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 Arguments
Applicant's arguments filed 01/21/2026 have been fully considered but they are not persuasive. Regarding claim 1, Applicant argues that Tanghoej does not disclose the amended limitation of the proximal portion having a central axis which aligns with the central axis of the rod. However, as set forth in the rejection below, Tanghoej’s guide member 2 may have a degree of flexibility, thus at least a portion of the central axis of guide member 2 is fully capable of being aligned with the central axis of the proximal portion. Applicant further argues that the combination of Tanghoej/Malek is improper, and that one of ordinary skill would not 1) externalize Malek’s internal reinforcing spines into two exposed rods; 2) Reconfigure the catheter so that the proximal, lumen-bearing portion extends from those rods; and 3) Redesign the rods so that they are suitable to be grasped by the user. However, In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Tanghoej already includes one external rod that extends from the proximal lumen-bearing portion that is suitable to be grasped by the user, and is merely modified by Malek to include a second rod based on the teachings of Malek to provide increased column strength of the catheter (as motivated by Malek ¶[0262]). Thus the new independent claim 31 is rejected over Tanghoej/Malek as set forth 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.
Claims 1-4, 6-7, 9-10, 12-16, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tanghoej (US 20060116661 A1).
Regarding Claim 1, Tanghoej discloses a catheter (device of Fig 2 ¶[0044]), comprising: a catheter shaft (Fig 2, combination of oblong member 20, guide member 2, and gripping means 3 (guide member 2 and gripping means 3 shown in Fig 2 but not labeled)) including a proximal portion (Fig 2, portion of device near inlets 22) and a distal portion (Fig 2, portion of device near gripping means 3); at least one eyelet in the proximal portion (Fig 2, inlets 22), wherein the proximal portion has a central axis (Fig 2, portion of device near inlets 22 has a central axis along its lumen); the at least one eyelet being in communication with an inner lumen of the proximal portion (Fig 2 ¶[0044] conduit 21 provided by the oblong member 20, consist of an inner canal connected to two inlets 22 in the tip of the oblong member); at least one drainage opening in the catheter shaft for draining fluid from the inner lumen (Fig 2 ¶[0044] and urine will pass through the sphincter along the conduit 21 and flow into the urine canal via the outlet 23 in the oblong member), wherein the at least one drainage opening is between the proximal portion and the distal portion of the catheter shaft (Fig 2 outlet 23 is disposed between the proximal and distal portions); the distal portion including at least one rod having a central axis and wherein the central axis of the proximal portion and the central axis of the rod are aligned (Fig 2 ¶[0043], guide member 2 may have a degree of flexibility, thus at least a portion of the central axis of guide member 2 is fully capable of being aligned with the central axis of the proximal portion); and the at least one drainage opening for draining fluid from the inner lumen to the outside of the at least one rod of the distal portion of the catheter shaft (Fig 2 ¶[0044] Upon insertion of the oblong member in the urethral sphincter, the bladder will start to be voided when the inlets reach the inside of the bladder, and urine will pass through the sphincter along the conduit 21 and flow into the urine canal via the outlet 23 in the oblong member).
Regarding Claim 2, Tanghoej discloses that the at least one rod is a solid structure (Fig 2, guide member 2 is shown as a solid structure with no lumen therethrough).
Regarding Claim 3, Tanghoej discloses a neckdown between the proximal portion and the rod (Fig 2, ¶[0044] the portion of the device at outlet 23 is considered a neckdown).
Regarding Claim 4, Tanghoej discloses that the neckdown is a partial neckdown or a circumferential neckdown (Fig 2, ¶[0044] the portion of the device at outlet 23 is considered a partial neckdown).
Regarding Claim 6, Tanghoej discloses that a cross-sectional width of the at least one rod is smaller than a cross-sectional width of the proximal portion (Fig 2, the cross-sectional width of guide member 2 is smaller than the cross-sectional width of any portion of oblong member 20).
Regarding Claim 7, Tanghoej discloses that the proximal portion has a proximal end that comprises a nelaton, curved, tapered or straight shape (Fig 2, proximal end of oblong member 20 is curved and tapered).
Regarding Claim 9, Tanghoej discloses a hydrophilic coating on the catheter shaft (¶[0035] at least the part including the oblong member may have a surface with low frictional characteristics. On this part, the surface could correspond to the surface of a regular gel-lubricated catheter, a hydrophilic catheter or any catheter known per se.).
Regarding Claim 10, Tanghoej discloses that the hydrophilic coating is on an outer surface of the catheter shaft (¶[0035] at least the part including the oblong member may have a surface with low frictional characteristics. On this part, the surface could correspond to the surface of a regular gel-lubricated catheter, a hydrophilic catheter or any catheter known per se.).
Regarding Claim 12, Tanghoej discloses that the catheter shaft has a gel on an outer catheter surface to aid insertion (¶[0035] at least the part including the oblong member may have a surface with low frictional characteristics. On this part, the surface could correspond to the surface of a regular gel-lubricated catheter, a hydrophilic catheter or any catheter known per se.).
Regarding Claim 13, Tanghoej discloses a handle associated with the distal portion of the catheter shaft (Fig 2 ¶[0043] guide member 2 is provided with a gripping means 3).
Regarding Claim 14, Tanghoej discloses that the distal portion bends between the rod and the handle (Fig 2 ¶[0017] guide member 2 may be bent by an applied force).
Regarding Claim 15, Tanghoej discloses that the bend is between 30 and 90 (Fig 4 ¶[0011] guide member 2 may have any angle from a straight configuration up to 360 degrees and is fully capable of bending between 30 and 90 degrees).
Regarding Claim 16, Tanghoej discloses that the catheter further includes at least flexible piece attached to the at least one rod and handle ([¶0043] guide member 2 may be made from a flexible polymer).
Regarding Claim 20, Tanghoej discloses that the handle is at the distal end of the distal portion of the catheter shaft (Fig 2, gripping means 3 is on the distal end of the device).
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.
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Tanghoej (US 20060116661 A1) in view of Lovmar (US 20120165791 A1).
Regarding Claim 8, Tanghoej is silent whether the catheter is formed by injection molding.
However, Lovmar teaches a urinary catheter, thus from the same field of endeavor, wherein the catheter is formed by injection molding (¶[0049]) to enable automated large scale production (¶[0049]).
Therefore, 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 device of Tanghoej so that the catheter is formed by injection molding, as taught by Lovmar, to enable automated large scale production (as motivated by Lovmar ¶[0049]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Tanghoej (US 20060116661 A1) in view of Murray (US 20200016380 A1).
Regarding Claim 19, Tanghoej is silent whether the handle has an oval shape.
However, Murray teaches a catheter with a handle, thus from the same field of endeavor, wherein the handle has an oval shape (Fig 4, ¶[0023] ring shaped portion 48 may be oval) for convenient grasping of the urinary catheter (¶[0023]).
Therefore, 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 device of Tanghoej so that the handle has an oval shape, as taught by Murray for convenient grasping of the urinary catheter (as motivated by Murray ¶[0023]).
Claims 11, 31-32 and 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Tanghoej (US 20060116661 A1) in view of Malek (US 20200069927 A1).
Regarding Claim 11, Tanghoej is silent whether the hydrophilic coating is on an inner surface of the catheter shaft.
However, Malek teaches a catheter, thus from the same field of endeavor, wherein the hydrophilic coating is on an inner surface of the catheter shaft (¶[0197] inner wall of the tubular member may include a hydrophilic coating) to reduce friction or facilitate smooth translation (¶[0197]).
Therefore, 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 device of Tanghoej so that the hydrophilic coating is on an inner surface of the catheter shaft, as taught by Malek to reduce friction or facilitate smooth translation (as motivated by Malek ¶[0197]).
Regarding Claim 31, Tanghoej discloses a catheter (device of Fig 2 ¶[0044]), comprising: a catheter shaft (Fig 2, combination of oblong member 20, guide member 2, and gripping means 3 (guide member 2 and gripping means 3 shown in Fig 2 but not labeled)) including a proximal portion (Fig 2, portion of device near inlets 22) and a distal portion (Fig 2, portion of device near gripping means 3); at least one eyelet in the proximal portion (Fig 2, inlets 22); the at least one eyelet being in communication with an inner lumen of the proximal portion (Fig 2 ¶[0044] conduit 21 provided by the oblong member 20, consist of an inner canal connected to two inlets 22 in the tip of the oblong member); at least one drainage opening in the catheter shaft for draining fluid from the inner lumen (Fig 2 ¶[0044] and urine will pass through the sphincter along the conduit 21 and flow into the urine canal via the outlet 23 in the oblong member), wherein the at least one drainage opening is between the proximal portion and the distal portion of the catheter shaft (Fig 2 outlet 23 is disposed between the proximal and distal portions); the distal portion including at least one rod (Fig 2, guide member 2); and the at least one drainage opening for draining fluid from the inner lumen to the outside of the at least one rod of the distal portion of the catheter shaft (Fig 2 ¶[0044] Upon insertion of the oblong member in the urethral sphincter, the bladder will start to be voided when the inlets reach the inside of the bladder, and urine will pass through the sphincter along the conduit 21 and flow into the urine canal via the outlet 23 in the oblong member).
Tanghoej is silent whether the distal portion includes at least two rods.
However, Malek teaches a catheter with reinforcing spine elements, thus from the same field of endeavor, wherein the distal portion includes at least two rods (Fig 47B ¶[0262], spine elements 22033 can be elongated rods or cylindrical members) to provide increased column strength of the shunt (¶[0262]).
Therefore, 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 device of Tanghoej so that the distal portion includes at least two rods, as taught by Malek to provide increased column strength of the catheter (as motivated by Malek ¶[0262]).
Regarding Claim 32, Tanghoej/Malek discloses that the proximal portion has a proximal end that comprises a nelaton, curved, tapered or straight shape (Fig 2, proximal end of oblong member 20 is curved and tapered).
Regarding Claim 34 and 35, the combination of Tanghoej/Malek teaches the invention of claim 5 as set forth above.
The combination of Tanghoej/Malek further teaches that the at least two rods form a handle (The combination of Tanghoej and Malek wherein the guide member 2 of Tanghoej is modified to be two rods would terminate in the gripping means 3 of Tanghoej, which is considered a handle), further including two connecting pieces on each rod attached to the rods and the handle (The combination of Tanghoej and Malek wherein the guide member 2 of Tanghoej is modified to be two rods would terminate in the gripping means 3 of Tanghoej, which is considered a handle and would require connecting pieces) to provide increased column strength of the shunt (¶[0262]).
Therefore, 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 device of Tanghoej so that the at least two rods form a handle, further including two connecting pieces on each rod attached to the rods and the handle, as taught by Malek to provide increased column strength of the catheter (as motivated by Malek ¶[0262]).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Tanghoej (US 20060116661 A1) in view of Malek (US 20200069927 A1) in view of Lovmar (US 20120165791 A1).
Regarding Claim 33, Tanghoej/Malek is silent whether the catheter is formed by injection molding.
However, Lovmar teaches a urinary catheter, thus from the same field of endeavor, wherein the catheter is formed by injection molding (¶[0049]) to enable automated large scale production (¶[0049]).
Therefore, 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 device of Tanghoej/Malek so that the catheter is formed by injection molding, as taught by Lovmar, to enable automated large scale production (as motivated by Lovmar ¶[0049]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY LEE FLYNN whose telephone number is (571)272-8255. The examiner can normally be reached Monday-Friday 7:30-5 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY L FLYNN/Examiner, Art Unit 3781 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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