DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s amendment, filed 10/06/2025, has been entered.
Claims 71-73 are pending.
Election/Restrictions
Applicant’s election of Group I and species SEQ ID NO: 247 in the reply filed on 10/06/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 73 has been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 71-72 are currently under examination as they read on a polypeptide.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 71-72 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Aaron et al. (US Patent 7,371,381 B2; see entire document).
The applied reference has a common assignee with the instant application. Based upon the pre-AIA 35 U.S.C. 102(e) date of the reference, it constitutes prior art. This rejection under pre-AIA 35 U.S.C. 102(e) might be overcome either by a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the inventor or joint inventors (i.e., the inventive entity) of this application and is thus not the invention “by another,” or if the same invention is not being claimed, by an appropriate showing under 37 CFR 1.131(a).
Aaron et al. taught a murine antibody 2F8 comprising VH CDR1 that has the same sequence as SEQ ID NO: 266 of the present application (see sequence alignment below and column 22, lines 30-33). The prior art antibody reads on a polypeptide comprising SEQ ID NO: 266. Moreover, Aaron et al. taught PEG conjugation (column 51, lines 32-39), albumin conjugation (column 51, lines 59-60).
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Claim 71 is rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Reiter et al. (US Patent 7,527,786 B2; see entire document).
Reiter et al. taught a PSCA mAb 1G8 comprising CDR1 that is the same as SEQ ID NO: 266 of the present application (see sequence alignment below and column 9, lines 53-57). The prior art antibody reads on a polypeptide comprising SEQ ID NO: 266.
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The
Claim Rejections - 35 USC § 103
following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 72 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over by Reiter et al. (US Patent 7,527,786 B2) in view of Aaron et al. (US Patent 7,371,381 B2).
The teachings of Reiter have been discussed above (see 102).
Reiter et al. does not teach conjugation of the antibody to PEG or albumin. However, it would have been obvious to one of ordinary skill in the art at the time of the invention was made to conjugate an antibody to PEG or albumin because it was a well known practice in the pertinent art as taught by Aaron et al. In particular, Aaron taught that conjugating antibodies with PEG would prolong serum circulation of the antibodies in vivo (column 51, lines 32-39) and conjugating antibodies to albumin would make the antibodies more stable in vivo or have a longer half live (column 51, lines 59-60). Therefore, one of ordinary skill in the art would have been motivated to conjugate the antibody taught by Reiter with PEG or albumin. The skilled artisan would also have reasonable expectation of success as these conjugations were well within his/her technical grasp.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time of the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 71-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 7,371,381. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims disclosed antibody 2F8 which comprises a CDR that has the same sequence as SEQ ID NO: 266 (see above 102). Therefore, the patent claims read on a polypeptide comprising SEQ ID NO: 266. Moreover, it would have been obvious to conjugate the antibody in view of the specification of the patent which qualifies as prior art (see above 103). Therefore, the claims of patent ‘381 anticipate and/or render obvious of the present claims.
Claims 71-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,939,372; claims 1-12 of US Patent 10,562,964; claims 1-16 of US Patent 9,296,812; claims 1-26 of US Patent 8,383,801; claims 1-25 of US Patent 7,872,106; claims 1-5 of US Patent 7,592,429 in view of Aaron et al. (US Patent 7,371,381)
The claims of the reference patents stated above disclose antibodies that comprise at least one of the CDRs recited in the present claims. As such, the patent claims read on a polypeptide comprising at least one of the reference sequences recited in the present claims. Moreover, it would have been obvious to conjugate the antibodies in view of the teachings by Aaron et al. as discussed above (see 103). Therefore, the patent claims anticipate and/or render obvious of the present claims.
It is noted that the present application is a Continuation, therefore the Safe Harbor of 35 USC 121 does not apply.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARON X WEN whose telephone number is (571)270-3064. The examiner can normally be reached Mon-Fri 8-5.
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/SHARON X WEN/Primary Examiner, Art Unit 1641