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
Applicant’s election without traverse of Group I (claims 1-7 and 9-13) in the reply filed on 01/29/2026 is acknowledged. Claims 1-7, 9-13 and 17-22 are pending; claims 17-22 are withdrawn from prosecution for being drawn to non-elected subject matter. Claims 1-7 and 9-13 are examined.
Claim Rejections - 35 USC § 112
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.
Claims 1-7 and 9-13 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 claims 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, at the time the application was filed, had possession of the claimed invention.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the
right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s
contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04 (emphasis added).
The claims are drawn to a method of treating melanoma or killing cancer cells, comprising administering a therapeutically effective amount of amlexanox and a therapeutically effective amount of at least one checkpoint inhibitor. The checkpoint inhibitor is selected from the group consisting of anti-PD-1 antibodies, anti- PD-L1 antibodies, anti-CTLA-4 antibodies, anti-A2AR antibodies, anti-KIR antibodies, anti-LAG3 antibodies, anti-B7-H3 antibodies. The method further comprises administering an anticancer agent selected from the group consisting of tamoxifen, toremifen, raloxifene, droloxifene, iodoxyfene, megestrol acetate, anasfrozole, letrazole, borazole, exemestane, flutamide, nilutamide, bicalutamide, cyproterone acetate, goserelin acetate, luprolide, finasteride, herceptin, methotrexate, 5-fluorouracil, cytosine arabinoside, doxorubicin, daunomycin, epirubicin, idarubicin, mitomycin-C, dactinomycin, mithramycin, cisplatin, carboplatin, melphalan, chlorambucil, busulphan, cyclophosphamide, ifosfamide, nitrosoureas, thiotephan, vincristine, taxol, taxotere, etoposide, teniposide, amsacrine, Irinotecan, topotecan, an epothilone, gefitinib, erlotinib, sorafenib, angiogenesis inhibitors, EGF inhibitors, VEGF inhibitors, CDK inhibitors, cytokines, Her1 and Her2 inhibitors, and monoclonal antibodies. Further, the treatment may comprise as well as immune modulators (TLR agonists, TNFR superfamily agonists, cyclic dinucleotides, T-cell agonists, cytokines, chemokines, oncolytic virus, and combination thereof) or epigenetic modulatory compounds (vorinostat, romidepsin, decitabine, 5-azocytidine, panobinostat, belinostat, and combination thereof).
Also dosages and routes of administration are claimed.
The instant specification presents data showing that C57BL/6 mice inoculated
subcutaneously at the right lower flank region with MC38 (colon cancer) tumor cells and
animals treated with amlexanox + anti-PD-1 antibody +anti-CTLA-4 antibody (and the
appropriate controls) showed a marked inhibition of the tumors when compared with
controls ([0401], table 8). This is the only experimental data presented. Nevertheless,
Applicant claims (without any data) treatment methods involving a long list of general
chemotherapeutic compounds or even classes of therapeutics that are to be used. Some of the compounds are known to be used for melanoma treatment. However, a large part of them are not used for the treatment of breast and colon cancer and Applicant just listed them without any data showing that they were actually used in
the method claimed. Also, the mentioning of types of cancer and reagents under the
umbrella of “combinations thereof” is devoid of any meaning in the context of the method of treatment claimed and it shows that Applicant is trying to claim any possible therapeutic and thus, given the lack of experimental data, it is considered that Applicant is not in possession of the full scope of the claims.
The only mentioning of melanoma cells is in Example 3: Xenograft studies with other cancer cell lines: “Syngeneic immune competent tumor models can be created with murine cancer cell lines… melanoma (B16BL6, B16F10, S91). As shown in Examples 1 and 2, mice will receive a suspension of tumor cells injected subcutaneously which develops into a tumor approximately 4-6 weeks after injection. To test the efficacy of treatments on early established mouse tumors, cohorts of 10 mice per group will receive drugs (or sham controls) beginning on days 3-7 or when tumors are palpable. Drugs will be given on a daily basis, twice daily basis, several times a week or dosed continuously until mice are sacrificed at 4-6 weeks or when tumors achieve 3-5 cm in size or become ulcerated. During treatment, tumor volume is determined using three-dimensional measurements by calipers three times a week. Tumors will be collected after sacrificing and will be weighed to determine final tumor volume.”
Thus it is clear that treating melanoma or killing melanoma cells is just an aspirational project without any underpinning results.
The first paragraph of 35 U.S.C. 112 requires that the "specification shall contain
a written description of the invention * * *." This requirement is separate and distinct from the enablement requirement. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111, 1114 (Fed. Cir. 1991). See also Univ. of Rochester v.
G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004)
(discussing history and purpose of the written description requirement); In re Curtis, 354
F.3d 1347, 1357, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) ("conclusive evidence of a
claim's enablement is not equally conclusive of that claim's satisfactory written
description"). The written description requirement has several policy objectives. "[T]he
'essential goal' of the description of the invention requirement is to clearly convey the
information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977).
Another objective is to put the public in possession of what the applicant claims as the invention. See Regents of the University of California v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998). *>"The 'written description' requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent's term.
A specification may describe an actual reduction to practice by showing that the
inventor constructed an embodiment or performed a process that met all the limitations
of the claim and determined that the invention would work for its intended purpose
(Cooper v. Goldfarb, 154 F.3d 1321 , 1327, 47 USPQ2d 1896, 1901 (Fed. Cir. 1998)).
See also UMC Elecs. Co. v. United States, 816 F.2d 647, 652, 2 USPQ2d 1465, 1468
(Fed. Cir. 1987) ("[T]here cannot be a reduction to practice of the invention*** without a
physical embodiment which includes all limitations of the claim. "); Estee Lauder Inc. v.
L'Oreal, S.A., 129 F.3d 588, 593, 44 USPQ2d 1610, 1614 (Fed. Cir. 1997) ("[A] reduction to practice does not occur until the inventor has determined that the invention will work for its intended purpose."); Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1578,
38 USPQ2d 1288, 1291 (Fed. Cir. 1996) (determining that the invention will work for its
intended purpose may require testing depending on the character of the invention and
the problem it solves).
Considering all the above, a skilled artisan would conclude that Applicant was
not in possession of the invention as claimed.
If Applicant is in possession of any data supporting the claims, it is strongly suggested that the data should be presented for critical evaluation. Until then, it is submitted that the Application is not in possession of the invention as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLY GERALD STOICA whose telephone number is (571)272-9941. The examiner can normally be reached M-F 8-5 EST.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647