Prosecution Insights
Last updated: April 19, 2026
Application No. 18/049,724

COMPLEXES FOR GENE DELETION AND EDITING

Non-Final OA §103§112§DP
Filed
Oct 26, 2022
Examiner
LEONARD, ARTHUR S
Art Unit
1631
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
UNIVERSITY OF MASSACHUSETTS
OA Round
1 (Non-Final)
51%
Grant Probability
Moderate
1-2
OA Rounds
3y 6m
To Grant
99%
With Interview

Examiner Intelligence

Grants 51% of resolved cases
51%
Career Allow Rate
255 granted / 503 resolved
-9.3% vs TC avg
Strong +51% interview lift
Without
With
+51.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
62 currently pending
Career history
565
Total Applications
across all art units

Statute-Specific Performance

§101
3.5%
-36.5% vs TC avg
§103
39.8%
-0.2% vs TC avg
§102
17.5%
-22.5% vs TC avg
§112
21.2%
-18.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 503 resolved cases

Office Action

§103 §112 §DP
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 . DETAILED ACTION Claim status Claims 17-18, 20, 26, 30, 69-83 are pending Claims 17-18, 20, 26, 30, 69-83 are under examination Election/Restrictions Applicant’s election of the following invention without traverse in the reply filed on 11/25/2025 is acknowledged. The requirement is still deemed proper and is therefore made FINAL. Group II, claims 17-18, 20, 26, 30, 69-83, drawn to methods of modifying a cell comprising nucleic acid guided nuclease, a targeting nucleic acid, and amphipathic helical peptide. Allowable subject matter Claims 76-79 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, 1st paragraph, and/or 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Specifically, the prior art is silent to sgRNAs that target the RIP140 gene comprising at least 90% sequence identity to SEQ ID NOs:1-4. Information Disclosure Statement The information disclosure statement (IDS) submitted on 4/18/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. However, Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Claim Rejections - 35 USC § 112(a) 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. Enablement Claims 75-79 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 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. The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The Court in Wands states: “Enablement is not precluded by the necessity for some 'experimentation.'” Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all of these factors are considered, a sufficient amount for a prima facie case is discussed below. SCOPE OF THE INVENTION Claim 75 encompass a genus of guide RNAs between 15-30 bases in length. Dependent claims 76-79 further limit the guide RNAs to comprising SEQ ID NOs 1-4. GUIDANCE & WORKING EXAMPLES In regard to claim 75 encompassing a genus of guide RNAs between 15-30 bases in length, the specification does not provide guidance for or a working example of a guide RNA limited to this length range. By contrast Applicant specification discloses the making and use of a single guide RNA using the well-known “pUC57-sgRNA” expression vector (p. 62, Example 1), that produces a guide RNA of at least 76 nucleotides (for the scaffold) and then another 20 nucleotides for the targeting domain. Thus, the guide RNAs disclosed by instant application are about 100 nucleotides in length. STATE OF THE ART & QUANTITY OF EXPERIMENTATION Moreover, at the time of invention of the present application neither applicant’s specification nor the prior art provided guidance for making and using guide RNAs between 15-30 bases in length. Specifically, the prior art of Zhang (US 2016/0175462) teaches making and using single RNAs that comprise about a 20 nucleotide targeting domain, followed by a scaffold of about 76 nucleotides (see Fig 31B of Zhang below). PNG media_image1.png 243 767 media_image1.png Greyscale [AltContent: textbox ([img-media_image2.png])]Furthermore, even when a single guide RNA is not used, Zhang teaches that the length of a functional guide RNA would still be greater than 30 nucleotides in length. Specifically, Zhang teaches the target region alone is to be 20 nucleotides with a tracr sequence of at least 12 nucleotides, and then a corresponding crRNA sequence of at least another 12 nucleotides, and then additional tracr sequence to form a hairpin secondary structure necessary for Cas binding [0770, 0787-0793]. Zhang teaches the naturally occurring lengths of the crRNA is 39-42 nucleotides and the tracr RNA is 75-89 nucleotides [0957, 0959-0960], so as to create at least one stem loop structures for stable Cas9 binding (see Fig. 2A of Zhang). Consequently, there is ample reason to conclude that there would be a high degree of unpredictability and undue experimentation in making and using guide RNAs between 15-30 bases in length. The physiological art is recognized as unpredictable (MPEP 2164.03). As set forth in In re Fisher, 166 USPQ 18 (CCPA 1970), compliance with 35 USC 112(a) requires: “That scope of claims must bear a reasonable correlation to scope of enablement provided by specification to persons of ordinary skill in the art; in cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific laws; in cases involving unpredictable factors, such as most chemical reactions and physiological activity, scope of enablement varies inversely with degree of unpredictability of factors involved.” Moreover, the courts have also stated that reasonable correlation must exist between scope of exclusive right to patent application and scope of enablement set forth in the patent application (27 USPQ2d 1662 Ex parte Maize!.). In view of the foregoing, due to the lack of sufficient guidance provided by the specification regarding the issues set forth above, the state of the relevant art, and the breadth of the claims, it would have required undue experimentation for one skilled in the art to make and use the instant broadly claimed invention. CONCLUSION In conclusion, given the breadth of the claims and the limited scope of the specification, an undue quantity of experimentation is require to make and use the invention. 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 18, 71, and 76-78 are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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. In regard to Claims 18 and 71, instant claims contains the trademark/trade name “Endo-Porter”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an amphipathic helical peptide and, accordingly, the identification/description is indefinite. Because this reagent was developed by the manufacturer Gene-Tools, LLC,. Philomath, OR at the time of filing of Applicant’s invention under the trade name “Endo-Porter” and as a result is proprietary, which means what constitutes as an amphipathic helical peptide can change, and these changes do not need to be disclosed by these companies to the public. Accordingly, the identification of the trade name is indefinite and the applicant is advised to employ a sequence, the SeqID, IUPAC name and/or CAS number for this agent. In regard to Claims 76-78, where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The phrase directed to nucleic acid sequences that are a certain % “homologous” in cited claims is used by the claims to mean that the encompassed nucleic acids sequences have a certain % “identity”, while the accepted meaning in context of nucleic acid sequences is “not-identical”. The term is indefinite because the specification does not clearly redefine the term. Applicant is recommended to amend “homologous” to “identity” or “sequence identity” (see [0156, 0159, 0162] of Applicant’s disclosure). 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 17, 69, 70, 72, and 74 are rejected under 35 U.S.C. 103 as being unpatentable over Guay et al. (US 2016/0298078, filed 4/18/2016, published 10/13/2016, see IDS filed 4/18/2023). In regard to claim 17, Guay teaches methods of using synthetic peptides for transducing cargo to target cells (Abstract, Summary). Guay et al. teaches a composition comprising: A nucleic acid-guided endonuclease such as CRISPR/Cas9, A sequence-specific targeting nucleic acid such as a guide RNA, and An amphipathic helical peptide such as LAH4 (see SEQ ID NO:6 of Guay “KKALLALALHHLAHLALHLALALKKA”), wherein the Cas9 and gRNA and the amphipathic helical peptide form a complex, and wherein the amphipathic helical peptide mediates delivery of the complex to a target cell and wherein the Cas9 endonuclease mediates editing or deletion of target gene in the target cell ([0013, 0025, 0029-0030, 0098-0102, 0287-0306], see Table A, Table 1.3, Table 10.1, Table 10.3a, and Example 13). In regard to claims 69 and 70, as stated supra, Guay et al. teaches the amphipathic helical peptide mediated delivery of the Cas9/guide RNA complex to the cell to mediate editing of the target gene. In regard to claim 72, Guay teaches the target cell is mammalian [0037, 0169, 0173, 0187, 0191, 0292, 0303]) In regard to claim 74, as stated supra, Guay et al. teaches a guide RNA. However, Guay is silent to a preferred embodiment of method of gene editing in a target cell comprising a CRISPR/Cas9 nuclease, gRNA, and amphipathic helical peptide in a complex. Nevertheless, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to practice such a method because each of the individual elements of the instant claims are independently presented by Guay as embodiments and are taught that they can be combined in various embodiments; therefore a combination of all the elements into a single embodiment would be apparent to an artisan skilled in gene editing in light of the Supreme Court’s KSR decision (see MPEP 2143 Exemplary Rationale (A)). Regarding the rationale for combining prior art elements according to known methods to yield predictable results, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of filing of the invention. Each of the elements (CRISPR/Cas9 nuclease, gRNAs, amphipathic helical peptides and formulations) are taught by Guay and further they are taught in various combinations and are shown to be used in a method for delivering Cas9/gRNA to a target cell. It would be therefore predictably obvious to use a combination of these elements in said method. Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary. Claims 18, 26, 71, and 83 are rejected under 35 U.S.C. 103 as being unpatentable over Guay et al. (US 2016/0298078, filed 4/18/2016), in view of Summerton et al., (ANYAS, 2005, 1058:62-75, see IDS filed 4/18/2023). As discussed previously, Guay suggests a method for gene editing in a cell comprising a CRISPR/Cas9 nuclease, gRNA, and amphipathic helical peptide in a complex delivered to the target cell. However, Guay is silent with respect to the amphipathic helical peptide being Endo-porter. In regard to claims 18 and 71, Summerton teaches a composition comprising the Endo-porter peptide and an oligonucleotide cargo (p. 72-74, see Fig. 6). Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to practice the method comprising a Cas nuclease and gRNA, and amphipathic helical peptide as taught by Guay and substitute Endo-porter as the amphipathic helical peptide as taught by Summerton with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by Summerton because of the Endo-porter peptide efficiency delivers cargo into cells with reduced cytotoxicity compared to other delivery peptides (Abstract, p. 63, 3rd para., p. 74, 2nd para.). In regard to claim 26, as stated supra, Guay et al. teaches the Cas9 endonuclease. In regard to claim 83, Guay specifically teaches the S. pyogenes Cas9 ([0287], see SEQ ID NO: 74 of Guay). Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary. Claim 20, 72 and 73 are rejected under 35 U.S.C. 103 as being unpatentable over Guay et al. (US 2016/0298078), in view of Czech et al. (US 2005/0261223, filed 3/07/2005, published 11/24/2005, see IDS filed 4/18/2023) and Zhang (US 2016/0175462, filed 12/16/2015). As discussed previously, Guay suggests a method for gene editing in a cell comprising a CRISPR/Cas9 nuclease, gRNA, and amphipathic helical peptide in a complex delivered to the target cell. However, although Guay teaches the method of modifying cells are suitable for clinical or therapeutic uses in a variety of cell types [0030-0031, 0167], they are silent with respect to targeting the RIP140 gene in adipocytes. Czech et al. teaches methods for targeting RIP140 in adipocytes ([0167], Fig. 6-8). Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to practice the method for targeting a gene in a cell as taught by Guay and choose the RIP140 gene in adipocytes as taught by Czech with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by Czech because inhibiting RIP140 in adipocytes potentiates insulin action on glucose transport into these cells, thereby providing a means to treat disorders associated with aberrant glucose transport such as diabetes (Abstract, [0011, 0172]). In regard to the reasonable expectation of success in making and using a guide RNA for the CRISPR/Cas9 systems of Guay, Zhang et al. (US2016/0175462) teaches making and using guide RNA to target a variety of genes, including RIP140 (alias NRIP1, see Table C), and discloses a web-based software tool to guide the selection and validation of target sequence [0268]. Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary. Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Guay et al. (US 2016/0298078) in view of Summerton et al., (ANYAS, 2005, 1058:62-75), as applied to claims 17 and 18, in further view of Czech et al. (WO2014134509, filed 2/28/2014, published 9/04/2014, see IDS filed 4/18/2023). As discussed previously, Guay suggests a method for gene editing in a cell comprising a CRISPR/Cas9 nuclease, gRNA, and an Endo-porter amphipathic helical peptide in a complex delivered to the target cell. However, although Guay teaches the method of modifying cells are suitable for clinical or therapeutic uses [0030-0031, 0167], they are silent with respect to the complex encapsulated in a glucan particle. Czech et al. teaches methods of using a composition comprising a sequence-specific targeting nucleic acid, and an amphipathic helical peptide to transduce a cell (Abstract). In regard to claim 30, Czech teaches the complex is encapsulated in a glucan shell (p. 80, last para.). Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to practice the method comprising a Cas nuclease, gRNA, and Endo-porter amphipathic helical peptide as suggested by Guay et al. and combine the a glucan shell as taught by Czech with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by Czech because the glucan shell protects the RNA based cargo in the blood stream and gut (p. 64, 5th para., p. 90, 2nd para.). Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary. Claims 80 and 81 are rejected under 35 U.S.C. 103 as being unpatentable over Guay et al. (US 2016/0298078, filed 4/18/2016), in view of Furch et al. (US 2018/0140717, filed 4/29/2016, see IDS filed 4/18/2023) and Mokhtarzadeh et al. (TIAC, 2016, 82:316-327, see IDS filed 4/18/2023). As discussed previously, Guay suggests a method for gene editing in a cell comprising a CRISPR/Cas9 nuclease, gRNA, and amphipathic helical peptide in a complex delivered to the target cell. However, Guay is silent with respect to an aptamer based cell targeting ligand conjugated to the amphiphilic peptide. Furch teaches a methods of modifying a cell comprising CRISPR/Cas9 nuclease, gRNA in a nanocarrier and cell targeting ligand (Abstract, [0045]). In regard to claim 80, Furch teaches the targeting ligand is an aptamer (Abstract, [0007, 0015, 0028, 0056]). In regard to claim 81, Furch teaches the targeting ligand is non-covalently embedded in the nanocarrier and discloses the use of targeting anchors for doing so [0028, 0040, 0056]. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to practice the method comprising a Cas nuclease, gRNA, and amphipathic helical peptide as suggested by Guay and combine an aptamer based cell targeting ligand non-covalently embedded in the complex as taught by Furch with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by Furch because the targeting ligand may direct the composition to a particular cell type and reduces off-target toxicity [0011]. In regard to choosing an aptamer as the targeting ligand, Mokhtarzadeh teaches that using aptamers for targeting nanocarriers would have been obvious because although they exhibit the affinities and specificities similar to monoclonal antibodies, they are easier to produce and show efficient uptake because of their small size (Introduction, p. 317). Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary. Claims 80 and 82 are rejected under 35 U.S.C. 103 as being unpatentable over Guay et al. (US 2016/0298078, filed 4/18/2016), in view of Colletti et al. (WO2015/069587, filed 11/03/2014, see IDS filed 4/18/2023) and Mokhtarzadeh et al. (TIAC, 2016, 82:316-327, see IDS filed 4/18/2023). As discussed previously, Guay suggests a method for gene editing in a cell comprising a CRISPR/Cas9 nuclease, gRNA, and amphipathic helical peptide in a complex delivered to the target cell. However, Guay is silent with respect to an aptamer based cell targeting ligand conjugated to the amphiphilic peptide. Colletti et al. teaches methods comprising a nucleic acid such as a siRNA, an amphipathic helical peptide and cell targeting ligand (Abstract, Description of the Invention, p. 3, Peptides, pgs. 19-20, Targeting Ligands, pgs. 70-71, Table 2). In regard to claim 80, Colletti teaches the targeting ligand is an aptamer (p. 70, last para.). In regard to claim 82, Colletti teaches the targeting ligand (L) is conjugated to the peptide (P) (Abstract, Summary of the Invention). Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to practice the method comprising a Cas nuclease, gRNA, and amphipathic helical peptide as taught by Guay and combine an aptamer based cell targeting ligand conjugated to the peptide as taught by Colletti with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by Colletti because the targeting ligand may direct the composition to a particular cell type (p. 70, 2nd para.). In regard to choosing an aptamer as the targeting ligand, Mokhtarzadeh teaches that using aptamers for targeting nanocarriers would have been obvious because although they exhibit the affinities and specificities similar to monoclonal antibodies, they are easier to produce and show efficient uptake because of their small size (Introduction, p. 317). Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary. 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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b). Claims 17-18, 20, 26, 30, 69-74, 80-83 are rejected on the grounds of nonstatutory double patenting over claims 1-14 of U.S. Patent No. 11,519,009 (Czeh et al., Patented 12/06/2022). The subject matter claimed in the instant application is disclosed in the referenced patent as follows: the composition for modifying a cell comprising nucleic acid guided nuclease, a targeting nucleic acid, and amphipathic helical peptide makes obvious the method of instant application. It is clear that all the elements of the cited patent composition claims are to be found in instant method claims. The difference between the cited patent claims and the instant claims lies in the fact that the instant claims are the intended use of the patent composition, and require no unobvious step beyond “contacting” the cell with the patented composition. Since the instant application claims are obvious over cited patent claims, said claims are not patentably distinct. Conclusion No claims are allowed. Examiner Contact Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ARTHUR S LEONARD/Examiner, Art Unit 1631
Read full office action

Prosecution Timeline

Oct 26, 2022
Application Filed
Feb 06, 2026
Non-Final Rejection — §103, §112, §DP (current)

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Prosecution Projections

1-2
Expected OA Rounds
51%
Grant Probability
99%
With Interview (+51.2%)
3y 6m
Median Time to Grant
Low
PTA Risk
Based on 503 resolved cases by this examiner. Grant probability derived from career allow rate.

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