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 .
Response to Amendment
The Amendment filed on 11/26/2025 has been entered. Claims 1 and 3-11 remain pending in the application. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejection previously set forth in the non-final Office Action mailed 8/27/2025.
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 1, 3-7, 9, 11 and 12 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 1 recites “in the step of determining a reaction efficiency,” the recitation of “a reaction efficiency” is unclear if this is referring to the same or different step as recited in line 6. For examination purposes, they are interpreted to be the same. Claims 3-7, 9, 11 and 12 are rejected by virtue of their dependence on a rejected base claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 5-7 and 9-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Application Publication No. 2005/0118620, hereinafter Vess as evidenced by United States Application Publication No. 2014/0095080, hereinafter Kurnik.
Regarding claim 1, Vess teaches a method for conducting a quantitative polymerase chain reaction (qPCR) process, the method comprising: cyclically executing qPCR cycles (paragraph [0047]); measuring a fluorescence at each qPCR cycle (paragraph [0049]) to obtain a qPCR curve composed of intensity values (paragraph [0058]); determining of a reaction efficiency for each qPCR cycle (paragraph [0060]); correcting a respective intensity value of each respective qPCR cycle depending on the reaction efficiency determined for the respective qPCR cycle to obtain a corrected qPCR curve (paragraph [0059]); conducting the qPCR process depending on a shape of the corrected qPCR curve (paragraphs [0058]-[0059)); and conducting a reaction liquid into a reaction chamber (paragraphs [0011] and [0025] which incorporates by reference United States Patent No. 5,476,774 which teaches adding a reaction mixture to a reaction chamber (column 14, lines 30-45)), wherein in the step of determining a reaction efficiency is determined depending a volume or an area of at least one bubble formed in the reaction chamber (paragraphs [0058]-[0060], when the signal changes suddenly, this is caused by a bubble and this anomaly is corrected and based upon this corrected growth curve the “elbow value” is determined and as evidenced by Kurnik, the elbow value/Ct value is a measure of the efficiency of the PCR process).
Regarding claim 5, Vess teaches the determining further comprising: determining the reaction efficiency depending on an area of at least one bubble in a reaction chamber for at least two of (i) a denaturation process, (ii) an annealing, and (iii) a elongation process (paragraph [0047]).
Regarding claim 6, Vess teaches further comprising: determining, using the corrected qPCR curve, based on a classification method, whether a DNA strand segment to be detected is present (abstract).
Regarding claim 7, Vess teaches the conducting the qPCR process further comprising: signaling that a ct value is determinable (paragraph [0060]); and determining the ct value from a parameterized presence function in response to a presence of the DNA strand segment to be detected being established (paragraph [0060]).
Regarding claim 9, Vess teaches wherein the method is carried out by executing a computer program (paragraph [0014]).
Regarding claim 10, Vess teaches a non-transitory electronic storage medium storing a computer program for conducting a quantitative polymerase chain reaction (qPCR) process (paragraph [0014]), the computer program being configured to, when executed by a computer, cause the computer to: cyclically execute of qPCR cycles (paragraph [0047]); measure a fluorescence at each qPCR cycle (paragraph [0049]) to obtain a qPCR curve composed of intensity values (paragraph [0058]); determine a reaction efficiency for each qPCR cycle (paragraph [0059]); correct a respective intensity value of each respective qPCR cycle depending on the reaction efficiency determined for the respective qPCR cycle to obtain a corrected qPCR curve (paragraph [0060]); and conducting the qPCR process depending on a shape of the corrected qPCR curve (paragraphs [0058]-[0059]); and conducting a reaction liquid into a reaction chamber (paragraphs [0011] and [0025] which incorporates by reference United States Patent No. 5,476,774 which teaches adding a reaction mixture to a reaction chamber (column 14, lines 30-45)), wherein the reaction efficiency is determined depending on a volume or an area of at least one bubble formed in the reaction chamber (paragraphs [0058]-[0060], when the signal changes suddenly, this is caused by a bubble and this anomaly is corrected and based upon this corrected growth curve the “elbow value” is determined and as evidenced by Kurnik, the elbow value/Ct value is a measure of the efficiency of the PCR process).
Regarding claim 11, Vess teaches the conducting the reaction liquid further comprising: conducting the reaction liquid into the reaction chamber in each qPCR cycle (paragraphs [0011] and [0025] which incorporates by reference United States Patent No. 5,476,774 which teaches adding a reaction mixture to a reaction chamber (column 14, lines 30-45)).
Regarding claim 12, Vess teaches wherein the reaction efficiency is determined depending on the area of the at least one bubble in the reaction chamber for an elongation process (paragraphs [0011] and [0025] which incorporates by reference United States Patent No. 5,476,774 which teaches the amplification profile includes denaturation, annealing and extension (elongation) (column 14, lines 30-45) and as Vess teaches determining the reaction efficiency over the whole process, the reaction efficiency would be determined during the elongation process.
Claim Rejections - 35 USC § 103
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(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vess in view of United States Application Publication No. 2019/0224682, hereinafter Kim.
Regarding claims 3 and 4, Vess teaches all limitations of claim 1; however, Vess fails to teach further comprising: recording an image of the reaction chamber with a camera; and determining the area of the at least one bubble with pattern recognition methods applied to the image of the reaction chamber; the determining further comprising: determining the reaction efficiency with a brightness of at least one pixel of the image that corresponds to the reaction liquid and the area of the at least one bubble as a proportion of a total area of the reaction chamber.
Kim teaches a PCR method in which the analysis involves recording an image of the reaction chamber with a camera (Kim, paragraph [0071]); and determining the area of the at least one bubble with pattern recognition methods applied to the image of the reaction chamber (Kim, paragraph [0071]); the determining further comprising: determining the reaction efficiency with a brightness of at least one pixel of the image that corresponds to the reaction liquid and the area of the at least one bubble as a proportion of a total area of the reaction chamber (Kim, paragraph [0071]) so that the ratio of the total area width of the bubble compared to the width of the channel can be determined (Kim, paragraph [0071]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have used the method of Kim for determining bubbles and the reaction efficiency because it would allow for the ratio of the total area width of the bubble compared to the width of the channel can be determined (Kim, paragraph [0071]).
Response to Arguments
Applicant's arguments filed 11/26/2025 have been fully considered but they are not persuasive.
Regarding applicant’s argument that Vess does not determine reaction efficiency based on any aspect of bubble formation is not found persuasive. As disclosed is Vess, Vess determines if there is an in homogeneity in the sample (a bubble) and if there is a bubble present in the fluorescence signal, the anomaly is corrected in the growth curve. This corrected growth is then utilized for determining an elbow value from the data. As described above, Kurnik teaches that the elbow value is a measure of the efficiency of the PCR. Since the reference of Vess corrects the signal inhomogeneity when there is a bubble present and then determines the elbow value (reaction efficiency) it is considered that the reaction efficiency is determined on a volume or an area of at least one bubble formed in the reaction chamber.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., that Vess does not correlate the size of the data spike to the geometry of the bubble and therefore Vess cannot determine an area or volume of the bubble) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claim only specifies that the reaction efficiency is determined based on the volume or area of the bubble formed. The claim does not specify that the volume or area of the bubble is specifically determined. As the size of the inhomogeneity would be dependent upon the size of the bubble (a larger bubble would have a larger inhomogeneity) and the method corrects this anomaly (the larger the inhomogeneity the more correction that would have to occur), therefore, the determination of the reaction efficiency would be dependent upon the size of the bubble.
Regarding applicant’s argument that Kim does not disclose determining an area of the bubble with pattern recognition methods to the image of the reaction chamber is not found persuasive. The claim does not specify what type of pattern recognition method is utilized and therefore, even as applicant has stated the measurements were taken manually from the photograph. As the claim does not specify what type of pattern recognition method is utilized, the manually measuring of the bubble would be considered a type of pattern recognition and read on the instant claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at (571)272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796