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 .
Application Status
Applicant’s response filed June 26, 2026 is acknowledged. Claims 1-9, 11-12, 14, 16-24, 26-28, 30-31, 33-40, and 42-43 are pending.
Restriction/Election
Applicant’s election without traverse of Group I (claims 1-9, 11-12, and 14) in the reply filed on June 26, 2026 is acknowledged. Claims 16-24, 26-28, 30-31, 33-40, and 42-43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Claims 1-9, 11-12, and 14 are under consideration hereinafter.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of Application No. CN202110413747.X has been received. However, Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date.
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. CN202110413747.X, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, Application No. CN202110413747.X does not disclose SEQ ID NOs: 43-46 recited in instant claim 7, or SEQ ID NOs: 34, 39-42, or 47 recited in instant claim 14. The first disclosure of the aforementioned SEQ ID NOs is in Application No. PCT/CN2021/133141. The effective filing date of claims 7 and 14 is November 25, 2021, accordingly. The remaining claims under examination find support in Application No. CN202110413747.X, and therefore, the effective filing date of claims 1-6, 8-9, and 11-12 is April 16, 2021.
Drawings
The drawings are objected to because of the following informalities:
37 CFR 1.84(l) states that “all drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined.” In the instant case, Figs. 7, 12, 16, 20, 23, 28, 34, 37-38, 43, 45, 47, and 49 contain illegible text which is not sufficient to provide satisfactory reproduction characteristics.
Appropriate correction is required.
Specification
The specification is objected to because of the following informalities:
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, i.e., “https://www.genscript.com.cn/industrial-grade-plasmid.html” (pg. 50). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
Claim Objections
Claim 7 is objected to because of the following informalities:
Claim 7 recites that “the replication original site comprises the following sequences: nucleotide sequences as set forth in SEQ ID NOs: 43-46….” Based on the specification, SEQ ID NOs: 43-46 are distinct replication original sites (see at least Table 28). It is clear based on the claims and specification that the precursor plasmid comprises a replication original site (i.e., one of SEQ ID NOs: 43-46), rather than each replication original site represented by SEQ ID NOs: 43-46 as the phrase “comprises the following sequences” would be literally interpreted. The claim should be amended to recite the following, accordingly: “the replication original site comprises a sequence selected from the following sequences: nucleotide sequences as set forth in SEQ ID NOs: 43-46 and nucleotide sequences that have at least 80% identity with the nucleotide sequences as set forth in SEQ ID NOs: 43-46 and can function as the replication origin.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 4-7, 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 4 recites “the loxP sequence,” “the FRT sequence,” and “the attB/attP sequence.” Claim 1 recites generic “paired recombination sites.” The generic term “paired recombination sites” does not provide sufficient antecedent basis for the aforementioned elements in claim 4, because the generic term does not explicitly or implicitly set forth any species of recombination sites, or sequences corresponding to any species of recombination sites. These terms lack sufficient antecedent basis, accordingly.
It is also not clear what the term “the attB/attP” intends to require, because to the skilled artisan, “attB” and “attP” represent distinct elements, such that the terms themselves are not interchangeable. It is not clear whether the “/” indicates, for example, that the distinct elements are alternatives and only one is required, e.g., paired recombination sites wherein each site in the pair is an attB site, or whether the “/” indicates that the distinct elements are connected in some way, such that both are required.
Claim 5 is rejected for depending from claim 4 and failing to remedy the indefiniteness.
Claim 5 recites “the lox71 sequence,” and “the lox66 sequence.” Claim 4 recites a generic “loxP sequence.” The generic term “loxP sequence” does not provide sufficient antecedent basis for the aforementioned elements in claim 5, because the generic term does not explicitly or implicitly set forth any specific species of loxP recombination site. These terms lack sufficient antecedent basis, accordingly.
Claim 6 recites “a replication original site for the pUC,” “a replication original site for the pMB1,” “a replication original site for the ColE1,” and “a replication original site for the R6Kγ.” Claim 1 recites a generic precursor plasmid comprising a generic replication original site. The recitation of a generic precursor plasmid comprising a generic replication original site does not provide sufficient antecedent basis for the specific species of replication original site recited in claim 6. Furthermore, at least the terms “pUC” and “pMB1” would be understood by the skilled artisan to refer to a genus of plasmids. It is not clear which species in the genus of pUC or pMB1 plasmids “the pUC” or “the pMB1” refers.
Claim 7 is rejected for depending from claim 6 and failing to remedy the indefiniteness.
Claim 12 recites that “the precursor plasmid can express the recombinase under suitable conditions.” The term “suitable” is a relative term, and neither the claim nor specification provide a metric for ascertaining the conditions which would be “suitable.” It is unclear what elements the precursor plasmid must comprise, in order to express the recombinase under “suitable conditions,” e.g., specific regulatory element(s), a particular recombinase sequence, etc. The scope of precursor plasmids encompassed by the claims is unclear, accordingly.
The claim will be interpreted hereinafter as requiring the coding sequence of a recombinase, as in claim 11.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-3 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 recites that “the sequences of the paired recombination sites are in the same direction.” As evidenced by the specification (see at least pg. 26), the functional limitations in claim 1, i.e., wherein the paired recombination sites enable the precursor plasmid to perform self-recombination to produce I) a daughter plasmid comprising the replication original site and the target gene or the cloning site, and II) a circular double-stranded DNA comprising the selectable marker gene, requires that the pair of recombination sites are oriented in the same direction, and positioned upstream and downstream of the replication original site and target gene/cloning site. The limitations of claim 2, therefore, are structural features inherent to claim 1, owing to the functional requirements recited therein. Claim 2 fails to further limit the subject matter of the claim upon which it depends.
Claim 3 encompasses a precursor plasmid in which the replication original site is adjacent to the target gene or cloning site, and the pair of recombination sites are positioned upstream and downstream of the replication original site and target gene/cloning site. As evidenced by the specification (see at least pg. 26), the functional limitations in claim 1, i.e., wherein the paired recombination sites enable the precursor plasmid to perform self-recombination to produce I) a daughter plasmid comprising the replication original site and the target gene or the cloning site, and II) a circular double-stranded DNA comprising the selectable marker gene, requires that the pair of recombination sites are oriented in the same direction, and positioned upstream and downstream of the replication original site and target gene/cloning site. The limitations of claim 3, therefore, are structural features inherent to claim 1, owing to the functional requirements recited therein. Claim 3 fails to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102 – Choi
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 1-6, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Choi (Choi and Lee, 2019, Microbial Biotechnology, 13(1), pg. 199-209; of record).
Regarding claims 1-3, as stated above, as evidenced by the specification (see at least pg. 26), the functional limitations in claim 1, i.e., wherein the paired recombination sites enable the precursor plasmid to perform self-recombination to produce I) a daughter plasmid comprising the replication original site and the target gene or the cloning site, and II) a circular double-stranded DNA comprising the selectable marker gene, requires that the pair of recombination sites are oriented in the same direction, and positioned upstream and downstream of the replication original site and the target gene or the cloning site. The limitations of claims 2-3, therefore, are structural features inherent to claim 1, owing to the functional requirements recited therein.
The precursor plasmid of claims 1-3 is interpreted hereinafter as a plasmid, intended to be used as a “precursor,” which comprises: 1) a selectable marker gene, 2) a replication original site adjacent to a target gene or cloning site for insertion of the target gene, and 3) paired recombination sites, wherein the paired recombination sites are oriented in the same direction, and located upstream and downstream, respectively, of the replication original site adjacent to the target gene or cloning site for insertion of the target gene.
Choi teaches a plasmid comprising 1) a selectable marker gene ("tetA(C), tetracycline-resistance gene"), 2) a replication original site ("pUC/p15A," “pUC, pUC origin of replication; p15A, p15A origin of replication”) adjacent to a target gene or cloning site for insertion of a target gene (“MCS,” “sacB,” "MCS, multiple cloning site"), and 3) paired recombination sites ("lox71," "lox66"). See "pTetSac-∆pvdD::Adaptor or PTetSac15-∆pvdD2::Adaptor” in Fig. 1 and description. As shown in Fig. 1, the paired recombination sites are oriented in the same direction, and located upstream and downstream, respectively, of the replication original site adjacent to the target gene or cloning site for insertion of the target gene. The plasmid of Choi has the same structural and organizational elements described in the specification as conferring the functional limitations of claim 1. The functional limitations of claim 1 are presumed to be inherent to Choi's plasmid. See MPEP 2112.
Regarding claims 4-5, as stated above, the plasmid of Choi comprises “lox71” and “lox66” recombination sites in the same direction (Fig. 1). Based on the specification, the term “loxP sequence” is interpreted as any loxP sequence, or derivative thereof, e.g., lox71 and lox66 (“the recombination sites loxP are the lox71 and lox66 sequences…, pg. 17-18). Choi meets the limitations of claims 4-5, accordingly.
Regarding claim 6, the replication original site is a pUC replication original site (“pUC, pUC origin of replication,” Fig. 1 and description).
Regarding claim 9, the selectable marker gene is an antibiotic resistance gene ("tetA(C), tetracycline-resistance gene," Fig. 1 and description).
Notice to Joint Inventors
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim Rejections - 35 USC § 103 – Choi in view of Engels
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 7 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Choi (Choi and Lee, 2019, Microbial Biotechnology, 13(1), pg. 199-209; of record) as applied to claims 1-6, and 9, in view of Engels (Engels et al., WO 2020/174079 A1, published 3 September 2020).
The teachings of Choi are described above and applied as to claims 1-6, and 9 therein.
Regarding claim 7, Choi teaches the plasmid comprises a pUC replication original site (“pUC, pUC origin of replication,” Fig. 1 and description), but does not teach the sequence of the pUC replication original site in the plasmid.
Engels teaches the sequence of a pUC replication original site, i.e., SEQ ID NO: 20 (“a conventional Ori derived from pUC (SEQ ID NO: 20),” pg. 33, line 28), which is 100% identical to instant SEQ ID NO: 45 as shown in the alignment in Appendix I (“Result 1”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have prepared the plasmid of Choi with the pUC replication original site sequence disclosed by Engels. It would have amounted to preparing a known plasmid with a known sequence of an element in the plasmid, by known means to yield predictable results. The skilled artisan would have had a reasonable expectation of success in preparing the plasmid of Choi with the pUC replication original site sequence disclosed by Engels because the sequence corresponds to pUC element in Choi’s plasmid, the sequence was known and functional as evidenced by Engels, and means of preparing plasmids with pUC replication original site sequences were well known in the prior art. The skilled artisan would have been motivated to use the pUC replication original site sequence disclosed by Engels in an effort to prepare the plasmid of Choi, for which no sequence information is explicitly disclosed.
Regarding claim 14, the phrase “a nucleotide sequence as set forth in SEQ ID NOs: 8, 34, 39-42, or 47” is interpreted as any two or more consecutive nucleotides (i.e., “a nucleotide sequence”) set forth in one of the recited SEQ ID NOs. SEQ ID NO: 41 comprises the sequence of SEQ ID NO: 45 (see Table 28, pg. 51), and therefore, claim 14 is also obvious for the reasons described above.
Claim Rejections - 35 USC § 103 – Choi in view of Cronan and GenBank
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Choi (Choi and Lee, 2019, Microbial Biotechnology, 13(1), pg. 199-209; of record) as applied to claims 1-6, and 9, in view of Cronan (Cronan et al., 2006, Plasmid, 55 (2006), pg. 152-157) and GenBank (Expression vector pBAD322T, complete sequence, GenBank: DQ119286.1, available 14 February 2006).
The teachings of Choi are described above and applied as to claims 1-6, and 9 therein. Choi teaches preparing the precursor plasmid in E. coli (pg. 203, right col.).
Regarding claim 8, Choi does not teach that the plasmid further comprises a rop gene sequence.
Cronan teaches that plasmids comprising a pUC replication original site are “high copy” (pg. 153, left col.). Cronan teaches that while “high copy number is of advantage in the preparation of plasmid DNA and in high-level of expression of proteins… [h]igh-level expression of proteins is often toxic to cell growth” (pg. 153, left col.). Cronan teaches that the copy number of pUC plasmids increases when rop is absent (pg. 153, left col.). Cronan teaches plasmids prepared with a rop gene (Figs. 2-3). Cronan teaches the plasmid sequences are available in GenBank (pg. 156, right col.). GenBank discloses the rop gene sequence of Cronan’s plasmid (“gene complement (4308..4499) /gene=”rop”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have prepared the plasmid of Choi with the rop gene sequence disclosed by Cronan and GenBank. It would have amounted to preparing a known plasmid with a known gene sequence suitable for inclusion in plasmids, by known means to yield predictable results. The skilled artisan would have had a reasonable expectation of success in preparing the plasmid of Choi with the rop gene sequence disclosed by Cronan and GenBank because the sequence was known and functional as evidenced by Cronan and GenBank, and means of preparing plasmids with a rop gene sequence was known in the prior art. Choi’s plasmid comprises a high copy pUC origin of replication, which Cronan teaches, despite its advantages, often results in toxic levels of protein expression. The skilled artisan would have been motivated to prepare the plasmid of Choi with the known rop gene sequence in an effort to prevent toxicity which reduces cell growth, e.g., during preparation of the plasmid in E. coli.
Claim Rejections - 35 USC § 103 – Choi
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Choi (Choi and Lee, 2019, Microbial Biotechnology, 13(1), pg. 199-209; of record) as applied to claims 1-6, and 9.
The teachings of Choi are described above and applied as to claims 1-6, and 9 therein.
Regarding claims 11-12, Choi does not teach that the plasmid further comprises the coding gene for the recombinase.
However, Choi suggests combining plasmid elements as a means to “expedite” engineering of strains using their system (pg. 208, left col.). Choi teaches a plasmid (“pRK2Cre”) which comprises a Cre recombinase controlled by an IPTG-inducible element (“PlacUV5”), which, when induced in the presence of the precursor plasmid, acts on the lox71 and lox66 sites in the precursor plasmid (pg. 200; Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the precursor plasmid with the Cre recombinase and IPTG-inducible elements of pRK2Cre in view of Choi. It would have amounted to combining a known plasmid with elements of another known plasmid, by known means to yield predictable results. The skilled artisan would have had a reasonable expectation of success that the resulting plasmid would be suitable for its purpose (i.e., recombineering), because the elements of the precursor plasmid, and Cre recombinase and IPTG-inducible elements of pRK2Cre, would be expected to have the same functions together, as when separate. Furthermore, means to prepare plasmids with desired sequences were well known in the prior art. The skilled artisan would have been motivated to combine the precursor plasmid with the Cre recombinase and IPTG-inducible elements of pRK2Cre because Choi suggests that combining plasmid elements will “expedite” engineering of strains using the system.
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.
Application No. 18/873,236
Claims 1-4, 6-8, and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-11, and 16 of co-pending Application No. 18/873,236. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons that follow. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending claim 1 recites a precursor plasmid which comprises each element of the precursor plasmid of instant claim 1, i.e., a species of replication original site (“a conditioned replication initiation site”), target gene or cloning site for inserting the target gene, a selectable marker gene (“screened tag gene”), and paired recombination sites. Co-pending claim 1 also recites the same functional requirements of the precursor plasmid as those required of instant claim 1. Therefore, co-pending claim 1 anticipates instant claim 1.
As stated above, the limitations of instant claims 2-3, are structural features inherent to instant claim 1, owing to the functional requirements recited in instant claim 1. Co-pending claim 1, which recites the same functional requirements as instant claim 1, also, therefore, anticipates instant claims 2-3.
Co-pending claim 11 anticipates instant claim 4, co-pending claim 5 anticipates instant claim 6, and co-pending claim 6 anticipates instant claim 8.
Co-pending SEQ ID NO: 8 is 100% identical to instant SEQ ID NO: 46. Thus, co-pending claim 9 anticipates instant claim 7.
Instant SEQ ID NO: 42 comprises instant SEQ ID NO: 46 (see Table 28, pg. 51), which is 100% identical to co-pending SEQ ID NO: 8. Thus, co-pending claim 9 also anticipates instant claim 14.
Claims 5, 9, and 11-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-11, and 16 of co-pending Application No. 18/873,236 as applied to claims 1-4, 6-8, and 14, in view of Choi (Choi and Lee, 2019, Microbial Biotechnology, 13(1), pg. 199-209; of record). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons that follow. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claims 5 and 9, the co-pending claims, while reciting generic “loxP” sites, and a generic “selectable tag gene,” do not recite that the loxP sites are lox71 and lox66, or that the selectable tag gene is an antibiotic resistance gene.
The teachings of Choi are described above and applied hereinafter with respect to instant claims 1-6, and 9 therein. Choi teaches a precursor plasmid substantially identical to the co-pending precursor plasmid, which comprises lox71 and lox66 sites, and an antibiotic resistance gene as a selectable marker.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the generic elements of the co-pending plasmid, for the specific elements taught by Choi. It would have amounted to substituting generic elements of a plasmid for specific elements used for the same purpose, by known means to yield predictable results. The skilled artisan would have had a reasonable expectation of success in substituting the elements, and would have been motivated to do so, because Choi’s precursor plasmid, and the co-pending precursor plasmid are substantially identical in design, and therefore, the specific elements would be predicted to function in the co-pending precursor plasmid.
Regarding claims 11-12, the co-pending claims do not recite that the precursor plasmid further comprise the coding gene for the recombinase. The teachings of Choi with respect to instant claims 11-12 is described above and applied hereinafter. The obviousness of combining the co-pending precursor plasmid, with the Cre recombinase and IPTG-inducible elements of pRK2Cre in view of Choi is described above and applied hereinafter.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNA L PERSONS whose telephone number is (703)756-1334. The examiner can normally be reached M-F: 9-5pm.
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/JENNA L PERSONS/Examiner, Art Unit 1637
/Soren Harward/Primary Examiner, TC 1600
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