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 .
Status of Claims
Claims 19-35 are pending and examined on the merits.
Claims 1-18 are cancelled.
Response to Amendment
Applicant amendments filed 12/03/2025 have been fully considered.
Response to Arguments
Applicant's arguments filed 12/03/2025 have been fully considered but they are not persuasive. Specifically, regarding the rebuttal to the rejection of claims 27-31 (see pages 6-9 of Remarks filed 12/03/2025), Examiner respectfully disagrees. Specifically, with the incorporation of the flap, adhesive, and closure film of Hodges with the device of Bernstein in view of Shelton, the second opening can be closed more securely about a user’s penis. As broadly recited, the claims merely require that that the flap is adapted to close the second opening and that the closure film and adhesive combine to allow the flap to re-closably seal the second opening, which the device of Bernstein, in view of Shelton, further in view of Hodges accomplishes by closing the second opening about a user’s penis (see pages 9-10 of Non-Final Rejection mailed 06/18/2025).
Therefore, Bernstein (U.S. Patent No. 5,478,334 A), Shelton (U.S. Pre Grant Pub. No. 2010/0263113 A1), and Hodges (U.S. Patent No. 10,307,305 B1) are reintroduced as primary and secondary references in the present rejection for disclosing and rendering obvious the limitations presented in the claims.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 19-20, 22-24, and 32-35 are rejected under 35 U.S.C. 103 as being unpatentable over Bernstein (U.S. Patent No. 5,478,334 A) in view of Shelton (U.S. Pre Grant Pub. No. 2010/0263113 A1)
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Regarding claim 19, Bernstein, with reference to Image 1, teaches: A male urinary incontinence device (see Abstract) comprising:
a pouch (see Image 1) including a proximal wall (Id.) sealed along an entirety of an outer periphery of the proximal wall (see col. 4, lines 5-9) to a distal wall (see Image 1) to form an inner cavity inside of the pouch (see Image 1);
an inlet opening formed in the proximal wall (see Image 1), with the inlet opening communicating with the inner cavity of the pouch and sized to receive a penis (see for example Image 1 and Fig. 4);
a second opening formed in the distal wall (see Image 1), with the second opening communicating with the inner cavity of the pouch (see Image 1); and
wherein the second opening is positioned opposite of the inlet opening (see Image 1 and Fig. 1) and is adapted to allow a user of the male urinary incontinence device to direct a position of the penis through the inlet opening and into the inner cavity of the pouch (as shown in Fig. 4, for example, when the penis is inserted through the second opening, the penis is positioned through the inlet opening and into the inner cavity of the pouch).
However, Bernstein fails to explicitly teach a urine absorbing element disposed inside of the inner cavity of the pouch, as required by the claim.
Shelton teaches an analogous male urinary incontinence device (see Abstract) comprising an insert having an absorbent function (see para. [0037]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Bernstein to incorporate the teachings of Shelton by including a urine absorbing element disposed inside of the inner cavity of the pouch at least in order for a user to wipe away excess urine from the urinogenital area on removal of the device following urination, as taught by Shelton (see para. [0037]).
Regarding claim 20, Bernstein in view of Shelton teach the invention as described above in claim 19. Additionally, Bernstein teaches wherein the inlet opening is positioned on a central longitudinal axis of the proximal wall with lateral symmetry relative to the proximal wall on each lateral side of the inlet opening (see Image 1).
Regarding claim 22, Bernstein in view of Shelton teach the invention as described above in claim 19. Additionally, Bernstein teaches wherein the second opening extends laterally across a width of the distal wall and intersects with a center of the inlet opening (as broadly recited, the second opening extends across the width of the distal wall and intersects with a center of the inlet opening; see Image 1).
Regarding claim 23, Bernstein in view of Shelton teach the invention as described above in claim 19. Additionally, Bernstein teaches wherein the inlet opening is circular (see Image 1).
Regarding claim 24, Bernstein in view of Shelton teach the invention as described above in claim 19. Additionally, Bernstein teaches wherein the distal wall comprises an upper wall portion and a lower wall portion (as broadly recited, this can be a top half and a lower half of the distal wall), the upper wall portion comprising a first edge and the lower wall portion comprising a second edge (as broadly recited, this can be the edges of the distal wall), and the first edge and the second edge combine to define a periphery of the second opening (as broadly recited, the edges of the distal wall form the periphery of the second opening; see Image 1).
Regarding claim 32, Bernstein in view of Shelton teach the invention as described above in claim 19. Additionally, Bernstein teaches wherein the proximal wall comprises an elastic cuff formed of silicone, and the inlet opening is formed in the elastic cuff and adapted to adjust in shape and size to accommodate a range of sizes of the penis (see col. 4, lines 10-16).
Regarding claims 33-35, Bernstein in view of Shelton teach the invention as described above in claim 19. Additionally, Shelton teaches an insert having an absorbent function (see para. [0037]). Therefore, Bernstein in view of Shelton teach that the urine absorbing element is connected to a proximal surface of the distal wall (as applied to claim 33), wherein the urine absorbing element is detachably secured inside of the pouch (as applied to claim 34; since the absorbent is an insert), and a textile comfort patch disposed on an inner surface of the proximal wall (as applied to claim 35).
Claims 21 and 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Bernstein (U.S. Patent No. 5,478,334 A), in view of Shelton (U.S. Pre Grant Pub. No. 2010/0263113 A1), and further in view of Hodges (U.S. Patent No. 10,307,305 B1).
Regarding claim 21, Bernstein in view of Shelton teach the invention as described above in claim 19. However, neither Bernstein nor Shelton explicitly teach an elongated slit, as required by the claim.
Hodges teaches an analogous male incontinence device comprising an opening 120 having radial slits (see Fig. 2 and col. 3, lines 20-24).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Bernstein in view of Shelton to incorporate the teachings of Hodges by including slits that more comfortably conform to the shaft of a penis passing therethrough, as taught by Hodges (see col. 3, lines 26-29). Additionally, one of ordinary skill in the art would have been motivated to make the radial slits into elongated slits, as required by the claim, since it has been held that changes in shape is a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the claimed configuration was significant. See In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966); see also MPEP 2144.04(IV)(B). In the instant case, since Applicant hasn’t indicated the criticality of the elongated slit shape, such a shape is obvious to one of ordinary skill in the art.
Regarding claim 25, Bernstein in view of Shelton teach the invention as described above in claim 19. Additionally, Bernstein teaches wherein the distal wall comprises an upper wall portion and a lower wall portion (as broadly recited, this can be a top half and a lower half of the distal wall) with the second opening positioned between the upper wall portion and the lower wall portion (since the distal wall forms the second opening, this limitation is met). However, neither Bernstein nor Shelton explicitly teach that the upper wall portion comprises a flap adapted to cover the second opening, as required by the claim.
Hodges teaches that the upper wall portion comprises a flap adapted to cover the second opening (see flaps 122 at least in Fig. 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Bernstein in view of Shelton to incorporate the teachings of Hodges by including flaps at least to more comfortably conform to the shaft of a penis passing therethrough, as taught by Hodges (see col. 3, lines 26-29).
Regarding claim 26, Bernstein in view of Shelton teach the invention as described above in claim 19. Additionally, Bernstein teaches wherein the second opening formed in the distal wall is located between an upper wall portion and a lower wall portion of the distal wall (as broadly recited, this can be a top half and a lower half of the distal wall). However, neither Bernstein nor Shelton explicitly teach that the upper wall portion comprises a hinged flap provided with adhesive for attachment to the lower wall portion, as required by the claim.
Hodges teaches the upper wall portion comprises a hinged flap provided with adhesive for attachment to the lower wall portion (see for example flap 250 in Fig. 4A and col. 4, lines 64-67).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Bernstein in view of Shelton to incorporate the teachings of Hodges by including a hinged flap provided with adhesive at least in order to secure the flap to a layer, as taught by Hodges (see col. 5, lines 2-3).
Regarding claim 27, Bernstein in view of Shelton teach the invention as described above in claim 19. Additionally, Bernstein teaches wherein the second opening formed in the distal wall is located between an upper wall portion and a lower wall portion of the distal wall (as broadly recited, the distal wall comprises the upper wall portion and the lower wall portion and the second opening is formed in the distal wall). However, neither Bernstein nor Shelton explicitly teach a flap, adhesive, or a closure film, as required by the claim.
Hodges teaches a flap secured to the upper wall portion (see flap 250 in Fig. 4A), with the flap adapted to close the second opening (see col. 4, lines 56-61), adhesive disposed on the flap (see col. 4, lines 64-66); and a closure film disposed on the lower wall portion (see fastener 252b in Fig. 4A); wherein the closure film and the adhesive combine to allow the flap to re-closably seal the second opening (see col. 4, lines 56-66).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Bernstein in view of Shelton to incorporate the teachings of Hodges by including a flap, adhesive, and a closure film at least in order to fasten the upper wall portion to the lower wall portion to secure the opening closed, as taught by Hodges (see col. 4, lines 56-66).
Regarding claim 28, Bernstein in view of Shelton teach the invention as described above in claim 19. Additionally, Bernstein teaches wherein the second opening formed in the distal wall is located between an upper wall portion and a lower wall portion of the distal wall (as broadly recited, the distal wall comprises the upper wall portion and the lower wall portion and the second opening is formed in the distal wall). However, neither Bernstein nor Shelton explicitly teach a flap, as required by the claim.
Hodges teaches a flap secured to the upper wall portion (see Fig. 2 and col. 3, lines 20-24), with the flap adapted to close the second opening (as broadly recited, the flaps are capable of closing the second opening 120); wherein the flap includes a tactile structure adapted to provide the user with tactile guidance in locating the second opening (the shape of the slits 122 is a tactile structure that provides the user with tactile guidance in locating the second opening).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Bernstein in view of Shelton to incorporate the teachings of Hodges by including slits that more comfortably conform to the shaft of a penis passing therethrough, as taught by Hodges (see col. 3, lines 26-29).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Bernstein (U.S. Patent No. 5,478,334 A), in view of Shelton (U.S. Pre Grant Pub. No. 2010/0263113 A1), further in view of Hodges (U.S. Patent No. 10,307,305 B1), and further in view of Heyman (U.S. Pre Grant Pub. No. 2013/0030401 A1).
Regarding claim 29, Bernstein in view of Shelton teach the invention as described above in claim 19. Additionally, Bernstein teaches wherein the second opening formed in the distal wall is located between an upper wall portion and a lower wall portion of the distal wall (as broadly recited, the distal wall comprises the upper wall portion and the lower wall portion and the second opening is formed in the distal wall). However, neither Bernstein nor Shelton explicitly teach a flap, as required by the claim.
Hodges teaches a flap secured to the upper wall portion (see Fig. 2 and col. 3, lines 20-24), with the flap adapted to close the second opening (as broadly recited, the flaps are capable of closing the second opening 120).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Bernstein in view of Shelton to incorporate the teachings of Hodges by including flaps at least to more comfortably conform to the shaft of a penis passing therethrough, as taught by Hodges (see col. 3, lines 26-29).
However, neither Bernstein, Shelton, nor Hodges explicitly teach a colored pattern, as required by the claim.
Heyman teaches an analogous male hygiene article (see Abstract) comprising decorations on a surface of the outer surface that may comprise a single color or pattern to enhance the aesthetic appearance of the hygienic article (see para. [0034]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Bernstein, Shelton, and Hodges to incorporate the teachings of Heyman by including color or pattern to enhance the aesthetic appearance of the article, as taught by Heyman (see para. [0034]). Additionally, the color or pattern will necessarily be a visual guide, as required by the claim.
Claims 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Bernstein (U.S. Patent No. 5,478,334 A), in view of Shelton (U.S. Pre Grant Pub. No. 2010/0263113 A1), further in view of Hodges (U.S. Patent No. 10,307,305 B1), and further in view of Heyden (U.S. Patent No. 4,865,595 A).
Regarding claim 30, Bernstein in view of Shelton teach the invention as described above in claim 19. Additionally, Bernstein teaches wherein the second opening formed in the distal wall is located between an upper wall portion and a lower wall portion of the distal wall (as broadly recited, the distal wall comprises the upper wall portion and the lower wall portion and the second opening is formed in the distal wall). However, neither Bernstein nor Shelton explicitly teach a flap, as required by the claim.
Hodges teaches a flap secured to the upper wall portion (see Fig. 2 and col. 3, lines 20-24), with the flap adapted to close the second opening (as broadly recited, the flaps are capable of closing the second opening 120).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Bernstein in view of Shelton to incorporate the teachings of Hodges by including flaps at least to more comfortably conform to the shaft of a penis passing therethrough, as taught by Hodges (see col. 3, lines 26-29).
However, neither Bernstein, Shelton, nor Hodges explicitly teach wherein the flap includes a reinforced foam layer, as required by the claim.
Heyden teaches an analogous male urinary device (see Abstract) comprising adhesive-surfaced foam tape used in the construction of the flap members (see col. 5, lines 61-65).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Bernstein, Shelton, and Hodges by incorporating the teachings of Heyden by including foam tape for the construction of the flap members at least because Heyden teaches that such construction is favorable for applying the catheter device to a penis (see col. 5, lines 60-68).
Regarding claim 31, Bernstein in view of Shelton teach the invention as described above in claim 19. Additionally, Bernstein teaches wherein the second opening formed in the distal wall is located between an upper wall portion and a lower wall portion of the distal wall (as broadly recited, the distal wall comprises the upper wall portion and the lower wall portion and the second opening is formed in the distal wall). However, neither Bernstein nor Shelton explicitly teach a flap, as required by the claim.
Hodges teaches a flap secured to the upper wall portion (see flap 250 in Fig. 4A), with the flap adapted to close the second opening (see col. 4, lines 56-61), and adhesive disposed on the flap (see col. 4, lines 64-66).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Bernstein in view of Shelton to incorporate the teachings of Hodges by including an adhesive flap at least in order to fasten the upper wall portion to the lower wall portion to secure the opening closed, as taught by Hodges (see col. 4, lines 56-66).
However, neither Bernstein, Shelton, nor Hodges explicitly teach wherein the flap includes a reinforced foam layer, as required by the claim.
Heyden teaches an analogous male urinary device (see Abstract) comprising adhesive-surfaced foam tape used in the construction of the flap members (see col. 5, lines 61-65).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Bernstein, Shelton, and Hodges by incorporating the teachings of Heyden by including foam tape for the construction of the flap members at least because Heyden teaches that such construction is favorable for applying the catheter device to a penis (see col. 5, lines 60-68). Additionally, by including the reinforced foam layer on the flap, the foam layer will necessarily extend longitudinally past the adhesive to provide the flap with a non-adhesive protruding grip portion, as required by the claim.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIHAD DAKKAK whose telephone number is (571)272-0567. The examiner can normally be reached Mon-Fri: 9AM - 5PM ET.
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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/ANDREW J MENSH/ Primary Examiner, Art Unit 3781