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
2. The amendment filed 01/30/2026 is acknowledged and has been entered.
Claims 1, 11, 12, 26-27, 29, and 49 are amended. Claims 25 and 39-41 have been canceled. New claim 58 has been added.
3. Claims 1, 9-14, 23, 26-27, 29, 31-38, 42, 49-50 and 56-58 are pending in the application. Claims 42, 50 and 56-57 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/15/2025.
4. Claims 1, 9-14, 23, 26-27, 29, 31-38, 49 and 58 have been examined.
Grounds of Objection and Rejection Withdrawn
5. Unless specifically reiterated below, Applicant’s amendment and/or arguments have obviated or rendered moot the grounds of objection and rejection set forth in the previous Office action mailed 10/31/2025.
New Grounds of Rejection
Claim Rejections - 35 USC § 103
6. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
7. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
8. Claims 1, 31-38 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Hansen et al. (WO 2016/007848, published on 14 January 2016, IDS) in view of Salamone et al. (WO 2011112358, published on 15 September 2011) (of record).
Claims 1, 31-38 and 49 are herein drawn to a conjugate of formula (I)
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362
840
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wherein: a is an integer from 1 to 10; A is phenyl; U is NH and CF2; R1 is hydrogen; X is NR2; R2 is independently hydrogen or C1-C6 alkyl; L is a cleavable linker or non-cleavable linker; and Bm is a binding moiety that is capable of specifically binding to a protein, wherein the binding moiety is an antibody.
Hansen et al. teach compounds of formula (I) for treating cancer
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270
550
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Wherein R1 is H, R2 and R3 are each halo.
Hansen et al. do no teach the compound is linked to a carrier, wherein the carrier is a protein (e.g., antibody).
However, these deficiencies are remedied by Salamone et al.
Salamone et al. teach a conjugate of formula III
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252
522
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Wherein B is -C(=O)-NH-CH2-, Y is an organic spacing group, X’ is a linker; see entire document, e.g., pages 5-6, 10. Salamone et al. teach the conjugate is linked to a carrier, wherein the carrier is a protein (e.g., antibody); see page 11-lines 10-11, page 21.
The formula (I) of Hansen et al. with the formula III of Salamone et al. has similar backbone. Thus, one skilled in the art would modify the formula (I) of Hansen et al. with the teachings of Salamone et al. to introduce a linker and antibody to arrive the instant claimed invention.
9. Claims 1, 9-14, 23, 26-27, 29 and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Hansen et al. (WO 2016/007848, published on 14 January 2016, IDS) in view of Salamone et al. (WO 2011112358, published on 15 September 2011) (of record) as applied to claims 1, 31-38 and 49 above, and further in view of Ackler et al. (US 20170182179, published on 06/29/2017, IDS).
Claims 9-14, 23, 26-27, 29 and 58 are herein drawn to the conjugate of claim 1, wherein the cleavable linker is cleavable by a protease, wherein the antibody binds to a surface antigen, wherein the surface antigen is Her2/neu, wherein the antibody is trastuzumab, or pertuzumab.
The teachings of Hansen et al. in view of Salamone et al. have been set forth in the above rejection of claims 1, 31-38 and 49 under 35 U.S.C. 103.
Hansen et al. in view of Salamone et al. do not teach wherein the cleavable linker is cleavable by a protease, wherein the antibody binds to a surface antigen, wherein the surface antigen is Her2/neu, wherein the antibody is trastuzumab, or pertuzumab.
However, these deficiencies are remedied by Ackler et al.
Ackler et al. teach the cleavable linker is cleavable by a protease; see entire document, e.g., [0114].
Ackler et al. teach linker
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266
612
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See pages 16-18, which is the same as the linker of the instant claims 13-14.
Ackler et al. teach that the linker is a β-glucuronidase cleavable linker (the instant claim 23); see [0122].
Ackler et al. teach that the surface antigen is Her2/neu and the antibody is trastuzumab, or pertuzumab (the instant claims 27, 29 and 58); see [0324].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the references so as to modify the conjugate of Hansen et al. in view of Salamone et al. with teachings of Ackler et al., to arrive the instant claimed invention by substitute the linker and protein (e.g., antibody) of Salamone et al. for another linker and antibody of Ackler et al., because simple substitution of the linker and protein (e.g., antibody) of Salamone et al. for another linker and antibody of Ackler et al. would obtain predictable results.
Given the examination guidelines for determining obviousness under 35 U.S.C. 103 in view of the Supreme Court decision in KSR International Co. V. Teleflex Inc. 82 USPQ2d 1385 (2007) and the Examination Guidelines set forth in the Federal Register (Vol. 72, No. 195, October 10, 2007) and incorporated recently into the MPEP (Revision 9, March 2014), the following rationales to support rejection under 35 U.S.C. 103(a) are noted:
A) Combining prior art elements according known methods to yield predictable results.
B) Simple substitution of one known element for another to obtain predictable results.
C) Use of known technique to improve similar devices (methods, or products) in the same way.
D) Applying known technique to a known device (method, or product) ready for improvement to yield predictable results.
E) “Obvious to try” --- choosing form a finite number of identified, predictable solutions, with a reasonable expectation of success.
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art.
G) Some teachings, suggestion, or motivation in the prior art that would lead to one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
In this case, simple substitution of the linker and protein (e.g., antibody) of Salamone et al. for another linker and antibody of Ackler et al. would obtain predictable results.
Obviousness is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR International Co. V. Teleflex Inc. 82 USPQ2d 1385 (2007). From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Conclusion
10. No claim is allowed.
11. Applicant's amendment necessitated the new ground(s) of objection/rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 date of this final action.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YAN XIAO whose telephone number is (571)270-3578. The examiner can normally be reached M-F 8-5 EST.
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/YAN XIAO/Primary Examiner, Art Unit 1642
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