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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 2, 2026 has been entered.
Previously Set Forth Rejections
All of the rejections as set forth in the final rejection (mailed October 1, 2025) are hereby withdrawn.
The following new grounds of rejection are set forth:
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 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) 1-20, 22 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nojoomi et al. (PCT Publication No. WO 2022/036250) in view of Ryba et al. (U.S. Patent Application Publication No. 2016/0038212).
In regard to claims 1, 6, 7, 9, 10, 12, 13, 15, 16, 18-20, 22 and 23, Nojoomi et al. teach an ablation system 100 used to treat a gallbladder having a control unit 110, an ablation catheter 150 and an ablation medium supply 120 (see para. 0061 and Fig. 1). The ablation medium can be a cryogenic liquid or gas that ranges from about -120 degree Celsius to about 0 degrees Celsius (see para. 0062). The control unit 110 can be coupled to a vacuum source 140 to apply a vacuum to a channel or lumen 262 of the ablation catheter 150 (see paras. 0063 and 0070). The ablation catheter 150 can be percutaneously inserted into a body lumen without the need for surgical removal of the anatomy (see para. 0067). An embodiment of ablation catheter 250 includes an outer shaft 260 that has a tapered portion at the distal end to aid in insertion into the body lumen BL (see para. 0073). The outer shaft 260 also includes an expandable structure 266 that can be transitioned from an undeployed state to a deployed state (see Figs. 6A-6B and para. 0074). The expandable structure 266 can be bounded within a region along the length of outer shaft 260 between two boundary rings and the expandable structure 266 can deploy upon bringing the two boundary rings closer together (see paras. 0075 and 0114). The expandable structure 266 can include elongate members (bands, fibers, wires, splines) arranged in a woven or braided pattern and can be composed of nitinol, stainless steel, a polymer or any suitable material that can be selected based on the material’s ability to withstand cryogenic temperatures without significantly affecting the cooling performance of the ablation catheter 250 (see paras. 0076 and 0083). Figure 9 shows that, as broadly as claimed, the expandable structure 266, 876 comprises a plurality of pre-programmed loops that are configured to contact a sufficient portion of an inner wall of the gallbladder to freeze the gallbladder (see para. 0112) and would be in thermal contact with the cryogenic fluid. Nojoomi et al. do not specifically teach that the expandable structure performs the function of freezing the gallbladder. However, Ryba et al. teach a similar a cryocatheter 102 with a cryo-balloon 124 at the distal end (see paras. 0121-0122). Ryba et al. further teach that strips and patterns of metal, such as silver, may be deposited on the surface of the balloon for various applications (see paras. 0248-0249) and these thermally conductive features can include bands 3341, patches 3343 or metal mesh or braid 3350 that can have a variety of different configurations (see para. 0250). Nojoomi et al. also teach that the expandable structure 266 can include an inflatable balloon (see para. 0074) and it follows that the balloon would be in fluid communication with the vacuum lumen so as to provide the necessary suction. Ryba et al. thus demonstrate that the use of an expandable balloon with a thermally conductive feature on its exterior is well known in the art for better thermal conduction. Accordingly, it would have been obvious, in view of the combined teachings of Nojoomi et al. and Ryba et al., to provide the device of Nojoomi et al. with an expandable balloon as the expandable structure 266 with the elongate members (bands, fibers, wires, splines) positioned on the exterior of the balloon as the thermally conductive features in order to create better thermal conduction. Furthermore, it would have been obvious to one of ordinary skill in the art at the effective filing date of the invention that when the expandable structure 266 is inflated or expanded, it would contact a sufficient portion of the inner wall of the gallbladder such that the thermally conductive features freeze the gallbladder. In regard to claims 2-5, the expandable structure 266 can be bounded within a region along the length of outer shaft 260 between two boundary rings and the expandable structure 266 can deploy upon bringing the two boundary rings closer together (see paras. 0075 and 0114). The expandable structure 266 can include elongate members (bands, fibers, wires, splines) arranged in a woven or braided pattern and can be composed of nitinol, stainless steel, a polymer or any suitable material that can be selected based on the material’s ability to withstand cryogenic temperatures without significantly affecting the cooling performance of the ablation catheter 250 (see paras. 0076 and 0083). In regard to claim 8, Figure 33B shows an embodiment of a conductive mesh or braid 3350 carried by a balloon 3341 where the mesh 3350 extends proportionally to match inflation of the balloon 3341 (see also para. 0250). In regard to claims 11 and 17, Ryba et al. teach that the thermally conductive feature may be a component of a composite elastomeric material such that the metal layer (thermally conductive layer) would be coupled to the elastomeric material (mandrel) (see para. 0248 of Ryba et al.). As noted above, Nojoomi et al. teach nitinol as a material for the expandable member. In regard to claim 14, as broadly as claimed, Figure 9 of Nojoomi et al. shows that at least two of the arms of the expandable member have different diameters. With further respect to claims 15 and 16, see paras. 0099-0104 of Noojomi et al.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nojoomi et al. (PCT Publication No. WO 2022/036250) in view of Ryba et al. (U.S. Patent Application Publication No. 2016/0038212) and further in view of Littrup et al. (U.S. Patent Application Publication No. 2008/0119836).
In regard to claim 21, Nojoomi et al. is silent as to the cross-sectional diameter of the expandable member 266. However, Littrup et al. teach a cryogenic probe with an outer diameter as small as 1.2 mm (see para. 0055). Furthermore, it is well settled that a change in size of a prior art device is a design consideration within the scope of one of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCAP 1955). Accordingly, it would have been an obvious matter of design choice to make the expandable member 266 of Nojoomi et al. with a cross-sectional diameter of 1.2 mm.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, the new grounds of rejection is based upon Nojoomi et al. in view of Ryba et al. while applicant’s arguments address the application of Nojoomi et al. alone and Arless et al. (see pages 6-9 of the response filed 1/2/26).
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794