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 .
Information Disclosure Statements
The information disclosure statements filed February 5, 2026 and November 21, 2024 have been entered and the references cited therein have been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Species I (claims 1-4, 6, 9, 11-14, 21-23, 26 and 27) in the reply filed on February 5, 2026 is acknowledged. New claims 30-35 will be examined along with the other claims of Species I.
Amendment Filed
Applicant’s amendment to the claims, filed February 5, 2026, has been entered and made of record. Accordingly, the status of the claims is as follows: Claims 1-4, 6, 9, 11-14 and 21-23 remain as originally filed; claims 5, 7, 8, 10, 15-20 and 24-29 are canceled; claims 30-35 are newly added.
Claim Objections
Claim 32 is objected to because of the following informalities: In claim 32, line 2, “active cap” should be “active tip.” Appropriate correction is required.
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.
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) 1-4, 9, 11, 12, 21-23, 30, 34 and 35 is/are rejected under 35 U.S.C. 103 as being obvious over Maurice (U.S. Patent Application Publication No. 2005/0038422) in view of Skorich et al. (U.S. Patent No. 11,628,007).
The applied Skorich et al. reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
In regard to claims 1, 21, 23 and 35, Maurice teaches an elongate cryoprobe 12 having a distal end 12a and a proximal end 12b with a mounting sleeve 40 secured to the proximal end portion of cryoprobe 12 that serves to have a holder 42 providing a hand hold through which an operator may grasp and manipulate the apparatus during use (see Fig. 1 and para. 0049). Maurice is silent as to the cryoprobe 12 having a generally rigid proximal portion and a generally malleable distal portion. However, Skorich et al. teach a similar cryoprobe device having a shaft with a tube 106 (proximal portion) that is substantially rigid and a malleable shaft 104 (distal portion) (see Fig. 12 and col. 6, lines 12-16) so that the cryoprobe can be bent to reposition the distal ablation tip (see col. 9, lines 52-58). Skorich et al. thus demonstrate that cryoprobe with rigid proximal portions and malleable distal portions are well known in the art. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to fabricate the cryoprobe 12 of Maurice with a rigid proximal portion and a malleable distal portion, in the manner disclosed by Skorich et al., in order to equip the device with the ability to bend the distal portion to reposition the distal ablation tip. Maurice teaches an elongate hollow needle member 16 that is closed and pointed at its distal end (active tip) and an elongate coaxially disposed inner tube 20 is mounted within member 12 that provides a cryogenic medium supply channel while a space between the outside of tube 20 and the inner walls of member 16 (exhaust conduit) provides a return path for cryogenic medium to exit through the proximal end of member 16 (see Fig. 5 and para. 0042). A layer of electrical insulating material 38 covers the major portion of member 16 between its proximal and distal ends and thus provides a vacuum insulating layer disposed around the inner tube 20 and the exhaust conduit (see para. 0048). In regard to claims 2, 4, 11 and 34, Maurice also teaches an elongate cannula 46 (tubular thermal barrier) that receives member 16 and its associated insulating material 38 therethrough (see Figs. 3 and 5 and para. 0050). Cannula 46 has a layer of electrically insulating material 48 (shell) (see Fig. 5 and para. 0050). Thus, material 48 at least partially defines a radially outer aspect of the insulating material 38 and the exhaust conduit at least partially defines a radially inner aspect of the insulating material 38 (see Fig. 5). In regard to claims 3 and 22, Figure 5 shows that the inner tube 20, the exhaust conduit, the insulating material 38, the cannula 46 and the material 48 are concentrically disposed about a longitudinal axis of the cryoprobe 12. In regard to claim 9, Maurice teaches a connector 30 (proximal end cap) comprising an elongated proximal portion extending within the handle 40 (see Fig. 5). In regard to claim 12, cryogenic medium from cryogenic supply 26 is directed through the tube 20 and fluid then returns from the exhaust conduit to exit the apparatus (see Fig. 5 and para. 0044). In regard to claim 30, see para. 0048 of Maurice.
Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 103 as being obvious over Maurice (U.S. Patent Application Publication No. 2005/0038422) in view of Skorich et al. (U.S. Patent No. 11,628,007) and further in view of Beckman et al. (U.S. Patent No. 4,995,403).
In regard to claims 13 and 14, Maurice is silent as to visible indicium on the cryoprobe 12. However, Beckman et al. teach a similar probe 10 with a shaft that has a fiber element 18 with a distal end portion 76 that has a series of annular bands 80 of different colors that make it possible to visually determine the location of the distal end portion 76 (see col. 6, line 56 to col. 7, line 10 and Fig. 4). Beckman et al. thus demonstrate that the use of color indicium on a probe was well known in the art. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the cryoprobe 12 of Maurice with the color indicium disclosed by Beckman et al. in order to equip the device with the ability to visually determine the location of the distal end of the cryoprobe 12.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 6, 9, 11-14, 21-23 and 30-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 19/381,653 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-4, 6, 9, 11-14, 21-23 and 30-35 of the instant application are broader than claims 1-19 of copending application as claims 1-4, 6, 9, 11-14, 21, 23 and 30-35 do not recite a nozzle with a lumen.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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