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
Election/Restrictions
Applicant’s election of species: antigen binding fragment to BTN1A1, antibody STC703, BTN1A1 ligand Galectin-9, lung cancer, and anti-PD-L1 therapy or anti-PD-L1 refractory cancer, in the reply filed on 10/10/2025 is acknowledged:
Claims 1-53 have been cancelled.
Claims 54-73 are pending and examined for a method of treating cancer comprising a lung cancer in a subject comprising administering a molecule or antigen binding fragment binding to BTN1A1 to inhibit interacting BTNN1A1 to its ligand on merits.
Priority
Applicant’s claim for the benefit as a divisional application of a prior-filed application 16/618764 given the priority to date 6/6/2017 is acknowledged.
Information Disclosure Statement
The information disclosure statement (s) (IDS) submitted on 3/15/2024, 4/30/2025 and 10/10/2025 are/is considered by the examiner and initialed copies/copy of the PTO-1449 are/is enclosed.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 65 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claim is rejected as being vague and indefinite because of its reliance upon a reference as a document set forth in the specification. The claim is improper reference to another application-international application No PCT/US 16/644436, in lieu of description.
Claim is indefinite because it attempts to incorporate by reference essential material from another patent of publication rather than explicitly reciting it. The claims themselves must clearly and concisely define the invention, and reliance on external document to define the scope of the claimed inventio is typically not permitted.
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Written description:
A molecule or antigen binding fragment that inhibits binding BTN1A1 to its ligand for treating cancer
Claims 54-65 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are broadly drawn to:
A method of treating cancer in a subject in need thereof comprising administering to the subject a therapeutically effective amount of a molecule; wherein the molecule comprises an antigen binding fragment that immune-specifically binds to BTN1A…; wherein the molecule inhibits binding of BTN1A1 to the BTN1A1 ligand; and wherein the BTN1A1 ligand is selected from the group consisting of Galectin-1 (GAL-1), Galectin-9 (GAL-9), NRP-2 (Nrp-2), and B- and T-Lymphocyte Attenuator (BTLA).
The terms and phrases “molecule” and “antigen binding fragment” read as any molecule/agent with any structure as long as it binds to BTN1A1 antigen. Thus, the claimed method encompasses a method of using a molecule/agent with any structure to bind to BTN1A1 to inhibit its interaction with its ligand for treating a cancer.
The specification teaches BTN1A1 protein that has fa unction involved in immune system and cancer growth (background, [0004]+). The specification provides numerous references of making antibody against BTN1A1 used for inhibiting the interaction BTN1A1 and its ligand (section 5.2). The specification contemplates a method comprising inhibiting the interaction of BTN1A1 and its ligand to reactivate T cell and immune system against cancer [0324-325]. The specification teaches a method of identifying BTN1A1 ligands including GAL-1, GAL-9 and neuropilin-2 etc. by in vitro method of determining molecule bound by BTN1A1 and co-immunoprecipitation (examples).
The application although refers a few references teaching antibodies to BTN1A1 and antibodies to BTN1A1 ligand, the specification does not teach any molecule and any antigen binding fragment other than antibody or fragment thereof or reduce to practice of using any of those to perform the function to treating any cancer as claimed.
One skilled in the art would understand that “molecule” and “antigen binding fragment” are broad terms that include wide ranges structurally and functionally different chemical and biological compounds existing in nature or synthetic forms. While the instant application merely provides antibodies, but not any of them as recited in the claims.
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed' ”. The courts have decided:
The purpose of the “written description” requirement is broader than to merely explain how to “make and use”; the applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the “written description” inquiry, whatever is now claimed.
See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Furthermore, the written description provision of 35 USC § 112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
The Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, paragraph 1, ``Written Description'' Requirement (66 FR 1099-1111, January 5, 2001) state, “[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention” (Id. at 1104). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed.
The Guidelines further state, “[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus” (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus.
The instant specification fails to provide sufficient descriptive information for a “molecule” or “an antigen binding fragment” with structure definitions that correspond to an inhibitory function for the interaction BTN1A1 to its ligand, for treating a cancer, one of skill in the art would reasonably conclude that the inventor(s), at the time the application was filed, did not have possession of the claimed invention.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description' inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, the skilled artisan cannot envision the detailed structure(s) and functional attribute(s) of the encompassed antibody/inhibitor used in the method as claimed, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF' s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
Therefore, only the antibody or antigen binding fragment of the antibody used in the claimed method for blocking the interaction of BTN1A1 to its ligand for reactivating T cell and treating a cancer, but not the claimed method encompassing a (any) molecule or an (any) antigen binding fragment binding to BTN1A1 as claimed, meet the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Applicant may also refer to Written Description Guideline at USPTO website:
http://www.uspto.gov/web/patents/guides.htm
Claim Rejections - 35 USC § 102/103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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) 54-73 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by or, in the alternative, under 35 U.S.C. 103 by Yoo et al (WO2017/096051, published June 8, 2017 and effective filing Dec 2015, text based on 371 National stage Publication US20180355035).
The molecule and antigen binding fragment recited in the claims are examined to the extent of antibody binding to BTN1A1.
Yoo et al teach human BTN1A1 protein, anti-BTN1A1 neutralizing antibodies or fragment thereof, and methods of using the antibody to mediated the activities of BTN1A1 including for cancer therapy [0059, 0163]). Specifically, Yoo et al teach numbers of antibodies (STC703, STC709, STC710, …. STC822) with defined CDRs and VH/VL structures and test them for binding affinities and activities to the antigen BTN1A1 and its glycosylated form ([0120-144], figs 9-10), wherein the antibodies are monoclonal, human or humanized antibodies or fragment Fab, F(ab)2 etc., which are recombinantly made [0053-57]. Yoo et al teach methods comprising administering the antibody or antigen binding fragment thereof to a subject having cancer including prostate, lung including NSCLC, and metastatic etc. cancers for treatment ([0020-21, 0271-0285] and claims 36-37). Yoo et al also teach the treatment of cancer including administering second anti-cancer therapy including radiation therapy at high dose [0022 and 0312-318]. That meet the limitation of claim 56. Yoo et al teach the antibodies are IgA, IgG or IgM ([0062] and claim 29).
Yoo et al further teach that anti-BTN1A1 antibody binding to BTN1A1 and modulating immune response including T cell activation and proliferation as well as cytokine productions ([0018-20, 0254- 0257+] and figure 7). Thus, BTN1A1 acts as an immune checkpoint protein, which antibody would be used for treating anti-PD-L1 therapy or anti-PD-L1 therapy resistant or refractory cancer set forth in claim 62.
Yoo et al although do not specifically teach BTN1A1 ligands such as GAL-9 (elected) listed in the claim 54, that antibody to inhibiting the interaction of BTN1A1 to its natural ligand taught in the reference would inhibit binding BTN1A1 binding to GAL-9 and other ligands listed in claim 54 inherently.
Claim 65 is included in this rejection because Yoo et al teach more monoclonal antibodies other than STC810, which would not comprise VH and VL of STC810.
Under 103 rejection:
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to claim a method for treating a cancer including checkpoint PD-1/PD-L1 refractory cancer with expected result. One of ordinary skill in the art before the effective filing date of was made would have been motivated with reasonable expectation of success to use and/or modify the teachings and suggestions of Yoo et al set forth above to arrive at current invention, a method of treating a cancer including lung cancer comprising administering a neutralizing anti-BTN1A1 antibody to a cancer patient for treatment, without unexpected results.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined 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).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Over Patents:
1. Claims 54-61 and 63-73 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,970,534 (original application No. 17/103308). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims encompass methods of inhibiting cancer cell or treating a cancer comprising administering anti- BTN1A1 antibody or antigen binding fragment thereof to cancer cell or subject having a cancer. The claims of ‘534 patent are more narrowly drawn than the instant claims, which would thus anticipate the instant claims.
The instant claims are drawn to:
A method of treating cancer comprising administering molecule or antigen binding fragment binding to BTN1A1 to inhibit binding of the BTN1A1 to a BTN1A1 ligand and wherein the BTN1A1 ligand is GAL-1, GAL-9 (elected), NRP-2, or BTLA,
wherein the cancer is anti-PD-1 therapy resistant or refractory cancer.
wherein the cancer is lung cancer,
wherein the molecule is an antibody.
The claims of U.S. Patent ‘534 are drawn to
A method of inhibiting the proliferation of cancer cells expressing BTN1A1 comprising contacting the cells with an effective amount of a molecule, wherein the molecule comprises an antigen binding fragment that immunospecifically binds to BTN1A1, wherein said antigen binding fragment comprises:
(i) (a) a heavy chain variable region (V.sub.H) comprising a V.sub.H complementarity-determining region (CDR) 1, a V.sub.H CDR2, and a V.sub.H CDR3 having an amino acid sequence of a V.sub.H CDR1, a V.sub.H CDR2, and a V.sub.H CDR3, respectively, of a V.sub.H having the amino acid sequence of SEQ ID NO:3; and
(b) a light chain variable region (V) comprising a V.sub.L CDR1, a V.sub.L CDR2, and a V.sub.L CDR3 having an amino acid sequence of a V.sub.L CDR1, a V.sub.L CDR2, and a V.sub.L CDR3, respectively, of a V.sub.L having the amino acid sequence of SEQ ID NO:5;……….
A method of treating cancer in a subject, comprising administering to the subject a therapeutically effective amount of a molecule, wherein the molecule comprises an antigen binding fragment that immunospecifically binds to BTN1A1, wherein said antigen binding fragment comprises: (i) (a) a heavy chain variable region (V.sub.H) comprising a V.sub.H complementarity-determining region (CDR) 1, a V.sub.H CDR2, and a V.sub.H CDR3 having an amino acid sequence of a V.sub.H CDR1, a V.sub.H CDR2, and a V.sub.H CDR3, respectively, of a V.sub.H having the amino acid sequence of SEQ ID NO:3; and (b) a light chain variable region (V) comprising a V.sub.L CDR1, a V.sub.L CDR2, and a V.sub.L CDR3 having an amino acid sequence of a V.sub.L CDR1, a V.sub.L CDR2, and a V.sub.L CDR3, respectively, of a V.sub.L having the amino acid sequence of SEQ ID NO:5; or …….
wherein cancer cell or cancer is lung cancer.
Both sets of the claims are drawn to a method of inhibiting or treating cancer comprising lung cancer comprising contacting/administering anti-BTN1A1 antibody or fragment thereof. the first difference is that the claims of ‘534 US patent are drawn to specific antibodies while the instant method are broadly drawn to a molecule or antigen binding fragment or genus of antibodies binding to BTN1A1. The claims with species of antibodies used in the method of ‘534 patent would anticipate present claimed invention encompassing a genus of the antibodies or binding molecule for treating the same diseases. The second difference is that claims 1-6 of ‘534 US patent recite in vitro method while the instant method involves in vivo treatment in a subject, one it would be obvious to try and use the method of ‘534 US patent to treat a subject since the patent also provides and claims an in vivo method of treating a cancer subject with the same antibody.
2. Claims 54-65 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,215,151 (original application No.17/618,050). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims encompass the same methods of treating a cancer comprising administering anti-BTN1A1 antibody or antigen binding fragment thereof to cancer cell or subject having a cancer. The claims of ‘151 patent are more narrowly drawn to species of cancers using the species of anti-BTN1A1 antibody, which would thus anticipate the instant claims.
The instant claims are drawn to:
A method of treating cancer comprising administering molecule or antigen binding fragment binding to BTN1A1 to inhibit binding of the BTN1A1 to a BTN1A1 ligand and wherein the BTN1A1 ligand is GAL-1, GAL-9 (elected), NRP-2, or BTLA,
wherein the method further comprising a high dose radiation therapy to the patient.
wherein the cancer is lung cancer,
wherein the molecule is an antibody,
wherein the cancer is anti-PD-1 therapy or anti-PD-L1 therapy resistant or refractory cancer….
The claims of ‘151 patent are drawn to
A method of treating cancer in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a molecule comprising an antigen binding fragment that immunospecifically binds to BTN1A1, wherein the cancer expresses PD-L1 at a level lower than or equal to a PD-L1 reference level; wherein the PD-L1 reference level is the average or medium expression level of PD-L1 in a population of healthy individuals; and wherein the antigen binding fragment comprises:
(i) a heavy chain variable region (V.sub.H) comprising a V.sub.H complementarity-determining region (CDR) 1, a V.sub.H CDR2, and a V.sub.H CDR3 having an amino acid sequence of a V.sub.H CDR1, a V.sub.H CDR2, and a V.sub.H CDR3, respectively, of a V.sub.H having an amino acid sequence of SEQ ID NO:31; and
(ii) a light chain variable region (V.sub.L) comprising a V.sub.L CDR1, a V.sub.L CDR2, and a V.sub.L CDR3 having an amino acid sequence of a V.sub.L CDR1, a V.sub.L CDR2, and a V.sub.L CDR3, respectively, of a V.sub.L having an amino acid sequence of SEQ ID NO:33.
wherein the method further comprising administering radiation therapy (claim 13-14),
wherein the cancer is breast cancer, lung cancer, prostate….(claims 16).
Both sets of the claims are drawn to a method of treating cancer comprising lung cancer comprising contacting/administering anti-BTN1A1 antibody or fragment thereof. The differences are that the claims of ‘151 US patent are drawn to specific anti-BTN1A1 antibody to treat species cancer expressing low PD-L1 antigen while the instant method are broadly drawn to a method with any molecule or any antigen binding fragment or genus of any antibodies binding to BTN1A1 for treating any cancer comprising lung cancer with or without indication of expressing PD-L1 levels and the cancers response or resistant or refractory to PD-L1 therapy. The species set forth in claims of ‘151 patent would anticipate present claimed invention encompassing a genus of the antibodies or binding molecule for treating the genus of cancers.
The claims of ‘151 patent do not specifically teach BTN1A1 ligands such as GAL-9 (elected) listed in the claim 54, the antibody to inhibiting the interaction of BTN1A1 to its natural ligand taught in the ‘151 US patent would inherently inhibit interacting BTN1A1 to GAL-9 and other ligands listed in the instant claim 54.
Over Applications:
1. Claims 54-65 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 81-97 of copending Application No. 18/990749 (filed 5/30/2018). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are directed to a method of treating the same cancer with the same BTN1A1 binding molecules.
The instant claims are drawn to:
A method of treating cancer comprising administering molecule or antigen binding fragment binding to BTN1A1 to inhibit binding of the BTN1A1 to a BTN1A1 ligand and wherein the BTN1A1 ligand is GAL-1, GAL-9 (elected), NRP-2, or BTLA,
wherein the method further comprising a high dose radiation therapy to the patient.
wherein the cancer is lung cancer,
wherein the molecule is an antibody,
wherein the cancer is anti-PD-1 therapy or anti-PD-L1 therapy resistant or refractory cancer….
The claims of application ‘749 are drawn to
A method of treating an anti-PD-1 therapy or anti-PD-L1 therapy resistant or refractory cancer in a subject, comprising administering to the subject a therapeutically effective amount of a molecule comprising an antigen binding fragment that immunospecifically binds to BTN1A1 in combination with a therapeutically effective amount of a radiation therapy,
wherein the radiation is high-dose radiation,
wherein cancer is breast, lung, liver…. Cancer.
Both sets of the claims are drawn to the same method of treating cancer comprising anti-PD-L1 therapy or anti-PD-L1 resistant or refractory cancer comprising administering BTN1A1 binding molecule or binding fragment. The difference is scope of the claims, in which the claims of ‘749 application encompass specific patient population with anti-PD-1 or anti-PD-L1 resistant or refractory cancer, while the instant claims encompass any cancer including the anti-PD-L1 resistant and refractory cancer. Thus, the claims of ‘749 application recited smaller patient population for treatment, which would anticipate and be obvious over the invention as presently claimed.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
2 Claims 54-65 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2, 4-5, 12, 19, 26, 28, 40, 43, 47, 49, and 74-75 of copending Application No. 18/847,179 (filed 3/15/2023). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims encompass the same BTN1A1 binding molecules and method of treating a cancer with thereof.
The instant claims are drawn to:
A method of treating cancer comprising administering molecule or antigen binding fragment binding to BTN1A1 to inhibit binding of the BTN1A1 to a BTN1A1 ligand and wherein the BTN1A1 ligand is GAL-1, GAL-9 (elected), NRP-2, or BTLA,
wherein the method further comprising a high dose radiation therapy to the patient.
wherein the cancer is lung cancer,
wherein the molecule is an antibody,
wherein the cancer is anti-PD-1 therapy or anti-PD-L1 therapy resistant or refractory cancer….
The claims of application ‘179 are drawn to
An antibody or antigen-binding fragment thereof that (a) binds to an epitope of BTN1A1 recognized by an antibody comprising
(i) a light chain variable region having an amino acid sequence of SEQ ID NO: 19 and a heavy chain variable region having an amino acid sequence of SEQ ID NO:20;
(ii) a light chain variable region having an amino acid sequence of SEQ ID NO:66 and a heavy chain variable region having an amino acid sequence of SEQ ID NO:68; or
(iii)…
A composition comprising the antibody or antigen-binding fragment thereof of any one of claims claim 1, and a pharmaceutically acceptable carrier.
A method of treating a subject with a BTN1Al targeting agent, comprising a step of detecting BTN1Al in a sample from the subject; optionally wherein the subject has a disease or condition mediated by BTNlA1,
wherein the targeting agent is antagonistic polypeptide binding to BTN1A1 comprising antibody binding to BTN1A1,
wherein the disease or condition comprises a cancer (claims 74-75).
Both sets of the claims encompass anti-BTN1A1 molecule or agent comprising antibodies and methods of treating a cancer with the molecule or agent. The difference is scope of the claims, in which the claims of ‘179 application encompass specific antibodies used and broad diseases to be treated, while the present claims are drawn to treating a cancer only with molecule or binding fragment or any anti-BTN1A1 antibody. Thus, the claims of ‘179 application and present claims would anticipate and be obvious over each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lei Yao, whose telephone number is (571) 272-3112. The examiner can normally be reached on 8:00am-6:00pm Monday-Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached on (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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/LEI YAO/Primary Examiner, Art Unit 1642