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.
Election/Restrictions
Applicant’s election of Invention I, drawn to a system for detecting glucose in a biological sample of claims 1-2, 4, and 9-11 in the reply filed on 5/19/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Newly submitted claim(s) 17-19 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The invention of claims 1-2, 4, and 9-11 and the invention of claims 17-19 are directed to related apparatuses. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed can have a materially different design, mode of operation, function, or effect as evidenced by “a processor programmed to calculate a change in a light absorption caused by blood in the biological sample and configured to receive an output photocurrent signal from at least one photocurrent signal generating light detector and calculate an attenuance attributable to blood in a sample present in a target area based on the received output photocurrent signal, and determine a blood glucose level associated with the sample present in the target area based on the calculated attenuance, wherein the processor is configured to 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,” as recited in claim 1 and “at least one light source configured to emit light at a predetermined wavelength toward a target area of the biological sample,” “at least one light filter configured to pass a selected wavelength band of light transmitted through the target area to generate filtered light,” “at least one light detector configured to receive the filtered light and generate a time-varying photocurrent signal corresponding to detected light intensity,” and “a processor in communication with the light detector and programmed to: determine a standard deviation of a logarithm of the time-varying photocurrent signal over a defined time window corresponding to at least one cardiac cycle; calculate an attenuance attributable to blood in the target area based on the determined standard deviation; and determine a blood glucose level based on the calculated attenuance, wherein the processor compensates for temperature-dependent variation in detector response by using the standard deviation of the logarithm of the time-varying photocurrent signal,” as recited in claim 17. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim(s) 17-19 is/are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Objections
Claim 1 is objected to because of the following informalities: “calculating standard deviation” (line 10) appears that it should be “calculating a standard deviation.”
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(s) 1-2, 4, and 9-11 is/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.
For claim 1, the claim term “the time dependent output current” (line 11) lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
For claim 4, the claim language “a standard deviation of a logarithm of the time dependent output current generated by the light power from the target area of the biological sample” is ambiguous. Claim 1, from which claim 4 depends, already recites 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.” Therefore, it is ambiguous whether this is the same standard deviation or a different standard deviation. The claim is examined under the former interpretation.
For claim 9, the claim term “a biological sample” is ambiguous. Claim 1, from which claim 9 depends, already recites “a biological sample.” It is unclear whether the same or a different biological sample is being referred to. The claim is examined under the former interpretation.
For claim 11, the claim term “at least one photocurrent signal generating light detector” is ambiguous. Claim 1, from which claim 11 depends, already recites “at least one photocurrent signal generating light detector.” It is unclear whether the same or different detector is being referred to. The claim is examined under the former interpretation.
For claim 11, the claim term “an output photocurrent signal” is ambiguous. Claim 1, from which claim 11 depends, already recites “an output photocurrent signal.” It is unclear whether the same or different signal is being referred to. The claim is examined under the former interpretation.
For claim 11, the claim term “a time dependent output current” is ambiguous. Claim 1, from which claim 11 depends, already recites a “time dependent output current.” It is unclear whether the same or different signal is being referred to. The claim is examined under the former interpretation.
Dependent claim(s) 2, 4, and 9-11 fail to cure the ambiguity of independent claim 1, thus claim(s) 1-2, 4, and 9-11 is/are rejected under 35 U.S.C. 112(b).
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 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.” 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 an output photocurrent signal 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.
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]).
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, 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 a biological sample (para [0019]-[0020]).
For claim 11, Mannheimer further discloses 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 an output photocurrent signal, having a 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 a 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 a 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.
Conclusion
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
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