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 07/31/2025 has been entered. Claims 1, 4-5, 12, and 19 have been amended. Claims 2, 6-7, 10-11, 13-14, 17-18, and 21-22 are cancelled. Claims 1, 3-5, 8-9, 12, 15-16 and 19-20 remain pending in this application.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-5, 8-9, 12, 15-16 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Winegar (Pub. No.: US 2011/0066139 A1) in view of Wolf (Pub. No.: US 2011/0112564 A1) and further in view of Antonucci (Pub. No.: US 2015/0038908 A1).
Regarding claim 1, Winegar discloses (fig. 1-7) a catheter (70) capable of passing through urethral stenosis section so as to permit introduction of lubricant, or withdrawal of urine (¶ 0121), or to keep a urine passageway open, wherein within a head end (catheter tip 75) of the catheter, there is provided with a cavity (fig. 7, see cavity wherein engagement device 18 is located, ¶ 0122), a span of the cavity within an internal space thereof is greater than that of a mouth of the cavity (fig. 7), and the cavity is a space to accommodate a check means which is a guiding core head end (engagement device 18) of a guiding core (stiffener 12, fig. 7), located at a front end of a guiding core (stiffener 12) so as to prevent the guiding core from penetrating through a hole for discharging urine (eyelets 77) on a side wall of a catheter body (fig. 7, ¶ 0123), the check means movably located at top of the guiding core being able to move back and forth in a longitudinal direction (the check means may be provided separately for later assembly ¶ 0119) during which the guiding core head end plays a check role (the engagement device may prevent or restrict flow, ¶ 0107); and the guiding core is centered inside the catheter body (fig. 7);
A liquid channel is arranged between a front end of the guiding core and the head end of the catheter (see channel provided in the catheter tip 75 which accommodates locking wire 20, fig. 7, ¶ 0111).
Winegar fails to disclose that the liquid channel forms a liquid turbulence within the cavity and reduces an injected liquid impacting on a patient’s urethra from the liquid channel and make the patient comfortable.
However, such limitations relate to the function of the system. Since the device of Winegar comprises a liquid channel arranged between the front end of the guiding core and the head end of the catheter and is identical to the device as claimed, it must necessarily function in the identical manner. Furthermore, the liquid channel of Winegar is fully capable of performing the above functions.
Features of an apparatus may be recited either structurally or functionally. In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997). See also MPEP § 2173.05(g). If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432.
Winegar fails to disclose a guiding core tube, the guiding core tube plays a guiding role.
Wolf teaches (fig. 1) a catheter (1) and thus in the same field of endeavor wherein the catheter comprises a guiding core (guide-wire 13) configured to move back and forth in a longitudinal direction within a guiding core tube (fig. 6, ¶ 0092), the guiding core tube plays a guiding role (¶ 0092).
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 catheter of Winegar such that it comprises the guiding core tube of Wolf, thereby facilitating: wherein the check means or the head end of the guiding core is configured to move back and forth in a longitudinal direction within a guiding core tube, the guiding core tube plays a guiding role, in order to provide a guide for the guiding core (Wolf ¶ 002).
Winegar in view of Wolf fail to teach wherein a hardness of the head end of the catheter is greater than that of a catheter body.
Antonucci teaches (fig. 1) a catheter (10) and thus in the same field of endeavor, comprising a head end (hardened tip 28) and a catheter body (catheter tube 16), wherein a hardness of the head end of the catheter is greater than that of a catheter body (¶ 0029).
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 catheter of Winegar in view of Wolf such that a hardness of the head end of the catheter is greater than that of a catheter body, as taught by Antonucci, in order to provide a head end of the catheter that is more readily insertable and more resistant to deformation (Antonucci ¶ 0028).
Regarding claim 3, Winegar discloses wherein the cavity comprises one or more cavities which are provided in series (fig. 7, cavities provided for engagement device 18).
Regarding claim 4, Winegar discloses wherein the head end of the catheter is directly connected with the guiding core (¶ 0103, fig. 7) and an internal cross-section area of a front end of the catheter for discharging urine is the same as an inner hole area of the catheter (fig. 7).
Regarding claim 5, Winegar discloses wherein the check means is arranged within the head end of the catheter (fig. 7, ¶ 105) and the front end of the guiding core is in engagement with a hanging down column of the head end of the catheter (annotated fig. 7).
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Winegar annotated fig. 7
Regarding claim 8, Winegar discloses wherein at a tail end of the guiding core, there is provided with a limiting means (¶ 0122). As discussed above in claim 1, 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 catheter of Winegar such that it includes the guiding core of Wolf. Accordingly, such modification results in regulating a position of the guiding core within the guiding core tube.
Regarding claim 9, Winegar discloses wherein at a tail end of the catheter, there is provided with a connecting means and the connecting means is provided with a conical hole for discharging urine (fig. 5, ¶ 0121) and a hole (the catheter can include additional ports ¶ 0121).
While Winegar fails to disclose that the hole is for injecting lubrication, such limitation relate to the intended use of the system, which, in this case, imparts no further limitations on the structure of the device. The hole of Winegar is capable of being used for injecting lubrication and using the device for this purpose requires only routine skill in the art (See § MPEP 2114 II).
Regarding claim 12, Winegar discloses the check means is directly arranged within the head end of the catheter (fig. 7, ¶ 0105).
Regarding claim 15, Winegar discloses a clamping means (holes 38, 39) of the front end of the guiding core is matched with the head end of the catheter (fig. 4, fig. 7, ¶ 110).
Regarding claim 16, Winegar discloses wherein in view of a longitudinal direction of the catheter from its tail end to its head end, the cavity is provided in front of the hole for discharging urine (fig. 7).
Regarding claim 19, Winegar discloses wherein within the catheter head end, there is provided a space to communicate with the liquid channel (fig. 7). While Winegar does not disclose “so as to form a liquid turbulence in the space before the liquid is injected out of the catheter head end”, such limitations of claim 19 relate to the intended use of the system, which, in this case, imparts no further limitations on the structure of the device. Further, the device disclosed by Winegar provides a space within the catheter head to communicate with a liquid channel and is this capable of performing the above function.
Regarding claim 20, while Winegar fails to disclose “wherein a lubricant is injected through the one of at least three ports for injecting lubricant, while urine is discharged from at least two channels for discharging urine”, such limitations of claim 20 relate to the intended use of the system, which, in this case, imparts no further limitations on the structure of the device. The device disclosed by Winegar is capable of discharging urine (¶ 0121). Further, Winegar discloses the catheter comprising ports (¶ 0121) which are capable of being used for injecting lubricant.
Response to Arguments
The amendments to the claims overcome the claim objections and rejections under 35 USC §112(b) and such objections and rejections are therefore withdrawn.
Applicant's arguments filed 07/31/2025 have been fully considered but they are not persuasive.
Applicant argues, page 7-8, that the projections 28 of Winegar cannot move within the engagement device and that the projections 28 are imbedded within the engagement. However, the rejection above points to the engagement device 18 as being analogous to the claimed check means. Claim 1 recites the check means movably located at a top of the guiding core being able to move back and forth in a longitudinal direction within a guiding core. Winegar discloses that the check means is movable back and forth in a longitudinal direction, as discussed in the rejection above. The rejection above does not rely on the projections 28 moving within the engagement device. Rather, such projections 28 are a structure of the check means.
Applicant argues, page 8-9, that the liquid channel of Winegar is longitudinally provided without any intermediate cavity, so that any liquid turbulence cannot be formed. However, claim 1 does not require a radially provided liquid channel and an intermediate cavity. Accordingly, based on the similarities between claim 1 and Winegar, the liquid channel of Winegar is capable of performing the claimed functions.
Regarding applicants arguments, page 9, with respect to Wolf, Wolf is relied upon to teach a guiding core tube.
Applicants arguments with respect to Martin are moot as Martin is no longer relied upon.
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.
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/MEAGAN NGO/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781