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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/18/2022 and 11/05/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-16 and 18-20 in the reply filed on 10/14/2025 is acknowledged.
Claim 17 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/14/2025.
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.
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.
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.
Claim limitations “control device” and “upper computer control program” invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim 1-16 and 18-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1-16 and 18-20 require specific steps of a control device and “upper computer control program” for controlling a solenoid valve assembly and a peristaltic pump assembly. However, the instant specification fails to teach or suggest an algorithm, a computer or microprocessor that performs that claimed steps. Therefore, the claims are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement.
Claim 1-16 and 18-20 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 pre-AIA the applicant regards as the invention.
The “control device” and “upper computer control program” limitation of claim 1 is indefinite under § 112(b) because the specification fails to adequately disclose structure (e.g., an algorithm that achieves the claimed function in sufficient detail, a computer readable medium, and a computer or microprocessor configured to carry out the algorithm) to perform the claimed function. Additionally, it is unclear as to whether the control device is mechanical and/or electrical.
Claims 2-16 and 18-20 depend on independent claim 1 and are therefore, rejected for the same reasons.
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.
Claims 1-16 and 18-20 are also 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.
Regarding claims 1, 4, 5 and 6, the phrase fin “type” radiator because it is unclear what “type” is intends to convey and thus, extends the scope of the expression so as to render it indefinite. See MPEP § 2173.05(b).
Claim 1 recites the limitation “a test tube rack configured to support a reaction tube…the raw reagent tube is connected to the reaction tube via a solenoid valve assembly and a peristaltic pump assembly, and the solenoid valve assembly and the peristaltic pump assembly are connected with a control device and are configured to be controlled by an upper computer control program” in the claim. While a reaction tube can be supported within the test tube rack a reaction tube does not appear to be positively recited and thus claimed as part of the apparatus. Therefore, it is unclear if the claim actually recites the inclusion of the reaction tube. Likewise, while a solenoid valve assembly and a peristaltic pump assembly connected with a control device and are configured to be controlled by an upper computer control program can be used to support both the PCR amplification device and reaction device, a solenoid valve assembly and a peristaltic pump assembly connected with a control device and are configured to be controlled by an upper computer control program does not appear to be positively recited and thus claimed as part of the apparatus. Therefore, it is unclear if the claim actually recites the inclusion of the solenoid valve assembly, the peristaltic pump assembly, the control device and the upper computer control program.
Claims 2-16 and 18-20 depend on independent claim 1 and are therefore, rejected for the same reasons.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Atwood et al. US 2002/0072112 A1 is relevant in that it discloses an instrument for performing PCR comprising a fan and a fin tube heat radiator.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYDIA EDWARDS whose telephone number is (571)270-3242. The examiner can normally be reached on Monday-Thursday 6:30-5:30 EST.
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796