DETAILED ACTION
This action is in response to the Request for Continued (RCE) filed 11/25/2025. Currently, claims 1-18 are pending in the application. New claims 11-18 are added by Applicant.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/25/2025 has been entered.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Arguments
Applicant's arguments filed 11/25/2025 have been fully considered but they are not persuasive.
In response to Applicant’s argument that the lower circumferential ring 124 does not extend axially away from a first surface of the membrane 12, the examiner respectfully disagrees. As detailed below, Lin teaches in Figure 8 that the collar (lower circumferential rim 124) extends axially away from (as shown in Figure 8, lower circumferential rim 124 projects outward away from the exposed, exterior surface of elastic fitting membrane 12) a first surface (exposed, exterior surface of elastic fitting membrane 12) of the membrane (elastic fitting membrane 12).
In response to Applicant’s argument that the membrane 12 and lower circumferential rim 124 do not allow elastic expansion of the aperture to fittingly engage with the penis, the examiner notes that Lin explicitly teaches in [0027] that “the lower circumferential rim 124 and the radius shrinking flange 123 of the elastic fitting membrane 12 are moved off the ring outer circumferential surface 113 to set back to the original position so that the lower circumferential rim 124 and the radius shrinking flange 123 of the elastic fitting membrane 12, due to elastic restoration power thereof, would resume the original condition, such that the lower circumferential rim 124 abuts a circumference of the sexual organ 80.” Further, Applicant is reminded that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Claim Objections
Claim 14 is objected to because of the following informalities: in order to correct a grammatical error, “the pocket expands to an non-planar configuration when the slit is opened” should be amended to recite ---the pocket expands to a non-planar configuration when the slit is opened---. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 12-14 and 17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 12 recites “the pocket is substantially planar in an initial state.” No support is provided for this claim limitation in Applicant’s specification as originally filed. Applicant’s original disclosure does not provide a description of the shape/planarity of the pocket and further, Applicant’s original Figures do not provide a cross-sectional view of the pocket that would enable one to determine its planarity. No support is provided for this claim limitation in Applicant’s specification as originally filed. Claim 13, 14 and 17 depend on claim 12 and therefore, include the same error.
Claim 14 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 14 recites “the pocket expands to an non-planar configuration when the slit is opened.” No support is provided for this claim limitation in Applicant’s specification as originally filed. Applicant’s original disclosure does not provide a description of the shape/planarity of the pocket when the slit is opened and further, Applicant’s original Figures do not provide a cross-sectional view of the pocket when the slit is opened that would enable one to determine its planarity. No support is provided for this claim limitation in Applicant’s specification as originally filed.
Claim 16 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 16 recites “the outer edge portion surrounds at least a portion of a perimeter of the membrane.” No support is provided for this claim limitation in Applicant’s specification as originally filed. Applicant’s original disclosure does not provide a teaching indicating that the outer edge portion (70) surrounds only a portion of the perimeter of the membrane (50) and instead solely teaches the outer edge portion (70) surrounding the entire perimeter of the membrane (50) (as shown in Applicant’s Figures, for instance).
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 17 is 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 17 recites the limitation "the outer edge portion" in lines 1-2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 is 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 18 recites the limitation "the tension set of the material" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-9, 11, 15, 16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin (US 2021/0315726 A1).
In regards to claim 1, Lin teaches in Figures 1-9, [0021] and [0027] a top end portion (as defined in the annotated copy of Figure 7 provided below), a bottom end portion (as defined in the annotated copy of Figure 7 provided below) and an intermediate portion (as defined in the annotated copy of Figure 7 provided below) between (as shown in Figure 7) the top end portion (as defined in the annotated copy of Figure 7 provided below) and the bottom end portion (as defined in the annotated copy of Figure 7 provided below), with the bottom end portion (as defined in the annotated copy of Figure 7 provided below) and the intermediate portion (as defined in the annotated copy of Figure 7 provided below) combining to form a pocket (interior space 23 disposed within the intermediate and bottom end portions) sized to contain at least a part of (as shown in Figure 7) a penis (sexual organ 80); a cuff member (contact piece 10) located in (as shown in Figure 7) the top end portion (as defined in the annotated copy of Figure 7 provided below), with the cuff member (contact piece 10) comprising (as shown in Figure 2; [0021] teaches “the contact piece 10 includes a ring 11 and an elastic fitting membrane 12”) a membrane (elastic fitting membrane 12) and a collar (lower circumferential rim 124); and an aperture (second through opening 122) formed in (as shown in Figure 2; [0021] teaches “the second through opening 122 has a hole circumference that is formed with a lower circumferential rim 124”) the collar (lower circumferential rim 124) to provide an inlet communicating with (as shown in Figure 8) the pocket (interior space 23 disposed within the intermediate and bottom end portions); wherein the collar (lower circumferential rim 124) extends axially away from (as shown in Figure 8, lower circumferential rim 124 projects outward away from the exposed, exterior surface of elastic fitting membrane 12) a first surface (exposed, exterior surface of elastic fitting membrane 12) of the membrane (elastic fitting membrane 12), and the membrane (elastic fitting membrane 12) and the collar (lower circumferential rim 124) are configured to allow elastic expansion of the aperture (second through opening 122) to fittingly engage with ([0027] teaches “the lower circumferential rim 124 and the radius shrinking flange 123 of the elastic fitting membrane 12 are moved off the ring outer circumferential surface 113 to set back to the original position so that the lower circumferential rim 124 and the radius shrinking flange 123 of the elastic fitting membrane 12, due to elastic restoration power thereof, would resume the original condition, such that the lower circumferential rim 124 abuts a circumference of the sexual organ 80”) the penis (sexual organ 80).
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Lin does not teach wherein the cuff member comprises a material with a hardness from 5 to 45 in Shore A scale, the cuff member has an elongation at break of 500 to 1100% as tested according to DIN 53504/ISO 37, and a tension set of the cuff member is between 0 and 10% as tested according to DIN ISO 2285 Method A.
However, it would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to provide that the cuff member comprises a material with a hardness from 5 to 45 in Shore A scale, the cuff member has an elongation at break of 500 to 1100% as tested according to DIN 53504/ISO 37, and a tension set of the cuff member is between 0 and 10% as tested according to DIN ISO 2285 Method A, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. One having ordinary skill in the art before the effective filing of the present invention would find it obvious that the material hardness, elongation at break and tension set of the cuff member could be modified as desired to accommodate the anatomy and comfort of an individual user.
In regards to claim 2, Lin teaches the apparatus of claim 1. Lin teaches in Figure 8 that the collar (lower circumferential rim 124) has a length, and teaches in [0027] that the collar (lower circumferential rim 124) is sized such that is “abuts a circumference of the sexual organ 80” and such that it “applies a moderate or proper level of pressing force to the sexual organ 80 to thereby provide a coupling or combining force that is desired for fixing or holding the urine discharge device 100 to or on the sexual organ 800.”
Lin does not teach that the collar has a length of 5-30 mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to provide that the collar has a length of 5-30 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. One having ordinary skill in the art before the effective filing of the present invention would find it obvious that the length of the collar could be modified as needed to provide the most secure coupling of the collar about an individual user’s penis.
In regards to claim 3, Lin teaches the apparatus of claim 1. Lin teaches in [0029] that the size of the ring 11 (and thus, the size of the elastic fitting membrane 12) “can be modified or designed according to the statistical data of the sexual organ size of different nations and different races.”
Lin does not explicitly teach that the membrane has a diameter of 50-100 mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to provide that the membrane has a diameter of 50-100 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. One having ordinary skill in the art before the effective filing of the present invention would find it obvious that the diameter of the membrane could be modified to accommodate the anatomy of a particular individual and/or “according to the statistical data of the sexual organ size of different nations and different races,” as Lin teaches in [0029].
In regards to claim 4, Lin teaches the apparatus of claim 1. Lin teaches in Figure 9 that the collar (lower circumferential rim 124) has an overall equal thickness (as shown in Figure 9).
In regards to claim 5, Lin teaches the apparatus of claim 1. Lin teaches in Figures 5 and 6 and [0027] that the membrane (elastic fitting membrane 12) comprises an outermost edge portion (perimeter edge where the elastic fitting member 12 is folded over ring 11, as shown in Figure 6) that has an enlarged thickness (the thickness of elastic fitting membrane 12 along ring 11 is enlarged when folded over ring 11 (as shown in Figure 6) in comparison to
In regards to claim 6, Lin teaches the apparatus of claims 1 and 5. Lin teaches in [0029] that the size of the ring 11 “can be modified or designed according to the statistical data of the sexual organ size of different nations and different races.”
Lin does not teach that the outermost edge portion (ring 11) has a width of 5-15 mm, measured in a radial direction.
However, it would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to provide that the outermost edge portion has a width of 5-15 mm, measured in a radial direction, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. One having ordinary skill in the art before the effective filing of the present invention would find it obvious that the width of the outermost edge portion (ring 11) could be modified to accommodate the anatomy of a particular individual and/or “according to the statistical data of the sexual organ size of different nations and different races,” as Lin teaches in [0029].
In regards to claim 7, Lin teaches the apparatus of claim 1. Lin teaches in Figure 8 that the collar (lower circumferential rim 124) is substantially perpendicular to (as shown in Figure 8) the membrane (elastic fitting membrane 12).
In regards to claim 8, Lin teaches the apparatus of claim 1. Lin teaches in Figures 2 and 5 and [0029] that a diameter in a radial direction of the membrane (elastic fitting membrane 12) is at least twice a diameter in a radial direction of (see Figure 2; [0029] teaches that “the inner diameter of the ring 11 is taken as 5 millimeters and a preferred size of the second through opening 122 is set to 1.2, 1.6, or 2 millimeters” Figure 5 teaches the diameter of the elastic fitting membrane 12 being larger than the inner diameter of the ring 11) the aperture (second through opening 122).
In regards to claim 9, Lin teaches the apparatus of claim 1. Lin teaches in [0028] that the collar (lower circumferential rim 124) and the membrane (elastic fitting membrane 12) are made from the same material ([0028] teaches “Since the elastic fitting membrane 12 possesses a waterproofness property, an effect of preventing urine leaking between the lower circumferential rim 124 and the circumference of the sexual organ 80 in contact therewith may be achieved,” which indicates that the lower circumferential rim 124 and elastic fitting membrane 12 are made from the same waterproof material).
In regards to claim 11, Lin teaches the apparatus of claim 1. Lin teaches in Figure 8 that the collar (lower circumferential rim 124) extends substantially perpendicularly away from (as shown in Figure 8) the membrane (elastic fitting membrane 12).
In regards to claim 15, Lin teaches the apparatus of claim 1. Lin teaches in Figures 1, 2, 5-9 that the collar (lower circumferential rim 124) and the membrane (elastic fitting membrane 12) form a single piece (inasmuch as the lower circumferential rim 124 and the elastic fitting membrane 12 are shown in Figures 1, 2, 5-9 to be integrally connected to form a single unit).
In regards to claim 16, Lin teaches the apparatus of claim 1. Lin teaches in Figure 5 that the membrane (elastic fitting membrane 12) is bounded by (surrounded by) an outer edge portion (surface defined in the annotated copy of Figure 5 provided below) of the cuff member (contact piece 10), and the outer edge portion (surface defined in the annotated copy of Figure 5 provided below) surrounds at least a portion of a perimeter of (as shown in Figure 5) the membrane (elastic fitting membrane 12).
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In regards to claim 18, Lin teaches the apparatus of claim 1. Lin teaches in [0027] that the aperture (second through opening 122) stretches to fit around ([0027] teaches “the second through opening 122 of the elastic fitting membrane 12 must be first expanded in respect of the opening size thereof and the lower circumferential rim 124 and the radius shrinking flange 123 so expanded are fit over the ring outer circumferential surface 113, so that the inlet opening 111 of the ring 11 is no longer covered by the elastic fitting membrane 12 and the inlet opening 111 of the ring 11 is completely open and not blocked (see FIG. 6f)” and “the sexual organ 80 of the user is then inserted, in sequence, through the inlet opening 111 and the outlet opening 112 of the ring 11 to be located in the interior space 23 of the urine conducting piece 20, and the inlet opening 111 of the ring 11 is set at a location adjacent to a root of the sexual organ 80”) the penis (sexual organ 80), wherein the tension set of the material allows the aperture (second through opening 122) to provide a tight fit engagement with the penis (sexual organ 80) after stretching ([0027] teaches “the lower circumferential rim 124 and the radius shrinking flange 123 of the elastic fitting membrane 12 are moved off the ring outer circumferential surface 113 to set back to the original position so that the lower circumferential rim 124 and the radius shrinking flange 123 of the elastic fitting membrane 12, due to elastic restoration power thereof, would resume the original condition, such that the lower circumferential rim 124 abuts a circumference of the sexual organ 80”).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin (US 2021/0315726 A1) in view of Goss (US 2008/0243097 A1).
In regards to claim 10, Lin teaches the apparatus of claim 1. Lin does not teach that the cuff member comprises a thermoplastic elastomer.
However, Goss teaches in Figures 1-3 and [0029] an analogous device wherein the cuff member (leak proof gasket 4) comprises a thermoplastic elastomer ([0029] teaches “the material used to make the gasket is a thermoplastic elastomer”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the cuff member of Lin to comprise a thermoplastic elastomer as taught by Goss because this material “allows the gasket to be easily stretched, but still has a stable configuration,” as Goss teaches in [0029].
Claim(s) 12 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin (US 2021/0315726 A1) in view of BEN-ARIE (US 2015/0065970 A1).
In regards to claim 12, Lin teaches the apparatus of claim 1. Lin does not teach that the pocket is substantially planar in an initial state.
However, BEN-ARIE teaches in Figure 1 and [0015] an analogous device wherein the pocket (washable pouch 1A) is substantially planar in an initial state (as shown in Figure 1; [0015] teaches “another advantage of the washable pouch described in this application is its very flat structure” and “the pouch including the washing inlet and the draining outlet is manufactured by fusing two flat sheets of flexible material such as plastic sheets at their margins”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the pocket of Lin to be substantially planar in an initial state as taught by BEN-ARIE because this element is known to provide the pocket with a structure that “is not conspicuous when the user wears the pouch under the user's clothes,” as BEN-ARIE teaches in [0015].
In regards to claim 17, Lin and BEN-ARIE teach the apparatus of claims 1 and 12. Lin teaches in Figure 5 that the outer edge portion (surface defined in the annotated copy of Figure 5 provided above) surrounds an entire perimeter of (as shown in Figure 5) the membrane (elastic fitting membrane 12).
Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin (US 2021/0315726 A1), in view of BEN-ARIE (US 2015/0065970 A1) and further in view of Schertiger (US 2018/0311068 A1).
In regards to claims 13 and 14, Lin and BEN-ARIE teach the apparatus of claims 1 and 12. Lin and BEN-ARIE do not teach that the male urinary incontinence device defines a slit configured to be opened when the penis is loaded within the male urinary incontinence device; and wherein the pocket expands to an non-planar configuration when the slit is opened.
However, Schertiger teaches in Figure 2 and [0022] an analogous device wherein the male urinary incontinence device (ostomy appliance 20) defines (as shown in Figure 2; also taught in [0022]) a slit (lateral slit 41) configured to be opened when the penis is loaded within (lateral slit 41 is capable of being opened when a penis is positioned into the ostomy appliance 20 via first opening 30) the male urinary incontinence device (ostomy appliance 20); and wherein the pocket (collecting bag 34) expands to an non-planar configuration when the slit (lateral slit 41) is opened (as shown in Figure 2).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the male urinary incontinence device of Lin as modified by BEN-ARIE to provide that the male urinary incontinence device defines a slit configured to be opened when the penis is loaded within the male urinary incontinence device; and wherein the pocket expands to an non-planar configuration when the slit is opened as taught by Schertiger because this element is known to provide an opening into the pocket that can be accessed during use of the male urinary incontinence device as needed for inspection, observation or adjustment, as Schertiger teaches in Figure 2.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VICTORIA H FISHER whose telephone number is (571)270-7033. The examiner can normally be reached M-TH 6:00AM-4:00PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael Bredefeld can be reached at (571) 270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 12/19/2025
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