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 .
Election/Restrictions
Newly submitted amended claims 17-20 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the new limitation in claim 17 reciting a “stone detection device external to a patient” is a new specie. Original claim 17 having the kidney stone blocker … in a kidney and the detection device determine a stone in a kidney could be said to be internal and paragraph 51 of the specification mentioned there is an embodiment to such a specie for an internal detection device. This was the implied original specie examined. Thus, Applicant is switching the requirement and evident based on argument of art.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 17-20 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
Applicant's arguments filed 4/17/26 have been fully considered but they are not persuasive. Applicant contends the apparatus of Walish does not have the ability to “engage tissue of a kidney” but fails to appreciate or consider the reference in its entirety. Thus, the examiner respectfully disagrees because clearly the elements of the kidney stone blocker of Walish engage tissue of the kidney and clearly stated such, see paragraph 29.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Callaghan is relevant to the method of Walish because while Walish may mention the passage of stone fragments, there is no desire to allow too large of a stone that would block a ureter and urine flow. Thus, the use of mesh to block any stone capable of clogging/block of the ureter per the teaching of Callaghan would be advantageous to consider and thus not a teaching away.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, The teaching of Harrah is relevant and the rejection is a combination of teachings not just the Harrah reference, thus the attack or comments stating Harrah is not for the same purpose is a moot point.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the new limitation of “the stone blocker remains entirely with the kidney” was not found in the written description. Additionally the new limitation of “elongated tubular member is configured to simultaneously function as: (i) a delivery conduit through which the kidney stone blocker is deliverable to the renal pelvis in a contracted configuration; and (ii) a working channel through which a stone treatment instrument is passable to the kidney stone blocker within the renal pelvis” was not found in the written description.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1,2,5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Walish et al. (2019/0167958) in view of Gellman (8007702) and also in view of Muvhar (WO 2010/109467). Walish et al. show (Fig. 1) medical apparatus comprising: a kidney stone blocker 104 configured to (i) remain in a human kidney after deployment (paragraph 29) and (ii) prevent passage of a kidney stone greater than a predetermined size into a ureter while allowing urine to pass to the ureter. In addition it is noted Walish discloses the kidney stone blocker further including a retention mechanism (antimigration feature, see paragraph 29) configured to engage tissue of the kidney to maintain position of the kidney stone blocker within a renal pelvis of the kidney; and an elongated, tubular member 102 and configured to be situated in the ureter. However, Walish et al. did not explicitly state the elongated member is mechanically coupled to the kidney stone blocker. Gellman teaches (Fig. 3A) that a medical apparatus 300 for insertion in the ureter and kidney is formed as an elongated member 310 is mechanically coupled (col. 5, lines 29-31) to the kidney retention member 125. It would have been obvious to one of ordinary skill in the art to use mechanical coupling of the tubular member with the kidney retention member as taught by Gellman and use in the medical apparatus of Walish et al. so that one may provide different material constructions can be coupled together, col. 4, lines 40-55, col. 5, lines 34-57. However, Walish et al. as modified by Gellman did not disclose the kidney stone blocker is a mesh screen. Muvhar teaches (page 7, lines 1-3) that a kidney stone blocking device can alternatively be provided as a mesh. It would have been obvious to one of ordinary skill in the art to alternatively provide a mesh screen as taught by Muvhar in the medical apparatus of Walish et al. as modified by Gellman such that it traps stones, common to mesh structures. The motivation to alternatively use a mesh would be for a more specific diameter stone size to capture. Regarding claim 2, it is noted that Walish discloses (paragraph 24) that the elongated tubular member is configured to simultaneously function as: (i) a delivery conduit through which the kidney stone blocker is deliverable to the renal pelvis in a contracted configuration; and (ii) a working channel through which a stone treatment instrument (wire analogous to an obturator or stylet) is passable to the kidney stone blocker within the renal pelvis. With respect to claim 5, Walish et al. show (Fig. 1) an anchor 106 configured to be retained in a bladder 14. However, Walish et al. did not explicitly state the elongated member is mechanically coupled to the kidney stone blocker. Gellman teaches (Fig. 3A) that a medical apparatus 300 for insertion in the ureter and bladder is formed as an elongated member 310 is mechanically coupled (col. 5, lines 31-33) to the bladder retention member 135. It would have been obvious to one of ordinary skill in the art to use mechanical coupling of the tubular member with the bladder retention member as taught by Gellman and use in the medical apparatus of Walish et al. so that one may provide different material constructions can be coupled together, col. 4, lines 40-55, col. 5, lines 34-57. Regarding claim 6, Walish et al. disclose (paragraph 43) the member is at least one of longitudinally extendable or elastic. With respect to claim 7, it can be construed that the kidney stone blocker of Walish includes at least one stem 126 or hook 124 (end curve of member) configured to engage with the kidney and retain the kidney stone blocker in the kidney. Please not claims are given their broadest reasonable interpretation and since Applicant fails to define the kidney stone blocker or stem as to where it is required, it is reasonable an extension can be defined as a stem or the end curve defines a hook on the kidney stone blocker of Walish. Regarding claim 8, Walish disclose (paragraph 44) the kidney stone blocker is expandable so as to fit through the ureter in a non-expanded form and to be retained in the kidney in an expanded form.
Claim(s) 1,3-8 are rejected under 35 U.S.C. 103 as being unpatentable over Walish et al. (2019/0167958) in view of Gellman (8007702) and also in view of Callaghan et al. (WO 2011/143137). Walish et al. show (Fig. 1) medical apparatus comprising: a kidney stone blocker 104 configured to (i) remain in a human kidney after deployment (paragraph 29) and (ii) prevent passage of a kidney stone greater than a predetermined size into a ureter while allowing urine to pass to the ureter. In addition it is noted Walish discloses the kidney stone blocker further including a retention mechanism (antimigration feature, see paragraph 29) configured to engage tissue of the kidney to maintain position of the kidney stone blocker within a renal pelvis of the kidney; and an elongated, tubular member 102 and configured to be situated in the ureter. However, Walish et al. did not explicitly state the elongated member is mechanically coupled to the kidney stone blocker. Gellman teaches (Fig. 3A) that a medical apparatus 300 for insertion in the ureter and kidney is formed as an elongated member 310 is mechanically coupled (col. 5, lines 29-31) to the kidney retention member 125. It would have been obvious to one of ordinary skill in the art to use mechanical coupling of the tubular member with the kidney retention member as taught by Gellman and use in the medical apparatus of Walish et al. so that one may provide different material constructions can be coupled together, col. 4, lines 40-55, col. 5, lines 34-57. However, Walish et al. as modified by Gellman did not disclose the kidney stone blocker is a mesh screen. Callaghan teaches (Figs. 6A-C) that a stone blocking device can be provided as a mesh 110. It would have been obvious to one of ordinary skill in the art to alternatively provide a mesh screen as taught by Callaghan et al. in the medical apparatus of Walish et al. as modified by Gellman such that it traps stones, common for mesh structures. The motivation to alternatively use a mesh would be for a more specific diameter stone size to capture. With respect to claim 5, Walish et al. show (Fig. 1) an anchor 106 configured to be retained in a bladder 14. However, Walish et al. did not explicitly state the elongated member is mechanically coupled to the kidney stone blocker. Gellman teaches (Fig. 3A) that a medical apparatus 300 for insertion in the ureter and bladder is formed as an elongated member 310 is mechanically coupled (col. 5, lines 31-33) to the bladder retention member 135. It would have been obvious to one of ordinary skill in the art to use mechanical coupling of the tubular member with the bladder retention member as taught by Gellman and use in the medical apparatus of Walish et al. so that one may provide different material constructions can be coupled together, col. 4, lines 40-55, col. 5, lines 34-57. Regarding claim 6, Walish et al. disclose (paragraph 43) the member is at least one of longitudinally extendable or elastic. With respect to claim 7, it can be construed that the kidney stone blocker of Walish includes at least one stem 126 or hook 124 (end curve of member) configured to engage with the kidney and retain the kidney stone blocker in the kidney. Please not claims are given their broadest reasonable interpretation and since Applicant fails to define the kidney stone blocker or stem as to where it is required, it is reasonable an extension can be defined as a stem or the end curve defines a hook on the kidney stone blocker of Walish. Regarding claim 8, Walish disclose (paragraph 44) the kidney stone blocker is expandable so as to fit through the ureter in a non-expanded form and to be retained in the kidney in an expanded form.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Walish et al. (2019/0167958) in view of Gellman (8007702) and Muvhar (WO 2010/109467) as applied to claim 8 above, and further in view of Stifelman et al. (WO 2020/163536). Walish et al. in view of Gellman and Muvhar is explained supra. However, Walish et al. as modified by Gellman and Muvhar did not disclose the kidney stone blocker includes a hydrophilic coating. Stifelman et al. teach (paragraph 9) that a kidney stone blocking device can include a hydrophilic coating. It would have been obvious to one of ordinary skill in the art to provide a hydrophilic coating on the medical device and the kidney stone blocker as taught by Stifelman et al. in the medical apparatus of Walish et al. as modified by Gellman and Muvhar such that it protects the structure, but permits it to be in contact with fluid or urine liquid.
Claim(s) 10,11 are rejected under 35 U.S.C. 103 as being unpatentable over Walish et al. (2019/0167958) in view of Gellman (8007702) and also in view of Muvhar (WO 2010/109467) as applied to claim 1 above, and further in view of Bonutti (2014/0046339). Walish et al. in view of Gellman and also in view of Muvhar is explained supra. However, Walish et al. as modified by Gellman and also in view of Muvhar did not disclose a stone breaking device situated in the member, the stone breaking device configured to break the kidney stone into a plurality of smaller kidney stones. Bonutti teaches (Figs. 13A,B) a tubular member 112 implantable in a patient with a stone breaking device. Bonutti further teaches (paragraph 62) the device can be used in treating a patient to break up kidney stones. It would have been obvious to one of ordinary skill in the art to incorporate the stone breaking device as taught by Bonutti with the apparatus of Walish et al. as modified with Gellman and Muvhar such that it gives the practitioner the ability to break stones as detected, see paragraphs 67,76 obviously for the intended use application. With respect to claim 11, Bonutti further teaches (paragraphs 39,56) the stone breaking device includes at least one of an optical device, an audio device, or a mechanical device.
Claim(s) 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Walish et al. (2019/0167958) in view of Callaghan et al. (WO 2011/143137). Fig. 1 of Walish et al. show a method comprising: providing a stone blocker (104 in giving the broadest reasonable interpretation as Applicant has no special definition) and placed into a kidney through a ureter. Walish et al. disclose (paragraph 37) the stone blocker formed with at least one opening for preventing passage of a kidney stone larger than the at least one opening into the ureter while allowing urine to pass to the ureter, see also paragraphs 38,39. Additionally please note the prior art discloses the ability to block as it has at least one opening that could prevent a large stone from passing therethrough, thus since the claim(s) sets forth no specifics in size of a stone, the blocker element of Walish has the same capability of preventing a large stone just as Applicant’s arbitrary opening or undefined size blocks an undefined stone size. Since Walish et al. is silent as to a “stone blocker” one can consider the retaining element of Walish as a stone blocker in giving the broadest reasonable interpretation and as seen in Fig. 1 it is positioned in the kidney but was not said explicitly of a positioning the stone blocker within a kidney such that the stone blocker remains entirely within the kidney. Callaghan et al. teach (Fig. 6B) placement of a stone blocker 100 entirely within the organ. It would have been obvious to one of ordinary skill in the art to utilize a stone blocker entirely placed in an organ as taught by Callaghan et al. in the method of Walish et al. to prevent a large stone from entering a ureter per the treatment by Walish such that flow is maintained for the patient and no blockage can result. Walish discloses (paragraph 29) structure within the kidney is to be retained, thus per the teaching of Callaghan to keep the blocker entirely in an organ and thus for Walish in the kidney, the kidney stone blocked will be larger than the at least one opening. Regarding claim 13, Walish et al. suggest that materials (paragraph 44) of the kidney stone blocker apparatus would be expanded, by activating an expansion mechanism (retaining mechanism see Figs. 6-8), the stone blocker after positioning the stone blocker within the kidney. Regarding claim 14, Walish et al. did not disclose the expansion mechanism includes at least one of a balloon. Callaghan et al. teach (paragraph 182) that a balloon is used as an expansion mechanism to expand medical apparatus within urinary vessels. It would have been obvious to one of ordinary skill in the art to alternatively use a balloon as the expansion mechanism as taught by Callaghan et al. in the method of Walish et al. such that the practitioner has more control of release or deployment of stone blocking elements as opposed to use of self-expanding materials.
Claim(s) 15,16 are rejected under 35 U.S.C. 103 as being unpatentable over Walish et al. (2019/0167958) in view of Callaghan et al. (WO 2011/143137) as applied to claim 12 above, and further in view of Harrah et al. (2017/0215964). Walish et al. in view of Callaghan et al. is explained supra. However, Walish et al. as modified by Callaghan et al. did not disclose the method involve detecting whether the kidney stone is present; and responsive to detecting the kidney stone is present, breaking up the kidney stone into smaller kidney stones or transmitting an indication to a communication device that the kidney stone is present. It is noted Callaghan mentioned imaging apparatus could be used in implantation and thus one can detect stones. It is noted that Walish et al. (paragraphs 24-27) disclose the apparatus includes a lumen in the kidney stone blocker to allow instrumentation to pass and can be any suitable size. Harrah et al. teach a tube 107 placed into the kidney 408. Harrah et al. further teach (paragraph 44) that a stone detection device 124 is used within the tube, see Fig. 5. It would have
been obvious to one of ordinary skill in the art to utilize a stone detection device as taught by Harrah et al. with the apparatus of Walish et al. such that the practitioner is able to know if stones need to be broken up. Further Harrah did teach apparatus to break up stones, paragraph 45. Thus it would have been obvious to one of ordinary skill in the art to use the apparatus to break stones as taught by Harrah in the method of Walish as modified with Callaghan and reduce the stone size and improve urine flow by detecting stones and breaking any when found.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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