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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/2/25 has been entered.
Claims 56 and 75 have been amended. Claims 1-55, 58, 63, 68-70, and 72-73 have been canceled. Claims 56, 57, 59-62, 64-67, 71, and 74-75 are pending.
It should be noted that claims 59-61, 65-67, and 71 have the status identifier “Currently Amended”; however, the claims do not have any markings to show all changes relative to the previous version of the claims. The claims should be have been marked “Previously Presented”. Appropriate correction is required in the next response to avoid a Notice of Non-compliance.
Claim 75 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/10/24.
Claims 56, 57, 59-62, 64-67, 71, and 74 are under examination.
Withdrawn Rejections
The rejection of claims 56-57, 59-62, 64-67, 71, and 74 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn in light of Applicant’s amendment thereto. See paragraph 11, page 3 of the previous Office action.
The rejection of claim 56 under 35 U.S.C. 103 as being unpatentable over Reddy et al (Cancer Res 2007;67(13):6376-82) in view of Tarasova et al. (US Patent Application Publication 20050171014A1) and White et al. (WO2016/004043 A1, published January 7, 2016), is withdrawn in light of Applicant’s persuasive arguments. Specifically, Applicant persuasively argues that the claimed conjugates demonstrate unexpected synergistic effects in killing cancer cells. See paragraph 16, page 14 of the previous Office action.
Maintained Rejection
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 56-57, 59-62, 64-67, 71, and 74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11571480. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a conjugate compound or a pharmaceutically acceptable salt thereof, comprising a payload, and a plurality of cell-interacting molecule comprising first and second cell-interacting molecules.
The ‘480 claims teach a conjugate compound or a pharmaceutically acceptable salt thereof, comprising a payload; and a plurality of cell-interacting molecules comprising first and second cell-interacting molecules, wherein
the first cell-interacting molecule comprises a first ligand, and
the second cell-interacting molecule comprises
an endocytosis molecule capable of mediating endocytosis,
wherein the first ligand comprises a peptide having the amino acid sequence SEQ ID NO: 15 which is capable of specifically binding to a transient receptor potential cation channel subfamily V member 6 (TRPV6),
wherein the endocytosis molecule is selected from the group consisting of folate and analogs thereof,
wherein the payload is selected from the group consisting of a small molecule compound, a nucleotide, a peptide, and a protein, wherein the payload is conjugated with at least one of the cell-interacting molecules directly or via a linker. The ‘480 claims teach wherein the payload is conjugated with at least one of the cell-interacting molecules via a linker. The ‘480 claims teach wherein the payload is a small molecule compound that is auristatins or any derivatives thereof. The ‘480 claims teach further comprising a third cell-interacting molecule, wherein the third cell-interacting molecule is the endocytosis molecule. The ‘480 claims teach a pharmaceutical composition comprising the conjugate compound of claim 1, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier. The ‘480 claims teach drug compound LDC10B, which comprises MMAE (payload), folate, and the peptide P10, which comprises the amino acid sequence set forth in SEQ ID NO: 15 (binds to TRPV6). The ‘480 claims teach drug conjugate LDC10BR, which comprises MMAE (payload), folate, the peptide P10, which comprises the amino acid sequence set forth in SEQ ID NO: 15 (binds to TRPV6), and RGD.
The ‘480 claims teach drug conjugate LDC10BX, which comprises MMAE (payload), folate, and the peptide P10, which comprises the amino acid sequence set forth in SEQ ID NO: 15 (binds to TRPV6). The ‘480 claims teach drug conjugate LDC11B, which comprises MMAE (payload), folate, and the peptide P11, which comprises the amino acid sequence set forth in SEQ ID NO: 16. The ‘480 claims teach drug conjugate LDC12B, which comprises MMAE (payload), folate, and the peptide P12, which comprises the amino acid sequence set forth in SEQ ID NO: 17. The ‘480 claims teach drug conjugate LDC13B, which comprises MMAE (payload), folate, and the peptide P13, which comprises the amino acid sequence set forth in SEQ ID NO: 18. The ‘480 claims teach drug conjugate LDC1013, which comprises MMAE (payload), the peptide P10, which comprises the amino acid sequence set forth in SEQ ID NO: 15, and the peptide P13, which comprises the amino acid sequence set forth in SEQ ID NO: 18. The ‘480 claims teach drug conjugate LDC10H, which comprises MMAE (payload), the peptide R9, and the peptide P10, which comprises the amino acid sequence set forth in SEQ ID NO: 15. The ‘480 claims teach drug conjugate LDC11H, which comprises MMAE (payload), the peptide R9, and the peptide P11, which comprises the amino acid sequence set forth in SEQ ID NO: 16. The ‘480 claims teach drug conjugate LDC12H, which comprises MMAE (payload), the peptide R9, and the peptide P112, which comprises the amino acid sequence set forth in SEQ ID NO: 17. The ‘480 claims teach drug conjugate LDC13H, which comprises MMAE (payload), the peptide R9, and the peptide P13, which comprises the amino acid sequence set forth in SEQ ID NO: 18. Thus, the ‘480 claims anticipate the instant claims.
Applicant’s Arguments
Applicant request that the rejection be held on abeyance until an indication of allowable subject matter is made in the instance application.
Response to Arguments
Applicant’s arguments have been fully considered but they are not persuasive.
MPEP 804 states that a complete response to a nonstatutory double patenting (NDP) 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. Such a response is required even when the nonstatutory double patenting rejection is provisional. As filing 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, such a filing should not be held in abeyance. Only objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. Therefore, an application must not be allowed unless the required compliant terminal disclaimer(s) is/are filed and/or the withdrawal of the nonstatutory double patenting rejection(s) is made of record by the examiner. Accordingly, the rejection is maintained.
Claim Status
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANDRA CARTER whose telephone number is (571)272-2932. The examiner can normally be reached 8:00-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa L. Ford can be reached at (571)272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SANDRA CARTER/Examiner, Art Unit 1674