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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 23 January 2026 has been entered.
Claim Rejections - 35 USC § 102
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.
Claim 10 is rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Saadat (US 2003/0088240).
Regarding claim 10, Saadat discloses a cryogenic catheter with a coolant flow loop with a distal end comprising multiple micro-tube loops for circulating a coolant (fig. 14). The loops together form a “basket” at least in the sense that they form a three-dimensional shape, where Applicant has used the word “basket” in the specification so broadly that it is almost meaningless (e.g. the very unclear multi-line arrow shape in fig. 25 being called a “basket”). Similarly, the claim recites at least one loop, but how a single loop can be called a “basket” as the word is commonly understood is unclear, which requires “basket” to be interpreted broadly to avoid indefiniteness issues. Saadat further discloses the “basket” is expandable ([0069], “loops 204 may be allowed to extend radially”). The claim recites that the loops are not insulated and the proximal catheter is insulated, but the claim does not recite what the loops are not insulated from or what the catheter is insulated from. Further, the claims do not recite the degree of insulation where there are no perfect insulators, nor even that “uninsulated” and “insulated” refer to the same property. Since the loops are used for temperature modification they are not thermally insulated ([0069]). The proximal catheter is insulated to some degree from something, whether optically, thermally, electrically or acoustically. The catheter of Saadat could be used for countless methods including blood clot retrieval (see MPEP 2114 and 2173.05(g)), and that includes using cryogenic temperatures of circulating fluid (although see also [0051]). Note that the embodiment in figure 16 also shows an expandable basket in comprising a series of coolant loops and specifically notes that the treatment part is non-insulated and the catheter part is insulated ([0071]).
Claim 10 is rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Lalonde (US 2014/0031804).
Regarding claim 10, Lalonde discloses a cryogenic catheter with a cooling, and therefore thermally uninsulated, expandable basket comprised of several loops (fig. 2A, [0026], [0032]). The catheter (18) is insulated in some manner (see discussion above). The catheter of Lalonde could be used for countless methods including blood clot retrieval (see MPEP 2114 and 2173.05(g)), and that includes using cryogenic temperatures of circulating fluid (although see also the abstract and [0032]).
Allowable Subject Matter
Claims 1-5 are allowed.
The following is an examiner’s statement of reasons for allowance: The prior art discloses all the various features of the claims but not together. More specifically, the claims recite a catheter defining a flow loop, a wire in a catheter lumen movable relative to the catheter to a position distal to the catheter, where the flow loop is arranged relative to the wire in the lumen so that sufficient thermal transfer occurs between the wire and the flow loop to allow blood clot retrieval. Cooling some proximal side of an element is common in the art (fig. 2 of US 2004/0000158 to Luo), and in fact the art teaches that circulating a coolant through an element and cooling the proximal end of the element are functionally equivalent (figs. 14B-C of US 2017/0165105 to Anderson). Devices where proximally-cooled elements are movable are less common but do exist (see Kim and Levin in previous Actions). However, none of these devices reasonably qualify as a catheter for use intravascularly. Catheters with extendable wires do exist, the most relevant being US 2002/0161360 to Carroll, which discloses a flow loop defined by a catheter through which is a positioned an extendable wire (56, fig. 3). However, Carroll discloses the wire is used for drug delivery ([0028]) and is totally silent about whether the wire is cooled by the flow loop. Since the purpose of the catheter is to treat tissue with the distal end of the catheter (42, fig. 3), there is no reason to configure the device to cool the wire sufficient to retrieve a blood clot. More generally speaking cryoadhesion is a common feature of various medical devices which results in some structurally related references. One of the closest is US 10,058,312 to Lalonde which discloses a wire extendable from a catheter with a cryosurgical feature (25, fig. 1B), but the cryosurgical features are for adhering the catheter itself to tissue so that the wire can puncture tissue without the catheter moving (col. 3 lines 9-11). But since the goal of the wire is to pass through tissue it clearly would not be obvious to apply cryosurgical temperatures to the wire because the subsequent cryoadhesion would prevent the wire from moving through tissue as desired. Finally, even though “wire” is a broad term it clearly excludes references such as US 2009/0221955 to Babaev which shows a cooled non-wire element extendable from a catheter (fig. 2). Therefore, while using cryoadhesion to remove blood clots is known in the art, there are no prior art references which together teach or suggest the collection of specific features recited in claim 1.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments with respect to claim 10 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding the extremely common use of thermal insulation on a catheter proximal to a freezing element, see for example paragraph [0034] of US 2003/0055415 to Yu.
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794