DETAILED ACTION
This action is in response to the amendment filed 5/12/2025. Currently, claims 1-10 are pending in the application.
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 arguments with respect to the previous objection to the drawings have been fully considered and are persuasive. The objection to the drawings has been withdrawn.
Applicant’s amendment to the abstract is sufficient to overcome the previous objection to the specification.
Applicant’s arguments with respect to the rejection of claims 1-10 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph have been fully considered and are persuasive. The rejection of claims 1-10 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph has been withdrawn.
Applicant’s amendment to claim 8 is sufficient to overcome the previous rejection of claim 8 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
Applicant’s amendment to claim 5 is sufficient to overcome the previous rejection of claim 6 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Applicant's remaining arguments filed 5/12/2025 have been fully considered but they are not persuasive.
Applicant argues that because Lin does not teach the material hardness, elongation at break and tension set of the cuff member being result-effective variables, one having ordinary skill in the art would not be motivated to optimize these parameters. In response, the examiner respectfully disagrees and notes “that after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).” See MPEP 2144.05(III)(C.). In the present case, one having ordinary skill in the art before the effective filing of the present invention would know and 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 response to Applicant’s argument that Lin does not contemplate any of the clamed parameters, and instead only employs differently sized, replaceable contact pieces for the contemplated device as taught in Figures 9-11 of Lin, the examiner respectfully disagrees. The examiner acknowledges that Lin teaches that the device “can be” made in various sizes (see [0029] of the publication of the present invention), but this teaching in no way teaches this being the only contemplated or understood method for accommodating the needs of users having different sizes of sexual organ.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., yielding a cuff member that is elastic enough to fit in a splash-proof manner to a wide range of penis sizes while also reducing incidence of pressure marks and discomfort) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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 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 9) 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).
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].
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.
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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 8/21/2025