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 .
Applicant’s response to restriction requirement and amendment of 9/2/26 are entered.
The amendment is a restatement of claims, with claim identifiers for withdrawn claims.
Claims 34-63 remain pending.
Formalities:
Applicant’s IDS filings of 5/15/25; 1/22/26; and 9/2/26, and references therein, have been considered. A signed copy is provided herewith.
The drawings of 11/12/24 are accepted.
The specification of 4/4/24 is accepted.
Applicant’s priority is noted to be:
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Election/Restrictions
Applicant’s election of the species of S223L in SEQ ID NO: 2, the mutants of Claims 36 and 40, Adenoviral and AAV, and glioma, in the reply filed on 9/2/26 is acknowledged. 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Claims 42, 44-46, 50, 56-57, 59-60, and 62 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/2/26.
Claims 34-41, 43, 47-49, 51-55, 58, 61, and 63 are considered with respect to the elected species.
However, if other species are realized for any particular rejection/objection, the appropriate rejection/objection will be provided, regardless of being to withdrawn species.
Claim Objections
Applicant is advised that should claim 47 be found allowable, claim 51 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 47 is to a cell comprising the vector of claim 34, while Claim 51 directly describes the structure of a cell comprising a structure which is the same as Claim 34. Thus, despite a slight difference in wording, these claims have substantially the same scope.
Applicant is advised that should claim 48 be found allowable, claims 53-54 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Similar to the comparison of Claims 47 and 51 above, the only distinction between the cancer cell of Claim 48 and Claim 53 is that the base claim of Claim 34 is simply to the vector, while separately claiming the cell in the dependency chain, while Claim 53 depends from Claim 51 which combines the vector into the cell in a single claim. Thus, despite a slight difference in wording, these claims have substantially the same scope.
Applicant is advised that should claim 53 be found allowable, claim 54 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 54 depends from Claim 53, but limits the cell to being a tumor cell. Claim 53 requires the cell to be a cancer cell. All cancer cells are tumor cells. Thus, despite a slight difference in wording, these claims have substantially the same scope.
Applicant is advised that should claim 49 be found allowable, claim 55 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claims 49 and 55 cover the same Markush of cell types. The distinction between these claims is that the dependency chain adds structure to arrive at the same transfected cell types differently. Thus, despite a slight difference in wording, these claims have substantially the same scope.
Applicant is advised that should claim 50 be found allowable, claim 62 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claims 50 and 62 cover the same non-cancer cells. The distinction between these claims is that the dependency chain adds structure to arrive at the same transfected cell types differently. Thus, despite a slight difference in wording, these claims have substantially the same scope.
Applicant is advised that should claim 61 be found allowable, claim 63 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 61 and 63 differ only in that the metastatic cell’s structure is added by way of dependency for Claim 61, and is claimed in one claim in Claim 63. Claim 61 does not state that the cell is cancerous, but all metastatic cells are cancerous. Despite a slight difference in wording, these claims have substantially the same scope.
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 35-40, 47-48, 51-57, 59-61 and 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,980,670. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 34: Claims 1, 18, and 24 describe cancer migration mitigation, detecting migration/development of cancer, and treating cancer, respectively, which comprise expressing nucleic acids/vectors comprising similar PCBP1 polypeptides comprising the same mutations from SEQ ID NO: 2 (Claims 1 and 18) and more generally described as reduced phosphorylation of a KH domain (which is the purpose for these mutations) in Claim 24. Thus, the structure of the vectors is described in the performance of these claims.
Claim 35: Claim 16 teaches C668T versus SEQ ID NO: 1.
Claim 36: Claim 17 teaches A178G and A379G versus SEQ ID NO 1.
Claim 37: Claims 1 and 18 specifically list S223L.
Claim 38: Claims 1, 17 and 18 teach T60A and T127A versus SEQ ID NO: 2.
Claim 39: Claim 8 teaches SEQ ID NO: 3, which has the mutation C668T already.
Claim 40: Claim 8 teaches SEQ ID NO: 5.
Claims 47-48: e.g., Claims 1, 18 and 24 teach cancer cells. In each instance, the result of the method requires transfection of the cancer cells with vectors to express the polynucleotide.
Claim 49: the cancer cell may be melanoma, prostate, ovarian or breast cancer (e.g., Claim 4).
Claim 51: As a consequence of the claims, e.g., Claims 1, 18 and 24, cells are necessarily transfected with the nucleic acid and express it.
Claim 52: Claim 23 requires PRL-3 be expressed.
Claim 53: Claims 1, 18 and 24 require cancer cells.
Claim 54: Claims 6, 20 and 24 teach tumor cells.
Claims 55-57 and 59-60: Claim 4 teaches melanoma, prostate, ovarian, and breast cancers.
Claim 61: Claims 19 and 24 teach metastatic cells.
Claim 63: As in Claims 1, 18 and 24, the result is that the cells are producing the variant claimed.
Thus, in light of the patent, the invention is obvious. The Artisan would make the compositions in the performing, and as a result of performing, the methods claimed in the patent. The Artsian would expect success, as it is claimed.
+ AAV vectors
Claims 35-43, 47-48, 51-57, 59-61 and 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,980,670 in view of Li, et al. (2008) “Engineering and Selection of Shuffled AAV Genomes: A New Strategy for Producing Targeted Biological Nanoparticles”, Molecular Therapy, 16(7): 1252-60.
As shown above, the various aspects are taught in the patent, however, the aspect of AAV vectors are not specifically claimed. Noted, however, is that transfection of Melanoma cells is certainly one embodiment (e.g., Claim 4).
On the other hand, Li teaches targeted transfection of melanoma cells with a chimeric AAV, i.e., “Chimeric-1829” which targets melanoma cells (e.g., ABSTRACT).
Thus, in light of Li, the Artisan would modify the patent, to utilize the AAV vectors of Li. The Artisan would do so to target melanoma cells, as claimed in the patent, and known to target the same cells by way of Li. The Artisan would expect success, as the components are utilized for Art recognized purposes.
+glioblastoma
Claims 35-40, 47-61 and 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,980,670 in view of Schonberg, et al. (2015) “Preferential Iron Trafficking Characterizes Glioblastoma Stem-Like Cells” Cancer Cell, 28: 441-55.
As shown above, the various aspects are taught in the patent, however, the aspect of performing this on Glioblastoma cancer cells is not specifically claimed.
On the other hand, Schonberg evidences that it is common knowledge in the Art that glioblastoma uses PCBP1 and this may be utilized in therapies for the same (e.g., p. 451, paragraph 1).
Thus, in light of the knowledge in the art as evidenced by Schonberg, it would be obvious to modify the invention of the patent to utilize glioblastoma cells. The Artisan would do so because it was known to express the PCBP1 and known as a potential avenue for therapies. The Artisan would expect success, as it is claimed and utilized for known purposes.
Claims 34, 47, 50, 51, and 62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 10-24 of copending Application No. 17/591,309 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 34, 47, 50, 51, and 62: Claim 1 teaches inducing iPS cells from a PCBP1 sequence comprising 70% identity SEQ ID NO: 1 and encoding a protein of 90% identity to SEQ ID NO: 2 (the sequences match present SEQ ID NO: 1 and SEQ ID NO: 2). Claim 12 teaches similar, but requires one of a markush of mutations, including s223L. Moreover, the cells are not cancerous (e.g., Claims 1 and 12).
Claims 41, 43
Thus, in light of the reference, the invention is obvious, the Artisan would make it in the process of performing the methods, and as a consequence of the methods claimed. The Artisan would expect success, as it is claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
+AAV
Claims 34, 41, 43, 47, 50, 51, and 62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 10-24 of copending Application No. 17/591,309 in view of Khan, et al. (2010) “Engineering of Human Pluripotent Stem Cells by AAV-mediated Gene Targeting”, Molecular Therapy, 18(6): 1192-99.
As shown above, the various aspects are taught in the reference claims. However, the aspect of an AAV vector is not claimed.
On the other hand, Khan teaches transfection of fibroblasts to make iPSCs using AAV as a vector (e.g., ABSTRACT).
Thus, in light of Khan, the Artisan would modify the reference, to utilize the AAV vectors as taught by Khan. The Artisan would do so to target fibroblasts. The Artisan would expect success, as the components are utilized for Art recognized purposes.
This is a provisional nonstatutory double patenting rejection.
Claims Free of the Art of Record
The Examiner has found no prior art to disclose or make obvious the particular mutations found in the base claims. Applicant’s advantage in cancer is shown to have utility. Thus, the claims are free of the Art of Record.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/ Primary Examiner, Art Unit 1638
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