DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-20 are directed to an abstract idea of mathematical relationships. The rationale for this determination is explained below and is based on the analysis presented in the “2014 Interim Guidance on Patent Subject Matter Eligibility" of December 16, 2014. This information can be found at: http://www.uspto.gov/patent/laws-and- requlations/examination-policy/2014-interim-quidance-subject-maitter-eligibility-0.
According to the 2014 interim Eligibility Guidance an initial two step analysis is required for determining statutory eligibility. Step 1 requires a determination of whether the claims are directed to a process, machine, manufacture, or a composition of matter. In the instant case the Step 1 requirement is satisfied as the claims are directed towards a process/machine/product. The Step 2 analysis is a two-part analysis, Step 2A and Step 2B, with the first part Step 2A requiring a determination of whether the claims are directed towards a judicial exception, i.e. a law of nature, natural phenomenon, or an abstract idea.
In the instant case, the claims as stated are drawn to an apparatus comprising at least a first computer-readable memory for storing data inputs and patient’s blood- glucose-level measurements; a processor operatively connected to the memory and programmed to determine from the data inputs and measurements whether and by how much to vary at least one of the one or more components of the patient’s present insulin dosage regimen; and a display operative to display information. As such, the instant claims encompass an abstract idea of a mathematical relationship, i.e. determining from data inputs and measurements whether and by how much to vary at least one component of the regimen. Therefore the result of Step 2A analysis is that the claims encompass a judicial exception, i.e. an abstract idea of a mathematical relationship. With regards to the claims being directed to a process implemented on a computer system or embedded on a computer readable medium comprising instructions for carrying out the method, it is the underlying invention that is analyzed to determine subject matter eligibility, not just the use of a computer system or computer program product. The method steps themselves are considered to be an abstract idea because they do not purport to improve the functioning of the computer itself, there is no specific or limitation recitation of improved computer technology, nor do they effect an improvement in any other technology or technical field.
The second part, Step 2B of the two step analysis is to determine whether any element or combination of elements, in the claim is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception. A display for displaying information is an insignificant, extra-solution activity. A glucose meter providing glucose measurements and an insulin pump providing insulin dosage are well- known, routine and conventional in the diabetes management technology. No additional steps are recited in the instantly claimed invention that would amount to significantly more than the judicial exception. Without additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible. Furthermore, if a claim is directed essentially to a method of calculating, using a mathematical formula, even if the solution is for a specific purpose, the claimed method is non-statutory. In other words, patenting abstract ideas cannot be circumvented by attempting to limit the use [the idea] to a particular technological environment. In the instant claims, the computer and/or program/product amount to mere instruction to implement an abstract idea. The hardware recited by the system claims do not offer a meaningful limitation beyond generally linking “the use of the method to a particular technological environment,’ that is, implementation via computers.” see Alice Corp v. CLS Bank Int'l 573 U.S. (2014).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Worthington et al. (US 5,822,715) in view of Bortz et al. (WO 03/065033).
The claims are drawn to an apparatus for optimizing a patient's insulin dosage regimen over time, comprising:
at least a first computer readable memory for storing data inputs corresponding at least to one or more components in a patient's present insulin dosage regimen and the patient's blood-glucose-level measurements determined at a plurality of times;
a processor operatively connected to the at least first computer-readable memory, the processor programmed at least to determine from the data inputs corresponding to the patient's blood-glucose-level measurements determined at a plurality of times whether and by how much to vary at least one of the one or more components of the patient's present insulin dosage regimen in order to maintain the patient's future blood-glucose-level measurements within a predefined range; and
a display operative to display information corresponding to at least the patient’s present insulin dosage regimen.
Regarding claim 1, Worthington, et al. teaches a system comprising a patient- operated apparatus for measuring blood glucose values representative of a blood glucose concentration of a patient over time and memory for storing data relating to insulin doses administered to the patient, (abstract; column 4). Worthington et al. teaches a processor connected to the glucose meter, user interface and memory, (column 4, lines 21-22). Worthington et al. teaches a processor programmed to determine future blood glucose values depending on measured blood glucose value and determine a corrective action of the patient when the glucose value goes outside of a target range, wherein the corrective action may be administration of a supplemental insulin dose, consumption of grams of carbohydrates, etc. (column 4). Worthington et al. teaches a displaying information corresponding to at least the patient’s present insulin dosage regimen, e.g. patient's blood glucose (figures).
Worthington does not teach a plurality of glucose measurements in a predetermined time period. Bortz teaches a method for analyzing blood glucose readings with a step of obtaining a plurality of blood glucose reading taken within a predetermined time period, performing calculations on the readings based on a range of glycaemia and selecting and applying a pattern label to the plurality of blood glucose readings, (abstract), suggesting a determination based on a plurality of measurements obtained in a predetermined time period.
Regarding claims 2-4, Worthington et al. teaches an input/output port, keypad or remote computer for inputting data to memory, (column 7, lines 27-35; column 9, lines 57-60; Figure 3). Worthington et al. teaches an input/output port for receiving data remotely, e.g. receiving the adjusted insulin sensitivity value, (column 4, lines 53-59). Worthington et al. teaches a blood glucose meter for measuring a blood sample for the patient producing from the measurement a blood glucose value, (column 4, lines 5-8).
It would have been obvious to one skilled in the art at the time of invention to combine Bortz et al. with Worthington et al., because each of the elements are known in the art, the art is in the same technology, i.e. are systems for controlling blood glucose and combinable. One of ordinary skill would have recognized that the results of the combination were predictable, because Worthington et al. predicts future blood glucose values based on measured glucose value, and corrective actions if said value is outside a range, (abstract), and Bortz et al. assesses glycemic controls using predetermined pattern analysis of blood glucose readings, (abstract), thus both use methods to analyze blood glucose and provide a means of altering said glucose and are combinable.
Claims 5-18 are rejected under 35 U.S.C. 103(a) as being unpatentable over Worthington et al. (US 5,822,715) in view of Bortz et al. (WO 2003/065033) as applied to claims 1-4 above, in view of Heller et al. (US 6,560,471).
The instant claims 5-8 and 9-16 depends from claim 1 with the extra limitations providing identifiers, data entry means, insulin pump and glucose meter. Worthington and Bortz are applied to claims 1-4 above. Worthington and Bortz do not teach the above additional limitations.
Regarding claims 5-8 and 13-16, Heller et al. teaches storing event markers with data of a particular event which are generated automatically or through input by the patient, (column 59, lines 36-42).
Regarding claim 9, Heller et al. teaches a drug administration protocol, when executed using the administration system may be an internal or external infusion pump, (column 61, lines 53-58).
Regarding claims 10 and 12, Worthington et al. teaches an input/output port, keypad or remote computer for inputting data to memory, (column 7, lines 27-35; column 9, lines 57-60; Figure 3).
Regarding claim 11, Worthington et al. teaches a processor connected to the glucose meter, user interface and memory, (column 4, lines 21-22).
It would have been obvious to one skilled in the art at the time of invention to combine Bortz et al. and Heller et al. with Worthington et al., because each of the elements are known in the art, the art is in the same technology, i.e. are systems for controlling blood glucose and combinable. One of ordinary skill would have recognized that the results of the combination were predictable, because Worthington et al. predicts future blood glucose values based on measured glucose value, and corrective actions if said value is outside a range, (abstract), Heller et al. measures a level of analyte, i.e. blood glucose, and a delivery system to help alter the level of analyte based on the measured analyte, (abstract), and Bortz et al. assesses glycemic controls using predetermined pattern analysis of blood glucose readings, (abstract), thus all use methods to analyze blood glucose and provide a means of altering said glucose and are combinable.
Regarding claims 17 and 18 the claims are interpreted and rejected using the same reasoning as claims 2 and 10 above. The selection of specific data inputs would be left to the artisan.
Claims 19 and 20 are rejected under 35 U.S.C. 103(a) as being unpatentable over Worthington et al. (US 5,822,715) in view of Bortz et al. (WO 03/065033) in view of Heller et al. (US 6,560,471), as applied to the claims above, in view of Bloomquist et al. (US 2003/0163088).
The instant claims 19 and 20 depend from claims 9 and 10, with the extra limitations providing data inputs corresponding to the number of insulin units administered and rate at which insulin is delivered. Worthington, Bortz and Heller are applied to claims 5, 6 and 9-14 above. Worthington, Bortz and Heller do not teach the above additional limitations.
Regarding claims 19 and 20 Bloomquist et al. teaches a programmable infusion pump that displays the rate and units of insulin delivered to the patient, (paragraph 45; figures).
It would have been obvious to one skilled in the art at the time of invention to combine Bloomquist et al. with Worthington et al., Bortz et al. and Heller et al. because each of the elements are known in the art, the art is in the same technology, i.e. are systems for controlling blood glucose and combinable. One of ordinary skill would have recognized that the results of the combination were predictable, because Worthington et al. predicts future blood glucose values based on measured glucose value, and corrective actions if said value is outside a range, (abstract), Heller et al. measures a level of analyte, i.e. blood glucose, and a delivery system to help alter the level of analyte based on the measured analyte, (abstract), Bortz et al. assesses glycemic controls using predetermined pattern analysis of blood glucose readings, (abstract), and Bloomquist et al. provides a programmable infusion pump with various operating parameters to provide a more consistently normal level of blood glucose, (abstract; paragraphs 4-9); thus all provide a means of managing said glucose and are combinable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC M BLOUNT whose telephone number is (571)272-2973. The examiner can normally be reached M-F 9:00a - 5:30p.
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ERIC M. BLOUNT
Primary Examiner
Art Unit 2685
/Eric Blount/Primary Examiner, Art Unit 2685