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 .
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 2-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 2 recites (additional elements crossed out):
A method for differentiating between a therapeutic dose of medication dispensed from a medication dispensing pen and a priming event of medication dispensed from the medication dispensing pen, the method comprising:
sensing,
determining,
timestamping,
determining,
if the information about the dispense event meets each criterion of the plurality of criteria, classifying the dispense event as a priming event; and
if the information about the dispense event fails to meet at least one criterion of the plurality of criteria, classifying the dispense event as a therapeutic event
The above limitations as drafted, is a process that, under its broadest reasonable interpretation covers managing personal behavior or relationships or interactions between people, and mental processes. That is, other than reciting the steps as being performed by a “sensor of a medicine dispensing pen”, a “processor of a medicine dispensing device” and a “mobile communications device” nothing in the claim precludes the steps as being described as managing personal behavior or relationships or interactions between people, and mental processes. For example, but for the recited “sensor of a medicine dispensing pen”, a “processor of a medicine dispensing device” and a “mobile communications device”, the limitations describe a method for sensing a dispense event, determining an amount of medicine dispensed, timestamping the dispense event, relaying the information about the dispense event and the timestamp, and determining if the dispense event is a priming event or a therapeutic event based on criterion. The limitations describe the management of personal behavior, as well as actions that can be performed mentally or with pen and paper. If a claim limitation, under its broadest reasonable interpretation, describes managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activities” grouping of abstract ideas. Further, if a claim limitation, under its broadest reasonable interpretation, describes steps that may be performed mentally or with pen and paper, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
The judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of a “sensor of a medicine dispensing pen”, a “processor of a medicine dispensing device” and a “mobile communications device” to perform the steps. These additional elements are recited at a high level of generality (see at least Paras. [0098], [0100], [0187]-[0190]) such that it amounts to no more than mere instructions to apply the exception using generic computing components. The claims also recite “wirelessly transmitting information about the dispense event from the medication dispensing pen to a mobile communications device…”, however this is merely extra-solution activity.
Accordingly, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. More specifically, the additional elements fail to include (1) improvements to the functioning of a computer or to any other technology or technical field (see MPEP 2106.05(a)), (2) applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition (see Vanda memo), (3) applying the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)), (4) effecting a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)), or (5) applying or using 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 is more than a drafting effort designed to monopolize the exception (see MPEP 2106.05(e) and Vanda memo).
Rather, the limitations merely add the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)) or generally link the use of the judicial exception to a particular technological environment or field of use (see MPEP 2106.05(h)), particularly as it relates to the recited “sensor of a medicine dispensing pen”, “processor of a medicine dispensing device” and “mobile communications device” elements. Therefore the claims are directed to ineligible subject matter.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a “sensor of a medicine dispensing pen”, a “processor of a medicine dispensing device” and a “mobile communications device” to perform the steps amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Further, the “sensor of a medicine dispensing pen”, “processor of a medicine dispensing device” and “mobile communications device” contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) and does not integrate the judicial exception or provide significantly more. Moreover, the element of “wirelessly transmitting information about the dispense event from the medication dispensing pen to a mobile communications device…” does not amount to significantly more than the judicial exception because in addition to being extra-solution activity, it is a well-understood, routine, and conventional function as evidenced by at least Symantec which featured the conventional activities of receiving or transmitting data over a network. The performance of routine and conventional functions does not provide an inventive concept. Therefore, the claims are not found to be patent eligible.
But for the limitations regarding the sensing of information indicative of a physical parameter, and determining the physical parameter (which are found to be part of the abstract idea), claim 12 features limitation similar to those of claim, and is therefore also found to be directed to an abstract idea without significantly more
Claims 3-11 are dependent on claim 2, and include all the limitations of claim 2. Claims 13-19 are dependent on claim 12, and include all the limitations of claim 12. Therefore, they are also found to be directed to an abstract idea. Claim 3 and 13 feature the use of an “encoder” to sense movement of a drive mechanism of the medicine dispensing pen, claim 14 features the use of an “accelerometer” to sense orientation of the medicine dispensing pen, and claim 15 features the use of a “pressure sensor” to sense pressure applied to the medicine dispensing pen. However, the use of these particular sensors contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) and does not integrate the judicial exception or provide significantly more. The remaining dependent claims have not been found to integrate the judicial exception into a practical application, or provide significantly more than the abstract idea since they merely further narrow the abstract idea. Therefore, the dependent claims are found to be directed to an abstract idea without significantly more.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Regarding claim 17, the limitations “determining, with the processor of the mobile communications device, whether the information regarding the user's glucose response meets a fourth criterion; if the first, second, and fourth criterion are met, classifying the dispense even as a priming event; and if the first, second, and fourth criterion are not met, classifying the dispense event as a therapeutic event” lack a proper written description. The Examiner points to paragraph [0049] which states “By way of example, data that the system may include in the confidence analysis include (but are not limited to): glucose response after dose, timing of the dose, number of doses within a time, deviation from normal dosing pattern, user feedback from the system designation fed back into the confidence score analysis, and additional sensor data available from the pen device such as orientation, force, speed of delivery, absolute plunger position sensor, etc.”, and paragraph [0184] which states, in part, “Data that the system 10 may include in the confidence analysis include (but are not limited to): 1. Glucose response after the dose - if the glucose values do not decrease as forecasted for a dose of the recorded size, and are better fit to the forecasted trend for the user taking no insulin, the confidence score may be low for therapeutic dose.” (emphasis added) Based on this, it appears as that the specification at most describes using glucose response to determine a confidence score for a therapeutic dose. The specification appears to be silent in regards to determining that a dose is a priming event or a therapeutic event based on the glucose response, amount of medicine dispensed, and physical parameter meeting or not meeting criterion; let alone what criterion are depended on to make the determination.
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.
Claim(s) 2-16 and 18-19 is/are rejected under 35 U.S.C. 102(a)(1)as being anticipated by Saint (US 2017/0270276)
Regarding claim 2, Saint discloses A method for differentiating between a therapeutic dose of medication dispensed from a medication dispensing pen and a priming event of medication dispensed from the medication dispensing pen, the method comprising:
sensing, with a sensor of a medicine dispensing pen, movement of a manually actuated drive mechanism of the medicine dispensing pen during a dispense event;
determining, with a processor of the medicine dispensing pen, an amount of medicine dispensed from the medicine dispensing pen during the dispense event based on the sensed movement;
timestamping, with the processor of the medicine dispensing device, the dispense event;
wirelessly transmitting information about the dispense event from the medication dispensing pen to a mobile communications device, the information about the dispense event including the amount of medicine dispensed and the timestamp;
(See at least Para. [0005] – “…a sensor unit to detect a dispensed dose based on one or both of positions and movements of the dose setting and dispensing mechanism, in which the dispensed dose includes an amount of medicine dispensed from the cartridge, and an electronics unit in communication with the sensor unit, the electronics unit including a processing unit including a processor and memory to process the detected dispensed dose and time data associated with a dispensing event to generate dose data, a transmitter to wirelessly transmit the dose data to a user's device,…”)
determining, with a processor of the mobile communications device, whether the information about the dispense event meets a plurality of criteria;
if the information about the dispense event meets each criterion of the plurality of criteria, classifying the dispense event as a priming event; and
if the information about the dispense event fails to meet at least one criterion of the plurality of criteria, classifying the dispense event as a therapeutic event
See at least Para. [0007] – “…determining a type of dispensing event as a priming event for a dispensing event in the dose dispensing sequence when the corresponding sensed rate is slower than the predetermined dispensing rate threshold, and determining the type of dispensing event as an injection event for a dispensing event in the dose dispensing sequence when the corresponding sensed rate is faster than the predetermined dispensing rate threshold…”
Regarding claim 3, Saint discloses The method according to claim 2, wherein sensing the movement of the manually actuated drive mechanism includes sensing rotational movement of the manually actuated drive mechanism with an encoder of the medicine dispensing pen. (See at least Para. [0026] – “In such implementations, the operations monitoring mechanism of the pen 10 will begin to sense movement of a rotating component or shaft that drives the plunger, for example, in which the movement is sensed through an encoder.”)
Regarding claim 4, Saint discloses the method according to claim 2, wherein a first criterion of the plurality of criteria is a pre-defined medicine amount threshold. (See at least Para. [0047] – “In another example, the dose classification method can be implemented such that when a first dose ( or intermediate dose) is larger than a predetermined dose quantity threshold, that dose is considered therapy.”)
Regarding claim 5, Saint discloses The method according to claim 2, wherein a second criterion of the plurality of criteria is a timing of the dispense event relative to other dispense events. (See at least Para. [0053] – “In an illustrative example of the voting method, the dose distinguishing module can implement multiple embodiments of the dose classification method in parallel for a particular dosing sequence, e.g., such as the exemplary dose grouping process (e.g., identifying the last dispensed dose in a sequence of doses dispensed in a predetermined time proximity as the therapy dose), the exemplary dose speed detection process, the exemplary movement data detection process, etc.)
Regarding claim 6, Saint discloses The method according to claim 2, further comprising:
sensing, with another sensor of the medicine dispensing pen, a physical parameter associated with the medicine dispensing pen during the dispense event,
wherein the wirelessly transmitted information about the dispense event further includes the physical parameter
(See at least Para. [0052] – “In some implementations, the dose classification method to determine prime doses versus therapy doses can involve the pen device 10 including an internal accelerometer, gyroscope, or other rate sensor to detect movement data of the pen device 10, which is transferred to the companion device 5 to analyze the movement data.”)
Regarding claim 7, Saint discloses The method according to claim 6, wherein the physical parameter includes an orientation of the medicine dispensing pen or a force exerted on the medicine dispensing pen. (See at least Para. [0052] – “For example, if the pen 10 senses an inward motion before the dose is dispensed and an outward motion after the dose is dispensed, the companion device 5 would indicate that the pen 10 had been injected into a patient and thereby identify the dispensed dose as a therapy dose; whereas if these motions were absent, it would indicate that the pen 10 had been held in the air.”)
Regarding claim 8, Saint discloses The method according to claim 2, further comprising:
wirelessly receiving, at the mobile communications device, information regarding a user's glucose response; and
determining, with the processor of the mobile communications device, whether the information regarding the user's glucose response meets an additional criterion of the plurality of criteria
(See at least Para. [0043] – “It is necessary to be able to determine which doses are the prime doses and which are therapeutic doses, in which data associated with the determination of the dose type should be included in the dose calculation (e.g., "Insulin on Board" calculation) and the therapy analytics.”, Para. [0055] – “In some embodiments, for example, the pen device 10 or the companion device 5 can receive health related information such as blood glucose information from an external device ( e.g., such as a blood glucose meter or continuous glucose monitor) for use in the dosing calculations. This information could be manually entered, downloaded manually or automatically from a central health information repository, e.g., such as Apple "Healthkit" or Google "Fit", or received wirelessly onto the companion device 5. In addition to being used in the dosing calculations, for example, the most recent health related data ( e.g., blood glucose information) could be displayed on the companion device 5, or the pen device 10 in certain embodiments. If recent blood glucose information was available from one of these sources, it could automatically be entered into the dose calculation device. In these examples, 'recent' for the purposes of blood glucose measurement can mean any time period in a range of 0 to 20 minutes old.” The Examiner asserts that blood glucose information being “recent” serves as a criterion.)
Regarding claim 9, Saint discloses The method according to claim 2, wherein the dispense event is initially classified as one of a therapeutic dose or a priming event and is subsequently reclassified as another of a therapeutic dose or a priming event. (See at least Para. [0044] – “In some embodiments, the dose distinguisher module is configured to implement a dose classification method to group data associated with dispensed medicine doses and classify the dispensed doses in the group as either a prime dose or an injected (e.g., therapy) dose; such that, for any group of doses happening in close temporal proximity, only the last dose is recorded as a therapeutic dose. The close temporal proximity is a predetermined temporal threshold value, e.g., which can be defined as 10 seconds, 30 seconds, 1 minute, 2 minutes, 5 minutes, or 10 minutes or other.”. The Examiner interprets this a dose being classified as a priming event until it is determined that it is the last dose. Also see Para. [0046] – “In one example of this additional dose identification mechanism, a user verification input can be included in the software application of the companion device 5 to allow the patient to identify that the recorded doses were one of the prime or therapy doses, which would then allow for such doses to be included in any therapy analytics and insulin on board calculation, as appropriate. This user verification input mechanism can include a radio button, a toggle switch, and/or graphic of the user interface allowing tapping on the dose, slider, or other mechanism.” )
Regarding claim 10, Saint discloses The method according to claim 2, wherein the dispense event is initially classified as a priming event and is subsequently reclassified as a therapeutic dose. (See at least Para. [0044] – “In some embodiments, the dose distinguisher module is configured to implement a dose classification method to group data associated with dispensed medicine doses and classify the dispensed doses in the group as either a prime dose or an injected (e.g., therapy) dose; such that, for any group of doses happening in close temporal proximity, only the last dose is recorded as a therapeutic dose. The close temporal proximity is a predetermined temporal threshold value, e.g., which can be defined as 10 seconds, 30 seconds, 1 minute, 2 minutes, 5 minutes, or 10 minutes or other.”. The Examiner interprets this a dose being classified as a priming event until it is determined that it is the last dose.)
Regarding claim 11, Saint discloses The method according to claim 10, wherein the reclassifying is based on at least one criterion of the plurality of criteria. (See at least Para. [0044] – “In some embodiments, the dose distinguisher module is configured to implement a dose classification method to group data associated with dispensed medicine doses and classify the dispensed doses in the group as either a prime dose or an injected (e.g., therapy) dose; such that, for any group of doses happening in close temporal proximity, only the last dose is recorded as a therapeutic dose. The close temporal proximity is a predetermined temporal threshold value, e.g., which can be defined as 10 seconds, 30 seconds, 1 minute, 2 minutes, 5 minutes, or 10 minutes or other.”. The Examiner interprets this as temporal proximity being a criterion for determining if the last dose is therapeutic.)
Regarding claim 12, Saint discloses A method for differentiating between a therapeutic dose of medication dispensed from a medication dispensing pen and a priming event of medication dispensed from the medication dispensing pen, the method comprising:
sensing, with a first sensor of a medicine dispensing pen, information indicative of an amount of medicine dispensed from the medicine dispensing pen during a dispense event;
determining, with a processor of the medicine dispensing pen, the amount of medicine dispensed from the medicine dispensing pen during the dispense event based on the information indicative of the amount of medicine dispensed;
sensing, with a second sensor of the medicine dispensing pen, information indicative of a physical parameter of the medicine dispensing pen during the dispense event;
determining, with the processor of the medicine dispensing pen, the physical parameter of the medicine dispensing pen based on the information indicative of the physical parameter;
wirelessly transmitting the amount of medicine dispensed and the physical parameter from the medication dispensing pen to a mobile communications device;
See at least Para. [0005] – “…a sensor unit to detect a dispensed dose based on one or both of positions and movements of the dose setting and dispensing mechanism, in which the dispensed dose includes an amount of medicine dispensed from the cartridge, and an electronics unit in communication with the sensor unit, the electronics unit including a processing unit including a processor and memory to process the detected dispensed dose and time data associated with a dispensing event to generate dose data, a transmitter to wirelessly transmit the dose data to a user's device,…”, Para. [0052] – “In some implementations, the dose classification method to determine prime doses versus therapy doses can involve the pen device 10 including an internal accelerometer, gyroscope, or other rate sensor to detect movement data of the pen device 10, which is transferred to the companion device 5 to analyze the movement data.”
Saint also discloses:
determining, with a processor of the mobile communications device, whether the amount of medicine dispensed meets a first criterion and whether the physical parameter meets a second criterion;
if both the first and second criterion are met, classifying the dispense event as a priming event; and
if both the first and second criterion are not met, classifying the dispense event as a therapeutic event.
(See at least Para. [0053] – “In some embodiments of the dose distinguishing module, for example, the module can include a 'voting' method to determine if a dose is a prime dose. In an illustrative example of the voting method, the dose distinguishing module can implement multiple embodiments of the dose classification method in parallel for a particular dosing sequence, e.g., such as the exemplary dose grouping process ( e.g., identifying the last dispensed dose in a sequence of doses dispensed in a predetermined time proximity as the therapy dose), the exemplary dose speed detection process, the exemplary movement data detection process, etc. If after a particular dosing or dosing sequence, a certain majority of the exemplary methods for dose distinguishing indicated that the dispensed dose is a prime dose, and a minority method indicated it is not, then the voting method would determine that in this case the dose would be identified as a prime dose”.
Regarding claim 13, Saint discloses The method according to claim 12, wherein the first sensor is a rotary encoder configured to sense movement of a manually actuated drive mechanism of the medicine dispensing pen. (See at least Para. [0026] – “In such implementations, the operations monitoring mechanism of the pen 10 will begin to sense movement of a rotating component or shaft that drives the plunger, for example, in which the movement is sensed through an encoder.”)
Regarding claim 14, Saint discloses The method according to claim 12, wherein the second sensor is an accelerometer configured to sense an orientation of the medicine dispensing pen. (See at least Para. [0052] – “In some implementations, the dose classification method to determine prime doses versus therapy doses can involve the pen device 10 including an internal accelerometer, gyroscope, or other rate sensor to detect movement data of the pen device 10, which is transferred to the companion device 5 to analyze the movement data.”)
Regarding claim 15, Saint discloses The method according to claim 12, wherein the second sensor is a pressure sensor configured to sense a pressure applied to the medicine dispensing pen. (See at least Para. [0049] – “In one non-limiting example, the pen device 10 can include a pressure sensor coupled to the needle assembly or tip or end of the body of the pen device 10 to determine if a force has been applied at the needle assembly or tip of the device (as when injecting).”)
Regarding claim 16, Saint discloses The method according to claim 12, further comprising:
timestamping, with the processor of the medicine dispensing device, the dispense event;
wirelessly transmitting the timestamp from the medication dispensing pen to the mobile communications device;
determining, with the processor of the mobile communications device, whether the timestamp meets a third criterion by comparing the timestamp of the dispense event to timestamps of other dispense events;
if the first, second, and third criterion are met, classifying the dispense event as a priming event; and
if the first, second, and third criterion are not met, classifying the dispense event as a therapeutic event.
(See at least Para. [0005] – “…a sensor unit to detect a dispensed dose based on one or both of positions and movements of the dose setting and dispensing mechanism, in which the dispensed dose includes an amount of medicine dispensed from the cartridge, and an electronics unit in communication with the sensor unit, the electronics unit including a processing unit including a processor and memory to process the detected dispensed dose and time data associated with a dispensing event to generate dose data, a transmitter to wirelessly transmit the dose data to a user's device,…”, and Para. [0053] – “In some embodiments of the dose distinguishing module, for example, the module can include a 'voting' method to determine if a dose is a prime dose. In an illustrative example of the voting method, the dose distinguishing module can implement multiple embodiments of the dose classification method in parallel for a particular dosing sequence, e.g., such as the exemplary dose grouping process ( e.g., identifying the last dispensed dose in a sequence of doses dispensed in a predetermined time proximity as the therapy dose), the exemplary dose speed detection process, the exemplary movement data detection process, etc. If after a particular dosing or dosing sequence, a certain majority of the exemplary methods for dose distinguishing indicated that the dispensed dose is a prime dose, and a minority method indicated it is not, then the voting method would determine that in this case the dose would be identified as a prime dose”.
Claim 18 features limitations similar to those of claim 9, and is therefore rejected using the same rationale.
Claim 19 features limitations similar to those of claim 10, and is therefore rejected using the same rationale.
Examiner Notes
No prior art could be found at this time for claim 17. In particular, no prior art was found for “determining, with the processor of the mobile communications device, whether the information regarding the user's glucose response meets a fourth criterion; if the first, second, and fourth criterion are met, classifying the dispense even as a priming event; and if the first, second, and fourth criterion are not met, classifying the dispense event as a therapeutic event.” While prior art was found in regards to making adjustments to future doses based on glucose response, no prior art was found in regards to making a determination that a dispense event is a therapeutic or priming event based on at least the glucose response.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Pasmooij (US 11,468,787) teaches adjusting a treatment based on an estimated blood glucose response (Fig. 3B).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE G ROBINSON whose telephone number is (571)272-9261. The examiner can normally be reached Monday - Thursday, 7:00 - 4:30 EST; Friday 7:00-11:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi can be reached at 571-272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE G ROBINSON/Examiner, Art Unit 3685
/MARK HOLCOMB/Primary Examiner, Art Unit 3685