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 .
Response to Amendment
The amendment filed 01/30/2026 has been entered. Claims 1, 3, 5, 17, and 19 have been amended. Claims 2 and 20 are cancelled. Claims 1, 3-19, 21-23 remain pending in this application.
Response to Arguments
Applicant's arguments filed 01/30/2026 have been fully considered but they are not persuasive.
Regarding claims 16-20 rejected under 35 SUC §112(b), applicant argues that claim 1 references the guidewire only as an object acted upon by the device whereas claim 16 affirmatively introduces and structurally claims the guidewire itself. However, as discussed below, claim 16 is indefinite because it is unclear whether claim 16 requires an additional guidewire or is the same guidewire recited in claim 1. The rejection is therefore maintained. Claim 19 remains rejected under 35 USC §112(b) for similar reasons.
Regarding amended claim 1, Blanchard in view of Scianmarello render claim 1 obvious. Applicant argues that the proposed modification of Blanchard in view of Scianmarello would render the prior art invention being modified unsatisfactory for its intended purpose. Applicant argues that the needle of Blanchard must be removed to avoid puncturing the urological catheter. However, as discussed in the rejection below, such recitation of the device being a urological catheter device for detecting when a stricture within a urethra of a male patient blocks insertion of a guidewire relates to an intended use. Further, while the claims recite a foley catheter connector, a foley catheter is not explicitly required by claim 1. Further, Blanchard discloses a configuration where the needle and guidewire are actuated separately with two separate actuator members (¶ 0055). Thus, the needle need not to be removed but can be selectively actuated and withdrawn.
Regarding claims 5-6, applicant argues that Blanchard discloses gates 712 configured to prevent the slider assembly from being withdrawn from the slot 22. However, the rejection below does not rely on the end comprising gates 712 as being the endcap. Rather, the rejection relies on retaining ring 730 as being analogous to the end cap, which Blanchard discloses as being removable (¶ 0060). Accordingly, Blanchard discloses the claimed endcap.
Regarding claim 17, applicant argues that claim 17 is nonobvious and that Blanchard teaches a coiled guidewire tip and that the coiled tip of Blanchard would make it more difficult for the guidewire to pass the obstruction. However, claim 17 requires that the guidewire is linear and flexible. Blanchard discloses that the guidewire is flexible and can have a straight configuration when the guidewire is withdrawn into the needle (¶ 0040). Applicant has not provided any reason as to why the coiled tip would make it more difficult for the guidewire to pass the obstruction. Rather, Blanchard discloses that the advantage of the coiled tip can prevent damage (¶ 0040). Further, since the guidewire of Blanchard is flexible, it is capable of passing an obstruction.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites “a guidewire”. It is unclear whether the guidewire recited in claim 16 differs from the guidewire previously recited in claim 1, from which claim 16 ultimately depends from.
Claims 17-18 are rejected due to dependency on claim 16.
Claim 19 recites “a manipulator-slide” in ln. 8. It is unclear whether this recitation of the manipulator slide is different from the manipulator slide previously recited in claim 19, ln. 4.
Claim 19 recites “a guidewire for inserting into the urethra” in ln. 11. It is unclear whether the guidewire recited in claim 19 differs from the guidewire previously recited in claim 19, ln. 8.
Claim 19 recites “a guidewire for inserting into the urethra”. It is unclear whether the guidewire recited in claim 19 differs from the guidewire previously recited in claim 1, from which claim 19 ultimately depends from.
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.
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, 3-7, 9-11, 16-17, 19 and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard et al. (Pub. No.: US 2021/0154439 A1) in view of Scianmarello (Pub. No.: US 2025/0288789 A1).
Regarding claim 1, Blanchard discloses (fig. 1-5) a catheter device (insertion device 20), comprising:
A guidewire-chamber (proximal housing 21A) for housing, retracting and extending a guidewire (9) past a stricture (¶ 0035), said guidewire-chamber having a distal guidewire-chamber lumen formed therein for allowing the guidewire to be extended distally therethrough (fig. 1, ¶ 0035), said guidewire-chamber having a proximal guidewire chamber lumen formed therein for allowing the guidewire to be extended proximally therethrough (fig. 1, ¶ 0035), said guidewire-chamber having a guidewire-chamber wall running from said distal guidewire-chamber lumen to said proximal guidewire-chamber lumen, said guidewire-chamber wall having a guidewire-chamber slot (22) formed therein (¶ 0035), said guidewire-chamber slot running lengthwise (¶ 0035), said guidewire-chamber wall defining a guidewire-chamber lumen (¶ 0035) interconnecting said distal guidewire-chamber lumen and said proximal guidewire-chamber lumen (fig. 1); and
a catheter connector (distal housing 21B) for connecting to a proximal end of a catheter (¶ 0048), the catheter connector having a connector wall forming a catheter connector lumen with a proximal catheter connector opening and a distal catheter connector opening (fig. 5).
Blanchard fails to disclose that the catheter device is a urological catheter device for detecting when a stricture within a urethra of a male patient blocks insertion of a guidewire. However, such limitation of claim 1 relates to the intended use of the system, which, in this case, imparts no further limitations on the structure of the device. The catheter device of Blanchard is capable of being a urological catheter device for detecting when a stricture within a urethra of a male patient blocks insertion of a guidewire and using the device for this purpose requires only routine skill in the art (See § MPEP 2114 II).
Blanchard fails to disclose that the catheter connector is a foley-catheter connector for connecting to a proximal end of a council foley catheter.
Scianmarello teaches (fig. 1-3) a urological catheter device (coupler, ¶ 0003) and thus in the same field of endeavor comprising: a foley-catheter connector (stalk 104) for connecting to a proximal end of a council foley catheter (¶ 0011, ¶ 0104).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connector of Blanchard such that it is a foley-catheter connector for connecting to a proximal end of a council foley catheter, as taught by Scianmarello, as foley catheters are commonly used medical devices for providing real time urine drainage and output information (Scianmarello, ¶ 0004).
Regarding claim 3, Blanchard in view of Scianmarello disclose wherein the foley-catheter connector is shaped generally frustoconically (Scianmarello fig. 3).
Regarding claim 4, Blanchard in view of Scianmarello disclose wherein the foley-catheter connector includes steps (Scianmarello fig. 3).
Regarding claim 5, Blanchard discloses (fig. 1-5, 6C, 7A-7C) a catheter device (insertion device 20), comprising:
A guidewire-chamber (proximal housing 21A) for housing, retracting and extending a guidewire (9) past a stricture (¶ 0035), said guidewire-chamber having a distal guidewire-chamber lumen formed therein for allowing the guidewire to be extended distally therethrough (fig. 1, ¶ 0035), said guidewire-chamber having a proximal guidewire chamber lumen formed therein for allowing the guidewire to be extended proximally therethrough (fig. 1, ¶ 0035), said guidewire-chamber having a guidewire-chamber wall running from said distal guidewire-chamber lumen to said proximal guidewire-chamber lumen, said guidewire-chamber wall having a guidewire-chamber slot (22) formed therein (¶ 0035), said guidewire-chamber slot running lengthwise (¶ 0035), said guidewire-chamber wall defining a guidewire-chamber lumen (¶ 0035) interconnecting said distal guidewire-chamber lumen and said proximal guidewire-chamber lumen (fig. 1); and
An endcap (retaining ring 730) with an endcap lumen formed therethrough (fig. 7C), said endcap being removably disposed on said guidewire-chamber with said endcap lumen being fluidly connected to said guidewire-chamber lumen (¶ 0060), said endcap retaining a manipulator slide (slider assembly 3) within said guidewire-chamber when said endcap is connected to said guidewire-chamber (fig. 6C).
Blanchard fails to disclose that the catheter device is a urological catheter device for detecting when a stricture within a urethra of a male patient blocks insertion of a guidewire. However, such limitation of claim 5 relates to the intended use of the system, which, in this case, imparts no further limitations on the structure of the device. The catheter device of Blanchard is capable of being a urological catheter device for detecting when a stricture within a urethra of a male patient blocks insertion of a guidewire and using the device for this purpose requires only routine skill in the art (See § MPEP 2114 II).
Blanchard fails to disclose “said endcap allowing a manipulator-slide to be inserted or removed from said guidewire-chamber when said endcap is removed”, however, such limitation relates to the intended use of the system, which, in this case, imparts no further limitations on the structure of the device. The endcap disclosed by Blanchard is removable and is therefore capable of allowing the manipulator-slide to be inserted or removed from said guidewire-chamber when said endcap is removed and using the device for this purpose requires only routine skill in the art (See § MPEP 2114 II).
Regarding claim 6, Blanchard fails to disclose wherein said endcap includes an endcap luer-lock for connecting to a further device.
However, Blanchard discloses that the endcap is configured to engage a further device (distal housing 21B) in rotatable relationship (¶ 0061). Blanchard further discloses a luer-lock to connect components of the device (¶ 0048).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the endcap of Blanchard such that it includes an endcap luer-lock for connecting to a further device as a luer-lock provides a rotatable relationship suitable for securing components.
Regarding claim 7, Blanchard discloses wherein said guidewire-chamber is transparent (¶ 0042).
Regarding claim 9, Blanchard discloses (fig. 1) a manipulator-slide (slider assembly 3) for extending and retracting the guidewire into and from said guidewire-chamber (¶ 0038), said manipulator-slide being sized to travel in said guidewire-chamber lumen, said manipulator-slide being reachable through said guidewire-chamber slot (¶ 0038).
Regarding claim 10, Blanchard discloses a manipulator post (tongue 23) being connected to said manipulator slide and extending through said guidewire-chamber slot (¶ 0038).
Regarding claim 11, Blanchard discloses a post knob (finger pad 33) disposed on said manipulator post and being located outside said guidewire-chamber (¶ 0038, fig. 3).
Regarding claim 16, Blanchard discloses a guidewire (9) running through said proximal guidewire-chamber lumen and said connector (¶ 0038, fig. 1).
Blanchard in view of Scianmarello fail to disclose that the guidewire is “for inserting into the urethra”. However, such limitation relates to the intended use of the system, which, in this case, imparts no further limitations on the structure of the device. The guidewire of Blanchard in view of Scianmarello is capable of being inserted into the urethra and using the device for this purpose requires only routine skill in the art (See § MPEP 2114 II).
Regarding claim 17, Blanchard discloses wherein said guidewire is linear and flexible (¶ 0040).
Blanchard in view of Scianmarello fail to disclose that the guidewire is “linear and flexible enough to bend when striking the stricture in the urethra while said guidewire is being extended, said guidewire indicating an impassable urethral obstruction when bent”. However, such limitation relates to the intended use of the system, which, in this case, imparts no further limitations on the structure of the device. The guidewire of Blanchard in view of Scianmarello is linear and flexible and is therefore capable of bending when striking the stricture in the urethra while said guidewire is being extended, said guidewire indicating an impassable urethral obstruction when bent and using the device for this purpose requires only routine skill in the art (See § MPEP 2114 II).
Regarding claim 19, Blanchard discloses (fig. 6C, 7A-7C) an endcap (retaining ring 730) with an endcap lumen formed therethrough (fig. 7C), said endcap being removably disposed on said guidewire-chamber with said endcap lumen being fluidly connected to said guidewire-chamber lumen (¶ 0060), said endcap retaining a manipulator slide (slider assembly 3) within said guidewire-chamber when said endcap is connected to said guidewire-chamber (fig. 6C);
A manipulator-slide (slider assembly 3) for extending and retracting the guidewire into and from said guidewire-chamber (¶ 0038), said manipulator-slide being sized to travel in said guidewire-chamber lumen, said manipulator-slide being reachable through said guidewire-chamber slot (¶ 0038); and
A guidewire (9), said guidewire being secured by said manipulator slide (¶ 0038), said guidewire extending through said guidewire-chamber and said foley-catheter connector (¶ 0038).
Blanchard in view of Scianmarello fail to disclose “said endcap allowing a manipulator-slide to be inserted or removed from said guidewire-chamber when said endcap is removed”, however, such limitation relates to the intended use of the system, which, in this case, imparts no further limitations on the structure of the device. The endcap disclosed by Blanchard is removable and is therefore capable of allowing the manipulator-slide to be inserted or removed from said guidewire-chamber when said endcap is removed and using the device for this purpose requires only routine skill in the art (See § MPEP 2114 II).
Blanchard in view of Scianmarello fail to disclose that the guidewire is “for inserting into the urethra”. However, such limitation relates to the intended use of the system, which, in this case, imparts no further limitations on the structure of the device. The guidewire of Blanchard in view of Scianmarello is capable of being inserted into the urethra and using the device for this purpose requires only routine skill in the art (See § MPEP 2114 II).
Regarding claim 21, Blanchard discloses wherein said guidewire-chamber slot is linear (fig. 1).
Regarding claim 22, Blanchard discloses wherein said guidewire-chamber slot runs longitudinally (fig. 1).
Regarding claim 23, Blanchard discloses wherein said guidewire-chamber is tubular shaped (fig. 1, ¶ 0035).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard in view of Scianmarello, as applied to claim 1 above, and further in view of Tran et al. (Pub. No.: US 2018/0071509 A1).
Regarding claim 8, Blanchard in view Scianmarello of fail to disclose wherein said guidewire-chamber is translucent.
Tran teaches (fig. 1A) a catheter device (insertion tool 10) and thus in the same field of endeavor, comprising a guidewire-chamber (housing 12, ¶ 0024), wherein said guidewire-chamber is translucent (¶ 0020).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guidewire-chamber of Blanchard in view of Scianmarello such that it is translucent, as taught by Tran, in order to allow the user to observe movement of the guidewire.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard in view of Scianmarello, as applied to claim 10 above, and further in view of Kwan et al. (Pub. No.: US 2021/0001080 A1).
Regarding claim 12, Blanchard in view of Scianmarello fail to disclose a thumb-ring for being held during operation, said thumb-ring being connected to said manipulator post.
Kwan teaches (fig. 8-9) a urological catheter device (urinary catheter 100) comprising a thumb-ring (ring 154) for being held during operation (¶ 0048), said thumb-ring being connected to a manipulator post (hook 152).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the manipulator-slide of Blanchard in view of Scianmarello such that it comprises the thumb-ring of Kwan, in order to allow a physician or medical provider to place his/her finger in the ring to facilitate moving of the guidewire (Kwan ¶ 0048).
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard in view of Scianmarello, as applied to claim 9 above, and further in view of Arnott (Pub. No.: US 2005/0096566 A1).
Regarding claim 13, Blanchard in view of Scianmarello fail to disclose wherein said manipulator-slide includes a dorsal manipulator-slide clamshell, a ventral manipulator-slide clamshell, and a manipulator hinge interconnecting said dorsal manipulator-slide clamshell and said ventral manipulator-slide clamshell, said dorsal manipulator-slide clamshell being separatable from said ventral manipulator-slide clamshell to allow the guidewire to be inserted and released, said dorsal manipulator-slide clamshell being closeable on said ventral manipulator-slide clamshell to hold the guidewire.
Arnott teaches (fig. 1-5) a guidewire device (abstract) and thus in the same field of endeavor, comprising a manipulator slide (torquer 1), wherein said manipulator-slide includes a dorsal manipulator-slide clamshell (top arm 14), a ventral manipulator-slide clamshell (bottom arm 15), and a manipulator hinge (flexible flap hinge 17) interconnecting said dorsal manipulator-slide clamshell and said ventral manipulator-slide clamshell (¶ 0035), said dorsal manipulator-slide clamshell being separatable from said ventral manipulator-slide clamshell to allow the guidewire (2) to be inserted and released (¶ 0038), said dorsal manipulator-slide clamshell being closeable on said ventral manipulator-slide clamshell to hold the guidewire (¶ 0038).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the manipulator-slide of Blanchard in view of Scianmarello such that it includes a dorsal manipulator-slide clamshell, a ventral manipulator-slide clamshell, and a manipulator hinge interconnecting said dorsal manipulator-slide clamshell and said ventral manipulator-slide clamshell, said dorsal manipulator-slide clamshell being separatable from said ventral manipulator-slide clamshell to allow the guidewire to be inserted and released, said dorsal manipulator-slide clamshell being closeable on said ventral manipulator-slide clamshell to hold the guidewire, as taught by Arnott, as such manipulator-slide can provide greater torqueability to manipulate the guidewire (Arnott, ¶ 0039).
Regarding claim 14, Blanchard in view of Scianmarello and further in view of Arnott disclose wherein said manipulator-slide is configured to secure to the guidewire (Arnott, ¶ 0038).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard in view of Scianmarello, as applied to claim 9 above, and further in view of MR et al. (Pub. No.: US 2023/0390532 A1).
Regarding claim 15, Blanchard in view of Scianmarello fail to disclose wherein said manipulator-slide has a manipulator-slide cruciform cross-section.
MR teaches a catheter device (fig. 3A) a catheter device (catheter system (30) and thus in the same field of endeavor, comprising a manipulator-slide (slider 44) for extending and retracting a guidewire into and from a guidewire-chamber (¶ 0084), wherein said manipulator slide has a manipulator-slide cruciform cross-section (fig. 2D).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the manipulator-slide of Blanchard such that it has a manipulator-slide cruciform cross-section, as taught by MR, in order to configure the manipulator-slide to be shaped to slide within the guidewire-chamber.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard in view of Scianmarello, as applied to claim 17 above, and further in view of Andrich (Pub. No.: US 2011/0218520 A1).
Regarding claim 18, Blanchard in view of Scianmarello fail to disclose wherein said guidewire has a diameter between 0.089 cm and 0.096 cm.
Andrich teaches (fig. 1) a urological catheter device (catheter 10, abstract) and thus in the same field of endeavor, comprising a guidewire (38), wherein said guidewire has a diameter between 0.08 cm and 0.09 cm (¶ 0072) which overlaps with the claimed range of 0.089 cm and 0.096 cm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guidewire of Blanchard in view of Scianmarello such that it has a diameter between 0.089 cm and 0.096 cm, as taught by Andrich, as such diameter is suitable for use with a urological catheter device (Andrich, ¶ 0072).
In this case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art”, a prima facie case of obviousness exists (MPEP §2144.05 I.).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Burkholz et al. (Pub. No.: US 2022/0355080 A1) discloses a device for insertion of a guidewire. Avneri et al. (Pub. No.: US 2013/0281787 A1) discloses a device for insertion of a guidewire that can be used with a Foley catheter.
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.
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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781