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 cancels claims 4, 7-9, 11-12, 14-22, 24, 26, 29-35, 37, 39-42, 44-46, 49, 51-54, 56-60 and 62-65. Claims 1-3, 5-6, 10, 13, 23, 25, 27-28, 36, 38, 43, 47-48, 50, 55, 61 and 66 are currently pending. Claims 36, 38, 43, 47-48, 50, 55, 61 and 66 are withdrawn from consideration as being drawn to a nonelected invention. Claims 1-3, 5-6, 10, 13, 23, 25 and 27-28 are currently under examination.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-3, 5-6, 10, 13, 23, 25 and 27-28, drawn to a composition and a reaction mixture, in the reply filed March 30, 2026 is acknowledged.
Claims 36, 38, 43, 47-48, 50, 55, 61 and 66 are withdrawn from further consideration to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 March 30, 2026, and is acknowledged.
Information Disclosure Statement
The Information Disclosure Statements filed November 10, 2023; February 27, 2026; and May 13, 2026 have 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 56 kilobytes, whereas the ASCII text file itself lists the size as 56,846 bytes.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see Page 23, [0097] and Page 39, [0137], ). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of the term NextSeq™, Triton® X-100, Tween®20, (Page 83, [0260], Page 73, [0219] and Page 74, [0221]), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 1, 10, 27 and 28 are objected to because of the following informalities:
In claim 1, lines 3-4, “a first programmable DNA binding unit capable of specifically binding to a first binding site”, should read “a first programmable DNA binding unit that specifically binds to a first binding site”.
In claim 1, lines 6-7, “a second programmable DNA binding unit capable of specifically binding to a second binding site”, should read “a second programmable DNA binding unit that specifically binds to a second binding site”.
In claim 10, lines 3-4, “a first guide RNA (gRNA) capable of specifically binding to the first binding site of the target dsDNA”, should read “a first guide RNA (gRNA) that specifically binds to the first binding site of the target dsDNA”.
In claim 10, lines 5-6, “a second gRNA capable of specifically binding to the second binding site on the target dsDNA”, should read “a second gRNA that specifically binds to the second binding site on the target dsDNA”.
In claim 27, lines 3-4, “a third programmable DNA binding unit capable of specifically binding to a third binding site on the target dsDNA”, should read “a third programmable DNA binding unit that specifically binds to a third binding site on the target dsDNA”.
In claim 28, lines 5-7, “a first programmable DNA binding unit capable of specifically binding to a first binding site”, should read “a first programmable DNA binding unit that specifically binds to a first binding site”.
In claim 28, lines 8-10, “a second programmable DNA binding unit capable of specifically binding to a second binding site”, should read “a second programmable DNA binding unit that specifically binds to a second binding site”.
Appropriate correction is required.
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, 5-6, 10, 13, 23, 25 and 27-28 are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by Steemers et al. (U.S. Patent Application Publication US 2023/0279385 A1, published September 07, 2023, effectively filed August 18, 2020),
Regarding claim 1, Steemers teaches a composition comprising a first protein complex and a second protein complex (Page 4, [0080], [0082] and [0090] and Page 14, [0336]). Steemers teaches the first protein complex comprises a transposome and a first programmable DNA binding unit capable of specifically binding to a first binding site on a target double-stranded DNA (dsDNA) and the second protein complex comprises the transposome and a second programmable DNA binding unit capable of specifically binding to a second binding site on the targeted dsDNA (Page 11, [0314], Page 12, [0317], Page 18, [0400], Page 19, [0418], Pages 20-21, [0426]-[0427], Page 23, [0463], Page 28, [0538]-[0540], Page 45, [0799] and Figs. 11 and 14). Steemers teaches the transposome comprises a transposase and two copies of an adaptor (Page 2, [0014], Page 3, [0033], Page 7, [0169], Page 10, [0282] and [0286], Page 14, [0336] and [0342], Page 22, [0447], Page 24, [0482] and Figs. 11 and 14).
Regarding claim 2, Steemers teaches plurality of protein complex pairs, wherein each of the plurality of protein complex pairs comprises the first protein complex and the second protein complex (Page 4, [0080], [0082] and [0090] and Page 14, [0336]). Steemers teaches the first binding site for each of the plurality of protein complex pairs is different from each other and/or the second binding site for each of the plurality of protein complex pairs is different from each other (Page 11, [0314], Page 12, [0317], Page 18, [0400], Page 19, [0418], Pages 20-21, [0426]-[0427], Page 23, [0463], Page 28, [0539]-[0540], Page 45, [0799] and Figs. 11 and 14). Steemers teaches all of the plurality of protein complex pairs has the same transposome (Page 14, [0336]).
Regarding claim 3, Steemers teaches the target dsDNA for two or more of the plurality of protein complex pairs are different (Page 2, [0012] and [0029], Pages 12-13, [0323]-[0324], Page 28, [0539] and Page 39, [0693]).
Regarding claim 5, Steemers teaches the plurality of protein complex pairs comprises about 5-3,000 protein complex pairs (Page 4, [0080], [0082] and [0090], Page 14, [0336], Pages, 12-13, [0323]-[0325], Page 15, [0346], Pages 20-21, [0427]-[0428], Page 27, [0533] and Page 28, [0539]).
Regarding claim 6, Steemers teaches the adaptor is a dsDNA or a DNA/RNA duplex, and wherein the adaptor is about 5-200 base pairs in length (Page 14, [0342] and Page 17, [0377]-[0379]).
Regarding claim 10, Steemers teaches the first programmable DNA binding unit comprises a nuclease-deficient CRISPR associated protein (dCAS protein) and a first guide RNA (gRNA) capable of specifically binding to the first binding site of the target dsDNA and the second programmable DNA binding unit comprises the dCAS protein and a second gRNA capable of specifically binding to the second binding site on the target dsDNA (Page 11, [0314], Page 12, [0317], Page 18, [0400]-[0404], Page 19, [0418], Pages 20-21, [0426]-[0427], Page 23, [0463], Page 28, [0538]-[0540], Page 45, [0799] and Figs. 11 and 14).
Regarding claim 13, Steemers teaches the transposase is present in a fusion protein with the dCAS protein of the first programmable DNA binding unit, the dCAS protein of the second programmable DNA binding unit, or both (Page 11, [0314] and Fig. 11).
Regarding claim 23, Steemers teaches the second binding site is 1-50000 nucleotides upstream or downstream of the first binding site on the target dsDNA, or wherein the second binding site is 100-500 nucleotides upstream or downstream of the first binding site on the target dsDNA (Page 25, [0495], Page 3, [0039], Page 17, [0377]-[0379], Page 7, [0158]-[0159], Page 28, [0538], Page 46, [0821] and Figs. 6, 11 and 14).
Regarding claim 25, Steemers teaches the distance between the first binding site and the second binding site on each target dsDNA is substantially the same, or wherein the distance between the first binding site and the second binding site on at least two target dsDNAs are different (Page 25, [0495], Page 3, [0039], Page 17, [0377]-[0379], Page 7, [0158]-[0159], Page 28, [0538], Page 46, [0821] and Figs. 6, 11 and 14).
Regarding claim 27, Steemers teaches a third protein complex, wherein the third protein complex comprises the transposome and a third programmable DNA binding unit capable of specifically binding to a third binding site on the target dsDNA (Page 11, [0314], Page 12, [0317], Page 18, [0400], Page 19, [0418], Pages 20-21, [0426]-[0427], Page 21, [0433], Page 23, [0463], Page 28, [0538]-[0540], Page 45, [0799] and Figs. 11 and 14).
Regarding claim 28, Steemers teaches composition comprising a plurality of protein complex pairs, wherein each of the plurality of protein complex pairs comprises a first protein complex and a second protein complex (Page 4, [0080], [0082] and [0090] and Page 14, [0336]). Steemers teaches the first protein complex comprises a transposome and a first programmable DNA binding unit capable of specifically binding to a first binding site on a target double-stranded DNA (dsDNA), and the second protein complex comprises the transposome and a second programmable DNA binding unit capable of specifically binding to a second binding site on the target dsDNA (Page 11, [0314], Page 12, [0317], Page 18, [0400], Page 19, [0418], Pages 20-21, [0426]-[0427], Page 23, [0463], Page 28, [0538]-[0540], Page 45, [0799] and Figs. 11 and 14). Steemers teaches the transposome comprises a transposase and two copies of an adaptor (Page 2, [0014], Page 3, [0033], Page 7, [0169], Page 10, [0282] and [0286], Page 14, [0336] and [0342], Page 22, [0447], Page 24, [0482] and Figs. 11 and 14). Steemers teaches the first binding site for each of the plurality of protein complex pairs is different from each other and/or the second binding site for each of the plurality of protein complex pairs is different from each other (Page 11, [0314], Page 12, [0317], Page 18, [0400], Page 19, [0418], Pages 20-21, [0426]-[0427], Page 23, [0463], Page 28, [0539]-[0540], Page 45, [0799] and Figs. 11 and 14). Steemers teaches all of the plurality of protein complex pairs has the same transposome (Page 14, [0336]). Steemers teaches sample nucleic acids suspected of comprising the target dsDNA (Page 6, [0149]). Steemers teaches a DNA polymerase and a plurality of dNTPs (Page 20 , [0424] and Page 29, [0552]).
Steemers teaches each and every limitation of claims 1-3, 5-6, 10, 13, 23, 25 and 27-28 and therefore Steemers anticipates claims 1-3, 5-6, 10, 13, 23, 25 and 27-28.
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 1-3, 5-6, 10, 13, 23, 25 and 27-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 11, 16, 20, 33-34 and 42 of copending Application No. 18/558,035 (reference application).
Although the claims at issue are not completely identical, they are not patentably distinct from each other because while the preambles slightly different it appears that the steps of the claims are identical, so it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to create a composition comprising a first protein complex and a second protein complex or create a composition comprising a plurality of protein complexes using those same steps. Therefore, the claims are not deemed to be patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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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