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 with traverse of Group II, claims 13-20, in the reply filed on 20 January 2026 is acknowledged. The traversal is on the ground(s) that the examiner has not shown that a serious search burden would result if all of the claims were examined together as required by 35 USC 121. This is not found persuasive because the instantly pending restriction requirement, mailed 25 November 2025, demonstrated that a lack of unity between the Groups as required by 37 CFR 1.475(a). Because the instant application is a 371 of PCT/US2021/048947, the lack of unity analysis done in the instantly pending restriction requirement is proper and demonstrates a lack of unity between the Groups. As applicant has not provided any specific arguments pertaining to the lack of unity analysis performed in the restriction requirement mailed 25 November 2025, accordingly, applicant’s arguments filed 20 January 026 are not found persuasive.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-2 and 4-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 20 January 2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Rejections - 35 USC § 103
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 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) 13-16 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pulé (PG Pub No. WO 2019/081935 A1, published 2 May 2019) in view of Close (Sensors 12.1 (2012): 732-752).
Regarding claim 13, Pulé is drawn towards an invention that utilizes a kit of vectors for the transduction of an immune cell with multiple transgenes (Abstract). Pulé teaches the use of two vectors, wherein the first vector comprises a first expression cassette that encodes a) a first promoter that is operably linked to c) a transcription factor and the second vector comprises a second expression cassette that encodes a) a second promoter that is operably linked to d) a sequence that is dependent on the transcription factor supplied by the first vector in order to express e) transgenes of interest (pg. 2, 27-28, 59; see Fig. 1 and Claim 1). Pulé teaches that the transcription factor may be a eukaryotic QF transcriptional activator that binds to a QF upstream activating sequences (QUAS) (i.e., a transcription factor binding sequence) (pg. 7) operably linked to the second promoter of the second vector (pg. 56; see FIG. 11). Pulé teaches that the promoter sequences may be from a prokaryote (pg. 23-24). Pulé teaches that e) the system can be utilized to express genes of interest within cells of interest (i.e., one or more genes of interest is regulated by the binding of the eukaryotic transcription factor to the eukaryotic transcription factor binding site sequence) (pg. 9, pg. 56; see FIG. 11). Pulé teaches that the first vector may comprise a marker gene (i.e., an operon) so that successful transduction of the system can be detected (pg. 2, 32-33, 56; see FIG. 1 and 11). Pulé teaches that bacterial neomycin and hygromycin phosphotransferase genes that confer resistance to G418 and hygromycin, respectively, can be utilized as marker genes alongside other bacterial marker genes (pg. 33).
Pulé does not teach or suggest the use of an operon, wherein the operon is endogenous to a prokaryotic cell (Claim 13).
However, one of ordinary skill in the art would have considered the teachings of Close as both references are common fields of endeavor pertaining to the use of marker genes.
Close is directed towards a study concerned with the use of a bacterial luciferase gene cassette (i.e., termed lux) as a reporter system (i.e., an operon which is endogenous to a prokaryotic cell) (Abstract). Close teaches that the lux operon can be utilized as a transgenic reporter system because of its facile detection and the ease of quantification of visible light produced by the lux proteins encoded by the operon (pg. 735). Close teaches that the lux operon could be operably connected to an inducible promoter in vivo to visualize gene expression (pg. 736).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the marker protein of Pulé for a lux operon that is endogenous to a prokaryotic cell, as described by Close. A person of ordinary skill in the art would have been motivated to do so in order to utilize a reporter system that is known in the art to easily quantify gene expression. A person of ordinary skill in the art would have had a reasonable expectation of success because both Pulé and Close teach the use of reporters that are operably connected to promoters of interest in order to detect gene expression.
Regarding claims 14-16, Pulé teaches that the transcription factor may be a eukaryotic QF transcriptional activator and the eukaryotic transcription factor binding site sequence may be a QUAS sequence (pg. 56; see FIG. 11).
Regarding claim 19, Pulé teaches that the marker gene is located between the first promoter and the transcription factor (pg. 2, 32-33, 56; see FIG. 1 and 11).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pulé (PG Pub No. WO 2019/081935 A1, published 2 May 2019) in view of Close (Sensors 12.1 (2012): 732-752) as applied to claims 13-16 and 19 above, and further in view of Kesik-Brodacka (Microbial Cell Factories 11.1 (2012): 109).
Regarding claim 17, Pulé in view of Close anticipates claims 13-16 and 19 as described above.
Pulé in view of Close does not teach or suggest that the first and second promoters are T7 promoters (Claim 17).
However, one of ordinary skill in the art would have considered the teachings of Kesik-Brodacka as both references are common fields of endeavor pertaining to the use of prokaryotic promoters.
Kesik-Brodacka is directed towards a study concerned with expression systems utilizing a T7 promoter (Abstract). Kesik-Brodacka teaches that the T7 promoter is a known prokaryotic promoter that can drive expression of recombinant proteins at a large scale (Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the prokaryotic promoter of Pulé in view of Close for a T7 promoter, as described by Kesik-Brodacka. A person of ordinary skill in the art would have had a reasonable expectation of success because Pulé in view of Close teaches the use of prokaryotic promoters and Kesik-Brodacka teaches that T7 promoters were known prokaryotic promoters.
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pulé (PG Pub No. WO 2019/081935 A1, published 2 May 2019) in view of Close (Sensors 12.1 (2012): 732-752) as applied to claims 13-16 and 19 above, and further in view of Sweet (E. coli Plasmid Vectors: Methods and Applications. Totowa, NJ: Humana Press, 2003. 277-288).
Regarding claim 17, Pulé in view of Close anticipates claims 13-16 and 19 as described above.
Pulé in view of Close does not teach or suggest that the first and second promoters are T7 promoters (Claim 17). Pulé in view of Close does not teach or suggest that the operon is a lac operon (Claim 18).
However, one of ordinary skill in the art would have considered the teachings of Sweet as both references are common fields of endeavor pertaining to the use of prokaryotic promoters and operons.
Sweet is directed towards a study concerned with the expression of recombinant proteins from lac promoters (Abstract). Sweet teaches the use of a system, termed T7lac, wherein a plasmid bearing the gene of interest contains a lac operator sequence (i.e., a lac operon) just downstream of a T7 promoter (pg. 281). Sweet teaches that the system completely inhibits leaky expression of the gene of interest (pg. 281).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the prokaryotic promoters and operon of Pulé in view of Close for a T7 promoter and a lac operon, as described by Sweet. A person of ordinary skill in the art would have been motivated to do so in order to eliminate leaky expression of the gene encoded by the first vector. A person of ordinary skill in the art would have had a reasonable expectation of success because Pulé in view of Close teaches the use of prokaryotic promoters and a bacterial operon and Sweet teaches that T7 promoters and lac operons were known to synergistically prevent leaky expression of a transgene of interest when present in a plasmid.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pulé (PG Pub No. WO 2019/081935 A1, published 2 May 2019) in view of Close (Sensors 12.1 (2012): 732-752) as applied to claims 13-16 and 19 above, and further in view of Molina (PG Pub No. US 2014/0107190 A1).
Regarding claim 20, Pulé in view of Close anticipates claims 13-16 and 19 as described above.
Pulé in view of Close does not teach or suggest the use of a prokaryotic cell comprising the inducible binary expression system of claim 13 (Claim 20).
However, one of ordinary skill in the art would have considered the teachings of Molina as both references are common fields of endeavor pertaining to the use of multiple vectors that can be utilized to express transgenes of interest within target cells.
Molina is drawn towards a study concerned with an expression system for use in a host cell comprising a first construct with a prokaryotic promoter that is linked to a bacterial transcription repressor (i.e., a transcription factor) and a second construct comprising a prokaryotic promoter linked to a transcription factor binding site ([0002], see Claim 36). Molina teaches that the host cell may a bacterial host cell ([0097]). Molina teaches that the system can be utilized for the production of products of interest in the host cells (Abstract) and teaches that utilizing bacterial cells at a production scale as host cells allows for the production and isolation of a large amount of proteins of interest ([0130]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the host cell of Pulé for the bacterial host cell of Molina. A person of ordinary skill in the art would have been motivated to do so in order to produce a large amount of therapeutic proteins of interest. A person of ordinary skill in the art would have had a reasonable expectation of success because both Pulé and Molina teach methods of utilizing dual-vector systems that allow for a transcription factor encoded by a first vector to influence the expression of a second vector in a host cell of interest.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE T REGA whose telephone number is (571)272-2073. The examiner can normally be reached M-R 8:30-4:30, every other F 8:30-4:30 (EDT/EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached at 571-270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE T REGA/Examiner, Art Unit 1636
/NEIL P HAMMELL/Supervisory Patent Examiner, Art Unit 1636