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 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 1-2 and 4-17 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.
Independent claims 1, 13, and 14 each recite estimating "glucose metabolism" or "lipid metabolism." Metabolism refers to "physical and chemical processes in an organism by which its material substance is produced, maintained, and destroyed, and by which energy is made available." For glucose and lipids, the term is modified to replace "material substance" with glucose or lipids, respectively.
If the term is to be given its broadest reasonable interpretation, then there must be a commensurate disclosure of how the invention relates to this broad meaning. Glucose or lipid metabolism is a broad genus metric for several different types of measurements. For example, does the metric allow an estimate of the glucose concentration in the blood (mg/dL)? Does it allow an estimate of glucose disposal rate (mg/kg/min)? Does it allow an estimate of glucose sensitivity? Glucose clearance rate (mL/kg/min)? A change in glucose concentration? Is there a scale by which to measure it? Fasting plasma glucose? How would the subject respond to an oral glucose tolerance test? The same questions may be asked of lipid metabolism. As the terms do not appear to have objective boundaries, they must be rejected as indefinite.
Response to Arguments
Applicants state that the amendments presented in response filed on May 19, 2026 pass muster under 35 U.S.C. 112(b) in that they define measurement timing in relation to a specific activity, which provides an objective boundary for glucose metabolism. This is not found persuasive, however, because it does not clarify how “glucose metabolism” is to be understood by one of ordinary skill in the art. A person who just finished exercising may be said to be metabolizing glucose quicker than a person at rest. Does this test distinguish between the two? If two people with different insulin sensitivities eat the exact same meal at the exact same time, what will the test say about their glucose metabolisms? There is uncertainty about the metes and bounds of the claimed inventions, rendering them indefinite.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Messersmith whose telephone number is (571)270-7081. The examiner can normally be reached M-Tu, 8:30 am - 5 pm.
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/ERIC J MESSERSMITH/ Primary Examiner, Art Unit 3791
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