5DETAILED 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 reply to the May 08, 2025 Office Action, filed November 04, 2025, is acknowledged. Applicant canceled claims 1-6, 9 and 11-20. Applicant newly adds claims 21-25. Claims 7-8, 10 and 21-25 are currently pending and under examination.
Any objection or rejection of record in the previous Office Action which is not addressed in this action has been withdrawn in light of Applicant’s amendments and/or arguments. This action is FINAL.
Information Disclosure Statement
The Information Disclosure Statement filed May 07, 2025 has been considered.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/patents-application- process/filing-online/legal-framework-efs-web), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1),
1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete.
Required response – Applicant must:
Amend the Sequence Listing Incorporation by Reference paragraph at page 1 of the
specification. It is noted the Sequence Listing Incorporation by Reference paragraph lists the size of the ASCII text file as 66 kilobytes, whereas the ASCII text file itself lists the size as 67,325 bytes.
Claim Objections
Claims 7 and 10 are objected to because of the following informalities:
In claim 7, line 11, “comprising the same, non-complementary overhangs” should read “comprising same, non-complementary overhangs”.
Additionally in claim 7, in order to be consistent with the title and preamble of the instant application, in lines 9-10, the terms “a first library of ds oligonucleotides (ds oligos)” should read “a first library of ds polynucleotides”; in line 12, “ds oligos” should read “ds polynucleotides”; in lines 16-17, the terms “a second library of ds oligos” should read “a second library of ds polynucleotides”.
Similarly, in claim 10, in order to be consistent with the title and preamble of the instant application, in line 4, “the first library of ds oligos comprises ds oligos” should read “the first library of ds polynucleotides comprises ds polynucleotides”; in line 6, the terms “the second library of ds oligos comprise ds oligos” should read” the second library of ds polynucleotides comprises ds polynucleotides”.
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.
Claims 20 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.
Claim 21, is vague and indefinite for the following reasons:
In Claim 21, line 1, the terms “the ds library members” are unclear and confusing. It is unclear as to which library members the claim is referring; the first library, the second library or both?
Claim 22, is vague and indefinite for the following reasons:
In Claim 22, line 1, the terms “the ds library members” are unclear and confusing. It is unclear as to which library members the claim is referring; the first library, the second library or both?
Claim 23, is vague and indefinite for the following reasons:
In Claim 23, line 1, the terms “each of said ds library members” are unclear and confusing. It is unclear as to which library members the claim is referring; the first library, the second library or both?
Claim 24, is vague and indefinite for the following reasons:
In Claim 24, line 1, the terms “said ds library members” are unclear and confusing. It is unclear as to which library members the claim is referring; the first library, the second library or both?
Claim 25, is vague and indefinite for the following reasons:
In Claim 25, line 1, the terms “each of said ds library members” are unclear and confusing. It is unclear as to which library members the claim is referring; the first library, the second library or both?
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 1-10 and 12-14 are rejected under 35 U.S.C. 102(a)(1) (a)(2) as being anticipated by Evans et al. (U.S. Patent US 6,670,127 B2, published December 30, 2003).
Regarding claim 7, Evans teaches a method for producing a library of double stranded (ds) polynucleotide library members of at least 12 base pairs (bp) in length (Column 13, Line 49—Column 14, Line 3, Column 4, Lines 23-30 and Column 26, Lines 27-29). Evans teaches providing a template nucleotide sequence (Column 6, Lines 1-4). Evans teaches providing a library of single stranded (ss) oligos in separate containments (Fig. 3). Evans teaches said ss oligos comprising a variety of sequences comprising one or more point mutations compared to the template (Column 17, Lines 33-39). Evans teaches selecting pairs of matching ss oligos from said library d) partially annealing said pairs of matching ss oligos, thereby obtaining a first library of ds oligonucleotides (ds oligos) (Column 4, Lines 1-17, Column 7, Lines 9-61 and Fig. 3). Evans teaches a variety of core sequences and comprising the same, non-complementary overhangs (Column 7, Lines 24-61, Column 8, Line 66—Column 9, Line 25 and Column 18, Lines 8-58).
Regarding claim 8, Evans teaches the ds polynucleotides are enriched by polymerase chain reaction (PCR) ( Column 1, Lines 47-65 and Column 21, Lines 18-23).
Regarding claim 10, Evans teaches the first library of ds oligos comprises ds oligos with a length of at least 6 bp (Column 4, Lines 23-30).
Regarding claim 21, Evans teaches the ds library members each comprise a leading strand and a lagging strand and said overhangs are on both the leading strand and the lagging strand (Column 4, Lines 4-10 and Column 7, Lines 24-61). Evans teaches library members comprises a first overhang sequence which is the 5' overhang of the leading strand, and a second overhang sequence which is the 5' overhang of the lagging strand, wherein the first overhang sequence which is the 5' overhang of the leading strand is the same in each library member, and wherein the second overhang sequence which is the 5' overhang of the lagging strand is the same in each library member (Column 5, Lines 39-41, Column 4, Lines 4-10 and Column 7, Lines 9-61 and Fig. 3 ), and which overhang sequences are not complementary to each other (Column 7, Lines 9-61, Column 9, Lines 1-14 and Column 18, Lines 8-47).
Regarding claim 22, Evans teaches the overhangs of the ds library members have a length of 4-8 nucleotides (Column 19, Lines 50-52).
Regarding claim 23, Evans teaches each of said ds library members comprises an identical modification selected from the group consisting of phosphorylation, methylation, biotinylation, and linkage to a fluorophore or quencher (Column 17, Lines 48-51, Column 20, Lines 5-8).
Regarding claim 24, Evans teaches said ds library members are contained in one library containment, or in a plurality of spatially distinct library containments (Column 36, Lines 30-37).
Regarding claim 25, Evans teaches each of said ds library members comprises a sequence which is at least 30% identical to a template ( Column 16, Lines 37-42).
Evans teaches each and every claim limit of claims 7-8, 10 and 21-25, therefore Evans anticipates claims 7-8, 10 and 21-25.
Response to Arguments
Applicant’s arguments and amendments filed November 04, 2025 with respect to the
rejections under 35 U.S.C. 112(b) have been fully considered and these rejections are rendered moot due to the cancellation of claims 1-6, 9 and 11-20. Therefore, these rejections are withdrawn.
Applicant’s arguments and amendments filed November 04, 2025 with respect to the
rejections under 35 U.S.C. 102 and 103 have been fully considered and these rejections are rendered moot due to the cancellation of claims 1-6, 9 and 11-20. Therefore, these rejections are withdrawn.
However, as discussed above, newly cited Evans discloses a method for producing a library of double stranded polynucleotide members of at least 12 base pairs in length comprising each and every limitation of claims 7-8, 10 and 21-25, and therefore Evans is deemed to render the instant invention anticipated.
Terminal Disclaimer
The terminal disclaimer filed on July 25, 2025 disclaiming the terminal portion of any
patent granted on this application which would extend beyond the expiration date of Patents
11,352,619; and 12,018,251, has been reviewed and is accepted. The terminal disclaimer has been recorded, and the nonstatutory double patenting rejections have been withdrawn.\
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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 at 571-272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA D PARISI/Examiner, Art Unit 1684
/HEATHER CALAMITA/Supervisory Patent Examiner, Art Unit 1684