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 7-8 and 13-14 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 7 recites the limitation "the pressure regulator" in line 1. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination claim 7 is being interpreted as being dependent on claim 6.
Claim 8 recites the limitation "the pressure regulator" in line 1. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination claim 7 is being interpreted as being dependent on claim 6.
Claim 13 recites the limitations “the bore”, “the guide pot” and “the handle” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination claim 13 is being interpreted as being dependent on claim 12.
Claim 14 recites the limitation "the guide catheter" in line 1. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination claim 14 is being interpreted as being dependent on claim 13.
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) 1-5, 10-15, 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jenkins et al. (US 20170056632 hereinafter "Jenkins").
Regarding Claim 1, Jenkins teaches (fig 12a-12b) A catheter system comprising:
a balloon dilation catheter (114) having a proximal end portion(left side of Fig 12a) and a distal end portion (right side of Fig 12a), the balloon dilation catheter comprising:
(i) an elongate shaft (166) having a dilation balloon lumen (178), the dilation balloon lumen being configured to couple with a first fluid supply (see [0063]),
(ii) an expandable dilation balloon (170) coupled to the elongate shaft and fluidly connected to the dilation balloon lumen (178), the expandable dilation balloon being configured to transition between an inflated state and a non-inflated state (see [0058] teaching that 170 is inflated and deflated; as such it is implied there is a transition between inflated and non-inflated state), and
(iii) an expandable stop element (172) coupled to the elongate shaft (166), the expandable stop element being distal to the expandable dilation balloon (See Figs 12a-12b), the expandable stop element (172) being configured to selectively transition among a range of expanded states including a non-expanded state (Fig 12a), a first expanded state (any state between Fig 12a and Fig 12b), and a second expanded state (fig 12b), the expandable stop element (172) defining an outer diameter such that the outer diameter defines a minimum diameter when the expandable stop element is in the non-expanded state (fig 12a is considered minimum diameter) and a maximum diameter when the expandable stop element is in the second expanded state (Fig 12b is considered maximum diameter).
Regarding Claim 2, Jenkins teaches the catheter system of claim 1, the expandable stop element being sized to fit within a Eustachian tube of a pediatric patient and configured to prevent translation beyond an isthmus of an adult patient when the outer diameter is greater than the minimum diameter (See [0058] teaching " In the deflated state, tip balloon (172) is sized to pass through a sinus ostium. In the inflated state, tip balloon (172) forms a bulbous stop element that is sized to arrest movement of balloon dilation catheter (114) at the isthmus (29) of a Eustachian tube (26).").
Regarding Claim 3, Jenkins teaches the catheter system of claim 1, the expandable stop element (172) being inflatable (See [0058] and Dis 12a-12b), the elongate shaft further including a stop element lumen (179) in fluid communication with the expandable stop element (172; see [0063]).
Regarding Claim 4, Jenkins teaches the catheter system of claim 1, the stop element lumen being configured to couple with a second fluid supply (See [0095] teaching a second fluid supply for 172).
Regarding Claim 5, Jenkins teaches the catheter system of claim 1, the stop element lumen being configured to couple with the first fluid supply (see [0079] teaching both 178 and 179 are connected to fluid supply 188).
Regarding Claim 10, Jenkins teaches the catheter system of claim 1, the minimum diameter being less than or equal to an outer diameter of the elongate shaft (See [0080] "The tip balloon (172) in the contracted state defines a contracted outer diameter generally equivalent to the outer shaft outer diameter").
Regarding Claim 11, Jenkins teaches the catheter system of claim 1, the elongate shaft (114) distally terminating at the expandable stop element (172) such that the expandable stop element forms a distal tip of the elongate shaft (Se Figs 12-12B).
Regarding Claim 12, Jenkins teaches the catheter system of claim 1, further comprising: a handle (116) configured to be gripped by an operator, the handle comprising: (i) a guide port (152) having a bore (190), the bore being configured to receive a proximal end portion of the balloon dilation catheter (114) such that the balloon dilation catheter distally projects from the handle (See fig 11A, 114 is extending distally from 116), and (ii) a balloon catheter movement actuator configured to translate the balloon dilation catheter longitudinally relative to the handle (See [0089] teaching movement due to an actuator).
Regarding Claim 13, Jenkins teaches the catheter system of claim 12 (see 112 rejection above), further comprising: a guide catheter (112) received within the bore (190) of the guide port (152) such that the guide catheter (112) distally projects from the handle (116; see fig 11a), the guide catheter being configured to slidably receive the balloon dilation catheter (see [0077-0078] and Fig 11a).
Regarding Claim 14, Jenkins teaches the catheter system of claim 13 (see 112 rejection above), the guide catheter (112) being configured to engage a second fluid supply assembly (188) and thereby direct fluid into the expandable stop element lumen (172; see [0078-0079]) to thereby inflate the expandable stop element (172) to thereby increase the outer diameter to be greater than the minimum diameter (see fig 12a-12b).
Regarding Claim 15, Jenkins teaches the catheter system of claim 1, the expandable stop element (172) being resiliently biased toward the non-expanded state (Fig 12a; See [0081]).
Regarding Claim 18, Jenkins teaches (Figs 11a-12b) A balloon dilation catheter (114) comprising:
(a) an elongate shaft (166);
(b) an expandable dilation balloon (170) coupled to the elongate shaft (166) and in fluid communication with a first fluid supply (178), the expandable dilation balloon being configured to transition between an inflated state and a non-inflated state, the inflated state being configured to dilate a Eustachian tube (see [0058] teaching that 170 is inflated and deflated; as such it is implied there is an inflated and non-inflated state); and
(c) an expandable stop element (172) coupled to the elongate shaft (166) and in fluid communication with a second fluid supply (179), the expandable stop element (172) being distal to the expandable dilation balloon (170; see Figs 12a-12b), the expandable stop element being configured to selectively transition among a range of expanded states including a non-expanded state (fig 12a), a first expanded state (state between Fig 12a and 12b), and a second expanded state (Fig 12b) through use of the second fluid supply (see [0058] and [0063]).
Regarding Claim 19, Jenkins teaches a method of using a balloon dilation catheter (114) sized to dilate a Eustachian tube (26), the balloon dilation catheter (114) including an expandable dilation balloon (170) and an expandable stop element (172) that is distal to the expandable dilation balloon (170;see Fig 12a-12b), the expandable stop element (172) being configured to selectively transition among a range of expanded states including a non-expanded state (Fig 12a), a first expanded state (expanded state of 172 between Fig 12a and Fig 12b), and a second expanded state (Fig 12b), the first expanded state including a first diameter that is smaller than a second diameter of the second expanded state and to prevent advancement of the balloon dilation catheter beyond an isthmus of a Eustachian tube (See [0058]), the method comprising:
(i) selectively transitioning the expandable stop element from the non-expanded state to the first expanded state (See [0058]).
Regarding Claim 20, Jenkins teaches the method of claim 19, further comprising: (i) gauging a size of the Eustachian tube, and (ii) selecting the first expanded state based on the gauged size of the Eustachian tube (See [0058] teaching how the 172 is expanded based on size of eustachian tube 26).
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) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jenkins (US 20170056632) in view of Gerrans et al. (US 20120259217 hereinafter “Gerrans”).
Regarding Claim 6, Jenkins teaches all elements of claim 1 as described above. Jenkins does not specify the stop element lumen including a pressure regulator configured to limit a fluid pressure at the expandable stop element.
Gerrans teaches ([0104-0105]) a pressure regulator (242, 243 and 244) used to indicate the amount of gas flow to the balloon, and limit fluid pressure (See [0104] teaching the processor keeps pressure constant).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter system of Jenkins such that the stop element lumen includes a pressure regulator configured to limit a fluid pressure at the expandable stop element as taught by Gerrans. One of ordinary skill in the art would have been motivated to do so in order to achieve the appropriate balloon size by keeping the fluid/gas pressure constant (see Gerrans [0104-0105]).
Regarding Claim 7, the combination of Jenkins and Gerrans teaches the catheter system of claim 6 (see 112 rejection above), the pressure regulator (gerrans 242, 243 and 244) including an indicia configured to indicate a maximum fluid pressure at the expandable stop element (See Gerrans [0104-0105] teaching how the pressure regulators send signals and that the processors track the pressure and flow).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jenkins and Gerrans as applied to claim 6 above, and further in view of O’Beirne et al. (US 20120271339 hereinafter “O’Beirne”).
Regarding Claim 8, the combination of Jenkins and Gerrans teaches all elements of claim 6 (see 112 rejection above) as described above. The combination does not specify the pressure regulator including an indicia configured to indicate the outer diameter of the expandable stop element.
O’Beirne teaches [0021] a strain gauge used to indicate pressure measurements with the balloon diameters.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure regulator of the modified Jenkins such that it includes indicia configured to indicate the outer diameter of the expandable stop element as taught by O’Beirne. One of ordinary skill in the art would have been motivated to do so in order to better correlate the pressure to the balloon size and prevent bursting of the balloon due to high pressure/size.
Claim(s) 9 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jenkins (US 20170056632) in view of Muni et al. (US 20060106361 hereinafter "Muni").
Regarding Claim 9, Jenkins teaches all elements of claim 1 as described above. Jenkins does not specify the catheter system the stop element lumen including a check valve configured to prevent fluid flow from the expandable stop.
Muni teaches a catheter system wherein the stop element lumen including a check valve configured to prevent fluid flow from the expandable stop (see [0132] teaching "Outer lumen 258 and inner lumen 256 may be provided with valves, plugging mechanisms, etc. disclosed elsewhere in this patent application to prevent the leakage of the fluid substance from the proximal ends of outer lumen 258 and inner lumen 256." and [0095] teaching " a check valve may be posititioned within that substance introducing lumen and/or within the reservoir to prevent backflow out of that substance introducing lumen."; since 256 is the lumen associated with the expandable stop 264; it is interpreted that the stop element lumen includes a check valve)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stop element lumen of Jenkins such that it includes a check valve as taught by Muni. One of ordinary skill in the art would have been motivated to do so in order t prevent backflow of the substance into the lumen (see Muni [0095]).
Regarding Claim 17, Jenkins teaches all elements of claim 1 as described above. Jenkins does not specify the catheter system further including a valve in fluid communication with the expandable stop element, the valve being configured to selectively change the outer diameter.
Muni teaches a catheter system wherein the stop element lumen including a check valve configured to prevent fluid flow from the expandable stop (see [0132] teaching "Outer lumen 258 and inner lumen 256 may be provided with valves, plugging mechanisms, etc. disclosed elsewhere in this patent application to prevent the leakage of the fluid substance from the proximal ends of outer lumen 258 and inner lumen 256." and [0095] teaching " a check valve may be posititioned within that substance introducing lumen and/or within the reservoir to prevent backflow out of that substance introducing lumen."; since 256 is the lumen associated with the expandable stop 264; it is interpreted that the stop element lumen includes a check valve, also it is interpreted that a check valve would determine size of the balloon based on direction of the valve allowing or preventing fluid from entering the balloon)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stop element lumen of Jenkins such that it includes a check valve as taught by Muni. One of ordinary skill in the art would have been motivated to do so in order t prevent backflow of the substance into the lumen (see Muni [0095]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jenkins (US 20170056632) in view of Webler et al. (US 20070142818 hereinafter “Webler”).
Regarding Claim 16, Jenkins teaches all elements of claim 1 as described above. Jenkins does not specify the catheter system further including a distal tip gauge configured indicate the outer diameter to an operator.
Webler teaches [0251-0253] a gauge and indicator used to notify the operator the diameter o the balloon of the device.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter system of Jenkins such that it includes a distal tip gauge configured indicate the outer diameter to an operator as taught by Webler. One of ordinary skill in the art would have been motivated to do so in order to ensure the operator may control the inflation of the balloon with controlled pressure/volume (Webler [0212-0253]) and prevent the balloon from bursting.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cornhill et al. (US 20150150436) teaches a catheter with multiple balloons and a check valve.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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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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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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