DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 1 and 3 are objected to because of the following informalities:
“the patient” in line 2 of claim 1 should read as “a patient”
“a self-care” in line 1 of claim 3 should read as “the self-care”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 16 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites the limitation “the likelihood of low glucose threshold” in lines 3-4. There is insufficient antecedent basis for this limitation. “Likelihood of low glucose threshold” was not previously recited and it is unclear what this limitation is referring to. For examination purposes, this limitation is interpreted as “a threshold.” It is noted that this language was taken from claim 6 as claim 16 mirrors the subject matter of claim 6.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
STEP 1
Regarding claim 1, the claim recites a series of structural elements, including a continuous glucose monitor. Thus, the claim is directed to a machine, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
determine glucose control measures based on the collected glucose data for each of a plurality of time of day periods, wherein the glucose control measures include one or more of a glucose median, a glucose variability, or a likelihood of low glucose,
assess the glucose control measures for each of the plurality of time of day periods as corresponding to one of a plurality of risk levels, and
determine a recommended action for one or more of the plurality of time of day periods based on the assessed risk levels for the glucose control measures, wherein the recommended action comprises one or more of addressing a self-care behavior or adjusting a medication dose
set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites outputting the recommended action on a display of the computing device, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The outputting of the recommended action on the display does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the outputted recommended action, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
a continuous glucose monitor configured to be worn by the patient and to collect glucose data, the continuous glucose monitor comprising a sensor configured to sense an interstitial glucose level; and
a computing device in wireless communication with the continuous glucose monitor to receive the glucose data, wherein the computing device comprises a processor coupled with non- volatile, non-transitory memory, the non-volatile, non-transitory memory storing a glucose data processing program.
The continuous glucose monitor as claimed and the computing device as claimed are well-understood, routine and conventional structures for those in the field of medical diagnostics (see 35 U.S.C. 102(a)(1) rejection below). Further, the collecting and receiving steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Regarding claim 1, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited continuous glucose monitor comprising a sensor are generic sensors configured to perform pre-solutional data gathering activity and the computing device comprising a processor with non-volatile, non-transitory memory is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The same rationale applies to claim 11.
The dependent claims also fail to add something more to the abstract independent claims. Claims 2, 4, 7, 12, 14, and 17 recite mental processing steps that add to the Abstract Idea. Claims 3, 5, 6, 8, 9, 13, 15, 16, 18, and 19 recite steps of organizing human activity that add to the Abstract Idea. Claims 10 and 20 recite outputting steps that do not provide an improvement to the technological field, does not effect a particular treatment, or effect a particular change based on the outputted assessment of the glucose control measures. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-5, 7, 8, 10-15, 17, 18, and 20 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Blomquist et al. ‘147 (US Pub No. 2009/0177147).
Regarding claim 1, Blomquist et al. ‘147 teaches a diabetes therapy decision guidance system (Title, Abstract), comprising:
a continuous glucose monitor configured to be worn by the patient and to collect glucose data (Fig. 4 blood glucose monitor 437 and [0034]), the continuous glucose monitor comprising a sensor configured to sense an interstitial glucose level ([0034]; “The blood glucose monitor 437 may be a continuous blood glucose monitor that includes a blood glucose sensor circuit to produce an electrical blood glucose signal representative of a blood glucose level of the patient. The blood glucose sensor circuit may sense blood glucose concentration from blood or from interstitial fluid.”); and
a computing device in wireless communication ([0033]; “wireless port”) with the continuous glucose monitor to receive the glucose data, wherein the computing device comprises a processor (Fig. 4 controller 405 and [0034]; Fig. 16 controller 1605 and [0101]) coupled with non-volatile, non-transitory memory, the non-volatile, non-transitory memory storing a glucose data processing program (Fig. 16 memory 1640 and [0105]) that, when executed by the processor, causes the processor to:
determine glucose control measures based on the collected glucose data for each of a plurality of time of day periods, wherein the glucose control measures include one or more of a glucose median, a glucose variability ([0102]), or a likelihood of low glucose,
assess the glucose control measures for each of the plurality of time of day periods as corresponding to one of a plurality of risk levels ([0104]),
determine a recommended action for one or more of the plurality of time of day periods based on the assessed risk levels for the glucose control measures, wherein the recommended action comprises one or more of addressing a self-care behavior ([0044]) or adjusting a medication dose ([0031]-[0032], [0039]), and
output the recommended action on a display of the computing device (Fig. 16 display 1630 and [0103]).
Regarding claim 2¸ Blomquist et al. ‘147 teaches wherein the glucose variability is assessed to have a first risk level when the glucose variability is below a threshold glucose variability and the glucose variability is assessed to have a second risk level when the glucose variability exceeds the threshold glucose variability ([0104]; “The controller 1605 increases the number of blood glucose testing times if the measure of blood glucose variability exceeds a blood glucose variability target value by more than a first threshold blood glucose variability value. The controller 1605 decreases the number of blood glucose testing times if the measure of blood glucose variability is less than the blood glucose variability target value by more than a second threshold blood glucose variability value. This rewards the user with less testing times if the user is managing to keep their blood glucose relatively stable at a normal level.”).
Regarding claim 3, Blomquist et al. ‘147 teaches wherein the recommended action comprises adjusting the self-care behavior when the glucose variability is assessed to have the second risk level ([0044]-[0049]).
Regarding claim 4, Blomquist et al. ‘147 teaches wherein the likelihood of low glucose is assessed to have a first risk level when the likelihood of low glucose is below a threshold and is assessed to have a second risk level when the likelihood of low glucose exceeds the threshold ([0104]; “The controller 1605 increases the number of blood glucose testing times if the measure of blood glucose variability exceeds a blood glucose variability target value by more than a first threshold blood glucose variability value. The controller 1605 decreases the number of blood glucose testing times if the measure of blood glucose variability is less than the blood glucose variability target value by more than a second threshold blood glucose variability value. This rewards the user with less testing times if the user is managing to keep their blood glucose relatively stable at a normal level.”).
Regarding claim 5, Blomquist et al. ‘147 teaches wherein the recommended action comprises decreasing a medication dose when the likelihood of low glucose is assessed to have the second risk level ([0044]-[0049]).
Regarding claim 7, Blomquist et al. ‘147 teaches wherein the glucose median is assessed to have a first risk level when the glucose median is below a goal glucose median and the glucose median is assessed to have a second risk level when the glucose median exceeds the goal glucose median ([0058], [0082]).
Regarding claim 8, Blomquist et al. ‘147 teaches wherein the recommended action comprises increasing a medication dose when the glucose median is assessed to have the second risk level ([0104]).
Regarding claim 10, Blomquist et al. ‘147 teaches wherein the processor is further caused to output the assessment of the glucose control measures (Fig. 12 display 1245 and [0085]).
Regarding claims 11-15, 17, 18, and 20, Blomquist et al. ‘147 teaches a method for diabetes therapy decision guidance, the method comprising: the claimed steps, as the subject matter of claims 11-15 and 20 are analogous to claims 1-5 and 10.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURELIE H TU whose telephone number is (571)272-8465. The examiner can normally be reached [M-F] 7:30-3:30.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791
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