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 .
Claims 1-4 are pending.
An action on the merits is set forth below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 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 1-4 are 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.
Claims 1-4 are indefinite over the recitation of “a model molecule” in part (1) of claim 1 and the “performing an electrophoresis using each model molecule” in (1) e of claim 1. The claims are indefinite as (1) requires creation of a single (e.g. “a” model molecule) whereas the performing step requires the use and analysis of a-e. Furthermore it is not clear as the phrase “creating a model molecule corresponding to each of…” is not clear rather the model molecules would have the structure of each of a-e or if there is some other undefined relationship based upon language of “corresponding to”.
Claims 1-4 are indefinite over step 2 of claim 1. The step requires “electrophoresing the reaction mixture “ however, the claims do not require a reaction mixture in step 1 rather a model molecule. Further the recitation of “between the double stranded DNA to be analyzed and the Y type adapter molecules under a specific condition together with each model molecule” is indefinite as step 1 does not require double stranded DNA and Y type adapter molecules and multiple model molecules. Further it is not clear the method and conditions of step 1 as step 1 only requires electrophoresis and not any particular conditions. The last sentence of step 2 requires an analysis of a molecule type having 4 Y type adapter DNA strands ligated to the ds DNA and the amount of the reaction product of the incomplete adapter ligation molecule type having 3 or less Y type adapter DNA strands, however, the claims do not require such molecules nor does step 1 require electrophoresis of these molecules.
Claim 2 is unclear as it is not clear is model DNA strands id the same or different from the double stranded DNA of claim 1.
Claim 3 is indefinite over the dependency of the claim to “performing the step (2) of the method according to claim 1”, as it is not clear which requirements from step 2 f claim 1 is required as the evaluation of efficiency in step 2 is based upon the electrophoresing performed in step 1 of claim 1 which is not required by claim 3. Therefore the metes and bounds are unclear.
Claim 4 is indefinite over “repeatedly multiple times” as it is not clear if the claim intends to continually repeat steps A and B and as such never perform step c by the claim language used of “repeatedly”.
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.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harkins et al. (WO 2019/14201 July 18, 2019).
With regard to claim 1, Harkins et al teaches a method of creating a model molecule by ligating a double stranded DNA to a Y type (p 13). Harkins et al. teaches that adapter can be ligated to either end, both ends or no adapter ligated and as such would encompass a molecule “corresponding to” (p 2, figure 4, p 18). Harkins et al. teaches performing electrophoresis (p 59 lines 10-25 and p 61 lines 1-15). Harkins et al. teaches evaluating efficiency of the reactions (p. 129 lines 1-15). As noted in the 35 USC 112(b) it is not clear which steps are required by step 2 other than evaluating efficiency as Harkins et al. teaches that, Harkins anticipated the broadly encompassed claim limitations.
With regard to claim 2, Harkins et al. teaches that the double strand can be a 5’overhang with Y type adapter molecules attached (p 85 lines 20-32). Harkins teaches restriction enzymes (p 126 lines 25-30). Harkins et al. teaches that these cleave restriction enzymes can include Type IIS types (for example ALU I) (p. 35 lines 4-10).
With regard to claim 3, the claim is interpreted as performing a ligation reaction under specific conditions and then performing another ligation reaction under another set of conditions and comparing which Harkins performs in ligation reactions that are different and comparison ( pages 108-109).
With regard to claim 4, Harkins et al. teaches that the steps can be repeated (p. 78, lines 23-25).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682