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 election filed 03/03/2026 in response to the Office Action of 11/06/2025 is acknowledged and has been entered.
Applicant has elected Group I, claims 1-16, drawn to an antibody-drug conjugate (ADC) comprising an anti-mesothelin antibody comprising amino acids as shown in
SEQ ID NOs: 7-12, and a topoisomerase inhibitor.
Upon review and reconsideration, Group II, claims 17-21 will be rejoined with Group I for examination.
Because applicant did not distinctly and specifically point out any supposed errors in the restriction requirement, the election has been treated as an election without traverse. See MPEP 818.03(a).
3. Claims 1-34 are pending in the application. Claims 22-34 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim.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 03/03/2026.
4. Claims 1-21 are currently under prosecution.
Priority
5. Applicant’s claim under 35 U.S.C. § 119(e) and 365(c) for benefit of the earlier filing date of application, is acknowledged.
6. 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 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.
Claim Rejections - 35 USC § 103
7. 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.
8. 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.
9. Claims 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Nicolaides et al. (WO 2020068511, published on 02 April 2020, IDS) in view of Wang et al. (WO 2018086239, published on 05/17/2018, IDS) evidenced by Machine Translation of WO 2018086239 (pages 1-46).
Claims 1-21 are herein drawn to an antibody-drug conjugate (ADC) comprising an anti-mesothelin antibody comprising amino acids as shown in SEQ ID NOs: 7-12, and a topoisomerase inhibitor.
Nicolaides et al. teach an antibody-drug conjugate (ADC) for treating cancer, wherein the ADC comprises an anti-mesothelin antibody comprising CDRs with amino acids of SEQ ID NOs: 14-19 (corresponding to SEQ ID NOs: 7-12 of the instant claim 1), and a drug (such as a chemical or polypeptide that has toxic activity to cells); see entire document, e.g., [0077], [0107]-[0108].
Nicolaides et al. teach an anti-mesothelin therapeutic agent may be administered to the subject, where the subject has a baseline CA125 level that is above the normal range (instant claims 20-21); see [106].
Nicolaides et al. do not teach the drug is a topoisomerase inhibitor, e.g., PNU159682, or SN38.
However, this deficiency is remedied by Wang et al.
Wang et al. teach an ADC for treating cancer comprises a topoisomerase inhibitor (e.g., PNU159682, or SN38) as a drug, wherein the topoisomerase inhibitor has anti-cancer activity with a 3,000-fold increase compared to doxorubicin as a conventional anti-cancer drug; see entire document, e.g., abstract, bridging paragraph of pages 5-6 and claim 1 in Machine Translation of WO 2018086239.
Wang et al. teach linker maleimidocaproyl-vc (valine-citrulline)-PABC (para-aminobenzyloxycarbonyl), PEG8-vc-PABC, n is a positive number of 2-6 (instant claims 7, 10 and 12-13); see pages 10-11 of Machine Translation of WO 2018086239, Formulas I-VI.
Wang et al. teach cancer includes breast, lung, colorectal, gastro-intestinal, or pancreatic cancers; see page 12.
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 substitute the drug of Nicolaides et al. for another drug (e.g., topoisomerase inhibitor of PNU1 59682, or SN38 of Wang et al.) to arrive instant claimed invention, because the teachings of Nicolaides et al. and Wang et al. are in the same technical field relating to the ADC for treating cancer, a person skilled in the art would easily arrive instant claimed invention by applying the topoisomerase inhibitor of Wang et al. to the drug of Nicolaides et al. and the effect of it would be predictable; additionally, simple substitution of the drug of Nicolaides et al. for another drug (e.g., topoisomerase inhibitor of PNU1 59682, or SN38 of Wang 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 drug of Nicolaides et al. for another drug (e.g., topoisomerase inhibitor of PNU1 59682, or SN38 of Wang et al.) would obtain predictable results.
Conclusion
10. No claim is allowed.
11. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached on 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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/YAN XIAO/Primary Examiner, Art Unit 1642
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