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 .
Status of the Claims
No amendment to the claims is made. Claims 50, 53, 76, 77, 79, 80, 84 and 85 are pending under examination.
A new rejection is made herein and the previous indication of allowability of claims 50, 76, 77 and 84 is hereby withdrawn. The examiner regrets any inconvenience to Applicant.
Rejections Withdrawn
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 103
The rejection of claims 53, 79, 80 and 85 as being unpatentable over Bigal et al. (US2015/0266948, effectively filed 03/21/2014), Kaisheva (US2003/0138417 and Allan et al. (US20110305711—on IDS filed 03/17/2022) is withdrawn upon further consideration. Applicant argues at that the that the primary reference by Bigal and colleagues does not specifically teach a monthly 300 mg dose to treat cluster headache because paragraph [0187], which discloses a 300 mg dose is part of a larger disclosure citing hundreds or thousands of doses and dose ranges across overlapping sub-ranges that are not limited to monthly dose regimens. Applicant asserts that when dosing amount and frequency are considered together, Bigal and colleagues disclose many thousands of possible regimens with no teaching suggestion or motivation to select a 300 mg monthly dose for treating cluster headache. Further, Applicant asserts cluster headache is not synonymous with migraine and the 300 mg dose for cluster headache was identified through extensive Phase III clinical development (see p. 23, lines 20-30). These arguments are persuasive. See also the post-filing date art of Goadsby et al. (New England Journal of Medicine, 2019: 38: 132-141), who teach the monthly 300 mg dose was effective in treating the most highly prevalent form of cluster headache (see abstract; p. 133, left column,1st paragraph and paragraph bridging left and right columns; p. 140, right column, last paragraph).
Double Patenting
The following rejections of on the ground of nonstatutory double patenting the following are withdrawn upon further consideration.
Claims 53, 79, 80 and 85 as being unpatentable over claims 1-8 of U.S. Patent No. 9,073,991 in view of Bigal et al. and Kaisheva.
Claims 53, 79, 80 and 85 as being unpatentable over claims 1-7 of U.S. Patent No. 9,505,838 in view of Bigal et al. and Kaisheva.
As noted above, Further, Applicant argues cluster headache is not synonymous with migraine and the 300 mg dose for cluster headache was identified through extensive Phase III clinical development (see p. 23, lines 20-30), which is persuasive. See also the post-filing date art of Goadsby et al. (New England Journal of Medicine, 2019: 38: 132-141), who teach the monthly 300 mg dose was effective in treating the most highly prevalent form of cluster headache (see abstract; p. 133, left column,1st paragraph and paragraph bridging left and right columns; p. 140, right column, last paragraph). See also the arguments at pages 6-7 of the Remarks 06/03/2026, which were persuasive.
The provisional rejection of claims 53, 79, 80 and 85 on the ground of nonstatutory double patenting over claims 42-60 and 64-69 of copending Application No. 17/883,072 in view of Bigal et al. (US2015/0266948) is withdrawn upon further consideration.
Specifically, Applicant argues persuasively that the primary reference by Bigal and colleagues does not specifically teach a monthly 300 mg dose to treat cluster headache because paragraph [0187], which discloses a 300 mg dose is part of a larger disclosure citing hundreds or thousands of doses and dose ranges across overlapping sub-ranges that are not limited to monthly dose regimens. Applicant asserts that when dosing amount and frequency are considered together, Bigal and colleagues disclose many thousands of possible regimens with no teaching suggestion or motivation to select a 300 mg monthly dose for treating cluster headache. A new rejection over this application is made herein.
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 50, 53, 76, 77, 79, 80, 84 and 85 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 42-60 and 64-68 of copending Application No. 17/883,072 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets recite an anti-CGRP antibody comprising a prefilled syringe comprising a pharmaceutical formulation comprising an anti-CGRP antibody having the amino acid sequences set forth in SEQ ID NO: 3 and SEQ ID NO: 4, 10 mM of histidine buffer, 150 mM of NaCl, 0.05% (w/v) of polysorbate-80 (PS-80) at a pH ranging from 5.5 to 6, including 5.8. Further, the claims of the reference application recite the formulation comprises 100 mg/ml of the anti-CGRP antibody and contemplates the formulation is suitable for subcutaneous injection.
The difference between the claim sets are as follows. The claims of the reference application are drawn to the anti-CGRP antibody, rather than a method of treating episodic or chronic migraine or cluster headache. Nevertheless, MPEP 804(B)(1) instructs that when construing the claims, it is proper to use the reference application disclosure, and particularly when ascertaining the scope of the reference’s claim(s) to a compound (emphasis added by examiner):
The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) (“[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning.”);…Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first “determine how much of the patent disclosure pertains to the invention claimed in the patent” because only “[t]his portion of the specification supports the patent claims and may be considered.” The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.” In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
To avoid improperly treating what is disclosed in a reference patent or copending application as if it were prior art in the context of a nonstatutory double patenting analysis, the examiner must first properly construe the scope of the reference claims. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02.
In the instant case, the specification of the reference application discloses treating and preventing episodic or chronic migraines and treating cluster headaches at p. 7, lines 5-20 (emphasis added by examiner):
[A] method of treating or preventing migraine, episodic headache, chronic headache, chronic cluster headaches, and/or episodic cluster headaches comprising administering to a patient in need thereof a therapeutically effective amount of a pharmaceutical formulation of the present invention. According to some embodiments, a method of treating or preventing chronic and episodic cluster headaches is provided comprising administering to a patient in need thereof a dose of 300 mg of an anti-CGRP antibody. Further embodiments provide a method of treating or preventing chronic and episodic cluster headaches administering to a patient in need thereof a dose of 360 mg of an anti-CGRP antibody. In other embodiments, the present invention provides a method of treating or preventing chronic and episodic migraines comprising administering to a patient in need thereof a dose of 120 mg of an anti-CGRP antibody.
Thus, in ascertaining the scope of the reference’s claims to the anti-CGRP compound, it is clear that the reference application’s specification indicates the disclosed uses are identical to the instantly claimed methods.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues at pages 8-9 of the Remarks filed 06/03/2026 that the product claims do not recite a method of treatment a therapeutic indication, a dosing regimen or cluster headache. Applicant also argues that the rejection is provisional and should be withdrawn.
This argument has been fully considered but is not found persuasive. See the rejection above, hereby incorporated, which demonstrates how the instantly claimed methods are not patentably distinct from those of the ‘072 application. Further, although this rejection is provisional, the instant application and the ‘072 application share the same US filing date, thus the rejection must be maintained.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M BORGEEST whose telephone number is (571)272-4482. The examiner can normally be reached M-F 9-5:30 EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 5712720911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675
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