DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The rejection under section 112(a) is withdrawn in view of Applicant’s amendments tailoring the recited GHR-106 antibodies to those supported by the specification.
The rejections under section 112(b) are withdrawn in view of Applicant’s amendments and remarks in connection with these grounds of rejection.
The rejection under section 103 is maintained:
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 5-9, 12, 13, 17, 21-29 remain rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/153075 (WO 075), in view of:
Behre et al., Journal of Clinical Endocrinology and Metabolism. May 1997, Vol. 82, pp. 1403-1408 (Behre); and
Lee et al., Global Journal of Reproductive Medicine. April 2017 (04-2017), Vol. 1, page 001, ISSN 2585-8594 (Lee).
WO 075 discloses the use of the antibody GHR-106 as an antagonist against GnRH receptor and suggests the use of said antibody to block luteinizing hormone /follicle-stimulating hormone (LH/FSH) release and control ovulation. WO 075 also teaches that said antibody has a longer half-life than cetrorelix and suggests the use of said antibody to treat any condition that can be treated by GnRH antagonists including antide or cetrorelix.
The GHR-106 antibody is the same as that covered by the instant claims:
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WO 075 may fail to explicitly teach use of GHR-106 to regulate a level of a sex related hormone in a mammalian subject.
However, the claims recite administering the GHR-106 monoclonal antibody or an antigen-binding fragment thereof to the mammalian subject. WO 075 discloses the use of the antibody GHR-106 as an antagonist against GnRH. Any observed effect of the antibody, such as those recited in the claims, is a necessary aspect of administering the anti-GHR-106 antibody, as disclosed by WO 075, see MPEP 2112.01 (“Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”).
Nonetheless, WO 075 teaches the use of the antibody GHR-106 as an antagonist against GnRH receptor and suggests the use of said antibody to block luteinizing hormone (LH)/follicle-stimulating hormone (FSH) release and control ovulation.
WO 075 also teaches that said antibody has a longer half-life than cetrorelix and suggests the use of said antibody to treat any condition that can be treated by GnRH antagonists including antide or cetrorelix.
Also, Behre teaches the use of the GnRH antagonist cetrorelix to regulate the levels of luteinizing hormone, follicle-stimulating hormone, and testosterone in men. In this connection Lee teaches that the antibody GHR-106 is bioequivalent to GnHR analogs and suggests the use of said antibody to regulate fertility and to treat sex hormone-sensitive cancers.
The difference between WO 075 and the claimed inventions is that WO 075 does not teach the invention with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, based on the above, WO 075 teaches the elements of the claimed invention with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Applicant argues that there would be no reasonable expectation on the part of the person skilled in the art (in the absence of confirmatory hindsight evidence) that the GHR-106 antibody will in fact have the same effects on GnRH receptors expressed in the anterior pituitary as the small molecule cetrorelix based on the prior experiments showing similar activity with GnRH expressed on the surface of cancer cells. The GHR-106 antibody is still a different molecule than cetrorelix that may have a different mechanism of interaction with the GnRH receptor than cetrorelix, and so it cannot be predicted in advance that the antibody will exert the same effect as a small molecule GnRH antagonist across all different tissues in which the GnRH receptor is expressed.
However, the instant antibodies and cetrorelix inhibit the same receptor. In this manner, those of ordinary skill would reasonably expect that they share the same pharmacological effects because they block the same biological pathway since both drugs bind to the identical receptor and inhibit the same downstream signaling.
The level of expectation here need only be reasonable, not absolute, see MPEP 2143.02 (“Conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) (“To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’”); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) (“This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness.” (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that “the expectation of success need only be reasonable, not absolute”)).”)
In the instant case, those of ordinary skill would reasonably expect the instant GHR-106 antibodies to mimic the effects of cetrorelix because both act as GnRH receptor antagonists. Therefore, it is reasonable to expect that both achieve the same functional outcome by antagonizing the receptor and preventing endogenous GnRH from binding, such as regulating the levels of luteinizing hormone, follicle-stimulating hormone, and testosterone, as instantly claimed. Therefore, the rejection is maintained.
The double patenting rejections remain outstanding:
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5-9, 12, 13, 19, 21-29 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11021541. Although the claims at issue are not identical, they are not patentably distinct from each other.
Specifically, the methods covered in the conflicting claims anticipate those covered in the rejected claims.
Alternatively, the difference between the conflicting claims and the instant methods is that the conflicting claims do not recite the instant methods with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, the conflicting claims recite the elements of the instant methods invention with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Namely, the claims recite administering the GHR-106 monoclonal antibody or an antigen-binding fragment thereof to the mammalian subject. The conflicting claims recite the use of the antibody GHR-106 as an antagonist against GnRH. Any observed effect of the antibody, such as those recited in the claims, is a necessary aspect of administering the anti-GHR-106 antibody, as recited by the conflicting claims, see MPEP 2112.01 (“Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”).
Claims 1-3, 5-9, 12, 13, 19, 21-29 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 8163283. Although the claims at issue are not identical, they are not patentably distinct from each other.
Specifically, the methods covered in the conflicting claims (claims 16 and 17) anticipate those covered in the rejected claims.
Alternatively, the difference between the conflicting claims and the instant methods is that the conflicting claims do not recite the instant methods with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, the conflicting claims recite the elements of the instant methods invention with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Namely, the claims recite administering the GHR-106 monoclonal antibody or an antigen-binding fragment thereof to the mammalian subject. The conflicting claims recite the pharmaceutical use of the antibody GHR-106. Any observed effect of the antibody, such as those recited in the claims, is a necessary aspect of administering the anti-GHR-106 antibody, as recited by the conflicting claims, see MPEP 2112.01 (“Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”).
The conflicting claims may recite the GHR-106 antibody whereas the instant claims recite methods of use. However, the specification of the conflicting patents discloses the utility of the recited antibodies as covered by the instant methods of using the antibodies, see Sun Pharmaceutical Industries, Ltd., v. Eli Lilly and Co. where the district court ruled that the claims of the ‘826 patent were invalid in light of the ‘614 patent which disclosed gemcitabine’s use in cancer treatment, but did not claim it. In making this ruling, the district court relied on the Federal Circuit’s earlier rulings on double patenting of compound claims, mainly Geneva Pharmaceuticals, Inc, v. GlaxoSmithKline PLC, 349 F. 3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008). In both of these cases, the Federal Circuit found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. The cases also established that in determining the scope of compound claims for a double patenting rejection one must look to the specification to interpret the utility of the compound.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARL J PUTTLITZ whose telephone number is (571)272-0645. The examiner can normally be reached on Monday to Friday from 9 a.m. to 5 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gregory Emch, can be reached at telephone number 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARL J PUTTLITZ/ Primary Examiner, Art Unit 1646
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