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 1-20 are pending and examined in the instant Office action.
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) 1-20 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 1-13 are drawn to methods, claims 14-18 are drawn to apparatus comprising processing circuitry, and claims 19-20 are drawn to systems comprising processing circuitry.
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:
The independent claims recite the mental step of identifying a plurality of compounds relevant to a mechanism.
The independent claims recite the mental step of determining combinations of compounds.
The independent claims recite the mental step of determining a compound sequence.
The independent claims recite the mental step and mathematical limitation of using a mathematical model for the biological system determining levels of biomarkers based on simulated administering of the compounds using dosages.
The independent claims recite the mental step of determining the maximum and minimum levels of the biomarkers based on simultaneous administering of the compounds.
The independent claims recite determining a third level of biomarkers as a result of administering the drugs.
The independent claims recite determining the effect of the combination of the drugs based on the comparison of levels.
Claims 2 and 15 recite the mental step of repeating portions of claim 1 based on other combinations of compounds.
Claims 3-5, 16-18, and 20 recite the mental steps of comparing the biomarker level based on individual administering of the compounds to a combination of the administering of the compounds to determine the presence of synergy and outputting the results.
Claim 6 recites the mental step of when there are two compounds, determining a sequence reversal.
Claims 7-8 recite the mental steps of determining ranges of sets of dosages of individual compounds.
Claim 9 recites the mental step of repeating the analysis for a second biomarker.
Claim 10 recites the mental step of constraining the ailment to joint pain and inflammation.
Claim 11 recites the mental steps of constraining the parameters for the mathematical model.
Claim 12 recites the mental step of constraining the simulation period to approximately two days.
Claim 13 recites the mental step of selecting a combination of compounds that have a synergistic effect.
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) 1-20 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.
While the claims recite simulated administering of compounds as drugs, the claims do not recite an active limitation of actually administering compounds as drugs as a particular treatment. While claim 13 recites manufacturing a product based on a selected combination of drugs, claim 13 does not recite manufacturing the selected combination of drugs.
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 1-20 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 1-20 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.
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.
35 U.S.C. 103 Rejection #1:
Claim(s) 1-9, 11-12, and 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. [Bioinformatics, volume 32, 2016, pages 3782-3789] as evidenced by Bliss [Ann. Appl. Biol., volume 26, 1939, pages 585-615].
Claim 1 is drawn to a method of determining particular combinations of compounds having a synergistic effect on a particular biological system of molecular mechanisms. The document of Liu et al. studies predicting synergistic effects between compounds through their structural similarity and effects on transcriptomes [title].
The method comprises identifying a set of a plurality compounds relevant to the molecular mechanism. Section 2.1 on page 3783 of Liu et al. teaches the study of 14 relevant compounds relevant to cancer.
The method comprises determining one or more combinations of compounds, each combination of compounds consisting of two or more compounds of the set of compounds. Section 2.1 on page 3783 of Liu et al. studies the 91 possible pairwise combinations of the 14 compounds.
The method comprises determining, for each combination of the one or more combinations of compounds, a set of compound sequences. Each compound sequence includes all compounds in the combination and being different from other of the compound sequences in the set of compound sequences. Section 2.1 on page 3783 of Liu et al. studies the 91 pairwise sequences of the 14 compounds.
The method comprises determining, using a mathematical model that described the biological system and for each compound sequence in the determined set of compound sequences of a particular combination of the one or more combinations, a level of a first biomarker of the biological system resulting from a simulated administration to the biological system of the compound sequence sequentially in time using a first set if dosages. Figure 1 on page 3786 of Liu et al. studies the EOB, or the expected Bliss effect, of combining compounds for administration on biomarkers in the OCL-LY3 cell line. The document of Bliss teaches the EOB mathematical model.
The method comprises determining a maximum level of the set of levels as a first level of the first biomarker and a minimum level of the set of levels as a second level of the first biomarker. In Figure 1 on page 3786 of Liu et al., the triangles illustrate the range of values that are additive.
The method comprises determining, using the mathematical model and for the particular combination, a third level of the first biomarker resulting from a simulated administration to the biological system of the compounds of the particular combination simultaneously using the first set of dosages. The method comprises determining, based on the three levels, an effect of the particular combination of the first biomarker using the first set of dosages. In Figure 1 on page 3786 of Liu et al., the circles illustrate a third level above the range of additive combination effects that indicates synergistic combination effects. Likewise, in Figure 1 on page 3786 of Liu et al., the square illustrate a third level below the range of additive combination effects that indicates antagonistic combination effects.
Claim 14 is drawn to similar subject matter as claim 1, except claim, 14 is drawn to an apparatus with processing circuitry.
Claim 19 is drawn to similar subject matter as claim 1, except claim, 19 is drawn to a system with processing circuitry.
Liu et al. does not teach automation of the tasks.
With regard to claims 2 and 15, Figure 1 on page 3786 of Liu et al. teaches repeating the analysis for all 91 possible pairwise combinations of compounds.
With regard to claims 3-6, 16-18, and 20, in Figure 1 on page 3786 of Liu et al., the circles illustrate a third level above the range of additive combination effects that indicates synergistic combination effects that indicate a more additive response than the sum of the individual compounds, or in a control. Figure 1 on page 3786 of Liu et al. illustrate results independent of the sequence of pairwise drugs.
With regard to claims 7-8, the paragraph bridging columns on page 3786 of Liu et al. teaches that, in experimenting in ranges of dosages, there is no optimal dosage of the compounds.
With regard to claims 9 and 11, Figure 1 on page 3785 of Liu et al. teaches the effect of the combination of compounds for administration on biomarkers in the OCL-LY3 cell line. Figure 2 on page 3785 of Liu et al. takes all of the genes into account in the cell line analysis.
With regard to claim 12, the paragraph bridging columns on page 3783 of Liu et al. teaches analysis at approximately 1 and 2 days.
It would have been obvious to modify the analysis of combinations of compounds on cell lines of Liu et al. by use of computers wherein the motivation would have been that automated manual activities lead to increased efficiency and accuracy. In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958).
35 U.S.C. 103 Rejection #2:
Claim(s) 10 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. as evidenced by Bliss as applied to claims 1-9, 11-12, and 14-20 above, in further view of Vali et al. [WO 2014/072950 A1].
Claim 10 is further limiting wherein the biological system is a joint pain system, and a level of the first biomarker is indicative of joint inflammation,
Claim 13 is further limiting comprising selecting a certain combination of compounds having a synergistic effect to be manufactured, and automatically instructing a manufacturing device to generate a product based on the selected certain combination of compounds and a corresponding set of dosages.
The document of Liu et al. makes obvious finding the synergy of combinations of drugs when treating cancer.
The document of Liu et al. does not teach joint pain systems or manufactured drugs.
The document of Vali et al. studies a systems and method for development of therapeutic solutions [title]. Page 26 of Vali et al. teaches the analysis of synergistic effects for rheumatoid arthritis. Table 24 on page 97 of Vali et al. lists relevant biomarkers for swollen and tender joints. Table 23 on page 96 of Vali et al. lists relevant manufactured drugs.
It would have been obvious to someone of ordinary skill in the art at the time of the filing date of the instant application to apply the expected Bliss effect model on caner of Liu et al. to rheumatoid arthritis of Vali et al. because it is obvious to substitute known elements in the prior art to yield a predictable result. In this instant rheumatoid arthritis is an alternative to cancer. There would have been a reasonable expectation of success in combining Liu et al. and Vali et al. because the expected Bliss effect model of Liu et al, is robust and generally applicable to biological systems of molecular mechanisms, including the rheumatoid arthritis of Vali et al.
Related Art
The document of Ayyadurai et al. [Applied Sciences, volume 12, 5 October 2022, article 10013, 17 pages] provided a detailed description of in silico modeling and quantification of synergistic effects of multi-combination compounds as a case study of the attenuation of joint pain using a combination of phytonutrients [title]. Ayyadurai et al, provides a detailed description of the discussion of synergy in drug combination in the instant specification.
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 August 2026
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