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 .
Response to Amendment
The amendments filed 04 May 2026 have been entered. Claims 1 – 4, 6 – 11, 13 – 19, and 48 – 76 are pending. Applicant’s amendments to the claims and specification have overcome each and every objection to the claims and specification previously applied in the office action dated 09 February 2026. Applicant’s amendments have overcome each and every rejection under 35 U.S.C. 112 previously applied in the office action dated 09 February 2026.
Claim Objections
Claim 55 is objected to because of the following informalities: the term “Bluetooth Low Energy (BTLE) antenna” is recited without a proper symbol indicating use in commerce such as ™, SM, or ®, as it is a trade name or a mark used in commerce. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: regarding the term “BTLE antenna”, it is suggested to revise the term to be “Bluetooth Low Energy (BTLE) ® antenna” for consistency with other recitations in the claims. 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.
Claims 65 – 68, 70 - 71, and 75 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Halac et. al., (United States Patent Application Publication US 2021/0307657 A1).
Regarding Claim 65, Halac discloses A system for measurement of an analyte level ([Abstract]), comprising:
an analyte sensor (Overall Figure 2, used to sense an analyte; [0169] “an analyte sensor attached to a sensor carrier”)(Examiner notes that these structures together are collectively used as an analyte sensor”) a flexible substrate (Fig 52B; [0296] “elongate substrate 4800”; Fig 51A and 51B; [0293] “elongate substrate 4800…flexible, or a combination rigid/flexible substrate.”) defining (i) an in vivo portion ([0207] “ in vivo portion of the sensor 138”) configured to be positioned in contact with an interstitial fluid of a user ([0212] “….through the interstitial fluid surrounding the sensor 138”) and (ii) an ex vivo portion ([0207] “ex vivo portion of the sensor 138”), wherein the ex vivo portion comprises a circular shape and defines an aperture (Fig. 3B, circular aperture “hole 180” opening shown through “adhesive patch 126” and “housing 128”), and wherein the in vivo portion extends from the ex vivo portion at the aperture (Fig 2B., “sensor 138” extending downward from the ex vivo portion at the aperture “hole 180”);
at least one working electrode ([0212] “the working electrode 211 a”) located on the in vivo portion ([0211] “the two electrodes 211 a and 212 a…affixed to a distal in vivo portion…”) of the flexible substrate ([0293] “elongate substrate 4800 formed using printed circuit board technology from either a rigid, flexible, or a combination rigid/flexible substrate.”);
a reference electrode (Fig 3D, “reference electrode 212 a.”; [0212]) located on the in vivo portion ([0209] “…in vivo portion of the sensor 138…forms an electrode 212 a.”) of the flexible substrate ([0293] “elongate substrate 4800 formed using printed circuit board technology from either a rigid, flexible, or a combination rigid/flexible substrate.”); and
a plurality of electronic components mounted on the ex vivo portion (Fig 53A; [0297] “portion 4802 may form a standalone processing circuit for sensor 138 (e.g., an implementation of sensor electronics 112.)“; [0173] “sensor electronics 112…electronic circuitry associated with measuring and processing data generated by the analyte sensor 138.”; [0184]; [0187] “sensor electronics 112 may comprise an application-specific integrated circuit (ASIC) 205 coupled to a user interface 222.”; Fig 2, “ASIC 205”) of the flexible substrate ([0293] “elongate substrate 4800 formed using printed circuit board technology from either a rigid, flexible, or a combination rigid/flexible substrate.”), wherein the at least one working electrode is configured to sense an analyte level in the interstitial fluid of the user ([0212] “….through the interstitial fluid surrounding the sensor 138”, “The magnitude of this current…on the working electrode 211 a is a measure of analyte concentration…”), and at least one of the plurality of electronic components is configured to receive generated signals associated with the analyte level (Fig 2, “telemetry module 232”; [0039] “communications circuitry operable by the processing circuitry to send and receive data associated with each of the analyte sensors…”)
Regarding Claim 66, Halac discloses as described above, The system of claim 65. For the remainder of Claim 66, Halac discloses wherein the in vivo portion ([0209] “…in vivo portion of the sensor 138…forms an electrode 212 a.”) is centrally located with respect to the ex vivo portion (Fig 2B., “sensor 138” extending downward centrally from the ex vivo portion at the aperture “hole 180”).
Regarding Claim 67, Halac discloses as described above, The system of claim 65. For the remainder of Claim 67, Halac discloses wherein the plurality of electronic components (Fig 2, “ASIC 205”; [0173] “sensor electronics 112”) comprises communication circuitry (0187] “The ASIC 205…include…telemetry module 232 “) that is configured to transmit the generated signals associated with the analyte level to a remote device having a display ([0187] “The ASIC 205…include…telemetry module 232 for transmitting data from the sensor electronics 112 to one or more devices, such as devices 114, 116, 118, and/or 120”; Fig 1, “display devices 114, 116, 118, and/or 120”; [0175]; [0178] “display device…configured to display…graphical representation of the sensor data including current and historic sensor data output by sensor system 100”; [0205])
Regarding Claim 68, Halac discloses as described above, The system of claim 67. For the remainder of Claim 68, Halac discloses wherein the remote device comprises a reader device ([0041] “…generally applicable embodiment…obtaining a signal from the analyte sensor… radio-frequency reader of the manufacturing station to obtain the identifier…”), a mobile phone (Fig 1, “display device 118”), or a wrist-mounted device (Fig 1, “display device 114”; [0177] “key fob-like display device 114 may comprise a wrist watch”)
Regarding Claim 70, Halac discloses as described above, The system of claim 65. For the remainder of Claim 70, Halac discloses wherein the flexible substrate (Fig 52B; [0296] “elongate substrate 4800”; Fig 51A and 51B; [0293] “…elongate substrate 4800…flexible…”) comprises one of polyamide or polyethylene terephthalate ([0293] “Flexible portion of the substrate may be manufactured from a material such as…polyester”)
Regarding Claim 71, Halac discloses as described above, The system of claim 65. For the remainder of Claim 71, Halac discloses wherein the ex vivo portion of the flexible substrate (Fig 51A and 51B, Fig 52 A; [0293] “ an elongate substrate 4800 formed using printed circuit board technology from either a rigid, flexible, or a combination rigid/flexible substrate, from which multiple sensor carriers 402 can be singulated.”)(Examiner notes that the sensor carrier 402 is an ex vivo portion.) comprises a first layer ([0293] “elongate substrate 4800”).
Regarding Claim 75, Halac discloses as described above, The system of claim 71. For the remainder of Claim 75, Halac discloses wherein the ex vivo portion of the flexible substrate comprises a second layer ([0204] “adhesive patch 126”; [0248] “Wearable assembly 600 may include sensor electronics and an adhesive patch (not shown).”; [0297] “Following testing and/or calibration operations, flexible portion 4802 may be folded around…for installation into on-skin sensor assembly 600.”; [0293] “ an elongate substrate 4800…flexible…”))
Claims 72 – 73 and 76 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Halac as evidenced by Shapiro of Vinatronic Inc, “PCB FR4: Which Material is Right for Your Project?”, hereinafter Vinatronic Inc.
Regarding Claim 72, Halac discloses as described above, The system of claim 71. For the remainder of Claim 72, Halac discloses wherein the first layer comprises a gradient mix of materials ([0293] “elongate substrate 4800 formed using printed circuit board technology from either a rigid, flexible, or a combination rigid/flexible substrate.”, ”Rigid portion of the substrate may be manufactured from a material such as FR4, FR5, FR6…”)(Examiner notes that FR4 is a circuit board material that is a mix of fiberglass and epoxy resin, as evidenced by Vinatronic Inc [Page 3, “What is FR4?” Section] “FR4 is the NEMA (National Electrical Manufacturers Association) designation for Flame-Retardant fiberglass reinforced epoxy material.”)
Regarding Claim 73, Halac discloses as described above, The system of claim 72. For the remainder of Claim 73, Halac discloses wherein the gradient mix of materials comprises fiberglass ([0293] “elongate substrate 4800 formed using printed circuit board technology from either a rigid, flexible, or a combination rigid/flexible substrate.”, ”Rigid portion of the substrate may be manufactured from a material such as FR4, FR5, FR6…”)(Examiner notes that FR4 is a circuit board material that is a mix of fiberglass and epoxy resin, as evidenced by Vinatronic Inc [Page 3, “What is FR4?” Section] “FR4 is the NEMA (National Electrical Manufacturers Association) designation for Flame-Retardant fiberglass reinforced epoxy material.”)
Regarding Claim 76, Halac discloses as described above, The system of claim 75. For the remainder of Claim 76, Halac discloses wherein each of the first layer ([0293] “elongate substrate 4800”) and the second layer ([0204] “adhesive patch 126”; [0248]; [0297]) comprise a gradient mix of materials ([0293] “elongate substrate 4800 formed using printed circuit board technology from either a rigid, flexible, or a combination rigid/flexible substrate.”,”Rigid portion of the substrate may be manufactured from a material such as FR4, FR5, FR6…”; [0204] “adhesive 126 can be a pressure sensitive adhesive (e.g. acrylic, rubber based, or other suitable type) bonded to a carrier substrate (e.g., spun lace polyester, polyurethane film, or other suitable type)(Examiner notes that FR4 is a circuit board material that is a mix of fiberglass and epoxy resin, as evidenced by Vinatronic Inc [Page 3, “What is FR4?” Section] “FR4 is the NEMA (National Electrical Manufacturers Association) designation for Flame-Retardant fiberglass reinforced epoxy material.”)
Claim Rejections - 35 USC § 103
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 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.
Claim 69 is rejected under 35 U.S.C. 103 as being unpatentable over Halac in view of Happy Holden, “Happy’s Tech Talk #3: Photonic Soldering”, hereinafter Happy.
Regarding Claim 69, Halac discloses as described above, The system of claim 65. For the remainder of Claim 69, Halac discloses wherein the plurality of electronic components (Fig 2, “ASIC 205”; [0173] “sensor electronics 112”) are mounted to the ex vivo portion using soldering ([0296] “sensors can be permanently connected…solder...or other suitable methods) to the sensor carriers 402.”)(Examiner notes that the “sensor carriers 402” are ex vivo.)
Halac does not disclose using photonic soldering.
Happy teaches how photonic soldering is used in printed electronics. Specifically for Claim 69, Happy teaches using photonic soldering ([Page 1, Paragraph 2 and 3] “curing and annealing of printed inks with flash tubes…”, “Inks cured to the temperature at which they become conductive using IR ovens requires substrates that can withstand these temperatures, like polyimides, ceramics, and epoxy fiberglass.”; Figure 1: “After: High-conductive printed electronic pattern with superior performance and throughput not possible by other methods”; Figure 2).
Happy provides a motivation to combine regarding advantages in manufacturability at [Page 3, Paragraph 1] with “This process was developed as part of enhancing the manufacturability of flexible hybrid electronics (FHE) by sintering metal particle-based inks into conductive traces.”, [Page 2, Paragraph 4] “Light-generated (ER) heating, as in laser soldering, can also be performed by flash tubes, but with the advantage of soldering components not in the line-of-sight”, and the list of advantages at [Page 4, Bottom, “Summary” Section”] – [Page 5, Top, “Summary” Section] A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that photonic soldering would be useful for integrating electronics into a printed circuit board, particularly if that board is of a material such as FR-4 (such as the substrate material taught by Halac).
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 combine the FR-4 material combination flexible and rigid printed circuit board substrate disclosed by Halac with photonic soldering electronic components onto printed circuit board substrate taught by Happy, creating a single analyte measurement system with photonic soldered electronics, increasing the ease of manufacturability for the associated materials and geometry.
Claim 74 is rejected under 35 U.S.C. 103 as being unpatentable over Halac in view of Brister et. al., (United States Patent Application Publication US 2006/0020187 A1).
Regarding Claim 74, Halac discloses as described above, The system of claim 72. For the remainder of Claim 74, Halac teaches the in vivo portion of the flexible substrate ([0207] “ in vivo portion of the sensor 138”; Fig 52B; [0296] “elongate substrate 4800”; Fig 51A and 51B; [0293] “…elongate substrate 4800…flexible…”)
Halac does not specifically disclose wherein the in vivo portion of the flexible substrate comprises PET.
Brister teaches a transcutaneous sensor assembly with porous material on a distal in vivo instrumented end to increase performance. Specifically for Claim 74, Brister teaches the in vivo portion of the flexible substrate comprises PET ([0108] “the sensor 32 includes a distal portion 42, also referred to as the in vivo portion, adapted to extend out of the mounting unit for insertion under the host’s skin”; [0165] “the distal portion 42 includes a porous material disposed over some portion thereof…Suitable porous materials include…polyester”)
Brister provides a motivation to combine at [0165] with “the porous material surrounding the sensor advantageously enhances and extends sensor performance and lifetime in the short term by slowing or reducing cellular migration to the sensor and associated degradation that would otherwise be caused by cellular invasion if the sensor were directly exposed to the in vivo environment.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that including a porous polyester section would be useful for an analyte sensor to have better performance an longevity to obtain percutaneous measurements.
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 combine the analyte sensor with a distal in vivo portion with sensors disclosed in Halac with the porous material disposed over the distal in vivo portion with sensors taught by Brister, creating a single analyte sensor for percutaneous measurements that performs with greater longevity and accuracy.
Claims 1- 3, 6, 8, 10 – 11, 13 – 14, 18, 49, and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Halac et. al., (US 2021/0307657 A1) in view of Rao et. al. (US 2020/196919 A1) in view of Rao (US 2020/0196919 A1).
Regarding Claim 1, Halac discloses A system for measurement of an analyte level ([Abstract]), comprising:
an analyte sensor (Overall Figure 2, used to sense an analyte; [0169] “an analyte sensor attached to a sensor carrier”)(Examiner notes that these structures together are collectively used as an analyte sensor”) comprising a flexible substrate ([0293] “elongate substrate 4800 formed using printed circuit board technology from either a rigid, flexible, or a combination rigid/flexible substrate.”) defining (i) an in vivo portion ([0207] “ in vivo portion of the sensor 138”) configured to be positioned in contact with an interstitial fluid of a user ([0212] “….through the interstitial fluid surrounding the sensor 138”) and (ii) an ex vivo portion ([0207] “ex vivo portion of the sensor 138”),
at least one working electrode ([0212] “the working electrode 211 a”) located on the in vivo portion ([0211] “the two electrodes 211 a and 212 a…affixed to a distal in vivo portion…”) of the flexible substrate ([0293] “elongate substrate 4800 formed using printed circuit board technology from either a rigid, flexible, or a combination rigid/flexible substrate.”),
a reference electrode (Fig 3D, “reference electrode 212 a.”; [0212]) located on the in vivo portion ([0209] “…in vivo portion of the sensor 138…forms an electrode 212 a.”) of the flexible substrate ([0293] “elongate substrate 4800 formed using printed circuit board technology from either a rigid, flexible, or a combination rigid/flexible substrate.”);
a plurality of electronic components mounted on the ex vivo portion of the flexible substrate (Fig 53A; [0297] “portion 4802 may form a standalone processing circuit for sensor 138 (e.g., an implementation of sensor electronics 112.)“; [0173] “sensor electronics 112…electronic circuitry associated with measuring and processing data generated by the analyte sensor 138.”; [0184]; [0187] “sensor electronics 112 may comprise an application-specific integrated circuit (ASIC) 205 coupled to a user interface 222.”; Fig 2, “ASIC 205”; [0293] “elongate substrate 4800 formed using printed circuit board technology from either a rigid, flexible, or a combination rigid/flexible substrate.”))
wherein the at least one working electrode is configured to sense an analyte level ([0212] “The magnitude of this current…on the working electrode 211 a is a measure of analyte concentration…”), and at least one of the plurality of electronic components (Fig 2, “ASIC 205”) is configured to receive generated signals associated with the analyte level ([0184] “sensor electronics 112 may include electronics components that are configured to process sensor information, such as sensor data…e.g., via a processor module.”; Fig 2, “processor module 214”; [[0185] “processor module 214 may be integral to sensor electronics 112”)(Examiner notes that the processor module is the first component to receive the sensor data for processing.);
an on-body sensor assembly ([0047] “a wearable device is provided….”) housing the analyte sensor (Overall Figure 2, used to sense an analyte; [0169] “an analyte sensor attached to a sensor carrier”; [0047] “wearable device…a housing and electronic circuitry configured to process analyte sensor signals. The electronic circuitry is enclosed within the housing. “)(Examiner notes that these structures together are collectively used as an analyte sensor”); and
Halac does not disclose an applicator for delivery of the analyte sensor including: a housing including a sensor carrier configured to secure the on-body sensor assembly within an interior of the applicator; and an applicator cap removably coupled to the housing to seal the interior of the applicator, wherein the flexible substrate further defines a biasing tower, the biasing tower including a bias fulcrum configured to contact an inner surface of a needle of the applicator to bias the in vivo portion of the flexible substrate into a slot of the applicator.
Rao teaches systems, devices, and methods for inserting a wearable analyte sensor using an applicator, including a housing, sensor carrier, and biasing tower to bias the tail of the in vivo portion into a slot of the applicator (Fig. 14, [0131]; [0093] – [0094]; [Abstract]). Specifically for Claim 1, Rao teaches an applicator for delivery of the analyte sensor including ([0250] “an applicator for inserting an analyte sensor into a subject is provided”):
a housing ([0093] “sensor applicator 150 includes a housing 702”) including a sensor carrier configured to secure the on-body sensor assembly within an interior of the applicator ([0094] “…sensor tray 810, including the sensor and sharp modules, being coupled to the electronics housing arranged within the sensor applicator 150…”); and
an applicator cap removably coupled to the housing to seal the interior of the applicator ([0093] “sensor applicator 150 includes a housing 702 sealed at one end with an applicator cap 708”, ‘…applicator cap 708 may or may not maintain a sterile environment for the electrical components…unscrewing the applicator cap 708 from the housing 702…”)
wherein the flexible substrate further defines a biasing tower (Fig. 14, “biasing tower 2412”; [0131]), the biasing tower including a bias fulcrum configured to contact an inner surface of a needle of the applicator to bias the in vivo portion of the flexible substrate into a slot of the applicator (Fig. 14, [0131] “…biasing tower 2412 can be a tab that biases the tail 2408 into a sharp slot 2208…bias fulcrum 2414 can be an offshoot of biasing tower 2412…contacts an inner surface of a needle to bias a tail into a slot…”).
Halac is open to combine with a housing as disclosed at [0302] with “Substrate 404 may be sized and shaped (or may include structural features) that form anchoring features for substrate 404 relative to manufacturing stations and/or a housing of a wearable device.” Rao provides a motivation to combine at [0008] with “The applicator can be used to position the sensor control device on a human body with a sensor in contact with the wearer's bodily fluid. The embodiments provided herein are improvements to prevent or reduce the likelihood that a sensor is improperly inserted or damaged, or elicits an adverse physiological response.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that Halac’s disclosed substrate 404 could be attached to the interior of an applicator structure such as that taught by Rao, which would be useful for keeping the sensor sterile within a capped structure prior to use. Further, a person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that including an applicator that can bias the in vivo portion of the analyte sensor in a slot, along with a housing to seal the interior of the applicator, would be useful for minimizing user error and contamination when donning a wearable analyte sensor device.
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 combine the analyte sensor on a substrate with anchoring features compatible with a housing disclosed in Halac with the inserter applicator structure housing with a biasing tower for an analyte sensor taught by Rao, creating a single analyte sensor system with interior sensors stored and deployed from a sterile housing environment to minimize user error and contamination.
Regarding Claim 2, Halac in view of Rao discloses as described above, The system of claim 1. For the remainder of Claim 2, Halac discloses as described above, wherein the plurality of electronic components comprises communication circuitry that is configured to transmit the generated signals associated with the analyte level to a remote device having a display screen (See citation in Claim 67 above)
Regarding Claim 3, Halac in view of Rao discloses as described above, The system of claim 2. For the remainder of Claim 3, Halac discloses as described above wherein the remote device comprises a reader device, a mobile phone, or a wrist-mounted device (See citation in Claim 68 above)
Regarding Claim 6, Halac in view of Rao discloses as described above, The system of claim 1. For the remainder of Claim 6, Halac discloses wherein the plurality of electronic components (Fig 2, “ASIC 205”; [0173] “sensor electronics 112”) include one or more processors (Fig 2; [0185] “processor module 214…”) and a battery ([0194] “a source of power, such as a battery 234.”)
Regarding Claim 8, Halac in view of Rao discloses as described above, The system of claim 1. For the remainder of Claim 8, Halac discloses wherein the at least one working electrode ([0212] “the working electrode 211 a”) is configured to sense at least one of lactate ([0212]; [0135] “’analyte’ as used herein…the analyte for measurement…lactate”; [0180]), glucose ([0212]; [0180] “…description herein…glucose as the analyte being measured”), and ketone ([0212]; [0180] “…description herein…glucose as the analyte being measured…other analytes may be used…ketone bodies”).
Regarding Claim 10, Halac in view of Rao discloses as described above, The system of claim 1. For the remainder of Claim 2, Halac discloses wherein the plurality of electronic components (Fig 2, “ASIC 205”; [0173] “sensor electronics 112”) includes at least a Wi-Fi antenna ([0336] “…wireless technologies…WiFi”), NFC antenna ([0336] “…wireless technologies…NFC”), Bluetooth® antenna (Fig 2; [0190] “A variety of wireless radio technologies that can be implemented in the telemetry module 232 include Bluetooth”), BTLE antenna ([0190] “…Bluetooth Low-Energy”), or GPS antenna.
Regarding Claim 11, Halac in view of Rao discloses as described above, The system of claim 1. For the remainder of Claim 11, Halac discloses as described above, wherein the flexible substrate comprises one of polyamide or polyethylene terephthalate (See citation above in Claim 70)
Regarding Claim 13, Halac in view of Rao discloses as described above, The system of claim 1. For the remainder of Claim 13, Halac discloses wherein the plurality of electronic components (Fig 2, “ASIC 205”; [0173] “sensor electronics 112”) are electrically coupled to the at least one working electrode and the reference electrode ([0211] “Electrodes 211 a, 212 a could be electrically connected to their respective contacts 211 b, 212 b a circuit traces on the planar substrate.”; [0171] “analyte sensor 138 may be physically connected to sensor electronics 112…”).
Regarding Claim 14, Halac in view of Rao discloses as described above, The system of claim 1. For the remainder of Claim 14, Halac discloses as described above, wherein the ex vivo portion of
the flexible substrate comprises a first layer (See citation above in Claim 71.)
Regarding Claim 18, Halac in view of Rao discloses as described above, The system of claim 14. For the remainder of Claim 18, Halac discloses as described above, wherein the ex vivo portion of the flexible substrate comprises a second layer (See citation above in Claim 75.)
Regarding Claim 49, Halac in view of Rao discloses as described above, The system of claim 14. For the remainder of Claim 18, Halac discloses the flexible substrate (Fig 52B; [0296] “elongate substrate 4800”; Fig 51A and 51B; [0293] “…elongate substrate 4800…flexible…”).
Halac does not disclose wherein the flexible substrate further defines a hook feature located on the ex vivo portion, the hook feature being configured to engage a catch feature of a sensor module of the on-body sensor assembly.
Rao teaches wherein the flexible substrate further defines a hook feature located on the ex vivo portion (Fig. 16A and 16B; “hook feature 3106”; [0133] “sensor 3104…proximal portion having a hook portion 3106…”), the hook feature being configured to engage a catch feature of a sensor module of the on-body sensor assembly ([0133] “sensor 3104 comprises a proximal portion having a hook feature 3106 configured to engage a catch feature 3506 of the sensor module 3504.”)
Rao provides a motivation to combine at [0133] with “embodiments described herein are directed to mitigating the effects of axial forces on the sensor as a result of insertion and/or retraction mechanisms, or from a physiological reaction to the sensor in the body” and [0134] with “ hook feature 3106 engages catch feature 3506 to prevent displacement of sensor 3104 in a proximal direction along the longitudinal axis.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that the hook and catch feature with the substrate would be useful for positively connecting the sensor 3104 to prevent displacement of the sensor in a proximal direction when it is not desired regarding the proper application of the sensor to the patient.
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 combine the analyte sensor on a substrate with anchoring features compatible with a housing disclosed in Halac with the hook and catch anchoring features for the analyte sensor on the applicator housing taught by Rao, creating a single sensor system with its sensors stored and deployed from a sterile housing environment with hook and catch features that prevent improper displacement of the sensor and sensor placement error.
Regarding Claim 63, Halac in view of Rao discloses as described above, The system of claim 1. For the remainder of Claim 63, Halac discloses wherein the flexible substrate defines a neck interconnecting the ex vivo portion and the in vivo portion (Fig. 53A and 53B, narrow portion near the “4804” callout in Fig. 53A connecting the ex vivo “portion 4802” to the in vivo “sensor 138” portion), and wherein bending of the neck forms an angle between the ex vivo portion and (i) the in vivo portion (Fig. 53A and 53B, bend of that narrow portion forms a 90 degree angle between the ex vivo “portion 4802” and the in vivo “sensor 138” portion)
Halac does not disclose forms an angle between the ex vivo portion and (ii) the biasing tower.
Halac does broadly disclose that the neck bend aligns the sensor in a ‘through-hole 180” slot feature on the flexible substrate.(Fig. 53B).
Rao teaches wherein the flexible substrate defines a neck (Fig. 14, “neck 2406”) interconnecting the ex vivo portion and the in vivo portion (Fig. 14, “neck 2406” between in vivo “tail 2408” and ex vivo “contacts 2418”, etc), and wherein bending of the neck forms an angle between the ex vivo portion and (i) the in vivo portion (Fig. 14, bend in “neck 2406” with 90 degree angle relative to the in vivo portion) and (ii) the biasing tower (Fig. 14, forms a second angle, 180 degrees, with 90 degree angle relative to the biasing tower)
Halac and Rao both disclose neck features on a flexible substrate that allow for the in vivo portion to be located at an angle relative to the ex vivo portion: Halac with the neck portion of Fig. 53A and 53B, and Rao with the “neck 2406” ” between in vivo “tail 2408” and ex vivo “contacts 2418” of Fig. 14. Rao provides a motivation to combine at [0131] “ A neck 2406 can be a zone which allows folding of the sensor, for example ninety degrees…” and “A biasing tower 2412 can be a tab that biases the tail 2408 into sharp slot 2208”. A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that a neck bend would be compatible with a biasing tower and useful to align the in vivo sensor portion with a sharp slot (as with Halac’s through-hole slot 180 for the sharp.
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 combine the neck bend and through-hole sharp slot for the in vivo portion of the analyte sensor on a flexible substrate disclosed in Halac with Rao’s taught neck bend on a flexible substrate to align the in vivo portion of the analyte sensor with a sharp slot relative to a biasing tower, creating a sensor system assembly that aligns its vivo sensor portion with a sharp slot using a flexible substrate, biasing tower, and neck bend, for consistent positioning on the user.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Halac in view of Rao, further in view of Happy Holden, “Happy’s Tech Talk #3: Photonic Soldering”.
Regarding Claim 4, Halac in view of Rao discloses as described above, The system of claim 1. For the remainder of Claim 4, Halac discloses wherein the plurality of electronic components (Fig 2, “ASIC 205”; [0173] “sensor electronics 112”) are mounted to the ex vivo portion using soldering ([0296] “sensors can be permanently connected…solder...or other suitable methods) to the sensor carriers 402.”)(Examiner notes that the “sensor carriers 402” are ex vivo.)
Halac does not disclose using photonic soldering.
The motivation for Claim 4 to combine Halac and Happy is the same as that described in more detail above in Claim 69. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the FR-4 material combination flexible and rigid printed circuit board substrate disclosed by Halac with photonic soldering electronic components onto printed circuit board substrate taught by Happy, creating a single analyte measurement system with photonic soldered electronics, increasing the ease of manufacturability for the associated materials and geometry.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Halac in view Rao, further in view of Zoss et. al., (United States Patent Application Publication US 2022/0255637 A1).
Regarding Claim 7, Halac in view of Rao discloses as described above, The system of claim 6. For the remainder of Claim 7, Halac discloses the battery ([0194] “a source of power, such as a battery 234.”).
Halac does not disclose wherein the battery includes a printed battery.
Zoss teaches a physiological parameter monitoring system with sensor electronics on a printed circuit board, including a printed battery. Specifically for Claim 7, Zoss teaches wherein the battery includes a printed battery ([0121] “ battery 216′ may comprise an even smaller, lower-profile battery that is printed onto PCB 480.”).
Zoss provides a motivation to combine at [0121] with “…an even smaller, lower-profile battery that is printed onto PCB 480.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that having a lower profile battery printed on the PCB would be useful for miniaturizing a device for user comfort, or for generally fitting more electronic components into a circuit board space.
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 combine the battery powering an analyte sensor on a printed circuit board substrate disclosed in Halac with the low-profile printed battery for an analyte sensor taught by Zoss, creating a single analyte device powered by a low-profile printed battery on a PCB, to enhance miniaturization efforts for the comfort and conveniences of the device’s users.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Halac in view of Rao, further in view of Srinivasan et. al., (United States Patent Application Publication US 2019/0008425 A1).
Regarding Claim 9, Halac in view of Rao discloses as described above, The system of claim 1. For the remainder of Claim 9, Halac discloses wherein the analyte sensor further comprises a substrate (Fig 52B; [0296] “elongate substrate 4800”; Fig 51A and 51B) and at least one antenna (Fig 2; [0190] “A variety of wireless radio technologies that can be implemented in the telemetry module 232 include Bluetooth”; [0321] “…one or more antennas…”)
Halac does not specifically disclose a second substrate.
Srinivasan teaches a percutaneous electrode-based analyte sensor with an in vivo portion and ex vivo portion, including a wired connection to a secondary circuit board with an antenna. Specifically for Claim 9, Srinivasan teaches wherein the analyte sensor further comprises a second substrate ([0110] “printed circuit board 108”; Fig 3)(Examiner notes that a first substrate for Srinivasan would be [0101] “a base substrate layer 402 to support the sensor 400.”, a substrate with electronics.) having at least one antenna (Fig 3, “printed circuit board 108…antenna 112”)
Srinivasan provides a motivation to combine at [0107] “the sensor systems disclosed herein can communicate with other medical devices/systems via a wired or wireless connection.” and Figure 3. A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that a second substrate could be used with a wired connection between the structures to have electronics such as the antennae placed at a distance outside the body, creating versatility in the arrangement of parts.
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 combine the antenna “telemetry module 232” of the analyte sensor electronics on the PCB substrate disclosed in Halac with Srinivasan’s taught second circuit board substrate with an antenna on a wired connection a distance outside of the body, creating a single analyte sensing apparatus with multiple substrates with electronics for design flexibility in arrangement of device parts relative to a patient.
Claims 15 – 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Halac in view of Rao, as evidenced by Shapiro of Vinatronic Inc, “PCB FR4: Which Material is Right for Your Project?”.
Regarding Claim 15, Halac in view of Rao discloses as described above, The system of claim 14. For the remainder of Claim 15, Halac discloses as described above, wherein the first layer comprises a gradient mix of materials (See citation in Claim 72 above.)
Regarding Claim 16, Halac in view of Rao discloses as described above, The system of claim 15. For the remainder of Claim 16, Halac discloses as described above, wherein the gradient mix of materials comprises fiberglass (See citation in Claim 73 above.)
Regarding Claim 19, Halac in view of Rao discloses as described above, The system of claim 18. For the remainder of Claim 19, Halac discloses as described above, wherein each of the first layer and the second layer comprise a gradient mix of materials (See citation in Claim 76 above.)
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Halac in view of Rao as evidenced by Vinatronic Inc., further in view of Brister et. al., (United States Patent Application Publication US 2006/0020187 A1).
Regarding Claim 17, Halac in view of Rao as evidenced by Vinatronic Inc. discloses as described above, The system of claim 15. For the remainder of Claim 17, Halac discloses the in vivo portion of the flexible substrate ([0207] “ in vivo portion of the sensor 138”; Fig 52B; [0296] “elongate substrate 4800”; Fig 51A and 51B; [0293] “…elongate substrate 4800…flexible…”)
Halac does not specifically disclose wherein the in vivo portion of the flexible substrate comprises PET.
Brister teaches a transcutaneous sensor assembly with porous material on a distal in vivo instrumented end to increase performance. Specifically for Claim 17, Brister teaches the in vivo portion of the flexible substrate comprises PET ([0108] “the sensor 32 includes a distal portion 42, also referred to as the in vivo portion, adapted to extend out of the mounting unit for insertion under the host’s skin”; [0165] “the distal portion 42 includes a porous material disposed over some portion thereof…Suitable porous materials include…polyester”)
The motivation for Claim 17 to combine Halac with Brister is the same as that described in more detail above in Claim 74. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the analyte sensor with a distal in vivo portion with sensors disclosed in Halac with the porous material disposed over the distal in vivo portion with sensors taught by Brister, creating a single analyte sensor for percutaneous measurements that performs with greater longevity and accuracy.
Claims 48, 50 – 53, 55 – 57, 61, and 64 are rejected under 35 U.S.C. 103 as being unpatentable over Halac in view of Happy, further in view of Rao.
Regarding Claim 48, Halac discloses A system for measurement of an analyte level ([Abstract]), comprising:
an analyte sensor (Overall Figure 1 and 2, used to sense an analyte; [0169] “an analyte sensor attached to a sensor carrier”)(Examiner notes that these structures together are collectively used as an analyte sensor”) the analyte sensor comprising:
a flexible substrate (Fig 52B; [0296] “elongate substrate 4800”; Fig 51A and 51B; [0293] “elongate substrate 4800…flexible, or a combination rigid/flexible substrate.”) defining (i) an in vivo portion ([0207] “ in vivo portion of the sensor 138”) configured to be positioned in contact with an interstitial fluid of a user ([0212] “….through the interstitial fluid surrounding the sensor 138”) and (ii) an ex vivo portion ([0207] “ex vivo portion of the sensor 138”),
a membrane disposed on the in vivo portion of the flexible substrate, the membrane ([0210] “membrane 108…typically formed of multiple layers”; Fig 3D; Fig 52B; [0296] “elongate substrate 4800…flexible…”) configured to regulate analyte influx
at least one working electrode ([0212] “the working electrode 211 a”) located on the in vivo portion of the flexible substrate ([0211] “the two electrodes 211 a and 212 a…affixed to a distal in vivo portion…”; Fig 52B; [0296] “elongate substrate 4800…flexible…”),
a reference electrode (Fig 3D, “reference electrode 212 a.”; [0212]) located on the in vivo portion of the flexible substrate ([0209] “…in vivo portion of the sensor 138…forms an electrode 212 a.”; Fig 52B; [0296] “elongate substrate 4800…flexible…”); and
a plurality of electronic components mounted on the ex vivo portion (Fig 53A; [0297] “portion 4802 may form a standalone processing circuit for sensor 138 (e.g., an implementation of sensor electronics 112.)“; [0173] “sensor electronics 112…electronic circuitry associated with measuring and processing data generated by the analyte sensor 138.”; [0184]; [0187] “sensor electronics 112 may comprise an application-specific integrated circuit (ASIC) 205 coupled to a user interface 222.”; Fig 2, “ASIC 205”), the plurality of electronic components (Fig 2, “ASIC 205”; [0173] “sensor electronics 112”) comprising a processor (Fig 2, [0185] “a processor module 214 “), a battery ([0194] “a source of power, such as a battery 234.”), and an antenna (Fig 2, “telemetry module 232”; [0321] “Circuitry 5806 may include communications circuitry such as one or more antennas…”);
an on-body sensor assembly housing the analyte sensor (Fig 53A; [0297] “installation on on-skin sensor assembly 600.”)(Examiner notes that the sensor assembly is used to control where the “analyte sensor 138” is placed on the body, and it houses it in position at its distal end.); and
an applicator for delivery of the analyte sensor (Fig 53A and Fig 53B; [0297] “installation on on-skin sensor assembly 600…envelope portion 4804”)(Examiner notes that the “envelope portion 4804” is used to deliver the analyte sensor 138 through the gap 180.) including:
a sensor carrier (Fig 53A and B; Fig 52A and B; “sensor carrier 402”),
wherein the at least one working electrode is configured to sense an analyte level in the interstitial fluid of the user ([0212] “….through the interstitial fluid surrounding the sensor 138”, “The magnitude of this current…on the working electrode 211 a is a measure of analyte concentration…”) and the antenna being further configured to receive generated signals associated with the sensed analyte level (Fig 2, “telemetry module 232”; [0039] “communications circuitry operable by the processing circuitry to send and receive data associated with each of the analyte sensors…”)
Halac does not disclose using photonic soldering, an applicator for delivery of the analyte sensor including: a housing including a sensor carrier configured to secure the on-body sensor assembly within an interior of the applicator; an applicator cap removably coupled to the housing to seal the interior of the applicator; and wherein the flexible substrate further defines a hook feature, the hook feature being configured to engage a catch feature of a sensor module of the on-body sensor assembly.
Happy teaches how photonic soldering is used in printed electronics. Specifically for Claim 48, Happy teaches using photonic soldering ([Page 1, Paragraph 2 and 3] “curing and annealing of printed inks with flash tubes…”, “Inks cured to the temperature at which they become conductive using IR ovens requires substrates that can withstand these temperatures, like polyimides, ceramics, and epoxy fiberglass.”; Figure 1: “After: High-conductive printed electronic pattern with superior performance and throughput not possible by other methods”; Figure 2).
The motivation for Claim 48 to combine Halac with Happy is the same as that described in more detail above in Claim 69. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the FR-4 material combination flexible and rigid printed circuit board substrate disclosed by Halac with photonic soldering electronic components onto printed circuit board substrate taught by Happy, creating a single analyte measurement system with photonic soldered electronics, increasing the ease of manufacturability for the associated materials and geometry.
Happy does not teach an applicator for delivery of the analyte sensor including: a housing including a sensor carrier configured to secure the on-body sensor assembly within an interior of the applicator; an applicator cap removably coupled to the housing to seal the interior of the applicator; and wherein the flexible substrate further defines a hook feature, the hook feature being configured to engage a catch feature of a sensor module of the on-body sensor assembly.
Rao teaches an applicator for delivery of the analyte sensor including ([0250] “an applicator for inserting an analyte sensor into a subject is provided”):
a housing ([0093] “sensor applicator 150 includes a housing 702”) configured to secure the on-body sensor assembly within an interior of the applicator ([0094] “…sensor tray 810, including the sensor and sharp modules, being coupled to the electronics housing arranged within the sensor applicator 150…”);
an applicator cap removably coupled to the housing to seal the interior of the applicator ([0093] “sensor applicator 150 includes a housing 702 sealed at one end with an applicator cap 708”, ‘…applicator cap 708 may or may not maintain a sterile environment for the electrical components…unscrewing the applicator cap 708 from the housing 702…”)
and wherein the flexible substrate further defines a hook feature (Fig. 16A and 16B; “hook feature 3106”; [0133] “sensor 3104…proximal portion having a hook portion 3106…”), the hook feature being configured to engage a catch feature (Fig. 16A, “catch feature 3506”) of a sensor module of the on-body sensor assembly ([0133] “sensor 3104 comprises a proximal portion having a hook feature 3106 configured to engage a catch feature 3506 of the sensor module 3504.”)
Rao provides a motivation to combine at [0133] with “embodiments described herein are directed to mitigating the effects of axial forces on the sensor as a result of insertion and/or retraction mechanisms, or from a physiological reaction to the sensor in the body” and [0134] with “ hook feature 3106 engages catch feature 3506 to prevent displacement of sensor 3104 in a proximal direction along the longitudinal axis.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that the hook and catch feature with the substrate would be useful for positively connecting the sensor 3104 to prevent displacement of the sensor in a proximal direction when it is not desired regarding the proper application of the sensor to the patient.
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 combine the analyte sensor on a substrate with anchoring features compatible with a housing disclosed in Halac with the hook and catch anchoring features for the analyte sensor on the applicator housing taught by Rao, creating a single sensor system with its sensors stored and deployed from a sterile housing environment with hook and catch features that prevent improper displacement of the sensor and sensor placement error.
Regarding Claim 50, Halac in view of Happy and Rao discloses as described above, The system of claim 48. For the remainder of Claim 50, Halac discloses wherein the antenna is configured to transmit the generated signals associated with the analyte level to a remote device having a display screen ([0187] “The ASIC 205…include…telemetry module 232 for transmitting data from the sensor electronics 112 to one or more devices, such as devices 114, 116, 118, and/or 120”; Fig 1, “display devices 114, 116, 118, and/or 120”; [0175]; [0178] “display device…configured to display…graphical representation of the sensor data including current and historic sensor data output by sensor system 100”; [0205])
Regarding Claim 51, Halac in view of Happy and Rao discloses as described above, The system of claim 50. For the remainder of Claim 51, Halac discloses as described above, wherein the remote device comprises a reader device, a mobile phone, or a wrist-mounted device (See citation in Claim 68 above)
Regarding Claim 52, Halac in view of Happy and Rao discloses as described above, The system of claim 48. For the remainder of Claim 52, Halac discloses as described above, wherein the flexible substrate comprises one of polyamide or polyethylene terephthalate (See citation above in Claim 70)
Regarding Claim 53, Halac in view of Happy and Rao discloses as described above, The system of claim 48. For the remainder of Claim 53, Halac discloses as described above, wherein the at least one working electrode is configured to sense at least one of lactate, glucose, or ketone (See citation above in Claim 8)
Regarding Claim 55, Halac in view of Happy and Rao discloses as described above, The system of claim 48. For the remainder of Claim 55, Halac discloses wherein the antenna (Fig 2, “ASIC 205”; [0173] “sensor electronics 112”; [0336]) comprises at least a Wi-Fi antenna ([0336] “…wireless technologies…WiFi”), NFC antenna ([0336] “…wireless technologies…NFC”), Bluetooth® antenna (Fig 2; [0190] “A variety of wireless radio technologies that can be implemented in the telemetry module 232 include Bluetooth”), Bluetooth Low Energy (BTLE) antenna ([0190] “…Bluetooth Low-Energy”), or GPS antenna.
Regarding Claim 56, Halac in view of Happy and Rao discloses as described above, The system of claim 48. For the remainder of Claim 56, Halac discloses as described above, wherein the plurality of electronic components are electrically coupled to the at least one working electrode and the reference electrode (See citation above in Claim 13).
Regarding Claim 57, Halac in view of Happy and Rao discloses as described above, The system of claim 48. For the remainder of Claim 57, Halac discloses as described above, wherein the ex vivo portion of the flexible substrate comprises a first layer (See citation above in Claim 71).
Regarding Claim 61, Halac in view of Happy and Rao discloses as described above, The system of claim 57. For the remainder of Claim 61, Halac discloses as described above, wherein the ex vivo portion of the flexible substrate further comprises a second layer (See citation above in Claim 75)
Regarding Claim 64, Halac in view of Happy and Rao discloses as described above, The system of claim 48. For the remainder of Claim 64, Halac discloses wherein the flexible substrate defines a neck interconnecting the ex vivo portion and the in vivo portion (Fig. 53A and 53B, narrow portion near the “4804” callout in Fig. 53A connecting the ex vivo “portion 4802” to the in vivo “sensor 138” portion), and wherein bending of the neck forms an angle between the ex vivo portion and (i) the in vivo portion (Fig. 53A and 53B, bend of that narrow portion forms a 90 degree angle between the ex vivo “portion 4802” and the in vivo “sensor 138” portion)
Halac does not disclose forms an angle between the ex vivo portion and (ii) the hook feature
Halac does broadly disclose that the neck bend aligns the sensor in a ‘through-hole 180” slot feature on the flexible substrate.(Fig. 53B).
Rao teaches wherein the flexible substrate defines a neck interconnecting the ex vivo portion and the in vivo portion ([0131] “ A neck… can be a zone which allows folding of the sensor, for example ninety degrees.”; Fig. 16B, neck near the 3104 call-out (similar to the “neck 2406” shown in Figs 14 and 15A and B) between in vivo “tail 2408” and ex vivo “contacts 2418”, etc.)(Examiner notes that the feature near the 3104 call-out appears to be such a “neck”), and wherein bending of the neck forms an angle between the ex vivo portion and (i) the in vivo portion (Fig. 16B, bend in neck near the 3104 call-out (similar to the “neck 2406” shown in Figs 14 and 15A and B) with 90 degree angle relative to the in vivo portion; [0131] “ A neck… can be a zone which allows folding of the sensor, for example ninety degrees.”)(Examiner notes that the feature near the 3104 call-out appears to be such a “neck”) and (ii) the hook feature (Fig. 16B, bend in neck near the 3104 call-out (similar to the “neck 2406” shown in Figs 14 and 15A and B) with 90 degree angle relative to the “hook feature 3106”; [0131] “ A neck… can be a zone which allows folding of the sensor, for example ninety degrees.”)(Examiner notes that the feature near the 3104 call-out appears to be such a “neck”).
Halac and Rao both disclose neck features on a flexible substrate that allow for the in vivo portion to be located at an angle relative to the ex vivo portion: Halac with the neck portion of Fig. 53A and 53B, and Rao with the “neck 2406” ” between in vivo “tail 2408” and ex vivo “contacts 2418” of Fig. 14. Rao provides a motivation to combine at [0131] “ A neck 2406 can be a zone which allows folding of the sensor, for example ninety degrees…” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that a neck bend would be useful to align the in vivo sensor portion with a sharp slot (as with Halac’s through-hole slot 180 for the sharp) relative to the ex vivo portions of the flexible substrate (like the hook and catch in the combination of Halac and Rao).
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 combine the neck bend and through-hole sharp slot for the in vivo portion of the analyte sensor on a flexible substrate disclosed in Halac with Rao’s taught neck bend on a flexible substrate to align the in vivo portion of the analyte sensor with a sharp slot relative to an ex vivo section with a hook and catch thereon, creating a sensor system assembly that aligns its vivo sensor portion with a sharp slot using a flexible substrate, hook and catch, and neck bend, for consistent positioning on the user.
Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over Halac in view of Happy and Rao, further in view of O’Driscoll et. al., (US 2021/0135344 A1).
Regarding Claim 54, Halac in view of Happy and Rao discloses as described above, The system of claim 48. For the remainder of Claim 54, Halac discloses wherein the analyte sensor (Overall Figure 2, used to sense an analyte; [0169] “an analyte sensor attached to a sensor carrier”; [0321] “Carrier 5800 may include circuitry 5806 ( e.g., one or more processors and/or memory) configured to communicate with sensors 138 and/or external computing equipment.)(Examiner notes that these structures together are collectively used as an analyte sensor”) further comprises having at least one additional antenna ([0321] “Circuitry 5806 may include communications circuitry such as one or more antennas for transmitting and/or receiving data from external equipment”) Halac broadly discloses where there could be a second substrate, as there is disclosed “external equipment” with an antenna to receive the data from the circuitry 5806.
For a more specific teaching of the limitation, O’Driscoll teaches wearable analyte sensor with two antennas that are each mounted to a different substrate surface of the wearable device (Fig. 1, Fig. 3, [0026]; [0041]; [0050] – [0055]). Specifically for Claim 54, O’Driscoll teaches wherein the analyte sensor ([0026] “biosensor 104…an analyte sensor, glucose sensor…”; Fig. 1) further comprises a second substrate having at least one additional antenna (Fig. 1., Fig. 3, “current-carrying antenna 112” and “scatterer antenna 114”; [0041] “the current-carrying antenna 112 is electrically and physically connected to the PCB 108 and the scatterer antenna 114 is physically connected to the second housing portion 102B…”; [0050] “…first housing portion may include a substrate…physically connected a first communications antenna….”; [0055] “second communications antenna…in a dielectric substrate...”)
O’Driscoll provides a motivation to combine at [0020] with Additionally, because the scatterer antenna is supported by the lid instead of being mounted to the printed circuit board in the bottom, space on the printed circuit board and within the device housing is conserved.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that mounting a second antenna on a different surface in the device would be useful for space-saving purposes for the arrangement of parts.
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 combine the “one or more antenna” in the analyte measurement device broadly disclosed by Halac with the two antennas (scatterer and current-carrying) attached on two different substrates within a wearable analyte sensor as taught by O-Driscoll, creating a single analyte sensor device with two antennas attached to different substrates to save space within the analyte sensing device on the primary printed circuit board.
Claims 58 – 59 and 62 are rejected under 35 U.S.C. 103 as being unpatentable over Halac in view of Happy and Rao, as evidenced by Shapiro of Vinatronic Inc, “PCB FR4: Which Material is Right for Your Project?”.
Regarding Claim 58, Halac in view of Happy and Rao discloses as described above, The system of claim 57. For the remainder of Claim 58, Halac discloses as described above, wherein the first layer comprises a gradient mix of materials (See citation in Claim 72 above.)
Regarding Claim 59, Halac in view of Happy and Rao discloses as described above, The system of claim 58. For the remainder of Claim 59, Halac discloses as described above, wherein the gradient mix of materials comprises fiberglass (See citation in Claim 73 above.)
Regarding Claim 62, Halac in view of Happy and Rao discloses as described above, The system of claim 19. For the remainder of Claim 62, Halac discloses as described above, wherein each of the first layer and the second layer comprise a gradient mix of materials (See citation in Claim 76 above.)
Claim 60 is rejected under 35 U.S.C. 103 as being unpatentable over Halac in view of Happy and Rao as evidenced by Vinatronic Inc., further in view of Brister et. al., (United States Patent Application Publication US 2006/0020187 A1).
Regarding Claim 60, Halac in view of Happy and Rao discloses as described above, The system of claim 58. For the remainder of Claim 60, Halac in view of Happy and Rao, as evidenced by Vinatronic Inc. does not disclose wherein the in vivo portion of the flexible substrate comprises polyethylene terephthalate (PET)
Brister teaches the in vivo portion of the flexible substrate comprises PET ([0108] “the sensor 32 includes a distal portion 42, also referred to as the in vivo portion, adapted to extend out of the mounting unit for insertion under the host’s skin”; [0165] “the distal portion 42 includes a porous material disposed over some portion thereof…Suitable porous materials include…polyester”)
The motivation for Claim 60 to combine Halac with Brister is the same as that described in more detail above in Claim 74. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the analyte sensor with a distal in vivo portion with sensors disclosed in Halac with the porous material disposed over the distal in vivo portion with sensors taught by Brister, creating a single analyte sensor for percutaneous measurements that performs with greater longevity and accuracy.
Response to Arguments
Applicant's arguments filed 04 May 2026 have been fully considered but they are not persuasive.
35 U.S.C. 102 Rejections:
Applicant argues at [Page 12, “35 USC 102 Rejections” Section] – [Page 13, 1st Full Paragraph] that for the amended Claim 1, Halac does not teach of suggest the presently recited configuration including any structure of the sensor substrate that engages or interacts with a needle of an applicator to perform biasing functions. Based on the amendment, a new grounds of rejection has been applied to Claim 1 under 35 U.S.C. 103 with the combination of Halac and Rao. The argument is not persuasive.
35 U.S.C. 103 Rejections:
Applicant argues at [Page 13, “35 USC 103 Rejections” Section, Paragraphs 1 – 2] that the 35 U.S.C. 103 rejections of claims 4, 7, 9, 12, and 17 are rendered moot by the amendments to independent claim 1 due to their dependency on Claim 1. Based on the amendment, a new grounds of rejection has been applied to Claim 1 under 35 U.S.C. 103 with the combination of Halac and Rao. The argument is not persuasive.
Applicant argues at [Page 13, “35 USC 103 Rejections” Section, Paragraph 3 - 4] and that Halac, Happy, and Donnay do not teach or suggest the presently recited configuration including photonic soldering and a hook feature defined by the substrate configured to engage a catch feature of a sensor module of the on-body sensor assembly. Halac is combined with Halac to teach photonic soldering. Based on the amendment regarding the hook and catch features, a new grounds of rejection has been applied to Claim 1 under 35 U.S.C. 103 with the combination of Halac and Rao. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The argument is not persuasive.
Applicant argues at [Page 13, “35 USC 103 Rejections” Section, Paragraph 5] that Halac in view of Happy and Donnay does not teach the presently recited configuration because Halac discloses photonic soldering generally, but does not describe analyte sensors or the mounting of electronic components on a flexible analyte sensor substrate. Looking to the list of advantages at the list of advantages at [Page 4, Bottom, “Summary” Section”] – [Page 5, Top, “Summary” Section] “This new soldering process can accommodate a substrate…” of “PET, TPU, PVC, PPE, PEI, PVF, PEN, etc.,”, “works equally as well with FR-4 and other traditional boards but with a smaller footprint”. As cited above, Happy teaches that photonic soldering “…was developed as part of enhancing the manufacturability of flexible hybrid electronics (FHE) by sintering metal particle-based inks into conductive traces.” Further, FR-4 is a material that is used a substrate material disclosed for the analyte sensor in Halac. The photonic soldering itself is not sensing the analytes. The photonic soldering taught by Happy is used to attach electronic elements to the substrate into their final positions, and the programming of the electronics themselves once aligned would be what is used for the particular application to detect analytes. The argument is not persuasive.
Applicant argues at [Page 13, “35 USC 103 Rejections” Section, Paragraph 5] that Donnay is cited for applicator features and does not address mounting electronic components on a substrate or the recited hook feature. Based on the amendments, Donnay is no longer relied upon for teaching in the 35 U.S.C. 103 rejections above. The argument is moot. .
Applicant argues at [Page 14, Paragraph 1] that none of the cited references teaches or suggests a hook feature…configured to engage a catch feature, or any substrate-defined mechanical engagement structure between the sensor and the on-body sensor assembly. Based on the amendment, a new grounds of rejection has been applied the claims regarding the hook and catch feature under 35 U.S.C. 103 with the combination of Halac and Rao. The argument is not persuasive.
Applicant argues at [Page 14, Paragraph 2 – 3] that the new claims 63 – 65 have been added to further define the structural aspects of the flexible substrate and are not described or suggested by the previously-cited references. Looking to the 35 U.S.C. 103 rejection above, newly-applied rejections have been made using Halac in combination with Rao per the addition of these claims. The argument is not persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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 MELISSA J MONTGOMERY whose telephone number is (571)272-2305. The examiner can normally be reached Monday - Friday 7:30 - 5:00 ET.
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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/JUSTIN XU/Primary Examiner, Art Unit 3791
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