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
Applicants’ arguments, filed 07/15/2025, 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 07/15/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 6, 31, and 33.
Applicants have canceled/previously canceled claims 9-20, 25, and 29.
Applicants have left claims 1-5, 7-8, 21-24, 26-28, 30, 32, and 34-36 as previously presented/originally filed.
Claims 1-8, 21-24, 26-28, and 30-36 are the current claims hereby under examination.
Priority - Maintained
Applicant’s updated claim for the benefit of a prior-application filed under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c), filed 06/05/2023, is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/15/2025 is being considered by the examiner.
Claim Objections - Withdrawn
Response to Arguments
Applicant’s arguments, see page 7 of Remarks, filed 07/15/2025, with respect to claim 6 have been fully considered and are persuasive. Applicants have amended claim 6 rendering the objections moot. The objection of claim 6 has been withdrawn.
Claim Rejections - 35 USC § 112 - Withdrawn
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.
Response to Arguments
Applicant’s arguments, see page 7 of Remarks, filed 07/15/2025, with respect to the 112(b) rejection of claims 31 and 33 have been fully considered and are persuasive. Applicants have amended claims 31 and 33 to remove “deeper”, rendering the rejection moot. The 112(b) rejection of claims 31 and 33 has been withdrawn.
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.
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 1-8, 21-24, 26-28, and 30-36 are rejected under 35 U.S.C. 103 as being unpatentable over Nazzaro et al. (Pub. No. US 2020/0069875) (previously presented), hereinafter referred to as Nazzaro, in view of Polsky et al. (US 9987427 B1) (cited in the IDS filed 12/14/2023) (previously cited), hereinafter referred to as Polsky, in view of Balczewski et al. (US 20190282167 A1) (previously cited), hereinafter referred to as Balczewski, in view of Pushpala et al. (US 20170172475 A1) (previously cited), hereinafter referred to as Pushpala.
The claims are generally directed towards a method for coupling an analyte-selective sensor and an infusion system into a singular body-worn device, the method comprising: positioning the analyte-selective sensor on a skin surface of a wearer, the analyte-selective sensor comprising an analog front end, a microneedle array and a plurality of electrical pads, the microneedle array configured to penetrate the stratum corneum to access the viable epidermis or dermis of the wearer and measure a presence of an analyte or a plurality of analytes; positioning the infusion system on the skin surface of the wearer, the infusion system comprising an energy source and a plurality of electrical contacts and configured to penetrate the stratum corneum and deliver a solution-phase therapeutic agent or collection of therapeutic agents to a physiological compartment beneath the dermis, the positioning comprising coupling the infusion system and the analyte-selective sensor by a mechanical retention to form the singular body-worn device, wherein the coupling engages each of the plurality of electrical contacts with a corresponding electrical pad of the plurality of electrical pads; and conveying electromagnetic energy from the energy source of the infusion system to the analog front end of the analyte-selective sensor via the engagement between each of the plurality of electrical pads and the corresponding electrical contacts of the plurality of electrical contacts to power the analyte-selective sensor.
Regarding claim 1, Nazzaro discloses a method for coupling an analyte-selective sensor and an infusion system into a singular body-worn device (Abstract, para. [0018-0019], “methods related to a drug delivery system … drug delivery system having a drug delivery device and an associated sensor …”, Fig. 1- Fig. 4, Fig. 8 - Fig. 10), the method comprising:
positioning the analyte-selective sensor on a skin surface of a wearer (Fig. 1, element 104, “sensor”, Fig. 4, element 104, Fig. 8, element 804, para. [0021], para. [0024], “worn directly on the body or skin of a user …”), the analyte-selective sensor comprising an analog front end (para. [0041], “CGM sensor can monitor glucose levels and store data …”, para. [0076-0077], para. [0083], “CGM sensor can include electronic components”, - the analyte-selective sensor inherently includes an analog front end to function with the electrodes/electronics of the CGM sensor);
positioning the infusion system on the skin surface of the wearer (Fig. 1, element 102, “drug delivery device”, Fig. 4, element 102, Fig. 10, element 902, para. [0022], para. [0024], “worn directly on the body or skin of a user …”), the infusion system comprising an energy source (para. [0043], “drug delivery device can include more resources (e.g., power resources …”), the infusion system configured to penetrate the stratum corneum and deliver a solution-phase therapeutic agent or collection of therapeutic agents to a physiological compartment beneath the dermis (Fig. 2, Fig. 4, element 206, “infusion cannula”, Fig. 10, element 904, para. [0020], “drug delivery device can store and deliver insulin to a user …”, para. [0028], “a cannula (e.g., an infusion cannula) can extend from the bottom surface …”, para. [0035], “cannula can have a depth (e.g., an infusion depth) …”, para. [0053]), the positioning comprising coupling the infusion system and the analyte-selective sensor by a mechanical retention to form the singular body-worn device (Fig. 2, element 110, element 210, para. [0023-0024], “base and the housing of the CGM sensor can fit within the central cavity of the drug delivery device …”, Fig. 8, element 808, para. [0058], “drug delivery device can be attached to the adhesive pad by a variety of techniques including using snaps or connectors …”, para. [0061], “drug delivery device can be coupled over the CGM sensor and can be coupled to the adhesive pad by the connectors …”).
Nazzaro discloses that the analyte-selective sensor is configured to penetrate the stratum corneum to access the viable epidermis or dermis of the wearer and measure a presence of an analyte or a plurality of analytes (Fig. 2, Fig. 4, element 212, “sensing cannula”, Fig. 10, element 906, para. [0021], “sensor can monitor one or more …. Medical conditions … continuous glucose monitoring sensor …”, para. [0025], “sensing cannula of the CGM sensor can remain fixed in place (e.g., within the body of the user), … para. [0030], para. [0035], “cannula can have a depth (e.g., a sensing depth) …”, the sensor and the sensing cannula are configured to be inserted into a user at a depth to monitor one or more analytes, such as glucose). However, Nazzaro does not explicitly disclose the analyte-selective sensor comprises a microneedle array, the microneedle array configured to penetrate the stratum corneum to access the viable epidermis or dermis of the wearer and measure a presence of an analyte or a plurality of analytes.
Polsky teaches of a method and a device for detecting and/or monitoring markers within a sample (Abstract, Fig. 2, col. 1, lines 19-27). Polsky teaches the device includes an analyte-selective sensor worn on a skin surface of a wearer (Fig. 2, col. 9, lines 15-21). Polsky further teaches the analyte-selective sensor comprises a microneedle array (Fig. 2, col. 23, lines 18-27, “microneedle array …”). Polsky further teaches the microneedle array is configured to penetrate the stratum corneum to access the viable epidermis or dermis of the wearer and measure a presence of an analyte or a plurality of analytes (Fig. 2, col. 9, lines 15-21, col. 18, lines 31-33, col. 23, lines 18-27, col. 24, lines 40-49). 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 analyte-selective sensor disclosed by Nazzaro to explicitly include a microneedle array, the microneedle array configured to penetrate the stratum corneum to access the viable epidermis or dermis of the wearer and measure a presence of an analyte or a plurality of analytes. Polsky teaches microneedle arrays are advantageous as a puncturing tool for analyte sensors because they cause minimal discomfort, while still being effective in extracting interstitial fluid for analyte measurements (col. 1, line 66 - col. 2, line 13).
However, modified Nazzaro does not explicitly disclose the analyte-selective sensor comprises a plurality of electrical pads, the infusion system comprises a plurality of electrical contacts, wherein the coupling engages each of the plurality of electrical contacts with a corresponding electrical pad of the plurality of electrical pads.
Balczewski teaches of a method of coupling two portions into a singular body-worn device (Abstract, Fig. 3B, Fig. 4A-4D, para. [0002-0003], para. [0095]). Balczewski further teaches a first portion comprises a plurality of electrical pads (Fig. 3B, elements 370, 372, para. [0104], “upper surface 364 also includes a third sensor connection 370 and a fourth sensor connection 372”, Fig. 4A, elements 418, 420, 422, 424, Fig. 4C, elements 468, 470, 472, 474, para. [0116]). Balczewski further teaches a second portion comprises a plurality of electrical contacts (Fig. 3C, elements 314, 316, “a first sensor connection 314 and a second sensor connection 316”, Fig. 4B, elements 426, 428, 430, 432, Fig. 4D, elements 476, 478, 480, 482, para. [0116]). Balczewski further teaches wherein coupling of the first portion and the second portion engages each of the plurality of electrical contacts with a corresponding electrical pad of the plurality of electrical pads (para. [0097], para. [0100], para. [0104-0105], para. [0116]). 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 connection by modified Nazzaro to explicitly include a plurality of electrical pads on the analyte-selective sensor and a plurality of corresponding electrical contacts on the infusion system. Balczewski teaches the plurality of electrical pads and the plurality of electrical contacts on two portions allows for a suitable connection for transferring data (para. [0003], para. [0097], para. [0100]), while also ensuring proper orientation and alignment of the two portions (para. [0106]).
However, while modified Nazzaro discloses the analog front end (see above), it does not explicitly disclose conveying electromagnetic energy from the energy source of the infusion system to the analog front end of the analyte-selective sensor to power the analyte-selective sensor.
Pushpala teaches of a system and method for monitoring body chemistry of a user (Abstract, Fig. 1, Fig. 10A-10B, para. [0033]). Pushpala teaches the system can include a modular housing, including a first housing portion and a second housing portion (Fig. 10A, Fig. 10B, para. [0073]). Pushpala teaches the first housing portion includes a microsensor (Fig. 9. Fig. 10A-10B, para. [0075]) and the second housing portion includes a power management module to provide power to the microsensor (Fig. 9, element 124, para. [0052], para. [0073-0076]). 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 method disclosed by modified Nazzaro to explicitly include conveying electromagnetic energy from the energy source of the infusion system to the analog front end of the analyte-selective sensor to power the analyte-selective sensor. Nazzaro teaches a single power source within one of the housings allows for portions of the system to be disposable and/or reusable (para. [0072]).
Regarding claim 2, modified Nazzaro discloses the method of claim 1, wherein the mechanical retention comprises, on the analyte-selective sensor, a geometric feature (Fig. 1, Fig. 2, Fig. 4, element 112, para. [0023], “housing can be cylindrically shaped … drug delivery device and the CGM sensor can each have any size, shape, or form factor …”) configured to couple with a corresponding structure on the infusion system when the analyte-selective sensor and the infusion system are coupled (para. [0024], “the base and the housing of the CGM sensor can fit within the central cavity of the drug delivery device … the drug delivery device can fit over the CGM sensor such that the bottom surfaces of the drug delivery device and the CGM sensor are aligned and/or level …”) thereby allowing the infusion system to be placed in a proper spatial orientation on the analyte-selective sensor (para. [0036], “drug delivery device can be positioned over the CGM sensor in any orientation … allows the infusion site to be rotated or adjusted …”).
However, modified Nazzaro does not explicitly disclose the geometric feature is configured to mechanically couple with a corresponding structure on the infusion system.
Balczewski further teaches the first portion comprises a geometric feature is configured to mechanically couple with a corresponding structure on the second portion (Fig. 3B, element 386, para. [0106]). 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 geometric feature disclosed by modified Nazzaro to explicitly be configured to mechanically couple with a corresponding structure on the infusion system. Balczewski teaches mechanical features allow for the first and second portions to be aligned correctly when connecting the two portions (para. [0106]). Further, multiple holes, posts, ridges, notches and/or the like would still allow for modified Nazzaro to be positioned in multiple orientations.
Regarding claim 3, modified Nazzaro discloses the method of claim 1, wherein the analyte-selective sensor is configured to be positioned on the skin surface of the wearer before being coupled to the infusion system (Fig. 1, Fig. 2, Fig. 4, para. [0025], “drug delivery device to be removed and replaced … CGM sensor can have a duration of use that is longer than the duration of use of the drug delivery device …”, para. [0028], “the drug delivery device fitting over the CGM sensor …”, para. [0061], para. [0064], the CGM sensor is positioned on the skin first, with the drug delivery device configured to fit over the CGM sensor).
Regarding claim 4, modified Nazzaro discloses the method of claim 1, wherein the analyte-selective sensor is an electrochemical sensor (para. [0021], “monitor one or more health, biological, biomedical, or medical condition … continuous glucose monitoring (CGM) sensor”, para. [0023], “include all components for monitoring glucose levels of a user”, para. [0041], para. [0075]).
Regarding claim 5, modified Nazzaro discloses the method of claim 1, wherein the infusion system comprises a fluid delivery apparatus configured to provide infusion via a microneedle, a macroneedle, a hypodermic needle, a cannula, a catheter, or an oral delivery route (Fig. 4, element 206, Fig. 10, element 904, “infusion cannula”, para. [0020], “store and deliver insulin …”, para. [0084]).
Regarding claim 6, modified Nazzaro discloses the method of claim 1, wherein the singular body-worn device comprises an adhesive patch (Fig. 5, para. [0037], “bottom surface … can include an adhesive to facilitate coupling to the body of a user …”, Fig. 8, Fig. 9, element 802, “adhesive pad”, para. [0057], “adhesive pad …”).
Regarding claim 7, modified Nazzaro discloses the method of claim 1, wherein the analyte or the plurality of analytes includes at least one of glucose, lactate, a ketone body, uric acid, ascorbic acid, alcohol, glutathione, hydrogen peroxide, a metabolite, an electrolyte, an ion, a drug, a pharmacologic, a biological, or a medicament (para. [0021], “sensor can monitor one or more health, biological, biomedical, or medical conditions of a user … the sensor can be a continuous glucose monitoring sensor …”, para. [0023]).
Regarding claim 8, modified Nazzaro discloses the method of claim 1, wherein the conveyance of electromagnetic energy comprises transferring at least one of information and energy (para. [0042], “to facilitate data sharing between the CGM sensor and the drug delivery device, the CGM sensor and the drug delivery device can be connected over a wired, wireless, optical, and/or infrared communication link …”).
Regarding claim 21, Nazzaro discloses a body-worn device (Abstract, para. [0018-0019], “drug delivery system having a drug delivery device and an associated sensor …”, Fig. 1- Fig. 4, Fig. 8 - Fig. 10), comprising:
an analyte-selective sensor (Fig. 1, element 104, “sensor”, Fig. 4, element 104, Fig. 8, element 804, para. [0021], para. [0024], “worn directly on the body or skin of a user …”) comprising an analog front end (para. [0041], “CGM sensor can monitor glucose levels and store data …”, para. [0076-0077], para. [0083], “CGM sensor can include electronic components”, - the analyte-selective sensor inherently includes an analog front end to function with the electrodes/electronics of the CGM sensor); and
an infusion system comprising an energy source (para. [0043], “drug delivery device can include more resources (e.g., power resources …”) configured to couple to the analyte-selective sensor and to be positioned on the skin surface of the wearer (Fig. 1, element 102, “drug delivery device”, Fig. 4, element 102, Fig. 10, element 902, para. [0022], para. [0024], “worn directly on the body or skin of a user …”), to penetrate the stratum corneum, and to deliver a solution-phase therapeutic agent or a composition of therapeutic agents to a physiological compartment beneath the dermis (Fig. 2, Fig. 4, element 206, “infusion cannula”, Fig. 10, element 904, para. [0020], “drug delivery device can store and deliver insulin to a user …”, para. [0028], “a cannula (e.g., an infusion cannula) can extend from the bottom surface …”, para. [0035], “cannula can have a depth (e.g., an infusion depth) …”, para. [0053]),
wherein the infusion system is coupled to the analyte-selective sensor by a mechanical retention (Fig. 2, element 110, element 210, para. [0023-0024], “base and the housing of the CGM sensor can fit within the central cavity of the drug delivery device …”, Fig. 8, element 808, para. [0058], “drug delivery device can be attached to the adhesive pad by a variety of techniques including using snaps or connectors …”, para. [0061], “drug delivery device can be coupled over the CGM sensor and can be coupled to the adhesive pad by the connectors …”).
Nazzaro discloses the analyte selective sensor is configured to be positioned on a skin surface of a wearer, to penetrate the stratum corneum to access the viable epidermis or dermis of the wearer, and to measure a presence of an analyte or a plurality of analytes (Fig. 1, element 104, “sensor”, Fig. 4, element 104, Fig. 8, element 804, para. [0021], para. [0024], “worn directly on the body or skin of a user …”, Fig. 2, Fig. 4, element 212, “sensing cannula”, Fig. 10, element 906, para. [0021], “sensor can monitor one or more …. Medical conditions … continuous glucose monitoring sensor …”, para. [0025], “sensing cannula of the CGM sensor can remain fixed in place (e.g., within the body of the user), … para. [0030], para. [0035], “cannula can have a depth (e.g., a sensing depth) …”, the sensor and the sensing cannula are configured to be inserted into a user at a depth to monitor one or more analytes, such as glucose). However, Nazzaro does not explicitly disclose the analyte-selective sensor comprises a microneedle array, the microneedle array configured to be positioned on a skin surface of a wearer, to penetrate the stratum corneum to access the viable epidermis or dermis of the wearer, and to measure a presence of an analyte or a plurality of analytes.
Polsky teaches of a method and a device for detecting and/or monitoring markers within a sample (Abstract, Fig. 2, col. 1, lines 19-27). Polsky teaches the device includes an analyte-selective sensor worn on a skin surface of a wearer (Fig. 2, col. 9, lines 15-21). Polsky further teaches the analyte-selective sensor comprises a microneedle array (Fig. 2, col. 23, lines 18-27, “microneedle array …”). Polsky further teaches the microneedle array is configured to be positioned on a skin surface of a wearer, to penetrate the stratum corneum to access the viable epidermis or dermis of the wearer and measure a presence of an analyte or a plurality of analytes (Fig. 2, col. 9, lines 15-21, col. 18, lines 31-33, col. 23, lines 18-27, col. 24, lines 40-49). 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 analyte-selective sensor disclosed by Nazzaro to explicitly include a microneedle array, the microneedle array configured to be positioned on a skin surface of a wearer, to penetrate the stratum corneum to access the viable epidermis or dermis of the wearer, and to measure a presence of an analyte or a plurality of analytes. Polsky teaches microneedle arrays are advantageous as a puncturing tool for analyte sensors because they cause minimal discomfort, while still being effective in extracting interstitial fluid for analyte measurements (col. 1, line 66 - col. 2, line 13).
However, modified Nazzaro does not explicitly disclose the analyte-selective sensor comprises a plurality of electrical pads, the infusion system comprises a plurality of electrical contacts, wherein the coupling engages each of the plurality of electrical contacts with a corresponding electrical pad of the plurality of electrical pads.
Balczewski teaches of a method of coupling two portions into a singular body-worn device (Abstract, Fig. 3B, Fig. 4A-4D, para. [0002-0003], para. [0095]). Balczewski further teaches a first portion comprises a plurality of electrical pads (Fig. 3B, elements 370, 372, para. [0104], “upper surface 364 also includes a third sensor connection 370 and a fourth sensor connection 372”, Fig. 4A, elements 418, 420, 422, 424, Fig. 4C, elements 468, 470, 472, 474, para. [0116]). Balczewski further teaches a second portion comprises a plurality of electrical contacts (Fig. 3C, elements 314, 316, “a first sensor connection 314 and a second sensor connection 316”, Fig. 4B, elements 426, 428, 430, 432, Fig. 4D, elements 476, 478, 480, 482, para. [0116]). Balczewski further teaches wherein coupling of the first portion and the second portion engages each of the plurality of electrical contacts with a corresponding electrical pad of the plurality of electrical pads (para. [0097], para. [0100], para. [0104-0105], para. [0116]). 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 connection by modified Nazzaro to explicitly include a plurality of electrical pads on the analyte-selective sensor and a plurality of corresponding electrical contacts on the infusion system. Balczewski teaches the plurality of electrical pads and the plurality of electrical contacts on two portions allows for a suitable connection for transferring data (para. [0003], para. [0097], para. [0100]), while also ensuring proper orientation and alignment of the two portions (para. [0106]).
However, modified Nazzaro does not explicitly disclose wherein the body-worn device is configured to convey electromagnetic energy from the energy source of the infusion system to the analog front end of the analyte-selective sensor via the engagement between each of the plurality of electrical pads and the corresponding electrical contacts of the plurality of electrical contacts to power the analyte-selective sensor.
Pushpala teaches of a system and method for monitoring body chemistry of a user (Abstract, Fig. 1, Fig. 10A-10B, para. [0033]). Pushpala teaches the system can include a modular housing, including a first housing portion and a second housing portion (Fig. 10A, Fig. 10B, para. [0073]). Pushpala teaches the first housing portion includes a microsensor (Fig. 9. Fig. 10A-10B, para. [0075]) and the second housing portion includes a power management module to provide power to the microsensor (Fig. 9, element 124, para. [0052], para. [0073-0076]). 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 modified Nazzaro to explicitly include conveying electromagnetic energy from the energy source of the infusion system to the analog front end of the analyte-selective sensor via the engagement between each of the plurality of electrical pads and the corresponding electrical contacts of the plurality of electrical contacts to power the analyte-selective sensor. Nazzaro teaches a single power source within one of the housings allows for portions of the system to be disposable and/or reusable (para. [0072]).
Regarding claim 22, Nazzaro discloses the body-worn device of claim 21, wherein the mechanical retention comprises, on the analyte-selective sensor, a geometric feature (Fig. 1, Fig. 2, Fig. 4, element 112, para. [0023], “housing can be cylindrically shaped … drug delivery device and the CGM sensor can each have any size, shape, or form factor …”) configured to couple with a corresponding structure on the infusion system when the analyte-selective sensor and the infusion system are coupled (para. [0024], “the base and the housing of the CGM sensor can fit within the central cavity of the drug delivery device … the drug delivery device can fit over the CGM sensor such that the bottom surfaces of the drug delivery device and the CGM sensor are aligned and/or level …”), the geometric feature and the corresponding structure allowing the infusion system to be placed in a proper spatial orientation on the analyte-selective sensor (para. [0036], “drug delivery device can be positioned over the CGM sensor in any orientation … allows the infusion site to be rotated or adjusted …”).
However, Nazzaro does not explicitly disclose the geometric feature is configured to mechanically couple with a corresponding structure on the bottom of the infusion system.
Balczewski further teaches the first portion comprises a geometric feature is configured to mechanically couple with a corresponding structure on the second portion (Fig. 3B, element 386, para. [0106]). 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 geometric feature disclosed by modified Nazzaro to explicitly be configured to mechanically couple with a corresponding structure on the infusion system. Balczewski teaches mechanical features allow for the first and second portions to be aligned correctly when connecting the two portions (para. [0106]). Further, multiple holes, posts, ridges, notches and/or the like would still allow for modified Nazzaro to be positioned in multiple orientations.
Regarding claim 23, modified Nazzaro discloses the body-worn device of claim 21, wherein the analyte-selective sensor is configured to be positioned on the skin surface of the wearer before being coupled to the infusion system (Fig. 1, Fig. 2, Fig. 4, para. [0025], “drug delivery device to be removed and replaced … CGM sensor can have a duration of use that is longer than the duration of use of the drug delivery device …”, para. [0028], “the drug delivery device fitting over the CGM sensor …”, para. [0061], para. [0064], the CGM sensor is positioned on the skin first, with the drug delivery device configured to fit over the CGM sensor).
Regarding claim 24, modified Nazzaro discloses the body-worn device of claim 21, wherein the analyte-selective sensor is an electrochemical sensor (para. [0021], “monitor one or more health, biological, biomedical, or medical condition … continuous glucose monitoring (CGM) sensor”, para. [0023], “include all components for monitoring glucose levels of a user”, para. [0041], para. [0075]).
Regarding claim 26, modified Nazzaro discloses the body-worn device of claim 21, wherein the body-worn device comprises an adhesive patch (Fig. 5, para. [0037], “bottom surface … can include an adhesive to facilitate coupling to the body of a user …”, Fig. 8, Fig. 9, element 802, “adhesive pad”, para. [0057], “adhesive pad …”).
Regarding claim 27, modified Nazzaro discloses the body-worn device of claim 21, wherein the analyte or the plurality of analytes includes at least one of glucose, lactate, a ketone body, uric acid, ascorbic acid, alcohol, glutathione, hydrogen peroxide, a metabolite, an electrolyte, an ion, a drug, a pharmacologic, a biologic, or a medicament (para. [0021], “sensor can monitor one or more health, biological, biomedical, or medical conditions of a user … the sensor can be a continuous glucose monitoring sensor …”, para. [0023]).
Regarding claim 28, modified Nazzaro discloses the body-worn device of claim 21, wherein the body-worn device is configured to convey the electromagnetic energy to transfer at least one of information and energy (para. [0042], “to facilitate data sharing between the CGM sensor and the drug delivery device, the CGM sensor and the drug delivery device can be connected over a wired, wireless, optical, and/or infrared communication link …”).
Regarding claim 30, modified Nazzaro discloses the method of claim 1, wherein the infusion system comprises a cavity formed in a distal surface of the infusion system (Fig. 2, element 204, “opening”, para. [0028]).
However, modified Nazzaro does not explicitly disclose wherein the coupling of the infusion system to the analyte- selective sensor comprises engaging the analyte-selective sensor within the cavity such that each of the plurality of electrical contacts is engaged with the corresponding electrical pad of the plurality of electrical pads.
Balczewski further teaches wherein coupling the first portion and the second portion comprises engaging one portion within a cavity such that each of the plurality of electrical contacts is engaged with the corresponding electric pad of the plurality of electrical pads (Fig. 3B-3C, Figs. 4A-4D, para. [0097], para. [0100], para. [0104-0105], para. [0116]). 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 location of the electrical contacts and electrical pads to explicitly be located in a position where they are engaged when the analyte-selective sensor is within the cavity. Balczewski teaches the plurality of electrical pads and the plurality of electrical contacts on two portions allows for a suitable connection for transferring data (para. [0003], para. [0097], para. [0100]), while also ensuring proper orientation and alignment of the two portions (para. [0106]).
Regarding claim 31, modified Nazzaro discloses the method of claim 1.
However, modified Nazzaro does not explicitly disclose wherein a fluid delivery apparatus of the infusion system is configured to be positioned within a physiological compartment separate from and below the microneedle array and the dermis.
Polsky further teaches of a fluid delivery apparatus of an infusion system is configured to be positioned within a physiological compartment separate from and below the microneedle array and the dermis (Fig. 2, “second needle”, col. 2, lines 14-19, col. 2, line 60, col. 9, lines 10-29, col. 23, lines 18-27). 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 fluid delivery apparatus to be positioned separate from and below the microneedle array and the dermis. Polsky teaches that the needle size and depth can be selected based on optimization of the type of fluid being delivered or the type of tissue (col. 9, lines 10-29, col. 17, lines 49-54).
Regarding claim 32, modified Nazzaro discloses the body-worn device of claim 21, wherein the infusion system comprises a cavity formed in a distal surface of the infusion system (Fig. 2, element 204, “opening”, para. [0028]).
However, modified Nazzaro does not explicitly disclose wherein the coupling of the infusion system to the analyte-selective sensor comprises engaging the analyte-selective sensor within the cavity such that each of the plurality of electrical contacts is engaged with the corresponding electrical pad of the plurality of electrical pads.
Balczewski further teaches wherein coupling the first portion and the second portion comprises engaging one portion within a cavity such that each of the plurality of electrical contacts is engaged with the corresponding electric pad of the plurality of electrical pads (Fig. 3B-3C, Figs. 4A-4D, para. [0097], para. [0100], para. [0104-0105], para. [0116]). 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 location of the electrical contacts and electrical pads to explicitly be located in a position where they are engaged when the analyte-selective sensor is within the cavity. Balczewski teaches the plurality of electrical pads and the plurality of electrical contacts on two portions allows for a suitable connection for transferring data (para. [0003], para. [0097], para. [0100]), while also ensuring proper orientation and alignment of the two portions (para. [0106]).
Regarding claim 33, modified Nazzaro discloses the body-worn device of claim 21.
However, modified Nazzaro does not explicitly disclose wherein a fluid delivery apparatus of the infusion system is configured to be positioned within a physiological compartment separate from and below the microneedle array and the dermis.
Polsky further teaches of a fluid delivery apparatus of an infusion system is configured to be positioned within a physiological compartment separate from and below the microneedle array and the dermis (Fig. 2, “second needle”, col. 2, lines 14-19, col. 2, line 60, col. 9, lines 10-29, col. 23, lines 18-27). 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 fluid delivery apparatus to be positioned separate from and below the microneedle array and the dermis. Polsky teaches that the needle size and depth can be selected based on optimization of the type of fluid being delivered or the type of tissue (col. 9, lines 10-29, col. 17, lines 49-54).
Regarding claim 34, modified Nazzaro discloses the body-worn device of claim 21, wherein the infusion system comprises a cavity formed in a distal surface of the infusion system and configured to receive the analyte-selective sensor (Fig. 2, element 204, “opening”, para. [0028], Fig. 4).
However, modified Nazzaro does not explicitly disclose wherein the plurality of electrical contacts is positioned within the cavity.
Balczewski further teaches wherein the plurality of electrical contacts is positioned within the cavity (Fig. 3B-3C, Figs. 4A-4D, para. [0097], para. [0100], para. [0104-0105], para. [0116]). 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 location of the electrical contacts to explicitly be positioned within the cavity. Balczewski teaches the plurality of electrical pads and the plurality of electrical contacts on two portions allows for a suitable connection for transferring data (para. [0003], para. [0097], para. [0100]), while also ensuring proper orientation and alignment of the two portions (para. [0106]).
Regarding claim 35, modified Nazzaro discloses the method of claim 1, wherein the infusion system comprises a cavity formed in a distal surface of the infusion system and configured to receive the analyte-selective sensor (Fig. 2, element 204, “opening”, para. [0028], Fig. 4).
However, modified Nazzaro does not explicitly disclose wherein the plurality of electrical contacts is positioned within the cavity.
Balczewski further teaches wherein the plurality of electrical contacts is positioned within the cavity (Fig. 3B-3C, Figs. 4A-4D, para. [0097], para. [0100], para. [0104-0105], para. [0116]). 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 location of the electrical contacts to explicitly be positioned within the cavity. Balczewski teaches the plurality of electrical pads and the plurality of electrical contacts on two portions allows for a suitable connection for transferring data (para. [0003], para. [0097], para. [0100]), while also ensuring proper orientation and alignment of the two portions (para. [0106]).
Regarding claim 36, modified Nazzaro discloses the method of claim 1.
However, modified Nazzaro does not explicitly disclose wherein coupling the infusion system and the analyte-selective sensor by the mechanical retention instigates the conveyance of the electromagnetic energy from the infusion system to the analyte-selective sensor.
Pushpala further teaches coupling the first housing to the second housing instigates the conveyance of the electromagnetic energy (para. [0075], “set of contacts … properly interface with the microsensor …”). 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 method disclosed by modified Nazzaro to explicitly include coupling the infusion system and the analyte-selective sensor by the mechanical retention instigates the conveyance of the electromagnetic energy from the infusion system to the analyte-selective sensor. Pushpala teaches the two housings can be connected in a set orientation to ensure proper communication between the microsensor and the electronics subsystem (para. [0075]).
Response to Arguments
Applicant’s arguments filed 07/15/2025 have been fully considered but they are not persuasive.
Applicants have argued on pages 9-10 of Remarks, filed 07/15/2025, that the function of powering sensing elements via an engagement would serve no purpose for Balczweski’s system because the sensing elements are merely passive and do not require power to function.
The Examiner respectfully disagrees. First, as stated by the Applicant’s, Barczewski is not used for teaching conveying electromagnetic energy via an engagement. Second, Applicants arguments regarding the sensing elements being merely passive is incorrect. Balczewski teaches in para. [0111], certain embodiments may include passive sensing, however Balczewski clearly teaches in other embodiments the sensing elements require power (Fig. 3F, para. [0104-0107]).
Applicants have argued on page 10 of Remarks, filed 07/15/2025, that “Pushpala’s power management module and analog front end are both located within the same second housing portion with a permanent wired connected to the battery” and “any power distribution that Pushpala describes is confined entirely within that single second housing portion and is unaffected by any engagement with the first housing portion”.
The Examiner respectfully disagrees. Pushpala explicitly teaches elements of the electronic subsystem can be integrated with the microsensor, and some elements of the electronic subsystem can be integrated in a first housing portion, and some elements of the electronic subsystem can be integrated in a second housing portion (para. [0040], para. [0076]). That is, Pushpala explicitly teaches power is transferred between the first housing and the second housing via the contact pads (para. [0040], para. [0076]).
Applicants have argued on pages 10-11 of Remarks, filed 07/15/2025, “Pushpala does not state that energy from the power management module/battery within the second housing portion is directed through this ring-and-filament interface …” and “Pushpala fails to teach or suggest conveying electromagnetic energy from an energy source via engaged pads and contacts”.
The Examiner respectfully disagrees. First, as recited above in the response to arguments, Pushpala teaches transmitting energy between housing portions. Second, Pushpala teaches contacts for conveying electromagnetic energy (para. [0075]).
Applicants have argued on pages 11-12 of Remarks, filed 07/15/2025, that “removing the CGM sensor’s power source would actually make it less reusable … a skilled artisan would still not have been motivated to modify Nazzaro’s teaching …”.
The Examiner respectfully disagrees. Applicants cited para. [0019] and para. [0043] of Nazzaro in the Remarks filed 09/12/2024 regarding the CGM sensor is designed to power itself. However, Nazzaro discloses in para. [0019], “the drug delivery device can be replaced at the end of its duration of use, which is shorter than the duration of use of the sensor, without disturbing the sensor”. “Disturbing the sensor” relates to the drug delivery device is not directly connected to the sensor and the sensor can remain inserted into the patient (see Fig. 1, Fig. 2, para. [0036]). Further, para. [0043] explicitly recites the drug delivery device includes more power resources compared to the CGM sensor. That is, Applicants arguments regarding “removing the CGM sensor’s power source would make it less reusable” is not considered persuasive.
Applicants have argued on pages 12-13 of Remarks, filed 07/15/2025, that “none of the cited references convey electromagnetic energy across the pad-and-contact interface to power the sensor” and “none of the cited references teach or suggest electromagnetic energy conveyance across device or housing boundaries via engagement between corresponding sets of electrical pads and contacts to power active sensor electrodes”.
The Examiner respectfully disagrees. As recited above, the combined references teach conveying electromagnetic energy across pad-and-contact interfaces to power a sensor and conveying energy across device or housing boundaries via engagement between corresponding sets of electrical pads and contacts to power active sensor electrodes. Therefore, the previous response to arguments regarding the electrical connection between the electrical contacts and the electricals inherently involving “conveying electromagnetic energy” are reiterated.
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.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791