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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 16 January 2026 has been entered. Claim 18 is currently amended, and claim 49 is new. Claims 1-10, 12, 14-20, 24-27, 31, 34-36, and 39-49 are pending in the application, with claims 39-48 withdrawn.
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.
Claims 1-6, 9-10, 15, 17-20, 24, 27, 31, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Pesantez et al. (US PGPub No. 2014/0163346), hereinafter Pesantez, in view of Tsukada et al. (US PGPub No. 2014/0303470), hereinafter Tsukada.
Regarding claim 1, Pesantez teaches a component, comprising: one or more sensors (Fig. 2: sensor 100), a sensor comprising an electrically conductive layer disposed on a substrate having an upper surface (Fig. 2: conductive layer 104, base layer 102; par. 0052: “a conductive layer 104 which is disposed on and/or combined with the base layer 102”); and an insulating material, the insulating material having an upper surface and a thickness (Fig. 2: cover layer 106), and the insulating material defining at least one aperture extending through the thickness of the insulating material, the at least one aperture being in register with a sensing location on the upper surface of the conductive layer of a sensor (Fig. 2 and par. 0052: “one or more exposed regions or apertures 108 can be made through the cover layer 106 to open the conductive layer 104 to the external environment and to, for example, allow an analyte such as glucose to permeate the layers of the sensor and be sensed by the sensing elements”).
Pesantez teaches wherein the conductive layer can be made using various techniques and materials (par. 0052: “the base layer 102 and/or conductive layer 104 can be generated using many known techniques and materials”) but does not explicitly teach wherein the conductive layer comprises a permeable substrate infused with an electrically conductive material. However, in an analogous art, Tsukada teaches the techniques of coating a substrate with conductive material and impregnating the substrate with conductive material as explicit alternatives for creating a conductor (par. 0035: “wherein a conductor containing a conductive polymer impregnates and/or adheres to base fibers”), and further that impregnating a substrate with conductive material has the advantage that the base material and conductive material have no risk of separation (par. 0093: “as the base fibers are impregnated with the conductor, there is no risk of separation between the conductor and the base fibers”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use Tsukada’s technique of impregnating conductive material within a permeable substrate to make the conductive layer of Pesantez’s sensor, in order to have no risk of separation between the base material and conductive material, as taught by Tsukada.
Regarding claim 2, the combination teaches the device of claim 1 as described previously. Tsukada further teaches wherein the electrically conductive material comprises a MXene material, graphene, graphene oxide, graphite, carbon black, a metal, a conductive polymer, or any combination thereof (par. 0035: “a conductor containing a conductive polymer impregnates and/or adheres to base fibers”).
Regarding claims 3-5, the combination teaches the device of claim 1 as described previously. Pesantez further teaches wherein at least two of the one or more sensors do not physically contact one another, wherein at least one sensor comprises a curved portion, and wherein at least some of the sensing locations of the one or more sensors define a periodic array that lies in a plane (Fig. 1: periodic array of circular sensor discs separated from one another).
Regarding claim 6, the combination teaches the device of claim 1 as described previously but does not explicitly teach wherein the sensing locations of the one or more sensors define a circle that lies in a plane. However, it would have been an obvious matter of design choice to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrange the sensor discs of the combined reference in a circle, since applicant has not disclosed that a circular array solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with a generally linear array as with a circular one.
Regarding claim 9, the combination teaches the device of claim 1 as described previously. Pesantez further teaches wherein at least two of the one or more sensors are individually electronically addressable (par. 0041: “the microarray electrodes can function as individually addressable working electrodes”).
Regarding claim 10, the combination teaches the device of claim 1 as described previously. Pesantez further teaches wherein a sensor of the one or more sensors is characterized as having a variable cross-sectional dimension (Fig. 2: insulating layer 106 and conductive layer 104 having a variable cross-sectional dimension, as broadly as claimed).
Regarding claim 15, the combination teaches the device of claim 1 as described previously. Tsukada further teaches wherein the permeable substrate comprises a porous material (par. 0093: “as the base fibers are impregnated with the conductor, there is no risk of separation between the conductor and the base fibers;” examiner notes that a degree of porosity must be present in the base fibers for impregnation to be possible).
Regarding claims 17-18, the combination teaches the device of claim 1 as described previously. Pesantez further teaches further comprising an electrocatalytic or biosensing element in electronic communication with the sensing location, the biosensing element comprising at least one of an enzyme, an aptamer, or an antibody (Fig. 2: analyte sensing layer 110; par. 0054: “an analyte sensing layer 110 is disposed on one or more of the exposed electrodes of the conductive layer 104. Typically, the analyte sensing layer 110 is an enzyme layer. Most typically, the analyte sensing layer 110 comprises an enzyme capable of producing and/or utilizing oxygen and/or hydrogen peroxide, for example the enzyme glucose oxidase”).
Regarding claim 19, the combination teaches the device of claim 1 as described previously. Pesantez further teaches wherein the component is configured for implantation into a subject (par. 0012: “implanting an analyte sensor having an electrode microarray within the mammal (e.g. in the interstitial space of a diabetic individual)”).
Regarding claim 20, the combination teaches the device of claim 1 as described previously. Pesantez further teaches a method comprising collecting a signal with a component according to claim 1 (par. 0032: “The sensor embodiments disclosed herein can use any known method, including invasive, minimally invasive, and non-invasive sensing techniques, to provide an output signal indicative of the concentration of the analyte of interest”).
Regarding claim 24, Pesantez teaches a method comprising providing a conductive layer (Fig. 2: conductive layer 104); disposing an electrically insulating material over the conductive layer, the electrically insulating material having an upper surface and defining a thickness; (par. 0053: “An electrically insulating cover layer 106 such as a polymer coating can be disposed on portions of the sensor 100”); and forming an opening through the thickness of the electrically insulating material, the opening being in register with a sensing location on the conductive layer (par. 0053: “one or more exposed regions or apertures 108 can be made through the cover layer 106 to open the conductive layer 104 to the external environment”).
Pesantez teaches wherein the conductive layer can be made using various techniques and materials (par. 0052: “the base layer 102 and/or conductive layer 104 can be generated using many known techniques and materials”) but does not explicitly teach wherein the conductive layer is made by infusing a fluid that comprises a carrier and a conductive material into a permeable substrate portion, and then removing at least some of the carrier, the infusing and removing being carried out under such conditions that the conductive material renders the permeable substrate conductive. However, Tsukada teaches impregnating a substrate with conductive material by infusing a fluid that comprises a carrier and a conductive material into a permeable substrate portion, and then removing at least some of the carrier (par. 0255: “an aqueous solution containing conductive polymer (e.g., a commercial PEDOT-PSS solution (Heraeus, Ltd.: CLEVIOS P)) is made to adhere to the surface of the base fiber 11 in a solution bath. Thereafter, or after uniformly applying the aforementioned solution to the surface of the base fiber 11 using a roller or a brush, a portion of the moisture contained in the aforementioned solution is removed by drying”), and further that impregnating a substrate with conductive material has the advantage that the base material and conductive material have no risk of separation (par. 0093: “as the base fibers are impregnated with the conductor, there is no risk of separation between the conductor and the base fibers”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use Tsukada’s technique of impregnating conductive material within a permeable substrate (including the disclosed steps of infusing and drying) to make the conductive layer of Pesantez’s sensor, in order to have no risk of separation between the base material and conductive material, as taught by Tsukada.
Regarding claim 27, the combination teaches the method of claim 24 as described previously. Tsukada further teaches wherein the conductive material is characterized as being hydrophilic (par. 0035: “A conductive polymer fiber of the first aspect of the present invention is a fiber, wherein a conductor containing a conductive polymer impregnates and/or adheres to base fibers, and the aforementioned conductive polymer is PEDOT-PSS;” examiner notes that polystyrene sulfonate [PSS] is hydrophilic).
Regarding claim 31, the combination teaches the method of claim 24 as described previously. Pesantez further teaches wherein the electrically insulating material comprises a polymer (par. 0053: “An electrically insulating cover layer 106 such as a polymer coating can be disposed on portions of the sensor 100. Acceptable polymer coatings for use as the insulating protective cover layer 106 can include, but are not limited to, non-toxic biocompatible polymers such as silicone compounds, polyimides, biocompatible solder masks, epoxy acrylate copolymers, or the like”).
Regarding claim 34, the combination teaches the method of claim 24 as described previously. Tsukada further teaches the limitations of claim 34 for the same reasons set forth previously in the rejection of claim 2.
Claims 7-8 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Pesantez in view of Tsukada and further in view of Vörös et al. (US PGPub No. 2013/0303873), hereinafter Vörös.
Pesantez in view of Tsukada teaches the device of claim 1 and the method of claim 24 as described previously, but does not explicitly teach further comprising a conductive extension contacting and extending from the sensing location of a sensor through the aperture of the insulating material so as to extend beyond the upper surface of the insulating material, wherein the conductive extension comprises the electrically conductive material.
However, in an analogous art, Vörös teaches a flexible implantable electrode comprising a conductive extension contacting and extending from the sensing location of a sensor, wherein the conductive extension comprises the electrically conductive material (Fig. 6: conductive PDMS extension 34 contacting and extending from base portion of cPDMS), through an aperture of an insulating material so as to extend beyond the upper surface of the insulating material (Fig. 6: cPDMS extension 34 and Ti/Pt-Ir layers 44, 55 extending beyond surface of insulating PDMS layer 33). Vörös teaches that the disclosed configuration is able to transmit signals under high mechanical stress (par. 0019). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the component of the combined reference by providing the conductive extension of Voros at the sensing location, in order to be capable of transmitting signals under high mechanical stress, as taught by Vörös.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Pesantez in view of Tsukada and further in view of Komatsu et al. (US PGPub No. 2020/0187803), hereinafter Komatsu.
Pesantez in view of Tsukada teaches the device of claim 1 as described previously. The combination does not explicitly teach wherein the permeable substrate is a woven textile. However, in an analogous art, Komatsu teaches a permeable substrate material for an electrode comprising a woven textile (par. 0138: “it is preferable that the conductive fabric used for the electrode be a woven or knitted fabric”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the permeable substrate of the combined reference for the woven fabric of Komatsu, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Claims 14, 25-26, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Pesantez in view of Tsukada and further in view of Costella et al. (US PGPub No. 2022/0151530), hereinafter Costella.
Regarding claims 14 and 35, Pesantez in view of Tsukada teaches the device of claim 1 as described previously. The combination does not explicitly teach wherein the permeable substrate comprises a non-woven textile, or wherein the permeable substrate portion comprises cellulose, polyester, or any combination thereof. However, in an analogous art, Costella teaches an implantable sensor using a non-woven textile substrate comprising cellulose (par. 0017: “nanofibers formed of cellulose acetate;” par. 0018: “The flexible electrodes disclosed herein may be formed by electrospinning a substrate layer comprised of a nonwoven mass of polymeric nanofibers”), which allows for better mechanical matching with tissue (par. 0048: “nanofibers as a flexible substrate for patterning conductive traces. Such embodiments therefore enable better mechanical matching of biological tissue properties”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of the combined reference by using a non-woven textile comprising cellulose for the permeable substrate, as taught by Costella, to allow for better mechanical matching with tissue, as taught by Costella.
Regarding claim 25, Pesantez in view of Tsukada teaches the method of claim 24 as described previously, but the combination does not explicitly teach further patterning the permeable substrate portion from a larger portion of the permeable substrate. However, Costella teaches patterning a permeable substrate portion from a larger portion of the permeable substrate as a known technique for forming sensors (Fig. 5, step 8: pattern in final electrode shape; par. 0018: “The final shape of the electrode may then be formed by removing excess material”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the known technique taught by Costella to the method of the combined reference, since one of ordinary skill in the art would have recognized that patterning the substrate of the combined reference would have yielded predictable results and resulted in an improved method, namely, a method that allows for the final shape of the sensor to be formed after other manufacturing steps that can be more easily performed with an unshaped substrate.
Regarding claim 26, the combination teaches the method of claim 25 as described previously. Costella is silent with respect to the means of patterning the final electrode shape and thus does not explicitly teach wherein the patterning comprises laser cutting, mechanical cutting, mechanical etching, chemical etching, or any combination thereof. However, Costella teaches mechanical cutting and chemical etching as techniques for patterning other parts of the electrode (par. 0081: “samples were cut using an 8.45 mm wide cutting die” and par. 0076: “wet chemical etching was used to transfer the pattern from the photoresist to the metal coating”), and it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use one of these disclosed patterning methods for patterning the final electrode, because there were a finite number of available solutions known in the art for patterning an electrode shape, and it would have been obvious to try laser cutting, mechanical cutting, mechanical etching, chemical etching, or any combination thereof.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Pesantez in view of Tsukada and further in view of Holder et al. (US PGPub No. 2018/0092560), hereinafter Holder.
Pesantez in view of Tsukada teaches the component of claim 1 but does not explicitly teach further comprising a sealant conformally disposed on the insulating material. However, in an analogous art, Holder teaches that electrical conductors may be insulated using one or more insulator layers (par. 0047: “Typically, the electrical conductors will be insulated using one or more insulator layers, preferably also of an elastomeric material, and the electrodes may be formed by exposing conductive material, for example the above-mentioned metal foil or another conductor layer, through apertures in these one or more layers”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the component of the combined reference by providing another layer of insulation (interpreted to be a sealant, as broadly as claimed) on the insulating material, as suggested by Holder, since Holder teaches that providing multiple layers of insulation is known in the bioelectrode art, and since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Pesantez in view of Tsukada and further in view of Vetter et al. (US PGPub No. 2008/0208283), hereinafter Vetter.
Pesantez in view of Tsukada teaches the device of claim 1 as described previously. The combination does not explicitly teach further comprising an amount of the insulating material at least partially infused into the permeable substrate. However, in an analogous art, Vetter teaches allowing an upper insulating layer to partially infuse into a substrate in order to facilitate adhesion between the layers (par. 0038: “To facilitate adhesion between the silicone and polymer, small non-homogeneous perforations are preferably micromachined in the polymer substrate to allow for liquid silicone to flow into and form a robust anchor after being cured”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of the combined reference by allowing the upper insulating layer to partially infuse into the permeable substrate, as taught by Vetter, in order to facilitate adhesion between the layers, as taught by Vetter.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794