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 .
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.
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.
Claims 1, 7, 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Buckner (US Pat 871,474) in view of Kavanagh et al. (US Pat 6,602,244).
Re claim 1, Buckner discloses a protective assembly (Fig 2; it is noted that all reference characters cited below refer to Fig 2 unless otherwise noted) comprising: a protective sheath assembly 5+8+20 (Fig 1) having a tubular catheter body 5+8 with a proximal and a distal end (the proximal end pointing to the left in Fig 2 and inserted into the connection fitting labeled in Fig C below; the distal end pointing to the right in Fig 2 and inserted into the introducer tip 21) and at least one connection fitting (seen in Fig 2 connecting shaft 5 to syringe 10, but not labeled; labeled in annotated Fig C below); an introducer tip 21; and a syringe 10 containing a fluid (“medicine or antiseptic fluid” – Page 1, Col 2, Lines 85-91) and securely attached to the at least one connection fitting (as seen in Fig 2). Buckner does not disclose that the introducer tip 21 is a part of a holding device assembly that also includes a housing and a self-closing retention device, wherein the introducer tip and the retention device each fit over a respective portion of the housing.
Kavanagh, however, teaches a protective assembly 10 (Fig 2 with Fig 3 showing a detailed drawing of the holding device assembly; it is noted that all reference characters cited below refer to Fig 2 and/or Fig 3 unless otherwise noted) comprising: a protective sheath assembly 15+18 having a tubular catheter body 15 with a proximal (to the left in Fig 2,3) and distal end and at least one connection fitting 18 (Col 3, Line 63 – Col 4, Line 3) at the proximal end (as seen in Fig 2,3); and a holding device assembly 16 having a housing 25, an introducer tip 30 (Col 4, Lines 31-34) fitting over a portion of the housing (as seen in Fig 3, the proximal end of tip 30 fits over portion 25a of housing 25), and a self-closing retention device 20 (Fig 3,4; Col 4, Lines 51-58; this device is considered “self-closing” since the material of gripping mechanism 42 automatically reduces the size of the passage 50 when the catheter is removed therefrom (as seen in moving from Fig 4 to Fig 5); note that the claim does not require that the “closing” prevent access to the housing or that the “closing” completely eliminate the pathway running therethrough) fitting over a portion of the housing (as seen in Fig 3, the distal end of retention device 20 fits over the portion of housing 25 labeled as “collar of housing 25” in annotated Fig A below). Like Buckner’s tip 21, Kavanagh’s holding device assembly 16 shields the catheter against contact with and contamination by the open end of the urethra adjacent the labia (Col 4, Lines 38-41). Additionally, Kavanagh’s holding device assembly 16 acts as a reservoir to provide an even distribution of lubricant to the catheter to ease patient discomfort and reduce the risk of possible injury during catheterization (Col 1, Lines 60-63). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Buckner to include the introducer tip as part of a holding device assembly with a housing and a self-closing retention device, as taught by Kavanagh, for the purpose of not only shielding the catheter against contact with and contamination by the open end of the urethra adjacent the labia (Col 4, Lines 38-41), but also providing an even distribution of lubricant to the catheter to ease patient discomfort and reduce the risk of possible injury during catheterization (Col 1, Lines 60-63). This modification would replace Buckner’s tip 21 with Kavanagh’s entire holding device assembly 16 (including the lubricant in chamber 24).
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Re claim 7, Buckner as modified by Kavanagh in the rejection of claim 1 above discloses all the claimed features with Kavanagh teaching that the housing of the holding device assembly has a catheter receiving passageway (formed by the inner walls of the “collar of housing 25” labeled in annotated Fig A above and lumen 28) therethrough with an internal volume containing an amount of lubricating jelly 52 (Col 5, Lines 48-51). Since the modification made in claim 1 incorporates the entirety of holding device assembly 16 in place of tip 21, the motivation cited in claim 1 also applies to this claim.
Re claim 22, Buckner as modified by Kavanagh in the rejection of claim 1 above discloses all the claimed features with Kavanagh teaching that the holding device assembly further comprises a removable cap (Col 4, Lines 26-28) for the purpose of protecting the insertion tip from contamination prior to use (Col 4, Lines 26-28). Therefore, it would have been obvious to further modify Buckner to include a removable cap, as taught by Kavanagh, for the purpose of protecting the insertion tip from contamination prior to use (Col 4, Lines 26-28).
Re claim 23, Buckman discloses that the fluid is a medicament (“medicine or antiseptic fluid” – Page 1, Col 2, Lines 85-91).
Claims 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Buckner (US Pat 871,474)/Kavanagh et al. (US Pat 6,602,244) in view of House (PG PUB 2008/0097463).
Re claim 8, Buckman as modified by Kavanagh in the rejection of claim 1 and 7 above discloses all the claimed features with Kavanagh teaching that the housing has a first end (to the left in Fig 3) and a second end (to the right in Fig 3) and that the introducer tip is configured to seal the second end of the housing (Col 4, Line 34-36), whereby the introducer tip distally seals the lubricating jelly within the internal volume of the housing (Col 4, Lines 34-36). Since the modification made in claim 1 incorporates the entirety of holding device assembly 16 in place of tip 21, the motivation cited in claim 1 also applies to this claim.
Although Kavanagh teaches that the retention device is configured to “substantially close off the proximal end of the chamber 24” (Col 4, Lines 11-13), Kavanagh does not explicitly teach that the retention device seals the first end of the housing so as to proximally seal the lubricating jelly within the internal volume of the housing. House, however, teaches an assembly (Fig 4) comprising a catheter 430 (Fig 4), a housing 415 (Fig 4), a retention device 442 (Fig 4) at a first end of the housing (to the left in Fig 4), and an sealing device 441 (Fig 4) at a second end of the housing (to the right in Fig 4), wherein the retention device seals the first end of the housing so as to proximally seal a lubricating jelly within an internal volume of the housing (Para 50) for the purpose of ensuring that the contents of the housing do not leak proximally from the housing when the catheter is not extending through the housing (Para 50). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Buckner/Kavanagh to include the retention seal as one that seals the first end of the housing to seal the lubricating jelly within the housing, as taught by House, for the purpose of ensuring that the contents of the housing do not leak proximally from the housing when the catheter is not extending through the housing (Para 50).
Re claim 9, Buckman as modified by Kavanagh in the rejection of claims 1 and 7 above discloses all the claimed features with Kavanagh teaching that the tubular catheter body is configured to pass and be advanced through the retention device, the housing and the introducer tip (Col 5, Line 57 – Col 6, Line 6). Since the modification made in claim 1 incorporates the entirety of holding device assembly 16 in place of tip 21, the motivation cited in claim 1 also applies to this claim.
Re claim 10, Buckman as modified by Kavanagh in the rejection of claims 1 and 7 above discloses all the claimed features with Kavanagh teaching that each of the retention device and introducer tip have a slit seal 50,33 (seal 50 can be seen in Fig 8 as being a slit1 and seal 33 is disclosed in Col 4, Line 36 as being a “slit”) to accommodate passage of the tubular catheter body (Col 5, Line 57 – Col 6, Line 6). Since the modification made in claim 1 incorporates the entirety of holding device assembly 16 in place of tip 21, the motivation cited in claim 1 also applies to this claim.
Re claim 11, Buckman as modified by Kavanagh in the rejection of claims 1 and 7 above discloses all the claimed features with Kavanagh teaching that the slit seal of the retention device serves to grip the tubular catheter body directed therethrough, and provides frictional resistance to free movement of the tubular catheter body relative to the retention device (Col 4, Lines 51-58). Since the modification made in claim 1 incorporates the entirety of holding device assembly 16 in place of tip 21, the motivation cited in claim 1 also applies to this claim.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Buckman (US Pat 871,474)/Kavanagh et al. (US Pat 6,602,244) in view of Spallek et al. (US Pat 5,897,532).
Re claim 12, Buckman as modified by Kavanagh in the rejection of claim 1 above discloses all the claimed features with Kavanagh teaching that the housing includes a pair of wings extending outwards (labeled as “gripping surface” in Fig B below). Since the modification made in claim 1 incorporates the entirety of holding device assembly 16 in place of tip 21, the motivation cited in claim 1 also applies to this claim.
Kavanagh does not disclose that these wings are grated. Spallek, however, teaches a housing (the entire structure seen in Fig 2) comprising a wing 1 (Fig 1,2) formed with a grated structure 7 (Fig 1,2) for the purpose of ensuring no slippage of the fingers when grasped by a user and for the purpose of saving on material cost (Col 3, Lines 54-59). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Kavanagh’s wings to have a grated structure, as taught by Spallek, for the purpose of ensuring no slippage of the fingers when grasped by a user and for the purpose of saving on material cost (Col 3, Lines 54-59).
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Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Buckner (US Pat 871,474)/Kavanagh et al. (US Pat 6,602,244) in view of Lin et al. (US Pat 5,250,029).
Re claim 15, Buckner as modified by Kavanagh in the rejection of claim 1 above discloses all the claimed features except that the tubular catheter body has graduation marks to indicate a penetration depth of the tubular catheter body when inserted in a urethra cavity of a living being.
Lin, however, teaches a substantially similar tubular catheter body 20 (Fig 1) that has graduation marks 48 (Fig 1) to indicate a penetration depth of the tubular catheter body when inserted into a urethra of a living being (Col 4, Lines 54-65) for the purpose of relaying to a viewer whether or not the catheter has slipped out of position (Col 4, Lines 60-65). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Buckner/Kavanagh to include graduation marks, as taught by Lin, for the purpose of relaying to a viewer whether or not the catheter has slipped out of position (Col 4, Lines 60-65).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Buckner (US Pat 871,474) in view of Kavanagh et al. (US Pat 6,602,244), House (PG PUB 2008/0097463) and Versi (PG PUB 2009/0171317).
Re claim 24, Buckner discloses a protective assembly (Fig 2; it is noted that all reference characters cited below refer to Fig 2 unless otherwise noted) for anesthetizing a length of a urethra of a living being (it is noted that although Buckner does not explicitly recite that the assembly is used in anesthetizing, one of ordinary skill in the art would recognize that it could be used in such a way if the syringe 10 were to be filled with anesthetizing solution instead of another medication) comprising: a protective sheath assembly 5+8+20+21 (Fig 1) having: an introducer tip 21; a tubular catheter body 5+8 with a proximal end (the proximal end pointing to the left in Fig 2) having at least one connection fitting (seen in Fig 2 connecting shaft 5 to syringe 10, but not labeled; labeled in annotated Fig C below), a distal end (the distal end pointing to the right in Fig 2 and inserted into the introducer tip 21) having at least one opening 17 (Fig 1), and an interior lumen 6 extending through the tubular catheter body (as seen in Fig 1); and an anesthetizing medicament device means 10 connected to the at least one connection fitting (as seen in Fig 2) and provided with a medicament (“medicine or antiseptic fluid” – Page 1, Col 2, Lines 85-91), the anesthetizing medicament device means is configured to advance the medicament through the interior lumen so that the medicament exits the at least one opening of the tubular catheter body (Page 2, Col 1, Lines 39-45). Buckner does not disclose that the introducer tip 21 is a part of a holding device assembly that also includes a housing and a retention device, wherein the retention device has a self-closable valve preventing access to the housing in a closed state, and wherein the introducer tip is positioned over a portion of the housing and the retention device is positioned over a collar of the housing; Buckner also does not explicitly disclose that the medicament is an anesthetizing medicament.
Kavanagh, however, teaches a protective assembly 10 (Fig 2 with Fig 3 showing a detailed drawing of the holding device assembly; it is noted that all reference characters cited below refer to Fig 2 and/or Fig 3 unless otherwise noted) comprising: a protective sheath assembly 15+18 having a tubular catheter body 15 with a proximal (to the left in Fig 2,3) and distal end and at least one connection fitting 18 (Col 3, Line 63 – Col 4, Line 3) at the proximal end (as seen in Fig 2,3); and a holding device assembly 16 having a housing 25, an introducer tip 30 (Col 4, Lines 31-34) fitting over a portion of the housing (as seen in Fig 3, the proximal end of tip 30 fits over portion 25a of housing 25), and a retention device 20 comprising a self-closable valve 40 (Fig 3,4; Col 4, Lines 51-58; this valve is considered “self-closing” since the material of gripping mechanism 40 automatically reduces the size of the passage 50 when the catheter is removed therefrom (as seen in moving from Fig 4 to Fig 5)) and positioned over a collar (labeled in Fig A above) of the housing (as seen in Fig 3 and annotated Fig A below). Like Buckner’s tip 21, Kavanagh’s holding device assembly 16 shields the catheter against contact with and contamination by the open end of the urethra adjacent the labia (Col 4, Lines 38-41). Additionally, Kavanagh’s holding device assembly 16 acts as a reservoir to provide an even distribution of lubricant to the catheter to ease patient discomfort and reduce the risk of possible injury during catheterization (Col 1, Lines 60-63). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Buckner to include the introducer tip as part of a holding device assembly with a housing having a collar and a retention device having a self-closable valve, as taught by Kavanagh, for the purpose of not only shielding the catheter against contact with and contamination by the open end of the urethra adjacent the labia (Col 4, Lines 38-41), but also providing an even distribution of lubricant to the catheter to ease patient discomfort and reduce the risk of possible injury during catheterization (Col 1, Lines 60-63). This modification would replace Buckner’s tip 21 with Kavanagh’s entire holding device assembly 16 (including the lubricant in chamber 24). Kavanagh does not explicitly teach that the self-closable valve prevents access to the housing in a closed state; Kavanagh also does not teach that the medicament is an anesthetizing medicament.
House, however, teaches an assembly (Fig 4) comprising a catheter 430 (Fig 4), a housing 415 (Fig 4), a retention device in the form of a self-closable valve 442 (Fig 4) at a first end of the housing (to the left in Fig 4), and an sealing device 441 (Fig 4) at a second end of the housing (to the right in Fig 4), wherein self-closable valve prevents access to the housing in a closed state (Para 50) for the purpose of ensuring that the lubricating jelly in the housing does not leak proximally from the housing when the catheter is not extending through the housing (Para 50). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Buckner/Kavanagh to include the self-closable valve as one that prevents access to the housing in a closed state, as taught by House, for the purpose of ensuring that the lubricating jelly does not leak proximally from the housing when the catheter is not extending through the housing (Para 50). House does not teach that the medicament is an anesthetizing medicament.
Versi, however, teaches an assembly (Fig 1) comprising a tubular catheter body 11 (Fig 1) and an anesthetizing medicament device means 10 (Fig 1; wherein the means 10 is a “syringe”, Para 31) that is provided with a solution comprising a treatment medicament in combination with an anesthetizing medicament (Para 19) for the purpose of reducing pain related to the procedure (Para 19). Therefore it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Buckner to include the medicament as a combination of a treatment medicament and an anesthetizing medicament, as taught by Versi, for the purpose of reducing pain related to the procedure (Para 19).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Buckner (US Pat 871,474)/Kavanagh et al. (US Pat 6,602,244) in view of Burkinshaw et al. (PG PUB 2008/0103564).
Re claim 29, Bucker as modified by Kavanagh in the rejection of claim 1 above discloses all the claimed features except that the fluid is a lubricant. Burkinshaw, however, teaches mixing a treatment medicament (as in Buckner) with a lubricant (Para 73) for the purpose of increasing the intrudability of the treatment medicament (Para 73). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Buckner/Kavanagh to include the solution in the syringe as a combination of a treatment medicament (as in Buckner) and a lubricant, as taught by Burkinshaw, for the purpose of increasing the intrudability of the treatment medicament (Para 73).
Response to Arguments
Applicant's arguments filed 7/14/2025 have been fully considered, but are not persuasive. Applicant asserts that “a person of ordinary skill in the art would not have been motivated to modify Buckner as taught [by] Kavanagh because the proposed modification teaches away from the intended purpose of Buckner and would require a completely different assembly and mechanism to adopt the modification as required” and that “the modification of Buckner as taught by Kavanagh would render Buckner unsatisfactory for its intended purpose, would change the basic principle of operation of Buckner, and would not have a reasonable expectation of success”.
Applicant argues that replacing Buckner’s jacket – which is designed to be pierced and then retracted before fluid delivery – “with the persistent slit-valved sleeve introducer of Kavanagh would block Buckner’s pointed cap and more critically, obstruct the radial spray orifices that must discharge the medication”. Applicant elaborates that “modification would require relocation or elimination of the orifices which would change the principle of operation of the invention and render Buckner unsatisfactory for its intended purpose”. The Examiner respectfully disagrees.
Kavanagh discloses that their jacket/sleeve 30 is retracted along catheter 15 proximally far enough to expose discharge orifice 17 – which is comparable to Buckner’s discharge orifices – so that it can be used to convey fluid between the catheter and the bladder (Col 6, Lines 4-8). Therefore, one of ordinary skill in the art would recognize that the application of Kavanagh’s assembly 16 to Buckner’s catheter 5 (by replacing Buckner’s tip 21) would not block Buckner’s pointed cap or obstruct Buckner’s orifices. Therefore, no relocation or elimination of the orifices would be required, Buckner’s principle of operation would not be changed and Buckner would still be satisfactory for its intended purpose.
Applicant argues that modifying Bucker – which inflates the collar and propels the antiseptic stream by pressurizing the tubular member – “to include the lubricant chamber and gripping mechanism of Kavanagh would surround the pressure conduit and with a gel-filled housing which would add bulk that limits the deep insertion into the urethra, risk blow-out when inflation pressures are applied, and flood the antiseptic path with gel, defeating Buckner’s therapeutic objective” and that “there would be no reasonable expectation of success”. The Examiner respectfully disagrees.
It is unclear as to which structural component of Buckner that Applicant is referring to as the “pressure conduit”. Buckner discloses collar 20 as being expansible material that is expanded by “pressure of the liquid within the chamber 13” (Page 1, Line 111 – Page 2, Line 10) so it is believed that cap 8 – which possesses chamber 13 – is the component with Applicant is interpreted as being the “pressure conduit”.
Kavanagh discloses that their jacket/sleeve 30 is retracted along catheter 15 proximally far enough to expose discharge orifice 17 – which is comparable to Buckner’s discharge orifices 17 which lie proximally past cap 8 – so that it can be used to convey fluid between the catheter and the bladder (Col 6, Lines 4-8). Therefore, one of ordinary skill in the art would recognize that the application of Kavanagh’s assembly 16 to Buckner’s catheter 5 (by replacing Buckner’s tip 21) would not surround the cap 8 or the orifices 17 when delivery occurs; therefore, it does not appear that there would be a risk of blow-out when inflation pressure is applied.
Additionally, there is no structural stop along Kavanagh’s catheter 15 that would prevent the assembly 16 from retracting all the way to the connection fitting 18. Therefore, one of ordinary skill in the art would recognize that the application of Kavanagh’s assembly 16 to Buckner’s catheter 5 (by replacing Buckner’s tip 21) would not limit the deep insertion into the urethra.
Lastly, Kavanagh’s gel 52 remains on the exterior of the catheter 15 and is always proximal to the orifice 17 even in storage (as seen in Fig 3). Therefore, one of ordinary skill in the art would recognize that the application of Kavanagh’s assembly 16 to Buckner’s catheter 5 (by replacing Buckner’s tip 21) would not result in the gel flooding the antiseptic path from orifices 17.
Therefore, one of ordinary skill in the art would recognize that replacing the tip 21 of Buckner with Kavanagh’s assembly 16 would have a reasonable expectation of success.
Applicant argues that “Buckner already provides a radial inflatable collar whose sole function is to block the urethra beyond infection when pressurized” and that “adapting the collar to become an axially squeeze-released gripper would eliminate the necessary urethral seal and again alter Buckner’s fundamental mode of action which would be another change in basic principle of operation”. The Examiner respectfully disagrees.
Kavanagh discloses that their jacket/sleeve 30 is retracted along catheter 15 proximally far enough to expose discharge orifice 17 – which is comparable to Buckner’s discharge orifices 17 which lie proximally past collar 20 – so that it can be used to convey fluid between the catheter and the bladder (Col 6, Lines 4-8). Therefore, one of ordinary skill in the art would recognize that the application of Kavanagh’s assembly 16 to Buckner’s catheter 5 (by replacing Buckner’s tip 21) would not inhibit the ability of collar 20 to inflate and seal the urethra beyond infection when pressurized since the sleeve 30 would be retracted proximally past the collar 20. Therefore, the operation of Kavanagh’s assembly 16 as an axially squeeze-released gripper would not eliminate the urethral seal provided by collar 20 of Buckner.
surround the cap 8 or the orifices 17 when delivery occurs; therefore, it does not appear that there would be a risk of blow-out when inflation pressure is applied.
Therefore, Bucker’s fundamental mode of action and basic principle of operation would not be altered.
Applicant notes that Kavanagh is directed to a female package designed to avoid peri-labial contamination while Buckner is directed to applying medicine to the urethra of the male organ, but does not utilize this assertion in any argument.
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 KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 A “slit” under broadest reasonable interpretation is “a long narrow cut or opening” as defined by Merriam Webster Online Dictionary. <<http://www.merriam-webster.com/dictionary/slit>>