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
Applicant’s amendment filed September 29, 2025 has been received and entered.
Claims 2, 4, 8-9, 11, 17, 19-21, and 23 were previously canceled.
Claims 1, 3, 5-7, 10, 12-16, 18, 22, and 24-29 are pending and under examination
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. Applicant is reminded that the disclosure of prior-filed application, Application No. 62/685,057, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) for one or more claims of this application.
The prior application does not disclose or contemplate margetuximab monotherapy treatment as recited in claims 1 and 16. Accordingly, the instant claims are not entitled to the benefit date for the provisional application of June 14, 2018. Accordingly, instant claims 1, 3, 5-7, 10, 12-16, 18, 22, and 24-29 are entitled to the benefit of the filing date of June 13, 2019 of PCT/US2019/037112.
Claim Rejections - 35 USC § 103 - Maintained
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 (i.e., changing from AIA to pre-AIA ) 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.
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, 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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 5-7, 10, 12-16, 18, 22, and 24-29 are rejected under 35 U.S.C. 103 as being obvious over Chan-Hui et al. (US 2009/0111127) (“Chan-Hui”), in view of Li et al. (JCO, 2018; 36(24):2532-2537) (“Li”). The applied reference Li et al. has a common joint inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(1).
The specific places where Chan-Hui and Li teach the particular limitations recited in the instant claims are set forth in the Office Action mailed March 31, 2025.
Response to Arguments
Applicant has submitted a 37 CFR 1.130 declaration, “Memorial Sloan Kettering Cancer Center Declaration”, with the reply received September 29, 2025.
Applicant argues on page 7 of the reply, that Li does not qualify as prior art in accordance with 35 U.S.C. 102(b)(1)(A) because the subject matter disclosed in Li was obtained directly from the joint inventors of the instant application, Maurizio Scaltriti and Bob T. Li, as evidenced by the declaration.
Applicant's arguments filed September 29, 2025 have been fully considered but they are not persuasive because the 37 CFR 1.130 declaration filed September 29, 2025 is insufficient to overcome the rejection.
Specifically, the “Memorial Sloan Kettering Cancer Center Declaration” does not contain an unequivocal statement from a joint inventor that the joint inventor (or some combination of named inventors) invented the subject matter of the disclosure. In addition, the declaration fails to establish the twenty-four co-authors of Li et al. are not joint inventors and did not contribute to the conception of the instantly claimed invention.
MPEP § 2155.01 states, Where the authorship of the prior art disclosure includes the inventor or a joint inventor named in the application, an unequivocal statement from the inventor or a joint inventor that the inventor or joint inventor (or some combination of named inventors) invented the subject matter of the disclosure, accompanied by a reasonable explanation of the presence of additional authors, may be acceptable in the absence of evidence to the contrary. See In re DeBaun, 687 F.2d 459, 463, 214 USPQ 933, 936 (CCPA 1982).
The applicant or patent owner may submit an appropriate affidavit or declaration to except a disclosure as prior art by establishing that the disclosure was made by the inventor or a joint inventor, or the subject matter disclosed was obtained directly or indirectly from the inventor or a joint inventor. However, an affidavit or declaration under 37 CFR 1.130(a) that is only a naked assertion of inventorship and that fails to provide any context, explanation or evidence to support that assertion is insufficient. See EmeraChem Holdings, LLC v. Volkswagen Grp. of Am., Inc., 859 F.3d 1341, 123 USPQ2d 1146 (Fed. Cir. 2017). See also Ex parte Kroger, 219 USPQ 370 (Bd. App. 1982) (affirming rejection notwithstanding declarations by the alleged actual inventors as to their inventorship in view of a nonapplicant author submitting a letter declaring the nonapplicant author's inventorship).
Applicant is encouraged to review the examples provided in MPEP § 2155.01 outlining the requirements of the 37 CFR 1.130 declaration.
Accordingly, the “Memorial Sloan Kettering Cancer Center Declaration” fails to establish that Li et al. is not prior art under U.S.C. 35 102(a)(1), therefore the rejection is maintained. Note that the declarant is not an inventor of the present application, the declaration fails to establish that the inventor or joint inventors named on the reference are the actual inventors of what was disclosed in that reference, and the declaration fails to account for each of the non-inventor authors listed on the publication.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN DRISCOLL whose telephone number is (571) 270-0730. The examiner can normally be reached Monday through Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel Kolker can be reached on (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/MAUREEN VARINA DRISCOLL/ Examiner, Art Unit 1644
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644
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