Keto Patent Group, Inc.

Patent Trials and Appeals BoardDec 11, 2020

2020001118 (P.T.A.B. Dec. 11, 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. 15/491,924 04/19/2017 Ryan Lowery 8973-004 1066 129565 7590 12/11/2020 Ferguson Braswell Fraser Kubasta PC 2500 Dallas Parkway, Suite 600 Plano, TX 75093 EXAMINER GEMBEH, SHIRLEY V ART UNIT PAPER NUMBER 1615 NOTIFICATION DATE DELIVERY MODE 12/11/2020 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): docketing@fbfk.law patent@fbfk.law PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte RYAN LOWERY, JACOB WILSON, SHAWN WELLS, BRIAN UNDERWOOD, CHRISTOPHER N. HARDING, and TERRY LACORE Appeal 2020-001118 Application 15/491,924 Technology Center 1600 ____________ Before ANTON W. FETTING, ULRIKE W. JENKS, and RACHEL H. TOWNSEND, Administrative Patent Judges. JENKS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s decision to reject the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-PART. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as Keto Patent Group, Inc. Appeal Br. 1. Appeal 2020-001118 Application 15/491,924 2 STATEMENT OF THE CASE Claims 1–3, 5–9, and 21–32 are on appeal, and can be found in the Claims Appendix of the Appeal Brief. Claim 1 is representative of the claims on appeal, and reads as follows: 1. A method for maintaining ketosis in an individual, the method comprising: orally administering a composition comprising approximately 0.5 g to approximately 10 g of R-beta-hydroxybutyrate; wherein administration induces or maintains ketosis in an individual. Appeal Br. 15 (Claim Appendix). Claim 21, the only other independent claim, recites administering less than 2 g of R-beta-hydroxybutyrate. Id. at 17. REFERENCES The prior art relied upon by Examiner is: Name Reference Date Martin et al. (“Martin”) US 6,380,244 B2 Apr. 30, 2002 D’Agostino et al. (“D’Agostino”) US 2014/0350105 Al Nov. 27, 2014 Greenwood et al. (“Greenwood”) EP 1 755 743 B1 Apr. 24, 2003 EnergyTimes-Herbal keto support (“EnergyTimes- Herbal”) https://energytimes.com/herbal- keto-support/ (last accessed Sept. 5, 2019) Jan. 15, 2008 REJECTIONS The following grounds of rejection are before us for review: I. Claim 1–3, 5–9, 21–28, 31, and 32 under 35 U.S.C. 103 over Greenwood in view of D’Agostino (Final Act. 3–6); Appeal 2020-001118 Application 15/491,924 3 II. Claims 1, 21, 29, and 30 under 35 U.S.C. 103 over Greenwood in view of D’Agostino and Martin (Final Act. 7–8); and III. Claims 1, 21, 29, and 30 under 35 U.S.C. 103 over Greenwood in view of D’Agostino and Martin and further in view of EnergyTimes-Herbal (Ans. 3–4). I. Obviousness over Greenwood and D’Agostino Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? A. Findings of Fact (FF) FF1. D’Agostino administers beta-hydroxybutyrate mineral salts in combination with medium chain fatty acids to induce ketosis in a subject. D’Agostino, Abstract, see also ¶¶ 70, 76–80, claim 15. Initiating rapid ketosis and accelerating the rate of ketoadaptation avoids “glucose withdrawal symptoms commonly experienced by individuals initiating a ketogenic diet, and minimizes the loss of lean body mass during dietary restriction.” D’Agostino, Abstract. “[A] composition of ketone precursors is disclosed which comprises at least one medium chain fatty acid, or an ester thereof such as a medium chain triglyceride, and a ẞ-hydroxybutyrate ketone source or precursor.” D’Agostino ¶ 33, see also ¶ 37. FF2. D’Agostino teaches administering between 2 to 50 g of the beta- hydroxybutyrate compound. Id. ¶ 33. D’Agostino teaches that “[t]he compound is optionally a racemic DL-beta hydroxybutyrate or the single isomer R-beta hydroxybutyrate.” Id. ¶ 34. FF3. D’Agostino teaches that the ketone precursors are preferably ingested Appeal 2020-001118 Application 15/491,924 4 along with nutritional substrates such as free amino acids including branched chain amino acids (leucine, isoleucine, valine). Id. ¶ 35. FF4. Greenwood teaches treating neurodegenerative diseases by inducing ketosis. Greenwood ¶ 2. [K]etosis can be provided by restriction of diet, eg by starvation or exclusion of carbohydrate, or by administration of ketogenic materials, such as triglycerides, free fatty acids, alcohols (eg butan-1, 3-diol), acetoacetate and (R)-3-hydroxybutyrate and their conjugates with each other and further moieties, eg. esters and polymers of these. Ketogenic materials thus produce a physiologically acceptable ketosis when administered to a patient. Greeenwood ¶ 2. FF5. Greenwood teaches that “[t]ypical dose ranges for example might be in the range 5 to 5000mg/kg body weight, particularly for an (R)-3- hydroxybuytrate containing material such as oligomeric (R)-3- hydroxybuytrate or its esters with, eg, glycerol or (R)-butan-1,3-diol.” Greenwood ¶ 12. B. Analysis Based on the combination of Greenwood and D’Agostino, Examiner concludes that at the time the invention was made it would have been prima facie obvious “to substitute the amount [of active] taught by Greenwood with that taught by D’Agostino with a reasonable expectation for maintaining ketosis because they are drawn to same technical fields (constituted with same ingredients and share common utilities, and pertinent to the problem which applicant concern[ed] about[)]”. Final Act. 4; FF1– FF5. Appeal 2020-001118 Application 15/491,924 5 Appellant contends that there is no motivation to combine Greenwood and D’Agostino (Appeal Br. 6); that the substitution as proposed by Examiner is inappropriate (id.); that Greenwood teaches away from using low-dose hydroxybutyrate (id. at 9–10); and that they have shown unexpected results (id. at 11). We have reviewed Appellant’s contention in light of Examiner cited art, but find that the evidence of record supports Examiner’s position that the claims are obvious. We address Appellant’s contentions below. Appellant contends that there is no motivation to combine Greenwood and D’Agostino. Appellant acknowledges that both references use hydroxybutyrate compounds. Appeal Br. 8. Appellant argues that the treatment of depression and anxiety is not in the same field as treating body weight and insulin control, therefore, the motivation to combine the references is inappropriate. Id. We are not persuaded by Appellant’s contention that D’Agostino and Greenwood are not in the same field endeavor. Appeal Br. 8. D’Agostino teaches administering between 2 to 50 g of beta hydroxybutyrate in order to induce ketosis in a subject. FF1, FF2. D’Agostino teaches administering the single isomer R-beta hydroxybutyrate. FF2. D’Agostino explains that the administration of hydroxybutyrate “exploits the metabolic and physiological advantages of sustained ketosis (e.g. keto-adaptation) which utilizes ketones as an alternative fuel to improve metabolic health, physical performance and enhance disease prevention.” D’Agostino ¶ 32; Ans. 5. Greenwood similarly teaches induction of ketosis by administering ketogenic substances such as hydroxybutyrate in the range of about 5 to 5000 mg/ kg. FF4, FF5. Appeal 2020-001118 Application 15/491,924 6 Here, both references are directed to administering hydroxybutyrate compounds for the purpose of inducing ketosis in a subject in order to derive a benefit of that physiological state in the subject. Thus, they are reasonably considered to be from in the same field of endeavor. Even if the two references were not in the same field of endeavor they would still be reasonably pertinent to the particular problem addressed in the instant claims, which is directed to inducing ketosis by administering hydroxybutyrate compounds. In re Clay, 966 F.2d 656, 658–9 (Fed. Cir. 1992). Just because Greenwood teaches that high doses of hydroxybutyrate are needed to observe an effect by EEG does not detract from the fact that the reference still discloses ketosis as the mechanism of action. FF4. Because both references teach that hydroxybutyrate induces ketosis we are not persuaded by Appellant’s contention that there is no motivation to combine the teachings of the references. See FF1, FF4. The law does not require that the references be combined for the same advantage or result as set out by appellant. In re Kahn, 441 F.3d 977, 987 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); see Ans. 5. As Examiner explains, “once ketosis has been induced the administration of the same composition will maintain ketosis and its effects of increasing strength, mental activity, and increase at least one of metabolism of fat loss, fat oxidation, motor function or muscle mass will naturally flow” because “[a] chemical composition and its properties are inseparable.” Ans. 5 (citing In re Spada, 911 F.2d 705, 709 (Fed. Circ. 1990)). Appeal 2020-001118 Application 15/491,924 7 We are not persuaded by Appellant’s contention that the substitution as proposed by Examiner is an inappropriate modification of Greenwood. Appeal Br. 6. “If a person of ordinary skill can implement a predictable variation [of a known work], § 103 likely bars its patentability.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). It is obvious to those skilled in the art to substitute one known equivalent for another, be those equivalents method steps or apparatus components. See In re Omeprazole Patent Litig., 483 F.3d 1364, 1374 (Fed. Cir. 2007). Here, Examiner points out that D’Agostino exploits the metabolic and physiological advantages of sustained ketosis by administering hydroxybutyrate compounds in a particular dosage range. Ans. 5; FF1, FF2. Greenwood administers the same compounds to induce ketosis but measures a different physiological endpoint, in this case changes in EEG. See Greenwood ¶¶ 23–29. Greenwood acknowledges that hydroxybutyrate is a ketogenic material that produces physiologically acceptable ketosis when administered to a patient. FF4. Thus, Greenwood just like D’Agostino recognizes that hydroxybutyrate can be administered to achieve ketosis. We note that the dosage ranges contemplated by Greenwood and D’Agostino overlap. Compare FF2 (administering between 2–50 g of a hydroxybutyrate compound) with FF5 (dosage range from 5–5000 mg/kg of body weight2). Based on this overlap we agree with Examiner that it would have been obvious to have 2 Using a body weight of the 62 kg and 100 kg the dosage range for the ketogenic materials disclosed in Greenwood is between 310-310000 mg (or 0.31–310 g), or 500-500000 mg (or 0.5–500 g). See Appeal Br. 7 (“an average human is approximately 62 kg”); Final Act. 5 (“a 100 kg individual, Greenwood would teach a 30,000 mg or 30 g.”). Appeal 2020-001118 Application 15/491,924 8 “substitute[d] the dosage range taught by Greenwood with that of D’Agostino with a reasonable expectation of success.” Ans. 6. Greenwood teaches administering ketogenic compositions in a dosage range of 0.31–310 g. FF5. We are not persuaded by Appellant’s contention that Greenwood’s teachings is limited to a subset of the range disclosed, specifically, those that were determined to be statistically significant when measured by EEG end point. See Appeal. Br. 6–7. It is well settled that “in a section 103 inquiry, ‘the fact that a specific [embodiment] is taught to be preferred is not controlling, since all disclosures of the prior art, including unpreferred embodiments, must be considered.’” Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (quoting In re Lamberti, 545 F.2d 747, 750 (CCPA 1976)); see also In re Mills, 470 F.2d 649, 651 (CCPA 1972) (“All the disclosures in a reference must be evaluated, including nonpreferred embodiments, and a reference is not limited to the disclosure of specific working examples.” (Citations omitted).). Here, D’Agostino teaches administering hydroxybutyrate at a concentration between 2–50 g for the purpose of inducing ketosis in a subject, while Greenwood teaches administration at a dosage range of 0.31– 310 g (or 0.5–500g). FF1, FF2, FF5; see above fn.2. Based on these combined teachings of Greenwood and D’Agostino we agree with Examiner that the record supports a prior art teaching of administering hydroxybutyrate across a dosage range that overlaps the dosages of the present claims, and thereby renders the claims obvious. We are not persuaded by Appellant’s contention that Greenwood teaches away from using low dose ranges. Appeal Br. 9–10. A reference is not limited to preferred examples or preferred outcomes. “All of the Appeal 2020-001118 Application 15/491,924 9 disclosures in a reference must be evaluated for what they fairly teach one of ordinary skill in the art.” In re Boe, 355 F.2d 961, 965 (C.C.P.A. 1966). It is well settled that disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or even non-preferred embodiments. See In re Susi, 440 F.2d 442, 446 n.3 (CCPA 1971). Here, Greenwood teaches administering ketogenic compositions to patients in a dosage range of 0.31–310 g (0.5–500 g). FF5; see above fn.2. As Examiner explains, “[t]he fact that Greenwood teaches such a large range, would motivate one skilled in the art to find the optimum working range within the range for the intended use [inducing ketosis]. . . . Greenwood using 30 mg/kg [] thus would yield [a] 1.95 g” dose. Ans. 6. “D’Agostino specifically teaches the claimed ranges and upon calculation Greenwood also teaches the dosage of 0.95 g which is within the range of 0.5-3 g.” Ans. 7. The references, therefore, teach the administration of hydroxybutyrate compounds at low concentrations within the scope of the claims rendering the claims obvious. We are not persuaded by Appellant’s contention that the Specification provides evidence of unexpected results. See Appeal Br. 11 (citing Spec. ¶¶ 11, 60, 72 (example 1), 82 (example 10), Figures 11A, 11B); see Reply Br. 13–15. According to the Specification, the single R-hydroxybutyrate isomer has the same effectiveness at half the dose of the racemic mixture DL-hydroxybutyrate. See Spec. ¶¶ 73, 92. However, the art teaches administering racemic mixtures as well as single R-hydroxybutyrate, the same compound as claimed at a dosage that overlaps the claimed range. See FF2, FF5; see also Ans. 7 (“D’Agostino specifically teaches the claimed ranges and upon calculation Greenwood also teaches the dosage of 0.95 g Appeal 2020-001118 Application 15/491,924 10 which is within the range of 0.5-3 g.”). Consequently, Appellant’s assertion that the same effectiveness may be achieved at half the dose of the racemic mixture DL-hydroxybutyrate does not demonstrate anything unexpected from the prior art teachings. That is, because the art teaches using the same isomer compound, using overlapping dosages for the same purpose – inducing ketosis – we agree with Examiner’s conclusion that the claims are obvious. See FF2, FF5. “[L]ack of novelty is the epitome of obviousness.” In re May, 574 F.2d at 1089. C. Conclusion We conclude that the preponderance of the evidence of record supports Examiner’s conclusion that the combination of Greenwood and D’Agostino renders obvious the method of inducing ketosis as recited in claims 1 and 21. We thus affirm the rejection of claims 1 and 21 under 35 U.S.C. § 103 as being obvious, as claims 2–9, 22–28, 31, and 32 fall with those claims, we affirm the rejection as to those claims as well. 37 C.F.R. § 41.37(c)(1). II. Obviousness over Greenwood, D’Agostino, and Martin Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? A. Findings of Fact (FF) FF6. Martin teaches compositions containing 3-hydroxyacids including 3-hydroxybutyrate. Martin Abstract. Martin teaches the use of oligomers and explains that “[a]n oligomer generally refers to a polymer of three or more hydroxyacids.” Id. Appeal 2020-001118 Application 15/491,924 11 B. Analysis Examiner has rejected claim 1, 21, 29, and 30 as obvious based Greenwood, D’Agostino, and Martin. Final Act. 7–8. Appellant’s only argument with respect to this rejection is that “Martin does not teach these features [that are missing from the combination of Greenwood and D’Agostino] nor does the Office Action allege that these features are taught by Martin.” Appeal Br. 12–13. This argument is not persuasive because, as discussed above (I.), we conclude that Greenwood and D’Agostino would have made obvious the method of maintaining ketosis. Accordingly, we affirm the rejection of claim 1, 21, and 29 for the reasons given by Examiner in the Final Action and Answer. Because as acknowledged by Examiner, Martin does not teach administration of berberine, we reverse the rejection of claim 30 reciting the administration of “at least one of berberine, dihydroberberine, or tetrahydroberberine”. See Ans. 4 (“However [the combination of Greenwood, D’Agostino and Martin] fails to teach the administration of berberine for maintaining ketosis.”). C. Conclusion We conclude that the preponderance of the evidence of record supports Examiner’s conclusion that the combination of Greenwood, D’Agostino, and Martin renders obvious the method of maintaining ketosis of claims 1, 21, and 29. We thus affirm the rejection of claim 1, 21, and 29 under 35 U.S.C. § 103 as being obvious. Because the Greenwood, D’Agostino, and Martin does not teach the administration of berberine we reverse the rejection of claim 30. Appeal 2020-001118 Application 15/491,924 12 III. Obviousness over Greenwood, D’Agostino, Martin, and EnergyTimes- Herbal Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? A. Findings of Fact (FF) FF7. EnergyTimes-Herbal keto support teaches that “[b]erberine is a compound found in a number of herbs, such as barberry, goldenseal and Oregon grape.” EnergyTimes-Herbal 2. Berberine “reduces glucose production within the liver and increases the breakdown of glucose within cells.” Id. B. Analysis Based on the combination of Greenwood, D’Agostino, Martin, and EnergyTimes-Herbal, Examiner concludes that at the time the invention was made it would have been prima facie obvious “to add a second agent that helps sustain ketosis to increase fat loss with the reasonable expectation of success.” Ans. 4; FF1–FF7. Examiner reasons that it is prima facie obvious to combine two compositions each known to be effective for the very same purpose, in this case maintaining ketosis in a subject, in order to form a third composition that is to be used for the very same purpose. Ans. 4; see In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980). Appellant contends that there is no clear indication that the EnergyTimes-Herbal is a printed publication having a priority before the earliest benefit date3 of the present application. See Reply Br. 5. Specifically, Appellant contends that the date provided at the bottom of the 3 This application claims benefit to U.S. Provisional Patent Application No. 62/324,798, filed on April 19, 2016. Spec. 1. Appeal 2020-001118 Application 15/491,924 13 article provides a copyright date of 2019, but also references a 2008 date in the body of the text. Id. Appellant contends that “[t]his article does not appear to be available on internet archives such as WayBack and so, it is unclear which portion of this article is from 2008 and which part is the copyrighted material of 2019.” Id. The issue is whether the EnergyTimes-Herbal article is a “printed publication” having a publication date before the earliest benefit date of the present application. Manual of Patent Examining Procedure (MPEP) § 2128 (9th Ed., June 2020) provides guidance that “[p]rior art disclosures on the Internet or on an on-line database are considered to be publicly available as of the date the item was publicly posted.” The Wayback Machine® is a digital library maintained by the Internet Archive (a non-profit organization) for viewing information on archived digital Internet webpages. Web objects are stored as Web captures that are saved with the capture time/date in the form of a time stamp and the URL of the original website. Prior art obtained via the Wayback Machine® sets forth a prima facie case that the art was publicly accessible at the date and time provided in the time stamp. The burden then shifts to the applicant should they wish to challenge the authenticity, reliability or accessibility of such information. See MPEP § 2128. Here, there is no indication that the present article cited by Examiner was captured by the Wayback Machine, such that we could have reasonably relied upon a date and time stamp of the URL and original website capture as the date of public accessibility. See MPEP § 2128. A reference is considered “publicly accessible” upon a satisfactory showing that the document has been “disseminated or otherwise made Appeal 2020-001118 Application 15/491,924 14 available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence[] can locate it.” Kyocera Wireless Corp. v. ITC, 545 F.3d 1340, 1350 (Fed. Cir. 2008) (citation and internal quotation marks omitted). Appellant contends, and we agree, that a search of the URL located at the bottom of the reference – https://energytimes.com/herbal-keto-support/ – does not result in the retrieval of the article supplied by Examiner. The two dates listed on the print out supplied by Examiner are January 15, 2008 located in the body of the reference and September 5, 2019 a date found at the bottom of the page. The September 5, 2019 date is reasonably interpreted as the print date of the article. Because this date is not before the earliest benefit date of the present application it cannot serve to anchor the reference as prior art based on the print date. Examiner, therefore, must rely on the January 15, 2008 date referenced within the supplied printout. “The general rule is that administrative agencies like the PTO are not bound by the rules of evidence that govern judicial proceedings.” In re Epstein, 32 F.3d 1559, 1565 (Fed. Cir. 1994). As such, in ex parte proceedings before the Board, the PTO is not bound by hearsay evidentiary rules for authenticating prior art documents. Even with this greater leeway, it is not clear from the printout whether the January 15, 2008 date is referencing the article itself or whether it references an embedded URL listed in the article. Because of this uncertainty, we agree with Appellant that Examiner has not sufficiently established that the EnergyTimes-Herbal article is prior art and available as a “printed publication” having a priority date before the earliest benefit application. Accordingly, Examiner has not presented a sufficient evidentiary basis from which to conclude that that Appeal 2020-001118 Application 15/491,924 15 “berberine, dihydroberberine, or tetrahydroberberine” limitations of claim 30 are disclosed in the art. C. Conclusion The preponderance of the evidence of record does not support Examiner’s conclusion that the combination of Greenwood, D’Agostino, Martin, and EnergyTimes-Herbal discloses a method having all limitations of dependent claim 30 that requires the addition of “at least one of berberine, dihydroberberine, or tetrahydroberberine.” Claims 1, 21, and 29 do not recite berberine and, therefore, fall for the same reasons discussed above (II.) relying on the combination of Greenwood, D’Agostino, and Martin. DECISION SUMMARY In summary: Claims Rejected Basis Reference Affirmed Reversed 1–3, 5–9, 21-28, 31, 32 § 103 Greenwood, D’Agostino 1–3, 5–9, 21-28, 31, 32 1, 21, 29, 30 § 103 Greenwood, D’Agostino, Martin 1, 21, 29 30 1, 21, 29, 30 § 103 Greenwood, D’Agostino, Martin, EnergyTimes- Herbal 1, 21, 29 30 Outcome 1–3, 5–9, 21-29, 31, 32 30 Appeal 2020-001118 Application 15/491,924 16 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED-IN-PART