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 II (claims 5-7 and 11-12) in the reply filed on 7/2/2026 is acknowledged.
Claims 4, 9 have been canceled, claims 1-3, 8, 10 and 13-14 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 5-7 and 11-12 have been considered on the merits.
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 7 and 12 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.
Claims 7 and 12 disclose the various “variants” or “derivatives” of the above-mentioned transposons.
Applicant generically claims the mammalian cell comprising the “derivatives” of transposons listed in the claims. However the specification does not contain an adequate description for the entire scope of this limitation and thus the claims. The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
There is no specific variants or derivatives of each transposon in the instant specification, and the specification fails to provide how to prepare variants and/or derivatives of the listed transposons.
In the absence of such description, it is considered that the instant specification fails to provide sufficient written description for the “derivatives” or “variants” of the transposon such that the invention had possession on the entire scope of the claimed genus.
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 5-7 and 11-12 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 5 is dependent on the withdrawn claim 1, and thus, the limitation directed to “the method of claim 1” renders claim 5 and its dependent claims indefinite.
Applicant is advised to disclose the subject matter of claim 1 in claim 5.
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)(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.
Claim(s) 5-7 and 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by George, JR. et al. (US2009/0042297A1) and as evidenced by Lentivirus Packaging Cell Line (2026, Bioinnovatise).
George, JR. et al. teach the use of transposon such as PiggyBac for simultaneous stable delivery of multiple genes in vivo or in mammalian cells in vitro such as HEK-293 cells, and this approach allows for stable cell line generation and regulate transgene expression in vivo (para. 316, 322). The plasmid comprising a transposon system taught by George, JR. et al. is considered to integrate into the genome.
George, JR. et al. also teach the use of two transposons comprising SB12/pT3 combination in HEK293 cells (para. 303, 309). SB12 is a hyperactive Sleeping Beauty transposase, and pT3 is a hyperactive SB transposon with identical IR elements (para. 9), and the combination of SB12 and pT3 is considered to meet the two transposons selected from SB transposon and its variants or derivatives in claim 7 because SB12 and pT3 are variants of SB transposon.
As it appears that SB12 and pT3 might overlap the sequence as they are variants of SB, this teaching does not address the limitation of claim 6.
However, George, JR. et al. also teach that multiple rounds of delivery such as piggy-Bac followed by SB and then phiC31 can also achieve the same end products (para. 323), and this teaching would meet the two transposon systems (piggy-Bac and SB) stably transfected into HEK-293 cells and their sequences should not be overlapping each other as they are two different transposon systems. Thus, this teaching would meet the limitations of claims 5-7 and 12.
Regarding claim 11 directed to the lentivirus producing cell line, George, JR. et al. teach HEK-293 cells and HeLa cells for expressing the plasmids comprising transposons. It is considered that these cell lines would meet the limitation as HEK293 cells and HeLa cells are known in the art for lentivirus packaging cell lines according to Lentivirus Packaging Cell line (p.4).
Thus, the reference anticipates the claimed invention.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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(s) 5-7 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over George, JR. et al. (supra) in view of Pule et al. (US2019/0055568A1; of record).
George, JR. et al. teach the subject matter of claims 5-7 and 11-12 as discussed above, and thus, render them obvious.
Regarding the lentivirus packaging cell line, although claim 11 does not particularly limits the type of cell line, it is extremely well known in the art that 293T cells which are derived from HEK-293 cells are used for transfecting piggyBAC transposase expression plasmid according to Pule et al. (Example 2; para. 270) In fact, the instant specification discloses 293T cells as an example of a lentivirus packaging cell line.
Thus, it would have been obvious to a person skilled in the art to use 293T cells for the expression of multiple transposons (e.g. piggyBac and SB) taught by George, JR. et al. with a reasonable expectation of success.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
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 5-7 and 11-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-9 of copending Application No. 17/766,684 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘684 application are directed to a method for preparing a producer cell for producing a retroviral vector carrying a nucleic acid fragment of interest, thus, a mammalian cell for packaging retrovirus including lentivirus, and the viral genome carrying the nucleic acid fragment of interest into the genome of a host cell using a Sleeping Beauty transposon system and a PiggyBac transposon system. Thus, the resulting cells would comprise two different transposons integrated into the genome of the host cells. While the host cells are not particularly disclosed as a lentivirus packaging cell line, however, it would have been obvious to a person skilled in the art to use a lentivirus packaging cell line for the lentiviral vector producing cells. The two PB and SB transposon systems integrated into the host cells produced by the method of the ‘684 application anticipate the claimed product of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAEYOON KIM whose telephone number is (571)272-9041. The examiner can normally be reached 9-5 EST Monday-Friday.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631
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