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 preliminary amendment filed November 18, 2024 has been entered. Claims 62-71 are currently pending.
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 62-68 and 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,321,995. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent and the instant application are claiming common subject matter including a side-delivered prosthetic heart valve comprising a self-expanding frame having a perimeter with proximal and distal areas fully capable of being folded, an inner flow control component, and a compressed configuration substantially parallel to a lengthwise cylindrical axis of the delivery catheter.
Claims 62-68 and 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,595,994. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent and the instant application are claiming common subject matter including a side-delivered prosthetic heart valve comprising a self-expanding frame having a perimeter with proximal and distal areas fully capable of being folded, an inner flow control component, and a compressed configuration substantially parallel to a lengthwise cylindrical axis of the delivery catheter.
Claims 62-68 and 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,071,627. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent and the instant application are claiming common subject matter including a side-delivered prosthetic heart valve comprising a self-expanding frame having a perimeter with proximal and distal areas fully capable of being folded, an inner flow control component, and a compressed configuration substantially parallel to a lengthwise cylindrical axis of the delivery catheter.
Claims 62-68 and 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,109,969. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent and the instant application are claiming common subject matter including a side-delivered prosthetic heart valve comprising a self-expanding frame having a perimeter with proximal and distal areas fully capable of being folded, an inner flow control component, and a compressed configuration substantially parallel to a lengthwise cylindrical axis of the delivery catheter.
Claims 62-68 and 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,273,033. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent and the instant application are claiming common subject matter including a side-delivered prosthetic heart valve comprising a self-expanding frame having a perimeter with proximal and distal areas fully capable of being folded, an inner flow control component, and a compressed configuration substantially parallel to a lengthwise cylindrical axis of the delivery catheter.
Claims 62-68 and 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,310,850. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent and the instant application are claiming common subject matter including a side-delivered prosthetic heart valve comprising a self-expanding frame having a perimeter with proximal and distal areas fully capable of being folded, an inner flow control component, and a compressed configuration substantially parallel to a lengthwise cylindrical axis of the delivery catheter.
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.
Claim(s) 62-66 and 68-71 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chambers (US 2018/0200049, hereinafter “Chambers”) in view of Alon et al. (US 2010/0049313, hereinafter "Alon").
Regarding claim 62, Chambers discloses a side delivered transcatheter prosthetic heart valve (300 or 500 or 900), the valve comprising:
a self-expanding outer annular support frame (909), said outer annular support frame having a central channel and an outer perimeter wall circumscribing a central vertical axis in an expanded configuration,
said perimeter wall having a front wall portion (907) and a back wall portion (907), the front wall portion and the back wall portion connected along a proximal side to a proximal fold area (908), and the front wall portion and the back wall portion connected along a distal side to a distal fold area (908) (para [0061] – fabric portions 908 fully capable of being folded and thus may be interpreted as the claimed fold area),
the front wall portion having a front upper collar portion (front portion of upper collar/apex of 900) and a front lower body portion (front portion of lower end of 900), the back wall portion having a back upper collar portion (back portion of upper collar/apex of 900) and a back lower body portion (back portion of lower end of 900),
said annular support frame having an inner flow control component (305 or 505 or 905) mounted within the annular support frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve (para [0051,0062]),
wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter (304 or 504) for implanting at a desired location in the body, said compressed configuration (Fig 3A) is oriented along a horizontal axis at an intersecting angle of between 45-135 degrees to the central vertical axis (approximately 90 degrees or perpendicular), and expandable to an expanded configuration (Fig 3B) having a horizontal axis at an intersecting angle of between 45-135 degrees to the central vertical axis (approximately 90 degrees or perpendicular), wherein the horizontal axis of the compressed configuration of the valve is substantially parallel to a lengthwise cylindrical axis of the delivery catheter (Fig 3A),
However, Chambers fails to disclose the dimensions of the valve. Alon discloses a well-known type of prosthetic heart valve (10) including a frame (stent 12) and a flow control component (leaflets 14). Alon teaches the frame is tubular (Figs 1, 3, 4), has a height of about 5-60 mm and a diameter of about 25-80 mm (para [0095]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chambers such the valve had a height of about 5-60 mm and a diameter of about 25-80 mm such that it was of a size and shape to fit within the native aortic valve (Figs 5A, 5B; para [0093]) and since it has been held that where the general conditions of a claim are disclosed in the prior art (a valve sized and shaped to fit within the native aortic valve), discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 63, Chambers teaches the annular support frame is comprised of a plurality of compressible wire cells (para [0061]) having an orientation and cell geometry substantially orthogonal to the central vertical axis (at least a portion of the cell is orthogonal to the central vertical axis) fully capable of minimizing wire cell strain when the annular support frame is configured in a vertical compressed configuration, a rolled compressed configuration, or a folded compressed configuration (when compared to another cell geometry with a greater wire cell strain).
Regarding claim 64, wherein said annular support frame is comprised of a braided, wire, or laser-cut wire frame (stented portion), and said annular support frame is covered with a biocompatible material (fabric covering) (para [0061]).
Regarding claim 65, Chambers teaches the diameter of the inner flow control component is smaller than the diameter of the outer annular support frame such that the inner flow control component fits inside the outer annular support frame (para [0051,0062]). However, Chambers fails to disclose the claimed dimensions. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chambers such that the outer annular support frame has a diameter R of 40-80 mm and a height of 5-20 mm, and the inner flow control component has a diameter of 20-35 mm since it has been held that where the general conditions of a claim are disclosed in the prior art (a valve sized and shaped to be delivered to the heart), discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 66, Chambers teaches the flow control component (305 or 505 or 905) is formed from 2-4 leaflets having an inflow end and a closable aperture at an outflow end (para [0061]), but fails to disclose leaflets are formed from pericardial material joined to form a rounded cylinder. Alon discloses a well-known type of prosthetic heart valve (10) including a frame (stent 12) and a flow control component (leaflets 14). Alon teaches the leaflet assembly (14) can comprise a plurality of leaflets (34a) made of a flexible material or any suitable biological material such as pericardial tissue (para [0097]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chambers such that the leaflets were formed from pericardial material joined to form a rounded cylinder since Alon teaches such a configuration is a known valve structure in the art and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.. Additionally, Chambers teaches the diameter of the inner flow control component is smaller than the diameter of the outer annular support frame such that the inner flow control component fits inside the outer annular support frame (para [0051,0062]). However, Chambers fails to disclose the claimed dimensions. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chambers such that the flow control component has an internal diameter of 20-35 mm and a height of 5-30 mm since it has been held that where the general conditions of a claim are disclosed in the prior art (a valve sized and shaped to be delivered to the heart), discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 68, Chambers fails to disclose the claimed tissue anchor. Alon teaches known prosthetic valves may be provided with additional anchoring or attachment devices to assist in anchoring the valve to the surrounding tissue (para [0006]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chambers such that the valve further comprised at least one tissue anchor connected to the annular support frame for engaging native tissue, since Alon teaches tissue anchors are known for assisting in anchoring the valve to surrounding tissue.
Regarding claim 69, wherein the front wall portion is a first flat panel and the back wall portion is a second flat panel, and wherein the proximal fold area (908) and the distal fold area (908) each comprise a sewn seam, a fabric panel, or a rigid hinge (para [0061] – fabric panels 908).
Regarding claim 70, wherein the proximal fold area (908) and the distal fold area (908), each comprise a flexible fabric span without any wire cells (para [0061] – fabric panels 908).
Regarding claim 71, wherein the annular support frame is comprised of compressible wire cells selected from the group consisting of braided-wire cells, laser-cut wire cells, photolithography produced wire cells, 3D printed wire cells, wire cells formed from intermittently connected single strand wires in a wave shape, a zig-zag shape, or spiral shape, and combinations thereof (para [0061]).
Allowable Subject Matter
Claim 67 would be allowable if rewritten or amended to overcome the rejection(s) on the ground of nonstatutory double patenting or if a terminal disclaimer is filed.
The following is a statement of reasons for the indication of allowable subject matter: The prior art fails to teach and/or disclose the valve further comprising: (i) an upper tension arm attached to a distal upper edge of the annular support frame, the upper tension arm comprised of wire loop or wire frame extending from about 2-20 mm away from the annular support frame; and(ii) a lower tension arm extending from a distal side of the annular support frame, the lower tension arm comprised of wire loop or wire frame, integrated frame section, or stent, extending from about 10-40 mm away from the annular support frame. Of the closest prior art, Chambers teaches it is undesirable to have a two chamber solution with a portion extending into the left ventricle, which is usually bulky and more difficult to deliver (para [0015-0016]). Although Chambers teaches the invention is readily applicable to single or 2-chamber solutions (para [0017]), it is unclear how known upper and lower tension arms designed to be deployed into the atrium and ventricle, respectively, would be added to Chambers' device and still maintain the orthogonal delivery. See for example Kovalsky et al. (US 2014/0222142) disclosing an atrial collar (1802) and lower tension arms (1871B) of a prosthetic heart valve (Fig 18) for an example of a known heart valve with tension arms. However, Kovalsky is not a side-delivered valve such that the horizontal axis of the compressed configuration of the valve is substantially parallel to a lengthwise cylindrical axis of the delivery catheter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kovalsky et al. (US 2014/0222142).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771