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 .
Claim Status
Claims 1-7 have been cancelled; claim 8 has been amended; and, claim 9 has been newly added, as requested in the preliminary amendment filed on 12/08/2023. Following the amendment, claims 8-9 are pending in the instant application.
Claims 8-9 are under examination in the instant office action.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The certified copy of the foreign priority document is in English, and as such the claim to foreign priority has been perfected.
Claims 8-9 have an effective filing date of March 08, 2021 corresponding to PCT/CN2021/079611.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/12/2023 and 06/24/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Art-Free Subject Matter
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It is noted that the antibody-drug conjugate (ADC) structures of claim 8, reproduced below, have been thoroughly searched and are free of the prior art.
The closest prior art made of record but not relied upon is WO 2015/165413 A1 (US equivalent US 2017/0112944 A1 relied upon for translation; herein after referred to as “Qin”) and WO 2020/056192 A1 (herein after referred to as “Smith”). Qin teaches ADCs of Formulas VII and VIII, reproduced below (Page 9):
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wherein exemplary ADC structures thereof include the one shown below (Page 13):
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wherein A can be a sequence as set forth in SEQ ID NOs: 1-8 (Page 13); it is noted that Qin SEQ ID NO: 1 comprises exact matches to both of instant SEQ ID NOs: 1 and 2. However, Qin does not teach or render obvious the instant ADCs because the reference does not disclose the instantly claimed payload (i.e., resiquimod) nor the PEG and -(CH2)2-C(O)-NH-(C2H4-O)- portions of the instantly claimed linker. Smith teaches imidzoquinoline compounds of formula IA reproduced below (Pages 1-3):
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as well as conjugates thereof which further comprise the linkers reproduced below (Pages 117-118):
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Smith further indicates that the antibodies of the ADCs may be HER2 antibodies (Page 101). However, Smith does not teach or render obvious the instant ADCs because the reference does not disclose the instantly claimed linker for conjugation to an antibody, nor the instantly claimed HER2 antibody comprising instant SEQ ID NOs: 1 and 2. Furthermore, there is no motivation for one of ordinary skill in the art to modify and/or combine the prior art references to arrive at the instantly claimed ADC structures provided above, which would require the modification and subsequent combination of various structural components from each prior art reference.
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 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8-10, 13, and 23 of U.S. Patent No. 11,717,576 (herein after referred to as “first reference patent”) in view of WO 2015/165413 A1 (US equivalent US 2017/0112944 A1 relied upon for translation; herein after referred to as “Qin”).
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Claim 1 of the first reference patent is drawn to a compound of formula I, reproduced below:
wherein the substituents thereof are defined by the claim. Subsequently dependent claims 3-4, 6, 8-10, 13, and 23 of the first reference patent define specific substituents/embodiments of the compound of formula I in claim 1, wherein notably the fully defined compound of first reference patent claim 23 is of the structure reproduced below:
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wherein, as corresponds to generic formula I: n = 3, Y and W are independently absent, X is NH2, B2 is -(CH2)2-C(O)-NH-(C2H4-O)-, PL is resiquimod (i.e., an immune agonist of formula i), and Lm2 is shown below:
Thus, the complete structure of the compound of first reference patent claim 23 directly reads on the structure of instant claim 8 reproduced below:
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It is further noted that claim 1 of the first reference patent also indicates that Lm2 may alternatively have the structure shown below:
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Thus, the first reference patent further reads on the additional structure of instant claim 8 reproduced below:
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However, the claims of the first reference patent do not teach/suggest the conjugation of an antibody (i.e., A) as required by the instant claims.
Qin teaches conjugates and preparation methods thereof (Abstract); exemplary conjugates are compounds of, for example, Formulas VII and VIII, reproduced below (Page 9):
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wherein an exemplary conjugate is of the structure reproduced below (Page 13):
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wherein Ab may be SEQ ID NO: 1 (i.e., an anti-HER2 antibody), n is an integer between 1 and 100, (LA3)b is 1 to 100 structural units connected in series selected from one or more glycine and alanine, LPXT is a ligase recognition sequence, and d is an integer between 1 and 20. It is noted that SEQ ID NO: 1 of Qin comprises exact matches to instant SEQ ID NOs: 1 and 2. Thus, Qin suggests that an antibody may be conjugated to a linker via an -NH group.
It would have been prima facie obvious to one of ordinary skill in the art that the compounds of the first reference patent could be conjugated to an antibody (e.g., an antibody comprising instant SEQ ID NOs: 1 and 2) via the terminal -NH2 group according to known methods with a reasonable expectation of success, as suggested by Qin. One of ordinary skill in the art would have been motivated to make such a modification because the resulting conjugate (i.e., ADC) would be expected to be useful as a targeted cancer therapeutic (i.e., specific to HER2-expressing cancers). Furthermore, the conjugation of an antibody, such as taught by Qin, to a single linker of the first reference application would correspond to a z of 1, which reads on instant claims 8 and 9.
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 7, 9, 11-15, and 20-21 of U.S. Patent No. 12,485,299 (herein after referred to as "second reference patent"). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of the second reference patent is drawn to an antibody-drug conjugate of formula II, reproduced below:
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wherein the substituents thereof are defined by the claim. Subsequently dependent claims 2, 4-5, 7, 9, 11-13, and 20-21 further define specific structural substituents/embodiments of the compound of formula I in claim 1, which read on the instant claims and more specifically define substituents/embodiments corresponding to those of the fully defined conjugate of second reference patent claim 12 reproduced below:
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wherein, as corresponds to generic formula I: n = 3, Y and W are independently absent, X is NH2, B2 is -(CH2)2-C(O)-NH-(C2H4-O)-, PL is resiquimod (i.e., an immune agonist of formula i), z is an integer from 1 to 20, and Lm2 is shown below:
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Thus, the complete structure of the conjugate of the second reference patent above directly reads on the structure of instant claim 8 reproduced below:
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It is further noted that claim 1 of the second reference patent also indicates that Lm2 may alternatively have the structure shown below:
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Thus, the first reference patent further reads on the additional structure of instant claim 8 reproduced below:
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It is further noted that second reference patent claims 13-14 further indicate that the antibody of the conjugate (i.e., A) may be an anti-human HER2 antibody comprising, for example, SEQ ID NOs: 1 and 2; second reference patent SEQ ID NOs: 1 and 2 are exact matches to instant SEQ ID NOs: 1 and 2. Thus, the claims of the second reference patent read directly on the ADCs of instant claim 8. As defined by second reference patent claim 1, z may be any integer from 1 to 20 (i.e., including 1 or 2) and it is further noted that second reference patent claim 22 further indicates that the conjugates according to claim 1 have a drug-to-antibody ratio of an integer or non-integer of 1 to 20 (i.e., including 1 or 2). Thus, the claims of the second reference patent also read directly on the additional limitation of instant claim 9.
Conclusion
Claims 8-9 are pending. Claims 8-9 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA RAE STONEBRAKER whose telephone number is (571)270-0863. The examiner can normally be reached Monday-Thursday 7:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571)270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA RAE STONEBRAKER/
Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642