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 .
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 104-121 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 104 is vague and indefinite because it is unclear of what exactly the first state and second state for the residues are.
Claim 104 is vague and indefinite because it is unclear of what are the metes and bounds for the term “sensitizer”.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 104-113, 116-121 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 268-271, 273-291 of copending Application No. 18809812 (reference application); over claims 114-142 of copending Application No. 18410087 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a method, comprising (a) providing a polymer, wherein said polymer comprises a plurality of convertible residues, wherein each convertible residue of said plurality of convertible residues is in a first state, and is capable of being converted into a second state by a stimulus; (b) encoding data into said polymer by converting convertible residues from said first state into said second state using said stimulus.
The instant application discloses the plurality of spacer residues are naturally occurring nucleobases, non-naturally nucleobases, tetrahydrofuran abasic residues, or ethylene glycol residues, or naturally occurring nucleobases [000127]; In some embodiments, the ratio of the total number of nucleotides of the convertible residues in the nucleic acid polymer is between 2 to 100 [00011].
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claim(s) 104-108, 110-113, 116-121 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brown et al. (WO 2020/128517).
Brown et al. teaches method for modifying the polynucleotide strand (polymer). The modifications made to the polynucleotide strand typically do not alter the overall length of the polynucleotide strand; i.e. data is encoded on the polynucleotide strand backbone rather than involving the addition or removal of monomer units from the polynucleotide strand. Any suitable modifications can be made to the polynucleotide strand. For example, the modifications may be epigenetic modifications. Selectively modifying portions of the polynucleotide strand may comprise subjecting the portions of the polynucleotide strand in the nanoreactor to reaction conditions comprising (i) the presence, absence or concentration of one or more chemical reagent(s); (ii) the engagement of an enzyme with the polynucleotide strand under conditions that the enzyme modifies the nucleotides within the polynucleotide strand; (iii) the presence or absence of electromagnetic radiation; and/or (iv) the presence or absence of applied heat (page 4 line 7 - page 5 line 18; page 6 line 25 - page 7 line 13; Fig. 1). (Thereby, converting the residues from a first state into a second state).
Brown et al. teaches in preferred embodiments data is written onto the polynucleotide through photocleavable moieties of the convertible residues that can be selectively modified by light (405 nm or 435 nm) when passing through a nanopore. The nanopore is conjugated to a photosensitizer, optionally via a cysteine residue (page 58 lines 26-29, page 60 line 1 - page 61 line 28; Examples 4, 5; Fig. 15).
Brown et al. teaches the movement of the polynucleotide with respect to the nanoreactor can be controlled with polynucleotide motors, for example polymerases, helicases, translocases, exonucleases, etc. Polynucleotide motors are also referred to herein as polynucleotide handling enzymes. In certain embodiments the nanopore is conjugated to a 'polynucleotide handling enzyme' that is a polymerase, nuclease or helicase (page 46 line 15 -page 47 line - 25; page 50 line 25 - page 52 line 16; page 53 lines 14-18), and thus the photosensitizer that is conjugated to the nanopore is also conjugated to the enzyme.
Brown et al. teaches the methods of the invention comprise selectively modifying portions of the polynucleotide strand. In some embodiments, such methods comprise selectively controlling the number of nucleotides that are modified within each portion of the polynucleotide strand. For example, in some embodiments 1 nucleotide may be selectively modified. In other embodiments more than one nucleotide may be selectively modified; for example from 1 to about 1000 nucleotides, such as from about 10 to about 500, e.g. from about 50 to about 250 nucleotides may be selectively modified. Different portions of the polynucleotide strand may have different numbers of modified nucleotides and thereby by distinguished (pages 55-56 and claims).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEZIA RILEY whose telephone number is (571)272-0786. The examiner can normally be reached 7:30-6:00pm.
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, Gary Benzion can be reached at 571-272-0782. 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.
/JEZIA RILEY/ Primary Examiner, Art Unit 1681 24 September 2026
