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 April 29, 2025 and May 1, 2025 have been entered and the references cited therein have been considered by the examiner.
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)(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(s) 1-10, 15 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saab (U.S. Patent Application Publication No. 2005/0273145).
In regard to claim 1, Saab teaches a heat transfer catheter apparatus 60 for delivering heat transfer fluids at temperatures above or below normal body temperatures to selected internal body sites (see para. 0002) comprised of an outer tube 140 having a distal end, a proximal end and a longitudinal direction (see Fig. 1) and a first inner tube (not numbered) with a guide wire lumen 124 and a plurality of supply lumens 126, 127, 128, 130 for allowing a fluid to pass therethrough where, in cross-section, the lumens 126, 127, 128, 130 are formed in regions different from a region in which lumen 124 is formed (see Fig. 7 and para. 0061). Outlet (discharge) lumens 134, 135, 136, 138 are formed between an inner surface of the outer tube 140 and an outer surface of the first inner tube and lumens 126, 130 could be provided with apertures in their sidewalls to permit fluid to pass into lumens 134, 135, 136, 138 (see para. 0061). Saab does not specifically state that the device is used for a duodenal papilla insertion. However, this recitation is considered an intended use recitation that is given little patentable weight. Moreover, the structure recited by Saab does not include any structural limitations that would preclude its use for duodenal papilla insertion. Thus, the device taught by Saab is capable of being used for duodenal papilla insertion 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 2, Figure 7 shows that in cross-section, an eccentric distance from a centroid of the first inner tube to a centroid of the lumens 126, 127, 128, 130 is longer than an eccentric distance from the centroid of the first inner tube to a centroid of the lumen 124. In regard to claim 3, Figure 7 shows that in cross-section, the lumen 124 is formed at a position that overlaps with a centroid of the first inner tube and each of the lumens 126, 127, 128, 130 is formed at a position that does not overlap with the centroid of the first inner tube. In regard to claim 4, see paras. 0051 and 0062. In regard to claim 5, Figure 7 shows that in cross-section, only one of the holes in the supply lumens is present on one straight line passing through a centroid of the first inner tube. In regard to claim 6, Figure 7 shows that in cross-section, only one of the lumens 126, 127, 128, 130 is present on one straight line passing through a centroid of the first inner tube and the holes. In regard to claim 7, Figure 7 shows that in cross-section, the lumens 126, 127, 128, 130 are located on an imaginary circle having a center at a centroid of the first inner tube. In regard to claims 8 and 9, see Fig. 3 and paras. 0053-0054. In regard to claim 10, see para. 0047. In regard to claim 15, see Figures 3 and 4. In regard to claim 16, see Fig. 1 and paras. 0045-0046.
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) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saab (U.S. Patent Application Publication No. 2005/0273145) in view of Garcia-Meza et al. (PCT Publication No. WO 2022/261146).
In regard to claim 11, Saab teaches that the multi-lumen catheter can have more of fewer lumens that the nine shown in Figures 7 and 8 (see para. 0061). Garcia-Meza et al. teach a similar cryogenic catheter with three delivery channels where the channels, due to their positioning within a catheter with a circular cross-section, would be between 105 degrees and 135 degrees apart from each other (see Figs. 15A and 15B). Garcia-Meza et al. thus demonstrate that the use of 3 fluid delivery channels spaced 105 to 135 degrees apart is well known in the art. Accordingly, since Saab teaches using fewer than nine lumens (fewer than 4 delivery lumens), it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Saab with 3 delivery lumens spaced between 105 degrees and 135 degrees apart from each other, in the manner disclosed by Garcia-Meza et al.
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, 3, 7, 8, 15 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 7, 9, 10 and 11, respectively, of copending Application No. 19/193,737 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 3, 7, 8, 15 and 16 of the instant application are broader than claims 1, 6, 7, 9, 10 and 11 of the reference application. Specifically, claim 1 of the reference application contains all of the limitations of claim 1 of the instant application as well as the additional limitation “an external shape of the inner tube is an irregular shape.” Thus, claim 1 of the instant application is broader than claim 1 of the reference application. Claims 6, 7, 9, 10 and 11 are identical to claims 3, 7, 8, 15 and 16 of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 12-14 are 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Duong et al., U.S. Patent Application Publication No. 2015/0216581, teaches a multi-lumen cryogenic catheter.
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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