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 Status: Claims 1-4, 6-9, and 11-14 are pending.
Response to Arguments
Applicant's arguments filed on July 14, 2025 have been fully considered but they are not persuasive.
Re Claims 11 and 13, Applicant made an argument that Examiner does not specifically identify where any reference discloses a “two-part” wrap configuration. Applicant stated that Klem discloses a flexible treatment surface but does not describe it as having two distinct parts or an upper or lower wing.
This argument has been considered and is not persuasive.
Examiner would like to note that the limitation “two-part” flexible wrap is a broad term and still includes structure where two parts are fully connected with one another.
Zhang discloses a two-part flexible wrap including an upper wing and a lower wing (fig. 21, para. [0294], vulva area light therapy delivery liner 2140 is configured to deliver light to vulvar regions 2155 and 2160 of patient 2100). The section of vulva area light therapy delivery liner 2140 that delivers light to vulvar region 2155 of the patient can be considered a lower wing of a two-part flexible wrap, as shown in annotated fig. 21. The section of vulva area light therapy delivery liner 2140 that delivers light to vulvar region 2160 of patient can be considered an upper wing of a two-part flexible wrap.
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Klem also discloses a device for external light therapy of a vulva of a user (abstract) an external treatment section including a two-part flexible wrap (para. [0028], flexible housing); the wrap including a flexible LED array, wherein the upper wing including a first wing LED array; the lower wing including a second wing LED array (fig. 1, fig. 2, para. [0100], The apparatus comprises a flat but somewhat flexible continuous upper treatment surface 2 in the form of a strip or sheet. The treatment surface 2 contains an illumination system 4 with LEDs 6 in strips of LEDs for projecting light from the treatment surface 2.).
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Re Claim 6, Applicant made an argument that no prior art disclosure of a frame joining an insertion structure and wrap is provided.
This argument has been considered and is persuasive.
Newly cited prior art, Garboggini, has been used to disclose “a frame joining an insertion structure and wrap”.
Re Claims 1, 6, and 11, Applicant made an argument that Jun does not disclose locking ridges on a cover that interface with locking teeth specifically on an insertion structure.
This argument has been considered but is not persuasive.
Jun teaches the cover including locking ridges, the locking ridges interface with locking teeth of the insertion structure; whereby the locking ridges keep the pliable cover in place on use (para. [0010], a housing locking part formed outside the housing expansion part and fixing the outer skin part; para. [0033], The case housing part 12 includes a housing inclined part 121, a housing expansion part 122, and a housing locking part 123).
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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.
Claims 1-4 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 2019/0083809) in view of Klem (US 20140350454), Mayer (US 2009/0319008), and Jun (KR 20200111837 – Please see the translation copy provided).
Re Claims 1, 2, 3, and 4, Zhang discloses a device for simultaneous internal and external light therapy of a vagina and a vulva of a user, the device comprising:
an internal treatment section (para. [0294], fig. 21, vaginal light therapy insert 2110);
the internal treatment section including an insertion structure enclosed by a pliable cover (para. [0289], a vaginal light therapy insert 2110, which can be fabricated of medical grade, optically transmitting clear material such as acrylic, polycarbonate, or silicone, para. [0186], silicone described as flexible material);
the insertion structure including an outward-facing light array (para. [0291], Vaginal light therapy insert 2110 is operationally and optically engaged with PBM control module 2130 via at least one light guide 2135 for transferring LLLT into vaginal light therapy insert 2110 for subsequent transmission to vaginal cavity 2105 etc. PBM control module 2130 can include at least one light source [not shown] that emits light in the blue, green, red to near-infrared wavelengths for various stages and indications during an overall treatment protocol.);
an external treatment section (para. [0294], vulvar area light therapy delivery liner 2140 having first and second sides 2145 and 2150);
the external treatment section including a wrap;
the wrap including a flexible light array (para. [0295], Light therapy delivery liner 2140 is operationally and optically engaged with PBM control module 2130 via at least one light guide 2165. The light source(s) [not shown] that are each, independently, engaged with vaginal light therapy insert 2110 and light therapy delivery liner 2140 from within PBM control module 2130 can be the same or different, para. [0071], para. [0186], The light therapy delivery liner can be sized and shaped for the comfort of the patient. Soft and flexible materials should be used);
whereby the user is able to simultaneously perform light therapy on the vagina and the vulva (para. [0298], LLLT treatment dosages can be applied to either or both vaginal cavity 2105 and vulvar regions 2155 and 2160 as prescribed by a medical provider).
Zhang discloses the wrap is a two-part flexible wrap that includes an upper wing and a lower wing, the upper wing including at least one light guide; the lower wing including at least one light guide, wherein the first wing light array and second wing light array treating the vulva area of the user (fig. 21, para. [0294], vulva area light therapy delivery liner 2140 is configured to deliver light to vulvar regions 2155 and 2160 of patient 2100, para. [0295], Light therapy delivery liner 2140 is operationally and optically engaged with PBM control module 2130 via at least one light guide 2165). The section of vulva area light therapy delivery liner 2140 that delivers light to vulvar region 2155 of the patient can be considered a lower wing of a two-part flexible wrap, as shown in annotated fig. 21. The section of vulva area light therapy delivery liner 2140 that delivers light to vulvar region 2160 of patient can be considered an upper wing of a two-part flexible wrap.
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Zhang is silent regarding the insertion structure having an outward-facing LED array and the wrap including a flexible LED array, wherein:
the outward-facing LED array includes a radial array of LEDs placed along a length of the insertion structure, and one or more tip mounted LEDs at an end of the insertion structure;
the radial array of LEDs and the one or more tip mounted LEDs act together to ensure complete internal light treatment of the vagina,
wherein the upper wing including a first wing LED array; the lower wing including a second wing LED array; the first wing LED array and the second wing LED array treating the vulva of the user,
wherein a central LED array; the central LED array integrated with the wrap; the central LED array shining light toward the vulva of the user.
However, Klem discloses a device for external light therapy of a vulva of a user (abstract) an external treatment section including a two-part flexible wrap; the wrap including a flexible LED array, wherein the upper wing including a first wing LED array; the lower wing including a second wing LED array; the first wing LED array and the second wing LED array treating the vulva of the user and wherein a central LED array; the central LED array integrated with the wrap; the central LED array shining light toward the vulva of the user (fig. 1, fig. 2, para. [0100], The apparatus comprises a flat but somewhat flexible continuous upper treatment surface 2 in the form of a strip or sheet. The treatment surface 2 contains an illumination system 4 with LEDs 6 in strips of LEDs for projecting light from the treatment surface 2.; para. [0101], The silicone layer 14 also encases other electrical parts of the apparatus. Depending on the type of silicone, the silicone layer may help to evenly distribute the light from the LEDs 6. White pigments are included in the silicon layer 14 to diffuse the light, provide a more even distribution of the light and increase the light dose due to back-scattering; para. [0023], The illumination system comprises at least one light source, preferably at least one LED and more preferably an array of more than one LEDs or fibre optic light guides, which may be supplied with light by at least one LED.).
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Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zhang, by configuring the two-part flexible wrap to include a flexible LED array, wherein the upper wing including a first wing LED array; the lower wing including a second wing LED array; the first wing LED array and the second wing LED array treating the vulva of the user and wherein a central LED array; the central LED array integrated with the wrap; the central LED array shining light toward the vulva of the user, as taught by Klem, because such a modification is the result of simple substitution of one known element for another producing a predictable result. More specifically, Zhang’s at least one light guide and Klem’s LED arrays perform the same general and predictable function, the predictable function being shining light towards the treatment area. Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself - that is in the substitution of Zhang’s at least one light guide by replacing it with Klem’s LED arrays. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
Klem is silent regarding the insertion structure having an outward-facing LED array, wherein: the outward-facing LED array includes a radial array of LEDs placed along a length of the insertion structure, and one or more tip mounted LEDs at an end of the insertion structure; the radial array of LEDs and the one or more tip mounted LEDs act together to ensure complete internal light treatment of the vagina.
However, Mayer discloses a device for internal light therapy of a vagina (abstract) and teaches an internal treatment section including an insertion structure enclosed by a pliable cover (para. [0086], probe member 12 carrying the light sources and intended to be inserted into the body cavity may be made of a rigid or flexible material. Preferably, the probe member is made of a relatively flexible material so as to reduce the chances of inadvertent injury to the body cavity. The probe member (or the outer cover as the case may be) is made of biocompatible material such as polycarbonate, polypropylene, acryl, and derivatives thereof, polyurethane, etc. as known in the art.) and the insertion structure including an outward-facing LED array, wherein: the outward-facing LED array includes a radial array of LEDs placed along a length of the insertion structure ([0087] As shown in the example of FIGS. 1A-1B, array of LEDs 18 (constituting light sources) is associated with a suitable electronics, e.g. the LEDs are arranged within a printed circuit board (PCB) film 20. The latter wraps at least a part of the outer surface of the probe member 12. For example, such a PCB with LEDs may be configured as a cover mountable onto at least a part of the probe member.). Mayer also discloses one or more tip mounted LEDs at an end of the insertion structure (fig. 3F, para. [0103], shows one or more tip mounted LEDs).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zhang as modified by Klem, by configuring the insertion structure to have an outward-facing LED array, wherein: the outward-facing LED array includes a radial array of LEDs placed along a length of the insertion structure, and one or more tip mounted LEDs at an end of the insertion structure; the radial array of LEDs and the one or more tip mounted LEDs act together to ensure complete internal light treatment of the vagina, as taught by Mayer, because such a modification is the result of simple substitution of one known element for another producing a predictable result. More specifically, Zhang’s at least one light guide and Mayer’s LED array and one or more tip mounted LEDs perform the same general and predictable function, the predictable function being shining light towards the treatment area. Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself - that is in the substitution of Zhang’s at least one light guide by replacing it with Mayer’s LED arrays. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
Zhang discloses that the pliable cover has a contoured shape; the contoured shape including areas of increased thickness, or apexes, and areas of decreased thickness, or valleys; whereby the contoured shape increases user comfort (para. [0187], When a patient is wearing both the vaginal insert and the liner simultaneously, such engageable fit can improve comfort and wearability, para. [0290], fig. 21 shows hemispheric end of vaginal light therapy insert 2110, which reads on the claimed contoured shape.).
Zhang is silent regarding the contoured shape of the pliable cover including a first circumferential apex and a second circumferential apex and a base with a flare; a first valley between the first circumferential apex and the second circumferential apex; a second valley between the second circumferential apex and the flare.
Zhang is silent regarding the cover including locking ridges, the locking ridges interface with locking teeth of the insertion structure; whereby the locking ridges keep the pliable cover in place on use.
However, Jun discloses a therapy apparatus for women (abstract) and teaches the contoured shape of the pliable cover (para. [0043]-[0048], fig. 6, fig. 7, the outer skin portion 60 includes an outer skin contact portion 61 and an outer skin fixing portion 62. The shell contact portion 61 has an open end and the case portion 10 is inserted therein. Referring to FIG. 7, the skin contacting part 61 according to the first embodiment of the present invention includes a skin cover part 71 and a skin electrode part 72. The outer cover portion 71 covers the case portion 10 and includes a silicon material; para. [0014], The outer skin contact portion includes an outer skin cover made of a silicon material covering the case portion; para. [0027], The outer skin portion 60 covers the case portion 10. For example, the outer skin 60 may include a waterproof material, and moisture may be prevented from entering the substrate 20 in which the electronic component is embedded. This outer skin 60 is washable and can be replaced when abrasion or contamination occurs) including a first circumferential apex and a second circumferential apex and a base with a flare; a first valley between the first circumferential apex and the second circumferential apex; a second valley between the second circumferential apex and the flare (annotated fig. 1 below).
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Jun teaches the cover including locking ridges, the locking ridges interface with locking teeth of the insertion structure; whereby the locking ridges keep the pliable cover in place on use (para. [0010], a housing locking part formed outside the housing expansion part and fixing the outer skin part; para. [0033], The case housing part 12 includes a housing inclined part 121, a housing expansion part 122, and a housing locking part 123).
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Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zhang as modified by Klem and Mayer, by configuring the contoured shape of the pliable cover to include a first circumferential apex and a second circumferential apex and a base with a flare; a first valley between the first circumferential apex and the second circumferential apex; a second valley between the second circumferential apex and the flare and configuring the cover to include locking ridges, the locking ridges interface with locking teeth of the insertion structure; whereby the locking ridges keep the pliable cover in place on use, as taught by Jun, for the purpose of treating urinary incontinence or fecal incontinence by electrically inducing contraction and relaxation of the vaginal muscle to improve the elasticity of the vaginal muscle through a skin electrode part (para. [0046], [0047]) and coupling two structures together on use (para. [0010]).
Re Claims 11-14, Claims 11-14 are rejected under substantially the same basis as claims 1-4.
Zhang is silent regarding an internal treatment element including a rigid insertion structure surrounded by a pliable cover; the rigid insertion structure primarily rod-like in shape with an external surface and a tip; the external surface supporting an outward facing LED array; the tip supporting one or more LEDs.
However, Mayer further teaches an internal treatment element including a rigid insertion structure surrounded by a pliable cover;
the rigid insertion structure primarily rod-like in shape with an external surface and a tip (para. [0082], fig. 1A, probe member 12);
the external surface supporting an outward facing LED array (para. [0082], fig. 1A, Probe member 12 carries a plurality of spaced apart light sources, generally at 18, arranged along of the surface of the probe member 12.);
the tip supporting one or more LEDs (fig. 3F, LEDs 18 on the top of probe 12);
the pliable cover enclosing the rigid insertion structure (para. [0089], As exemplified in FIG. 1B by dashed curve, member 12 with LEDs 18 may be further coated by an external cover 22 made of a suitable biocompatible material, which is transparent for the spectral range(s) used, e.g. made of transparent latex. The cover material may be diffusive to direct light output from the light source to larger surface area. Preferably, such cover 22 is configured to be removably mountable onto member 12, thus enabling the cover to be disposable.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zhang as modified by Klem and Mayer, by configuring an internal treatment element to include a rigid insertion structure surrounded by a pliable cover; the rigid insertion structure primarily rod-like in shape with an external surface and a tip; the external surface supporting an outward facing LED array; the tip supporting one or more LEDs, the pliable cover enclosing the rigid insertion structure, as taught by Mayer, because such a modification is the result of simple substitution of one known element for another producing a predictable result.
Regarding simple substitution, more specifically, Zhang’s at least one light guide inside the tube structure and Mayer’s LED array and one or more tip mounted LEDs on the external surface of rigid rod-like structure perform the same general and predictable function, the predictable function being shining light towards the treatment area. Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself - that is in the substitution of Zhang’s at least one light guide inside the tube structure by replacing it with Mayer’s LED array and one or more tip mounted LEDs on the external surface of rigid rod-like structure. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 2019/0083809) in view of Klem (US 20140350454), Mayer (US 2009/0319008), Jun (KR 20200111837 – Please see the translation copy provided), and Garboggini et al. (BR 102017026980).
Re Claims 6-9, Claims 6-9 are rejected under substantially the same basis as claims 1-4.
Zhang is silent regarding the insertion structure (internal treatment component) and the wrap (external treatment component) being further joined by frame.
However, Garboggini discloses an internal treatment component and an external treatment component being joined by frame (page 3, fig. 2 show Region of intravaginal LED emission (2) composed of LED lights and region of vulvar LED emission (3) are joined by frame, i.e. support chamber 4; fig. 4 and fig. 6).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zhang as modified by Klem and Mayer, by joining the insertion structure and the wrap by frame, as taught by Garboggini, since it has been held that the use of a one piece construction instead of the structure disclosed in Zhang would be merely a matter of obvious engineering choice. MPEP 2144.04 V.B.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYNN V HUH whose telephone number is (571)272-4684. The examiner can normally be reached Monday to Friday from 9 am to 5 pm.
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/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, December 20, 2025Examiner, Art Unit 3792