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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/8/2025 has been entered.
Status of the Claims
2. Claims 1-49 are the original claims filed on 12/9/2022. In the Response to Notice to File Corrected Application Papers of 3/27/2023, Claims 1-49 are canceled and new Claims 50-58 are added. In the Response of 3/27/2025, claims 50-53, and 57 are amended and new claims 59-66 are added. In the Response filed 10/8/2025, claims 52, 54, 57 and 60-64 are amended, claim 59 is canceled and new claims 67-80 are added.
Claims 50-58 and 60-80 are all the claims under examination. This Office Action contains new grounds for rejection.
Priority
3. USAN 18/078,378, filed 12/09/2022, and having 1 RCE-type filing therein is a Continuation of 16/755,685, filed 04/13/2020, now U.S. Patent # 11555074,
16/755,685 is a National Stage entry of PCT/US2018/055905, International Filing Date: 10/15/2018, PCT/US2018/055905 Claims Priority from Provisional Application 62/571,961, filed 10/13/2017.
Information Disclosure Statement
4. As of 10/11/2025, a total of two (2) IDS are filed: 12/9/2022; and 10/8/2025. The corresponding initialed and dated 1449 is considered and of record.
Withdrawal of Objections
Claim Objections
5. The objection to Claims 52, 54 and 57 because of informalities is withdrawn.
a) Claim 52 is amended to delete “a taxane”.
b) Claim 52 is amended to delete “vinca alkaloid”.
c) Claim 54 is amended to recite “wherein the conjugate is internalized by a PTGFRN-expressing cell.”
d) Claim 57 is amended to recite “single chain Fv [or] (scFv).”
e) Claim 57 is amended to delete “mAb2”.
Claim Objections
6. The rejection of Claims 52, 59 and 62 because of informalities is moot for canceled claim 59 and withdrawn for the pending claims.
a) i) claim 52 is amended to recite the broad recitation “microtubule assembly inhibitor”.
ii) claim 52 is amended to recite the broad recitation “intercalating agent”.
b) Claim 59 is canceled.
c) Claim 62 is amended to recite the subgenus for a “microtubule assembly inhibitor”.
Rejections Withdrawn-in-Part/ Maintained-in-Part
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
7. The rejection of Claim 57 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends is maintained.
Withdrawn-in-part
Claim 57 is amended to delete vNAR.
Maintained-in-part
Claim 57 recites species corresponding to singe domain antibodies: Ig-NAR; Fd; and single-domain antibody. Examples of single domain antibodies are precluded from the requirement for the presence of paired VH/VL domains for both a full antibody and an antigen-binding fragment thereof in Claim 50.
The response is incomplete.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
The rejection is maintained.
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.
8. The rejection of Claims 50-58 and 60-80 on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11555074 is maintained. Applicants request the rejection is held in abeyance is granted. The response is incomplete. The rejection is maintained.
New Grounds for Rejection
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
9. Claims 55 and 57 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
a) Claim 55 is drawn to the antibody or fragment thereof that is human. The claimed CDRs of claim 50 are murine so at most the antibody is murine, humanized or chimeric but it is inconceivable that the antibody is human.
b) Claim 57 is drawn to a “domain” that comprises the isolated antibody or antigen binding fragment thereof of claim 50. Examples of single domain antibodies are precluded from the requirement for the presence of paired VH/VL domains for both a full antibody and an antigen-binding fragment thereof in Claim 50.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
10. No claims are allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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LYNN ANNE BRISTOL
Primary Examiner
Art Unit 1643
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643