered as beetroot juice “once a day” in an amount of at least 3 deciliters. Pet. 29. Petitioner argues that the priority applications “lack any description of once-daily administration of beetroot juice to a subject requiring a reduction in blood pressure, nor any description of doing so for a person requiring a reduction in systolic BP.” Id. Petitioner argues that the examples and disclosure provided by the priority applications either do not mention beetroot juice; do not employ once daily dosing, but rather employ thrice-daily dosing or do not specify a dosing schedule; or disclose administering the dose to a subject not requiring a reduction in systolic blood pressure. Id. at 29-30 (citing 1003 ¶¶ 92, 224; Ex. 1005; Ex. 1006 ¶ 60; Ex. 1007 ¶¶ 53, 108, 109; Ex. 1009 ¶ 53; Ex. 1010 ¶ 80; Ex. 1011 ¶ 80; Ex. 1012 ¶ 80). Patent Owner responds that Claim 5 is entitled to priority to PCT1 (Ex. 1007, U.S. Patent No. 10,406,118). Prelim. Resp. 25-32. Patent Owner argues that “PCT1 explains that nitrate can be used to reduce elevated systolic blood pressure to normal levels” and discloses “a method to reduce blood pressure, preferably to normal levels (about 140/80 mmHg).” PGR2021-00094 Patent No. 10,842,813 B2 17 Id. at 26 (citing Ex. 10087 ¶ 53). Patent Owner argues that the need to have a reduction in systolic blood pressure to 140 mmHg indicates that the subject had a “non-normal, high systolic blood pressure over 140mmHg” “[u]nder the proper construction of ‘requiring a reduction in systolic blood pressure’” and would therefore require a reduction in systolic blood pressure. Id. at 26- 27. Patent Owner further argues that PCT1 discloses that the nitrates mentioned in paragraph 53 are “inorganic nitrates, such as nitrates from natural sources, including beetroot juice” and notes that the paragraph states “(Examples of nitrite and/or nitrate sources are natural sources of nitrate (such as vegetables as mentioned above or juices thereof)” Id. at 27. Patent Owner argues that PCT1 demonstrates “a working example demonstrating reduction in systolic blood pressure via administration of inorganic nitrates in the form of fresh beetroot juice.” Id. (citing Ex. 1008 ¶ 108 (working example) and additional paragraphs ¶¶ 49, 51, 57 (additional references to administration of inorganic nitrate as beetroot juice)). Patent Owner argues that the subject, having a systolic pressure of 142 mmHg, requires a reduction in systolic blood pressure because 142 exceeds the normal value of “about 140mmHg.” Id. Patent Owner notes that PCT1 discloses that beetroot juice administration “did result in a decrease of systolic blood pressure” and that stopping the treatment resulted in an increase in the blood pressure to basal levels. Id. at 28 (citing Ex. 1008 ¶¶ 25, 86, 109, Figure 9). 7 Although Patent Owner claims priority to PCT1 (Prelim. Resp. 25), Patent Owner’s references in the discussion cite to Ex. 1008, which Petitioner identified as “Parent 1” (Pet. iv). Because the referenced paragraphs of these two documents are identical, we treat the references as such. PGR2021-00094 Patent No. 10,842,813 B2 18 Patent Owner next argues that PCT1 discloses administration of inorganic nitrate once a day, in the context of the beetroot juice example discussed above. Id. at 31. Patent Owner cites Ex. 1008 ¶ 108 (Parent 1) for the disclosure “43 year old non-smoking subject with hypertension ingested fresh beetroot juice (300-400 ml/day) for 14 days” and alleges that a teaching of “per day” encompasses a single administration when the amount administered comprises 10-13.5 fluid ounces, which could be consumed in a single administration. Id. In addition, Patent Owner notes that PCT1 discloses administration of inorganic nitrate as a single “bolus” dose: “[t]he nitrate and/or nitrate comprising composition and possible further combinations described herein can be administered continuously or as single bolus doses.” Id. at 32 (citing Ex. 1008 ¶ 41). We agree with Patent Owner’s arguments that PCT1 contains the disclosures as explained by Patent Owner, and we conclude that, on this record, Petitioner has not shown sufficiently that the features of claim 5 are not disclosed in PCT 1. The written description requirement does not require the specification to provide an example for each embodiment of the invention. Ariad, 598 F.3d 1352. On this record, we disagree with Petitioner’s contention that one of skill in the art would not have understood that the specification of PCT1 discloses administration of beetroot juice in doses that could include once a day administration to a subject requiring a reduction in blood pressure, which could include the need for a reduction in systolic blood pressure. We are thus unpersuaded that the ordinarily skilled artisan would not have understood the inventor possessed the subject matter of claim 5 as of the filing date of PCT1. Vas-Cath, 935 F.2d at 1563. Petitioner’s allegations with regard to claims 6 and 7 rely on their PGR2021-00094 Patent No. 10,842,813 B2 19 dependency from claim 5; thus, we are not persuaded that any of claims 5-7 lacked written descriptive support in PCT1. B. Claims 8-13, 24 With regard to claims 8-13 and 24, Petitioner argues that each recites administration of “a composition consisting of the inorganic nitrate and at least one additive,” but that none of the priority applications provides written descriptive support for a “nitrate-and-additive-only composition.” Pet. 30 (citing Ex. 1003, ¶¶ 95-98). Petitioner argues that any additives mentioned are “only in the context of ‘functional food,’ not in a composition consisting of nitrate and one or more additives, and not for a person requiring a reduction in systolic BP.” Id. at 30-31 (citing Ex. 1003 ¶¶ 95-97; Ex. 1007; Ex. 1008; Ex. 1009 ¶¶ 30-32; Ex. 1010 ¶¶ 23, 38-44). Patent Owner responds that PCT1 discloses that “administering inorganic nitrate in the form of a nitrate salt reduces systolic blood pressure in an adult human subject requiring reduction in systolic blood pressure.” Prelim. Resp. 33-34 (citing Ex. 1008 ¶ 53). Patent Owner cites a working example it argues demonstrates “reduction in systolic blood pressure via administration of inorganic nitrates in the form of a nitrate salt.” Id. at 34 (citing Ex. 1008 ¶¶ 89, 98, 102). Patent Owner argues that the effects disclosed in PCT1 of lowered blood pressure would likewise occur in persons needing the reduction in blood pressure for other health-related reasons. Id. at 34-35 (citing Ex. 1008 ¶¶ 51, 54; Ex. 1056 at 9-15). Patent Owner argues that PCT1 discloses using additives, including combinations of additives, with inorganic nitrate. Id. at 35-37. Patent Owner argues the additives disclosed are antimicrobials, pH stabilizers, or health-promoting substances disclosed for use with inorganic nitrate. Id. at 35-36 (citing Ex. 1008 ¶¶ 39, 57). Patent Owner also argues that PCT1 PGR2021-00094 Patent No. 10,842,813 B2 20 discloses combinations of inorganic nitrate or nitrate with polyphenols and, optionally, live non-pathogenic bacteria as synergists that contribute to effectiveness of the active ingredient. Id. at 36-37 (citing Ex. 1008 ¶¶ 10, 17, 50-54; Ex. 2001 at v). We agree with Patent Owner’s arguments that PCT18 contains the disclosures as explained by Patent Owner and conclude that, on this record, Petitioner has not shown sufficiently that the features of claims 8 and 24 are not disclosed in PCT1. As discussed above, the written description requirement does not require the specification to provide the exact embodiment claimed provided that the skilled artisan would have understood the disclosure to include use of the components in the claimed manner, despite that the components were not disclosed in a single composition. Vas-Cath Inc,, 935 F.2d at 1563. On this record, we disagree with Petitioner’s contention that one of skill in the art would not have understood that the specification of PCT1 discloses administration of inorganic nitrate in the form of a nitrate salt as recited in claim 8 and an additive in the composition for use as a preservative as recited in claim 24, given the disclosures in PCT1. We are thus unpersuaded that the ordinarily skilled artisan would not have understood the inventor possessed the subject matter of claims 8 and 24 as of the filing date of PCT1. Petitioner’s allegations with regard to claims 9-13 rely on their dependency from claim 8 and the arguments Petitioner made with regard to the limitations of claim 8; thus, we 8 Patent Owner additionally argues that PCT2 provides similar and additional disclosures providing written description support for the challenged claims. Prelim. Resp. 38-51. As we conclude PCT1 provides sufficient independent disclosure, we do not reach these arguments here. PGR2021-00094 Patent No. 10,842,813 B2 21 are not persuaded that any of claims 8-13 and 24 lacked written descriptive support in PCT1. C. Claims 14-18 Petitioner argues that claims 14-18 recite dosages specific to body weight, but that the priority applications provide no “written description support for administering these doses to a person requiring a reduction in blood pressure generally, or systolic pressure specifically.” Pet. 31-32. Rather, Petitioner argues, the priority applications “disclose the recited dosages for nitrate salt administration to ‘lower[] the metabolic rate in a mammal’ or for preoperative drinks” but not “for the treatment of subjects needing a lower systolic BP [blood pressure], including for the beetroot- juice-hypertension-treatment example. Id. at 31 (citing Ex. 1003 ¶¶ 99-101; Ex. 1005 at 4, Ex. 1009 at ¶ 53, Provisional at ¶¶ 8, 33-36, 60; Ex. 1007 ¶¶ 9, 40, 44, 69, 108, 109; Ex. 1008 ¶¶ 9, 40, 44, 69, 108, 109). Petitioner further argues that the limited disclosures of “the 0.1 mmol/kg/day sodium nitrate dosage that reduced systolic BP in the healthy-subject-example” does not support claims 14-16’s ranges, which are “significantly broader” and claim 17-18’s dosages of “any inorganic nitrate rather than of sodium nitrate.” Id. at 32 (citing Ex. 1003 ¶ 100; Ex. 1007 ¶ 89; Ex. 1008 ¶ 89). Finally, Petitioner argues that claim 18 “further lacks support for the recited once-a-day administration for the reasons explained for claims 5-8.” Id. (citing Ex. 1003 ¶ 100). Patent Owner argues that PCT1 provides support for each of the dosage ranges of claims 14-16 as well as a working example using the claimed dosage of claim 17. Prelim. Resp. 44-45 (citing Ex. 1008 ¶¶ 9, 21, 44, 69, 89). Patent Owner argues that the ranges as included in the originally filed claims provide sufficient written description, citing Union PGR2021-00094 Patent No. 10,842,813 B2 22 Oil Co. of Calif. v. Atlantic Richfield Co., 208 F.3d 989 (Fed. Cir. 2000) for the proposition that claim ranges in originally filed claims provide sufficient written description support for those claimed ranges. Id. Petitioner further argues that the specification’s example of administering inorganic nitrate from beetroot juice to an individual with hypertension discloses “administering inorganic nitrate to a person requiring a reduction of systolic blood pressure.” Id. at 46. Petitioner argues that disclosure of the use of sodium nitrate in a working example is sufficient to convey to the ordinarily skilled artisan the use of a representative example sufficient to convey how the remainder of the claimed nitrate sources would be used, as all nitrate sources contain the same source of nitrate anion, (NO3-). Id. at 47-48. We agree with Patent Owner’s arguments that PCT1 contains the disclosures as explained by Patent Owner and conclude that, on this record, Petitioner has not shown sufficiently that the features of claim 14-18 are not disclosed in PCT1. The cited paragraphs of PCT1 state identical ranges as those in claims 14-18, and the originally filed claims in PCT1’s parent application lend additional written descriptive support. See Ex. 1008 ¶¶ 9, 21, 44, 69, 89; Ex. 1007 at 40-41. As we discussed above, we agree with Patent Owner that the specification’s example administering inorganic nitrate from beetroot juice to an individual with hypertension teaches use of inorganic nitrate for the purpose of reducing systolic blood pressure. Given that this example teaches use within a claimed range (claim 17), we are thus unpersuaded that the ordinarily skilled artisan would not have understood the inventor possessed of the subject matter of claims 14-18 as of the filing date of PCT1. PGR2021-00094 Patent No. 10,842,813 B2 23 Accordingly, we find that Petitioner has not identified any challenged claim that has an effective filing date on or after March 16, 2013. For this reason, we find that Petitioner has not shown sufficiently that the ’813 patent is eligible for post-grant review. III. CONCLUSION After considering the evidence and arguments presently before us, we determine Petitioner has not shown that the ’813 patent is eligible for post- grant review. Accordingly, we do not institute a post-grant review. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(d), the Petition is denied. PGR2021-00094 Patent No. 10,842,813 B2 24 FOR PETITIONER: Eagle H. Robinson Michael Pohl NORTON ROSE FULBRIGHT US LLP eagle.robinson@nortonrosefulbright.com michael.pohl@nortonrosefulbright.com FOR PATENT OWNER: Amy E. Hayden Philip X. Wang RUSS, AUGUST & KABAT ahayden@raklaw.com pwang@raklaw.com