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 .
DETAILED ACTION
1. The Applicant’s response to the office action filed on January 12, 2026 is acknowledged.
Status of the Application
2. Claims 1-30 are pending under examination. New claims 31 and 32 are added. The Applicant’s arguments and the amendment have been fully considered and found persuasive in-part for the following reasons.
Specification-Withdrawn
3. The objection to the specification has been withdrawn in view of the Applicant’s arguments and the amendment.
Double Patenting-Maintained
4. 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.
A. Claims 1-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No.10,768,173 (hereafter the ‘173).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are entirely within the scope of the claims 1-30 of the patent ‘173, specifically the instant claims comprising a kit composition a plurality of particle-nucleotide conjugates comprising a polymer core coupled with a plurality of nucleotide moieties, a plurality of detectable labels and a comprising are within the scope of the claims 1-30 of the patent ‘173. The instant claims differ from the claims in patent ‘173 in reciting a kit composition which is obvious over the claims disclosing use of said composition in the patent ‘173 and co-extensive in scope. Thus, the instant claims are obvious over the claims in the patent ‘173.
B. Claims 1, 6-9 and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,22, 22, 24, 28 of co-pending Application No. 17/999,023 (US 2023/023539). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims 1, 6-9 and 19 are entirely within the scope of the claims in the co-pending application, specifically the instant claims comprising a kit composition a plurality of particle-nucleotide
conjugates comprising a polymer core coupled with a plurality of nucleotide moieties, a plurality of detectable labels and a comprising are within the scope of the claims 1, 22, 24, 28 of the co-pending application. The instant claims differ from the claims in the co-pending application in reciting a kit composition which is obvious over the claims disclosing use of said composition in the co-pending application and co-extensive in scope. Thus, the claims are obvious over the claims in the co-pending application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments:
A. With reference to the rejection of claims under obviousness type of double patenting over the claims in the US patent 10,768,173 (the ‘173), the Applicant’s arguments were found unpersuasive. With reference to no teaching of a particle-nucleotide conjugate, the arguments were found unpersuasive because the claims in the patent ‘173 disclose, specifically claims 1 and 21, 24-26, 30, of the patent ‘173 disclose a polymer-nucleotide conjugate two or more nucleotide moieties attached to polymer core and comprises one or more detectable labels, which is within the scope of the claims in the instant application. For all the above, the rejection has been maintained and restated to include new claim 31.
B. With reference to the rejection of claims under obviousness type of double patenting over the claims in the co-pending application 17/999,023 (the ‘023), the Applicant’s arguments were found unpersuasive. With reference to no teaching of a particle-nucleotide conjugate, the arguments were found unpersuasive because the particle-nucleotide conjugate is within the scope of a nucleotide conjugate of the co-pending application because the claims 22, 24, 28 one or more polymer- nucleotide conjugates of the co-pending application ‘023 comprises polymer core and one or more distinct detectable labels (ii) plurality of nucleotides coupled to the common core, which is within the scope of a particle-nucleotide conjugate of the instant claims. For all the above the rejection has been maintained.
5. The rejection of claims under obviousness type of double patenting over the claims in the co-pending application 17/511, 046 (the ‘046) has been withdrawn in view of the Applicant’s arguments.
6. The rejection of claims under obviousness type of double patenting over the claims in the US patent 11,781,185 (the ‘185) has been withdrawn in view of the amendment reciting polymer core.
7. The rejection of claims under obviousness type of double patenting over the claims in the US patent 12,139,727 has been withdrawn in view of the persuasive arguments.
Claim Rejections - 35 USC § 102-maintained
8. 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.
Claims 1-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bjornson et al. (WO 2013/123258).
Note: Claims 19-30 are drawn to a product by process claims. As noted in the MPEP 2113 which states "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), the claims given patentable weight to the product not to the method steps.
Bjornson et al. teach a kit of 1, 19, comprising: a plurality of particle-nucleotide conjugates, wherein a particle-nucleotide conjugate of the plurality of particle-nucleotide conjugates comprises: (a) a plurality of nucleotide moieties; (b) a plurality of detectable labels; and (c) a polymer core (protein core), wherein at least two nucleotide moieties of the plurality of nucleotide moieties and at least two detectable labels of the plurality of detectable labels is independently coupled to the core directly or indirectly; and
instructions that direct use of the plurality of particle-nucleotide conjugates in a nucleotide binding reaction in which a nucleotide is not incorporated into an elongating nucleotide acid chain (para 0235-0236, 0240-0243, 0008-0017, 0019-0020, 0025).
With reference to claim 2, Bjornson et al. teach that the kit further comprising a stabilizing buffer reagent configured to stabilize a binding complex formed between one or more nucleotide moieties of the plurality of nucleotide moieties and one or more complementary nucleotides in a primed nucleic acid sequence (para, 0235, 0196).
With reference to claims 3, 25, Bjornson et al. teach that the stabilizing buffer reagent comprises a monovalent cation, wherein the monovalent cation comprises nickel, manganese, magnesium, calcium, strontium, or any combination thereof (para 0235).
With reference to claims 4-5, Bjornson et al. teach that the kit further comprising a polymerizing enzyme configured to form the binding complex with the one or more nucleotide moieties and the one or more or two or more complementary nucleotides, without incorporating the one or more nucleotide moieties into the primed nucleic acid sequence (para 0022-0025).
With reference to claim 6, Bjornson et al. teach that at least two nucleotide moieties of the plurality of nucleotide moieties have an identical nucleotide base type (para 0051, 0235, 00240).
With reference to claim 7-9, 23-24, Bjornson et al. teach that the kit further comprising a second, third and a fourth plurality of particle-nucleotide conjugates, wherein at least one of the second plurality of particle-nucleotide conjugates comprises: a second, third, and fourth plurality of nucleotide moieties, a second, third and fourth plurality of detectable labels and a second, third and fourth core coupled to second, third and fourth plurality of nucleotide moieties, and second, third and fourth plurality of
detectable labels directly or indirectly (para 0014-0017, 0083, 0089).
With reference to claim 10, 22, 27, Bjornson et al. teach that the plurality of nucleotide moieties comprises a sugar, wherein the sugar comprises a 3’ carbon that does not comprise a reversable terminator moiety configured to inhibit elongation during a primer extension reaction (para 0020, 0082, 0090-0098).
With reference to claim 11, 22, Bjornson et al. teach that the coupling of core to the plurality of nucleotide moieties is not cleavable (para 0019, 0022-0027, 00109, 00132).
With reference to claim 12-14, Bjornson et al. teach that the particle-nucleotide conjugate further comprises a linker coupled to the core directly or indirectly, wherein the linker is disposed between a nucleotide moiety of the plurality of nucleotide moieties and the core, wherein the linker comprises polyethene glycol (PEG) or a functional variant thereof, wherein the linker is linear (para 0015, 0051).
With reference to claims 15-16, 22, Bjornson et al. teach that the particle-nucleotide conjugate further comprises a binding coupled to the core directly, wherein the binding is disposed between the core and the linker, wherein the binding comprises an avidin, a biotin, an affinity tag, or any combination thereof (para 00138, 0020-0024).
With reference to claim 17, Bjornson et al. teach that the particle-nucleotide conjugate comprises a first number of the plurality of nucleotide moieties that is different than a second number of the plurality of detectable labels (para 0024-0027, 0030, 0087, para 0248).
With reference to claim 18, Bjornson et al. teach that a particle-nucleotide conjugate of the plurality of particle-nucleotide conjugates has a star, comb, cross-linked, bottle brash, or dendrimer configuration (para 0088, 00154, 0208).
With reference to claims 20-21, 26, 28-30, Bjornson et al. teach that the kit comprises unlabeled nucleotides and nucleotide conjugates attached to sequencing system (flow cell) (para 00200, 00234, 0090, 00133, 0176, 00225).
With reference to claims 31-32, Bjornson et al. teach that the polymer core comprises plurality of branches and the two or more nucleotide moieties are attached to said branches, wherein the polymer core comprises a branched polyethylene glycol molecule (para 0088-0089, 00167-0168). For all the above the claims are anticipated.
Response to Arguments:
8. With reference to the rejection under 35 USC 102(a)(1) as being anticipated by Bjornson et al., the Applicant’s arguments were found unpersuasive. With reference to no teaching of a particle-nucleotide comprising a polymer core by Bjornson et al., the arguments were found unpersuasive. As discussed in the rejection, the Examiner cited paragraphs 0009-0017 teach a polymerase-nucleotide conjugate wherein the polymerase enzyme substrate is a protein that reads on a polymer core. Further, the cited paragraphs also teach two or more nucleotide components and two or more fluorescent dye moieties as required by the claims. For all the above the rejection has been maintained and restated the rejection to address the new claims 31-32.
New Rejections necessitated by IDS with fee
Double Patenting
9. 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.
A. Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14-19 of U.S. Patent No. 11,287,422 (the ‘422). Although the claims at issue are not identical, they are not patentably distinct from each other because the claim 1 is entirely within the scope of the claims 1, 14-10 of the patent ‘422 specifically the comprising a kit composition a plurality of particle-nucleotide conjugates comprising a polymer core coupled with a plurality of nucleotide moieties, a plurality of detectable labels and a comprising are within the scope of the claims 1 and 14-19 disclosing detectable -nucleotide conjugate comprising a polymer core of the patent ‘422. The claim 1 differ from the claims in patent ‘422 in reciting a kit composition which is obvious over the claims disclosing use of said composition in the patent ‘422 and co-extensive in scope. Thus, the instant claims are obvious over the claims in the patent ‘422.
B. Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-10 of U.S. Patent No. 12,241,891 (the ‘891). Although the claims at issue are not identical, they are not patentably distinct from each other because the claim 1 is entirely within the scope of the claims 1, 9-10 of the patent ‘891 specifically the comprising a kit composition a plurality of particle-nucleotide conjugates comprising a polymer core coupled with a plurality of nucleotide moieties, a plurality of detectable labels and a comprising are within the scope of the claims 1 and 9-10 disclosing detectable polymer-nucleotide conjugate comprising a polymer core of the patent ‘891. The claim 1 differ from the claims in patent ‘891 in reciting a kit composition which is obvious over the claims disclosing use of said composition in the patent ‘891 and co-extensive in scope. Thus, the instant claims are obvious over the claims in the patent ‘891.
Conclusion
No claims are allowable.
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 1/12/2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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 SURYAPRABHA CHUNDURU whose telephone number is (571)272-0783. The examiner can normally be reached 8.00am-4.30pm.
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Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681