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 amendment and argument of 5/22/26 are entered.
Claims 1, 3-6, 9, and 12 are amended.
Claims 8 and 11 are canceled.
Claims 18-23 are newly added.
Claims 1-7, 9-10, 12 and 13-23 are pending and are considered herein.
Claim Status, Canceled Claims
In light of the cancelation of Claims 8 and 11, all rejections/objections thereto, are withdrawn.
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 1, 4, and 12 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.
Claim 1 recites “two or more genes encoding two or more therapeutic polypeptides”. It is not clear if the two or more genes each encode two or more therapeutic polypeptides, or if each gene is required to encode at least one polypeptide.
Claim 4 recites “the gene” in Claim 1. There are two genes in Claim 1. Thus there is insufficient antecedent basis.
Claim 12 depends from Claim 11, however, Claim 11 is canceled. Thus, the scope is not clear.
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 1-2, 4-7, 9-10, and 12-13 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 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.
As seen by non-rejected Claim 3 (drawn to “further comprising a promoter …”), the claims here are generic for not requiring an operatively-linked promoter to the genes encoding the therapeutic peptides in the claimed pharmaceutical composition for treating cancer.
The specification provides antecedent basis for the same, in the manner of claiming each component may be present, or not. For example page 5, paragraph 4 teaches that a promoter may be upstream of the heterologous genes. Further, the definition for promoter, on pages 28-29, paragraph bridging, it states that “Promoters provide the sequence sufficient to direct transcripton and/or recognition sites for RNA polymerase and other transcription factors required for efficient transcripton and can direct cell-specific expression.” From this we see that transcription is provided for, by way of the promoter, and transcription and translation are required for the therapeutic polypeptides to become reality. Given that the pharmaceutical composition encodes “therapeutic polypeptides” from this alone, the Artisan would understand a promoter should be part of the structure. This alone is in conflict with the depending Claim 3 declaring the presence of a promoter.
When looking to the Art it is the understanding of the Artisan that promoters allow for transcription and translation allows for the production of the protein. While it is assumed Applicant is well aware the basics of the science, the Examiner cites Clancy, et al. (2008) “Translation: DNA to mRNA to Protein”, Nature Education, 1(1): 101, printed from Translation: DNA to mRNA to Protein | Learn Science at Scitable, 7 pages as printed. Figure 1 is an overview of the process of protein production from DNA sequence, to polypeptide. Figure 3 demonstrates the presence of a promoter for transcription.
Thus, given the lack of showing how else to obtain a therapeutic polypeptide in any other way than having a promoter, and general knowledge in the Art that a promoter is present for transcription, the Artisan would not have understood Applicant to have been in possession of the absence of a promoter in such pharmaceutical composition.
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, 9-10, 12 and 13-23 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 have been amended to specifically claim a generic composition for treating cancer, the composition being a synthetic circular DNA vector that lacks an ORI, lacks a drug resistance gene, and lacks a site-specific recombination recognition site, and also carries at least two genes, each gene encoding a generic therapeutic polypeptide, the two genes being 10Kbp or greater, in combined size.
The specification teaches a large number of genes, both specific and generas of genes, interspersed with diseases, of which cancer is a member (e.g., pp. 2-20). Specifically, toward cancer, P53 and HSV-TK are taught among other genes (e.g., p. 39, paragraph 4). Further, with regard to the combination being larger than 10Kb, the specification separately teaches a single gene may be in ranges including 10kb and may be about 10kb (e.g., p. 39), the one or more heterologous genes, alone or together, may be in ranges including 10kb or about 10kb (e.g., p. 6, paragraph 2), and the or more genes may be 4.5kb, and several ranges including 10kb (e.g., pp. 18-19, paragraph bridging). However, there exists no single example of two proteins that encoded are at least 10kb in size combined and are therapeutic for cancer.
Looking to art, the Art provides a few examples of dual gene therapy for cancer. For example, at the time of invention, it was known to utilize CD and HSV-TK to treat cancers in a suicide gene therapy protocol, treating further with 5-Fluorocytosine and ganciclovir (e.g., Kubo, et al. (2018) “Dual-vector prodrug activator gene therapy using retroviral replicating vectors”, Cancer Gene Therapy, 26(5): 128-35, e.g., ABSTRACT). However, cytosine deaminase is between about 150 and 426 amino acids in size, depending on source organism, which is at most 1278 bases long, while HSV-tk is about 2300 bases long. These sequences are 3578 bases long, which is much smaller than the minimal requirement of 10 kilobases in length.
Given the lack of any exemplary embodiments of combined genes encoding cancer therapeutic proteins, in the context of the particular vectors lacking the elements of origin of replication, recombination site, and drug resistance site, and lack of prior art recognizing dual gene therapy for cancers with combinations of genes that are over 10 kilobases in length, the Artisan would not have understood applicant to have been in possession of the invention at the time of filing.
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.
In light of the amendments to dual genes larger than 10 kilobases in total size, combined with the composition being amended to treating cancer, the rejections of the claims on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11,324,839; claims 1-23 of U.S. Patent No. 11,602,569; claims 1-17 of U.S. Patent No. 11,684,680 claims 1-28 of U.S. Patent No. 11,766,490; claims 35-44 of copending Application No. 18/626,384 are withdrawn.
To wit, the combination of size and number of genes, in the context of treating cancer is not obvious, for similar reasoning as provided in the written description rejection, above.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(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.
In light of the amendments, the rejections of Claim(s) 1-2, 5-7, 10, 12, and 15-16 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by U.S. Patent No. 9,931,392 to Wren, et al., are withdrawn.
To wit, the new combination of elements is not taught, nor obvious, for similar reasoning as the written description rejection above.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(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.
In light of the amendments, the rejections of Claim(s) 1-2, 4-7, 10, 12, and 15-17 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by U.S. Patent No. 9,796,986, to Schroeder, et al., are withdrawn.
To wit, the combination of amended elements is not obvious, similar to the reasoning as the written description rejection, above.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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