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 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 1-19 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 1 is a single claim which claims both an apparatus and a method step. Such is indefinite because it is not directed to the system, but the actions of a user, which creates confusion as to when direct infringement occurs. See MPEP 2173.05(p). Specifically, “wherein the intermediate portion of the outflow member passes through the kidney, renal pelvis and/or ureter” is drawn to the use of the device, not the structure of the device. The examiner suggests amending “passes” to “capable of passing”.
In claim 9, Applicant requires “wherein the inflow member and/or the outflow member comprise... a distal end...” It is unclear how such relates to “a distal end” of the outflow member in claim 1.
Claim 17 is a single claim which claims both an apparatus and a method step. Such is indefinite because it is not directed to the system, but the actions of a user, which creates confusion as to when direct infringement occurs. See MPEP 2173.05(p). Specifically, “wherein the intermediate portion of the outflow member passes through the kidney, renal pelvis and/or ureter” is drawn to the use of the device, not the structure of the device. The examiner suggests amending “passes” to “capable of passing”.
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.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious in view of Erbey et al (WO 2020/217214).
Regarding claim 1, Erbey discloses a negative pressure therapy device (figs 21 and 22; ¶336-341) for inducing negative pressure in a portion of a urinary tract, the device comprising a urinary catheter comprising: (a) an inflow member 814 comprising at least one inflow lumen 818 configured to be in fluid communication with a negative pressure source 840, the inflow member comprising (i) a proximal portion 820, (ii) a retention portion 824 configured to be deployed within a renal pelvis of the urinary tract (¶337), the retention portion comprising at least one drainage hole (¶340) leading to the at least one inflow lumen, and (iii) at least one intermediate portion between the proximal portion and the retention portion (section between 820 and 824), wherein the at least one intermediate portion is configured to extend through at least a portion of a kidney to the renal pelvis (¶336); and (b) an outflow member 816 comprising at least one outflow lumen configured to be in fluid communication with the negative pressure source (¶341), the outflow member comprising (i) a proximal portion (end connected to port 830), (ii) a distal end configured to be positioned in a ureter or bladder (¶341), and (iii) at least one intermediate portion extending from the proximal portion to the distal end, wherein the intermediate portion of the outflow member
Regarding claim 2, wherein the negative pressure source comprises an implanted pump positioned outside of the urinary tract (¶341).
Regarding claim 3, wherein, when negative pressure is applied through the at least one inflow lumen by the negative pressure source, fluid is drawn into the at least one inflow lumen through the at least one drainage hole, and passes through the at least one inflow lumen and the at least one outflow lumen to the ureter and/or the bladder (¶336-341).
Regarding claims 4-6, wherein the inflow member is fluidly connected to the outflow member, such that fluid passes directly from the at least one inflow lumen to the at least one outflow lumen, the inflow member is integral with the outflow member forming a continuous tube, and the at least one inflow lumen is contiguous with the at least one outflow lumen (¶341, fig 21B).
Regarding claim 7, wherein the retention portion of the inflow member is configured to retain at least a distal portion of the inflow member within the kidney and/or the renal pelvis (¶339).
Regarding claim 8, wherein, when deployed, a maximum outer diameter of the retention portion of the inflow member is greater than a diameter of the at least one inflow lumen of the inflow member (fig 22A, due to pigtail shape).
Regarding claim 9, wherein the inflow member and/or the outflow member comprise elongated tubular members comprising a proximal end, a distal end, and a sidewall extending between the proximal end and the distal end (figs 21A/B).
Regarding claim 10, wherein the inflow member comprises at least one radiopaque band on the sidewall, and wherein the at least one radiopaque band is proximate to the retention portion for identifying a location of the retention portion using fluoroscopic imaging (¶373).
Regarding claim 11, wherein the retention portion of the inflow member, when deployed, defines a three-dimensional shape sized and positioned to maintain patency of fluid flow between the kidney and/or the renal pelvis and the proximal portion of the inflow member by inhibiting mucosal tissue from appreciably occluding the at least one drainage hole when the negative pressure is applied through the inflow member (fig 22A, ¶340).
Regarding claim 12, wherein, when deployed, the at least one intermediate portion of the outflow member is configured to pass through the three-dimensional shape defined by the retention portion of the inflow member (fig 22B, as the intermediate portion of the outflow member is a catheter, it is capable of being arranged as claimed).
Note with respect to claim 12, “when deployed” is not defined by the claim. If Applicant was to specify the device is configured such that the intermediate portion of the outflow member is configured to pass through the 3D shape defined by the retention portion of the inflow member and through the ureters to the bladder, such would be considered allowable as while catheters/flow members of Erbey are considered to have a significant length, they are not considered to have such length that they may meet such a limitation.
Regarding claim 13, wherein the retention portion of the inflow member comprises at least a first coil having a first diameter and at least a second coil having a second diameter, the first diameter being greater than the second diameter (fig 22A).
Regarding claim 14, wherein the retention portion of the inflow member comprises a radially inwardly facing side comprising the at least one drainage hole, and a radially outwardly facing side that is essentially free of drainage holes (fig 22B, ¶361).
Regarding claim 15, wherein the retention portion of the inflow member is configured to be deployed in the kidney and/or the renal pelvis of a patient (¶339).
Regarding claim 16, wherein the patient is at least one of a human or a dog (¶3; human kidney shown in fig 21A).
Regarding claim 17, Erbey discloses a system for inducing negative pressure in a portion of a urinary tract (figs 21 and 22; ¶336-341), the system comprising: a negative pressure source 840; and a urinary catheter configured to be deployed in the urinary tract, comprising: (a) an inflow member 814 comprising at least one inflow lumen 818 in fluid communication with the negative pressure source 840, the inflow member comprising (i) a proximal portion 820, (ii) a retention portion 824 configured to be deployed within a renal pelvis of the urinary tract (¶337), the retention portion comprising at least one drainage hole (¶340) leading to the at least one inflow lumen, and (iii) at least one intermediate portion between the proximal portion and the retention portion (section between 820 and 824), wherein the at least one intermediate portion is configured to extend through at least a portion of a kidney to the renal pelvis (¶336); and (b) an outflow member 816 comprising at least one outflow lumen in fluid communication with the negative pressure source (¶341), the outflow member comprising (i) a proximal portion (end connected to port 830), (ii) a distal end configured to be positioned in a ureter or bladder (¶341), and (iii) at least one intermediate portion extending from the proximal portion to the distal end, wherein the intermediate portion of the outflow member bladder), and wherein when negative pressure is applied through the at least one inflow lumen by the negative pressure source, fluid is drawn into the at least one inflow lumen through the at least one drainage hole, and passes through the at least one inflow lumen and the at least one outflow lumen to the ureter and/or the bladder (¶336-¶341).
Regarding claim 18, wherein the negative pressure source comprises a pump configured to be implanted in a body outside of the urinary tract of the body and positioned posterolateral to the kidney or proximate to an abdominal wall of the body (¶341).
Regarding claim 19 wherein the retention portion of the inflow member, when deployed, defines a three-dimensional shape sized and positioned to maintain patency of fluid flow between the kidney and/or the renal pelvis and the proximal portion of the inflow member by inhibiting mucosal tissue from appreciably occluding the at least one drainage hole when the negative pressure is applied through the inflow member (fig 22A, ¶340)), and wherein, when the inflow member and the outflow member are deployed in the urinary tract, the outflow member extends through the three-dimensional shape defined by the retention portion of the inflow member (capable of such, see claim 12 above).
Allowable Subject Matter
Claim 20 is allowed.
The examiner did not find a teaching or suggestion for modifying closest art Erbey (see above) that includes the step of inserting an outflow member 816 of the urinary catheter through the kidney, the renal pelvis, a ureter, and to a bladder of the urinary tract. While Erbey teaches going to the bladder, and prior art supports usage of the ureter for the outflow member, there is no reason, absent impermissible hindsight to also go through the kidney and renal pelvis.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
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