DETAILED ACTION
Claims 1-20 are currently pending and have been examined.
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 .
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 1-20 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Subject Matter Eligibility Criteria - Step 1:
Claims 1-20 are directed to a method (i.e., a process). Accordingly, claims 1-20 are all within at least one of the four statutory categories.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong One:
Regarding Prong One of Step 2A, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 1 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites:
11. A method comprising:
determining, by a computing device, one or more physiological measurements associated with an individual;
applying the one or more physiological measurements to a multi-compartment model, wherein the multi-compartment model represents a bidirectional flux by diffusion of a hormone between a vascular compartment, an interstitial compartment, a hepatic compartment, and a renal compartment of the individual;
determining, based on the application of the one or more physiological measurements to the multi-compartment model, one or more physiological parameters associated with the individual; and
administering, based on the one or more physiological parameters, a treatment associated with one or more medical conditions associated with the individual.
The Examiner submits that the foregoing underlined limitations constitute “methods of organizing human activity” because determining physiological measurements, using a model with the physiological measurements to determine physiological parameters are associated with managing personal behavior or relationships or interactions between people. For example, but for the system, this claim encompasses a person facilitating data access, receiving data, and outputting data in the manner described in the identified abstract idea. The Examiner notes that “method of organizing human activity” includes a person’s interaction with a computer – see MPEP 2106.04(a)(2)(II)(C). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
The Examiner submits that the foregoing underlined limitations constitute “a mental process” because determining physiological measurements, using a model with the physiological measurements to determine physiological parameters are observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind.
Accordingly, independent claim 11 and analogous independent claim 1 recite at least one abstract idea.
Furthermore, dependent claims 2-10 & 12-20 further narrow the abstract idea described in the independent claims. Claims 2 & 12 recite the type of measurements, Claims 3 & 13 recite the model equations, Claims 4 & 14 recite the hormone type, Claims 5 & 15 recite the type of physiological parameters, Claims 6, 8, 16, & 18 recite determining a condition, Claims 7 & 17 recite an attribute type, Claims 9 & 19 recite the type of medical condition. These limitations only serve to further limit the abstract idea and hence, are directed towards fundamentally the same abstract idea as independent claim 11 and analogous independent claims 1, even when considered individually and as an ordered combination.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP §2106.04(II)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
In the present case, the additional limitations beyond the above-noted at least one abstract idea recited in the claim are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
11. A method comprising:
determining, by a computing device, one or more physiological measurements associated with an individual;
applying the one or more physiological measurements to a multi-compartment model, wherein the multi-compartment model represents a bidirectional flux by diffusion of a hormone between a vascular compartment, an interstitial compartment, a hepatic compartment, and a renal compartment of the individual;
determining, based on the application of the one or more physiological measurements to the multi-compartment model, one or more physiological parameters associated with the individual; and
administering, based on the one or more physiological parameters, a treatment associated with one or more medical conditions associated with the individual.
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of the computing device, the Examiner submits that these limitations amount to merely using computers as tools to perform the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitation of using a multi-compartment model, the Examiner submits that these additional claim limitations amount to an attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result and is equivalent to the words “apply it”. See MPEP 2106.05(f)(1).
Regarding the additional limitation of administering a treatment, the Examiner submits that these additional limitations amount to mere instructions to “apply” the exception in a generic way because the administration step is not particular and encompass all applications of the judicial exception. The administration step does not integrate the abstract idea step into a practical application – see MPEP 2106.04(d)(2)(a).
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole with the abstract idea, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole does not integrate the abstract idea into a practical application of the abstract idea. MPEP §2106.05(I)(A) and §2106.04(II)(A)(2).
For these reasons, representative independent claim 11 and analogous independent claim 1 do not recite additional elements that integrate the judicial exception into a practical application.
Accordingly, the claims recite at least one abstract idea.
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
Claims 10, 16, 18, & 20: These claims recite administering a treatment, the Examiner submits that these additional limitations amount to mere instructions to “apply” the exception in a generic way because the administration step is not particular and encompass all applications of the judicial exception. The administration step does not integrate the abstract idea step into a practical application – see MPEP 2106.04(d)(2)(a).
Thus, taken alone, any additional elements do not integrate the at least one abstract idea into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claim 11 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
As discussed above, regarding the additional limitations of the computing device, the Examiner submits that these limitations amount to merely using computers as tools to perform the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitation of using a multi-compartment model, the Examiner submits that these additional claim limitations amount to an attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result and is equivalent to the words “apply it”. See MPEP 2106.05(f)(1).
Regarding the additional limitation of administering a treatment, the Examiner submits that these additional limitations amount to mere instructions to “apply” the exception in a generic way because the administration step is not particular and encompass all applications of the judicial exception. The administration step does not integrate the abstract idea step into a practical application – see MPEP 2106.04(d)(2)(a).
The dependent claims also do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
Therefore, claims 1-20 are ineligible under 35 USC §101.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17993282. Although the claims at issue are not identical, they are not patentably distinct from each other because both applications contain limitations regarding using a multi-compartment model to process measured physiological data, where the multi-compartment model represents a bidirectional flux by diffusion of a hormone in different compartments, determining physiological parameters using the multi-compartment model, and determining a treatment and medical condition of a patient.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Prior Art Rejection
All of the cited references fail to expressly teach or suggest, either alone or in combination, the features found within the independent claims. In particular, the cited prior art of record fails to expressly teach or suggest the combination of: determining, by a computing device, one or more physiological measurements associated with an individual; applying the one or more physiological measurements to a multi-compartment model, wherein the multi-compartment model represents a bidirectional flux by diffusion of a hormone between a vascular compartment, an interstitial compartment, a hepatic compartment, and a renal compartment of the individual;
determining, based on the application of the one or more physiological measurements to the multi-compartment model, one or more physiological parameters associated with the individual; and administering, based on the one or more physiological parameters, a treatment associated with one or more medical conditions associated with the individual.
The most relevant prior art of record includes:
Dorin (US20230157586) teaches to modeling and determining of the cortisol elimination rate in patients are described. One or more physiological measurements associated with a patient may be determined and applied to a multi-compartment model. One or more physiological parameters, including the cortisol elimination rate, may be determined based on applying the one or more physiological measurements to the multi-compartment model.
Potocka et al. “Population Pharmacokinetic Model of Human Insulin Following Different Routes of Administration” teaches to developing a pharmacokinetic model for RHI administered by the IV, subcutaneous, and inhalation routes and to demonstrate that 2-compartment disposition is a characteristic of insulin.
Conclusion
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/Jonathan Ng/ Primary Examiner, Art Unit 3619
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