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 .
Response to Amendment
In the reply filed 3/6/2026, applicant amended claims 1, 15, and 20 and canceled claim 3. Claims 1, 2, and 4-20 are currently pending, and claims 10-14 and 18 are withdrawn from consideration.
Response to Arguments
Applicant’s arguments with respect to the 103 and 103 rejections over claims 1, 2, 4-9, 15-17, and 19-20 have been fully considered and are persuasive. The art rejections of claims 1, 2, 4-9, 15-17, and 19-20 have been withdrawn.
However, the double patenting rejections have been maintained because the amended claim language is also claimed in US Patent Nos. 11,964,091 and 12,226,564. See the updated double patenting rejections below.
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, 2, 4-9, 15-17, and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,964,091. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a coaxial, dual lumen catheter system and corresponding method of use, the catheter comprising a first inner catheter that slides within a second outer catheter, wherein the surfaces of the inner and outer catheters are flush with each other to form an interference fit. In use the catheters are advanced from the LA, through the mitral valve, toward the aortic valve, and into the ascending aorta.
Instant claims 1-9 are drawn to a system that corresponds to the method of the ‘091 claims. Additionally, instant claims 1-9, 15-17, and 19-20 are broader than the ‘091 claims because they do not necessarily require a first inner catheter and a second inner catheter, wherein the second inner catheter is advanced over the first inner catheter.
While the independent claims of the ‘091 patent do not require the use of a belooon to center the inner sheath with respect to the mitral valve, this limitation is required in dependent claims 3, 4, 12, and 13.
Claims 1, 2, 4-9, 15-17, and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,226,564. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a coaxial, dual lumen catheter system and corresponding method of use, the catheter comprising a first inner catheter that slides within a second outer catheter, wherein the surfaces of the inner and outer catheters are flush with each other to form an interference fit. In use the catheters are advanced from the LA, through the mitral valve, toward the aortic valve, and into the ascending aorta. The instant claims are broader than the ‘564 claims because they do not necessarily require a first inner catheter and a second inner catheter, wherein the second inner catheter is advanced over the first inner catheter.
While the independent claims of the ‘564 patent do not require the use of a belooon to center the inner sheath with respect to the mitral valve, this limitation is required in dependent claims 4, 5, 12, and 13.
Allowable Subject Matter
Claims 1, 2, 4-9, 15-17, and 19-20 would be allowable upon filing a terminal disclaimer to overcome the double patenting rejection.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art does not teach or suggest the claims as amended. Specifically, it is unclear why one of ordinary skill in the art would have modified Alaswad to have both an arterial sheath catheter and an arterial sheath inner catheter as claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Banchieri et al. (US 2011/0152741) teaches a cannula system with a tapered inner catheter for inserting a catheter system into the body.
Macoviak (US 6,673,041) teaches a multi-lumen catheter system for insertion into a patient’s heart.
Kelly (US 2016/0082176) teaches a coaxial dual-lumen catheter system providing ECMO.
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 Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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/PHILIP R WIEST/ Primary Examiner, Art Unit 3781