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 § 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 and 5-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deem (US 2010/0125266 A1) in view of Gonzales (US 2004/0039430 A1).
Regarding claim 1 and 11, Deem discloses a medical device comprising; a proximal end portion and a distal end portion opposite the proximal end portion, an elongate shaft (264) disposed between the proximal and distal end portions and defining a lumen therebetween; and a distal end portion including a plurality tubes (254) extending from a distal end of the elongate shaft, the plurality of tubes defining a fluid pathway therein in communication with the lumen for circulation of cryogenic fluid, the plurality of tubes having a common exhaust lumen (256) in fluid communication with the lumen, wherein the plurality of tubes are transitionable between a collapsed configuration disposed within a sheath and an expanded configuration extending outward from the sheath, the plurality of tubes collectively defining a cryogenic treatment structure when in the expanded configuration (e.g. Fig. 12a shows the expanded configuration of the tubes once they have been passed through the sheath).
Deem discloses the invention as claimed but fails to explicitly teach the collapsed configuration is disposed within a sheath. Gonzales teaches that it is known to use an introducer sheath for storing a catheter in a collapsed configuration as set forth in paragraph 60 for providing a collapsed configuration and smooth delivery profile to avoid snagging on any structures while navigating and delivering the catheter to the desired target site. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Deem with the collapsed configuration is disposed within a sheath since such a modification would provide the predictable results of providing a collapsed configuration and smooth delivery profile to avoid snagging on any structures while navigating and delivering the catheter to the desired target site.
Regarding claim 5, Deem discloses the plurality of tubes defines a basket (e.g. Fig. 12).
Regarding claim 6, Deem discloses the plurality of tubes surrounds the exhaust lumen (e.g. Fig. 12B and fig. 12A).
Regarding claims 7-9, Deem discloses each of the plurality of tubes defines a prong (see Fig 12A), the plurality of prongs are transitionable from a first substantially linear configuration to a second expanded configuration, each of the plurality of prongs are curved in different directions from each and every other one of the plurality of prongs when in the second expanded configuration; and wherein each prong of the plurality of prongs is biased to extend outwards radially when in the second expanded configuration.
Regarding claim 10, Deem discloses the entirety of the prong is thermally conductive (paragraph 78).
Regarding claim 11, Deem additionally teaches the plurality of tubes circumferentially surround the exhaust lumen (e.g. see Fig. 12B and 12A).
Regarding claim 12, Deem further shows weherin the exhaust lumen is co-axial with the elongate shaft (see Fig. 12B and 12A).
Regarding claim 13, Deem discloses wherein the plurality of tubes defines a basket (e.g. 12A).
Claim(s) 2-4, 14-16, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deem in view of Gonzales as applied above, in view of Carroll (WO2006/104837 A1).
Regarding claims 2-4 and 14-16, Deem discloses the invention substantially disclosed and discussed, supra, with respect to claims 1 and 11. Deem does not disclose thermally conductive elements disposed about at least one of the plurality of tubes; however, such a solution for the same problem is taught by Carroll (p.7, I. 17-30, fig.3., element 34). Therefore, one having ordinary skill in the art would envisage the use of thermally conductive elements as disclosed by Carroll on the prongs of Deem in order to concentrate the thermal energy on specific points along the tubes as taught by Carroll.
With respect to claims 3, 4, 15, and 16, Fig 3 also discloses the at least one thermally conductive treatment elements include a plurality of thermally conductive treatment elements longitudinally spaced along at least one of the plurality of tubes and circumferentially disposed about at least one of the plurality of tubes (p. 7, I. 31-p.8, I. 7).
Regarding claim 18, Carroll teaches wherein the thermally conductive elements are composed of gold plated copper which meets the limitation of gold (p.7, I. 29).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deem in view of Gonzales as applied above, in view of Adagio Medical Inc. (WO 2015/047961 A2) herein after “Adagio”.
Deem in view of Gonzales disclose the invention as claimed but fail to explicitly teach the plurality of tubes is composed of Nitinol. Adagio teaches the plurality of tubes are comprised of Nitinol see paragraph 135 as Nitinol is known as a biocompatible conductive material for use. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Deem with using Nitinol as the material for the plurality of tubes since Adagio teaches that it is known to use Nitinol for a plurality of tubes on the basis of its conductive biocompatible properties.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deem in view of Gonzales as applied above, further in view of Stewart et al. (US 9,554,848) and Corroll (WO 2006/104837).
Deem discloses the invention substantially disclosed and discussed, supra, with respect to claim 1. Deem fails to disclose: a) the plurality of tubes being transitionable from a first position in which the tubes are disposed within the elongate shaft to a second position in which the tubes extend outward and away from the elongate shaft; and b) a plurality of thermally conductive elements circumferentially disposed about each of the plurality of tubes. In Deem the cage is expanded by retracting the return tube and therefore longitudinally compressing the basket. Stewart teaches the well-known alternative way of expanding a basket by deploying out the end of a catheter (see Fig 11; {113]). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date to choose to deploy the basket through a catheter as an equally effective alternative to the basket expansion of Deem.
Furthermore, Deem does not disclose thermally conductive elements on the tubes but such a solution for the same problem is taught by Carroll (p.7, I. 17-30, fig.3). Therefore, one having ordinary skill in the art before the effective filing date would envisage the use of thermally conductive elements as disclosed by Carroll on the prongs of Deem in order to concentrate the thermal energy on specific points along the tubes as taught by Carroll.
Response to Arguments
Applicant's arguments filed 2/6/2026 have been fully considered but they are not persuasive. Applicant argues Deem discloses a fundamentally different expansion mechanism. Examiner does not disagree with this; however, Applicant’s claims fail to capture this distinction. The claims only require the plurality of tubes are transitionable from a collapsed configuration within the sheath and an expanded configuration outside the sheath. The claims do not claim the mechanism for expansion, for example the tubes being self expanding. Therefore the manual mechanical expansion disclosed by Deem still meets the claim as written.
With regard to claim 17, Applicant argues the cited portion of Adagio refers to the cover portion and not the fluid transfer tubes. Examiner respectfully disagrees. The proposed combination of using the Nitinol as the material for the plurality of tubes of Deem is related to the making the tissue contacting region being made of Nitinol. Therefore the cover portion is the relevant portion from Adagio that is relied upon.
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 JOSEPH A STOKLOSA whose telephone number is (571)272-1213. The examiner can normally be reached M-F 930AM-530PM.
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/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
