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 .
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.
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: “processing unit” in claims 12-13.
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
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 8, 12-13 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 8 recites the limitation "The method according to claim 1 for providing a detection output representative for the presence of at least one molecule of interest in a plurality of samples," in the preamble. There is insufficient antecedent basis for this limitation in the claim because claim 1 recites “A method for providing a detection output which is representative for the presence of a molecule of interest in a sample,”
Claim 12 recites a “processing unit” arranged to perform the method of claim 1, which represents structure disclosed in the specification for performing the method, which includes the functions attributed to “an input” and “an output” previously recited in claim 12, which appear to be generic representations of some unknown structure. This makes the structure of claim 12 and 13 unclear. Claim 13 further defines functioning of the generic “output”, which again appears to be functioning which is performed by the actual structure of the “processing unit” from claim 12. For continued examination claims 12 and 13 are interpreted as having those functions attributed to the “processing unit” only.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because it is directed to software (“computer program product comprising a computer-executable program of instructions”).
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recite(s) “A method for providing a detection output which is representative for the presence of a molecule of interest in a sample, wherein the method is a computer implemented method comprising the steps of: providing assay data, wherein said assay data comprises a plurality of data values for a plurality of time points being indicative for at least one detection curve obtained from an assay containing said sample; determining, from said assay data, a value of a second derivative of said detection curve; comparing said determined value of the second derivative with a predetermined non-zero threshold”, wherein the entirety of the underlined portion of the claim above is capable of being performed as a mental process. (The final step: “providing said detection output” is not included in the broadest reasonable interpretation of the claim because it is contingent on the condition “if, following from said comparison, the absolute value of said determined value of the second derivative exceeds said threshold” [See MPEP 2111.04 II as noted in the 102 section below], but the final step would nevertheless also be included in the judicial exception capable of performance as a mental process).
This judicial exception is not integrated into a practical application because the claim does not provide any additional limitations except for mere computer implementation (“wherein the method is a computer implemented method”), which is explicitly listed in MPEP 2106.04(d) I. and 2106.05(f) as an example of not integrating the judicial exception into a practical application, and the claim does not provide anything which those sections would otherwise imply integrates the judicial exception into a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the same reasons.
Claims 2-11 and 14-15 merely add more detail to the judicial exception which may be performed as a mental process, and therefore do not integrate the judicial exception into a practical application nor do they add significantly more.
Claims 12-13 merely add some computer hardware (“processing unit”) to perform the method which was previously described in claim 1 as “computer implemented”, but this does not integrate the judicial exception into a practical application nor does it add significantly more, as discussed above in reference to MPEP 2106.04(d) I. and 2106.05(f).
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) 1-6, 8-9, and 11-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hopper (US2019/0376129A1).
Regarding claim 1, Hopper teaches a method for providing a detection output which is representative for the presence of a molecule of interest in a sample (Abstract), wherein the method is a computer implemented method comprising the steps of: providing assay data, wherein said assay data comprises a plurality of data values for a plurality of time points being indicative for at least one detection curve obtained from an assay containing said sample; determining, from said assay data, a value of a second derivative of said detection curve; and comparing said determined value of the second derivative with a predetermined non-zero threshold (Paragraphs 0130-0138).
The additional step "providing said detection output" is not included in the broadest reasonable interpretation of the claim because it is contingent on the condition "if, following from said comparison, the absolute value of said determined value of the second derivative exceeds said threshold" (and the claim is directed to a method). As stated in MPEP 2111.04 II, "The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met."
Regarding claim 2, Hopper discloses the invention of claim 1 as discussed above, and Hopper teaches determining a plurality of values of the second derivative from the assay data and comparing said plurality of determined values of the second derivative with the threshold (Paragraph 0132)
Regarding claim 3, Hopper discloses the invention of claim 2 as discussed above, and Hopper teaches determining a value for the second derivative from the assay data for each data value (See previously cited sections).
Regarding claim 4, Hopper discloses the invention of claim 1 as discussed above, and Hopper teaches that the step of providing assay data comprises consecutively receiving a plurality of data values, the plurality of data values forming the assay data, wherein the step of determining the value for the second derivative comprises calculating, for at least a part of the consecutively received data values, said second derivative based on the assay data (See previously cited sections and Figures 5-7 showing the consecutive data and its subsequent second derivative determination).
The additional step "the detection output is provided" is not included in the broadest reasonable interpretation of the claim because it is contingent on the condition "if following from said comparison, at least one determined second derivative exceeds said threshold" (and the claim is directed to a method). As stated in MPEP 2111.04 II, "The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met."
Regarding claim 5, Hopper discloses the invention of claim 1 as discussed above, and Hopper teaches the steps of: a) receiving a data value, said data value being one of a plurality of data values forming the assay data; b) determining a value of the second derivative for said received data value and on the basis of the assay data; c) comparing said value of the determined second derivative with the threshold (Paragraphs 0130-0138; Figure 5-7).
The additional step "d) providing said detection output" is not included in the broadest reasonable interpretation of the claim because it is contingent on the condition "if, following from said comparison, said determined second derivative exceeds said threshold" (and the claim is directed to a method). As stated in MPEP 2111.04 II, "The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met."
Regarding claim 6, Hopper discloses the invention of claim 5 as discussed above, and the step recited in the claim is contingent on the condition of step d recited above, and is therefore also not included in the broadest reasonable interpretation since step d is not.
Regarding claim 8, Hopper discloses the invention of claim 1 as discussed above, and Hopper teaches that the step of providing assay data comprises providing assay data comprises a plurality of channels of data values being indicative for a plurality of detection curves obtained from an assay containing said plurality of samples, and wherein the steps of determining and comparing are performed for each (Paragraphs 0060, 0113-0115 [providing detection output is not included in the broadest reasonable interpretation as noted above]).
Regarding claim 9, Hopper discloses the invention of claim 5 as discussed above, and Hopper teaches that the step of providing assay data comprises providing assay data comprises a plurality of channels of data values being indicative for a plurality of detection curves obtained from an assay containing said plurality of samples, and wherein steps a-c are repeated for each of the respective channels in the optical assay data (Paragraphs 0060, 0113-0115, and 0130-0138 [step d is not included in the broadest reasonable interpretation as noted above]).
Regarding claim 11, Hopper discloses the invention of claim 1 as discussed above, and Hopper teaches a non-transitory computer readable medium storing a computer-executable program of instructions for performing, when executed on a computer, the steps of the method of claim 1 (Paragraph 0102).
Regarding claim 12, Hopper discloses the invention of claim 1 as discussed above, and Hopper teaches processing unit configured to perform the method according to claim 1 as recited above (Paragraph 0102, 0140).
Regarding claim 13, Hopper discloses the invention of claim 12 as discussed above, and Hopper teaches that processing unit is capable of providing an output datafile (since it is integrated in an electronic controller which outputs the assay result data).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN R STECKBAUER whose telephone number is (571)270-0433. The examiner can normally be reached Monday - Thursday 9:30-7:30 PST.
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/KEVIN R STECKBAUER/Primary Examiner, Art Unit 3747