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 4/14/2026, applicant amended claims 1, 6, 9-12, 15, 17, and 18, and cancelled claim 16. Claims 1-15 and 17-19 are currently pending.
Response to Arguments
Applicant’s arguments with respect to the 112(b), 103, and Statutory Double Patenting rejections have been found persuasive in view of the amendments to the claims. These rejections have been withdrawn.
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 1-15 and 17-19 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 method for performing transseptal ECMO, the method comprising: advancing a first inner catheter through a transseptal puncture; deflecting the first inner catheter within the left atrium so that a distal tip of the first inner catheter is disposed substantially toward a mitral valve; advancing the first inner catheter through the mitral valve; deflecting the distal tip of the first inner catheter toward an aortic valve; advancing the first inner catheter through the aortic valve so that a distal end of the second inner catheter is in an ascending aorta; advancing a second inner catheter distally over the first inner catheter, wherein the second inner catheter is coaxial with and surrounds the first inner catheter; withdrawing the first inner catheter; and receiving, from the patient, oxygen-poor blood through an outer catheter and returning oxygenated blood through the second inner catheter to the ascending aortic arch.
Instant claims 1-10 are broader than the ‘091 claims at least because they do not necessarily require that the first inner catheter is distally tapered.
Instant claims 11-19 are broader than the ‘091 claims because they do not require the step of advancing a first catheter that includes an inner sheath and an outer sheath through a transseptal puncture.
Claims 1-15 and 17-19 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 because both claim sets are drawn to a method for performing transseptal ECMO, the method comprising: advancing a first inner catheter through a transseptal puncture; deflecting the first inner catheter within the left atrium so that a distal tip of the first inner catheter is disposed substantially toward a mitral valve; advancing the first inner catheter through the mitral valve; deflecting the distal tip of the first inner catheter toward an aortic valve; advancing the first inner catheter through the aortic valve so that a distal end of the second inner catheter is in an ascending aorta; advancing a second inner catheter distally over the first inner catheter, wherein the second inner catheter is coaxial with and surrounds the first inner catheter; withdrawing the first inner catheter; and receiving, from the patient, oxygen-poor blood through an outer catheter and returning oxygenated blood through the second inner catheter to the ascending aortic arch. The claims differ in that the instant claims require advancing the first inner catheter through the aortic valve so that the distal end of the first distal end is in an ascending aorta, while the ‘564 claims require that the second distal end is in the ascending aorta. However, this step is implicit given that both claim sets explicitly require advancing the first inner catheter through the aortic valve.
Claims 1-15 and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,569,608. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method of implanting a catheter from through the heart chambers and into the aorta. The instant claims are broader than the ‘723 claims because they do not necessarily require that the arterial sheath catheter is advanced over the inner catheter until the arterial sheath catheter is at least 1 cm distal to the aortic valve. The ‘838 application also uses different terminology for the first inner catheter, second inner catheter, and outer catheter than the instant application.
The examiner notes that this rejection was previously presented as a provisional rejection over copending Application No.19/264,838. However, a patent was issued on this application on 3/10/2026.
Allowable Subject Matter
Claims 1-15 and 17-19 would be allowable upon filing a terminal disclaimer to overcome the double patenting rejections.
The following is a statement of reasons for the indication of allowable subject matter: Applicant has moved the allowable portions of claims 9 and 17 into independent claims 1 and 11, respectively. See the reasons for allowance in the previous office action.
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 Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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