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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-9 and 14-18, in the reply filed on 10 July 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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.
Claims 6 and 9 are 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 6, because claim 1 recites “at least one membrane”, the phrase “the membrane” in claim 6 lacks proper antecedent basis. For this examination, the phrase “the membrane” in claim 6 is being interpreted as “the at least one membrane”.
Regarding claim 9, the wording of the claim makes it unclear from what groups the second electrode is selected. Specifically, use of the phrase “and/or” makes the claim unclear. For this examination, the claim is being interpreted such that the second electrode is any one of: a counter electrode, a combined counter/reference electrode, an oxygen electrode.
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.
Claims 1, 3, and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Janssen et al.’625 (EP 0 539 625 A1 – cited by Applicant).
Regarding claim 1, Figure 1 of Janssen et al.’625 discloses an analyte sensor for use in medical devices for measuring analyte data in an analyte carrying fluid (see ABSTRACT), the analyte sensor comprising: a first electrode 2, the first electrode being a working electrode (see the ABSTRACT and the description of Figure 1); a second electrode 3/4/5/6 (see the ABSTRACT and the description of Figure 1); a substrate 1 supporting the first electrode and the second electrode (see the ABSTRACT and the description of Figure 1); at least one membrane 8 which at least partially covers the first electrode (see the ABSTRACT and the description of Figure 1); wherein the at least one membrane comprises a membrane material that is impermeable to the analyte carrying fluid and/or the analyte, wherein the at least one membrane comprises at least one opening 10, and wherein the at least one membrane is configured for controlling the flux of the analyte carrying fluid and/or the analyte to the first electrode via the at least one opening (see the ABSTRACT and the description of Figure 1).
Regarding claim 3, it is noted that the claim recites a product-by-process limitation. According to section 2113 I. of the MPEP, “The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698 227 USPQ 964, 966 (Fed. Cir. 1985).” As the at least one opening of Janssen et al.’625 is the same as the at least one opening of the claimed invention, the manner in which the at least one opening is formed is not being given patentable weight.
Regarding claim 7, Figure 1 of Janssen et al.’625 discloses that the analyte sensor further comprises a sensing layer 7, wherein the sensing layer is configured for providing at least one enzyme to the first electrode (see the ABSTRACT and the description of Figure 1).
Regarding claim 8, Figure 1 shows that the first and second electrodes are arranged on opposing sides of the substrate (in this case, oxygen producing electrode 5 is considered the first electrode and reference electrode 4 is considered the second electrode – electrodes 5 and 4 are on opposing (left and right) sides of the substrate).
Regarding claim 9, the second electrode is a counter electrode (electrodes 3 and 6 are counter electrodes). Furthermore, the second electrode 6 is an oxygen electrode that is configured to use oxygen solved in the analyte carrying fluid as electron acceptor and can comprise gold or platinum as conductive material (col. 3, lines 47-51).
Claims 1, 3, 6, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kuypers et al.’788 (EP 0 396 788 A1).
Regarding claim 1, Figures 2 and 3 of Kuypers et al.’788 disclose an analyte sensor for use in medical devices for measuring analyte data in an analyte carrying fluid (page 4, line 32 and page 5, lines 32-34), the analyte sensor comprising: a first electrode 5, the first electrode being a working electrode (see the description of Figure 2 beginning on page 5, line 32); a second electrode 7 (see the description of Figure 2 beginning on page 5, line 32); a substrate supporting the first electrode and the second electrode (see the description of Figure 2 beginning on page 5, line 32); at least one membrane 2 which at least partially covers the first electrode (see the description of Figure 2 beginning on page 5, line 32); wherein the at least one membrane comprises a membrane material that is impermeable to the analyte carrying fluid and/or the analyte, wherein the at least one membrane comprises at least one opening 6, and wherein the at least one membrane is configured for controlling the flux of the analyte carrying fluid and/or the analyte to the first electrode via the at least one opening (see the description of Figure 2 beginning on page 5, line 32).
Regarding claim 3, it is noted that the claim recites a product-by-process limitation. According to section 2113 I. of the MPEP, “The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698 227 USPQ 964, 966 (Fed. Cir. 1985).” As the at least one opening of Kuypers et al.’788 is the same as the at least one opening of the claimed invention, the manner in which the at least one opening is formed is not being given patentable weight.
Regarding claim 6, membrane 2 is hydrophobic (page 5, lines 39-48).
Regarding claim 7, Figures 2 and 3 of Kuypers et al.’788 disclose that the analyte sensor further comprises a sensing layer 4, wherein the sensing layer is configured for providing at least one enzyme to the first electrode (page 4, lines 37-39; page 5, line 49 – page 6, line 2).
Claim 14 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shah et al.’857 (US Pub No. 2017/0328857).
Figure 21C of Shah et al.’857 discloses an analyte sensor for use in medical devices for measuring analyte data in an analyte carrying fluid (section [0002]), the sensor comprising: a first electrode 102, the first electrode being a working electrode (section [0167]); a second electrode 2100/2102 (section [0167]); a substrate carrying the first electrode and the second electrode (section [0005]); and wherein the first electrode comprises a material that is impermeable to the analyte carrying fluid and/or impermeable to the analyte (section [0148]), wherein the first electrode comprises at least one opening (see annotated Figure 21C below), and wherein the first electrode is configured for controlling the flux of the analyte carrying fluid and/or the analyte to an electrochemical active layer 202 of the first electrode via the at least one opening (section [0089] defines 202 as a reactive chemistry layer made of glucose oxidase; sections [0166-0167] define 202 as a “transport material”, and the ABSTRACT and section [0010] state that the transport material enables analyte flux to a reactive surface).
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Annotated Figure 21C
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Janssen et al.’625, as applied to claim 1.
Janssen et al.’625 discloses all of the elements of the current invention, as discussed in paragraph 6 above, except for the diameter of the at least one opening being substantially equivalent to the thickness of the at least one membrane and falling within the range of 10 to 100 micrometers. It is noted that Applicant has failed to provide details of criticality of unexpected results in the specification with regard to the particularly claimed opening diameter. As such, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to have determined the optimum diameter of the at least one opening.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kuypers et al.’788, as applied to claim 1.
Kuypers et al.’788 discloses all of the elements of the current invention, as discussed in paragraph 7 above, except for the diameter of the at least one opening being substantially equivalent to the thickness of the at least one membrane and falling within the range of 10 to 100 micrometers. It is noted that Applicant has failed to provide details of criticality of unexpected results in the specification with regard to the particularly claimed opening diameter. As such, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to have determined the optimum diameter of the at least one opening.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Janssen et al.’625, as applied to claim 1, in view of McKinlay et al.’926 (US Pub No. 2019/0241926).
This rejection is being provided as an alternative to the 35 U.S.C. 102(a)(1) rejection in paragraph 6 above.
Janssen et al.’625 discloses all of the elements of the current invention, as discussed in paragraph 6 above, except for the at least one opening being formed by a laser ablation process.
McKinlay et al.’926 teaches that apertures in an electrochemical sensor can be formed by laser ablation (section [0053]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have formed the at least one opening of Janssen et al.’625 using laser ablation, as McKinley et al.’926 teaches that apertures in an electrochemical sensor can be formed by laser ablation. The modification to Janssen et al.’625 would merely be combining prior art elements according to known methods to yield predictable results.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kuypers et al.’788, as applied to claim 1, in view of McKinlay et al.’926.
This rejection is being provided as an alternative to the 35 U.S.C. 102(a)(1) rejection in paragraph 7 above.
Kuypers et al.’788 discloses all of the elements of the current invention, as discussed in paragraph 7 above, except for the at least one opening being formed by a laser ablation process.
McKinlay et al.’926 teaches that apertures in an electrochemical sensor can be formed by laser ablation (section [0053]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have formed the at least one opening of Kuypers et al.’788 using laser ablation, as McKinley et al.’926 teaches that apertures in an electrochemical sensor can be formed by laser ablation. The modification to Kuypers et al.’788 would merely be combining prior art elements according to known methods to yield predictable results.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Kuypers et al.’788, as applied to claim 1, further in view of Kuypers et al.’057 (USPN 5,134,057).
Regarding claim 4, Kuypers et al.’788 discloses all of the elements of the current invention, as discussed in paragraph 7 above, except for the at least one opening being at least partially filled with a material that is permeable to the analyte carrying fluid and/or the analyte, wherein the material is a hydrophilic polymer that is selected from the group consisting of a polyvinylpyridine based copolymer, a polyurethane and a hydrogel.
Figures 1 and 2 of Kuypers et al.’057 show an electrochemical analyte sensor wherein at least one opening formed by a membrane (openings 6 defined by membrane 5) is filled with a hydrophilic polymer material (material 8) that is permeable to an analyte carrying fluid and/or an analyte, the material being a hydrogel (col. 5, lines 12-22 and 57-67). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the analyte sensor of Kuypers et al.’788 such that its at least one opening is at least partially filled with a hydrogel, as taught by Kuypers et al.’057, as it would merely be combining prior art elements according to known methods to yield predictable results.
Regarding claim 5, as seen in Figure 1 of Kuypers et al.’057, the material that is permeable to the analyte carrying fluid and/or the analyte covers at least partially a first and second electrode. As modified by Kuypers et al.’057, the second electrode of Kuypers et al.’788 would be at least partially covered by the material.
Claims 15, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Janssen et al.’625 in view of Say et al.’338 (US Pub No. 2003/0187338).
Regarding claim 15, Janssen et al.’625 discloses a method for operating an analyte sensor according to claim 1, the method comprising measuring analyte data based on a generated current signal (col. 2, lines 25-34). Janssen et al.’625 fails to disclose applying a voltage signal between the first electrode and the second electrode; integrating an electrical signal between the first electrode and the second electrode via at least one capacitor; and measuring the analyte data based on the generated voltage signal.
Say et al.’338 teaches a method for operating an electrochemical analyte sensor, the method comprising: applying a voltage signal between a first (working) electrode and a second electrode (sections [0008-0009], [0070], [0072]); integrating an electrical signal between the first electrode and the second electrode via at least one capacitor (the current-to-voltage converter of sections [0249], [0255-0257] performs the integrating step), wherein the electrical signal is generated in response to an electrochemical reaction of the first electrode with an analyte or analyte carrying fluid (this is inherent), the integration generating a voltage signal that is proportional to the charge of the at least one capacitor (section [0257]); and measuring analyte data based on the generated voltage signal (section [0263]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Janssen et al.’625 such that it applies a voltage signal between the first electrode and the second electrode, integrates an electrical signal between the first electrode and the second electrode via at least one capacitor to generate a voltage signal, and measures analyte data based on the generated voltage signal, as Say et al.’338 teaches that these method steps may be performed to provide a visual output of the level of a measured analyte (see ABSTRACT, and section [0014]). The modification to Janssen et al.’625 would merely be combining prior art elements according to known methods to yield predictable results.
Regarding claim 17, Janssen et al.’625 fails to recite that its analyte sensor is part of a continuous analyte monitoring system. Say et al.’338 teaches using an analyte sensor as part of a continuous analyte monitoring system, the continuous analyte monitoring system including an analyte sensor and one or more processors configured for processing data collected by the analyte sensor (sections [0007], [0055], [0246-0247], [0249], [0263]). Say et al.’338 teaches that such a continuous analyte monitoring system allows for continuous analyte monitoring while a user is engaged in a wide range of activities (section [0007]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have used the analyte sensor of Janssen et al.’625 as part of a continuous analyte monitoring system including the analyte sensor and one or more processors configured for processing data collected by the analyte sensor, as this would allow continuous analyte monitoring of an individual while the individual is engaged in a wide range of activities.
Regarding claim 18, Say et al.’338 discloses using a mounting unit to place an analyte sensor on the skin of a user, wherein the analyte sensor is detachably coupled to the mounting unit (section [0011]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have included a mounting unit with the analyte sensor of Janssen et al.’625 as it would provide a means by which to couple the analyte sensor to an individual.
Claims 15, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kuypers et al.’788 in view of Say et al.’338.
Regarding claim 15, Kuypers et al.’788 discloses a method for operating an analyte sensor according to claim 1, the method comprising measuring analyte data based on a generated current signal (page 3, lines 11-17). Kuypers et al.’788 fails to disclose applying a voltage signal between the first electrode and the second electrode; integrating an electrical signal between the first electrode and the second electrode via at least one capacitor; and measuring the analyte data based on the generated voltage signal.
Say et al.’338 teaches a method for operating an electrochemical analyte sensor, the method comprising: applying a voltage signal between a first (working) electrode and a second electrode (sections [0008-0009], [0070], [0072]); integrating an electrical signal between the first electrode and the second electrode via at least one capacitor (the current-to-voltage converter of sections [0249], [0255-0257] performs the integrating step), wherein the electrical signal is generated in response to an electrochemical reaction of the first electrode with an analyte or analyte carrying fluid (this is inherent), the integration generating a voltage signal that is proportional to the charge of the at least one capacitor (section [0257]); and measuring analyte data based on the generated voltage signal (section [0263]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Kuypers et al.’788 such that it applies a voltage signal between the first electrode and the second electrode, integrates an electrical signal between the first electrode and the second electrode via at least one capacitor to generate a voltage signal, and measures analyte data based on the generated voltage signal, as Say et al.’338 teaches that these method steps may be performed to provide a visual output of the level of a measured analyte (see ABSTRACT, and section [0014]). The modification to Kuypers et al.’788 would merely be combining prior art elements according to known methods to yield predictable results.
Regarding claim 17, Kuypers et al.’788 fails to recite that its analyte sensor is part of a continuous analyte monitoring system. Say et al.’338 teaches using an analyte sensor as part of a continuous analyte monitoring system, the continuous analyte monitoring system including an analyte sensor and one or more processors configured for processing data collected by the analyte sensor (sections [0007], [0055], [0246-0247], [0249], [0263]). Say et al.’338 teaches that such a continuous analyte monitoring system allows for continuous analyte monitoring while a user is engaged in a wide range of activities (section [0007]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have used the analyte sensor of Kuypers et al.’788 as part of a continuous analyte monitoring system including the analyte sensor and one or more processors configured for processing data collected by the analyte sensor, as this would allow continuous analyte monitoring of an individual while the individual is engaged in a wide range of activities.
Regarding claim 18, Say et al.’338 discloses using a mounting unit to place an analyte sensor on the skin of a user, wherein the analyte sensor is detachably coupled to the mounting unit (section [0011]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have included a mounting unit with the analyte sensor of Kuypers et al.’788 as it would provide a means by which to couple the analyte sensor to an individual.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Janssen et al.’625 in view of Say et al.’338, as applied to claim 15, further in view of Wu’048 (US Pub No. 2018/0059048).
Janssen et al.’625 in view of Say et al.’338 discloses all of the elements of the current invention, as discussed in paragraph 15 above, except for the electrodes being operated periodically in an open circuit mode. Wu’048 teaches operating the electrodes of an electrochemical analyte sensor in an open circuit mode in order to improve measurement accuracy (sections [0025], [0036], [0102], [0137]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Janssen et al.’625 in view of Say et al.’338 such that the electrodes are operated periodically in an open circuit mode, as Wu’048 teaches that this would improve the accuracy of the analyte measurements.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Kuypers et al.’788 in view of Say et al.’338, as applied to claim 15, further in view of Wu’048.
Kuypers et al.’788 in view of Say et al.’338 discloses all of the elements of the current invention, as discussed in paragraph 16 above, except for the electrodes being operated periodically in an open circuit mode. Wu’048 teaches operating the electrodes of an electrochemical analyte sensor in an open circuit mode in order to improve measurement accuracy (sections [0025], [0036], [0102], [0137]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Kuypers et al.’788 in view of Say et al.’338 such that the electrodes are operated periodically in an open circuit mode, as Wu’048 teaches that this would improve the accuracy of the analyte measurements.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hoss et al.’285 (US Pub No. 2010/0230285) discloses the analyte sensor of claim 14 (see Figures 20A-20C, and section [0080], which states that coverlay material 2030 of electrode 2000 can be made of a material – glass or ceramics – that is impermeable to an analyte).
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