Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/15/2025 has been entered.
Response to Amendment
3. This action is responsive to the amendments filed 10/15/2025. Claims 21, 37, and 40-42 have been amended. Claims 45-48 were newly added. Claims 29 and 32 were cancelled.
Response to Arguments
4. Applicant’s arguments filed on 10/15/2025 with respect to the art rejections have been fully considered but they are not persuasive. In substance, applicant argues that A) Schuler does not disclose deriving gradients from different limbs and comparing them.
5. In response to A), the examiner respectfully notes the change in the rejection provided below. The examiner has relied on a different embodiment of Shuler to teach this limitation. Shuler discloses taking measurements from sensors located on two different extremities and comparing them (see paragraph 0050). This would provide a better assessment of the patient. By allowing for a comparison between measurements of two limbs one can readily ascertain an aberration in a measurement. One such aberration could be the increase in pressure in one limb indicating compartment syndrome. Early detection of such conditions is crucial to saving the limb and avoiding amputation. Therefore, it would be highly advantageous to compare the measurements between the two limbs. Thus, the updated combination teaches the limitations as currently claimed.
Claim Rejections - 35 USC § 103
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.
Claims 21-25, 27-28, 31, 35, 37-42, and 45-48 are rejected under 35 U.S.C 103 as being unpatentable over Shuler et al. (US Pub.: 2010/0292549, – Previously Cited).
Regarding claim 21, Shuler teaches an apparatus for detecting a cardiac performance indicator (e.g. abstract – oxygenation levels), comprising:
a first plurality of sensors (405A, B, C) configured to be arranged between a core location and an extremity location along a first appendage of a patient (See fig. 13A, showing positioning of the sensors 405 in groups);
a second plurality of sensors configured to be arranged between a core location and an extremity location along a second appendage of a patient (See fig. 13A, showing positioning of the sensors 405 in groups);
and a controller (420C1) configured to
receive data from the first and second pluralities of sensors (e.g. paragraph 0118),
analyze the data to determine a first gradient between the core location and the extremity location along the first appendage and a second gradient between the core location and the extremity location along the second appendage (e.g. paragraph 0314 – comparing oxygenation values between the respective NIRS sensors 405 positioned along the length of the extremity. It should be noted that the definition of a gradient consistent with the specification is a measure of the magnitude of a property observed over time or along a path.), and
determine a cardiac performance indicator based on the first and second gradients (e.g. paragraphs 0314-0315, – extremities with low oxygenation levels require amputation),
wherein the data includes relative position data, and the relative position data includes data about the position of any of the first and second pluralities of sensors relative to the patient or relative to another of the first and second pluralities of sensors (e.g. Fig. 14C; paragraphs 0314-0315).
However, the relied upon embodiment of Shuler does not explicitly teach compare the first gradient to the second gradient, and determine a cardiac performance indicator based on the comparison of the first and second gradients.
Shuler, in another embodiment, discloses comparing the first gradient to the second gradient, and determine a cardiac performance indicator based on the comparison of the first and second gradients (e.g. paragraph 0050, – comparing oxygenation values taken from sensors located on different extremities)
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shuler to include comparing first and second gradients from different limbs, as taught and suggested by another embodiment of Shuler, in order to provide a better assessment of the patient. By allowing for a comparison between measurements of two limbs one can readily ascertain an aberration in a measurement.
Regarding claim 22, modified Shuler teaches the apparatus of claim 21 as
discussed above, and modified Shuler further teaches wherein the first appendage is a first arm and the second appendage is a second arm (e.g. Fig. 13A; paragraphs 0050, 0345).
Regarding claim 23, modified Shuler teaches the apparatus of claim 21 as
discussed above, and modified Shuler further teaches wherein the first appendage is a first leg and the second appendage is a second leg (e.g. Fig. 13A; paragraphs 0050, 0345, 0377).
Regarding claim 24, modified Shuler teaches the apparatus of claim 21 as
discussed above. However, modified Shuler does not explicitly teach wherein the data is temperature data.
Shuler, in another embodiment, discloses wherein the data is temperature data (e.g. paragraphs 0153, 0325).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modified Shuler reference to incorporate temperature data, as taught and suggested by another embodiment of Shuler, because it is a simple substitution of one known physiological parameter used to assess patient health for another in order to obtain the predictable results of more accurate assessment and diagnosis of a medical condition.
Regarding claim 25, modified Shuler teaches the apparatus of claim 21 as
discussed above. Modified Schuler teaches wherein the data is oxygenation data. However, modified Shuler does not explicitly teach wherein the data is dermal oxygen saturation data.
Shuler, in another embodiment, discloses wherein the data is dermal oxygen saturation data (e.g. paragraph 0153).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modified Shuler reference to incorporate dermal oxygen saturation data, as taught and suggested by another embodiment of Shuler, because it is a simple substitution of one known physiological parameter used to assess patient health for another in order to obtain the predictable results of more accurate assessment and diagnosis of a medical condition.
Regarding claim 27, modified Shuler teaches the apparatus of claim 21 as
discussed above. However, modified Shuler does not explicitly teach wherein the data is pH data.
Shuler, in another embodiment, discloses wherein the data is pH data (e.g. paragraph 0325).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modified Shuler reference to incorporate pH data, as taught and suggested by another embodiment of Shuler, because it is a simple substitution of one known physiological parameter used to assess patient health for another in order to obtain the predictable results of more accurate assessment and diagnosis of a medical condition.
Regarding claim 28, modified Shuler teaches the apparatus of claim 21 as
discussed above, and modified Shuler further teaches wherein at least one of the first and second pluralities of sensors are arranged on a strip (e.g. paragraphs 0121, 0180).
Regarding claim 31, modified Shuler teaches the apparatus of claim 21 as
discussed above. However, modified Shuler does not explicitly teach wherein the data includes frequency data.
Shuler, in another embodiment, discloses wherein the data includes frequency data (e.g. paragraph 0041).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modified Shuler reference to include frequency data, as taught and suggested by another embodiment of Shuler, in order to obtain the predictable results of more accurate assessment and diagnosis of a medical condition by having both short-term and long-term measured data being available to the clinician.
Regarding claim 35, modified Shuler teaches the apparatus of claim 21 as
discussed above, and modified Shuler further teaches wherein the controller is configured to perform of cardiac performance heuristics based on the cardiac performance indicator (e.g. abstract, paragraphs 0211, 0322).
Regarding claim 37, modified Shuler teaches the apparatus of claim 21 as
discussed above, and modified Shuler further teaches further comprising an adhesive layer configured to facilitate positioning the first and second pluralities of sensors on skin of the patient (e.g. paragraph 0106).
Regarding claim 38, modified Shuler teaches the apparatus of claim 21 as
discussed above, and modified Shuler further teaches wherein the core location along the first appendage of a patient is closer to a torso of the patient than the extremity location along the first appendage of a patient, and wherein the core location along the second appendage of a patient is closer to a torso of the patient than the extremity location along the second appendage of a patient (e.g. Fig. 13A; paragraph 0345).
Regarding claim 39, modified Shuler teaches the apparatus of claim 21 as discussed above. However, modified Shuler does not explicitly wherein the controller is configured to plot a sensor reading of each of the first plurality of sensors against the position of each of the first plurality of sensors to determine the first gradient.
Shuler, in another embodiment, discloses wherein the controller is configured to plot a sensor reading of each of the first plurality of sensors against the position of each of the first plurality of sensors to determine the first gradient (e.g. Fig. 16; paragraphs 0194, 0332).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of the invention to have modified the modified Shuler reference to have the controller plot a sensor reading of each of the first plurality of sensors against the position of each of the first plurality of sensors to determine the first gradient and having it displayed on a user interface as doing so would provide additional information to the clinician as well as make it easier and more convenient for the clinician to make better decisions.
Regarding claim 40, modified Shuler teaches the apparatus of claim 39 as discussed above, and modified Shuler further teaches wherein the controller is configured to compare an absolute value of the first gradient to a predetermined threshold amount, and if the absolute value is below the threshold, to determine that the cardiac performance indicator corresponds to a healthy condition (e.g. paragraphs 0325, 0332-0333).
Regarding claim 41, modified Shuler teaches the apparatus of claim 39 as discussed above, and modified Shuler further teaches wherein the controller is configured to compare an absolute value of the first gradient to a threshold amount, and if the absolute value is above the threshold, to determine that the cardiac performance indicator corresponds to an unhealthy condition (e.g. paragraphs 0325, 0332-0333, 0345).
Regarding claim 42, modified Shuler teaches the apparatus of claim 39 as discussed above, and modified Shuler further teaches wherein the core location along the first appendage of a patient is closer to a torso of the patient than the extremity location along the first appendage of a patient (e.g. Fig. 13A; paragraph 0345), the controller is configured to plot the sensor reading of the first plurality of sensors against the position of the first plurality of sensors to determine the first gradient (e.g. paragraph 0194), and wherein the controller is configured to compare an absolute value of the first gradient to a threshold amount, and if the absolute value is below the threshold, to determine that the cardiac performance indicator corresponds to a healthy condition (e.g. paragraphs 0325, 0332-0333, 0345).
Regarding claim 45, Schuler teaches an apparatus for assessing cardiac performance (e.g. abstract – oxygenation levels), comprising:
a first sensor array comprising a plurality of sensors configured to be positioned along a first appendage of a patient between a core location and an extremity location (e.g. fig. 13A);
a second sensor array comprising a plurality of sensors configured to be positioned along a second appendage of the patient between a core location and an extremity location, the second appendage different from the first appendage (e.g. fig. 13A);
and a controller (e.g. Fig. 27; paragraphs 0324, 0401) configured to: receive sensor readings from the first and second sensor arrays, each sensor reading being associated with a relative position of its corresponding sensor along the respective appendage (e.g. Fig. 14C; paragraphs 0314-0315; 0401);
determine a first gradient based on the sensor readings and relative positions from the first sensor array and a second gradient based on the sensor readings and relative positions from the second sensor array (e.g. Fig. 14C; paragraph 0314 – comparing oxygenation values between the respective NIRS sensors 405 positioned along the length of the extremity).
However, the relied upon embodiment of Shuler does not explicitly teach compare the first and second gradients to detect a difference in physiological conditions between the first and second appendages; and generate a cardiac performance indicator based on the comparison.
Shuler, in another embodiment, discloses compare the first and second gradients to detect a difference in physiological conditions between the first and second appendages (e.g. paragraph 0050); and generate a cardiac performance indicator based on the comparison (e.g. paragraph 0050).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shuler to include comparing first and second gradients from different limbs and generating a cardiac performance indicator, as taught and suggested by another embodiment of Shuler, in order to provide a better assessment of the patient. By allowing for a comparison between measurements of two limbs one can readily ascertain an aberration in a measurement.
Regarding claim 46, modified Shuler teaches the apparatus of claim 45 as discussed above, and modified Shuler further teaches wherein the controller is configured to receive the sensor readings from the first and second sensor arrays simultaneously for comparison of concurrent physiological conditions between the first and second appendages (e.g. Fig. 27; paragraphs 0050; 0314).
Regarding claim 47, modified Shuler teaches the apparatus of claim 45 as discussed above, and modified Shuler further teaches wherein the controller is configured to generate an alert associated with the cardiac performance indicator (e.g. paragraph 0050).
Regarding claim 48, modified Shuler teaches the apparatus of claim 21 as discussed above. However, modified Shuler does not explicitly teach wherein the controller is configured to cause a display of the first gradient and the second gradient simultaneously.
Shuler, in another embodiment, discloses wherein the controller is configured to cause a display of the first gradient and the second gradient simultaneously (e.g. paragraph 0041).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shuler to include having the controller configured to display the first gradient and second gradient simultaneously, as taught and suggested by another embodiment of Shuler, in order to provide the predictable results of the clinician being able to assess measured data more quickly and conveniently.
8. Claim 26 is rejected under 35 U.S.C 103 as being unpatentable over modified Shuler
and further in view of Feldkamp et al. (US Pub.: 2010/0222696 A1).
Regarding claim 26, modified Shuler teaches the apparatus of claim 21 as discussed above. However, modified Shuler does not explicitly teach wherein the data is electrical conductivity data.
Feldkamp, in a same field of endeavor of vascular/tissue monitoring devices, discloses wherein the data is electrical conductivity data (e.g. paragraphs 0074, 0079).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of the invention to have modified the modified Shuler reference to include wherein the data is electrical conductivity data, as taught and suggested by Feldkamp, because it is a simple substitution of one known physiological parameter used to assess patient health for another in order to obtain the predictable results of more accurate assessment and diagnosis of a medical condition.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792