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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 9, 2026 has been entered.
Response to Amendment
This is an office action in response to applicant’s arguments and remarks filed on March 9, 2026. Claims 1-7, 9-15, and 17-18 are pending in the application and are being examined herein.
Status of Objections and Rejections
The objections to and rejections of claim 16 are obviated by Applicant’s cancellation.
The objection to claim 5 is withdrawn in view of Applicant’s amendment.
New objections to the claims are necessitated by the amendments.
The rejection of the claims under 35 U.S.C. 103 are maintained and modified in view of Applicant’s amendment.
New grounds of rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are necessitated by the amendments.
Claim Objections
Claim 1 is objected to because of the following informalities:
In lines 9-10, “the size of the accessible surface maintained free” should read “a size of the accessible surface of the conductive layer maintained free”.
In lines 10-11, “the size of the area of the silver comprising layer” should read “a size of the area of the silver comprising layer”.
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.
Claims 1-7, 9-15, and 17-18 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.
Claim 1 recites the limitation "the measured Equivalent Series Resistance" in line 12 of the claim. There is insufficient antecedent basis for this limitation in the claim because it is not a constant value, and it is heavily affected by external factors and the measurement method itself. Claims 2-7, 9-15, and 17-18 are rejected as dependent thereon.
The term “significantly” in claim 1 is a relative term which renders the claim indefinite. The term “significantly reduced” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Furthermore, it is unclear what the measured ESR is being compared to. Claims 2-7, 9-15, and 17-18 are rejected as dependent thereon.
Claim 15 recites the limitation “the protective layer is applied to fully cover the silver comprising layer” in line 2 of the claim. Claim 15 ultimately depends from claim 1 which recites “a protective layer covering the silver comprising layer except for an area of the silver comprising layer that is accessible to a body fluid” in lines 5-6 of claim 1. It is unclear how the protective layer can fully cover the silver comprising layer in claim 15 when claim 1 requires an area of the silver comprising layer to not be covered by the protective layer. This limitation of claim 15 contradicts what is required by claim 1.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7, 9-15, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Hoss et al. (US 2010/0230285 A1), as evidenced by Applicant’s specification with respect to claim 9.
Regarding claim 1, Hoss teaches an analyte sensor for determining an analyte (an analyte sensor for detection of an analyte in body fluid, Figs. 9A-9C, para. [0057], [0106]), comprising:
a substrate (a substrate 902, Fig. 9C, para. [0107]);
a working electrode and a conductive layer located on different sites on the substrate (a working electrode 904a and sensing component 906 together read on the working electrode covering the top surface of the substrate 902, with their overlap defining the active area, Figs. 9A & 9C, para. [0107], [0109]; a bottom conductive layer 904b covers the bottom side of the substrate 902, Fig. 9C, para. [0107]; the working electrode 904a/906 and the bottom conductive layer 904b are located on opposite sides of the substrate 902, Fig. 9C, para. [0107]);
a silver comprising layer partially covering the conductive layer (an Ag/AgCl layer 910 partially covering the bottom conductive layer 904b, Figs. 9B-9C, para. [0112]); and
a protective layer covering the silver comprising layer except for an area of the silver comprising layer that is accessible to a body fluid having the analyte (a layer 908b covering the Ag/AgCl layer 910 except for side edges of the Ag/AgCl layer 910 that are exposed to the in vivo environment upon transcutaneous positioning, Figs. 9B-9C, see Image 1 below, para. [0112]-[0114]), wherein the protective layer covers a portion of the conductive layer and the conductive layer has an accessible surface that is maintained free from the protective layer (the layer 908b covers a portion of the bottom conductive layer 904b and the bottom conductive layer 904b has an accessible surface that is maintained free from the layer 908b, Figs. 9B-9C, see Image 1 below, para. [0113]-[0114]).
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Image 1. Annotated version of Figs. 9B-9C of Hoss.
Hoss teaches that the bottom conductive layer 904b has an accessible surface that is maintained free from the layer 908b and exposed to the in vivo environment (Figs. 9B-9C, see Image 1 above, para. [0113]-[0114]). Hoss teaches that the side edges of the Ag/AgCl layer 910 are exposed to the in vivo environment upon transcutaneous positioning (Figs. 9B-9C, see Image 1 above, para. [0112]-[0114]). Hoss is silent with respect to the relative sizes of these areas, and therefore fails to explicitly teach wherein the size of the accessible surface maintained free from the protective layer exceeds the size of the area of the silver comprising layer that is accessible to the body fluid by a factor of at least 10.
While patent drawings are not to scale, relationships clearly shown in the drawings of a reference patent cannot be disregarded in determining the patentability of claims. See In re Mraz, 455 F.2d 1069, 173 USPQ 25 (CCPA 1972). Although Hoss does not disclose that the drawings are to scale, it has been held that the description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art. In re Wright, 569 F.2d 1124, 1127-28, 193 USPQ 332, 335-36 (CCPA 1977). MPEP § 2125(II). In this case, when viewing Figs. 9B-9C (see Image 1 above) of Hoss, Examiner notes that the size of the accessible surface of the bottom conductive layer 904b (including the front edge, side edges, and planar surface of the bottom conductive layer 904b that are not covered by the layer 908b) is much larger than the size of the side edges of the Ag/AgCl layer 910 and also appears to exceed the size of side edges of the Ag/AgCl layer 910 by a factor of at least 10. Furthermore, Hoss teaches that the layer 908b may extend any suitable length of the analyte sensor's tail section, i.e., it may extend the entire length of both of the primary and secondary conductive layers 904b, 910 or portions thereof to insulate the proximal portion of the bottom conductive layer 904b and the Ag/AgCl layer 910 (Fig. 9C, para. [0113]-[0114]). Hoss also teaches that the Ag/AgCl layer 910 may be positioned at any suitable location on the tail portion 900 of the bottom conductive layer 904b (Figs. 9B-9C, para. [0112]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the position of the Ag/AgCl layer 910 and the length of the layer 908b of Hoss to both shift to the left in Figs. 9B-9C to increase the size of the accessible surface of the bottom conductive layer 904b such that the size of the accessible surface of the bottom conductive layer 904b maintained free from the layer 908b exceeds the size of the side edges of the Ag/AgCl layer 910 by a factor of at least 10 in order to yield the predictable result of insulating the proximal portion of the bottom conductive layer 904b and the Ag/AgCl layer 910 (Figs. 9B-9C, para. [0113]). Furthermore, the Federal Circuit has held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. MPEP § 2144.04(IV)(A). Additionally, generally, differences in a rearrangement of parts will not support the patentability of subject matter encompassed by the prior art absent persuasive evidence that the particular configuration is significant. MPEP § 2144.04(VI)(C).
The limitations “for determining an analyte,” “accessible to a body fluid having the analyte,” and “whereby the measured Equivalent Series Resistance (“ESR”) of the analyte sensor when applying a fast-transient voltage is significantly reduced” are interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The analyte sensor disclosed by Modified Hoss teaches all of the structural limitations of the claim and thus is configured for and capable of the intended use and/or functional language as recited in the rejection supra.
The limitation “whereby the measured Equivalent Series Resistance (“ESR”) of the analyte sensor when applying a fast-transient voltage is significantly reduced” is an intended result of the claimed analyte sensor, and does not further limit the structure. The court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. MPEP 2111.04(I). In this case, Modified Hoss teaches the claimed structure of claim 1 (see rejection supra), so Modified Hoss is expected to predictably yield the same significantly reduced ESR result as claimed.
Regarding claim 2, Modified Hoss teaches wherein the conductive layer, the silver comprising layer and the protective layer form a further electrode selected from the group consisting of a counter electrode, a reference electrode and a combined counter/reference electrode (the bottom conductive layer 904b, the Ag/AgCl layer 910, and the layer 908b collectively form a combined counter/reference electrode at their intersecting areas, Figs. 9B-9C, para. [0108], [0111]-[0112], [0114], [0123]).
Regarding claim 3, Modified Hoss teaches wherein the further electrode is or comprises the combined counter/reference electrode (the combined counter/reference electrode, Figs. 9B-9C, para. [0108], [0111]-[0112], [0114], [0123]).
Regarding claim 4, Modified Hoss teaches wherein the working electrode is located on a first side of the substrate and wherein the further electrode is located on a second side of the substrate, wherein the first side and the second side of the substrate are positioned opposite each other (the working electrode 904a and sensing component 906 together read on the working electrode covering the top surface of the substrate 902, with their overlap defining the active area, Figs. 9A & 9C, para. [0107], [0109]; the bottom conductive layer 904b, the Ag/AgCl layer 910, and the layer 908b collectively forming the bottom electrode cover the bottom side of the substrate 902, Figs. 9B-9C, para. [0107]-[0108], [0111]-[0112], [0114]; the top surface and the bottom side of the substrate 902 are positioned opposite each other, Fig. 9C, para. [0107]).
Regarding claim 5, Modified Hoss teaches wherein the working electrode and the silver comprising layer are located on the substrate in a manner such that the silver comprising layer does not overlap with or project over the working electrode (a geometrical projection of the active area of the working electrode 904a/906 onto the bottom side of the substrate 902 does not overlap with the Ag/AgCl layer 910, Fig. 9C, para. [0108]-[0109], [0112], [0123]).
Regarding claim 6, Modified Hoss teaches wherein the conductive layer comprises an electrically conductive carbon material (the bottom conductive layer 904b includes gold carbon, Fig. 9C, para. [0112]).
Regarding claim 7, Modified Hoss teaches wherein the silver comprising layer comprises Ag/AgCl (the Ag/AgCl layer 910, Fig. 9C, para. [0112]).
Regarding claim 9, Modified Hoss teaches wherein the protective layer is a hydrophobic layer (the insulation/dielectric layer 908b may include polyethylene terephthalate, Fig. 9C, para. [0080], [0113]). As evidenced by Applicant's instant specification, polyethylene terephthalate is hydrophobic (para. [0043] of the instant US PGPub).
Regarding claim 10, Modified teaches wherein the protective layer is a membrane comprising a plurality of holes configured to provide access to the layer comprising silver for the body fluid having the analyte (the layer 908b comprises two holes, one on either side after singulation of the sensors, that exposes the side edges of the Ag/AgCl layer 910 to the in vivo environment, Figs. 9B-9C, para. [0113]-[0114], [0124]).
The limitation "provide access to the layer comprising silver for the body fluid having the analyte" is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The analyte sensor disclosed by Modified Hoss teaches all of the structural limitations of the claim and thus is configured for and capable of the intended use and/or functional language as recited in the rejection supra.
Regarding claim 11, Modified Hoss teaches wherein the layer comprising silver comprises an exposed cutting edge which provides access to the layer comprising silver for the body fluid comprising the analyte (the Ag/AgCl layer 910 comprises exposed side edges that are exposed to the in vivo environment, Figs. 9B-9C, para. [0112]-[0114]).
The limitation "provides access to the layer comprising silver for the body fluid comprising the analyte" is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The analyte sensor disclosed by Modified Hoss teaches all of the structural limitations of the claim and thus is configured for and capable of the intended use and/or functional language as recited in the rejection supra.
Regarding claim 12, Modified Hoss teaches wherein the analyte sensor is a flat sensor (the two sided analyte sensor comprises the planar substrate 902 with the electrode layers formed thereon, Figs. 9A-9C, para. [0106]-[0114]). Examiner notes that Applicant's instant specification defines "flat sensor" to refer to a particular type of analyte sensor which comprises a planar substrate that provides a carrier for the further elements, preferably the electrodes, of the analyte sensor to be provided, preferably, in form of layers, directly or indirectly, deposited on the substrate (para. [0029] of the instant US PGPub). Therefore, Modified Hoss teaches that the analyte sensor is a flat sensor. Generally, drawings and pictures can anticipate claims if they clearly show the structure which is claimed. In re Mraz, 455 F.2d 1069, 173 USPQ 25 (CCPA 1972). See MPEP § 2125(I). It has been held that the description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art. In re Wright, 569 F.2d 1124, 1127-28, 193 USPQ 332, 335-36 (CCPA 1977). MPEP § 2125(II).
Regarding claim 13, Modified Hoss teaches wherein the analyte sensor is partially implantable (the analyte sensor is implantable, Figs. 9A-9C, para. [0106]).
The limitation "partially implantable" is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The analyte sensor disclosed by Modified Hoss teaches all of the structural limitations of the claim and thus is configured for and capable of the intended use and/or functional language as recited in the rejection supra.
Regarding claim 14, Modified Hoss teaches a method for producing the analyte sensor according to claim 1 (a fabrication process of the two sided analyte sensor of claim 1, Figs. 9A-9C, para. [0106], [0119]-[0120], see rejection of claim 1 supra), the method comprising:
a) providing a raw substrate (providing a continuous film or web of substrate material, para. [0120]);
b) applying the conductive layer on the raw substrate (forming the bottom conductive layer 904b on the substrate web, Fig. 9C, para. [0107], [0120]);
c) applying the silver comprising layer in a manner that it partially covers the conductive layer (applying the Ag/AgCl layer 910 such that it partially covers the bottom conductive layer 904b, Fig. 9C, para. [0112], [0122]);
d) applying the protective layer in a manner that it covers the silver comprising layer and the portion of the conductive layer (disposing the layer 908b such that it covers the Ag/AgCl layer 910 and the portion of the bottom conductive layer 904b, Fig. 9C, para. [0113]-[0114], [0124]);
e) preparing the working electrode (forming the working electrode 904a and sensing layer 906 on the substrate web, Fig. 9C, para. [0107]-[0109], [0120], [0122]); and
f) cutting the raw substrate to obtain the analyte sensor (the sensor precursors, i.e., the template of substrate material as well as the conductive, sensing, and dielectric materials provided on the substrate at the time of singulation, may be singulated from each other using any convenient cutting or separation protocol, Fig. 9C, para. [0114], [0124]).
Regarding claim 15, Modified Hoss teaches wherein:
the protective layer is applied to fully cover the silver comprising layer (disposing the layer 908b such that it fully covers the Ag/AgCl layer 910, Fig. 9C, para. [0113]-[0114], [0124]);
the protective layer comprises a plurality of holes configured to provide access to the layer comprising silver for a body fluid having the analyte (the layer 908b comprises two holes, one on either side after singulation of the sensors, that exposes the side edges of the Ag/AgCl layer 910 to the in vivo environment, Figs. 9B-9C, para. [0113]-[0114], [0124]); and/or
after cutting the raw substrate, the silver comprising layer has an exposed cutting edge which provides access to the layer comprising silver for a body fluid having the analyte (after cutting the substrate, the Ag/AgCl layer 910 has exposed side edges which are exposed to the in vivo environment, Figs. 9B-9C, para. [0113]-[0114], [0124]).
Examiner notes that the limitation "wherein: the protective layer is applied to fully cover the silver comprising layer; the protective layer comprises a plurality of holes configured to provide access to the layer comprising silver for a body fluid having the analyte; and/or after cutting the raw substrate, the silver comprising layer has an exposed cutting edge which provides access to the layer comprising silver for a body fluid having the analyte" (emphasis added by Examiner) only requires at least one of the three recited limitations since it recites "and/or".
Regarding claims 17-18, Modified Hoss teaches wherein the factor is at least 10 (see rejection and modification of claim 1 supra). Modified Hoss fails to teach wherein the factor is at least 25, of instant claim 17, or wherein the factor is at least 50, of instant claim 18.
However, Hoss teaches that the layer 908b may extend any suitable length of the analyte sensor's tail section, i.e., it may extend the entire length of both of the primary and secondary conductive layers 904b, 910 or portions thereof to insulate the proximal portion of the bottom conductive layer 904b and the Ag/AgCl layer 910 (Fig. 9C, para. [0113]-[0114]). Hoss also teaches that the Ag/AgCl layer 910 may be positioned at any suitable location on the tail portion 900 of the bottom conductive layer 904b (Figs. 9B-9C, para. [0112]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the position of the Ag/AgCl layer 910 and the length of the layer 908b of Hoss to both shift to the left in Figs. 9B-9C to increase the size of the accessible surface of the bottom conductive layer 904b such that the size of the accessible surface of the bottom conductive layer 904b maintained free from the layer 908b exceeds the size of the side edges of the Ag/AgCl layer 910 by a factor of at least 25 or 50 in order to yield the predictable result of insulating the proximal portion of the bottom conductive layer 904b and the Ag/AgCl layer 910 (Figs. 9B-9C, para. [0113]). Furthermore, the Federal Circuit has held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. MPEP § 2144.04(IV)(A). Additionally, generally, differences in a rearrangement of parts will not support the patentability of subject matter encompassed by the prior art absent persuasive evidence that the particular configuration is significant. MPEP § 2144.04(VI)(C).
Response to Arguments
Applicant's arguments filed March 9, 2026 have been fully considered but they are not persuasive.
In the arguments presented on page 5 of the amendment, Applicant argues that in Applicant's sensors, the size of the accessible surface of the conductive layer that is free of the protective layer greatly exceeds the accessible area of the silver comprising layer, which, surprisingly, significantly lowers Equivalent Series Resistance ("ESR") when applying a fast transient voltage. Applicant asserts that instant Fig. 4 provides the evidence of criticality of the ratio now recited in claim 1.
Examiner respectfully disagrees. Applicant has not established criticality of the claimed range of the factor in claim 1. Fig. 4 in the instant disclosure only shows results for a factor of 0 (prior art analyte sensor 160 where 0 mm2 / 0.025 mm2 = 0) and a factor of 56 (exemplary analyte sensor 110 where 1.4 mm2 / 0.025 mm2 = 56) (para. [0168]-[0170] of the instant US PGPub). The claimed range is a factor of at least 10, yet Fig. 4 only shows one result outside of the claimed range (factor of 0) and one result inside the claimed range (factor of 56), and these results are not near the end point (factor of 10) of the claimed range to show that the specific range yields unexpected results. To establish unexpected results over a claimed range, applicant should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). The specification generically disclosing at para. [0173]-[0177] of the instant US PGPub that the exemplary analyte sensors 110 exhibit a considerably decreased value for the ESR due to the predominant contribution of the accessible surface 156 does not show that the claimed range achieves unexpected results. The burden is on applicant to establish that results are unexpected and significant. See MPEP § 716.02. Applicant has not shown that the claimed ranges produce unexpected results. Further, although Hoss does not disclose that the drawings are to scale, it has been held that the description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art. In re Wright, 569 F.2d 1124, 1127-28, 193 USPQ 332, 335-36 (CCPA 1977). MPEP § 2125(II). In this case, when viewing Figs. 9B-9C (see Image 1 above) of Hoss, Examiner notes that the size of the accessible surface of the bottom conductive layer 904b (including the front edge, side edges, and planar surface of the bottom conductive layer 904b that are not covered by the layer 908b) is much larger than the size of the side edges of the Ag/AgCl layer 910 and also appears to exceed the size of side edges of the Ag/AgCl layer 910 by a factor of at least 10. Furthermore, Hoss teaches that the layer 908b may extend any suitable length of the analyte sensor's tail section, i.e., it may extend the entire length of both of the primary and secondary conductive layers 904b, 910 or portions thereof to insulate the proximal portion of the bottom conductive layer 904b and the Ag/AgCl layer 910 (Fig. 9C, para. [0113]-[0114]). Since the general conditions of the claim are disclosed in the prior art of record, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
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/V.T./ Examiner, Art Unit 1794
/JAMES LIN/ Supervisory Patent Examiner, Art Unit 1794