DETAILED ACTION
Receipt of Arguments/Remarks filed on February 18 2026 is acknowledged. Claims 1-28 are pending. Claims 19-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on September 30 2025. Claims 1-18 are directed to the elected invention.
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 .
Withdrawn Objections/Rejections
The amendments filed February 18 2026 are sufficient to overcome the objections of the drawings. The figures now recite Fig. as required.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Farfournoux et al (USPGPUB No. 20140322184) as evidenced by Dimitrov (Nature Reviews, 2004) in view of Kabadi et al. (Nucleic Acids Research, 2014).
Applicant Claims
The instant application claims a method for the controlled expression of a nucleic acid encoding a CRISPR (Clustered regularly interspaced short palindromic repeats) associated protein (Cas) nuclease in at least one target cell of an individual, limiting the off targets of the Cas nuclease, comprising at least the steps of:
- providing to a target cell a nucleic acid encoding a Cas nuclease under the control of a regulatory polynucleotide comprising a minimal promoter and from one to twenty AARE (amino acid response element) nucleic acids; and
- inducing the expression of the Cas nuclease by providing a medium deficient in at least one essential amino acid to the target cell.
The instant application claims a method for editing the genome into at least one target cell of an individual, comprising at least the steps of :
- administering to an individual in need thereof a pharmaceutical composition comprising (a) a nucleic acid encoding a Cas nuclease under the control of a regulatory polynucleotide comprising a minimal promoter and from one to twenty AARE (amino acid response element) nucleic acids and (ii) a pharmaceutically acceptable vehicle,
and - inducing the expression of the Cas nuclease upon consumption by the individual of a diet deficient in at least one essential amino acid.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Farfournoux et al. is directed to an inducible expression cassette. Claimed is an expression cassette including a gene of interest operationally linked to an inducible promoter, wherein said inducible promoter includes (i) at least one CARE (C/EBP-ATF Responsive Element) regulatory sequence and (ii) a minimal promoter (claim 1). The inducible promoter includes an AARE sequence (claim 24). Amino acid response elements (AARE) are CARE regulatory sequences that are targeted by the ATF4 transcription factor in case of amino acid deficiency (paragraph 0039). As claimed the inducible promoter includes at least two copies of a care regulatory sequence (claim 19). The at least two copies of a CARE regulatory sequences are selected from SEQ ID NO: 2-6 (claim 20). The gene of interest may derive from a eukaryote organism, a prokaryote, a parasite or a virus. The gene of interest may be genomic or it may code for an RNA that will subsequently be translated into a polypeptide of interest. This may be a polypeptide such as those found in nature (paragraph 0049). The goal is to deliver gene medicines to the patient in order to covey the therapeutic gene toward its target cell (paragraph 0004). The inducible promoter is inducible by an essential amino acid deficiency (claims 22-23). The expression cassette of the invention makes it possible to express, overexpress, or inhibit the expression of a gene of interest. This modulation of the expression of the gene of interest may preferably be controlled by the application or non-application of a diet deficient in one or more amino acids, preferably (an) essential amino acid(s) (paragraph 0050).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Farfournoux et al. teaches providing to a target cell a nucleic acid under the control of a regulatory polynucleotide comprising a minimal promoter and more than two copies of CARE which include an AARE sequence and that the promoter is inducible by an essential amino acid deficiency, Farfournoux et al. does not teach a nucleic acid encoding a Cas nuclease. However, this deficiency is cured by Kabadi et al.
Kabadi et al. teach that the CRISPR/Cas9 system is used for nuclease-based genome editing and comprises a Cas9 protein that is directed to a predefined target sequence by a single guide RNA (sgRNA) ( page 1, right column, full paragraph). Kabadi et al. teach a user-friendly platform to express Cas9 protein (page 2, left column, 1st paragraph). Kabadi et al. teach a gene encoding human codon optimized Cas9 (hCas9) nuclease for cloning into a lentiviral vector (page 2, left column, 2nd paragraph). Kabadi et al. teach that the disclosed system provides for effective modification of target genes at relatively high efficiency (paragraph bridging pages 8-9). Kabadi et al. teach that it would be advantageous to control the duration of Cas9 nuclease expression to decrease the possibility of unwanted off-target modifications (paragraph bridging pages 8-9). To address these concerns, Kabadi et al. teach that Cas9 can be expressed under the control of a chemically inducible promoter (paragraph bridging pages 8-9). Kabadi et al. teach a single lentiviral CRISPR/Cas9 system is useful for both basic science and therapeutic applications by enabling highly efficient and tunable genomic manipulations in cell types that are difficult to transfect, such as primary cells and progenitor cells (page 7, paragraph bridging columns).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Farfournoux et al. and Kabadi et al. and modify the expression cassette of Farfournoux et al. to include the Cas9 nuclease of Kabadi et al. as a protein of interest encoded by the expression cassette. Farfournoux et al. teach that the expression cassette may encode any polypeptide of interest from any organism. Kabadi et al. teach that Cas9 nuclease is a protein of interest for both basic science and therapeutic applications. There is a reasonable expectation of success as Kabadi et al. specifically suggest the use of a chemically inducible promoter and Farfournoux et al teach promoters that are regulated by the presence of an amino acid.
One would have been motivated to make such a modification in order to receive the expected benefit of providing an expression cassette encoding Cas9 under the control of the amino acid-regulatable promoter as taught by Farfournoux et al. to achieve the objective of providing an expression cassette capable of being used to control the duration of Cas9 nuclease expression as suggested by Kabadi et al. Kabadi et al. teach that this is advantageous, because the controlled expression would address concerns regarding unwanted, off-target modifications. Additionally, one would have been motivated to select Cas9 nuclease as the polypeptide of interest, because Kabadi et al teach that Cas9 has applications in basic science and therapeutics.
Regarding the steps of claim 1/9, Farfournoux et al. teaches the goal is to deliver gene medicines to the patient in order to covey the therapeutic gene toward its target cell which reads on the instantly claimed providing step. Farfournoux et al. teaches that the promoter is inducible by an essential amino acid deficiency and that modulation of expression is controlled by the application or non-application of a diet deficient in one or more essential amino acids. This reads on inducing the expression by providing a medium deficient in at least one essential amino acid to the target cell.
Regarding the “for the controlled expression of a nucleic acid encoding a CRISPR (Clustered regularly interspaced short palindromic repeats) associated protein (Cas) nuclease in at least one target cell of an individual, limiting the off targets of the Cas nuclease”, this is the intended use of the method. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02 and MPEP 2145. In the instant case, Kabadi et al. teaches control the duration of Cas9 nuclease expression to decrease the possibility of unwanted off-target modifications. Farfournoux et al. teaches the exact same structural inducible promoters (see explanation for claim 3 below) and the exact same conditions for induction (i.e. medium deficient in at least one essential amino acid). Therefore, the structure suggested by the prior art would be capable of performing the intended use.
Regarding claim 9, Farfournoux et al teach a pharmaceutical composition comprising the expression cassette, or expression vector comprising the expression cassette combined with a pharmaceutically acceptable support, diluent, adjuvant or excipient, as well as solubilizers, stabilizers and preservatives (Abstract; paragraphs 0007, 0072, 0073, 0075 and 0077). As set forth above, Farfournoux et al. teaches administering the pharmaceutical composition and inducing expression of the gene of interest (paragraph 0009).
Regarding claims 2 and 10, Kabadi et al. teaches a Cas9 nuclease.
Regarding claim 3 and 11, Farfournoux et al. teaches CARE regulatory sequences are selected from SEQ ID NO: 2-6. As set forth below instant SEQ ID No: 1 (Qy) is identical to SEQ ID NO: 2 (Db); instant SEQ ID NO: 2 (Qy) is identical to SEQ ID No. 3 (Db); instant SEQ ID NO: 3 (Qy) is identical to SEQ ID NO: 4 (Db); instant SEQ ID NO: 4 (Qy) is identical to SEQ Id NO: 5 (Db); instant SEQ ID NO: 5 (Qy) is identical to SEQ ID NO: 6 (Db) of Farfournoux et al.
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Regarding claims 4-5 and 12-13, Farfournoux et al. teaches at least two copies of a CARE regulatory sequence and amino acid response elements (AARE) are CARE regulatory sequences. This suggests an overlapping number of AARE nucleic acids.
Regarding claims 6 and 14, Farfournoux et al. teach a vector comprising the expression cassette (Abstract; paragraphs 0006 and 0062).
Regarding claims 7 and 15, Farfournoux et al. teach a synthetic vector that is a cationic lipid, or polymer liposome, for example, containing the vector comprising the expression cassette (paragraphs 0062-0064).
Regarding claims 8 and 16, Farfournoux et al. teach the vector is a viral vector in the form of an infectious viral particle (delivery particle of the claim) (paragraph 0068). Because the viral particle is infectious, it must be suitable for binding a target receptor exposed at the membrane of a targeted cell. As evidenced by Dimitrov et al. 2004, viral particles comprise ligands suitable for binding to a target receptor exposed at the membrane of a targeted cell (Abstract).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Farfournoux et al. as evidenced by Dimitrov in view of Kabadi et al. as applied to claims 1-16 above and in further view of Gersbach et al. (WO2014197748).
Applicant Claims
The instant application claims wherein the pharmaceutical composition further comprises a guide DNA or RNA, which is specific of a target genomic nucleic acid to be edited in the target cell and a donor nucleic acid comprising a nucleic acid intended to replace the target genomic nucleic acid. The instant application claims the target genomic nucleic acid comprises a genetic mutation.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The teachings of Farfournoux et al. and Kabadi et al. are set forth above. Farfournoux et al. teaches the use of the pharmaceutical composition in gene therapy (paragraph 0074; 0080). Kabadi et al. teaches Cas9 and a sgRNA.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While a guide is taught, a donor nucleic acid is not expressly taught. However, this deficiency is cured by Gersbach et al.
Gersbach et al. is directed to RNA-guided gene editing and gene regulation. Taught is correcting a mutant gene in a cell. The method comprises administering to a cell a DNA targeting system which can include a donor DNA (paragraph 0016). Donor DNA is a double stranded DNA fragment or molecule that includes at least a portion of the gene of interest. The donor DNA may encode a full-functional protein or a partially functional protein (paragraph 0120). Correcting a mutant gene is taught. Taught is administering a composition for genome editing. Administration of the site-specific nuclease and donor DNA which can replace the entire gene or the region containing the mutation (page 0233). Taught is donor DNA in combination with the CRISPR/Cas9 based system which includes a gRNA (paragraph 0238).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Farfournoux et al., Kabadi et al. and Gersbach et al. and utilize a donor DNA in combination with the Cas9/sgRNA. One skilled in the art would have been motivated to include a donor DNA in order to replace the entire gene or the region containing the mutation to repair the genetic mutation as taught by Gersbach et al. Since Farfournoux et al. teaches the pharmaceutical composition is for gene therapy, there is a reasonable expectation of using a donor DNA/sgRNA and Cas9 combination as it is a known way to provide for genome editing as taught by Gersbach et al.
Response to Arguments
Applicants’ arguments filed February 18 2026 have been fully considered but they are not persuasive.
Applicants argue (page 7) that (1) the present invention is not a mere combination of the inducible promoter AARE with a nucleic acid encoding a Cas nuclease. The present invention aims at providing a new fined-tune controlled expression system for the expression of a nucleic acid encoding a Cas nuclease in an individual for safe gene therapy approaches based on genome editing. The technical solution of the claimed invention therefore differs from the disclosure of Farfournoux et al. in that the invention defines that exogenous protein is a Cas nuclease. The technical problem to be solved by Farfournoux et al. is to provide a different nucleic acid for implementing gene therapy.
Regarding Applicants first argument, it is well settled that "any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed." KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 420 (2007). As long as some suggestion to combine the elements is provided by the prior art as a whole, the law does not require that they be combined for the reason or advantage contemplated by the inventor. In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992); In re Kronig, 539 F.2d 1300, 1304 (CCPA 1976). MPEP 2143.01 and 2144 (IV).
The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) ("One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings."); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991)
In In re Lintner, the claimed invention was a laundry composition consisting essentially of a dispersant, cationic fabric softener, sugar, sequestering phosphate, and brightener in specified proportions. The claims were rejected over the combination of a primary reference which taught all the claim limitations except for the presence of sugar, and secondary references which taught the addition of sugar as a filler or weighting agent in compositions containing cationic fabric softeners. Appellant argued that in the claimed invention, the sugar is responsible for the compatibility of the cationic softener with the other detergent components. The court sustained the rejection, stating "The fact that appellant uses sugar for a different purpose does not alter the conclusion that its use in a prior art composition would be [sic, would have been] prima facie obvious from the purpose disclosed in the references." 173 USPQ at 562.
Furthermore, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Therefore, while Farfournoux et al. does not expressly teach a Cas nuclease, the rejection is not based on Farfournoux et al. alone, Kabadi et al. teaches a Cas nuclease. Farfournoux et al. makes it clear that the gene of interest may be genomic or it may code for RNA that will subsequently be translated into a polypeptide of interest wherein this polypeptide can be those found in nature. Thus, while Farfournoux et al. is broader in scope than the instant claims, the examiner cannot agree that the combination with Kabadi et al. would not suggest the instantly claimed providing and inducing steps. As set forth above, it is not a requirement to render the claims obvious that the prior art teaches inducing expression of the Cas nuclease for the same reason as applicants, merely that such inducing is obvious and there is a reason to induce the expression.
Applicants argue (page 8-10) that (2) Farfournoux et al. is silent to the process of editing or concerning the use of Cas nuclease as a therapeutic gene. Cas technology is an emerging and novel technology that cannot be disclosed in Farfournoux et al. It is surprising that the examiner considers that a person skilled in the art who is interested in genome editing would not consider Farfournoux et al. to be relevant teaching or even the closest prior art. It is argued that Cas nuclease is not a therapeutic protein in the sense of Farfournoux et al. since a bacterial protein/gene that has deleterious effects cannot be a therapeutic gene in any way. Clearly Farfournoux et al. and the present invention aim at expressing two different types of genes. Genome editing, in contrast to gene augmentation strategies, is a hit and run appreciate associated with the enzymatic nature of Cas nuclease. Cas repeatedly performs its modification while being transcribed. Such a mechanism results in undesired and potentially harmful off-target genomic modification. Despite the existence of Farfournoux et al. and Kabadi et al., several high-level scientific publications emphasized the safety problem linked to the use of CRISPR-Cas that is the necessity of alleviating the off-targets as well as the immunogenicity of Cas. Applicants point to two differences Porteus and Cox. In other words, the claimed invention in the presentation application was first to properly address an unmet medical need. It is argued that the examiner’s assertion is based on an a posteriori approach that is not permitted.
Regarding Applicants second argument, firstly only claim 9 and the dependents recite the intended use of “for editing the genome”. Claim 1 is directed to a method for controlled expression. A step of editing isn’t required. Even in claim 9, nothing in the method steps actually requiring editing. Claim 9 recites two method steps administering and inducing expression. Therefore, Applicants are arguing limitation not in the claims. Nothing in the currently examined claims require a therapeutic effect. Therefore, while Porteus and Cox might discuss difficulties with gene editing, these references do not establish an unexpected or unobvious effect based on the current claim language. Neither of these references establish that Cas9 can’t be delivered and expression induced as recited by the instant claims and the only requirement of the instant claims. Applicants appear to be of the position that Farfournoux et al only teaches therapeutic proteins. But this would be a very narrow interpretation of Farfournoux et al. The gene of interest may encode any one of a number of proteins, including proteins that function as cytokines, enzymes, enzyme inhibitors, proteins acting on gene expression, cytostatic agents, markers, such as beta-galactosidase or luciferase, or proteins that have therapeutic effect (paragraph 0051). Farfournoux et al. is prior art for all it teaches. Farfournoux et al. teaches that the protein of interest may be an enzyme. Kabadi et al. teaches that Cas9 is an enzyme (see for example the Abstract). Furthermore, Kabadi et al teach that the nucleic acid encoding Cas9 is useful for basic science and therapeutic applications (See the paragraph bridging the columns of page 7). Thus, the position that Cas9 cannot be considered a therapeutic protein is not supported by the evidence on the record. Moreover, Kabadi et al suggest the regulatable expression of Cas9 by chemical regulation methods to address concerns of unwanted off-targeted modification (See the paragraph bridging pages 8-9). Thus, one would have had a reason or motivation to use Cas9 as the protein in the diet-regulatable expression cassette of Farfournoux et al as a way to provide an expression cassette for diet-regulatable expression of Cas9, which would address concerns of unwanted off-targeted modification. To establish a long-felt and unmet need, the following elements must be proven. First, the need must have been persistent and recognized by skilled artisans. In re Gershon, 372 F.2d 535,538 (CCPA 1967). Second, the long-felt need must not have been satisfied by another before Appellants' invention. See Newell Companies, Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988)
("[O]nce another supplied the key element, there was no long-felt need or, indeed,
a problem to be solved."). And third, Appellants' invention must satisfy the need.
In re Cavanagh, 436 F.2d 491,496 (CCPA 1971). See MPEP 716.04.
Each of these elements is established based on the preponderance of the evidence of the record. Here, since the references cited were at the time of the invention it does not appear that there was a need that persisted and recognized by skilled artisans. The evidence must also show unsuccessful efforts to solve the problem. See Orthopedic Equipment CO., Inc. v. All Orthopedic Appliances, Inc. 707 F.2d 1376, 217 USPQ 1281 (Fed. Cir. 1983). Therefore, the examiner cannot agree that Applicants have established a long-felt and unmet need that was met by Applicants. Furthermore, as set forth above, Kabadi et al. suggests ways in which unwanted off-targeted modification can be addressed. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Here, Farfournoux et al. suggests a variety of different proteins can be utilized and Kabadi et al. teaches a specific protein that can be expressed. Therefore, the examiner cannot agree that the rejection is solely based on hindsight.
Conclusion
THIS ACTION IS MADE FINAL. 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 ABIGAIL VANHORN whose telephone number is (571)270-3502. The examiner can normally be reached M-Th 6 am-4 pm 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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/ABIGAIL VANHORN/ Primary Examiner, Art Unit 1636
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