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 .
Applicant’s amendment of claims 1, 4, 10, 15, 17, in the paper of 8/27/2025, is acknowledged. Claims 1-30 are still at issue and are present for examination.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-11, drawn to an enzyme composition, classified in C12N 9/22.
II. Claims 12-19, 20-26, 27-30, drawn to a method of DNA authentication/forming screening products/DNA fragment analysis, classified in C12Q 1/6806.
The inventions are distinct, each from the other because of the following reasons:
Invention I and inventions II are related as product and processes of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product (MPEP § 806.05(h)). In the instant case, the enzyme composition can be used to make antibodies against the enzymes.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition less than 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
Because these inventions are distinct for the reasons given above, have acquired a separate status in the art as shown by their different classification, and/or the literature and sequence searches required for each of the Groups are not required for another of the Groups, restriction for examination purposes as indicated is proper.
Applicant is advised that the reply to this requirement to be complete must include an election of the invention to be examined even though the requirement be traversed (37 CFR 1.143).
The examiner has required restriction between product and process claims. Where applicant elects claims directed to the product, and the product claims are subsequently found allowable, withdrawn process claims that depend from or otherwise require all the limitations of the allowable product claim will be considered for rejoinder. All claims directed to a nonelected process invention must require all the limitations of an allowable product claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product are found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product claim will not be rejoined. See MPEP § 821.04(b). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product claims. Failure to do so may result in a loss of the right to rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Telephonic Election
During a telephone conversation with Guy Birkenmeir on 8/27/202 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-11. Affirmation of this election must be made by applicant in replying to this Office action.
Claims 12-30 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Information Disclosure Statement
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 A(1) states, "the list may not be incorporated into the specification but must be submitted in a separate paper."
Applicants filing of information disclosure statements on 8/15/2023 and 4/25/2024 are acknowledged and have been considered.
Specification
The disclosure is objected to because of the following informalities:
The use of the terms: Tween (page 20, line 16) 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.
The specification comprises multiple nucleotide sequences in Figure 2A which require a sequence identifier as per 37 CFR 1.831(b)(see MPEP 2420). Further applicants are required to include the sequence identifier(s) either in the figure itself or the description of the figure.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Potter and Netuschil (WO 2021/178809).
Potter and Netuschil (WO 2021/178809) describe compositions and methods for the synthesis of nucleic acid molecules with low error rates. Potter and Netuschil (WO 2021/178809) describe compositions and methods for the high throughput synthesis of nucleic acid molecules with high sequence fidelity. Potter and Netuschil disclose that the endonucleases are used to reduce the percentage of nucleic acid molecules containing errors by cleaving the nucleic acids that contain errors (paragraph 84). Potter and Netuschil discloses that a combination of different MMEs can be used in each of the possibly several steps of error correction (paragraph 128), including T4Endo VII and EndoMS, which are disclosed as possible MMEs that can be used together. Thus, Potter and Netuschil teach an enzyme composition comprising a T4EndoVII and a EndoMS mismatch endonuclease.
Thus, claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Potter and Netuschil (WO 2021/178809).
Claim(s) 1-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vakulskas et al. (US 2020/0407776).
Vakulskas et al. (US 2020/0407776) describe compositions and methods for detecting single and/or multiple nucleotide mismatches on DNA fragments in vitro by enzymatic cleavage using a mixture of mismatch endonucleases. Vakulskas et al. teach an enzyme composition for detecting edited genomic DNA comprising a mixture of mismatch endonucleases, wherein the mixture of mismatch endonucleases comprises T7E1 and T4E7 (see claim 7 and supporting text). Thus, Vakulskas et al. teach an enzyme composition comprising a T4EndoVII and a mismatch endonuclease (claim 1). Vakulskas et al. further teach the utilization of T4/T7 nuclease blend to cleave heteroduplexes containing 1, 2, 3, and 12 nucleotide mismatches (Example 1). Vakulskas et al. teach a polymerase chain reaction (PCR) equimolar mixture (comprising a polymerase and NTPs) of deletion mutants and wild type sequence used to generate various heteroduplex and homoduplex DNAs. These 50/50 mixtures of homoduplex/heteroduplex DNAs were cleaved with a mixture of T7E1 and T4E7 for analysis of the cleavage products with a CE instrument (see Example 1 and supporting text). Vakulskas et al. teach that while the individual enzymes T7E1 and T4E7, recognized different types of mismatches ( 2, 3, and 12 base mismatches as well as single indel species) with different efficiencies, the combination of both enzymes as a T7E1+T4E7 cocktail cleaved all of the heteroduplex fragment species.
Thus, claim(s) 1-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vakulskas et al. (US 2020/0407776).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vakulskas et al. (US 2020/0407776) and Potter and Netuschil (WO 2021/178809).
As discussed above, Vakulskas et al. (US 2020/0407776) describe compositions and methods for detecting single and/or multiple nucleotide mismatches on DNA fragments in vitro by enzymatic cleavage using a mixture of mismatch endonucleases. Vakulskas et al. teach an enzyme composition for detecting edited genomic DNA comprising a mixture of mismatch endonucleases, wherein the mixture of mismatch endonucleases comprises T7E1 and T4E7 (see claim 7 and supporting text). Thus, Vakulskas et al. teach an enzyme composition comprising a T4EndoVII and a mismatch endonuclease (claim 1). Vakulskas et al. further teach the utilization of T4/T7 nuclease blend to cleave heteroduplexes containing 1, 2, 3, and 12 nucleotide mismatches (Example 1). Vakulskas et al. teach a polymerase chain reaction (PCR) equimolar mixture (comprising a polymerase and NTPs) of deletion mutants and wild type sequence used to generate various heteroduplex and homoduplex DNAs. These 50/50 mixtures of homoduplex/heteroduplex DNAs were cleaved with a mixture of T7E1 and T4E7 for analysis of the cleavage products with a CE instrument (see Example 1 and supporting text). Vakulskas et al. teach that while the individual enzymes T7E1 and T4E7, recognized different types of mismatches ( 2, 3, and 12 base mismatches as well as single indel species) with different efficiencies, the combination of both enzymes as a T7E1+T4E7 cocktail cleaved all of the heteroduplex fragment species.
While Vakulskas et al. teach an enzyme composition comprising a T4EndoVII and a mismatch endonuclease such as T7E1, they do not teach a composition comprising a T4EndoVII and a Endo MS mismatch endonuclease.
Potter and Netuschil (WO 2021/178809) describe compositions and methods for the synthesis of nucleic acid molecules with low error rates. Potter and Netuschil (WO 2021/178809) describe compositions and methods for the high throughput synthesis of nucleic acid molecules with high sequence fidelity. Potter and Netuschil disclose that the endonucleases are used to reduce the percentage of nucleic acid molecules containing errors by cleaving the nucleic acids that contain errors (paragraph 84). Potter and Netuschil discloses that a combination of different MMEs can be used in each of the possibly several steps of error correction (paragraph 128), including T4Endo VII and EndoMS, which are disclosed as possible MMEs that can be used together. Thus, Potter and Netuschil teach an enzyme composition comprising a T4EndoVII and a EndoMS mismatch endonuclease.
One of ordinary skill in the art before the effective filing date would have been motivated to practice the methods for detecting single and/or multiple nucleotide mismatches on DNA fragments in vitro by enzymatic cleavage using a mixture of mismatch endonucleases as taught by Vakulskas et al. substituting the mismatch endonucleases taught by Potter and Netuschil for those mismatch endonucleases used by Vakulskas et al. Specifically one of ordinary skill in the art before the effective filing date would have been motivated to practice the methods for detecting single and/or multiple nucleotide mismatches on DNA fragments in vitro by enzymatic cleavage using a mixture of mismatch endonucleases as taught by Vakulskas et al. substituting the mismatch endonucleases, T4EndoVII and EndoMS, as taught by Potter and Netuschil for those mismatch endonucleases taught by Vakulskas et al. leading to compositions comprising a T4EndoVII and EndoMS as well as the additional components taught by Vakulskas et al. discussed above (claims 1-8) . The motivation for the substitution of the mismatch endonucleases T4EndoVII and EndoMS as taught by Potter and Netuschil for the mismatch endonuclease taught by Vakulskas et al. is that both Potter and Netuschil and Vakulskas et al. teach that the taught mismatch endonucleases perform the same function in the disclosed methods of mismatch detection. Further Vakulskas et al. teach that in the above taught methods two different mismatch endonucleases is preferable to a single mismatch endonuclease and Potter and Netuschil teach that compositions comprising a T4EndoVII and EndoMS which are disclosed as possible MMEs that can be used together. The packaging of the obvious compositions as well as different enzymes and buffers used in the methods of Vakulskas et al. into a kit is regarded as conventional to a person of ordinary skill in the art and useful for convenience of practicing the obvious methods (claims 9-11). The expectation of success is high based upon the high level of skill in the art of recombinant DNA technology as exemplified by both Vakulskas et al. and Potter and Netuschil who teach all the resources and methods necessary to produce and use the obvious compositions.
Remarks
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G HUTSON whose telephone number is (571)272-0930. The examiner can normally be reached 6-3 EST Mon-Fri.
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rgh
12/3/2025
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652