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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the transparent windows of claim 9 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 11 and 24 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. The claims recite an “intensity” with units of J/cm2, which are units of fluence, rendering the claims unclear. In the interest of compact prosecution the examiner is assuming “intensity” should be “fluence.”
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 1, 7, 10, 17 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Reign (US 2022/0193440) in view of Zipper (US 2019/0125448).
[Claims 1, 17] Reign discloses a phototherapy device, comprising:
a treatment probe (#1), comprising a cylindrical probe housing (insertion structure, #40, and pliable cover, #20), the treatment probe operable for insertion into a vaginal cavity [par. 0033];
a plurality of light emitters (outward facing LEDS, #44, and distal LEDs, #46), disposed in the probe housing, each of the light emitters configured to emit light through the probe housing toward a treatment area of the vaginal cavity [par. 0042-0043]; and
a controller (power switch, #58), communicatively coupled with the light emitters, the controller configured to control a light emission of the light emitters (the power switch turns on the LEDs) [par. 0035].
Reign does not disclose (1) inserting the treatment probe into the rectal cavity, (2) a plurality of pressure sensors, disposed in the probe housing, each of the pressure sensors configured to detect a pressure exerted by a rectal wall on the treatment probe, or (3) a user interface, communicatively coupled with the controller, the user interface operative to issue an alert responsive to a threshold pressure of the pressure detected by the pressure sensors.
Zipper discloses an analogous phototherapy probe for use in the vagina or rectum [par. 0004] comprising a plurality of pressure sensors (Fig. 12C #517). The pressure sensors sequentially sense a rise in pressure (i.e. a threshold pressure) as the probe is inserted. A controller (Fig. 13 #350) communicates with each pressure sensor to determine how many sensors have been inserted into a body cavity and controls light emission dose and timing by determining the insertion depth and total treatment surface area [pars. 0069-0070, 0073; Fig. 15]. Auditory and or visual cues may be provided by an energy source user interface (display, #510, speaker, #514) in communication with the controller to facilitate the movement of the probe [pars. 0056, 0061, 0072].
It would have been obvious to one of ordinary skill in the art before the effective filing date to use the vaginal probe of Reign in the rectal cavity as Zipper teaches probes that maybe used in both the vaginal/rectal cavities. It would further I have been obvious to one of ordinary skill in the art before the effective filing date to configure the probe of Reign to include a plurality of pressure sensors and a controller connected to a user interface as taught by Zipper in order to alert the user to an insertion depth within the cavity. The method of claim 17 would be performed by using the device rendered obvious as described above.
[Claim 7] Reign discloses the cylindrical probe housing comprises a single flexible element (flexible/pliable cover, #20) [pars. 0011, 0037].
[Claims 10, 23] Reign discloses a wavelength of the emitted light is selected from 440-600 nm (470 nm) or 600-700 nm (680 nm) [par. 0020]. Zipper discloses a wavelength selected from between 700-1400 nm [par. 0035].
Claims 2-6, 9 and 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Reign (US 2022/0193440) in view of Zipper (US 2019/0125448) as applied to claim 1 and 17 above, and further in view of Courtion et al. (US 2017/0095398).
[Claims 2, 18] Reign in view of Zipper renders obvious detecting pressure from a rectal wall but does not disclose a plurality of proximity sensors, disposed in the probe housing, each of the proximity sensors configured to detect a proximity of the treatment probe to the rectal wall.
Courtion discloses an analogous phototherapy device wherein contact of vaginal tissue with the device or presence of vaginal tissue within a threshold distance with the device can also be detected using optical sensors, capacitive sensors (detecting capacitive proximity), as well as any other suitable proximity sensor [par. 0097].
It would have been obvious to one of ordinary skill in the art before the effective filing date to configure the probe rendered obvious by Reign in view of Zipper to include proximity sensors in addition to contact/pressure sensors as taught by Courtion in order to alert the user that the probe is near rectal tissue.
[Claim 3] The applied references render obvious proximity sensors at a distal end of the probe housing (insertion structure) but do not disclose the proximity sensors are circumferentially disposed. However, because the LED light sources of Reign are circumferentially disposed about the distal end of the probe and the proximity sensors are used to inform control of the LEDS, it would have been obvious to one of ordinary skill in the art before the effective filing date to include proximity sensors circumferentially around the distal end of the probe to detect the proximity of the various LEDs to rectal tissue.
[Claims 4, 19] Reign in view of Zipper renders obvious the user interface operative to issue an alert and Courtion discloses issuing an alert (notification) responsive to a threshold proximity of the proximity detected by the proximity sensors [par. 0097]. It would have been obvious to one of ordinary skill in the art before the effective filing date to configure the user interface to provide an alert related to the proximity of the probe to rectal tissue in order to properly control phototherapy.
[Claims 5-6, 20-21] As explained in the rejection of claim 1 above, Zipper discloses the controller (Fig. 13 #350) communicates with each pressure sensor to determine how many sensors have been inserted into a body cavity and controls light emission dose and timing by determining the insertion depth and total treatment surface area [pars. 0069-0070, 0073; Fig. 15]. Zipper further discloses using a phototherapeutic protocol (predefined total dose value), determining a total laser ON time T for a pre-determined energy/unit area (J/area), where T=(TSA*J/area)/P, step 1205; using T and L, calculate the timing between metronome beats from a metronome signal selected from the group consisting of an audio signal, a video signal or a haptic signal for signaling when to transition from IN to OUT probe translation and vice versa, step 1206; inserting probe into a body cavity which may be a vagina or a rectum of a patient [par. 0073]. It would have been obvious to one of ordinary skill in the art before the effective filing date to configure the probe to control light emission characteristics of the emitted light in accordance with phototherapeutic protocol determined based on a proximity detected by the proximity sensors and based on a treatment plan of a phototherapeutic treatment in order to provide the proper treatment based on insertion depth and tissue proximity.
[Claims 9, 22] Reign discloses the light emitters emit radially through the transparent cover but does not disclose the light emitters are configured to radially emit light through circumferentially arranged transparent windows of the treatment probe.
Courtion discloses a plurality of circumferentially arranged LED emitters (Fig. 8C #848A-D) that may emit through windows (transparent convex lenses, Fig. 8C #842A-D) that focus light emitted from the LED emitters into targeted tissue [par. 0070].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the circumferentially arranged LEDs of Reign to include windows (transparent convex lenses) as taught by Courtion in order to focus light emitted onto the target tissue.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Reign (US 2022/0193440) in view of Zipper (US 2019/0125448) as applied to claim 1 above, and further in view of Schwarz et al. (US 2022/0305275).
[Claim 8] Reign in view of Zipper renders obvious the cylindrical probe housing but does not disclose the cylindrical probe housing comprises a plurality of flexibly linked housing segments.
Schwarz discloses an analogous phototherapy probe to treat body cavities including the vagina and anus [par. 0136] comprising a pad including a flexible substrate (Fig. 5A #500) which may comprise a central part (Fig. 5A #501) and one or more segments (Fig. 5A #502), which may move at least partially independently from each other. The number of segments may be in the range of 1 to 100. The segments of the pad may be more flexible and may provide a greater amount of contact with the patient than conventional pads routinely used [pars. 0188-0190].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the flexible/pliable cover taught by Reign with one comprising a plurality of segments as taught by Schwarz in order to provide greater flexibility and tissue contact within the rectal cavity.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Reign (US 2022/0193440) in view of Zipper (US 2019/0125448) as applied to claims 1 and 7 above, and further in view of Abu Dayyeh (US 2023/0027861).
[Claims 11, 24] Reign in view of Zipper does not disclose a fluence of the emitted light is selected from the group consisting of: 0.1-3.0 J/cm2; 3.1-9.0 J/cm2; and 9.1-12.0 J/cm2.
Abu Dayyeh discloses an analogous phototherapy probe comprising an energy density in the range of 1 J/cm2 to 80 J/cm2 [par. 0034] for treating the rectum [par. 0044].
It would have been obvious to one of ordinary skill in the art before the effective filing date to select a fluence/energy density of 1-12 J/cm2 as taught by Abu Dayyeh because it is within the disclosed range for treating the rectum.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
(1) Pryor et al. (US 2011/0224584) discloses an analogous phototherapy probe for use in the vagina that may also be used in rectal cavities [par. 0018]. The probe includes a pressure sensor to control the on/off status of a light source [par. 0015; claim 8].
(2) Klang (US 10,004,918) discloses a pressure activated switch 104 located on an outer surface of a phototherapy probe configured to control activation of the one or more light sources based at least in part on pressure sensing intravaginal walls of a vagina within which the device is introduced.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN J JENNESS whose telephone number is (571)270-5055. The examiner can normally be reached M-F 8:00-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jonathan Moffat can be reached at 571-272-4390. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN J JENNESS/Supervisory Patent Examiner, Art Unit 3733 17 August 2026
