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 .
Response Filed
Applicant’s response and amendment, filed April 28, 2026, has been entered and made of record.
Previously Set Forth Rejections
The status of the rejections as set forth in the previous Office action (mailed February 27, 2026) is as follows:
The 35 USC 103 rejection of claims 1-20, 22 and 23 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 (U.S. Patent Application Publication No. 2016/0038212) is hereby withdrawn.
The 35 USC 103 rejection of claim 21 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 (U.S. Patent Application Publication No. 2008/0119836) is hereby withdrawn.
The following new grounds of rejection are set forth:
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claim 1 has been amended to recite “at a plurality of points circumferentially spaced about the elongated body.” Applicant has stated that paras. 0022 and 0026 of the specification support this new recitation. The examiner cannot find any support in those paragraphs. Paragraph 0021 states “When deployed in a gallbladder, the compliant thermal conductive wire 112 is positioned at various points of the gallbladder wall 102” in reference to Fig. 1B. However, this disclosure does not equate to “a plurality of points circumferentially spaced about the elongated body.” As claims 2-16 depend from claim 1, they are likewise rejected.
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)(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) 17-22 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Saadat (PCT Publication No. WO 03/039338).
In regard to claims 17-19 and 22 Saadat teaches a cryotherapy device 10 comprised of a hollow guidewire 20 (mandrel) configured to form multiple, loosely-spaced helical loops 22 (see Fig. 1). The loops 22 are held within a lumened catheter 18 in a first configuration while being delivered to the desired treatment site (see para. 0043). Once ejected or pushed from catheter 18, guidewire 20 may be self-deploying such that when it is unconstrained, it reconfigured itself into a second configuration (see para. 0044). Guidewire 20 may be formed from a metal such as spring steel or nitinol or be made from a composite such as a nitinol tube disposed within the guidewire structure (thermally conductive outer material) and guidewire 20 may be made from other biocompatible materials such as copper, constantan, chromel or alumel (see paras. 0044-0045). As such, the thermally conductive outer material would be wrapped around the spring steel or nitinol tube disposed within the guidewire structure along the longitudinal length of the spring steel or nitinol tube. Saadat teaches that the helical loops 22 reconfigure themselves such that they extend radially to come into gentle contact with the inner wall or endothelium 14 of vessel 12 and come into contact with a location of the tissue to be treated such as plaque 16 (see para. 0046). Saadat does not specifically state that the cryotherapy device 10 is positioned within a gallbladder to contact an inner wall of the gallbladder to freeze the gallbladder while a gallstone is located against the inner wall. However, these recitations are considered intended use recitations that are given little patentable weight. Moreover, the structure recited by Saadat does not include any structural limitations that would preclude its use for being positioned within a gallbladder to contact an inner wall of the gallbladder and freeze the gallbladder while a gallstone is located against the inner wall. Thus, the device taught by Saadat is capable of being used to be positioned within a gallbladder to contact an inner wall of the gallbladder to freeze the gallbladder while a gallstone is located against the inner wall and one of ordinary skill in the art at the effective filing date of the invention would have been motivated to utilize the device in such a manner. Finally, it should be noted that it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). Also, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004). In regard to claim 20, since Saadat teaches the use of other biocompatible materials such as copper, constantan, chromel or alumel (see paras. 0044-0045), it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to form the thermally conductive outer material of Saadat from a biocompatible material, such as silver. In regard to claim 21, Saadat teaches that the guidewire 20 is a thin wire (see para. 0043) and thus it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to utilizes a guidewire 20 that is between 1 mm and 4 mm.
Allowable Subject Matter
Claim 23 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
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 BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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