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 .
Status of Claims
Applicant's arguments, filed 04/28/2026 and 05/04/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 04/28/2026 and 05/04/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 1, 3-5, 7-9, and 11-14.
Applicants have left claims 2, 6, 10, and 15-28 as originally filed/previously presented.
Claims 2, 6, and 15-28 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, and nonelected species.
Claims 1, 3-5, and 7-14 are the current claims hereby under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/04/2026 is being considered by the examiner.
Claim Objections - Withdrawn
Response to Arguments
Applicant’s arguments, see pages 9-14 of Remarks, filed 04/28/2026 and 05/04/2026, with respect to the objections of claims 1, 3-5, 7-9, and 11-14 have been fully considered and are persuasive. Applicants have amended the claims, rendering the objections moot. The objections of claims 1, 3-5, 7-9, and 11-14 have been withdrawn.
Claim Interpretation - 35 USC § 112(f) - Maintained
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 1: The claim limitation “at least one feature configured to be inserted into a body … configured to provide at least one of a resistance to abrasion effect or a pressure effect” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “feature” coupled with functional language “configured to be inserted into a body … configured to provide at least one of a resistance to abrasion effect or a pressure effect” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “feature”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“features include microneedles … single indwelling needle … a flexible circuit … a protective membrane applied to protect the sensor from abrasion or pressure effects”, or equivalents thereof, as described in para. [0024] and [0027] of the disclosure filed on 03/21/2023.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102 - Maintained
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)(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, 3, 4, 7, and 8 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kendall et al. (US 20210338158 A1) (previously cited), hereinafter referred to as Kendall.
The claims are generally directed towards a continuous sensing device for measuring at least one analyte in interstitial fluid, the device comprising: at least one feature configured to be inserted into a body, the at least one feature configured to be inserted into a skin of the body, the at least one feature at least partially coated with at least one electrode functionalized with an aptamer sensing monolayer layer, the aptamer sensing monolayer layer comprising an aptamer with attached redox couples and passivating material, wherein the at least one feature is configured to provide at least one of a resistance to abrasion effect or a pressure effect for the aptamer sensing monolayer layer when the at least one feature is placed into the body.
Regarding claim 1, Kendall discloses a continuous sensing device for measuring at least one analyte in interstitial fluid (Abstract, Fig. 1, para. [0057], para. [0233], para. [0243]), the device comprising:
at least one feature (Fig. 1, element 112, “microstructure”, para. [0243], para. [0309]) configured to be inserted into a body, the at least one feature configured to be inserted into a skin of the body (Fig. 1, para. [0243], “microstructures are configured to breach the stratum corneum … entering at least the viable epidermis …”), the at least one feature at least partially coated with at least one electrode functionalized with an aptamer sensing monolayer layer, the aptamer sensing monolayer layer comprising an aptamer with attached redox couples and passivating material (para. [0309-0310], “microstructures include an electrode … one or more microstructure electrodes interact with one or more analytes …”, para. [0320], para. [0323-0326], “aptamer is a coating on the microstructure … aptamer has a first conformation in the absence of analyte binding and a second conformation upon analyte binding … change … may then be detected using, for example, a labelling moiety such as a redox moiety or fluorescent label attached to or close to the relevant portion of the aptamer …”, para. [0340-0342], “aptamer comprises … redox moiety … methylene blue …”, para. [0724], “methylene blue and the thiol group were covalently attached … aptamer … 6-mercaptohexanol … solution”),
wherein the at least one feature is configured to provide at least one of a resistance to abrasion effect or a pressure effect for the aptamer sensing monolayer layer when the at least one feature is placed into the body (para. [0432-0433], “microstructures could contain a material, or include a coating, such as polyethylene glycol (PEG), which generally repels substances from the surface of the microstructure … cellulose membrane …” - the instant specification describes the feature including a membrane, which includes cellulose membranes. see para. [0029]).
Regarding claim 3, Kendall discloses the device of claim 1, wherein the at least one feature comprises a membrane covering the at least one electrode (para. [0309-0310], “microstructures include an electrode … one or more microstructure electrodes interact with one or more analytes …”, para. [0432-0433], “microstructures could contain a material, or include a coating, such as polyethylene glycol (PEG), which generally repels substances from the surface of the microstructure … cellulose membrane …”).
Regarding claim 4, Kendall discloses the device of claim 1, wherein at least one material is added onto the at least one feature to provide the configuration that provides the at least one of the resistance to abrasion effect or the pressure effect for the aptamer sensing monolayer layer when the at least one feature is placed into the body (para. [0432-0433], “microstructures could contain a material, or include a coating, such as polyethylene glycol (PEG), which generally repels substances from the surface of the microstructure … cellulose membrane …” - the instant specification describes the feature including a membrane, which includes cellulose membranes. see para. [0029]).
Regarding claim 7, Kendall discloses the device of claim 1, further comprising at least one biocompatible dissolvable material applied to the aptamer sensing monolayer layer (para. [0424-0428], “outer coating … dissolves once in-situ, allowing an underlying functional coating to be exposed, for example to allow analytes to be detected …”).
Regarding claim 8, Kendall discloses the device of claim 4, wherein a biocompatible dissolvable material is the at least one material added onto the at least one feature to provide the configuration that provides the at least one of the resistance to abrasion effect or the pressure effect for the aptamer sensing monolayer layer when the at least one feature is placed into the body (para. [0427], “selectively dissolvable coating … exposing … functional feature, so that analytes are only detected once the coating has dissolved …”, para. [0430], “coating can also be used to … repel … at least one substance …”, para. [0433], “cellulose membrane”, para. [0661], “methyl cellulose/sucrose formulation … coating was dissolving off the electrode …”).
Response to Arguments
Applicant's arguments filed 04/28/2026 and 05/04/2026 have been fully considered but they are not persuasive.
Applicants have argued on pages 14-19 of Remarks, filed 04/28/2026 and 05/04/2026, that “Kendall, however, does not teach or disclose a device that is configured to resist abrasion to the sensor, even from the membrane itself”.
The Examiner respectfully disagrees. Applicants arguments are not commensurate in scope with the claimed invention. The claims currently do not limit what “resistance to abrasion effect or a pressure effect” is, or the cause of such effects. As reiterated in the rejection above, Kendall discloses the at least one feature is configured to provide at least one of a resistance to abrasion effect or a pressure effect for the aptamer sensing monolayer layer when the at least one feature is placed into the body (para. [00432-00433]). Specifically, Kendall discloses the at least one feature repels substances from the at least one feature, which also assists with prevent biofouling. Repelling substances provides resistance to abrasion of the at least feature and repelling substances provides a pressure effect by reducing a pressure to the at least one feature caused by biofouling.
Claim Rejections - 35 USC § 103 - Maintained
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.
Claims 5 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kendall et al. (US 20210338158 A1) (previously cited), hereinafter referred to as Kendall as applied to claims 1 and 3 above, and further in view of Gottlieb et al. (US 20100030045 A1) (previously cited), hereinafter referred to as Gottlieb.
Regarding claim 5, Kendall discloses the device of claim 3.
However, Kendall does not explicitly disclose wherein the membrane and the aptamer sensing monolayer layer are physically separated.
Gottlieb teaches an analogous continuous sensing device for measuring at least one analyte in interstitial fluid (Abstract, Fig. 2, Fig. 3, para. [0008-0009]) comprising at least one feature coated with at least one electrode functionalized with a sensing monolayer (Fig. 2, element 100, para. [0061-0066], para. [0081]) and a membrane covering the electrode (Fig. 2, para. [0061-0066]). Gottlieb further teaches the membrane and the sensing monolayer layer are physically separated (para. [0065], “sensing layer is coated and or disposed next to one or more additional layers … adhesion promoting layer …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Kendall to additionally have the membrane and the aptamer sensing monolayer layer be physically separated, as taught by Gottlieb. This is because Gottlieb teaches multiple layers can be disposed over the analyte sensing layer, such as an adhesion promoting layer, which facilitates the adhesion of the one or more membrane and the sensing layer (para. [0066]).
Regarding claim 9, Kendall discloses the device of claim 1, wherein exposed portions of the at least one electrode are coated with at least one material different from the aptamer sensing monolayer layer (para. [0724], “aptamers were immobilized to the gold electrode … electrode was washed … process was repeated with … 6-mercaptohexanol …”).
However, Kendall does not explicitly disclose wherein the aptamer sensing monolayer layer is not exposed to tissue or cellular content in the body, and the at least one electrode coats both exposed and non-exposed portions of the at least one feature inserted into the skin.
Gottlieb teaches an analogous continuous sensing device for measuring at least one analyte in interstitial fluid (Abstract, Fig. 2, Fig. 3, para. [0008-0009]) comprising at least one feature coated with at least one electrode functionalized with a sensing monolayer (Fig. 2, element 100, para. [0061-0066], para. [0081]). Gottlieb further teaches the aptamer sensing monolayer layer is not exposed to tissue or cellular content in the body (para. [0062], “insulating cover layer … disposed on portions of the sensor …”), and the at least one electrode coats both exposed and non-exposed portions of the at least one feature inserted into the skin (Fig. 2, element 102, 104, 110, para. [0061-0066]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Kendall to additionally have the aptamer sensing monolayer layer not exposed to tissue or cellular content in the body, and the at least one electrode coat both exposed and non-exposed portions of the at least one feature inserted into the skin, as taught by Gottlieb. This is because Gottlieb teaches an insulating material coating the device allows for one or more exposed regions to be created to allow a target analyte to reach the electrode at certain locations, while also providing protection (para. [0062]).
Regarding claim 10, modified Kendall discloses the device of claim 9, wherein the exposed portions of the at least one feature inserted into the skin are configured to absorb at least one endogenous solute found in the body (para. [0335], “suitable aptamer …”, para. [0386], “the analyte is a protein …”).
Regarding claim 11, modified Kendall discloses the device of claim 9, wherein the at least one material different from the aptamer sensing monolayer layer comprises an exogeneous passivating material (para. [0724], “aptamers were immobilized to the gold electrode … electrode was washed … process was repeated with … 6-mercaptohexanol …” - see para. [0031] of the instant specification).
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kendall et al. (US 20210338158 A1) (previously cited), hereinafter referred to as Kendall as applied to claim 1 above, and further in view of Gottlieb et al. (US 20100030045 A1) (previously cited), hereinafter referred to as Gottlieb, in view of Negi et al. (US 20170007813 A1) (previously cited), hereinafter referred to as Negi.
Regarding claim 12, Kendall discloses the device of claim 1.
However, Kendall does not explicitly disclose wherein the at least one feature comprises an exposed area configured to be exposed to tissue or cellular content in the body after the at least one feature is inserted into the body, and an unexposed area that is configured to be unexposed to tissue or cellular content in the body after the at least one feature is inserted into the body, and which carriers the aptamer sensing monolayer layer.
Gottlieb teaches an analogous continuous sensing device for measuring at least one analyte in interstitial fluid (Abstract, Fig. 2, Fig. 3, para. [0008-0009]) comprising at least one feature coated with at least one electrode functionalized with a sensing monolayer (Fig. 2, element 100, para. [0061-0066], para. [0081]). Gottlieb further teaches the at least one feature comprises an exposed area configured to be exposed to tissue or cellular content in the body after the at least one feature is inserted into the body (Fig. 2, element 108, para. [0062], “one or more exposed regions or apertures … allow an analyte such as glucose to permeate the layers of the sensor and be sensed by the sensing elements …”), and an unexposed area that is configured to be unexposed to tissue or cellular content in the body after the at least one feature is inserted into the body, and which carriers the sensing monolayer layer (Fig. 2, element 106, para. [0062], “insulating cover layer … disposed on portions of the sensor …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Kendall to additionally include an exposed area configured to be exposed to tissue or cellular content in the body after the at least one feature is inserted into the body, and an unexposed area that is configured to be unexposed to tissue or cellular content in the body after the at least one feature is inserted into the body, and which carriers the aptamer sensing monolayer layer, as taught by Gottlieb. This is because Gottlieb teaches an insulating material coating the device allows for one or more exposed regions to be created to allow a target analyte to reach the electrode at certain locations, while also providing protection (para. [0062]).
However, modified Kendall does not explicitly disclose wherein a ratio of the unexposed to the exposed area is configured to be at least one of >1.3X, >3X, >10X, >30X, >100X.
Negi teaches an analogous continuous sensing device for measuring at least one analyte in interstitial fluid (Abstract, Fig. 1, Fig. 2, para. [0006]). Negi further teaches the feature includes exposed and unexposed areas (Fig. 2, para. [0044]) and the number of exposed areas and the distance between the areas can vary (para. [0056-0058]). Because Negi clearly teaches that variability of the dimensions and dimensional relationships of the components, it suggests that the dimensions can be optimized based on manufacturing, design, and use applications. As such, the dimensions and dimensional relationships of the components are results-effective variables that would have been optimized through routine experimentation based on the manufacturing, design, and use applications. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to select the dimensions and dimensional relationships of the components, using the teachings of Negi as a starting point, so as to obtain the desired manufacturing, design, and use applications.
Regarding claim 13, Kendall discloses the device of claim 1.
However, Kendall does not explicitly disclose wherein the at least one feature comprises an exposed area configured to be exposed to tissue or cellular content in the body after the at least one feature is inserted into the body, and an unexposed area that is configured to be unexposed to tissue or cellular content in the body after the at least one feature is inserted into the body, and which carriers the aptamer sensing monolayer layer.
Gottlieb teaches an analogous continuous sensing device for measuring at least one analyte in interstitial fluid (Abstract, Fig. 2, Fig. 3, para. [0008-0009]) comprising at least one feature coated with at least one electrode functionalized with a sensing monolayer (Fig. 2, element 100, para. [0061-0066], para. [0081]). Gottlieb further teaches the at least one feature comprises an exposed area configured to be exposed to tissue or cellular content in the body after the at least one feature is inserted into the body (Fig. 2, element 108, para. [0062], “one or more exposed regions or apertures … allow an analyte such as glucose to permeate the layers of the sensor and be sensed by the sensing elements …”), and an unexposed area that is configured to be unexposed to tissue or cellular content in the body after the at least one feature is inserted into the body, and which carriers the aptamer sensing monolayer layer (Fig. 2, element 106, para. [0062], “insulating cover layer … disposed on portions of the sensor …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Kendall to additionally include an exposed area configured to be exposed to tissue or cellular content in the body after the at least one feature is inserted into the body, and an unexposed area that is configured to be unexposed to tissue or cellular content in the body after the at least one feature is inserted into the body, and which carriers the aptamer sensing monolayer layer, as taught by Gottlieb. This is because Gottlieb teaches an insulating material coating the device allows for one or more exposed regions to be created to allow a target analyte to reach the electrode at certain locations, while also providing protection (para. [0062]).
However, modified Kendall does not explicitly disclose wherein the ratio of the unexposed to the exposed area is at least one of less than <3X, <10X, <30X, <100X, <300X.
Negi teaches an analogous continuous sensing device for measuring at least one analyte in interstitial fluid (Abstract, Fig. 1, Fig. 2, para. [0006]). Negi further teaches the feature includes exposed and unexposed areas (Fig. 2, para. [0044]) and the number of exposed areas and the distance between the areas can vary (para. [0056-0058]). Because Negi clearly teaches that variability of the dimensions and dimensional relationships of the components, it suggests that the dimensions can be optimized based on manufacturing, design, and use applications. As such, the dimensions and dimensional relationships of the components are results-effective variables that would have been optimized through routine experimentation based on the manufacturing, design, and use applications. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to select the dimensions and dimensional relationships of the components, using the teachings of Negi as a starting point, so as to obtain the desired manufacturing, design, and use applications.
Regarding claim 14, modified Kendall discloses the device of claim 13, wherein a coverage density of aptamer across the aptamer sensing monolayer layer will vary by at least one of <30%, <100%, <300%, <1000% (para. [0354], “number of aptamers and/or aptamer density in the coating will depend on the analyte … aptamer density in the coating should be a density which results in a measurable response upon analyte binding … density in the coating is in the range of from …”).
Response to Arguments
Applicants arguments, filed 04/28/2026 and 05/04/2026, did not directly address the 35 USC 103 rejections. Therefore, the Examiner cannot find a reason to withdraw the rejections.
Conclusion
THIS ACTION IS MADE FINAL. 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 KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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