Ex Parte Walt et alDownload PDFPatent Trial and Appeal BoardMar 29, 201813069665 (P.T.A.B. Mar. 29, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/069,665 03/23/2011 51957 7590 04/02/2018 ALLERGAN, INC. 2525 DUPONT DRIVE, T2-7H IRVINE, CA 92612-1599 FIRST NAMED INVENTOR John G. Walt 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. 18642 (AP) 1547 EXAMINER DICKINSON, PAUL W ART UNIT PAPER NUMBER 1618 NOTIFICATION DATE DELIVERY MODE 04/02/2018 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): patents_ip@allergan.com pair_allergan@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Exparte JOHN G. WALT, DAVID F. WOODWARD, and AMANDAM. VANDENBURGH 1 Appeal 2016-003437 Application 13/069,665 Technology Center 1600 Before RICHARD J. SMITH, TA WEN CHANG, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. CHANG, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a method for treating alopecia, which have been rejected as anticipated and/or obvious. We have jurisdiction under 35 U.S.C. § 6(b ). We AFFIRM. 1 Appellants identify the Real Party in Interest as Allergan, Inc. (Appeal Br. 3.) 1 Appeal2016-003437 Application 13/069,665 STATEMENT OF THE CASE Alopecia, or baldness, is "a deficiency of either normal or abnormal hair." (' 404 patent, 2 6:40-41.) The Specification states that "[h ]air loss can result from a variety of causes," that "[a]t present there is no cure for hair loss," and that, thus, "[a]n agent that safely and effectively reduces hair loss due to any cause or increases hair growth would be highly desirable." (Spec. iii! 2-3.) Claims 1, 2, and 6-11 are on appeal. Claim 1, the only independent claim, is illustrative and reproduced below: 1. A method for treating alopecia in an individual in need thereof comprising the step of administering a therapeutically effective amount of a composition comprising a prostamide, prodrug thereof, salt thereof, or mixtures thereof to the individual, wherein the administration results in a reduction in alopecia. (Appeal Br. 24 (Claims App.). The Examiner rejects claims 1, 2, and 6-8 under pre-AIA 35 U.S.C. § 102(a) as being unpatentable over Ochoa. 3 (Ans. 2.) The Examiner rejects claims 1, 2, and 6-10 under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over Ochoa. (Id.) 2 Woodward et al., U.S. Patent No. 7,351,404, issued Apr. 1, 2008 ("'404 patent"). 3 Blanca E. Ochoa, MD et al., Letters, Instilled Bimatoprost Ophthalmic Solution in Patients with Eyelash Alopecia Areata, 61 J. AM. AcAD. DERMATOLOGY 530-532 (2009) ("Ochoa"). 2 Appeal2016-003437 Application 13/069,665 The Examiner rejects claims 1, 2, 6-8, and 11 4 under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over Ochoa and Chochinov. 5 (Id. at 9.) The Examiner rejects claims 1, 2, and 6-11 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 8,298,518 ("'518 patent"). (Id. at 4.) The Examiner rejects claims 1, 2, and 6-11 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 8,038,988 ("'988 patent"). (Id.) Issue I. PRIORITY CLAIM According to the Specification, [t]his application is a Continuation-in-Part of U.S. Patent Application Ser. No. 12/425,933 filed on April 17, 2009, which is a continuation of U.S. Patent Application Ser. No. 11/943,714, filed November 21, 2007, which is a continuation of U.S. patent 4 In the Answer, the Examiner on one occasion refers to the claims rejected as obvious over Ochoa as claims 1, 2, and 6-11 (Ans. 8), and on another occasion refers to the claims rejected as obvious over Ochoa as claims 1, 2, and 6-10 (id. at 2). Likewise, the Examiner on one occasion in the Answer refers to the claims rejected over Ochoa and Chochinov as claims 1, 2, 6---8, and 11 (Ans. 9), and on another occasion refers to the claims rejected over Ochoa and Chochinov as claims 1, 2, 7, 8, and 11 (Ans. 3). Because the Final Action does not specify that claim 11 is rejected as obvious over Ochoa while specifying that claim 6 is rejected as obvious over Ochoa and Chochinov, we understand that the obviousness rejections on appeal are (1) claims 1, 2, 6-10 as obvious over Ochoa and (2) claims 1, 2, 6-8, and 11 as obvious over Ochoa and Chochinov. (Final Act. 4--5.) This understanding is also consistent with the "GROUNDS OF REJECTION TO BE REVIEWED ON APPEAL" set forth in the Appeal Brief. (Appeal Br. 7.) 5 Chochinov et al., U.S. Patent No. 8,288,366 B2, issued Oct. 16, 2012 ("Chochinov"). 3 Appeal2016-003437 Application 13/069,665 application Ser. No. 11/805, 122, filed May 22, 2007, which is a continuation ofU.S. Patent No. 7 ,351,404 [("' 404 patent")], filed on January 15, 2003, which claims the benefit of U.S. Provisional Application No. 60/354,425, filed on February 4, 2002. This application also claims the benefit of U.S. Provisional Application No. 61/316,967, filed on March 24, 2010. (Spec. if 1.) The Examiner's rejections under pre-AIA 35 U.S.C. §§ 102(a) and 103(b) are based in whole or in part on Ochoa, which was published September 2009. (Ans. 2-3, 5.) The Examiner finds that the appealed claims should be given a priority benefit date of March 24, 2010, which is the filing date of provisional Application No. 61/316,967. (Id. at 5.) Accordingly, the Examiner finds that Ochoa is prior art to the appealed claims under pre-AIA 35 U.S.C. § 102(a), because it was published less than a year before the priority date of the appealed claims. Appellants contend that Ochoa is not prior art to the appealed claims because the claims are entitled to "the earliest effective priority date of the '404 Patent," which predates Ochoa. (Appeal Br. 18.) The issue is whether the appealed claims are entitled to the earliest effective filing date of the '404 patent. Findings of Fact 1. The '404 patent teaches pharmaceutical compositions for topical application to enhance hair growth comprising an effective amount of a cyclopentane heptanoic acid, 2-cycloalkyl or arylalkyl compound represented by formula I 4 Appeal2016-003437 Application 13/069,665 R2 x wherein the dashed bonds represent a single or double bond which can be in the cis or trans configuration, A is an alkylene or alkenylene radical having from two to six carbon atoms, which radical may be interrupted by one or more oxa radicals and substituted with one or more hydroxy, oxo, alkyloxy or alkylcarboxy groups wherein said alkyl radical comprises from one to six carbon atoms; B is a cycloalkyl radical having from three to seven carbon atoms, or an aryl radical, selected from the group consisting of hydrogen, a lower alkyl radical having from four to ten carbon atoms wherein the heteroatom is selected from the group consisting of nitrogen, oxygen and sulfur atoms; X is -N(R4) 2 wherein R4 is selected from the group consisting of hydrogen, a lower alkyl radical having from one to six carbon atoms, 0 . II R~-o-c- wherein R5 is a lower alkyl radical having from one to six carbon atoms; Z is =O; one of Ri and R2 is =O, --OH or a---O(CO)R6 group, and the other one is---OH or---O(CO)R6, or R1 is =O and R2 is H, wherein R6 is a saturated or unsaturated acyclic hydrocarbon group having from 1 to about 20 carbon atoms, or ---(CH2)mR7 wherein mis 0 or an integer of from 1 to 10, and R7 is cycloalkyl radical, having from three to seven carbon atoms, or a hydrocarbyl aryl or heteroaryl radical, as defined above in free form or a pharmaceutically acceptable salt thereof, in 5 Appeal2016-003437 Application 13/069,665 association with a pharmaceutical carrier adapted for topical application to mammalian skin. (Id. at 4: 18---67 .) 2. The '404 patent teaches "methods for stimulating the rate of hair growth ... by administering to the skin of the animal an effective amount of a compound wherein the compound has the formula [recited in FFl]." (Id. at 5:45---6:25; see also id. at 8:55---64.) 3. The '404 patent teaches that the most preferred compound of its invention is bimatoprost. (Id. at 5:41--44.) The '404 patent teaches that bimatoprost is not a prostaglandin derivative but has been found to be effective in increasing the growth of eyelashes. (Id. at 3:49--53, 7:25-28.) 4. The '404 patent does not teach hair loss due to chemotherapy. (Reply Br. 5.) 5. The Specification states that "[p ]rostamides are prostaglandin- ethanolamides." (Spec. i-f 32.) 6. The Specification states that, [i]n another aspect of this embodiment, a prostamide analog comprises a compound having the structure: z x wherein the dashed bonds represent a single or double bond which can be in the cis or trans configuration, X is -N(R4) 2 wherein R4 is selected from hydrogen, a lower alkyl radical having from one to six carbon atoms, 6 Appeal2016-003437 Application 13/069,665 0 g II or 0 II R5-o-c--R"-C--· wherein R5 1s a lower alkyl radical having from one to six carbon atoms; Z is =O or represents two hydrogen radicals; one of R1 and R2 is =O, --OH or a --O(CO)R6 group, and the other one is --OH or --O(CO)R6, or Ri is =O and R2 is hydrogen, wherein R6 is a saturated or unsaturated acyclic hydrocarbon group having from 1 to about 20 carbon atoms, or - (CH2)mR7 wherein mis 0 or an integer of from 1 to 10, and R7 is cycloalkyl radical, having from three to seven carbon atoms, or a hydrocarbyl aryl or heteroaryl radical, as defined above; A is an alkylene or alkenylene radical having from two to six carbon atoms, which radical may be interrupted by one or more oxide radicals and substituted with one or more hydroxy, oxo, alkyloxy or akylcarboxy groups wherein the alkyl radical comprises from one to six carbon atoms; and B is a cycloalkyl radical having from three to seven carbon atoms, an aryl radical, selected from hydrocarbyl aryl and heteroaryl radicals having from four to ten carbon atoms wherein the heteroatom is selected from nitrogen, oxygen and sulfur atoms. (Id. if 48.) 7. The Specification teaches that a prostamide analog comprises bimatoprost, which has the following structure: OH (Id. ifif 49--50.) 7 H N'--.../ Appeal2016-003437 Application 13/069,665 Analysis The Examiner finds that Application No. 10/345,788, which issued as the '404 patent upon which Appellants' priority arguments are based, does not adequately support the appealed claims under 35 U.S.C. § 112, and thus cannot provide an earlier effective filing date for the appealed claims. (Ans. 6.) With regard to claims 1, 2, and 6, the Examiner agrees that the '404 patent discloses bimatoprost, which the Specification describes as a prostamide analog. (Ans. 6; FF7.) However, the Examiner finds that "bimatoprost does not represent the vast number of compounds encompassed by 'prostamide. "' (Ans. 6.) In particular, the Examiner finds that "the genus of prostamides includes prostaglandin-ethanolamides," which are not described in the '404 patent. (Id. at 7.) The Examiner further finds that the '404 patent also fails to adequately support claim 7 and its dependent claims 8-11, even though these claims limit the prostamide to bimatoprost. (Id.) More specifically, the Examiner finds that claim 7 depends from claim 6, which is directed to a method of treating alopecia "wherein the hair loss is due to chemotherapy," whereas the '404 patent does not teach hair loss due to chemotherapy. (Id.) Appellants contend that the '404 patent teaches prostamides other than bimatoprost. (Appeal Br. 9.) Citing Woodward, 6 Appellants first contend that the term prostamides are not limited to ethanolamides. (Id. at 16.) In the briefs, Appellants also contend that, contrary to the Examiner's finding, the '404 patent discloses prostaglandin-ethanolamides, of which 6 DF Woodward et al., Review, Prostamides (Prostaglandin-Ethanolamides) and Their Pharmacology, 153 BRIT. J. PHARMACOLOGY 410 (2008). 8 Appeal2016-003437 Application 13/069,665 bimatoprost is one. (Appeal Br. 10-16; Reply Br. 4--5.) In particular, Appellants contend in the Reply Brief that where X in Formula I recited in the '404 patent is-N(R4) 2 and R4 is a hydrogen and a lower alkyl radical having two carbon atoms (i.e., an ethyl), compounds having the following chemical structure would be produced: z /ethyl group NH(C2Hs) _,J (Reply Br. 4.) Appellants contend that compounds having the above formula would be prostaglandin-ethanolamides where Z, R1, R2, A, and B are as otherwise defined for Formula I in the '404 patent. (Id. at 4--5; see also Appeal Br. 9--16.) Accordingly, Appellants contend that "there are more than a representative number of prostamides in the priority documents to properly support the genus 'prostamides' under 35 USC 112(1) in the present application" and "full priority as claimed to the filing date of the '404 patent should be granted." (Reply Br. 5.) Claims 1, 2, and 6 On balance, we find the Examiner to have the better argument. Whether a claim should receive the benefit of an earlier-filed application depends on whether a skilled artisan would recognize that "the applicant possessed what is claimed in the later filed application as of the filing date of the earlier filed application." Noelle v. Lederman, 355 F.3d 1343, 1348 (Fed. Cir. 2004). In this case, there appears to be no dispute that, however broadly or narrowly the limitation "prostamide, prodrug thereof, and salt 9 Appeal2016-003437 Application 13/069,665 thereof' in claim 1 is construed, it includes at least prostaglandin ethanolamides. (FF5; see also Transcript of Oral Hearing (Dec. 4, 2017) ("Hearing Tr.") 4:22-25 (agreeing that prostamides "could be an ethanolamide"); 6:2-3 (agreeing that "a type of prostamide could be a prostaglandin-ethanolamide").) Because we agree with the Examiner that the '404 patent does not teach prostaglandin-ethanolmides and therefore provides support for at most a subgenus (for claim 1) or species (for claims 2 and 6) of the claimed genus, 7 we find that claims 1, 2, and 6 are not entitled to the priority based on the effective filing date of the '404 patent. See, e.g., Chester v. Miller, 906 F.2d 1574 (Fed. Cir. 1990) (holding that parent application's disclosure of species within the genus does not adequately support child continuation-in-part's claims to genus); In re Gosteli, 872 F.2d 1008 (Fed. Cir. 1989) (foreign priority application's disclosure of a subgenus of chemical compounds insufficient to support genus claims of U.S. application). Appellants argued in their briefs that the '404 patent teaches prostaglandin-ethanolamides having the following structure, z /ethyl group NH(C2Hs) •midogm~ 7 Although we do not rely on the findings of the District Court in the claim construction order of Allergan, Inc. et al. v. Athena Cosmetics, Inc. et al., Case No. 8:07-0cv-01326, we note that the District Court in that order also found that the '404 patent disclosed no ethanolamides. (Appeal Br. Ex. B 44, n. 23.) 10 Appeal2016-003437 Application 13/069,665 where Z, R1, R2, A, and B are as otherwise defined for Formula I in the '404 patent. (Appeal Br. 10-16; Reply Br. 4--5.) As Appellants appeared to acknowledge at oral argument, however, the above structure does not describe an ethanolamide, which would include an ethanol group (C2H40H), rather than an ethyl group (C2Hs), attached to the amide. (Hearing Tr. 3:21- 25 (agreeing that "bimatoprost ... does not contain an ethanolamide group"), 6:6-7 (stating that bimatoprost is not a prostaglandin- ethanolamide ), 6:13-16 (explaining that bimatoprost is not a prostaglandin- ethanolamide because it has an ethyl group at the end rather than an ethanolamide ).) Appellants suggested at the hearing that the claims are supported by the '404 patent because paragraph 48 of the Specification, which provides a chemical structure for the genus of prostamide analog, may be considered a definition of prostamide and is substantially similar to compounds of Formula I taught in the '404 patent. (Hearing Tr. 4:2-9 (referring to paragraph 48 in response to question regarding definition of prostamide in the Specification), 5:2-13. 6:1-5, 7:6-22 (arguing that the species disclosed in the priority document should be "relatively coextensive" with the claimed prostamide species, if not broader).) We are not persuaded. The chemical structure described in paragraph 48 of the Specification is that of a prostamide analogue, which is thus different from the group of "prostamide, prodrug thereof, salt thereof, or mixtures thereof' recited in claim 1. (FF6.) Thus, similarity between the structures described in paragraph 48 of the Specification and Formula I of the '404 patent does not necessarily indicate adequate support in the '404 patent for the full scope of the claimed invention. 11 Appeal2016-003437 Application 13/069,665 Indeed, as already discussed above, we do not find Formula I to encompass a prostaglandin ethanolamide, which indisputably falls within the definition of a prostamide. In particular, the basic structure of' 404 patent's Formula I, would not encompass an prostaglandin ethanolamide unless X is defined to encompass an ethanolamide. The '404 patent, however, defines X as "-N(R4) 2 wherein R4 is selected from the group consisting of hydrogen, a lower alkyl radical having from one to six carbon atoms, 0 0 c n R"-C- imu - II R'-O-C- wherein R5 is a lower alkyl radical having from one to six carbon atoms," which we do not find to encompass an ethanolamide. 8 (FFI.) 8 We are cognizant that Formula I may encompass an ethanolamide if "a lower alkyl radical having from one to six carbon atoms" is construed to encompass substituted alkyl groups (i.e., alkyl groups wherein one or more hydrogen atoms bonded to the carbon atoms are substituted with other atoms or groups, such as hydroxyl groups). Appellants have not made this argument in the Appeal Brief or Reply Brief, however, and the argument is thus waived. Ex parte Borden, 93 USPQ2d 1473, 1477 (BPAI 2010) (informative) ("Properly interpreted, the Rules do not require the Board to take up a belated argument that has not been addressed by the Examiner, absent a showing of good cause."). In any event, we are not persuaded that a skilled artisan would understand "a lower alkyl radical having from one to six carbon atoms" to encompass an ethanol group in light of the ordinary 12 Appeal2016-003437 Application 13/069,665 Claim 2 and claim 6, which depends from claim 2, are directed to a narrower genus of prostamides than claim 1, i.e., prostamides selected from the group of "bimatoprost, a prostamide D2, prostamide E2, a prostamide F 2a, a 1 lB-prostamide F2a, a prostamide G2, a prostamide H2, or a prostamide b." (Appeal Br. 24 (Claims App.).) This narrower genus nevertheless comprises prostamides that are prostaglandin ethanolamides, which as discussed above are not supported by the disclosures in the '404 patent. (See, e.g., Appeal Br. Ex. C Fig. 2 (depicting chemical structures of prostamide E2, F2a, G2, and H2).) Accordingly, we agree with the Examiner that the effective filing date of claims 1, 2, and 6 is no earlier than March 24, 2010, and that Ochoa is prior art under pre-AIA 35 U.S.C. § 102(a). Claims 7-11 Claim 7, and its dependent claims 8-11, further limit the prostamide to bimatoprost, which is disclosed in the '404 patent. As the Examiner points out, however, each of these claims depend directly or indirectly from claim 6, which recites the method in claim 2 of treating alopecia "wherein meaning of alkyl and the Specification, which do not suggest that the phrase encompasses substituted alkyl radicals. See, e.g., "alkyl group." A Dictionary of Chemistry, http://www.oxfordreference.com/view/10.1093/acref/9780199204632.001.0 001/acref-9780199204632-e-161 ?rskey= BH 4EJE&result=1 (last visited Mar. 18, 2018) (defining alkyl group as "[a] group obtained by removing a hydrogen atom from an alkane, e.g., methyl group, CH3-, derived from methane"); see also '404 patent, 5: 16-19 (distinguishing between alkyl and "halo substituted alkyl"). Finally, although we do not rely on the findings of the District Court in the claim construction order of Allergan, Inc. et al. v. Athena Cosmetics, Inc. et al., Case No. 8:07-0cv-01326, we note that the interpretation of "lower alkyl radical" is consistent with the construction of the District Court in that case. (Appeal Br. Ex. B. 40-44.) 13 Appeal2016-003437 Application 13/069,665 the hair loss is due to chemotherapy and the hair loss is associated with eyelashes, eyebrows and scalp hair." (Ans. 7.) The Examiner finds and Appellants do not dispute that the '404 patent does not teach treating hair loss due to chemotherapy. (Id.; Reply Br. 5.) "A disclosure in a parent application that merely renders the later- claimed invention obvious is not sufficient to meet the written description requirement; the disclosure must describe the claimed invention with all its limitations." Tronzo v. Biomet, Inc., 156 F.3d 1154, 1158 (Fed. Cir. 1998). Because there is no dispute that the '404 patent does not teach teaching hair loss where "hair loss is due to chemotherapy," we agree with the Examiner that the '404 patent does not provide adequate support for claims 7-11, that the effective filing date of these claims is no earlier than March 24, 2010, and that Ochoa is prior art under pre-AIA 35 U.S.C. § 102(a). II. ANTICIPATION Issue The Examiner has rejected claims 1, 2, and 6-8 under pre-AIA 35 U.S.C. § 102(a) as anticipated by Ochoa. The Examiner finds that Ochoa meets each limitation of claims 1, 2, and 7 because it teaches "a method for treating eyelash alopecia areata ... in an individual in need thereof comprising the step of administering a therapeutically effective amount of a composition comprising bimatoprost (a prodrug of a prostamide) ... to the individual, wherein the administration results in reduction in alopecia." (Ans. 2.) The Examiner finds that, "[a]lthough Ochoa does not disclose that the method restores natural hair color" as recited in claim 8, "as the method steps of Ochoa are identical to the instant invention, the method must provide the same effects, i.e., restoration in natural hair color." (Id.) 14 Appeal2016-003437 Application 13/069,665 Appellants argue that Ochoa is not prior art to one or more of the claims because the effective filing date of the claims on appeal is earlier than the date of the Ochoa reference. (Appeal Br. 8-17.) Appellants further argue that, even if Ochoa were prior art to claims 1, 2, and 6-8, Ochoa does not anticipate these claims because it does not teach all of the limitations of these claims. (J d. at 18-19.) As discussed above, we find that Ochoa is properly prior art to the appealed claims. Accordingly, the remaining issue with respect to this rejection is whether a preponderance of the evidence of record supports the Examiner's finding that Ochoa anticipates claims 1, 2, and 6-8. Findings of Fact 8. Ochoa teaches that glaucoma patients treated with bimatoprost, a prostanoid F2alfa receptor agonist, have noticed longer, darker, and thicker eyelashes and that a patient with alopecia areata (AA) "was reported to grow eyelashes after cutaneous eyelid application of latanoprost, a prostaglandin analogue." (Ochoa 530, right column.) 9. Ochoa describes a "16-week, open-label, prospective study ... to assess the safety and efficacy of instilled bimatoprost ophthalmic solution in promoting eyelash growth in patients with AA" wherein participants had "at least 50% bilateral eyelash loss for a period of longer than 6 months." (Id.) 15 Appeal2016-003437 Application 13/069,665 10. Table I of Ochoa is excerpted below: S€X i'9"' (y) AO.. type AA dur~tkm \y\ r1:linf-.% A~: l (:. ·~· .. •K> .. ~~ "vel~sl"Ns S~;je eifem P"a~fon:($ n::µu~t Physit:~an '.~· .~p:c.1rl f 44 M'!AIJ Q Non<; (> ~~cm;; ~fo{>0 54 JO N<}Cl~ n (l 0 -..-..-..-..-..-..-..-..-..-..-..-..-..-..-..-.. 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