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 1-5, 7-9, 13, 15-17, 21, 23, 26-27 and 30-32) and of the species represented by SEQ ID NO: 1 in the reply filed on 12/23/2025 is acknowledged. Upon further consideration, the Election/ Restriction requirement is withdrawn and all the pending claims are examined. Claims 1-3, 5, 7-10, 13, 15-17, 21, 23, 26-27, and 30-32 are pending and are examined.
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.
Claims 1-3, 5, 7-10, 13, 15-17, 21, 23, 26-27, and 30-32 are 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 claims are drawn to a method of treating or preventing a cancer in a subject, said method comprising: administering to the subject at least one immunogenic peptide, a nucleotide sequence that expresses the immunogenic peptide, or combinations thereof, wherein the immunogenic peptide is expressed by one or more chimeric nucleotide sequences derived from cells associated with the cancer, wherein the cells associated with the cancer comprise cancer cells and cells near the cancer cells, wherein the one or more chimeric nucleotide sequences have a higher prevalence in cancer cells when compared to non-cancer cells, wherein the immunogenic peptide comprises a neoantigenic region, and wherein the immunogenic peptide elicits an immune response against cells associated with the cancer.
For a method of treatment, it unclear if the “subject” represents the general population of organisms at large or is it a subject in need of treatment. Further, the method claimed is being considered as incomplete for omitting essential elements, such omission amounting to a gap between the elements. The omitted elements are:
The dosage, administration regimen, length of treatment and metrics to assess the effectiveness of the treatment.
As such the metes and bounds of the method cannot be determined.
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, 8-9, 13, 15-17, 21-27 and 30-32 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 contain 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 inventors, 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.
For a claim to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of the genus must be capable of doing, not of the substance and structure of the members.
“[A] sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
Lastly, even if a selection procedure is disclosed that was, at the time of the invention, sufficient to enable the skilled artisan to identify antibodies with the recited functional properties, the written description provision of 35 U.S.C § 112 is severable from its enablement provision. Ariad, 94 USPQ2d at 1167; Centocor at 1876.
In the instant case, the specification discloses a method of treating (and not preventing) breast cancer by administering immunogenic peptides selected from the group consisting of SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 16 and SEQ ID NO: 17 expressed at the junction point at the junction region between NSF and LLRC37A3 (NSF-LRRC37A3) derived from cells associated with breast cancer. However, the claims are drawn to a method of treating or preventing any (all?) cancer by using a genus of reagents described by functionality or provenience only.
First of all, as disclosed in the Specification, the only type of cancer treated is breast cancer. There are at least 300 hundreds of types of cancer existent (since any type of cell may develop the morphologic and functional characteristics of a “cancer” cell) (see for example: (https://en.wikipedia.org/wiki/List_of_cancer_types- accessed 05/22/2020; https://www.cancer.gov/about-cancer/understanding/what-is-cancer). Clearly treating just breast cancer does not represent the genus of methods of treatment of all cancers. Further, the prevention aspect of the claims is totally lacking any support since the phrase "preventing a disorder", given its broadest reasonable interpretation in light of the teachings in the specification, requires that absolutely no cell, nor tissue, or individual would present any symptom of a disorder after treatment with the regents claimed. There is no evidence, either in the specification or in the prior art, that any method to date can accomplish this goal.
Second, regarding the reagents to be used in the method, Applicant is claiming an enormous genus, characterized by functionality and provenience while presenting evidence of use in treatment of just 4 species. Given the vast genus claimed without any common structures, a person of ordinary skill in the art would be forced to conclude that the specification fails to disclose a representative number of species to describe the claimed genera.
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 is rejected under 35 U.S.C. 102)a)(1) as being anticipated by Artomov et al. (WO2017177207 -cited by Applicant).
The reference a method of selecting a therapeutic fusion-specific vaccine for a cancer patient, the method comprising: a) determining the presence of one or more tumor-specific gene fusions in a biological sample from the cancer patient; b) obtaining information relating to one or more HLA alleles of the cancer patient; c) analyzing a library of fusion-specific vaccines, wherein each fusion specific vaccine in the library comprises one or more fusion-derived neoantigens having a nucleic acid sequence and/or an amino acid sequence corresponding to one or more tumor-specific gene fusions; and d) selecting at least one fusion specific vaccine in the library as the therapeutic fusion-specific vaccine for the cancer patient by selecting the fusion-specific vaccine comprising one or more fusion-derived neoantigens that i) correspond to one or more tumor-specific gene fusions of the cancer patient, and ii) bind one or more HLA alleles of the cancer patient (claims). This method claimed was validated in Example 9: two most frequent types of the EWSR1 /FLl1 fusion, which is found in Ewing's sarcoma, occur due to junction of exon 7 of the EWSR1 gene with exon 5 or exon 6 of the FLU gene; fusion-derived peptides having 8-10 amino acids corresponding to the fusion junction were used for predicting peptide binding to MHC class I proteins (see Table 10).
Thus, in the broadest reasonable interpretation, claim 1 is anticipated by the reference cited.
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