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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-6, drawn to a method for producing a sensor unit for nucleic acid analysis in the reply filed on March 9, 2026 is acknowledged. Claims 7-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group II, drawn to a nucleic acid analysis sensor unit, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on March 9, 2026.
The traversal is on the ground(s) that claim 1 and claim 7 share the same limitation and thus no undue burden for the examination. This is not found persuasive because these two inventions are independent and distinct from each other and belong to different classifications that result in search and/or examination burden.
The requirement is still deemed proper and is therefore made FINAL.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “6” in Fig. 2 has been used to designate both the first and the second electrode and electrode material. 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. 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.
Claim(s) 3-6 is/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 pre-AIA the applicant regards as the invention.
Claim 3 recites the limitation "a second electrode" in line 4. It is suggested to be “the second electrode.”
Dependent claim(s) 5-6 is/are rejected based on rejected claim 3.
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 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goto (US 2009/0029115) in view of Ashcroft (US 2018/0223356).
Regarding claims 1-2, Goto teaches a method for producing a sensor unit for analysis (¶8) having a first electrode (e.g., Fig. 1B: electrode 2a) and a second electrode (Fig. 1B: electrode 2b) in a microchannel (Fig. 1B: micro channel 3, the method comprising:
arranging a main direction of extension of the microchannel at an angle γ to a direction of extension of edges of exposed surface portions of the first and second electrodes (Fig. 1A: the main direction of the microchannel 3 is the direction β; Fig. 1B: indicating the exposed surface of the electrodes, e.g., 3a, having an angle θ with the lamination direction α; Examiner notes here that the recited angle is the one between the exposed surface of the electrodes at the inner surface 3a and the microchannel direction β).
Goto discloses the micro channel structure body can correctly detect a concentration of a liquid flowing inside the channel, a concentration of a target substance in the liquid (¶8), but fail to teach it is for nucleic acid analysis or the microchannel is a nanochannel.
However, Ashcroft teaches a polymer, such as DNA, would be driven into a linearized form passing along a channel with lateral dimensions comparable to the diameter of the polymer. For example, DNA has a diameter of 2 nm, the channel could be up to about 100 nm in width (¶4). A small reading device, e.g., nanoelectrode, can be placed into the channel to read the sequence as each base passes the reading device (Fig. 1; ¶4). Thus, Ashcroft teaches a nanochannel including inside readers would be able to analyze nucleic acid.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Goto by adjusting the channel dimensions at the nanoscale for nucleic acid analysis as taught by Ashcroft because it is known in the art that a nanochannel is suitable for DNA sequence reading, e.g., a channel up to 100 nm in width for a DNA having a diameter of 2 nm (Ashcroft, ¶4). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Goto does not disclose the angle γ from about 70° to about 110° (claim 1) or wherein the angle γ is about 90° (claim 2).
However, Goto teaches the angle is acute, less than 90⁰ (¶53). When the angle θ us 0⁰, i.e., parallel to the lamination direction αdue to the rectangular shape of the micro channel 3 (¶37), the angel between the exposed surface of the electrodes at the inner surface 3a and the microchannel direction β is 90⁰, which overlaps the claimed range.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Goto by adjusting the angle γ at 90⁰ because it is known in the art for analyzing analytes inside a channel. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05(I). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP 2144.05(I).
Regarding claim 3, Goto teaches the method further comprising:
depositing a first electrode material to form the first electrode in step (S100) (Fig. 2A: e.g., electrode 2a; ¶47);
depositing an intermediate layer material to form an intermediate layer between the first electrode and a second electrode (Fig. 2B; ¶48: the substrates are stacked up) such that the intermediate layer defines an electrode distance between the first and second electrodes in step (S200) (e.g., Fig. 1B: the thickness of substrate 1b is the distance between electrodes 2a and 2b); and
depositing a second electrode material on the intermediate layer to form the second electrode in step (S300) (Fig. 2A: e.g., electrode 2b; ¶47).
Regarding claim 4, Goto teaches the method further comprising structuring the first electrode material of the first electrode, an intermediate layer material of the intermediate layer, the second electrode material of the second electrode, or their combination to form a chamfer with at least one chamfer angle a in step (S400) (Fig. 1C, 2C: the V-shaped recess; ¶50).
Regarding claim 5, Goto teaches the method further comprising:
depositing a sacrificial layer material on the first electrode, the intermediate layer, the second electrode, or their combination to form a sacrificial layer (Fig. 2B: substrate 1c), and depositing a coating material on the sacrificial layer to form a coating layer in step (S500) (¶49: substrates are laminated by means of adhesive among them);
structuring the sacrificial layer and/or the coating material in step (S600) (Fig. 2B: substrates 1c are stacked up); and
partially under-etching the deposited and structured sacrificial layer to form the nano-channel in step (S700) (Fig. 2C; ¶50; when the recess having a shape of V is machined, the substrate 1c is partially under-etched).
Regarding claim 6, Goto teaches the method further comprising depositing an additional coating material on the deposited coating material to form a second coating layer to close the nanochannel in step (S800) (Fig. 2D; ¶54: the substrate 1e is laminated via the adhesive to the upper surface of the substrate 1d, whereby an opening of the V-shaped recess formed in the stacked laminate is closed and forming the microchannel 3 having a triangle-like shape in cross-section).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLYN M SUN whose telephone number is (571)272-6788. The examiner can normally be reached M-F: 8:30am - 5:30pm.
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/C. SUN/Primary Examiner, Art Unit 1795
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