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 Arguments
Applicant's arguments filed 03/20/2026 have been fully considered but they are not persuasive.
The applicant argues the apertures 24 are not at the apex but on the side of the insertion aid. Apical is not defined as the apex, according to Merriam-Webster apical is defined as “of, relating to, or situated at an apex”. The apertures of Boxer are related to the apex. The examiner has broadly interpreted apically to be relating to an apex or near where the apex is formed. The apertures are at the distal most tip of the follower 12 and are where the apex is formed, thus the examiner takes the stance they are apical.
The applicant argues the apertures 24 are configured to receive a backflow of urine and does not teach they are configured to release a substance. However, the phrase “an apical opening that is configured to release a lubricating substance” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the apertures 24 is considered to be capable of releasing a lubricating substance as they are connected to a tube intended for the flow of a fluid. The apertures are intended for the flow of urine in a singular direction but that does not mean fluid cannot flow in the opposite direction.
The amendment to claim 15 has been reviewed and overcomes the current prior art rejection. However, upon further consideration a new ground of rejection is being made in this Final Office action over Fourkas reference (see below).
Claim Status
The drawing objections and the 35 U.S.C. 112(b) rejections have been overcome.
Claims 1, 14-16 and 27 are examined below.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boxer (US 4,155,346 A).
Regarding claim 1, Boxer teaches a device for draining urine from a bladder of a patient (abstract), the device comprising:
a shaft-shaped indwelling component placeable in the bladder and in a urethra of the patient (14, urinary catheter, fig. 2), wherein the shaft-shaped indwelling component has at least one drainage opening proximate to a distal tip of the shaft-shaped indwelling component (38, aperture, fig. 2); and
a retractable insertion aid inserted into the shaft-shaped indwelling component (12, follower, fig. 4), wherein the retractable insertion aid facilitates insertion of the shaft-shaped indwelling component into the urethra and passage of the shaft-shaped indwelling component through the urethra (col 3, liens 9-38), wherein the retractable insertion aid has a tubular construction (fig. 4) with an apical opening (24, apertures, fig. 4) that is configured to release a lubricating substance. The phrase “an apical opening that is configured to release a lubricating substance” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the apertures 24 is considered to be capable of releasing a lubricating substance as fluid is able to through the aperture.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boxer in view of Loske (US 2016/0367747 A1).
Regarding claim 14, Boxer teaches a shaft portion (16, urethra, fig. 2). Boxer fails to teach a film-like tube material. However, Loske teaches a balloon catheter that includes a shaft portion of the shaft-shaped indwelling component is made of film-like, thin-walled tube material (3, open-pore film, fig. 1f). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Boxer to include a film-like tube material as taught by Loske in order to drain the body fluid along and inside the wall of the fluid-carrying element (¶ [0022], Loske).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boxer in view of Loske as applied to claim14 above, and further in view of Fourkas (US 6,808,520 B1).
Regarding claim 15, Boxer and Loske fail to teach one or more rod-like structures arranged in the tube material. However, Fourkas teaches a catheter sheath that includes one or more rod-like or tubular structure (19, elongate elements, fig. 5) arranged in the film-like, thin-walled tube material (fig. 6, col 5 line 61 - col 6 line 23). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Boxer and Loske to include teach one or more rod-like structures arranged in the tube material as taught by Fourkas in order to provide a gradation in stiffness (col 5 line 61 - col 6 lines 23, Fourkas).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boxer in view of Loske as applied to claim 14 above, and further in view of Pingleton (US 2007/0215268 A1).
Regarding claim 16, Boxer in view of Loske fails to teach a net-like reinforcement. However, Pingleton teaches medical tubing that includes a net-like reinforcement (110, braid, figs. 13-14) is connected to the film-like, thin walled tube material (¶ [0057]-[0058]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Boxer and Loske to include a net-like reinforcement as taught by Pingleton in order to form a kink-resistant sheath (¶ [0057], Pingleton).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boxer in view of Mitts (US 7,410,481 B1).
Regarding claim 27, Boxer further teaches a distal end of the shaft-shaped indwelling part (26, tip, fig. 4) that insertable into the urethra (col 3, lines 25-38).
Boxer fails to teach externally lubricating the distal end. However, Mitts teaches a urethral catheter device and method that includes externally lubrication (col 8, lines 49-50). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Boxer to include external lubrication as taught by Mitts since it is a use of a known technique to improve similar devices in the same way for ease of insertion.
Conclusion
THIS ACTION IS MADE FINAL. 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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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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