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 . 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 (i.e., changing from AIA to pre-AIA ) 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 6 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. While originally filed claims are presumed to have support in the written description, they do not inherently have support, and in this case since the specification is absolutely silent about both pressure and temperature being used to determine an inflation state, claim 6 has no support in the written description. Temperature is discussed in four paragraphs: [0063] and [0078]-[0080]. These paragraphs note that temperature sensors may be used within the cryoballoon ([0063]), and that temperature can be used as part of the graphical representation of the balloon ([0078]) such as by color-coding the balloon ([0079]). That the system is capable of generating a depiction of the cryoballoon based on its inflation state is only discussed in [0078] but that paragraph expressly discloses that pressure, without any mention of temperature, is used to determine the inflation state.
Claim 6 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Applicant’s specification is absolutely silent about the use of both pressure and temperature to determine inflation state and it is not clear how such a function could occur. While the level of ordinary skill in the art is very high, Applicant has provided no direction whatsoever, including no working examples, as to how temperature could be correlated to inflation state in conjunction with pressure. In fact, Applicant states that inflation state can be determined based on pressure in conjunction with stored mechanical properties of the balloon ([0078]) such that it is not clear why temperature is even brought in to the equation, much less how. In fact, Applicant explicitly distinguishes between state of inflation and internal temperature ([0078]) such that the specification makes no connection whatsoever between pressure and temperature together and inflation state.
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.
Claim 4 is 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.
Regarding claim 4, the claim recites that the stored property is the compliance of the cryoballon. However, claim 4 depends from claim 3 which recites that the stored property includes diameter vs. pressure information. Compliance includes by definition the relationship between diameter and pressure such that, if claim 4 limits claim 3 as it must, it is not clear what compliance means in claim 4 if not a diameter vs. pressure relationship (e.g. what are the units of “compliance” that would exclude a diameter/pressure relationship?). This may be an issue under 35 U.S.C 112(d) for a dependent claim failing to further limit a claim from which it depends.
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.
Claims 1, 2, 7, 11, 12, 14-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wittenberger (US 2016/0015444) in view of Krimsky (US 2018/0256263), Wenderow (US 2011/0238082), Jacobsen (US 2016/0287342) and Lalonde (US 20190336192).
Regarding claims 1, 2, 7, 11, 12, 14-18 and 20, Wittenberger discloses what can be considered a generic cryosurgical system/method including a handle (40, figs. 1-4), tubular shaft (18), guidewire lumen ([0022]) and cryoballoon (24). The system further includes two auxiliary devices: an introducer (86) and a mapping catheter (46). Wittenberger does not disclose any sort of position sensing. However, position sensing and the structure associated with that function are very common in the art and Applicant has not disclosed that the use of such common elements is critical or produces unexpected results. Krimsky discloses a cardiac ablation system that uses an auxiliary device/introducer sheath (96, figs. 3-4) with a location sensor (94) for determining the location of the sensor response to a localization field ([0040], see also [0061] for display) which allows a user-accessible relative position indicator (122) on a slidable ablation device to provide an indication of the relative position of the ablation device and the location sensor. Further, Krimsky discloses that the indicator can include fiducial markers ([0044]) and that a mechanical locking element can be used to fix the position of the ablation device relative to the auxiliary device ([0048]). The location sensor is positioned within an electromagnetic field, generated by a localization field generator (76), which is understood to be both an electric field and a magnetic field ([0046]). Krimsky further discloses that the localization field generator is part of an electroanatomical mapping system that further includes a navigation and mapping controller that receives location information from the location sensor to generate a graphical representation of the ablation device on a 3D rendering of an anatomical chamber based on the relationship between the sensor and indicators ([0061] and [0068]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to provide the system of Wittenberger with the structures and steps taught by Krimsky, such as the location sensor on an auxiliary device, fiducial indicator, location field generator and navigation and mapping controller that would allow the creation of a 3D map of the cardiac chamber, the auxiliary device and the ablation element (which would be the cryoballoon), to produce the predictable result of allowing a user to visualize the procedure for increased safety and efficacy. It would also have been obvious to modify the device of Wittenberger with the mechanical locking element of Krimsky to ensure that the various elements can be fixed in a desired position. Wittenberger as modified does not disclose the cryoballoon has a pressure sensor which is used by the navigation and mapping controller to generate a graphical representation of the cryoballoon based on the pressure in addition to the location. However, the prior art is familiar with the idea that the size of a balloon in the body is information relevant to the safe and/or effective treatment of tissue. Wenderow, for example, discloses an electrophsiological system (fig. 5) and teaches that pressure measured in a balloon can be used to determine and display the size of the balloon in the body ([0059]) where the balloon can be displayed along with the size of the balloon ([0075]). Wenderow specifically notes that for compliant balloons there is a relationship between the pressure and the inflation state of a balloon ([0059], which is understood to be a function of “compliance”), which would only be knowable based on the properties of the specific cryoballoon which also would only be knowable by the system if those properties were “stored” in some manner (see Conclusion below for additional examples of balloon parameters stored for determining diameter based on pressure). It is not immediately clear from Wenderow whether the displayed balloon itself is a function of the inflation state, although that would be within the level of ordinary skill in the art. In the interest of compact prosecution, it is noted that the prior art is also familiar with displaying a balloon both according to its location and inflation state, such as taught by Jacobsen ([0068]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of Wittenberger to include a compliant balloon with information about the balloon stored so that a pressure sensor in the balloon can be used to determine the pressure in the balloon which can then be used to determine the size of the balloon, such as taught by Wenderow, so that the balloon can be displayed both as a function of its location and inflation state, such as taught by Jacobsen using the navigation and mapping controller, to produce the predictable result of allowing a user to know the size of the balloon at least by looking at the balloon on the display. Wittenberger as modified does not specifically state that the pressure sensor is within the balloon. However, placing pressure sensors within the balloon for determining the inflation state of the balloon is common in the art, such as taught by Lalonde (70, fig. 1, [0076], note also the relationship between pressure and diameter in conformable balloons shown in fig. 8). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of Wittenberger to place the pressure sensor anywhere it would measure the pressure within the balloon, including inside the balloon as taught by Lalonde, that would produce the predictable result of providing balloon pressure to the navigation and mapping controller.
Claims 3, 4 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Wittenberger, Krimsky, Wenderow, Jacobsen and Lalonde, further in view of Gerrans (US 2016/0067465).
Regarding claims 3 and 4, the system of Wittenberger as modified does not explicitly disclose the use of balloon diameter vs. pressure information (another term for compliance) as the stored properties which allows the inflation state of the balloon to be correlated to the pressure. However, balloon lookup tables that allow pressure to be correlated to diameter are commonly used in the art such as taught by Gerrans ([0091]). Therefore, before the application was filed, it would have been obvious to further modify the system of Wittenberger to employ any commonly known relationship between physical balloon dimensions and pressure, including diameter vs. pressure as taught by Gerrans, to produce the predictable result of allowing the system to generate a display of the balloon to allow a user to know the size/diameter of the balloon at least by looking at the balloon on the display
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Wittenberger, Krimsky, Wenderow, Jacobsen, Lalonde and Gerrans, further in view of Harvey-Poncelet (US 2011/0092967).
Regarding claims 5 and 6, the system of Wittenberger does not specifically disclose a temperature sensor for sensing the temperature inside the balloon, where that temperature information is used as part of the inflation-state determination. However, generally speaking, the prior art recognizes that temperature is a useful control parameter related to flow rate of a coolant which itself is related to an inflation state. Harvey-Poncelet, for example, discloses a cryosurgical balloon which uses an internal temperature sensor ([0056]) to control flow rate and thus temperature and “inflation state” ([0055]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of Wittenberger to include a temperature sensor inside the balloon for controlling the flow rate and degree of inflation, such as taught by Harvey-Poncelet, and further to employ the that information in conjunction with the pressure information used to display inflation state in the system of Wittenberger as modified to produce the predictable result of allowing a user to know the size of the balloon at least by looking at the balloon on the display while controlling the flow rate and temperature in the cryoballoon.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Wittenberger, Krimsky, Wenderow, Jacobsen and Lalonde, further in view of Kottenstette (US 2018/0185099).
Regarding claim 8-10, the system of Wittenberger does not disclose that the fiducial markers are on the auxiliary device where the catheter handle includes optical/electrotechnical sensor for determining the position of the markers. However, the principles disclosed by Krimsky are that a first element can be accurately depicted on a display based on the position of the first element relative to a second element and the position of the second element in the body. The system of Wittenberger-Krimsky is functional as long as those principles are maintained and there is no evidence that the exact manner disclosed by Krimsky of proving the relative position and what might be called the absolute position is of central importance. Using fiducial markers in a handle for determining the relative relationship between two elements is fairly common in the art and Applicant has not disclosed this method of determining the relative relationship between two elements is critical or produces unexpected results. The fact that Applicant has disclosed several mutually exclusive ways to acquire this information suggests the opposite, that it is not of central importance how the information is acquired. Kottenstette, for example, discloses a catheter which uses a fiducial sensor in a handle (340, fig. 14) to determine the relative position of an element with fiducial markers that passes through the handle (fig. 18) for the purpose of determining the distance traveled by the element relative to the sensor and thus the handle ([0059]). Kottenstette is used because of the extensive details about the relative movement system but the art is replete with similar systems that may be closer in function and additional structure to the claimed invention while having less details about the relative information collection elements (see the Conclusion below for examples). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to provide the system of Wittenberger-Krimsky with any commonly known mechanism of collecting the relative position of the cryoballoon to an auxiliary device, including markers on an auxiliary device and an optical sensor in a handle as taught by Kottenstette, to produce the predictable result of allowing a user to visualize the location of the cryoballoon relative to the auxiliary device. It is noted that this modification is understood to be equally applicable to both auxiliary devices disclosed by Wittenberger (i.e. the introducer and the mapping catheter).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Wittenberger, Krimsky, Wenderow, Jacobsen and Lalonde, further in view of Leo (US 2018/0214215).
Regarding claim 13, the auxiliary device of the system of Wittenberger-Krimsky is an introducer sheath as disclosed by Krimsky. However, there is no evidence that it makes a meaningful difference which auxiliary device has the location sensor. The fact that Applicant has claimed two mutually exclusive locations for the location sensor suggests the opposite, that it is not of central importance. Wittenberger discloses an auxiliary device which is a mapping catheter, and providing mapping catheters with location sensors is common in the art. Leo teaches that guidewires, catheters and introducers can all be provided with location sensors ([0003]) which is understood to be a teaching both of the functional equivalence of these various locations for position sensing and a that putting position sensors on medical devices is well within the level of
ordinary skill in the art. Therefore, before the application was filed, it would have been obvious to provide any one or all of the internally located devices of the system of Wittenberger-Krimsky with position sensors, as taught by Leo, that would produce the predictable result of allowing the system to know the position of those elements.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding the use of a lookup table with information about a balloon that allows pressure to be correlated to various parameters including balloon size, see paragraph [0053] of US 2012/0289982 to Gunday. Regarding another system that displays the size and location of a balloon, see paragraphs [0074] and [0092] of US 2018/0344202 to Bar-Tal. Regarding a related system that uses colors overlayed on a balloon to communicate pressure, see the discussion associated with figure 6 of US 2018/0360545 to Cole. Regarding a system with stored information about the relationship between pressure and diameter (although for the purpose of setting a diameter with pressure accounting for hysteresis), see the discussion associated with figures 3A-B of US 2019/0336193 to Harper.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794
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