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 .
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 is: “a reaction member” in claims 4 and 18.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this limitation 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 to avoid it 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 recites sufficient structure to perform the claimed function so as to avoid it 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Martin et al., “Epidermal Microfluidic Electrochemical Detection System: Enhanced Sweat Sampling and Metabolite Detection,” ACS Sens. 2017, 2, 1860−1868 with Supplementary Information (hereafter “Martin”) in view of Scandurra et al., “Laser and thermal dewetting of gold layer onto graphene paper for non-enzymatic electrochemical detection of glucose and fructose,” Sensors & Actuators: B. Chemical 301 (2019) 127113 (hereafter “Scandurra”) and Rauf et al. US 2023/0341350 A1 (hereafter “Rauf”) or in view of Zhu et al., “Disposable and portable gold nanoparticles modified - laser-scribed graphene sensing strips for electrochemical, non-enzymatic detection of glucose,” Electrochimica Acta 378 (2021) 138132 (hereafter “Zhu”).
Addressing claim 1, Martin discloses an enzymatic glucose sensor (see the title, Abstract, and Figure 4(A)) comprising:
one or more electrodes (see Figure 1(B), Figure S1 (Supplementary Information), and the first paragraph in the left column of page 1864 (“The three-electrode . . . .”));
a microfluidic channel (see Figure 2 and the last paragraph in the left column of page 1864 (“Careful consideration . . . .”)); and
at least one inlet (there are four inlets in the main embodiment; however, embodiments with 1-12 inlets were also made. See Figure 2 (noting especially “# inlets” along the x-axis in Figure 2(A) and the last paragraph in the left column of page 1864, bridging to the right column.), wherein the at least one inlet is configured to deliver a fluid to the microfluidic channel and wherein the microfluidic channel is configured to transport the fluid to the one or more electrodes (see Figures 1(B), 2, S4, and S5).
Martin, though, as indicated above, does not disclose a non-enzymatic glucose sensor, but an enzymatic glucose sensor. Also, Martin does not disclose “. . . ., wherein at least one of the one or more electrodes is a laser-induced graphene electrode, wherein the laser-induced graphene electrode comprises a uniform coating of a metal.”
As a first matter, note that the phrase “a laser-induced graphene electrode” renders the claim as a product-by-process claim. As such the claim is not limited to the manipulation of the recited step (laser-induced graphene), only the structure implied by the step. See MPEP 2113. Scandurra discloses a non-enzymatic glucose sensor comprising: one or more electrodes, wherein at least one of the one or more electrodes is a graphene electrode, wherein the graphene electrode comprises a uniform coating of a metal (Au). See in Scandurra the title, Abstract, Figure 1, and 2.2. Preparation methods of graphene paper – gold nanostructures (GPAuNPs), which is on page 2, bridging to page 3. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to substitute the non-enzymatic glucose-sensitive working electrode of Scandurra for the enzymatic glucose-sensitive electrode in Martin because it is prima facie obvious as simple substitution of one known element (glucose-sensitive working electrode) for another to obtain predictable result. See MPEP 2143(I)(B). Moreover, Scandurra discloses
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See Scandurra page 1.
Although Scandurra does not disclose that the graphene electrode is laser-induced (it comprises graphene paper), this is a product-by-process feature that does not appear to necessarily materially distinguish the graphene electrode of Scandurra from that in claim 1. In any event, to the extent that Applicant can show that the phrase “laser-induced” does impart a material difference the Examiner turns to Rauf. Rauf discloses, “A biomarker detection sensor includes a substrate; a working electrode formed by laser-scribing directly into the substrate so that a material of the substrate is transformed into graphene; a metal nanostructure formed on a graphene surface of the working electrode, . . . .” See in Rauf the title and Abstract. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to have the graphene in Scandurra be laser-induced as taught by Rauf because Rauf discloses,
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Also, note in this regard that Scandurra does already use a laser during manufacture of the working electrode. See Scandurra Figure 1.
Alternatively, Zhu discloses a non-enzymatic glucose sensor comprising: one or more electrodes, wherein at least one of the one or more electrodes is a laser-induced graphene electrode, wherein the laser-induced graphene electrode comprises a uniform coating of a metal (Au). See in Zhu the title, Abstract, Figure 1, and 2.2. Fabrication of laser-scribed graphene electrode (LSGE), which is on page 2. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to substitute the non-enzymatic glucose-sensitive working electrode of Zhu for the enzymatic glucose-sensitive electrode in Martin because it is prima facie obvious as simple substitution of one known element (glucose-sensitive working electrode) for another to obtain predictable result. See MPEP 2143(I)(B). Moreover, Zhu discloses
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See the left column on Zhu page 2.
Addressing claim 15, Martin discloses a method of forming a non-enzymatic glucose sensor (implied by the title, Abstract, and Figure 4(A)), comprising:
providing a substrate ((i) in Figures 1(A) and 1(B)); and
providing a microfluidic channel (see Figures 1(A), 1(B), and Figure 2, and the last paragraph in the left column of page 1864 (“Careful consideration . . . .”)), wherein the microfluidic channel is configured to transport a fluid to the one or more electrodes (see Figures 1(B), 2, S4, and S5).
Martin, though, does not disclose
“providing a laser device;
laser-scribing the substrate using the laser device to form one or more laser-induced graphene electrodes;
depositing a uniform coating of a metal on at least one of the one or more laser-induced graphene electrodes; …”
On the other hand, Martin does disclose forming at least one graphene electrode on a substrate. See Martin Figures 1(A) and 1(B), and the fourth paragraph of Fabrication of Electrochemical Biosensors. (“Sweat biomarker levels . . . “), which is on page 1862.
Scandurra discloses a non-enzymatic glucose sensor comprising: one or more electrodes, wherein at least one of the one or more electrodes is a graphene electrode, wherein the graphene electrode comprises a uniform coating of a metal (Au). See in Scandurra the title, Abstract, Figure 1, and 2.2. Preparation methods of graphene paper – gold nanostructures (GPAuNPs), which is on page 2, bridging to page 3. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to substitute the non-enzymatic glucose-sensitive working electrode of Scandurra for the enzymatic glucose-sensitive electrode in Martin because it is prima facie obvious as simple substitution of one known element (glucose-sensitive working electrode) for another to obtain predictable result. See MPEP 2143(I)(B). Moreover, Scandurra discloses
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See Scandurra page 1.
Although Scandurra does not disclose that the graphene electrode is laser-induced (it comprises graphene paper), the Examiner turns to Rauf. Rauf discloses, “A biomarker detection sensor includes a substrate; a working electrode formed by laser-scribing directly into the substrate so that a material of the substrate is transformed into graphene; a metal nanostructure formed on a graphene surface of the working electrode, . . . .” See in Rauf the title and Abstract. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to have the graphene in Scandurra be laser-scribed (which implies providing a laser) as taught by Rauf because Rauf discloses,
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Also, note in this regard that Scandurra does already use a laser during manufacture of the working electrode. See Scandurra Figure 1.
Alternatively, Zhu discloses a non-enzymatic glucose sensor comprising: one or more electrodes, wherein at least one of the one or more electrodes is a laser-scribed graphene electrode, wherein the laser-scribed graphene electrode comprises a uniform coating of a metal (Au). See in Zhu the title, Abstract, Figure 1, and 2.2. Fabrication of laser-scribed graphene electrode (LSGE), which is on page 2. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to substitute the non-enzymatic glucose-sensitive working electrode of Zhu for the enzymatic glucose-sensitive electrode in Martin because it is prima facie obvious as simple substitution of one known element (glucose-sensitive working electrode) for another to obtain predictable result. See MPEP 2143(I)(B). Moreover, Zhu discloses
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See the left column on Zhu page 2.
Addressing claim 19, for the additional limitation of this claim see in Zhu
2.3. Electrodeposition of AuNPs on LSGE, which is on page 2.
Allowable Subject Matter
Claims 2-8, 16-18, and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 9-14 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
a) the International Search Report for international application no. PCT/US2022/075397 cites an article by Pravati et al. as a “X” document against claims 1 and 15 of the application as a "Y” document against claims 9 and 12-14; and cites US 2020/359942 A1 as a “Y” document against claims 9 and 12-14. The corresponding Written Opinion deems claims 1-20 to have novelty and claims 2-8, 10, 11, and 16-20 to have an inventive step, but deems claims 1, 9, and 12-15 to lack an inventive step. The claims are rejected over the aforementioned article and US patent document, respectively referred to as D1 and D2. The rejection of claim 11 states,
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However, neither the Search Report2 nor Written Opinion3 indicate where these features are taught in D1 nor has the U.S Examiner found them in D1. Also, regarding the acknowledged missing claim 1 features, the claim 1 rejection turns to D2, but only argues
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b) in claim 2 the combination of limitations requires the following underlined features
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In contrast, in neither Martin as modified by Scandurra and Rauf nor in Martin as modified by Zhu does the laser-induced graphene electrode further comprises a second uniform coating of a second metal.
Miao et al., “ Enzymatic Biosensor Based on One-step Electrodeposition
of Graphene-gold Nanohybrid Materials and its Sensing Performance for Glucose,” Electroanalysis 2021, 33, 2243 – 2251 (hereafter “Miao”4) discloses a glucose sensor comprising a working electrode comprising graphene , a first metal (nickel) layer, and a second metal (gold) layer. However, the glucose sensor of Miao is enzymatic, not non-enzymatic, and the graphene is not said to be laser-induced. Also, the second metal layer is not on the first metal layer. These two metal layers are separated by the graphene.
c) claims 3-8 depend directly or indirectly from allowable claim 2.
d) in independent claim 9 the combination of limitations requires the following underlined feature
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In contrast, although in Martin as modified by Scandurra and Rauf and in Martin as modified by Zhu the non-enzymatic glucose sensor does comprise a top layer (i); a bottom layer (iii); and an intermediate layer (ii), the intermediate layer does not comprise one or more electrode as all of the electrodes are in the top player (i). See Martin Figures 1(A) and (B), and Figure 3. Relocating one or more of the electrodes to the intermediate layer would be clearly more than simple rearrangement of parts.
e) claims 10-14 depend directly or indirectly from allowable claim 9.
f) in claim 16 the combination of limitations requires the following underlined feature
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The discussion above regarding the allowability of claim 2 pertains to claim 16 also.
g) claims 17 and 20 each depend from allowable claim 16.
h) in claim 18 the combination of limitations requires the following underlined feature5
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In contrast, neither Martin as modified by Scandurra and Rauf nor Martin as modified by Zhu discloses nor suggests this reaction member. Also, it does not seem that it could be readily adopted into the sensor configuration of Martin Figures 1(A) and 1(B).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER STEPHAN NOGUEROLA whose telephone number is (571)272-1343. The examiner can normally be reached on Monday - Friday 9:00AM-5:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan Van can be reached on 571 272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER S NOGUEROLA/ Primary Examiner, Art Unit 1795
1 The rejections of claims 9 and 15 rely in part upon the rejection of claim 1.
2 He Search Report cites “the Whole document”.
3 The Written Opinion is silent as to a citation in D1.
4 Published online on August 9, 2021
5 Note that “a reaction member” is being interpreted under 35 U..C.S. 112(f), so it only covers the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. See Claim Interpretation above.
Prosecution Insights