DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 6, 2026 has been entered.
Applicants previously canceled claims 2-3. No amendments were made, but Applicants added new claim 8. Claims 1 and 4-8 are pending in this application, and are under examination.
Any objection or rejection of record in the previous Office and Advisory Actions, mailed November 7, 2025 and March 16, 2026, respectively, which is not addressed in this action has been withdrawn in light of Applicants’ amendments and/or arguments.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, U.S. Provisional Patent Application Nos. 61/736, 527 and 61/748,427 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior-filed applications fail to provide support for “[a] method of inducing cell death of one or more prokaryotic cell(s) comprising introducing one or more vectors into the prokaryotic cell(s); wherein the one or more vectors drive expression of one or more of: a CRISPR enzyme, a guide sequence linked to a tracr mate sequence, and a tracr sequence; and all of a CRISPR enzyme, a guide sequence linked to a tracr mate sequence, and a tracr sequence, are produced in the prokaryotic cell(s); wherein the CRISPR complex comprises the CRISPR enzyme complexed with (1) the guide sequence that is hybridized to a target sequence within a target polynucleotide, and (2) the tracr mate sequence that is hybridized to the tracr sequence; wherein binding of the CRISPR complex to the target polynucleotide results in Cas9- directed cleavage at a targeted site in the prokaryote(s) and induces cell death.”
Therefore, claims 1-7 have an effective filing date of January 29, 2013, which is the filing date of U.S. Provisional Patent Application No. 61/757,972, which is the earliest application to disclose a method of inducing cell death in prokaryotic cells via introduction of a CRISPR enzyme and guide sequence into prokaryotic cells.
Information Disclosure Statement
The Information Disclosure Statement filed May 7, 2026 has been considered.
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.
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 1, 4-6, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,660,943.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘943 patent claims a composition for inducing cell death of certain bacteria, while the instant application claims a method of inducing bacterial cell death by contacting the bacteria with a CRISPR/Cas system, which leads to the death or reduction of the targeted bacterial population.
While the instant claims do not specify the vector for introducing the CRISPR/Cas system to the bacteria, it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute any well-known vector for introducing CRISPR/Cas systems, including the ‘943 patent’s phagemid vector for the instant application’s plasmid vector with a predictable and reasonable expectation of success. It would also have been obvious to one with ordinary skill in the art at the time the invention was made target more than one site in the sequences of the prokaryotic cell in order to ensure that the cell could not survive. Further, it would have been obvious to one with ordinary skill in the art at the time the invention was made that the ‘943 patent’s composition could be used in the instant method of inducing prokaryote cell death. The instant case is analogous to Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. July 28, 2010), where the courts ruled that obviousness-type double patenting exist between previously-disclosed, but newly-claimed utility. Therefore, the instant claims are not patentably distinct from the issued claims.
Claims 1, 4-6, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11,135,273.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘273 patent claims a composition for inducing cell death of certain bacteria, while the instant application claims a method of inducing bacterial cell death by contacting the bacteria with a CRISPR/Cas system, which leads to the death or reduction of the targeted bacterial population.
While the instant claims do not specify the vector for introducing the CRISPR/Cas system to the bacteria, it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute any well-known vector for introducing CRISPR/Cas systems, including the ‘273 patent’s phagemid vector for the instant application’s vector with a predictable and reasonable expectation of success. It would also have been obvious to one with ordinary skill in the art at the time the invention was made target more than one site in the sequences of the prokaryotic cell in order to ensure that the cell could not survive. Further, it would have been obvious to one with ordinary skill in the art at the time the invention was made that the ‘273 patent’s composition could be used in the instant method of inducing prokaryote cell death. The instant case is analogous to Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. July 28, 2010), where the courts ruled that obviousness-type double patenting exist between previously-disclosed, but newly-claimed utility. Therefore, the instant claims are not patentably distinct from the issued claims.
Claims 1, 4-6, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,452,765.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘765 patent claims a composition for inducing cell death of certain bacteria, while the instant application claims a method of inducing bacterial cell death by contacting the bacteria with a CRISPR/Cas system, which leads to the death or reduction of the targeted bacterial population.
While the instant claims do not specify the vector for introducing the CRISPR/Cas system to the bacteria, it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute any well-known vector for introducing CRISPR/Cas systems, including the ‘765 patent’s phagemid vector for the instant application’s vector with a predictable and reasonable expectation of success. It would also have been obvious to one with ordinary skill in the art at the time the invention was made target more than one site in the sequences of the prokaryotic cell in order to ensure that the cell could not survive. Further, it would have been obvious to one with ordinary skill in the art at the time the invention was made that the ‘765 patent’s composition could be used in the instant method of inducing prokaryote cell death. The instant case is analogous to Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. July 28, 2010), where the courts ruled that obviousness-type double patenting exist between previously-disclosed, but newly-claimed utility. Therefore, the instant claims are not patentably distinct from the issued claims.
Claims 1, 4-6, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,491,209.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘209 patent claims a composition for inducing cell death of certain bacteria, while the instant application claims a method of inducing bacterial cell death by contacting the bacteria with a CRISPR/Cas system, which leads to the death or reduction of the targeted bacterial population.
While the instant claims do not specify the vector for introducing the CRISPR/Cas system to the bacteria, it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute any well-known vector for introducing CRISPR/Cas systems, including the ‘209 patent’s phagemid vector for the instant application’s vector with a predictable and reasonable expectation of success. Further, it would have been obvious to one with ordinary skill in the art at the time the invention was made that the ‘209 patent’s composition could be used in the instant method of inducing prokaryote cell death. The instant case is analogous to Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. July 28, 2010), where the courts ruled that obviousness-type double patenting exist between previously-disclosed, but newly-claimed utility. Therefore, the instant claims are not patentably distinct from the issued claims.
Claims 1, 4-6, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,491,210.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘210 patent claims a composition for inducing cell death of certain bacteria, while the instant application claims a method of inducing bacterial cell death by contacting the bacteria with a CRISPR/Cas system, which leads to the death or reduction of the targeted bacterial population.
While the instant claims do not specify the vector for introducing the CRISPR/Cas system to the bacteria, it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute any well-known vector for introducing CRISPR/Cas systems, including the ‘210 patent’s phagemid vector for the instant application’s vector with a predictable and reasonable expectation of success. It would also have been obvious to one with ordinary skill in the art at the time the invention was made target more than one site in the sequences of the prokaryotic cell in order to ensure that the cell could not survive. Further, it would have been obvious to one with ordinary skill in the art at the time the invention was made that the ‘210 patent’s composition could be used in the instant method of inducing prokaryote cell death. The instant case is analogous to Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. July 28, 2010), where the courts ruled that obviousness-type double patenting exist between previously-disclosed, but newly-claimed utility. Therefore, the instant claims are not patentably distinct from the issued claims.
Claims 1, 4-6, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,497,797.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘797 patent claims a composition for inducing cell death of certain bacteria, while the instant application claims a method of inducing bacterial cell death by contacting the bacteria with a CRISPR/Cas system, which leads to the death or reduction of the targeted bacterial population.
While the instant claims do not specify the vector for introducing the CRISPR/Cas system to the bacteria, it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute any well-known vector for introducing CRISPR/Cas systems, including the ‘797 patent’s phagemid vector for the instant application’s vector with a predictable and reasonable expectation of success. It would also have been obvious to one with ordinary skill in the art at the time the invention was made target more than one site in the sequences of the prokaryotic cell in order to ensure that the cell could not survive. Further, it would have been obvious to one with ordinary skill in the art at the time the invention was made that the ‘797 patent’s composition could be used in the instant method of inducing prokaryote cell death. The instant case is analogous to Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. July 28, 2010), where the courts ruled that obviousness-type double patenting exist between previously-disclosed, but newly-claimed utility. Therefore, the instant claims are not patentably distinct from the issued claims.
Claims 1, 4-6, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,918,631.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘631 patent and the instant application claim a method for inducing cell death of certain bacteria by contacting the bacteria with a CRISPR/Cas system, which leads to the death or reduction of the targeted bacterial population.
While instant claims 1-6 do not specify the type of vector for introducing the CRISPR/Cas system to the bacteria, it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute any well-known vector for introducing CRISPR/Cas systems, including the ‘631 patent’s phagemid vector, for the instant application’s vector with a predictable and reasonable expectation of success. It would also have been obvious to one with ordinary skill in the art at the time the invention was made target more than one site in the sequences of the prokaryotic cell in order to ensure that the cell could not survive.
Claims 1, 4-6, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,168,040.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘040 patent and the instant application claim a method for inducing cell death of certain bacteria by contacting the bacteria with a CRISPR/Cas system, which leads to the death or reduction of the targeted bacterial population.
While the instant claims do not specify the vector for introducing the CRISPR/Cas system to the bacteria is a plasmid, it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute any well-known vector for introducing CRISPR/Cas systems, including the ‘040 patent’s phagemid vector, for the instant application’s vector with a predictable and reasonable expectation of success. It would also have been obvious to one with ordinary skill in the art at the time the invention was made target more than one site in the sequences of the prokaryotic cell in order to ensure that the cell could not survive.
Claims 1, 4-6, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12,246,061.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘061 patent and the instant application claim a method for inducing cell death of certain bacteria by contacting the bacteria with a CRISPR/Cas system, which leads to the death or reduction of the targeted bacterial population.
While the instant claims do not specify the vector for introducing the CRISPR/Cas system to the bacteria is a plasmid, it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute any well-known vector for introducing CRISPR/Cas systems, including the ‘061 patent’s phagemid vector, for the instant application’s vector with a predictable and reasonable expectation of success. It would also have been obvious to one with ordinary skill in the art at the time the invention was made target more than one site in the sequences of the prokaryotic cell in order to ensure that the cell could not survive.
Claims 1, 4-6, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12,285,466.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘466 patent claims a composition for inducing cell death of certain bacteria, while the instant application claims a method of inducing bacterial cell death by contacting the bacteria with a CRISPR/Cas system, which leads to the death or reduction of the targeted bacterial population.
While the instant claims do not specify the vector for introducing the CRISPR/Cas system to the bacteria, it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute any well-known vector for introducing CRISPR/Cas systems, including the ‘466 patent’s phagemid vector for the instant application’s vector with a predictable and reasonable expectation of success. It would also have been obvious to one with ordinary skill in the art at the time the invention was made target more than one site in the sequences of the prokaryotic cell in order to ensure that the cell could not survive. Further, it would have been obvious to one with ordinary skill in the art at the time the invention was made that the ‘466 patent’s composition could be used in the instant method of inducing prokaryote cell death. The instant case is analogous to Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. July 28, 2010), where the courts ruled that obviousness-type double patenting exist between previously-disclosed, but newly-claimed utility. Therefore, the instant claims are not patentably distinct from the issued claims.
Claims 1, 4-6, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,285,467.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘467 patent and the instant application claim a method for inducing cell death of certain bacteria by contacting the bacteria with a CRISPR/Cas system, which leads to the death or reduction of the targeted bacterial population.
While the instant claims do not specify the vector for introducing the CRISPR/Cas system to the bacteria, it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute any well-known vector for introducing CRISPR/Cas systems, including the ‘467 patent’s phagemid vector, for the instant application’s vector with a predictable and reasonable expectation of success. It would also have been obvious to one with ordinary skill in the art at the time the invention was made target more than one site in the sequences of the prokaryotic cell in order to ensure that the cell could not survive.
Claims 1, 4-6, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,295,993.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘993 patent and the instant application claim a method for inducing cell death of certain bacteria by contacting the bacteria with a CRISPR/Cas system, which leads to the death or reduction of the targeted bacterial population.
While the instant claims do not specify the vector for introducing the CRISPR/Cas system to the bacteria, it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute any well-known vector for introducing CRISPR/Cas systems, including the ‘993 patent’s phagemid vector, for the instant application’s vector with a predictable and reasonable expectation of success. It would also have been obvious to one with ordinary skill in the art at the time the invention was made target more than one site in the sequences of the prokaryotic cell in order to ensure that the cell could not survive.
Claims 1, 4-6, and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/191,803 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘803 application claims a composition and method for inducing cell death of certain bacteria, while the instant application claims a method of inducing bacterial cell death by contacting the bacteria with a CRISPR/Cas system, which leads to the death or reduction of the targeted bacterial population.
While the instant claims do not specify the vector for introducing the CRISPR/Cas system to the bacteria, it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute any well-known vector for introducing CRISPR/Cas systems, including the ‘803 application’s phagemid vector for the instant application’s vector with a predictable and reasonable expectation of success. It would also have been obvious to one with ordinary skill in the art at the time the invention was made target more than one site in the sequences of the prokaryotic cell in order to ensure that the cell could not survive. Further, it would have been obvious to one with ordinary skill in the art at the time the invention was made that the ‘803 application’s composition could be used in the instant method of inducing prokaryote cell death, and that the ‘803 application’s method has similar steps and uses similar compositions to reduce bacterial populations. The instant case is analogous to Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. July 28, 2010), where the courts ruled that obviousness-type double patenting exist between previously-disclosed, but newly-claimed utility. Therefore, the instant claims are not patentably distinct from the issued claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Amendments and Arguments
Regarding the non-statutory double patenting rejections set forth above, Applicants’ arguments have been fully considered and are not deemed to be persuasive.
Applicants assert that, because the priority date of the applications and patents is later than that of the instant application, those patent terms would not be extended by the issuance of a patent from the instant application. Citing Ex parte Baurin, Applicants assert that the non-statutory double patenting rejections are not proper.
However, as noted in the Advisory Action issued March 16, 2026, Ex part Baurin is a non-precedential decision and is not yet settled law. Because there is not yet a final decision in Ex parte Baurin, reliance on Ex parte Baurin is not applicable to the facts of the instant application.
For these reasons, and those listed above, the non-statutory double patenting rejections set forth above are maintained, and now also include newly added claim 8.
Allowable Subject Matter
Claim 7, which recites that the one or more vectors are plasmids, is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art is Sorek et al. (PCT Patent Application Publication No. WO 2012/164,565, and cited in the Information Disclosure Statement filed February 28, 2019) and Doudna et al. (U.S. Patent Application Publication No. 2014/00688797, and cited in the Information Disclosure Statement filed February 28, 2019). However, neither Sorek nor Doudna provide for induction of cell death in a prokaryotic cell. Sorek does not disclose the use of Cas9 to induce cell death in a prokaryotic cell. Doudna does not disclose the introduction of an active Cas9 into prokaryotic cells; only an inactive Cas9 is disclosed with regard to induction of cell death in a prokaryotic cell.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NANCY J LEITH whose telephone number is (313)446-4874. The examiner can normally be reached Monday - Thursday 8:00 AM - 6:30 PM.
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NANCY J. LEITH
Primary Examiner
Art Unit 1636
/NANCY J LEITH/Primary Examiner, Art Unit 1636
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