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 .
Status of the Claims
Claims 3-15 are pending in the application and are the subject of this office action.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 19 May 2026 has been entered.
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(s) is/are:
In claim 15: “wherein the portable sensing and readout device is configured to simultaneously or sequentially test a plurality of the disposable test strips coupled to the portable sensing and readout device”
This limitation is interpreted under 112(f) because it recites a generic structure (i.e. portable sensing and readout device) linked to a particular function, (i.e. testing a plurality of test strips) wherein the structure provided in the claim is insufficient to fully support the recited structure. That is, it is unclear what particular structural features or elements of a portable sensing and readout device are responsible for facilitating the function of testing a plurality of test strips, and as such it is unclear exactly how the sensing and readout device is “configured” to perform this function. Further discussion is provided in the 112(b) section below.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are 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/these limitation(s) 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(s) to avoid it/them 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(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(b)
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 3-15 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 15 is rejected as indefinite over the recitation “A medical system, comprising: of claim 1” wherein the recitation does not make sense and refers to a claim which has been cancelled. Clarification is required.
Claim limitation “wherein the portable sensing and readout device is configured to simultaneously or sequentially test a plurality of the disposable test strips coupled to the portable sensing and readout device” in claim 15 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
The specification does not link the recited function of the limitation to any particular structural feature or configuration of the claimed portable sensing and readout device. A claim to a system is defined and distinguished by its physical features and structures. As such, the metes and bounds of the claim are unclear because it is not clear what structural limitations are required by the recited function or exactly how the device is “configured to” facilitate this function.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Dependent claims 3-14 are rejected as indefinite because they depend from an indefinite claim and fail to remedy its deficiencies.
Claim Rejections - 35 USC § 112(d)
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 3-14 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form.
Claims 3-14 are of improper dependent form because they do not reference a claim previously set forth. That is, claims 3-14 depend from claim 15 which does not precede any of claims 3-14.
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.
Subject Matter Free of Prior Art
Claims 3-15 are rejected as described above, but appear to contain subject matter which is free of the prior art.
The closest prior art is Yang et al (Rapid detection of cardiac troponin I detection in physiological environment using antibody immobilized gate pulsed AIGaN/GaN high electron mobility transistor structures. Appl. Phys. Lett. 111, 202104 (November 2017); IDS entered) in view of Byrne et al (US 2018/0299403 A1; previously cited), Tabib-Azar et al (US 2021/0270771 Al; previously cited) and Bhat et al (US 2022/0050101 A1; previously cited) as described in the non-final office action of 19 March 2025. However, this combination of prior art fails to establish a prima facie case of obviousness for the instant claims, for the reasons described in Applicant’s remarks filed 19 June 2025.
Namely, Yang teaches a test strip comprising a gate electrode area electrically connected to a nearby area functionalized with antibody, as seen in Fig. 1.
Yang further teaches a pulse generator capable of producing a step waveform function for both gate (or cover glass active) and drain electrodes, thereby reading on “pulse generation circuitry configured to generate synchronized gate and drain pulse, the first electrode of the disposable sensing unit electrically coupled to a gate pulse output of the pulse generation circuitry” (Pg. 2, Col. 2, Par. 2-Pg. 3, Col. 1, Par. 1). Yang teaches the drain electrode as a part of a FET device, e.g. HEMT (Pg. 1, Col. 1, Par. 2: FETs functionalized with antibodies or aptamer layers in the gate region; Pg. 2, Col. 2, Par. : teaching that the HEMTs were biased with 2V on the drain), thereby reading on “a transistor having a drain electrically controlled by a drain pulse output of the pulse generation circuity”. Yang teaches a gate of the FET device, e.g. HEMT is electrically connected to the reference area/unfunctionalized Au electrode, thereby reading on “a gate electrically coupled to the second electrode of the disposable sensing unit (Fig. 1, Pg. 3, Col. 2, Par. 2).
Yang does not explicitly teach that the sensing system comprises a functionalized area disposed between first and second electrodes.
Byrne discloses a device comprising an active sensor (i.e. test strip) having a functionalized sensing area disposed between first and second electrodes (Par. 7; Fig. 2). Moreover, the device is not reused, and is therefore considered disposable (Par. 31). Byrne further teaches a gate electrode configured to apply a gate bias to the channel (Par. 71). The gate electrode can be beneath, on a side, or adjacent to the channel (Par. 71). The sensing system taught by Byrne is used to detect analytes based on a change in the electrical properties of the FET (Par. 7).
Tabib-Azar and Bhat disclose a biosensors functionalized with anti-SARS-CoV-2 spike protein antibodies.
However, as applicant indicates in their remarks, while Byrne and Tabib-Azar disclose transistors (FET) with the functionalized area disposed on the transistor between the source and drain electrodes of the transistor, neither Byrne nor Tabib-Azar teach or suggest functionalizing an area between a gate electrode and a reference electrode, wherein the reference electrode is electrically coupled to the gate of the transistor, as disclosed by Yang.
While Yang discloses a functionalized area disposed on a gate electrode spaced apart from a second reference electrode connected to the gate of a separate HEMT, Byrne and Tabib-Azar disclose transistors with the functionalized area disposed on the transistor between the source and drain electrodes with the gate electrode separated from the functionalized area. Further, it is not obvious to modify Yan in view of the teachings of Byrne and Tabib-Azar to meet the instant claim. Modification of the sensor to comprise the functionalized area between the drain and source electrodes (as taught by Byrne and Tabib-Azar) would mean that the functionalized area would no longer be in direct electrical connection to the gate of the transistor or in the path of the gate pulse signal. As such, the configuration of the sensor of Yang is structurally and functionally distinct from the configuration of the sensors taught by Byrne and Tabib-Azar, such that substitution of the configuration of Yang with the configuration of Byrne or Tabib-Azar would not yield predictable results or a reasonable expectation of success.
Moreover, applicant persuasively argues (see Remarks filed 15 January 2026), such a modification would no longer satisfy the claim language which requires that the first electrode of the disposable test strip be electrically coupled to a gate pulse output, because the source electrode of the transistor taught by Byrne and Tabib-Azar is not equivalent to or directly substitutable for the gate electrode taught by Yang.
Response to Arguments
Applicant’s arguments filed 19 May 2026 have been fully considered.
Applicant’s arguments regarding the previous Double Patenting rejection are persuasive in view of the amendments to the claims, and the Double Patenting rejection is withdrawn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIS LUSI whose telephone number is (571)270-0694. The examiner can normally be reached M-Th 8am-6pm ET.
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/ELLIS FOLLETT LUSI/Examiner, Art Unit 1677
/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
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