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 .
This office action is in response to the amendment filed on November 19, 2025. Claims 3 and 6 have been cancelled. Claims 1, 2, 4, 5, and 7 are currently pending and are under examination.
Withdrawal of Rejections
The rejection of claims 4, 5, and 7 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn based on the remarks filed on November 19, 2025 and the amendment to the claims.
The rejection of claims 1 and 2 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn based on the remarks filed on November 19, 2025 and the amendment to the claims.
The rejection of claims 1 and 2 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for a detection of novel binding proteins of a pharmaceutical chemical compound comprising protein tyrosine kinase inhibitors afatinib, erlotinib, gefitinib and protein tyrosine phosphatase inhibitors phenyl vinyl sulfone, phenyl vinyl sulfonate, and Bay 11-7082, does not reasonably provide enablement for any pharmaceutical chemical compound conjugated to any protein carrier for the genus of any protein tyrosine kinase inhibitor or protein tyrosine phosphatase inhibitor is withdrawn based on the remarks filed on November 19, 2025 and the amendment to claims.
The rejection of claim(s) 3 under 35 U.S.C. 102(a)(1) as being anticipated by Yu et al. (Oncotarget Vol. 9, No. 30, pp. 21512-21529 (2018)) is withdrawn based on the amendment to cancel the claim.
Pending Rejection(s)
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu et al. (Oncotarget Vol. 9, No. 30, pp. 21512-21529 (2018)).
Yu et al. disclose the antibody assisted target identification of ribonucleotide reductase when using human lung adenocarcinoma cell line, PC-9, which were treated with tyrosine kinase inhibitor afatinib (see entire document, particularly page 21519, figure 5). Yu et al. disclose preparation of anti-afatinib antiserum by coupling ovalbumin to afatinib. PC-9 cells were treated with afatinib, lysed and immunoprecipitated with anti-afatinib (see page 21523, Materials and Methods section).
Applicant may rely on the exception under 35 U.S.C. 102(b)(1)(A) to overcome this rejection under 35 U.S.C. 102(a)(1) by a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application, and is therefore not prior art under 35 U.S.C. 102(a)(1). Alternatively, applicant may rely on the exception under 35 U.S.C. 102(b)(1)(B) by providing evidence of a prior public disclosure via an affidavit or declaration under 37 CFR 1.130(b).
Claim Rejections - 35 USC § 103
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.
Claim(s) 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. (Oncotarget Vol. 9, No. 30, pp. 21512-21529 (2018)).
Yu et al. disclose the antibody assisted target identification of a novel binding protein, ribonucleotide reductase, when using human lung adenocarcinoma cell line, PC-9, which were treated with tyrosine kinase inhibitor afatinib (see entire document, particularly page 21519, figure 5). Yu et al. disclose preparation of anti-afatinib antiserum by coupling ovalbumin to afatinib. PC-9 cells were treated with afatinib, lysed and immunoprecipitated with anti-afatinib (see page 21523, Materials and Methods section). The anti-afatinib antibody was pulled down by Protein A-conjugated resin. Proteins were eluted by SDS sample buffer. The eluted sample was SDS-PAGE and gel bands were further processed and subjected to downstream MS analysis (see Materials and Methods, particularly page 21524 method sections). Yu et al. does not disclose the target binding protein as either NF kappa B or arginine methyltransferase 1, but it would have been obvious to the person having ordinary skill in the art to identify target proteins using MS proteomic analysis, since Yu et al. disclose that analytical method for protein analysis.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir.1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. The prior art discloses the method steps as currently claimed of generating a detection agent, generating cellular lysates, executing an immunoprecipitation, and executing a proteomic analysis. Theefore, it would have been obvious to the person having ordinary skill in the art to perform the method as claimed, because Yu et al. discloses all the active method steps as currently claimed. The end result of using the same starting materials should necessarily result in identifying the target binding protein, since the invention is an enabled method invention. Thus, claims 5 and 7 are will necessarily result after execution of the proteomic analysis.
Conclusion
All references have been previously cited.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of 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 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 ANAND U DESAI whose telephone number is (571)272-0947. The examiner can normally be reached 9:00-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655