DETAILED ACTION
This action is in response to the amendment filed 4/15/2026. Currently, claims 1-13, 15, 16 and 18-22 are pending in the application. New claims 19-22 are added by Applicant. Claims 14 and 17 are cancelled 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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Arguments
Applicant’s amendment to claim 12 is sufficient to overcome the previous rejection of claim 12 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. Applicant’s amendment to claim 16 is sufficient to overcome the previous rejection of claim 16 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
Applicant’s amendment to claim 18 is sufficient to overcome the previous rejection of claim 18 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Applicant’s arguments with respect to the prior art rejection(s) of claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 recites “the openable slit extending at least partially across the intermediate portion,” which is a claim limitation lacking proper antecedent basis in the specification. This is not an issue of new matter. Applicant should amend the specification to include the cited language to avoid this error. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the slit” in line 2 of the claim should be amended to recite ---the openable slit---. 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.
Claim 12 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 12 recites that “the pocket transitions between an unloaded configuration and a loaded configuration in which when the at least part of the penis is loaded within the male urinary incontinence device.” No support is provided for this claim limitation in Applicant’s specification as originally filed. While Applicant’s originally disclosure teaches the device being capable of achieving the recited loaded and unloaded configurations, Applicant’s original disclosure does not teach that the transition therebetween is achieved via the pocket, as claimed. There is no teaching in Applicant’s original disclosure that the pocket is responsible for moving the penis into and out of the male urinary incontinence device, as claimed.
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 22 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 22 contains the trademark/trade name Velcro®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe hook and loop material and, accordingly, the identification/description is indefinite.
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, 11-13, 15, 16 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin (US 2021/0315726 A1) in view of Schertiger (US 2018/0311068 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 a distal wall having overlapping portions defining an openable slit therebetween, the openable slit configured to allow access within the pocket, the openable slit extending at least partially across the intermediate portion from a first side of the intermediate portion to a second side of the intermediate portion that opposes the first side.
However, Schertiger teaches in Figure 2 and [0022] an analogous device with a distal wall (second comfort layer 39) having overlapping portions defining an openable slit (lateral slit 41; [0022] teaches the slit 41 “defining an opening”) therebetween (as shown in Figure 2; also taught in [0022]), the openable slit (lateral slit 41) configured to allow access within (as shown in Figure 2) the pocket (as defined in the annotated copy of Figure 2 provided below), the openable slit (lateral slit 41) extending at least partially across the intermediate portion (as defined in the annotated copy of Figure 2 provided below) from a first side of the intermediate portion to a second side of the intermediate portion that opposes the first side (as shown in Figure 2).
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It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the device of Lin to include a distal wall having overlapping portions defining an openable slit therebetween, the openable slit configured to allow access within the pocket, the openable slit extending at least partially across the intermediate portion from a first side of the intermediate portion to a second side of the intermediate portion that opposes the first side 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.
In regards to claim 2, Lin and Schertiger teach 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 and Schertiger do 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 and Schertiger teach 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 and Schertiger do 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 and Schertiger teach the apparatus of claim 1. Lin teaches in Figure 9 that the collar (lower circumferential rim 124) has an overall equal thickness along length of the collar (as shown in Figure 9).
In regards to claim 5, Lin and Schertiger teach 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 and Schertiger teach 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 and Schertiger do 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 and Schertiger teach 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 and Schertiger teach 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 and Schertiger teach 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 and Schertiger teach 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 12, Lin and Schertiger teach the apparatus of claim 1. Lin teaches in Figures 5-7 and [0027] that the pocket (interior space 23 disposed within the intermediate and bottom end portions) transitions between (as shown in Figures 5-7; [0027] teaches “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”) an unloaded configuration (shown in Figures 5 and 6) and a loaded configuration (shown in Figure 7) in which when the at least part of the penis (sexual organ 80) is loaded within (as shown in Figure 7) the male urinary incontinence device (urine discharge device 100).
In regards to claim 13, Lin and Schertiger teach the apparatus of claim 1. Lin does not teach that the slit is configured to be opened when the at least part of the penis is loaded within the male urinary incontinence device.
However, Schertiger teaches in Figure 2 and [0022] an analogous device wherein the slit (lateral slit 41) is configured to be opened when the at least part of the penis is loaded within (lateral slit 41 is capable of being opened manually when a penis is positioned into the ostomy appliance 20 via first opening 30) the male urinary incontinence device (ostomy appliance 20).
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 Schertiger to provide that the slit is configured to be opened when the at least part of the penis is loaded within the male urinary incontinence device 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.
In regards to claim 15, Lin and Schertiger teach 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 and Schertiger teach 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 an entire perimeter of (as shown in Figure 5) the membrane (elastic fitting membrane 12).
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In regards to claim 18, Lin and Schertiger teach 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 a tension set of a material of the cuff member (contact piece 10) allows (Figure 5 teaches the material of contact piece 10 defining second through opening 122 and therefore, the function thereof) 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”).
In regards to claim 19, Lin and Schertiger teach the apparatus of claim 1. Lin and Schertiger do not teach 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.
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 20, Lin and Schertiger teach the apparatus of claim 1. Lin teaches in Figures 5 and 7 and [0024] that the bottom end portion (as defined in the annotated copy of Figure 7 provided above) is configured to be coupled to a urine collecting bag (Figure 5 and 7 teach the drain tube 40 being positioned within the bottom end portion; [0024] teaches “a urine drain tube 40 connected to the urine discharge device 100, and a urine bag 50 connected to the urine drain tube 40 for collection of the urine”).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin (US 2021/0315726 A1), in view of Schertiger (US 2018/0311068 A1) and further in view of Goss (US 2008/0243097 A1).
In regards to claim 10, Lin and Schertiger teach the apparatus of claim 1. Lin and Schertiger so 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 as modified by Schertiger 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) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin (US 2021/0315726 A1), in view of Schertiger (US 2018/0311068 A1) and further in view of Masters et al. (US 2013/0253455 A1).
In regards to claim 21, Lin and Schertiger teach the apparatus of claim 1. Lin and Schertiger do not teach a proximal wall sealed together with the distal wall along a periphery of the intermediate portion and the bottom end portion to form the pocket.
However, Masters et al. teaches in Figures 1 and 2 and [0042] an analogous device with a proximal wall (bodyside wall 30) sealed together with ([0042] teaches “a bodyside wall 30 and an outer wall 32, which may be sealed together”) the distal wall (outer wall 32) along a periphery of the intermediate portion and the bottom end portion ([0042] teaches “the pouch 16 may include a bodyside wall 30 and an outer wall 32, which may be sealed together along their outer peripheral edges 34;” Figure 1 teaches the outer peripheral edges 34 extending along the entire perimeter, including that of the intermediate portion and the bottom end portion) to form the pocket (cavity 36).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the device of Lin as modified by Schertiger to include a proximal wall sealed together with the distal wall along a periphery of the intermediate portion and the bottom end portion to form the pocket as taught by Masters et al. because this element is known in the art for to be a suitable configuration for forming the pocket, as Masters et al. teaches in [0042].
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin (US 2021/0315726 A1), in view of Schertiger (US 2018/0311068 A1) and further in view of Becker et al. (US 2021/0228401 A1).
In regards to claim 22, Lin and Schertiger teach the apparatus of claim 1. Lin and Schertiger do not teach that the slit is releasably sealed by one of an adhesive or Velcro.
However, Becker et al. teaches in Figures 8 and 9 and [0061] an analogous device wherein the slit (slit 390) is releasably sealed by one of an adhesive or Velcro ([0061] teaches “the overlapping portion 370 of the distal wall may be provided with means for closing the slit 390, such as adhesive or Velcro”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the slit of Lin as modified by Schertiger to be releasably sealed by one of an adhesive or Velcro as taught by Becker et al. because this element is known to enable the slit to be closed as desired to avoid inadvertent tugging or movement thereof, as Becker et al. teaches in Figures 8 and 9.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 VICTORIA H FISHER whose telephone number is (571)270-7033. The examiner can normally be reached M-TH 6:00AM-4:00PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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 7/21/2026
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