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 .
Response to Arguments
Applicant's arguments filed 01/21/2026 have been fully considered but they are not persuasive.
Regarding the amendments that the temporal frequencies are between 1 and 2 Hz, newly-found reference of Zhao has been introduced. Examiner asserts that all over amendments continue to be taught by Godavarty.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 6, 8-16 are rejected under 35 U.S.C. 103 as being unpatentable over Godavarty (US 2020/0352515) in view of Hielscher (US 2013/0289394) and Zhao (US 2023/0160806).
Regarding claims 1, 8-9, & 12-13, Godavarty teaches a method for performing non-contact, peripheral vascular imaging on a subject, the method comprising:
providing a near-infrared (NIR) optical imager (near-infrared optical scanner, [0050]) comprising at least one NIR light (plurality of LEDs 154, [0065]), a filter (NIR filter 142, [0059]) configured to optically filter ambient light and allow only NIR light to pass ([0063]), and an NIR-sensitive image sensor (NIR sensitive camera, [0010]) configured to detect NIR signals reflected from tissue of the subject (diffuse reflected signal, [0079]);
applying a vascular occlusion protocol to the subject ([0088]);
utilizing the NIR optical imager to scan tissue of the subject in a non-contact manner ([0052]) both before the vascular occlusion protocol is applied (rest, [0088]) and while the vascular occlusion protocol is applied (occlusion, [0088]);
acquiring spatio-temporal diffuse reflected maps based on the reflected NIR signals detected by the NIR-sensitive image sensor ([0070]);
Paragraph [0070] teaches that the diffuse reflected maps comprise “a continuous stream of time stamp (i.e., dynamic) images”. Because these maps comprise images taken over time, they satisfy the limitation of spatio-temporal diffuse reflected maps.
generating dynamic maps (hemoglobin concentration maps (in terms of oxy-hemoglobin, deoxy-hemoglobin, total hemoglobin, oxygen saturation), [0070]) based on the spatio-temporal diffuse reflected maps ([0070]), the dynamic maps comprising at least one hemoglobin parameter, the at least one hemoglobin parameter comprising at least one of a total hemoglobin (HbT) map, an oxy-hemoglobin (HbO) map, a deoxy-hemoglobin (HbR) map, and an oxygen saturation (StO2) map ([0070]) for a region of interest (ROI) of the tissue of the subject (region of interest, [0049]);
displaying, via a graphical user interface (GUI) ([0051] & [0083], Figure 16(b)) stored on a machine-readable medium (smartphone, [0051]) in operable communication with the NIR optical imager ([0050]), the dynamic maps ([0051] & [0083], Figure 16(b));
Paragraphs [0051] & [0083] teach providing a visual output of the images on the smartphone. This is also illustrated in Figure 16(b).
analyzing the dynamic maps ([0073]);
the at least one NIR light of the NIR optical imager being a multi-wavelength light (multi-wavelength LED, [0065]) configured to emit light at multiple wavelengths including a first wavelength and a second wavelength different from the first wavelength ([0065]);
each of the first wavelength and the second wavelength being in a range of from 650 nanometers (nm) to 950 nm ([0065]);
the at least one NIR light of the NIR optical imager being a light-emitting diode (LED) (plurality of LEDs 154, [0065]);
the NIR optical imager further comprising an LED driver (LED driver, [0070]) configured to multiplex light from the at least one NIR light ([0068]);
the method further comprising multiplexing the first wavelength and the second wavelength at a first temporal frequency and a second temporal frequency, respectively (multiplexing frequency, [0080]);
the filter being a long-pass filter or a band-pass filter ([0059]); and
the first temporal frequency being the same as both the second temporal frequency and the third temporal frequency ([0080]).
However, Godavarty fails to disclose: generating flow correlation maps from the dynamic maps; determining the likelihood that the subject has vascular calcification (VC) based on the flow correlation maps; the flow correlation maps being generated by spatially correlating the at least one hemoglobin parameter in a peripheral vascular region of the subject; the flow correlation maps being a determinant of a synchrony or asynchrony in a flow of blood in the subject in response to the vascular occlusion protocol; and the flow correlation maps being generated based on spatio-temporal diffusely reflected NIR signals obtained at a plurality of different wavelengths including the first wavelength and the second wavelength.
Hielscher teaches:
generating flow correlation maps from the dynamic maps ([0076]-[0077]);
Per [0076]-[0077], the spatial maps are obtained in response to the application and release of a pressure cuff. The changes in hemoglobin concentrations are the result of the changes in blood flow.
determining the likelihood that the subject has vascular calcification (VC) based on the flow correlation maps ([0080]);
the flow correlation maps being generated by spatially correlating the at least one hemoglobin parameter in a peripheral vascular region of the subject ([0077]);
the flow correlation maps being a determinant of a synchrony or asynchrony in a flow of blood in the subject in response to the vascular occlusion protocol ([0076]-[0077]); and
the flow correlation maps being generated based on spatio-temporal diffusely reflected NIR signals ([0086]) obtained at a plurality of different wavelengths including the first wavelength and the second wavelength ([0086]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method taught by Godavarty to include: generating flow correlation maps from the dynamic maps; determining the likelihood that the subject has vascular calcification (VC) based on the flow correlation maps; the flow correlation maps being generated by spatially correlating the at least one hemoglobin parameter in a peripheral vascular region of the subject; the flow correlation maps being a determinant of a synchrony or asynchrony in a flow of blood in the subject in response to the vascular occlusion protocol; and the flow correlation maps being generated based on spatio-temporal diffusely reflected NIR signals obtained at a plurality of different wavelengths including the first wavelength and the second wavelength, as taught by Hielscher. Because the presence of calcifications in blood vessels is expected to alter blood flow, generating flow correlation maps from the dynamic maps can be useful in diagnosing a medical condition. Additionally, because different wavelengths of light interact differently with tissue, using multiple wavelengths can increase the diagnostic capabilities of the system.
However, Godavarty in view of Hielscher fail to disclose each of the first temporal frequency and the second temporal frequency being in a range of from 1 Hertz (Hz) to 2 Hz.
Zhao teaches each of the first temporal frequency and the second temporal frequency (modulation/pulse frequency, [0079]) being in a range of from 1 Hertz (Hz) to 2 Hz ([0076] & [0079]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method of Godavarty and Hielscher such that each of the first temporal frequency and the second temporal frequency being in a range of from 1 Hertz (Hz) to 2 Hz, as taught by Zhao. No criticality of this frequency range has been provided in the instant specification. It is expected that a system that multiplexes light at .5 Hz, as is taught by Godavarty, will continue to function properly if the multiplexing frequency is between 1 and 2 Hz.
Regarding claim 3, Godavarty in view of Hielscher and Zhao teach the method of claim 1, and Godavarty further teaches the subject being a human subject ([0051] & [0055]).
Paragraph [0051] teaches that the invention takes the form of a smartphone app; [0055] teaches that the app can be used for self-testing. It is expected that a human is the user of the smartphone.
Regarding claim 6, Godavarty in view of Hielscher and Zhao teach the method according to claim 1, and Godavarty further teaches the multi-wavelength light being a dual-wavelength light configured to emit light at the first wavelength and the second wavelength different from the first wavelength ([0065]).
Regarding claim 10, Godavarty in view of Hielscher and Zhao teach the method according to claim 1, and Godavarty further teaches the multi-wavelength light being configured to emit light at the first wavelength, the second wavelength and third wavelength different from the first wavelength and the second wavelength ([0065]), and the third wavelength being in a range of from 650 nm to 950 nm ([0065]).
Regarding claim 11, Godavarty in view of Hielscher and Zhao teach the method according to claim 10, and Godavarty further teaches the method further comprising multiplexing the third wavelength at a third temporal frequency (multiplexing frequency, [0080]).
Regarding claim 14, Godavarty in view of Hielscher and Zhao teach the method according to claim 1.
However, Godavarty fails to disclose determining the likelihood that the subject has VC based on an extent of change in the at least one hemoglobin parameter, or its related derivative, from the dynamic maps.
Hielscher teaches determining the likelihood that the subject has VC based on an extent of change in the at least one hemoglobin parameter (total hemoglobin concentration, [0077]), or its related derivative, from the dynamic maps ([0077] & [0080]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method taught by Godavarty to include determining the likelihood that the subject has VC based on an extent of change in the at least one hemoglobin parameter, or its related derivative, from the dynamic maps, as taught by Hielscher. This provides functionality to the step of acquiring the dynamic maps, as they can be used to diagnose a medical condition.
Regarding claim 15, Godavarty in view of Hielscher and Zhao teach the method according to claim 1.
However, Godavarty fails to disclose: analyzing the spatio-temporal diffuse reflected maps; and determining the likelihood that the subject has VC based on the spatio-temporal diffuse reflected maps.
Hielscher teaches:
analyzing the spatio-temporal diffuse reflected maps ([0077]); and
determining the likelihood that the subject has VC based on the spatio-temporal diffuse reflected maps ([0080]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method taught by Godavarty to include: analyzing the spatio-temporal diffuse reflected maps; and determining the likelihood that the subject has VC based on the spatio-temporal diffuse reflected maps, as taught by Hielscher. This provides functionality to the step of acquiring the spatio-temporal diffuse reflected maps, as they can be used to diagnose a medical condition.
Regarding claim 16, Godavarty in view of Hielscher and Zhao teach the method according to claim 1, further comprising:
measuring a hemoglobin parameter in real-time ([0055] & [0070]).
However, Godavarty fails to disclose determining the likelihood that the subject has VC based on the rate of occlusion or a rate of occlusion determined from the at least one hemoglobin parameter, or its related derivative, measured from the dynamic maps.
Hielscher teaches determining the likelihood that the subject has VC based on a rate of occlusion determined from the at least one hemoglobin parameter, or its related derivative, measured from the dynamic maps ([0077] & [0080]).
Paragraph [0076] teaches that measurements are obtained both at rest and while the patient’s leg is occluded with a pressure cuff; [0077] teaches that the changes of hemoglobin concentration can be measured at these time points.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method taught by Godavarty to include determining the likelihood that the subject has VC based on a rate of occlusion determined from the at least one hemoglobin parameter, or its related derivative, measured from the dynamic maps, as taught by Hielscher. This provides functionality to the step of acquiring the dynamic maps, as they can be used to diagnose a medical condition.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Godavarty in view of Hielscher and Zhao, as applied to claim 1, above, in further view of Godavarty (US 2015/0190061), hereinafter Godavarty ‘061.
Regarding claim 18, Godavarty in view of Hielscher and Zhao teach the method according to claim 1.
However, Godavarty in view of Hielscher and Zhao fail to disclose that the vascular occlusion protocol comprises providing an external stimulus configured to alter peripheral tissue oxygenated flow under skin of the subject.
Godavarty ‘061 teaches that the vascular occlusion protocol comprises providing an external stimulus (blood pressure cuff, [0105]) configured to alter peripheral tissue oxygenated flow under skin of the subject ([0105]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method taught by Godavarty, Hielscher, and Zhao such that the vascular occlusion protocol comprises providing an external stimulus configured to alter peripheral tissue oxygenated flow under skin of the subject, as taught by Godavarty ‘061. Per [0105] of Godavarty ‘061, the occlusion and subsequent release of a vein allow changes in hemoglobin concentration to be analyzed.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Godavarty in view of Hielscher and Zhao, as applied to claim 1, above, in further view of Bechtel (US 2017/0303861).
Regarding claim 19, Godavarty in view of Hielscher and Zhao teach the method according to claim 1.
However, Godavarty in view of Hielscher and Zhao fail to disclose that changes in the at least one hemoglobin parameter of the dynamic maps are independent of a color of skin of the subject.
Bechtel teaches that changes in the at least one hemoglobin parameter (oxygen saturation, [0071]) of the dynamic maps are independent of a color of skin of the subject ([0071]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method taught by Godavarty, Hielscher, and Zhao such that changes in the at least one hemoglobin parameter of the dynamic maps are independent of a color of skin of the subject, as taught by Bechtel. This produces a more equitable health system, as the efficiency of the procedure does not change depending on the patient’s skin color.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Godavarty in view of Hielscher, Zhao, Godavarty ‘061, and Bechtel.
Claim 20 is rejected for similar reasons to claims 1, 3, 6, 8-16, & 18-19.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM KOLKIN whose telephone number is (571)272-5480. The examiner can normally be reached Monday-Friday 1:00PM-10:00PM EDT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached on (572)-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
Prosecution Insights