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 April 30, 2026, have not been amended.
Response to Arguments
Applicant’s arguments filed April 30, 2026, with respect to the rejection(s) of claim(s) independent claims 1 and 12 depending claims under 35 U.S.C. 103 as being obvious over Heininger US 6117120 in view of Dann US 5752944 and 35 U.S.C. 102(a) (1) as being anticipated by Heininger US 6117120 respectively 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 Therefore, the rejection has been withdrawn.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 Goulter et al. US 5797890 in view of Heininger US 6117120.
Of note based on the arguments specifically about the multiple parts of Heininger and after re-reading through applicant’s specification it appears applicant uses the term collar or grip and ring interchangeably. It was thought that the collar has a sub part that was a ring. It appears the ring is the shape of the collar and describes the collar itself.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 and depending claims (13-17) rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 defines the collar which compromises a ring and a tubular sheath, the tubular sheath however is attached to the collar which is being defined by the tubular sheath which makes the claim unclear.
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 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Goulter et al. US 5797890 in view of Heininger US 6117120 and Dann US 5752944.
With regards to claim 1, Goulter discloses an improved external male catheter (10 fig 2, abstract), comprising:
a tubular sheath (or outer sheath 10, fig 1) with an opening therethrough (seen annotated below), the sheath having an insertion end (Col. 3 line 25-30, which discloses putting the condom catheter in the penis thereby having an insertion end), 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 50 (or applicator ring), fig 9, Col 5 lines 15-23), the collar being fixedly attached to the insertion end of the tubular sheath (Col 5 lines 15-23), the collar comprising a ring (Col 5 lines 15-23) 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 8, which shows the interior and exterior of the ring and fig 9 shows the sheath on the ring thereby the external circumference of the ring being smaller than the sheath).
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Goulter fails to disclose a urine tube adapter end whereby the opening at the urine tube adapter end is sized and shaped to attach to a urine drainage tube; however, Goulter discloses the end has a cap for emptying (fig 1).
Goulter fails to disclose the collar comprised of a stiffer material than the tubular sheath; however, the ring is designed to accommodate the sheath so it must be stiffer to prevent collapsing into itself as the condom is pulled over the aid in fig 9).
Haininger discloses a condom catheter (abstract) thereby being in a related field of endeavor. Haininger teaches the condom catheter has 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)
With regards to claim 12, Goulter discloses a collar for securing to a part of the penis, the collar comprising: a ring (or applicator 50), the ring having an interior circumferential surface and an exterior circumferential surface (fig 8, which shows the ring shaped applicator thereby having an internal and external circumference); and a tubular-shaped internal wrap (or condom 10 figs 1 and unlabeled in figs 8 and 9) 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 9 which shows the internal wrap (or condom catheter threaed through the interior of the applicator and folded over a portion of the exterior of the applicator (or collar)).
Claim(s) 2-4 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Goulter et al. US 5797890 in view of Heininger US 6117120 and Dann US 5752944
Regards claim 2 and 16, Goulter and Heininger fail 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, Goulter and Heininger fail to disclose wherein the collar is fixedly attached to the insertion end of the tubular sheath by adhesive tape.
Regards claim 4 and 15, Goulter and Heininger fail to disclose wherein the collar is fixedly attached to the insertion end of the tubular sheath by a heat-seal adhesive.
Regards claim 13, Goulter and Heininger fail 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 Goulter and 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 Goulter et al. US 5797890 in view of Heininger US 6117120 and in further view of Cheng US 2021/0369495 A1.
With regards to claims 17, Goulter, 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 Goulter and 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 Goulter et al. US 5797890 in view of Heininger US 6117120 in view of Goulter US 5009649 (Goulter 2).
Regards claim 11, Goulter and 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 2 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 2 to the device of Goulter and Heininger to provide a means to prevent leaking should a collection bag not be available after the device is applied.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA E BURNETTE whose telephone number is (571)272-9574. The examiner can normally be reached M-S: 0830-1900 EST.
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/GABRIELLA E BURNETTE/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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