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 .
Priority
This application, Serial No. 17/623,158 was filed on 12/27/2021 and is a 35 U.S.C 371 national stage entry of PCT Application No. EP2020/068014 filed 06/26/2020, and claims benefit under 35 U.S.C. 119 to Application number DKPA 2020 70251, filed on 04/23/2020, and claims benefit to DKPA 2019 70441, filed on 07/05/2019.
Status of the Claims
Claims 1-9,11-12,14-17,19-22 and 24 are pending.
Claims 1-9,11-12,14-17,19-22 and 24 are amended.
Claims 10, 13, 18, 23, and 25 have been previously cancelled.
Claims 1, 4-9,11-12,14-17,19 and 21 are currently under consideration.
Information Disclosure Statement
The information disclosure statement filed 01/05/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 4-9, 11-12, 14-17, 19, and 21 in the reply filed on 06/11/2025 is acknowledged.
Claims 2-3, 20, 22, and 24 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/11/2025.
Drawings
Figures 5a, 5b, 6a, and 6b should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. These drawings appear to be identical to those in US9869652. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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.
Specification
The use of the term TOPAS, which is a trade name or a mark used in commerce, has been noted in this application in the specification on: pg. 7 line 26, pg. 14, line 15, and pg. 20, line 23. 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 4, 5, 12, 14, 15, and 17 is objected to because of the following informalities:
The capitalization of reductases, processes, and other materials infers they are proper nouns, but this is not the case.
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, 6-9, 11-12, 17, 19, and 21 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Rozlosnik et al (US9869652).
The applied reference has a common joint inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Rozlosnik discloses a biosensor for point of care diagnostic and on-site measurements.
Regarding claim 1, Rozlosnik discloses in col. 2, lines 22-44 a biosensor which comprises a non-conducting substrate comprising a primary substrate surface; a conducting polymer electrode layer comprising one or more conducting polymers layers, the conducting polymer electrode layer comprising a primary electrode surface and a secondary electrode surface, wherein the secondary electrode surface covers part of the primary substrate surface; a probe layer bonded to part of the primary electrode surface; and a second non-conducting substrate comprising a secondary substrate surface, wherein the secondary substrate surface of the second substrate and the primary substrate surface of the first substrate are interconnected such that the electrode layer and the probe layer are confined within an area defined by the first substrate and the second substrate; wherein the electrode layer comprises at least a first electrode pair, the first electrode pair comprising a primary electrode and a secondary electrode, where the probe layer is bonded to the primary electrode and/or the secondary electrode of the at least first electrode pair, the probe layer being adapted for selectively binding of the target substance. This meets the limitations in claim 1 of the components of the biosensor. Rozlosnik teaches in col. 4, lines 20-28 one or more conducting polymer layers of the conducting polymer electrode layer is selected from the group of PEDOT and PEDOT derivatives containing one or more functional groups. Fig. 2, and col. 6, lines 44-46 disclose the second polymer layer (108b), formed by polymerization and containing functional groups (col. 6, lines 8-37) between the first layer (108a) and the probe layer (110). This meets limitations in claim 1 wherein the second electrode sub-layer is positioned between the first electrode sub-layer and the probe layer, and is selected from the group consisting of: … a polymerized functionalization layer.
Regarding claims 6 and 7, Rozlosnik discloses in col. 4, lines 13-28 one or more conducting polymer layers of the conducting polymer electrode layer is selected from the group of PEDOT and PEDOT derivatives. In one or more embodiments the PEDOT derivatives contain one or more functional groups, meeting limitations in claim 6 of a functionalization layer comprising a polymer with one or more functional groups. Said functional groups are selected from the group of alcohols, carboxylic acids, azides, and alkynes. This meets limitations in claim 7 of one or more functional groups selected from alcohol, carboxylic acids, azides, or alkynes.
Regarding claim 8, Rozlosnik discloses in col. 2, lines 61- Col. 3, line 3, the target substance could be a virus, a protein, a cell, a peptide, a molecule (both organic and inorganic), and col. 4, lines 40-42 the probe layer comprises an entity selected from aptamers, oligonucleotides, and/or peptides, any of which would be directed towards an organic molecule, such as an antibody, and as such act as an antigen in an antibody/antigen bonding. This meets limitations in claim 8 of the target substance is an antibody, an organic molecule, wherein the probe layer is an antigen probe layer comprising at least one antigen.
Regarding claim 9, Rozlosnik discloses in col. 4 lines 13-18 one or more conducting polymer layers of the conducting polymer electrode layer is selected from the group of poly(3,4-ethylenedioxythiophene) (PEDOT), polypyrrole (PPy), poly(3,4-propylenedioxythiophene), triacetonamine (TAA), polyaniline (PANI), derivatives thereof and/or co-polymers thereof, meeting limitations in claim 9 wherein the conducting polymer electrode layer comprises one or more conductive polymer micro-layers, wherein the polymer(s) are selected from poly(3,4- ethylenedioxythiophene) (PEDOT), polypyrrole (PPy), poly(3,4-propylenedioxythiophene), triacetonamine (TAA), polyaniline (PANI), derivatives thereof and/or co-polymers thereof.
Regarding claim 11, Rozlosnik discloses in col. 4, lines 3 -12, the first substrate and/or the second substrate is a non-conducting polymer substrate. The non-conducting polymer substrate is selected from the group of polystyrenes, polyolefins and cyclic olefin copolymers such. This meets limitations in claim 11 wherein the primary substrate surface and/or the secondary substrate surface is a non-conducting polymer substrate, wherein the non-conducting polymer substrate is selected from the group consisting of polystyrenes, polyolefins, and cyclic olefin copolymers.
Regarding claim 12, Rozlosnik discloses in col. 4, lines 36-39 the probe layer is covalently bonded to part of the primary electrode surface, thereby creating a strong bond between the probe layer and the electrode layer. This meets limitations in claim 12 wherein the probe layer is bonded to the conducting electrode layer by chemical binding.
Regarding claim 17, Rozlosnik discloses Col. 4, lines 40-55 the probe layer comprises an entity selected from the group of aptamers, oligonucleotides and/or peptides. Probes of aptamers, oligonucleotides and/or peptides are a superior substitute to probes comprising antibodies in immunoassays, since aptamers, oligonucleotides and peptides have a higher stability, affinity, and specificity compared to antibodies in immunoassay. This meets limitations in claim 17 of the probe layer comprises oligonucleotide aptamers.
Therefore, the invention, as claimed, is anticipated.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Rozlosnik as applied to claim 1 above, and further in view of Fernandez et al (Biotechnology Advances, 2013).
Rozlosnik discloses as above, but fails to disclose the use of a redox material in the electrode sub-layers.
Fernandez teaches recent developments and applications of immobilized laccase.
Regarding claims 4 and 5, Fernandez teaches on pg. 1821 right col., 3rd para. electrochemical biosensors are normally based on the production or consumption of electrons by enzymatic catalysis. The target analyte is involved in the reaction, which takes place on the active electrode surface, and the produced ions create a potential, which is subtracted from that of the reference electrode to give a measurable signal. Throughout the Biosensing portion, 3.2.2 starting on pg. 1821, of the paper examples are given of the different uses of laccase as sub-layers of electrodes to detect different analytes using various processes. On pg. 1812, left col. 3rd para. Fernandez teaches the major advantages of laccase immobilization are the increase in the thermostability of the enzyme and its resistance to extreme conditions and chemical reagents. This meets limitations in claim 4 of second electrode sub-layer is a redox material electrode layer which comprises an oxidoreductase and limitations in claim 5 of the oxidoreductase is laccase.
Therefore, it would have been obvious, to a person of ordinary skill in the art,
before the effective filing date of the claimed invention, to use the electrodes and biosensor disclosed by Rozlosnik and improve it by using the technique of Fernandez to create a redox material electrode layer using immobilized laccase. Fernandez teaches the major advantages of utilizing this technique to improve electrode based biosensors is the adaptability to different types of electrodes, an increase in thermostability, and resistance to extreme conditions and chemical reagents. One of ordinary skill in the art would have recognized that this improvement would have yielded predictable results and resulted in an improved system.
Therefore, the invention, as claimed, is obvious.
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Rozlosnik as applied to claim 1 above, and further in view of Lee et al (US8663451).
Rozlosnik discloses as above, but fails to disclose a linker connecting the probe layer to the electrode layer.
Lee discloses a linker, impedance biochip, and method of quantitatively detecting target analyte in fluid sample using the biochip.
Regarding claims 14-16, Lee discloses in fig. 1d and in col. 4, lines 4-5, a schematic diagram which shows a linker for joining a capture probe to an electrode of the biochip and a target analyte in the fluid sample and in col. 6 lines 37-53, a phosphate buffered saline solution was used for the preparation of the capture probe, the activation reagents, N-Hydroxy succinimide (NHS) and N-Ethyl-N'-(3-dimethylaminopropyl) carbodiimide hydrochloride (EDC) for activation, The blocking reagent (for blocking unbinding site of a linker), Ethanolamine hydrochloride (ETA-HCl). Lee discloses in col. 4, line 35 – 47, the linker provides a more electrically accessible modified surface. When adopted in the faradaic impedance biochip which requires the addition of redox species to measure the surface impedance change induced by binding of target analyte and the capture probe, the linker offers a more electrically accessible surface can enhance the faradaic current. With lower impedance baseline, the device designed to measure the signal of the biochip could be further simplified on the electrical circuit design and be made in lower cost, compacter size and get the potential to be used in point-of-care applications. This meets limitations in claim 14 of a linker connecting the probe layer to the conducting electrode layer, wherein the linker is bonded by chemical bonding. This meets limitations in claim 15 of the chemical binding is Carbodiimide (EDC) chemistry. This meets limitations in claim 16 of supplementing EDC chemistry with N-Hydroxy succinimide (NHS).
Therefore, it would have been obvious, to a person of ordinary skill in the art,
before the effective filing date of the claimed invention, to use the electrodes and biosensor disclosed by Rozlosnik, and improve on the electrodes by using a linker between the electrode surface and probe layer as disclosed by Lee. The linker as disclosed by Lee would provide an electrically accessible surface which can enhance the faradaic current used in redox reactions in impedance spectroscopy. With a lower impedance baseline, the device could be further simplified on the electrical circuit design and be made in lower cost, a more compact size and get the potential to be used in point-of-care applications. This improvement to the biosensor disclosed by Rozlosnik would be recognized by one of ordinary skill in the art to yield predictable results, and would have resulted in an improved, more compact and cheaper system.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Rozlosnik as applied to claim 1 above, and further in view of Daniels et al (Electroanalysis, 2007).
Rozlosnik teaches as above, but fails to teach the use of a non-target specific probe layer bonded to the second primary and second secondary electrode surfaces to serve as reference electrodes.
Daniels teaches label-free impedance biosensors: opportunities and challenges.
Regarding claim 19, Daniels teaches on pg. 14, 1st para., that in complex samples, nonspecific binding is also expected to give a response unrelated to target concentration. To compensate, a reference sensor can be used. Ideally, no target binding occurs on the reference sensor but otherwise it has an identical response to the solution. This otherwise identical response would have to include a non-target specific probe layer to bind non-target specific constituents of the sample in order to have a proper comparison using a differential. The signal then consists of the difference between the working and reference sensor responses, hopefully eliminating any common-mode signal due to extraneous environmental factors. The advantage of this is the ability to remove the signal from nonspecific binding that occurs on the reference electrode to account for the nonspecific binding that occurs on the working electrode to provide a more specific result. This meets limitations in claim 19 wherein a non-target specific probe layer is bonded to the secondary primary electrode surface and the second secondary electrode surface, thereby serving as a reference electrode.
Therefore, it would have been obvious, to a person of ordinary skill in the art,
before the effective filing date of the claimed invention, to use the electrodes and biosensor disclosed by Rozlosnik, and improve on the electrodes by using a non-target specific probe layer on the second electrode surface to act as a reference electrode as taught by Daniels. The reference electrode as taught by Daniels would remove the signal from nonspecific binding that occurs on the reference electrode to account for the nonspecific binding that occurs on the working electrode to provide a more specific result. This improvement to the biosensor disclosed by Rozlosnik would be recognized by one of ordinary skill in the art to yield predictable results, and would have resulted in an improved, more compact and cheaper system.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Rozlosnik as applied to claim 1 above, and further in view of Nakonieczna et al (Food Control, 2016).
Rozlosnik discloses as above and also discloses in col. 4, lines 61-64 the use of the biosensor for point-of-care measurement and/or on-site detecting of a target substance in a liquid sample. Rozlosnik fails to disclose performing either point-of-care measurement and/or on-site detecting of the target substance in the sample, wherein the sample is a liquid sample obtained during process and/or quality control measurements, during manufacturing of medicine, during manufacture of agents for therapy, or during a content control process in connection with food preparation.
Nakonieczna teaches electrical impedance measurements for detecting artificial chemical additives in liquid food products.
Regarding claim 21, Nakonieczna teaches in the abstract, analyzing the content of artificial chemical additives in food products is important due to their twofold role in food processing and consumption, i.e., their positive impact on the shelf life or sensory properties of food products and possible negative effect on human health. The impedance spectroscopy technique has a potential to become an effective method for food quality and safety control in the context of the artificial additives content, because it allows to describe the content in a relatively simple manner when the compounds of interest are present in small quantities in chemically complex materials such as foods.
This meets limitations in claim 21 of the biosensor performing either point-of-care measurement and/or on-site detecting of the target substance in the sample, wherein the sample is a liquid sample, wherein the sample is a liquid sample obtained during process and/or quality control measurements, during manufacturing of medicine, during manufacture of agents for therapy, or during a content control process in connection with food preparation.
Therefore, it would have been obvious, to a person of ordinary skill in the art,
before the effective filing date of the claimed invention, to use the electrodes and biosensor disclosed by Rozlosnik, and use said device to analyze food quality and safety in a simple manner when detecting small quantities of target in chemically complex materials such as foods as taught by Nakonieczna. One of ordinary skill in the art would have been motivated to use the biosensor of Rozlosnik to analyze the content of artificial additives in food because of the ability to measure these small quantities in complex materials. The person of ordinary skill in the art would have had a reasonable expectation of success in using the biosensor of Rozlosnik in analyzing food for quality control as taught by Nakonieczna to determine the positive impact on shelf life and sensory properties and negative impact on human health because of the previously discussed capabilities of foo analysis using impedance spectroscopy.
Therefore, the invention, as claimed, is obvious.
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, 6-7, 9, 11-12, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-8, and 11-12 of U.S. Patent No. US9869652. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant claim 1, the reference claim 1 discloses substantially the same composition of a biosensor disclosed in the instant claim 1 to include two non-conducting substrate surfaces, primary and secondary electrodes, and multiple layers in the electrodes. The one or more conducting polymer layers in the electrode which has a probe layer on the surface in the reference claim are substantially the same as the sub-layer of a polymerized functionalization layer directly below the probe layer in the instant claim.
Regarding instant claim 6, the reference claims 7 and 8 disclose substantially the same one or more conducting layer of an electrode comprising PEDOT or PEDOT derivatives in reference claim 7 as the polymer, and the PEDOT derivatives contain one or more functional groups in reference claim 8.
Regarding instant claim 7, the reference claim 8 discloses substantially the same functional groups of alcohols, carboxylic acids, azides, and alkynes.
Regarding instant claim 9, the reference claim 6 discloses substantially the same one or more conducting polymer layers of the conducting polymer electrode layer, selected from the group of poly(3,4-ethylenedioxythiophene) (PEDOT), polypyrrole (PPy), poly(3,4-propylenedioxythiophene), triacetonamine (TAA), polyaniline (PANI), derivatives thereof and/or co-polymers thereof.
Regarding instant claim 11, reference claims 4 and 5 disclose substantially the same non-conducting polymer substrates and potential materials for said substrate.
Regarding instant claim 12, reference claim 11 discloses substantially the same chemical binding of the probe layer to the conducting electrode layer using covalent bonding.
Regarding instant claim 17, reference claim 12 discloses substantially the same probe layer comprising one or more entities selected from aptamers, oligonucleotides, and/or peptides.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIM ATWELL, D.Sc., M.S., MLS whose telephone number is (571)272-0890. The examiner can normally be reached Generally Mon-Thurs: 7:30-5:00 EST and every other Fri: 7:30-4:00 EST.
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/JIM ATWELL/Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 September 2, 2025