DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Notice of Amendment
In response to the amendment(s) filed on 9/3/26, amended claim(s) 1, 4, 9, and 11, and canceled claim(s) 17-19 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
Claim Objections
Claim 11 is objected to because of the following informalities: “an the” (line 4) appears that it should be “the.”
Claim 11 is objected to because of the following informalities: “a the” (line 4) appears that it should be “the.”
Appropriate correction is required.
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.
Claim(s) 1-2, 4, and 9-11 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 1 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 1 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “calculate a change in a light absorption caused by blood in the biological sample,” “receive an output photocurrent signal that passes through a first and second aperture from at least one photocurrent signal generating light detector,” “calculate an attenuance attributable to blood in a sample present in a target area based on the received output photocurrent signal,” “determine a blood glucose level associated with the sample present in the target area based on the calculated attenuance,” and “eliminate effect of uncertainty caused by temperature dependent detector response of the at least one light detector by calculating standard deviation of a logarithm of the time dependent output current generated by a light power from the target area of the biological sample to establish a correlation between an optical measurement and blood glucose level which improves signal-to-noise ratio.” This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional element is “a processor.” However, this element is not “significantly more” because it is a generic computer structure, which has been held to be well-known, routine, and/or conventional by Bilkski and Alice. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 1 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 2 and 4 fail to cure the deficiencies of independent claim 1 by merely reciting additional abstract idea(s) and/or further limitations on abstract ideas already recited. Dependent claim 9 fails to cure the deficiencies of independent claim 1 because the additional element(s) recited is/are well-known, routine, and/or conventional in view of para [0981] of U.S. Patent Application Publication No. 2009/0105605 to Abreu. Dependent claim 10 fails to cure the deficiencies of independent claim 1 because the additional element(s) recited is/are well-known, routine, and/or conventional in view of para [0027] of U.S. Patent Application Publication No. 2010/00249548 to Muller. Dependent claim 11 fails to cure the deficiencies of independent claim 1 because the additional element(s) recited is/are well-known, routine, and/or conventional in view of para [0981] to Abreu. Thus, claim(s) 1-2, 4, and 9-11 is/are rejected under 35 U.S.C. 101.
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 negated by the manner in which the invention was made.
Claim(s) 1-2, 9, and 11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Application Publication No. 2008/0081325 to Mannheimer et al. (hereinafter “Mannheimer”) in view of U.S. Patent Application Publication No. 2006/0058622 to Tearneye al. (hereinafter "Tearney").
For claim 1, Mannheimer discloses a system for detecting glucose in a biological sample (Abstract) (para [0038]), comprising:
a processor programmed to calculate a change in a light absorption caused by blood in the biological sample (see Fig. 3) (para [0018]) and configured to receive (Examiner’s Note: functional language, i.e., capable of) an output photocurrent signal that passes through a first and second aperture (Examiner’s Note: this limitation being a further limitation of the processor in an apparatus-type claim) (as can be seen in Fig. 2) from at least one photocurrent signal generating light detector (para [0019]) and calculate an attenuance attributable to blood in a sample present in a target area based on the received output photocurrent signal (para [0018]), and determine a blood glucose level associated with the sample present in the target area based on the calculated attenuance (para [0018], [0020]-[0022], and [0038]), wherein the processor is configured to eliminate effect of uncertainty caused by (Examiner’s Note: the processor has no control over what causes the uncertainty, it just processes the effect of uncertainty on the signal) temperature dependent detector response (see, for example, “bright lights” in para [0006], which put off heat and increase temperature) of the at least one light detector (para [0031], [0033], and [0038]).
Mannheimer does not expressly disclose calculating a standard deviation of a logarithm of the time dependent output current generated by a light power from the target area of the biological sample to establish a correlation between an optical measurement and blood glucose level which improves signal-to-noise ratio.
However, Tearney teaches calculating a standard deviation of a logarithm of the time dependent output current generated by a light power from the target area of the biological sample (para [0061] and [0064]) to establish a correlation between an optical measurement and blood glucose level (Examiner’s Note: this language seems to be intended use/functional language since it defines a result of the calculation (i.e,, the result being to establish a correlation) instead of an active method step of the claimed processor) (para [0061] and [0064]) which improves signal-to-noise ratio (Examiner’s Note: this claim language being functional language, i.e., capable of since it describes a result of the calculation) (para [0061] and [0064]) (also see para [0038]).
It would have been obvious to a skilled artisan to modify Mannheimer to include calculating a standard deviation of a logarithm of the time dependent output current generated by a light power from the target area of the biological sample to establish a correlation between an optical measurement and blood glucose level which improves signal-to-noise ratio, in view of the teachings of Tearney, because such a modification is just a simple modification/substitution of the calculation of Tearney for the calculation of Mannheimer that would lead to the predictable result of blood detection (which is what both references want to do).
For claim 2, Mannheimer further disclose wherein the time dependent output current is a function of a baseline current, a noise current and a time dependent cyclic current corresponding to a heartbeat (para [0018], [0022], [0029]-[0030], and [0032]).
For claim 9, Mannheimer further discloses at least one light source configured to generate one or more light beams and to strike the target area of the biological sample (para [0019]-[0020]).
For claim 11, Mannheimer further discloses the at least one photocurrent signal generating light detector positioned to receive light from at least one light source (para [0017]-[0019]) and filtered by at least one light filter (para [0023]), and to generate the output photocurrent signal, having the time dependent output current, which is indicative of the power of light detected (para [0019], [0023], and [0025]).
Claim(s) 4 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mannheimer in view of Tearney, and further in view of U.S. Patent Application Publication No. 2009/0157813 to Jung et al. (hereinafter “Jung”).
For claim 4, Mannheimer and Tearney do not expressly disclose wherein the calculated attenuance is based at least in part on an approximation of the standard deviation of a logarithm of the time dependent output current generated by the light power from the target area of the biological sample.
However, Jung teaches calculating attenuance based at least in part based on a function that can be approximated using Taylor series expansion (para [0085]).
It would have been obvious to a skilled artisan to modify Mannheimer wherein the calculated attenuance is based at least in part on an approximation of the standard deviation of a logarithm of the time dependent output current generated by the light power from the target area of the biological sample, in view of the teachings of Jung, for the obvious advantage of contributing to speed and accuracy of the calculation.
Claim(s) 10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mannheimer in view of Tearney, and further in view of U.S. Patent No. 4,632,559 to Brunsting.
For claim 10, Mannheimer and Tearney do expressly disclose at least one light filter positioned to receive light transmitted through the target area of the sample from at least one light source.
However, Brunsting teaches at least one light filter (22) (Fig. 1) positioned to receive light transmitted through the target area (18) of the sample from the at least one light source (i.e., 12) (as can be seen in Fig. 1); and that the detector receives light filtered by the at least one light filter (as can be seen in Fig. 1).
It would have been obvious to a skilled artisan to modify Mannheimer to include at least one light filter positioned to receive light transmitted through the target area of the sample from at least one light source, in view of the teachings of Brunsting, because such a modification is just another way to filter the light (other than the way disclosed by Mannheimer) that would lead to the predictable result of removing unwanted elements from the data/signal.
Response to Arguments
Applicant’s arguments filed 9/3/26 have been fully considered.
With respect to the claim objection(s), Applicant’s amendments and arguments are persuasive and thus the objection(s) is/are withdrawn.
With respect to the 112 rejections, Applicant’s amendments and arguments are persuasive and thus the rejections are withdrawn.
With respect to the 101 rejection(s), the arguments will be treated in the order they were presented in the response. With respect to the first argument, the claims don’t recite “light-sensing devices,” or “interference filters.” Therefore, this argument is arguing features not in the claim(s). Dependent claim 9 does recite a “light source,” but it is not significantly more under step 2B of the Alice/Mayo framework. Also, a “processor” is a generic computer structure and therefore not significantly more. With respect to the next argument it is possible to mentally calculate blood glucose levels based on an output signal because a human being can look at a computer screen that shows the output signal and mentally calculate their head blood glucose levels. The calculation is “based on” the output signal because the human has to look and decipher the output signal because the human can mentally calculate the blood glucose level. With respect to the next argument, “reducing error and improving accuracy” is not an improvement in technology, but instead an improvement in mathematical parameters. That is, “error” and “accuracy” are not technologies, but mathematical concepts that are being improved. With respect to the next argument, the claim language recites “a processor programmed to … receive an output photocurrent signal from at least one photocurrent signal generating light detector.” So it’s the processor that receives the signal, but the processor is a generic computer structure and therefore doesn’t transform the patent-ineligible subject matter into patent-eligible subject matter.
With respect to the 103 rejection(s), claim 1 recites “a processor … configured to receive an output photocurrent signal that passes through a first and second aperture from at least one photocurrent signal generating light detector.” Claim 1 is an apparatus-type claim and therefore more patentable weight is given to structure instead of function. The “processor” is a structure of the apparatus. The processor then performs the function (as evidence by “configured to” in the claim language) receiving “an output photocurrent signal that passes through a first and second aperture.” So the limitation “through a first and second aperture” modifies the functional language of “receive an output photocurrent signal.” Mannheimer discloses a processor that is capable of (i.e., configured to) receiving an output photocurrent signal that passes through a first and second aperture because Fig. 2 shows that the beam from the light source(s) pass through two solid lines (where two apertures would allow for the beam to pass that solid structure) before being detected by the detector and then sent to be received by the processor.
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 DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
