Ex Parte DeLuca et al

Patent Trial and Appeal BoardApr 23, 2018

13463557 (P.T.A.B. Apr. 23, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/463,557 05/03/2012 81391 7590 04/25/2018 Andrus Intellectual Property Law, LLP 100 East Wisconsin A venue Suite 1100 Milwaukee, WI 53202-4178 FIRST NAMED INVENTOR Hector F. DeLuca 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. 1256-01791 3129 EXAMINER BAD IO, BARBARA P ART UNIT PAPER NUMBER 1628 NOTIFICATION DATE DELIVERY MODE 04/25/2018 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): patentdocketing@andruslaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte HECTOR F. DELUCA, MARGARET CLAGETT-DAME, PA WEL GRZYWACZ, GRAZIA CHIELLINI, and LORI A. PLUM Appeal2017-006924 Application 13/463,557 1 Technology Center 1600 Before DONALD E. ADAMS, RICHARD J. SMITH, and TA WEN CHANG, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This Appeal under 35 U.S.C. Â§ 134(a) involves claims 1-26 (App. Br. 2). Examiner entered rejections under 35 U.S.C. Â§ 103(a) and obviousness- type double patenting. We have jurisdiction under 35 U.S.C. Â§ 6(b ). We AFFIRM. 1 Appellants identify the real party in interest as "Wisconsin Alumni Research Foundation" (App. Br. 1 ). Appeal2017-006924 Application 13/463,557 STATEMENT OF THE CASE Appellants' disclosure "relates to vitamin D compounds, and more particularly to 2a-methyl and 2B-methyl analogs of 19,26-dinor-la,25- dihydroxyvitamin D3 and their pharmaceutical uses" (Spec. ,r 2). Appellants' claim 1 is representative and reproduced below: 1. A compound of the formula: where the methyl group attached to carbon 2 is of an R or S configuration, and where the methyl group attached to carbon 20 is of an R or S configuration, and where the substituent -OX3 is of an R or S configuration, and where X1, X2 and X3 are the same or different and are each independently selected from hydrogen or a hydroxy-protecting group. (App. Br. 19.) 2 Appeal2017-006924 Application 13/463,557 The claims stand rejected as follows: Claims 1-26 stand rejected under 35 U.S.C. Â§ I03(a) as unpatentable over the combination ofDeLuca '410; 2 DeLuca '559; 3 DeLuca '844; 4 DeLuca '642Â· 5 DeLuca '868Â· 6 DeLuca '909Â· 7 DeLuca '122Â· 8 DeLuca '789Â· 9 ' ' ' ' ' DeLuca '666; 10 DeLuca '295 11 and DeLuca '169 12 in view ofDeLuca '143; 13 DeLuca '829; 14 and DeLuca '969. 15 Claims 1-26 stand rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over the claims of DeLuca '410; DeLuca '559; DeLuca '844; DeLuca '868; DeLuca '909; DeLuca '122; DeLuca '789; DeLuca '666; DeLuca '295 and DeLuca '169 in view ofDeLuca '143; DeLuca '829; and DeLuca '969. Obviousness: ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? 2 DeLuca et al., US 5,945,410, issued Aug. 31, 1999. 3 DeLuca et al., US 6,127,559, issued Oct. 3, 2000. 4 DeLuca et al., US 6,306,844 Bl, issued Oct. 23, 2001. 5 DeLuca et al., US 6,316,642 Bl, issued Nov. 13, 2001. 6 DeLuca et al., US 6,939,868 B2, issued Sept. 6, 2005. 7 DeLuca et al., US 7,241,909 B2, issued July 10, 2007. 8 DeLuca et al., US 7,528,122 B2, issued May 5, 2009. 9 DeLuca et al., US 7,803,789 B2, issued Sept. 28, 2010. 10 DeLuca et al., US 7,947,666 B2, issued May 24, 2011. 11 DeLuca et al., US 8,030,295 B2, issued Oct. 4, 2011. 12 DeLuca et al., US 8,193,169 B2, issued June 5, 2012. 13 DeLuca et al., US 7,259,143 B2, issued Aug. 21, 2007. 14 DeLuca et al., US WO 99/03829, published Jan. 28, 1999. 15 DeLuca et al., US 6,544,969 B2, issued Apr. 8, 2003. 3 Appeal2017-006924 Application 13/463,557 ANALYSIS We incorporate by reference Examiner's findings as set forth on pages 4--10 of Examiner's 2014 Office Action 16, which were incorporated into Examiner's 2015 Office Action17 (see 2015 Office Action 3; see also Ans. 3-7). Examiner finds that the prior art relied upon discloses compounds that are structurally similar and make obvious compounds within the scope of Appellants' claimed invention, wherein "[t]he motivation to modify [the prior art compounds] is based on the teachings in the art that said modification would result in compounds useful in treating conditions such as psoriasis and leukemia" (see 2014 Office Action 9; cf App. Br. 24 (Appellants' claim 15 recites a method of treating a condition selected from, inter alia, psoriasis and leukemia by "administering to a patient with said condition an effective amount of a compound" made obvious by the prior art relied upon by Examiner)). See In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995) ( there is a rebuttable "presumption [] that similar compositions have similar properties); see also Bristol---A1vers Squibb Co. v. 1e-va Pharm. USA, Inc., 752 F.3d 967, 976 (Fed. Cir. 2014). In this regard, we note that [ s ]tructural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties. In re Deuel, 51 F.3d 1552, 1558 (Fed. Cir. 1995). Thus, we find no error in Examiner's prima facie case of obviousness. We recognize, however, that 16 Office Action mailed June 2, 2014. 17 Office Action mailed August 3, 2015. 4 Appeal2017-006924 Application 13/463,557 "[a] prima facie case of obviousness based on structural similarity is rebuttable by proof that the claimed compounds possess unexpectedly advantageous or superior properties." In re Payne, 606 F.2d 303, 315-16 (CCPA 1979) (citing In re Papesch, 315 F.2d 381, 386-87 (CCPA 1963)). Appellants focus attention on Examiner's use of the term "equivalence" in articulating the grounds of rejection (see App. Br. 6 ( citing 2014 Office Action 7-8)). As Examiner explains, however, "the term 'equivalence'[, as used in Examiner's 2014 Office Action,] is not meant to suggest that compounds would have similar potencies but [rather] that the skilled artisan would have the reasonable expectation that the compounds would have similar use as indicated by the prior art and the instant invention" (2015 Office Action 4). See, e.g., In re Soni, 54 F.3d at 750. Therefore, we are not persuaded by Appellants' contention that "Examiner' position [in the 2015 Office Action and Answer, regarding the term "equivalence,"] is contrary to the Examiner's own basis for presenting the primafacie rejection in the claims in the first place (Reply Br. 3; see App. Br. 17; see generally Ans. 8 (Examiner's "rejection is premised on the allegation that a methyl substituent at the 27-carbon, as in the presently claimed compounds, is 'equivalent' to a hydrogen substituent as in the compounds of [DeLuca '909]"); cf 2014 Office Action 7 ("the art teaches an equivalent between hydrogen and methyl at the 26-position and/or methyl and methylene at the 2-position") ). Nevertheless, Appellants direct attention to the Deluca Declaration, 18 and associated exhibits, in an attempt to establish that the compounds in the prior art relied upon by Examiner do not have "equivalent" properties to 18 Declaration of Hector F. DeLuca signed April 30, 2015. 5 Appeal2017-006924 Application 13/463,557 Appellants' claimed invention (App. Br. 8-16). Examiner, however, distilled the evidence relied upon by Appellants, as set forth in the Deluca Declaration, into table form and found that Appellants failed "to explain how a showing that the claimed compounds might have greater than or less than or similar potencies in regards to vitamin D binding, HL-60 cell differentiation, 24-0Hase transcription, bone calcium mobilization and intestinal calcium transport as compared to the prior art compounds is unexpected" (see Ans. 8-9). In this regard, Examiner finds that such "differences would [have been] expected [by those of ordinary skill in this art] because the compounds are not identical" and Appellant "has not shown that said differences in potencies correlate to differences in biological activities ... such as [in the treatment ofJ psoriasis and leukemia" (Ans. 9- 1 O; see id. at 7-8 (Examiner finds that "as evidenced by the prior art cited ... modification of each of said position in order to obtain the instantly claimed compounds is rendered prima facie obvious because the art teaches said single change does not change the biological properties of the compounds" as they relate to their use in the treatment of, inter alia, psoriasis and leukemia)). Further, we note that although DeLuca identifies differences between the compounds activities, Appellants fail to identify, and we do not find, a statement by DeLuca or disclosure in Appellants' Specification, that these differences were unexpected (see DeLuca Dec. ,r,r 10-12; see generally Spec.). A showing of unexpected results requires Appellants to "demonstrate[] substantially improved results ... and state[] that the results were unexpected." In re Soni, 54 F.3d at 751. Although Appellants' counsel characterized these differences as "unexpected" (see, e.g., App. Br. 6 Appeal2017-006924 Application 13/463,557 8; Reply Br. 1-2), "[a]ttomey's argument in a brief cannot take the place of evidence." In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974). Thus, we find no error in Examiner's findings or rationale. A demonstration of mere improvement, without a showing that the improvement is significant or unexpected, is insufficient evidence of unexpected results. See In re Soni, 54 F .3d at 7 51. Similarly, "the mere submission of some evidence that a new compound possesses some unpredictable properties does not require an automatic conclusion of nonobviousness in every case." In re Chupp, 816 F.2d 643, 646 (Fed. Cir. 1987). With respect to a nexus between Appellants' evidentiary showing and biological activity, i.e., the treatment of psoriasis and leukemia, Appellants contend that some of the claimed compounds might have a higher therapeutic index than the prior art compounds for treating diseases such as psoriasis and leukemia. For example, the claimed compounds might exhibit sufficient biological activity in regard to one or more of vitamin D binding, HL-60 cell differentiation, and 24-0Hase transcription in order to be efficacious for treating diseases such as psoriasis and leukemia, while at the same time the claimed compounds might exhibit low or minimal biological activity in regard to bone calcium mobilization and intestinal calcium transport so as to avoid a negative side effect such as hypercalcemia in a patient that is administered the claimed compounds. (Reply Br. 2 (emphasis added).) Stated differently, Appellants' evidence fails to support a finding that their alleged unexpected results are a difference in kind as opposed to a difference in degree. See In re Huang, 100 F.3d 135, 139 (Fed. Cir. 1996) (holding that claimed ranges must "produce a new and unexpected result which is different in kind and not 7 Appeal2017-006924 Application 13/463,557 merely in degree from results of the prior art"); see also In re Harris, 409 F.3d 1339, 1344 (Fed. Cir. 2005) (a "32-43% increase in stress-rupture life, however, does not represent a 'difference in kind' that is required to show unexpected results"). To the contrary, Appellants evidence, at best, demonstrates that "the claimed compounds do exhibit different biological activity than the cited prior art compounds," which, as Examiner makes clear, is not unexpected "because the compounds are not identical," and these differences have not been shown to "correlate to differences in biological activities ... in the treat[ ment] [ ofJ diseases, such as, psoriasis and leukemia" (Ans. 9-10). In addition, we recognize Appellants' contention that "some," unidentified, compounds within the scope of their claimed invention "might have a higher therapeutic index than the prior art compounds for treating diseases such as psoriasis and leukemia" (Reply Br. 2 ( emphasis added)). We note, however, that "[i]n order to establish unexpected results for a claimed invention, objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support." In re Clemens, 622 F.2d 1029, 1035 (CCPA 1980). To be complete, we recognize, but are not persuaded by, Appellants contentions regarding what Appellants refer to as "dicta" from Procter & Gamble Co. v Teva Pharma. USA, Inc., 566 F.3d 989 (see App. Br. 17; see also Reply Br. 2). CONCLUSION The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness. The rejection of claim 1 under 35 U.S.C. Â§ 103(a) as unpatentable over the combination ofDeLuca '410; DeLuca 8 Appeal2017-006924 Application 13/463,557 '559; DeLuca '844; DeLuca '642; DeLuca '868; DeLuca '909; DeLuca '122; DeLuca '789; DeLuca '666; DeLuca '295 and DeLuca '169 in view of DeLuca '143; DeLuca '829; and DeLuca '969 is affirmed. Claims 2-26 are not separately argued and fall with claim 1. Obviousness-type Double Patenting: ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness-type double patenting? ANALYSIS We incorporate by reference, Examiner's findings as set forth on pages 4--10 of Examiner's 2014 Office Action, which were incorporated into Examiner's 2015 Office Action (see 2015 Office Action 3; see also Ans. 3- 7). Appellants' contentions with respect to the obviousness-type double patenting rejection are no different than those set forth above with respect to the obviousness rejection. For the reasons set forth above, we are not persuaded. CONCLUSION The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness-type double patenting. The rejection of claim 1 under the judicially created doctrine of obviousness-type double patenting as being unpatentable over the claims ofDeLuca '410; DeLuca '559; DeLuca '844; DeLuca '868; DeLuca '909; DeLuca '122; DeLuca '789; DeLuca '666; DeLuca '295 and DeLuca '169 in view ofDeLuca '143; DeLuca '829; 9 Appeal2017-006924 Application 13/463,557 and DeLuca '969 is affirmed. Claims 2-26 are not separately argued and fall with claim 1. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a). AFFIRMED 10