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 and amendments, see pages 9-10, filed 7/27/2026, with respect to the rejection(s) of claim(s) 1-2, 7-8, 11, 14, 20, 22, 24, 26, 28, 33-34, 38, 40, 44, 47-48, and 50-51 under USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Barnea (US 6162188 A) in view of Doyle (US 10213550 B2).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 50-51 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 50-51, the specification shows mainly a two-photodiode arrangement but does not show support for an arrangement with four photodiodes positioned as claimed.
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.
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.
Claim(s) 1, 7-8, 11, 20, 22, 26, 28, 33-34, 40, 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barnea (US 6162188 A) in view of Doyle (US 10213550 B2).
Regarding claim 1 and 33, Barnea discloses an optical penile structure function monitoring system comprising: a measuring probe configured to be secured via an attachment mechanism to a penis of a patient during and over tumescence and flaccid penile events (Eg. Col. 4, Ln. 55 – Col. 5, Ln. 30, Col. 9 ,Ln. 25-55, Fig 1 and 6), and a control system comprising: a first detector that detects penile blood flow based on signals received from the measuring probe; and a second detector that detects tumescence and flaccid penile events based on signals received from the first detector (eg. Fig. 6, Col. 3, Ln. 45 – Col. 4, Ln. 25, Col. 9, Ln. 15-67). but does not disclose the measuring probe comprising: an optical source comprising at least one LED capable of producing red wavelength light and near infrared wavelength light; a first photodiode; and a second photodiode, wherein the first photodiode is placed closer to the optical source for detecting red and near infrared light from the optical source that probes a shallower region and the second photodiode is placed further from the optical source for detecting red and near infrared light from the optical source that probes a deeper region;
Doyle teraches a light source including a red light emitting light source and an IR light emitting light source (Eg. Fig 1, Col. 6, Ln. 25-50) with a first photodiode closer to the optical source and a second sensor located farther from the source (eg. Col. 5, Ln. 30 – Col. 6, Ln. 15, Fig. 1 and 4, red and IR with one farther from the other).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Barnea with the red and infrared wavelengths and near-far sensor arrangement as taught by Doyle since both are in the realm of using light sensors and it is known in the art that the depth of penetration desired and signal strength depend on distance between the light emitter and receiver (eg. Barnea, Col. 9, Ln. 54-67) and red and IR are commonly known for blood oxygenation (eg. Doyle, Col. 5, Ln. 5-15) commonly used in PPG.
Regarding claim 7, the combined invention of Barnea and Doyle discloses wherein the control system includes a control unit separate from the measuring probe, optionally wherein communication between the control unit and the measuring probe comprises flexible shielded cables or a wireless connection (eg. Doyle, Col. 12, Ln. 14-27, Col. 19 Ln. 50 – Col 20, Ln. 35).
Regarding claims 8 and 40, the combined invention of Barnea and Doyle discloses the attachment mechanism is configured to adapt to different penile sizes using the same hardware, optionally wherein the attachment mechanism comprises a penile clip and/or double-sided tape (eg. Col. 9, Ln. 54-67).
Regarding claims 11 and 44, the combined invention of Barnea and Doyle discloses the control system includes a control unit separate from the measuring probe, optionally wherein communication between the control unit and the measuring probe comprises flexible shielded cables or a wireless connection (eg. Barnea Col. 9 , Ln. 15-53 and Doyle, Col. 14, Ln. 24-30).
Regarding claim 20, the combined invention of Barnea and Doyle discloses the red and near infrared wavelengths are used respectively as the probing light for oxyhemoglobins and deoxyhemoglobins that have opposite relative optical absorbance between the two wavelengths (eg. Barnea, Col. 9, Ln. 54-67, pulse oximeters inherently probe for oxyhemoglobins and dioxyhemoglobins).
Regarding claim 22, the combined invention of Barnea and Doyle discloses measurements alternate between the red and near infrared wavelengths, optionally wherein the measurements alternate at a fixed rate (eg. Doyle, Col. 7, Ln. 60 – Col. 9, Ln. 47).
Regarding claim 26, the combined invention of Barnea and Doyle discloses east one of: the at least one LED comprises at least one red wavelength LED and at least one near infrared wavelength LED; the measuring probe comprises at least one optically non-reflecting mask configured to prevent undesired optical cross-interference between the at least one LED and the first and second photodiodes and further configured to ensure that probing light from the at least one LED does not have a path for reaching the first and second photodiodes without going through the probed tissue first; or the measuring probe optical source is configured or controllable to alternate between producing red wavelength light and producing near infrared wavelength light (eg. Doyle, Col. 7, Col. 7, Ln. 60 – Col. 8, Ln. 15, switches for components).
Regarding claim 28, the combined invention of Barnea and Doyle discloses at least one photodiode comprises at least one red wavelength photodiode and at least one near infrared photodiode (eg. Doyle, Col. 6, Ln. 25-50, LEDs).
Regarding claim 34, the combined invention of Barnea and Doyle discloses at least one red wavelength LED and at least one near infrared wavelength LED, optionally wherein the optical source is configured or controllable to alternate between producing red wavelength light and producing near infrared wavelength light (eg. Doyle, Col. 6, Ln. 25-50.
Claim(s) 2 and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barnea (US 6162188 A) in view of Doyle (US 10213550 B2), further in view of McKenna (US 2013/0317330 A1).
Regarding claims 2 and 38, the combined invention of Barnea and Doyle discloses the invention of claim 1, but does not disclose the measuring probe comprises a compressible optically non-reflective mask to separate at least two optical components selected from the at least one LED, the first photodiode, and the second photodiode.
McKenna teaches a compressible light barrier configured to block undesired light from reaching the detector (Eg. Para. 23-31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Barnea and Doyle with the compressible barrier as taught by McKenna to provide the predictable result of reducing variability in pulse oximetry measurements due to shunted and ambient light (eg. McKenna, Para. 21).
Claim(s) 14 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barnea (US 6162188 A) in view of Doyle (US 10213550 B2), further in view of Jeong (US 2019/0254545 A1).
Regarding claim 14, the combined invention of Barnea and Doyle discloses the invention of claim 1, but does not disclose normal ranges of variability, thresholds, and types of significant data changes as a function of surgical maneuver or other physiological parameters are established and stored, optionally wherein at least one of (a) the normal ranges of variability, thresholds, and types of significant data changes are established using machine learning, or (b) the in-time warnings are generated using machine learning.
Jeong teaches normal ranges of variability, thresholds, and types of significant data changes as a function of surgical maneuver or other physiological parameters are established and stored (eg. Para. 41, 50-53, 61-62, 82).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Barnea and Doyle with the setting and monitoring of thresholds as taught by Jeong to providing the predictable result of not damaging tissue where not desired (eg. Jeong, Para. 51, the machine learning limitations in the claims were written as optional).
Regarding claim 24, the combined invention of Barnea, Doyle, and Jeong discloses to monitor the intensity and speed of the change in penile blood flow to develop pathological patterns and identify nerve irritation and vascular irritation in real-time when combined with signals from the EMG monitor, optionally wherein the control system is further configured to develop pathological patterns and identify nerve irritation and vascular irritation in real- time using machine learning (eg. Jeong, Para. 34 58, CC-EMG signals with excitation signals 830 from electrode 212).
Claim(s) 47-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barnea (US 6162188 A) in view of Doyle (US 10213550 B2), further in view of Ganguly (US 11285321 B2).
Regarding claim 47, the combined invention of Barnea and Doyle discloses the invention of claim 1, but does not disclose monitoring penile blood flow of the patient using signals from the measuring probe; determining a normal range of penile blood flow for the patient; initiating nerve stimulation to elicit tumescence; applying a machine learning-trained algorithm to identify and classify penile blood flow in response to the nerve stimulation; and initiating intervention when the penile blood flow in response to the nerve stimulation is outside of the normal range of penile blood flow for the patient.
Ganguly teaches a peripheral nerve stimulation for enhancing conditions like erectile dysfunction via stimulation (eg. Col. 15, Ln. 1-15, Col. 16, Ln. 65 – Col. 17, Ln. 20, Col. 25, Ln. 40 – Col. 26 Ln. 1-12) with machine learning (Col. 20, Ln. 35-46, Col. 25 Ln. 40 – Col. 26 Ln. 1-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Barnea and Doyle with the stimulation and machine learning as taught by Ganguly to provide the predictable result of having an additional treatment step to improve sexual dysfunction and to improve accuracy and personalization of diagnoses.
Regarding claim 48, the combined invention of Barnea, Doyle, and Ganguly discloses monitoring penile blood flow of the patient comprises monitoring blood data; or initiating nerve stimulation uses a stimulating electrode (eg. Ganguly, Col. 15, Ln. 1-15, Col. 16, Ln. 65 – Col. 17, Ln. 20, Col. 25, Ln. 40 – Col. 26 Ln. 1-12).
Claim(s) 50-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barnea (US 6162188 A) in view of Doyle (US 10213550 B2), further in view of Bechtel (US 2017/0303834 A1).
Regarding claim 50, the combined invention of Barnea and Doyle discloses the invention of claim 1, but does not disclose a third photodiode placed further from the optical source than the second photodiode; and a fourth photodiode placed further from the optical source than the third photodiode.
Bechtel teaches an oximetry probe with selectable tissue analysis using 4 detectors placed at increasing lengths from the source (eg. Fig. 2 and 8, Para. 66-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Barnea and Doyle to have 4 detectors since both are related to oximetry monitoring with photodiodes and would it is well-known in the art that detectors at increasing distances detect light reflected at lower depts of tissue (eg. Bechtel, Para. 66-67).
Regarding claim 51, combined invention of Barnea, Doyle, and Bechtel discloses a third photodiode placed further from the optical source than the second photodiode; anda fourth photodiode placed further from the optical source than the third photodiode (eg. Bechtel, Para. 66-67).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MICHAEL J LAU whose telephone number is (571)272-2317. The examiner can normally be reached 8-5:30 PM.
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/MICHAEL J LAU/Examiner, Art Unit 3796
