DETAILED ACTION
In Applicant’s Response filed 9/9/26, Applicant has amended claims 1, 5-8 and 10; and amended the abstract. Currently, claims 1-20 are pending.
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 .
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, 3-8 and 10-19 are rejected under 35 U.S.C. 103 as being unpatentable over Bialick (US 3203421) in view of IRINEU SPIANDORELLO (BR 202015001634 Y1).
With respect to claim 1, Bialick discloses a method of using a male incontinence clamp (method steps for using clamp device 10 are described i.e. in col 2 lines 29-33, col 3 lines 47-54) to address incontinence in a user (col 1 lines 7-8), the method comprising: increasing the volume of a member cavity of the male incontinence clamp (the volume of the space between arms 11 and 12 of clamp device 10, which accommodates the male member as shown in fig 1, is increased by adjustment at nut 17 to move arms 11 and 12 away from each other and/or by adjustment of thumb nut 31 to move element 23 upwards towards arm 11; see col 2 line 7-col 3 line 54), the male incontinence clamp (10) comprising: a first bar (arm 12; fig 1) that includes a first bar internal face and a first bar external face (internal and external faces of arm 12 shown in fig 1), a second bar (arm 11) comprising a second bar internal face and a second bar external face (internal and external faces of arm 11 shown in fig 1), a rotatable adjustment assembly (adjustment assembly for element 23 via thumb nut 31 – fig 1; col 2 lines 43-51) coupled to and extending through the second bar (as shown in fig 1, the adjustment assembly for element 23 is coupled to and extends through arm 11), the rotatable adjustment assembly comprising a screw with threads (jack screw 27; fig 1) and configured to extend and retract away from and toward the internal face of the second bar and into the member cavity (col 2 lines 40-61), by rotating at least a portion of the rotatable adjustment assembly (via rotation of the thumb nut 31 – col 2 lines 40-61), the member cavity defined at least in part by the first bar and the rotatable adjustment assembly (as shown in fig 1), wherein a portion of the rotatable adjustment assembly and the first bar are configured to engage a male member disposed within the member cavity (as shown in fig 1, the element 23 engages the male member during use), and a mechanism configured to adjust the fit of the male incontinence clamp including allowing the volume of the member cavity to be increased and decreased (adjustment at nut 17 to move arms 11 and 12 towards or away from each other), wherein increasing the volume of the member cavity of the male incontinence clamp includes configuring the mechanism to increase the volume of the member cavity (adjustment at nut 17 to move arms 11 and 12 away from each other inherently increases the volume of the space between arms 11 and 12); inserting the male member into the member cavity defined at least in part by the first bar and the rotatable adjustment assembly (col 2 lines 29-33; col 3 lines 47-54; shown with the male member inserted in fig 1); adjusting the fit of the male incontinence clamp while the male member is within the member cavity (col 3 lines 47-54); adjusting the fit of the male incontinence clamp via the rotatable adjustment assembly, by rotating the rotatable adjustment assembly while the male member is within the member cavity (col 2 lines 40-51), wherein adjusting the fit of the male incontinence clamp causes: the male incontinence clamp to be coupled to the male member (col 3 lines 47-54; shown in fig 1), and the male incontinence clamp to apply sufficient pressure to a urethra of the male member to address incontinence associated with the male member of the user (claim 1; col 3 line 66 – col 4 line 22); and de-coupling the incontinence clamp from the male member and removing the male member from the member cavity by adjusting the fit of the male incontinence clamp while the male member is within the member cavity (means 16-17 are used for applying and/or removing the device one the desired pressure setting is set – col 3 lines 47-54).
Bialick does not, however, disclose a plurality of sliders configured to adjust the fit of the male incontinence clamp including allowing the volume of the member cavity to be increased and decreased, wherein increasing the volume of the member cavity of the male incontinence clamp includes configuring the one or more plurality of sliders to increase the volume of the member cavity and, wherein the fit of the clamp is adjusted via the plurality of sliders.
IRINEU SPIANDORELLO, however, teaches a male urinary incontinence device that comprises a plurality of sliders (regulators 3 on each side of the device as shown in figs 2-3 which are adapted to “slide” into groves on the ends of the upper and lower parts) configured to adjust the fit of the male incontinence clamp including allowing the volume of the member cavity to be increased and decreased (the regulators 3 attach to locking elements at the ends of the upper and lower parts to allow the fixation of the upper and lower parts, as well as the adjustment of the distance between them, in order to allow a better adaptation to the penile diameter – translation para [029]), wherein increasing the volume of the member cavity of the male incontinence clamp includes configuring the one or more plurality of sliders to increase the volume of the member cavity (positioning of the regulators within the slots on the locking elements allows for adjustment of the spacing between the upper and lower parts which, therein, also adjusts the volume of the cavity defined therein by increasing or decreasing the spacing/volume) and, wherein the fit of the clamp is adjusted via the plurality of sliders (translation para [029]). 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 clamp of Bialick by replacing the single slider element (16/17) and hinge 13 with the adjustment structure which comprises regulators 3 and locking elements on the upper/lower parts of the clamps, like the adjustment mechanism in IRINEU SPIANDORELLO, in order to provide improved adjustment capabilities by allowing for independent adjustment on each side of the device for a more customized fit.
With respect to claim 3, Bialick in view of IRINEU SPIANDORELLO discloses the method as claimed (see rejection of claim 1) and Bialick also discloses that the second bar (arm 11) is planar (as shown in fig 1).
With respect to claim 4, Bialick in view of IRINEU SPIANDORELLO discloses the method as claimed (see rejection of claim 1) and Bialick also discloses that the first and second bars (arms 11 and 12) are made of plastic (col 3 lines 19-20).
With respect to claim 5, Bialick discloses a method of using a male incontinence clamp (method steps for using clamp device 10 are described i.e. in col 2 lines 29-33, col 3 lines 47-54) to address incontinence in a user (col 1 lines 7-8), the method comprising: applying the male incontinence clamp to a male member of the user (as shown in fig 1); the male incontinence clamp (10) comprising: a first bar (arm 12; fig 1) that includes a first bar internal face (internal face of arm 12 shown in fig 1), a second bar (arm 11) comprising a second bar internal face and a second bar external face (internal and external faces of arm 11 shown in fig 1), a rotatable adjustment assembly (adjustment assembly for element 23 via thumb nut 31 – fig 1; col 2 lines 43-51) coupled to and extending through the second bar (as shown in fig 1, the adjustment assembly for element 23 is coupled to and extends through arm 11), the rotatable adjustment assembly comprising a screw with threads (jack screw 27; fig 1) and configured to extend and retract away from and toward the internal face of the second bar (col 2 lines 40-61), by rotating at least a portion of the rotatable adjustment assembly (via rotation of the thumb nut 31 – col 2 lines 40-61), a member cavity defined at least in part by the first bar and the rotatable adjustment assembly (the space between arms 11 and 12 of clamp device 10 as shown in fig 1), wherein a portion of the rotatable adjustment assembly and the first bar are configured to engage a male member disposed within the member cavity (as shown in fig 1, the element 23 engages the male member during use), and a mechanism configured to adjust the fit of the male incontinence clamp including allowing the volume of the member cavity to be increased and decreased (adjustment at nut 17 to move arms 11 and 12 towards or away from each other), adjusting the fit of the male incontinence clamp via the mechanism while the male member is within the member cavity (col 3 lines 47-54); adjusting the fit of the male incontinence clamp via the rotatable adjustment assembly, by rotating the rotatable adjustment assembly while the male member is within the member cavity (col 2 lines 40-51), wherein adjusting the fit of the male incontinence clamp causes: the male incontinence clamp to be coupled to the male member (col 3 lines 47-54; shown in fig 1), and the male incontinence clamp to apply sufficient pressure to a urethra of the male member to address incontinence associated with the male member of the user (claim 1; col 3 line 66 – col 4 line 22).
Bialick does not, however, disclose a plurality of sliders configured to adjust the fit of the male incontinence clamp including allowing the volume of the member cavity to be increased and decreased, wherein the fit of the clamp is adjusted via the plurality of sliders.
IRINEU SPIANDORELLO, however, teaches a male urinary incontinence device that comprises a plurality of sliders (regulators 3 on each side of the device as shown in figs 2-3 which are adapted to “slide” into groves on the ends of the upper and lower parts) configured to adjust the fit of the male incontinence clamp including allowing the volume of the member cavity to be increased and decreased (the regulators 3 attach to locking elements at the ends of the upper and lower parts to allow the fixation of the upper and lower parts, as well as the adjustment of the distance between them, in order to allow a better adaptation to the penile diameter – translation para [029]), wherein increasing the volume of the member cavity of the male incontinence clamp includes configuring the one or more plurality of sliders to increase the volume of the member cavity (positioning of the regulators within the slots on the locking elements allows for adjustment of the spacing between the upper and lower parts which, therein, also adjusts the volume of the cavity defined therein by increasing or decreasing the spacing/volume) and, wherein the fit of the clamp is adjusted via the plurality of sliders (translation para [029]). 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 clamp of Bialick by replacing the single slider element (16/17) and hinge 13 with the adjustment structure which comprises regulators 3 and locking elements on the upper/lower parts of the clamps, like the adjustment mechanism in IRINEU SPIANDORELLO, in order to provide improved adjustment capabilities by allowing for independent adjustment on each side of the device for a more customized fit.
With respect to claim 6, Bialick in view of IRINEU SPIANDORELLO discloses the method as claimed (see rejection of claim 5) and IRINEU SPIANDORELLO teaches that increasing the volume of the member cavity of the male incontinence clamp includes configuring the sliders to increase the volume of the member cavity (positioning of the regulators within the slots on the locking elements allows for adjustment of the spacing between the upper and lower parts which, therein, also adjusts the volume of the cavity defined therein by increasing or decreasing the spacing/volume; see para [029]; figs 2-3). 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 clamp of Bialick by replacing the single slider element (16/17) and hinge 13 with the adjustment structure which comprises regulators 3 and locking elements on the upper/lower parts of the clamps, like the adjustment mechanism in IRINEU SPIANDORELLO, in order to provide improved adjustment capabilities by allowing for independent adjustment on each side of the device for a more customized fit.
With respect to claim 7, Bialick in view of IRINEU SPIANDORELLO discloses the method as claimed (see rejection of claim 6) and Bialick also discloses that increasing the volume of the member cavity of the male incontinence clamp by configuring the mechanism to increase the volume of the member cavity allows the user insert the male member into the member cavity defined at least in part by the first bar and the rotatable adjustment assembly (adjustment means 16-17 are used for applying and/or removing the device one the desired pressure setting is set – col 3 lines 47-54).
With respect to claim 8, Bialick in view of IRINEU SPIANDORELLO discloses the method as claimed (see rejection of claim 5) and Bialick also discloses de-coupling the incontinence clamp from the male member and removing the male member from the member cavity by adjusting the fit of the male incontinence clamp via the mechanism while the male member is within the member cavity (adjustment means 16-17 are used for applying and/or removing the device one the desired pressure setting is set – col 3 lines 47-54).
With respect to claim 10, Bialick discloses a method of using a male incontinence clamp (method steps for using clamp device 10 are described i.e. in col 2 lines 29-33, col 3 lines 47-54) to address incontinence in a user (col 1 lines 7-8), the method comprising: applying the male incontinence clamp to a male member of the user (as shown in fig 1); the male incontinence clamp (10) comprising: a first bar (arm 12; fig 1); a second bar (arm 11); a rotatable adjustment assembly (adjustment assembly for element 23 via thumb nut 31 – fig 1; col 2 lines 43-51) coupled to the second bar (as shown in fig 1, the adjustment assembly for element 23 is coupled to arm 11), a member cavity defined at least in part by the first bar and the rotatable adjustment assembly (the space between arms 11 and 12 of clamp device 10 as shown in fig 1), and one or more sliders (nut 17 which rotates to slide up and down along stem 16) configured to adjust the fit of the male incontinence clamp including allowing the volume of the member cavity to be increased and decreased (adjustment at nut 17 to move arms 11 and 12 towards or away from each other).
Bialick does not, however, disclose that a screw and threads are absent from the one or more sliders.
IRINEU SPIANDORELLO, however, teaches a male urinary incontinence device that comprises a plurality of sliders (regulators 3 on each side of the device as shown in figs 2-3 which are adapted to “slide” into groves on the ends of the upper and lower parts) configured to adjust the fit of the male incontinence clamp including allowing the volume of the member cavity to be increased and decreased (the regulators 3 attach to locking elements at the ends of the upper and lower parts to allow the fixation of the upper and lower parts, as well as the adjustment of the distance between them, in order to allow a better adaptation to the penile diameter – translation para [029]), wherein increasing the volume of the member cavity of the male incontinence clamp includes configuring the one or more plurality of sliders to increase the volume of the member cavity (positioning of the regulators within the slots on the locking elements allows for adjustment of the spacing between the upper and lower parts which, therein, also adjusts the volume of the cavity defined therein by increasing or decreasing the spacing/volume) and, wherein the fit of the clamp is adjusted via the plurality of sliders (translation para [029]). Additionally, as shown in figs 2-3, the regulators and locking elements do not include screw and/or threaded elements. 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 clamp of Bialick by replacing the single slider element (16/17) and hinge 13 with the adjustment structure which comprises regulators 3 and locking elements on the upper/lower parts of the clamps, which do not include screws or threaded elements, like the adjustment mechanism in IRINEU SPIANDORELLO, in order to provide improved adjustment capabilities by allowing for independent adjustment on each side of the device for a more customized fit.
With respect to claim 11, Bialick in view of IRINEU SPIANDORELLO discloses the method as claimed (see rejection of claim 10) and Bialick also discloses that the first bar (arm 12; fig 1) includes a first bar internal face (internal face of arm 12 shown in fig 1).
With respect to claim 12, Bialick in view of IRINEU SPIANDORELLO discloses the method as claimed (see rejection of claim 10) and Bialick also discloses that the second bar (arm 11) includes a second bar internal face and a second bar external face (internal and external faces of arm 11 shown in fig 1).
With respect to claim 13, Bialick in view of IRINEU SPIANDORELLO discloses the method as claimed (see rejection of claim 10) and Bialick also discloses that the rotatable adjustment assembly (adjustment assembly for element 23 via thumb nut 31 – fig 1; col 2 lines 43-51) is coupled to and extends through the second bar (as shown in fig 1, the adjustment assembly for element 23 is coupled to arm 11).
With respect to claim 14, Bialick in view of IRINEU SPIANDORELLO discloses the method as claimed (see rejection of claim 10) and Bialick also discloses that the rotatable adjustment assembly comprises a screw with threads (jack screw 27; fig 1).
With respect to claim 15, Bialick in view of IRINEU SPIANDORELLO discloses the method as claimed (see rejection of claim 10) and Bialick also discloses that the rotatable adjustment assembly is configured to extend and retract away from and toward the internal face of the second bar (col 2 lines 40-61), by rotating at least a portion of the rotatable adjustment assembly (via rotation of the thumb nut 31 – col 2 lines 40-61).
With respect to claim 16, Bialick in view of IRINEU SPIANDORELLO discloses the method as claimed (see rejection of claim 10) and Bialick also discloses that the member cavity is defined at least in part by the first bar and the rotatable adjustment assembly (as shown in fig 1), wherein a portion of the rotatable adjustment assembly and the first bar are configured to engage a male member (as shown in fig 1, the element 23 engages the male member during use).
With respect to claim 17, Bialick in view of IRINEU SPIANDORELLO discloses the method as claimed (see rejection of claim 10) and Bialick also discloses adjusting the fit of the male incontinence clamp via the one or more sliders while the male member is within the member cavity (col 3 lines 47-54).
With respect to claim 18, Bialick in view of IRINEU SPIANDORELLO discloses the method as claimed (see rejection of claim 10) and Bialick also discloses adjusting the fit of the male incontinence clamp via the rotatable adjustment assembly, by rotating the rotatable adjustment assembly while the male member is within the member cavity (col 2 lines 40-51).
With respect to claim 19, Bialick in view of IRINEU SPIANDORELLO discloses the method as claimed (see rejection of claim 10) and Bialick also discloses that adjusting the fit of the male incontinence clamp via the one or more sliders and/or via the rotatable adjustment assembly causes: the male incontinence clamp to be coupled to the male member (col 3 lines 47-54; shown in fig 1), and the male incontinence clamp to apply sufficient pressure to a urethra of the male member to address incontinence associated with the male member of the user (claim 1; col 3 line 66 – col 4 line 22).
Claim(s) 2, 9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Bialick (US 3203421) in view of IRINEU SPIANDORELLO (BR 202015001634 Y1) and further in view of Higgins et al (US 20210015594 A1).
With respect to claim 2, Bialick in view of IRINEU SPIANDORELLO discloses the method as claimed (see rejection of claim 1) but does not disclose that the first bar has an arched shape.
Higgins teaches a method of using a male incontinence clamp to address incontinence in a user (para [0001;0007;0033]; incontinence clamping device 100), the male incontinence clamp (100) comprising: a first bar (bottom clamp arm 104; fig 9-10) and a second bar (upper clamp arm 102), wherein the first bar (arm 104) has an arched shape (as shown in fig 9). 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 first bar on the incontinence clamp of Bialick in view of IRINEU SPIANDORELLO so that it has an arched shape, like the arm 104 on the clamp of Higgins, so that the first bar has a shape that more closely matches the anatomical shape/contour of the male member for improved fit and comfort.
With respect to claim 9, Bialick in view of IRINEU SPIANDORELLO discloses the method as claimed (see rejection of claim 5) and Bialick also discloses that the second bar (arm 11) is planar (as shown in fig 1) but does not disclose that the first bar has an arched shape.
Higgins teaches a method of using a male incontinence clamp to address incontinence in a user (para [0001;0007;0033]; incontinence clamping device 100), the male incontinence clamp (100) comprising: a first bar (bottom clamp arm 104; fig 9-10) and a second bar (upper clamp arm 102), wherein the first bar (arm 104) has an arched shape (as shown in fig 9). 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 first bar on the incontinence clamp of Bialick in view of IRINEU SPIANDORELLO so that it has an arched shape, like the arm 104 on the clamp of Higgins, so that the first bar has a shape that more closely matches the anatomical shape/contour of the male member for improved fit and comfort.
With respect to claim 20, Bialick in view of IRINEU SPIANDORELLO discloses the method as claimed (see rejection of claim 10) and Bialick also discloses that the second bar (arm 11) is planar (as shown in fig 1) but does not disclose that the first bar has an arched shape.
Higgins teaches a method of using a male incontinence clamp to address incontinence in a user (para [0001;0007;0033]; incontinence clamping device 100), the male incontinence clamp (100) comprising: a first bar (bottom clamp arm 104; fig 9-10) and a second bar (upper clamp arm 102), wherein the first bar (arm 104) has an arched shape (as shown in fig 9). 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 first bar on the incontinence clamp of Bialick in view of IRINEU SPIANDORELLO so that it has an arched shape, like the arm 104 on the clamp of Higgins, so that the first bar has a shape that more closely matches the anatomical shape/contour of the male member for improved fit and comfort.
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 9/9/26 have been fully considered as follows:
Regarding the objections to the specification, Applicant’s amendments to the abstract have been fully considered and are sufficient to overcome the objections which, accordingly, have been withdrawn.
Regarding the claim rejections under 35 USC 102 and 35 USC 103, Applicant’s arguments on pages 9-12 of the Response have been fully considered but are rendered moot in view of the new grounds of rejection presented above which were necessitated by Applicant’s amendments to the claims.
Citation of Pertinent Prior Art
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 2008/0121241 A1, US 6463932; WO 01/62192A1.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael Bredefeld can be reached at 571-270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786
