CTNF 18/847,848 CTNF 87219 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. Drawings 06-36 AIA The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the shaft having ports along a distal segment (claims 4 and 14, shaft 16 in the specification does not have ports) and the shaft delivering the cooling fluid by using a Joule-Thomson valve (claims 8 and 18) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 1-20 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. Regarding claims 1-10, claim 1 recites “at least one expandable treatment element” followed by “the at least one treatment element” followed by “an expandable treatment element.” Further, the dependent claims mix “the at least one expandable treatment element” (claims 2, 3, 5) and “an expandable treatment element” (claims 7-9). It is not clear what the relationship is between “the at least one treatment element” and “an expandable element.” More specifically, it is unclear if they are the same or different elements and it is unclear how many expandable elements the claims require. Regarding claims 11-20, claim 11 recites “at least one expandable element” followed by “the at least one expandable element” followed by “at least one expandable element.” Further, claims 13, 15 and 17-19 recite “an expandable element.” It is not clear how many groups of “at least one expandable element” the claim 11 requires, or what the relationship is between the one or more “at least one expandable element” and “an expandable element.” Regarding claims 4, 14, 9 and 19, these claims recite limitations sufficiently incompatible that the relationship between the shaft and the expandable treatment element is rendered unclear. Claims 1/11 recites a shaft, claims 4/14 recites the shaft has ports (a feature not shown as discussed above) while claims 9/19 recites the shaft includes a fluid supply lumen with ports. It is not clear in what sense the shaft delivers a cooling fluid if it is not the shaft but the supply lumen that delivers the cooling fluid. Further, since the supply lumen/“shaft” with ports extends to the distal end of the expandable treatment element, it is not clear if the “shaft” is understood to be part of the expandable treatment element or not (particularly since the shaft in the specification terminates at the proximal end of the expandable treatment element). Because the exact relationship between the shaft and the expandable treatment element cannot be determined, the claims are indefinite. Regarding claim 6 and 16, the claim is missing one or more words, potentially between “fluid” and “below,” which renders the claim indefinite. Regarding claim 10, the claim recites a plurality of shafts. It is not clear what the relationship is between these shafts and the “at least one shaft” in claim 1. Further, the claim raises the specter of a rejection under 35 U.S.C. 112(a) because the specification always associates one shaft with one expandable treatment element while claim 10 appears to imply that a plurality of shafts may exist with reference to a single expandable treatment element. 07-36 AIA The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. 07-36-01 AIA Claim s 6 and 16 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 1/11 recites a hypothetical fluid, while claims 6/16 only recites a temperature range of the hypothetical fluid. Thus claim 6 does not further limit the structure recited in claim 1 . Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1-3, 5-7, 11-13, 15-17 and 20 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Lalonde (US 2014/0031804) . Regarding claim 1-3, 5, 6, 11-13, 15, 16 and 20, Lalonde discloses a cryogenic catheter (figs. 1 and 2B) including a shaft (40) for delivering a fluid to a connected expandable treatment element biased to form a multiple loop coil structure when expanded (note the coil form of element 14 and the flexibility of the “cryoballoon” as discussed [0026]). Balloons are, by definition, expandable by pressure. The expandable treatment element forms a plurality of “approximately parallel”/helical coil structures when expanded (fig. 2B). The term “flexible linear” is being interpreted to be broad rather than indefinite, where Lalonde shows the expandable treatment element has some degree of linear flexibility, whether or not the element is expanded ([0026], see also figs. 3A-B). Lalonde further shows electrodes (44, fig. 2B), where all electrodes are “configurable” for sensing, and further includes a “reinforced guide sheath” encompassing the shaft (18). The claim recites numerous functional limitations (“configured to”). 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. In this case, Lalonde could be supplied with near-critical-temperature argon (including argon in a specific temperature range) and could be used to ablate parasympathetic nerve fibers in a wall or a passageway of any kind within a patient. This argon could be used to expand the expandable element, while the coil can be approximately parallel to the passageway. Regarding claims 7 and 17, it is noted this is a further limitation to an element recited in the alternative in claim 1/11 (respectively): expansion via “at least one of” pressure and mechanical force. Since the prior art shows one (pressure) it does not need to show the other (mechanical force). However, in the interest of compact prosecution, see the Conclusion below for an example of push wires for controlling the shapes of coils . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lalonde . Regarding claim 10, the claim is unclear as noted above. However, Lalonde at least discloses a reinforced guide sheath (18, fig. 2B), where “reinforced” is being interpreted as extremely broad rather than contributing to the indefiniteness issues. 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 one of ordinary skill in the art to modify the system of Lalonde to have any number of disclosed elements, including shafts within the “reinforced guide sheath,” that would produce the predictable result of a device that functions in a desired manner . 07-21-aia AIA Claim s 4, 9, 14 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Lalonde in view of Saadat (US 2003/0088240) . Regarding claims 4, 9, 14 and 19, Lalonde does not disclose the exact manner in which coolant is supplied to the expandable treatment element. However, using a shaft with distal ports for delivering cooling fluid, or alternatively, using a fluid supply lumen with distal ports, is known in the art where 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)). Saadat, for example, discloses a cryocatheter and teaches that the distal end of shaft/fluid supply lumen (142, fig. 11) may be provided with ports (148) for delivering fluid to an expandable treatment element (144). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the cryocatheter of Lalonde to use any commonly known structure for delivering coolant to an expandable treatment element, including a shaft/fluid supply lumen with distal ports as taught by Saadat, that would produce the predictable result of allowing the expandable treatment element to be cooled in a desired manner . 07-21-aia AIA Claim s 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Lalonde in view of Lalonde (US 2011/0054453), hereinafter Lalonde2 . Regarding claims 8 and 18, Lalonde does not disclose the use of a Joule-Thomson valve. However, Joule-Thomson valves are very common in the art. Lalonde 2 discloses a cryogenic catheter and teaches that an expandable element may be cooled by passing fluid through a joule-Thomson valve ([0046]). Therefore, before the application was filed, it would have been obvious to provide the shaft of Lalonde with any commonly known cooling element, including a Joule-Thomson valve as taught by Lalonde2, that would produce the predictable result of allowing the expandable treatment element to be cooled in a desired manner. Note that while not directly relevant to the rejections as this time, Lalonde2 expressly uses argon ([0047]) in a supercritical state ([0046]) which can be considered to be “near-critical-temperature.” Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding the use of a push/pull element for shaping a coil (which therefore does not have the central element as in Lalonde), see figure 1 and paragraph [0045] of US 2011/004087 to Fish. Regarding another cryoablation catheter that employs an inflated coil, see figures 13-14 of US 7,220,257 to Lafontaine. Regarding a device with a shaft holding a plurality of shafts for supplying fluid to a plurality of longitudinally expandable elements, see figures 1 and 2 of US 2017/0035498 to Boden. Regarding the use of argon at a temperature of down to -186°C, see paragraph [0161] of US 2003/0060762 to Zvuloni, which also discloses an inflatable element cooled by use of one or more Joule-Thomson valves ([0139], [0168], fig. 5). Regarding a device for denervation in an airway which includes a plurality of longitudinally spaced treatment elements with respective shafts, see figures 91 and 92 of US 2016/0058502 to Clark, which notes that that the treatment elements can be spirals or coils or form a helix ([0339]) and that the device can employ cryosurgical temperatures ([0221]). Regarding the general teaching that near-critical-point pressures and temperatures have distinct benefits in Joule-Thomson systems, see paragraph [0043] of US 2013/0204241 to Baust . 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /DANIEL W FOWLER/Primary Examiner, Art Unit 3794 Application/Control Number: 18/847,848 Page 2 Art Unit: 3794 Application/Control Number: 18/847,848 Page 3 Art Unit: 3794 Application/Control Number: 18/847,848 Page 4 Art Unit: 3794 Application/Control Number: 18/847,848 Page 5 Art Unit: 3794 Application/Control Number: 18/847,848 Page 6 Art Unit: 3794 Application/Control Number: 18/847,848 Page 7 Art Unit: 3794 Application/Control Number: 18/847,848 Page 8 Art Unit: 3794 Application/Control Number: 18/847,848 Page 9 Art Unit: 3794
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