DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 18 November 2025 has been entered.
Information Disclosure Statement
The information disclosure statement filed 18 November 2025 has been considered.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
Claim(s) 1-16, 19, 21, 22, and 24 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Gjorsvik et al. (US Publication no. 2018/0369603 – disclosed by Applicant).
In regard to claim 1, Gjorsvik et al. disclose a device for vaginal light therapy of a patient (para 24 and 113), comprising:
an elongate member 12 comprising a proximal portion 14, a distal portion 10 sized for introduction into a vaginal canal terminating in a distal tip 24 (para 93), and one or more light sources 22, 24, 26 (para 26) on the distal portion 10;
an expandable member 18,20 carried on the distal portion 10 and surrounding the one or more light sources 22, 24, 26, the expandable member 18 comprising a proximal end attached to the elongate member proximal to the distal tip and an enclosed distal end that extends over the distal tip of the distal portion (see figure 2), the expandable member configured to emit light outwardly from the one or more light sources (para 80) at one or more wavelengths within a range of germicidal light to treat one or more pathogens without injuring vaginal tissue (para 137, catheter used in photodynamic treatment of viral, bacterial, or function infections in the inter surface of an organ such as the vagina); and
an inflator for expanding the expandable member from a delivery condition for introduction into a vaginal canal, and an expandable condition once inserted for delivering the light to treat one or more conditions (para 63),
wherein the one or more light sources 22, 24, 26 comprise a plurality of light sources spaced apart from one another on a wall of the distal portion to transmit light radially outwardly through the expandable member (see figure 2).
As the recitation for use in the vagina and for outputting a germicidal light wavelength are the intended uses of the device and light emitters. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In view that Gjorsvik et al. teaches that the device may be used in the vagina and may be used to treat viral, bacterial, and fungal infections of the vagina, the disclosed device necessarily is capable of meeting the intended use limitations. Thus, the present invention is anticipated by Gjorsvik et al. Moreover, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Gjorsvik et al. for use in the vagina to apply germicidal light since it is explicitly suggested by Gjorsvik et al.
In regard to claim 9, Gjorsvik et al. discloses a device for vaginal light therapy of a patient (para 24 and 113), comprising:
an elongate member 12 comprising a proximal portion 14, and a distal portion 10 sized for introduction into a vaginal canal terminating in a distal tip 24 (para 93);
an expandable member 18,20 carried on the distal portion 10 carrying a plurality of light sources 22, 24, 26 configured to emit light radially outwardly (para 80) at one or more wavelengths within a range of germicidal light to treat one or more pathogens without injuring vaginal tissue (para 137, catheter used in photodynamic treatment of viral, bacterial, or function infections in the inter surface of an organ such as the vagina) the expandable member comprising a proximal end attached to the elongate member and an enclosed distal end that extends over the distal tip of the distal portion (see figure 2); and
an inflator for expanding the expandable member from a delivery condition for introduction into a vaginal canal, and an expandable condition once inserted for delivering the light to treat one or more conditions (para 63).
As the recitation for use in the vagina and for outputting a germicidal light wavelength are the intended uses of the device and light emitters. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In view that Gjorsvik et al. teaches that the device may be used in the vagina and may be used to treat viral, bacterial, and fungal infections of the vagina, the disclosed device necessarily is capable of meeting the intended use limitations. Thus, the present invention is anticipated by Gjorsvik et al. Moreover, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Gjorsvik et al. for use in the vagina to apply germicidal light since it is explicitly suggested by Gjorsvik et al.
In regard to claim 19, Gjorsvik et al. disclose a method for vaginal light therapy of a patient (para 24 and 113), comprising: providing a treatment device comprising an elongate member 12 including a distal portion 10 carrying an expandable member 18,20 comprising a proximal end 14 attached to the elongate member 18,20 and an enclosed distal end 10 that extends over a distal tip 12 of the distal portion 10, the treatment devices comprising one or more light sources; inserting the distal portion into a vaginal canal with the expandable member in a contracted condition (suggested by para 63 and 137, catheter used in photodynamic treatment of viral, bacterial, or function infections in the inter surface of an organ such as the vagina);
expanding the expandable member within the vaginal canal (para 130, expandable member distends the organ);
activating the one or more light sources to emit light radially outwardly along the distal portion from the expandable member at one or more wavelengths within a range of germicidal light to treat one or more pathogens without injuring vaginal tissue (para 80); and
removing the device from the vaginal canal after treatment (not explicit, but implied, the device is not intended to be permanent).
Modification of Gjorsvik et al. for use for insertion in to the vaginal canal to apply germicidal is considered to have been obvious to one of ordinary skill in the art since Gjorsvik et al., explicitly suggest this use (para 137).
In regard to claims 2 and 10, Gjorsvik et al. in figures 1 and 2 show a device comprising an elongate member 12 with expandable balloons 18, 20 attached to the distal end 10 of elongate member 12 (para 89, 91, and 92). The balloons are expanded with inflation media similar to Gertner et al. The inflation media is introduced through conduit 44 (i.e., an inflation lumen) from an inflator (i.e., syringe 48) coupled to the conduit 44 at connector 46 (para 63 and 98). This is obvious since Gjorsvik et al. teaches that this is a typical arrangement for inflating as distally located expandable balloon.
In regard to claims 3 and 11, in Gjorsvik et al., when the syringe or other suitable device for providing inflation is coupled to the elongate member via connector 46, it is considered at that point to be “on” the elongate member. Additionally, alternatively to a syringe, another manually actuatable device such as an infusion bag may be used to deliver the inflation media. In this instance, a clip/clamp is incorporated to control (i.e., stop flow) (para 63). The clip/clamp is considered to be a suitable equivalent for a valve since the clip/clamp provides a similar function of starting and stopping flow. This is obvious since Gjorsvik et al. teaches this to allow for control of flow.
In regard to claims 4 and 12, Gjorsvik et al. teaches that the inflator may comprise a syringe or other manually actuatable device (para 63) to introduce inflation media. In view that a pump is defined as a device that raises, transfers, delivers, or compresses fluids or that attenuates gases by suction or pressure (Merriam-Webster dictionary), the syringe or manually actuatable device taught by Gjorsvik et al. for transferring inflation media is considered to satisfy the requirement of a manual pump. Since a manual pump is claimed as alternative to the motorized pump, it is considered that the manual pump is just as suitable as a motorized pump for the inflator, therefore the motorized pump would present an obvious alternative equivalent suitable for the intended use. Providing a pump type inflator to Gertner et al. is considered to have been obvious to one of ordinary skill in the art in order to transfer and deliver inflation media to the balloon.
In regard to claims 5 and 13, Gjorsvik et al. teaches that a syringe is a typical device for conveying/transferring inflation media to a balloon (para 63), and that the syringe may be filled to predetermined volume in order to achieve balloon expansion to a predetermined volume (para 90; e.g., an example is provided with preferential expansion parameters of a balloon to achieve a specified diameter with a specified volume of 3 mL, wherein it is considered that this suggests that the syringe may be preloaded with the specified amount of media to achieve the specified volume). Therefore, it is considered to have been obvious to one of ordinary skill in the art at the time of the invention to utilize a syringe as an inflator since Gjorsvik et al. teaches that a syringe is a typical device for transferring inflation media to a balloon. Additionally, filling the syringe to a predetermined volume is also considered to have been obvious to one of ordinary skill in the art at the time of the invention in order to control the expansion pressure and volume of the balloon.
In regard to claims 6, 14, and 21, in Gjosvik et al., the expandable members 18,20 comprises a balloon formed from elastic material such that the balloon at least partially conforms to the subject's anatomy when expanded (para 55).
In regard to claims 7, 15, and 22, in Gjosvik et al., the expandable member 18,20 comprises a balloon formed from elastic material (para 55) configured to dilate the subject's anatomy when expanded (para 130). It is considered that the expandable member 18,20 and light sources 22, 24, 26 irradiate the whole length of the intended cavity.
In regard to claims 8, 16, and 24, in Gjosvik et al., the plurality of light sources 22, 24, 26 comprise a plurality of LEDs mounted to the wall and spaced apart from one another on the distal portion (para 33, 93, 94, and figure 2).
Claim(s) 17, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gjorsvik et al. (US Publication no. 2018/0369603 – disclosed by Applicant) in view of Anderson et al. (US Patent no. 5,527,308 – previously cited).
In regard to claim 17, Gjosvik et al. is considered to substantially describe the invention as claimed however does not teach that the light sources comprise a plurality of optical light fibers with the ends spaced apart from one another to deliver light radially outwardly from the expandable member. Anderson et al. describes a light emitting catheter comprising an expandable member assembly 64 attached to a distal end 72 an elongate member 66 and surround light emitting fiber optic bundle 44 (i.e. a plurality of optical fibers). The expandable member 64 is formed from an optically transparent material to allow light from fibers 44 to be emitted to target tissue (col 9 lines 30-38, col 10 lines 14-16). Figure 4 of Anderson et al. shows that in the expanded state, fibers 44a and 44b expand and emit light outwardly from the elongate member 66 through the balloon 64 to the target tissue (col 8 lines 30-38), in this configuration the fibers are spaced apart from one another to deliver light. Anderson et al. is considered to demonstrate that a bundle of optical fibers is suitable for conveying light through an elongate member and therefore a suitable equivalent to a single light guide. The bundle of optical fibers provides the advantage of optimizing the uniformity of illumination along the expandable member. Modification of the single fiber optic light guide suggested by Gjosvik et al. for the plurality of fibers of Anderson et al. is considered to have been obvious to one of ordinary skill in the art at the time of the invention since the modification would comprise the substitution of a known element for a suitable alternative equivalent to yield an improvement for optimizing uniformity of light energy along the expandable member.
In regard to claim 18, in the embodiment of figure 12B, Gertner et al. teach that instead of using LEDs as light sources at the point of therapy, a fiber optic light guide may be substituted (para 226). Should the fiber optic light guide be used, the light source may be located at any point along the light guide, which the Examiner considers to suggest that an LED light source may be located in the handpiece section such as in figure 9D near where the inflation media is introduced (para 190) such as shown in the figure 1. In this manner, the light energy from light source would be internally transported along the light guide to be emitted from elements 416 at the point of therapy. It is therefore considered to have been obvious to one of ordinary skill in the art at the time of the invention to modify the location of the light source to be near the inflation means when using a fiber light guide since Gertner et al. teaches that the light source can be located along any point along the light guide.
In regard to claim 20, Gertner et al. at paragraphs 161 and 165 is considered to support use of the treatment device of figure 12B in view of 9D for use in a vaginal procedure. However, Gertner et al. does not teach that when inserting the treatment device into the vaginal canal, the expansion of the expandable member is monitored using external imaging. Anderson et al. teaches that the insertion and expansion of the device shown in figure 4 may be useful for placement in the uterus, wherein the device is inserted using ultrasonic guidance (col 9 lines 44-46). Ultrasonic guidance is considered a form of external imaging. Modification of the technique in Gertner et al. described at para 165 and 188 to use external imaging to aid in insertion and expansion of the treatment device is considered to have been obvious to one of ordinary skill in the art to assist the operator in proper placement at the target anatomical region and preventing injury to the patient.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gjorsvik et al. (US Publication no. 2018/0369603 – disclosed by Applicant) in view of Klang (US Patent no. 10,004,918 – previously cited).
In regard to claim 23, Gjorsvik et al. does not teach that when inserting the treatment device into the vaginal canal, the distal tip is positioned at the cervix. Klang describes a device for providing treatment to the vaginal cavity. The device shown in figure 1a includes a distal tip or cervix support 101 that Klang teaches is meant to place the device smoothly against the cervix (col 7 lines 20-22; and figure 2 reproduced below).
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The cervix is the upper most part of the vagina before entering the uterus. If the intent is to provide treatment to the vaginal canal, then the cervix would be an obvious boundary for the distal tip of the treatment device. Advancement of the treatment device beyond the cervix would place the device in the uterus which would not be an appropriate location for performing therapy to the vaginal cavity. Therefore, it is considered to have been obvious to one of ordinary skill in the art at the time of the invention to position the distal tip of the treatment device for treating the vagina adjacent the cervix since the cervix is the natural anatomical boundary delineating the vaginal cavity from the uterus ensuring proper placement of the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 2 February 2026