DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 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been timely paid, the finality of the previous Office action (mailed 18 November 2025, "1st Final Rejection") has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12 February 2026 has been entered.
Status of Claims
Claim(s) 39-40, 42-44, 49-51 and 53-58 is/are currently amended. Claim(s) 1-38, 41, 45-48 and 52 has/have been canceled. Claim(s) 39-40, 42-44, 49-51 and 53-58 is/are pending.
Rejections Withdrawn
Rejections under 35 U.S.C. 112(b) (pre-AIA 35 U.S.C. 112, second paragraph) presented in the 1st Final Rejection, but not reproduced below, have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
Claim Objections
Claim(s) 56 is/are objected to because of the following informalities: the duplicate "of apertures" should be deleted from the end of the claim.
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 pre-AIA 35 U.S.C. 112, second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 42, 51 and claims dependent thereon is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention.
Regarding claim 42, claim 51, and claims dependent thereon, there is insufficient antecedent basis for "the complementary reactant" in each of the limitation "the second transport material being permeable to the complementary reactant and impermeable to the target analyte" of claim 42 and the limitation "the rib of second transport material being permeable to the complementary reactant and impermeable to the target analyte" of claim 51. For the purpose of this Office action, claims 42 and 51 will be further discussed with the understanding they are dependent on claims 40 and 50, respectively, which provide sufficient antecedent basis for the above-noted term.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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.
Claim(s) 39-40 and 49-50 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0173711 A1 (previously cited, Shah) in view of US 2004/0111017 A1 (previously cited, Say).
Regarding claims 39-40, Shah discloses and/or suggests a working electrode assembly comprising:
a working conductor (Figs. 1, 4, etc., conductive layer 54a forming electrode 18a) having a planar top surface (Figs. 1, 4, etc., planar surface of conductive layer 54a/electrode 18a opposite base layer 42) including a sensing surface portion (Figs. 1, 4, etc., portion of conductive layer 54a/electrode 18a, or planar top surface thereof, exposed by aperture 19a and/or opening in cover layer 44a);
an insulator layer disposed over the planar top surface of the working conductor and defining an aperture that exposes the sensing surface portion (Figs. 1, 4, etc., aperture 19a and/or opening in cover layer 44a);
an enzyme layer disposed on the sensing surface portion of the planar top surface of the working conductor (Fig. 4, etc., sensor chemistry layer 72; ¶ [0032] sensor chemistry layer 72 is an enzyme layer), the enzyme layer filling the aperture of the insulator layer and protruding above a top surface of the insulator layer and extending laterally on to a portion of the top surface of the insulator layer (e.g., Fig. 4); and
at least one additional layer of material applied over the enzyme layer (Fig. 4, layers 74, 76, etc.), wherein the additional layer(s) is/are substantially centered over the working conductor and/or aperture, wherein each of enzyme layer and additional layer(s) have exposed lateral edges at the lateral edges of the assembly (Fig. 4).
Shah discloses the additional layer(s) of material applied over the enzyme layer are provided to, inter alia, regulate the amount of enzyme (e.g., glucose) that contacts the enzyme layer on the electrode (e.g., ¶ [0034]). Shah does not disclose the additional layer(s) comprise a layer of first transport material disposed over the enzyme layer, laterally encasing the enzyme layer by extending onto the top surface of the insulator layer laterally outside of the enzyme layer, the first transport material being permeable to a target analyte and/or configured to permit diffusion of the target analyte without limiting analyte flux relative to a complementary reactant; and a layer of second transport material applied over the layer of first transport material and sealing a portion of a top surface, the second transport material being permeable to the complementary reactant and impermeable to the target analyte.
Say discloses a working electrode assembly comprising: an enzyme layer disposed on a sensing surface (sensing layer 134 deposited on or near a working electrode; ¶ [0035]), wherein the enzyme layer does not extend to the lateral edge(s) of the working electrode assembly (¶ [0036] the sensing layer 134 may be recessed from the edge). In such embodiments, Say discloses care must be taken to ensure that the enzyme layer is directly or through a layer of first transport material exposed at an edge of the assembly (¶ [0036]), wherein the first transport material is permeable to a target analyte (glucose) and/or configured to permit diffusion of the target analyte without limiting analyte flux relative to a complementary reactant (oxygen) (¶ [0034], ¶ [0036], etc., analyte-permeable membrane). Say discloses the working electrode assembly further comprises a layer of second transport material permeable to complementary reactant and impermeable to the target analyte (top layer 116; ¶ [0037] top layer 116 can allow passage of reactants (e.g., oxygen) through the top layer 116 and can be impervious to the analyte), wherein the layer of second transport material is applied over and seals a top surface of the layer of first transport material, so that flux of target analyte to the enzyme layer is limited, e.g., through the exposed lateral surface(s) of the layer of the first transport material (¶ [0037] top layer 116 covers as much of the implanted portion of the working electrodes 104 as possible other than at the sensing region edge; ¶ [0046]; etc.). Say discloses the above-noted sensor geometry inherently limits the mass transport of analyte to the sensing layer, thereby eliminating the need for a mass transport limiting membrane (e.g., ¶ [0063]).
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 working electrode assembly of Shah with the enzyme layer not extending to the lateral edges of the working electrode assembly (i.e., the lateral edges of the enzyme layer being recessed from the lateral edges of the insulator layer), and the additional layer(s) comprising a layer of a first transport material disposed over the enzyme layer and extending onto the top surface of the insulator layer laterally outside of the enzyme layer thereby laterally encasing the enzyme layer, the layer of first transport material being permeable to a target analyte and/or permitting diffusion of the target analyte without limiting analyte flux relative to a complementary reactant and having exposed lateral/side surfaces; and a layer of second transport material is applied over/sealing a top surface of the layer of the first transport material, the second transport material being permeable to the complementary reactant and impermeable to the target analyte as taught/suggested by Say in order to restrict entry of analyte to the enzyme layer to the exposed surfaces of the first transport material, thereby addressing a fundamental constraint on subcutaneous glucose sensors based on peroxide detection, namely the dependence of the signal on a stoichiometrically adequate supply of oxygen to the sensing layer (Say, ¶ [0046]) and/or as a simple substitution of one means for ensuring an excess of oxygen and a restricted amount of analyte to the working electrode (e.g., sensor/layer geometry) for another (e.g., an analyte-limiting membrane) to yield no more than predictable results. See MPEP 2143(I)(B).
Shah as modified does not expressly disclose the layer of first transport material comprises a "first rib," or said layer terminates inward of the lateral edges of the insulator layer. However, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the assembly of Shah with the layer of first transport material terminating inward of lateral edges of the insulator layer such that the exposed side surfaces of the first transport material are inwardly offset from the lateral edges of the insulator layer because Applicant has not disclosed that the above-noted configuration provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant discloses a layer of first transport material in which the lateral edges thereof extend to the lateral edges of the assembly, or the underlying insulator layer thereof, as a suitable alternative (e.g., Fig. 11T). As no evidence has been provided to the contrary, one of ordinary skill in the art, furthermore, would have expected Applicant's invention to perform equally well with the layer of first transport material having lateral exposed edges terminating at the lateral edges of the insulator layer as taught/suggested by Shah as modified above because either arrangement leaves the lateral edges of the layer of first transport material exposed to permit analyte flux therethrough.
Regarding claims 49-50, Shah discloses and/or suggests a working electrode assembly comprising:
a working conductor (Figs. 1, 4, etc., conductive layer 54a forming electrode 18a) having a planar top surface (Figs. 1, 4, etc., planar surface of conductive layer 54a/electrode 18a opposite base layer 42) including a sensing surface portion (Figs. 1, 4, etc., portion of conductive layer 54a/electrode 18a, or planar top surface thereof, exposed by aperture 19a and/or opening in cover layer 44a);
an insulator layer disposed over the planar top surface of the working conductor and defining an aperture that exposes the sensing surface portion (Figs. 1, 4, etc., aperture 19a and/or opening in cover layer 44a);
an enzyme layer disposed on the sensing surface portion of the planar top surface of the working conductor (Fig. 4, etc., sensor chemistry layer 72; ¶ [0032] sensor chemistry layer 72 is an enzyme layer), the enzyme layer filling the aperture of the insulator layer and protruding above a top surface of the insulator layer and extending laterally on to a portion of the top surface of the insulator layer (e.g., Fig. 4); and
at least one additional layer of material applied over the enzyme layer (Fig. 4, layers 74, 76, etc.), wherein the additional layer(s) is/are substantially centered over the working conductor and/or aperture, wherein each of enzyme layer and additional layer(s) have exposed lateral edges at the lateral edges of the assembly (Fig. 4).
Shah discloses the additional layer(s) of material applied over the enzyme layer are provided to, inter alia, regulate the amount of enzyme (e.g., glucose) that contacts the enzyme layer on the electrode (e.g., ¶ [0034]). Shah does not disclose the additional layer(s) comprise a layer of first transport material disposed over the enzyme layer, laterally encasing the enzyme layer by extending onto the top surface of the insulator layer laterally outside of the enzyme layer, the first transport material being permeable to a target analyte and/or configured to permit diffusion of the target analyte without limiting analyte flux relative to a complementary reactant; and a layer of second transport material applied over the layer of first transport material and sealing a portion of a top surface, the second transport material being permeable to the complementary reactant and impermeable to the target analyte.
Say discloses a working electrode assembly comprising: an enzyme layer disposed on a sensing surface (sensing layer 134 deposited on or near a working electrode; ¶ [0035]), wherein the enzyme layer does not extend to the lateral edge(s) of the working electrode assembly (¶ [0036] the sensing layer 134 may be recessed from the edge). In such embodiments, Say discloses care must be taken to ensure that the enzyme layer is directly or through a layer of first transport material exposed at an edge of the assembly (¶ [0036]), wherein the first transport material is permeable to a target analyte (glucose) and/or configured to permit diffusion of the target analyte without limiting analyte flux relative to a complementary reactant (oxygen) (¶ [0034], ¶ [0036], etc., analyte-permeable membrane). Say discloses the working electrode assembly further comprises a layer of second transport material permeable to complementary reactant and impermeable to the target analyte (top layer 116; ¶ [0037] top layer 116 can allow passage of reactants (e.g., oxygen) through the top layer 116 and can be impervious to the analyte), wherein the layer of second transport material is applied over and seals a top surface of the layer of first transport material, so that flux of target analyte to the enzyme layer is limited, e.g., through the exposed lateral surface(s) of the layer of the first transport material (¶ [0037] top layer 116 covers as much of the implanted portion of the working electrodes 104 as possible other than at the sensing region edge; ¶ [0046]; etc.). Say discloses the above-noted sensor geometry inherently limits the mass transport of analyte to the sensing layer, thereby eliminating the need for a mass transport limiting membrane (e.g., ¶ [0063]).
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 working electrode assembly of Shah with the enzyme layer not extending to the lateral edges of the working electrode assembly (i.e., the lateral edges of the enzyme layer being recessed from the lateral edges of the insulator layer), and the additional layer(s) comprising a layer of a first transport material disposed over the enzyme layer and extending onto the top surface of the insulator layer laterally outside of the enzyme layer thereby laterally encasing the enzyme layer, the layer of first transport material being permeable to a target analyte and/or permitting diffusion of the target analyte without limiting analyte flux relative to a complementary reactant and having exposed lateral/side surfaces; and a layer of second transport material is applied over/sealing a top surface of the layer of the first transport material, the second transport material being permeable to the complementary reactant and impermeable to the target analyte as taught/suggested by Say in order to restrict entry of analyte to the enzyme layer to the exposed surfaces of the first transport material, thereby addressing a fundamental constraint on subcutaneous glucose sensors based on peroxide detection, namely the dependence of the signal on a stoichiometrically adequate supply of oxygen to the sensing layer (Say, ¶ [0046]) and/or as a simple substitution of one means for ensuring an excess of oxygen and a restricted amount of analyte to the working electrode (e.g., sensor/layer geometry) for another (e.g., an analyte-limiting membrane) to yield no more than predictable results. See MPEP 2143(I)(B).
Claim(s) 42-44, 51 and 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shah in view of Say as applied to claim(s) 39 and 49 above, and further in view of US 2001/0003045 A1 (previously cited, Davis).
Regarding claims 42-44, Shah as modified discloses/suggests the limitations of claim 39, and discloses/suggests the working electrode assembly comprises a layer of second transport material applied over and sealing a top surface of the layer of the first transport material, or "first rib," and substantially centered over the working conductor, wherein the second transport material being permeable to the complementary reactant and impermeable to the target analyte, as discussed above. Shah as modified does not disclose the layer of second transport material defines a second rib, or has a lateral width that is narrower than a lateral width of the first rib of first transport material, thereby exposing top edge surfaces of the first transport material laterally outside of the aperture.
Davis discloses/suggests a working electrode assembly comprising a comparable layer of second transport material (analyte barrier (AB) layer) applied on a top surface of a layer of first transport material (diffusion layer 18), wherein the layer of second transport material may be centered over the layer of first transport material or a working conductor (transducing element 12) surrounded thereby (e.g., Fig. 1) and not extend to the lateral edges of the working electrode assembly, or first transport material thereof (¶¶ [0059]-[0060]). Davis further discloses the amount (e.g., surface area) of the layer of the first transport material (diffusion layer) exposed by the above-noted application of the layer of the second transport material (AB layer), and/or the size of an aperture(s) in the layer of second transport material that define said exposure, are a function of, inter alia, the amount of analyte flux desired and the stoichiometry of the reaction (¶ [0060]).
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 working electrode assembly of Shah with the layer of second transport material defining a second "rib," or having a lateral width that is narrower than a lateral width of the first rib of first transport material, thereby exposing top edge surfaces of the first transport material laterally outside of the aperture, wherein the top edge surfaces of the first transport material increase surface area of exposed first transport material to increase flux of the target analyte within the first transport material (e.g., the layer of second transport material being applied to the top surface of the layer of first transport material in such a manner that a portion/the perimeter of said top surface is additionally exposed and capable of target analyte flux) as taught and/or suggested by Davis in order to increase surface area of exposed first transport material surface(s), permitting increased target analyte flux when needed or desired and/or based on the stoichiometry of the reaction (Davis, ¶ [0060]).
Regarding claims 51 and 53, Shah as modified discloses/suggests the limitations of claim 49, and discloses/suggests the working electrode assembly comprises a layer of second transport material applied over and sealing a top surface of the layer of the first transport material and substantially centered over the working conductor, wherein the second transport material being permeable to the complementary reactant and impermeable to the target analyte, as discussed above. Shah as modified does not disclose the layer of second transport material defines a rib, or has a lateral width that is narrower than a lateral width of the first transport material, thereby exposing top edge surfaces of the first transport material laterally outside of the aperture.
Davis discloses/suggests a working electrode assembly comprising a comparable layer of second transport material (analyte barrier (AB) layer) applied on a top surface of a layer of first transport material (diffusion layer 18), wherein the layer of second transport material may be centered over the layer of first transport material or a working conductor (transducing element 12) surrounded thereby (e.g., Fig. 1) and not extend to the lateral edges of the working electrode assembly, or first transport material thereof (¶¶ [0059]-[0060]). Davis further discloses the amount (e.g., surface area) of the layer of the first transport material (diffusion layer) exposed by the above-noted application of the layer of the second transport material (AB layer), and/or the size of an aperture(s) in the layer of second transport material that define said exposure, are a function of, inter alia, the amount of analyte flux desired and the stoichiometry of the reaction (¶ [0060]).
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 working electrode assembly of Shah with the layer of second transport material defining a "rib," or having a lateral width that is narrower than a lateral width of the first transport material, thereby exposing top edge surfaces of the first transport material laterally outside of the aperture (e.g., the layer of second transport material being applied to the top surface of the layer of first transport material in such a manner that a portion/the perimeter of said top surface is additionally exposed and capable of target analyte flux) as taught and/or suggested by Davis in order to increase surface area of exposed first transport material surface(s), permitting increased target analyte flux when needed or desired and/or based on the stoichiometry of the reaction (Davis, ¶ [0060]).
Claim(s) 54-58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shah in view of Say and Davis as applied to claim(s) 53 above, and further in view of US 2013/0245412 A1 (previously cited, Rong).
Regarding claims 54-58, Shah as modified discloses/suggests the limitations of claim 53, and discloses the working electrode assembly includes a first transport material disposed over the aperture/working electrode sensing portion, a rib of second transport material is applied over the first transport material sealing a portion of the top surface of the transport material over the aperture, wherein the rib of second transport material has a lateral width that is narrower than a lateral width of the first transport material, the rib of second transport materials being substantially centered over the aperture, as discussed above, but does not disclose the insulator layer includes a plurality of apertures, each aperture having a sensing surface portion, the plurality of apertures defining an array of apertures.
Rong discloses a working electrode assembly comprising: a working conductor having a surface including a plurality of sensing surface portions; an insulator layer applied to the surface of the working conductor, the insulator layer including a plurality and/or array of apertures, each aperture having a sensing surface portion (¶ [0209] plurality of micro-windows spaced and/or staggered along a length of the conductive core defining the electroactive portion of the working electrode); and an enzyme layer disposed on each of the plurality of sensing surface portions of the planar top surface of the working conductor (¶¶ [0165]-[0166] membrane 108 covers exposed electroactive portion of the working electrode; ¶ [0171] membrane includes an enzyme). Rong discloses a plurality or array of apertures (micro-windows) can be used as an alternative to a single, larger aperture (window 106) (e.g., ¶ [0209]).
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 working electrode assembly of Shah with the insulator layer including a plurality of apertures, each aperture having a sensing surface portion, the plurality of apertures defining an array of apertures (e.g., along the length of base layer 42), wherein each aperture within the array of apertures has the enzyme layer disposed on the sensing surface portion, the first transport material is disposed and centered over the array of apertures, the rib of second transport material is applied centered over the first transport material sealing a portion of the top surface of the transport material over the array of apertures, and the rib of second transport material has a lateral width that is narrower than a lateral width of the first transport material as taught and/or suggested by Rong, thereby providing a plurality array of smaller working electrode sensing portions configured as discussed above with respect to claim 49 as a simple substitution of one method or means for providing a sensing surface of a desired surface area for another to yield no more than predictable results. See MPEP 2143(I)(B).
Double Patenting
The nonstatutory double patenting ("NSDP") 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 NSDP 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 NSDP rejection 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 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 (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.
Claim(s) 39-40, 42-44, 49-51 and 53-58 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1 and 8 of USPN 11,298,059 in view of Shah and Say; or in view of Shah, Say and Rong.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 8 of USPN 11,298,059 recites each limitation of the pending claims with the exception of the transport material(s) being centered over the working conductor, the first transport material laterally encasing the enzyme layer, the first transport material defining a first rib (i.e., terminating in exposed side surfaces that are inwardly offset from the lateral edges of the insulator layer), and the insulator layer includes a plurality or array of apertures and sensing portions configured substantially the same as the aperture/sensing portion of claim 49. However, as discussed with respect to the prior art rejections above, Shah and Say, or Shah, Say and Rong, disclose/suggest each of the above-noted features and/or there is no/insufficient evidence of record that said features are any more than a mere matter of design choice. Accordingly, it would have been obvious to modify claims 1 and 8 of USPN 11,298,059 with said features for at least the reasons discussed with respect to the prior art rejections above and/or as a simple substitution of one suitable layered arrangement for another to yield no more than predictable results. See MPEP 2143(I)(B).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
With respect to the prior art rejection of claim 39, Applicant submits the first transport material terminating inward of lateral edges of the insulator layer, or defining a "first rib" with exposed side surfaces that are inwardly offset from the lateral edges is more than a mere matter of design choice, specifically citing Figs. 5D-E and the corresponding description thereof. Applicant contends said disclosure indicates the arrangement of claim 39 "provides an advantage of 'greater surface to enable increased flux of analyte within the first transport material,' relative to the embodiment described in Fig. 5D" (Remarks, pgs. 3-4).
The examiner respectfully disagrees. While the examiner acknowledges the specification indicates the embodiment of Applicant's Fig. 5E has "a greater surface area to enable increased flux of analyte," this is relative to the embodiment in Applicant's Fig. 5D, as acknowledged by Applicant. Further, it is not the length of the first transport material layer alone than provides the alleged benefit of Fig. 5E, but the relative lengths and/or relative arrangement of the first and second transport material layers. Accordingly, Applicant fails to disclose any advantage provided by, particular purpose for, or problem solved by the first material layer not extending to the edge of the insulator layer per se.
Further, Shah as modified by Say is not comparable to Applicant's Fig. 5D. Rather, Shah as modified to include layers of first and second transport materials (as taught/suggested by Say) reasonably discloses/suggests each of first and second transport material layers extend to the lateral surface of the assembly (comparable to the layers in Fig. 4 of Shah). Contrary to Applicant's alleged "benefit" of the claimed arrangement, shortening the layer of first transport material of Shah as modified such that it does not extend to the lateral edges of the assembly or underlying insulator layer would provide the top surface of the first transport material layer with less surface area, not more, particularly as claim 39 does not require any second transport material layer.
With respect to the rejection of claim 49, Applicant contends, "For at least reasons similar to those discussed above with respect to claim 39, the Applicant submits that the cited references fail to disclose or render obvious at least the highlighted features of amended claim 49. Therefore, the Applicant respectfully requests that claim 49 be allowed" (Remarks, pgs. 4-5).
The examiner respectfully disagrees. The only feature of claim 39 that Applicant argues is not disclosed/suggested by the cited prior art is the layer of first transport material defining a first rib, or having exposed side surfaces that are inwardly offset from the lateral edges of the underlying insulator layer. However, this feature is not required by claim 39. Claim 39 encompasses a first transport layer that extends laterally to the same extent as the underlying insulator layer and/or the overall assembly, comparable to the equal width layers disclosed by Shah/Shah as modified above.
Applicant's remarks again fail to acknowledge or address the double patenting rejections. In accordance with MPEP 714.03, since the amendment/reply is a bona fide attempt to advance the application, and is substantially a complete reply to the prior Office action, the examiner has accepted the amendment as an adequate reply and maintained the double patenting rejection(s). However, Applicant is reminded 37 C.F.R. 1.111(b) requires "The reply by the applicant or patent owner must be reduced to a writing which distinctly and specifically points out the supposed errors in the examiner's action and must reply to every ground of objection and rejection in the prior Office action" (emphasis added).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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/Meredith Weare/Primary Examiner, Art Unit 3791