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 .
Specification
The abstract of the disclosure is objected to because in line 3, “a first bar that with a first pad assembly” should be revised to recite “a first bar with a first pad assembly”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 3-4, 6 and 18 are objected to because of the following informalities which require appropriate correction:
In claim 1 line 13: “below past a plane the first bar” should be amended to recite “below a plane of the first bar”.
In claim 1 line 14: “on configuration” should be revised to recite “one configuration”.
In claim 3 line 1: “wherein adjustment” should be amended to recite “wherein the adjustment”
In claim 4 line 3: “an adjustment cylinder” should be revised to recite “ the adjustment cylinder”.
In claim 6 line 10: “below past a plane the first bar” should be amended to recite “below a plane of the first bar”.
In claim 6 line 10: “on configuration” should be revised to recite “one configuration”.
In claim 18 line 2: “below past a plane of a first bar” should be amended to recite “below a plane of a first bar”.
In claim 18 line 3: “on configuration” should be revised to recite “one configuration”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3 and 5-11 are rejected under 35 U.S.C. 103 as being unpatentable over Higgins et al (US 20210015594 A1) in view of Bialick (US 3203421) and further in view of Dennis (US 2008/0121241 A1).
With respect to claim 1, Higgins discloses a method of using a male incontinence clamp to address incontinence in a user (para [0001;0007;0033]; incontinence clamping device 100), the method comprising: opening the male incontinence clamp (shown in fig 11), the male incontinence clamp (100) comprising: a first bar (bottom clamp arm 104; fig 9-10) that includes: a first bar central body from which a first rear arm and first front arm extend (identified in annotated fig 9-a), the first bar (104) defining a first first bar sidewall (sidewall of 104 that is visible in fig 9) and a second first bar sidewall (sidewall on opposing side of arm 104 that is not visible in fig 9), a first bar external face and a first bar internal face (identified in annotated fig 9-a), the first front arm comprising a ratchet end (end that includes device locking component 104a; fig 3a-3b) that defines: a first arm tip (identified in annotated fig 9-a), a plurality of ratchet slots (gaps 104b; fig 3a-3b), and a stop notch (identified in annotated fig 9-a), wherein a portion of the ratchet end, including at least the first arm tip and one or more of the plurality of ratchet slots, is configured to extend below a plane the first bar external face in at least one configuration of the male incontinence clamp (best illustrated in figs 12-13), a first pad assembly (silicone fitting 114) disposed at the first bar internal face (as shown in figs 9 and 13), the first pad assembly (114) comprising a convex central ridge (protrusion 114a; fig 8b) and a pair of peripheral concave valleys on opposing sides of the convex central ridge (areas on each side of protrusion 114a, identified in annotated fig 8B) with a continuous sloping connection thereto (as shown in fig 8B, the outer surface of fitting 114 continuously and gradually slopes downwardly from the highest point at the center of protrusion 114a, into each valley, and then to the substantially horizontal portion that extends out to the left and right edges of the fitting which then slope downwardly), the first pad assembly (114) having symmetry about a first pad central axis that extends centrally through the convex central ridge (see fig 8b; axis is interpreted as extending vertically through center of protrusion 114a), and a second bar (upper clamp arm 102) that includes: a second bar central body from which a second rear arm and second front arm extend (identified in annotated fig 9-b), the second bar (102) defining a first second bar sidewall (sidewall of 102 that is visible in fig 9) and second second bar sidewall (sidewall on opposing side of arm 102 that is not visible in fig 9), a second bar external face and a second bar internal face (identified in annotated fig 9-b), the second bar central body defining a dorsal gap configured to provide visual assistance with placement and alignment of the male incontinence clamp on a male member of the user (the gap between the openings in arm 102 is interpreted as being capable of providing visual assistance with placement/alignment during use since it is located at the center of the arm 102 as shown in fig 9), the second bar further comprising a stop tip at an end of the second front arm (identified in annotated fig 9-b), the stop tip configured to engage with the stop notch of the ratchet end of the first bar to generate a closure stop between the first bar and the second bar (shown in figs 1, 10, 12 and 13), the stop tip comprising a ratchet tooth (stopper 102a;para [0040]) configured to engage respectively with the plurality of ratchet slots of the ratchet end of the first bar to couple the first and second bars together (para [0040]; shown in fig 13), and a second pad assembly disposed on the second bar internal face symmetrically about a second bar axis (silicone fitting 112; fig 9; axis is interpreted as extending vertically through the center of fitting 112 and arm 102), and in at least one configuration of the male incontinence clamp, the second bar axis and the first pad central axis being coincident along a central axis Y of the male incontinence clamp (shown in fig 9), a hinge assembly that rotatably couples the first bar and the second bar at the first rear arm and the second rear arm of the first bar and the second bar (nut-bolt assemblies 116, 118, and 120; see fig 9 and 11; para [0056]) and a member cavity defined at least in part by the first pad assembly and the second pad assembly (space between silicone fittings 112 and 114 that is shown in fig 12); inserting the male member into the member cavity with the male incontinence clamp surrounding a shaft of the male member (configured for easy positioning on the penile shaft which inherently involves inserting the male member into the cavity formed between fittings 112 and 114 - para [0037]); and closing the male incontinence clamp (as shown in fig 13) around the shaft of the male member (it is inherent that device 100 is closed around the shaft in order to be positioned on the penile shaft and apply pressure to the urethra and the corpus spongiosum as described in para [0037]) to cause: the stop tip of the second bar to engage with the stop notch of the ratchet end of the first bar to generate the closure stop between the first bar and the second bar (the stopper 102a is inserted into one of the pluralities of interlocking gaps 104b to establish the locking of the upper clamp arm 102 with the bottom clamp arm 104 – para [0057]; fig 13), the ratchet tooth (102a) to engage a final ratchet slot of the plurality of ratchet slots to releasably lock the first and second bars together (fig 13; para [0057]), a configuration of the male incontinence clamp where the second bar axis and the first pad central axis are coincident along the central axis Y of the male incontinence clamp (alignment of elements along centrally disposed vertical axis is shown in fig 9), and the convex central ridge of the first pad assembly to apply sufficient pressure to a urethra of the male member to address incontinence associated with the male member of the user (para [0037]).
ANNOTATED FIG 9-a of Higgins et al (US 20210015594 A1):
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ANNOTATED FIG 8B of Higgins et al (US 20210015594 A1):
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ANNOTATED FIG 9-b of Higgins et al (US 20210015594 A1):
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Higgins does not, however, disclose an adjustment assembly configured to adjust the first pad assembly disposed at the first bar internal face based at least in part on an extension shaft of the adjustment assembly configured to extend and retract between a minimum and maximum distance of between 0.5 mm - 2.0 mm to adjust the first pad assembly.
Bialick, however, teaches an analogous incontinence clamp device which includes an adjustment assembly configured to adjust the first pad assembly disposed at the first bar internal face based at least in part on an extension shaft of the adjustment assembly configured to extend and retract (element 23 which is disposed on the internal face of arm 11 as shown in fig 1 is adjustably mounted on arm 11 and is moved by a jack screw 27 which is rotatably engaged in the body of the element 23 by a holding screw 28 such that the element 23 may be moved toward or away from the arm 11 guided by the pins 25 – col 2 lines 34-51). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of Higgins to further include an adjustment assembly configured to adjust the first pad assembly disposed at the first bar internal face based at least in part on an extension shaft of the adjustment assembly configured to extend and retract, as taught by Bialick, in order to allow for the degree of clamping pressure to be precisely achieved (Bialick col 1 lines 45-48). Although Bialick does not explicitly disclose the exact minimum and/or maximum distance by which the adjustment assembly can move the element 23, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have configured the adjustment assembly to allow extension and retraction between a specific minimum and maximum distance of 0.5 mm - 2.0 mm in order to permit small, finely-tuned adjustments for improved comfort and customization to best meet the needs of a given user and, furthermore, because discovering the optimum or workable ranges involves only routine skill in the art.
Higgins also does not disclose that the second pad assembly comprises a separate first pad and a second pad disposed on the second bar internal face symmetrically on opposing sides of a second bar axis; the separate first pad and the second pad defining a member gap therebetween with respective central ends of the separate first pad and the second pad facing the member gap sloping to make the first and second pads thicker farther from the respective central ends; a member cavity defined at least in part by the first pad assembly and the first pad and the second pad; wherein the method includes orienting the male incontinence clamp on the male member using the dorsal gap for visual guidance such that a dorsal end of the male member is disposed proximate to and engaging the separate first pad and the second pad and disposed within the member gap defined by the separate first pad and the second pad, and oriented with a ventral end of the male member disposed proximate to and engaging the first pad assembly.
Dennis, however, teaches an analogous incontinence device 100 comprising a first pad assembly (ventral pad 108; fig 1a); a second pad assembly that comprises a separate first pad and a second pad (two dorsal pads 106 shown in fig 1a) disposed on the second bar internal face (pads 106 are on the internal face of dorsal arm 102 as shown in fig 1a) symmetrically on opposing sides of a second bar axis (the pads 106 are arranged symmetrically on each side of a vertical axis that runs through the center of arm 102 as shown in fig 1a); the separate first pad and the second pad (pads 106) defining a member gap therebetween (space between pads 106 shown in fig 1a) with respective central ends of the separate first pad and the second pad facing the member gap (as shown in fig 1a) sloping to make the first and second pads thicker farther from the respective central ends (as shown in fig 1a the pads 106 are shaped having curved edges that provide a sloped contour – this shape makes the pads have a thickened region on the sides farthest from the central member gap when compressed during use as shown in fig 6); a member cavity defined at least in part by the first pad assembly and the first pad and the second pad (space at the center of device 100 between pads 106 and pad 108 as shown in fig 1a); wherein the second bar (102) has a central body (center section of arm 102, located in region between pads 106 in fig 1a) defining a dorsal gap (area on arm 102 between pads 106 in fig 1a) configured to provide visual assistance with placement and alignment of the male incontinence clamp on a male member of the user (the area at the gap between the pads 106 is interpreted as being capable of providing visual assistance with placement/alignment during use since it is located at the center of the arm 102 as shown in fig 1a and is specifically configured for alignment with the central dorsal vascular group 20 during use as shown in fig 6; see para [0042) wherein the method of using the device (see i.e. para [0022,0043,0044]) includes orienting the male incontinence clamp on the male member using the dorsal gap for visual guidance such that a dorsal end of the male member is disposed proximate to and engaging the separate first pad and the second pad and disposed within the member gap defined by the separate first pad and the second pad and oriented with a ventral end of the male member disposed proximate to and engaging the first pad assembly (see method steps outlined in para [0043-0044] and positioning in fig 6). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have further modified the device of Higgins in view of Bialick so that that the second pad assembly comprises a separate first pad and a second pad disposed on the second bar internal face symmetrically on opposing sides of a second bar axis; the separate first pad and the second pad defining a member gap therebetween with respective central ends of the separate first pad and the second pad facing the member gap sloping to make the first and second pads thicker farther from the respective central ends; a member cavity defined at least in part by the first pad assembly and the first pad and the second pad; wherein the method includes orienting the male incontinence clamp on the male member using the dorsal gap for visual guidance such that a dorsal end of the male member is disposed proximate to and engaging the separate first pad and the second pad and disposed within the member gap defined by the separate first pad and the second pad, and oriented with a ventral end of the male member disposed proximate to and engaging the first pad assembly, as taught by Dennis, in order to provide a configuration that reduces pressure upon the lateral superficial veins while maintaining sufficient overall pressure to constrict the urethra (Dennis para [0042]).
With respect to claim 2, Higgins in view of Bialick and further in view of Dennis discloses the method substantially as claimed (see rejection of claim 1) and Higgins further discloses that the first bar (bottom clamp arm 104; fig 9-10) biases the ratchet end toward the ratchet tooth (pressing the clamp arms together as described in para [0040]) such that the ratchet tooth (102a) is configured to be respectively held within each of the plurality of ratchet slots (104b) (para [0040;0042]; as shown in fig 13).
With respect to claim 3, Higgins in view of Bialick and further in view of Dennis discloses the method substantially as claimed (see rejection of claim 1) and Bialick further teaches that the adjustment assembly (adjustment assembly on arm 11 in fig 1) further comprises an adjustment cylinder (jack screw 27; fig 1) that when rotatable actuated causes the extension shaft (holding screw 28; fig 1) to extend and retract to adjust the first pad assembly (element 23) (element 23 is adjustably mounted on arm 11 and is moved by jack screw 27 which is rotatably engaged in the body of the element 23 by a holding screw 28 such that the element 23 may be moved toward or away from the arm 11 – col 2 lines 34-51). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the adjustment assembly on the device of Higgins in view of Bialick and further in view of Dennis to further include an adjustment cylinder, that when rotatably actuated, causes the extension shaft to extend and retract to adjust the first pad assembly, as taught by Bialick, in order to allow for the degree of clamping pressure to be precisely achieved (Bialick col 1 lines 45-48). Although Bialick does not explicitly disclose the exact minimum and/or maximum distance by which the adjustment assembly can move the element 23, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have configured the adjustment assembly to allow extension and retraction between a specific minimum and maximum distance of 0.5 mm - 2.0 mm in order to permit small, finely-tuned adjustments for improved comfort and customization to best meet the needs of a given user and, furthermore, because discovering the optimum or workable ranges involves only routine skill in the art.
With respect to claim 5, Higgins discloses a method of using a male incontinence clamp to address incontinence in a user (para [0001;0007;0033]; incontinence clamping device 100), the method comprising: applying the male incontinence clamp to a male member of the user (it is inherent that device 100 is applied to the penis of a user in order to be positioned on the penile shaft and apply pressure to the urethra and the corpus spongiosum as described in para [0037]); the male incontinence clamp (100) comprising: a first bar (bottom clamp arm 104; fig 9-10) that includes: a first pad assembly (silicone fitting 114) disposed at a first bar internal face (as shown in figs 9 and 13, fitting 114 is disposed on the internal face of arm 104; the internal face of arm 104 is identified in annotated fig 9-a), the first pad assembly (114) comprising a convex central ridge (protrusion 114a; fig 8b) and a pair of peripheral concave valleys on opposing sides of the convex central ridge (areas on each side of protrusion 114a, identified in annotated fig 8B) with a continuous sloping connection thereto (as shown in fig 8B, the outer surface of fitting 114 continuously and gradually slopes downwardly from the highest point at the center of protrusion 114a, into each valley, and then to the substantially horizontal portion that extends out to the left and right edges of the fitting which then slope downwardly), the first pad assembly (114) having symmetry about a first pad central axis that extends centrally through the convex central ridge (see fig 8b; axis is interpreted as extending vertically through center of protrusion 114a), and a second bar (upper clamp arm 102) that includes: a second pad assembly disposed on the second bar internal face symmetrically about a second bar axis (silicone fitting 112; fig 9; axis is interpreted as extending vertically through the center of fitting 112 and arm 102; fitting 112 is disposed on the internal face of arm 102 as shown in figs 9 and 13; the internal face of arm 102 is identified in annotated fig 9-b), and in at least one configuration of the male incontinence clamp, the second bar axis and the first pad central axis being coincident along a central axis Y of the male incontinence clamp (shown in fig 9), a hinge assembly that rotatably couples the first bar and the second bar (nut-bolt assemblies 116, 118, and 120; see fig 9 and 11; para [0056]) and a member cavity defined at least in part by the first pad assembly and the second pad assembly (space between silicone fittings 112 and 114 that is shown in fig 12).
ANNOTATED FIG 9-a of Higgins et al (US 20210015594 A1):
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ANNOTATED FIG 8B of Higgins et al (US 20210015594 A1):
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ANNOTATED FIG 9-b of Higgins et al (US 20210015594 A1):
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Higgins does not, however, disclose an adjustment assembly configured to adjust the first pad assembly disposed at the first bar internal face.
Bialick, however, teaches an analogous incontinence clamp device which includes an adjustment assembly configured to adjust the first pad assembly disposed at the first bar internal face (element 23 which is disposed on the internal face of arm 11 as shown in fig 1 is adjustably mounted on arm 11 and is moved by a jack screw 27 which is rotatably engaged in the body of the element 23 by a holding screw 28 such that the element 23 may be moved toward or away from the arm 11 guided by the pins 25 – col 2 lines 34-51). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of Higgins to further include an adjustment assembly configured to adjust the first pad assembly disposed at the first bar internal face, as taught by Bialick, in order to allow for the degree of clamping pressure to be precisely achieved (Bialick col 1 lines 45-48).
Higgins also does not disclose that the second pad assembly comprises a separate first pad and a second pad disposed on the second bar internal face symmetrically on opposing sides of a second bar axis; the separate first pad and the second pad defining a member gap therebetween; a member cavity defined at least in part by the first pad assembly and the first pad and the second pad.
Dennis, however, teaches an analogous incontinence device 100 comprising a first pad assembly (ventral pad 108; fig 1a); a second pad assembly that comprises a separate first pad and a second pad (two dorsal pads 106 shown in fig 1a) disposed on the second bar internal face (pads 106 are on the internal face of dorsal arm 102 as shown in fig 1a) symmetrically on opposing sides of a second bar axis (the pads 106 are arranged symmetrically on each side of a vertical axis that runs through the center of arm 102 as shown in fig 1a); the separate first pad and the second pad (pads 106) defining a member gap therebetween (space between pads 106 shown in fig 1a); a member cavity defined at least in part by the first pad assembly and the first pad and the second pad (space at the center of device 100 between pads 106 and pad 108 as shown in fig 1a); wherein the second bar (102) has a central body (center section of arm 102, located in region between pads 106 in fig 1a) defining a dorsal gap (area on arm 102 between pads 106 in fig 1a) configured to provide visual assistance with placement and alignment of the male incontinence clamp on a male member of the user (the area at the gap between the pads 106 is interpreted as being capable of providing visual assistance with placement/alignment during use since it is located at the center of the arm 102 as shown in fig 1a and is specifically configured for alignment with the central dorsal vascular group 20 during use as shown in fig 6; see para [0042). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have further modified the device of Higgins in view of Bialick so that that the second pad assembly comprises a separate first pad and a second pad disposed on the second bar internal face symmetrically on opposing sides of a second bar axis; the separate first pad and the second pad defining a member gap therebetween; a member cavity defined at least in part by the first pad assembly and the first pad and the second pad, as taught by Dennis, in order to provide a configuration that reduces pressure upon the lateral superficial veins while maintaining sufficient overall pressure to constrict the urethra (Dennis para [0042]).
With respect to claim 6, Higgins in view of Bialick and further in view of Dennis discloses the method substantially as claimed (see rejection of claim 5) and Higgins further discloses that the first bar (bottom clamp arm 104; fig 9-10) comprises: a first bar central body from which a first rear arm and first front arm extend (identified in annotated fig 9-a), the first bar (104) defining a first first bar sidewall (sidewall of 104 that is visible in fig 9) and a second first bar sidewall (sidewall on opposing side of arm 104 that is not visible in fig 9), a first bar external face and a first bar internal face (identified in annotated fig 9-a), the first front arm comprising a ratchet end (end that includes device locking component 104a; fig 3a-3b) that defines: a first arm tip (identified in annotated fig 9-a), a plurality of ratchet slots (gaps 104b; fig 3a-3b), and a stop notch (identified in annotated fig 9-a), wherein a portion of the ratchet end, including at least the first arm tip and one or more of the plurality of ratchet slots, is configured to extend below a plane of the first bar external face in at least one configuration of the male incontinence clamp (best illustrated in figs 12-13).
With respect to claim 7, Higgins in view of Bialick and further in view of Dennis discloses the method substantially as claimed (see rejection of claim 5) but Higgins does not, however, disclose an adjustment assembly configured to adjust the first pad assembly disposed at the first bar internal face based at least in part on an extension shaft of the adjustment assembly configured to extend and retract between a minimum and maximum distance of between 0.5 mm - 2.0 mm to adjust the first pad assembly.
Bialick, however, teaches an analogous incontinence clamp device which includes an adjustment assembly configured to adjust the first pad assembly disposed at the first bar internal face based at least in part on an extension shaft of the adjustment assembly configured to extend and retract (element 23 which is disposed on the internal face of arm 11 as shown in fig 1 is adjustably mounted on arm 11 and is moved by a jack screw 27 which is rotatably engaged in the body of the element 23 by a holding screw 28 such that the element 23 may be moved toward or away from the arm 11 guided by the pins 25 – col 2 lines 34-51). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of Higgins to further include an adjustment assembly configured to adjust the first pad assembly disposed at the first bar internal face based at least in part on an extension shaft of the adjustment assembly configured to extend and retract, as taught by Bialick, in order to allow for the degree of clamping pressure to be precisely achieved (Bialick col 1 lines 45-48). Although Bialick does not explicitly disclose the exact minimum and/or maximum distance by which the adjustment assembly can move the element 23, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have configured the adjustment assembly to allow extension and retraction between a specific minimum and maximum distance of 0.5 mm - 2.0 mm in order to permit small, finely-tuned adjustments for improved comfort and customization to best meet the needs of a given user and, furthermore, because discovering the optimum or workable ranges involves only routine skill in the art.
With respect to claim 8, Higgins in view of Bialick and further in view of Dennis discloses the method substantially as claimed (see rejection of claim 5) and Higgins further discloses that the second bar (upper clamp arm 102) comprises: a second bar central body from which a second rear arm and second front arm extend (identified in annotated fig 9-b), the second bar (102) defining a first second bar sidewall (sidewall of 102 that is visible in fig 9) and second second bar sidewall (sidewall on opposing side of arm 102 that is not visible in fig 9), a second bar external face and a second bar internal face (identified in annotated fig 9-b), the second bar further comprising a stop tip at an end of the second front arm (identified in annotated fig 9-b), the stop tip configured to engage with the stop notch of the ratchet end of the first bar to generate a closure stop between the first bar and the second bar (shown in figs 1, 10, 12 and 13), the stop tip comprising a ratchet tooth (stopper 102a;para [0040]) configured to engage with the first bar to couple the first and second bars together (para [0040]; shown in fig 13).
With respect to claim 9, Higgins in view of Bialick and further in view of Dennis discloses the method substantially as claimed (see rejection of claim 5) but Higgins does not, however, disclose that respective central ends of the separate first pad and the second pad facing the member gap are sloping to make the first and second pads thicker farther from the respective central ends.
Dennis, however, teaches an analogous incontinence device 100 comprising a first pad assembly (ventral pad 108; fig 1a); a second pad assembly that comprises a separate first pad and a second pad (two dorsal pads 106 shown in fig 1a) disposed on the second bar internal face (pads 106 are on the internal face of dorsal arm 102 as shown in fig 1a) with respective central ends of the separate first pad and the second pad facing the member gap (as shown in fig 1a) sloping to make the first and second pads thicker farther from the respective central ends (as shown in fig 1a the pads 106 are shaped having curved edges that provide a sloped contour – this shape makes the pads have a thickened region on the sides farthest from the central member gap when compressed during use as shown in fig 6). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have further modified the device of Higgins in view of Bialick so that that respective central ends of the separate first pad and the second pad facing the member gap are sloping to make the first and second pads thicker farther from the respective central ends, as taught by Dennis, in order to provide a configuration that reduces pressure upon the lateral superficial veins while maintaining sufficient overall pressure to constrict the urethra (Dennis para [0042]).
With respect to claim 10, Higgins in view of Bialick and further in view of Dennis discloses the method substantially as claimed (see rejection of claim 5) and Higgins further discloses inserting the male member into the member cavity with the male incontinence clamp surrounding a shaft of the male member (configured for easy positioning on the penile shaft which inherently involves inserting the male member into the cavity formed between fittings 112 and 114 - para [0037]).
Higgins does not, however, disclose that the second pad assembly comprises a separate first pad and a second pad and a member cavity defined at least in part by the first pad assembly and the first pad and the second pad; wherein the method includes orienting the male incontinence clamp on the male member such that a dorsal end of the male member is disposed proximate to and engaging the separate first pad and the second pad and disposed within the member gap defined by the separate first pad and the second pad, and oriented with a ventral end of the male member disposed proximate to and engaging the first pad assembly.
Dennis, however, teaches an analogous incontinence device 100 comprising a first pad assembly (ventral pad 108; fig 1a); a second pad assembly that comprises a separate first pad and a second pad (two dorsal pads 106 shown in fig 1a) disposed on the second bar internal face (pads 106 are on the internal face of dorsal arm 102 as shown in fig 1a); a member cavity defined at least in part by the first pad assembly and the first pad and the second pad (space at the center of device 100 between pads 106 and pad 108 as shown in fig 1a); wherein the method of using the device (see i.e. para [0022,0043,0044]) includes orienting the male incontinence clamp on the male member such that a dorsal end of the male member is disposed proximate to and engaging the separate first pad and the second pad and disposed within the member gap defined by the separate first pad and the second pad and oriented with a ventral end of the male member disposed proximate to and engaging the first pad assembly (see method steps outlined in para [0043-0044] and positioning in fig 6). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have further modified the device of Higgins in view of Bialick so that that the second pad assembly comprises a separate first pad and a second pad; a member cavity defined at least in part by the first pad assembly and the first pad and the second pad; wherein the method includes orienting the male incontinence clamp on the male member such that a dorsal end of the male member is disposed proximate to and engaging the separate first pad and the second pad and disposed within the member gap defined by the separate first pad and the second pad, and oriented with a ventral end of the male member disposed proximate to and engaging the first pad assembly, as taught by Dennis, in order to provide a configuration that reduces pressure upon the lateral superficial veins while maintaining sufficient overall pressure to constrict the urethra (Dennis para [0042]).
With respect to claim 11, Higgins in view of Bialick and further in view of Dennis discloses the method substantially as claimed (see rejection of claim 5) and Higgins further discloses closing the male incontinence clamp (as shown in fig 13) around the male member (it is inherent that device 100 is closed around the shaft in order to be positioned on the penile shaft and apply pressure to the urethra and the corpus spongiosum as described in para [0037]) to cause: engagement between the first bar and the second bar to generate a closure stop between the first bar and the second bar (the stopper 102a is inserted into one of the pluralities of interlocking gaps 104b to establish the locking of the upper clamp arm 102 with the bottom clamp arm 104 – para [0057]; fig 13), engagement between the first bar and the second bar to releasably lock the first and second bars together (fig 13; para [0057]), a configuration of the male incontinence clamp where the second bar axis and the first pad central axis are coincident along the central axis Y of the male incontinence clamp (alignment of elements along centrally disposed vertical axis is shown in fig 9), and the convex central ridge of the first pad assembly to apply sufficient pressure to a urethra of the male member to address incontinence associated with the male member of the user (para [0037]).
Claim(s) 12-13 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Higgins et al (US 20210015594 A1) in view of Dennis (US 2008/0121241 A1).
With respect to claim 12, Higgins discloses a method of using a male incontinence clamp to address incontinence in a user (para [0001;0007;0033]; incontinence clamping device 100), the method comprising: applying the male incontinence clamp to a male member of the user (it is inherent that device 100 is applied to the penis of a user in order to be positioned on the penile shaft and apply pressure to the urethra and the corpus spongiosum as described in para [0037]); the male incontinence clamp (100) comprising: a first bar (bottom clamp arm 104; fig 9-10) that includes: a first pad assembly (silicone fitting 114) disposed at a first bar internal face (as shown in figs 9 and 13; internal face of arm 104 is identified in annotated fig 9-a), a second bar (upper clamp arm 102) that includes: a second pad assembly disposed on the second bar internal face (silicone fitting 112; fig 9; internal face of arm 102 is identified in annotated fig 9-b); a hinge assembly that rotatably couples the first bar and the second bar (nut-bolt assemblies 116, 118, and 120; see fig 9 and 11; para [0056]) and a member cavity defined at least in part by the first pad assembly and the second pad assembly (space between silicone fittings 112 and 114 that is shown in fig 12).
ANNOTATED FIG 9-a of Higgins et al (US 20210015594 A1):
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ANNOTATED FIG 9-b of Higgins et al (US 20210015594 A1):
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Higgins does not, however, disclose that the second pad assembly comprises a separate first pad and a second pad disposed on the second bar internal face; and a member cavity defined at least in part by the first pad assembly and the first pad and the second pad.
Dennis, however, teaches an analogous incontinence device 100 comprising a first pad assembly (ventral pad 108; fig 1a); a second pad assembly that comprises a separate first pad and a second pad (two dorsal pads 106 shown in fig 1a) disposed on the second bar internal face (pads 106 are on the internal face of dorsal arm 102 as shown in fig 1a) and a member cavity defined at least in part by the first pad assembly and the first pad and the second pad (space at the center of device 100 between pads 106 and pad 108 as shown in fig 1a). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have further modified the device of Higgins so that that the second pad assembly comprises a separate first pad and a second pad disposed on the second bar internal face and a member cavity defined at least in part by the first pad assembly and the first pad and the second pad, as taught by Dennis, in order to provide a configuration that reduces pressure upon the lateral superficial veins while maintaining sufficient overall pressure to constrict the urethra (Dennis para [0042]).
With respect to claim 13, Higgins in view of Dennis discloses the method substantially as claimed (see rejection of claim 12) and Higgins further discloses the first pad assembly (114) comprising a convex central ridge (protrusion 114a; fig 8b) and a pair of peripheral concave valleys on opposing sides of the convex central ridge (areas on each side of protrusion 114a, identified in annotated fig 8B) with a continuous sloping connection thereto (as shown in fig 8B, the outer surface of fitting 114 continuously and gradually slopes downwardly from the highest point at the center of protrusion 114a, into each valley, and then to the substantially horizontal portion that extends out to the left and right edges of the fitting which then slope downwardly).
ANNOTATED FIG 8B of Higgins et al (US 20210015594 A1):
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With respect to claim 15, Higgins in view of Dennis discloses the method substantially as claimed (see rejection of claim 12) and Higgins further discloses that in at least one configuration of the male incontinence clamp, the second bar axis and a first pad central axis are coincident along the central axis Y of the male incontinence clamp (alignment of elements along centrally disposed vertical axis is shown in fig 9).
Higgins does not, however, disclose that the second pad assembly comprises a separate first pad and a second pad disposed on the second bar internal face symmetrically on opposing sides of a second bar axis.
Dennis, however, teaches an analogous incontinence device 100 comprising a first pad assembly (ventral pad 108; fig 1a); a second pad assembly that comprises a separate first pad and a second pad (two dorsal pads 106 shown in fig 1a) disposed on the second bar internal face (pads 106 are on the internal face of dorsal arm 102 as shown in fig 1a) symmetrically on opposing sides of a second bar axis (the pads 106 are arranged symmetrically on each side of a vertical axis that runs through the center of arm 102 as shown in fig 1a). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have further modified the device of Higgins so that that the second pad assembly comprises a separate first pad and a second pad disposed on the second bar internal face symmetrically on opposing sides of a second bar axis, as taught by Dennis, in order to provide a configuration that reduces pressure upon the lateral superficial veins while maintaining sufficient overall pressure to constrict the urethra (Dennis para [0042]).
With respect to claim 16, Higgins in view of Dennis discloses the method substantially as claimed (see rejection of claim 12) but Higgins does not, however, disclose a separate first pad and a second pad defining a member gap therebetween.
Dennis, however, teaches an analogous incontinence device 100 comprising a first pad assembly (ventral pad 108; fig 1a); a second pad assembly that comprises a separate first pad and a second pad (two dorsal pads 106 shown in fig 1a), the separate first pad and the second pad (pads 106) defining a member gap therebetween (space between pads 106 shown in fig 1a). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have further modified the device of Higgins so that that the second pad assembly comprises a separate first pad and a second pad defining a member gap therebetween, as taught by Dennis, in order to provide a configuration that reduces pressure upon the lateral superficial veins while maintaining sufficient overall pressure to constrict the urethra (Dennis para [0042]).
With respect to claim 17, Higgins in view of Dennis discloses the method substantially as claimed (see rejection of claim 12) and Higgins further discloses that the first bar (bottom clamp arm 104; fig 9-10) comprises a ratchet end (end that includes device locking component 104a; fig 3a-3b) that defines: a first arm tip (identified in annotated fig 9-a), and one or more ratchet slots (gaps 104b; fig 3a-3b).
With respect to claim 18, Higgins in view of Dennis discloses the method substantially as claimed (see rejection of claim 17) and Higgins further discloses that the first arm tip and at least one of the one or more ratchet slots are configured to extend below a plane of the first bar external face in at least one configuration of the male incontinence clamp (best illustrated in figs 12-13).
With respect to claim 19, Higgins in view of Dennis discloses the method substantially as claimed (see rejection of claim 12) and Higgins further discloses the second bar further comprising a ratchet tooth (stopper 102a; para [0040]) configured to engage with the first bar (para [0040]; shown in fig 13) to releasably lock the first and second bars together (fig 13; para [0057]).
With respect to claim 20, Higgins in view of Dennis discloses the method substantially as claimed (see rejection of claim 12) and Higgins further discloses the second bar further comprising a stop tip at an end of the second bar (identified in annotated fig 9-b), the stop tip configured to engage with the stop notch of the first bar to generate a closure stop between the first bar and the second bar (shown in figs 1, 10, 12 and 13).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Higgins et al (US 20210015594 A1) in view of Dennis (US 2008/0121241 A1) and further in view of Bialick (US 3203421).
With respect to claim 14, Higgins in view of Dennis discloses the method substantially as claimed (see rejection of claim 12) but Higgins does not, however, disclose an adjustment assembly configured to adjust the first pad assembly disposed at the first bar internal face.
Bialick, however, teaches an analogous incontinence clamp device which includes an adjustment assembly configured to adjust the first pad assembly disposed at the first bar internal face. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of Higgins to further include an adjustment assembly configured to adjust the first pad assembly disposed at the first bar internal face, as taught by Bialick, in order to allow for the degree of clamping pressure to be precisely achieved (Bialick col 1 lines 45-48).
Allowable Subject Matter
Claim 4 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The subject matter of claim 4 could either not be found or was not suggested in the prior art of record. The subject matter not found was a method of using a male incontinence claim comprising adjusting tightness of the male incontinence clamp via the adjustment assembly including using a key to rotate an adjustment cylinder back and/or forth, to cause the extension shaft to extend to press on the first pad assembly to cause the first pad assembly to flexibly distend into the member cavity against the male member to provide more compression of the urethra of the male member, wherein the key is separate from the male incontinence clamp, but configured to releasably engage with the adjustment cylinder, in combination with the other elements in the claims.
The closest prior art of record is Bialick (3203421) which teaches an incontinence clamp device 10 which includes an adjustment assembly (adjustment assembly on arm 11 in fig 1) configured to adjust the first pad assembly (element 23) based at least in part on an extension shaft of the adjustment assembly configured to extend and retract (element 23 which is disposed on the internal face of arm 11 as shown in fig 1 is adjustably mounted on arm 11 and is moved by a jack screw 27 which is rotatably engaged in the body of the element 23 by a holding screw 28 such that the element 23 may be moved toward or away from the arm 11 guided by the pins 25 – col 2 lines 34-51) wherein tightness of the clamp is adjusted by moving element 23 toward or away from arm 11 (col 2 lines 34-51) and involves rotation of a thumb nut 31 (fig 1) to rotate an adjustment cylinder (jack screw 27) back and/or forth to cause an extension shaft (holding screw 28; fig 1) to move element 23 (col 2 lines 34-51). However, in Bialick, the thumb nut 31 is not a key, and it is not separate from the male incontinence clamp 10 or configured to releasably engage with the adjustment cylinder because the jack screw 27 has threaded engagement in a fixed washer 30 carried by arm 11 and the outer end is connected to a thumb nut 31 (col 2 lines 46-49). For at least this reason, Bialick fails to disclose the subject matter of claim 4.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Citation of Pertinent Prior Art
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 6463932; WO 01/62192A1.
Conclusion
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786
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