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 .
Priority
The instant application claims benefit to PCT/US2022/011052, filed on 01/03/2022 and US Provisional Application No. 63,134938, filed 01/07/2021, which is acknowledged. The instant claims herein are examined using the effective filing date of 01/07/2021 for the basis of any prior art rejections.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 10/10/2023 and 10/24/2024 were properly filed in compliance with 37 CFR 1.97. Accordingly, the information disclosure statement(s) were considered.
Specification
The use of the term MADzymes®, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “a nuclease system configured to perform nucleic acid-guided nuclease editing, wherein the nuclease system is selected from a MAD293 system comprising SEQ ID NO: 1 (MAD293 nuclease), SEQ ID NO: 2 (CRISPR RNA) and SEQ ID NO: 3 (trans-activating crispr RNA); a MAD294 system comprising SEQ ID NO: 4 (MAD294 nuclease), SEQ ID NO: 5 (CRISPR RNA) and SEQ ID NO: 6 (trans-activating crispr RNA); a MAD295 system comprising SEQ ID NO: 7 (MAD295 nuclease), SEQ ID NO: 8 (CRISPR RNA) and SEQ ID NO: 9 (trans-activating crispr RNA); a MAD296 system comprising SEQ ID NO: 10 (MAD296 nuclease), SEQ ID NO: 11 (CRISPR RNA) and SEQ ID NO: 12 (trans-activating crispr RNA); a MAD297 system comprising SEQ ID NO: 13 (MAD297 nuclease), SEQ ID NO: 14 (CRISPR RNA) and SEQ ID NO: 15 (trans-activating crispr RNA); a MAD298 system comprising SEQ ID NO: 16 (MAD298 nuclease), SEQ ID NO: 17 (CRISPR RNA) and SEQ ID NO: 18 (trans-activating crispr RNA); and a MAD299 system comprising SEQ ID NO: 19 (MAD299 nuclease), SEQ ID NO: 20 (CRISPR RNA) and SEQ ID NO: 21 (trans-activating crispr RNA).”
It is suggested that Applicant remove the parentheticals, such that the claims read, e.g., “a MAD293 system comprising SEQ ID NO: 1, SEQ ID NO: 2 and SEQ ID NO: 3. . .”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
First rejection
Claim 1 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claim 1 is improper for the following reasons:
Claim 1 recites, inter alia, ““a nuclease system configured to perform nucleic acid-guided nuclease editing, wherein the nuclease system is selected from a MAD293 system comprising. . .” (emphasis added) for each claimed nuclease system. Here, each nuclease system is made of a different nuclease (e.g., MAD293 vs MAD299), CRISPR RNA (e.g., SEQ ID NO: 8 vs SEQ ID NO: 17), and trans-activating RNA (e.g., SEQ ID NO: 3 vs SEQ ID NO: 21). A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group “consisting of” (rather than “comprising” or “including”) the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group “comprising” or “consisting essentially of” the recited alternatives), the claim [is] indefinite because it is unclear what other alternatives are intended to be encompassed by the claim. See In re Kiely, 2022 USPQ2d 532 at 2* (Fed. Cir. 2022) (see MPEP 2173.05(h)(I).
Second rejection
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 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.
Claim 3 recites, inter alia “wherein the nuclease system is a MAD294 system comprising SEQ ID NO: 4 (MAD294 nuclease), SEQ ID NO: 5 (CRISPR RNA) and SEQ ID NO: 6 (trans-activating crispr RNA)”. There is a missing a period after “(trans-activating crispr RNA)”, thus rendering the claim indefinite as the lack of the period makes the scope of the claim unclear. For the purposes of compact patent prosecution, the limitation is interpreted to have a period.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-8 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-8 of prior U.S. Patent No. 11332742 B1. This is a statutory double patenting rejection.
Regarding claim 1, patent claim 1 teaches a nuclease system configured to perform nucleic acid-guided nuclease editing, wherein the nuclease system is selected from the group consisting of: a MAD293 system comprising SEQ ID NO: 1, SEQ ID NO: 2 and SEQ ID NO: 3; a MAD294 system comprising SEQ ID NO: 4, SEQ ID NO: 5 and SEQ ID NO: 6; a MAD295 system comprising SEQ ID NO: 7, SEQ ID NO: 8 and SEQ ID NO: 9; a MAD296 system comprising SEQ ID NO: 10, SEQ ID NO: 11 and SEQ ID NO: 12; a MAD297 system comprising SEQ ID NO: 13, SEQ ID NO: 14 and SEQ ID NO: 15; a MAD298 system comprising SEQ ID NO: 16, SEQ ID NO: 17 and SEQ ID NO: 18; and a MAD299 system comprising SEQ ID NO: 19, SEQ ID NO: 20 and SEQ ID NO: 21. All of the nuclease systems and sequences disclosed in the patent are identical to the instantly claimed invention (see ABSS/STIC search results 11/19/2025).
Regarding claim 2, patent claim 2 teaches the nuclease system of claim 1, wherein the nuclease system is a MAD293 system comprising SEQ ID NO: 1, SEQ ID NO: 2 and SEQ ID NO: 3.
Regarding claim 3, patent claim 3 teaches the nuclease system of claim 1, wherein the nuclease system is a MAD294 system comprising SEQ ID NO: 4, SEQ ID NO: 5 and SEQ ID NO: 6.
Regarding claim 4, patent claim 4 teaches the nuclease system of claim 1, wherein the nuclease system is a MAD295 system comprising SEQ ID NO: 7, SEQ ID NO: 8 and SEQ ID NO: 9.
Regarding claim 5, patent claim 5 teaches the nuclease system of claim 1, wherein the nuclease system is a MAD296 system comprising SEQ ID NO: 10, SEQ ID NO: 11 and SEQ ID NO: 12.
Regarding claim 6, patent claim 6 teaches the nuclease system of claim 1, wherein the nuclease system is a MAD297 system comprising SEQ ID NO: 13, SEQ ID NO: 14 and SEQ ID NO: 15.
Regarding claim 7, patent claim 7 teaches the nuclease system of claim 1, wherein the nuclease system is a MAD298 system comprising SEQ ID NO: 16, SEQ ID NO: 17 and SEQ ID NO: 18.
Regarding claim 8, patent claim 8 teaches the nuclease system of claim 1, wherein the nuclease system is a MAD299 system comprising SEQ ID NO: 19, SEQ ID NO: 20 and SEQ ID NO: 21.
As such, it is clear that the patented invention is the exact same invention as instantly claimed.
Conclusion
NO CLAIMS ALLOWED.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
EP3642334B1: discloses various nucleic acid-guided nucleases for modification of target regions in the genome of a cell including MAD nucleases (see paragraph 0002; Fig. 1B; paragraph 0221; Table 2).
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/G.C.R./Examiner, Art Unit 1651
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672