DETAILED ACTION
Status of the Claims
Claims 1-19 and 22-25 are currently pending and are the subject of this Office Action.
The following Office Action is in response to Applicant’s communication dated 02/04/2026. Rejection(s) and/or objection(s) not reiterated from previous office actions are hereby withdrawn. The following rejection(s) and/or objection(s) are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Modified Claim Rejections – 35 U.S.C. 102
Necessitated by Amendment
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 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.
Mitra et al.
Claims 1, 3-19, and 22-25 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Mitra et al. (WO 2010/065531, cited in IDS of 10/12/2022, of record).
Regarding claims 1 and 9-12, Mitra teaches a flowcell (e.g. as per the Abstract and Figures), comprising:
at least a first surface on a substrate disposed within the flowcell;
a plurality of polypeptide molecules from a biological sample immobilized on the at least first surface, wherein the at least first surface comprises at least 100,000,000,000 individual polypeptide molecules immobilized on the at least first surface, each of the at least 100,000,000,000 individual polypeptide molecules being positioned to be individually spatially resolvable from each other on the first surface via spatially separated locations (e.g. either ~109 proteins, denatured and cleaved, as per page 12 lines 1-2, and/or 600µL of 100ng/mL antibody ≈ 240 x 109 molecules as per page 29), with each of the spatially separated locations being a unique coordinate defined by a pre-determined grid (e.g., the flow cell is imaged and defines a grid corresponding to the pixels of the CCD as per the Imaging section on pp. 27-28, then the iterative images are collected and the proteins are assigned X-Y coordinates as per pp. 30-31, see also Fig. 7); and
wherein the plurality of polypeptide molecules immobilized on the first surface comprises a plurality of different polypeptides present on the first surface (e.g. either ~109 denatured and cleaved proteins, as per page 12 lines 1-2, and/or polyclonal antibodies as per page 29), and wherein the number of times a first polypeptide is immobilized on the surface corresponds to the amount of the first polypeptide in the biological sample (e.g. the number of immobilized polypeptides reasonably corresponds to the amount of that polypeptide, since number = amount).
Regarding claims 3-8, Mitra teaches the above flowcell with at least 100-100,000 different polypeptides (e.g. ~109 proteins, denatured and cleaved, as per page 12 lines 1-2).
Regarding claim 13, Mitra teaches the above flowcell, further comprising a source of a plurality of different affinity reagents fluidly connected to the flowcell, each of the plurality of different affinity reagents having a specificity for one or more epitopes in the plurality of individual polypeptide molecules immobilized on the first surface, such that a binding profile of the plurality of different affinity reagents against the polypeptides immobilized on the first surface is capable of characterizing at least 90% of the plurality of different polypeptides immobilized on the first surface (e.g. sensitivity= 99.96% ± 0.07%, specificity= 98.47% ± 0.76%, as per Example 2).
Regarding claim 14, Mitra teaches the above flowcell, wherein the plurality of polypeptide molecules immobilized on the first surface comprise intact proteins (e.g. intact antibodies as per page 28).
Regarding claim 15, Mitra teaches the above flowcell, wherein the plurality of polypeptide molecules immobilized on the first surface are denatured (e.g. 109 proteins denatured and cleaved as per page 12 lines 1-2).
Regarding claim 16, Mitra teaches the above flowcell, wherein the polypeptide molecules are from a subject suspected of having a disease or disorder (e.g., as per page 3 in the first paragraph of the SUMMARY section).
Regarding claim 17, Mitra teaches the above flowcell, wherein the polypeptide molecules are from an embryo, fetus, or pregnant woman (e.g., as per page 3 in the first paragraph of the SUMMARY section).
Regarding claim 18, Mitra teaches the above flowcell, wherein the polypeptide molecules were treated to remove proteins over 400kD (e.g. ~109 proteins denatured and cleaved as per page 12 lines 1-2).
Regarding claim 19, Mitra teaches the above flowcell, wherein the substrate comprises a functionalized substrate with chemical links to the polypeptide molecules (e.g. as per the Preparation of Surfaces section on pages 28-29).
Regarding claim 22, Mitra teaches the above flowcell, wherein the flow cell comprises a textured substrate and microwells (e.g. as per the Preparation of Surfaces section on pages 28-29).
Regarding claim 23, Mitra teaches the above flowcell, wherein the substrate comprises a silane treated substrate (e.g. as per Fig. 8A).
Regarding claim 24, Mitra teaches the above flowcell, wherein the silane treated substrate comprises an epoxysilane, acrylatesilane or acrylamidesilane treated substrate (e.g. as per Fig. 8A).
Regarding claim 25, Mitra teaches the above flowcell, wherein the flowcell comprises openings for channels at the bottom of the flow cell (e.g. as per the Fluidics section on page 28).
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Response to Arguments
The 02/04/2026 remarks argue: not all elements are taught.
Applicant's arguments have been fully considered but they are not persuasive for at least the following reasons.
Specifically, the remarks assert that the reference does not disclose the newly added limitations. In response, it is noted that the rejection has been changed to reflect the new amendments. Also, note that the broadest reasonable interpretation of “each of the spatially separated locations being a unique coordinate defined by a pre-determined grid” does not require the drawing or etching of grid lines on the surface, but rather encompasses embodiments wherein the “grid” is defined virtually, for example, based on the image collected by the CCD.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
11,448,647 B2
Claims 1-19 and 22-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,448,647 B2 (the ‘647 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be anticipated and/or rendered obvious by the subject matter in the claims of the reference patent.
Regarding claims 1-2 and 9-12, the claims of the ‘647 patent disclose a flowcell, comprising at least a first surface on a substrate disposed within the flowcell; a plurality of polypeptide molecules from a biological sample immobilized on the at least first surface, wherein the at least first surface comprises at least 100,000,000,000 individual polypeptide molecules immobilized on the at least first surface, each of the at least 100,000,000,000 individual polypeptide molecules being positioned to be individually spatially resolvable from each other on the first surface via spatially separated locations, with each of the spatially separated locations being a unique coordinate defined by a pre-determined grid (e.g., as per the microwells of claim 21);
and wherein the plurality of polypeptide molecules immobilized on the first surface comprises a plurality of different polypeptides present on the first surface, and wherein the number of times a first polypeptide is immobilized on the surface corresponds to the amount of the first polypeptide in the biological sample (e.g., as per claims 1 and 7-11 of the ‘647 patent).
Regarding claims 3-8, the claims of the ‘647 patent disclose the above flowcell with at least 100-100,000 different polypeptides (e.g., as per claims 2-5 of the ‘647 patent).
Regarding claim 13, the claims of the ‘647 patent disclose the above flowcell, further comprising a source of a plurality of different affinity reagents fluidly connected to the flowcell, each of the plurality of different affinity reagents having a specificity for one or more epitopes in the plurality of individual polypeptide molecules immobilized on the first surface, such that a binding profile of the plurality of different affinity reagents against the polypeptides immobilized on the first surface is capable of characterizing at least 90% of the plurality of different polypeptides immobilized on the first surface (e.g., as per claim 12 of the ‘647 patent).
Regarding claim 14, the claims of the ‘647 patent disclose the above flowcell, wherein the plurality of polypeptide molecules immobilized on the first surface comprise intact proteins (e.g., as per claim 13 of the ‘647 patent).
Regarding claim 15, the claims of the ‘647 patent disclose the above flowcell, wherein the plurality of polypeptide molecules immobilized on the first surface are denatured (e.g., as per claim 14 of the ‘647 patent).
Regarding claim 16, the claims of the ‘647 patent disclose the above flowcell, wherein the polypeptide molecules are from a subject suspected of having a disease or disorder (e.g., as per claim 15 of the ‘647 patent).
Regarding claim 17, the claims of the ‘647 patent disclose the above flowcell, wherein the polypeptide molecules are from an embryo, fetus, or pregnant woman (e.g., as per claim 16 of the ‘647 patent).
Regarding claim 18, the claims of the ‘647 patent disclose the above flowcell, wherein the polypeptide molecules were treated to remove proteins over 400kD (e.g., as per claim 17 of the ‘647 patent).
Regarding claim 19, the claims of the ‘647 patent disclose the above flowcell, wherein the substrate comprises a functionalized substrate with chemical links to the polypeptide molecules (e.g., as per claim 18 of the ‘647 patent).
Regarding claim 22, the claims of the ‘647 patent disclose the above flowcell, wherein the flow cell comprises a textured substrate and microwells (e.g., as per claim 21 of the ‘647 patent).
Regarding claim 23, the claims of the ‘647 patent disclose the above flowcell, wherein the substrate comprises a silane treated substrate (e.g., as per claim 22 of the ‘647 patent).
Regarding claim 24, the claims of the ‘647 patent disclose the above flowcell, wherein the silane treated substrate comprises an epoxysilane, acrylatesilane or acrylamidesilane treated substrate (e.g., as per claim 23 of the ‘647 patent).
Regarding claim 25, the claims of the ‘647 patent disclose the above flowcell, wherein the flowcell comprises openings for channels at the bottom of the flow cell (e.g., as per claim 24 of the ‘647 patent).
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Response to Arguments
The 02/04/2026 remarks argue: not all elements are taught.
Applicant's arguments have been fully considered but they are not persuasive for at least the following reasons.
Specifically, the remarks assert that the reference does not disclose the newly added limitations. In response, it is noted that the rejection has been changed to reflect the new amendments.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEREMY FLINDERS whose telephone number is (571)270-1022. The examiner can normally be reached M-F 10-6:00 EST.
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/JEREMY C FLINDERS/Primary Examiner, Art Unit 1684
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