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 .
Election/Restrictions
Applicant’s response to the election/restriction requirement (mailed January 27, 2026) has been reviewed. In light of the preliminary amendment filed November 13, 2023, which canceled claims 3-6, 13, 19-20, 22-23 and 29-56, the restriction requirement is hereby withdrawn. Claims 1-2, 7-12, 14-18, 21, 24-28 and 57 will be examined on the merits.
Information Disclosure Statements
The information disclosure statements filed January 8, 2024, March 5, 2025 and November 18, 2025 have been entered and the references cited therein have been considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: There is an inconsistency in the use of the terms “inflow” and “outflow” in the specification. Initially, with respect to Figure 1B, the channels that convey the cryogenic fluid and the washing fluid to the distal end of the device are termed “outflow” channels. However, later in the specification, as, for example, with respect to Figure 2A, the channels that convey the cryogenic fluid and the washing fluid to the distal end of the device are termed “inflow” channels. Applicant should utilize either “outflow” or “inflow” consistently throughout the specification.
Appropriate correction is required.
Claim Objections
Claim 1-2, 7-12, 14-18, 21, 24-28 and 57are objected to because of the use of “inflow” in the claims which contradicts the specification at points (see above). In addition, claim 28 is objected to because of the following informalities: In line 4, “position” should be “positioned.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10-12, 14-16, 21 and 57 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 10-12, 14-16, 21 and 57 recite “and/or” which is vague and indefinite as the metes and bounds of the claims cannot be determined.
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.
Claims 1, 2, 7-12, 14-18, 21, 24-28 and 57 is/are rejected under 35 U.S.C. 103 as being obvious over Kochavi (PCT Publication No. WO 2018/142411) in view of Mulcahey et al. (U.S. Patent Application Publication No. 2017/0311789).
The applied reference has a common assignee and inventor 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, 7-11 and 57, Kochavi teaches a cryotherapy system 1000 comprised of an elongated cryotherapy probe 1002 having a distal end 1021 and a proximal end 1025 that is shaped and sized to be introducible into a body lumen and to face a target region on the internal surface of the lumen (see page 36, lines 5-16 and Fig. 1A). The cryotherapy probe 1002 has an inflow channel 1006 for delivering cryogenic fluid or gas from a cryogenic fluid source, an optics channel 1018 for delivering images and/or visual signals and a washing channel 1014 for insertion of a washing gas (see Fig. 1A). Washing fluid is introduced through the inflow wash path and through opening 1115 facing the treated tissue and at least one sideways opening 1117 for introducing fluid near a distal opening of optics 1110 (see Figs. 20A and 20B and page 70, lines 3-9). Kochavi is silent as to at least one flow reducer positioned within the washing inflow path distally to the openings 1117 that blocks enough lumen to increase washing fluid flow through the openings 1117. However, Mulcahey et al. teach a similar medical device with a purging fluid supply mechanism 306 that fits over an endoscope 312 (see Figs. 1A and 3A). Mulcahey et al. teach that the channels of the mechanism 306 may vary in cross-sectional width and shape along the length and variable cross-sections may be used to increase or decrease the mass flow rate of the fluid being supplied through the sheath (see para. 0064). Mulcahey et al. thus demonstrate that variations in width and shape in a fluid delivery lumen are sheath for the purpose of increasing or decreasing the flow rate 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 provide the inflow wash path of Kochavi with a variation in width or shape in order to decrease the mass flow rate through the opening 1115, thereby directing more washing fluid through the sideways openings 1117. In order to do so, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to place this variation in width or shape distal to the sideways openings 1117 and proximal to the distal opening 1115. In regard to claim 2, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to vary the width of shape of the washing inflow channel by at least 10% in order to achieve the redirection of flow through the sideways openings 1117. With further respect to claim 10, Figure 20A of Kochavi shows that the distal opening 1115 surrounds at least party the cryogenic spray path. In regard to claim 12, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to make the variation in width or shape as an arc contacting the inner surface of the washing inflow path in Kochavi. In regard to claims 14 and 15, Figure 20A of Kochavi shows that the sideways openings 1117 are a plurality of openings axially distributed in a wall of the washing inflow path facing the optics 1110 and the field of view and at least partly surrounding the washing inflow path lumen. In regard to claims 16-18, Figure 20A of Kochavi shows that the sideways openings 1117 are evenly distributed. Kochavi also teaches that the wash openings can comprise a slot or a notch (see page 71, lines 14-16). Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to make the sideways openings 1117 in different sizes and shapes or to varying the distribution density of the openings 1117. In regard to claims 21 and 24, see Figs. 7A and 7B and page 55, line 7 to page 8, line 2 of Kochavi. In regard to claim 25, see page 13, lines 14-16 of Kochavi. In regard to claim 26, Figure 20A of Kochavi shows that the cryo inflow path and the washing inflow path are coaxial along at least 30% of the length of the washing inflow path. In regard to claim 27, Figure 20A of Kochavi shows that the washing inflow path surrounds at least partly the cryo inflow path along at least 30% of a length. In regard to claim 28, Figure 20A of Kochavi shows that the surface of the optics 1110 is angled relative to a longitudinal axis of the device and the sideways openings 1117 are positioned, shaped and sized to release washing fluid towards the optics 1110 surface.
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, 7, 10, 14, 15 and 57 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, 14, 63, 77-79, 83 and 84 of copending Application No. 16/482,721 in view of Mulcahey et al. (U.S. Patent Application Publication No. 2017/0311789).
Claims 1, 12, 14, 63, 77-79, 83 and 84 of copending application no. 16/482,721 teaches all of the limitations of claims 1, 7, 10, 14, 15 and 57 of the instant invention with the exception of at least one flow reducer. However, as noted above, Mulcahey et al. teach a similar medical device with a purging fluid supply mechanism 306 that fits over an endoscope 312 (see Figs. 1A and 3A). Mulcahey et al. teach that the channels of the mechanism 306 may vary in cross-sectional width and shape along the length and variable cross-sections may be used to increase or decrease the mass flow rate of the fluid being supplied through the sheath (see para. 0064). Mulcahey et al. thus demonstrate that variations in width and shape in a fluid delivery lumen are sheath for the purpose of increasing or decreasing the flow rate 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 provide the inflow wash path copending application no. 16/482,721 with a variation in width or shape in order to decrease the mass flow rate through the opening 1115, thereby directing more washing fluid through the sideways openings 1117. In order to do so, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to place this variation in width or shape distal to the sideways openings 1117 and proximal to the distal opening 1115.
This is a provisional nonstatutory double patenting rejection.
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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