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 .
Response to Amendment
The amendments filed 18 DECEMBER 2025 have been entered. Claims 1, 5, 7, 9, and 11 - 12 are pending. Applicant’s amendments to the claims have overcome each and every objection to the claims previously applied in the office action dated 18 JULY 2025. Applicant’s amendments have overcome each and every rejection under 35 U.S.C. 112 previously applied in the office action dated 18 JULY 2025.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show geometrically
how the graphene sheet is “disposed across the fluidic channel” as described in the specification. It is unclear if the graphene sheet is nested inside the channel in a roll or on top flat, across the fluidic channel. While [0012] describes that Fig 1 A shows “a graphene microsheet in a microfluidic channel”, it does not lend clarity to where the channel and graphene sheet are.
the structure of “a microfluidic sensor.” It is unclear how the microfluidic channel and other components are located relative to each other. While there is a dark rectangular component shown from a distance in Figure 4, the components are unlabeled, and it is insufficient to understand orientation of the critical components that make up the “microfluidic sensor”.
how the structure is arranged that makes the blood flow monitor implantable, per “an implantable blood flow monitor”. The specification at [0047] mentions a “needle to the inlet” and a “needle to the outlet”, and [0063] that they were connected to the device with Loctite. If this is a structure critical to making the blood flow monitor “implantable”, it is not shown in a figure. The provided drawings are insufficient to understand orientation of the critical components that make up the “implantable blood flow monitor”.
Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 5, 7, 9, and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “An electrical nanodevice having a single microelectrode, comprising: a Cr/Au electrode deposited on a monolayer graphene sheet”. The preamble recites a single microelectrode, but there are also additional electrodes recited. In light of Applicant’s arguments at [Page 7, Paragraphs 1 - 6] and [Page 9, Paragraph 1 – 3] that the nanodevice’s scope is intended to be a single microelectrode, it is unclear if the “electrical nanodevice” structure is supposed to encompass just the single microelectrode. If so, it is unclear if that single microelectrode is the Cr/Au electrode or the “monolayer graphene sheet serving as the single microelectrode” (in Applicant’s specification at [0007] and the now-deleted limitation in Claim 1). For the purposes of examination, the term “An electrical nanodevice having a single microelectrode, comprising: a Cr/Au electrode deposited on a monolayer graphene sheet” is deemed to claim “An electrical nanodevice including at least a single microelectrode, comprising: a Cr/Au electrode deposited on a monolayer graphene sheet”. Claims 5, 7, 9, and 11 are similarly rejected due to their dependence on Claim 1.
Claim 1 recites the term “a Cr/Au electrode deposited on a monolayer graphene sheet disposed across a microfluidic channel”. It is unclear if the intent is that the Cr/Au electrode, the monolayer graphene sheet, or both are intended to be disposed across the microfluidic channel. There are not supplied drawings to clarify the orientation of the components, and the specification does not provide clear orientation description. For the purposes of examination, the term “a Cr/Au electrode deposited on a monolayer graphene sheet disposed across a microfluidic channel” is deemed to claim “a Cr/Au electrode deposited on a monolayer graphene sheet, the monolayer graphene sheet disposed across a microfluidic channel.” Claims 5, 7, 9, and 11 are similarly rejected due to their dependence on Claim 1.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 12 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et. al., “Flow-Sensory Contact Electrification of Graphene”, hereinafter Zhang.
Zhang discloses A method for blood flow monitoring ([Front Page Summary]: “real-time quantification of whole-blood flows”; [PDF numbered Page 3], “…blood flow measurements”) comprising in vivo measuring ([Front Page Summary]: “six months stability…real-time quantification of whole-blood flows”; [PDF numbered Page 11, 1st Full Paragraph] “applications of our technology include in vivo biofluid mechanics”) a hydrovoltaic current variation arising from contact electrification between an implanted monolayer graphene sheet ([Front Page Summary]: “real-time quantification of whole-blood flows”; [PDF numbered Page 3, “Results and Discussion” Section] “a single microelectrode of monolayer graphene that harvests charge from flowing blood through contact electrification”) and a microfluidic blood flow ([Front Page Summary]: “microelectrodes….real-time quantification of whole-blood flows”; [PDF numbered Page 3, “Results and Discussion” Section] “…flowing blood…”, [PDF numbered Page 3, Top] “flow of continuous blood in a microfluidic channel…”), wherein the current variation is measured at the µm/s level ([Front Page Summary]: “sub-micrometer/sec resolution…”; [PDF numbered Page 3, Top] “…devices deliver a resolution of 0.49 +/- 0.01 µm/s-1)
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The 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, 5, 7, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et. al., (United States Patent Application Publication US 2015/0038378 A1), hereinafter Cheng, in view of Levine (United States Patent 8,421,437 B2), hereinafter Levine, further in view of Liga et. al., “Safe and cost-effective rapid-prototyping of multilayer PMMA microfluidic devices”, hereinafter Liga.
Regarding Claim 1, Cheng discloses An electrical nanodevice ([Abstract]) having a single microelectrode ([0083] “the biosensor 300 is a single graphene sensor with an exposed graphene sheet…”)(Examiner notes that the device has at least a single electrode. Under broadest reasonable interpretation, a device having more than one electrode also has one single electrode.), comprising a Cr/Au electrode (Fig 2, “electrodes 102 and 104”; [0052] “…Cr/Au layers… to form the electrodes 102 and 104…”) deposited on a monolayer graphene sheet (Fig 2, “graphene sheet 10”; [0042] “flat single atomic layer of carbon atoms”; Figs 3c, 3d, and 3e, “electrodes 102 and 104” shown on “graphene sheet 10”; [0052] “…Cr/Au layers…deposited...to form the electrodes 102 and 104…”) disposed across a microfluidic channel (Fig 2. [0083] “an exposed graphene sheet”; Fig 3i, [0055] “microscopical flow channel for liquid entering through the inlet 134 and exiting through the outlet 136”) and
the monolayer graphene sheet having a dimension in the range from about 1 µm x 1 µm to about 1 mm x 1 mm (Fig 15, using the scale on the figure as in Figure A below, then the sensor has a dimension 40 µm wide and 90 µm tall, which is more than 1 µm and less than 1000 µm in each direction.)(Examiner notes the 5 µm legend line in Fig 15, suggesting that the figure is drawn to scale. The disclosed sensor has this dimension, as shown in the center of Figure 6).
wherein the microfluidic channel is defined (Figs 3f – 3i, [0053] – [0055]), and bonded to the graphene sheet (Fig 3d, [0051] “…applied to the top…and the graphene sheet 10”. (Fig 3f – Fig 3i; [0054 – 0055] including “the silicone block 132 can be bonded with the SiO2 layer 118”)(Examiner notes that the edges of the channel remain bonded with the graphene sheet at the end of the process at Fig 3i.).
and the electrical nanodevice does not comprise an external electrical supply ([0005] “graphene biosensor comprises an electrically insulating substrate, a first metallic electrode and a second metallic electrode…mounted on the substrate, a single-layer graphene sheet in electrical contact with and connecting the first and second metallic electrodes.”; [0083] “The connector is configured to connect the biosensor 300 to a power supply (not shown) and to measuring equipment (not shown). “)(Examiner notes where the electrical nanodevice “graphene biosensor” is defined as electrical components, not including a power supply, then that structure does not comprise an external electrical supply. Based on the biosensor’s inclusion mounted to a catheter, it can be connected to an external power supply, but the biosensor structure itself does not include the power supply).
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Figure A: Examiner-annotated Cheng Figure 15, using the provided scale line to determine the width (8 x 5 µm) and length (18 x 5 µm) dimension of the graphene sensor center portion.
Cheng does not disclose an operation amplifier having a feedback capacitor; and is defined on an acrylic sheet using laser cutting.
Levine teaches a circuit with an improved signal-to-noise ratio for operational amplifier specification, as applied to sensors of biological processes like ISFETs (ion-sensitive field effect transistors). Specifically for Claim 3, Levine teaches an operation amplifier (Fig 5C, Op amp A) having a feedback capacitor (Fig 5C, capacitor symbol Cgd, [Col 12, Line 7] “feedback capacitance”)
Levine teaches a motivation to combine at [Col 12, Lines 1 – 26] including “This negative Voltage gain forms a natural feedback loop with the parasitic capacitors in order to control the gain” and “the higher the gain, the more sensitive the pixel is. This makes the common Source configuration preferable.” A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that being able to control the gain and affect the sensitivity of the pixel would be useful for better quality measurements and simplified processing. It would have been predictable to use the op amp configured with a feedback capacitor taught by Levine in any similar electrical nanodevice sensor such as an ISFET, as it would continue to operate with the function of allowing control of the gain and attaining favorable sensitivity of the measurement.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the graphene biosensor disclosed in Cheng with the “common source configuration” with an op amp and feedback capacitor taught by Levine, creating a single electrical nanodevice to configurable gain and favorable sensitivity in measurement. All claimed elements are known in prior art and could have been combined with no change to their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time the invention was properly filed.
Levine does not teach is defined on an acrylic sheet using laser cutting.
Liga teaches a method to laser cut complex microfluidic channels in acrylic for use in microfluidics and nanofluidics. Specifically for Claim 4, Liga teaches is defined on an acrylic sheet using laser cutting (Fig 1, “laser cutting of PMMA layers”; [Page 164, “3.6.1 Five-layer split-and-recombine mixer” section] including “average channel cross section was 200 μm × 500 μm.”)
Cheng is open to combine with Liga to include laser-cut microfluidic channels from PMMA, as it already attaches PMMA to the top surface of the graphene during the fabrication process. Liga provides a motivation to combine in the title, “Safe and cost‑effective rapid‑prototyping of multilayer PMMA microfluidic devices” and [Abstract] with “we propose an innocuous cost-effective, under 2-min technique which enables the bonding of multiple poly(methyl methacrylate) layers.” A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that rapid prototyping through laser cutting would allow for a quick, repeatable, and cost-effective method to create custom microfluidics channels (which could include more complex geometries such as that shown in Liga Fig 6). It would have been predictable to use the laser-cut acrylic microfluidics channels taught by Liga in any microfluidics sensor requiring microfluid channels, as it would continue to operate with the function of creating microfluidics channels in acrylic to be used with microfluidics sensors.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the graphene biosensor with microchannels disclosed in Cheng with the laser cutting method to create microchannels in acrylic taught by Liga, creating a single microfluidic device with microchannels made in a cost-effective and customizable way.
Regarding Claim 5, Cheng in view of Levine, further in view of Liga discloses as described above, The electrical nanodevice of claim 1. For the remainder of Claim 5, Cheng discloses wherein the monolayer graphene sheet (Fig 2, “graphene sheet 10”) is fabricated with a poly(methyl methacrylate) (PMMA) polymer layer (Fig 3d, “a thermoplastic layer 126, for instance…(PMMA)…applied on top of…graphene sheet 10)(Examiner notes that PMMA is acrylic and it is attached during the fabrication process.)
Regarding Claim 7, Cheng in view of Levine, further in view of Liga discloses as described above, The electrical nanodevice of claim 5. For the remainder of Claim 7, Cheng discloses wherein the microfluidic channel has a dimension in the range from 1 µm x 1 µm to 1 mm x 1 mm ([0008] “holes or gaps…diameter smaller than about 5 µm.)(Examiner notes that a round hole with a diameter of 5 µm would have a cross-sectional area of 19.625 µm2 , a dimension greater than 1 µm x 1 µm, (which is 1 µm2 ), and smaller than 1 mm x 1 mm, (which is 1,000,000 µm2))
Regarding Claim 9, Cheng in view of Levine, further in view of Liga discloses as described above, The electrical nanodevice of claim 5, For the remainder of Claim 9, Cheng discloses wherein the electrical nanodevice is biocompatible ([Title])
Regarding Claim 11, Cheng in view of Levine, further in view of Liga discloses An implantable blood flow monitor ([0037] “…an ISFET inserted into a blood vessel”, [0088])(Examiner notes that it is a sensor that monitors characteristics that can be found within a blood flow) comprising an electrical nanodevice of claim 1 (See citations above for Claim 1).
Response to Arguments
Applicant's arguments filed 18 DECEMBER 2025 have been fully considered but they are not persuasive.
Regarding the Drawing Objections
Applicant argues at [Page 5, “Objection to the Drawings” Section, All] – [Page 6, Paragraph 1] that a person of ordinary skill in the art would readily, fully understand the invention based on the specification alone (and the drawings as originally filed). The only illustration of the orientation of components on the nanodevice is the small, somewhat blurry rectangle in the photograph on the right side of Figure 4. There are structure-related clarity issues in Claim 1 (as presented in the 112(b) rejections above), regarding whether there is a single electrode; there is more than one electrode; it is the Cr/Au electrode(s) across the microchannel; it is the graphene sheet across the microchannel; or it is both the Cr/Au electrode(s) and graphene sheet across the microchannel. Looking to the Applicant’s arguments filed 18 DECEMBER 2025, additional ambiguity is added, as it is argued that the claimed invention is a single microelectrode, when multiple electrodes are described in the specification and in amended claim 1. The identity and orientation of electrode(s) (including the “graphene as the electrode” and Cr/Au deposited electrode(s)) is not readily apparent from the specification alone, and clarity could be assisted with structural layout drawings. The objection of the drawings is maintained, as they would increase understanding of the invention as claimed. The argument is not persuasive.
Regarding the 35 U.S.C. 102 Rejections
Applicant argues at [Page 7, Paragraph 7] that Cheng does not teach or disclose that the single microelectrode includes an operation amplifier having a feedback capacitor. The disclosure of Cheng has been combined with Levine to teach that structure includes an operation amplifier having a feedback capacitor, based on the amendments to the claim. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The argument is not persuasive.
Applicant summarily argues at [Page 8, Paragraph 1] that the prior art reference does not teach each and every claim limitation of claim 1, therefore the amended claim 1 is not anticipated under 35 U.S.C. 102. Based on the amendments, the disclosure of Cheng has been combined with Levine and Liga to teach all of the limitations of Claim 1. The rejection for Claim 1 under Cheng under 35 U.S.C. 102 is withdrawn, and a 35 U.S.C. 103 Rejection is applied.
Regarding the 35 U.S.C. 103 Rejections
Applicant argues at [Page 7, Paragraphs 1 - 6] and [Page 9, Paragraph 1 – 3) that the claimed invention is an electrical nanodevice with single microelectrode, and that Cheng does not teach or disclose an electrical nanodevice with a single microelectrode that comprises a Cr/Au electrode deposited on a monolayer graphene sheet disposed across a microfluidic channel. Applicant argues that Cheng employs a first and a second metallic electrode on a single-layer graphene sheet. Overall, the currently- recited claim language broadly does not prohibit additional electrodes from being present, since the preamble recites that it is a nanodevice having at least a single electrode. Cheng recites Cr/Au electrode deposited on a monolayer graphene sheet, and the graphene sheet is disposed across the microfluidic channel. The Cr/Au electrode is deposited on that monolayer graphene sheet, but there is nothing particular recited in the claims that the Cr/Au electrode must be disposed across the entirety of the graphene sheet. Further, under broadest reasonable interpretation, a device having more than one electrode also has one single electrode.
Regarding Applicant’s invention, multiple electrodes are also described in the specification and in amended claim 1, the Cr/Au electrode and the monolayer graphene sheet, described in Applicant’s specification at [0007] (and the now-deleted limitation in Claim 1) “monolayer graphene sheet serving as the single microelectrode”. As described above, the identity and orientation of electrode(s) (including the “graphene as the electrode” and Cr/Au deposited electrode(s)) are not readily apparent from the specification alone, and clarity could be assisted with structural layout drawings. Also, there are structure-related clarity issues in Claim 1 (as presented in the 112(b) rejections above), regarding whether there is only a single electrode; there is more than one electrode; it is the Cr/Au electrode(s) across the microchannel; it is the graphene sheet across the microchannel; or it is both the Cr/Au electrode(s) and graphene sheet across the microchannel. It is not clear that there is only one electrode, and this is also not the clear scope of the currently-recited claim. The argument is not persuasive.
Applicant argues at [Page 9, Paragraph 3] – [Page 10, Paragraph 1] that none of the cited prior art references cure the deficiencies of Cheng for amended Claim 1. Based on the 35 U.S.C. 103 rejection and the discussion above, Cheng discloses the single electrode aspect, and Cheng in view of Levine, further in view of Liga disclose all of the elements of Claim 1. The argument is not persuasive.
Applicant argues at [Page 10, Paragraph 2] – [Page 11, Top] that the combination of the modification of Tew, Kamalov, and Song would not be successful due to there being no reasonable expectation of success and no motivation to combine. There were no references named Tew, Kamalov, and Song that were cited or combined for any teaching in the previous office action dated 18 AUGUST 2025 or in the present office action. The argument is not persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA J MONTGOMERY whose telephone number is (571)272-2305. The examiner can normally be reached Monday - Friday 7:30 - 5:00 ET.
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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791