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 .
Response to Amendment
This action is in response to the amendment filed on 05/14/2026. Claims 2-5, 12, 13, and 16 are amended, claims 8, 11, and 17 are canceled, claim 1 was previously canceled, and new claims 20-23 have been added. Claims 2-7, 9, 10, 12-16, and 18-23 are currently pending.
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 2-7, 9, 10, 12-16, and 18-23 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,
classifying,
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”, a “continuous glucose monitor”, 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”, “processor of a medicine dispensing device”, “continuous glucose monitor” and “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, relaying information about a user’s glucose response, and determining if the dispense event is a priming event or a therapeutic event based on the information about the dispense event and the glucose response. 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” a “continuous glucose monitor”, 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…”, and “wirelessly transmitting, from a continuous glucose monitor (CGM) to the mobile communications device…” however these are merely extra-solution activities.
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”, “continuous glucose monitor”, 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 elements of “wirelessly transmitting information about the dispense event from the medication dispensing pen to a mobile communications device…” and “wirelessly transmitting, from a continuous glucose monitor (CGM) to the mobile communications device…” do not amount to significantly more than the judicial exception because in addition to being extra-solution activity, they are well-understood, routine, and conventional functions 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 3-7, 9-11, 20, and 22 are dependent on claim 2, and include all the limitations of claim 2. Claims 13-16, 18-19, 21, and 23 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 2, the limitation “classifying, with a processor of the mobile communications device, the dispense event as a priming event or a therapeutic event based on the information about the dispense event and the information about the glucose response” lacks 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 classifying a dose as a priming event or a therapeutic event based on the glucose response and the amount of medicine dispensed, let alone what criterion are depended on to make the classification.
Claim 12 features limitations similar to those of claim 2, and is therefore rejected using the same rationale.
Regarding claims 22 and 23, the limitations “wherein classifying the dispense event includes: determining a confidence score based on the information about the dispense event and the information about the glucose response; and classifying the dispense event as a prime event or a therapeutic event based on the confidence score” lack a proper written description. The Examiner points to 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.” This is not sufficient in disclosing how the confidence score is determined. First, the statement that “the confidence score may be low” is insufficient as the term “low” is a relative term. Further, the specification fails to disclose any particular algorithms/methodologies detailing how the glucose response is used with the information about the dispensing event to determine an actual confidence score.
Examiner Notes
No prior art could be found at this time for claims 2 and 12. None of the prior arts of record either individually or in combination teach the limitations present in claim 2 and 12. In particular, no prior art was found for “classifying, with a processor of the mobile communications device, the dispense event as a priming event or a therapeutic event based on the information about the dispense event and the information about the glucose response” 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.
Response to Arguments
Applicant's arguments regarding claims rejected under 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant argues with substance:
Applicant argue that the claims present a technical solution to a technical problem of “how to determine how much (if any medicine the user actually received”. This is not persuasive as the claims merely present automation of the existing practice of verifying dispensing of medication. The claims present no improvement to any involved computing components (i.e., medicine delivery pen, mobile communication device, and CGM).
Applicant’s arguments regarding “implement a judicial exception in a particular machine (e.g., a medicine delivery pen, mobile communication device, and CGM system”) is not persuasive since the stated elements are invoked computers merely as tools to perform an existing process (See MPEP 2106.05(b)).
Applicant's arguments regarding claims rejected under 35 U.S.C. 102 have been fully considered and are tentatively persuasive. The Examiner notes that the Applicant has included claim language that was rejected under 112(a) in the previous action that has not been addressed.
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).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KYLE G ROBINSON/Examiner, Art Unit 3685
/KAMBIZ ABDI/ Supervisory Patent Examiner, Art Unit 3685
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