DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicants’ submission filed on 6/5/2026 has been entered.
Claims 19-23, 26-30 and 33-40 are pending.
This application is a 371 filing of PCT/ES2020/070315 filed 5/15/2020 which claims priority to Spanish applications ESP201930427 and ESP201930428 both filed 5/15/2019. All of the prior art documents are provided in English.
Response to Amendments
Applicants’ amendments are sufficient to overcome the objections to the drawings.
Claim Objections
Claims are objected to because of the following informalities: “SEQ ID NO:” is misspelled in each of the claims 26 and 39. As well, in part B) the sentence lacks a verb prior to “the nucleotide sequence of SEQ ID NO:2”.
Appropriate correction is required.
Claims 27-29 are objected to under 37 CFR 1.75 as being a substantial duplicate of claim 26. 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). While the claims might intend on limiting the composition to the DNA over the RNA, the claim actually recites properties already recited within claim 26 and that is that the first DNA comprises the sequence of SEQ ID NO:1 and the second SEQ ID NO:2.
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 34 is 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. This is a new rejection necessitated by applicants’ amendment.
Claim 34 lacks antecedent basis for “the RNA encoding the nucleotide sequence of SEQ ID NO:1” in claim 19. SEQ ID NO:L1 is a DNA sequence and encodes the RNA. Hence, it is unclear if applicants intend the RNA or the DNA sequence encoding the RNA.
Claim Rejections - 35 USC § 112, first paragraph
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.
Claims 21, 23, 30, 35, 36 and 40 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new rejection upon reconsideration.
The claims are drawn to a composition used to treat breast, colon or cervical cancer. The composition comprises either a DNA sequence or the encoded RNA sequence wherein the sequence encodes hokD and ldrB respectively. These are two bacterial toxin/antitoxin modules (TA) called hokD (SEQ ID NO:1) and ldrB (SEQ ID NO:2).
[0030] The inventors have selected two genes, hokD and ldrB, to study their behavior in eukaryotic cells, since they may be possible new candidates for being used in the suicide gene therapy in cancer given their many qualities in causing death in the host cell.
Claims 21, 23, 30, 35, 36 and 40 refer to either just hybrid DNA/RNA or a combination of the hybrid DNA/RNA and the recited DNA/RNA of the base claims. It is not clear what these hybrids are structurally or functionally. As well, the disclosure does not use the term hybrid nor does it describe hybrid DNA/RNA. The MPEP teaches, “New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads). (see e.g. MPEP 2105). Hence, claims drawn to hybrids lack adequate description.
Double Patenting
A rejection based on double patenting of the "same invention" type finds its support in the language of 35 U.S.C. 101 which states that "whoever invents or discovers any new and useful process ... may obtain a patent therefor ..." (Emphasis added). Thus, the term "same invention," in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957); and In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
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. See 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);and, 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 19-23, 26-30 and 33-40 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1, 2, 5, 6 and 8-14 of copending Application 18/704,750. Because rejections remain, this rejection is maintained.
Because none of the applications have restriction requirements present, there is no prohibition against double patenting.
Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims recite compositions and methods of treating a proliferative disease using hokD and/or ldrB. The difference between the two is that the instant claims use the SEQ ID NO:1 while the copending claims refer to the sequence by name. It would have been obvious to one of ordinary skill at the time of the invention was made to use the disclosed sequences which are present in both applications as SEQ ID NO:1 and 2. Specifically copending Application 18/704,750 discloses that hokD and ldrB are inherently SEQ ID NO:1 and 2. Based upon the teachings of the cited references, the high skill of one of ordinary skill in the art, and absent evidence to the contrary, there would have been a reasonable expectation of success to result in the claimed invention.
Additionally, if a patent resulting from the instant claims was issued and transferred to an assignee different from the assignee holding a patent from copending Application 18/704,750, then two different assignees would hold a patent to the claimed invention of copending Application 18/704,750, and thus improperly there would be possible harassment by multiple assignees.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
Prior art identified but not cited US 20190169623, Starlz et al.
SEQ ID NO:2 sequence is disclosed as a cell death gene (SEQ ID NO:127) by Starzl, ¶0080). However, this sequence is not cited for use in proliferative disorders and there is no evidence that HokD is known to be used in proliferative disorders.
0080] In some embodiments, the synthetic microorganism comprises a kill switch molecular modification comprising a cell death gene selected from the group consisting of sprA1, sprA2, kpn1, sma1, sprG, relF, rsaE, yoeB, mazF, yefM, or lysostaphin toxin gene. In some embodiments, the cell death gene comprises a nucleotide sequence selected from the group consisting of SEQ ID NOs: 122, 124, 125, 126, 127, 128, 274, 275, 284, 286, 288, 290, 315, and 317, or a substantially identical nucleotide sequence.
SEQ ID NO 127 <211> LENGTH: 156 <212> TYPE: DNA <213> ORGANISM: Escherichia coli <400> SEQUENCE: 127
atgaagcagc aaaaggcgat gttaatcgcc ctgatcgtca tctgtttaac cgtcatagtg 60
acggcactgg taacgaggaa agacctctgc gaggtacgaa tccgaaccgg ccagacggag 120
gtcgctgtct tcacagctta cgaacctgag gagtaa 156
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/MARIA MARVICH/Primary Examiner, Art Unit 1634
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