DETAILED ACTION
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 .
Notice to Applicant
In the preliminary amendment filed on 4/2/2025: Claims 1-2 have been canceled. Claim 3 is original. Claims 4-19 are new. Now, claims 3-19 are pending.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1/27/2025; 2/4/2025; and 6/25/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
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.
4. Claims 3-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 3-19 are directed to recommending a medication dose to a user, which is considered managing personal behavior. Managing personal behaviors fall within a subject matter grouping of abstract ideas which the Courts have considered ineligible (Certain methods of organizing human activity). The claims do not integrate the abstract idea into a practical application, and do not include additional elements that provide an inventive concept (are sufficient to amount to significantly more than the abstract idea).
Under step 1 of the Alice/Mayo framework, it must be considered whether the claims are directed to one of the four statutory classes of invention. In the instant case, claim 3-11 recite a method and at least one step. Claims 12-19 recite a system comprising a user interface and a controller. Therefore, the claims are each directed to one of the four statutory categories of invention (process, apparatus, manufacture).
Under step 2A of the Alice/Mayo framework, it must be considered whether the claims are “directed to” an abstract idea. That is, whether the claims recite an abstract idea and fail to integrate the abstract idea into a practical application.
Regarding independent claim 3, the claim sets forth a process in which medication doses are recommended to a user, including through the facilitation of managing personal behaviors, in the following limitations:
receiving input including a timing and amount of one or more doses of at least one active substance previously taken by the user and/or one or more planned doses; and
automatically generating a time-based recommendation based at least partially on estimating at least one of a timing and magnitude of at least one effect expected to be induced by the at least one active substance on the user, the time-based recommendation including an indication of the user's capability for engaging in one or more activities, wherein the capability is correlated with the at least one effect; and
outputting the recommendation.
The above-recited limitations recommend a medication dosage for a user. This arrangement amounts to managing personal behaviors. Such concepts have been considered ineligible certain methods of organizing human activity by the Courts (See MPEP 2106.04(a)).
Claim 1 does not recite any additional elements. However, claim 12 does recite additional elements:
A user interface;
A controller.
These additional elements merely amount to the general application of the abstract idea to a technological environment (“a user interface”, “a controller”) and insignificant pre-and-post solution activity (receiving and generating). The specification makes clear the general-purpose nature of the technological environment. Paragraphs 46, 49, 50, 140, 204, and 231 indicate that while exemplary general purpose systems may be specific for descriptive purposes, any elements or combinations of elements capable of implementing the claimed invention are acceptable. That is, the technology used to implement the invention is not specific or integral to the claim.
Therefore, considered both individually and as an ordered combination, the additional elements do no more than generally link the use of the abstract idea to a particular technological environment or field of use. That is, given the generality with which the additional limitations are recited, the limitations do not implement the abstract idea with, or use the abstract idea in conjunction with, a particular machine or manufacture that is integral to the claim. Additionally, the claims do not reflect an improvement in the functioning of a computer, or an improvement to other technology or technical field, do not apply or use the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition, do not effect a transformation or reduction of a particular article to a different state or thing; and do not apply or use the abstract idea in some other meaningful way beyond generally linking the use of the abstract idea to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the abstract idea. Accordingly, the Examiner concludes that the claim fails to integrate the abstract idea into a practical application, and is therefore “directed to” the abstract idea.
Under step 2B of the Alice/Mayo framework, it must finally be considered whether the claim includes any additional element or combination of elements that provide an inventive concept (i.e., whether the additional element or elements are sufficient to amount to significantly more than the abstract idea). As indicated above, considered both individually and as an ordered combination, the additional elements do not implement the abstract idea with, or use the abstract idea in conjunction with, a particular machine or manufacture that is integral to the claim, do not reflect an improvement in the functioning of a computer, or an improvement to other technology or technical field, do not apply or use the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition, do not effect a transformation or reduction of a particular article to a different state or thing, and do not apply or use the abstract idea in some other meaningful way beyond generally linking the use of the abstract idea to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the abstract idea
Further, the additional elements (recited above) simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. Communicating information (i.e., receiving or transmitting data over a network) has been repeatedly considered well-understood, routine, and conventional activity by the Courts (See MPEP 2106.05(d)). Accordingly, the Examiner asserts that the additional elements, considered both individually, and as an ordered combination, do not provide an inventive concept, and the claim is ineligible for patent.
Independent Claim 12 is parallel in scope to claim 3 and ineligible for similar reasons.
Dependent claims
Each of these steps of the dependent claims 4-11 and 13-19 only serve
to further limit or specify the features of independent claims 3 and 12 accordingly,
and hence are nonetheless directed towards fundamentally the same abstract idea as
the independent claim and utilize the additional elements already analyzed in the
expected manner.
For example, claim 5 sets forth:
wherein the input includes input received.
Such a recitation merely embellishes the abstract idea of recommending a medication dosage for a user. While the claim does set forth the additional limitation of “via a user interface”, this recitation is similar to the additional limitations in claim 3, as it does no more than generally link the use of the abstract idea to a particular technological environment. As such, it does not integrate the abstract idea into a practical application, and does not provide an inventive concept. Accordingly, the claim does not confer eligibility on the claimed invention and is ineligible for similar reasons to claim 3.
Claim Rejections - 35 USC § 102
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 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.
4. 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 3-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Patent Application Publication Number 2018/0089393, Zdeblick, et al., hereinafter Zdeblick.
Regarding claim 3, Zdeblick discloses a method for generating time-based recommendations to a user, comprising:
receiving input including a timing and amount of one or more doses of at least one active substance previously taken by the user and/or one or more planned doses, (para. 38, the methods included obtaining from the patient two or more sets of a confirmatory over a given period of time, e.g., 2 or more sets of confirmatory data over a period of 1 day, 1 week, 1 month, 1 year, etc., depending on the particular regimen of the patient. While the two or more sets of confirmatory data may be generated from the same first device, in certain embodiments, e.g., where the first device is a pharma-informatics enabled dosage, e.g., such as a smart dosage described above, the first and second devices will be different dosages, e.g., different pills, and para. 40, actionable interface (e.g., in the form of a graphical user interface (GUI)), outcome measure, etc.); and
automatically generating a time-based recommendation based at least partially on estimating at least one of a timing and magnitude of at least one effect expected to be induced by the at least one active substance on the user, the time-based recommendation including an indication of the user's capability for engaging in one or more activities, wherein the capability is correlated with the at least one effect, (para. 36, the second device may be a device configured to receive data transmitted through a body from the first device (and record and retransmit the data where desired), where the second device may be a personal health companion device that is configured to detect dosage administration, e.g., by a signal emitted by an identifier of a pharma-informatics enabled dosage formulation, and para. 39, physiological parameter data, e.g., as may be obtained using any convenient sensing device, including the sensors and systems developed by some of the inventors of the assignee of the present application and described in co-owned applications and patents, as referenced below; lifestyle data, such as historical information about the patient (e.g., the patients activities on a given day, how the patient was feeling, etc.); anticipated activities of the patient (e.g., whether or not the patient expects to exercise, whether or not the patient is feeling well, etc.); and the like); and
outputting the recommendation, (para. 40, obtaining from the decision support tool a recommendation based on the confirmatory data as to whether a change is the therapeutic regimen is desirable).
Regarding claim 4, Zdeblick discloses the method of claim 3 as described above. Zdeblick further discloses wherein the input includes input obtained by automatically accessing information on a delivery device used for delivering the at least one or more doses previously taken by the user, (para. 22, the clinician will be able to compare the response of the heart and body to the administered pharmaceutical and make patient specific customized therapeutic regimen modifications to achieve and optimal patient specific therapeutic regimen and para. 35, Dosage compliance data can also be obtained using smart therapeutics systems, e.g., systems that provide specific identification and detection of beneficial agents or beneficial agents taken into the body through other methods, for example, through the use of a syringe, inhaler, infusion machine, dialysis machine, or other device that administers medicine).
Regarding claim 5, Zdeblick discloses the method of claim 3 as described above. Zdeblick further discloses wherein the input includes input received via a user interface, (para. 67, One type of application in which the subject compositions and systems find use is in tailoring therapeutic regimens based on patient compliance. In such applications, data obtained about whether a patient has or has not taken a particular dosage is employed to determine future dosages and/or timing of such dosages. In certain embodiments, data concerning patient compliance is combined with additional data, e.g., sensed physiological data, to make customized changes or modifications to a given therapeutic regimen).
Regarding claim 6, Zdeblick discloses the method of claim 3 as described above. Zdeblick further discloses wherein the recommendation is set for a pre-defined likelihood of the user being capable to engage an activity, (para. 67, cardiac stimulating drugs can be titrated to the most appropriate dosages, minimizing side effects such as cardiac muscle exhaustion and rebound effects among others, and optimizing both dosage and timing for each individual patient).
Regarding claim 7, Zdeblick discloses the method of claim 3 as described above. Zdeblick further discloses wherein the recommendation includes a regimen of future deliveries of the same active substance previously taken by the user, (para. 67, One type of application in which the subject compositions and systems find use is in tailoring therapeutic regimens based on patient compliance. In such applications, data obtained about whether a patient has or has not taken a particular dosage is employed to determine future dosages and/or timing of such dosages. In certain embodiments, data concerning patient compliance is combined with additional data, e.g., sensed physiological data, to make customized changes or modifications to a given therapeutic regimen).
Regarding claim 8, Zdeblick discloses the method of claim 3 as described above. Zdeblick further discloses wherein the recommendation includes a regimen of future deliveries of a different active substance which is known to affect at least one of the timing and magnitude of the effect of the active substance previously taken by the user, (para. 67, One type of application in which the subject compositions and systems find use is in tailoring therapeutic regimens based on patient compliance. In such applications, data obtained about whether a patient has or has not taken a particular dosage is employed to determine future dosages and/or timing of such dosages. In certain embodiments, data concerning patient compliance is combined with additional data, e.g., sensed physiological data, to make customized changes or modifications to a given therapeutic regimen).
Regarding claim 9, Zdeblick discloses the method of claim 3 as described above. Zdeblick further discloses wherein delivery is via inhalation, (para. 35, Dosage compliance data can also be obtained using smart therapeutics systems, e.g., systems that provide specific identification and detection of beneficial agents or beneficial agents taken into the body through other methods, for example, through the use of a syringe, inhaler, infusion machine, dialysis machine, or other device that administers medicine).
Regarding claim 10, Zdeblick discloses the method of claim 3 as described above. Zdeblick further discloses further comprising controlling a delivery device to deliver the active substance according to the regimen, (para. 34, the use of “smart” dosages that are activated upon contact with a target body location (e.g., the stomach), where activation occurs, for example, via completion of a power source. Such dosages may include identifiers associated with pharmaceutical compositions and provide information (i.e., confirmatory data) about when a patient is actually administered the dosage (e.g., by emitting a signal upon contact with a targeted physiological site, such as the stomach), such that the information obtained is not a proxy for the dosage administration but is, in fact, tied to actual administration of the dosage).
Regarding claim 11, Zdeblick discloses the method of claim 3 as described above. Zdeblick further discloses wherein the recommendation includes a probability of the user's capability to engage an activity at a certain time, (para. 67, One type of application in which the subject compositions and systems find use is in tailoring therapeutic regimens based on patient compliance. In such applications, data obtained about whether a patient has or has not taken a particular dosage is employed to determine future dosages and/or timing of such dosages. In certain embodiments, data concerning patient compliance is combined with additional data, e.g., sensed physiological data, to make customized changes or modifications to a given therapeutic regimen).
Regarding claims 12 and 15-19, these claims are rejected for the same reasons as set forth above with regard to claims 3, 5, 7-9 and 11.
Regarding claim 13, Zdeblick discloses the system of claim 12 as described above. Zdeblick further discloses further comprising a delivery device configured to deliver the at least one active substance in accordance with the recommendations generated by the controller, (para. 40, obtaining from the decision support tool a recommendation based on the confirmatory data as to whether a change is the therapeutic regimen is desirable. The dosage administration data is assessed to identify whether, based on the information received from the patient, such as compliance data, physiological parameters and lifestyle data, any modification should be made to the therapeutic regimen in order to optimize the therapeutic regimen for the patient in some way. The data may be evaluated by a health care practitioner, e.g., manually or through use of any convenient decision tool).
Regarding claim 14, Zdeblick discloses the system of claims 12 and 13 as described above. Zdeblick further discloses wherein the input includes input obtained by automatically accessing information on said delivery device, (para. 35, The broadcasted signal can indicate the type of beneficial agent extracted from the vial. Upon injection into the patient, the information can be sent from the syringe to an information management database located in, on, or near the patient, e.g., a personal health companion device.).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Method and apparatus for analyzing data on medical agents and devices (US 20120078648 A1) teaches an itemized analytical tool which creates a series of standardized and objective metrics related to each individual step in the overall process of pharmaceutical development and delivery.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amber A. Misiaszek whose telephone number is (571) 270-1362. The examiner can normally be reached on M-Th 7:30-5, F 7:30-4, every other Friday Off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Fonya Long can be reached on 5712705096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMBER A MISIASZEK/
Primary Examiner, Art Unit 3682
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