DETAILED ACTION
Comments
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Claims 1-14 are pending and examined in the instant Office action.
Information Disclosure Statement
The IDSs submitted have been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Line 32 of page 1 of the specification contains a hyperlink.
Claim Objections
Claims 1 and 8-10 objected to because of the following informalities:
Line 8 of claim 1 recites “a confidence interval or a quantile” which should recite “a confidence interval of a quantile”.
Line 7 of claim 8 recites “a confidence interval or a quantile” which should recite “a confidence interval of a quantile”.
Line 6 of claim 9 recites “a confidence interval or a quantile” which should recite “a confidence interval of a quantile”.
Line 6 of claim 10 recites “a confidence interval or a quantile” which should recite “a confidence interval of a quantile”.
Appropriate correction is required.
Priority
Applicant claims foreign priority to Japanese application JP 2021-092141.
In view of 37 CFR 1.55(g)(3), since there is the intervening prior art of Brass [WO 2020/245140 A1; on IDS] in the below prior art rejection, an English translation of Japanese application JP 2021-092141 is required to perfect the foreign priority claim.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
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(s) 1-14 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea/law of nature/natural phenomenon without significantly more. Claims 1-8 and 11-12 are drawn to devices, and claims 9-10 and 13-14 are drawn to methods.
In accordance with MPEP § 2106, claims found to recite statutory subject matter ( Step 1 : YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea:
Independent claims 1 and 8-10 recite the mental step of acquiring quantitative information of a test substance.
Independent claims 1 and 8-10 recite the mental step of reading a generalized reaction model obtained by generalization of a plurality of reaction models.
Independent claims 1 and 8-10 recite the mathematical limitations of estimating a posterior distribution of a parameter of the generalized reaction model using Bayesian inference.
Independent claims 8 and 10 recite the mathematical limitations that the reaction models are based on the Arrhenius and/or modified Arrhenius equations.
Independent claims 1 and 8-10 recite the mental steps of calculating a confidence interval of the quantitative information over a period of time or until a threshold specified limit of the confidence interval is attained.
Claim 2 recites the mental step of selecting the plurality of reaction models.
Claim 3 recites the mental step of setting a combination of the plurality of reaction models as a plurality of prior distributions.
Claim 4 recites the mathematical limitation of summing the plurality of reaction models.
Claim 5 recites the mental step of the reaction model including a plurality of reaction models.
Claim 6 recites the mental step of switching the reaction models based on whether the reaction of the sample includes accelerated reaction.
Claim 7 recites the mathematical limitation of using the quadratic approximation to determine whether an accelerated reaction is included.
Claims 11-14 recite the mental step of constraining the test substance to be a drug comprising an active ingredient or impurities.
These recitations are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind or mathematical relationships. Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas. Merely reciting that a mental process is being performed in a generic computer environment does not preclude the steps from being performed practically in the human mind or with pen and paper as claimed. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then if falls within the “Mental processes” grouping of abstract ideas. As such, claim(s) 1-14 recite(s) an abstract idea/law of nature/natural phenomenon (Step 2A, Prong 1 : YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). This judicial exception is not integrated into a practical application because the claims do not recite an additional element that reflects an improvement to technology or applies or uses the recited judicial exception to affect a particular treatment for a condition. Rather, the instant claims recite additional elements that amount to mere instructions to implement the abstract idea in a generic computing environment or mere instructions to apply the recited judicial exception via a generic treatment.
As such, these limitations equate to mere instructions to implement the abstract idea on a generic computer that the courts have stated does not render an abstract idea eligible in Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. As such, claims 1-14 is/are directed to an abstract idea/law of nature/natural phenomenon (Step 2A, Prong 2 : NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that equate to mere instructions to apply the recited exception in a generic way or in a generic computing environment.
As discussed above, there are no additional limitations to indicate that the claimed analysis engine requires anything other than generic computer components in order to carry out the recited abstract idea in the claims. Claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. MPEP 2106.05(f) discloses that mere instructions to apply the judicial exception cannot provide an inventive concept to the claims. The additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B : No). As such, claims 1-14 is/are not patent eligible.
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.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al. [KR 20160143158 A; on IDS] in view of Brass [WO 2020/245140 A1; on IDS]. The English translation of Choi et al. provided by applicant is cited in the instant Office action.
Claim 9 is drawn to a sample analysis method. The method comprises acquiring quantitative information of a test substance present in a sample. The method comprises reading a generalized reaction model obtained by generalization of a plurality of reaction models from a storage device and estimating a posterior distribution of a parameter of the generalized reaction model using Bayesian inference. The method comprises calculating a confidence interval of a quantile of the quantitative information of a test substance in any period of time based on the estimated posterior distribution of a parameter.
Claim 1 is drawn to the same subject matter as claim 9, except claim 1 is drawn to a device.
Claims 8 and 10 are drawn to the subject matter of claims 1 and 9, respectively, with the additional limitation that an Arrhenius equation or modified Arrhenius equation is combined with the reaction model.
Claims 11-14 are dependent from claims 1 and 8-10, respectively, with the additional limitations that the sample includes a formulation or drug substance, and the test substance includes an active ingredient.
The document of Choi et al. studies an apparatus and method for estimating a dose response curve and a benchmark dosage of a drug [title]. It is interpreted that the drug has a traceable active ingredient. Claim 1 of Choi et al. teaches estimating the generalized model of a dose response curve. Claim 1 of Choi et al. teaches use of a posterior distribution and Bayesian inference. Claim 7 of Choi et al. teaches calculation of a confidence interval of the model of the dose response data over a period of time.
Choi et al. does not teach that the reaction model is obtained by a generalization of a plurality of reaction models.
The document of Brass studies a method for determining at a current time point a preservation state of one product [title]. Table 1 on pages 13-14 of Brass teaches obtaining a modified Arrhenius equation model from a generalized combination of Arrhenius-like models of lesser orders.
With regard to claim 2-3, Claim 1 of Choi et al. teaches basing the drug reaction model on a prior distribution. Table 1 on pages 13-14 of Brass teaches stochastically selecting a plurality of reaction models (i.e. which would correspond to a plurality of prior distributions).
With regard to claims 4-5, Table 1 on pages 13-14 of Brass teaches generalized reaction modes comprising a plurality of reaction models (i.e. and suggesting a summation of reaction models).
With regard to claims 6-7, page 18 of Brass teaches switching to the Prout-Tompkins model of Sestak n/p model for accelerated reactions. Page 20, lines 1-15 of Brass teaches using a quadratic approximation on reaction models.
It would have been obvious to someone of ordinary skill in the art at the time of the effective filing date of the instant application to modify the reaction model of drugs of Choi et al. by use of the Arrhenius reaction models of Brass because it is obvious to combine known elements in the prior art to yield a predictable result. In this instance, Arrhenius reaction models are an alternative to a drug reaction model. There would have been a reasonable expectation of success in combining Choi et al. and Brass because the mathematical reaction modeling of Brass is robust and generally applicable to reaction scenarios, including the drug reaction modeling of Choi et al.
E-mail Communications Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Russell Negin, whose telephone number is (571) 272-1083. This Examiner can normally be reached from Monday through Thursday from 8 am to 3 pm and variable hours on Fridays.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s Supervisor, Larry Riggs, Supervisory Patent Examiner, can be reached at (571) 270-3062.
/RUSSELL S NEGIN/ Primary Examiner, Art Unit 1686 16 December 2025