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 .
Response to Amendment
The amendment filed 04/27/2026 has been considered. Regarding the Office action mailed 01/27/2026, the rejection of claim 38 under 35 USC 102(a)(2) over Chhabra (US 2017/0073393) is withdrawn in view of the amendment. In the context of the amendment to claim 32, claim 38 would permit only two different “informational sequences”. The rejection is maintained (though modified in accordance with the amendment) for claims 32-37 and applied to new claim 39 in accordance with one interpretation given for this claim. New claim 39 is rejected under 35 USC 112b as well. Applicant’s arguments will be addressed following the rejections.
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 39 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 39 recites “wherein adjacent oligomeric cassettes are ligated by a topoisomerase.” The scope of this claim is unclear, as it is not understood whether this language indicates an intended use for the claimed DNA sequence (in which case it does not structurally distinguish over the DNA sequence of claim 32), or whether it represents a “product-by-process” limitation as to how the DNA sequence of claim 32 was made. Appropriate clarification is required. Any amendment to obviate this rejection must find support in the application as-filed.
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.
(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.
Claim(s) 32-37 and 39 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chhabra (US 2017/0073393).
As a preliminary matter, claim 32 reads (with emphasis provided): “A DNA sequence comprising an informational series of oligomeric cassettes, wherein each oligomeric cassette comprises a topoisomerase recognition sequence and an informational sequence.”
The term “comprises” permits the claimed DNA sequence to contain additional sequence in addition to the topoisomerase recognition sequences and informational sequences. The term “series” is not explicitly defined in the specification. Therefore, the term “series” is construed as “two or more”. The term “oligomeric cassettes” is not explicitly defined in the specification, nor is the term “informational sequence”, nor are these terms limited to any particular nucleotide sequences.
Chhabra disclosed a DNA sequence comprising three “oligomeric cassettes”, each containing a topoisomerase recognition sequence (CCCTT) and an “informational sequence”. The DNA sequence is shown on pages 98-99, the relevant portion of which is reproduced below, with the topoisomerase recognition sequences underlined and the informational sequences boxed:
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Regarding the language “wherein the informational series contains information in binary code form”, the claim does not particularly define what this requires. Under the broadest reasonable interpretation, “binary code form” would mean that the information is encoded using two “digits”, 0 and 1. In this sense, the underscored “informational sequences” are made up of purines (A, G) and pyrimidines (C, T). Thus, a purine could represent 0 and a pyrimidine could represent 1. Thus, e.g., the first “informational sequence” indicated above would be ATGCT=01011.
Regarding claim 33, CCCTT is a recognition site for vaccinia virus topoisomerase (see paragraph [0492] of the instant specification.
Regarding claims 34 and 35, the topoisomerase recognition site is CCCTT.
Regarding claim 36, the informational sequences are two different sequences.
Regarding claim 37, the informational sequences are each 5 nucleotides.
Regarding claim 39, whether the language of claim 39 represents an intended use for the claimed DNA sequence, or a process by which it was made, it does not distinguish over the sequence disclosed by Chhabra.
Claim(s) 32-36, 38-39 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by King (US 2014/0135472).
King disclosed a DNA sequence comprising seven “oligomeric cassettes”, each comprising a topoisomerase recognition sequence (CCCTT) and an informational sequence (T) 5’ of the topoisomerase recognition sequence; see SEQ ID NO: 106 on page 27:
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The instant specification allows for an informational sequence to be a nucleotide or sequence; see page 68, paragraph [0239], “(ii)”, of WO 2019/213437: “…an informational sequence (e.g., selected from at least two different nucleotides or sequences…”.
Regarding the language “wherein the informational series contains information in binary code form”, the claim does not particularly define what this requires. Under the broadest reasonable interpretation, “binary code form” would mean that the information is encoded using two “digits”, 0 and 1. In this sense, the “informational sequences” are all “T”, which could represent, e.g., 0. Alternatively, T could represent 1.
Regarding claims 36 and 38, the claim requires that the informational sequences are “selected from” two different sequences. The claim does not require that the claimed DNA sequence comprises both of these “different sequences”. Thus, the other “informational sequence” could be “C”, but in this particular DNA sequence, “T” was selected in all instances. Since T could represent 0 (or, alternatively, 1), the binary code of this DNA sequence would be 0000000 (or, alternatively, 1111111).
Regarding claim 39, whether the language of claim 39 represents an intended use for the claimed DNA sequence, or a process by which it was made, it does not distinguish over the sequence disclosed by King.
Response to Arguments
Applicant's arguments filed 04/27/2026 have been fully considered but they are not persuasive. Regarding the modified rejection over Chhabra, the disclosed sequence comprises more than two “oligomeric cassettes, and the rejection explains how the informational sequences indicated therein can be used to represent binary code.
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 SAMUEL C WOOLWINE whose telephone number is (571)272-1144. The examiner can normally be reached 9am-5:30pm.
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/SAMUEL C WOOLWINE/ Primary Examiner, Art Unit 1681
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