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 .
Election/Restrictions
Applicant's reply to the Restriction Requirement, dated April 13, 2026, has been received. By way of this reply, Applicant has amended claims 19 and 28 and elected Group II: claims 2-4, 6, 8, 10, 12, 14-15, 19, 21, 27-28, 31, 33, 37, 51-52 and 55, and the species of metastatic triple negative breast cancer (mTBC), SEQ ID NO: 15 (HC-CDR1); SEQ ID NO: 18 (HC-CDR2); SEQ ID NO: 21 (HC-CDR3); SEQ ID NO: 39 (LC-CDR1); SEQ ID NO: 41 (LC-CDR2); and SEQ ID NO: 42 (LC-CDR3) as species of complementarity determining regions, SEQ ID NO: 116 (VL); and SEQ ID NO: 138 (VH) as species of light and heavy chains, and nab-paclitaxel as the species of chemotherapy.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-4, 6, 8, 10, 12, 14-15, 19, 21, 27-28, 31, 33, 37, 51-52 and 55 are pending in the application. Claims 1, 6, 8, 10, 12, 14-15, 31, 33, and 52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (1) or species (6, 8, 10, 12, 14-15, 31, 33, and 52), there being no allowable generic or linking claim.
Claims 2-4, 19, 21, 27-28, 37, 51 and 55 are therefore under examination before the Office.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code at pages 31, 32, and 111. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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.
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)(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.
(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 2-3, 19, 21, 27-28, 37, and 55 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Meehl (US20190153093A1, cited in IDS).
Meehl teaches a method of treating cancer, comprising administering an antibody that binds ILT3 (i.e., an anti-ILT3 antigen binding protein) (para. 0037 and claim 21). Meehl further teaches that this antibody may be formulated into a pharmaceutical composition with a pharmaceutically acceptable carrier or excipient (para. 0156-0157).
Meehl further teaches a dosage of the above antibody of about 1 to 30 mg/kg (para. 0158). Assuming a 70 kg patient, this results in a 70 to 2,100 mg dose, which is within the claimed ranges. Meehl also teaches that dosage regimens may be adjusted to provide the optimum desired response (para. 0164-0165).
Meehl further teaches administering the above antibody in combination with an anti-PD-1 antibody (para. 0039 and 0195, and claim 23), which is pertinent to claim 3.
Meehl further teaches that the anti-ILT3 antibody may have a light chain of SEQ ID NO: 118 and a heavy chain of SEQ ID NO: 140 (para. 0130), which are identical to Applicant's SEQ ID NOs: 116 and 138, respectively, and also include Applicant's SEQ ID NOs: 15, 18, 21, 39, 41, and 42, which is pertinent to claims 19, 21, and 27-28.
Meehl further teaches that the anti-PD-1 antibody may be pembrolizumab (para. 0040 and claim 24). According to Applicant's specification at page 75, pembrolizumab has a heavy chain of SEQ ID NO: 236 and a light chain of SEQ ID NO: 237. Meehl therefore inherently teaches the subject matter of claim 37.
Meehl further teaches that the anti-ILT3 antibody may be administered in combination with chemotherapy (para. 0190).
Meehl further teaches that the above method is useful for treating breast cancer (para. 0038 and claim 22).
Claim Rejections - 35 USC § 103
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Meehl as applied to claim 2 above, and further in view of Darce (US20200031926A1) and Kulangara (US20170285037A1).
The teachings of Meehl have been discussed supra. However, while Meehl teaches that an anti-ILT3 antibody is useful for treating breast cancer, Meehl does not teach triple negative breast cancer.
Darce teaches a method of treating cancer, comprising administering an anti-ILR3 antibody (para. 0167). Darce further teaches that the cancer may be triple negative breast cancer (para. 0168 and claim 207). Darce also teaches that this method is useful for treating metastatic cancers (para. 0222 and 0413).
Kulangara teaches that tumors scored with a CPS score of 1 or higher are PD-L1 positive and suitable for anti-PD-1 therapy (para. 0085 and 0105).
Kulangara further teaches that the anti-PD-1 therapy may be pembrolizumab (para. 0128 and 0130).
Kulangara further teaches that the score may be calculated prior to treatment (para. 0130).
Kulangara further teaches that the tumor may be triple negative breast cancer (para. 0141 and claim 16).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Meehl, Darce, and Kulangara to arrive at the claimed invention. An ordinary artisan would have been motivated to do so, and have a reasonable expectation of success, since all of Meehl, Darce, and Kulangara are concerned with breast cancer therapy. Meehl teaches that an anti-ILT3 antibody is useful for treating breast cancer. Darce likewise teaches that such antibodies are useful in treating triple negative breast cancer. Kulangara teaches methods to assess PD-L1 enrichment of triple negative breast tumors for suitability of anti-PD-1 therapy. One of ordinary skill could apply the patient and tumor criteria described by Darce and Kulangara to the method of Meehl by known methods, with each component of the combination performing its known, usual function, and the combination would have yielded nothing more than predictable results.
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Meehl as applied to claim 37 above, and further in view of Renschler (US20170326234A1).
The teachings of Meehl have been discussed supra. However, while Meehl teaches that an anti-ILT3 antibody may be combined with chemotherapy, Meehl does not teach nab-paclitaxel or gemcitabine.
Renschler teaches a chemotherapy schedule for cancer, comprising 125 mg/m2 nab-paclitaxel and 1000 mg/m2 gemcitabine on days 1, 8, and 15 of a 28-day cycle, and an anti-PD1 antibody (para. 0371).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Meehl and Renschler to arrive at the claimed invention. An ordinary artisan would have been motivated to do so, and have a reasonable expectation of success, since both Meehl and Renschler are concerned with cancer therapy. Meehl teaches combinations of an anti-ILT3 antibody, an anti-PD-1 antibody, and chemotherapy. Renschler teaches a suitable treatment regimen of nab-paclitaxel and gemcitabine that can be combine with an anti-PD-1 antibody. One of ordinary skill could apply the chemotherapy of Renschler to the method of Meehl by known methods, with each component of the combination performing its known, usual function, and the combination would have yielded nothing more than predictable results.
All the claimed elements were known in the prior art and one of ordinary skill in the art could have arrived at the claimed invention by using known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, the invention, as a whole, was prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-4, 19, 21, 27-28, 37, 51 and 55 are rejected on the ground of nonstatutory double patenting as being unpatentable over the following U.S. patents and patent applications in view of Meehl, Darce, Kulangara, and Renschler:
Conflicting patent/ Conflicting
Patent application claims
12,441,792 1, 7-12
12,435,133 1-3, 9-14
18/291,621 1, 5-11, 14-20, 22-23, 31, 37-38
18/998,702 1, 7-815, 19, 21-23, 35, 46-47
By means of example, the '133 patent claims a method of treating a subject having a cancer, comprising administering to the subject a therapeutically effective amount of an antibody or antigen binding fragment thereof that binds the extracellular domain of human immunoglobulin-like transcript 3 (ILT3) and one or more inhibitors of PD-1, wherein the anti-ILT3 antibody has the same CDRs as described in Applicant's claim 21 (claim 1).
The '133 patent further claims that the anti-PD-1 antibody may be pembrolizumab (claim 2).
However, the '133 patent does not claim the dosage claimed by the instant application.
Meehl teaches a method of treating cancer, comprising administering an antibody that binds ILT3 (i.e., an anti-ILT3 antigen binding protein) (para. 0037 and claim 21). Meehl further teaches that this antibody may be formulated into a pharmaceutical composition with a pharmaceutically acceptable carrier or excipient (para. 0156-0157).
Meehl further teaches a dosage of the above antibody of about 1 to 30 mg/kg (para. 0158). Assuming a 70 kg patient, this results in a 70 to 2,100 mg dose, which is within the claimed ranges. Meehl also teaches that dosage regimens may be adjusted to provide the optimum desired response (para. 0164-0165).
Meehl further teaches administering the above antibody in combination with an anti-PD-1 antibody (para. 0039 and 0195, and claim 23), which is pertinent to claim 3.
Meehl further teaches that the anti-ILT3 antibody may have a light chain of SEQ ID NO: 118 and a heavy chain of SEQ ID NO: 140 (para. 0130), which are identical to Applicant's SEQ ID NOs: 116 and 138, respectively, and also include Applicant's SEQ ID NOs: 15, 18, 21, 39, 41, and 42, which is pertinent to claims 19, 21, and 27-28.
Meehl further teaches that the anti-PD-1 antibody may be pembrolizumab (para. 0040 and claim 24). According to Applicant's specification at page 75, pembrolizumab has a heavy chain of SEQ ID NO: 236 and a light chain of SEQ ID NO: 237. Meehl therefore inherently teaches the subject matter of claim 37.
Meehl further teaches that the anti-ILT3 antibody may be administered in combination with chemotherapy (para. 0190).
Meehl further teaches that the above method is useful for treating breast cancer (para. 0038 and claim 22).
Darce teaches a method of treating cancer, comprising administering an anti-ILR3 antibody (para. 0167). Darce further teaches that the cancer may be triple negative breast cancer (para. 0168 and claim 207). Darce also teaches that this method is useful for treating metastatic cancers (para. 0222 and 0413).
Kulangara teaches that tumors scored with a CPS score of 1 or higher are PD-L1 positive and suitable for anti-PD-1 therapy (para. 0085 and 0105).
Kulangara further teaches that the anti-PD-1 therapy may be pembrolizumab (para. 0128 and 0130).
Kulangara further teaches that the score may be calculated prior to treatment (para. 0130).
Kulangara further teaches that the tumor may be triple negative breast cancer (para. 0141 and claim 16).
Renschler teaches a chemotherapy schedule for cancer, comprising 125 mg/m2 nab-paclitaxel and 1000 mg/m2 gemcitabine on days 1, 8, and 15 of a 28-day cycle, and an anti-PD1 antibody (para. 0371).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the claims of the '133 patent with the teachings of Meehl, Darce, Kulangara, and Renschler to arrive at the claimed invention. The '133 patent claims a method of using the antibody recited in the instant claims to treat cancer. Meehl teaches suitable dosages for this antibody. Other aspects of the claims are taught by Darce, Kulangara, and Renschler, and are applicable in the field of cancer therapy. One of ordinary skill could apply the methods of Meehl, Darce, Kulangara, and Renschler to the claims of the ‘133 patent by known methods, with each component of the combination performing its known, usual function, and the combination would have yielded nothing more than predictable results.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 7:00 to 3:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (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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/PETER JOHANSEN/Examiner, Art Unit 1644
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