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 .
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.
Claims 2, 7, and 14 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.
Regarding claim 2, 7, the language is unclear if the claims require only one of the measuring probe has a synchronization mechanism to allow the sharing of optical components; or at least one of the measuring probe or the control system is configured to provide visual guidance to configure the system according to the surgery type since the claims also read the control system is configured to process the electrical signals from the measuring probe and to record continuous raw data and penile function data. It is unclear which of the limitations are optional or not. Further clarification is required. For example, amend it to say “the control system is further configured to…”. The same applies to the other claims with this language.
Regarding claim 14, there is no antecedent basis for normal ranges, thresholds, and types of significant data changes.
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, 8, 11, 26, 33, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hotaling (US 2014/0171767 A1).
Regarding claim 1, Hotaling discloses an optical penile structure function monitoring system (eg. Fig. 1A and 3A, Para. 53-54 and 76) 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. diagnostic sensors 6 on adjustable ring 11 secured around shaft, Fig. 1B, Para. 18 and 66); and a control system comprising: a first detector that detects penile blood flow based on signals received from the measuring probe (eg. microntroller 17 with diagnostic sensor 6 with pulse oximeter 16, Para. 76); and a second detector that detects tumescence and flaccid penile events based on signals received from the first detector (Eg. Application 30, Fig 1B, Para. 78-80).
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 embodiments of Hotaling to have all the sensors and microprocessors to improve the detection of multiple biological and mechanical properties in multiple contexts (eg. Para. 18-21).
Regarding claims 8 and 40, Hotaling 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. Fig. 1B, Para. 60 and 67 device 5 secured by clip).
Regarding claim 11, Hotaling discloses he 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.
Regarding claims 26 and 33, Hotaling discloses the measuring probe comprises at least one LED capable of producing red wavelength light and near infrared wavelength light and further comprises at least one photodiode capable of measuring red wavelength light and near infrared wavelength light, optionally wherein at least 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 at least one photodiode and further configured to ensure that probing light from the at least one LED does not have a path for reaching the at least one photodiode without going through the probed tissue first; or the measuring probe is configured or controllable to alternate between producing red wavelength light and producing near infrared wavelength light. (eg. Para. 78, photo transistor can switch between electrodes).
Claim(s) 2, 20, 22, 34, 38, 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hotaling (US 2014/0171767 A1) in view of McCombie (US 2020/0008724 A1).
Regarding claims 2, 38, and 44, Hotaling discloses measuring probe comprises at least one optode assembly of optical components to measure penile blood flow hemodynamics; the measuring probe and control system are configured to measure optical absorbance signals with at least one wavelength and optionally with at least two wavelengths (eg. Para. 76, Fig. 6A pulse oximeter diodes 16a-b), the measuring probe is configured to convert optical signals to electrical signals, and wherein the control system is configured to process the electrical signals from the measuring probe and to record continuous raw data and penile function data (eg. Para. 76, 80-81); but does not disclose the measuring probe comprises a compressible optically non-reflective mask to separate at least two optical components; the measuring probe has a synchronization mechanism to allow the sharing of optical components; or at least one of the measuring probe or the control system is configured to provide visual guidance to configure the system according to the surgery type.
McCombie teaches a measuring probe using photodetectors with using different LEDs (eg. pulse oximeter 16 with infrared and red LEDs, Para. 41 and 76) with a compressible non-reflective mask to separate the optical components (eg. Fig. 2, Para. 43-44 silicone elastomer housing 110) and a synchronization mechanism to allow for sharing of optical components to drive the LEDs according to a timing diagram (eg. Para. 48).
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 Hotaling with the mask and synchronization of different LEDs as taught by McCombie to improve sensor performance by filtering undesired light frequencies and reducing bulk of the device through software controlled sharing of resources.
Regarding claim 20, the combined invention of Hotaling and McCombie discloses the at least two wavelengths include red and near infrared wavelengths, optionally wherein 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. McCombie Para. 76, pulse oximeters inherently detect oxyhemoglobins and deoxyhemoglobins).
Regarding claims 22 and 34, the combined invention of Hotaling and McCombie discloses measurements alternate between the red and near infrared wavelengths, optionally wherein the measurements alternate at a fixed rate (eg. McCombie Para. 51).
Claim(s) 7, 14, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hotaling (US 2014/0171767 A1) in view of Jeong (US 2019/0254545 A1)
Regarding claim 7, Hotaling discloses the invention of claim 1, but does not disclose the control system is configured to provide in-time warnings to surgeons operating on a patient who might have their penile function at risk based on the signals received from the measuring probe a optionally wherein at least one of: the in-time warnings include at least one of a visually warning or an audible warning; or the control system includes a memory to record any warnings and their associated measurements.
Jeong teaches a surgical control system that provides intime warnings to surgeons operating on a patient who might have their penile function at risk based on the signals received from the measuring probe (Eg. Para. 34 and 41, device 210 with electrode 210) with a visual warning or audible warning (eg. Para. 41, Fig. 3, display 308).
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 Hotaling with the display of Jeong to provide the predictable result of ensuring safety and preservation of penile function post-surgery.
Regarding claim 14, the combined invention of Hotaling and Jeong discloses the system of claim 7, wherein 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, thresholds, and types of significant data changes are established using machine learning, or (b) the in-time warnings are generated using machine learning (Eg. Jeong, Para. 83-85).
Regarding claim 24, the combined invention of Hotaling and Jeong discloses comprising an EMG monitor that measures muscle response or electrical activity in response to stimulation of a nerve of the patient, wherein the control system is configured 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. Hotaling, Para. 79, 83, 85 and Jeong, Para. 34 58, CC-EMG signals with excitation signals 830 from electrode 212).
Claim(s) 28, 35, and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hotaling (US 2014/0171767 A1) in view of Rovatti (US 2021/0015990 A1), further in view of Wu (US 10568525 B1).
Regarding claims 28, 35, and 37, Hotaling discloses the invention of claim 1, but does not disclose at least one photodiode comprises at least one red wavelength photodiode and at least one near infrared photodiode; the at least one photodiode comprises a single photodiode used to detect both the red wavelength light and the near infrared wavelength light; or the at least one photodiode comprises at least a first photodiode placed closer to the red and near infrared LEDs for detecting light that probes a shallower region and a second photodiode placed further from the red and near infrared LEDs for detecting light that probes a deeper region.
Rovatti teaches at least one photodiode with a red wavelength photodiode and one near infrared photodiode (eg. detector 57 including corresponding photodiode receivers PD1-PD4 for receiving the signal emitted by source LEDs, Fig. 3A, Para. 219-222).
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 Hotaling with the LED diode as taught by Rovatti to provide the predictable result of collecting light more effectively.
Wu teaches using emitters with different spacings to optimize for deeper/shallower light paths (eg. Col. 12, Ln. 55 – Col. 14, Ln. 37).
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 Hotaling and Rovatti with the spacing as taught by Wu to optimize for signal strength under various user skin conditions (eg. Wu, Col. 12, Ln. 55 – Col. 14, Ln. 37).
Claim(s) 47-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hotaling (US 2014/0171767 A1) in view of Ganguly (US 11285321 B2).
Regarding claim 47, Hotaling discloses a method for monitoring a patient, the method comprising: monitoring penile blood flow of the patient patient (eg. diagnostic sensors 6 on adjustable ring 11 secured around shaft, Fig. 1B, Para. 18 and 66); determining a normal range of penile blood flow for the; initiating nerve stimulation to elicit tumescence (eg. Hotaling, Para/ 19, 23, 24, 30); but does not disclose 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 Hotaling 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 Hotaling and Ganguly discloses monitoring penile blood flow of the patient comprises monitoring blood data (Eg. Hoaling, Application 30, Fig 1B, Para. 78-80; 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).
Conclusion
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/MICHAEL J LAU/ Examiner, Art Unit 3796