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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/17/2026 has been entered.
Claims pending 1-8,11-21
Claims withdrawn 2,21 and 5
Claims currently under consideration 1,3-4,6-8,11-20
Priority
This application has a filing date of 05/27/2021 and is a 371 of
PCT/EP2019/083124 filed 11/29/2019
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to EP 18209672.7, filed 11/30/2018. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Withdrawn Rejection(s)
All rejections from the previous action have been overcome by Applicant’s amendment.
New Claim Rejection(s) – 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1,3-4,6-8,11-20 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This rejection concerns new matter.
Claim 1 adds the limitation “wherein when the marker is CD38 a higher gene expression is related to a higher likelihood of a pathological complete response (pCR)” and the remarks contend support therefor may be found at pp 3-6 and 25-27 of the original specification. In reviewing the pages however, the examiner finds nothing regarding higher expression of CD38 whatsoever, much less being favorable, or even less being positively correlated with a pCR as a candidate for treatment with an anti-PD-1 antibody or an anti-PD-L1 antibody checkpoint inhibitor.
As such, the specification as originally filed provided no implicit or explicit support for such added material and the remarks do not point to where the priority documents the new wherein clause is described.
Applicants are reminded that it is their burden to show where the specification supports any amendments to the disclosure. See MPEP 714.02, paragraph 5, last sentence and also MPEP 2163.06 I.
MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).” MPEP 2163.02 teaches that “Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed...If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application. MPEP 2163.06 further notes “When an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not “new matter” is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure.
New Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1,3-4,6-8,11-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Anderson et al (US AppPub 20210113605).
As disclosed throughout the document and especially the abstract as detailed in paragraphs 0401,0125, 0003-0009,0353,0387,0146,0162 and figure 13, Anderson et al is drawn to, for instance, inhibitors of APRIL (A proliferation-inducing ligand) and TACI (transmembrane activator and calcium modulator and cyclophilin ligand interactor) in an effort to prognose and treat cancer by preventing expansion of Tregs (regulatory T cells) that contributes to impaired anti-tumor immune responses resulting in immune escape and progression of solid (e.g. breast) cancer. Anderson et al specify said inhibitors may be optionally combined with immune checkpoint blockers like atezolizumab; (an anti-PD-L1 antibody) or durvalumab (anti-PD-L1 antibody) and/or paclitaxel chemotherapy in an effort to treat recurrence that may be monitored with biomarkers including SLAMF7 and CTLA4. That is, like claims 1,3,4,6,7,8,11,12,13,14,15,16,18,20a, in the passages the examiner submits Anderson et al teaches a method for predicting a pathological complete response, or resistance to and/or a benefit from a cancer immune checkpoint inhibitor therapy in a subject suffering from recurrent breast cancer including: determining in a sample obtained from said subject the expression level of SLAMF7 and/or CTLA4 (each related to immune response) compared to GAPDH reference as markers; that the expression level thereof is indicative for predicting the response or resistance to and/or the benefit from the treatment with the cancer immune checkpoint inhibitor therapy in said subject, providing the subject with the cancer immune checkpoint inhibitor therapy that may be optionally combined with paclitaxel as appropriate, wherein the immune checkpoint inhibitor may be atezolizumab or durvalumab. Finally, in paragraphs 0084 and 0164, Anderson et al further teach measuring tumor size as in claims 17 and 19(i) respectively.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER M GROSS whose telephone number is (571)272-4446. The examiner can normally be reached M-F 10-6.
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, Heather Calamita can be reached on (571)272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER M GROSS/Primary Examiner, Art Unit 1684