DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment of 9/25/25 has been entered in full. Claims 59-68 are canceled. New claims 79-96 are added and are the pending claims.
Election/Restrictions
New claims 79-96 are directed to the subject matter of Invention II, elected without traverse in the reply filed on 5/15/25.
New claims 79-96 are directed to the species of anti-PACAP antibody comprising the HCDRs of SEQ ID NO: 1284, 1286 and 1288, and the LCDRs of SEQ ID NO: 1304, 1306 and 1308, elected in the reply filed on 3/24/17.
As such, all pending claims are currently directed to the elected invention and species under consideration.
Claims 79-96 are under consideration.
Withdrawn Objections and/or Rejections
The objection to the specification at page 2 of the 7/16/25 Office action is withdrawn in view of the amendments to the title.
The objections to claims 59, 61-63, 65 and 67 are withdrawn in view of the cancelation of these claims.
The rejection of claims 61, 65 and 67 under 35 U.S.C. 112(b) as being indefinite are withdrawn in view of the cancelation of these claims.
The rejection of claims 59, 61-63, 65 and 67 under 35 U.S.C. 112(a) as failing to comply with the written description requirement is withdrawn in view of the cancelation of these claims.
The rejection of claims 59, 61-63, 65 and 67 on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,913,783, issued 2/9/21 is withdrawn in view of the cancelation of these claims; however, note that Applicants’ addition of new claims 79-96 necessitate application of this rejection to these new claims.
Maintained Objections and/or Rejections
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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer (TD) 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 §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A TD must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains TD 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 (eTD) may be filled out completely online using web-screens. An eTD that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTDs, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 79-96 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,913,783, issued 2/9/21, and which shares the same inventors with the instant application. This rejection was set forth previously for claims 59, 61-63, 65 and 67 (now canceled); Applicants addition of new claims 79-96 necessitates applying the rejection to these new claims.
Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
New claims 79-83 each encompass an isolated nucleic acid sequence encoding an anti-PACAP antibody that comprises a variable heavy chain having the amino acid sequence of SEQ ID NO: 1282 (which comprises the HCDRs of SEQ ID NO: 1284, 1286 and 1288) and a variable light chain amino acid sequence of SEQ ID NO: 1302 (which comprises the LCDRs of SEQ ID NO: 1304, 1306 and 1308).
Claim 13 of the ‘783 encompasses an isolated nucleic acid sequence encoding an anti-PACAP antibody of claim 1, which encompasses an antibody comprising the heavy and light chain variable regions comprising SEQ ID NO: 1282 and SEQ ID NO: 1302. As such, the instant claims and the claims of ‘783 each encompass the same isolated nucleic acid sequence, and thus are not patentably distinct.
New claim 84 encompasses an isolated nucleic acid of claim 79 wherein the encoded antibody is humanized. Claim 13 of ‘783 encompasses a humanized antibody, as the antibody of parent claim 1 is stated in line 1 to be humanized. As such, the instant claims and the claims of ‘783 each encompass the same isolated nucleic acid sequence, and thus are not patentably distinct.
New claims 85-87 each encompass an expression vector comprising an isolated nucleic acid encoding an anti-PACAP antibody comprising the heavy and light chain variable regions comprising SEQ ID NO: 1282 and SEQ ID NO: 1302. Claim 13 of ‘783 in the alternative encompasses a vector containing an isolated nucleic acid sequence encoding an anti-PACAP antibody of claim 1, which encompasses an antibody comprising heavy and light chain variable regions comprising SEQ ID NO: 1282 and SEQ ID NO: 1302. Furthermore, this vector is an expression vector as evidenced by its use in expressing the encoded antibody in the method of dependent claim 16 of ‘783. As such, the instant claims and the claims of ‘783 each encompass the same vector sequences, and thus are not patentably distinct.
New claims 88-90 each encompass an isolated recombinant cell which comprises an isolated nucleic acid encoding an anti-PACAP antibody comprising the heavy and light chain variable regions comprising SEQ ID NO: 1282 and SEQ ID NO: 1302. Claim 14 of ‘783 encompasses a host cell comprising, in the alternative, the nucleic acid sequence of claim 1 of ‘783. As the antibody is humanized, it is not naturally-occurring and thus such as cell is inherently recombinant. As such, the instant claims and the claims of ‘783 each encompass the same host cell, and thus are not patentably distinct.
New claims 91 and 92 each depend from claim 88 and further limit the recombinant cell to one selected from a group including mammalian cell (claim 91) or a CHO cell. These further limitations both correspond to further limitations present in claim 15 of ‘783, depending from claim 14. As such, the instant claims and the claims of ‘783 each encompass the same cell, and thus are not patentably distinct.
New claims 93 and 94 each depend from claim 88 and further limit the recombinant cell to a CHO cell selected from a subclone that is DP12 (claim 93) or a cell that is a Pichia pastoris cell (claim 94). While the claims of ‘783 do not expressly recite these further limitations, the portion of the specification describing the claimed invention includes this CHO cell strain (col 34, line 3) and Pichia pastoris cells (col 33, line 57). As such, the host cell of claim 15 of ‘783 is properly construed as encompassing each of these embodiments. As such, the instant claims and the claims of ‘783 each encompass the same cell, and thus are not patentably distinct.
New claims 95 and 96 each encompass a method of expressing an anti-PACAP antibody comprising culturing a host cell of claim 88 or 90 under conditions that provide for expression of said antibody. Claim 16 of ‘783 encompasses a method of expressing an anti-PACAP antibody comprising culturing the host cell of claim 14 under conditions that provide for expression of said antibody. As such, the instant claims and the claims of ‘783 each encompass the same method of expressing an anti-PACAP antibody, and thus are not patentably distinct.
Applicants’ arguments (9/25/25; pg 10) as they pertain to the rejection have been fully considered but are not deemed to be persuasive for the following reasons.
In the reply, Applicants request that "this double patenting rejection be held in abeyance until this application is otherwise in condition for allowance" (pg 13).
Applicants’ request for abeyance is noted, but per MPEP 804, “[a] complete response to a nonstatutory [DP] rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action.” As Applicants have not provided either a showing that the rejected claims are patentably distinct from the claims of the '057 application, or a terminal disclaimer, the rejection is maintained.
New objections necessitated by Applicants’ amendment
Claim Objections
Claims 79-96 are objected to because of the following informalities:
Portions of each of claims 79-96 are bolded inconsistently. Claims 79-83 have “according claim X” bolded; claims 85-90 have no bold type; claims 91-94 have “Claim X” bolded; and claims 95 and 96 each have “of Claim X” bolded. The bold type should be standardized or removed from the claims (as it is not needed and will not be printed in an issued patent).
In each of claims 85-86, 90, the phrase “isolated nucleic acid sequence” is missing an article; i.e., “an isolated nucleic acid sequence”.
In each of claims 85-90, the second recitation of “nucleic acid” is missing the word “sequences”. Compare with parent claim 79, 80 or 83.
The remaining claim(s) are objected to for depending from an objected claim.
Appropriate correction is required.
Conclusion
No claims are allowed.
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 extension fee 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 ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
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) Form at https://www.uspto.gov/patents/uspto-automated-interview-request-air-form.
/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674