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.
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) is/are:
“a thermal cycler block adapted to receive…” in claim 14, section (a);
“a detection device capable of detecting luminescence in claim 14, section (b);
“a thermal top-heat assembly adapted to….” In claim 14, section (c).
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.
A thermal cycler is interpreted to encompass a thermal cycler as disclosed by Applicant in paragraph 0103 [a thermal block], and its equivalents.
As detection device is interpreted to encompass detection devices as disclosed by Applicant such as in paragraph 0104, and their equivalents.
A thermal top-heat assembly is disclosed in Applicant’s specification in paragraph 0102, and its equivalents.
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 § 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.
Claims 2-7, 10-11, 13-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claim(s) recite(s) the following, which are each an abstract idea (which encompasses a mental step) and is therefore a judicial exception:
(d) determine a plurality of residual sum of squares (RSS) values for the first and second models at each tested value of the first independent variable;
(e) analyzing the plurality of RSS values using a non-parametric goodness of fit test at each tested value of the first independent variable;
(f) identifying the single analyte as having activity in the biological system if the second model is a better fit than the first model for at least one tested value of the first independent variable.
Moreover, the claims recite the following which is based on a mathematical concept, i.e., a natural law:
(c) fitting the results for each concentration of a single analyte to a first model and a second model at each tested value of the first independent variable, wherein the first model is a linear null model with a slope of 0, and the second model is an alternative logarithmic model
(e) analyze the plurality of RSS values using a non-parametric goodness of fit test at each tested value of the first independent variable.
These judicial exceptions are not integrated into a practical application because none of the methods of claims 2-7, 10-11, 13-16 recite a practical application nor include additional elements that are sufficient to amount to significantly more than the judicial exception. Steps (b) through (e), as well as step (f), which recites repeating steps (c)-(f), are directed to the judicial exceptions themselves (an abstract idea or mathematical concept), as noted further above, and therefore cannot amount to a practical application nor an element that is sufficient to amount to significantly more than the judicial exception.
Regarding claims 2 and 14, Examiner notes that performing RT-CETSA, differential scanning fuorimetry, thermal shift analysis, intrinsic fluorescence differential scanning fluorimetry, and nano differential scanning fluorimetry (nanoDSF) are recited at a high level of generality and therefore do not amount to more than a well-known, conventional, and routine analytical device and processor.
The remaining claims also do not recite a practical application nor elements that are sufficient to amount to significantly more than the judicial exception, for the following reasons.
Regarding claim 3, the non-parametric goodness of fit test is directed to a mathematical concept (a judicial exception itself).
Regarding claims 4 and 5, the log-logistic fit model is directed to a mathematical concept (a judicial exception itself).
Regarding claim 6, which recites “calculating an EC50 value for the single analyte by plotting the RSS values from the first and second models at each value of the first independent variable, and then fitting the second model to the processed results at the value of the first independent variable where the amount of the RSS difference between the first and second models is greatest” (emphasis added), this claim is also directed to a mathematical concept (“calculate” and “fitting”), which is a judicial exception itself.
Regarding claims 7, 10 and 11, these claims recite details regarding the analyte, which is recited as part of the intended use of the device of claim 1, or is recited as part of the data gathering in which the results are used by the method of claim 2. Neither an intended use of a system, nor data gathering of a method is considered to amount to a practical application or elements which are sufficient to amount to significantly more than the judicial exception.
Response to Arguments
Applicant’s amendments or arguments have overcome some rejections in the previous Office action. However, the above rejections under 35 USC 101 remain.
Applicant argues that given that claim 2 is amended to recite that the method pertains to “conducting a biological assay” (as opposed to the previous claim 2 drawn to a method of analyzing data), claim 2 is drawn to “significantly more” than an abstract idea.
This argument is not persuasive since claim 2 recites abstract ideas as part of conducting the assay, and there are no limitations that include a practical application or limitations that amount to “significantly more”.
Conclusion
THIS ACTION IS MADE FINAL. 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 Ann Montgomery whose telephone number is (571)272-0894. The examiner can normally be reached Mon-Fri, 9-5:30 PM PST.
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/Ann Montgomery/Primary Examiner, Art Unit 1678
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