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 without traverse of claims 1-8 in the reply filed on 08/07/2026 is acknowledged.
Claims 9-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of detection, a detection chip, and , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/07/2026.
Specification
The disclosure is objected to because of the following informalities:
The specification does not mention some figure references such as 106. 107, 108, 109, and 110.
Appropriate correction is required.
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) are: ‘temperature control device configured to control a temperature of a fluid in the sensing device’ in claim 3 and ‘main control device connected to the temperature control device, the sensing device, and the detector and configured to perform data collection, data storage, and data analysis’ in claim 3.
The specification defines the ‘temperature control device’ to be a semiconductor temperature module based on Proportional integral Derivative (PID) logic control (Specification, para 00109).
Under the 3-prong analysis, the limitation should be interpreted under 112(f) for the following reasons:
The claim limitation uses the term ‘device’ which is a generic place holder for the term ‘means’.
The generic placeholder is modified by functional language. The functional language is ‘configured to control a temperature of a fluid in the sensing device’.
The generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. See MPEP §2181(I). The term "device" is not modified by sufficient structure.
The specification doesn’t define the ‘main control device’.
Under the 3-prong analysis, the limitation should be interpreted under 112(f) for the following reasons:
The claim limitation uses the term ‘device’ which is a generic place holder for the term ‘means’.
The generic placeholder is modified by functional language. The functional language is ‘configured to perform data collection, data storage, and data analysis.’
The generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. See MPEP §2181(I). The term "device" is not modified by sufficient structure.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they 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
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 and 5-6 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 limitation “main control device” 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 is devoid of adequate structure to perform the claimed function. In particular, the specification merely states the claimed function of performing data collection, data storage, and data analysis. There is no disclosure of any particular structure, either explicitly or inherently, to perform data collection, data storage, and analysis. It does not describe a particular structure for the function and does not provide enough description for one of ordinary skill in the art to understand which device structure or structures perform(s) the claimed 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.
Claim 5 recites the limitation "first electrodes". The singular limitation ‘first electrode’ has been recited, however, plural ‘first electrodes’ have not been defined in previous claims. There is insufficient antecedent basis for this limitation in the claim. Claim 6 is also dependent upon claim 5, thus also rejected.
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.
Claim 3 is rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because the claim purports to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, but fails to recite a combination of elements as required by that statutory provision and thus cannot rely on the specification to provide the structure, material or acts to support the claimed function. As described above, the specification is devoid of adequate structure to perform the claimed function. In particular, the specification merely states the claimed function of performing data collection, data storage, and data analysis. There is no disclosure of any particular structure, either explicitly or inherently, to perform data collection, data storage, and analysis. It does not describe a particular structure for the function and does not provide enough description for one of ordinary skill in the art to understand which device structure or structures perform the claimed function.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1, 2, 5, 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. (US 20190111420 A1).
Regarding claim 1, Jones teach a sensing device (‘sensor system’, Abstract) comprising a detection chip (‘chip’, para 0037), and a fluid tank (‘assay chamber’, Abstract). Jones further teaches a detector configured to capture and analyze a signal generated in the sensing device (‘sensor’, para 0026).
Jones further teaches a base substrate which can be interpreted as a carrier plate with a substrate (para 0036). Although, the Jones combines the carrier plate and the substrate, it would be obvious to one of ordinary skill in the art before the effective filing date to modify to modify the carrier plate and substrate to be combined as taught by Jones for the benefit of utilizing less materials.
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Jones teaches a cavity formed with the fluid tank and microfluid cap and base substrate (Figure 7 and Figure 8). The cavity can be seen in the annotated Figure 7 below. The cavity is indicated by the red arrow. The cavity can be seen below:
Jones further teaches the base substrate (para 0036) comprising a first electrode (‘first electrode structure’, para 0036) and first circuit (‘integrated circuits’, para 0037). Jones further teaches the first electrode being connected to a second electrode through the first circuit to form an electrical circuit (para 0036-0038).
Regarding claim 2, Jones teaches the invention of claim 1. Jones further teaches that the detector is capable of being integrally disposed in the sensing device (para 0026) and the second electrode is capable of being integrally disposed at the detection chip (para 0024).
Regarding claim 5, Jones teaches the invention of claim 1. Jones further teaches the first electrodes are arranged in an array at the substrate (para 0025), and first circuit is disposed in the substrate (para 0037).
Regarding claim 7, Jones teaches the invention of claim 1. Jones further teaches a base substrate which can be interpreted as a carrier plate with a substrate (para 0036) and the fluid tank (‘assay chamber’) is connected to the carrier plate (Figure 7). Jones further teaches the base substrate can include integrated circuits (para 0037) and that electrically conductive material can be used to electrically couple one or more to the active circuit elements (para 0046).
Jones does not teach a second circuit connected to the first circuit is embedded in the carrier plate.
However, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the second circuit which is connected to the first circuit is embedded in the carrier plate as taught by Jones for the benefit of integrating digital logic device or amplifier (para 0037).
Regarding claim 8, Jones teaches the invention of claim 7. Jones further teaches that the fluid tank has a sample hole for a sample supply to a or a sample withdrawal from the cavity (‘aperture’, para 0044).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. (US 20190111420 A1) as applied to claim 1 above, and further in view of Fish et al. (WO 2009019658 A2). The examiner has obtained a machine translation of the WO document. The rejection below is based off the machine translation.
Regarding claim 3, Jones teaches the invention of claim 1. Joens further teaches a main control device connected to the sensing device and detector and configured to perform data collection, data storage and date gathering (‘controller’, para 0003-0039).
Jones does not teach a temperature control device configured to control the temperature of a fluid in the sensing device.
Fish teaches a microfluidic device having a fluid tank, controller, and a substrate (Abstract) and how microfluidic devices are being used in bio chip technology (pg 1, Section: Background, line 7). Fish further teaches chambers being temperature controlled using semiconductor processing techniques (pg 9, line 3-12). Fish further teaches a proportional integral differential (PID) control system for temperature control (pg 22, line 19-22). Thus, it would be obvious to on of ordinary skill in the art before the effective filing date to modify Jones with a temperature control device configured to control the temperature of a fluid in the sensing device as taught by Fish for the benefit of enabling low cost high performance system (pg 9, line 12).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. (US 20190111420 A1) as applied to claim 1 above, and further in view of Sando et al. (WO 2007099736 A1). The examiner has obtained a machine translation of the WO document. The rejection below is based off the machine translation.
Regarding claim 4, Jones teaches the invention of claim 1. Jones further teaches a detector configured to capture and analyze a signal generated in the sensing device (‘sensor’, para 0026).
Jones does not teach the detector as a light detector.
Sando teaches a detection chip (‘micro inspection chip’) which enables a reaction of reagent and analyte at a detection site of a flow microchannel (pg 7, para 0006). Sando teaches a system with two electrodes and a substrate (pg 11, para 0026) to detect analyte in biological samples (pg 15, para 0063). Sando teaches the detector to be a light detector for the benefit of optically detecting the reaction between the analyte and the reagent (pg 11, para 0027). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify Jones with the detector being a light detector as taught by Sando for the benefit of optically detecting the reaction between the analyte and the reagent (pg 11, para 0027).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. (US 20190111420 A1) as applied to claim 5 above, and further in view of Chou et al. (US 20200033288 A1).
Regarding claim 6, Jones teaches the invention of claim 5.
Jones does not teach the isolation well has a thickness greater than the thickness of the first electrode, and a gap is provided between an end of the isolation well away from the substrate and a bottom of the fluid tank.
Chou teaches a device which includes a plate for hosting a small sensing chip to facilitate bio/chemical sensing of a biological fluid sample (Abstract). Chou also teaches two electrodes attached to the surface of the first plate and second plate (para 0038). Chou further teaches isolation wells with lateral dimension between about 0.5 um-100 um (‘spacer’, para 0032-0036). Chou further teaches a gap is provided between an end of the isolation well between the first and second plate (para 0033). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify Jone with isolation well having a thickness greater than the thickness of the first electrode, and a gap is provided between an end of the isolation well away from the substrate and a bottom of the fluid tank as taught by Chou for the benefit of breaking the target component in the fluid sample to release the bio/chemical material for detection (para 0092).
Conclusion
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/H.R.B./ Examiner, Art Unit 1798
/CHARLES CAPOZZI/ Supervisory Patent Examiner, Art Unit 1798
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