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 . 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 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.
Response to Amendment
This Office Action is responsive to the amendment filed 07/22/2025 (“Amendment”). Claims 174-183, 188-193, 196-198, and 200-204 are currently under consideration. The Office acknowledges the amendments to claims 174 and 191, as well as the cancellation of claims 194 and 195.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “biorecognition element” in claim 175 and “analyte monitoring device” in claims 174 and 188-191 (because the claims do not include sufficient structure to achieve the function of analyte monitoring).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof (e.g. for “biorecognition element,” an enzyme as in claim 176, and for “analyte monitoring device,” device 110 as shown in Fig. 2A).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 174-179, 183, 196-198, 203, and 204 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2014/0378804 (“Kalvesten”) and US Patent Application Publication 2011/0077490 (“Simpson”).
Regarding claim 174, Kalvesten teaches [a] microneedle array for an analyte monitoring device (Fig. 9, multiple needles 376 – also see ¶ 0001, for electrical insulation of individual micro needle elements, and ¶ 0003, applications include arrays of micro-needles), the microneedle array comprising: a plurality of solid sensing microneedles (Figs. 6-10, solid needles 376 – also see claim 19, describing a device comprising a plurality of micro-electrodes in the form of micro-needles), wherein each sensing microneedle comprises: a body portion comprising a conductive core (Fig. 6, elements 376 are conductive so as to provide electrical communication between contacts 375 (Figs. 5, 6, etc.) and conductive coatings 401 (Figs. 9, 10, etc.) – see ¶¶s 0034, 0038, 0039, 0056, 0062, etc. – also note that there would be no need for insulative oxide 372 (¶ 0054) if the needles were not conductive) and an insulative sheath around the conductive core (Figs. 6-10, oxide 372 – also see Abstract, etc.); and a tapered portion distal to the body portion (Fig. 9, towards the top, above wafer 370) …, wherein the conductive core of the body portion provides an electrical connection to the [conductive coating] (conductive coatings 401 (Figs. 9, 10, etc.), ¶¶s 0034, 0038, 0039, 0056, 0062, etc.), and wherein the insulative sheath insulates the conductive core of the respective sensing microneedle such that each [conductive coating] is individually addressable and electrically isolated from every other [conductive coating] in the microneedle array (Abstract, ¶ 0034, etc.).
Kalvesten does not appear to explicitly teach the tapered distal portion comprising a working electrode configured to sense an analyte (although it does teach that this portion include a conductive coating 401 (Figs. 9 and 10), ¶ 0062), wherein the working electrode is on only a segment of the tapered portion (although it does teach the working electrode being disposed on and limited to the tapered portion (Fig. 16, ¶ 0075)), the working electrode being individually addressable and electrically isolated from other working electrodes.
Simpson teaches a transcutaneous analyte sensor (Title) that can be in the form of a microneedle (¶ 0304), including a working electrode for sensing an analyte of interest (¶¶s 0168, 0170, etc.). Simpson teaches the working electrode being disposed on only a segment of the tapered portion (Simpson: Figs. 15A and 15B and ¶ 0306 describe arranging a working electrode in a recess on a segment of the tapered portion).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the conductive coating of Kalvesten act as a working electrode, as in Simpson, for the purpose of enabling specific analyte detection (Simpson: ¶ 0146). It would have been obvious to create a recess for the working electrode of the combination, and to arrange it on only a segment of the tapered portion, as in Simpson, for the purpose of creating room for a membrane to be deposited over this portion (Simpson: ¶ 0306), and for protecting the electrode during insertion (Simpson: ¶ 0306)).
Regarding claims 175-177, Kalvesten-Simpson teaches all the features with respect to claim 174, as outlined above. Kalvesten-Simpson further teaches wherein at least one sensing microneedle comprises a biorecognition layer arranged over the working electrode, wherein the biorecognition layer comprises a biorecognition element, wherein the biorecognition element comprises an enzyme, wherein the enzyme is glucose oxidase (Simpson: ¶¶s 0146, 0205, for the purpose of detecting glucose).
Regarding claims 178 and 179, Kalvesten-Simpson teaches all the features with respect to claim 174, as outlined above. Kalvesten-Simpson further teaches wherein the microneedle array further comprises at least one microneedle comprising a counter electrode configured to source or sink current to sustain an electrochemical reaction on the working electrode of at least one sensing microneedle (Simpson: ¶¶s 0146, 0168, 0298, for the purpose of balancing current as described), wherein the microneedle array further comprises at least one microneedle comprising a reference electrode configured to provide a reference potential for at least one working electrode (Simpson: ¶ 0168, etc., for the purpose of referencing the working electrode).
Regarding claim 183, Kalvesten-Simpson teaches all the features with respect to claim 174, as outlined above. Kalvesten-Simpson further teaches wherein in at least one sensing microneedle, a portion of the working electrode is recessed into the tapered portion (Simpson: Figs. 15A and 15B and ¶ 0306 describe arranging a working electrode in a recess. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to create a recess for the electrode of the combination, as in Simpson, for the purpose of creating room for a membrane to be deposited over this portion of the electrode (Simpson: ¶ 0306), and for protecting the electrode during insertion (Simpson: ¶ 0306)).
Regarding claims 196 and 197, Kalvesten-Simpson teaches all the features with respect to claim 174, as outlined above. Kalvesten-Simpson further teaches wherein a first portion of the body portion of each sensing microneedle extends from a semiconductor substrate (Kalvesten: ¶¶s 0036, 0038, etc., a semiconductor substrate, Figs. 6, 8, etc., the microneedle extends beyond the substrate) and a second portion of the body portion of each sensing microneedle is within the semiconductor substrate (Kalvesten: Figs. 6, 8, 10, etc., as shown), wherein a section of the insulative sheath around the second portion of the body portion of each sensing microneedle forms an insulating moat that electrically isolates the second portion of the body portion of the respective sensing microneedle from the semiconductor substrate (Kalvesten: Abstract, ¶ 0034, etc.).
Regarding claim 198, Kalvesten-Simpson teaches all the features with respect to claim 174, as outlined above. Kalvesten-Simpson further teaches wherein the conductive core of the body portion provides the electrical connection between the working electrode and an electrical contact proximal to the body portion (Kalvesten: Fig. 6, elements 376 are conductive so as to provide electrical communication between contacts 375 (Figs. 5, 6, etc.) and conductive coatings 401 (Figs. 9, 10, etc.) – see ¶¶s 0034, 0038, 0039, 0056, 0062, etc. – also note that there would be no need for insulative oxide 372 (¶ 0054) if the needles were not conductive).
Regarding claim 203, Kalvesten-Simpson teaches all the features with respect to claim 174, as outlined above. Kalvesten-Simpson further teaches wherein the microneedle array further comprises a semiconductor substrate from which the plurality of solid sensing microneedles extend (Kalvesten: ¶¶s 0036, 0038, etc., a semiconductor substrate).
Regarding claim 204, Kalvesten-Simpson teaches all the features with respect to claim 174, as outlined above. Kalvesten-Simpson further teaches wherein the insulative sheath is the outermost layer of the body portion (Kalvesten: Figs. 6-10, oxide 372 – also see Abstract, etc.)).
Claim 180 is rejected under 35 U.S.C. 103 as being unpatentable over Kalvesten-Simpson in view of International Application Publication WO 2020/023804 (“Mansoor”).
Regarding claim 180, Kalvesten-Simpson teaches all the features with respect to claim 174, as outlined above. Kalvesten-Simpson does not appear to explicitly teach wherein in at least one sensing microneedle, the tapered portion comprises an insulated distal apex and the working electrode is proximal to the insulated distal apex.
Mansoor teaches a microneedle array (Title, Abstract), each needle of the array having an
insulated apex distal of the electrode (Fig. 17, electrode 1512 proximal of insulated tip portion 1510).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to insulate the apex of the microneedles of the combination, for the purpose of protecting the electrodes (Mansoor: ¶ 0219).
Claims 181 and 182 are rejected under 35 U.S.C. 103 as being unpatentable over Kalvesten-Simpson-Mansoor in view of US Patent Application Publication 2016/0157764 (“Di Palma”).
Regarding claims 181 and 182, Kalvesten-Simpson-Mansoor teaches all the features with respect to claim 180, as outlined above. Kalvesten-Simpson-Mansoor does not appear to explicitly teach wherein a distal end of the working electrode is offset from the insulated distal apex, wherein the distal end of the working electrode is offset from the insulated distal apex by an offset distance of at least about 10 μm, wherein the offset distance is measured along a longitudinal axis of the at least one sensing microneedle.
Di Palma teaches an electrode offset from a distal apex by greater than 10 μm (Fig. 4 shows that
the sensing area 22a, which is above the conductive layer/electrode 26, is larger than 10 μm in height
based on relative dimensions).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to offset the electrodes of the combination by at least 10 μm as in Di Palma, for the purpose of protecting them during insertion (Simpson: ¶ 0306; Mansoor: ¶ 0219), and as a known electrode arrangement on a microneedle, that produces a predictable result (Di Palma: Fig. 4, ¶ 0005, etc.) and is a mere matter of design choice (Di Palma: ¶ 0053). Further, the offset distance is a known results-effective variable because it can be changed as desired to expose different amounts of the electrode, or to protect against different types of insertions. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to choose a distance greater than 10 μm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges through routine experimentation is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 188-190 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2016/0213908 (“McAllister”) in view of Kalvesten and Simpson.
Regarding claims 188-190, McAllister teaches [a]n analyte monitoring device (¶ 0077, monitoring whether an analyte was successfully collected) comprising the microneedle array of claim 174 (as outlined above, which would have been obvious to use for the array 214 shown in Fig. 2A of McAllister as a simple substitution of one microneedle array for another, with predictable results (¶ 0077, diagnostic application)) and a wearable housing (Fig. 2A, substrate 216 – also see Figs. 9-11, showing the microneedles extending from a substrate, and Figs. 12A-12C, showing indicator structure 1210), wherein the microneedle array extends outwardly from the housing (as shown in Fig. 2A, etc.), wherein the housing comprises one or more indicator lights configured to communicate status information (¶¶s 0070, 0071, etc., a light to indicate the application of sufficient pressure), wherein the analyte monitoring device is a skin-adhered patch (Abstract).
Claims 191-193 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2011/0077490 (“Simpson”) in view of US Patent Application Publication 2014/0378804 (“Kalvesten”).
Regarding claim 191, Simpson teaches [a] method for monitoring a user, comprising: accessing a dermal interstitial fluid (¶ 0140, interstitial fluid) of the user with an analyte monitoring device (Figs. 5D and 11, Abstract, ¶ 0292, Figs. 15A and 15B, etc.) comprising a [microneedle] (Figs. 5B, 5D, 15A, 15B, ¶¶s 0304, 0305, etc.) … comprising … a tapered portion distal to the body portion and comprising a working electrode configured to sense an analyte (¶¶s 0168, 0170, 0305, 0306, Fig. 15B, on tissue piercing element 1512, etc.), wherein the working electrode is on only a segment of the tapered portion (Figs. 15A and 15B and ¶ 0306 describe arranging a working electrode in a recess on a segment of the tapered portion), …; and quantifying one or more analytes in the dermal interstitial fluid (Abstract, analyte concentrations) … .
Simpson does not appear to explicitly teach the analyte monitoring device comprising a single microneedle array (although ¶ 0304 does mention a microneedle), the single microneedle array comprising a plurality of solid sensing microneedles, each of the plurality of solid sensing microneedles comprising: a body portion comprising a conductive core and an insulative sheath around the conductive core, and a tapered portion distal to the (particular) body portion and comprising a working electrode configured to sense an analyte (although Simpson does teach a tapered portion comprising a working electrode, as outlined above), wherein the conductive core of the body portion provides an electrical connection to the working electrode; and quantifying the analytes in the dermal interstitial fluid using the plurality of solid sensing microneedles in the microneedle array, wherein the insulative sheath insulates the conductive core of the respective solid sensing microneedle such that each working electrode is individually addressable and electrically isolated from every other working electrode in the analyte monitoring device.
Kalvesten teaches a microneedle array for an analyte monitoring device (Fig. 9, multiple needles 376 – also see ¶ 0001, for electrical insulation of individual micro needle elements, and ¶ 0003, applications include arrays of micro-needles), the microneedle array comprising: a plurality of solid sensing microneedles (Figs. 6-10, solid needles 376 – also see claim 19, describing a device comprising a plurality of micro-electrodes in the form of micro-needles), wherein each sensing microneedle comprises: a body portion comprising a conductive core (Fig. 6, elements 376 are conductive so as to provide electrical communication between contacts 375 (Figs. 5, 6, etc.) and conductive coatings 401 (Figs. 9, 10, etc.) – see ¶¶s 0034, 0038, 0039, 0056, 0062, etc. – also note that there would be no need for insulative oxide 372 (¶ 0054) if the needles were not conductive) and an insulative sheath around the conductive core (Figs. 6-10, oxide 372 – also see Abstract, etc.); and a tapered portion distal to the body portion (Fig. 9, towards the top, above wafer 370) and comprising a [conductive coating], wherein the conductive core of the body portion provides an electrical connection to the [conductive coating] (conductive coatings 401 (Figs. 9, 10, etc.), ¶¶s 0034, 0038, 0039, 0056, 0062, etc.), and wherein the insulative sheath insulates the conductive core of the respective solid sensing microneedle such that each [conductive coating] is individually addressable and electrically isolated from every other [conductive coating] in the microneedle array (Abstract, ¶ 0034, etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the microneedle array of Kalvesten with the sensor device of Simpson, for the purpose of enabling the electrodes (of Simpson) to be individually addressable and electrically isolated from every other electrode (Kalvesten: Abstract, ¶ 0034, etc.), for detecting on an electrode-by-electrode basis, thereby obtaining spatial data, as the simple substitution of one means of accessing dermal interstitial fluid for another with predictable results (Kalvesten: claim 19, electrodes), and as already contemplated to achieve miniaturization, minimal invasiveness, and ease of manufacture (Simpson: ¶ 0304). It would have been obvious to keep a recess for the working electrode on the tapered portion of the microneedle of the combination, as in Simpson, for the purpose of creating room for a membrane to be deposited over this portion (Simpson: ¶ 0306), and for protecting the electrode during insertion (Simpson: ¶ 0306)).
Regarding claims 192 and 193, Simpson-Kalvesten teaches all the features with respect to claim 191, as outlined above. Simpson-Kalvesten further teaches wherein quantifying one or more analytes comprises quantifying a plurality of analytes in the dermal interstitial fluid using the plurality of solid sensing microneedles (Simpson: ¶ 0295), wherein the plurality of analytes comprises glucose (Simpson: ¶ 0140).
Claim 200 is rejected under 35 U.S.C. 103 as being unpatentable over Kalvesten-Simpson in view of US Patent Application Publication 2016/0157764 (“Di Palma”).
Regarding claim 200, Kalvesten-Simpson teaches all the features with respect to claim 174, as outlined above. Kalvesten-Simpson does not appear to explicitly teach wherein in at least one sensing microneedle, a distal end of the working electrode is offset from a distal apex of the tapered portion.
Di Palma teaches an electrode offset from a distal apex by greater than 10 μm (Fig. 4 shows that
the sensing area 22a, which is above the conductive layer/electrode 26, is larger than 10 μm in height
based on relative dimensions).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to offset the electrodes of the combination by at least 10 μm as in Di Palma, for the purpose of protecting them during insertion (Simpson: ¶ 0306; Mansoor: ¶ 0219), and as a known electrode arrangement on a microneedle, that produces a predictable result (Di Palma: Fig. 4, ¶ 0005, etc.) and is a mere matter of design choice (Di Palma: ¶ 0053).
Claim 201 is rejected under 35 U.S.C. 103 as being unpatentable over Kalvesten-Simpson-Di Palma in view of International Application Publication WO 2020/023804 (“Mansoor”).
Regarding claim 201, Kalvesten-Simpson-Di Palma teaches all the features with respect to claim 200, as outlined above. Kalvesten-Simpson-Di Palma does not appear to explicitly teach wherein the tapered portion of each sensing microneedle further comprises insulation distal to the working electrode.
Mansoor teaches a microneedle array (Title, Abstract), each needle of the array having an
insulated apex distal of the electrode (Fig. 17, electrode 1512 proximal of insulated tip portion 1510).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to insulate the apex of the microneedles of the combination, distal to the working electrodes, for the purpose of protecting the electrodes (Mansoor: ¶ 0219).
Claim 202 is rejected under 35 U.S.C. 103 as being unpatentable over Kalvesten-Simpson in view of US Patent Application Publication 2017/0007813 (“Negi”).
Regarding claim 202, Kalvesten-Simpson teaches all the features with respect to claim 174, as outlined above. Kalvesten-Simpson does not appear to explicitly teach wherein in at least one sensing microneedle, the working electrode is annular.
Negi teaches using annular electrically active sites on a microneedle (Fig. 6, ¶ 0057).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the working electrode of the combination with annular electrodes, as in Negi, for the purpose of enabling analysis at different depths (Negi: ¶ 0067, without having to advanced or retract the needle).
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 174 and 191 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,109,032. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are generally broader than, and therefore anticipated by, the claim of the reference patent.
Claims 174 and 191 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 11,478,194 in view of Kalvesten. Claim 11 of the reference patent details that the columnar body portion as insulated, and Kalvesten teaches that this insulation can extend with the needle through a semiconductive substrate (Abstract, ¶ 0034, Figs. 9 and 10, etc.). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to extend this insulation through the substrate for the purpose of preventing shorting to ensure that the electrodes were individually addressable (Kalvesten: Abstract, ¶ 0034, etc.).
Claims 174 and 191 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of copending Application No. 18/824,598. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are generally broader than, and therefore anticipated by, the claim of the reference application.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s arguments filed 07/22/2025 have been fully considered, but they are not persuasive.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Making the conductive coating of Kalvesten (or the electrode portion of Kalvesten in general) to be on only a segment of the needle is neither a complete reconstruction nor does it destroy its intended purpose. Examiner has not found where in Kalvesten it says that its purpose is to achieve lateral insulation within a device that is entirely covered in a conductive coating. Even if that is what Kalvesten does, it does not say that the structure or process is closed to modification or improvement. Indeed, the signal detected at the conductive coating/electrode, even when the coating is not on the entire tapered portion, would still travel though the needle 376 to the contact 375, and achieve Kalvesten’s purpose of creating lateral insulation for a wide range of applications (¶¶s 0005, 0007, etc.). Applicant also assumes that there would be a significant reduction in signal transmission area so as to detrimentally impact behavior and reliability. But, Simpson shows that the electrode is still on almost the entire surface of the tapered portion. Thus, it is entirely possible to achieve the benefits of Simpson (which provide the motivation for combination, not hindsight) without significantly altering Kalvesten. Notably, the portions of coating 401 that are above wafer 370 are not considered part of the signal transmission area because they are electrically isolated from the needle/electrode.
The modification does not leave Kalvesten’s disclosure hollow because lateral insulation is still achieved. And, Simpson teaches the desirability of additional benefit (e.g. using a membrane to protect the electrodes during insertion (Simpson: ¶ 0306)), which would have been obvious to incorporate. Not every skilled person would always want to only minimize costs, at the expense of other features. But this is what Applicant argues. Kalvesten does not teach a requirement to minimize costs. It simply teaches a cost-effective method. Another skilled person would want to add features, even if at an expense. There is no teaching away because Kalvesten does not disparage other methods. And, there is nothing limiting further processing of the wafer after application of coating 401, such as the addition of insulating or other layers onto the tapered portion.
The Office disagrees that use of a recess and membrane would provide no value to Kalvesten. Simpson teaches that this configuration protects the electrode during insertion. Thus, the integrity of Kalvesten’s electrodes would be improved. Kalvesten itself need not teach these benefits, since they are taught by Simpson.
As noted above, the modification also need not disadvantageously or significantly reduce the surface area of Kalvesten’s coating. Simpson teaches that the electrode is on the majority of the tapered portion of the needle. Other portions of coating 401 do not actually interface with contact 375 and therefore do not contribute to the measurement.
Kalvesten does not teach that its coating 401 e.g. protects the system from parasitic capacitance, leakage paths, contamination by moisture, floating nodes, etc. This is all Applicant’s speculation. As admitted/argued by Applicant, Kalvesten uses coating 401 to minimize cost, not to protect the substrate.
Regarding claim 191, the embodiment in Fig. 12 of Simpson is different than the embodiment of Fig. 15. And, both embodiments would have been obvious to replace with an array like that of Kalvesten, while seeking to achieve the benefits explained with respect to Simpson’s Fig. 15. Further, Applicant has not addressed all motivations provided for modifying Simpson based on Kalvesten.
All claims remain rejected in light of the prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791