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
The amendments filed on 06/18/2026 have been entered. Claims 1-16 are pending in the application. The double patenting rejection is maintained below and should not be held in abeyance.
Response to Arguments
Applicant’s arguments, see pages 5-7, filed 06/18/2026, with respect to the rejection(s) of claim(s) 1 under 35 USC 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Boretos (US 4,056,854) and in view of Merhi (US 2012/0179033).
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, 3, 4, 6, 7, 8, 9, 10, and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 4, 6, 5, 7, 8, 9, 11, 12, 13 respectively of U.S. Patent No. 10,751,181. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined application claims are anticipated by the patent claims. Specifically, the patent claims also recite a temporary aortic valve apparatus comprising: a catheter shaft adapted to be advanced through a vasculature of a patient for placement within an aorta of the patient (Col 16 lines 37-40); and a flexible occluding membrane having a lateral side fixedly coupled to the catheter shaft (Col 16 lines 41-42) and adapted to alternate between an expanded occluding configuration and a collapsed lesser occluding configuration in the aorta in synchrony with ventricular diastole and systole (Col 16 lines 42-47) when the catheter shaft is placed within the aorta of the patient (col 16 line 48).
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) 1-8 and 10-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Merhi (US 2012/0179033).
Regarding claim 1, Merhi discloses a temporary aortic valve apparatus (100, FIG 1A-1D) comprising: a catheter shaft (102, [0039]) adapted to be advanced through a vasculature of a patient for placement within an aorta of the patient (FIG 10B shows placement in the aorta); and a flexible occluding membrane (110, [0042] the material to be a flexible membrane, which occludes to at least some degree by structurally blocking the aorta) and having a lateral side fixedly coupled to the catheter shaft ([0042-0043], FIG 1B and 1D) and adapted to alternate between an expanded occluding configuration (FIG 10C) and a collapsed lesser occluding configuration (FIG 10D) in the aorta (as shown deployed in the aorta) in synchrony with ventricular diastole and systole when the catheter shaft is placed within the aorta of the patient (The device is at least configured to alternate between the state of FIG 10C and 10D in the aorta, in synchrony with ventricular diastole and systole since it can be controlled via outer sheath 112).
Regarding claim 2, Merhi discloses the flexible occluding membrane includes an opening (140, [0042] or in the alternative, at least one opening of the porous membrane is interpreted as the opening) positioned at substantially a center of the flexible occluding membrane (FIG 1B; placed at the center of the distal end, or in the alternative, an opening formed by the porosity of the membrane is positioned along the side of 110).
Regarding claim 3, Merhi discloses the flexible occluding membrane includes an opening positioned at a location offset from a center of the flexible occluding membrane (Wherein an opening which forms the porosity of the membrane material, the opening is located on the side of 110 where the membrane is shown to be located).
Regarding claim 4, Merhi discloses the center of the flexible occluding membrane is disposed at a distal tip of the flexible occluding membrane (Wherein a center can be taken at the distal open end of 110, an opening in the porous membrane is offset from said center).
Regarding claim 5, Merhi discloses the catheter shaft is coupled to the flexible occluding membrane at the center of the flexible occluding membrane ([0043] “the embolic filter 110 is coupled to the catheter 102 on the side of the catheter facing the distal portion 104 when the distal portion 104” therefore showing the coupling point is at the center located at the distal tip of the membrane, FIG 1B and 1D).
Regarding claim 6, Merhi discloses the flexible occluding membrane includes a plurality of openings (The other opening forming the porosity are interpreted as the plurality of openings) to allow blood perfusion therethrough when in the expanded occluding configuration ([0042 and 0091] “The open distal end 140 of the embolic filter 110 is located in the ascending aorta so that blood flows through the filter before flowing into the carotid arteries or descending aorta… embolic debris dislodged or otherwise in the blood stream during the procedure is captured by the embolic filter 110”).
Regarding claim 7, Merhi discloses the flexible occluding membrane includes an opening ([0042] discloses “the embolic filter 110 comprises a porous membrane, for example a semi-permeable polyurethane membrane”, wherein one hole of the porous membrane is interpreted as the opening) with a cross-sectional size of 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less of an artery (it is understood that an opening in a semi-permeable polyurethane membrane is size less than 50% of a cross section of an artery).
Regarding claim 8, Merhi discloses the catheter shaft comprises a distal anchoring loop (Arcuate shape of 104, [0041, 0043], see loop shape in FIG 1A-1D) having an expanded curved configuration for anchoring the catheter shaft and the flexible occluding membrane in the aorta (Expanded curved shape in FIG 1A and 10B, [0090]) and a collapsed, straightened configuration for advancement into or retraction from an artery (FIG 10A, [0090] “ The guidewire 740 keeps the distal portion 104 of the catheter 102 substantially straight (e.g., from being in the generally arcuate state) as the catheter 102 is inserted into and navigated within the patient's body”).
Regarding claim 10, Merhi discloses the flexible occluding membrane is adapted to be positioned within an ascending aorta of the patient to provide occlusion therein (FIG 10C shows placement in the aorta, [0090]. Upon deployment, 110 at least partially occludes due to the semi-permeable nature of the membrane material, [0042]).
Regarding claim 11, Merhi discloses the flexible occluding membrane is adapted to be positioned within the ascending aorta just above the Sinus of Valsalva and coronary ostia (FIG 10C shows placement in the aorta, [0090]. FIG 10C appears to show placement above the Sinus of Valsalva and coronary ostia. Additionally, the device is at least configured to be deployed at various locations along the aorta, which could include above the Sinus of Valsalva and coronary ostia).
Regarding claim 12, Merhi discloses the flexible occluding membrane is adapted to be positioned within the ascending aorta between the coronary ostia and the brachiocephalic artery (FIG 10C appears to show placement between the coronary ostia and the brachiocephalic artery. Additionally, the device is at least configured to be deployed at various locations along the aorta, which could include between the coronary ostia and the brachiocephalic artery).
Regarding claim 13, Merhi discloses the flexible occluding membrane is biased to be in the expanded occluding configuration ([0044] “The embolic filter 110 self-expands to the expanded, open configuration when not contained by the outer sheath 112”).
Regarding claim 14, Merhi discloses the catheter shaft is adapted to advance transapically (The catheter is at least dimensioned and configured for transapical delivery).
Regarding claim 15, Merhi discloses the catheter shaft is adapted to advance transaortically (FIGs 10A-10 show transaortic delivery of the catheter, [0090-0092]).
Regarding claim 16, Merhi discloses the catheter shaft is adapted to advance transfemorally (The catheter is at least dimensioned and configured for transfemoral delivery).
Claim(s) 1 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boretos (US 4,056,854).
Regarding claim 1, Boretos discloses a temporary aortic valve apparatus (10, FIG 1) comprising: a catheter shaft (20, FIG 1, 2B, 3A-3B, col 2 lines 58-63) adapted to be advanced through a vasculature of a patient (30, 32, 34, FIG 2A-2B) for placement within an aorta of the patient (Col 3 lines 20-45); and a flexible occluding membrane (18) having a lateral side fixedly coupled to the catheter shaft (FIG 1 and 3A-3B show the lateral sides of 11 are fixed to the shaft via arms 14a-14c. The shaft and membrane do not decouple during use of the device and therefore are interpreted as being fixedly coupled) and adapted to alternate between an expanded occluding configuration (FIG 4A) and a collapsed lesser occluding configuration (FIG 4B) in the aorta in synchrony with ventricular diastole and systole (Col 2 lines 13-18 and col 3 lines 46-56) when the catheter shaft is placed within the aorta of the patient (FIGs 3A-4B show the shaft is placed within the aorta during use).
Regarding claim 9, Boretos discloses the flexible occluding membrane includes an annular proximal lip (The annular rim of valve material 18 at proximal opening) adapted to appose an inner wall of an artery when the flexible occluding membrane is in the expanded occluding configuration (FIG 4A).
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 BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
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