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 .
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 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-9, 12, 17, 19 of U.S. Patent No. 10,376,363. Although the claims at issue are not identical, they are not patentably distinct from each other because the Patent discloses:
Claim 1, the Patent discloses a transseptal delivery system for replacement heart valve implantation (column 49, lines 26-27), the delivery system comprising: a nose cone shaft having a proximal end and a distal end and a lumen extending therethrough (column 49, lines 28-29); a nose cone provided on the distal end of the nose cone shaft (column 49, lines 30-31); an inner retention shaft slideably positioned over the nose cone shaft, the inner retention shaft having a proximal end and a distal end; an inner retention ring provided on the distal end of the inner retention shaft (column 49, lines 32-34), the inner retention ring configured to receive struts at a proximal portion of a replacement heart valve prosthesis (column 49, lines 35-38); a mid shaft slideably positioned over the inner retention shaft, the mid shaft having a proximal end and a distal end (column 49, lines 39-41); an outer retention ring provided on the distal end of the mid shaft, the outer retention ring configured to be positioned over the inner retention ring to hold the proximal portion of the replacement heart valve prosthesis within the inner retention ring (column 49, lines 42-46); and an outer sheath assembly slideably positioned over the mid shaft and over the outer retention ring, the outer sheath assembly configured to radially restrain a distal portion of the replacement heart valve prosthesis when the proximal portion of the replacement heart valve prosthesis is held by the outer retention ring within the inner retention ring (column 49, lines 47-53), wherein the outer sheath assembly comprises a proximal segment and a distal segment, wherein the distal segment is configured to cover the replacement heart valve prosthesis (column 50, lines 7-10), and wherein the distal segment is formed from an inner polymer layer and an outer polymer layer (column 50, lines 14-16).
Claim 2, the Patent discloses wherein the outer sheath assembly is configured to slide over the nose cone (column 49, lines 65-67).
Claim 3, the Patent discloses wherein the distal segment further comprises: a proximal section comprising a hypotube sandwiched between the inner and outer polymer layers (column 50, lines 18-19); and a distal section comprising an intermediate polymer layer sandwiched between the inner and outer polymer layers (column 50, lines 20-22).
Claim 4, the Patent discloses wherein the distal section has a greater diameter than the proximal section (column 50, lines 23-25).
Claim 5, the Patent discloses further comprising a polymer reinforcement in the distal section that at least partially overlaps the intermediate polymer layer (column 50, lines 26-28).
Claim 6, the Patent discloses wherein the inner polymer layer and the outer polymer layer comprise ePTFE with generally longitudinally extending polymer chains, and the intermediate polymer layer comprises ePTFE having generally circumferentially extending polymer chains (column 50, lines 29-34).
Claim 7, the Patent discloses wherein the hypotube comprises a plurality of circumferentially extending cuts along a longitudinal length thereof.
Claim 8, the Patent discloses wherein the mid shaft comprises a longitudinally pre-compressed polymer tube located within the outer sheath assembly (column 49, lines 54-56), wherein the pre-compressed polymer tube is configured so that deflection of the mid shaft does not substantially change the location of the outer retention ring relative to the inner retention ring (column 49, lines 58-62).
Claim 9, the Patent discloses wherein the nose cone comprises an elongate hollow body that is distally tapered to facilitate bending of the nose cone when the nose cone is delivered over a guidewire and comes into contact with an internal body surface (column 50, lines 46-50).
Claim 10, the Patent discloses a flexible delivery system for replacement heart valve implantation, the delivery system comprising (column 51, lines 1-2): an outer sheath comprising a distal segment configured to cover a replacement heart valve, wherein the distal segment is formed from an inner polymer wall and an outer polymer wall (column 51, lines 3-6), and wherein the distal segment further comprises: a proximal section comprising a hypotube sandwiched between the inner polymer wall and the outer polymer wall (column 51, lines 6-10); and a distal section comprising an intermediate polymer layer sandwiched between the inner polymer wall and the outer polymer wall (column 51, lines 11-13).
Claim 11, the Patent discloses wherein a proximalmost end of the intermediate polymer layer is distal from a distal most end of the hypotube (column 51, lines 14-16).
Claim 12, the Patent discloses wherein the distal section has a greater diameter than the proximal section (column 51, lines 21-22).
Claim 13, the Patent discloses wherein the inner polymer wall, the outer polymer wall, and the intermediate polymer layer comprise ePTFE (column 52, lines 17-18).
Claim 14, the Patent discloses further comprising a polymer reinforcement in the distal section that at least partially overlaps the intermediate polymer layer (column 51, lines 17-19).
Claims 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17 and 19 of U.S. Patent No. 10,376,363 in view of Rabito et al. U.S. Publication 2015/0342736 A1 (provisional application filed on May 20, 2014).
Claim 17, the Patent discloses a flexible delivery system for replacement heart valve implantation, the delivery system comprising (column 51, lines 1-2): an outer sheath comprising a distal segment, wherein the distal segment is configured to cover a replacement heart valve (column 51, lines 3-4), wherein the distal segment is formed from two or more layers (column 51, lines 4-6), wherein the two or more layers comprise an inner layer, an outer layer, and one or more intermediate layers positioned between the inner and outer layers (column 51, lines 4-6 and lines 11-13), and wherein the one or more intermediate layers comprises a nitinol hypotube (column 52, lines 1-5). However, the Patent does not expressly disclose the outer sheath has a proximal segment. Rabito et al. teaches a delivery system for replacement heart valve implantation (abstract and paragraphs [0003], [0008-0009]), the system 300 comprising an outer sheath 316 comprising a proximal segment and a distal segment (paragraph [0041] and as seen in Figure 6), wherein the distal segment is configured to cover a replacement heart valve (paragraphs [0028], [0041]), wherein the outer sheath comprises a proximal segment for the purpose of having a sheath that is concentric with the one or more shafts of the delivery system (paragraphs [0028], [0040]).
Claim 18, the Patent discloses wherein the inner layer comprises ePTFE (column 52, lines 17-19).
Claim 19, the Patent discloses wherein the outer layer comprises ePTFE (column 52, lines 17-19).
Allowable Subject Matter
Claims 15-16 and 20 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. The following is a statement of reasons for the indication of allowable subject matter: the closest prior art Rabito et al. U.S. Publication 2015/0342736 does not expressly disclose nor render obvious wherein the polymer reinforcement comprises a fluorinated ethylene propylene insert and a replacement heart valve loaded within the distal section of the distal segment, wherein the replacement heart valve comprises ventricular anchors that apply a radially outward force to the distal section of the distal segment and wherein the distal segment comprises a proximal portion and a distal portion, wherein the proximal portion comprises a first intermediate layer of the one or more intermediate layers and the distal portion comprises a second intermediate layer of the one or more intermediate layers located distal to the first intermediate layer, and wherein a gap exists between the first intermediate layer and the second intermediate layer.
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) 10 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goodin et al. U.S. Publication 2007/0208405 A1.
Regarding Claim 10, Goodin et al. discloses a flexible delivery system for replacement heart valve implantation (abstract), the delivery system comprising: an outer sheath 76 comprising a distal segment 90 configured to cover a replacement heart valve 54 (paragraphs [0046], [0058-0059]), wherein the distal segment 90 is formed from an inner polymer wall and an outer polymer wall 78, 86 (paragraphs [0032], [0034-0035] and [0039]), and wherein the distal segment 90 further comprises: a proximal section comprising a hypotube sandwiched between the inner polymer wall 86 and the outer polymer wall 74; and a distal section comprising an intermediate polymer layer sandwiched between the inner polymer wall and the outer polymer wall (paragraphs [0032], [0034-0035], [0039-0041] and [0043]).
Regarding Claim 17, Goodin et al. discloses a flexible delivery system for replacement heart valve implantation (abstract), the delivery system comprising: an outer sheath 76 comprising a proximal segment 88 and a distal segment 90 (paragraph [0053]), wherein the distal segment 90 is configured to cover a replacement heart valve 54 (paragraphs [0046], [0058-0059]), wherein the distal segment 90 is formed from two or more layers 78, 86 (paragraphs [0032], [0034-0035] and [0039]), wherein the two or more layers comprise an inner layer 86, an outer layer 78, and one or more intermediate layers (the inner shaft 86 and the outer shaft 78 includes additional layers formed of one or more micromachined hypotubes made of nitinol) positioned between the inner and outer layers (paragraphs [0032], [0034-0035], [0039], [0042], [0052] and [0060-0061]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
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