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
This Office Action is responsive to the amendment filed on 11/11/2025. As directed by the amendment: Claims 1, 14-16, and 19 have been amended, no claims have been cancelled, and no claims have been added. Claims 5-8, 11-13, and 17-18 were previously withdrawn due to a Restriction Requirement. Thus, claims 1-4, 9-10, 14-16, and 19-20 are presently under consideration in this application.
Response to Arguments
Applicant’s arguments, see page 6, filed 11/11/2025, with respect to 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of the claim has been withdrawn.
Applicant’s arguments, see pages 6-8, filed 11/11/2025, with respect to the rejection(s) of the claim(s) under 35 U.S.C. 102 have been fully considered and are persuasive. Amendments to the claim obviate the rejection of record. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Biederman et al. (US 20170027514)(Hereinafter Biederman) in view of Brister et al. (US 20070197889)(Hereinafter Brister).
Terminal Disclaimer
The terminal disclaimer for 11529053 filed on 11/11/2025 disclaiming the terminal portion of any patent granted on this application has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-4, 9-10, 14-16, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biederman et al. (US 20170027514)(Hereinafter Biederman) in view of Brister et al. (US 20070197889)(Hereinafter Brister).
Regarding claim 1, Biederman teaches A biosensor assembly (Fig. 1A-C), comprising:
a first implantable probe having a plurality of electrodes (Fig. 1A-C(125) [0077] “the sensor probe 120 to penetrate the skin and dispose the analyte sensor 125 and/or other elements disposed on the sensor probe 120 in contact with interstitial or other fluids within the skin.” [0073] “the sensor probe 120 could have one or more dimensions specified to provide sufficient area for electrodes or other elements disposed on the sensor probe 120, to minimally interfere with the skin”);
a first skin contactable electrode being located on a skin-contact surface of a bottom surface of the biosensor assembly ([0079] “a particular sensor probe of a body-mountable sensor platform could include a plurality of sensors disposed along the length of the particular sensor probe to allow for detection of some property of skin (e.g., a concentration of an analyte within the skin) at a variety of depths within the skin. A body-mountable sensor platform could include more than one sensor probe and such sensor probes could have respective widths, lengths, thicknesses, sensors, sensor locations, or other properties.” [0085] “the traces 220a, 220b could provide antennas (e.g., loop antennas), electrodes of electrochemical sensors, electrodes of electrophysiological sensors (e.g., Galvanic skin response sensors, electromyogram sensors, skin conductivity sensors, electrocardiogram sensors)” Examiner notes that sensor probe (120/460) contains multiple sensors and impedance can be measured between 125 and the additional sensor, which the additional sensor must be an electrode because a concentration of analyte is detected, which requires an electrode to do this. Further, one of the sensors with the electrodes can be located on the proximal side of the probe, allowing the electrode to be skin contactable.); and
an electronics module configured to measure a first physiological parameter is between the first implantable probe and the first skin contactable electrode ([0079] “a particular sensor probe of a body-mountable sensor platform could include a plurality of sensors disposed along the length of the particular sensor probe to allow for detection of some property of skin (e.g., a concentration of an analyte within the skin) at a variety of depths within the skin. A body-mountable sensor platform could include more than one sensor probe and such sensor probes could have respective widths, lengths, thicknesses, sensors, sensor locations, or other properties.” [0136] “the sensor interface 452 can measure a magnitude of the potentiometric voltage between the working electrode and the reference electrode to provide an indication of analyte concentration [first physiological parameter]. In such embodiments, the sensor interface 452 can include a high-impedance voltmeter configured to measure the voltage difference between working and reference electrodes while substantially preventing the flow of current through the working and reference electrodes.” This can be done in electronics module 450, specifically sensor interface 452. Examiner notes that sensor probe (120/460) contains multiple sensors and impedance can be measured between 125 and the additional sensor (electrode), both on the probe, because determining a concentration of analyte requires the electrode at the variable length of the additional sensor, and the analyte sensor.).
Although Biederman teaches electrodes on the biosensor assembly (via traces [0085]), Biederman does not teach first skin contactable electrode being located on a skin-contact surface. Brister, in the same field of endeavor, teaches a device for measuring glucose (analyte sensor) via an implantable probe with electrodes (Abstract and Fig. 8B-D), and further electrode that is penetrated through the skin and an on-skin electrode ([0306]) to optimally measures glucose data ([0305]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Biederman, with the first skin contactable electrode being located on a skin-contact surface of Brister, because such a modification would allow to optimally measures glucose data.
However, Biederman and Brister do not teach the electrode on the bottom surface of the biosensor assembly. Brister teaches the working electrode can be on the skin ([0306]), and would be obvious to place under the biosensor device to optimize the location of obtaining the physiological parameter. Therefore, the combination of Biederman and Brister would provide a first skin contactable electrode being located on a skin-contact surface of a bottom surface of the biosensor assembly to optimize the location of obtaining the physiological parameter. It would have been obvious to one having ordinary skill in the art at before the effective filing date of the claimed invention to relocate the electrode, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 2, Biederman teaches wherein the first implantable probe is configured to be inserted through skin of a subject and to measure a second physiological parameter independent of the first skin contactable electrode ([0055] “change in the analyte concentration over time [second physiological parameter] (e.g., between a most-recent detected value of the analyte concentration and a second-most-recent detected value of the analyte concentration).”).
Regarding claim 3, Biederman teaches wherein the first implantable probe is configured to measure a third physiological parameter independent of the first skin contactable electrode ([0150] “many biomarkers [third physiological parameter] found in blood that are analyzed to characterize a person's health condition(s). For example, the interstitial fluid includes urea, glucose, calcium, sodium, cholesterol, potassium, phosphate, other biomarkers, etc.”).
Regarding claim 4, Biederman teaches wherein the first skin contactable electrode is positioned on a skin-contact surface of the biosensor assembly, such that placement of the skin-contact surface of the biosensor assembly against skin of a subject locates the first skin contactable electrode against the skin thereby enabling automated periodic measurements of the first physiological parameter ([0151] “the sensing platform 400 could operate to periodically operate the sensor 462 to detect an analyte and to store information related to the detection of the analyte in the memory 454.” [0086] “the flexible substrate 210 and traces 220a, 220b formed thereon can be composed of a variety of materials and formed by a variety of processes. For example, the flexible substrate 210 could be composed of polyimide, polyethylene terephthalate, or some other flexible polymeric or other material.” [0085] “the traces 220a, 220b could provide antennas (e.g., loop antennas), electrodes of electrochemical sensors, electrodes of electrophysiological sensors (e.g., Galvanic skin response sensors, electromyogram sensors, skin conductivity sensors, electrocardiogram sensors)” [0088] “The polymer substrate layer 245 is composed of a polymer material configured to be flexible (e.g., to allow the device 200 as a whole to conform to a skin or other tissue surface and to deform in response to deformation of such surfaces)”).
Regarding claim 9, Biederman teaches wherein the first implantable probe is configured to measure at least one physiological parameter independent of the first skin contactable electrode ([0150] “many biomarkers found in blood that are analyzed to characterize a person's health condition(s). For example, the interstitial fluid includes urea, glucose, calcium, sodium, cholesterol, potassium, phosphate, other biomarkers, etc [plurality of physiological parameters].”).
Regarding claim 10, Biederman teaches wherein the first implantable probe is configured to measure a first plurality of physiological parameters independent of the first skin contactable electrode ([0150] “many biomarkers found in blood that are analyzed to characterize a person's health condition(s). For example, the interstitial fluid includes urea, glucose, calcium, sodium, cholesterol, potassium, phosphate, other biomarkers, etc [plurality of physiological parameters].”).
Regarding claim 14, Biederman teaches wherein the plurality of the electrodes of first implantable probe electrodes are distributed on both an A-side and a B-side thereof ([0079] “a body-mountable sensor platform 100 having a single sensor probe 120 on a distal end of which a single analyte sensor 125 is disposed … A particular body-mountable sensing platform could include additional sensors disposed at different locations of the sensing platform (e.g., particular locations on a sensor probe). For example, a particular sensor probe of a body-mountable sensor platform could include a plurality of sensors disposed along the length of the particular sensor probe to allow for detection of some property of skin (e.g., a concentration of an analyte within the skin) at a variety of depths within the skin.” A-side can be the proximal side and the B-side can be the distal end as A and B side can refer to any side.).
However, Biederman does not teach electrodes distributed on both an A-side and a B-side. Although Biederman discloses a plurality of electrodes on the implantable probe ([0079]), the electrodes distributed on both an A-side and a B-side can also be used to optimize the location of data collection. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have electrodes distributed on both an A-side and a B-side, for the purpose of optimizing the location of data collection, since it has been held to be within the general skill of a worker in the art to select a known location on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 15, Biederman teaches wherein the electronics module is configured to measure the first physiological parameter between the first skin contactable electrode and both of at least one of the plurality of electrodes on the A-side and at least one of the plurality of electrodes being formed on the B-side of the first implantable probe ([0079] “Further, a body-mountable sensing platform could include sensors that are not disposed at a distal end or other locations on a sensor probe. For example, one or more sensors could be disposed on a flexible substrate (e.g., optical sensor 127 disposed on the bottom surface 150 of the flexible substrate 110) or other element(s) of such a body-mountable sensing platform.” [0136] “the sensor interface 452 can measure a magnitude of the potentiometric voltage between the working electrode and the reference electrode to provide an indication of analyte concentration [first physiological parameter]. In such embodiments, the sensor interface 452 can include a high-impedance voltmeter configured to measure the voltage difference between working and reference electrodes while substantially preventing the flow of current through the working and reference electrodes.” This can be done in electronics module 450, specifically sensor interface 452. Potentiometric sensor can be used as the analyte sensor along with the electrode traces 220 of electrochemical sensors. [0135] can be used the same way to detect the analyte.).
Although Biederman teaches electrodes on the biosensor assembly (via traces [0085]), Biederman does not teach first skin contactable electrode being located on a skin-contact surface. Brister, in the same field of endeavor, teaches a device for measuring glucose (analyte sensor) via an implantable probe with electrodes (Abstract and Fig. 8B-D), and further electrode that is penetrated through the skin and an on-skin electrode ([0306]) to optimally measures glucose data ([0305]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Biederman, with the first skin contactable electrode being located on a skin-contact surface of Brister, because such a modification would allow to optimally measures glucose data.
However, Biederman and Brister do not teach the electrode on the bottom surface of the biosensor assembly. Brister teaches the working electrode can be on the skin ([0306]), and would be obvious to place under the biosensor device to optimize the location of obtaining the physiological parameter. Therefore, the combination of Biederman and Brister would provide a first skin contactable electrode being located on a skin-contact surface of a bottom surface of the biosensor assembly to optimize the location of obtaining the physiological parameter. It would have been obvious to one having ordinary skill in the art at before the effective filing date of the claimed invention to relocate the electrode, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 16, Biederman teaches wherein the electronics module is configured to measure the first physiological parameter between the plurality of electrodes on either the A-side or the B-side of the first implantable probe and the first skin contactable electrode ([0079] “Further, a body-mountable sensing platform could include sensors that are not disposed at a distal end or other locations on a sensor probe. For example, one or more sensors could be disposed on a flexible substrate (e.g., optical sensor 127 disposed on the bottom surface 150 of the flexible substrate 110) or other element(s) of such a body-mountable sensing platform.” [0136] “the sensor interface 452 can measure a magnitude of the potentiometric voltage between the working electrode and the reference electrode to provide an indication of analyte concentration [first physiological parameter]. In such embodiments, the sensor interface 452 can include a high-impedance voltmeter configured to measure the voltage difference between working and reference electrodes while substantially preventing the flow of current through the working and reference electrodes.” This can be done in electronics module 450, specifically sensor interface 452. Potentiometric sensor can be used as the analyte sensor along with the electrode traces 220 of electrochemical sensors. [0135] can be used the same way to detect the analyte.).
Regarding claim 19, Biederman teaches wherein the first implantable probe projects from the skin-contact surface ([0088] “The polymer substrate layer 245 is composed of a polymer material configured to be flexible (e.g., to allow the device 200 as a whole to conform to a skin or other tissue surface” See Figs. 1A-C where 120 protrudes out of the housing.).
Regarding claim 20, Biederman teaches wherein:
the first implantable probe is disposed on a first lengthwise half of the skin-contacting surface (Figs. 1A-C (125) Examiner interprets the first lengthwise as the probe furthest/distal to the skin surface.); and
the first skin contactable electrode is disposed on a second lengthwise half of the skin-contact surface ([0079] “a particular sensor probe of a body-mountable sensor platform could include a plurality of sensors disposed along the length of the particular sensor probe to allow for detection of some property of skin (e.g., a concentration of an analyte within the skin) at a variety of depths within the skin. A body-mountable sensor platform could include more than one sensor probe and such sensor probes could have respective widths, lengths, thicknesses, sensors, sensor locations, or other properties.” Examiner notes that sensor probe (120/460) contains multiple sensors and impedance can be measured between 125 and the additional sensor, which the additional sensor must be an electrode because a concentration of analyte is detected, which requires an electrode to do this. Examiner interprets the first lengthwise as the probe closest/proximal to the skin surface.).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Wolfe (US 20110230735) See electrodes back to back. Jeong (US 20220257153) ([0080]).
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 MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796