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 12-16 are 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 12 recites the limitation "the openings" in line 4 of the claim. In line 3 of the claim the use of open ended language of “at least one opening” is used. Thus, there can be one opening, but is the next recitation of a plural amount the same feature? One cannot have it both ways of two variations in a claim. There is insufficient antecedent basis for this limitation in the claim. Further in claim 12, it is not understood if the stone blocker is to be present in the ureter or not because the claim recites it is placed in the ureter, but then the claim recites in line 6, the stone blocker is positioned in the kidney. Is the method just meaning to pass the stone blocker through the ureter and into the kidney? Or is there part of the stone blocker device remaining in the ureter and part in the kidney? Clarification is required. Dependent claims are indefinite and fail to further limit the indefinite independent claim.
Claim Rejections - 35 USC § 102
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) 12-14 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Walish et al. (2019/0167958) or, in the alternative, under 35 U.S.C. 103 as obvious over Callaghan et al. (WO 2011/143137).
Fig. 1 shows a method of providing a stone blocker 100 into a ureter 10. Figs. 6-8 show the stone blocker formed with at least one opening 109 for preventing passage of a kidney stone larger than the openings into the ureter while allowing urine to pass to the ureter (paragraph 37). It can also be seen in the method (Fig. 1) positioning the stone blocker section 104 within a kidney; and maintaining the stone blocker within the kidney to retain (paragraph 29) in the kidney, the kidney stone larger than the at least one opening. However, Walish et al. did not explicitly state the openings are preventing a stone from passing therethrough. Callaghan et al. teach (paragraphs 16,17,97) a filtering or mesh structure on kidney treatment device is provided with openings smaller than a stone or alternatively the stone is larger than a mesh opening. It would have been obvious to one of ordinary skill in the art to provide a filtering device with a size less than stone dimension as taught by Callaghan et al. in the method of Walish et al. so that it assures the stones do not enter the ureter. 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 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) 1,5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Walish et al. (2019/0167958) in view of Gellman (8007702). 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; and an elongated, tubular member 102 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. 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) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Walish et al. (2019/0167958) in view of Gellman (8007702) as applied to claim 1 above, and further in view of Muvhar (WO 2010/109467). Walish et al. in view of Gellman is explained supra. 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.
Claim(s) 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Walish et al. (2019/0167958) in view of Gellman (8007702) as applied to claim 1 above, and further in view of Callaghan et (WO 2011/143137). Walish et al. in view of Gellman is explained supra. However, Walish et al. as modified by Gellman did not disclose the kidney stone blocker is a mesh screen and further multiple mesh screens. Callaghan et al. teach (figs. 6A-6C) that a kidney stone blocking device can alternatively 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 to mesh structures. The motivation to alternatively use a mesh would be for a more specific diameter stone size to capture. With respect to claim 3, Callaghan et al. teach (paragraph 121) different size or dimensions could be used in a plurality of filters or mesh used. With respect to claim 4, Callaghan et al. also teach spacing multiple mesh apart thus one would be situated further from a ureter as it would be situated further in the kidney per the modification of using a mesh alternatively for the stone blocker of Walish.
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) as applied to claim 8 above, and further in view of Stifelman et al. (WO 2020/163536). Walish et al. in view of Gellman is explained supra. However, Walish et al. as modified by Gellman 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 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) as applied to claim 1 above, and further in view of Bonutti (2014/0046339). Walish et al. in view of Gellman is explained supra. However, Walish et al. as modified by Gellman 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 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) 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.
Claim(s) 17,20 are rejected under 35 U.S.C. 103 as being unpatentable over Walish et al. (2019/0167958) in view of Harrah et al. (2017/0215964). Walish et al. disclose (Fig. 1) a kidney stone blocker 100 configured to (i) remain in a kidney (part 104) after deployment and (ii) prevent passage of the kidney stone into a ureter while allowing urine to pass to the ureter, paragraphs 70,75. However, Walish et al. did not disclose a kidney stone detection device configured to determine whether a kidney stone is present in a kidney of a patient. 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. Regarding claim 20, Walish et al. 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) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Walish et al. (2019/0167958) in view of Harrah et al. (2017/0215964) as applied to claim 17 above, and further in view of Bonutti (2014/0046339). Walish et al. in view of Harrah et al. is explained supra. However, Walish et al. as modified by Harrah et al. did not disclose the kidney stone detection device produces at least one of sound waves or light to determine whether a kidney stone is present in a kidney of a patient. Bonutti teaches (paragraph 111) detection devices that produce at least one of sound waves or light to determine a condition or diagnostic condition can be used in implantation. 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 a stone detecting device that produce at least one of sound waves or light to determine if stones are present as taught by Bonutti with the apparatus of Walish et al. as modified with Harrah et al. such that it gives the practitioner the ability to break stones as detected, see paragraphs 67,76 obviously for the intended use application.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Walish et al. (2019/0167958) in view of Harrah et al. (2017/0215964) as applied to claim 17 above, and further in view of Gellman (8007702). Walish et al. in view of Harrah et al. is explained supra. Walish shows (Fig. 1) an elongated, tubular member 102 configured to be situated in the ureter. However, Walish et al. as modified by Harrah et al. did not disclose the elongated, tubular 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. in view of Harrah et al. so that one may provide different material constructions can be coupled together, col. 4, lines 40-55, col. 5, lines 34-57.
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