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 1-7, 9, 11, and 13 are pending and examined in the instant Office action.
Withdrawn Objections
The objection to the specification is withdrawn in view of amendments filed to the instant specification on 17 March 2017.
The objections to claims 1 and 8-10 are withdrawn in view of arguments on pages 9-11 of the Remarks.
Priority
Applicant claims foreign priority to Japanese application JP 2021-092141.
The foreign priority claim has been perfected with the filing of a certified translation of JP 2021-092141 on 17 March 2026.
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.
The following rejection is reiterated:
Claim(s) 1-7, 9, 11, and 13 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 1-7 and 11 are drawn to devices, and claims 9 and 13 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 9 recite the mental step of acquiring quantitative information of a test substance.
Independent claims 1 and 9 recite the mental step of reading a generalized reaction model composed of a plurality of reaction models and describing a single reaction of a test substance.
Independent claims 1 and 9 recite the mathematical limitations of estimating a posterior distribution of a parameter of the generalized reaction model using Bayesian inference.
Independent claims 1 and 9 recite the mathematical limitations that the reaction models are based on the Arrhenius and/or modified Arrhenius equations.
Independent claims 1 and 9 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 and 13 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) 1-7, 9, 11, and 13 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 1-7, 9, 11, and 13 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 1-7, 9, 11, and 13 is/are not patent eligible.
Response to arguments:
Applicant's arguments filed 17 March 2026 have been fully considered but they are not persuasive.
Applicant argues that the fact pattern of the instant set of claims is analogous to Diamond v. Diehr in which the Arrhenius equation is critical limitation in the rubber molding process. In this set of claims, applicant argues that use of the Arrhenius and Arrhenius-like equations result in more reliable shelf-life predictions than conventional algorithms with analogous objectives. This argument is not persuasive because a judicial exception, by itself, that is an improvement to a conventional judicial exception with analogous objectives remains a judicial exception. In addition, applicant does not cite evidence connecting use of the Arrhenius and/or Arrhenius-like equations with better predictions of shelf-life.
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 following rejection is reiterated:
Claim(s) 1-7, 9, 11, and 13 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 pharmaceutical sample. The method comprises reading a generalized reaction model composed of a plurality of reaction models and describing a single reaction of the test substance from a storage device. The generalized reaction model is obtained by combining an Arrhenius equation or a modified Arrhenius equation with the plurality of reaction models. The method comprises 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 11 and 13 are dependent from claims 1 and 9, 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. The equations in Table 1 of Brass are based on the generalized model of the Arrhenius equation.
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.
Response to arguments:
Applicant's arguments filed 17 March 2026 have been fully considered but they are not persuasive.
Applicant argus that applicant selects a single reaction equation from Table 1 on pages 13-14 of Brass. While this may be accurate, the combination of Arrhenius-like equations in Table 1 of Brass is based on the general Arrhenius equation model.
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., the simultaneous extrapolation of time and temperature) 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).
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.
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 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 31 July 2026
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