DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicants’ arguments and amendments, filed June 30, 2025, have been fully considered and they are persuasive in-part. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Status of the Claims
Claims 1-14, and 21-25 are under examination.
Claim Rejections - 35 USC § 101
2. 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 1-14, 21 and 22. are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claims 1-14, 21 and 22 are directed to a methods for pharmacokinetic profile selection and achieving a predictable bioavailability of an oral compound . As described in Alice Corp. Pty. Ltd. V. CLS Bank Int’l, 573 U.S._, 134 S. Cr. 2347, 110 U.S.P.Q.2d 1976 (2014), a two-step analysis is required in considering the patent eligibility of the claimed subject matter. The first step requires determining if the claimed subject matter is directed to a judicial exception. The instant claims require a system that includes a pharmacokinetic model of absorption of the oral compound based on the representation of the subject accounting for the different phases of digestion, a representation of the oral compound, a representation of the co-administration agent, simulating the absorption of the oral compound in the presence of the co-administration agent, generating a pharmacokinetic profile, storing the profile in memory, where the pharmacokinetic profile guides the development of a formulation of a drug or selecting a pharmacokinetic profile or creating a formulation, providing an in silico environment for testing the formulation, producing a dose of the oral compound and outputting the formulation toward the creation of a drug.. However, these elements are drawn to a mathematical algorithm and defines a mathematical model. The dependent claims include additional steps for the mathematical algorithm. The courts have found mathematical algorithms to be drawn to the judicial exception of an abstract idea (In re Grams, 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989)). Thus, the instant claims are drawn to a judicial exception.
This judicial exception is not integrated into a practical application. The instant claims do not recite an element that reflects an improvement in the functioning of a computer or other technology, an element that applies the judicial exception to affect a particular treatment, an element that implements the judicial exception with a particular machine, or an element that effects a transformation of a particular article to a different state or thing. The instant claims do recite a computer, memory, and processor. However, the claims do not recite any structural limitations to these elements are not drawn to a particular machine. Thus, the instant claims do not integrate the judicial exception into a practical application.
The second part of the analysis requires determining if the claims include additional elements that are sufficient to amount to significantly more than the judicial exception. The instant claims recite the additional elements of a computer, memory, and processor. However, these elements are well-understood, routine, and conventional elements of a computer (Specification, pages 15 and 16). Reciting such well-understood, routine, and conventional elements do not transform a judicial exception into patent eligible subject matter. In addition, the recitation of the specific types of data, to be used in the judicial exception does not transform the abstract idea into a non-abstract idea. (See buySAFE, Inc. v Google, Inc. 765 F.3d 1350, 112 U.S.P.Q.2d 1093 (Fed.Cir.2014)). Furthermore, the elements taken as a combination are also well-understood, routine, and conventional, since the elements are merely specifying use of a computer for implementing the judicial exception. Thus, the instant claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Response to arguments
3. Applicants have responded to this rejection by stating that the amendments are sufficient to overcome the rejection. However, the amendments are drawn to additional mathematical steps which are part of the judicial exception. In addition, the amendments do not provide an element that reflects an improvement in the functioning of a computer or other technology, an element that applies the judicial exception to affect a particular treatment, an element that implements the judicial exception with a particular machine, or an element that effects a transformation of a particular article to a different state or thing. The amendments state that the output of the formulation produce toward the creation of the drug or that the formulation is outputted to the next stage of drug development where the next stage of drug development is to create the drug. While both of these steps are intended to create the drug, neither step activity creates the drug according to the formulation. Thus, these amendments do not provide a physical transformation.
This rejection is re-applied to claims 21-22, because the claims were amended to remove the step of creating a drug and replacing the step with outputting the formulation to the next stage of drug development. As stated above, this step does not provide a physical transformation that integrates the judicial exception into a practical application.
This rejection is maintained and modified as necessitated by amendment.
Claim Rejections - 35 USC § 102
4. 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.
Claims 1, 4-8. 11-14 and 21-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rezhdo et al. (“Lipid-associated Oral Delivery: Mechanisms and Analysis of Oral Absorption Enhancement” Journal of Controlled Release (2016) volume 2040, pages 544-560) (IDS, filed 7/3/24, entry #21)..
Regarding claims 1, 8, 21, 23, and 25, Rezhdo et al. teach a system that includes a representation of a subject accounting for the different phases of digestion (page 552, right column); a representation of the oral compound (page 553, left column); a representation of a co-administration agent (page 553, left column); simulating the absorption of the oral compound in the presence of the co-administration agent based on the pharmacokinetic model (page 553, left column); generating a pharmacokinetic profile accounting for the different phases of digestion on the absorption of the oral compound and co-administration agent (page 553, left column); where the pharmacokinetic profile includes a representation of concentrations over time of the oral compound in blood of the subject (page 553, left column); the pharmacokinetic profile guiding the development of a formulation to be consumed by the subject, the formulation representing a combination of the oral compound and co-administration agent, and discovering absent in vivo testing of the formulation, the formulation achieving a predictable bioavailability of the oral compound in the subject in accordance with the pharmacokinetic profile (page 553, left column) or selecting a pharmacokinetic profile (page 553, left column), where the system provides an in silico environment for producing the formulation (pages 552-556), producing a reduced dose of the oral compound relative to a dose of the oral compound that achieves the predictable bioavailability absent the co-administration of the agent (page 544, right column and page 557, left column), and outputting the formulation produced toward the creation of a drug (page 553 left column and page 557, left column). In addition, Rezhdo et al. teach the method is available on commercially available software which would require memory and a computer (page 553, left column).
Regarding claims 4 and 11, Rezhdo et al. teach determining the bioavailability of an oral compound in the subject based on the representation of concentrations over time of the oral compound in the blood of the subject (page 553, left column).
Regarding claims 5 and 12, Rezhdo et al. teach where the oral compound is a drug (page 553).
Regarding claims 6 and 13, Rezhdo et al. teach where the co-administration agent is lipid based or food (page 553, left column).
Regarding claims 7 and 14, Rezhdo et al. teach where the subject is a human (page 552, right column).
Regarding claims 22 and 24, Rezhdo et al. teach considering a pharmacokinetic profile based on a fed or fasted state (page 553, left column).
Response to Arguments
5. Applicants state that Rezhdo et al. do not teach an “in silico environment” or the limitations of the amendments. Rezhdo et al. teach where the system provides an in silico environment for producing the formulation (pages 552-556), producing a reduced dose of the oral compound relative to a dose of the oral compound that achieves the predictable bioavailability absent the co-administration of the agent (page 544, right column and page 557, left column), and outputting the formulation produced toward the creation of a drug (page 553 left column and page 557, left column). This Rezhdo et al. do teach these limitations.
This rejection is maintained and modified as necessitated by amendment.
Claim Rejections - 35 USC § 103
6. 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 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.
Claims 2, 3, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Rezhdo et al. (“Lipid-associated Oral Delivery: Mechanisms and Analysis of Oral Absorption Enhancement” Journal of Controlled Release (2016) volume 2040, pages 544-560) (IDS, filed 7/3/24, entry #21) as applied to claims 1, 4-8. 11-14 and 21-24 above, and further in view of Buyukozturk et al. (“Effect of Ingested Lipids on Drug Dissolution and Release with Concurrent Digestion: A Modeling Approach” Pharm. Res. (2013) volume 30:3131-3144) (IDS, filed 7/3/24, entry #6).
Rezhdo et al. is applied as above.
However, Rezhdo et al. does not teach a system that may simulate absorption of the oral compounds by simultaneously solving a plurality of mechanism-based differential equations.
Regarding claims 2 and 9, Buyukozturk et al. teach a system that may simulate absorption of the oral compounds by simultaneously solving a plurality of mechanism-based differential equations representing gastrointestinal processes of the subject (page 3139, right column).
Regarding claims 3 and 10, Rezhdo et al. and Buyukozturk et al. teach where the gastrointestinal processes are represented by a plurality of mechanism based differential equations (Rezhdo et al., pages 552-556; Buyukozturk et al., pages 3135-3137).
It would have been obvious for one of ordinary skill in the art, at the time of filing, to combine the teachings of Rezhdo et al. and Buyukozturk et al. Rezhdo et al. teaches a method that intended to provide a model of oral absorption of a drug with a co-administration lipid (abstract). Buyukozturk et al. teach a method of modeling the effect of lipids on drug transport. One of ordinary skill in the art would have incorporated the teachings of Buyukozturk et al. into the teachings of Rezhdo et al. to create a more complete model of oral absorption of a drug with a co-administration lipid. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of successes since the mathematical equations are readily combinable.
Response to Arguments
7. Applicants have responded to this rejection by relying on their response to the rejection made under 35 U.S.C. §102. See above the Examiner’s response.
Withdrawn Rejections
8. Applicant’s arguments and amendments, filed June 30, 2025, with respect to the rejections made under 35 U.S.C. §112 have been fully considered and are persuasive. The amendment are sufficient to overcome these rejections. This rejection has been withdrawn.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JERRY LIN whose telephone number is (571)272-2561. The examiner can normally be reached T-F 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Olivia Wise can be reached at (571) 272-2249. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JERRY LIN/Primary Examiner, Art Unit 1685