DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The claims filed December 31, 2025, have not been amended.
Response to Arguments
Applicant’s arguments, filed December 31, 2025, with respect to the rejection(s) of claim(s) independent claims 1 and depending claims under 35 U.S.C. 102(a) (1) as being anticipated by Heininger US 6117120 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 Therefore, the rejection has been withdrawn.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 35 U.S.C. 103 as being obvious over Heininger US 6117120 in view of Dann US 5752944
Claim Rejections - 35 USC § 102
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.
(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.
Claim(s) 12 is rejected under 35 U.S.C. 102(a) (1) as being anticipated by Heininger US 6117120.
With regards to claim 12, Heininger discloses a collar for securing to a part of the penis, the collar comprising: a ring (or inner sheath 21), the ring having an interior circumferential surface and an exterior circumferential surface (fig 1, which shows the inner sheath inside the outer sheath 10, Col 4 lines 20-44, thereby having an internal and external circumference); and a tubular-shaped internal wrap (or annular collar 36 figs 1 and 3, Col 5 lines 1-11,) attached to the collar by threading the internal wrap through the interior circumferential surface of the collar and folding a portion of the internal wrap over the exterior circumferential surface of the collar (fig 1 and 3 and which disclose the collar 36 (or internal wrap) is placed in the inner sheath 21 (or the collar which comprises a ring) and extends over the external circumference of the inner sheath 21 in fig 1).
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.
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.
Claim(s) 1, 2-4 and 13- 16 are rejected under 35 U.S.C. 103 as being unpatentable over Heininger US 6117120 in view of Dann US 5752944.
With regards to claim 1, Heininger discloses an improved external male catheter (element 10 fig 2, abstract), comprising:
a tubular sheath (or outer sheath 10, fig 1) with an opening therethrough (Col. 3 line 63- Col. 4 line 3), the sheath having an insertion end (Col. 3 line 63- Col. 4 line 3) and a urine tube adapter end (Col. 3 line 63- Col. 4 line 3), whereby the opening at the urine tube adapter end is sized and shaped to attach to a urine drainage tube ( fig 2 generally and close up fig 4- 16 is the drainage tube); and
a collar (element 28 (or insert), fig 3, Col 4 lines 45-57), the collar being fixedly attached to the insertion end of the tubular sheath (Col. 4 lines 45-57, note the insert is positioned in the inner sheath), the collar comprising a ring (or annular membrane 33,34) with an internal circumference and an external circumference, wherein the external circumference is smaller than a circumference of the opening on the tubular sheath at the insertion end (fig 3, which shows the membrane inside of the insert which goes into the sheath, Col 4 lines 58-67).
Heininger fails to disclose the collar comprised of a stiffer material than the tubular sheath. Heininger does disclose the collar is rigid (Col 4 lines 45-46 notes the insert is rigid. Heininger also discloses the outer sheath which connects to the drain tube can be rigid.
Dann also discloses a urinary catheter thereby being in the related field of endeavor to the claimed invention. Dann discloses a two-part male catheter system with an inner sleeve (20- fig 1) for direct attachment to the penis and an outer sleeve (30- fig 1) connected to a urinary collection system (50 fig 1). Dann discloses that the inner and outer sleeves can be formed from the same material (Col 2 lines 21-28) and that those materials can be flexible (Col. 4 lines 38-45 and Col 2 lines 38-47 which discloses the outer sheath maybe rolled on).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have used a flexible material for the outer sheath (or tubular structure) relative to the inner sheath/ insert (or collar). Since it is well known in the art to form the outer sheath using a flexible material as taught by Dann, it would have been obvious to try having a reasonable expectation of success. Additionally, the flexible device would be less noticeable than a rigid device especially since the outer sheath extends beyond the penis.
Regards claim 2 and 16, Heininger fails to disclose wherein the collar is comprised of silicone that substantially holds its shape when pressure is applied to the collar.
Regards claim 3 and 14, Heininger fails to disclose wherein the collar is fixedly attached to the insertion end of the tubular sheath by adhesive tape.
Regards claim 4 and 15, Heininger fails to disclose wherein the collar is fixedly attached to the insertion end of the tubular sheath by a heat-seal adhesive.
Regards claim 13, Heininger fails to disclose wherein the folded-over portion of the internal wrap is secured to the exterior circumferential surface of the collar by an adhesive.
Regarding claims 2-4 and 13-16 Dann discloses a male external two-part catheter; thereby, being in the same field of invention as the instant claims. Dann discloses the inner and outer sheath can be made from “an elastomeric material such as urethane, silicone, thermoplastic, or synthetic polymeric material” and that to parts can be adhered together with adhesive (Col 2 lines 21-28).
It would have been obvious to one of ordinary skill in the art before the effective date that have selected silicone for the collar as it is well known in the art to be used in urinary devices as taught by Dunn. Using a known material based on its suitability for its intended use supported a prima facie obviousness, as per In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960), and also in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Dann clearly teaches a male external two-part catheter thereby being in the same field of endeavor as such using a known material to form an external catheter would be obvious.
Additionally, it would have been obvious to one of ordinary skill in the art to have used an adhesive as taught by Dann to ensure the parts do not separate as Heininger only teaches a friction fit (Col 4 lines 35-44) which could disengage should there be change the material forces.
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Heininger US 6117120 in view of Dann US 5752944 and in further view of Cheng US 2021/0369495 A1.
With regards to claims 17, Heininger and Dann fail to disclose wherein the internal wrap is comprised of nitrile.
Cheng teaches a wearable urinary receptacle thereby being in the related field of endeavor as the instant claims. Cheng teaches the receptacle can be formed from silicone, rubber, latex, polychloroprene, nylon fabric, polypropylene, polyvinyl chloride, nitrile rubber, other suitable polymers, a metal foil, a composite, or combinations thereof in paragraph 0028. As such Cheng supports nitrile is a known equivalent material which can used instead of silicone or used with silicon and is suitable for urinary devices.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have selected nitrile as it is an elastic and flexible material as required by Heininger and it is known to be used in urinary devices as taught by Cheng. Using a known material based on its suitability for its intended use supported a prima facie obviousness, as per In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960), and also in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Heininger US 6117120 in view of Goulter US 5009649.
Regards claim 11, Heininger fails to disclose a stopper sized and shaped to snugly fit into the opening at the urine tube adapter end of the tubular sheath.
Goulter teaches an external male urine collection device that has a plug for the closing of the collection vessel to prevent leaking and allowing for the device to be emptied Col 4 lines 45-55.
It would have been obvious to one of ordinary skill in the art before the effective filling date to have added the plug of Goulter to the device of Heininger to provide a means to prevent leaking should a collection bag not be available after the device is applied.
Conclusion
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/GABRIELLA E BURNETTE/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781