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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-6 and 20) and Species A1 (claim 2 in part and 3) in the reply filed on 10 July 2026 is acknowledged.
Claims 2 (in part) and 4-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 July 2026. Claims 1-6 and 20 are pending in the application. Claims 7-19 have been cancelled.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Illumina [Illumina. Patterned Flow Cells. 2020 Oct 30: 3pgs. Accessed from the WayBack Machine on 24 July 2026] and Anderson [US 6030782 A].
Illumina teaches a sequencing flow cell comprising a glass substrate upon which DNA probes are immobilized at defined locations on the surface, called nanowells, wherein the regions between the locations are devoid of probes. This ensures that DNA clusters only form within the nanowells themselves, providing even, consistent spacing between adjacent clusters allowing for better resolution [Illumina, p1]. However, Illumina does not teach that the nanowells comprise a reactive sulfur moiety, such as thiol.
Anderson teaches a method of covalently immobilizing nucleic acid molecules modified with either disulfide or sulfhydryl to a solid phase by means of a reversible disulfide bond. This method can be used in a variety of applications, including solid phase DNA sequencing. In this method, the solid phase is coated with a mercaptosilane compound which introduces sulfhydryl, or thiol, groups onto its surface [C8 L5-12; C11 L5-9]. This provides for a very hydrophobic surface which allows oligonucleotide probe droplets to form at specific and localized positions on the solid surface [C6 L32-35]. Advantageously, the solid phase can be reused by treating the surface with a mild reducing agent. This treatment will release the covalently immobilized oligonucleotides from the surface, freeing the thiol groups to immobilize other oligonucleotides [C9 L11-16]. Anderson states that this feature would provide for a quick and inexpensive method for preparing DNA arrays with the added benefit of allowing for the arrays to be reused [C4 L30-40].
Therefore, a person of ordinary skill in the art prior to the effective filing date of the claimed invention would have been motivated to prepare the surface of Illumina’s flow cell using Anderson’s method resulting in a sequencing flow cell whose probe-binding locations comprise thiol-functionalized surface groups, thereby achieving the benefits of reduced consumable spending and waste described by Anderson.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Illumina, Anderson, and Polansky [US 20040023207 A1].
Illumina and Anderson teach the claimed flow cell component, as described in the rejection of claims 1-3. Briefly, Illumina teaches a flow cell comprising a glass substrate upon which DNA probes are immobilized at defined locations called nanowells. Anderson teaches a method of reversibly immobilizing nucleic acids to a surface which has free thiols resulting in reusable arrays. The combination of Illumina’s flow cell with the method of Anderson results in a flow cell whose probe-binding locations comprise thiol-functionalized surface groups which has the benefit of reducing consumable spending and waste.
Anderson’s method is further described in Example 1. First, a glass slide is subjected to silane treatment. Then, 5`-disillfide modified oligonucleotides in a carbonate buffer are incubated on the slide during which time a disulfide bond forms between the RS group on the oligonucleotide and the available thiol of the mercaptosilane [C12 L62 – C13 L15]. Treating the surface with a mild reducing agent will release the covalently immobilized oligonucleotides from the surface, freeing the thiol groups to immobilize other oligonucleotides [C9 L11-16].
Therefore, Illumina and Anderson teach (1) a flow cell in which free thiol groups (i.e., the first reactive sulfur moiety) are present in nanowells, (2) 5`-disillifide oligonucleotides in a carbonate buffer (i.e., the priming reagent, and (3) a mild reducing agent (i.e., a cleaving reagent) which frees the surface thiol groups (i.e., the second reactive sulfur moiety) from the bonded oligonucleotides.
While neither Illumina or Anderson teach including these components in a kit, Polansky teaches that the inclusion of individual components in a commercial kit impart well known advantages such as convenience and reproducibility due to manufacturing standardization, quality control, and validation procedures [Polansky, 0919]. Therefore, one of ordinary skill in the art prior to the effective filling date of the claimed invention would have been motivated to place the three components described by Illumina and Anderson in a kit to provide a standardized, commercially available assay system thereby achieving the well-known benefits described by Polansky while also enhancing the cost-saving benefits described by Anderson.
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 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 30 of copending Application No. 19/168,500 (CoApp ‘500).
Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 30 of CoApp ‘500 describes a patterned substrate comprising a base support with a plurality of protrusions each of which have (1) a first resin layer having an exposed surfaced comprising a polymer having a first functional group (such as thiol) and (2) a second resin layer over a portion of the first layer which is adjacent to the exposed surface and comprises a polymer having a second function group.
Claims 1-3 of the instant application describes a flow cell (i.e., patterned substrate) comprised of a substrate (i.e., base support) comprising a plurality of primer sites (i.e., the exposed surface) with a reactive sulfur moiety, such as a thiol (i.e., the first functional group).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/K.N.K./Examiner, Art Unit 1681
/SAMUEL C WOOLWINE/Primary Examiner, Art Unit 1681
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