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 .
Claims 1-11 and 33-40 are the currently pending claims hereby under examination. Claims 12-32 have been canceled.
Election/Restrictions
The Applicant’s election without traverse of Group I in the reply filed on 8/4/2026 is acknowledged.
Response to Amendment
The amendment filed on 8/4/2026 is not in conformance with the Office's rules and regulations regarding claim amendments. In particular, claim 38 does not have a status identifier when it should have the status identifier “New”. In an effort to continue prosecution, the amendments have been entered, but the Applicant should be mindful of the proper format for making amendments.
Drawings
The drawings are objected to under 37 CFR 1.84. Figure 11 contains four separate SEM views presented under the single designation “FIG. 11,” without individual identification of the respective views, and the text and identifying information appearing within the SEM images are not sufficiently legible to permit their contents to be readily understood. See 37 CFR 1.84(l), (o), and (u). The specification describes Figure 11 only generally as showing SEM images of micropillars having a coating of biosensitive material and does not identify or explain the respective views. Accordingly, it is not possible to determine from the drawings and specification what each of the four SEM views is intended to depict or how the respective views correspond to the written description. Applicant is required to submit a replacement drawing in which the respective SEM views are sufficiently clear and are individually identified, for example as FIGS. 11A-11D, and to amend the Brief Description of the Drawings and/or Detailed Description as necessary to identify what each respective view depicts. Any amendment must not introduce new matter.
Claim Interpretation
Claims 33 and 39 use the term “slurry” differently. Claim 33 affirmatively defines the composition of the micropillars present in the finished biosensor as conductive-metal particles suspended in a slurry. Claim 39 instead uses “in the slurry” within a manufacturing relationship describing how the porosity of the finished micropillars was varied. For purposes of examination, the recitation in claim 39 is treated as product-by-process language and does not require the slurry to remain in the finished micropillars. Only structural characteristics imparted to the finished product by the recited manufacturing relationship are accorded patentable weight. This interpretation does not resolve the separate indefiniteness arising from claim 39’s failure to identify the second quantity in the recited ratio as shown below.
Claim 37 recites “the micropillars have sides approximately 150 µm in length and a height of approximately 600 μm” in lines 1-2. Because claim 37 depends from claim 36, which ultimately depends from the biosensor of claim 1, the recited dimensions are interpreted as dimensions of the micropillars present in the claimed biosensor, rather than dimensions of micropillars of a mastermold or another manufacturing structure. The Instant Application distinguishes the dimensions selected for the micropillars by design from dimensional changes that may occur during manufacture. Original claim 10 generally contemplates that micropillars may be designed to vary in size, shape, or height within a single array or from array to array. Claim 37 positively selects particular side-length and height characteristics from that broader design flexibility. The general disclosure that micropillar dimensions may vary does not render the specific dimensions recited in claim 37 optional and does not establish that every possible combination of side length and height was originally disclosed. Separately, the Instant Application distinguishes the dimensions of the manufacturing structures from the dimensions of the resulting micropillars. Paragraph [0029] expressly describes the micropillars of the mastermold as having sides approximately 150 µm in length and a height of approximately 600 µm. Original claim 20 likewise expressly recited that “the micropillars in the mastermold” have sides approximately 150 µm in length and a height of approximately 600 µm. The disclosure thereafter describes forming green arrays using a negative production mold made from the mastermold and subsequently sintering the green arrays. Paragraph [0035] states that the micropillars have a tendency to shrink during sintering and provides as an example that a 150 µm per-side square micropillar may shrink to 125 µm. Paragraph [0032] likewise describes a square micropillar having 125 µm sides. In view of the disclosed 150 µm to 125 µm shrinkage example, the recitation of sides “approximately 150 µm in length” is interpreted to encompass, at least, a finished micropillar having sides of 125 µm. The Examiner does not assign a broader fixed numerical range to the term “approximately.” The disclosure does not, however, identify a corresponding post-sintering height associated with the disclosed 125 µm side dimension or otherwise identify approximately 600 µm as the height of a finished micropillar incorporated into the biosensor. Accordingly, for purposes of examination, claim 37 requires finished biosensor micropillars having the specifically recited combination of side length and height, with the side-length limitation interpreted as set forth above.
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.
Claim 3 recites “a means of offboarding output of the biosensor” in line 4. This limitation is interpreted under 35 U.S.C. § 112(f) because “means” is recited in functional terms to perform “offboarding output of the biosensor” and the limitation does not itself recite sufficiently definite structure for performing that function. The claimed function is “offboarding output of the biosensor.” The Instant Application at ¶[0039] discloses Bluetooth connectivity and electrical adaptors to external devices for offboarding results, and ¶[0040] identifies electrical connectors 812 as means for offboarding the sensor output. Accordingly, the limitation is interpreted to cover the disclosed Bluetooth connectivity and electrical adaptors or connectors to external devices, and equivalents thereof, for performing the claimed function. Because the means limitation is recited as one alternative within a “one or more of” list, claim 3 does not require that alternative to be present when another recited alternative is satisfied.
Claim Objections
Claims 2 and 39-40 are objected to because of the following informalities:
In claim 2, line 6: “printed circuity board” appears to contain a typographical error and should be revised to “printed circuit board”;
In claim 39, lines 2-3: “the particles of one or more conductive metals” and “the slurry” lack explicit antecedent basis, although in view of the claim language and the disclosure at ¶¶[0032] and [0037], the Examiner understands these terms to refer to conductive-metal particles and the slurry used to form the micropillars, respectively, and Applicant is requested to provide proper antecedent basis; and
In claim 40, line 2: “the particles of one or more conductive metals” lacks explicit antecedent basis, although in view of the claim language and the disclosure at ¶¶[0032] and [0037], the Examiner understands this term to refer to conductive-metal particles used to form the micropillars, and Applicant is requested to provide proper antecedent basis.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 33-35 and 37 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 33 recites “the micropillars are composed of particles of one or more conductive metals suspended in a slurry” in lines 1-2. The Instant Application at ¶[0031] describes depositing slurry 208 into cavities of production mold 206, and ¶[0032] states that the slurry consists of metal powder mixed with a binding agent. Paragraph [0034] describes removal of the resulting green arrays from the production mold. Paragraph [0035] then describes sintering the green arrays and expressly states that during sintering the binder molecules are burnt and removed from the arrays, creating porous voids in micropillars that at that point consist only of metal. Paragraph [0038] states that after manufacture the array of micropillars is used as the sensing element in the biosensor. Original claim 12 likewise recited mixing powdered metal with a binder to yield a slurry, forming green arrays, and sintering the green arrays. Thus, the original disclosure describes the slurry as a manufacturing precursor and, after sintering, expressly describes the binder as removed and the micropillars as consisting only of metal. The original disclosure therefore does not describe the finished biosensor micropillars as being composed of conductive-metal particles suspended in a slurry. Accordingly, the original disclosure does not reasonably convey to a person of ordinary skill that the inventor had possession of the biosensor as presently recited in claim 33.
Claims 34-35 are rejected by virtue of their dependence from claim 33.
Claim 37 recites “the micropillars have sides approximately 150 µm in length and a height of approximately 600 μm” in lines 1-2. As set forth above under Claim Interpretation, because claim 37 ultimately depends from the biosensor of claim 1, the recited dimensions apply to the micropillars present in the claimed biosensor. The original disclosure generally conveys that micropillar dimensions may be selected or varied as a matter of design. Original claim 10 states that micropillars “may vary in size, shape or height within a single array or from array to array.” The written-description issue therefore is not based on an interpretation that all disclosed micropillars must have one fixed size or height. However, the general disclosure that micropillar dimensions may be varied does not itself provide a range, representative finished-product dimensions, or other identifying information that reasonably conveys possession of every possible combination of micropillar side length and height. Claim 37 now positively selects a particular combination of finished micropillar dimensions from that broader design flexibility. The original disclosure does not reasonably convey possession of that particular finished-product combination. Paragraph [0029] expressly states that the micropillars of the mastermold are approximately 150 µm on a side and approximately 600 µm in height. Original claim 20 likewise expressly recited that “the micropillars in the mastermold” have sides approximately 150 µm in length and a height of approximately 600 µm. The disclosure thereafter describes creating a negative production mold from the mastermold, forming green arrays in the production mold, removing the green arrays, and sintering the green arrays (Instant Application, ¶¶[0030]-[0035]; original claim 12). Paragraph [0035] further states that the resulting micropillars have a tendency to shrink during sintering and provides as an example that a 150 µm per-side square micropillar may shrink to 125 µm. Paragraph [0032] likewise describes a square micropillar having 125 µm sides. Accordingly, the disclosure provides support for a finished micropillar having a 125 µm side dimension, which falls within the Examiner’s interpretation of sides “approximately 150 µm in length.” The disclosure does not provide comparable support for the claimed height in the finished biosensor micropillars. Neither the general disclosure that micropillar height may be varied by design nor the particular manufacturing disclosure identifies a finished micropillar having a height of approximately 600 µm in combination with the claimed side dimension. The approximately 600 µm height is expressly attributed to the micropillars of the mastermold, while the disclosure separately teaches that the produced micropillars may undergo dimensional shrinkage during sintering. The disclosure does not identify the corresponding post-sintering height of the disclosed 125 µm-side micropillar, provide another finished-micropillar example having a height of approximately 600 µm, or otherwise reasonably convey that approximately 600 µm was selected as the height of the finished micropillars incorporated into the biosensor. Thus, although the original disclosure reasonably conveys possession of biosensor micropillars whose size and height may be varied by design, it does not reasonably convey possession of the specific finished-product combination of dimensions presently recited in claim 37. Accordingly, claim 37 fails to comply with the written description requirement of 35 U.S.C. §112(a).
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 2-9, 33-35, and 39 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 2 recites “an array of the micropillars” in lines 7, but it is not clear if this recitation is the same as, related to, or different from “one or more arrays of micropillars” of claim 1, line 3. That is, it is not clear how the arrays in these two recitations re related. Clarification is required.
Claims 3-9 are rejected by virtue of their dependence from claim 2.
Claim 5 contains the trademark/trade name Bluetooth®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a wireless communication and, accordingly, the identification/description is indefinite.
Claim 6 recites “one or more of the working electrode electrodes, one or more of the reference electrode electrodes and one or more of the counter electrode electrodes” in lines 3-5, but it is not clear if these recitations are exactly the same as the recitations “one or more reference electrodes defined on the printed circuit board; one or more counter electrodes defined on the printed circuit board; and one or more working electrodes defined on the printed circuity board”, respectively, in claim 2, lines 4-6 or the recitations from claim 6, lines 3-5 are reciting subsets of the recitations from claim 2, lines 4-6. Clarification is required.
Claims 7-9 are rejected by virtue of their dependence from claim 6.
Claim 7 recites “a subject liquid” in line 3, but it is not clear if this recitation is the same as, related to, or different from “one or more subject liquids” in claim 1, line 5. The relationship between these two recitations should be made clear.
Claims 8-9 are rejected by virtue of their dependence from claim 7.
Claim 33 recites “the micropillars are composed of particles of one or more conductive metals suspended in a slurry” in lines 1-2. The Instant Application at ¶[0031] describes depositing slurry 208 into cavities of production mold 206, and ¶[0032] states that the slurry consists of metal powder mixed with a binding agent. Paragraph [0034] describes removal of the resulting green arrays from the production mold. Paragraph [0035] then describes sintering the green arrays and expressly states that during sintering the binder molecules are burnt and removed from the arrays, creating porous voids in micropillars that at that point consist only of metal. Paragraph [0038] states that after manufacture the array of micropillars is used as the sensing element in the biosensor. Original claim 12 likewise recited mixing powdered metal with a binder to yield a slurry, forming green arrays, and sintering the green arrays. Thus, the original disclosure describes the slurry as a manufacturing precursor and, after sintering, expressly describes the binder as removed and the micropillars as consisting only of metal. The scope of the claim is not clear since the claim structurally defines a product using a structural condition during the manufacturing process, but does not occur in the finished product. Such a mixing of structural conditions conveys two structural conditions that contradict each other. Such a contradiction is indefinite.
Claims 34-35 are rejected by virtue of their dependence from claim 33.
Claim 34 recites “the particles of conductive metals are in a range of 5 µm in size” in lines 1-2. The recitation identifies a “range” but supplies only a single numerical value and does not identify an upper limit, lower limit, tolerance, or other objective boundary for the range. The Instant Application at ¶[0032] similarly states that metal particles “may be in the 5 µm range,” but does not establish the bounds of that range. For purposes of examination, the Examiner interprets the limitation as encompassing conductive-metal particles approximately 5 µm in size. However, neither the claim nor the disclosure provides an objective standard for determining how much deviation from 5 µm remains within the recited range. Accordingly, the scope of claim 34 cannot be determined with reasonable certainty.
Claim 35 is rejected by virtue of its dependence from claim 34.
Claim 39 recites “the porosity of the micropillars is varied by varying a ratio of the particles of one or more conductive metals in the slurry” in lines 1-3. The phrase “a ratio of the particles of one or more conductive metals in the slurry” does not identify the second quantity against which the conductive-metal particles are compared. The Instant Application at ¶[0032] describes a slurry containing approximately 80% by weight metal particles and 20% by weight binding agent, and ¶[0037] states that micropillar porosity may be affected by “the ratio of the metal powder to the binder in the slurry.” These disclosures identify a metal-powder-to-binder relationship, while the present claim omits the binder or any other denominator. The claim therefore reasonably permits materially different interpretations, including a ratio of conductive-metal particles to binder, a proportion of conductive-metal particles relative to the total slurry, or a ratio involving another slurry constituent. For purposes of examination, the Examiner interprets the limitation as varying the ratio of conductive-metal particles to binder, consistent with ¶[0037]. That interpretation, however, is not compelled by the claim language. Accordingly, claim 39 is indefinite under 35 U.S.C. § 112(b).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 10-11 and 38 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, for failing to further limit the subject matter of the claim upon which it depends.
Claim 10 recites “micropillars may vary in size, shape or height within a single array or from array to array” in lines 1-2, and claim 11 recites “micropillars may vary in density, arrangement, porosity or composition from array to array” in lines 1-2. The phrase “may vary” is permissive and does not require the micropillars actually to differ in any of the recited characteristics, either within an array or from array to array. Claim 1 already encompasses biosensors in which those characteristics are the same as well as biosensors in which those characteristics differ. Because the recitations in claims 10 and 11 do not require any further limitation of the subject matter of claim 1, claims 10 and 11 fail to comply with 35 U.S.C. § 112(d).
Claim 38 recites “further comprising a coating of one or more biosensitive materials disposed on each array of micropillars” in lines 1-3. Claim 38 depends from claim 11, which in turn depends from claim 1. Claim 1 already requires “one or more arrays of micropillars coated with one or more biosensitive materials.” Thus, through its dependence from claim 1, claim 11 already requires the claimed micropillar arrays to be coated with one or more biosensitive materials. Claim 38 does not require any additional coating composition, property, or arrangement beyond the biosensitive coating already required. Accordingly, claim 38 does not further limit the subject matter of claim 11 and fails to comply with 35 U.S.C. § 112(d).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 10-11, and 38 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 41 of copending U.S. Application No. 18/013,951, hereinafter Reference or Ref, in view of Wang et al. (US 2018/0196025 A1), hereinafter Wang, and Janata et al. (US 2010/0197524 A1), hereinafter Janata.
Although the claims at issue are not identical, they are not patentably distinct from each other as shown below.
Instant Application Claim Language(bold + underlined = absent from / materially different from Ref claim)
Corresponding Reference-Claim Language
Concise Double-Patenting / Obviousness Analysis
Claim 1: A biosensor comprising an electronics module;
Ref claim 41: “one or more sensing electrodes in a chamber or channel configured to receive a liquid test sample”; Ref claim 41: “wherein the sensing electrode comprises a substrate and an electrode array comprising a working electrode, a counter electrode, and, optionally, a reference electrode on the substrate, and the working electrode comprises the electrode of claim 29.”
Ref claim 41 already claims a microfluidic analyte-sensing test device having an electrode array. Janata teaches a biosensor instrument in which the biosensor array is physically connected to a printed circuit board containing signal-processing circuitry (¶[0014], ¶¶[0082]-[0083]; claim 27). Adding the known signal-processing electronics provides the recited electronics module.
Claim 1: a sensing module comprising one or more arrays of micropillars coated with one or more biosensitive materials;
Ref claim 41: “wherein the sensing electrode comprises a substrate and an electrode array comprising a working electrode, a counter electrode, and, optionally, a reference electrode on the substrate, and the working electrode comprises the electrode of claim 29.” Ref claim 41, via its dependence from claim 29: “a substrate comprising a droplet-based printed, and optionally sintered, conductive material, and a coating comprising a binding reagent covalently bonded to the surface of the conductive material that binds to an analyte”
Ref claim 41/29 already requires a sensing-electrode working electrode having conductive material coated with an analyte-binding reagent. Wang teaches a working electrode formed by an array of free-standing micropillars, states that the three-dimensional micropillar arrangement increases effective sensing area and sensitivity, and expressly teaches modifying the protrusion surfaces with DNA/RNA molecules, including functionalized aptamers (¶¶[0026], [0028], [0044]; claim 14). Applying Wang’s micropillar architecture and biomolecular surface functionalization to Ref’s working electrode provides the recited micropillar array coated with biosensitive material while retaining the analyte-binding function required by inherited claim 29.
Claim 1: and a microfluidic module for routing one or more subject liquids to the sensing module.
Ref claim 41: “one or more sensing electrodes in a chamber or channel configured to receive a liquid test sample”
Ref claim 41 places the sensing electrode in a chamber or channel configured to receive the liquid test sample. The claimed microfluidic routing is therefore substantially present in Ref. Wang additionally teaches a microfluidic channel coupling an inlet to a chamber and directing sample liquid toward the micropillar working electrode (¶¶[0031]-[0032]).
Claim 10: The biosensor of claim 1 wherein micropillars may vary in size, shape or height within a single array or from array to array.
No corresponding limitation is recited in Ref claim 41 or inherited claim 29.
Under the interpretation applied in this action, “may vary” is permissive and does not require actual variation. Claim 10 therefore adds no mandatory limitation that renders the claim patentably distinct. Wang additionally discloses selectable micropillar heights of about 10 µm to about 1000 µm (¶[0026]).
Claim 11: The biosensor of claim 1 wherein micropillars may vary in density, arrangement, porosity or composition from array to array.
No corresponding limitation is recited in Ref claim 41 or inherited claim 29.
Under the interpretation applied in this action, “may vary” is permissive and does not require actual variation. Claim 11 therefore adds no mandatory limitation that renders the claim patentably distinct. Wang also discloses alternative protrusion arrangements and surface compositions (claim 5; ¶[0044]; claim 14).
Claim 38: The biosensor of claim 11 further comprising a coating of one or more biosensitive materials disposed on each array of micropillars.
Ref claim 41, via its dependence from claim 29: “a substrate comprising a droplet-based printed, and optionally sintered, conductive material, and a coating comprising a binding reagent covalently bonded to the surface of the conductive material that binds to an analyte”
Ref claim 29 already requires a coating comprising an analyte-binding reagent on the conductive material. In the single-array embodiment encompassed by claim 1, that coating is disposed on each array. Claim 38 therefore does not render the subject matter patentably distinct.
A person of ordinary skill would have applied Wang’s known micropillar working-electrode geometry to the working electrode of Ref claim 41 to increase effective electrode area and sensing sensitivity. The modification would retain the droplet-based printed, and optionally sintered, conductive material required by Ref claim 29 as the conductive working-electrode substrate or base and would provide Wang’s free-standing conductive micropillars electrically coupled thereto. Wang expressly teaches micropillar electrodes electrically connected to a base working electrode and further teaches functionalizing the micropillar surfaces with aptamers. The analyte-binding coating required by Ref claim 29 therefore would be retained on the conductive sensing surface rather than replaced by the modification. The skilled person also would have connected the resulting sensing device to Janata’s known printed-circuit-board signal-processing electronics so that the electrochemical sensor output could be processed in a biosensor instrument. Wang and Janata demonstrate compatible electrochemical sensing, microfluidic, and electronics structures, and the modifications would not require changing the analyte-binding function or liquid-sample arrangement required by Ref claim 41. Accordingly, claims 1, 10-11, and 38 are not patentably distinct from Ref claim 41 in view of Wang and Janata.
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 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 1, 10-11, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2018/0196025 A1), hereinafter Wang, and further in view of Janata et al. (US 2010/0197524 A1), hereinafter Janata.
Regarding claim 1, Wang teaches a chemical sensor for detecting analytes in a sample liquid (Wang, Abstract; ¶[0025]). Wang is in the same field of electrochemical microfluidic sensing of liquid samples as the Instant Application and is reasonably pertinent to the sensing problem addressed by the Instant Application because Wang employs a microfluidic sensor having a three-dimensional micropillar sensing surface and expressly contemplates functionalizing that sensing surface with DNA/RNA molecules, including functionalized aptamers, to enhance molecular interaction, sensitivity, selectivity, and the range of molecules that can be detected (Wang, ¶[0028], [0044]).
Wang teaches a sensing module comprising one or more arrays of micropillars coated with one or more biosensitive materials (Wang, ¶[0026]: the working electrode includes “a large number of free-standing micro-sized pillar electrodes or protrusions 24”; ¶[0028]: Wang describes “the three-dimensional arrangement of the micropillar array of working electrodes 18”; ¶[0044]: the surface of protrusions 24 may be modified with DNA/RNA molecules, including “functionalized aptamers,” wherein working electrode 18 provides the sensing module, protrusions 24 provide the micropillar array, and the functionalized aptamers provide biosensitive material on the micropillar surfaces; see also claim 14). This interpretation of “coated with” is consistent with the Instant Application, which describes micropillar geometry “functionalized by biosensitive nanomaterials” and subsequently refers to the micropillars as “coated with the nanomaterials” (Instant Application, ¶[0043]).
Wang further teaches a microfluidic module for routing one or more subject liquids to the sensing module (Wang, ¶[0031]: first microfluidic channel 28 couples inlet 12 to chamber 14; ¶[0032]: sample solution introduced through the first microfluidic channel is directed through subchannels 30 toward the micropillar working electrodes so that the micropillars participate in analyte collection, wherein the microfluidic channel and subchannels route the sample solution to the micropillar sensing module).
Also, regarding claim 1, Wang does not fully teach that a biosensor comprises an electronics module. Rather, Wang teaches an electrochemical chemical sensor whose micropillar sensing surfaces may be modified with DNA/RNA molecules, including functionalized aptamers, and further teaches contact pads electrically connected to the working, reference, and counter electrodes (Wang, ¶[0030], [0044]). However, Wang does not expressly disclose the claimed biosensor implementation having an electronics module.
Janata discloses electrochemical biosensor devices for detecting chemical or biochemical target analytes and teaches capture molecules that may be specific for one or more target analytes so that the biosensor detects interaction between a capture molecule and a target analyte (Janata, ¶[0034]-[0035]). Janata further discloses a biosensor instrument in which the biosensor array is physically connected to a printed circuit board containing signal-processing circuitry. Janata states that the printed circuit board is generally the first outside component to which the biosensor array is connected and that the printed circuit board contains signal-processing circuitry coupling the biosensor array to a signal-processing medium (Janata, ¶[0014], [0082]-[0083]; claim 27). Janata's claim 27 likewise expressly recites the printed circuit board, its signal-processing circuitry, and the electrical connection of the biosensor array to the printed circuit board as components of the biosensor instrument.
It would have been prima facie obvious to a person having ordinary skill in the art at the time of the invention to combine Wang with Janata by implementing Wang's aptamer-functionalized electrochemical sensing platform as an electrochemical biosensor and connecting the sensing platform to Janata's printed circuit board containing signal-processing circuitry, thereby providing a biosensor comprising an electronics module. A person of ordinary skill would have been motivated to make the modification because Wang expressly teaches that functionalizing the micropillar surfaces with DNA/RNA molecules, including functionalized aptamers, can enhance molecular interaction, sensitivity and/or selectivity, and the range of molecules that can be detected (Wang, ¶[0044]). Wang further expressly teaches that combining micromechanical parts with electronic circuitry provides an integrated MEMS product having fast computing and processing capabilities (Wang, ¶[0068]). The modification would have constituted a combination of known elements according to known methods, with Janata's biosensor architecture and printed-circuit-board signal-processing electronics performing their established biosensing and signal-processing functions in Wang's electrochemical sensing platform. A person of ordinary skill would have had a reasonable expectation of success because Wang already provides electrical contact pads for its electrochemical sensing electrodes, while Janata expressly teaches physically connecting a biosensor array to a printed circuit board containing signal-processing circuitry, such that the modification would not require changing Wang's micropillar geometry or microfluidic sample-routing arrangement (Wang, ¶[0030]; Janata, ¶[0082]-[0083]). The resulting device would provide the claimed biosensor and electronics module together with Wang's micropillar sensing module and microfluidic module.
Regarding claim 10, the modified Wang teaches that the biosensor micropillars may vary in size, shape or height within a single array or from array to array. As set forth above under 35 U.S.C. § 112(d), the phrase “may vary” is permissive and does not require the micropillars actually to differ in size, shape, or height either within a single array or from array to array. Accordingly, claim 10 imposes no mandatory limitation beyond the micropillar arrays of claim 1, and the modified Wang therefore satisfies the added recitation for the same reasons set forth regarding claim 1. Wang additionally teaches that each micropillar may have a height between about 10 μm and about 1000 μm, thereby expressly contemplating selectable micropillar heights, and its prototype includes an array of twenty-four micropillars each having a diameter of about 100 μm and a height of about 120 μm (Wang, ¶[0026], [0053]).
Regarding claim 11, the modified Wang teaches that the biosensor micropillars may vary in density, arrangement, porosity or composition from array to array. As set forth above under 35 U.S.C. § 112(d), the phrase “may vary” is permissive and does not require the micropillars actually to differ in density, arrangement, porosity, or composition from array to array. Accordingly, claim 11 imposes no mandatory limitation beyond the micropillar arrays of claim 1, and the modified Wang therefore satisfies the added recitation for the same reasons set forth regarding claim 1. Wang additionally confirms that micropillar characteristics are selectable by teaching alternative arrangements for the protrusions, including parabolic, rectilinear, diagonal, and curvilinear arrangements, and alternative surface compositions including metallic nanoparticles, two-dimensional materials, and DNA/RNA molecules (Wang, claim 5; ¶[0044]; claim 14).
Regarding claim 38, the modified Wang further teaches that the biosensor further comprises a coating of one or more biosensitive materials disposed on each array of micropillars, as discussed regarding claim 1 (Wang, ¶[0044]; claim 14). Wang teaches that the surface of protrusions 24 may be modified with DNA/RNA molecules, including “functionalized aptamers,” thereby providing the biosensitive coating on the micropillar array. As discussed regarding claim 1, this interpretation of “coating” is consistent with the Instant Application, which describes micropillar geometry “functionalized by biosensitive nanomaterials” and subsequently refers to the micropillars as “coated with the nanomaterials” (Instant Application, ¶[0043]).
Wang's single disclosed micropillar array also satisfies the recitation that the coating is disposed on “each” array because claims 1 and 38 encompass an embodiment having only one array, and in that embodiment the coating is disposed on that array.
Claims 2-7 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2018/0196025 A1), hereinafter Wang, and further in view of Janata et al. (US 2010/0197524 A1), hereinafter Janata, and further in view of Kahn et al. (US 2012/0187000 A1), hereinafter Kahn.
The modified Wang teaches the limitations of claim 1 as discussed above.
Regarding claim 2, the modified Wang does not fully teach that the electronics module comprises: a printed circuit board; one or more reference electrodes defined on the printed circuit board; one or more counter electrodes defined on the printed circuit board; and one or more working electrodes defined on the printed circuity board, each working electrode having an array of the micropillars coupled thereto. Rather, the modified Wang includes Janata's printed circuit board containing signal-processing circuitry as part of the electronics module (Janata, ¶[0014], [0082]; claim 27). Wang further teaches a working electrode 152, a reference electrode 154, a counter electrode 156, and a micropillar working electrode array 158, with all of the micropillar electrodes electrically connected to the base working electrode (Wang, ¶[0052]-[0054]). However, the modified Wang does not teach the reference, counter, and working electrodes defined on the printed circuit board.
Kahn discloses an electrochemical sensor comprising a printed circuit board having thereon a counter electrode, a reference electrode, and one or more working electrodes. Kahn further teaches that the printed circuit board brings the electrodes into electrical communication with connectors used to interface the electrochemical sensor with a computer system or other device (Kahn, ¶[0402]: “comprises a printed circuit board having thereon a counter electrode, a reference electrode and one or more working electrode”). Kahn also discloses an electrochemical sensor formed on a printed circuit board, with the electrodes disposed on the printed circuit board and a connector providing a connection between the sensor and a reader or other electronics unit (Kahn, ¶[0403]).
It would have been prima facie obvious to a person having ordinary skill in the art at the time of the invention to have further modified the modified Wang in view of Kahn by defining Wang's base working electrode, reference electrode, and counter electrode on the printed circuit board provided by Janata, in the manner taught by Kahn, while retaining Wang's micropillar array electrically coupled to the working electrode. A person of ordinary skill would have been motivated to make the modification because Kahn expressly teaches that providing the electrochemical electrodes on the printed circuit board brings the electrodes into electrical communication with connectors for interfacing the sensor with a computer system or other device, and further teaches connecting the resulting printed-circuit-board sensor to a reader or other electronics unit (Kahn, ¶[0402]-[0403]). Thus, placing Wang's electrochemical electrodes on the printed circuit board would provide the established PCB-based electrical interface between the sensing electrodes and associated electronics. A person of ordinary skill would have had a reasonable expectation of success because Kahn demonstrates working, reference, and counter electrodes disposed on a printed circuit board, while Wang expressly teaches that its micropillar electrodes are electrically connected to the base working electrode, such that Wang's micropillar-to-working-electrode coupling could be retained when the base working electrode is defined on the printed circuit board (Wang, ¶[0054]; Kahn, ¶[0402]). The modification would have constituted a combination of known elements according to known methods, with Kahn's printed-circuit-board electrode arrangement performing its established electrical-interconnection function. In Kahn's disclosed one-working-electrode embodiment, the resulting electronics module would comprise a printed circuit board having a reference electrode, a counter electrode, and a working electrode defined thereon, with Wang's micropillar array coupled to the working electrode, thereby satisfying the recited “one or more” electrode limitations and the requirement that each working electrode have an array of micropillars coupled thereto.
Regarding claim 3, with respect to the electronics module further comprising one or more of: circuitry for controlling operation of the biosensor, a power source, one or more indicators and a means of offboarding output of the biosensor, the modified Wang includes the printed-circuit-board-based electronics module established above, does not teach that the electronics module further comprises one or more indicators or a means of offboarding output of the biosensor. Because claim 3 recites the alternatives in a “one or more of” formulation, the limitation is satisfied when the electronics module includes any one of the listed alternatives. The rejection below relies on Kahn's display and Bluetooth transmitter as satisfying the indicator and offboarding alternatives, respectively. As set forth in the Claim Interpretation Under 35 U.S.C. § 112(f) above, the claimed function of the means limitation is offboarding output of the biosensor, and the corresponding structure includes Bluetooth connectivity and electrical adaptors or connectors to external devices, and equivalents thereof (Instant Application, ¶[0039]-[0040]).
Kahn teaches an analyte-monitoring system having a user interface with a display and further teaches that the system may alternatively be configured as “a one-unit disposable device including all electronics, microneedles, chemistry, sensors, mechanics and user interface.” Kahn expressly states that its design permits “any distribution of components between one or more system modules” based on considerations including system cost, user safety, and performance (Kahn, ¶[0302]). Kahn further teaches a portable-computing-device user interface having a display, including a monochrome or color LCD, that can display the measured analyte value, instructions for responding to the measured analyte level, or actions taken in response to the measured level (Kahn, ¶[0305]).
Kahn additionally teaches an electrochemical sensor, including an electrochemical sensor on a printed circuit board, having a transmitter for wirelessly transmitting sensor information to an external system configured to collect the information. Kahn teaches that the transmitter may be reduced in size so that it is included in the sensor or probe and expressly teaches configuring the electrochemical sensor for Bluetooth transmission (Kahn, ¶[0426]). Kahn's Bluetooth transmitter therefore provides structure corresponding to the Bluetooth-connectivity structure identified in the Instant Application for performing the claimed offboarding function.
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 have further modified the modified Wang in view of Kahn by configuring the electronics module to include Kahn's display for presenting sensor information to the user and Kahn's Bluetooth transmitter for offboarding sensor output to an external information-collection system. The modification would have been technically feasible because Kahn expressly teaches a one-unit device containing the sensor, electronics, and user interface and further permits components to be distributed among one or more system modules according to system-design considerations. Kahn also expressly teaches reducing the wireless transmitter in size so that it can be included within a printed-circuit-board electrochemical sensor or probe (Kahn, ¶[0302], [0426]). A person of ordinary skill would have been motivated to make the modification because Kahn identifies component distribution according to system cost, user safety, and performance as a design consideration, teaches using the display to present the measured analyte value and responsive information to the user, and teaches wireless transmission so that sensor information can be provided to an external information-collection system (Kahn, ¶[0302], [0305], [0426]). The modification therefore would have applied Kahn's known user-output and wireless-communication techniques to the compatible electrochemical sensing system for their established functions of providing local sensor information to a user and communicating sensor output to external equipment. A person of ordinary skill would have had a reasonable expectation of success because Kahn itself contemplates both integrated and distributed sensor-electronics architectures and expressly provides for miniaturization of the transmitter for inclusion in the electrochemical sensor or probe. The resulting electronics module would further comprise one or more indicators and a means of offboarding output of the biosensor corresponding to Bluetooth connectivity.
Regarding claim 4, the modified Wang teaches that the indicators include one or more of LED lights, digital read-outs and a display because the Kahn display teaching previously incorporated regarding claim 3 supplies the recited display. Kahn teaches a user interface having a display and specifically teaches that the display may be a monochrome or color LCD that displays the measured analyte value and other information concerning the measured analyte level (Kahn, ¶[0302], [0305]).
Regarding claim 5, the modified Wang teaches that the means of offboarding comprises one or more of Bluetooth® connectivity and electrical adaptors to external devices because the Kahn Bluetooth-transmitter teaching previously incorporated regarding claim 3 supplies the recited Bluetooth-connectivity alternative. Kahn expressly teaches an electrochemical sensor having a transmitter for wirelessly transmitting sensor information to an external collection system, wherein the transmitter may be included in the sensor or probe and the electrochemical sensor may be configured for Bluetooth transmission (Kahn, ¶[0426]).
Regarding claim 6, the modified Wang teaches that the microfluidic module defines one or more microfluidic elements, each microfluidic element defining a testing chamber, each testing chamber containing one or more of the working electrodes, one or more of the reference electrodes and one or more of the counter electrodes (Wang, ¶[0034]: working electrode 18, reference electrode 20, and counter electrode 22 are provided in second portion 36 and chamber 14 is defined between first portion 34 and second portion 36; ¶[0036]: first portion 34 includes first microfluidic channel 28 and chamber 14 “for electrochemical reaction,” while second portion 36 provides the sensor base supporting working electrode 18, reference electrode 20, and counter electrode 22, wherein Wang's assembled microfluidic structure provides a microfluidic element defining reaction chamber 14 with the working, reference, and counter electrodes disposed at the chamber for performing the electrochemical reaction).
Regarding claim 7, the modified Wang teaches that each microfluidic element further comprises: a channel to direct a subject liquid to the testing chamber (Wang, ¶[0031]: “A first microfluidic channel 28 couples the inlet 12 to the chamber 14”; ¶[0032]: when sample solution is pumped into the inlet passage of first microfluidic channel 28, the sample solution is directed through subchannels 30 toward the working electrode in chamber 14, wherein first microfluidic channel 28 directs the sample solution to the testing chamber; see also Wang, claim 7).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2018/0196025 A1), hereinafter Wang, and further in view of Janata et al. (US 2010/0197524 A1), hereinafter Janata, and further in view of Kahn et al. (US 2012/0187000 A1), hereinafter Kahn, and further in view of Battrell et al. (US 2009/0181411 A1), hereinafter Battrell.
The modified Wang teaches the limitations of claim 7 as discussed above.
Regarding claim 8, the modified Wang does not fully teach that each microfluidic element has a portion that, when pushed, forces the subject liquid through the channel into the testing chamber and into contact with the working electrodes, the reference electrodes and the counter electrodes. Rather, Wang teaches that sample solution is pumped into first microfluidic channel 28 and directed through the microfluidic flow path into chamber 14 and toward the sensing electrodes (Wang, ¶[0031]-[0032], [0034], [0036]). However, Wang does not teach that the microfluidic element has a portion that, when pushed, provides the pumping force that drives the subject liquid through the channel into the testing chamber.
Battrell teaches microfluidic devices having manually actuated bellows or diaphragm pumps fluidically connected with microfluidic channels. Battrell teaches that such pumps may be operated by hand and may be used in place of external drives to propel sample and reagent flow through microfluidic-device-based assays (Battrell, ¶[0066]). Battrell further teaches a manual bellows-pump embodiment in which depressing a flexible pump surface displaces fluid from the bellows reservoir through fluidically connected microchannels, with depression of the pump surface generating positive pressure to produce fluid flow through the microfluidic device (Battrell, ¶[0120]-[0121]; see also ¶[0069]).
It would have been prima facie obvious to a person having ordinary skill in the art at the time of the invention to have further modified the modified Wang in view of Battrell by providing Wang's microfluidic element with Battrell's manually depressible pump portion so that pushing the pump portion supplies the pumping force for moving the subject liquid through Wang's microfluidic channel and into the testing chamber. The modification would have been technically feasible because Battrell expressly teaches integrating a manually depressible pump with microfluidic channels such that depression of the pump surface generates positive pressure and displaces fluid through the fluidically connected channels (Battrell, ¶[0120]-[0121]). A person of ordinary skill would have been motivated to make the modification because Battrell expressly teaches using manually operated microfluidic pumps in place of external drives to propel sample and reagent flow through microfluidic assay devices, thereby providing an onboard mechanism for generating the pumping action used to move sample through the microfluidic flow path (Battrell, ¶[0066]). The modification would have constituted the application of a known microfluidic pumping technique to a compatible microfluidic sensing device for the established purpose of propelling sample liquid through a microfluidic channel. A person of ordinary skill would have had a reasonable expectation of success because Battrell demonstrates that manual depression of its pump produces positive-pressure flow through connected microchannels without requiring alteration of the downstream assay components. The resulting microfluidic element would have a portion that, when pushed, forces the subject liquid through Wang's channel into the testing chamber and into contact with the working, reference, and counter electrodes already positioned for sensing therein.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2018/0196025 A1), hereinafter Wang, and further in view of Janata et al. (US 2010/0197524 A1), hereinafter Janata, and further in view of Kahn et al. (US 2012/0187000 A1), hereinafter Kahn, and further in view of Puntambekar et al. (US 2012/0328488 A1), hereinafter Puntambekar.
The modified Wang teaches the limitations of claim 7 as discussed above.
Regarding claim 9, the modified Wang does not fully teach that the microfluidic element comprises an absorbent material that, when absorbing a sacrificial liquid, creates a vacuum that pulls the subject liquid through the channel into the testing chamber and into contact with the working electrodes, the reference electrodes and the counter electrodes. Rather, Wang teaches that a sample solution is pumped into the inlet passage of first microfluidic channel 28 and directed through subchannels 30 toward the micropillar working electrodes, and further teaches pumping the sample solution through inlet 12 and first microfluidic channel 28 into reaction chamber 14 (Wang, ¶[0032], [0038]). However, Wang does not teach using an absorbent material and a sacrificial liquid to provide the pumping force. The recitation “when absorbing a sacrificial liquid” identifies the condition under which the absorbent material performs the recited suction function and does not separately require the sacrificial liquid itself to be a component of the claimed biosensor.
Puntambekar teaches a microfluidic fluid-routing arrangement in which a microchannel is fluidically connected to an absorbent pad. When liquid reaches the absorbent pad, the pad exerts a stronger capillary force and draws liquid through the microchannel (Puntambekar, ¶[0058]; see also ¶[0025]). Puntambekar further explains that, after initial filling, the channel acts as a fixed resistance while “the pad acts as a vacuum (or capillary suction) source,” and that the flow rate may be controlled by, among other things, the absorbing characteristics of the pad (Puntambekar, ¶[0068]-[0071]). Puntambekar additionally teaches an embodiment in which a first “priming liquid,” such as isopropyl alcohol, is used to fill the channel, the priming liquid contacts the absorbent pad to create a continuous fluid path to the loading well, and “[l]iquids added thereafter will be automatically drawn into the channel” (Puntambekar, ¶[0091]). The priming liquid thus corresponds to the sacrificial liquid because it is a liquid used to prime the fluidic path and establish the capillary connection to the absorbent pad before the subsequently introduced liquid is drawn through the channel.
It would have been prima facie obvious to a person having ordinary skill in the art at the time of the invention to have further modified the modified Wang in view of Puntambekar by fluidically coupling an absorbent material to Wang's microfluidic flow path and using a priming liquid to establish the fluidic connection to the absorbent material, such that the resulting capillary suction provides the pumping force for drawing subsequently introduced subject liquid through Wang's first microfluidic channel and into the testing chamber containing the working, reference, and counter electrodes. The modification would have been technically feasible because Puntambekar expressly teaches coupling an absorbent pad to a microfluidic channel such that the pad acts as a vacuum or capillary-suction source for moving liquid through the channel (Puntambekar, ¶[0058], [0071]). A person of ordinary skill would have been motivated to make the modification because Puntambekar teaches its capillary-driven microfluidic arrangement for simplifying assay operation, increasing operational speed, and reducing reagent consumption (Puntambekar, Abstract). The modification would have constituted the application of a known microfluidic fluid-propulsion technique to Wang's compatible microfluidic sensor for the same established purpose of moving liquid through a microfluidic flow path. A person of ordinary skill would have had a reasonable expectation of success because Puntambekar expressly demonstrates that, after a priming liquid establishes contact with the absorbent pad, subsequently introduced liquids are automatically drawn into the channel (Puntambekar, ¶[0091]). The resulting arrangement would therefore cause the absorbent material, upon absorbing the priming or sacrificial liquid, to create the suction that pulls the subsequently introduced subject liquid through Wang's channel into the testing chamber and into contact with the working, reference, and counter electrodes.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2018/0196025 A1), hereinafter Wang, and further in view of Janata et al. (US 2010/0197524 A1), hereinafter Janata, and further in view of Champigneux et al., “Effect of surface nano/micro-structuring on the early formation of microbial anodes with Geobacter sulfurreducens: Experimental and theoretical approaches,” Bioelectrochemistry 121 (2018) 191-200, hereinafter Champigneux.
The modified Wang teaches the limitations of claim 1 as discussed above.
Regarding claim 36, the modified Wang does not fully teach that the micropillars are square or rectangular in cross-sectional shape. Rather, Wang teaches a three-dimensional array of free-standing micro-sized pillar electrodes or protrusions 24 extending into the fluid flow path, wherein the three-dimensional micropillar arrangement substantially increases the effective sensing area in contact with the sample solution and thereby enhances sensor sensitivity (Wang, ¶[0026], [0028]). However, Wang does not expressly teach that the micropillars have a square or rectangular cross-sectional shape.
Champigneux discloses gold electrodes designed with micro-pillars having a square cross section of 100 µm by 100 µm and a height of 500 µm. Champigneux further teaches that adding the micro-pillar arrays substantially increased the geometric electrode surface area and relates the increased current production of the micro-pillar electrodes to the larger surface area created by the pillars (Champigneux, pp. 194-196, §3.2). Champigneux is reasonably pertinent to the problem addressed by the claimed invention because it addresses how micropillar geometry on an electrochemical electrode affects available interfacial area and electrochemical performance, the same type of electrode-surface-area problem addressed by Wang's three-dimensional micropillar sensing structure (Wang, ¶[0028]; Champigneux, pp. 194-196, §3.2).
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 have further modified the modified Wang in view of Champigneux to provide Wang's micropillar working electrodes with the square cross-sectional geometry taught by Champigneux. The modification would have been technically feasible because Champigneux demonstrates square micropillars functioning as an electrochemical electrode structure, such that use of the square geometry would not have required changing Wang's function of the micropillars as three-dimensional electrochemical sensing structures. A person of ordinary skill would have been motivated to make the modification because Champigneux demonstrates square cross-sectional geometry as a known and successfully implemented geometry for electrochemical micropillar electrodes, thereby providing a predictable alternative for configuring Wang’s three-dimensional micropillar electrodes while retaining their established electrochemical sensing and surface-area functions (Wang, ¶[0028]; Champigneux, pp. 194-196, §3.2). The modification would have constituted the substitution of one known micropillar cross-sectional geometry with another known micropillar cross-sectional geometry in a compatible electrochemical electrode structure, with the resulting square micropillars predictably continuing to function as three-dimensional electrochemical electrode structures. A person of ordinary skill would have had a reasonable expectation of success because Champigneux demonstrates the square micropillar geometry in an operating electrochemical electrode, and changing Wang's micropillar cross-sectional geometry would not have required changing Wang's microfluidic routing or electrochemical sensing principle. The resulting micropillars would have a square cross-sectional shape.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2018/0196025 A1), hereinafter Wang, in view of Janata et al. (US 2010/0197524 A1), hereinafter Janata, in view of Champigneux et al., “Effect of surface nano/micro-structuring on the early formation of microbial anodes with Geobacter sulfurreducens: Experimental and theoretical approaches,” Bioelectrochemistry 121 (2018) 191-200, hereinafter Champigneux, and further in view of Zheng et al., “Electrochemical measurements of biofilm development using polypyrrole enhanced flexible sensors,” Sensors and Actuators B 182 (2013) 725-732, hereinafter Zheng.
The modified Wang teaches the limitations of claim 36 as discussed above.
Regarding claim 37, the modified Wang does not fully teach that the micropillars have sides approximately 150 μm in length and a height of approximately 600 μm. Wang expressly teaches that each micropillar column may have a height between about 10 µm and about 1000 µm, thereby encompassing a height of approximately 600 µm. Wang’s disclosed range includes 600 µm itself. Therefore, whatever precise breadth is accorded the term “approximately”, Wang encompasses the recited height under any reasonable construction of “approximately 600 µm”. Wang further teaches providing sufficient spacing between adjacent micropillars to permit analyte in the test solution to reach each individual micropillar electrode and teaches that the three-dimensional micropillar arrangement substantially increases the effective sensing area in contact with the sample solution and thereby enhances sensor sensitivity (Wang, ¶¶[0026], [0028]). The Champigneux teaching incorporated regarding claim 36 provides electrochemical electrode micropillars having a square cross section of 100 µm by 100 µm and a height of 500 µm, and teaches that the increase in current production obtained with the micropillar electrodes was related to the larger geometric electrode surface area created by the micropillars (Champigneux, pp. 194-196, §3.2). However, the modified Wang does not expressly teach square micropillars having sides approximately 150 µm in length.
Zheng teaches an electrochemical biosensor for detecting and monitoring biological material using microelectrode working electrodes and expressly states that the sensor design permits optimization of the electrochemical measurement, including optimization of sensitivity based on the size of the working electrodes. Zheng provides square working electrodes having dimensions of 150 µm by 150 µm, 130 µm by 130 µm, 100 µm by 100 µm, 70 µm by 70 µm, and 50 µm by 50 µm, and uses the 150 µm by 150 µm electrode as the primary working electrode for the reported electrochemical measurements (Zheng, p. 726, §2.1; pp. 728-729, Figs. 3-4).
t would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Wang in view of Zheng by selecting a side dimension of approximately 150 µm for the square micropillar working electrodes incorporated from Champigneux, while selecting a micropillar height of approximately 600 µm from Wang’s expressly disclosed height range. Champigneux demonstrates operating square electrochemical micropillars having 100 µm sides and a height of 500 µm, while Zheng demonstrates 150 µm by 150 µm as a known, actually used square lateral dimension for an electrochemical working-electrode feature. These references place the claimed dimensions within the known working dimensional scale for electrochemical electrode structures. In the absence of any disclosed criticality or unexpected result associated with the claimed values, selection of the known workable approximately 150 µm lateral dimension and the approximately 600 µm height expressly encompassed by Wang would have constituted an ordinary selection of dimensions from the dimensional teachings of the art.
The modification would have been technically feasible because Champigneux demonstrates operating square micropillar electrodes having a height of 500 µm, Wang expressly contemplates micropillar heights throughout a range extending to about 1000 µm, and Zheng demonstrates electrochemical sensing with square working-electrode dimensions including 150 µm by 150 µm. A person of ordinary skill would also have understood that selection of the micropillar side dimension and height would not require retaining the original array spacing without adjustment. Wang itself teaches providing sufficient spacing between adjacent micropillars so that analyte can reach the individual micropillar electrodes, while Champigneux teaches arrays of 500 µm-high micropillars at different separation distances and expressly identifies the ratio of micropillar height to separation distance as a parameter to be optimized to maximize interfacial area. Champigneux further demonstrates that 500 µm-high pillars spaced 100 µm apart permitted the pillar sides and base surface to be substantially utilized (Wang, ¶[0026]; Champigneux, pp. 194-196, §3.2). Accordingly, a person of ordinary skill modifying the micropillar dimensions would have understood to select or adjust the array spacing as appropriate to preserve analyte access, available interfacial area, and the intended electrochemical operation of the array, rather than changing the pillar dimensions without regard to the surrounding microfluidic geometry.
A person of ordinary skill would therefore have had a reasonable expectation of success because the selected approximately 600 µm height falls within Wang's expressly disclosed micropillar-height range, the approximately 150 µm side dimension is a known electrochemical working-electrode dimension expressly taught by Zheng, Champigneux demonstrates functioning square three-dimensional electrode structures at substantially the same dimensional scale, and Wang and Champigneux provide express guidance for maintaining appropriate fluid access and spacing when configuring the micropillar array. The resulting micropillars would have sides approximately 150 µm in length and a height of approximately 600 µm.
Claims 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2018/0196025 A1), hereinafter Wang, and further in view of Janata et al. (US 2010/0197524 A1), hereinafter Janata, and further in view of Saleh et al., “Polycrystalline micropillars by a novel 3-D printing method and their behavior under compressive loads,” Scripta Materialia 149 (2018) 144-149, hereinafter Saleh, and further in view of Kiyota (US 5,006,164), hereinafter Kiyota.
The modified Wang teaches the limitations of claim 11 as discussed in the 103 rejection above.
Regarding claim 39, the modified Wang does not fully teach wherein the porosity of the micropillars is varied by varying a ratio of the particles of one or more conductive metals in the slurry. As set forth above under 35 U.S.C. § 112(b), for purposes of examination the recited ratio is interpreted as the ratio of conductive-metal particles or metal powder to binder, consistent with the Instant Application, which describes the slurry as metal powder mixed with a binding agent and states that micropillar porosity may be affected by “the ratio of the metal powder to the binder in the slurry” (Instant Application, ¶[0032], [0037]). The modified Wang teaches the micropillar sensing arrays discussed above, but does not teach forming the micropillars from a conductive-metal-particle/binder mixture and varying micropillar porosity by varying the metal-powder-to-binder ratio.
Saleh teaches a fabrication technique for polycrystalline metal micropillars in which metal nanoparticles are arranged in three-dimensional space followed by binder removal and sintering. Saleh identifies limitations of existing microscale fabrication techniques, including electrochemical deposition and etching, based on chemical compatibility and difficulty in changing microstructure, and teaches that its particulate-metal printing technique permits micropillars to be directly printed to final net shape while providing flexibility in the selection of materials and microstructures (Saleh, pp. 144-145). Saleh expressly identifies demonstrating flexibility in creating micropillars having different microstructures and internal porosities as an objective of the work, and its fabricated silver micropillars exhibit internal porosities of approximately 17-20%, 15%, and less than 1% under different processing conditions (Saleh, pp. 145-146, Fig. 2). Saleh further teaches that micropillar mechanical response and effective stiffness depend on microstructural characteristics including porosity, pore size, pore density, and grain size (Saleh, pp. 148-149). Saleh also expressly anticipates applications of its fabricated micropillars in bioprobes, further supporting the suitability of its micropillar fabrication technique for a sensing implementation (Saleh, p. 149).
Kiyota teaches a metal-powder molding starting material comprising an organic binder and the balance conductive iron powder, followed by debinding and sintering to produce a finished metal part (Kiyota, Abstract). Kiyota expressly investigates binder amount as a processing variable affecting the resulting sintered density. At a fixed average iron-particle size and sintering temperature, Figure 2 shows that sintered density decreases as binder amount increases. Kiyota explains that increasing binder amount decreases the iron-powder packing ratio, thereby increasing average pore size and reducing the density obtainable after sintering (Kiyota, col. 3, Fig. 2). Because the balance of Kiyota's powder/binder starting material is the metal powder, changing the binder fraction correspondingly changes the metal-powder-to-binder ratio. Kiyota is reasonably pertinent to the problem of controlling porosity in the sintered-metal-particle fabrication process supplied by Saleh because Kiyota addresses how binder loading affects metal-powder packing, pore size, and the final density of a debound and sintered metal-powder structure.
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 have further modified the modified Wang in view of Saleh and Kiyota by fabricating Wang's micropillar sensing structures using Saleh's direct-printing and sintering technique for conductive metal particles and controlling the resulting micropillar porosity by selecting and varying the metal-powder-to-binder ratio according to Kiyota. Wang fabricates its micropillar working-electrode structures using MEMS processing that includes photolithography, etching, and electroplating (Wang, ¶[0050]), while Saleh expressly identifies limitations of electrochemical-deposition and etching techniques and provides a particulate-metal printing and sintering technique that permits final-net-shape micropillars with greater flexibility in material and microstructure selection (Saleh, pp. 144-145). A person of ordinary skill therefore would have had a reason independent of the claimed porosity limitation to employ Saleh's known fabrication technique as an alternative technique for forming Wang's micropillar structures.
Having selected Saleh's sintered-particle fabrication technique, a person of ordinary skill would further have been motivated to control, rather than leave uncontrolled, the internal porosity produced by that process because Saleh demonstrates that porosity and related pore characteristics materially affect the mechanical response and effective stiffness of the resulting micropillars (Saleh, pp. 148-149). Kiyota identifies binder loading as a known process variable for controlling metal-powder packing, pore size, and resulting sintered density (Kiyota, col. 3, Fig. 2). Applying Kiyota's known powder-metallurgy process control to Saleh's sintered-metal micropillars therefore would have permitted selection of a desired micropillar porosity and associated structural behavior for the intended micropillar implementation. The modification would have constituted the use of a known process variable to control a known process-dependent structural property of a compatible sintered-metal article. A person of ordinary skill would have had a reasonable expectation of success because Saleh demonstrates fabrication of porous conductive silver micropillars from sintered metal particles, and Kiyota experimentally demonstrates that changing binder loading changes powder packing, pore characteristics, and final sintered density. Because varying Kiyota's binder fraction correspondingly varies the ratio of conductive metal powder to binder, the resulting micropillars would have their porosity varied by varying the ratio of conductive-metal particles to binder, thereby providing the claimed limitation under the interpretation set forth above.
Regarding claim 40, the modified Wang does not fully teach wherein the porosity of the micropillars is varied by varying the size of the particles of one or more conductive metals. Consistent with the antecedent-basis treatment above, “the particles of one or more conductive metals” is understood to refer to conductive-metal particles used to form the micropillars. The modified Wang does not teach forming the micropillars from conductive-metal particles and varying the resulting micropillar porosity by varying the size of those particles.
Saleh teaches fabricating polycrystalline metal micropillars from metal nanoparticles followed by binder removal and sintering and expressly seeks flexibility in producing micropillars having different microstructures and internal porosities (Saleh, pp. 144-145). Saleh further teaches that the microstructure of printed and sintered metal structures is defined by the starting nano- or microparticles, that starting nanoparticle size may be varied to change the resulting microstructure, and that the resulting micropillars possess process-dependent internal porosity that affects their mechanical response (Saleh, pp. 144-145, 148-149). Saleh also expressly anticipates applications of its fabricated micropillars in bioprobes, further supporting the suitability of its micropillar fabrication technique for a sensing implementation (Saleh, p. 149).
Kiyota expressly teaches the effect of conductive-metal-powder particle size on porosity and density. Kiyota states that decreasing the particle size of the iron powder makes porosity in the molded part smaller and reduces the average pore size present during sintering, thereby permitting a higher-density sintered part. Kiyota further experimentally evaluates the relationship between average iron-powder particle size and the density ratio of the resulting sintered part (Kiyota, col. 3, Fig. 1). Kiyota is reasonably pertinent to the problem of controlling porosity in the sintered-metal-particle fabrication process supplied by Saleh because Kiyota addresses how starting metal-powder particle size affects pore size, porosity, and the final density of a sintered metal-powder structure.
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 have further modified the modified Wang in view of Saleh and Kiyota by fabricating Wang's micropillar sensing structures using Saleh's direct-printing and sintering technique for conductive metal particles and selecting or varying the size of the starting conductive-metal particles according to Kiyota to control the resulting micropillar porosity. Wang's existing MEMS fabrication relies on photolithography, etching, and electroplating, while Saleh expressly identifies limitations of electrochemical-deposition and etching techniques and provides a particulate-metal fabrication technique permitting direct formation of micropillars with flexible material and microstructure selection (Wang, ¶[0050]; Saleh, pp. 144-145). Thus, a person of ordinary skill would have had a reason independent of the claimed particle-size relationship to employ Saleh's particulate-metal fabrication route for Wang's micropillar structures.
Once employing that sintered-particle fabrication route, a person of ordinary skill would have been motivated to control the resulting porosity because Saleh demonstrates that porosity and related pore characteristics affect the mechanical response and effective stiffness of the fabricated micropillars (Saleh, pp. 148-149). Kiyota provides an expressly identified process variable for doing so by teaching that reducing metal-powder particle size reduces porosity and pore size and affects the resulting sintered density (Kiyota, col. 3, Fig. 1). Applying Kiyota's particle-size control to Saleh's sintered-metal micropillar process therefore would have permitted the skilled person to select the internal porosity and associated structural behavior of the micropillars rather than accept whatever porosity resulted from an uncontrolled starting particle size. The modification would have constituted the application of a known powder-metallurgy process-control technique to a compatible sintered-metal micropillar fabrication process for its established effect on porosity. A person of ordinary skill would have had a reasonable expectation of success because Saleh demonstrates that conductive-metal particles can be assembled and sintered into porous micropillars, while Kiyota expressly demonstrates the relationship between starting metal-powder particle size, pore characteristics, and resulting density. The resulting micropillars would therefore have their porosity varied by varying the size of the conductive-metal particles used to form the micropillars.
Allowable Subject Matter
Claim 33, as presently written, is allowable over the prior art of record. The prior art of record does not teach or suggest the additional limitation of claim 33 requiring the micropillars of the finished biosensor to be composed of particles of one or more conductive metals suspended in a slurry. The references directed to fabrication of metal micropillars use a slurry containing metal particles as a precursor material from which the micropillars are formed and subsequently processed. The resulting micropillars are solid structures rather than micropillars in which the conductive-metal particles remain suspended in the slurry.
Claims 34-35 are likewise allowable over the prior art of record by virtue of their dependence from claim 33 and incorporation of the limitation discussed above. Accordingly, no rejection of claims 33-35 under 35 U.S.C. §§ 102 or 103 is presently made.
Claims 33-35 remain rejected under 35 U.S.C. § 112(a) for the reasons set forth above, and claims 33-35 additionally remain rejected under 35 U.S.C. § 112(b). Any amendment to claims 33-35 to overcome the rejections under 35 U.S.C. § 112 will be considered on its merits, including with respect to the prior art.
Conclusion
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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