Ex Parte FeinDownload PDFPatent Trial and Appeal BoardMay 31, 201613599768 (P.T.A.B. May. 31, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/599,768 08/30/2012 51957 7590 06/02/2016 ALLERGAN, INC. 2525 DUPONT DRIVE, T2-7H IRVINE, CA 92612-1599 FIRST NAMED INVENTOR Seymour H. Fein 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. 18720 CON4 (URO) 1270 EXAMINER HEARD, THOMAS SWEENEY ART UNIT PAPER NUMBER 1675 NOTIFICATION DATE DELIVERY MODE 06/02/2016 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 Ex parte SEYMOUR H. FEIN Appeal2014-002722 Application 13/599,768 Technology Center 1600 Before DEMETRA J. MILLS, ERIC B. GRIMES, and TA WEN CHANG, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134. The Examiner has rejected the claims under various statutory provisions. We have jurisdiction under 35 U.S.C. § 6(b). We affirm, but designate the affirmance as new grounds of rejection. Appeal2014-002722 Application 13/599,768 STATEMENT OF CASE The following claims are on appeal. 1. A pharmaceutical composition comprising desmopressin and a pharmaceutically acceptable carrier in a dosage form adapted for transmucosal administration which when administered to a patient establishes a plasma/serum desmopressin concentration in the range of from about 0.1 pico grams desmopressin per mL plasma/serum to a maximum of about 10.0 picograms desmopressin per mL plasma/serum and decreases urine production. 2. The dosage form of claim 1 which establishes a plasma/serum desmopressin concentration of from about 0.5 picograms desmopressin per mL plasma/serum to about 5.0 picograms desmopressin per mL plasma/ serum. 3. The composition of claim 1 which establishes said plasma/serum desmopressin concentration range for a time between four and six hours. 4. The composition of claim 1 adapted for oral mucosal administration. 5. The composition of claim 1 adapted for nasal mucosal administration. 6. The composition of claim 1, wherein the pharmaceutical composition is solid. Cited References Harris Nilsson et al. Grounds of Rejection us 5,498,598 WO 03/094885 Al Mar. 12, 1996 Nov. 20, 2003 1. Claims 1-6 are rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. 2 Appeal2014-002722 Application 13/599,768 2. Claim 3 is rejected under 35 U.S.C. § 112, fourth paragraph, as being of improper dependent form. 3. Claims 1-5 stand rejected under 35 U.S.C. § 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. 4. Claims 1-3 and 5 are rejected under 35 U.S.C. § 102(b) as being anticipated by Harris. 5. Claims 1-4 and 6 are rejected under 35 U.S.C. § 102(e) as being anticipated by Nilsson. FINDINGS OF FACT The Examiner's findings of fact are set forth in the Answer at pages 2-16. The following facts are highlighted. 1. The Specification discloses that Spec. 24. plasma/plasma/serum [sic] desmopressin concentrations following administration of the pharmaceutical composition of the invention preferably range from about 0.1 pg/mL to about 10.0 pg/mL, and more preferably from about 0.5 pg/mL to about 5.0 pg/mL. These amounts and ranges of desmopressin may be administered by any method known in the art, including, without limitation, ... intranasal; transmucosal (buccal and sublingual, e.g., orodispersible tablets ... 2. The Specification, pages 24-25 disclose that the dose ranges of desmopressin outlined above in FF 1 can produce appropriate antidiuretic effect when administered by various routes as summarized in the examples below: 3 Appeal2014-002722 Application 13/599,768 Route of Administration Intravenous (bolus and infusion) Subcutaneous (bolus, infusion, depot) Intranasal Transmucosal including buccal and sub lingual ( orodispersible tablets, wafers, film and effervescent formulations), conjunctiva! ( eyedrops ), rectal (suppository, enema) Transdermal (passive via patch, gel, cream, ointment or iontophoretic) Intradermal (bolus, infusion, depot) Effective Daily Dose Range 0.5 ng-2000 ng 0.5 ng-2000 ng 0.1 mcg - 20 mcg 0.1 mcg - 20 mcg 0.05 mcg - 10 mcg 0.05 mcg - 10 mcg 3. Harris discloses "[a]n aqueous composition for spray nasal administration of a synthetic analog of vasopressin ( desmopressin; actate containing between 2.5 and 7.5 µg per 100 µl." Abstract; see also col. 3, 11. 7-17. 4. Harris, col. 1 11. 28-31, discloses an intranasal administration of about 200 µl MINIRIN® spray, containing about 20 µg of desmopressin, provides an antidiuretic effect lasting in most adult patients for about 8 to 12 hours. 5. Nilsson discloses an orodispersible desmopressin formulation which disperses rapidly in the mouth. P. 1, 1. 28-p. 2, 1. 9. 4 Appeal2014-002722 Application 13/599,768 6. Nilsson discloses that The daily dosage of desmopressin, measured as the free base, will generally be from 0.5 or 1 µg to l mg per dosage form. In one preferred dosage range, the dosage will typically range from 2 µg to 800 µg per dosage form and preferably from 10 µg to 600 µg. Relative low doses are also specifically contemplated, for example from 0.5 µg to 75 µg, preferably 0.5 or 1 µg to 50 µg. P. 2, 11. 10-14. PRINCIPLES OF LAW In making our determination, we apply the preponderance of the evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 (Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings before the Office). The Board "determines 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. A WH 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). In order for a prior art reference to serve as an anticipatory reference, it must disclose every limitation of the claimed invention, either explicitly or inherently. See In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). "It is well settled that a claim is anticipated if each and every limitation is found either expressly or inherently in a single prior art reference." Celeritas Techs. Ltd. v. Rockwell Int'! Corp., 150 F.3d 1354, 1361 (Fed. Cir. 1998). Anticipation has been found even when a prior art range "does not exactly correspond to [the] claimed range," but the prior art 5 Appeal2014-002722 Application 13/599,768 "range entirely encompasses, and does not significantly deviate from, [the] claimed ranges." See Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377 (Fed. Cir. 2005) (court found that a claimed range of 0.025 to 5% did not significantly deviate from a prior art range of 0.01to20%). ANALYSIS 35 U.S.C. § 112 Rejections 1-3 We do not find that the Examiner has provided evidence to support Rejections 1-3. Written Description The Examiner argues that [i]t is unquestionable that Claim(s) 1 is/are a broad generic, with respect to all possible compound formulations encompassed by the claims. The possible compositional variations are limitless to any class of composition that is formulated in generic terms to do specific functions. Ans. 5. The Examiner then argues that the claims lack written description because "[t]here is nothing claimed that informs the skilled artisan of what is to be made, only the function of that which is made." (Id.) We are not persuaded. "[F]unctionally defined claims can meet the written description requirement if a reasonable structure-function correlation is established, whether by the inventor as described in the specification or known in the art at the time of the filing date." Abb Vie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1301 (Fed. Cir. 2014). According to the Specification, page 25, and dependent claims 4 and 5, buccal tablets, orodispersible compositions and compositions for nasal 6 Appeal2014-002722 Application 13/599,768 administration comprising particular desmopressin dose ranges are within the scope of claim 1. The Examiner has failed to indicate any deficiencies in this disclosure, or how this disclosure fails to provide a reasonable structure- function correlation for purposes of the written description requirement. 1 For this reason, the written description rejection is reversed. Fourth Paragraph The Examiner finds that claim 3 fails to further limit claim 1 because it merely recites properties of the formulation of claim 1 and thus is in improper dependent claim format. Ans. 6. We are not persuaded. Claim 3 further limits the formulation of claim 1 by requiring that the formulation establishes the claimed plasma/serum desmopressin concentration range for a time between four and six hours. Claim 1 encompasses transmucosal dosage forms that achieve a plasma/sert1m desmopressin concentration \'l1ithin the recited range, \'l1ithout requiring that that concentration be maintained for any length of time. Thus claim 1 includes other transmucosal dosage forms with different plasma concentration time profiles. Accordingly, claim 3 further limits the pharmaceutical composition of claim 1, and the 35 U.S.C. § 112, fourth paragraph rejection is reversed. 1 In the Response to Argument, the Examiner maintains the rejection because "[t]here is no written description of a novel desmopressin nasal formulation, only amounts of a known active ingredient." (Ans. 12-13 (emphasis added).) Lack of novelty, however, is a different rejection from written description. 7 Appeal2014-002722 Application 13/599,768 Indefiniteness The Examiner rejects claims 1-5 under 35 U.S.C. § 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Ans. 6. The Examiner argues that, "Claim 1 is missing critical information to the invention" but fails to specifically indicate what critical information is missing from the claim. Id. Instead, the Examiner argues only that "[Appellants] spend less effort in describing how the desmopressin and carrier are adapted to a dosage form, but rather spend more time claiming what it does." Id. However, functional language in and of itself does not render a claim improper. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). We find that the Examiner has failed to support this rejection and the indefiniteness rejection is reversed. ~1nticipation ~lfarris Claims 1-3 and 5 are rejected under 35 U.S.C. § 102(b) as being anticipated by Harris. We address separately argued claims, individually. Claims 1 and 5 The Examiner finds that Harris discloses desmopressin in a nasal spray form which inherently meets the limitations of claim 1. Ans. 7-8. Appellant contends that "Harris does not inherently anticipate the claimed invention." Br. 7. Appellant further argues that The Office action does not argue that Harris expressly describes a dosage form that establishes a plasma/serum desmopressin concentration in the range of from about 0.1 picograms desmopressin per mL plasma/serum to a maximum of about 10.0 pico grams desmopressin per mL plasma/serum. 8 Appeal2014-002722 Application 13/599,768 Br. 7. Nor does the Office action argue that Harris describes a dosage form that, when administered, necessarily establishes a plasma/serum desmopressin concentration in the range of from about 0.1 picograms desmopressin per mL plasma/serum to a maximum of about 10.0 picograms desmopressin per mL plasma/ serum. We are not persuaded by Appellant's arguments. The Table on page 25 of the Specification (reproduced in FF2 herein) shows that formulations adapted for transmucosal administration within the scope of the invention and consistent with claim 1 provide an effective daily dose of 0.1 mcg-20 mcg of desmopressin. The Table (FF2) also shows that intranasal formulations that provide an effective daily dose of 0.1 mcg-20 mcg of desmopressin result in the claimed plasma/serum desmopressin levels. Thus, an effective daily dose of 0.1 mcg-20 mcg of desmopressin provides a plasma/sert1m desmopressin concentration in the range of from about 0.1 pico grams desmopressin per mL plasma/serum to a maximum of about 10.0 picograms desmopressin per mL plasma/serum, within the scope of claims 1 and 5. Harris discloses a nasal spray for the administration of desmopressin containing between 2.5 and 7.5 µg per 100 µ1. Abstract. The delivery pump of Harris is "designed for delivering a dose ranging from 2.5 to 7.5 µg desmopressin per actuation, with the optimum amount at about 5 µg." Harris, col. 3, 11. 24-26. Harris' 2.5 to 7.5 µg of desmopression falls within the effective daily dose of between 0.1 mcg-20 mcg of desmopressin within the scope of the present claims. See Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377 (Fed. Cir. 2005). 9 Appeal2014-002722 Application 13/599,768 Appellant argues that the Declaration of Ronald V. Nardi shows that the amount of desmopressin that reaches the bloodstream depends on the amount and rate of desmopressin administration and its bioavailability, which itself depends on the route and formulation of administration. Br. 8. We are not persuaded. The Nardi Declaration fails to specifically address the disclosure of Harris. Furthermore, Appellant "does not regard his invention as comprising the particular structure his claimed dosage forms take, beyond the recited specific language of the claims limiting the dose to various suitable forms for transmucosal use." Br. 4. Appellant has failed to provide evidence that the nasal dosage forms of Harris are not within the scope of the pending claims. Appellant has failed to provide evidence that the disclosed dosages of Harris are not consistent with the pharmaceutical compositions of claim 1 and 5. Thus, Harris anticipates claims 1 and 5. Claim 2 Claim 2 depends from claim 1 and further requires the dosage form to establish a plasma/serum desmopressin concentration of from about 0.5 pg/mL to about 5.0 pg/mL. With respect to claim 2, Harris' 2.5 to 7.5 µg of desmopression nasal spray falls within the lower end of the effective daily dose of 0.1 mcg-20 mcg of desmopressin (FF2) which provides a plasma/serum desmopressin concentration from about 0.1 pg/mL to about 10.0 pg/mL, and more preferably from about 0.5 pg/mL to about 5.0 pg/mL. FF 1. Because Harris' dosages are at the lower end of the disclosed effective daily dose range, it is reasonable to find that they will provide plasma/serum desmopressin concentrations within the lower end of the range recited in claim 1. 10 Appeal2014-002722 Application 13/599,768 Where ... the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. ... Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on "prima facie obviousness" under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (emphasis added.) Thus, the burden of proof has shifted to Appellant to show that Harris' 2.5 to 7.5 µg of desmopression dosage forms are not consistent with the claimed dosage forms and would not establish a plasma/serum desmopressin concentration of from about 0.5 pico grams desmopressin per mL plasma/serum to about 5.0 picograms desmopressin per mL plasma/serum. This Appellant has not done. The anticipation rejection of claim 2 is affirmed. Claim 3 Claim 3 depends from claim 1 and further requires that the pharmaceutical composition establish the claimed plasma/serum desmopressin concentration range "for a time between four and six hours." We interpret the claim 3 language, "said plasma/serum desmopressin concentration range for a time between four and six hours" to mean that the dosage form establishes a plasma/serum desmopressin concentration of 0.1- 10.0 picograms desmopressin per mL for at least four hours. With respect to claim 3, Harris discloses a MINlRIN® nasal spray, which contains 10 µg of desmopressin acetate per 100 µ1. Col. 1, 11. 25-27. 11 Appeal2014-002722 Application 13/599,768 "Intranasal administration of about 200 µl MINIRIN® spray, containing about 20 µg of desmopressin, provides an antidiuretic effect lasting in most adult patients for about 8 to 12 hours." Col. 1, 11. 25-31. Harris' 10 µg per actuation (col 1, 11. 4 7-51) and 20 µg dose of MINIRIN® spray desmopressin are between Appellant's O. l mcg-20 mcg of desmopressin (FF2) which provides a plasma/serum desmopressin concentration from about 0.1 pg/mL to about 10.0 pg/mL, and more preferably from about 0.5 pg/mL to about 5.0 pg/mL. FFl. Where ... the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. ... Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on "prima facie obviousness" under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (emphasis added.) Thus, the burden of proof has shifted to Appellant to show that Harris' 10 µg or 20 µg dosage form (Harris, col. 1, 11. 47-51) is not consistent with the claimed dosage forms and would not inherently establish a plasma/serum desmopressin concentration of 0.1-10.0 pico grams desmopressin per mL for at least four hours. This Appellant has not done. The anticipation rejection of claim 3 over Harris is affirmed. Anticipation Nilsson 12 Appeal2014-002722 Application 13/599,768 Claims 1-4 and 6 are rejected under 35 U.S.C. § 102(e) as being anticipated by Nilsson. We address separately argued claims individually. Claims 1, 4 and 6 The Examiner finds that Nilsson "teaches desmopressin in solid form for transmucosal absorption, see entire document devoted to this form of administration, readable on Claims 1-3 and 6." Ans. 9. Appellant contends that Nilsson neither expressly nor inherently describes a dosage form which when administered to a patient establishes a plasma/serum desmopressin concentration in the range of from about 0.1 picograms desmopressin per mL plasma/serum to a maximum of about 10.0 picograms desmopressin per mL plasma/serum. Nilsson therefore does not anticipate claim 1, 4, or 6, for the same reasons that Harris fails to anticipate claims 1 and 5. Br. 15-16. We are not convinced by Appellant's argument. Nilsson discloses an orodispersible dosage form which rapidly disperses in the mouth. FF5; Nilsson, p. 2. Nilsson further discloses that The daily dosage of desmopressin, measured as the free base, will generally be from 0.5 or 1 µg to l mg per dosage form. In one preferred dosage range, the dosage will typically range from 2 µg to 800 µg per dosage form and preferably from 10 µg to 600 µg. Relative low doses are also specifically contemplated, for example from 0.5 µg to 75 µg, preferably 0.5 or 1 µg to 50 µg. Id. Nilsson's disclosed daily dosage of desmopressin significantly overlaps with the range disclosed in the Specification. FF6. Nilsson's orodispersible 13 Appeal2014-002722 Application 13/599,768 or buccal (p. 9) formulation is a dosage consistent with the dosages in the Table on page 25 of the Specification (reproduced in FF2 herein) which indicates that formulations adapted for transmucosal administration, including orodispersible tablets, within the scope of the invention provide an effective daily dose of between O. l mcg-20 mcg of desmopressin. Thus, it is reasonable to find that the effective daily dose of desmopressin disclosed in Nilsson provides a plasma/serum desmopressin concentration in the range of from about 0.1 picograms desmopressin per mL plasma/serum to a maximum of about 10.0 picograms desmopressin per mL plasma/serum, within the scope of claims 1, 2, 4 and 6. Appellant has failed to provide evidence that the disclosed dosages of Nilsson are not consistent with the pharmaceutical composition of claims 1, 4 and 6. Claim 2 With respect to claim 2, Nilsson's disclosed dose range of desmopression (FF6) encompasses the lov; end of the ,,L\ .. ppellant's effective daily dose of between O. l mcg-20 mcg of desmopressin (FF2) which provides a plasma/serum desmopressin concentration from about 0.1 pg/mL to about 10.0 pg/mL, and more preferably from about 0.5 pg/mL to about 5.0 pg/mL. FF 1. Because Nilsson's disclosed dose range that encompasses the low end of the range disclosed in the Specification, it is reasonable to find Nilsson inherently disclosed pharmaceutical formulations that, when administered, will establish plasma/serum desmopressin concentration from about 0.5 pg/mL to about 5.0 pg/mL (i.e., at the lower end of the range recited in claim 1 ). Where ... the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially 14 Appeal2014-002722 Application 13/599,768 identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. ... Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on "prima facie obviousness" under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (emphasis added.) Thus, the burden of proof has shifted to Appellant to show that Nilsson's disclosed desmopression dosage forms are not consistent with the claimed dosage forms and would not establish a plasma/serum desmopressin concentration of from about 0.5 pico grams desmopressin per mL plasma/serum to about 5.0 picograms2 desmopressin per mL plasma/serum. This Appellant has not done. Claim 3 With respect to claim 3, the Examiner has established with evidence that Nilsson's dosage forms provide similar dosages as the claimed dosage forms. Ans 8. However, the Examiner provides no evidence as to whether Nilsson's dosage forms provide a plasma/serum desmopressin concentration range for a time range of at least between four and six hours. Because the Examiner has not provided evidence to support a prima facie case of anticipation of claim 3 over Nilsson, the rejection of claim 3 is reversed. 2 Claim 2 does not recite a maximum plasma concentration range other than through dependency upon claim 1. 15 Appeal2014-002722 Application 13/599,768 The anticipation rejections based on Harris and Nilsson are affirmed, except the anticipation rejection of claim 3 in view of Nilsson is reversed. Because our analysis differs somewhat from that of the Examiner we designate both anticipation rejections as new grounds of rejection. CONCLUSION OF LAW All 35 U.S.C. § 112 rejections are reversed. The cited references support the Examiner's anticipation rejections of all of the claims, except for the rejection of claim 3 based on Nilsson. The rejection of all of the claims is affirmed, but designated as new grounds of rejection. All claims fall. TIME PERIOD FOR RESPONSE 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 reviev"1." 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 .... 16 Appeal2014-002722 Application 13/599,768 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § l.136(a). AFFIRMED; 37 C.F.R. § 41.50(b) 17 Copy with citationCopy as parenthetical citation