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 1-4, in the reply filed on 08/17/2026 is acknowledged.
Claims 5-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 08/17/2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “substrate for producing a sensor for analysis comprising: A) a substrate body; and B) particles disposed on the substrate body in a state of a single layer” (claim 1); “wherein the particles are disposed without agglomeration” (claim 2); “wherein the particles include particles integrated with a modifier” (claim 3); and “the substrate further comprising C) a polymer matrix disposed on the substrate body, the polymer matrix having a concave portion that at least partially fits into an object, wherein the particles are disposed in the concave portion” (claim 4) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Note that Figs. 2-1, 3-1, 3-2, 4, and 5-1 appear to show a substate body, however it is unclear if the figures show the abovementioned limitations.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 4 is 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.
Regarding claim 4, claim 4 recites “a concave portion that at least partially fits into an object” in lines 3-4. It is unclear if the concave portion has a function of “at least partially fits into an object” or if applicant intended to claim that the concave portion has a structure that allows an object to at least partially fit into. I.e. does the concave portion partially fit into an object or does an object partially fit into the concave portion?
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.
(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 1-4 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Takeuchi et al. (US 20200110084 A1; cited in the IDS filed 05/28/2024).
Regarding claim 1, Takeuchi teaches a substrate (Figs. 1-11, base material 20) for producing a sensor for analysis (interpreted as an intended use, see MPEP 2114; [0070] teaches the base material is for producing a sensor for analysis 10) comprising:
A) a substrate body (Fig. 4, body of base material 20); and
B) particles (Fig. 4, templates 40, which are particles) disposed on the substrate body in a state of a single layer (Fig. 4 teaches templates 40 are disposed on base material 20 via at least elements 21, 22b, 22c, 24, in a single layer).
Regarding claim 2, Takeuchi further teaches wherein the particles (Fig. 4, templates 40, which are particles) are disposed without agglomeration (Fig. 4, templates 40 are disposed without agglomeration).
Regarding claim 3, Takeuchi further teaches wherein the particles (Fig. 4, templates 40, which are particles) include particles integrated with a modifier (Figs. 5-11 and [0107] teaches modifying a surface of templates 40 with a polymerizable functional group 33 and binding signal substance 32, i.e. modifier; [0086]-[0088] teaches the group for binding signal substance 32 allows a signal substance to be introduced into the base material for producing a sensor for analysis 10 by binding the signal substance, a signal substance 53; therefore the polymerizable functional group 33 in combination with the binding signal substance 32 is a modifier).
Regarding claim 4, Takeuchi further teaches the substrate further comprising C) a polymer matrix disposed on the substrate body (Fig. 1 and [0070] teaches “polymer film 30 is provided on the surface of the base material 20”), the polymer matrix having a concave portion (Fig. 1 and [0070] concave 31; [0073] teaches multiple concaves 31; therefore, the multiple concaves 31 are interpreted as “a concave portion”) that at least partially fits into an object ([0070],[0073] and Fig. 12 teach detection target 60, i.e. object, at least partially fits into the concave portion), wherein the particles are disposed in the concave portion ([0073] and Figs. 8-12 teaches multiple concaves 31 are formed with the templates 40 disposed in the concaves 31 in order to form the sensor with multiple concaves as shown in Fig. 12).
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 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 41-42 of copending Application No. 18/687,023 (herein, “App ‘023”) in view of Takeuchi et al. (US 20200110084 A1; cited in the IDS filed 05/28/2024).
Regarding claim 1, App ‘023 recites a substrate for producing a sensor for analysis (claim 41) comprising:
A) a substrate body (claim 41, “substrate”); and
B) particles disposed on the substrate body (claim 42 recites particles are disposed on a polymer matrix on the substrate).
App ‘023 fails to recite: the particles disposed on the substrate body in a state of a single layer.
Takeuchi teaches a substrate (Figs. 1-11, base material 20) for producing a sensor for analysis (interpreted as an intended use, see MPEP 2114; [0070] teaches the base material is for producing a sensor for analysis 10) comprising: A) a substrate body (Fig. 4, body of base material 20); and B) particles (Fig. 4, templates 40, which are particles) disposed on the substrate body in a state of a single layer (Fig. 4 teaches templates 40 are disposed on base material 20 via at least elements 21, 22b, 22c, 24, in a single layer). Takeuchi teaches the sensor allows for quick and highly specific detection of a target (abstract; [0012],[0014]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the particles of App ‘023 to incorporate Takeuchi’s teachings of particles disposed in a single layer (Figs. 1-4) to provide: the particles disposed on the substrate body in a state of a single layer. Doing so would have a reasonable expectation of successfully producing a sensor for quick and highly specific detection of a target.
Regarding claim 2, App ‘023 fails to recite: wherein the particles are disposed without agglomeration.
Takeuchi further teaches wherein the particles (Fig. 4, templates 40, which are particles) are disposed without agglomeration (Fig. 4, templates 40 are disposed without agglomeration).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the particles of App ‘023 to incorporate Takeuchi’s teachings of particles disposed in a single layer without agglomeration (Figs. 1-4) to provide: wherein the particles are disposed without agglomeration. Doing so would have a reasonable expectation of successfully producing a sensor for quick and highly specific detection of a target.
Regarding claim 3, App ‘023 fails to recite: wherein the particles include particles integrated with a modifier.
Takeuchi further teaches wherein the particles (Fig. 4, templates 40, which are particles) include particles integrated with a modifier (Figs. 5-11 and [0107] teaches modifying a surface of templates 40 with a polymerizable functional group 33 and binding signal substance 32, i.e. modifier; [0086]-[0088] teaches the group for binding signal substance 32 allows a signal substance to be introduced into the base material for producing a sensor for analysis 10 by binding the signal substance, a signal substance 53; therefore polymerizable functional group 33 and binding signal substance 32 is a modifier).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the particles of App ‘023 to incorporate Takeuchi’s teachings of particles integrated with a modifier (Figs. 5-11; [0086]-[0088],[0107]) to provide: wherein the particles include particles integrated with a modifier. Doing so would have a reasonable expectation of successfully improving functionalization of the sensor and producing a sensor for quick and highly specific detection of a target.
Regarding claim 4, App ‘023 further recites the substrate further comprising C) a polymer matrix disposed on the substrate body (claim 42).
App ‘023 fails to recite: the polymer matrix having a concave portion that at least partially fits into an object, wherein the particles are disposed in the concave portion.
Takeuchi further teaches the substrate further comprising C) a polymer matrix disposed on the substrate body (Fig. 1 and [0070] teaches “polymer film 30 is provided on the surface of the base material 20”), the polymer matrix having a concave portion (Fig. 1 and [0070] concave 31; [0073] teaches multiple concaves 31; therefore, the multiple concaves 31 are interpreted as “a concave portion”) that at least partially fits into an object ([0070],[0073] and Fig. 12 teach detection target 60, i.e. object, at least partially fits into the concave portion), wherein the particles are disposed in the concave portion ([0073] and Figs. 8-12 teaches multiple concaves 31 are formed with the templates 40 disposed in the concaves 31 in order to form the sensor with multiple concaves as shown in Fig. 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the polymer matrix of App ‘023 to incorporate Takeuchi’s teachings of a polymer matrix including concave portions for specific binding of detection targets (Figs. 1, 8-12; [0015],[0070],[0073]) to provide: the polymer matrix having a concave portion that at least partially fits into an object, wherein the particles are disposed in the concave portion. Doing so would have a reasonable expectation of successfully improving quick and highly specific detection of a target.
This is a provisional nonstatutory double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Takeuchi et al. (Takeuchi et al., “Antibody-Conjugated Signaling Nanocavities Fabricated by Dynamic Molding for Detecting Cancers Using Small Extracellular Vesicle Markers from Tears”, Journal American Chemical Society (2020) 142 (14): 6617–6624) teaches: a substrate for producing a sensor for analysis (Fig. 1) comprising: A) a substrate body (Fig. 1a, base substrate); and B) particles disposed on the substrate body in a state of a single layer (Fig. 1 and page 6618, right column teaches His-MAA-SS-NPs disposed on the substrate; Fig. 1G teaches the His-MAA-SS-NPs are immobilized in a single layer); wherein the particles are disposed without agglomeration (Fig. 1G teaches the His-MAA-SS-NPs are immobilized in a single layer without agglomeration); wherein the particles include particles integrated with a modifier (Fig. 1a teaches the NPs include modifiers); the substrate further comprising C) a polymer matrix disposed on the substrate body (Fig. 1, teaches a polymer matrix on the base substrate), the polymer matrix having a concave portion that at least partially fits into an object (Fig. 1 teaches concave portions that at least partially fits His-tagged proteinG), wherein the particles are disposed in the concave portion (Fig. 1 and page 6618, right column teaches the His-Maa-SS-NPs are disposed in the nanocavities).
Mori et al. (Mori et al. “A Pretreatment-Free, Polymer-Based Platform Prepared by Molecular Imprinting and Post-Imprinting Modifications for Sensing Intact Exosomes”, Angew Chem Int Ed Engl. 2019 Feb 4;58(6):1612-1615. doi: 10.1002/anie.201811142. Epub 2019 Jan 3) teaches a sensing platform for exosomes (abstract; Scheme 1) including nanocavities formed on a substrate (Scheme 1, Au substrate), and particles (template exosomes) disposed in concave portions of a polymer matrix (Scheme 1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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, Maris Kessel can be reached at (571) 270-7698. 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.
/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
