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 of Claims 18-34 in the reply filed on 06/16/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Specification
The disclosure is objected to because of the following informalities:
The use of the term 'Bluetooth [pg 6, line 17]', which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 limitations are ‘test module’ in claim 18, ‘detection element’ in claims 18 and 29, ‘output module’ in claim 18, ‘heating module’ in claim 23, and ‘element (for preparing the sample and/or purifying products)’ in claim 30.
The specification defines the ‘test module’ to be a chromatographic test strip (Specification, pg. 3, lines 17-18). Under the 3-prong analysis, the limitation should be interpreted under 112(f) for the following reasons:
The claim limitation uses the term ‘module’ which is a generic place holder for the term ‘means’.
The generic placeholder is modified by functional language. The functional language is ‘to receive a biological sample’.
The generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. See MPEP §2181(I). The term "module" is not modified by sufficient structure.
The specification defines the ‘detection element’ to be a CCD sensor (Specification, pg. 4, line 16). Under the 3-prong analysis, the limitation should be interpreted under 112(f) for the following reasons:
The claim limitation uses the term ‘element’ which is a generic place holder for the term ‘means’.
The generic placeholder is modified by functional language. The functional language is ‘to record a result or a stage of progress of the chemical, biochemical or immunochemical detection process’ (claim 18) and ‘to record the light signal emitted or reflected by the test module’(claim 29).
The generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. See MPEP §2181(I). The term "element" is not modified by sufficient structure.
The specification defines the ‘output module’ to be an LED or display (Specification, pg. 6, lines 10-11). Under the 3-prong analysis, the limitation should be interpreted under 112(f) for the following reasons:
The claim limitation uses the term ‘module’ which is a generic place holder for the term ‘means’.
The generic placeholder is modified by functional language. The functional language is ‘to output the result or the stage of progress of the chemical, biochemical or immunochemical detection process’.
The generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. See MPEP §2181(I). The term "module" is not modified by sufficient structure.
The specification defines ‘heating module’ to be a ceramic plate (Specification, pg. 3 lines 5-7. Under the 3-prong analysis, the limitation should be interpreted under 112(f) for the following reasons:
The claim limitation uses the term ‘module’ which is a generic place holder for the term ‘means’.
The generic placeholder is modified by functional language. The functional language is ‘to heat the sample for preparation before performing the polymerase chain reaction’ (claim 23).
The generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. See MPEP §2181(I). The term "module" is not modified by sufficient structure.
The specification defines the ‘element (for preparing the sample and/or purifying products)’ to be a chamber (Specification, pg. 5, lines 28-29). Under the 3-prong analysis, the limitation should be interpreted under 112(f) for the following reasons:
The claim limitation uses the term ‘element’ which is a generic place holder for the term ‘means’.
The generic placeholder is modified by functional language. The functional language is ‘for preparing the sample and/or for purifying products of the chemical, biochemical or immunochemical detection process’.
The generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. See MPEP §2181(I). The term "element" 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 these limitations 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.
Claim 23 is 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 23 recites the limitation "the heating module". There is no mention of that limitation in any previous claim. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the limitation will be interpreted as “a heating module”.
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.
Claims 18-19, 24-25, 27-29, and 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over Markovsky et al. (US 20130177214 A1), and further in view of Cameron (US 20170046357 A1).
Regarding claim 18, Markovsky teaches system for a chemical, biochemical or immunochemical detection process (para 0030). Markovsky further teaches a consumption product (‘cavity’, para 0027), which includes a test module (‘test strip’, para 0027). Markovsky teaches the test strip receiving a sample that contains the analyte of interest (para 0031), which could include samples of blood and urine (para 0030), for detection (para 0030). Markovsky teaches the system of detection including a detection element, such as a CCD image sensor (para 0036), configured to record the result or the stage of progress the detection process (para 0018). Markovsky teaches the system for detection including an output module, such as a result display (para 0054).
However, Markovsky does not teach a steam generator in the system for detection.
Cameron teaches an electronic vapor device that has applications in sensor-based testing such as diagnostic testing (para 0091). Cameron teaching a steam generator (‘vapor device’, para 0091) that can be used to vaporize samples and release it into the atmosphere (para 0081). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Markovsky with the steam generator as taught by Cameron to vaporize the sample and release it into the atmosphere (para 0081).
Regarding claim 19, Markovsky in view of Cameron teaches the invention in claim 18. Markovsky further teaches a heating element adapted to the heat the test strip (‘heater’, para 0040).
Regarding claim 24, Markovsky in view of Cameron teaches the invention in claim 18. Markovsky further teaches the test module is a chromatographic test strip (‘lateral flow test strip’, para 0027).
Regarding claim 25, Markovsky in view of Cameron teaches the invention in claim 24. Markovsky further teaches the detection element being a CCD sensor (para 0036).
Regarding claim 27, Markovsky in view of Cameron teaches the invention in claim 18. Markovsky further teaches the result or stage of progress is a light signal emitted or reflected by the test module (para 0035).
Regarding claim 28, Markovsky in view of Cameron teaches the invention in claim 27. Markovsky further teaches wherein the result or stage of progress is a color change (para 0047).
Regarding claim 29, Markovsky in view of Cameron teaches the invention in claim 27. Markovsky further teaches the detection element is configured to record the light signal emitted or reflected by the test module (para 0036-0037).
Regarding claim 31, Markovsky in view of Cameron teaches the invention in claim 18. Markovsky further teaches the output module is an optical output module (para 0047).
Regarding claim 32, Markovsky in view of Cameron teaches the invention in claim 31. Markovsky further teaches the optical output module is an LED or a display (para 0054).
Regarding claim 33, Markovsky in view of Cameron teaches the invention in claim 18. Markovsky further teaches the output module is a wireless communication interface (para 0025).
Regarding claim 34, Markovsky in view of Cameron teaches the invention in claim 18.
However, Markovsky does not teach a steam generator being an e-cigarette.
Cameron teaching a steam generator (‘vapor device’, para 0091) that can be used to vaporize samples and release it into the atmosphere (para 0081). Cameron further teaches the vapor device could be an e-cigarette for the benefit of providing network-related services to the user device (para 0132). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Markovsky with the steam generator being an e-cigarette as taught by Cameron for the benefit of providing network-related services to the user device (para 0132).
Claims 20-23 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Markovsky et al. (US 20130177214 A1) and Cameron (US 20170046357 A1), further in view of Liu (CN 106367336 A). The examiner has obtained a machine translation of the CN document above from Espacenet. The rejection below is based off the machine translation.
Regarding claim 20, Markovsky in view of Cameron teaches the invention in claim 19.
Markovsky in view of Cameron does not teach the heating element is adapted to perform amplification by heating the test module.
Liu teaches an apparatus for carrying out chemical reactions using thermal cycling for sample detection (pg 10, para 0005). Liu further teaches the apparatus for performing nucleic acid amplification for the benefit of enabling immediate detection of samples (pg 11, para 0012). Thus, it would be obvious to one of ordinary skill in the art before the effective filling date to modify Markovsky and Cameron with the heating element that is adapted to perform amplification by heating the test module as taught by Liu for the benefit of enabling immediate detection of samples (pg 11, para 0012).
Regarding claim 21, Markovsky and Cameron in view of Liu teaches the invention in claim 20.
Markovsky in view of Cameron does not teach the amplification is an isothermal amplification.
Liu teaches the apparatus for performing isothermal amplification (pg, 34, para 0124) for the benefit of higher efficiency (pg 60, para 0219). Thus, it would be obvious to one of ordinary skill in the art before the effective filling date to modify Markovsky and Cameron with the heating element that is adapted to perform isothermal amplification as taught by Liu for the benefit of higher efficiency (pg 60, para 0219).
Regarding claim 22, Markovsky and Cameron in view of Liu teaches the invention in claim 20.
Markovsky in view of Cameron does not teach the heating element being adapted to heat the test module in prespecified heating cycles and to perform a polymerase chain reaction.
Liu teaches the heating element being adapted to heat the test module in prespecified heating cycles and to perform a polymerase chain reaction (pg 31, para 0116) for the benefit of lower energy consumption (pg 60, para 0219). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to be modify the teaching of Markovsky and Cameron with the test module in prespecified heating cycles and to perform a polymerase chain reaction as taught by Liu for the benefit of lower energy consumption (pg 60, para 0219).
Regarding claim 23, Markovsky and Cameron in view of Liu teaches the invention in claim 22.
Markovsky in view of Cameron does not teach the heating module is adapted to heat the sample for preparation before performing the polymerase chain reaction.
Liu teaches the sample being sample receiving unit which is in the first position and exchanges heat with the first thermostatic module (pg 12, para 0016). Liu further teaches that the first thermostatic module is maintained at 90-110 °C (pg 12, para 0017) to allow the DNA to denature (pg 35, para 0127). This shows the sample is heated prior to the polymerase chain reaction. Thus, it would be obvious to one of ordinary skill in the art before the effective filling date to modify the teaching of Markovsky and Cameron with the heating module that is adapted to heat the sample for preparation before performing the polymerase chain reaction as taught by Liu ) to allow the DNA to denature (pg 35, para 0127).
Regarding claim 30, Markovsky in view of Cameron teaches the invention in claim 18. Cameron further teaches a mixing chamber (‘element operative’) for the vaporized material (para 0107).
Markovsky and Cameron do not teach the mixing chamber for purifying products of the chemical, biochemical or immunochemical detection process.
Liu teaches the biological sample may be pretreated such as purified (pg 43, para 0156) for obtaining a sample for further accurate analysis (pg 43, para 0156). Thus, it would be obvious for one of ordinary skill in the to modify the teaching of Markovsky and Cameron with the chamber to purify the sample as taught by Liu for obtaining a sample for further accurate analysis (pg 43, para 0156).
Claims 26 are rejected under 35 U.S.C. 103 as being unpatentable over Markovsky et al. (US 20130177214 A1) and Cameron (US 20170046357 A1), further in view of Schmitt (US 20060023078 A1).
Regarding claim 26, Markovsky in view of Cameron teaches the invention in claim 25.
However, Markovsky in view of Cameron does not teach the CCD sensor being 4-pixel or 16-pixels.
Schmitt teaches detectors that use optical camera such as CCD camera (para 0004). Schmitt teaches a CCD sensor having a 16 pixel for the benefit of increasing the light sensitivity of the optical camera (para 0060). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Markovsky and Cameron with a 16-pixel CCD sensor as taught by Schmitt for the benefit of increasing the light sensitivity of the optical camera (para 0060).
Conclusion
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/H.R.B./ Examiner, Art Unit 1798
/CHARLES CAPOZZI/ Supervisory Patent Examiner, Art Unit 1798
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