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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 20th, 2025 has been entered.
Claim Status
The amendment filed October 20th, 2025 has been entered. Claims 1, 4-5, 9-13, and 16-20 remain pending in the application. Claims 1, 13, and 18 have been amended. Claims 2-3, 6-8, and 14-15 remain cancelled. Amendments to the claim language have overcome the previously set forth 112(a) rejection in the Non-Final Office Action mailed on April 18th, 2025.
Response to Arguments
Applicant's arguments filed October 20th, 2025 have been fully considered but they are not persuasive.
Regarding applicant’s argument that the examiner is arguing that the different elements 50, 102, 104, 106 make up a single claim element, the recited rim gasket examiner does not see how this interpretation of the elements invalidates the presented rejection of the examiner, elements 50, 102, 104, and 106 all work together to form a sealing rim structure that seals around the vaginal area anatomy and surrounds the micturition cup. There is no requirement of the current claim language for the rim gasket claim element to be a uniform material or not be made up of multiple elements, as such the examiner has applied the presented elements as the rim gasket. As such this argument is found to be unpersuasive.
Regarding applicant’s argument that the examiner states elements 62 and 108 to teach the semi-rigid cup floor, examiner does not state that element 108 teaches the semi-rigid cup floor, rather the examiner has stated the rigid structure of 108 imparts a more rigid structure on element 62 allowing element 62 to be considered more rigid than sidewall 102. As such this argument is found to be unpersuasive.
Regarding applicant’s argument that element 102 is called both the flexible sidewall and the rim gasket, examiner disagrees in that element 102 is called the flexible sidewall, the rim gasket is created utilizing element 102 with the other elements of 50 102,104, and 106. It is not just the upper lip that allows for sealing of the device around the vaginal area but rather the flexing and structure of all these elements that forms a fluid tight seal and as such this has been noted by the examiner. It is also noted that there is no current claim limitation that requires the rim gasket to be completely separate from the sidewall simply positioned atop of which elements 50, and 106 are positioned atop of the sidewall 102 and therefore the rim gasket is positioned atop of the sidewall. As such this argument is found to be unpersuasive.
Regarding applicant’s argument that element 50 is an upper lip is stated as being the recited rim gasket has the broadest reasonable interpretation of a structural element on an upper or outer edge (definition of rim https://www.merriam-webster.com/dictionary/rim) that creates a fluid tight joint (definition of gasket https://www.merriam-webster.com/dictionary/gasket) that is positioned on atop the flexible sidewall and configured to surround the micturition cup that has a thickness greater than the flexible sidewall for molding and sealing around the vaginal area anatomy. There is no current claim language that requires the rim gasket to be a separate piece from the sidewall or to be one continuous material that is not made up of multiple materials and as such elements 50, 102,104,106 are all required and create the structure necessary to form a gasketed seal about the anatomy of user around the rim of the urine receiving cup. it is noted that the features upon which the applicant’s argument relies (i.e., a rim gasket that is a separate element from the flexible sidewall or that the rim gasket not be the same as an upper lip of a sidewall) 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). As such this argument is found to be unpersuasive.
Regarding applicant’s argument that the rim gasket having a thickness greater than the flexible sidewall is interpreted as rolling together shells 102,104, and the gel 106 inside of it, it is the top of inner sidewall 102, the top of outer side wall 104 and the gel agent between that create the moldable sealing gasket and the thickness of these elements combined is thicker than that of the sidewall element 102. Examiner fails to see how this argument invalidates the examiners rejection as no claim limitation require the rim gasket to be made of a unitary material or not include multiple elements. As such this argument is found to be unpersuasive.
Regarding applicant’s argument that stating the flexible sidewall as element 102 clearly ignores what Beecher teaches as the true sidewall element 48 and that the sidewall 48 has a thickness that is generally the same up to the upper lip 50, the examiner has taken the broadest interpretation of what a sidewall can be defined as in regards to a formed cup and the interpretation is that a sidewall can consists of the wall extending from the edge of the semi-rigid cup floor with the cup consisting of the inner surface that collects urine, as such only element 102 extends from the cup floor of the device and as such only 102 forms the sidewall of the device with 106 filling the in-between gap formed within the sidewall of the device and therefore element 106 would not necessarily form the wall of the device but rather is a structural filling of the wall of the device, the current claim limitations has not limited the claim structure to prevent this interpretation of the structure of sidewall and therefore it is noted that the features upon which the applicant’s argument relies (i.e., a sidewall that also includes any potential in-between substances) are not recited in the rejected claim(s). As such this argument is found to be unpersuasive.
Regarding applicant’s argument that there is no rim gasket taught in Beecher, examiner disagrees in that a rim gasket, as stated by the current structure of the claim limitations, is only required to be a structural element on an upper or outer edge (definition of rim https://www.merriam-webster.com/dictionary/rim) that creates a fluid tight joint (definition of gasket https://www.merriam-webster.com/dictionary/gasket) that is positioned on atop the flexible sidewall and configured to surround the micturition cup that has a thickness greater than the flexible sidewall for molding and sealing around the vaginal area anatomy. There is no current claim language that requires the rim gasket to be a separate piece from the sidewall or to be one continuous material that is not made up of multiple materials and as such elements 50, 102,104,106 are all required and create the structure necessary to form a gasketed seal about the anatomy of user around the rim of the urine receiving cup. it is noted that the features upon which the applicant’s argument relies (i.e., a rim gasket that is a separate element from the flexible sidewall or that the rim gasket not be the same as an upper lip of a sidewall) 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).
Regarding applicant’s argument that the one piece molding of Beecher teaches in completely the opposite direction of a semi-rigid floor cup and a flexible sidewall extending outwardly from an outside edge of the semi-rigid cup floor and the flexible sidewall being more flexible than the semi-rigid cup floor, examiner disagrees in that the claim limitations do not require the material of the cup floor itself to be semi-rigid, but rather that the structure of the cup floor be semi-rigid which is disclosed by Beecher as imparted by the stiffer material construction of element 108, element 108 as noted above is not considered to be a part of the cup floor but rather a structure that imparts greater rigidity to element 62 which is seen to incorporate the cup floor. As such even though Beecher teaches a one piece molding as stated by the applicant, different portions of this mold have different flexibility degrees due to the structure elements that surround them with 102 being imparted greater flexibility due to being surrounded only by flexible elements such as element 106 where as the cup floor is surrounded by element 108 which as stated below is disclosed by Beecher to provide greater rigidity which would in turn impart greater rigidity upon the cup floor element 62.
Regarding applicant’s argument that there is no teaching of a semi-rigid material slide plate or slide fitting as claimed, examiner disagree as the slide plate 108 and the slide fitting as shown in illustrative diagram )) below are shown to be of unitary construction and Col. 7 lines 4-23 clearly states that the bottom closure plate may be a somewhat stiffer material with a lesser degree of softness which would impart that the material is semi-rigid which has been established by the current claim limitations to mean more rigid than the flexible sidewall which is equivalent to “stiffer” as stated by Beecher. As such this argument is not found to be persuasive.
Regarding applicant’s argument that that a person of ordinary skill in the art would not go to a completely different system of Giacolone and try to modify Beecher, examiner does not agree in that the systems of Giacolone and Beecher are analogous art and are within the field of the inventor’s endeavor of urinary collection devices and as such one of ordinary skill in the art would have been apprised of the teachings that both of these devices provide.
Regarding applicant’s question of whether the receptacle 42 of Beecher would be replace with the catheter tube 38 of Giacalone, the examiner has said nothing in the below rejection that would indicated that the receptacle 42 of Beecher would be replaced, but rather is only relying upon the teaching of channels and a washer opposite a slide plate to engage said channels which teaches that the device can be held in place along a direction transverse to the garment which would hold the device within a transverse direction so that it was better held in place on the wearers garment. There is no indication of replacing the receptacle of Beecher.
Regarding applicant’s argument that the modification with Giacolone is done by stripping of pieces and ignoring the entire teaching of the Giacolone reference
Regarding applicant’s argument that the Beecher reference is one piece if the pessary 58 is used and if the similar arrangement of the vaginal plug 24 and catheter tube 38 of the Giacolone reference are used the combination would make no sense as Beecher is not two pieces as in Giacolone,
Regarding applicant’s argument that once the vaginal insert 58 of Beecher is in position, you cannot move Beecher as it would be painful to the wearer and would defeat the entire purpose of Beecher, examiner disagrees in that the device of Beecher already includes a slot 182 in which the device once inserted can be positioned at different positions along the slot depending on how the garment is arranged with relation to the patient anatomy, the teachings of Giacolone are utilized to show the obviousness of having the device of Beecher further engage the slot to prevent the drainage tube of the device from being wrongly positioned within the garment avoiding the need to readjust device positioning in relation to the garment. Furthermore, Beecher discloses the need for the crotch panel to retain the device (Col. 10 lines 12-25) which is the problem that Giacolone seeks to teach a resolution too. As such examiner does not find this argument persuasive. Furthermore, Beecher discloses the ability to utilize the device without the pessary member at which point a method to retain the device in place more efficiently such as that taught by Giacolone would be highly beneficial.
Regarding the applicant’s argument that modification of Beecher with Giacolone would destroy both reference and then create the claimed invention out of the different parts, examiner does not see how either reference would be destroyed by the inclusion of the channel teachings of Giacolone with Beecher and it is not clear in the applicant’s arguments what part of the combination would effectually destroy said devices. As such the examiner does not find this argument persuasive.
Regarding applicant’s argument that the combination of Beecher with Giacolone is purely hindsight, In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Regarding applicant’s argument that both references require an element engaging a vaginal opening of the vagina, which the current invention does not use, examiner disagrees in that Beecher specifically states in Col. 8 lines 29-35, the provision of a detachable pessary makes it possible to use the female urinary collection device, with or without a pessary, as desired” showing that it is free of the element engaging the vaginal opening during use and is not necessary.
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, 4-5, 9-13, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Beecher (U.S. Patent No. 4,889,533) in view of Giacolone et al. (U.S. Patent No. 4,615,692).
Regarding claim 1, Beecher discloses a micturition device (Figures 18 and 19) for fluid removal, the micturition device comprising:
a garment 172 configured to be worn over the pelvic area (Col. 9 lines 57-68, crotch);
a micturition cup 42, the micturition cup 42 being a unitary element configured to encircle vaginal area anatomy of a wearer (Col. 5 lines 5-31 around orifice of urethra) including the urethral opening (sidewall 102 encircles urethral opening) and vaginal opening (extension of 108 containing element 128 positioned to surround vaginal opening) for capturing fluids of the vaginal area anatomy, and being free of an element engaging a vaginal opening of the vagina (Col. 5 lines 32-43, pessary member 58 is an optional construction and may be detachable mounted thus device would be free of pessary member when detached; Col. 8 lines 29-35 provision of a detachable pessary makes it possible to use the female urinary collection device, with or without a pessary, as desired);
the micturition cup 42 a semi-rigid cup floor (62; abuts 108 which is made of a stiffer material Col. 7 lines 4-23 which would impart less flexion of the floor than sidewall which abut material 106 which causes sidewall and upper lip 50 to be mor compliant and soft imparting greater flexibility Col. 6 lines 55-64) and an outlet port 64 in the cup floor for evacuating fluids from the micturition cup (Col. 5 lines 44-65, urine flows out of receptacle through drain tube into drain hose connected to drain tube);
a flexible sidewall 102 extending outwardly (extends both laterally and longitudinally outward) from an outside edge (edge of cup floor 62 that occurs at transverse joining point of 102 to 62) of the semi-rigid cup floor of the unitary micturition cup, the flexible sidewall being more flexible than the semi-rigid cup floor (Col. 7 lines 4-23, element 108 is made of a stiffer material than sidewall and bottom wall which would impart a greater stiffness to bottom wall 62 than element 102 as 62 has greater support from element 108), the cup floor being contoured from the sidewall to the outlet port to direct the fluids to leave the cup (see below illustrative diagram of Fig. 3)
a rim gasket (elements 50, 102, 104, and 106 in combination) formed of a different material than the cup floor and sidewall (formed of viscous liquid silicone elastomer gum or gel Col. 6 lines 55-64), the gasket positioned atop the flexible sidewall (positioned atop element 50 and surrounding the interior of flexible sidewall) and configured to surround the micturition cup (106 surrounds the receptacle space of cup); the rim gasket having a thickness greater than the flexible sidewall for molding and sealing around the vaginal area anatomy (comprises the thickness of shells 102, 104 and fluid 106, seals around urethral opening and is flexible and therefore molds when positioned);
a slide plate 108 having a complementary shape (shaped to be bonded to bottom wall 62) with the micturition cup 42, the slide plate including a semi-rigid (Col. 7 line 22 stiffer material) slide fitting 110 having a passage (area that surrounds and contains drain tube 66) extending through the slide plate 108, the semi-rigid slide fitting having an end on a side thereof opposite the micturition cup that is spaced from the slide plate (see below illustrative diagram of Figure 3), the slide fitting configured to connect, at an opposite end, to the outlet port of the micturition cup to join the micturition cup and the slide plate and to form a common flow passage from the micturition cup through the slide plate (Col. 7 lines 4-23, silicone adhesive is employed as a bonding agent between the drain tube and the surrounding shell 110, thus connected to outlet port at both ends as 110 is functionally unified with 66) ;
the garment including a slide track 174, the micturition cup and slide plate being positioned in the garment on one side of the slide track (Col. 10 lines 12-26, urine collection receptacle 42 and bottom flange 56 inserted through the slot 182);
the slide fitting being positioned on the other side of the slide track (Col. 10 lines 12-26, drain tube extend through the slot to other side of garment, as fitting 110 is unitary element with drain tube it to extends through slot).
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Illustrative diagram of Figure 3 of Beecher.
Beecher does not expressly disclose the rigid slide fitting forming a pair of rigid channels on the end opposite the micturition cup, the slide track being rigid, or the slide track engaging the pair of rigid channels between the slide plate and the slide fitting, the rigid channels being configured to engage engaging with the slide track so that the slide plate and micturition cup together slidably engage with and move along the slide track of the garment to adjust a position of the micturition device on the garment relative to the vaginal anatomy or a wearer.
However, Giacolone, in the same field of endeavor of urine collection devices, discloses a slide plate (top washer 48 that is positioned on the side of the garment facing toward the user urethra when assembled into slide track) and a slide fitting (bottom washer 48 that is positioned on the side of the garment facing away from user urethra) positioned on the opposite side of the garment to the slide plate when assembled, the slide fitting forming channels (spaces on either side of tube 38 between washers 48) positioned such that the channels engage a rigid slide track 52 (Col. 3 lines 3-22, fairly stiff to retain its shape, plastic materials preferred) of the garment so that the collection device is slidably engaged with and moves along the slide track of the garment to adjust a position of the collection device on the garment relative to the vaginal anatomy of a wearer (Col. 4 lines 1-20) for the purpose of keeping the device positioned in the garment such that there is limited movement toward and away from vaginal plug (Col. 3 lines 47-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer surface of the rigid slide fitting to have an extension of its surface such as a washer opposite the slide plate that forms channels between the slide plate and washer, as taught by Giacolone, and for the slide track to have been made from a rigid plastic, as taught by Giacolone, for the purpose of keeping the device positioned in the garment such that there is limited movement toward and away from vaginal plug (Col. 3 lines 47-62) providing the advantage of holding the device in place along a direction transverse to the garment which would prevent the drainage tube of the device from being wrongly positioned within the garment avoiding the need to readjust device positioning in relation to the garment.
Regarding claim 4, Beecher in view of Giacolone suggests the micturition device of claim 1. Beecher further discloses the garment 172 is a compression short (Col. 9 lines 57-68, elastic panties or briefs), the compression short configured to hold the micturition cup securely in place (Col. 2 lines 42-52, retaining the urinary collection device)
Regarding claim 5, Beecher in view of Giacolone suggests the micturition device of claim 1. Giacolone further suggests the slide track being made of plastic (Col. 3 lines 3-22, fairly stiff to retain its shape, plastic materials preferred) for the purpose of providing a material that is fairly stiff to retain its shape.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the slide track of Beecher in view of Giacolone to have been plastic for the purpose of providing a material that is fairly stiff in order to retain its shape.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the main body of Trinder out of rubber, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 9, Beecher in view of Giacolone suggests the micturition device of claim 1. Beecher further discloses the rim gasket being formed from an elastomeric material (Col. 1 lines 59-68 and Col. 2 lines 1-13, elastomer material).
Regarding claim 10, Beecher in view of Giacolone suggests the micturition device of claim 1. Beecher further discloses the passage at the slide fitting end (see illustrative diagram of Figure 20 below) including an orifice (see illustrative diagram of Figure 16), the orifice configured to connect to a tube 68 to join the micturition cup to the disposable tube through the slide plate and to form the common flow passage from the micturition cup to the disposable tube for further evacuation of fluid from the micturition cup (Col. 5 lines 44-65, drain opening connected to drain tube comprising flexible section which connects to drain hose 68).
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Illustrative diagram of Figure 20 of Beecher.
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Illustrative diagram of Figure 16 of Beecher.
Beecher does not expressly disclose the tube being disposable, however, the limitation of “disposable” is considered functional language (function of disposing of). However, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Levine discloses all the structure as claimed. As such, it is capable of performing the functions as claimed (i.e., it is capable of being disposed of).
Regarding claim 11, Beecher in view of Giacolone suggests the micturition device of claim 1. Beecher in view of Giacolone do not expressly disclose or suggest the micturition cup and the slide plate being integrally formed with each other.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the micturition cup and the slide plate be integrally formed, since the court has held that the use of a one-piece construction instead of the structure disclosed in Beecher would be merely a matter of obvious engineering choice. In re Larson, 40 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). Furthermore, applicant has provided no criticality in the specification for the micturition cup and the slide plate being integrally formed (Paragraph [0041], may be integrally formed with one another)
Regarding claim 12, Beecher in view of Giacolone suggests the micturition device of claim 11. Beecher in view of Giacolone do not expressly disclose or suggest the slide fitting being separate from the slide plate and the micturition cup.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the fitting separate from the slide plate, since the court has held that if it were considered desirable for any reason to be able to gain access to the part, it would be obvious to make the part separable for that purpose. The use of a separable structure instead of the structure disclosed by Levine would be merely a matter of obvious engineering choice, and applicant has provided no criticality in the specification for the removability of these parts. See MPEP 2144.04. In re Dulberg 289 F.2d 522, 523, 129 USPQ 348,349 (CCPA 1961).
Regarding claim 13, Beecher discloses a method of using a micturition device (Fig. 18 and 19), the method comprising:
providing (Col. 1 lines 41-46 provide) a garment 172 configured to be worn over the pelvic area (Col. 9 lines 57-68, crotch) of a wearer;
providing (Col. 1 lines 41-46 provide) a micturition device for placement in the garment (Col. 2 lines 42-52 receives and retains device), the micturition device comprising:
a micturition cup 42, the micturition cup 42 being a unitary element configured to encircle vaginal area anatomy of a wearer (Col. 5 lines 5-31 around orifice of urethra) including the urethral opening (sidewall 102 encircles urethral opening) and vaginal opening (extension of 108 containing element 128 positioned to surround vaginal opening) for capturing fluids of the vaginal area anatomy, and being free of an element engaging a vaginal opening of the vagina (Col. 5 lines 32-43, pessary member 58 is an optional construction and may be detachable mounted thus device would be free of pessary member when detached; Col. 8 lines 29-35 provision of a detachable pessary makes it possible to use the female urinary collection device, with or without a pessary, as desired);
the micturition cup 42 including a semi-rigid cup floor (62; abuts 108 which is made of a stiffer material Col. 7 lines 4-23 which would impart less flexion of the floor than sidewall which abut material 106 which causes sidewall and upper lip 50 to be more compliant and soft imparting greater flexibility Col. 6 lines 55-64) and an outlet port 64 in the cup floor for evacuating fluids from the micturition cup (Col. 5 lines 44-65, urine flows out of receptacle through drain tube into drain hose connected to drain tube)
a flexible sidewall 102 extending outwardly (extends both laterally and longitudinally outward) from an outside edge (edge of cup floor 62 that occurs at transverse joining point of 102 to 62) of the semi-rigid cup floor of the unitary micturition cup, the flexible sidewall being more flexible than the semi-rigid cup floor (Col. 7 lines 4-23, element 108 is made of a stiffer material than sidewall and bottom wall which would impart a greater stiffness to bottom wall 62 than element 102 as 62 has greater support from element 108), the cup floor being contoured from the sidewall to the outlet port to direct the fluids to leave the cup (see below illustrative diagram of Fig. 3)
a rim gasket (elements 50, 102, 104, and 106 in combination) formed of a different material than the cup floor and sidewall (formed of viscous liquid silicone elastomer gum or gel Col. 6 lines 55-64), the gasket positioned atop the flexible sidewall (positioned atop element 50 and surrounding the interior of flexible sidewall) and configured to surround the micturition cup (106 surrounds the receptacle space of cup); the rim gasket having a thickness greater than the flexible sidewall for molding and sealing around the vaginal area anatomy (comprises the thickness of shells 102, 104 and fluid 106, seals around urethral opening and is flexible and therefore molds when positioned);
a slide plate 108 having a complementary shape (shaped to be bonded to bottom wall 62) with the micturition cup 42, the slide plate including a rigid (Col. 7 line 22 stiffer material) slide fitting 110 having a passage (area that surrounds and contains drain tube 66) extending through the slide plate 108, the rigid slide fitting having an end on a side thereof opposite the micturition cup that is spaced from the slide plate (see below illustrative diagram of Figure 3), the slide fitting configured to connect, at an opposite end, to the outlet port of the micturition cup to join the micturition cup and the slide plate and to form a common flow passage from the micturition cup through the slide plate (Col. 7 lines 4-23, silicone adhesive is employed as a bonding agent between the drain tube and the surrounding shell 110, thus connected to outlet port at both ends as 110 is functionally unified with 66);
the garment including a rigid slide track 174, the micturition cup and slide plate being positioned in the garment on one side of the rigid slide track (Col. 10 lines 12-26, urine collection receptacle 42 and bottom flange 56 inserted through the slot 182);
the slide fitting being positioned on the other side of the rigid slide track (Col. 10 lines 12-26, drain tube extend through the slot to other side of garment, as fitting 110 is unitary element with drain tube it to extends through slot).
Beecher does not expressly disclose the rigid slide fitting forming a pair of rigid channels on the end opposite the micturition cup, the slide track being rigid, or the slide track engaging the pair of rigid channels between the slide plate and the slide fitting, the rigid channels being configured to engage engaging with the slide track so that the slide plate and micturition cup together slidably engage with and move along the slide track of the garment to adjust a position of the micturition device on the garment relative to the vaginal anatomy or a wearer.
However, Giacolone, in the same field of endeavor of urine collection devices, discloses a slide plate (top washer 48 that is positioned on the side of the garment facing toward the user urethra when assembled into slide track) and a slide fitting (bottom washer 48 that is positioned on the side of the garment facing away from user urethra) positioned on the opposite side of the garment to the slide plate when assembled, the slide fitting forming channels (spaces on either side of tube 38 between washers 48) positioned such that the channels engage a rigid slide track 52 (Col. 3 lines 3-22, fairly stiff to retain its shape, plastic materials preferred) of the garment so that the collection device is slidably engaged with and moves along the slide track of the garment to adjust a position of the collection device on the garment relative to the vaginal anatomy of a wearer (Col. 4 lines 1-20) for the purpose of keeping the device positioned in the garment such that there is limited movement toward and away from vaginal plug (Col. 3 lines 47-62) and adjusting a position of the collection device on the garment relative to the vaginal anatomy of a wearer (Col. 4 lines 1-20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer surface of the rigid slide fitting to have an extension of its surface such as a washer opposite the slide plate that forms channels between the slide plate and washer, as taught by Giacolone, and for the slide track to have been made from a rigid plastic, as taught by Giacolone, for the purpose of keeping the device positioned in the garment such that there is limited movement toward and away from vaginal plug (Col. 3 lines 47-62) providing the advantage of holding the device in place along a direction transverse to the garment which would prevent the drainage tube of the device from being wrongly positioned within the garment avoiding the need to readjust device positioning in relation to the garment.
Regarding claim 16, Beecher in view of Giacolone suggest the micturition device of claim 13. Beecher further discloses attaching (Col. 7 lines 4-23, silicone adhesive is employed as a bonding agent between the drain tube and the surrounding shell 110) a tube 66 to the fitting to form the common flow passage (tube forms common flow passage) from the micturition cup to the disposable tube for further evacuation of fluid from the micturition cup.
Beecher does not expressly disclose the tube being disposable, however, the limitation of “disposable” is considered functional language (function of disposing of). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Levine discloses all the structure as claimed. As such, it is capable of performing the functions as claimed (i.e., it is capable of being disposed of).
Regarding claim 17, Beecher in view of Giacolone suggests the micturition device of claim 13. Beecher further discloses the disposable tube comprising a connector (Col. 7 lines 4-23, silicone adhesive) to interface with the slide fitting of the slide plate.
Claim(s) 18-20 is rejected under 35 U.S.C. 103 as being unpatentable over Beecher (U.S. Patent No. 4,889,533) in view of Giacolone et al. (U.S. Patent No. 4,615,692) and further in view of Martin (U.S. Patent No. 4,631,061).
Regarding claim 18, Beecher discloses a micturition system (Fig. 16) for fluid removal, the micturition system comprising:
a garment 172 configured to be worn over the pelvic area (Col. 9 lines 57-68, crotch);
a micturition cup 42, the micturition cup 42 being a unitary element configured to encircle vaginal area anatomy of a wearer (Col. 5 lines 5-31 around orifice of urethra) including the urethral opening (sidewall 102 encircles urethral opening) and vaginal opening (extension of 108 containing element 128 positioned to surround vaginal opening) for capturing fluids of the vaginal area anatomy, and being free of an element engaging a vaginal opening of the vagina (Col. 5 lines 32-43, pessary member 58 is an optional construction and may be detachable mounted thus device would be free of pessary member when detached; Col. 8 lines 29-35 provision of a detachable pessary makes it possible to use the female urinary collection device, with or without a pessary, as desired);
the micturition cup 42 including a semi-rigid cup floor (62; abuts 108 which is made of a stiffer material Col. 7 lines 4-23 which would impart less flexion of the floor than sidewall which abut material 106 which causes sidewall and upper lip 50 to be mor compliant and soft imparting greater flexibility Col. 6 lines 55-64) and an outlet port 64 in the cup floor for evacuating fluids from the micturition cup (Col. 5 lines 44-65, urine flows out of receptacle through drain tube into drain hose connected to drain tube);
a flexible sidewall 102 extending outwardly (extends both laterally and longitudinally outward) from an outside edge (edge of cup floor 62 that occurs at transverse joining point of 102 to 62) of the semi-rigid cup floor of the unitary micturition cup, the flexible sidewall being more flexible than the semi-rigid cup floor (Col. 7 lines 4-23, element 108 is made of a stiffer material than sidewall and bottom wall which would impart a greater stiffness to bottom wall 62 than element 102 as 62 has greater support from element 108), the cup floor being contoured from the sidewall to the outlet port to direct the fluids to leave the cup (see below illustrative diagram of Fig. 3);
a rim gasket (elements 50, 102, 104, and 106 in combination) formed of a different material than the cup floor and sidewall (formed of viscous liquid silicone elastomer gum or gel Col. 6 lines 55-64), the gasket positioned atop the flexible sidewall (positioned atop element 50 and surrounding the interior of flexible sidewall) and configured to surround the micturition cup (106 surrounds the receptacle space of cup); the rim gasket having a thickness greater than the flexible sidewall for molding and sealing around the vaginal area anatomy (comprises the thickness of shells 102, 104 and fluid 106, seals around urethral opening and is flexible and therefore molds when positioned);
a slide plate 108 having a complementary shape (shaped to be bonded to bottom wall 62) with the micturition cup 42, the slide plate including a rigid (Col. 7 line 22 stiffer material) slide fitting 110 having a passage (area that surrounds and contains drain tube 66) extending through the slide plate 108, the rigid slide fitting having an end on a side thereof opposite the micturition cup that is spaced from the slide plate (see below illustrative diagram of Figure 3), the slide fitting configured to connect, at an opposite end, to the outlet port of the micturition cup to join the micturition cup and the slide plate and to form a common flow passage from the micturition cup through the slide plate (Col. 7 lines 4-23, silicone adhesive is employed as a bonding agent between the drain tube and the surrounding shell 110, thus connected to outlet port at both ends as 110 is functionally unified with 66);
the garment including a slide track 174, the micturition cup and slide plate being positioned in the garment on one side of the slide track (Col. 10 lines 12-26, urine collection receptacle 42 and bottom flange 56 inserted through the slot 182);
the slide fitting being positioned on the other side of the slide track (Col. 10 lines 12-26, drain tube extend through the slot to other side of garment, as fitting 110 is unitary element with drain tube it to extends through slot), a tube 66, the tube configured to connect to the slide fitting to transport fluid away from the micturition cup.
Beecher does not expressly disclose the rigid slide fitting forming a pair of rigid channels on the end opposite the micturition cup, the slide track being rigid, or the slide track engaging the pair of rigid channels between the slide plate and the slide fitting, the rigid channels being configured to engage engaging with the slide track so that the slide plate and micturition cup together slidably engage with and move along the slide track of the garment to adjust a position of the micturition device on the garment relative to the vaginal anatomy or a wearer.
However, Giacolone, in the same field of endeavor of urine collection devices, discloses a slide plate (top washer 48 that is positioned on the side of the garment facing toward the user urethra when assembled into slide track) and a slide fitting (bottom washer 48 that is positioned on the side of the garment facing away from user urethra) positioned on the opposite side of the garment to the slide plate when assembled, the slide fitting forming channels (spaces on either side of tube 38 between washers 48) positioned such that the channels engage a rigid slide track 52 (Col. 3 lines 3-22, fairly stiff to retain its shape, plastic materials preferred) of the garment so that the collection device is slidably engaged with and moves along the slide track of the garment to adjust a position of the collection device on the garment relative to the vaginal anatomy of a wearer (Col. 4 lines 1-20) for the purpose of keeping the device positioned in the garment such that there is limited movement toward and away from vaginal plug (Col. 3 lines 47-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer surface of the rigid slide fitting to have an extension of its surface such as a washer opposite the slide plate that forms channels between the slide plate and washer, as taught by Giacolone, and for the slide track to have been made from a rigid plastic, as taught by Giacolone, for the purpose of keeping the device positioned in the garment such that there is limited movement toward and away from vaginal plug (Col. 3 lines 47-62) providing the advantage of holding the device in place along a direction transverse to the garment which would prevent the drainage tube of the device from being wrongly positioned within the garment avoiding the need to readjust device positioning in relation to the garment.
Beecher does not expressly disclose the tube being disposable, however, the limitation of “disposable” is considered functional language (function of disposing of). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Levine discloses all the structure as claimed. As such, it is capable of performing the functions as claimed (i.e., it is capable of being disposed of).
Beecher further fails to expressly disclose a vacuum tube, the vacuum tube configured to connect to the disposable tube to transport fluid away from the disposable tube; a receptacle, the receptacle configured to connect to the vacuum tube and to receive fluid from the vacuum tube; a vacuum source, the vacuum source configured to connect to the vacuum tube and to create a negative pressure to draw a fluid away from the micturition cup; and a pressure controller, the pressure controller configured to adjust the negative pressure.
However, Martin, in the same field of endeavor of micturition systems, teaches a micturition system (Figure 1) including a vacuum tube, the vacuum tube (24) configured to connect to a micturition cup (22) to transport fluid away (Col. 4 lines 1-9) from the tube (24); a receptacle (32), the receptacle configured to connect to the vacuum tube (24) and to receive fluid (Col. 4 lines 1-9) from the vacuum tube (24); a vacuum source (43), the vacuum source (43) configured to connect (Col. 3 lines 59-68 and Col. 4 lines 1-9) to the vacuum tube (24) and to create a negative pressure (Col. 3 lines 59-68 and Col. 4 lines 1-9; vacuum) to draw a fluid away (Col. 3 lines 59-68 and Col. 4 lines 1-9) from the micturition cup (22); and a pressure controller (48), the pressure controller (48) configured to adjust (Col. 3 lines 59-68 and Col. 4 lines 1-9; activates the pump turning it on or off thus adjusting pressure) the negative pressure (Col. 3 lines 59-68 and Col. 4 lines 1-9; vacuum) for the purpose of providing a vacuum which operates automatically to eliminate wetness from contact with the skin of the wearer (Col. 1 lines 49-62).
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 system disclosed by Levine to have included the vacuum portions of the system taught by Martin, for the purpose of providing a vacuum which operates automatically to eliminate wetness from contact with the skin of the wearer (Col. 1 lines 49-62).
Regarding claim 19, Beecher in view of Giacolone and further in view of Martin suggest the micturition system of claim 18. Beecher in view of Giacolone and further in view of Martin do not expressly disclose or suggest a bag configured to transport and store the receptacle and vacuum source. However, Martin further teaches a bag (82) configured to transport and store (Col. 3 lines 1-14) the receptacle (32) and vacuum source (43) for the purpose of providing an inconspicuous easy-to-carry means of enclosure (Col. 3 lines 1-14).
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 system disclosed by Beecher in view of Giacolone and Martin to have included a bag as taught by Martin for the purpose of providing an inconspicuous easy-to-carry means of enclosure (Col. 3 lines 1-14).
Regarding claim 20, Beecher in view of Giacolone and further in view of Martin suggest the micturition system of claim 18. Martin further suggests the pressure controller (48) having at least a low pressure setting (Col. 3 lines 38-58; inactive state) and a high pressure setting (Col. 3 lines 38-58; activated state).
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 system disclosed by Levine to have included the vacuum portions of the system taught by Martin including the low pressure setting and high pressure setting, for the purpose of providing a vacuum which operates automatically by transferring from inactive to active to eliminate wetness from contact with the skin of the wearer (Col. 1 lines 49-62).
Conclusion
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781