REVISIT
DP present claim 1 genus anticipating application 18/687723 species of claims 1-15
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 .
DETAILED ACTION
Responsive to claim-set of 4/17/2024
Claims cancelled 9
Claims pending 1-8
Claims currently under consideration 1-8
Priority
This application has a filing date of 04/17/2024 and has been published as 20250320486 and is a 371 of
PCT/US2022/078452 10/20/2022
PCT/US2022/078452 has PRO 63/270,499 10/21/2021
Claim Rejections - 35 USC § 102
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.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lahoud et al (2008 Nucleic Acids Research 36: 6806-15).
Lahoud et al teach throughout the document and especially the abstract and figures 1,3, selectively binding complementary oligodeoxynucleotide derivatives having structure:5'-(Affinity tag)-(SBC sequence 2)-(Spacer)-(SBC sequence 1)-3’OH, wherein: SBC sequences 1 and 2 may be construed as 5-100 bases long with strands complementary to a selected region of a larger targeted dsDNA with such targeted DNA preserving a partial double stranded structure after invasion of such SBCs (referred to as ON hybrids by Lahoud); and include 2-thiothymine:2-aminoadenine (2sT – 2amA) base pairs and have an affinity for RecA at their 5'-ends (an affinity tag connected to linker nucleotide(s)). The foregoing appears to read on claims 1-2.
Claim Rejections - 35 USC § 103
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.
Claims 1,2,and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Lahoud et al (2008 Nucleic Acids Research 36: 6806-15) in view of Brenner (US AppPub 20100216125)
Lahoud et al is relied on as above as well as regarding claims 7, 8 (see figure 3) and claim 5a lines 1-3; claim 5b (see abstract regarding ON hybrids forming strong double-D joints (loops) with target DNA).
Lahoud et al do not explicitly teach an affinity tag for pulling down particular targets with beads, protecting dsDNA and melting as in claim 5a line 4 & claim 5c-e; nor standard library prep for sequencing of claim 6.
Brenner teaches throughout the document and especially the abstract, nucleic acid sequencing featuring nucleic acid tokens. More particularly in paragraphs 0091 and 0074 Brenner teaches standard library prep for sequencing; pulling down biotinylated protected dsDNA with beads and melting like claim 5a line 4 & 5c-e and claim 6.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have combined Brenner’s token sequencing with strand invasion of Lahoud et al.
One of ordinary skill in the art would have been motivated to have combined Brenner’s token sequencing with strand invasion of Lahoud et al in the interest of detecting rare alleles, advantageous in medical genetics according to Brenner in paragraph 0080 and indeed in the abstract Lahoud et al suggests joint formation by ON hybrids may be beneficially applied toward gene correction.
One of ordinary skill in the art would have had a reasonable expectation of success in applying melting, biotin-avidin and protection chemistry of Brenner et al toward strand invasion of Lahoud et al in so far as such techniques are art recognized as robust, having been used in molecular biology for decades.
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.
Claims 1-8 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 line 6 sets forth the limitation “another biotin”, whereas no other biotin is recited. Each of claims 2,3 & 4 recite the limitation "the sequence” (singular) in line 1, whereas claim 1 from which each of claims 2-4 depend recites at least two sequences. Claim 6 recites the limitation “the sequencing” in line 2. There is insufficient antecedent basis for the foregoing limitations in said claims, rendering their metes and bounds uncertain.
Regarding claim 1, the phrases "e.g.” and “such as” renders the claim indefinite because it is unclear whether the limitations following the phrase/term constitute the metes and bounds of the claim or not and thus are part of the claimed invention. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 5c recites the broad recitation "substrate”, and the claim also recites "solid phase" and “bead” which are the narrower statements of thereof. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In accordance with MPEP 2173.02: If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112, second paragraph, would be appropriate. See Morton Int ’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
In so far as the metes and bounds of the offending claim(s) may not be interpreted properly for the reasons above, all dependent claims therefrom claims1 and 5 are rejected as being indefinite as well.
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER M GROSS whose telephone number is (571)272-4446. The examiner can normally be reached M-F 10-6.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached on (571)272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER M GROSS/Primary Examiner, Art Unit 1684
15AUG2026 6:30 pm
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