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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 19, 2026 has been entered.
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 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for some small dimensions, does not reasonably provide enablement for all small dimensions. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention. The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261, 270 (1916), which asked: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). A conclusion of lack of enablement means that, based on the evidence regarding each of the factors given below, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993) (emphasis added).
The factors outlined in Wands for determining whether there is sufficient evidence to support a determination that a disclosure include, but are not limited to: 1) the breadth of the claim; 2) the nature of the invention; 3) the state of the prior art; 4) the level of one of ordinary skill in the art; 5) the level of predictability in the art; 6) the amount of direction provided by the inventor; 7) the existence of working examples; 8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Breadth of the Claim and Nature of the Invention
The claim embraces subject matter having a maximum length of the entire analyte sensing region measured between the opposite ends is less than 80 µm, that is any length between zero and 80 µm. There may be a lower bound that is supported by the invention, but a patent can only issue on that which inventors have disclosed. A 10 nm length, for example, is embraced by the claims.
The State of the Prior Art and Level of Predictability and Level of Ordinary Skill in the Art
The sensing of analytes at small dimensions is an art where whether a sensor works depend heavily on its size and construction. One of ordinary skill in this art has a high level of skill, but the ability to make a working sensing region becomes less predictable as the size gets smaller, and no known sensor operates at the picometer scale, which is embraced by the scope of these claims.
The Amount of Direction provided by the Inventor and Existence of Working Examples
A critical aspect of this specification is that there are no new fabrication methods disclosed. The inventors point out that “at least one microfabrication technique” is used, and points to photolithography, ultraviolet etching, and electrochemical plating as examples. These are all well-known and conventional techniques, as evidenced by their lack of explanation in the text. The text even admits that “[f]urther improvements in fabrication or other manufacturing techniques according to embodiments of the invention may still further yield sensor members with even smaller sensing regions.” This is not a disclosure of either direction or working examples that is commensurate with the scope of the claims.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
As pointed out above, there are no new techniques that are explored or discussed in the fabrication of the claimed sensors. For this reason, more must be shown or else the case is reduced to various features that would be theoretically useful, but have not been proven to be capable of manufacture.
For the reasons given above, there would be undue experimentation to make and use invention of claims.
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 1-20 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.
As pointed out above, there is no lower bound for Applicants’ scope of the claimed invention. To the extent that it may be argued that there is some gray area between what is clearly claimed (the upper bound) and that which may be lower than the upper bound while still being enabled (Would 38 microns work? What about 12 microns?), that gray area causes the claims to be indefinite.
Claim Rejections - 35 USC § 103
The prior art rejections set forth in the Final Office action mailed on February 20, 2026 rejecting claims 1-20 are maintained for the reasons discussed therein. The addition of the length of the entire analyte sensing region does not distinguish from Hoss as that reference states that only two sensing elements are required and shows dimensions that correspond to those that are claimed. The amended language of, for example, claims 8-9 fail to distinguish over the applied prior art in the February 20, 2026 action for the reasons discussed therein.
Response to Arguments
Applicant's arguments filed May 19, 2026 have been fully considered but they are not persuasive.
Applicants argue that Hoss fails to disclose the cited limitations in sufficient specificity to anticipate claims 1 and 13. Examiner respectfully disagrees for at least two reasons. First, those structures have issued in US 11,457,840 B2 and are prima facie valid under 35 USC 112. Second, Atofina was the type of “or less” disclosure that is present in the claims of this case. Unlike in the claims of this case, however, Hoss points out specific numbers that are contemplated by the inventors therein and unlike the instant application specification, the inventors there pointed out (in arguably more clarity and detail than Applicants’ specification) how and why the element-by-element deposition was conducted, even going so far as to point out that each element may constitute picoliter-scale volumes. Given that there is sufficient specificity in Hoss, Examiner finds Applicants’ arguments to the contrary unpersuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Messersmith whose telephone number is (571)270-7081. The examiner can normally be reached M-Tu, 8:30 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791
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