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 .
Claims Status
Claim(s) 1-22 are currently pending and under examination herein.
Claim(s) 1-22 is/are rejected.
Information Disclosure Statement
The Information Disclosure Statements filed on 22 Aug 2023 and 04 Apr 2024 are in compliance with the provisions of 37 CFR 1.97 and has/have been considered. A signed copy of list of references cited from the/each IDS is included with this Office Action.
Priority
The instant application claims the benefit of priority to Provisional Application No. 63/382856, filed 08 Nov 2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.78. As such, the effective filing date of claims 1-22 is 02 Nov 2022.
Drawings
The drawings are objected to because Fig. 5 text and labels are faded and difficult to see. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
For purposes of examination, claim 1 “determining a set of patient inputs” will be interpreted as “receiving a set of patient inputs.”
For purposes of examination, claims 15, 17, and 18-20 “…further comprising providing a model [or mechanism] that generates an optimal time for taking a drug” will be interpreted as “further comprising a model [or mechanism] that generates an optimal time for taking a drug.”
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 and claims 2-22 as being dependent, or multiply dependent, on claim 1 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are:
Where patient inputs come from i.e. wearable device data, other sensor data, etc. (see spec ¶ [0056])
Estimating a circadian trajectory and determining circadian mapping of the patient from the set of patient inputs ¶ [0056]
Claims 15, 17, and 18-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The limitation “providing a model…”is indefinite in that the steps for how a model is provided is unclear.
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The limitation “filling in gaps in one or more of the models” is indefinite. ¶ [0092] describes data inputs as having time gaps or missing data, but it is unclear in the claims and specification what “gaps” in the models are to be filled.
Claims 18 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 18 and 19 recite the limitation “the core circadian pacemaker.” There is insufficient antecedent basis for this limitation in the claim.
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 1-22 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.
Step 2A, Prong 1 Considerations
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/law of nature/natural phenomenon:
Claim 1 recites a computer-implemented method for administering a treatment comprising determining patient inputs, treatment, circadian mapping profiles, circadian mapping trajectories and treatment time periods, and estimating circadian mapping profiles.
Claim 16 recites variables representing molecular equations and parameters representing binding rates.
Claims 2-20 being dependent or multiply dependent from claim 1 also have these limitations.
Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas. While claims 1-22 recite performing some aspects of the analysis “computer-implemented,” there are no additional limitations that indicate that this analysis engine requires anything other than carrying out the recited mental process or mathematical concept in a generic computer environment. 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, claims 1-22 recite an abstract idea/law of nature/natural phenomenon (Step 2A, Prong 1 : YES).
Step 2A, Prong 2 Considerations
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 condition. Specifically, the claims recite the following additional elements:
Claim 1 recites administering a treatment.
Claim 5 recites administration of a substance.
Claim 6 recites the substance of claim 5 being one or more of a drug, nutrient or medicament.
The steps for administering the treatment is not particular because the claim generically recites treatment with no limitation on the type of treatment applied. This administration step is not particular and is instead merely instructions to "apply" the exception in a generic way. Thus, the administration step does not integrate the mental analysis step into a practical application. See MPEP § 2106.04(d)(2)(a).
Claims 1-20 recite a computer-implemented method.
Claim 10 recites presenting patient treatment outputs in human-interpretable form.
Claim 11 recites connecting a model output to environmental controls to adjust an environment such that circadian-relevant behaviors are adjusted towards a target-constrained time.
Claims 15, 17, 18, 19 and 20 recite a model or mechanism that generates an optimal time for taking a drug.
Claim 21 recites a non-transitory computer-readable storage medium.
Claim 22 recites a computer system.
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 computer medium and/or use of a hardware processor. There are no limitations that indicate that the claimed system, method or storage medium require anything other than generic computing systems. 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.
The steps for determining the treatment time during a determined preferred treatment time period by computational means are well-understood, routine and conventional functions such as performing repetitive calculations and mere data extracting (see MPEP 2106.05(d)(2)). As such, claims 1-22 are directed to an abstract idea/law or nature/natural phenomenon (Step 2A, Prong 2 : NO).
Step 2B (MPEP 2106.05.A i-vi)
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 to apply a generic treatment step and/or in a generic computing environment.
As discussed above, there are no additional limitations to indicate that the claimed system and method requires anything other than generic administration or 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 (see MPEP §2106.05(d)). Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984.
The limitation for administering a treatment equate to mere instructions to apply the judicial exception in a generic way because the treating step is so generically recited. 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 1-22 are not patent eligible.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4, 7, 9-11, and 20-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pederson (US Patent 11478658, IDS entered 04Apr2024).
Claim 1 1st element recites a computer-implemented method for administering a treatment, comprising: under the control of one or more computer systems configured with executable instructions: determining a set of patient inputs. Pederson teaches obtaining patient data and medication information (see col. 31 line 28 claim 9).
Claim 1 2nd element recites determining a treatment. Pederson teaches obtaining patient medication information (see col. 31 line 28) and using a light therapy treatment to affect circadian rhythms (see claim 9 col. 31 line 40).
Claim 1 3rd element recites estimating a circadian trajectory of the patient. Pederson teaches determining the circadian rhythm of the patient (see claim 9 col. 31 line 35).
Claim 1 4th element recites determining one or more circadian mapping profiles. Pederson teaches determining circadian profiles (see claim 9 col. 31 line 36).
Claim 1 5th element recites administering the treatment in response to an alert that the preferred treatment time period is occurring or is to occur. Pederson teaches the use of a 3rd party alert system for preferred treatment time period and administration (see col. 18 line 30).
Claim 4 recites a length of the time period varies according to an uncertainty measure of the circadian trajectory, with the length being longer when the uncertainty measure is higher and the length being shorter when the uncertainty measure is lower. Pederson teaches a transformation function that can be generated based on clinical research data as well as shifted or adjusted on a received patient’s current circadian rhythm and a desired circadian rhythm (col. 7 line 30).
Claim 7 recites the set of patient inputs comprises data derived from signals received of a patient from wearing a wearable data system. Pederson teaches use of wearable data systems for patient data inputs (col. 6 line 42-52).
Claim 9 recites the computer-implemented method of claim 1, wherein the preferred treatment time period is optimized based on associating a circadian time with a time for taking a drug for generating a raw model output. Pederson teaches determining medication administration, optimized based on circadian rhythms (see Fig. 5 label 513).
Claim 10 recites the computer-implemented method of claim 1, further comprising presenting patient treatment outputs in a human-interpretable form. Pederson teaches an interface GUI of a client-facing portion of the platform (see col. 22 line 66).
Claim 11 recites the computer-implemented method of claim 1, further comprising: connecting a model output to environmental controls to adjust an environment such that circadian-relevant behaviors are adjusted towards a target-constrained time. Pederson recites use of light therapy to adjust circadian rhythms to a target-constrained time (see col. 31 claims 6 and 7).
Claim 20 recites the computer-implemented method of claim 1, further comprising providing a mechanism converting the raw model output into a human-interpretable form, the method provides an optimal time for taking a drug, subject to a rule that a patient can take only one of these drugs in a particular day. Pederson teaches single, one-time treatment (Col. 4 line 63).
Claim 21 recites a non-transitory computer-readable storage medium storing instructions, which when executed by at least one processor of a computer system, causes the computer system to carry out the method of claim 1. Pedersen teaches a non-transitory computer-readable storage medium to carry out the method described in claim 1 (Col. 32 Line 63 Claim 18).
Claim 22 recites a computer system comprising: one or more processors; and a storage medium storing instructions, which when executed by the at least one processor, cause the system to implement the method of claim 1. Pederson teaches a computer system comprising processors and storage media to implement the method described in claim 1 (Col. 32 Line 24 Claim 15).
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 5-6, 12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Pederson as applied to claims 1, 4, 7, 9-11, and 20-22 under 102 above, and further in view of Halberg (Halberg et al. 1973 Experientia 29(8) pgs. 909-1044).
With respect to claim 2, Pederson does not teach a 24-hour preferred treatment time period specifically. Halberg teaches a 24-hour preferred treatment time period (see Fig 11 pg. 918).
With respect to the limitations of claims 5 and 6 where the administered substance is a drug or medicament, Halberg teaches administration of ara-C cancer treatment, being both a drug and medicament, based on the body’s circadian rhythms (Fig. 11 pg. 918).
With respect to the limitation of claim 12 wherein the treatment is administered at an infusion clinic, Pederson does not teach administration of treatments at an infusion clinic. Halberg teaches clinical chronotherapy for cancer, including infusions, which occurs at a clinic (§ VIII Discussion pg. 928 3rd ¶).
With respect to the limitation of claim 15 providing a model that generates an optimal preferred treatment time period wherein the treatment is the administering of a drug and wherein the model associates a circadian time with a time for taking the drug, the model including rules representing how different molecules in the drug and body bind and interact with each other. Pederson does not teach rules representing how different molecules in the drug and body bind and interact with each other. Halberg teaches tolerance for treatment of a leukemia by ara-C being markedly increased when a sinusoidal schedule of variegating dosing was used when putatively adjusted to a leukemic cell cycle (§Abstract pg. 910 2nd ¶).
Taken together, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine Pederson and Halberg to determine the optimal time period for administering a treatment, that treatment time period being one day in order to specify the types of treatments administered based on circadian rhythms; to perform infusions at a clinic based on one’s circadian rhythms in order to improve patient outcomes for treatment; and to train a model to account for tolerance of a treatment according to cell cycle in order to improve treatment outcomes.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Pederson in view of Halberg as applied to 1-2, 4-7, 9-12, 15 and 20-22 above, and further in view of Hughey (Hughey et al. 2016 Nucleic Acid Reports 44(8) e80). Claim 8 recites the computer-implemented method of claim 1, wherein the circadian trajectory is derived by a scheduler using at least one biophysics model of a human circadian clock and at least one a statistical model of the human circadian clock. Applicant has defined in the specification a statistical model can be a machine learning model trained on wearable time series data streams and that a biophysics model can be human generated or derived from data (see ¶0161 in specification). Pederson teaches the elements of claim 1 as described above as well as a machine learning model trained on patient data input derived from wearable time series data (col. 16 line 10). Pederson does not teach use of a specific biophysical model of a human circadian clock as per applicant’s definition. Hughey teaches a machine learning model derived from time series data in mice to predict periodic variables from high-dimensional observation (§Abstract).
Taken together, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine Pederson and Hughey in order to improve capabilities for determining circadian rhythms based on data derived from different schedulers.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Pederson and Halberg as applied to claims 1 and 11 above and further in view of Montaigne (Montaigne et al. 2018 Lancet 391 pgs. 59-69). Claim 13 recites the computer-implemented method of claim 11, wherein the treatment is a scheduled surgery. Pederson does not teach a treatment as being a scheduled surgery. Montaigne teaches scheduling surgery at times more favorable to circadian rhythms (§ Interpretation pg. 59 and § Discussion pg. 68 4th ¶).
Taken together, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine Pederson and Montaigne to account for better outcomes post-op.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Pederson as applied to claim 1 above and further in view of Hesse (Hesse et al. 2020 Cancers 12(3103) pgs. 1-33). Claim 14 recites the computer-implemented method of claim 1, further comprising filling in gaps in one or more of the models in missing data according to a ruleset. Pederson does not teach filling in gaps in the model when data is missing. Hesse teaches extrapolating additional data points to help derive peak time and oscillation amplitude and predict missing data (§ 3.3 Modelling Genetic Networks Related to Cancer and Circadian Tiem pg. 17 3rd ¶).
Taken together, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine Pederson and Hesse in order to account for data that isn't measured experimentally but is nonetheless included in the model.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Pederson in view of Halberg, as applied to 1-2, 4-7, 9-12, 15, and 20-22 above, and further in view of Geertz (US PgPub 2007/0106479 A1, IDS entered 04Apr2024). Claim 16 recites the computer-implemented method of claim 15, wherein the rules include variables representing molecular equations and parameters represent binding rates. Pederson and Halberg do not teach rules including variables representing molecular equations and parameters representing binding rates. Geertz discloses variables representing molecular equation and parameters representing binding rates (¶’s 0087 and 0090).
Taken together, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine Pederson, Halberg and Geertz in order to improve the accuracy and precision of the models.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Pederson in view of DiPierro (US PgPub 2020/0330369 A1, IDS entered 04 Apr 2024). Claim 17 recites the computer-implemented method of claim 1, further comprising providing a model that generates an optimal time for taking a drug by associating a circadian time with a time for taking a drug for generating a raw model output and gating the triggering alerts based on logical gating in order to provide an optimal time for spacing treatments. Pederson does not teach gating the triggering alerts based on logical gating. DiPierro teaches a programmable dosage controller configured to control the time and dosage of the active substance according to a dosage profile corresponding to a circadian rhythm of the user (claim 2).
Taken together, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine DiPierro and Pederson to determine the best time to administer a treatment.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Pederson as applied to claim 1 above and further in view of Shaker (Shaker et al. 2021 Bioinformatics 37(8) pgs. 1135-1139). Claim 18 recites the computer-implemented method of claim 1, further comprising providing a model that generates an optimal time for taking a drug by associating a circadian time with a time for taking a drug for generating a raw model output, the model of the core circadian pacemaker can be connected to a model of the blood-brain barrier. Pederson does not teach connecting the model to a model of the blood-brain barrier. Shaker teaches a model for the blood-brain barrier (§ Abstract).
Taken together, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to use the blood-brain barrier model of Shaker in combination with the model of Pederson in order to determine the best time of day to administer a medication based on diseases of the blood-brain barrier.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Pederson as applied to claim 1 above and further in view of Ashworth (Ashworth et al. 2021 PLOS Computational Biology 12(9) e1005105). Claim 19 recites the computer-implemented method of claim 1, further comprising providing a model that generates an optimal time for taking a drug by associating a circadian time with a time for taking a drug for generating a raw model output, the model of the core circadian pacemaker can be connected to a model of the liver. Pederson does not teach connecting the model to a model of the liver. Ashworth teaches a model for the liver (§ Abstract).
Taken together, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to use the blood-brain barrier model of Shaker in combination with the model of Pederson in order to determine the best time of day to administer a medication based on diseases of the liver.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Asgari-Targhi et al. 2019 Wiley Interdiscip Rev Syst Biol Med 11(2) e1439, Hill et al. 2020 PLOS Computational Biology 16(1) e1007218 (IDS entered 22 Aug 2023), Wagner 2021 Int. J. of Molec. Sci. 22(8289).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Maranda S Cantrell whose telephone number is (571)270-5651. The examiner can normally be reached Monday - Thursday 7:30-4:30 pm.
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/M.S.C./Examiner, Art Unit 1687
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687
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