DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s amendment filed on 02/17/2026 has been entered.
Amended claims 7, 10-12, 21, 23, 31, 33, 36, 39, 42 and new claim 46 are pending in the present application.
Applicant elected previously the following species without traverse: (i) the nucleic acid molecule of (1) as a third nucleic acid molecule; (ii) rpsL gene as a negative selection marker; (iii) the nucleic acid molecule of (1) as a second nucleic acid molecule; and (iii) an f-episomal factor origin of replication as a species of bacterial nucleotide sequence for single copy replication.
In light of currently amended independent claim 12, all previously withdrawn species have been rejoined and examined together with the above elected species.
Accordingly, amended claims 7, 10-12, 21, 23, 31, 33, 36, 39, 42 and 46 are examined on the merits herein.
Response to Amendment
The rejection under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for Lack of Written Description was withdrawn in light of currently amended independent claim 12.
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.
Amended claims 7, 10-12, 21, 23, 31, 33, 36, 39, 42 and 46 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. This is a modified rejection necessitated by Applicant’s Amendment.
The instant claims encompass an embodiment of a combination comprising a first separate constituent and a second separate constituent, wherein the first separate constituent comprises a third nucleic acid molecule and the second separate constituent comprises a second nucleic acid molecule, and wherein the third nucleic acid molecule comprises a nucleic acid molecule identical to the heterologous nucleic acid molecule contained in the organism deposited with the DSMZ under the Budapest treaty under accession number DSM 23754 and/or wherein the second nucleic acid molecule comprises a nucleic acid molecule identical to the heterologous nucleic acid molecule contained in the organism deposited with the DSMZ under the Budapest treaty under accession number DSM 24298 or DSM24299; and a kit comprising the same third nucleic acid molecule and the same second nucleic acid molecule.
The application discloses a third nucleic acid molecule comprising a nucleic acid molecule identical to the heterologous nucleic acid molecule contained in the organism deposited with the DSMZ under the Budapest treaty under accession number DSM 23754, and a second nucleic acid molecule comprises a nucleic acid molecule identical to the heterologous nucleic acid molecule contained in the organism deposited with the DSMZ under the Budapest treaty under accession number DSM 24298 or DSM24299, that are encompassed by the definitions for biological material set forth in 37 C.F.R. § 1.801. Because it is apparent that both the third nucleic acid molecule and the second nucleic acid molecule are essential for practicing the claimed invention, they must be obtainable by a reproducible method set forth in the specification or otherwise be known and readily available to the public as detailed in 37 C.F.R. §§ 1.801 through 1.809.
It is unclear whether the third nucleic acid molecule identical to the heterologous nucleic acid molecule contained in the organism deposited with the DSMZ under the Budapest treaty under accession number DSM 23754, and the second nucleic acid molecule identical to the heterologous nucleic acid molecule contained in the organism deposited with the DSMZ under the Budapest treaty under accession number DSM 24298 or DSM 24299 are known and readily available to the public or that the written instructions are sufficient to reproducibly construct these biological materials from starting materials known and readily available to the public. Accordingly, availability of such biological materials is deemed necessary to satisfy the enablement provisions of 35 U.S.C. § 112. If the biological material is not obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological material. In order for a deposit to meet all criteria set forth in 37 C.F.R. §§ 1.801-1.809, applicants or assignee must provide assurance of compliance with provisions of 37 C.F.R. §§ 1.801-1.809, in the form of a declaration or applicant's representative must provide a statement. Because such deposit will not have been made prior to the effective filing date of the instant application, applicant is required to submit a verified statement from a person in a position to corroborate the fact, which states that the biological material which has been deposited is the biological material specifically identified in the application as filed (37 C.F.R. § 1.804). Such a statement need not be verified if the person is an agent or attorney registered to practice before the Office. Applicant is also reminded that the specification must contain reference to the deposit, including deposit (accession) number, date of deposit, name and address of the depository, and the complete taxonomic description.
It is noted that the Examiner has repeatedly remind Applicant to comply with the Biological Deposit requirements in the Interviews dated 09/08/2025, 01/23/2026 and 02/05/2026; and yet nothing was done. Once again, please refer to the Examiner’s suggestions in the e-mail communication dated 09/09/2025 (scanned documents dated 09/18/2025).
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.
Amended claims 7, 10-12, 21, 23, 31, 33, 36, 39, 42 and 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-37 of copending Application No. 19/028,986 (reference application). This is a modified rejection necessitated by Applicant’s Amendment.
Although the claims at issue are not identical, they are not patentably distinct from each other because a combination comprising a first separate constituent and a second separate constituent, wherein the first separate constituent comprises a first nucleic acid molecule and the second separate constituent comprises a second nucleic acid molecule, wherein the first nucleic acid molecule (e.g., a nucleic acid molecule identical to the heterologous nucleic acid molecule contained in the organism deposited with the DSMZ under the Budapest treaty under accession number DSM 23754 that is identical to that of a third nucleic acid molecule of the present application; see independent claim 25) and the second nucleic acid molecule (e.g., a nucleic acid molecule comprising SEQ ID NO: 2, 13, or 14; a nucleic acid molecule identical to the heterologous nucleic acid molecule contained in the organism deposited with the DSMZ under the Budapest treaty under accession number DSM 24298 or DSM 24299; see independent claim 25) comprise the elements as recited in independent claim 25, and a kit comprising the same combination in claims 25-37 of copending Application No. 19/028,986 anticipate and/or encompass the combination comprising a first separate constituent and a second separate constituent, and a kit comprising the same combination in the application being examined and, therefore, a patent to the genus would, necessarily, extend the rights of the species or sub- should the genus issue as a patent after the species of sub-genus.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments related to the above provisional nonstatutory double patenting rejection in the Amendment filed on 02/17/2026 (pages 9-10) have been fully considered, but they are respectfully not found persuasive for the reasons discussed below.
Applicant argued basically that claims of co-pending application 19/028,986 have been amended, and that independent claim 25 is directed to the combination of the first and second nucleic acid molecules, rather than the instant claims to the third and second nucleic acid molecules; particularly the first nucleic acid molecule of co-pending application 19/028,986 does not include a nucleotide sequence encoding a negative selection marker, do not include that the exactly one recombination site is Frt or oriented in the same direction as that in the second nucleic acid molecule. Accordingly, the instant claims are patently distinct over the amended claims of the co-pending application 19/028,986.
Please note that independent claim 25 of the co-pending application 19/028,986 recites specifically “wherein the first nucleic acid molecule comprises…..or (3) a nucleic acid molecule identical to the heterologous nucleic acid molecule contained in the organism deposited with the DSMZ under the Budapest treaty under accession number DSM 23754”. Thus, the first nucleic acid molecule of the co-pending application 19/028,986 is identical to the third nucleic acid molecule of the present application. Additionally, it is noted that dependent claims 32-33 of the co-pending application 19/028,986 also recite specifically “wherein the exactly one site-specific recombination site of the first nucleic acid and the exactly one site-specific recombination site of the second nucleic acid are Frt recombination sites” and “wherein the Frt recombination site in the first nucleic acid molecule and the Frt recombination site in the second nucleic acid molecule are non-identical and/or the Frt recombination sites are oriented in the same direction”, respectively. Moreover, please note that due to the open language of the term “comprises”, the first nucleic acid molecule of the co-pending application 19/028,986 does not necessarily exclude the presence of a nucleotide sequence encoding a negative selection marker.
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 Quang Nguyen, Ph.D., at (571) 272-0776.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s SPE, James Douglas (Doug) Schultz, Ph.D., may be reached at (571) 272-0763.
To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Group Art Unit 1631; Central Fax No. (571) 273-8300.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
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/QUANG NGUYEN/Primary Examiner, Art Unit 1631
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