Ex Parte CredeDownload PDFPatent Trials and Appeals BoardJun 18, 201914240759 - (D) (P.T.A.B. Jun. 18, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 14/240,759 02/25/2014 Philipp Crede 23550 7590 06/20/2019 HOFFMAN WARNICK LLC 540 Broadway 4th Floor ALBANY, NY 12207 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 ATTORNEY DOCKET NO. CONFIRMATION NO. CN0-0001-US 8881 EXAMINER FAY,ZOHREHA ART UNIT PAPER NUMBER 1617 NOTIFICATION DATE DELIVERY MODE 06/20/2019 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): PTOCommunications@hoffmanwarnick.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte PHILIPP CREDE 1 Appeal2018-004942 Application 14/240, 7 59 Technology Center 1600 Before JEFFREY N. FREDMAN, JOHN G. NEW, and JAMIE T. WISZ, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL 1 Appellant identifies Crede Oils (Pty) Ltd. as the real party-in-interest. App. Br. 1. Appeal2018-004942 Application 14/240,759 SUMMARY Appellant files this appeal under 35 U.S.C. § I34(a) from the Examiner's Final Rejection of claims 1, 3, 4, 6-11, and 22-24 as unpatentable under 35 U.S.C. § I03(a) as being obvious over the combination of Crede (US 6,531,164 B 1, March 11, 2003) ("Crede"), I. Tekeoglu et al., Effects of Thymoquinone (Volatile Oil of Black Cumin) on Rheumatoid Arthritis in Rat Models, 20 PHYTOTHER. RES. 869-71 (2006) ("Tekeoglu"), Pacioretty et al., (US 2010/0028468 Al, February 4, 2010) ("Pacioretty"), and Bruzzese (US 2010/0160435 Al, June 24, 2010) ("Bruzzese"). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. NATURE OF THE CLAIMED INVENTION Appellant's claimed invention is directed to the treatment of inflammatory diseases and disorders and, more particularly, to the treatment of symptoms of inflammatory diseases and disorders using thymoquinone ("TQ") alone or in combination with other compounds, including eicosapentaenoic acid ("EPA"). Abstr. REPRESENTATIVE CLAIM Claim 1 is representative of the claims on appeal and recites: 1. A method of treating at least one symptom of an inflammatory disease or disorder in an individual in need of such treatment, the method comprising: 2 Appeal2018-004942 Application 14/240,759 administering to the individual an amount of thymoquinone between about 1 mg/day and about 800 mg/day; and administering to the individual a quantity of eicosapentaenoic acid, wherein the inflammatory disease or disorder is selected from a group consisting of: psoriasis, psoriatic arthritis, multiple sclerosis, and osteoarthritis. App. Br. 6. ISSUES AND ANALYSES We adopt the Examiner's findings, reasoning, and conclusion that the claims are primafacie obvious over the cited prior art. We address the arguments raised by Appellant below. Issue 1 Appellant argues that the Examiner erred in finding that Pacioretty teaches or suggests: "the use of thymoquinone as an inflammatory [sic] agent for the treatment of inflammation and infection," and that: "[ t ]he amount of thymoquinone is taught in table 1, Para [0020], [0022] and [0060], which is taught to be 1-27-57% [sic] and 5mg/kg." App. Br. 2 ( alterations in original) ( quoting Final Act. 3 ). Analysis The Examiner finds that Crede teaches the use of a pharmaceutical preparation of black cumin (Nigella sativa) oil in combination with omega 3 fatty acids for the treatment of psoriasis. Final Act. 3 ( citing Crede Abstr., Examples). The Examiner finds that Tekeoglu teaches that thymoquinone is 3 Appeal2018-004942 Application 14/240,759 a main ingredient of the seeds of Nigella sativa and that, therefore, it follows that the extracts taught by Crede contain thymoquinone. Id. The Examiner finds that Crede differs from the claimed invention in the amounts of administered thymoquinone and in the presence of eicosapentaenoic acid. Id. The Examiner finds, however, that Pacioretty teaches the use of thymoquinone as an inflammatory agent for the treatment of inflammation and infection in amounts that are within the range recited in the claims. Final Act. 3 ( citing Pacioretty ,r,r 3, 20, 22, 60, Table 1 ). The Examiner finds that Bruzzese teaches the use of eicosapentaenoic acid for the treatment of different disorders, including psoriasis. Final Act. 3 ( citing Bruzzese Abstr., claim 30). The Examiner finds that the amount of EPA used is taught in Example 4. Id. The Examiner concludes that it would have been obvious to a person of ordinary skill in the art to combine eicosapentaenoic acid, as taught by Bruzzese, with the thymoquinone composition of Crede and Pacioretty, because the references teach compositions used for the same purpose, i.e., the treatment of inflammatory diseases or disorder, including psoriasis. Final Act. 3--4 (citing In re Kerkhoven, 626 F.2d 846, 850 (C.C.P.A. 1980) (holding that: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for same purpose, in order to form a third composition which is to be used for the very same purpose")). Appellant points to the passages of Pacioretty relied upon by the Examiner and argues that these passages teach administration of quantities of thymoquinone up to 50 times less than that alleged by the Examiner. App. Br. 2 (citing Pacioretty ,r,r 20, 22, 60). According to Appellant, these 4 Appeal2018-004942 Application 14/240,759 paragraphs teach that the thymoquinone content of Pacioretty' s supplement is distinguishably lower than what the Examiner alleges. Id. at 3. Appellant asserts that a dose of 1 to 5 mg/kg of a thymoquinone formulation that contains 2% to 6% thymoquinone constitutes an absolute amount of thymoquinone of between 0.02 mg/kg thymoquinone (1 mg/kg dose of a formulation containing 2% thymoquinone) and 0.3 mg/kg thymoquinone (5 mg/kg dose of a formulation containing 6% thymoquinone ). Id. Assuming a body mass of 50 kg, Appellant argues, this results in a dosage of between 1.0 mg/day and 15 mg/day. Id. Appellant points out that this is below the doses in, e.g., claims 3 and 4. Appellant contends that much of the disagreement between the Examiner and Appellant appears to stem from a misapplication or miscalculation of the relevant concentrations disclosed in the cited prior art. App. Br. 3. Appellant argues, by way of example, that the Examiner finds that: "Pacioretty in Para[0020] teaches that the extract of sativa has 2.0-6% thymoquinone. Such amounts equals [sic] to 20-60 mg/ml, which is within the scope of the claims amounts [sic]." App. Br. 3 (alterations in original) ( quoting Final Act. 3). Appellant contends that the claims do not recite a concentration of thymoquinone ( whether as a percentage or as mg/ml), but rather recite a dosage expressed in absolute terms, i.e., mg/day. Id. Appellant argues further that the Examiner's finding that any body mass may be considered in order to reach the claimed thymoquinone doses is impractical. App. Br. 3. For example, argues Appellant, by using Pacioretty's concentrations, reaching the upper limit of the dosage range recited in claim 1, would require an individual possessing a body mass of 2,667 kg. Id. Even the upper limit of the dosage range recited in claim 3, 5 Appeal2018-004942 Application 14/240,759 Appellant asserts, would still require an individual body mass of 400 kg (880 pounds). Appellant contends that there is nothing in Pacioretty that teaches or suggests that the compositions described therein were contemplated for administration to individuals of such unrealistic body masses. App. Br. 3. Rather, argues Appellant, Pacioretty intended the compositions to be administered to individuals having typical body masses, and that therefore the compositions contain a much lower total dose of thymoquinone than that claimed by Appellant. Id. The Examiner responds that Pacioretty teaches an extract of N. sativa that is effective in treating inflammation and which contains 2-6% (w/w) thymoquinone. Ans. 6. The Examiner calculates that 2---6% (w/w) thymoquinone equals 2---6 g/100 ml, which equals 20-60 mg/1, or 20---60 mg/1.1 ml of oil (where the density of the oil equals 0.9 g/ml), or 18-55 mg/ml of oil. 2 Id. Therefore, reasons the Examiner, to obtain 50 mg thymoquinone daily, an individual would need to consume between 0.9 ml (6.0% w/w) and 2.7 ml (2.0% w/w) of thymoquinone in a dietary supplement per day. Similarly, to obtain a daily dosage of 250 mg thymoquinone, an individual would need to consume between 4.5 ml (6.0% w/w) and 13.5 ml (2.0% w/w) per day. Id. The Examiner finds that such amounts are within the scope of the amounts of thymoquinone recited in the claims. We agree with the Examiner's calculations, and are consequently not persuaded by Appellant's arguments. Pacioretty teaches: "A novel, 2 1.0 milliliters of water has a mass of 1.0 grams. 6 Appeal2018-004942 Application 14/240,759 supercritical CO2 extract of N. sativa has is [sic] described that contains 2.0 to 6.0% (w/w) thymoquinone, an amount between that of the fixed and essential oils, and exhibits anti-inflammatory activity in excess of its thymoquinone content alone." Pacioretty ,r 20. Even at the upper end of the range recited in claim 1 (800 mg), a person would need to consume a mere 14.5 mls of a 6% thymoquinone extract, approximately one tablespoonful, 3 to consume the required amount. Such an amount is, Appellant's reasoning to the contrary notwithstanding, hardly an impractical amount, even when included as part of a dietary supplement. See Pacioretty ,r,r 22, 60. Appellant's reasoning founders principally in attempting to determine a dosage in terms of dosage as a function of mg/kg body mass per day. No such dosage is recited in the claims; rather, the dosage recited is in absolute terms of grams per day, regardless of body mass. We are consequently not persuaded by Appellant's arguments with respect to this issue. Issue 2 Appellant argues that the Examiner erred in failing to provide a reason why a person of ordinary skill would have been motivated to combine the references. App. Br. 4. Analysis Appellant argues that the Examiner has pointed to no motivation why a person of ordinary skill would have combined the references, and 3 1 tablespoon of measure equals 14.8 mls. 7 Appeal2018-004942 Application 14/240,759 Appellant asserts that there is none. App. Br. 4. According to Appellant, Pacioretty describes dietary supplements, including 2---6% thymoquinone extracts, for treating "lower urinary tract disorders or to support normal urinary tract function in animals." Id. ( quoting Pacioretty Abstr.). Appellant contends that, even if one were to accept, arguendo, that Crede and Bruzzese teach compounds or compositions used for the same purpose, Pacioretty's compositions are clearly used for an entirely different purpose, and one for which a person of skill in the art would not find a counterpart in Crede or Bruzzese. Id. Appellant argues that the Examiner has stated that the anti- inflammatory properties of Pacioretty' s compositions are enough to motivate its combination with the other references. App. Br. 4. However, Appellant contends, this is at odds with the rejection itself. Appellant asserts that there is no mention in Pacioretty of the treatment of psoriasis or any of the other disorders described by Crede and Bruzzese, and Appellant contends that the Examiner, therefore, cannot find that the compositions are being used for the same purpose. Id. Appellant therefore contends that there is no motivation to combine the teachings of the references to be found in either the references themselves or the knowledge of one of ordinary skill in the art. Id. We are not persuaded. Appellant's independent claim 1 recites, in relevant part: "A method of treating at least one symptom of an inflammatory disease or disorder ... wherein the inflammatory disease or disorder is selected from a group consisting of: psoriasis, psoriatic arthritis, multiple sclerosis, and osteoarthritis." Pacioretty teaches that: "A novel, supercritical CO2 extract of N. sativa has is described that contains 2.0 to 8 Appeal2018-004942 Application 14/240,759 6.0% (w/w) thymoquinone, an amount between that of the fixed and essential oils, and exhibits anti-inflammatory activity in excess of its thymoquinone content alone." Pacioretty ,r 20 ( emphasis added). Similarly, Tekeoglu expressly teaches that it is well known in the art that extracts of N. sativa containing thymoquinone possess anti-inflammatory properties. Tekeoglu Abstr. ("Many studies have been carried out in recent years on the pharmacological effects of [NJ igella sativa seeds that have uncovered their antiinflammatory and immunological effects"). Bruzzese teaches that eicosapentaenoic acid is known in the art for its efficacy in teaching inflammatory conditions, including, e.g.,: "autoimmune diseases, tumour diseases, arthritis, connective tissue diseases, Crohn disease, psoriasis, and several other illnesses shown in the literature, all that in analogy with the use of similar compositions." Bruzzese ,r 57; see also ,r 10 (citing, e.g., R.A. Lewis et al., The Biologically Active Leukotrienes. Biosynthesis, Metabolism, Receptors, Functions, and Pharmacology, 73(4) J. CLIN. INVEST. 889--97 (1984) ("Lewis") (effectiveness of EPA in treating rheumatoid arthritis, connective tissue disease and inflammation)). We agree with the Examiner that a person of ordinary skill, understanding that the thymoquinone compositions of Pacioretty exhibit anti-inflammatory activity, would have had reason and been motivated, and with a reasonable expectation of success, to combine the thymoquinone compositions with those of Bruzzese, which also exhibit such activity, in the treatment of inflammatory diseases or disorders, including psoriasis. We consequently affirm the Examiner's rejection of claims. 9 Appeal2018-004942 Application 14/240,759 DECISION The Examiner's rejection of claims 1, 3, 4, 6-11, and 22-24 under 35 U.S.C. § 103(a) is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv). AFFIRMED 10 Copy with citationCopy as parenthetical citation