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 January 15, 2025, Claims 1-13 have been canceled. Claim 19 has been amended. Claims 21-33 are new. Now, claims 14-33 remain pending and are examined hereinbelow.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 3, 2025 and August 25, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 14-33 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 14-33 are directed to a medicine administration and tracking system. Managing personal behavior falls 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 14-18 and 32-33 recite a system comprising a processor and a memory. Claims 19-23 recite a method and at least one step. Claims 24-31 recite a system comprising a processor and a processor-readable media storing instructions. Therefore, the claims are each directed to one of the four statutory categories of invention (manufacture, process, and apparatus).
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 14, the claim sets forth a medicine administration and tracking system, which is considered managing personal behaviors, in the following limitations:
deliver a plurality of doses of medicine to a user and to transmit, for each dose of the plurality of doses, dose information indicative of a time of delivery of the dose; and
receive the dose information for each dose of the plurality of doses, to:
automatically tag or receive input instructions to tag a dose of the plurality of doses as a dose of interest associated with an event;
identify a first physiological parameter reading from a plurality of physiological parameter readings as a pre-event physiological parameter reading;
identify a second physiological parameter reading from the plurality of physiological parameter readings as a post-event physiological parameter reading; and
determine whether a risk of an adverse physiological condition is too high based on the pre-event physiological parameter reading and the post-event physiological parameter reading.
The above-recited limitations establish medicine administration and tracking system which is considered managing personal behavior. This arrangement amounts to “managing personal behavior or relationships or interactions between people" including social activities, teaching, and following rules or instructions. Such concepts have been considered ineligible certain methods of organizing human activity by the Courts (See MPEP 2106.04(a)).
Claim 14 does recite additional elements:
a medicine delivery device;
a computing device in communication with the medicine delivery device;
the computing device including a data processing unit including a processor and a software application stored in a memory of the data processing unit and having instructions operable to cause the computing device.
These additional elements merely amount to the general application of the abstract idea to a technological environment (“a medicine delivery device”; “a computing device in communication with the medicine delivery device”; “the computing device including a data processing unit including a processor and a software application stored in a memory of the data processing unit and having instructions operable to cause the computing device”) and insignificant pre-and-post solution activity (delivering, receiving, tagging, identifying and determining). The specification makes clear the general-purpose nature of the technological environment. Paragraphs 31, 32, 36, 45-47, and 49 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 Claims 19 and 24 are parallel in scope to claim 14 and ineligible for similar reasons.
Dependent claims
Each of these steps of the dependent claims 15-18, 20-23, and 25-33 only serve to further limit or specify the features of independent claims 14, 19, and 24 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 33 sets forth:
determine if an increase in a dose of medicine to be delivered to the user is recommended based on a determination that the risk of the adverse physiological condition is not too high.
Such a recitation merely embellishes the abstract idea of a medicine administration and tracking system which is considered managing personal behavior. This arrangement amounts to “managing personal behavior or relationships or interactions between people" including social activities, teaching, and following rules or instructions which falls within a subject matter grouping of abstract ideas which the Courts have considered ineligible (Certain methods of organizing human activity). While the claim does set forth the additional limitation of “from the medicine delivery device”, this recitation is similar to the additional limitations in claim 14, 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 14.
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 (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 14-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Patent Application Publication Number 2019/0371467, Soni, et al., hereinafter Soni.
Regarding claim 14, Soni discloses a medicine administration and tracking system, comprising:
a medicine delivery device configured to deliver a plurality of doses of medicine to a user and to transmit, for each dose of the plurality of doses, dose information indicative of a time of delivery of the dose, (paragraphs 43, 45, 46, 57, and 70, Such data along with a date-time stamp 169 for each measured glucose value and administered insulin dose value is stored in a data file and para. 86, clinicians 14 can prescribe other diabetes therapy devices for patients 12 such as an ambulatory insulin pump 46 as well as electronically based insulin pen. The insulin pump 46 can record and provide insulin dosage and other information, as well as the electronically based insulin pen 48, to a computer, and thus can be used as another means for providing biomarker data as requested by the structured collection procedure…); and
a computing device in communication with the medicine delivery device and configured to receive the dose information for each dose of the plurality of doses, the computing device including a data processing unit including a processor and a software application stored in a memory of the data processing unit and having instructions operable to cause the computing device, (Fig. 1, Fig. 12, Para. 70, Such data along with a date-time stamp 169 for each measured glucose value and administered insulin dose value is stored in a data file and para. 86, clinicians 14 can prescribe other diabetes therapy devices for patients 12 such as an ambulatory insulin pump 46 as well as electronically based insulin pen. The insulin pump 46 can record and provide insulin dosage and other information, as well as the electronically based insulin pen 48, to a computer, and thus can be used as another means for providing biomarker data as requested by the structured collection procedure…) to:
automatically tag or receive input instructions to tag a dose of the plurality of doses as a dose of interest associated with an event, (para. 159, the processor 102 will tag the associated data record 152 for the event 237 with the unique identifier 167 for such a biomarker measurement or data entry accordingly.);
identify a first physiological parameter reading from a plurality of physiological parameter readings as a pre-event physiological parameter reading, (para. 5, The guidelines may specify a desired biomarker value, e.g., a fasting blood glucose value of less than 100 mg/dl, or the clinician can specify a desired biomarker value based on the clinician's training and experience in treating patients with diabetes);
identify a second physiological parameter reading from the plurality of physiological parameter readings as a post-event physiological parameter reading, (para. 109, Examples of such biomarker data, in the context of diabetes, include fasting blood glucose values, pre-prandial glucose values, postprandial glucose values, and the like. Examples of a set of circumstances can include data associated with the biomarker value which identifies collected information in the patient data about meals, exercises, therapeutic administration, sleep, hydration, and the likes); and
determine whether a risk of an adverse physiological condition is too high based on the pre-event physiological parameter reading and the post-event physiological parameter reading, (para. 85, low overnight glucose levels, high blood glucose levels between meals, and early morning spikes in blood glucose levels as well as how diet and physical activity affect blood glucose along with the effect of therapy changes, and para. 134, then processor 102 has assessed that there is minimum risk that adjusting a parameter of the procedure could readily result in a severe event, e.g., hyper- or hypoglycemic event).
Regarding claim 15, Soni discloses the system of claim 14 as described above. Soni further discloses further comprising: a sensor device configured to obtain the plurality of physiological parameter readings and to transmit the plurality of physiological parameter readings to the computing device, (para. 70, Data, comprising at least the information collected by the biosensor 140, is provided by the measurement engine 138 to the processor 102 which may execute a computer program stored in memory 110 to perform various calculations and processes using the data, and para. 91, the type of collection (e.g., user input, sensor, data, etc.), as well as any reminder screen text (e.g., static, and/or dynamic in both formatting and value insertion) for each collection).
Regarding claim 16, Soni discloses the system of claim 14 as described above. Soni further discloses wherein the event is consumption of a meal, the plurality of physiological parameter readings are blood glucose readings, the pre-event physiological parameter reading is a pre-meal blood glucose reading, the post-event physiological parameter reading is a post-meal blood glucose reading, and the adverse physiological condition is hypoglycemia, (para. 73, patient of daily times for bG measurements and events, such as for example, to take a meal, of possible future hypoglycemia and para. 95, the patient 12 can also be requested by the processor 102 to document his meals, activity, stress, and other relevant details to ensure that the conditions that led to hypoglycemia are recorded and para. 119, a structured collection procedure 70a used to obtain contextualized biomarker data from a diabetic patient. The horizontal axis shows the performance times 238 of the various events 237, and the vertical axis shows adherence criteria 224 without values. In the illustrated embodiment, the events 237 can include recording information regarding a meal 248 and sleep 250 in which to provide context 252 for the five-biomarker samplings 254 also events 237 that are part of the schedule of events 222. In this example, the adherence criteria 224 for the meal 248 can be a value which must be greater than a minimum value, e.g., for a carbohydrate amount).
Regarding claim 17, Soni discloses the system of claims 14 and 16 as described above. Soni further discloses further comprising: a blood glucose sensor device configured to obtain the blood glucose readings and to transmit the blood glucose readings to the computing device, (para.78, the collection device 24 can be provided as portable blood glucose meter, which is used by the patient 12 for recording self-monitored data comprising insulin dosage readings and spot measured glucose levels. Examples of such bG meters as mentioned above previously include but are not limited to, the Accu-Chek® Active meter and the Accu-Chek® Aviva system both by Roche Diagnostics, Inc. which are compatible with the Accu-Chek® 360° Diabetes management software to download test results to a personal computer or the Accu-Chek® Pocket Compass Software for downloading and communication with a PDA. Accordingly, it is to be appreciated that the collection device 24 can include the software and hardware necessary to process, analyze and interpret the self monitored data in accordance with predefined flow sequences (as described below in detail) and generate an appropriate data interpretation output).
Regarding claim 18, Soni discloses the system of claims 14 and 16 as described above. Soni further discloses wherein determining whether the risk of hypoglycemia is too high is based upon the pre-meal blood glucose reading and the post-meal blood glucose reading, (para. 95, if the patient 12 measures a glucose value indicating hypoglycemia, upon exiting the procedure, the processor 102 run automatically another alternative procedure which instructs the patient 12 to ingest carbohydrates and measure his blood glucose value every half an hour until the blood glucose exceeds 120 mg/dL. For this alternative procedure, the patient 12 can also be requested by the processor 102 to document his meals, activity, stress, and other relevant details to ensure that the conditions that led to hypoglycemia are recorded. The patient 12 may also be instructed by the processor 102 to contact the clinician 14 in this and other such special cases as deemed fit.).
Regarding claims 19 and 24, these claims are rejected for the same reasons as set forth above with regard to claim 14. Soni further discloses one or more processor-readable media storing instructions which, when executed by the one or more processors, cause performance of, (para. 137).
Regarding claims 20 and 28, these claims are rejected for the same reasons as set forth above with regard to claim 16.
Regarding claims 21 and 29, these claims are rejected for the same reasons as set forth above with regard to claim 18.
Regarding claim 22, Soni discloses the method of claim 19 as described above. Soni further discloses further comprising calculating a decrease in a recommended dose of medicine to be delivered from the medicine delivery device to the user based on a determination that the risk of the adverse physiological condition is too high, (para. 95, Other conditions when the procedure may stop can include adverse events such as a hypoglycemic event, the patient is sick, the patient undergoes a therapy change, etc. Additional detail may also by provided by the processor 102 on the display 108 to the patient 12 based on what the specific exit criteria has been met. For example, in one example, if the patient 12 measures a glucose value indicating hypoglycemia, upon exiting the procedure, the processor 102 run automatically another alternative procedure which instructs the patient 12 to ingest carbohydrates and measure his blood glucose value every half an hour until the blood glucose exceeds 120 mg/dL).
Regarding claim 23, Soni discloses the method of claim 19 as described above. Soni further discloses further comprising determining if an increase in a dose of medicine to be delivered from the medicine delivery device to the user is recommended based on a determination that the risk of the adverse physiological condition is not too high, (para. 95, Other conditions when the procedure may stop can include adverse events such as a hypoglycemic event, the patient is sick, the patient undergoes a therapy change, etc. Additional detail may also by provided by the processor 102 on the display 108 to the patient 12 based on what the specific exit criteria has been met. For example, in one example, if the patient 12 measures a glucose value indicating hypoglycemia, upon exiting the procedure, the processor 102 run automatically another alternative procedure which instructs the patient 12 to ingest carbohydrates and measure his blood glucose value every half an hour until the blood glucose exceeds 120 mg/dL).
Regarding claim 25, Soni discloses the system of claim 24 as described above. Soni further discloses further comprising a medicine delivery device configured to deliver the dose of medicine to the user and to transmit dose information indicative of a time of delivery of the dose of medicine, (70, Such data along with a date-time stamp 169 for each measured glucose value and administered insulin dose value is stored in a data file and para. 86, clinicians 14 can prescribe other diabetes therapy devices for patients 12 such as an ambulatory insulin pump 46 as well as electronically based insulin pen. The insulin pump 46 can record and provide insulin dosage and other information, as well as the electronically based insulin pen 48, to a computer, and thus can be used as another means for providing biomarker data as requested by the structured collection procedure…, para. 114, running a structured test for determining the best time for administering a bolus in regards to a start of a meal, such as for example, structured collection procedure 70c (FIG. 6C), which needs a current I:C ratio, can be conditioned such that the processor 102 can implement automatically a schedule of events of the second structured collection procedure 70c upon meeting the exit criteria of the first structured collection procedure 70b at some unknown time).
Regarding claim 26, Soni discloses the system of claims 24 and 25 as described above. Soni further discloses further a mobile computing device in communication with the medicine delivery device and configured to receive the dose information, (70, Such data along with a date-time stamp 169 for each measured glucose value and administered insulin dose value is stored in a data file and para. 86, clinicians 14 can prescribe other diabetes therapy devices for patients 12 such as an ambulatory insulin pump 46 as well as electronically based insulin pen. The insulin pump 46 can record and provide insulin dosage and other information, as well as the electronically based insulin pen 48, to a computer, and thus can be used as another means for providing biomarker data as requested by the structured collection procedure…).
Regarding claims 27, this claim is rejected for the same reasons as set forth above with regard to claim 15.
Regarding claims 30 and 32, these claims are rejected for the same reasons as set forth above with regard to claim 22.
Regarding claims 31 and 33, these claims are rejected for the same reasons as set forth above with regard to claim 23.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
System for determining the minimum effective dose of an inhaled drug for an individual patient at a given time, useful especially for chronic asthma patients, comprises an apparatus for measuring pulmonary performance, and a data processor (US 20040118398 A1) teaches determining a minimum effective dose of an inhaled drug for an individual patient at a given time, comprises a measuring apparatus for measuring pulmonary performance indicator measurement(s), and a data processor capable of communication with the measuring apparatus configured to provide a computed minimum effective dose by applying a predetermined rule to the pulmonary performance indicator measurement.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amber Misiaszek whose telephone number is 571-270-1362. The examiner can normally be reached M-F 8:00-5:30, First 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 571-270-5096. 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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