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 .
Claim Objections
The claims contain minor informalities.
In claim 1, the language “… wherein the first balloon is positioned closer to an indwelling end of the urine passage than the retaining balloon [[is]] …” should be changed for clarity.
In claims 6 and 7, the language “… wherein the retaining balloon [[surrounding]] surrounds a perimeter of …” should be changed for proper grammar.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-3, 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Goedje; Oliver et al. (US 20120035595 A1) in view of Wiita; Gregory D. et al. (US 20110098683 A1).
Regarding claim 1, Goedje discloses a urinary catheter device (¶ [0001], a urinary catheter; ¶ [0015] FIG. 1 is a view, with multiple interruptions, of a urinary catheter);
comprising: a catheter body insertable into a urethra comprising: a urine passage with a cavity open on both ends to allow the drainage of urine (¶ [0024] Openings 4 which make it possible to carry off urine through the urine drainage lumen 5 and the proximal port 10, as is the case in conventional Foley catheters, are located distally from the measurement balloon 7);
a first balloon inflation channel with a central cavity and an inflatable first balloon on an indwelling end of the first balloon inflation channel (¶ [0021] There is a gas connection, via the opening 13 and the measurement lumen 14, between the interior of the measurement balloon 7 and the proximal port 11, to which connection a pressure measurement and evaluation assembly which is known per se can be attached);
a retaining balloon inflation channel separate from the first balloon inflation channel; a retaining balloon in communication with the retaining balloon inflation channel (¶ [0022] Similarly to conventional Foley catheters, the blocking balloon 3 primarily prevents the urinary catheter 1 from being withdrawn too far from the bladder, which is undesirable. It can be inflated with filling gas via the balloon lumen 2 and the opening 15. For this purpose a gas feed device, which is not shown and is known per se from the prior art, can be connected to the proximal port 12, towards which the balloon lumen 2 extends);
the first balloon positioned closer to an indwelling end of the urine passage than the retaining balloon is (Figs. 1-3, measurement balloon 7 is positioned closer to the distal portion than blocking balloon 3).
Goedje is silent whether the catheter device will drain urine without causing interference or obstruction to a descending fetal head during a labor process. However, Goedje discloses all the same structures as the claimed catheter, and also calls for inserting it through the patient’s urethra and into the bladder (¶ [0016] FIG. 2 shows the positioning of a distal portion of the urinary catheter of FIG. 1 in the bladder of patient, the blocking balloon being further inflated compared to FIG. 1). Goedje also advises to construct the catheter with a small size (¶ [0023] Owing to a suitably selected distance d, which is preferably 3 cm or less, between the measurement balloon 7 and the blocking balloon 3, the latter is protected from becoming trapped between a fold in the bladder).
The difference between Goedje and the claimed invention appears to be the catheter’s relative size, which enables the claimed catheter to drain urine during a labor process. Scaling a device larger or smaller does not patentably distinguish over an otherwise old device unless there are new or unexpected results. See MPEP 2144.04(IV)(A) Changes in Size/Proportion.
Goedje lacks an outer layer that incorporates the urine passage, first balloon inflation channel and retaining balloon inflation channel into one single and functional unit. Wiita discloses a urinary catheter device (¶ [0003], [0010], [0052], [0055]);
comprising: a catheter body insertable into a urethra comprising: a urine passage with a cavity open on both ends to allow the drainage of urine (¶ [0052], drain lumen 26 of the catheter tube 24; ¶ [0055], drain lumen 226 of the catheter tube 224);
a first balloon inflation channel with a central cavity and an inflatable first balloon on an indwelling end of the first balloon inflation channel (¶ [0052], first balloon 13 constructed and arranged to encapsulate the distal end 12 of the catheter; ¶ [0053], The balloons 13 and 14, see FIG. 3, are expandable by admitting a preferably sterile fluid through one or more control lumen(s) 30 extending through the catheter tube 24 … multiple control lumens could be provided without departing from the scope of the invention; ¶ [0055] FIGS. 9-14 … first balloon 213);
a retaining balloon inflation channel; a retaining balloon in communication with the retaining balloon inflation channel; the first balloon positioned closer to an indwelling end of the urine passage than the retaining balloon is (¶ [0052], second balloon 14; [0053], one or more control lumen(s) 30 extending through the catheter tube 24 … multiple control lumens; ¶ [0055], second balloon 214; ¶ [0057], plurality of control lumens 230A and 230B);
wherein the catheter body further comprises an outer layer that incorporates the urine passage, first balloon inflation channel and retaining balloon inflation channel into one single and functional unit (¶ [0052], The attached sleeve portion 20 is extended over the outer surface 28 of the end portion of the catheter tube 24 … in a manner that forms a first balloon 13 … and at least one second balloon 14; ¶ [0056] The attached sleeve portion 220 is extended over the outer surface 228 of the end portion of the catheter tube 224 and is selectively attached to the outer surface 228 of the catheter tube 224 in a manner that forms a first balloon 213 … and at least one second balloon 214).
Wiita demonstrates how to manufacture a catheter from a single elastic sleeve, which is selectively bonded to portions of a catheter body. Wiita’s outer layer provides a technique for reliably manufacturing a catheter having two differently sized inflatable balloons. One would be motivated to modify Goedje with Wiita’s outer layer to manufacture the catheter according to a known technique. Therefore, it would have been obvious to modify Goedje with Wiita’s outer layer in order to manufacture the catheter with a suitable technique.
Regarding claims 2 and 6, Goedje discloses a urinary catheter wherein the urine passage is centrally located in the catheter body (Fig. 3, urine drainage lumen 5 extends centrally through the catheter);
wherein the retaining balloon surrounds a perimeter of the catheter body (Figs. 1-3, blocking balloon 3 surrounds the catheter body 6).
Regarding claims 3 and 9, Goedje lacks a check valve. Wiita discloses a catheter further comprising a check valve on an external end of a balloon inflation channel, the check valve preventing inadvertent deflation of the balloon (¶ [0053], Check valves, or the like, (not shown), may be utilized to control the flow of fluid into and/or out of the balloons; ¶ [0058] Check valves 233, 235).
Wiita independently controls the movement of fluids through parallel inflation lumens and prevents balloons from deflating inadvertently. A skilled artisan would have been able to modify Goedje with Wiita’s check valves by installing respective check valves on Goedje’s catheter. One would be motivated to modify Goedje with Wiita’s check valves to reliably inflate the balloons. Therefore, it would have been obvious to modify Goedje with Wiita’s check valves in order to reliably inflate a catheter’s balloons.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Goedje and Wiita in view of Uchida; Andy H. et al. (US 20220022916 A1).
Regarding claims 10 and 11, Goedje and Wiita lack a syringe docking port. Uchida discloses a syringe docking port in communication with a check valve (¶ [0080], The valve in valved port 239 can be, for example, a check valve that prevents fluid flow therethrough when not engaged by a syringe and opens to allow fluid therethrough when engaged with the syringe. FIG. 34 shows an exemplary syringe 234 configured to be inserted into valved port 239 for introduction of inflation medium).
Uchida interfaces a syringe with an inflatable catheter balloon in order for a user to inflate the balloon with a syringe. One would be motivated to modify Goedje and Wiita with Uchida’s syringe docking port so that a user can fill Goedje’s balloons with a well-known inflation device.
A skilled artisan would have been able to modify Goedje and Wiita with Uchida’s syringe docking port by installing respective docking ports on Goedje’s catheter. Therefore, it would have been obvious to modify Goedje and Wiita with Uchida’s syringe docking port in order to connect an inflation syringe with the catheter and inflate its balloon.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Goedje and Wiita in view of Kim; Sungyul D. (US 20130331824 A1).
Regarding claim 14, Goedje and Wiita do not explicitly disclose a retaining balloon having an internal volume of approximately 3 cc. Kim discloses a urinary catheter with a retaining balloon having an internal volume of approximately 3 cc (¶ [0028], Balloons 14 and 15 in FIG. 2 are illustratively two 5 mL balloons. However, depending on the application and the substance filling the balloon, e.g. air versus fluid, the balloon size may vary between about 0.1-10 mL).
Kim demonstrates an acceptable range for a balloon inflation volume. One would be motivated to modify Goedje and Wiita with Kim’s balloon volume range to appropriately configure the balloon for a patient without over- or under-inflating the balloon. Therefore, it would have been obvious to modify Goedje and Wiita with Kim’s balloon volume range in order to configure a balloon to retain a urinary catheter in the patient’s bladder without injuring the patient.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-9 and 12 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 1 of Wood; Gregory Douglas (US 11904106 B2).
Regarding pending claim 1, Wood claims all limitations in patented claim 1, namely a urinary catheter device for obstetrical patients that will allow drainage of urine from a bladder without causing interference or obstruction to a descending fetal head during a labor process (claim 1, a urinary catheter device … during a labor process);
the urinary catheter device comprising: a catheter body insertable into a urethra (claim 1, catheter body);
comprising: a urine passage with a cavity open on both ends to allow the drainage of urine (claim 1, a centrally located urine passage with a central cavity open on both ends to allow the drainage of urine);
a first balloon inflation channel with a central cavity and an inflatable first balloon on an indwelling end of the first balloon inflation channel (claim 1, a spherical balloon inflation channel with a central cavity and an inflatable spherical balloon on an indwelling end of the spherical balloon inflation channel);
a retaining balloon inflation channel separate from the first balloon inflation channel (claim 1, a retaining balloon inflation channel separate from the spherical balloon inflation channel);
a retaining balloon in communication with the retaining balloon inflation channel (claim 1, a non-spherical flat low-profile-retaining balloon on an indwelling end of the retaining balloon inflation channel);
the first balloon positioned closer to an indwelling end of the urine passage than the retaining balloon is (claim 1, the spherical balloon positioned closer to an indwelling end of the urine passage than the retaining balloon is);
wherein the catheter body further comprises an outer layer that incorporates the urine passage, first balloon inflation channel and retaining balloon inflation channel into one single and functional unit (claim 1, wherein the catheter body further comprises an outer layer that incorporates the centrally located urine passage, spherical balloon inflation channel and retaining balloon inflation channel into one single and functional unit).
Regarding pending claims 2-9 and 12, Wood claims all limitations in patented claim 1.
Claims 10 and 11 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 1 of Wood; Gregory Douglas (US 11904106 B2) in view of Uchida; Andy H. et al. (US 20220022916 A1).
Regarding claims 10 and 11, Wood does not explicitly claim a syringe docking port in communication with the check valve. Uchida discloses a syringe docking port in communication with a check valve (¶ [0080], The valve in valved port 239 can be, for example, a check valve that prevents fluid flow therethrough when not engaged by a syringe and opens to allow fluid therethrough when engaged with the syringe. FIG. 34 shows an exemplary syringe 234 configured to be inserted into valved port 239 for introduction of inflation medium).
Uchida interfaces a syringe with an inflatable catheter balloon in order for a user to inflate the balloon with a syringe. One would be motivated to modify Wood’s claim with Uchida’s syringe docking port so that a user can fill Wood’s balloon with a well-known inflation device. Therefore, it would have been obvious to modify Wood’s claim with Uchida’s syringe docking port in order to connect an inflation syringe with the catheter and inflate its balloon.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Otto; Ullrich WO 2013010600 A1
Engel; Konrad et al. US 6119697 A
Hinchliffe, Peter W. J. US 20020013548 A1
Cioanta, Iulian et al. US 20020165521 A1
Gerrans; Lawrence J. et al. US 20110218494 A1
Lawinger; Jason et al. US 20190117242 A1
Geva; Avner et al. US 20210052873 A1
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/Adam Marcetich/
Primary Examiner, Art Unit 3781