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 previously canceled claims 8, 11, 14-15, 20, 22-23 and 25. Claims 1-7, 9-10, 12-13, 16-19, 21 and 24 are currently pending. Claims 16-19, 21 and 24 are withdrawn as being drawn to a nonelected invention. Claims 1-7, 9-10 and 12-13 are under examination.
Election/Restrictions
Applicant's election without traverse of Group I, claims 1-7, 9-10 and 12-13, drawn to a solid support with capture moieties and clustering primers, in the reply filed on April 23, 2026 is acknowledged.
Claims 16-19, 21 and 24 are withdrawn from further consideration to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 23, 2026, and is acknowledged.
Information Disclosure Statement
The Information Disclosure Statement filed July 08, 2025 been considered.
Claim Objections
Claims 1 and 7 are objected to because of the following informalities:
In claim 1, line 5, the terms “wherein the capture moieties are orthogonal to the clustering primers”, should read “ wherein the plurality of capture moieties are orthogonal to the plurality of clustering primers.
In claim 7, line 2, the terms “and are configured to capture the template”, should read “and capture the template”.
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.
Claim 2 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 2 is considered vague and indefinite for the following reasons:
In claim 2, the terms “1:2 or more” in line 2, is unclear and confusing. It is unclear as to which part of the ratio, the capture moieties or the cluster primers or both, are to be included in the “or more”? Can the capture moieties, the cluster primers or both increase?
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.
Claims 1, 3-7, 9-10 and 12-13 are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by Fisher et al. (United States Patent No.: US 11,124,829 B2, patented September 21, 2021, effectively filed June 07, 2019).
Regarding claim 1, Fisher teaches a solid support for use in sequencing (Column 2, Lines 42-48, Column 3, Lines 66-67 and Column 15, Lines 58-59). Fisher teaches the solid support comprises a plurality of capture moieties adapted to capture a template (Column 2, Lines 42-48, Column 3, Lines 18-58, Column 19, Lines 5-9 and 24-39 and Column 51, Lines 37-62). Fisher teaches a plurality of clustering primers (Column 22, Lines 36-48, Column 3, Lines 18-35, and Column 15, Line 60—Column 16, Line 7). As disclosed by the instant specification, “orthogonal” here is meant that the capture mechanism used to fix the template to the flowcell surface is different from the primers used to generate the clusters, and therefor Fisher teaches the capture moieties are orthogonal to the clustering primers (Column 2, Lines 52-59, Column 2, Line 66-Column 3, Line 7, Column 15, Line 60—Column 16, Line 31, Column 75, Lines 12-28).
Regarding claim 3, Fisher teaches the clustering primers comprise a mixture of P5 and P7 primers (Column 24, Lines 43-65).
Regarding claim 4, Fisher teaches the capture moieties comprise an oligonucleotide seeding sequence (Column 74, Lines 15-24, Column 90, Lines 60-67).
Regarding claim 5, Fisher teaches the oligonucleotide seeding sequence comprises between 10 and 30 nucleotides (Column 22, Lines 47-48).
Regarding claim 6, Fisher teaches an oligonucleotide seeding sequence with a sequence that is partially overlapping instant claim 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 10, SEQ ID NO: 12 , SEQ ID NO: 14 as well as SEQ ID NO: 16, and is therefore regarded as a “variant” of the seeding sequences claimed in claim 6 (Column 24, Lines 53-56, Column 74, Lines 15-24, Column 22, Lines 47-48 and Column 90, Lines 60-67).
Regarding claim 7, Fisher teaches the capture moieties do not include nucleotides and are configured to capture the template by a non-covalent interaction or by a covalent interaction (Column 18, Lines 8-43 and Column 19, Lines 24-39).
Regarding claim 9, Fisher teaches the capture moieties comprise an avidin or a biotin (Column 19, Lines 24-39).
Regarding claim 10, Fisher teaches the covalent interaction is reversible (Column 18, Lines 8-43, Column 64, Lines 10-21, Column 90, Lines 19-22).
Regarding claim 12, Fisher teaches the solid support is a flow cell, and the flow cell comprises a plurality of nano wells (Column 7, Lines 18-19 and Column 40, Lines 22-29).
Regarding claim 13, Fisher teaches the solid support is a microbead (Column 5, Lines 8-12, Column 18, Lines 23-43, Column 35, Lines 21-22 and Column 59, Line 61-65).
Fisher teaches each and every limitation of claims 1, 3-7, 9-10 and 12-13, and therefore Fisher anticipates claims 1, 3-5, 7, 9-10 and 12-13.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Fisher et al. (United States Patent No.: US 11,124,829 B2, patented September 21, 2021, effectively filed June 07, 2019).
Regarding claim 2, Fisher teaches different capture sites, including capture moieties and beads, may be designed by user’s choice and have different patterns/shapes on a substrate (Column 59, Line 51—Column 60, Line 57 and Column 70, Line 61—Column 71, Line 44). Fisher teaches that any suitable density may be used as well as the densities of the clusters may be designed with the patterned resin according to user’s choice which in turn could increase (or decrease depending on the pattern chosen), the amount of primers used (Column 16, Lines 14-32, Column 39, Lines 22-64, Column 70, Line 61—Column 71, Line 44, Column 80, Lines 25-67).
Fisher does not teach or suggest explicitly the ratio of capture moieties to clustering primers is about 1:2 or more.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Fisher to include the ratio of capture moieties to clustering primers to be about 1:2 or more, because Fisher teaches the densities of the array design as well as the amount of cluster primers may be designed by user’s choice and therefore could be chosen/designed with a capture moiety to clustering primer ratio being 1:2.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA DANIELLE PARISI whose telephone number is (571)272-8025. The examiner can normally be reached Mon - Friday 7:30-5:00 Eastern with alternate Fridays off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached at 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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/JESSICA D PARISI/ Examiner, Art Unit 1684
/HEATHER CALAMITA/ Supervisory Patent Examiner, Art Unit 1684
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