CTNF 18/698,758 CTNF 97631 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Information Disclosure Statement 06-52 The information disclosure statements (IDSs) submitted on 04/04/24 and 08/12/25 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. Response to Preliminary Amendment The preliminary amendment filed 06/02/26 has been entered. Claim 19 has been amended. Claims 1-18 and 20-22 are in the original/ previously presented form. Thus, claims 1-22 remain pending in the application. Drawings 06-36 AIA The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “heater” such as in claim 20 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15 AIA Claims 1- 5, 7, and 15 are re jected under 35 U.S.C. 102(a) (1) a s being an ticipated by Ha kim et al. (U.S. PGPUB No. 2018/0071502), hereinafter Hakim. Re garding claim 1, Hakim discloses an expandable vaginal dilator (see FIG. 2A, ‘Modified FIG. 2A’ below for immediate reference, and [0020] & [0026]) , comprising: PNG media_image1.png 601 557 media_image1.png Greyscale a stretchable sheath (202, see [0026-0028]) defining at least one fluid chamber (see ‘Modified FIG. 2A’ above and [0028]: “region bound by wall 202”) therein and being shaped and sized according to vaginal measurements (see FIG. 1 and [0020-0025]: vaginal dilator fabricated based on 3D measurements—see [0021]—of the vagina) ; and a support (206, see [0028]: central core 206, which aligns with Applicant disclosure in [0019] & [0030] defining the “support” as an inner rod) within the sheath (202) that seals and holds the sheath (202, see [0028]) and provides one or more fluid channels (see ‘Modified FIG. 2A’ above and [0028]: plurality of holes) configured for delivery of fluid into the at least one fluid chamber to expand the sheath (see [0026-0028]: plurality of holes to facilitate flow into chamber to inflate wall 202 to desired level shape) , wherein the support (206) is configured to permit vaginal insertion of the sheath when the sheath is in an unexpanded state and to stabilize the sheath during expansion of the sheath (see [0026-0028]) . Regarding claim 2, Hakim discloses the expandable vaginal dilator of claim 1, and Hakim further discloses wherein the sheath and support are sized and shaped according to a personalized patient measurement (see FIG. 1 and [0020-0025]: vaginal dilator fabricated based on individualized patient measurements) . Regarding claim 3, Hakim discloses the expandable vaginal dilator of claim 2, and Hakim further discloses wherein one or both of the sheath and support are sized and shaped according to a 3D measurement scan of a patient (see FIG. 1 and [0020-0025]: vaginal dilator fabricated based on individualized patient measurements, see [0021-0022] for 3D) . Regarding claim 4, Hakim discloses the expandable vaginal dilator of claim 1, and Hakim further discloses wherein the sheath (202, see FIG. 2A) is structured to provide differential expansion (see ‘Modified FIG. 2Ai’ below and [0027-0028]: sheath 202 inflated to desired level and/or shape). PNG media_image2.png 601 522 media_image2.png Greyscale Regarding claim 5, Hakim discloses the expandable vaginal dilator of claim 4, and Hakim further discloses wherein the differential expansion (see ‘Modified FIG. 2Ai’ above and [0027-0028]: sheath 202 inflated to desired level and/or shape) is set according to the 3D scan of the patient (see [0020-0025]: desired shape can be formed according to 3D scan) . Regarding claim 7, Hakim discloses the expandable vaginal dilator of claim 1, and Hakim further discloses wherein the sheath is formed of silicone (see [0023]: dilator of the disclosure formed of extrudable materials which include silicone) . Regarding claim 15, Hakim discloses the expandable vaginal dilator of claim 1, and Hakim further discloses wherein the support (206, see FIG. 2A) comprises an inner rod (central core forming 206) coaxial and within the sheath (202, as seen in FIG. 2A) that stabilizes (see [0026]) and seals (see [0027-0028]) the at least one fluid chamber (see ‘Modified FIG. 2A’above) at a proximal end opening (see openings filled by support in ‘Modified FIG. 2Aii’ below and 206 seals both ends because only way to inflate is by luer fluid communicating within 206 as described in [0027-0028]) , of the sheath (202) , PNG media_image3.png 609 406 media_image3.png Greyscale the rod (central core of 206) including a plurality of fluid channels (as shown in ‘Modified FIG. 2A’ above) arranged to introduce expansion fluid in the at least one fluid chamber (as described in [0027-0028]) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-22-aia AIA Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hakim as applied to claim 4 above, and further in view of Varma (U.S. PGPUB No. 2019/0142467) . Regarding claim 6, Hakim discloses the expandable vaginal dilator of claim 4, but Hakim is silent to “wherein the differential expansion is obtained according to thickness changes of the sheath in the longitudinal and circumferential directions along the sheath.” However, Varma teaches an expandable vaginal dilator (see FIG. 10 and [0009]: expandable device insertable vaginally as shown in FIGs. 6&7), comprising a stretchable sheath (12) defining at least one fluid chamber therein (see [0060]: balloon has inflation tube for providing fluid to inflate balloon and thus must have a fluid chamber for retaining fluid and inflating as shown from FIG. 2 to FIG. 5 and see [0081]: device of FIG. 10 has same structures as in FIG. 2 to 5, and therefore description of the embodiments of FIGs. 2-5 is referenced for like features not described again for FIG.10) , wherein the sheath (12, see FIG. 10) is structured to provide differential expansion (see [0082]: changing wall thickness adapts shape of balloon to mold to desired shape when contacting surface, such as a fetal head) , wherein the differential expansion is obtained according to thickness changes (see thickness 1,2,3 in ‘Modified FIG. 10’ below) of the sheath (12) in the longitudinal and circumferential directions (see longitudinal and circumferential directions in ‘Modified FIG. 10’ below) along the sheath (12, see ‘Modified FIG. 10’ below and [0082]: changing wall thickness adapts shape of balloon to mold to desired shape when contacting surface, such as a fetal head) . PNG media_image4.png 431 567 media_image4.png Greyscale Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the differential expansion of the sheath disclosed in Hakim to be obtained according to thickness changes of the sheath in the longitudinal and circumferential directions along the sheath as taught by Varma for the purpose of adapting the shape of the balloon to conform to a contacting surface (see [0082]) , such as a fetal head in Varma or the vaginal wall as in Hakim, thus achieving “wherein the differential expansion is obtained according to thickness changes of the sheath in the longitudinal and circumferential directions along the sheath.” 07-22-aia AIA Claim s 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Hakim as applied to claim 1 above, and further in view of Arcand et al. (U.S. PGPUB No. 2014/0107402), hereinafter Arcand . Regarding claim 8, Hakim discloses the expandable vaginal dilator of claim 1, but Hakim is silent to “ wherein the sheath comprises a therapeutic coating ”. However, Arcand teaches an expandable vaginal dilator (10, see FIG. 1C & 1D and [0012]) comprising a stretchable sheath (see device 10 ‘stretchable’ between expanded and contracted configurations such as shown in FIGs. 1C &1D and described as flexible in [0012-0014] & [0023]) , wherein the sheath (10) comprises a therapeutic coating (see [0030]: device 10 can have coating, such as for estrogen therapy release). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sheath disclosed in Hakim to include a therapeutic coating as taught by Arcand for the purpose of eluting a therapeutic agent to air in the treatment (see [0030]) , thus achieving “ wherein the sheath comprises a therapeutic coating ”. Regarding claim 9, the modified system of Hakim teaches the expandable vaginal dilator of claim 8, but Hakim is silent to “ wherein the therapeutic coating comprises a medication .” However, Arcand teaches an expandable vaginal dilator (10, see FIG. 1C & 1D and [0012]) comprising a stretchable sheath (see device 10 ‘stretchable’ between expanded and contracted configurations such as shown in FIGs. 1C &1D and described as flexible in [0012-0014] & [0023]) , wherein the sheath (10) comprises a therapeutic coating (see [0030]: device 10 can have coating, such as for estrogen therapy release), wherein the therapeutic coating comprises a medication (see [0030]). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sheath disclosed in Hakim to include a therapeutic coating comprising a medication as taught by Arcand for the purpose of eluting a therapeutic agent to air in the treatment (see [0030]) , thus achieving “ wherein the therapeutic coating comprises a medication .” 07-22-aia AIA Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hakim in view of Arcand as applied to claim 9 above, and further in view of Maloney (U.S. PGPUB No. 2002/0177582) . Regaridng claim 10, the modified system of Hakim teaches the expandable vaginal dilator of claim 9, but Hakim is silent to “ wherein the medication is selected from the group consisting of an estrogen cream, an anti-inflammatory, a topical cytokine, a topical steroid cream, and a vascular endothelial growth factor (VEGF).” However, Arcand teaches an expandable vaginal dilator (10, see FIG. 1C & 1D and [0012]) comprising a stretchable sheath (see device 10 ‘stretchable’ between expanded and contracted configurations such as shown in FIGs. 1C &1D and described as flexible in [0012-0014] & [0023]) , wherein the sheath (10) comprises a therapeutic coating (see [0030]: device 10 can have coating, such as for estrogen therapy release), wherein the therapeutic coating comprises a medication (see [0030]). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sheath disclosed in Hakim to include a therapeutic coating comprising a medication as taught by Arcand for the purpose of eluting a therapeutic agent to air in the treatment (see [0030]) , thus achieving wherein the therapeutic coating comprises a “medication .” Hakim in view of Arcand remain silent to the therapeutic coating comprising a medication such as for estrogen therapy release being wherein the medication “ is selected from the group consisting of an estrogen cream, an anti-inflammatory, a topical cytokine, a topical steroid cream, and a vascular endothelial growth factor (VEGF) .” However, Maloney teaches a medication selected from the group consisting of an estrogen cream (see [0007-0010]) , an anti-inflammatory, a topical cytokine, a topical steroid cream, and a vascular endothelial growth factor (VEGF) for delivery to the vagina by a sheath (11, see FIG. 1 and [0015]) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the therapeutic coating of medication for estrogen therapy disposed on the sheath taught by Hakim in view of Arcand to be specifically an estrogen cream as taught by Maloney for the purpose of using known available pharmaceutical compositions, such as a cream, for the administration of estrogen to the vagina (see [0007-0010]) , thus achieving wherein the medication “ is selected from the group consisting of an estrogen cream, an anti-inflammatory, a topical cytokine, a topical steroid cream, and a vascular endothelial growth factor (VEGF) .” 07-22-aia AIA Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hakim as applied to claim 1 above, and further in view of Sham (U.S. PGPUB No. 2020/0214617) . Regarding claim 11, Hakim teaches the expandable vaginal dilator of claim 1, but Hakim is silent to “ wherein the sheath comprises a strain sensor”. However, Sham teaches an expandable vaginal dilator (see [0008]: device is a vaginal therapeutic device (VTD) and see FIG. 5B and [0206-0210]: device in FIG. 5B is hodge type VTD) comprising a stretchable sheath (210, see [0211-0216], specifically [0214]: casing 510 is exterior body contact portion formed of silicone and is therefore inherently flexible), wherein the sheath (510) comprises a strain sensor (5100, see [0217]: sensors 5100 embedded in casing/sheath 510 and may be a strain sensor) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sheath disclosed in Hakim to include a strain sensor as taught by Sham for the purpose of ensuring that the expansion of the sheath aligns with the user physiology according to strain sensor measurements (see [0319-0320]) , thus achieving “ wherein the sheath comprises a strain sensor” . 07-22-aia AIA Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Hakim as applied to claim 1 above, and further in view of Hunter (U.S. PGPUB No. 2017/0196478) . Regarding claim 12, Hakim teaches the expandable vaginal dilator of claim 1, but Hakim is silent to “ wherein the sheath comprises a motion sensor”. However, Hunter teaches an expandable vaginal dilator (see [0054]: vaginal applications and [0067]: including balloon catheters which are expandable) with a stretchable sheath (see FIG. 3 and [0067-0068]) , wherein the sheath comprises a motion sensor (see [0015] and [0068]: motion sensors and accelerometers) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify [the sheath disclosed in Hakim to include a motion sensor as taught by Hunter for the purpose of accurately determining any movement of the expandable sheath during placement by a physician (see [0015] & [0070]), thus achieving “ wherein the sheath comprises a motion sensor” . 07-22-aia AIA Claims 1 3-14 are re jected under 35 U.S.C. 103 as being unpatentable over Ha kim as applied to claim 1 a b ove, and further in view of Sh arma et al. (U.S. PGPUB No. 2016/0354140), hereinafter Sharma. Re garding claim 13, Hakim discloses the expandable vaginal dilator of claim 1, but Hakim is silent to “ wherein the at least one fluid chamber comprises at least two independent fluid chambers ”. However, Sharma teaches an expandable vaginal dilator (see catheter inserted via vagina into uterus in FIG. 7A and [0511]) comprising a stretchable sheath (positioning elements 738j and 775 in FIG. 7J. see [0075]: “positioning elements”—such as 738j and 775-- include expandable elements such as balloons) , wherein the stretchable sheath defines at least one fluid chamber (775 and 738j have individually inflated chambers via inflation ports as described in FIG. 3F in [0498]. [0498] describes embodiments with venting tubes/ports, similar to venting ports 791/792 in FIG. 7J and [0527]) therein, wherein the at least one fluid chamber comprises at least two independent fluid chambers (chambers of 775 and 738j, see ‘Modified FIG. 7j’ below for further visual) . PNG media_image5.png 651 523 media_image5.png Greyscale Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sheath disclosed in Hakim to include two independent fluid chambers as taught by Sharma for the purpose of providing two separate expandable elements to aid in the positioning of the device (see [0066]) , thus achieving “ wherein the at least one fluid chamber comprises at least two independent fluid chambers ”. Regarding claim 14, the modified system of Hakim teaches the expandable vaginal dilator of claim 13, but Hakim is silent to “ wherein the two independent fluid chambers comprise a tip chamber and a base chamber, and the support comprises a separate tip and base support .” However, Sharma teaches an expandable vaginal dilator (see catheter inserted via vagina into uterus in FIG. 7A and [0511]) comprising a stretchable sheath (positioning elements 738j and 775 in FIG. 7J. see [0075]: “positioning elements”—such as 738j and 775-- include expandable elements such as balloons) , wherein the stretchable sheath defines at least one fluid chamber (775 and 738j have individually inflated chambers via inflation ports as described in FIG. 3F in [0498]. [0498] describes embodiments with venting tubes/ports, similar to venting ports 791/792 in FIG. 7J and [0527]) therein, wherein the at least one fluid chamber comprises at least two independent fluid chambers (chambers of 775 and 738j, see ‘Modified FIG. 7j’ above for further visual), wherein the two independent fluid chambers comprise a tip chamber (738j, see FIG. 7J and [0527]) and a base chamber (775) , and a support (774 & 735j) , wherein the support comprises a separate tip (735j) and base support (774) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sheath disclosed in Hakim to include two independent fluid chambers with a tip chamber and a base chamber as taught by Sharma for the purpose of providing two separate expandable elements to aid in the positioning of the device (see [0066]) , thus achieving “ wherein the at least one fluid chamber comprises at least two independent fluid chambers, wherein the two independent fluid chambers comprise a tip chamber and a base chamber ”. Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the support of the sheath taught by Hakim in view or Sharma to include a separate tip and base support as taught by Sharma for the purpose of allowing the two chambers of the sheath to be individually controlled via the respective supports (see [0066]) , thus achieving “ and the support comprises a separate tip and base support ” . 07-22-aia AIA Claim s 16-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hakim as applied to claim 1 above, and further in view of Hardart et al. (U.S. PGPUB No. 2021/0315730), hereinafter Hardart . Regarding claim 16, Hakim discloses the expandable vaginal dilator of claim 1, but Hakim is silent to “ comprising one or more shaped structures arranged on the sheath to provide for predetermined amounts of expansion in predetermined directions or locations and different amounts in other locations .” However, Hardart teaches an expandable vaginal dilator (see FIG. 4A) , the dilator comprising a stretchable sheath (12) and comprising one or more shaped structures (27, 28, 29, 30, see [0028-0033]) arranged on (see [0031]) the sheath (12) to provide for predetermined amounts of expansion in predetermined directions or locations and different amounts in other locations (see [0017], [0021], & [0030-0031]) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sheath disclose din Hakim to include one or more shaped structures arranged on the sheath to provide for predetermined amounts of expansion as taught by Hardart for the purpose of physically modeling the internal geometry of the wall of the vaginal cavity (see [0033]) , thus achieving “ comprising one or more shaped structures arranged on the sheath to provide for predetermined amounts of expansion in predetermined directions or locations and different amounts in other locations ”. Regarding claim 17, the modified device of Hakim teaches the expandable vaginal dilator of claim 16, but Hakim is silent to “ wherein the one or more shaped structures are located and sized according to a vaginal physical exam to conform to the vaginal canal of the patient and a dilation treatment plan .” However, Hardart teaches an expandable vaginal dilator (see FIG. 4A) , the dilator comprising a stretchable sheath (12) and comprising one or more shaped structures (27, 28, 29, 30, see [0028-0033]) arranged on (see [0031]) the sheath (12) to provide for predetermined amounts of expansion in predetermined directions or locations and different amounts in other locations (see [0017], [0021], & [0030-0031]) , wherein the one or more shaped structures (27-30, see [0028-0033]) are located and sized according to a vaginal physical exam to conform to the vaginal canal of the patient and a dilation treatment plan (see [0005] & [0028-0033]) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sheath disclose din Hakim to include one or more shaped structures arranged on the sheath to provide for predetermined amounts of expansion as sized according to a vaginal physical exam as taught by Hardart for the purpose of physically modeling the internal geometry of the wall of the vaginal cavity (see [0033]) , thus achieving “ wherein the one or more shaped structures are located and sized according to a vaginal physical exam to conform to the vaginal canal of the patient and a dilation treatment plan. ” Regarding claim 19, Hakim discloses a vaginal dilator system including an expandable vaginal dilator of claim 1, and Hakim discloses the system comprising the support to controllably supply expansion fluid into the at least one fluid chamber (see FIG. 2A and [0026-0028]: luer lock connector 204 inflates fluid chamber via support plurality of holes) . Hakim is silent to the system comprising “ a bidirectional peristaltic pump in fluidic communication with an expansion fluid reservoir; pressure, volume and/or strain sensors to monitor expansion of the at least one fluid chamber; and a feedback system that adjusts the expansion according to pressure measurements provide by pressure, volume, and/or strain sensing .” However, Hardart teaches a vaginal dilator system (see FIG. 3) including an expandable vaginal dilator (see [0005-0006]) , the system comprising a bidirectional peristaltic pump (87, see [0023]: reversible peristaltic pump) in fluidic communication with an expansion fluid reservoir (85, see [0024]) ; pressure, volume and/or strain sensors to monitor expansion of an at least one fluid chamber (see [0026]: pressure gauge for monitoring pressure in each fluid chamber/balloon, thus each balloon must have some kind of pressure sensor) ; and a feedback system that adjusts the expansion according to pressure measurements provide by pressure, volume, and/or strain sensing (see [0026]: pressure data provided to physician that adjust expansion or [0027]: system can adjustable inflate and deflate according to pressure measurements) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed in Hakim to include a bidirectional peristaltic pump in fluidic communication with an expansion fluid reservoir; pressure, volume and/or strain sensors to monitor expansion of the at least one fluid chamber; and a feedback system that adjusts the expansion according to pressure measurements provide by pressure, volume, and/or strain sensing as taught by Hardart for the purpose of automatically inflating the fluid chamber to a desired pressure according to patient anatomy (see [0027]) , which would be advantageous to Hakim that appears to rely on manual inflation, thus achieving “ a bidirectional peristaltic pump in fluidic communication with an expansion fluid reservoir; pressure, volume and/or strain sensors to monitor expansion of the at least one fluid chamber; and a feedback system that adjusts the expansion according to pressure measurements provide by pressure, volume, and/or strain sensing .” 07-22-aia AIA Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Hakim as applied to claim 1 above, and further in view of Jayol (U.S. PGPUB No. 2019/0262591) . Regarding claim 18, Hakim discloses the expandable vaginal dilator of claim 1, but Hakim is silent to “comprising a vibration motor.” However, Jayol teaches an expandable vaginal dilator (see FIG. 28C and [0004-0006]) comprising a vibration motor (22, see [0113]) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the expandbale vaginal dilator disclosed by Hakim to include a vibration motor as taught by Jayol for the purpose of enhancing the dilation at the region by stimulating muscles and ligaments (see [0145]) , thus achieving “comprising a vibration motor.” 07-22-aia AIA Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Hakim in view of Hardart as applied to claim 19 above, and further in view of Cioanta et al. (U.S. PGPUB No. 2004/0172112), hereinafter Cioanta . Regarding claim 20, the modified system of Hakim teaches the system of claim 19, but Modified Hakim is silent to “ comprising a heater for the expansion fluid, wherein the feedback system regulates temperature of the expansion fluid .” However, Cioanta teaches a system (see Figure 3) with a fluid chamber inflated by an expansion fluid (see [0027] and [0056]) , the system comprising a heater (57) for the expansion fluid (see [0027]) , wherein a feedback system regulates temperature of the expansion fluid (see [0027], [0029], and [0056]) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system delivering the expansion fluid from the expansion fluid reservoir and having feedback system taught by Modified Hakim to include a heater for the expansion fluid, wherein the feedback system regulates temperature of the expansion fluid as taught by Cionata for the purpose of controlling the inflation fluid temperature in a closed loop system (see [0056]) to provide increased therapeutic responsiveness via delivery of heat (see [0016-0017]) , thus achieving “ comprising a heater for the expansion fluid, wherein the feedback system regulates temperature of the expansion fluid .” 07-22-aia AIA Claim 2 1 is r ejected under 35 U.S.C. 103 as being unpatentable over H akim in view of Hardart and Cioanta a s applied to claim 2 0 a bove, and further in view of S harma (U.S. PGPUB No. 2016/0354140). R egarding claim 21, the modified system of Hakim teaches the system of claim 20, but Modified Hakim is silent to “ wherein the temperature is regulated to be approximately 38 °C- 39°C .” However, Sharma teaches a vaginal dilator system (see [0511]) . Sharma further teaches that a device temperature that is regulated to be approximately 38 °C- 39°C will have no effect on contacting tissue ( see [0494] and Table 1 ). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the temperature regulation of the fluid taught by Modified Hakim to be within the range of 38 and 39 degree C as taught by Sharma to ensure that no significant tissue effect occurs where the device is inserted (see [0494] with Table 1—i.e.: no ablative effect is happening) , thus achieving “ wherein the temperature is regulated to be approximately 38 °C- 39°C ” . 07-22-aia AIA Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Hakim in view of Hardart as applied to claim 19 above, and further in view of Ziarno et al. (U.S. PGPUB No. 2013/0053657), hereinafter Ziarno . Regarding claim 22, the modified system of Hakim teaches the system of claim 19, but Modified Hakim is silent to “ comprising a telemedicine communications module .” However, Ziarno teaches a vaginal system (see FIG. 1 and [0019-0021]) comprising a vaginal device (105, see [0073]), the system comprising a telemedicine communications module (151, see [0073]) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the vaginal dilator system taught by Modified Hakim to include a telemedicine communications module as taught by Ziarno for the purpose of providing data to healthcare professionals to assist in diagnosis and/or treatment delivered with the device (see [0073]) , thus achieving “ comprising a telemedicine communications module .” Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783 /MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783 Application/Control Number: 18/698,758 Page 2 Art Unit: 3783 Application/Control Number: 18/698,758 Page 3 Art Unit: 3783 Application/Control Number: 18/698,758 Page 5 Art Unit: 3783 Application/Control Number: 18/698,758 Page 6 Art Unit: 3783 Application/Control Number: 18/698,758 Page 7 Art Unit: 3783 Application/Control Number: 18/698,758 Page 8 Art Unit: 3783 Application/Control Number: 18/698,758 Page 9 Art Unit: 3783 Application/Control Number: 18/698,758 Page 10 Art Unit: 3783 Application/Control Number: 18/698,758 Page 11 Art Unit: 3783 Application/Control Number: 18/698,758 Page 12 Art Unit: 3783 Application/Control Number: 18/698,758 Page 13 Art Unit: 3783 Application/Control Number: 18/698,758 Page 14 Art Unit: 3783 Application/Control Number: 18/698,758 Page 15 Art Unit: 3783 Application/Control Number: 18/698,758 Page 16 Art Unit: 3783 Application/Control Number: 18/698,758 Page 18 Art Unit: 3783 Application/Control Number: 18/698,758 Page 19 Art Unit: 3783 Application/Control Number: 18/698,758 Page 21 Art Unit: 3783 Application/Control Number: 18/698,758 Page 22 Art Unit: 3783
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