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 § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 5-13 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Deem (US2010/0125266 A1).
Regarding claims 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 a defining a lumen therebetween; and the distal end portion including a plurality of 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 (see Fig. 12B).
Regarding claims 5 and 13, Deem discloses the plurality of tubes defines a basket (see Fig. 12A).
Regarding claim 6, Deem discloses the plurality of tubes surrounds the exhaust lumen (see 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 wherein the entirety of the prongs is thermally conductive [0078].
Regarding claim 11, Deem additionally discloses the plurality of tubes circumferentially surround the exhaust lumen (see Fig 12B and fig 12A).
Regarding claim 12, Deem further shows wherein the exhaust lumen is co-axial with the elongate shaft (see Fig 12B and fig 12A).
Regarding Claim 13, Deem discloses wherein the plurality of tubes defines a basket (Fig. 12A).
Claim(s) 1, 11 and 17 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Adagio Medical Inc (WO2015/047961 A2), hereinafter Adagio.
Regarding claims 1 and 11, Adagio discloses a medical device, comprising: a proximal end portion and a distal end portion opposite the proximal end portion; an elongate shaft (12) disposed between the proximal and distal end portions and a defining a lumen therebetween; and the distal end portion including a plurality of tubes (40) 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 (Fig 17, 36’) in fluid communication with the lumen (see Fig. 16,17; [0116], [0117]).
Regarding claim 17. Adagio teaches wherein the plurality of tubes is composed of Nitinol (see [0135], Nitinol being known as thermally conductive biocompatible material usable for cryotechnology).
Claim Rejections - 35 USC § 103
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.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2-4 and 14-16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deem (US2010/0125266 A1) 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, l. 31-p.8, l. 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, l. 29).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deem (US2010/0125266 A1) in view of Stewart et al (US 9,554,848) and further in view of Carroll (WO2006/104837 A1).
Regarding claim 19, 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.
Conclusion
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LINDA C. DVORAK
Supervisory Patent Examiner
Art Unit 3739
/LINDA C DVORAK/Primary Examiner, Art Unit 3794
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