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 .
Election/Restrictions
Applicant’s election without traverse of group I claims 1-8 in the reply filed on 6/10/2026 is acknowledged.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 1,
“an initiation system”; “physiological assessment system”; “cardiac fitness assessment system”; “cardiac fitness reporting system”; “trigger system”.
Claim 2,
“cardiac fitness assessment system”
Claim 5,
“one or more optical emitters”; “one or more detectors”; “sensor control system”; “trigger system”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khosrow-Khavar et al (Pub. No.: US 2020/0405170).
Regarding claim 1, Khosrow-Khavar et al disclose an apparatus for determining the cardiac fitness of a user, comprising:
(a) a noninvasive sensor system, comprising one or more cardiovascular sensors configured to produce a signal that indicates a time of opening and closing of the user's aortic valve [see 0111] by disclosing SCG-Z measurements may indicate particularly useful cardiac timing information, such as cardiac timing information regarding opening and closing of heart valves such as the aortic valve [see 011];
(b) an initiation system (computing device), configured to detect an event indicating a cardiac fitness test is to be initiated [see 0097, 0099, 0184-0186, 0192, 0229-0232 and figs 5, 16] by disclosing the CPI may indicate an estimation of cardiac fitness [see 0231] and the CPI may be a number between 0 and 100 and may indicate an estimated cardiac fitness level of the subject [see 0232];
(c) a sensor control system responsive to the initiation system configured to operate the noninvasive sensor system at a first set of operational parameters to produce a first measurement signal that indicates the times of opening and closing of the user's aortic valve during two or more successive cardiac cycles [see 0111, claim 152];
(d) a physiological assessment system configured to determine the presence of a basal physiological state [see 0242] from the first measurement signal based on:
(1) an interbeat time interval between successive openings of the user's aortic valve from each of two or more cardiac cycles [see 0111];
(2) a variability between two or more interbeat time intervals [see 0235-0236, 0242-0245];
(e) a trigger system, responsive to the physiological assessment system [see fig 16, 0089];
(f) a cardiac fitness assessment system responsive to the trigger system configured to activate when the trigger system indicates that a basal physiological state (metabolic measurements such as oxygen levels) is detected [see 0242] and further configured to determine a cardiac fitness score from the first measurement signal based on an ejection time interval between an opening and an immediately subsequent closing of the user's aortic valve [see 0111, 0230-0232];
(g) a cardiac fitness reporting system configured to report the first cardiac fitness score [see 0197-0198, 0226, 0229-0232 and fig 16] by disclosing the CPI may indicate an estimation of cardiac fitness [see 0231] and the CPI may be a number between 0 and 100 and may indicate an estimated cardiac fitness level of the subject [see 0232].
Regarding claim 2, Khosrow-Khavar et al disclose wherein the sensor control system is responsive to the trigger system and is configured to operate the sensor system at a second set of operational parameters to produce a second measurement signal when the trigger system indicates that a basal physiological state (metabolic measurements such as oxygen levels) is detected [see 0242];
wherein the cardiac fitness assessment system is configured to determine a cardiac fitness score from the second measurement signal [see 0229-0232 and fig 16] by disclosing the CPI may indicate an estimation of cardiac fitness [see 0231] and the CPI may be a number between 0 and 100 and may indicate an estimated cardiac fitness level of the subject [see 0232].
Regarding claim 3, Khosrow-Khavar et al disclose wherein the sensor system comprises optical emitters and detectors [see 0058, 0060].
Regarding claim 4, Khosrow-Khavar et al disclose wherein the noninvasive sensor system includes at least one of the following:
electrocardiogram sensor, phonocardiogram sensor [see 0064], seismocardiogram sensor [see 0035], ballistocardiogram sensor, or echocardiogram sensor [see 0249].
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Khosrow-Khavar et al (Pub. No.: US 2020/0405170) in view of Lizzio et al (Pub. No.: US 2022/0249020).
Regarding claim 5, Khosrow-Khavar et al don’t disclose (a1) the noninvasive sensor system comprises an optical measurement system comprising (i) one or more optical emitters configured to emit light toward a measurement region of the user and (ii) one or more detectors configured such that light reaches the detectors from the one or more emitters after the light from the emitters has interacted with the measurement region;
(c1) the sensor control system is configured to operate the one or more emitters and the one or more detectors at a first set of operational parameters to detect changes in blood flow or blood volume to produce a first measurement signal that is indicative of opening and closing of the user's aortic valve;
(e1) the trigger system is configured to respond to the presence of a basal physiological state as determined by the physiological assessment system.
Nonetheless, Lizzio et al disclose (a1) the noninvasive sensor system comprises an optical measurement system comprising (i) one or more optical emitters configured to emit light toward a measurement region of the user and (ii) one or more detectors configured such that light reaches the detectors from the one or more emitters after the light from the emitters has interacted with the measurement region [see 0052];
(c1) the sensor control system is configured to operate the one or more emitters and the one or more detectors at a first set of operational parameters to detect changes in blood flow or blood volume to produce a first measurement signal that is indicative of opening and closing of the user's aortic valve [see 0075];
(e1) the trigger system is configured to respond to the presence of a basal physiological state as determined by the physiological assessment system [see 0018, 0247].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Khosrow-Khavar et al and Lizzio et al by operating the one or more emitters and the one or more detectors at a first set of operational parameters to detect changes in blood flow or blood volume to produce a first measurement signal that is indicative of opening and closing of the user's aortic valve; operating the one or more emitters and the one or more detectors at a first set of operational parameters to detect changes in blood flow or blood volume to produce a first measurement signal that is indicative of opening and closing of the user's aortic valve; for evaluating vascular stiffness and aging indices [see 0075]
Regarding claim 6, Khosrow-Khavar et al disclose wherein the sensor control system is responsive to the trigger system and operates the sensor system at a second set of operational parameters to produce a second measurement signal when the trigger system indicates that a basal physiological state is detected, and wherein the cardiac fitness assessment system is configured to determine a cardiac fitness score from the second measurement signal [see fig 16, 0232].
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Khosrow-Khavar et al (Pub. No.: US 2020/0405170) in view of Lizzio et al (Pub. No.: US 2022/0249020) as applied to claim 5 above and further in view of Agell et al (Pub. No.: US 2020/0390348).
Regarding claims 7-8, Khosrow-Khavar et al don’t disclose a speckle plethysmography sensor wherein the optical measurement system includes a photo plethysmography sensor.
Nonetheless, Agell et al disclose a speckle plethysmography sensor and a photo plethysmography sensor [see 0038].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Khosrow-Khavar et al and Lizzio et al, Agell et al by using a speckle plethysmography sensor and a photo plethysmography sensor; SPG produces a more stable signal with a higher signal-to-noise ratio compared to PPG, which is often affected by vasoconstriction and low SNR. This stability improves the accuracy of physiological measurements and Non-invasive and user-friendly PPG sensors work without inserting electrodes or needles, making them comfortable for continuous monitoring. They can be integrated into everyday wearables like smartwatches and fitness bands, requiring no special training for the user.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL F BRUTUS whose telephone number is (571)270-3847. The examiner can normally be reached Mon-Sat, 11:00 AM to 7:00 PM.
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/JOEL F BRUTUS/ Primary Examiner, Art Unit 3797
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