UNIVERSITY OF IOWA RESEARCH FOUNDATION

Patent Trials and Appeals BoardMar 26, 2021

2020004959 (P.T.A.B. Mar. 26, 2021)

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. 15/509,438 03/07/2017 Rajan Sah 17023.153US1 8363 53137 7590 03/26/2021 VIKSNINS HARRIS PADYS MALEN LLP 7851 Metro Parkway Suite 325 Bloomington, MN 55425 EXAMINER SIMMONS, CHRIS E ART UNIT PAPER NUMBER 1629 NOTIFICATION DATE DELIVERY MODE 03/26/2021 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@vhpmlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ________________ Ex parte RAJAN SAH1 ________________ Appeal 2020-004959 Application 15/509,438 Technology Center 1600 ________________ Before DONALD E. ADAMS, JOHN G. NEW, and TAWEN CHANG, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL 1 We use the term “Appellant” to refer to the “applicant” as defined in 37 C.F.R. § 1.142. Appellant identifies University of Iowa Research Foundation as the real party-in-interest. App. Br. 2. Appeal 2020-004959 Application 15/509,438 2 SUMMARY Appellant files this appeal under 35 U.S.C. § 134(a) from the Examiner’s Final Rejection of claims 1, 2, and 4–6. Specifically, claims 1 and 2 stand rejected as unpatentable under 35 U.S.C. § 102(a)(1) as being anticipated by Zoorob (US 2006/0188588 A1, August 24, 2006) (“Zoorob”). Claims 1, 2 and 6 stand rejected as unpatentable under 35 U.S.C. § 103 as being obvious over the combination of Zoorob and Critchley et al. (US 2006/0171945 A1, August 3, 2006) (“Critchley”). Claims 1, 2, and 4–6 stand rejected as unpatentable under 35 U.S.C. § 103 as being obvious over the combination of Zoorob, Critchley, and D. Nauffal et al., Influence of Recent Immobilization and Recent Surgery on Mortality in Patients with Pulmonary Embolism, 10(9) J. THROMBOSIS AND HAEMOSTASIS 1752–60 (2012) (“Nauffal”). We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE and enter NEW GROUNDS OF REJECTION. NATURE OF THE CLAIMED INVENTION Appellant’s claimed invention is directed to therapeutic methods comprising the administration of thymol or carvacrol for modulating muscle atrophy, performance, recovery, generation, or maintenance in animals. Spec. Abstr. Appeal 2020-004959 Application 15/509,438 3 REPRESENTATIVE CLAIM Independent claim 1 is representative of the claims on appeal and recites: 1. A method comprising modulating muscle atrophy, performance, recovery, generation, or maintenance in a mammal in need thereof by systemically administering thymol or a pharmaceutically acceptable salt thereof to the mammal. App. Br. 10. ISSUES AND ANALYSES We decline to adopt the Examiner’s findings, reasoning, and conclusion that the claims on appeal are (1) anticipated; and (2) prima facie obvious over the combined cited prior art. We additionally enter new grounds of rejection. We address the arguments raised by Appellant below. 1. Rejection of claims 1 and 2 under 35 U.S.C. § 102(a)(1) Issue: Appellant argues that the Examiner erred in finding that Zoorob teaches or suggests the limitation of claim 1 reciting “modulating muscle ... maintenance … by systemically administering thymol….” App. Br. 3. Analysis The Examiner finds that Zoorob discloses the use of an herbal preparation containing thyme (which naturally contains thymol), sage, and cumin that relieves inflammation and smooth muscle contractions such that, within minutes of administration, the smooth muscles relax. Final Act. 3 (citing Zoorob ¶¶ 16, 22, claims 1–4). The Examiner finds that Zoorob Appeal 2020-004959 Application 15/509,438 4 discloses that its composition can be administered orally, i.e., systemically, and that women treated with gelcaps containing thyme, sage and cumin experienced relief of menstrual cramps. Id. (citing Zoorob ¶¶ 29, 44, 21– 26). The Examiner concludes that Zoorob thus anticipates claim 1, because it discloses modulating muscle maintenance by administering thymol. Id. Appellant points to paragraph [0022] of Zoorob, upon which the Examiner relies, as disclosing that “[i]t has been found that within minutes, the uterine muscle is relaxed and the symptoms of cramps, bloating, nausea, backache, headache, fatigue and mood swings are relieved. Relief lasts for hours.” App. Br. 3. Appellant argues that the paragraph [0022] of Zoorob makes no mention of “muscle maintenance,” and asserts that the Examiner has mischaracterized Zoorob in finding that the reference discloses that limitation. Id. Furthermore, argues Appellant, there is in fact no disclosure of “muscle maintenance” in Zoorob, nor does the reference provide any data relating to changes in the amount of any muscle tissue. App. Br. 4. According to Appellant, Zoorob is directed to an herbal preparation to relieve inflammation and smooth muscle contraction. Id. Appellant acknowledges Example 2 of Zoorob as demonstrating the use of gelcaps to treat menstrual cramps and to Example 4 as providing data showing in vivo inhibition of uterine contractions. Id. Appellant also acknowledges that paragraph [0064] of Zoorob discloses that “the test solution has certain ingredients to inhibit contractions induced by PGF2n and PGE2 by virtue of non-competitive antagonism.” However, Appellant contends, there are no data relating to “modulating muscle maintenance,” as required by claim 1. Appeal 2020-004959 Application 15/509,438 5 Appellant contends that the Examiner improperly equates “muscle relaxation” with “modulating muscle maintenance.” App. Br. 4. However, Appellant argues, a person of ordinary skill in the art would not construe the two terms as having the same meaning. Id. Appellant points to the Merriam-Webster dictionary definition of “modulating” as meaning “to keep in proper measure or proportion,” and the definition of “maintenance” as meaning “the act of maintaining.” Id. Given these definitions, Appellant invites us to construe “modulating muscle maintenance,” as recited in claim 1, as the act of “maintaining a muscle by keeping in proper measure or proportion.” This construction, argues Appellant, is in contrast with the dictionary definition of “relaxation” as meaning “to make less tense or rigid.” Id. Appellant therefore argues that the terms “modulating muscle maintenance” and “relaxation” would not be construed by a skilled artisan as having the same meaning. Id. The Examiner responds that the claim term “modulating muscle maintenance,” when given its broadest reasonable interpretation, encompasses maintaining proper muscle function. Ans. 7. The Examiner reasons that Zoorob’s teachings about using thyme (i.e., thymol) to relax uterine contractions is encompassed by the broadest reasonable interpretation of the claim language, because the uterine muscle’s contractility is being maintained by administering thyme (i.e., thymol). Id. We are not persuaded that the Examiner has established a prima facie case of anticipation. The Examiner reasons that Zoorob discloses the limitation of claim 1 reciting “[a] method comprising modulating muscle …maintenance….” Although Appellant’s Specification provides no express definition for the claim term “muscle maintenance,” the Specification Appeal 2020-004959 Application 15/509,438 6 discloses several examples of the scope of the effect the claimed administration of thymol is intended to achieve: Accordingly these compounds can be used to: 1) enhance skeletal muscle endurance and performance in sedentary patients and in the elderly; 2) prevent skeletal muscle atrophy in the chronically ill or immobilized; 3) improve overall metabolic health by increasing basal metabolic rate via increased lean body weight and reduced adiposity in the obese; or 4) prevent the negative effects of prolonged space flight on skeletal muscle (atrophy). Spec. 2. We “determine[ ] the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’” Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). Based upon these disclosures of the Specification, as well as the dictionary definition of “maintenance” relied upon by Appellant, we construe the claim term “muscle … maintenance,” as meaning “to preserve the condition of a muscle and prevent atrophy.” Zoorob discloses, with respect to administration of its claimed, thymol-based composition: “It has been found that within minutes, the uterine muscle is relaxed and the symptoms of cramps, bloating, nausea, backache, headache, fatigue and mood swings are relieved. Relief lasts for hours.” Zoorob ¶ 22. We do not interpret this passage to mean that Zoorob discloses maintaining uterine muscle, as we have construed that term, but rather meaning altering the tendency of the muscle to contract. As such, we Appeal 2020-004959 Application 15/509,438 7 disagree with the Examiner that Zoorob discloses modulating muscle …maintenance…,” and we reverse the Examiner’s rejection of the claim. 2. Rejection of claims 1, 2, and 4–6 under 35 U.S.C. § 103 Claims 1, 2, and 6 stand rejected as unpatentable under 35 U.S.C. § 103 as being obvious over the combination of Zoorob and Critchley, and claims 1, 2, and 4–6 as unpatentable on the same ground over the combination of Zoorob, Critchley, and Nauffal. In each rejection, the Examiner relies upon the same reasoning as in the rejection above; viz., that Zoorob teaches or suggests the limitation of claim 1 reciting “modulating muscle … maintenance.” See Final Act. 4–6; App. Br. 5–8. We have explained our reasoning as to why we find that Zoorob does not disclose this limitation. For the same reasons, we find that Zoorob neither teaches nor suggests the same limitation. We consequently reverse the Examiner’s rejections of the claims upon this ground. NEW GROUNDS OF REJECTION We enter new grounds of rejection. Independent claim 1 is rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Zoorob and/or under 35 U.S.C. § 103 as being obvious over Zoorob. Claim 1 recites, in relevant part: “A method comprising modulating muscle atrophy, performance, recovery, generation, or maintenance in a mammal in need thereof….” (emphases added). As we have explained above, Zoorob discloses that, subsequent to administration of its claimed thymol-based composition, “the uterine muscle is relaxed.” Zoorob further discloses, in its Example 4, that “the test solution has certain ingredients to Appeal 2020-004959 Application 15/509,438 8 inhibit the contractions induced by PGF2α and PGE2 by virtue of non- competitive antagonism. The test substance has more specific inhibitory activity on PGF2α than compared to PGE[2].” Zoorob ¶ 64. “For a claim to be anticipated, each claim element must be disclosed, either expressly or inherently, in a single prior art reference, and the claimed arrangement or combination of those elements must also be disclosed, either expressly or inherently, in that same prior art reference.” Therasense, Inc. v. Becton, Dickinson and Co., 593 F.3d 1325, 1332–33 (Fed. Cir. 2010). Furthermore, “[i]t is well settled that ‘anticipation is the epitome of obviousness.”’ Connell v. Sears Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983) (quoting In re Fracalossi, 681 F.2d 792, 794 (C.C.P.A. 1982). Consequently, a reference that anticipates another also renders it obvious. Because Zoorob discloses that thymol can inhibit the contraction of uterine muscle via competitive inhibition at the muscle PGF2α and PGE2 receptor sites, we find that Zoorob teaches that thymol administration can modulate (i.e., alter) the contractile properties of uterine muscle and, hence, the muscle’s performance. This finding is supported by the Merriam- Webster dictionary definition of “modulate” as meaning “to keep in proper measure or proportion,” because Zoorob discloses that administration of its thymol-based compositions can inhibit the severe cramping of uterine muscle experienced in dysmenorrhea. See Merriam Webster, Modulate, available at: https://www.merriam-webster.com/dictionary/modulate (last visited March 19, 2021); see also Zoorob ¶ 22. We consequently conclude that Zoorob discloses “modulating muscle … performance,” as recited in claim 1. Appeal 2020-004959 Application 15/509,438 9 We have entered the new grounds only for the independent claim 1 and leave to the Examiner the evaluation of the patentability of the other claims in view of this reference alone, or in combination with other newly found or previously cited references. CONCLUSION The Examiner’s rejection of claims 1 and 2 under 35 U.S.C. § 102(a)(1) is reversed. The Examiner’s rejection of claims 1, 2, and 4–6 under 35 U.S.C. § 103 is reversed. We have also entered new grounds of rejection under 37 C.F.R. § 41.50(b) for claim 1. This decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides that “[a] new ground of rejection . . . shall not be considered final for judicial review.” 37 C.F.R. § 41.50(b) also provides that 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 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 proceeding will be remanded to the examiner…. (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same record…. Appeal 2020-004959 Application 15/509,438 10 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). See 37 C.F.R. § 1.136(a)(1)(iv). REVERSED 37 C.F.R. § 41.50(b) Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed New Ground 1, 2 102(a)(1) Zoorob 1, 2 1 1, 2, 6 103 Zoorob, Critchley 1, 2, 6 1, 2, 4–6 103 Zoorob, Critchley, Nauffal 1, 2, 4–6 1 102 and/or 103 Zoorob 1 Overall Outcome 1, 2, 4–6 1