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 05/20/2026. As directed by the amendment: Claims 1-2 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 Claims 5-8, 11-13, and 17-18 were previously withdrawn due to a Restriction Requirement.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 pages 1-3, filed 05/20/2026, with respect to the rejection(s) of the claim(s) under 35 U.S.C. 103 have been fully considered and are persuasive. Applicant argues on page 2 that “Accordingly, Brister's reference electrode 46, whether wound around working electrode 44 or placed in its "on-skin" alternative position, is an integral component of the same implanted sensor system. Moreover, the reference electrode of Brister, in any configuration, is associated with the transcutaneous sensor probe. Even the "on-skin reference electrode" alternative from paragraph [0306] of Brister refers to an electrode near the skin insertion point of the probe… Even accepting the theory that thee on-skin reference electrode of Brister would naturally be placed on the bottom surface 150 of Biederman, the result would be an electrode at or near the skin insertion site of the sensor probe 120 of Biederman, rather than the structurally independent, explicitly non-penetrating electrode positioned on the bottom surface of the housing at a location separate and spaced apart from the implantable sensor probe 120 of Biederman, as required by the amended independent claim.”.
Although the on-skin electrode configuration of Brisker means that the paired electrode is not inserted, but on the skin, as noted by the Applicant, Brister does not specify the location of the on-skin electrode. Applicant asserts that the on-skin electrode is near the skin insertion point of the probe, however, this cannot be extrapolated from Brister because Brister makes not reference regarding the length/distance from the inserted needle. Nevertheless, 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 Therefore, the rejection has been withdrawn.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 Bhavaraju et al. (US 20140005509)(Hereinafter Bhavaraju).
Claim Objections
Claim 15 is objected to because of the following informalities: the phrase “of electrodes” of line 3 should be amended to recite “of electrodes”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 4, it is unclear if the “skin-contact surface” of line 2 and 3 is the same or different than the “skin-contact surface” of claim 1 line 5.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-4, 9-10, 14, 16, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bhavaraju et al. (US 20140005509)(Hereinafter Bhavaraju).
Regarding claim 1, Bhavaraju teaches A biosensor assembly (Fig. 7 Abstract “continuous analyte sensor”), comprising:
a first implantable probe having a plurality of electrodes, the first implantable probe configured to be inserted through skin of a subject to position at least a portion of the plurality of electrodes within subcutaneous tissue of the subject (Fig. 7(704,706 electrodes) [0110] “an in vivo portion [implantable probe] of a transcutaneous sensor is a portion of the sensor that is inserted through the host's skin and resides within the host.” [0194] “working and reference electrodes 704, 706 can extend from the bottom surface of the housing 702 and into the patient's skin.”);
a first skin contactable electrode being located on a skin-contact surface of a bottom surface of the biosensor assembly, and being separate and spaced apart from the first implantable probe, the first skin contactable electrode configured to contact skin of the subject without penetrating the skin ([0194] “electrodes can be arranged in any concentric polygon shape, or electrodes on the skin surface can be arranged as discs placed linearly along any axis relative to the sensor, as shown in FIG. 7. As shown, a plurality of linearly placed electrodes 700 are spaced along the bottom surface of the housing 702, and working and reference electrodes 704, 706 can extend from the bottom surface of the housing 702 and into the patient's skin.” Examiner notes that Fig. 7 shows electrodes 700 being separate and spaced apart from the first implantable probe and its electrodes 704 and 706.); and
an electronics module configured to measure a first physiological parameter is between the first implantable probe and the first skin contactable electrode ([0195] “the additional electrode(s) can be activated so that an impedance measurement can be made between two electrodes, e.g., one of the electrodes on the housing and in contact with the skin surface and one of the subcutaneous sensing electrodes, or two subcutaneous electrodes, or two electrodes on the skin surface. In some embodiments, one or more sensor systems can be configured to measure impedance values, and a processing module can be configured to compare the one or more impedance values to normal or expected impedance values… the processing module [electronics module] can be further configured to process the data streams to identify a physiological condition” [0175] “Physiological conditions can be identified by considering any of a variety of in vivo properties and measured parameters, such as, for example: 1) measuring H.sub.2O.sub.2; 2) measuring a constant analyte; 3) measuring impedance; 4) measuring pH; 5) measuring values at two separate electrodes; 6) analyzing processing signals; 7) evaluating T.sub.90; 8) analyzing two sensors with different sensitivities; 9) measuring oxygen; and/or 10) measuring reference potential.”).
Regarding claim 2, Bhavaraju 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 ([0195] “the additional electrode(s) can be activated so that an impedance measurement can be made between two electrodes, e.g., one of the electrodes on the housing and in contact with the skin surface and one of the subcutaneous sensing electrodes, or two subcutaneous electrodes, or two electrodes on the skin surface. In some embodiments, one or more sensor systems can be configured to measure impedance values, and a processing module can be configured to compare the one or more impedance values to normal or expected impedance values… the processing module [electronics module] can be further configured to process the data streams to identify a physiological condition”” [0175] “Physiological conditions can be identified by considering any of a variety of in vivo properties and measured parameters, such as, for example: 1) measuring H.sub.2O.sub.2; 2) measuring a constant analyte; 3) measuring impedance; 4) measuring pH; 5) measuring values at two separate electrodes; 6) analyzing processing signals; 7) evaluating T.sub.90; 8) analyzing two sensors with different sensitivities; 9) measuring oxygen; and/or 10) measuring reference potential.”).
Regarding claim 3, Bhavaraju teaches wherein the first implantable probe is configured to measure a third physiological parameter independent of the first skin contactable electrode ([0195] “the additional electrode(s) can be activated so that an impedance measurement can be made between two electrodes, e.g., one of the electrodes on the housing and in contact with the skin surface and one of the subcutaneous sensing electrodes, or two subcutaneous electrodes, or two electrodes on the skin surface. In some embodiments, one or more sensor systems can be configured to measure impedance values, and a processing module can be configured to compare the one or more impedance values to normal or expected impedance values… the processing module [electronics module] can be further configured to process the data streams to identify a physiological condition”” [0175] “Physiological conditions can be identified by considering any of a variety of in vivo properties and measured parameters, such as, for example: 1) measuring H.sub.2O.sub.2; 2) measuring a constant analyte; 3) measuring impedance; 4) measuring pH; 5) measuring values at two separate electrodes; 6) analyzing processing signals; 7) evaluating T.sub.90; 8) analyzing two sensors with different sensitivities; 9) measuring oxygen; and/or 10) measuring reference potential.”).
Regarding claim 4, Bhavaraju 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 ([0195] “the additional electrode(s) can be activated so that an impedance measurement can be made between two electrodes, e.g., one of the electrodes on the housing and in contact with the skin surface and one of the subcutaneous sensing electrodes, or two subcutaneous electrodes, or two electrodes on the skin surface. In some embodiments, one or more sensor systems can be configured to measure impedance values, and a processing module can be configured to compare the one or more impedance values to normal or expected impedance values… the processing module [electronics module] can be further configured to process the data streams to identify a physiological condition”” [0093] “refers without limitation to the period in which monitoring of plasma glucose concentration is continuously or continually [periodic] performed, for example, at time intervals ranging from fractions of a second up to, for example, 1, 2, or 5 minutes, or longer.”).
Regarding claim 9, Bhavaraju teaches wherein the first implantable probe is configured to measure at least one physiological parameter independent of the first skin contactable electrode ([0195] “the additional electrode(s) can be activated so that an impedance measurement can be made between two electrodes, e.g., one of the electrodes on the housing and in contact with the skin surface and one of the subcutaneous sensing electrodes, or two subcutaneous electrodes, or two electrodes on the skin surface. In some embodiments, one or more sensor systems can be configured to measure impedance values, and a processing module can be configured to compare the one or more impedance values to normal or expected impedance values… the processing module [electronics module] can be further configured to process the data streams to identify a physiological condition”” [0175] “Physiological conditions can be identified by considering any of a variety of in vivo properties and measured parameters, such as, for example: 1) measuring H.sub.2O.sub.2; 2) measuring a constant analyte; 3) measuring impedance; 4) measuring pH; 5) measuring values at two separate electrodes; 6) analyzing processing signals; 7) evaluating T.sub.90; 8) analyzing two sensors with different sensitivities; 9) measuring oxygen; and/or 10) measuring reference potential.”).
Regarding claim 10, Bhavaraju teaches wherein the first implantable probe is configured to measure a first plurality of physiological parameters independent of the first skin contactable electrode ([0195] “the additional electrode(s) can be activated so that an impedance measurement can be made between two electrodes, e.g., one of the electrodes on the housing and in contact with the skin surface and one of the subcutaneous sensing electrodes, or two subcutaneous electrodes, or two electrodes on the skin surface. In some embodiments, one or more sensor systems can be configured to measure impedance values, and a processing module can be configured to compare the one or more impedance values to normal or expected impedance values… the processing module [electronics module] can be further configured to process the data streams to identify a physiological condition”” [0175] “Physiological conditions can be identified by considering any of a variety of in vivo properties and measured parameters, such as, for example: 1) measuring H.sub.2O.sub.2; 2) measuring a constant analyte; 3) measuring impedance; 4) measuring pH; 5) measuring values at two separate electrodes; 6) analyzing processing signals; 7) evaluating T.sub.90; 8) analyzing two sensors with different sensitivities; 9) measuring oxygen; and/or 10) measuring reference potential.”).
Regarding claim 14, Bhavaraju teaches wherein the plurality of the electrodes of first implantable probe electrodes are distributed on both an A-side and a B-side thereof (Fig. 12 see left (A) side electrode and right (B) side electrode. [0169] “Windows 1202' can be formed by removing a cut portion (i.e., a cut that does not correspond to 360 degrees around the perimeter of the elongated body) of the conductive layer 1214 and a portion of the insulating layer 1204, thereby exposing electroactive surfaces of elongated body E. All the working electrodes 1202' and 1202 share a common electrical connection.”).
Regarding claim 16, Bhavaraju 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 ([0168] “If that specific region is near a single working electrode, and that sensor only has that single working electrode for measuring glucose, then measurements may be inaccurate. To overcome this, in some embodiments, sensors are designed with single or a plurality of electrodes, with each electrode comprising a plurality of working electrodes (e.g., exposed through windows).” [0195] “the additional electrode(s) can be activated so that an impedance measurement can be made between two electrodes, e.g., one of the electrodes on the housing and in contact with the skin surface and one of the subcutaneous sensing electrodes, or two subcutaneous electrodes, or two electrodes on the skin surface. In some embodiments, one or more sensor systems can be configured to measure impedance values, and a processing module can be configured to compare the one or more impedance values to normal or expected impedance values… the processing module [electronics module] can be further configured to process the data streams to identify a physiological condition””).
Regarding claim 19, Bhavaraju teaches wherein the first implantable probe projects from the skin-contact surface (Fig. 7 shows electrodes for the in vivo portion projecting from the device, which can be seen in Fig. 2, 3A-C.).
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) 15 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bhavaraju et al. (US 20140005509)(Hereinafter Bhavaraju).
Regarding claim 15, Bhavaraju 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 ([0191] “In some embodiments, through use of impedance measurements, e.g., impedance measurements between the bottom surface of the sensor housing 602, 702 (skin surface) and the tip of the sensor 606, 706--individual patient physiologic information may be provided to an algorithm used to calculate analyte concentration.” [0195] “the additional electrode(s) can be activated so that an impedance measurement can be made between two electrodes, e.g., one of the electrodes on the housing and in contact with the skin surface and one of the subcutaneous sensing electrodes, or two subcutaneous electrodes, or two electrodes on the skin surface. In some embodiments, one or more sensor systems can be configured to measure impedance values, and a processing module can be configured to compare the one or more impedance values to normal or expected impedance values… the processing module [electronics module] can be further configured to process the data streams to identify a physiological condition””).
However, Bhavaraju does not teach 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. Although Bhavaraju teaches the multiple measurements of impedance values from a single working electrode on the probe ([0191]), using multiple working electrodes on the probe to measure impedances and inputting into the algorithm would allow to improve the reliability of the data ([0191]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention 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, for the purpose of improving the reliability of the data, since it has been held to be within the general skill of a worker in the art to select multiple known electrodes 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 20, Bhavaraju teaches wherein:
the first implantable probe is disposed on a first lengthwise half of the skin-contacting surface (Figs. 7 (704, 706)); and
the first skin contactable electrode is disposed on a second lengthwise half of the skin-contact surface (Fig. 7(700) where the surface electrodes can be found on both sides of the lengthwise half of the skin-contact surface.).
However, Bhavaraju fails to teach the first implantable probe is disposed on a first lengthwise half of the skin-contacting surface. Duval teaches the implantable probe in the center of the skin-contacting surface, and the skin contactable electrode on both sides of the probe (Fig. 6-7) and that the probe can be rearranged for one of the electrodes to optimize the measurement of data based on the position ([0193]). It would have been obvious to one having ordinary skill in the art at before the effective filing date of the claimed invention to dispose the probe on a first lengthwise half of the skin-contacting surface, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Conclusion
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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/MOUSSA HADDAD/Examiner, Art Unit 3796
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