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
Responsive to communications entered 26JUN2026
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Claims withdrawn 2,21 and 5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Withdrawn Objection(s) and/or Rejection(s)
The rejection of claims 1,3-4,6-8,11-20 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph concerning new matter is hereby withdrawn in view of Applicant’s persuasive arguments.
Maintained 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 (pCR), 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) reference as Treg 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. See also paragraphs 0010, 0371.
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Please note that the above rejection has been updated from the original version to more clearly address applicants’ newly amended claims and/or arguments.
Response to Arguments
The remarks accompanying the present response argue not all elements are taught.
Applicant’s arguments have been fully considered but they are not deemed persuasive for the following reasons.
First more particularly, the current remarks at paragraphs on p 24 urge Anderson et al do not teach predicting a response to cancer immunotherapy, but rather Anderson is drawn to administering an agent that modulates interaction of APRIL (a proliferation-inducing ligand) with TACI (transmembrane activator and calcium modulator and cyclophilin ligand interactor) proteins, that is the remarks contend Anderson et al do not teach determining whether expression level of one marker (recited in claim 1) is indicative for predicting the response or resistance to and/or the benefit from the treatment with a cancer immune checkpoint inhibitor therapy in a subject, as set forth in claim 1.
In this vein the following is noted. In accordance with paragraphs 0010, 0371 as cited in the previous action, Anderson et al expressly teach that APRIL binding TACI significantly upregulates proliferation and survival of regulatory T (Treg) cells that have undesirable immune inhibitory function in treating cancer and as such overcoming such immunosuppression in a tumor microenvironment may be accomplished by reducing the Treg population therein the tumor with an inhibitor targeting APRIL together with similar immune checkpoint therapy (e.g. antibodies blocking PD1/PD-L1) desirably enhances cytotoxicity of cancer cells which is predicted to improve patient outcome, even to the point of pCR (as in present claim 15), cCR (clinical complete remission), etc. And in paragraph 0353, as cited in the previous action, Anderson et al further teach adjunct chemotherapy. Whereas in figure 13B, Anderson et al teach SLAM7 RNA being inversely and CTLA4 RNA being positively correlated with TACI.
Therefore taken together, in contrast with Applicant’s argument, the examiner submits, Anderson et al: determines whether expression level of at least one marker (recited in claim 1) is indicative for predicting the response and/or the benefit from treatment with a TACI inhibitor, cancer immune checkpoint inhibitor and optionally a chemotherapeutic in a subject as in the manner set forth in claim 1 lines 51-60.
Additionally, the paragraph spanning pp 24-25 of the current remarks further contends Anderson claim 24 is drawn to analyzing whether a patient has responded to treatment already administered as opposed to predicting therapeutic success.
In response, as interpreted in MPEP 2123, the courts have held the use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). Here, that CTLA4 may be used as markers for prognosing cancer treatment does not change the fact that that it may be also used to predict whether a patient would benefit from treatment with a TACI inhibitor, cancer immune checkpoint inhibitor and optionally a chemotherapeutic in the first place. In other words, a patient with a high low tumor Treg population would not be expected to respond to a TACI-APRIL downregulator: Anderson et al is relevant for it contains.
Finally the third paragraph at p 24 and first full paragraph at p 25 of the remarks assert the claimed subject matter does not extend to a treatment with an additional immunotherapeutic inhibitor such as an APRIL-TACI modulator and that Anderson et al do not teach using CD38 to predict pCR, respectively.
In response to the former assertion, it is noted the claimed subject matter is open to additional elements by using the preamble transition “comprising” and regarding the latter it is noted the claimed method is NOT limited to only CD38 as a marker. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Future Communications
As reflected on the attached interview summary, Applicant’s representative inquired about a potential supplemental amendment, however no filing has been received past the deadline this application needed to be acted upon. Applicant is further advised the present application will be reassigned, whereas the current examiner will be leaving the Office effective 9/30/2026.
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.
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.
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
