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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/2/2026 has been entered.
Claim Objections
Claim 1 is objected to because of the following informalities: The manner in which claim 1 was amended renders the claim grammatically incorrect and difficult to read. It is suggested to amend claim 1 to recite “a holding device assembly having a housing having a first end, [[and]] a second end and an exposed griping portion positioned between the first end and the second end, an introducer tip fitting over a portion of the housing at the second end, wherein the second end comprisesa flanged end. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: The comma on line 2 should be removed in order to be grammatically correct. Appropriate correction is required.
Claim 24 is objected to because of the following informalities: The phrase “an end with a retaining feature selected from a barbed end or flanged end” on lines 6-7 is grammatically incorrect. The phrase “the distal end of the housing” on line 8 lacks proper antecedent basis, but it is clear that the “distal end” is intended to be the same as the “end” introduced on line 6 (since lines 6-7 set forth that the “end” includes the retaining feature and lines 7-8 set forth that the retaining feature secures the introducer tip). It is suggested to amend lines 6-8 to recite “an end comprising a flanged end. Appropriate correction is required.
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) and Reif et al. (US Pat 4,811,847).
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) a housing with a barbed or flanged end and an exposed gripping portion and (b) a self-closing retention device, wherein the introducer tip is received over the housing and retained by the barbed/flanged end and the retention device fits over 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 having a first end (to the left in Fig 3) and a second end (to the right in Fig 3), an introducer tip 30 (Col 4, Lines 31-34) fitting over a portion of the housing at the second end (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), the housing further providing an exposed gripping portion (the portion of housing 25 comprising the “gripping surfaces” labeled in annotated Fig B below is the “exposed gripping portion”; as seen in Fig 3, the distal-facing surface (labeled in Fig A below) of this portion is exposed to the external environment) positioned between the first end and the second end of the housing (as seen in Fig 3 and 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). Kavanagh is silent as to how the introducer tip is retained on the second end of the housing.
Reif, however, teaches retaining a substantially similar introducer tip 18+19 (Fig 9) on a housing 12’’ (Fig 9) by means of a retaining feature comprising a flanged end (located at the distal end of housing 12’’, distal to the lugs 20 of tip 18+19 in Fig 9; labeled in Fig D below) for the purpose of ensuring that the introducer tip and the housing are attached strongly enough to ensure that they do not separate from each other when the catheter pushes through the introducer tip (Col 5, Lines 56-61). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the second end of Buckner/Kavanagh’s housing to include a flanged end, as taught by Reif, for the purpose of ensuring that the introducer tip and the housing are attached strongly enough to ensure they do not separate when the catheter pushes through the introducer tip (Col 5, Lines 56-61).
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Re claim 7, Buckner as modified by Kavanagh and Reif 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 and Reif 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)/Reif et al. (US Pat 4,811,847) in view of House (PG PUB 2008/0097463).
Re claim 8, Buckman as modified by Kavanagh and Reif in the rejection of claim 1 and 7 above discloses all the claimed features with Kavanagh teaching 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 the retention seal of Buckner/Kavanagh to be 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 and Reif 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 and Reif 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 and Reif 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)/Reif et al. (US Pat 4,811,847) in view of Spallek et al. (US Pat 5,897,532).
Re claim 12, Buckman as modified by Kavanagh and Reif 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 above). 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 Buckman/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).
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)/Reif et al. (US Pat 4,811,847) in view of Lin et al. (US Pat 5,250,029).
Re claim 15, Buckner as modified by Kavanagh and Reif 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 the catheter body of Buckner 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) a housing with a barbed or flanged end and an exposed gripping portion and (b) a retention device with a self-closable valve preventing access to the housing in a closed state, wherein the introducer tip is positioned over the housing and retained in secure engagement with the housing by the barbed/flanged end 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 with an exposed gripping portion (the portion of housing 25 comprising the “gripping surfaces” labeled in annotated Fig B above is the “exposed gripping portion”; as seen in Fig 3, the distal-facing surface (labeled in Fig A above) of this portion is exposed to the external environment), an introducer tip 30 (Col 4, Lines 31-34) positioned 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 is silent as to how the introducer tip is retained on the second end of the housing and 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.
Reif, however, teaches retaining a substantially similar introducer tip 18+19 (Fig 9) on a housing 12’’ (Fig 9) by means of a retaining feature comprising a flanged end (located at the distal end of housing 12’’, distal to the lugs 20 of tip 18+19 in Fig 9; labeled in Fig D above) for the purpose of ensuring that the introducer tip and the housing are attached strongly enough to ensure that they do not separate from each other when the catheter pushes through the introducer tip (Col 5, Lines 56-61). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the second end of Buckner/Kavanagh’s housing to include a flanged end, as taught by Reif, for the purpose of ensuring that the introducer tip and the housing are attached strongly enough to ensure they do not separate when the catheter pushes through the introducer tip (Col 5, Lines 56-61). Reif does not disclose a self-closable valve preventing access to the housing in a closed state nor the provision of 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)/Reif et al. (US Pat 4,811,847) in view of Burkinshaw et al. (PG PUB 2008/0103564).
Re claim 29, Bucker as modified by Kavanagh and Reif 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 the solution in the syringe of Buckner to include 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 1/2/2026 have been fully considered.
Applicant’s argument that the previously-cited references do not teach the newly-added barbed/flanged end is moot in view of the present rejections that utilize the newly-cited Reif et al. reference to teach this feature.
Applicant’s argument that Kavanagh does not teach the newly-added “exposed gripping portion” is not persuasive since the distal-facing surface of element 25 is exposed to the external environment (as seen in Fig 3 of Kavanagh).
Conclusion
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>>
Prosecution Insights