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 .
Election/Restrictions
Claims 1-18 are pending and are examined.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The priority date is considered to be the date of the filing of the provisional Application 63/232,611, which is 0/12/2021.
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.
Claims 1-7 and 9-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (WO2020232051).
The reference teaches isolated monoclonal antibodies or an antigen-binding
portion thereof that specifically bind CSF-1R as well as method of using them for
treatment (abstract). The antibody or the antigen-binding portion thereof can be, for
example, a mouse, chimeric or humanized antibody. The cancer or tumor includes
tenosynovial giant cell tumor (which, Nota Bene, may appear in any joint; Evidentiary
reference Benner et al.-Drug Design, Development and Therapy, 14, 1693-1704, 2020)
([0023]). Inhibition of CSF-1R signaling is likely to control the number of macrophages in
the joint and alleviate the pain from the associated bone destruction. In order to minimize adverse effects and to further understand the impact of the CSF-1R signaling in these indications, one method is to specifically inhibit CSF-1R without targeting myriad kinases, such as Raf kinase ([0153]). The antibody is administered in dosage ranges from about 0.0001 to 100 mg/kg of the host body weight. The treatment regime entails administration once per week, once every two weeks, once every three weeks, once every four weeks, once a month, once every 3 months or once every three to 6 months. The dosage is adjusted to achieve a plasma antibody concentration of about 1-1000 μg/ml and in some methods about 25-300 μg/ml ([0132]). The antibodies used comprised, inter alia, Cabiralizumab ([0166]). The pharmaceutical composition is suitable for intravenous, intramuscular, subcutaneous, parenteral, spinal or epidermal administration (e.g., by injection or infusion). Depending on the route of administration, the active ingredient can be coated in a material to protect it from the action of acids and other natural conditions that may inactivate it. The phrase "parenteral administration" as used herein means modes of administration other than enteral and topical administration, usually by injection, and includes, without limitation, intracapsular and intraarticular injection. Pharmaceutical compositions can be in the form of sterile aqueous solutions or dispersions. They can also be formulated in a microemulsion, liposome, or other ordered structure suitable to high drug concentration ([00129] and [00128]).
Thus, in the broadest reasonable interpretation, the claims 1-7 and 9-17 are anticipated by the reference cited.
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.
Claims 1, 3-10, 12-14 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over unpatentable over Sikorski et al. (U.S. Pat. 10, 040,858) in view of Flynn et al. (U.S. Pub. No. 20200253973).
The claims are drawn to method for locally administering a composition comprising an anti-CSF1R (colony stimulating factor 1 receptor) antibody, at or proximate to a tissue in a joint impacted with a tumor, and wherein the tissue comprises at least a cell that expresses CSF1R on the surface. Also claimed is a method of treating a tumor at a joint in a patient, comprising administering an anti- CSF1R (colony stimulating factor 1 receptor) antibody at or proximate to the joint in the patient. Additional limitations comprise the dose (10-50 mg), length of treatment (3 weeks to 6 months) and the composition further comprising polymers.
As of note, if the tumor is in an articulation, intratumoral injection is the same as intraarticular injection.
Sikorski et al. disclosed methods of treating a proliferative disorder involving a synovial joint and/or tendon sheath in a subject, comprising administering to the subject an effective amount of an antibody that binds CSF1R. The proliferative disorder is selected from pigmented villonodular synovitis (PVNS), giant cell tumor of the tendon sheath (GCTTS), and tenosynovial giant cell tumor (TGCT) such as diffuse type tenosynovial giant cell tumor (dtTGCT). The antibody is administered once per week, once per two weeks, once per three weeks, or once per month. In some embodiments, the antibody is administered at a dose of at least 1, at least 2, at least 3, at least 4, at least 5, at least 6, at least 7, at least 8, at least 10, at least 12, at least 15, at least 16, at least 20, at least 30, at least 40, at least 50, or at least 100 mg/kg. The tumor volume is reduced by at least 30% after administration of at least two, at least three, at least four, at least five, at least six, at least seven, at least eight, at least nine, or at least ten doses of the antibody that binds CSF1R. The tumor volume is tumor volume in a single joint. In some embodiments, the single join is selected from a hip joint and a knee joint (col. 2 lines 30-61). The compositions comprising the antibody may also be formulated, in various embodiments, into sustained release microcapsules, such as with biodegradable or non-biodegradable polymers. A non-limiting exemplary biodegradable formulation includes poly lactic acid-glycolic acid polymer. A non-limiting exemplary non-biodegradable formulation includes a polyglycerin fatty acid ester (col. 28, lines 17-21).
The reference is silent about providing the antibody intra- articularly or intratumorally.
Flynn et al. disclosed methods of treating disorders such as tenosynovial giant cell tumors comprising administering to the patient a therapeutically effective amount of the compound 2-(isopropylamino)-3-methyl-5-(6-methyl-5-((2-(1-methyl-1H-pyrazol-4-yl)pyridin-4-yl)oxy)pyridin-2-yl)pyrimidin-4(3H)-one or a pharmaceutically acceptable salt thereof ([0007]). In some embodiments, such compositions are for parenteral (by injection) administration (e.g., a composition formulated for local injection at the site of a tumor, e.g., a diffuse-type giant cell tumor) ([0037], [0131]).
It would have been obvious for a person of ordinary skill in the art to have used the antibodies of Sikorski et al. and treat a proliferative disorder involving a synovial joint and/or tendon sheath in a subject by intratumorally inject their antibody with a reasonable expectation of success. This is because Flynn et al, used CSF1R inhibitors to treat tenosynovial giant cell tumors by local injection at the site of a tumor.
A person of ordinary skill in the art is always motivated to pursue the known options within her or his technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
Claim(s) 2 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Sikorski et al. (U.S. Pat. 10, 040,858) in view of Flynn et al. (U.S. Pub. No. 20200253973) and in further view of Sheng et al. (CN111068054, published 04/28/2020- translation provided).
The claims add the limitations that the antibody is selected from the group consisting of AM001, emactuzumab, cabiralizumab, axatilimab and IMC-CS4.
The teachings of Sikorski et al and Flynn et al. were presented supra and they were silent about the specific antibodies mentioned.
Sheng et al. reflect the state of the art at the time that the invention was filed and indicates that, because CSF1R is overexpressed in many cancers and tumor-associated macrophages (TAMs), CSF1R inhibitors have been studied for many years as a potential treatment for cancer or inflammatory diseases. As of 2017, CSF1R inhibitors in clinical trials included: Pexidartinib, PLX7486, ARRY-382, JNJ-40346527, BLZ945, Emactuzumab, AMG820, and IMC-CS4. Another CSF1R inhibitor that targets and depletes TAM is Cabiralizumab (cabira; FPA-008), a monoclonal antibody that is currently in early clinical trials for metastatic pancreatic cancer ([0010]).
Thus, it would have been obvious for a person of ordinary skill in the art at the time that the invention was filed to have used that teaching of Sikorski et al and Flynn et al., in the light of the disclosure of Cheng et al. and treat a proliferative disorder involving a synovial joint and/or tendon sheath in a subject by intratumorally inject their antibody with a reasonable expectation of success. This is because a skilled artisan would have used known and tested methods to treat diseases impacted by CSF1R with known reagents.
A person of ordinary skill in the art is always motivated to pursue the known options within her or his technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
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 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,752,096. Although the claims at issue are not identical, they are not patentably distinct from each other because they claim the same subject matter and the claim of the patent anticipate the instant claims.
Claim 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of copending Application No. 19,111,100 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because, if allowed first, the claims of the reference Application would anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647
