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 § 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 14-16, 18-20, 23, 26-29 and 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Kurtulus (US 2009/0182324) in view of Schuler (US 2017/0189106) and Woloszko (US 2005/0251134).
Regarding claims 14-16, 18-20, 23, 26-29 and 31-33, Kurtulus discloses a tissue cutting catheter system including an elongate catheter body/outer tubular sheath (51, fig. 5) and a loop/hoop cutting element including a continuous shape-memory wire segment (54 including 55, [0002], note “single conductor” in [0047]) connected to an elongated control member (52). Kurtulus further disclose the use of insulation covering the wire except for the tissue treating portion (54, [0047], see also [0037]). Kurtulus does not disclose which shape memory metal is used, or that non-shape memory material is applied in the form of a sleeve/tube over the shape memory metal to form an electrode. However, using various materials to make electrodes, and constructing electrodes in various manners, is common in the art and there is no evidence that providing a shape-memory wire segment with a non-shape memory metal coating produces an unexpected result (within the meaning of MPEP 716.02(a)). Schuler discloses a medical device with electrodes (1504, fig. 15A-C, see [0122] regarding the fact that electrodes can be used for sensing and/or ablation), where the electrodes are made by covering/electrically connecting a nitinol wire (153, [0165]) with a stainless-steel sleeve/tube/cylindrical/curved electrode ([0173]) radially larger than the wire (fig. 15A-C). Note that “nitinol” is an art-recognized term for nickel-titanium alloy, and that Schuler also discloses the wire is electrically insulated except for where the stainless-steel electrodes are located ([0173]). It has been held that the simple substation of one known element for another is an obvious modification (MPEP 2141(III)), where in this case the element is how an electrode is created in a medical system. Additionally or alternatively, it has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)). Where in this case the known element is the use of stainless steel over nitinol for electrode construction. Therefore, before the application was filed, it would have been obvious to modify the system of Kurtulus to any commonly known electrode structure, including an uninsulated electrode formed by a stainless-steel sleeve over a nitinol wire that is otherwise insulated, such as taught by Schuler, that would produce the predictable result of allowing a user to interact with tissue using the system in a desired manner. Kurtulus does not disclose a particular type of generator is used to apply RF to tissue which suggests the details of the generator are a matter for a person of ordinary skill in the art to determine. However, generators that output electrical parameters “configured to” generate sparks/plasma are common in the art, including generators that output particular power/frequency values. This includes the power values Applicant associates with sparks/plasma in the single place in the Application where sparks/plasma are discussed, 5-1600 watts ([00469] of the application as filed). Therefore, instead of this limitation being indefinite, the limitation is interpreted to be directed to that power range and/or the frequency range recited in claim 33. Woloszko discloses a similar resection device and teaches that the generator can output power in the range of milliwatts to hundreds of watts ([0090]) and frequencies in the range of 5kHz to 20 MHz ([0151]). 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 Kurtulus to use a generator configured to output any parameters commonly known to be associated with tissue treatment, including configured to output power and frequency in the ranges disclosed by Woloszko, that would produce the predictable result of allowing an operator the choice of how to treat tissue using the system. This modification the system thus includes a generator “configured to” supply energy that would generate sparks/plasma. The claims include substantial language directed to how the cutting loop functions, including “sized to fit within a heart,” “pass around a heart valve therapy device” and “reduce damage to the… wire.” While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim. First, the cutting loop as described by Kurtulus can fit within a heart, either by defining the loop to be less than the entire wire when extended, or because the cutting loop when fully extended in an enclosed space will fold in on itself. Second, the cutting loop can pass around any hypothetical heart valve therapy device which is neither positively recited nor described in any detail. Third, because the claims do not define the specific features which would reduce damage to the wire, the claims are being interpreted broadly to mean that the use of a tube/sleeve itself necessarily produces the result. The alternative is a rejection under 35 U.S.C. 112(b) because it is not clear what other structural elements/features would produce this result, and potentially under 35 U.S.C. 112(a) if the specification is not clear about what specific characteristics of the tube/sleeve produce this result. See the Response to Arguments below for additional discussion.
Claims 21 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Kurtulus, Schuler and Woloszko, further in view of Woloszko (US 2011/0288539), hereinafter Woloszko2.
Regarding claims 21 and 30, Kurtulus does not disclose any dimensions for the electrode, presumably because a person of ordinary skill in the art would be able to choose appropriate dimensions. Further, there is no evidence that the claimed surface area produces an unexpected result (within the meaning of MPEP 716.02(a)). Electrodes with the claimed surface area are known in the art (e.g. 0.005 square inches such as taught by Woloszko2, [0073]). Further, duplication of parts has been held to be an obvious modification (MPEP 2144.04(VI)(B)). Therefore, before the application was filed, it would have been obvious to further modify the system of Kurtulus to include an electrode having any commonly known surface area, including 0.005 square inches such as taught by Woloszko2, and further to modify the system of Kurtulus to have any number of electrodes with that surface area, that would produce the predictable result of allowing a user to treat a specific region of tissue in a desired manner using the electrodes.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Kurtulus, Schuler and Woloszko, further in view of Bonyak (US 11,006,902).
Regarding claim 22, the system of Kurtulus does not disclose a plurality of independently activatable electrodes (and thus the various elements that make such control possible). However, using a plurality of independently controllable ablation electrodes, controllable from an interface (and therefore including the generator, processor and software to translate the user’s intent into system behavior) is very common in the art. Bonyak, for example, discloses a medical system with a plurality of electrodes individually controllable by a user interface, generator, processor and software (fig. 1, col. 4 lines 44-60, see also discussion associated with fig. 3). Further, it has been held that making elements adjustable is an obvious modification (MPEP 2144.04(V)(D)), where in this case “adjustable” includes adjusting which electrodes apply which energy parameters to tissue. 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 Kurtulus to include a plurality of individually controllable electrodes (and associated structures), such as taught by Bonyak, that would produce the predictable result of allowing a user fine control over which electrodes are employed according to any circumstances, including mere preference, according to which a user performs a medical procedure.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Kurtulus, Schuler and Woloszko, further in view of Laufer (US 2013/0041373).
Regarding claim 24, the system of Kurtulus does not disclose a snare loop connected to an inner control member and a sheath which has two openings for holding parts of the snare loop such that the snare loop cannot be completely pulled into the lumen of the sheath. However, using snare loops connected to control members is very common in the art, and using a tube with split lumens is also very common in the art (see e.g. fig. 2 of Kurtulus). Further, it is noted that the elements of claim 24 have no claimed relationship to any other part of the system. Laufer, for example, discloses a snare loop (fig. 1A) connected to an inner control member (not shown, the element that allows the loop to be extended and retracted, figs. 1A-B) within a lumen of a sheath (2), where the sheath includes first and second openings (9, 10) that allow the snare loop to be retracted, but not entirely (fig. 1B). All parts of any system are connected to all the other parts, including the various parts of Laufer. It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)). 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 Kurtulus to include the lumen, sheath, inner control member, snare loop and lumen openings, such as taught by Laufer, that would produce the predictable result of allowing a user to interact with tissue using the snare loop in a desired manner.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Kurtulus, Schuler, and Laufer, further in view of Landry (US 2020/0315649) and Uchida (US 2002/0188291).
Regarding claim 25, the system of Kurtulus as discussed above does not disclose that the snare loop has the claimed dimensions of an “unconstrained expanded diameter” where it is noted that this phrase is being interpreted broadly to mean working diameter rather than indefinite for failing to clearly articulate the amount of force that may or may not be experienced by the loop to define the difference between “constrained” and “unconstrained.” Laufer, cited for the snare loop, does not disclose any dimensions for these elements at all, suggesting that a person of ordinary skill in the art would be able to choose appropriate values. Nitinol loops, and loops with the claimed dimensions, are common in the art and there is no evidence these common elements produce an unexpected result (within the meaning of MPEP 716.02(a)). Landry discloses a nitinol loop with a diameter range overlapping with the claimed range ([0039]). Uchida discloses a loop with an unconstrained diameter in various ranges including overlapping with the claimed range ([0156]). It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to further modify the snare loop of Kurtulus to include any commonly known wire diameter, including a value within the claimed range as taught by Landry, and to include any commonly known unconstrained loop diameter, including a value within the claimed range as taught by Uchida, that would produce a predictable result of a snare loop that can be used to interact with tissue in a desired manner.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the amendments have precipitated the new grounds of rejection. However, in the interest of compact prosecution, some notes are provided.
First, generally speaking, the examiner broadly agrees with Applicant’s assessment of the category of invention represented by a device like that disclosed by Kurtulus (mostly directed to uterine resection even if other types of organs are contemplated, e.g. [0037]) and the category of invention represented by the pending application (heart valve therapy). It seems quite possible that it would not be obvious to use the device of Kurtulus in a method of heart valve therapy, except that the claims are not directed to a method. It also seems possible that it would not be obvious to modify the system of Kurtulus in a manner that would allow heart valve therapy if such modifications would prevent the system from being used to resect human organs ([0015] of Kurtulus), but none of the newly recited elements, being extremely broad due to their largely functional nature, fit that description as noted in the rejection. It seems very likely that there are meaningful differences between Kurtulus (and the other cited references) and the disclosed invention, both because of their different functions and because of the extensive information provided in the application. If Applicant would care to propose and/or discuss some possibilities before filing a response, the examiner’s contact information can be found below.
Second, independent of the broad, functional claim language now present in the independent claims (discussed above and in the rejections), the modification to Krutulus is unrelated to the reasons Applicant may have for the claimed features, particularly those related to sparking/plasma generation. It is well established that a rationale different from Applicant’s is permissible (MPEP 2144(IV)). More specifically, if the prior art discloses the claimed structure and a reason for combination (including even the combination of known elements according to known methods to yield predictable results, MPEP 2141(III)), the claims are obvious even if Applicant has some other reason for the claimed structure.
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 DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794
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