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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
DETAILED ACTION
This action is in response to claim amendments filed 5/18/26. Claims 8-9, 11, 31, 38, 43, 46, 50-51 and 55 are pending and under examination.
Withdrawn Rejections
The objection to the drawings is withdrawn in light of the amendments to the specification.
The claim objections are withdrawn in light of the amendments.
The rejections under §112b are withdrawn as those claims have been canceled.
The rejections under §112a are withdrawn; the claims all now require specific combinations of CDRs and the subjects all suffer from neuropathic pain. The claims no longer recite human antibodies.
The rejection under §102 is withdrawn in light of the amendments.
The double patenting rejections over US11332521, US12202889, and 18/982077 are withdrawn. Applicant states on the record that the US Patents and co-pending applications do not claim any of the 25 sequence combinations instantly claimed. As stated in the previous actions, those documents that do not claim these particular combinations do not warrant a double patenting rejection.
The double patenting rejection over 18/987829 is withdrawn. The rejection was not over claims that contained the specific combination of CDRs, which are now required by the instant claims.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 8-9, 11, 31, 38, 43, 46, 50-51 and 55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11970532. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are also directed to a FAM19A5 antibody. The reference claims also include the antibody being a Fab (claim 5) and humanized (claim 4). The reference claims treating various diseases including fibrosis, neurodegenerative diseases, stroke, and neuropathic pain (claim 14). These are considered subjects in need of the instantly claimed results. Further, a subject with neuropathic pain is the example provided in the instant specification of someone “in need” of increased threshold latency, increased sensory nerve velocity, and increased motor function. As the instant claims are directed to results of administering the antibody, these results must necessarily follow from the same active step (administer the antibody) performed on the same subject (one with neuropathic pain). Under the definition of “administering”, the reference patent discloses “orally”.
Claims 8-9, 11, 31, 38, 43, 46, 50-51 and 55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11634484. Although the claims at issue are not identical, they are not patentably distinct from each other because reference claim 1 claims the same antibodies as instantly claimed. Further, the reference claims the antibodies in a method of treating neuropathic pain. A subject with neuropathic pain is the example provided in the instant specification of someone “in need” of increased threshold latency, increased sensory nerve velocity, and increased motor function and so the reference claim anticipates the instant claims. The reference claims also explicitly claim the effect on threshold (claims 6-7), that the antibody is a Fab (claim 9), humanized (claim 10), and provided orally (claim 11).
Note that Applicant has voluntarily filed the instant application as a divisional of parent application 17/050056 (now US 11634484). As there was no restriction set forth in the parent application, there is no safe harbor protection available under 35 USC 121 (see MPEP §804.01).
Response to Arguments
Applicant's arguments filed 5/18/26 have been fully considered but they are not persuasive.
Applicant argues the double patenting rejection over 18/987829 should be withdrawn because, while applicant is correct that the instant application has an earlier patent date, applicant is incorrect that this is the only rejection remaining. However, the rejection was withdrawn for the reasons set forth above.
Applicant does not argue the merits of the rejection over US11970532 or US11634484. The actual filing of a terminal disclaimer or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims is necessary for further consideration of the rejection of the claims; nonstatutory double patenting rejections, including provisional ODP rejections, are not held in abeyance (MPEP §804(I)(B)(1)). Failure to provide an appropriate response to the double patenting rejections will not be considered a bona fide attempt at a complete response.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM M WEIDNER whose telephone number is (571)272-3045. The examiner can normally be reached M-F 9-16.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached on 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Weidner/Primary Examiner, Art Unit 1675
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