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 .
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 final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/19/2025 has been entered.
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.
Claim(s) 1-2, 5-6 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kaneaki et al. (JP2019130258A) in view of Xing et al. (WO2019/223189 A1) and further in view of Herman et al. U.S. Patent No. (6,350,463 B1).
With respect to claim 1, Kaneaki et al. substantially discloses an insertable vaginal sheath for the alleviation of vulvovaginal pain during penetration sexual intercourse (abstract), the insertable vaginal sheath comprising:
a) a tubular structure (cylindrical pouch structure, Abstract; main body 18 forms tubular structure, fig. 2) having an inner wall surface (inner wall inside main body 18, fig. 2) and an outer wall surface (outer wall of main body 18, fig. 2);
b) the tubular structure further comprising a wall thickness between the inner wall surface and the outer wall surface thickness of main body 18 is approximately 1.5 mm, ([Page 3, 1st paragraph]) and fig. 2).
Kaneaki substantially discloses the invention as claimed except the tubular structure further comprising a hydrogel material.
Xing et al., however, teaches a PVA hydrogel for manufacture of condom [Abstract]. The PVA is biodegradable ([Page 2], 3rd paragraph) and provides excellent mechanical properties, shape memory, hydrophilicity, biocompatibility ([Page 4], 1st and 4th paragraph).
In view of the teachings of Xing et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the condom of Kaneaki by forming the condom using a hydrogel material that provides excellent mechanical properties, shape memory, hydrophilicity, biocompatibility ([Page 4], 1st and 4th paragraph).
The combination of Kaneaki/ Xing et al. substantially discloses the invention as claimed except the hydrogel material comprising a carrageenan and koniac gum mixture.
Herman et al., however, teaches a device to be applied to one or more of the uterine wall or cervix ([Col.4], lines 8-13) made from hydrogel ([Col.9], lines 30-31); hydrogels are known materials that are a preferred fluent material for formation of a barrier material in the invention. Hydrogels have numerous properties favorable to their use in this application, which include excellent biocompatibility; low, controlled rates of water migration through a gel; controllable strength, elasticity, degree of swelling and gelatinization, and pre-gelation viscosity; and the ability to be cast in place to ensure conformal fitting to the available spaces. Suitable hydrogels may be either biodegradable or non-degradable; if degradable, their strength and other key properties should not change significantly for several weeks, preferably for one to two months, and more preferably for about four months or more; Hydrogels suitable for the use of the invention, and methods for their formation, are known. A wide variety of hydrogels are known which may satisfy the above criteria. Hydrogels formed of natural gel-forming polysaccharide and protein polymers can serve a barrier function. These polymers are believed to be of low toxicity, and the polymerization to form a gel is in many cases spontaneous. Such polymers include, among others, agarose, alginate, pectin, xanthan, gellan, carrageenan, konjac glucomannan, galactomannans, chitosan, hyaluronic acid, collagen, and gelatin ([Col.9], lines 30-56).
The invention of the instant application and the prior art drawn to Herman et al. is being utilize within the same environment (the female reproductive system) and are interacting with tissues of the reproductive system to provide biocompatibility; therefore, in view of the teachings of Herman et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the hydrogel material of Kaneaki/ Xing et al. by incorporating a carrageenan and koniac gum mixture which serves as a serve a barrier function and in addition, to be of low toxicity and biocompatible ([Col.9], lines 1-6 and 47-48) of Herman et al.
With respect to claim 2, the combination of Kaneaki/Xing et al./Herman et al. substantially discloses the invention as claimed. Kaneaki further discloses the tubular structure further comprises a proximal end portion (proximal end portion of main body 18 at seat 14, fig. 2) wherein a flange extends outwardly from the proximal end portion of the tubular structure (seat 14 extends outwardly, fig. 2).
With respect to claim 5, the combination of Kaneaki/Xing et al./Herman et al. substantially discloses the invention as claimed. Kaneaki et al. further discloses the inner wall surface of the tubular structure further comprises a textured surface (protrusion structures 21 can be formed on the inner surfaces, ([Page 3], 1st paragraph]; fig. 2).
With respect to claim 6, the combination of Kaneaki/Xing et al./Herman et al. substantially discloses the invention as claimed. Kaneaki et al. further discloses the outer wall surface further comprises an annular ring extending outwardly from a periphery of a central portion of the tubular structure (seat 14 extends outwardly from a periphery of main body 18, fig. 2).
With respect to claim 20, the combination of Kaneaki/Xing et al./Herman et al. substantially discloses the invention as claimed except the hydrogel material has a degradation rate such that the tubular structure is maintained at least 20 minutes of time after insertion, however, the PVA hydrogel taught by Xing et al. is biodegradable that provides excellent mechanical properties, shape memory, hydrophilicity, biocompatibility, therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to recognize that the hydrogel would maintain the tubular structure for at least 20 minutes, during sexual intercourse or sexual act(s), when exposed to one or multiple factors of friction, heat, and vaginal fluids with a reasonable expectation of success.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kaneaki/Xing et al./Herman et al. as applied to claim 1 above, and further in view of Dhanjal U.S. Publication No. (2011/0139161 A1).
With respect to claim 3, the combination of Kaneaki/Xing et al./Herman et al. substantially discloses the invention as claimed except the wall thickness of the tubular structure is at least 3mm.
Dhanjal however, teaches a condom comprising a typical wall thickness T1 for embodiments targeting PME will be preferably less than 3 mm but can be higher for certain design variations [0083]. Dhanjal fairly suggests and teaches adding thickness to the wall of the condom primarily for increasing girth of the penis [0083]-[0084].
In view of the teachings of Dhanjal, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the wall thickness of Kaneaki/Xing et al./Herman et al. by optimizing the thickness of at least 3 mm for increasing girth of the penis by adding thickness the wall of the condom.
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kaneaki/Xing et al./Herman et al. as applied to claim 1 above, and further in view of Schwartz U.S. Patent No. (5,513,652).
With respect to claim 4, the combination of Kaneaki/Xing et al./Herman et al. substantially discloses the invention as claimed except the inner wall surface further comprises a recessed channel extending from a proximal portion of the inner wall surface of the tubular structure to a distal portion of the inner wall surface of the tubular structure to define an air pocket.
Schwartz however, teaches a condom for assisting and establishing and maintaining male erectile function (abstract) comprising an internal chamber (28, figs.8-10) extending from the proximal end to the distal end which is filled with gas in order to provide external pressure and penile support ([Col.5], lines 55-67) and ([Col.6], lines 1-7).
In view of the teachings of Schwartz, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the inner wall surface of Kaneaki/Xing et al./Herman et al. by incorporating a recessed channel extending from a proximal portion of the inner wall surface of the tubular structure to a distal portion of the inner wall surface of the tubular structure to define an air pocket in order to provide external pressure and penile support.
Claim(s) 7, 9-11 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Kaneaki et al. (JP2019130258A) in view of Dhanjal U.S. Publication No. (2011/0139161 A1).
With respect to claim 7, Kaneaki et al. substantially discloses an insertable apparatus for the alleviation of vulvovaginal pain (Abstract), the insertable apparatus (instrument 10, Fig. 2) comprising:
a) a tubular structure (cylindrical pouch structure, Abstract; main body 18 forms tubular structure, as shown in fig. 2) having an inner wall surface (inner wall inside main body 18, Fig. 2) and an outer wall surface (outer wall of main body 18, Fig. 2), wherein:
b) the outer wall surface is dimensioned to be insertable within a vaginal canal (device protects the vaginal canal, (abstract); instrument 10 inserted into vagina, ([Page 4, 2nd paragraph]) and, upon insertion, to frictionally engage a surface of the vaginal canal during sexual intercourse (projection structures 21 capable of frictionally engaging with the vaginal canal, fig. 2; penis inserted, ([Page 4, 2nd paragraph]);
c) the inner wall surface is dimensioned to be capable of enabling penetration therein during sexual activity (penis inserted into device, ([Page 4, 2nd paragraph, on the other hand, because the body part 18 can largely block friction and compression shock due to drawing motion, it can protect the vaginal tract, improve sexual intercourse pain]); and
d) the tubular structure further comprising a force diffusion and dispersion property (device transmits/reduces friction as well as compressive impact, ([Page 4, 2nd paragraph], body part 18 can largely block friction and compression shock due to drawing motion) comprising a predetermined combination of a material composition of the tubular structure (instrument 10 is made of medical grade silicone rubber, ([Page 2, last paragraph]) and a wall thickness of the tubular structure the predetermined combination being capable of alleviating vulvovaginal pain during sexual intercourse (thickness of main body 18 is approximately 1.5 mm, ([Page 3, 1st paragraph]); fig. 2; device mitigates sexual pain by protecting the vaginal canal (abstract).
Kaneaki et al. substantially discloses the invention as claimed except the wall thickness is at least 2.5mm.
Dhanjal however, teaches a condom comprising a typical wall thickness T1 for embodiments targeting PME will be preferably less than 3 mm but can be higher for certain design variations [0083]. Dhanjal fairly suggests and teaches adding thickness to the wall of the condom primarily for increasing girth of the penis [0083]-[0084].
In view of the teachings of Dhanjal, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the wall thickness of Kaneaki et al. by optimizing the thickness of at least 2.5 mm for increasing girth of the penis by adding thickness the wall of the condom.
With respect to claim 9, the combination of Kaneaki et al./Dhanjal substantially discloses the invention as claimed. Kaneaki et al. further discloses the tubular structure further comprises an annular ring extending outwardly from a periphery of the outer wall surface of the tubular structure (seat 14 extends outwardly from a periphery of main body 18, fig. 2).
With respect to claim 10, the combination of Kaneaki et al./Dhanjal substantially discloses the invention as claimed. Kaneaki et al. further discloses the tubular structure further comprises a recessed channel extending along at least a portion of the inner wall surface (channel formed at crease 19, Fig. 2) and ([Page 3], 3rd paragraph].
With respect to claim 11, the combination of Kaneaki et al./Dhanjal substantially discloses the invention as claimed. Kaneaki et al. further discloses the tubular structure further comprises a textured surface on the inner wall surface thereof (protrusion structures 21 can be formed on the inner surfaces, ([Page 3], 1st paragraph] and Fig. 2).
With respect to claim 14, the combination of f Kaneaki et al./Dhanjal substantially discloses the invention as claimed. Kaneaki et al. further discloses the material composition of the tubular structure is a non-hydrogel (instrument 10 is made of medical grade silicone rubber, ([Page 2, last paragraph]) except the wall thickness is at least 3mm.
Dhanjal however, teaches a condom comprising a typical wall thickness T1 for embodiments targeting PME will be preferably less than 3 mm but can be higher for certain design variations [0083]. Dhanjal fairly suggests and teaches adding thickness to the wall of the condom primarily for increasing girth of the penis [0083]-[0084].
In view of the teachings of Dhanjal, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the wall thickness of Kaneaki et al. by optimizing the thickness of at least 3 mm for increasing girth of the penis by adding thickness the wall of the condom.
With respect to claim 15, the combination of Kaneaki et al./Dhanjal substantially discloses the invention as claimed. Kaneaki et al. further discloses tubular structure further comprises a distal portion defining a receptacle (distal portion of main body 18 has apex 16 which forms a receptacle, Figs. 2 and 5) and ([Page 3], 3rd paragraph] and having contraceptive properties (main body 18 can block impacts caused by extraction and thus functions as a contraceptive, ([Page 4], 2nd paragraph); material of apex 16 thus imparts contraceptive property by maintaining a barrier, Figs. 2 and 5).
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kaneaki et al./ Dhanjal as applied to claim 7 above, and further in view of Xing et al. (WO2019/223189 A1).
With respect to claim 8, the combination of Kaneaki et al./Dhanjal substantially discloses the wall thickness of the tubular structure is at least 3mm [0083] of Dhanjal except the material composition of the tubular structure is a hydrogel.
Xing et al., however, teaches a PVA hydrogel for manufacture of condom [Abstract]. The PVA is biodegradable ([Page 2], 3rd paragraph) and provides excellent mechanical properties, shape memory, hydrophilicity, biocompatibility ([Page 4], 1st and 4th paragraph).
In view of the teachings of Xing et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the condom of Kaneaki et al./ Dhanjal by forming the condom using a hydrogel material that provides excellent mechanical properties, shape memory, hydrophilicity, biocompatibility ([Page 4], 1st and 4th paragraph).
Claim(s) 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Kaneaki et al./Dhanjal as applied to claim 11 above, and further in view of Preslicka U.S. Patent No. (11,534,332).
With respect to claim 12, the combination of Kaneaki et al./Dhanjal substantially discloses the invention as claimed except the textured surface is a ribbed pattern.
Preslicka however, in the field of condoms (Abstract) and teaches a textured surface is a ribbed pattern (radial ribs 28, Fig. 1) and ([Col.3], lines 5-8).
In view of the teachings of Preslicka, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the tubular surface of Kaneaki et al./Dhanjal such that the textured surface is a ribbed pattern for the purpose of providing a gradually increasing impedance to the flow of blood through the profunda and dorsal arteries as the blood flows from the first end of the sheath towards the second end of the sheath ([Col.3], lines 29-33) of Preslicka.
With respect to claim 13, the combination of Kaneaki et al./Dhanjal/Preslicka substantially discloses the invention as claimed. Kaneaki et al. further discloses the tubular structure further comprises a lubrication layer on the outer wall surface (lubricant applied in advance to the vaginal opening or the tip of main body 18, ([Page 4], 1st paragraph) and figs. 2 and 5).
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Kaneaki et al./Dhanjal as applied to claim 10 above, and further in view of Xing et al. (WO2019/223189 A1).
With respect to claim 16, the combination of Kaneaki et al./Dhanjal substantially discloses the invention as claimed except the material composition of the tubular structure is the hydrogel that maintains the tubular structure for at least 10 minutes when exposed to one or multiple factors of friction, heat, and vaginal fluids.
Xing et al., however, teaches a PVA hydrogel for manufacture of condom [Abstract]. The PVA is biodegradable ([Page 2], 3rd paragraph) and provides excellent mechanical properties, shape memory, hydrophilicity, biocompatibility ([Page 4], 1st and 4th paragraph).
In view of the teachings of Xing et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the condom of Kaneaki et al./Dhanjal by forming the condom using a hydrogel material that provides excellent mechanical properties, shape memory, hydrophilicity, biocompatibility ([Page 4], 1st and 4th paragraph).
The combination of Kaneaki et al./Dhanjal/Xing et al. substantially discloses the invention as claimed except the hydrogel that maintains the tubular structure for at least 10 minutes when exposed to one or multiple factors of friction, heat, and vaginal fluids, however, the PVA hydrogel taught by Xing et al. is biodegradable that provides excellent mechanical properties, shape memory, hydrophilicity, biocompatibility, therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to recognize that the hydrogel would maintain the tubular structure for at least 10 minutes, during sexual intercourse or sexual act(s), when exposed to one or multiple factors of friction, heat, and vaginal fluids with a reasonable expectation of success.
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kaneaki et al./Dhanjal as applied to claim 7 above, and further in view of Xing et al. (WO2019/223189 A1) and further in view of Herman et al. U.S. Patent No. (6,350,463 B1).
With respect to claim 17, the combination of Kaneaki et al./Dhanjal substantially discloses the invention as claimed except (1) the material composition of the tubular structure comprises a hydrogel (2) comprising a carrageenan and konjac gum mixture.
Xing et al., however, teaches a PVA hydrogel for manufacture of condom [Abstract]. The PVA is biodegradable ([Page 2], 3rd paragraph) and provides excellent mechanical properties, shape memory, hydrophilicity, biocompatibility ([Page 4], 1st and 4th paragraph).
In view of the teachings of Xing et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the condom of Kaneaki et al./Dhanjal by forming the condom using a hydrogel material that provides excellent mechanical properties, shape memory, hydrophilicity, biocompatibility ([Page 4], 1st and 4th paragraph).
The combination of Kaneaki et al./Dhanjal/Xing et al. substantially discloses the invention as claimed except the hydrogel comprising a carrageenan and konjac gum mixture.
Herman et al., however, teaches a device to be applied to one or more of the uterine wall or cervix made from hydrogel; hydrogels are known materials that are a preferred fluent material for formation of a barrier material in the invention. Hydrogels have numerous properties favorable to their use in this application, which include excellent biocompatibility; low, controlled rates of water migration through a gel; controllable strength, elasticity, degree of swelling and gelatinization, and pre-gelation viscosity; and the ability to be cast in place to ensure conformal fitting to the available spaces. Suitable hydrogels may be either biodegradable or non-degradable; if degradable, their strength and other key properties should not change significantly for several weeks, preferably for one to two months, and more preferably for about four months or more; Hydrogels suitable for the use of the invention, and methods for their formation, are known. A wide variety of hydrogels are known which may satisfy the above criteria. Hydrogels formed of natural gel-forming polysaccharide and protein polymers can serve a barrier function. These polymers are believed to be of low toxicity, and the polymerization to form a gel is in many cases spontaneous. Such polymers include, among others, agarose, alginate, pectin, xanthan, gellan, carrageenan, konjac glucomannan, galactomannans, chitosan, hyaluronic acid, collagen, and gelatin ([Col.9], lines 30-56).
The invention of the instant application and the prior art drawn to Herman et al. is being utilize within the same environment and interacting the tissues of the reproductive system; therefore, in view of the teachings of Herman et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the hydrogel material of Kaneaki/ Xing et al. by incorporating a carrageenan and koniac gum mixture which serves as a serve a barrier function and in addition, to be of low toxicity.
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Kaneaki et al./Dhanjal as applied to claim 7 above, and further in view of Xing et al. (WO2019/223189 A1) and further in view of Sternberg et al. U.S. Publication No. (2021/0000742 A1).
With respect to claim 18, the combination of Kaneaki et al./Dhanjal substantially discloses the invention as claimed except (1) the material composition of the tubular structure comprises a hydrogel (2) comprising and a carrageenan and locust bean gum mixture.
Xing et al., however, teaches a PVA hydrogel for manufacture of condom [Abstract]. The PVA is biodegradable ([Page 2], 3rd paragraph) and provides excellent mechanical properties, shape memory, hydrophilicity, biocompatibility ([Page 4], 1st and 4th paragraph).
In view of the teachings of Xing et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the condom of Kaneaki et al./Dhanjal by forming the condom using a hydrogel material that provides excellent mechanical properties, shape memory, hydrophilicity, biocompatibility ([Page 4], 1st and 4th paragraph).
The combination of Kaneaki et al./Dhanjal/Xing et al. substantially discloses the invention as claimed except the hydrogel comprising a carrageenan and locust bean gum mixture.
Sternberg et al., however, teaches in [0092] the present invention provides a delivery device adapted to be inserted into a pelvic anatomical canal of a human subject so as to dilate the pelvic anatomical canal. The device comprises a gel, preferably a hydrogel or a gel comprising an oil-in-water emulsion prior to gelation/solidification, which gel comprises a hydrophilic agent and/or a hydrophobic agent, each agent having a beneficial or therapeutic effect in the pelvic anatomical canal. The present invention further provides methods for vaginal dilation and/or for treating female sexual dysfunction and/or improving female sexual wellness comprising a step of inserting the delivery device of the present invention into the vagina of said woman, thereby dilating the vaginal canal. Sternberg et al. further teaches in According to some embodiments, the delivery device comprises a composition comprising: [0177] (a) a naturally occurring polysaccharide selected from the group consisting of locust bean gum, carrageenan, gellan gum, agar, gum karaya, gum arabic, gum tragacanth, guar gum, konjac gum, pectin, xanthan gum, welan gum, native or modified starch, inulin, cellulose derivatives, chitin, chitosan, and alginates or a combination thereof; [0178] (b) water in an amount of about 60% to 88% by weight of the composition; [0179] (c) a nonionic surfactant in an amount of 0% to about 5% by weight of the composition; [0180] (d) a naturally occurring vegetable oil selected from the group consisting of coconut oil, canola oil, almond oil, castor oil, corn oil, olive oil, peanut oil, safflower oil, shia oil, soybean oil, sesame seed oil, sunflower oil, and walnut oil, or mixtures thereof in an amount of 0% to about 40% by weight of the composition; [0181] (e) a cross-linking agent; and [0182] (f) a hydrophilic agent and/or a hydrophobic agent, each having a beneficial or therapeutic effect in the pelvic anatomical canal, [0183] wherein the composition being formulated in the form of a gel. In addition, [0109] and [0030, the naturally occurring polysaccharide is locust bean gum, carrageenan, gellan gum, or a combination thereof].
In view of the teachings of Sternberg et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the hydrogel composition of Kaneaki et al./Dhanjal/Xing et al. by incorporating a carrageenan and locust bean gum mixture since the naturally occurring polysaccharides are generally recognized as safe (GRAS), the delivery devices of the present invention have self-lubrication effects, thus reducing discomfort, pain and/or injury during insertion of the devices into the vagina, and hence enhance compliance [0018] of Sternberg et al.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Kaneaki/Xing et al./Herman et al. as applied to claim 1 above, and further in view of Patterson et al. U.S. Publication No. (2008/0234642 A1).
With respect to claim 19, the combination of Kaneaki/Xing et al./Herman et al. substantially discloses the invention as claimed except the tubular structure further comprises a padded wall thickness at a distal end of the tubular structure, wherein the padded wall thickness has a greater wall thickness than the wall thickness of the tubular structure.
Patterson et al., however, teaches a condom (5) comprising a padded wall (figs.2-3) at the distal end of the condom and the padded wall thickness has a greater wall thickness than the wall thickness of the tubular structure (as shown in figs.2-3).
In view of the teachings of Patterson et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the tubular structure of Kaneaki/Xing et al./Herman et al. by incorporating a padded wall thickness at a distal end of the tubular structure, wherein the padded wall thickness has a greater wall thickness than the wall thickness of the tubular structure that offers security from inadvertent urine release.
Response to Arguments
Applicant’s arguments, see pages 1-5, filed 12/19/2025, with respect to the rejection(s) of directed to the prior art drawn to Uexkull et al. and Jun et al. in view of 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a newly discovered reference drawn to Herman et al. to cure the deficiencies of Kaneaki/Xing et al. as to independent claim 1; Dhanjal to cure the deficiencies of Kaneaki et al. as to independent claim 7 and Sternberg et al. to cure the deficiencies of Kaneaki et al./Dhanjal/Xing et al. as to claim 18. The Office maintains the previously recited teachings references to cure the deficiencies the primary references.
Conclusion
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/OPHELIA A HAWTHORNE/ Primary Examiner, Art Unit 3786