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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 19 May 2026 has been entered.
Claim Status
Claims 1, 4-5, 17, 20-21, 29, 34-36, 41, and 43-44 are pending.
Claims 1 and 43 are currently amended.
Claims 1, 4-5, 17, 20-21, 29, 34-36, 41, and 43-44 are examined on the merits.
Response to Arguments - Indefiniteness
Applicant's arguments filed 19 May 2026 have been fully considered but they are not persuasive.
Applicant urges that the mechanism by which a donor DNA or a polynucleotide modification template are integrated into the genome are the same, a donor DNA is intended to mean a piece of DNA that it intended to facilitate a larger DNA insertion while a polynucleotide modification template can be used to introduce a mutation as small as a single substitution but also encompasses templates that facilitate larger indel mutations. Thus, it appears that Applicant is using the phrase polynucleotide modification template as a broader generic term that encompasses what they intend their meaning of donor DNA to encompass. This claim structure remains confusing at best. It is suggested that the claims be amended to only recite “a polynucleotide modification template” and then add dependent claims to specify features of the polynucleotide modification template to address the intended limitation of “donor DNA.”
Claim Rejections - 35 USC § 112
Indefiniteness
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.
Claims 1, 4-5, 17, 20-21, 29, 34-36, 41, and 43-44 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 pre-AIA the applicant regards as the invention.
Claim 1 requires, “a donor DNA or a polynucleotide modification template.” It is unclear what the distinct structure of the donor DNA is compared the to the recited polynucleotide modification template, as these phrases are typ8ically used interchangeably in the art. If they are interchangeable, only a single phrase should be recited in the claim as the presence of both suggests that the phrases are intended to have distinct meanings. As such, the metes and bounds of the claim cannot be determined. Claims 4-5, 17, 20-21, 29, 34-36, 41, and 43-44 are rejected for depending from an indefinite claim and failing to recite additional limitations that would render the claim definite.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R KEOGH whose telephone number is (571)272-2960. The examiner can normally be reached M-Th 7-4:30, half day on Fridays.
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/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
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