Ex Parte Popp et alDownload PDFPatent Trials and Appeals BoardMay 10, 201913700351 - (D) (P.T.A.B. May. 10, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/700,351 05/29/2013 123223 7590 05/14/2019 Drinker Biddle & Reath LLP (WM) 222 Delaware A venue, Ste. 1410 Wilmington, DE 19801-1621 FIRST NAMED INVENTOR Michael Popp 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. 16666-00023-us 2577 EXAMINER GHALI, ISIS AD ART UNIT PAPER NUMBER 1611 NOTIFICATION DATE DELIVERY MODE 05/14/2019 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): DBRIPDocket@dbr.com IPDocketWM@dbr.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MICHAEL POPP and ELENA LAS HIN A 1 Appeal2018-005785 Application 13/700,351 Technology Center 1600 Before DEMETRA J. MILLS, RICHARD M. LEBOVITZ, and ROBERT A. POLLOCK, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL The claims in this appeal are directed to processes for the treatment of chronic obstructive pulmonary disease. The Examiner rejected the claims under 35 U.S.C. § 103 as obvious. Pursuant to 35 U.S.C. § 134(a), Appellants appeal the Examiner's determination that the claims are unpatentable. We have jurisdiction for the appeal under 35 U.S.C. § 6(b). The Examiner's decision is affirmed. STATEMENT OF THE CASE The claims stand rejected by the Examiner as follows: 1. Claims 15, 16, 30, 32, and 43 under pre-AIA 35 U.S.C. § 103(a) as obvious in view of Samuel Biiechi et al., Open Trial to Assess Aspects of 1 The Appeal Brief ("Br." entered Jan. 2, 2018) lists Bionorica SE, as the real-parties-in-interest. Appeal Br. 3. Appeal2018-005785 Application 13/700,351 Safety and Efficacy of a Combined Herbal Cough Syrup with Ivy and Thyme, FORSCHENDE KOMPLEMENTARMEDIZIN UND KLASSISCHE NATURHEILKUNDE 12:328-332 (2005) ("Biiechi"), or Kemmerich et al., ARZNEIM.- FORSCH!DRUG RES., 2006, 56(9):652---600 ("(ARZNEIM.-FORSCH!DRUG RES., 2006, 56(9):652---600) ("KEMMERICH (2006)"), and S. Fazio et al., Tolerance, Safety and Efficacy of Hedera Helix Extract in Inflammatory Bronchial Diseases Under Clinical Practice Conditions: A Prospective, Open MulticenterPostmarketing Study in 9657 Patients, 16 PHYTOMEDICINE 17-24 (2009) ("Fazio"), J. Engelbertz et. al., Thyme Extract, but not Thymol, Inhibits Endothelin-Induced Contractions of Isolated Rat Trachea, PLANTA MED. 74 12: 1436-40, (2008) ( "Engelbertz") and Wunderlich et al. (US 5,401,502; Mar. 28, 1995) ("Wunderlich"). Ans. 3. 2. Claims 19, 27, 37, 38, and 41 under pre-AIA 35 U.S.C. § I03(a) as obvious in view of Biiechi or Kemmerich (2006), Fazio, Engelbertz, Wunderlich, Gergely et al. (US 6,190,697 Bl; Feb. 20, 2001) ("Gergely"), Kemmerich (2007), and R. Van Den Hoven et al. Study of the Effect of Bronchipret on the Lung Function of Five Austrian Saddle Horses Suffering Recurrent Airway Obstruction (Heaves), 55 THE VETERINARY RECORD 556- 557 (2003) ("Hoven"). Ans. 3--4. 3. Claims 21, 23-25, 38, and 40 under pre-AIA 35 U.S.C. § I03(a) as obvious in view ofKemmerich et al., ARNZNEIMITTEL-FORSCHUNG (DRUG RESEARCH), 2007, 57(9):607---615 ("Kemmerich (2007)") and Engelbertz. Ans. 4. 4. Claims 29 and 34--36 under pre-AIA 35 U.S.C. § I03(a) as obvious in view of Kemmerich (2007), Engelbertz, and Wunderlich. Ans. 4 2 Appeal2018-005785 Application 13/700,351 5. Claim 42 under pre-AIA 35 U.S.C. § 103(a) as obvious in view of Kemmerich (2007), Engelbertz, and Remington Pharmaceutical Science, 1519, 21, 1631, 35-37 (18th ed. 1990). Ans. 4. Independent claims 16 and 21 are representative of the claimed subject matter. The claims are reproduced below: 16. A process for treatment of chronic obstructive pulmonary disease (COPD) in humans which comprises administering a pharmaceutical which comprises an aqueous extract or a mixture aqueous and ethanolic extracts made of thyme and ivy to humans suffering from chronic obstructive pulmonary disease and wherein the pharmaceutical is present in a sugar- coated tablet, a film-coated tablet, a capsule, sprays, ointments, emulsions, powder, ground material, syrup, a formulation for topical application, liquid or solid preparations for inhalation, compresses, tamponades, or tonsil brush solutions. 21. A process for the treatment of chronic obstructive pulmonary disease (COPD) in humans which comprises administering a pharmaceutical which comprises extracts made of thyme and primrose, to humans suffering from chronic obstructive pulmonary disease, and wherein the pharmaceutical is present in a sugar-coated tablet, a film-coated tablet, a capsule, sprays, ointments, emulsions, powder, ground material, a formulation for topical application, liquid or solid preparations for inhalation, compresses, tamponades, or tonsil brush solutions. CHRONIC PULMONARY OBSTRUCTIVE DISORDER (COPD) All the claims are directed to the treatment of COPD. The Specification describes COPD as follows: Within the scope of the present invention, chronic obstructive pulmonary diseases (COPD) denotes a group of chronic diseases which are characterized by cough, increased expectoration and shortness of breath under stress conditions, with chronic diseases of the bronchopulmonary system with 3 Appeal2018-005785 Application 13/700,351 obstructive ventilatory disorder, wherein inhomogeneous ventilation of the alveoli and increasing pulmonary hyperinflation occurs, all the way to insufficient gas exchange. The disease pattern is characterized in that breathing out ( expiration) in particular is labored. Spec. 2-3 ( emphasis added). According to the invention, asthma, and more particularly bronchial asthma, is therefore likewise included, wherein the attack-like shortness of breath with variable and reversible bronchoconstriction occurs due to inflammation and hyperreactivity of the respiratory tracts, which accompany COPD and can occur, or are even causally related to COPD. The symptoms and clinical characteristics comprise dyspnea, cough with generally thick sputum ( contains eosinophil granulocytes, Curschmann' s spirals, or Charcot-Leyden crystals). Spec. 3 ( emphasis added). OBVIOUSNESS REJECTIONS The Examiner found that Biiechi describes a cough syrup comprising ivy leaves extract and thyme extract as required by claim 16. Final Act. 4. The Examiner also found that Kemmerich (2006) describes treatment of productive cough in adults suffering from acute bronchitis comprising administering a thyme-ivy extract in the form of a syrup. Id. at 5. The Examiner found that Biiechi describes "treatment of chronic obstructive air way in patients suffering bronchial asthma," but not specifically COPD as required by claim 16. Id. The Examiner found that it would have been expected that thyme and ivy would treat COPD based on the teachings in Fazio and Engelbertz. Id. The Examiner found that Engelbertz teaches that thyme extract helps in diseases of the bronchi, such as asthma and COPD, and that Fazio teaches that ivy treated COPD. Id. 4 Appeal2018-005785 Application 13/700,351 Claim 16 requires the extract of thyme and ivy to be aqueous or a mixture aqueous and ethanolic extracts. The Examiner found that neither Biiechi nor Kemmerich (2006) describes an aqueous extract, but cited Wunderlich for its teaching that plant extracts can be alcoholic or aqueous. Final Act. 6. The Examiner concluded it would have been obvious to have utilized an aqueous extract of thyme and ivy because "Wunderlich teaches equivalency between alcoholic and aqueous plant extract in pharmaceutical compositions." Id. The Examiner further cited Kemmerich (2007) for disclosing the combination of thyme and primrose as required by independent claim 21. Final Act. 10. Appellants argued the claims as Groups I-IX. We address their arguments below. Claims 15, 16, 30, 32, and 43 (Group I) Appellants argue that Biiechi does not perform a controlled study and does not teach treating COPD, a necessary element of the claims. Br. 9. Appellants admit that Kemmerich (2006) utilized the same composition used in their study. Br. 10. Appellants argue that Kemmerich (2006)' s "focus ... is acute bronchitis and the corresponding symptoms of cough," and expressly excluded patients with COPD. Br. 10-11. Appellants contend that Fazio and Engelbertz do not address the deficiencies of Biiechi and Kemmerich. Appellants argue that Fazio is "concerned with treating chronic bronchitis-not COPD" and that "Engelbertz is a petri-dish lab study of smooth muscle contraction - far removed from any suggestion ( expectation of a successful result) for a treatment of COPD in humans." Br. 13, 14. 5 Appeal2018-005785 Application 13/700,351 These arguments do not persuade us that the Examiner erred in rejecting the claims. While it may be true that treatment of COPD is not expressly described in Biiechi and Kemmerich as required by all the rejected claims, Fazio teaches treating bronchial inflammatory disease with ivy extract, and further summarizes previously published studies "to show the safety and efficacy of the therapy with H. helix [ivy] extract in inflammatory bronchial diseases." Fazio 21. Table 11 in Fazio summarizes the studies. Fazio 11-12. COPD treatment with ivy leaf dry extract is listed in one of the studies. Fazio 23. Biiechi, in describing prior studies, states that ivy extracts had been used in the treatment of inflammatory bronchial disease. Biiechi 329 (in section titled "Introduction"). Thus, contrary to Appellants' arguments it was known in the art at the time of the invention that ivy extract was useful in the treatment of inflammatory bronchial diseases, such as COPD. Appellants' argument that Fazio excluded COPD from its studies by not treating patients with "severe respiratory disease" (Br. 13) is not persuasive since Table 11 of Fazio establishes that ivy leaf extract had been to treat COPD, a fact that Appellants did not challenge in the Appeal Brief. We agree with Appellants that Engelbertz does not expressly treat COPD with thyme extract. However, based on the properties of thyme extract on inhibiting endothelin-induced contraction, which is involved in its spasmolytic effects on trachea, Engelbertz suggested that "thyme extract may help in diseases related to endothelin hyper-reagibility [sensitivity] of the bronchus system such as asthma and COPD." Engelbertz, Abstract. Kemmerich (2006) also teaches that thyme has "bronchspasmolytic" properties. Kemmerich (2006) 653, 658 (2nd column). Appellants have not 6 Appeal2018-005785 Application 13/700,351 provided any reason to doubt that thyme extract would not work in treating COPD as suggested by Engelbertz, particularly in view of the teaching by Kemmerich (2006) that thyme is bronchspasmolytic and useful to treat a bronchial condition. Kemmerich (2006) 653, 658, 652 ("Results"). COPD is a bronchial condition. Spec. 2-3 (reproduced above). While Kemmerich (2006) excluded COPD from its own studies, this was because Kemmerich (2006) chose to study treatment of "acute bronchitis" with the combination of ivy and thyme. Kemmerich 654 ("2.1. Patients"). Appellants have not identified a reason why this exclusion from the studied patient population would make it unpredictable that ivy or thyme could be used to treat COPD. For the foregoing reasons, the obviousness rejection of claim 16 is affirmed. Claims 15, 30, 32, and 43 were not argued separately and fall with claim 16. 37 C.F.R. § 4I.37(c)(l)(iv). Claims 19, 27, 37, and 39 (Groups II and III) Appellants argued claims 19, 27, 39 (Groups II) and claim 37 (Group III) under separate headings, but merely identified the limitations recited in the claims, asserting that the limitations were not described in the prior art, but did not identify a deficiency in the Examiner's rejection. Br. 15-16. Therefore, we affirm the rejection of these claims for the reasons set forth by the Examiner. Final Act. 8-9. Claim 41 ( Group IV) Claim 41 depends from claim 16, and further "consists of administering a pharmaceutical which consists of an aqueous extract or a 7 Appeal2018-005785 Application 13/700,351 mixture aqueous and ethanolic extracts made of thyme, ivy and optionally additives, to humans suffering from chronic obstructive pulmonary disease." Appellants contend that Biiechi includes other extracts in its formula which would be excluded by the "consists of' language." Br. 17-18. Appellants also argue that Kemmerich (2006) "requires that the extractant is 70% ethanol" and contends that "that Kemmerich [2006] [does not] disclose[] an aqueous extract or a mixture aqueous and ethanolic extracts." Br. 18. This argument is not persuasive. With respect to the argument about the composition of Kemmerich (2006)' s syrup, the Examiner relied on Wunderlich for its teaching that plant extracts can be alcoholic or aqueous. Final Act. 6. Thus, even if Kemmerich (2006) formula of thyme and ivy does not meet the claim limitation, the Examiner did not rely on it alone for this limitation. Nonetheless, as noted by the Examiner (Ans. 12), Appellants stated in the Appeal Brief that Kemmerich (2006) treat patients "with Bronchipret® syrup (5.4 mL 3x day), which is the same medicinal composition used in Appellant's study." Br. 10. Thus, Appellants' argument regarding the composition of the syrup of Kemmerich (2006) is inconsistent with their own admission. Furthermore, as stated by the Examiner, the claim recites that "optionally additives" may be included which "is broad and permits other extracts," including those said to be administered by Biiechi. Ans. 12. Thus, the claim as a whole does appear to exclude other ingredients, despite the "consisting of' language. Nonetheless, the Examiner did not rely on the other extracts present in Biiechi' s syrup, but cited it for its teaching of thyme and ivy as active 8 Appeal2018-005785 Application 13/700,351 ingredients and therefore would have reasonably suggested to the ordinary skilled worker treating with these two herbs, and no other component. See Biiechi (Titled, "Open Trial to Assess Aspects of Safety and Efficacy of a Combined Herbal Cough Syrup with Ivy and Thyme." Accordingly, the rejection of claim 41 is affirmed. Claims 21, 23-25, and 40 (Group V) Claim 21 is directed to treating COPD with thyme and primrose. The Examiner cited Kemmerich (2007) for studying the treatment of adults suffering from acute bronchitis with extracts of thyme and primrose. Final Act. 10. The Examiner relied on Engelbertz for its suggestion of the use of thyme to treat COPD. Id. Appellants distinguish Kemmerich (2007) by arguing that it specifically excludes COPD from its patient population. Br. 19. However, Kemmerich (2007) was designed to study "patients suffering from acute bronchitis with productive cough" and thus COPD patients with a different condition were excluded. Kemmerich (2007) 608 ("2. Patients, materials and methods."). COPD was excluded because Kemmerich (2007) was studying a different patient population, namely, "Adults Suffering from Acute Bronchitis with Productive Cough." Kemmerich (2007) (Title of publication). Kemmerich (2007) teaches that the combination of thyme and primrose reduced coughing fits in patients with acute bronchitis (under "Results" of Abstract). The Specification teaches the COPD is disease of the bronchopulmonary system and characterized by cough. Spec. 2. For this reason, one of ordinary skill in the art would have understood that the combination of thyme and primrose would have been of benefit in treating 9 Appeal2018-005785 Application 13/700,351 the cough associated with COPD. Appellants did not provide arguments to the contrary, but rather only argued that COPD was excluded from the patient population of Kemmerich (2007). Appellants made the same unavailing argument about Engelbertz' s suggestion2 to use thyme to treat COPD (Br. 20) as discussed above, but provided no reason to doubt that it would work as suggested by Engelbertz. Appellants also argue that neither Kemmerich (2007) nor Engelbertz teach "sugar-coated tablet, a film-coated tablet, a capsule, sprays, ointments, emulsions, powder, ground material, syrup, a formulation for topical application, liquid or solid preparations for inhalation, compresses, tamponades, or tonsil brush solutions" as recited in claim 21. Br. 9. However, the Examiner found that Kemmerich (2007) teaches a film coated tablet (Final Act. 11 ), meeting the limitation of the claim because the recited pharmaceutical forms are listed as alternatives ("or") and therefore only one pharmaceutical form must be found in the prior art for the limitation to be met. For the foregoing reasons, the obviousness rejection of claims 21, 23- 25, and 40 is affirmed. Claim 3 8 ( Group VI) Dependent claim 3 8 excludes a syrup from claim 16. The Examiner found that Kemmerich (2007) teaches tablets and not a syrup. Final Act. 11. Appellants contend that Kemmerich II [2007] requires the use of a syrup, 2 See Engelbertz (Abstract) ("[T]hyme extract may help in diseases related to endothelin hyper-reagibility [sensitivity] of the bronchus system such as asthma and COPD."). 10 Appeal2018-005785 Application 13/700,351 which is excluded from the claim. We do not agree. Kemmerich (2007) describes tablets comprising thyme and primrose. Kemmerich (2007) 609 ("2.2. Treatment"). Kemmerich (2006) describes a syrup, but the Examiner cited Gergely as teaching that thyme and ivy may be in the form of a tablet. Final Act. 8. Appellants arguments to the contrary are not supported by adequate evidence. The rejection of claim 38 is affirmed. Claim 29 (Group VII) Claim 29 depends from claim 21, and further recites that the extracts are aqueous. The Examiner found that Wunderlich teaches that extracts may be aqueous, making an aqueous extract obvious. Final Act. 12. Appellants state there would be no reason to combine the publications with Wunderlich, but do not identify any deficiency in the Examiner's rejection. Br. 22. The rejection of claim 29 is affirmed for the reasons set forth by the Examiner. Claims 34--36 (Group VIII) and 42 (Group IX) Appellants identify the limitations in the claims and contend that there would have been no reason to have arrived at them by combining the cited publications. Br. 23, 25. However, the Examiner explained why it would have been obvious to combine the cited publications to have arrived at the claimed invention. Final Act. 12, 14. Appellants do not identify a defect in the Examiner's fact-finding nor reasoning. We therefore affirm the rejections of claims 34--36 and 42 for the reasons set forth by the Examiner. Summary Obviousness rejections 1-5 are affirmed. 11 Appeal2018-005785 Application 13/700,351 TIME PERIOD 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 12 Copy with citationCopy as parenthetical citation