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 Amendment
This office action is in response to the communications filed on 06/12/2025, concerning Application No. 19/138,132. The preliminary amendments to the specification and the claims filed on 06/12/2025 are acknowledged. Presently, claims 1-15 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 06/12/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “41” and “ϕ” in Fig. 1; “101” in Fig. 5; and “A. Surgery Light”, “B. Modulated Light”, “(c) Niche Manipulator”, and “(2) Raw Image” in Fig. 6. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1-14 are objected to because of the following informalities:
In each of the claims 1-14, each of the claimed reference characters respectively placed in parentheses should be deleted;
Claim 1, line 2, the limitation “the device” should be changed to “the uterine transillumination device”;
Claim 1, lines 5-6, the limitation “having at least a tip portion (10) for being introduced in the cervix and the uterus cavity” should be changed to “having at least a tip portion configured for being introduced in a cervix and an uterus cavity of the uterus”;
Claim 1, line 12, the limitation “toward the opposite direction of the first radial direction” should be changed to “toward an opposite direction of the first radial direction”;
Claims 2-10, line 1 of each claim, each limitation “The device (1) according to claim” should be changed to “The uterine transillumination device according to claim”;
Claim 3, lines 7-8, the limitation “particularly wherein the angle range extends from -70° to 70°, more particularly the angle range extends” should be changed to “particularly wherein the azimuthal angle range extends from -70° to 70°, more particularly the azimuthal angle range extends”;
Claim 4, lines 3-6, the limitation “wherein the light sources (L1, L2, L3, L4) are arranged on the first side (10-1) of the tip portion (10) along the longitudinal axis (z), particularly wherein the light sources (L1, L2, L3, L4) are arranged in a row along the longitudinal direction (z)” should be changed to “wherein the plurality of light sources are arranged on the first side of the tip portion along the longitudinal axis, particularly wherein the plurality of light sources are arranged in a row along the longitudinal axis”;
Claim 5, line 3, the limitation “the wavelength range 590 nm to 1000 nm” should be changed to “a wavelength range of 590 nm to 1000 nm”;
Claim 6, lines 5-6, the limitation “brought in occluding contact to the external orifice of the cervix, particularly wherein the contact is a sealing contact” should be changed to “brought in occluding contact to an external orifice of the cervix, particularly wherein the occluding contact is a sealing contact”;
Claim 8, line 2, the limitation “the device” should be changed to “the uterine transillumination device”;
Claim 8, line 4, the limitation “the device” should be changed to “the uterine transillumination device”;
Claim 8, line 6, the limitation “the device” should be changed to “the uterine transillumination device”;
Claim 8, line 7, the limitation “said first fixing device” should be changed to “said first releasable fixing device”;
Claim 8, line 9, the limitation “the first fixing device” should be changed to “the first releasable fixing device”;
Claim 9, line 2, the limitation “the device” should be changed to “the uterine transillumination device”;
Claim 10, line 2, the limitation “configured to modulate the illumination intensity” should be changed to “configured to modulate an illumination intensity”;
Claim 11, lines 4-7, the limitation “via a surgical access/incision into the abdominal or the pelvic cavity (103), wherein the surgical system (201, 202) comprises an illumination device (201L) for illuminating the uterine wall (104) from the side of the abdominal cavity (103) or the pelvic cavity, a camera” should be changed to “via a surgical access/incision into an abdominal cavity or a pelvic cavity, wherein the surgical system comprises an illumination device for illuminating an uterine wall from a side of the abdominal cavity or the pelvic cavity, and a camera”;
Claim 12, line 1, the limitation “The system (200) according to claim 11, wherein the system” should be changed to “The uterine transillumination system according to claim 11, wherein the uterine transillumination system”;
Claim 12, lines 8-9, the limitation “the transillumination device (1) and propagated through the uterine wall (104) to the pelvic or abdominal cavity” should be changed to “the uterine transillumination device and propagated through the uterine wall to the pelvic cavity or the abdominal cavity”;
Claim 13, line 6, the limitation “the uterine cavity” should be changed to “the uterus”;
Claim 13, line 7, the limitation “the transillumination device” should be changed to “the uterine transillumination device”;
Claim 13, line 8, the limitation “the uterine cavity” should be changed to “the uterus”;
Claim 13, lines 12-13, the limitation “e) transmitting the recorded images in form of image data to a computer, particularly the computer of the system (200)” should be changed to “e) transmitting the recorded series of images in form of image data to a computer, particularly the computer of the uterine transillumination system”;
Claim 13, line 22, the limitation “the recorded images” should be changed to “the recorded series of images”;
Claim 14, lines 2-3, the limitation “executed on the system (200) according to claim 11, causes the system (200) to execute” should be changed to “executed on the uterine transillumination system according to claim 11, causes the uterine transillumination system to execute”;
Claim 14, line 6, the limitation “the uterine cavity” should be changed to “the uterus”;
Claim 14, line 7, the limitation “the transillumination device” should be changed to “the uterine transillumination device”;
Claim 14, line 8, the limitation “the uterine cavity” should be changed to “the uterus”;
Claim 14, lines 12-13, the limitation “e) transmitting the recorded images in form of image data to a computer, particularly the computer of the system (200)” should be changed to “e) transmitting the recorded series of images in form of image data to a computer, particularly the computer of the uterine transillumination system”;
Claim 14, line 23, the limitation “the recorded images” should be changed to “the recorded series of images”; and
Claim 14, line 25, the limitation “particularly the step b) to g).” should be deleted.
Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Sauer (US 2015/0127016 A1, of record, hereinafter Sauer) in view of Song et al. (US 2020/0305724 A1, with publication date 10/01/2020, hereinafter Song).
Regarding claim 1, Sauer discloses a uterine transillumination device (uterine manipulator 10) for detecting scars on an uterus, particularly a human uterus (see, e.g., Fig. 1, and corresponding disclosure, and Para. [0009-0010]), the device (10) comprising at least the following components:
a longitudinal body (device 40) extending along a longitudinal axis, the longitudinal body having at least a tip portion for being introduced in the cervix and the uterus cavity, wherein the longitudinal body further comprises a sheath portion for the tip portion (see, e.g., Figs. 1-3, and Para. [0010], “a uterine manipulator includes a generally straight, elongate body having a longitudinal axis and defining a substantially linear passageway therethrough, terminating at an opening in the cup; […] a distal tip protruding from the opening in the cup. The cup has an opening angled relative to the longitudinal axis of the elongate body”, and Para. [0052], “Referring to FIG. 1, a perspective view of a uterine manipulator 10 is shown, comprised of a sound 20 and a light wand 30 accepted within and housed by a device 40. The sound 20 and light wand 30 are generally manufactured such that they are reusable and preferably comprised of rigid, sterilizable, and cleanable materials such as stainless steels and the like. The device 40 is typically disposable and generally comprised of sterilizable molded polymers”), wherein the tip portion:
a) is movable along the longitudinal axis inward and outward the sheath portion (see, e.g., Figs. 1-3 and 12-17, and Para. [0054-0056], and Para. [0082], “FIGS. 15 through 17 are orthogonal section views taken along lines 15-15 of FIG. 1 and are useful to detail the introduction of the light wand 30 subsystem into the device 40 subsystem. For clarity, the sound 20 subsystem is not shown. The light wand 30 is intended to pass through the device 40 and rest in proximity to the window 70 of the cup 60 such that optical efficiency is maintained and light loss is avoided as light emitted from the exit face 32C passes through the window”),
b) comprises a first side facing along a first radial direction away from the longitudinal axis and a second side facing toward the opposite direction of the first radial direction (see, e.g., Figs. 1-3, where the longitudinal body of the device 10/40 is shown to comprise first, second, etc. sides facing radially outward from the longitudinal axis),
c) comprises an illumination assembly (light wand 30) (see, e.g., Figs. 1-3 and 12-17, and Para. [0017], and Para. [0052], “Referring to FIG. 1, a perspective view of a uterine manipulator 10 is shown, comprised of a sound 20 and a light wand 30 accepted within and housed by a device 40”, and Para. [0056], “The light wand 30 is insertable proximally into the device 40 through a wand port 45, in the textured handle 41, best shown in FIG. 2A, until a winged snap 31 engages with receiving edges 46 of the wand port 45. A wand fan 32 mates adjacent to a window 70 within the cup 60”, and Para. [0077], “The light wand 30 subsystem is detailed in FIGS. 12 through 14. Generally, the light wand 30 is used to transilluminate the vaginal fornices during dissection to help visualize the internal structure of the area being dissected. Vascular structures are highlighted with the use of the light wand 30 and can help the surgeon choose satisfactory areas to perform the dissection to reduce bleeding. In one embodiment, the light wand 30 is intended to be a rigid, cleanable, and reusable component that is selectively received in and removed from the device 40”, and Para. [0082], “FIGS. 15 through 17 are orthogonal section views taken along lines 15-15 of FIG. 1 and are useful to detail the introduction of the light wand 30 subsystem into the device 40 subsystem. For clarity, the sound 20 subsystem is not shown. The light wand 30 is intended to pass through the device 40 and rest in proximity to the window 70 of the cup 60 such that optical efficiency is maintained and light loss is avoided as light emitted from the exit face 32C passes through the window”).
Sauer does not specifically disclose [1] wherein the illumination assembly is arranged on the first side of the tip portion; and [2] wherein the illumination assembly is configured to emit light radially away from the longitudinal axis along the first radial direction.
However, in the same field of endeavor of transvaginal medical devices, Song discloses wherein the illumination assembly is arranged on the first side of the tip portion; and wherein the illumination assembly is configured to emit light radially away from the longitudinal axis along the first radial direction (see, e.g., Figs. 1 and 7, and Para. [0032], “A uterus OCT catheter, as shown in FIG. 1, FIG. 7, comprising a catheter body 2; the catheter body 2 comprises an outer sleeve 21, an OCT imaging catheter 22 […] the outer sleeve 21 is provided with an exit window 211”, and Para. [0034], “the shape of the exit window 211 is ring shape or circular arc shape or rectangle shape. As shown in FIG. 7, the shape of the exit window 211 is circular arc; the outer sleeve 21 is made of a medical high-density polyethylene material with moderate hardness which improves the overall strength while increasing the overall diameter. The thickness of the outer sleeve 21 is related to the detection depth of the uterus OCT catheter, specifically, the thickness of the outer sleeve 21 is equal to the distance the exit beam 25 from the outside of the outer nylon tube of the OCT imaging catheter 22 to the waist position of the exit beam 25, the exit beam 25 is transmitted from the light guiding tube 23 in the OCT imaging catheter 22. Specifically, the exit window 211 is coaxial with the center of the exit beam 25 of the light guiding tube 23 to ensure that the OCT equipment has an accurate focal length and accurate measurement”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the uterine transillumination device of Sauer by including [1] wherein the illumination assembly is arranged on the first side of the tip portion; and [2] wherein the illumination assembly is configured to emit light radially away from the longitudinal axis along the first radial direction, as disclosed by Song. One of ordinary skill in the art would have been motivated to make this modification in order to provide the desired light to ensure that the device has an accurate focal length and accurate measurement, as recognized by Song (see, e.g., Para. [0034]).
Regarding claim 2, Sauer modified by Song discloses the device according to claim 1, as set forth above. Sauer further discloses wherein the tip portion is azimuthally rotatable around the longitudinal axis relative to the sheath portion (see, e.g., Figs. 1-3 and 12-20, and Para. [0054-0056], and Para. [0082], “FIGS. 15 through 17 are orthogonal section views taken along lines 15-15 of FIG. 1 and are useful to detail the introduction of the light wand 30 subsystem into the device 40 subsystem. For clarity, the sound 20 subsystem is not shown. The light wand 30 is intended to pass through the device 40 and rest in proximity to the window 70 of the cup 60 such that optical efficiency is maintained and light loss is avoided as light emitted from the exit face 32C passes through the window”, and Para. [0087], “The sound 20 is used to probe the cervix and retain the uterus 150 for removal after a uterine dissection. The rotational anchor 26 described above is actuated to its perpendicular position to serve these purposes”, and Para. [0088], “FIG. 19 is an enlarged detail view of the proximal end of FIG. 18 showing the method of engagement of the sound 20. Specifically, the anchor nut 22 is moved in a clockwise rotation 22C, as viewed from proximal end, while the orientation of the sound 20 is maintained in relation to the anatomy. The result of this rotation is shown in FIG. 20. More specifically, FIG. 20 shows that the rotational anchor 26 is moved in the rotation direction 26C such that the rotational anchor 26 is deployed and anchor fingers 26D engage the endometrial lining 151 of the uterus 150. The anchor nut 22 activated in FIG. 19 deploys the rotational anchor 26 such that it is, for the most part, perpendicular to the angled shaft 25. In this perpendicular position, the rotational anchor 26 with the anchor fingers 26D, the uterus is held securely and readily extracted when desired. Likewise, rotating the anchor nut 22 in a counterclockwise direction will return the rotational anchor 26 to its original position parallel to the angled shaft 25 and allow for the ready release of the extricated uterine tissue”).
Regarding claim 3, Sauer modified by Song discloses the device according to claim 1, as set forth above. Sauer further discloses wherein the first radial direction extends orthogonally away from the first side (see, e.g., Figs. 1-3, where the longitudinal body of the device 10/40 is shown to comprise first, second, etc. sides facing radially outward from the longitudinal axis).
Sauer does not specifically disclose wherein the illumination assembly is configured to emit light within, particularly only within an azimuthal angle range, wherein said azimuthal angle range extends relative to the first radial direction, wherein said azimuthal angle range covers azimuthal angles in the range of -110° to 110°, particularly wherein the azimuthal angle of 0° lies on the first radial direction, particularly wherein the angle range extends from -70° to 70°, more particularly the angle range extends from -40° to 40°.
However, in the same field of endeavor of transvaginal medical devices, Song discloses wherein the illumination assembly is configured to emit light within, particularly only within an azimuthal angle range, wherein said azimuthal angle range extends relative to the first radial direction, wherein said azimuthal angle range covers azimuthal angles in the range of -110° to 110°, particularly wherein the azimuthal angle of 0° lies on the first radial direction, particularly wherein the angle range extends from -70° to 70°, more particularly the angle range extends from -40° to 40° (see, e.g., Figs. 1 and 7, and Para. [0032], “A uterus OCT catheter, as shown in FIG. 1, FIG. 7, comprising a catheter body 2; the catheter body 2 comprises an outer sleeve 21, an OCT imaging catheter 22 […] the outer sleeve 21 is provided with an exit window 211”, and Para. [0034], “the shape of the exit window 211 is ring shape or circular arc shape or rectangle shape. As shown in FIG. 7, the shape of the exit window 211 is circular arc; the outer sleeve 21 is made of a medical high-density polyethylene material with moderate hardness which improves the overall strength while increasing the overall diameter. The thickness of the outer sleeve 21 is related to the detection depth of the uterus OCT catheter, specifically, the thickness of the outer sleeve 21 is equal to the distance the exit beam 25 from the outside of the outer nylon tube of the OCT imaging catheter 22 to the waist position of the exit beam 25, the exit beam 25 is transmitted from the light guiding tube 23 in the OCT imaging catheter 22. Specifically, the exit window 211 is coaxial with the center of the exit beam 25 of the light guiding tube 23 to ensure that the OCT equipment has an accurate focal length and accurate measurement”, and particularly, Fig. 7, in which the azimuthal angle range of the emitted light can be estimated via the side view of the distal tip of the device, and more particularly, via the side view of the exit beam 25 being emitted through the exit window 211).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the uterine transillumination device of Sauer modified by Song by including wherein the illumination assembly is configured to emit light within, particularly only within an azimuthal angle range, wherein said azimuthal angle range extends relative to the first radial direction, wherein said azimuthal angle range covers azimuthal angles in the range of -110° to 110°, particularly wherein the azimuthal angle of 0° lies on the first radial direction, particularly wherein the angle range extends from -70° to 70°, more particularly the angle range extends from -40° to 40°, as disclosed by Song. One of ordinary skill in the art would have been motivated to make this modification in order to provide the desired light to ensure that the device has an accurate focal length and accurate measurement, as recognized by Song (see, e.g., Para. [0034]).
Regarding claim 4, Sauer modified by Song discloses the device according to claim 1, as set forth above. Sauer further discloses wherein the illumination assembly comprises a plurality of light sources that are configured to be controlled selectively, wherein the light sources are arranged on the first side of the tip portion along the longitudinal axis, particularly wherein the light sources are arranged in a row along the longitudinal direction, such that the illumination assembly extends at least along a portion of the tip portion (see, e.g., Para. [0079], “FIG. 13 is an orthogonal section view taken along lines 13-13 of FIG. 12 further indicating the component structure of the light wand 30. As illustrated, an optical bundle 36 is centrally housed within the wand shaft 34”, and Para. [0081], “The optical bundle 36 is packed within the wand shaft 34, and made flush with the input face 35A of the input adapter 35 and the exit face 32C of the wand fan 32. The optical bundle 36 is most typically comprised of a group of tightly packed optical fibers that are polished at each end to maintain optical efficiency and prevent light loss”).
Regarding claim 6, Sauer modified by Song discloses the device according to claim 1, as set forth above. Sauer further discloses wherein the longitudinal body further comprises a contact portion that has an annular shape and is at least partially, particularly completely translucent, wherein the contact portion protrudes radially away from the sheath portion and is configured to be brought in occluding contact to the external orifice of the cervix, particularly wherein the contact is a sealing contact such that the external orifice of the cervix is sealed in a gas tight fashion by the contact portion (see, e.g., Para. [0053], “Evident in the device 40 are a proximally located textured handle 41 imparting a tactile surface for ease of physical manipulation of manipulator 10 and device 40, an indicator ridge 42 to delineate manipulator 10 orientation within a surgical field, a centrally situated shaft or body 43 providing support to and visual indication of insertion depth for the manipulator 10, a distally positioned occluder 50 to maintain intra-peritoneal gas pressure within the surgical field, and a distally sited cup 60 for cervical engagement”, and Para. [0090-0092]).
Regarding claim 7, Sauer modified by Song discloses the device according to claim 1, as set forth above. Sauer further discloses wherein the longitudinal body further comprises a control portion, wherein the control portion is arranged at a proximal end of the sheath portion, particularly wherein the control portion is connected to the tip portion and configured to rotate with the tip portion, if the tip portion is azimuthally rotatable with respect to the sheath portion, wherein the control portion comprises an indicator that is configured to provide a unique visual information regarding an azimuthal orientation of the first side of the tip portion, particularly with respect to the sheath portion (see, e.g., Figs. 18-20, and Para. [0087], “The sound 20 is used to probe the cervix and retain the uterus 150 for removal after a uterine dissection. The rotational anchor 26 described above is actuated to its perpendicular position to serve these purposes”, and Para. [0088], “FIG. 19 is an enlarged detail view of the proximal end of FIG. 18 showing the method of engagement of the sound 20. Specifically, the anchor nut 22 is moved in a clockwise rotation 22C, as viewed from proximal end, while the orientation of the sound 20 is maintained in relation to the anatomy. The result of this rotation is shown in FIG. 20. More specifically, FIG. 20 shows that the rotational anchor 26 is moved in the rotation direction 26C such that the rotational anchor 26 is deployed and anchor fingers 26D engage the endometrial lining 151 of the uterus 150. The anchor nut 22 activated in FIG. 19 deploys the rotational anchor 26 such that it is, for the most part, perpendicular to the angled shaft 25. In this perpendicular position, the rotational anchor 26 with the anchor fingers 26D, the uterus is held securely and readily extracted when desired. Likewise, rotating the anchor nut 22 in a counterclockwise direction will return the rotational anchor 26 to its original position parallel to the angled shaft 25 and allow for the ready release of the extricated uterine tissue”).
Regarding claim 8, Sauer modified by Song discloses the device according to claim 1, as set forth above. Sauer further discloses wherein the device is configured to adopt at least two states, an extended state in which the tip portion protrudes further out of the sheath portion along the longitudinal axis than in a compact state of the device in which the tip portion is retracted deeper in the sheath portion than in the extended state, wherein the device further comprises a first releasable fixing device, wherein said first fixing device is configured to adjustably limit how far the tip portion in the extended state protrudes from the sheath portion along the longitudinal axis and/or wherein the first fixing device is configured to adjustably fixate the tip portion with respect to an azimuthal orientation relative to the sheath portion (see, e.g., Figs. 1-3 and 9-17, and Para. [0054-0056], and Para. [0074], “FIG. 9 shows the sound 20 as it enters the device 40 through the sound port 61 of the cup 60”, and Para. [0075], “FIG. 10 illustrates the insertion progression of the sound 20 through the device 40 wherein the sound is advanced in direction 120 such that the activation wedge 23J of the guide shaft 23 engages the ramp 44B forcing the latch 44 to flex in direction 44C providing physical resistance and subsequent tactile feedback of sound 20 engagement with the latch 44 of device 40”, and Para. [0076], “FIG. 11 illustrates the next sequence of advancing the sound 20 through the device 40. Therein the sound 20 has further advanced through the device 40 in direction 120 such that, distally, the cervical stop 21 of the sound 20 rests firmly against stop ledge 62 in the cup 60, and proximally, the activation wedge 23J of the guide shaft 23 has cleared the ramp 44B of the latch 44. The latch 44 returns to its normal position through direction 44D and latch catch 23K rests within latch recess 44E such that a shaft stop 23M interfaces with a sound stop 44F, physically locking the sound 20 within the device 40. In this position, inadvertent decoupling of the subsystems while in use is prevented. Removal of the sound 20 from the device 40 is accomplished by simply lifting the latch 44 to disengage the latch 44 by allowing the latch recess 44E to clear the latch catch 23K so that sound 20 may be extracted from the distal end of device 40”, and Para. [0082], “FIGS. 15 through 17 are orthogonal section views taken along lines 15-15 of FIG. 1 and are useful to detail the introduction of the light wand 30 subsystem into the device 40 subsystem. For clarity, the sound 20 subsystem is not shown. The light wand 30 is intended to pass through the device 40 and rest in proximity to the window 70 of the cup 60 such that optical efficiency is maintained and light loss is avoided as light emitted from the exit face 32C passes through the window”).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Sauer (US 2015/0127016 A1) in view of Song (US 2020/0305724 A1), as applied to claim 1 above, and further in view of Pierangelo et al. (US 2022/0370002 A1, with publication date 11/24/2022, hereinafter Pierangelo).
Regarding claim 5, Sauer modified by Song discloses the device according to claim 1, as set forth above. Sauer modified by Song does not specifically disclose wherein the illumination assembly is configured to emit light in the wavelength range 590 nm to 1000 nm.
However, in the same field of endeavor of illuminating a uterine cervix, Pierangelo discloses wherein the illumination assembly is configured to emit light in the wavelength range 590 nm to 1000 nm (see, e.g., Abstract, “A method of quantifying progression of pregnancy, includes a) illuminating a uterine cervix with polarized light having a wavelength comprised between 600 and 1100 nm”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the uterine transillumination device of Sauer modified by Song by including wherein the illumination assembly is configured to emit light in the wavelength range 590 nm to 1000 nm, as disclosed by Pierangelo. One of ordinary skill in the art would have been motivated to make this modification in order to desirably illuminate the uterine cervix, as recognized by Pierangelo (see, e.g., Abstract).
Claims 9-15 are rejected under 35 U.S.C. 103 as being unpatentable over Sauer (US 2015/0127016 A1) in view of Song (US 2020/0305724 A1), as applied to claim 1 above, and further in view of Bennett et al. (US 2011/0190581 A1, with publication date 08/04/2011, hereinafter Bennett).
Regarding claim 9, Sauer modified by Song discloses the device according to claim 1, as set forth above. Sauer modified by Song does not specifically disclose wherein the device comprises an electronic circuit system configured to control the illumination assembly.
However, in the same field of endeavor of transvaginal medical devices, Bennett discloses wherein the device comprises an electronic circuit system configured to control the illumination assembly (see, e.g., Para. [0050], “FIG. 1 is a schematic block diagram illustrating an intravaginal monitoring device 101 and its supporting network infrastructure; wherein the intravaginal monitoring device 101 communicates via a communication interface 121 to local external devices 171 and/or external servers 151, 161 via wired and/or wireless network pathways 131. In specific, the depiction shows flow of data between the intravaginal monitoring device 101 and the supporting network infrastructure 171, 151, 161 via communication pathways 133, 135, 137, 139 and/or 141”, and Para. [0078], “The intravaginal monitoring device 511 itself contains a cap or head 513 (that contains most of the built in electronics), stem 515 (that aids user in insertion/removal and stabilization/orientation during wear) and bottom cap (or, finger ring) 517 that assists insertion/removal. The stem 515 are, in some configurations, also contain built in electronics. The cap 513 and stem 515 are include one or more of camera and illumination system, sensors, user interfaces, power management system, communication interfaces”, and Para. [0081], “FIG. 6 is a schematic diagram illustrating the components of the intravaginal monitoring device of FIG. 1. The intravaginal monitoring device 611 contains wired and/or wireless communication interfaces 661 as well as firmware and program & operational logic codes 693 that makes it possible for the intravaginal monitoring device 611 to communicate with the local external electronic devices as well as receive control signals via (immediate) external electronic devices. Moreover, the intravaginal monitoring device 611 also contains memory 681, processing circuitry 641, displays 663 and user input devices 665”, and Para. [0084], “In all of the above-mentioned sensor cases, a processing circuitry 641 executes, as mentioned above, the operational logics, and takes measurements at appropriate intervals and also verifies if the limits are exceeded and precautionary actions should be taken. Other components of the intravaginal monitoring device 611 depicted include normal (infrared and ultraviolet) illuminators 667”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the uterine transillumination device of Sauer modified by Song by including wherein the device comprises an electronic circuit system configured to control the illumination assembly, as disclosed by Bennett. One of ordinary skill in the art would have been motivated to make this modification in order to desirably control/monitor/communicate with the intravaginal device, as recognized by Bennett (see, e.g., Para. [0050]).
Regarding claim 10, Sauer modified by Song and Bennett discloses the device according to claim 9, as set forth above. Sauer modified by Song does not specifically disclose wherein the electronic circuit system is configured to modulate the illumination intensity of the light emitted by the illumination assembly with a modulation frequency, particularly by means of a pulse-width modulation, particularly wherein the modulation frequency is selectable or adjustable via input data provided to the electronic circuit system, wherein the input data may be selected from the group consisting of: preselected input data, input data determined from an information obtained from a separate data source, and input data provided by a user input.
However, in the same field of endeavor of transvaginal medical devices, Bennett discloses wherein the electronic circuit system is configured to modulate the illumination intensity of the light emitted by the illumination assembly with a modulation frequency, particularly by means of a pulse-width modulation, particularly wherein the modulation frequency is selectable or adjustable via input data provided to the electronic circuit system, wherein the input data may be selected from the group consisting of: preselected input data, input data determined from an information obtained from a separate data source, and input data provided by a user input (see, e.g., Para. [0050], “FIG. 1 is a schematic block diagram illustrating an intravaginal monitoring device 101 and its supporting network infrastructure; wherein the intravaginal monitoring device 101 communicates via a communication interface 121 to local external devices 171 and/or external servers 151, 161 via wired and/or wireless network pathways 131. In specific, the depiction shows flow of data between the intravaginal monitoring device 101 and the supporting network infrastructure 171, 151, 161 via communication pathways 133, 135, 137, 139 and/or 141”, and Para. [0078], “The intravaginal monitoring device 511 itself contains a cap or head 513 (that contains most of the built in electronics), stem 515 (that aids user in insertion/removal and stabilization/orientation during wear) and bottom cap (or, finger ring) 517 that assists insertion/removal. The stem 515 are, in some configurations, also contain built in electronics. The cap 513 and stem 515 are include one or more of camera and illumination system, sensors, user interfaces, power management system, communication interfaces”, and Para. [0081], “FIG. 6 is a schematic diagram illustrating the components of the intravaginal monitoring device of FIG. 1. The intravaginal monitoring device 611 contains wired and/or wireless communication interfaces 661 as well as firmware and program & operational logic codes 693 that makes it possible for the intravaginal monitoring device 611 to communicate with the local external electronic devices as well as receive control signals via (immediate) external electronic devices. Moreover, the intravaginal monitoring device 611 also contains memory 681, processing circuitry 641, displays 663 and user input devices 665”, and Para. [0084], “In all of the above-mentioned sensor cases, a processing circuitry 641 executes, as mentioned above, the operational logics, and takes measurements at appropriate intervals and also verifies if the limits are exceeded and precautionary actions should be taken. Other components of the intravaginal monitoring device 611 depicted include normal (infrared and ultraviolet) illuminators 667”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the uterine transillumination device of Sauer modified by Song and Bennett by including wherein the electronic circuit system is configured to modulate the illumination intensity of the light emitted by the illumination assembly with a modulation frequency, particularly by means of a pulse-width modulation, particularly wherein the modulation frequency is selectable or adjustable via input data provided to the electronic circuit system, wherein the input data may be selected from the group consisting of: preselected input data, input data determined from an information obtained from a separate data source, and input data provided by a user input, as disclosed by Bennett. One of ordinary skill in the art would have been motivated to make this modification in order to desirably control/monitor/communicate with the intravaginal device, as recognized by Bennett (see, e.g., Para. [0050]).
Regarding claim 11, Sauer modified by Song discloses the device according to claim 1, as set forth above. Sauer further discloses a uterine transillumination system comprising the uterine transillumination device according to claim 1, wherein the uterine transillumination system further comprises a surgical system configured to be inserted via a surgical access/incision into the abdominal or the pelvic cavity, wherein the surgical system comprises an illumination device for illuminating the uterine wall from the side of the abdominal cavity or the pelvic cavity (see, e.g., Para. [0003], “Surgeons have been placing medical implements through the vagina in efforts to treat gynecologic maladies for centuries. With the advent of sterile techniques, anesthesia and antibiotics, more advanced surgical interventions were developed. Initially a wide variety of generally cylindrical different size and shape devices, called sounds, were employed to explore and manipulate patients' vaginal canals, cervices and uteri”, and Para. [0016], “For uterine manipulation during, for example, laparoscopic hysterectomy surgery, the components of this technology will have to be provided sterile to the operative field”, and Para. [0017], “In addition to a passageway for the angled sound, each cervical engagement device can also incorporate a passageway leading from its proximal end to a sealed transparent section in the distal cup. This passageway is parallel to the passageway for the angled sound and can be used to receive and secure a vaginal illumination device. This vaginal illuminator has a fan shaped, metal and fiber optic distal end, a shaft, and a proximal attachment feature. A standard threaded coupler is located at its proximal end to enable connection to a standard surgical light source”, and Para. [0063], “Referring to FIGS. 5 through 8, the sound 20, a subsystem of the uterine manipulator 10, is detailed. The sound 20, as described, is preferably meant to be supplied as a sterile, cleanable, and reusable product that is used to probe and couple to the uterine structures”).
Sauer modified by Song does not specifically disclose wherein the surgical system comprises a camera for recording images of the uterine wall from the side of the abdominal cavity or the pelvic cavity.
However, in the same field of endeavor of transvaginal medical devices, Bennett discloses wherein the surgical system comprises a camera for recording images of the uterine wall from the side of the abdominal cavity or the pelvic cavity (see, e.g., Para. [0188], “A network consisting of: an intravaginal monitoring device for visualizing conditions or events within a vagina, the device consisting of a camera, and having a wireless data transmission mode of functionality, and a remote device, the remote device located outside of a female's body is also considered in one of the embodiments”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the uterine transillumination device of Sauer modified by Song by including wherein the surgical system comprises a camera for recording images of the uterine wall from the side of the abdominal cavity or the pelvic cavity, as disclosed by Bennett. One of ordinary skill in the art would have been motivated to make this modification in order to desirably control/monitor/communicate with the intravaginal device, as recognized by Bennett (see, e.g., Para. [0050]).
Regarding claim 12, Sauer modified by Song and Bennett discloses the system according to claim 11, as set forth above. Sauer modified by Song does not specifically disclose wherein the system comprises a computer, wherein the computer is configured to receive image data comprising information on the recorded images from the camera and wherein the computer is further configured to generate processed image data from the received image data, wherein the processed image data comprises transillumination image information configured to generate one or a series of transillumination images indicative of a spatial light distribution on the uterine wall of light emitted by the transillumination device and propagated through the uterine wall to the pelvic or abdominal cavity.
However, in the same field of endeavor of transvaginal medical devices, Bennett discloses wherein the system comprises a computer, wherein the computer is configured to receive image data comprising information on the recorded images from the camera and wherein the computer is further configured to generate processed image data from the received image data, wherein the processed image data comprises transillumination image information configured to generate one or a series of transillumination images indicative of a spatial light distribution on the uterine wall of light emitted by the transillumination device and propagated through the uterine wall to the pelvic or abdominal cavity (see, e.g., Para. [0056-0057], and Para. [0188], “A network consisting of: an intravaginal monitoring device for visualizing conditions or events within a vagina, the device consisting of a camera, and having a wireless data transmission mode of functionality, and a remote device, the remote device located outside of a female's body is also considered in one of the embodiments”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the system of Sauer modified by Song and Bennett by including wherein the system comprises a computer, wherein the computer is configured to receive image data comprising information on the recorded images from the camera and wherein the computer is further configured to generate processed image data from the received image data, wherein the processed image data comprises transillumination image information configured to generate one or a series of transillumination images indicative of a spatial light distribution on the uterine wall of light emitted by the transillumination device and propagated through the uterine wall to the pelvic or abdominal cavity, as disclosed by Bennett. One of ordinary skill in the art would have been motivated to make this modification in order to desirably control/monitor/communicate with the intravaginal device, as recognized by Bennett (see, e.g., Para. [0050]).
Regarding claims 13-14, Sauer modified by Song and Bennett discloses the system according to claim 11, as set forth above. Sauer further discloses wherein the method executes at least the steps of: a) selecting or setting a modulation frequency of the illumination assembly, b) illuminating the uterine wall from inside the uterine cavity with the illumination assembly of the transillumination device, and c) illuminating the uterine wall from outside the uterine cavity with the illumination device (see, e.g., Figs. 1-3 and 12-17, and Para. [0017], and Para. [0052], “Referring to FIG. 1, a perspective view of a uterine manipulator 10 is shown, comprised of a sound 20 and a light wand 30 accepted within and housed by a device 40”, and Para. [0056], “The light wand 30 is insertable proximally into the device 40 through a wand port 45, in the textured handle 41, best shown in FIG. 2A, until a winged snap 31 engages with receiving edges 46 of the wand port 45. A wand fan 32 mates adjacent to a window 70 within the cup 60”, and Para. [0077], “The light wand 30 subsystem is detailed in FIGS. 12 through 14. Generally, the light wand 30 is used to transilluminate the vaginal fornices during dissection to help visualize the internal structure of the area being dissected. Vascular structures are highlighted with the use of the light wand 30 and can help the surgeon choose satisfactory areas to perform the dissection to reduce bleeding. In one embodiment, the light wand 30 is intended to be a rigid, cleanable, and reusable component that is selectively received in and removed from the device 40”, and Para. [0082], “FIGS. 15 through 17 are orthogonal section views taken along lines 15-15 of FIG. 1 and are useful to detail the introduction of the light wand 30 subsystem into the device 40 subsystem. For clarity, the sound 20 subsystem is not shown. The light wand 30 is intended to pass through the device 40 and rest in proximity to the window 70 of the cup 60 such that optical efficiency is maintained and light loss is avoided as light emitted from the exit face 32C passes through the window”).
Sauer modified by Song does not specifically disclose a method for imaging the uterine wall executed on the uterine transillumination system according to claim 11 (and a corresponding computer program comprising computer program code that when executed on the system according to claim 11, causes the system to execute at least the method steps), wherein the method further executes at least the steps of: d) recording a series of images of the uterine wall with the camera from the outside of the uterus, e) transmitting the recorded images in form of image data to a computer, particularly the computer of the system, f) determining by the computer processed image data from the image data, wherein the processed image data comprise transillumination image information being configured to generate one or a series of transillumination images reflecting the uterine wall illuminated only by the transilluminated light from the illumination assembly, and g) displaying the processed image data in form of one or a series of processed images on a display, particularly wherein the one or the series of processed images comprises the one or the series of the transillumination images as an overlay, particularly as a false color overlay, on the recorded images, such that additional optical information on the uterine wall is obtained.
However, in the same field of endeavor of transvaginal medical devices, Bennett discloses a method for imaging the uterine wall executed on the uterine transillumination system according to claim 11 (and a corresponding computer program comprising computer program code that when executed on the system according to claim 11, causes the system to execute at least the method steps), wherein the method further executes at least the steps of: d) recording a series of images of the uterine wall with the camera from the outside of the uterus, e) transmitting the recorded images in form of image data to a computer, particularly the computer of the system, f) determining by the computer processed image data from the image data, wherein the processed image data comprise transillumination image information being configured to generate one or a series of transillumination images reflecting the uterine wall illuminated only by the transilluminated light from the illumination assembly, and g) displaying the processed image data in form of one or a series of processed images on a display, particularly wherein the one or the series of processed images comprises the one or the series of the transillumination images as an overlay, particularly as a false color overlay, on the recorded images, such that additional optical information on the uterine wall is obtained (see, e.g., Para. [0056-0057], more particularly Para. [0056], “The intravaginal monitoring device 101 are be plugged directly to a television 173 (or communicate with a wireless connection through an intranet wireless network connection or Internet connection) or personal computer 177 display using display management 110 and display driver” and Para. [0057], “The intravaginal monitoring device 101, while inserted in place (inside the vaginal channel) or after usage and removal, allows an authenticated supporting personal computing device 171 to send control signals (as well as firmware and other logistical program codes) and receive images/video clips/sensor data and so forth from the intravaginal monitoring device 101”, and Para. [0081-0082], more particularly Para. [0081], “FIG. 6 is a schematic diagram illustrating the components of the intravaginal monitoring device of FIG. 1. The intravaginal monitoring device 611 contains wired and/or wireless communication interfaces 661 as well as firmware and program & operational logic codes 693 that makes it possible for the intravaginal monitoring device 611 to communicate with the local external electronic devices as well as receive control signals via (immediate) external electronic devices”, and Para. [0188], “A network consisting of: an intravaginal monitoring device for visualizing conditions or events within a vagina, the device consisting of a camera, and having a wireless data transmission mode of functionality, and a remote device, the remote device located outside of a female's body is also considered in one of the embodiments”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the system of Sauer modified by Song and Bennett by including a method for imaging the uterine wall executed on the uterine transillumination system according to claim 11 (and a corresponding computer program comprising computer program code that when executed on the system according to claim 11, causes the system to execute at least the method steps), wherein the method further executes at least the steps of: d) recording a series of images of the uterine wall with the camera from the outside of the uterus, e) transmitting the recorded images in form of image data to a computer, particularly the computer of the system, f) determining by the computer processed image data from the image data, wherein the processed image data comprise transillumination image information being configured to generate one or a series of transillumination images reflecting the uterine wall illuminated only by the transilluminated light from the illumination assembly, and g) displaying the processed image data in form of one or a series of processed images on a display, particularly wherein the one or the series of processed images comprises the one or the series of the transillumination images as an overlay, particularly as a false color overlay, on the recorded images, such that additional optical information on the uterine wall is obtained, as disclosed by Bennett. One of ordinary skill in the art would have been motivated to make this modification in order to desirably control/monitor/communicate with the intravaginal device, as recognized by Bennett (see, e.g., Para. [0050]).
Regarding claim 15, Sauer modified by Song and Bennett discloses the computer program according to claim 14, as set forth above. Sauer modified by Song does not specifically disclose a computer-readable, non-transitory storage medium having stored thereon the computer program of claim 14.
However, in the same field of endeavor of transvaginal medical devices, Bennett discloses a computer-readable, non-transitory storage medium having stored thereon the computer program of claim 14 (see, e.g., Para. [0056-0057], and Para. [0081-0082], more particularly Para. [0081], “FIG. 6 is a schematic diagram illustrating the components of the intravaginal monitoring device of FIG. 1. The intravaginal monitoring device 611 contains wired and/or wireless communication interfaces 661 as well as firmware and program & operational logic codes 693 that makes it possible for the intravaginal monitoring device 611 to communicate with the local external electronic devices as well as receive control signals via (immediate) external electronic devices”, and Para. [0188]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the system of Sauer modified by Song and Bennett by including a computer-readable, non-transitory storage medium having stored thereon the computer program, as disclosed by Bennett. One of ordinary skill in the art would have been motivated to make this modification in order to desirably control/monitor/communicate with the intravaginal device, as recognized by Bennett (see, e.g., Para. [0050]).
Conclusion
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/T.D./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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