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 § 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.
Claim 2-4, 14-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Specifically, the specification does not provide any description of how the formula is used to determine a dosage of insulin to be administered to a patient. While paragraph 0045 of the specification states that the formula can be incorporated into software used to determine insulin doses, it is unclear how the dosage is to be calculated based on the claimed formula.
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.
Claims 3, 4, 15, 16 are 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.
Claims 3 and 15 recite the limitation “new software”. It is unclear what comprises new software vs existing software. New software must exist to use it, so all usable software exists. Further, how new constitutes “new” software? For the sake of examination, the limitation will be interpreted as “software”.
Claims 4 and 16 recite the limitation “a new software system and an existing software system”. It is unclear what comprises new software vs existing software. New software must exist to use it, so all usable software exists. Further, how new constitutes “new” software? For the sake of examination, the limitation will be interpreted as “a software system”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5, 6, 10-12, 17, 20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 defines the numerator as 1800, while the claims 10-12 and 20 then define the numerator as a range of values. This broadens the subject matter as opposed to further limiting the claimed subject matter. Claims 5, 6, and 17 describes that the formula provides an accurate estimation of the sensitivity of the patient and that the insulin sensitivity estimate is dynamic in nature. It is unclear how this further modified the formula or further defines the method. While these claims describe inherent properties of the formula, they do not provide any further limitation to the claimed subject matter. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 5-6, 10-13, 17, 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.
Step 2A, Prong 1
Specifically, Claims 1, 5-6, 10-13, 17, 20 are directed to calculating using a formula an estimated insulin sensitivity with no additional method steps. Mathematical calculations are considered an abstract idea and therefore falls under a judicial exception.
Step 2A, Prong 2
Further, Claims 1, 5-6, 10-13, 17, 20 do not provide any structure or method steps that link the abstract idea to a particular technological environment. The listed claims require the additional elements of: the formula provides an accurate estimation of the sensitivity; the numerator of the function has a range; a second step of computing a dosage of insulin, and the insulin sensitivity estimate is dynamic in nature. These above-identified additional elements fail to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply calculating a value. In order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition (MPEP 2106.04(d)(2)). The claims do not affirmatively recite an action that clearly effects anything. Claims 5-6, 10-13, 17, 20 simply define further properties of the formula such as the formula providing an accurate estimation and being dynamic, as well as further defining the numerator range or further calculations to be made.
For at least these reasons, the abstract idea identified above is not integrated into a practical application.
Step 2B
None of the additional elements of claims 1, 5-6, 10-13, 17, 20 are sufficient to amount to significantly more than the abstract idea for at least the following reasons:
The listed claims require the additional elements of: the formula provides an accurate estimation of the sensitivity; the numerator of the function has a range; a second step of computing a dosage of insulin, and the insulin sensitivity estimate is dynamic in nature.
The above-identified additional elements are properties, variables, or further calculations related to the formula itself. The indicated claims to not further provide significantly more than just calculating. Thus, the additional elements do not amount to significantly more than the abstract idea itself.
Allowable Subject Matter
Claims 1-6, 10-17, and 20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 101, 35 U.S.C. 112(a), 35 U.S.C. 112(b), and/or 35 U.S.C. 112(d) set forth in this office action.
Claims 7-9, 18-19 are objected to as being dependent upon a rejected claim, but would be allowable if the rejections are overcome.
The following is a statement of reasons for the indication of allowable subject matter: the subject matter of the independent claim 1 could either not be found or was not suggested in the prior art of record. The closest prior art is Yodfat (US 2011/0054439) and Ranganath (“Assessing Insulin Sensitivity and Resistance in Humans”). Yodfat teaches a method of calculating an estimated sensitivity to a required dose of insulin to correct hyperglycemia, comprising: a formula as follows: ISF = 1800/TDD (Para 0015), however, lacks the other elements of the formula such as Basal/Bolus Ratio Factor, Current Blood Glucose, and Time-to-Peak factor.
Ranganath, in Table 1 on Page 12, teaches numerous ways to estimate Insulin Sensitivity including multiplying fasting glucose and fasting insulin divided by a constant (HOMA) or dividing the log of fasting insulin plus the log of fasting glucose over 1, they still do not include the other elements of the formula such as Basal/Bolus Ratio Factor, Current Blood Glucose, and Time-to-Peak factor.
Thus, the prior art of record fails to teach the specific formula for calculating an estimated sensitivity as defined in claim 1. It would not have been obvious to modify the prior art of record to arrive at the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783