Ex Parte BajpaiDownload PDFPatent Trial and Appeal BoardMar 24, 201612054129 (P.T.A.B. Mar. 24, 2016) Copy Citation 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. 12/054,129 03/24/2008 Mangala P. Bajpai 5548 30621 7590 03/25/2016 JENSEN + PUNTIGAM, P.S. 2033 6th Ave, Suite 1020 SEATTLE, WA 98121 EXAMINER MARTIN, PAUL C ART UNIT PAPER NUMBER 1653 MAIL DATE DELIVERY MODE 03/25/2016 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte MANGALA P. BAJPAI __________ Appeal 2013-010566 Application 12/054,129 Technology Center 1600 __________ Before JEFFREY N. FREDMAN, ULRIKE W. JENKS and RICHARD J. SMITH, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to a method for identifying medicinally active chemical entities. The Examiner rejected the claims as anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellant identifies the Real Party in Interest as Mukul Bajpai (see Br. 3). Appeal 2013-010566 Application 12/054,129 2 Statement of the Case Background “This invention relates generally to methods of drug discovery and development, and more specifically concerns such a method which is substantially faster in identifying safe and effective drugs produced from ethnobotanical substances than existing methods.” (Spec. 1, ll. 8–11). The Claims Claims 1–8, 12–24 and 28–42 are on appeal.2 Independent claim 1 is representative and reads as follows: 1. A method for identifying medicinally active chemical entities in ethnobotanical substances, comprising the steps of: (1) providing an ethnobotanical natural substance occurring in nature, the ethnobotanical substance comprising an existing land or marine plant source and extracts thereof identified as having an active agent associated with a medicinal effect on humans; (2) performing an in-vitro assay with the ethnobotanical substance with one or more of the following: (a) human intestinal preparations and (b) human liver preparations, thereby producing an array of human chemical entities; (3) performing an in-vitro assay of said ethnobotanical substance using one or more of the following: (a) animal intestinal preparations and (b) animal liver preparations from at least one selected animal species to produce an array of animal chemical entities; (4) comparing the array of human chemical entities with the array of animal chemical entities; 2 Claims 9–11 and 25–27 were withdrawn from consideration (see Non-final Action 6/25/2010). Appeal 2013-010566 Application 12/054,129 3 (5) determining any matches between the human chemical entities in the array of human chemical entities and the animal chemical entities in the array of animal chemical entities to identify a matched animal species; (6) performing an in-vivo dosing of the ethnobotanical substance with the matched animal species; (7) obtaining a biological fluid sample from the matched animal species following the in-vivo dosing; (8) performing an analysis of the biological fluid sample from the matched animal species to determine the presence of chemical entities in the biological fluid sample; and (9) comparing the chemical entities in the biological fluid sample with the human chemical entities from the in- vitro assay and determining any matches between the chemical entities in the biological fluid sample with the human chemical entities from the in-vitro assay. (Br. 11.) The Issues3 A. The Examiner rejected claims 1, 2, 4–7, 12, 13, 15, 17, 18, 20–23, 28, 29, 31, 33, 34, 36–39, and 41 under 35 U.S.C. § 102(b)4 over Ireson5 (see Non-Final Action 8/11/2011 at 9–11). 3 The Examiner withdrew the indefiniteness rejection before appeal (see Adv. Action 9/19/2012). Therefore, this rejection is moot. 4 We take note that Appellant incorrectly identified the claims as rejected under 35 U.S.C. § 102(a) (Br. 6). 5 Ireson et al., Characterization of Metabolites of the Chemopreventive Agent Curcumin in Human and Rat Hepatocytes and in the Rat in Vivo, and Evaluation of Their Ability to Inhibit Phorbol Ester-induced Prostaglandin E2 Production, 61 CANCER RES. 1058–1064 (2001). Appeal 2013-010566 Application 12/054,129 4 B. The Examiner rejected claims 1–7, 12, 13, 15, 17–23, 28, 29, 31, 33– 39, and 41 under 35 U.S.C. § 103(a) over Ireson (see Non-Final Action 8/11/2011 at 11–12). C. The Examiner rejected claims 1–8, 12–15, 17–24, 28–31, and 33–41 under 35 U.S.C. § 103(a) over Ireson and Lu6 (see Non-Final Action 8/11/2011 at 13). D. The Examiner rejected claims 1–7, 12, 13, 15, 16–23, 28, 29, 31–39, 41, and 42 under 35 U.S.C. § 103(a) over Ireson and Barnes7 (see Non-Final Action 8/11/2011 at 14–15). A. 35 U.S.C. § 102(b) over Ireson The Examiner states that Ireson teaches, inter alia, “a method comprising the steps of: providing the ethnobotanical substance curcumin associated with anti-inflammatory and cancer chemopreventative activities, which reads on step 1” (Non-Final Action 10). Appellant concedes that Ireson teaches “using a previously identified (i.e. known), purified single compound as a starting point for its drug investigation . . . [which is] obtained as a processed and purified compound, or as a chemically synthesized compound” (Br. 7). Appellant contends, 6 Lu et al., Comparison of Intrinsic Clearance in Liver Microsomes and Hepatocytes from Rats and Humans: Evaluation of Free Fraction and Uptake in Hepatocytes, 34 DRUG METABOLISM AND DISPOSITION 1600–1605 (2006). 7 Barnes et al., Applications of LC-MS in the study of the uptake, distribution, metabolism and excretion of bioactive polyphenols from dietary supplements, 78 LIFE SCIENCES 2054–2059 (2006). Appeal 2013-010566 Application 12/054,129 5 however, that “[t]he claimed invention, on the other hand, starts with ethnobotanical natural substances, specifically, unrefined and unpurified natural substances which occur in nature” (id.). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that Ireson teaches an extract of an ethnobotanical natural substance, as required by claims 1, 17, and 33? Findings of fact 1. The Specification teaches that “[t]he term ethnobotanical substance used herein includes extracts thereof” (Spec. 4, ll. 23–24). 2. Ireson teaches that “[c]urcumin . . . is the major yellow pigment extracted from turmeric, the powdered rhizome of the herb Curcuma longa” (Ireson 1058, col. 1). Principles of Law “A single prior art reference that discloses, either expressly or inherently, each limitation of a claim invalidates that claim by anticipation.” Perricone v. Medicis Pharmaceutical Corp., 432 F.3d 1368, 1375 (Fed. Cir. 2005). Analysis We adopt the Examiner’s findings of fact and reasoning regarding the scope and content of the prior art (see Non-Final Action 8/11/2011 at 9–11; FF 1, 2) and agree that the claims are anticipated by Ireson. We address Appellant’s arguments below. During prosecution, the USPTO must interpret terms in a claim using “the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into Appeal 2013-010566 Application 12/054,129 6 account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in the applicant’s specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). Turning to the language of independent claims 1, 17, and 33 themselves we find that the claim language expressly recites “an ethnobotanical natural substance . . . and extracts thereof identified as having an active agent associated with a medicinal effect on humans”. The specification teaches that “[t]he term ethnobotanical substance used herein includes extracts thereof” (FF 1). Having considered the plain language of the claims in light of the Specification, and keeping in mind that Ireson teaches that “[c]urcumin . . . is the major yellow pigment extracted from turmeric” (FF 2; emphasis added), we conclude that Ireson teaches an extract of an ethnobotanical natural substance, as required by independent claims 1, 17, and 33. Appellant concedes that Ireson teaches “using a previously identified (i.e. known), purified single compound as a starting point for its drug investigation . . . [which is] obtained as a processed and purified compound, or as a chemically synthesized compound” (Br. 7). Appellant contends, however, that the “claimed invention, on the other hand, starts with ethnobotanical natural substances, specifically, unrefined and unpurified natural substances which occur in nature . . . These natural substances always comprise a plurality of compounds, not just a single previously identified compound which has been processed/purified/chemically synthesized for specific investigation” (Br. 7). Appeal 2013-010566 Application 12/054,129 7 We are not persuaded. If Appellant wished to only claim unrefined and unpurified natural substances which occur in nature, and are not extracts thereof, they were free to amend the claims to exclude the phrase “and extracts thereof” to further limit the method claim. See In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989) (“[D]uring patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.”) There is no requirement in claims 1, 17, and 33 that the method cannot be employed on previously identified substances, nor is there a limitation in the claims excluding extracts composed of purified compounds. See In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (“[A]ppellant’s arguments fail from the outset because . . . they are not based on limitations appearing in the claims.”) Conclusion The evidence of record supports the Examiner’s conclusion that Ireson teaches an extract of an ethnobotanical natural substance, as well as the other claim limitations, as required by claims 1, 17, and 33. B-D. 35 U.S.C. § 102(b) over Ireson Appellant does not separately argue the three obviousness rejections, and contends that “the reasons provided above with respect to Ireson are applicable to the rejection of the above claims under 35 U.S.C. § 103(a) (Br. 8–9). We adopt the Examiner’s findings of fact and reasoning regarding the scope and content of the prior art (see Non-Final Action 8/11/2011 at 11– 15). Having affirmed the rejection of claims 1, 17, and 33 over Ireson as Appeal 2013-010566 Application 12/054,129 8 anticipated, we necessarily affirm the three obviousness rejections for the reasons stated above. SUMMARY We affirm the rejection of claim 1, 17 and 33 under 35 U.S.C. § 102(b) as anticipated by Ireson. Claims 2, 4–7, 12, 13, 15, 18, 22, 23, 28, 29, 31, 34, 36–39, and 41 fall with claims 1, 17 and 33. 37 C.F.R. § 41.37(c)(1)(iv). We affirm the rejection of claims 1–7, 12, 13, 15, 17–23, 28, 29, 31, 33–39 under 35 U.S.C. § 103(a) over Ireson. We affirm the rejection of claims 1–8, 12, 13–15, 17–24, 28–31, 33– 41, under 35 U.S.C. § 103(a) over Ireson and Lu. We affirm the rejection of claims 1–7, 12, 13, 15, 16–23, 28, 29, 31– 39, 41, and 42 under 35 U.S.C. § 103(a) over Ireson and Barnes. 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 Copy with citationCopy as parenthetical citation