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 .
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 1, 5, 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muthukumar et al. (US 2019/0250153 A1 – cited by Applicant), hereinafter MK, in view of Nackaerts et al. (US 2013/0328142 A1 – cited by Applicant), hereinafter Nackaerts further as evidenced by JEDEC (https://www.jedec.org/standards-documents/dictionary/terms/interconnect-layer; 2015 – cited by Applicant), further in view of Lucisano et al. (US 2013/0197332 A1 – cited by Applicant), hereinafter Lucisano.
Regarding Claim 1, MK teaches: A biocompatible medical device comprising: an electrochemical sensor (element 400) comprising: a single common reference electrode (element 130); a counter electrode adjacent the common reference electrode (element 140-1,140-2); a work electrode platform (substrate 210) comprising a plurality of respective work electrodes (elements 120-1 and 120-2), wherein each respective work electrode of the plurality of respective work electrodes is adjacent at least one other respective work electrode of the plurality of respective work electrodes (figure 4), wherein each respective work electrode of the plurality of respective work electrodes comprises a respective reagent substrate configured to react with a respective analyte to produce a respective signal indicative of a concentration of the respective analyte (paragraph 0174 - different capture reagents that are configured to selectively bind to the different target analytes).
MK does not mention and an interconnect layer electrically coupling the common reference electrode and the counter electrode to each respective work electrode of the plurality of respective work electrodes.
Nackaerts teach the use of interconnect/metal layers under electrodes of a sensor (paragraph 0010). Examiner further notes Nackaerts further teaches the interconnect layer connects the active elements in a circuit – i.e. between the electrode components in an electrochemical sensor (paragraph 0014; interconnecting the plurality of circuit elements). Examiner notes that it is further evidenced by Jedec that it is common knowledge that the interconnect layer connects active elements in a circuit (page 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device of MK to include an interconnect layer electrically coupling the common reference electrode and the counter electrode to each respective work electrode of the plurality of respective work electrodes in order to only allowing electrical communication via the interconnect layer to avoid any interference.
While MK teaches the use of any number of counter electrodes in any configuration (paragraph 0200), Mk in view of Nackaerts do not explicitly mention the use of a single common counter electrode. Lucisano teaches an implantable analyte sensor (abstract/title) that uses a single shared/common counter electrode (figure 4E; 0029; 0093). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the device of MK in view of Nackaerts to use a single common counter electrode in order to minimize the overall size of the device.
While MK mentions that the device can be configured to detect analytes in blood (paragraph 0180 – finger pricked blood) and further mentions the device to be wearable and transdermal with a housing (paragraph 0258-0260), Mk does not explicitly mention anything about biocompatibility of a housing configured for insertion.
Lucisano teaches the use of an implantable biocompatible, sealed housing to house all the components (paragraph 0012). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the device of MK in view of Nackaerts in view of Luciano to use a biocompatible housing configured for insertion through skin and into interstitial fluid of a patient to avoid incompatible interactions with a patient.
MK in view of Nackaerts in view of Lucisano do not mention wherein the work electrode platform is stacked on top of the common reference electrode and the common counter electrode within the housing. However, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention wherein the work electrode platform is stacked on top of the common reference electrode and the common counter electrode within the housing as it has been held that rearrangement of parts only takes routine skill in the art (See MPEP 2144.04). Examiner notes that Applicant has not showed evidence of criticality or unexpected results in relation to the order of the layers/stacks of components.
Regarding Claim 5, MK in view of Nackaerts in view of Lucisano teach: The biocompatible medical device of claim 1, wherein the interconnect layer comprises a first interconnect layer, but MK does not mention wherein the electrochemical sensor further comprises: a first dielectric substrate defining a first major surface, wherein the first interconnect layer is on at least a portion of the first major surface and defines a second major surface opposing the first major surface, and wherein the plurality of respective work electrodes are disposed on the second major surface; a second dielectric substrate defining a third major surface; and a second interconnect layer on at least a portion of the third major surface and defining a fourth major surface opposing the third major surface, wherein the common reference electrode and the common counter electrode are disposed on the fourth major surface, wherein the first interconnect layer is electrically coupled to the second interconnect layer, wherein the common counter electrode and the common reference electrode define a fifth major surface, and wherein the first dielectric substrate is disposed on the fifth major surface.
Nackaerts teaches multiple layers interconnect and dielectric layers stacked (paragraph 0032-42). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the invention to include herein the electrochemical sensor further comprises: a first dielectric substrate defining a first major surface, wherein the first interconnect layer is on at least a portion of the first major surface and defines a second major surface opposing the first major surface, and wherein the plurality of respective work electrodes are disposed on the second major surface; a second dielectric substrate defining a third major surface; and a second interconnect layer on at least a portion of the third major surface and defining a fourth major surface opposing the third major surface, wherein the common reference electrode and the common counter electrode are disposed on the fourth major surface, wherein the first interconnect layer is electrically coupled to the second interconnect layer, wherein the common counter electrode and the common reference electrode define a fifth major surface, and wherein the first dielectric substrate is disposed on the fifth major surface in order to insulate the electrical components via the dielectric layers only allowing electrical communication via the metal layers to avoid any interference.
Regarding the configuration of the electrical components on separate layers, Examiner notes that it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention wherein the different electrical components are stacked on different layers as it has been held that rearrangement of parts only takes routine skill in the art (See MPEP 2144.04). Examiner notes that Applicant has not showed evidence of criticality or unexpected results in relation to the order of the layers/stacks of components.
Regarding Claim 6, MK in view of Nackaerts (further as evidenced by JEDEC) in view of Lucisano teach: The biocompatible medical device of claim 5, wherein the electrochemical sensor further comprises a plurality of dielectric barriers, and wherein the plurality of dielectric barriers are integrally formed with the first dielectric substrate such that each of the plurality of respective work electrodes are disposed within a respective cavity of a plurality of cavities defined by the dielectric substrate (paragraph 0020, dielectric z-planes).
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over MK in view of Nackaerts (further as evidenced by JEDEC) in view of Lucisano further in view of Pace (US 4,225,410 – cited by Applicant).
Regarding Claim 2, MK in view of Nackaerts (further as evidenced by JEDEC) in view of Lucisano teach: The biocompatible medical device of claim 1, but do not mention wherein the plurality of respective work electrodes comprises at least: a first work electrode comprising a first reagent substrate configured to react with glucose; a second work electrode comprising a second reagent substrate configured to react with potassium; and a third work electrode comprising a third reagent substrate configured to react with creatinine.
Pace teaches a sensor array comprising sensors with working electrodes for sensing potassium, glucose, potassium, and creatine (table 1; abstract). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device of MK in view of Nackaerts (further as evidenced by JEDEC) in view of Lucisano wherein the plurality of respective work electrodes comprises at least: a first work electrode comprising a first reagent substrate configured to react with glucose; a second work electrode comprising a second reagent substrate configured to react with potassium; and a third work electrode comprising a third reagent substrate configured to react with creatinine as such a plurality of electrodes would simplify and shorten medical testing in a convenient compact sensor device.
Regarding Claim 3, MK in view of Nackaerts (further as evidenced by JEDEC) in view of Lucisano teach: The biocompatible medical device of claim 1, but do not mention wherein the plurality of respective work electrodes comprises at least: a first work electrode comprising a first reagent substrate configured to react with sodium ions; a second work electrode comprising a second reagent substrate configured to react with chloride ions; a third work electrode comprising a third reagent substrate configured to react with blood urea nitrogen; a fourth work electrode comprising a fourth reagent substrate configured to react with glucose; a fifth work electrode comprising a fifth reagent substrate configured to react with potassium; a sixth work electrode comprising a sixth reagent substrate configured to react with bicarbonate or carbon dioxide; and a seventh work electrode comprising a seventh reagent substrate configured to react with creatinine.
Pace teaches a sensor array comprising sensors with working electrodes for sensing sodium, chloride, blood urea nitrogen, glucose, potassium, CO2, and creatinine (table 1; abstract). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device of MK in view of Nackaerts (further as evidenced by JEDEC) in view of Lucisano wherein the plurality of respective work electrodes comprises at least: a first work electrode comprising a first reagent substrate configured to react with sodium ions; a second work electrode comprising a second reagent substrate configured to react with chloride ions; a third work electrode comprising a third reagent substrate configured to react with blood urea nitrogen; a fourth work electrode comprising a fourth reagent substrate configured to react with glucose; a fifth work electrode comprising a fifth reagent substrate configured to react with potassium; a sixth work electrode comprising a sixth reagent substrate configured to react with bicarbonate or carbon dioxide; and a seventh work electrode comprising a seventh reagent substrate configured to react with creatinine as such a plurality of electrodes would simplify and shorten medical testing in a convenient compact sensor device.
Regarding Claim 4, MK in view of Nackaerts (further as evidenced by JEDEC) in view of Lucisano teach: The biocompatible medical device of claim 1, but do not mention wherein the plurality of respective work electrodes comprises at least: a first work electrode comprising a first reagent substrate configured to react with sodium ions; a second work electrode comprising a second reagent substrate configured to react with chloride ions; a third work electrode comprising a fifth reagent substrate configured to react with potassium; and a fourth work electrode comprising a sixth reagent substrate configured to react with bicarbonate or carbon dioxide.
Pace teaches a sensor array comprising sensors with working electrodes for sensing sodium, chloride, potassium, CO2, (table 1; abstract). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device of MK in view of Nackaerts (further as evidenced by JEDEC) in view of Lucisano wherein the plurality of respective work electrodes comprises at least: a first work electrode comprising a first reagent substrate configured to react with sodium ions; a second work electrode comprising a second reagent substrate configured to react with chloride ions; a third work electrode comprising a fifth reagent substrate configured to react with potassium; and a fourth work electrode comprising a sixth reagent substrate configured to react with bicarbonate or carbon dioxide as such a plurality of electrodes would simplify and shorten medical testing in a convenient compact sensor device.
Claim(s) 7, 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over MK in view of Nackaerts (further as evidenced by JEDEC) in view of Lucisano further in view of Chen et al. (US 2019/0320947 A1 – cited by Applicant), hereinafter Chen.
Regarding Claim 7, MK in view of Nackaerts (further as evidenced by JEDEC) in view of Lucisano teach: The biocompatible medical device of claim 1, but do not mention further comprising a power source stacked below the common reference electrode and the common counter electrode within the housing.
Chen teaches the use of a power source inside the housing for a similar sensor (paragraph 0038). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the invention to include a power source to power to sensor.
Regarding the location of the power source, Examiner notes that it would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the invention wherein the power source is stacked below the common reference electrode and the common counter electrode within the housing as it has been held that rearrangement of parts only takes routine skill in the art (See MPEP 2144.04). Examiner notes that Applicant has not showed evidence of criticality or unexpected results in relation to the location of the power source in the housing.
Regarding Claim 8, MK in view of Nackaerts (further as evidenced by JEDEC) in view of Lucisano teach: The biocompatible medical device of claim 1, but do not mention wherein the electrochemical sensor further comprises a protrusion fluidically coupling the plurality of respective work electrodes, the common counter electrode, and the common reference electrode to interstitial fluid of a patient.
Chen teaches wherein the electrochemical sensor further comprises a protrusion fluidically coupling the plurality of respective work electrodes, the common counter electrode, and the common reference electrode to interstitial fluid of a patient (paragraph 0065). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the invention to include wherein the electrochemical sensor further comprises a protrusion fluidically coupling the plurality of respective work electrodes, the common counter electrode, and the common reference electrode to interstitial fluid of a patient – in order to contact sensors elements with the fluid to be measured.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over MK in view of Nackaerts (further as evidenced by JEDEC) in view of Lucisano further in view of Gottlieb et al. (US 2010/0025238 A1 – cited by Applicant), hereinafter Gottlieb.
Regarding Claim 9, MK in view of Nackaerts (further as evidenced by JEDEC) in view of Lucisano teach: The biocompatible medical device of claim 1, comprising a discrete stack of functional layers comprising: a first electrochemical sensor layer comprising the plurality of respective work electrodes; a second electrochemical sensor layer comprising the common counter electrode and the common reference electrode (MK - paragraph 0117); but do not mention a power source layer comprising a power source for the biocompatible medical device; and an antenna layer comprising an antenna configured to transmit data representative of the concentration of the respective analyte to an external device.
Gottlieb teaches a power source layer comprising a power source for the biocompatible medical device; and an antenna layer comprising an antenna configured to transmit data representative of the concentration of the respective analyte to an external device (paragraph 0095; figure 3). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the invention to include a power source layer comprising a power source for the biocompatible medical device; and an antenna layer comprising an antenna configured to transmit data representative of the concentration of the respective analyte to an external device in order to power the sensor and transmit collected data.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 11744492 and claims 1-20 of U.S. Patent No. 12138050. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims overlap in scope with the patented claims, where the differences in scope are obvious variants over one another.
Conclusion
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JAY SHAH
Primary Examiner
Art Unit 3791
/JAY B SHAH/Primary Examiner, Art Unit 3791
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