DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application is a CON of 17/852,220 06/28/2022 PAT 12343252
17/852,220 is a CON of 16/601,054 10/14/2019 PAT 11376119
16/601,054 is a CON of 15/288,693 10/07/2016 PAT 10441412
15/288,693 is a CON of 14/313,160 06/24/2014 PAT 9585747
14/313,160 is a CON of 13/755,863 01/31/2013 PAT 9339379
13/755,863 is a CON of 12/761,349 04/15/2010 PAT 8414644
12/761,349 has PRO 61/169,367 04/15/2009 is acknowledged.
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 12-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18 of U.S. Patent No. 9585747. Although the claims at issue are not identical, they are not patentably distinct from each other because the narrower claims of the patent anticipate the broader claims of the instant application.
Patent claims anticipate Instant application claims
12 18
13 18
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites “a third portion” which already recited in claim 1. It is unclear if this is another portion or the same portion as in clam 1. The examiner’s position is that it is the same portion.
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 pre-AIA 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1, 3-7, 12-13, 15-18 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by US 2009/0276040 to Rowe et al. (Rowe).
The applied reference has a common assignee with the instant application. Based upon the pre-AIA 35 U.S.C. 102(e) date of the reference, it constitutes prior art. This rejection under pre-AIA 35 U.S.C. 102(e) might be overcome either by a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the inventor or joint inventors (i.e., the inventive entity) of this application and is thus not the invention “by another,” or if the same invention is not being claimed, by an appropriate showing under 37 CFR 1.131(a).
Rowe teaches:
Claim 1: A replacement heart valve configured to be delivered to a native valve, the native valve positioned between an atrium and a ventricle, the replacement heart valve comprising:
an expandable frame comprising a first portion configured to be positioned in an atrium of the heart, a second portion configured to be positioned inside of a native valve annulus, and a third portion configured to be positioned in a ventricle of the heart (Fig. 6 reproduced with annotation below), wherein:
the frame comprises a D-shape cross-section (Abstract) to facilitate engagement with the native valve annulus; and
the first portion has a first dimension, the third portion has a second dimension, and the first dimension is larger than the second dimension (Fig. 6 reproduced with annotation below);
a plurality of anchors (Fig. 6 reproduced with annotation below) extending from the frame, wherein each of the plurality of anchors extends generally toward the first portion of the frame when the frame is in an expanded configuration (Fig. 6 below), and wherein at least one anchor of the plurality of anchors extends towards an anterior native leaflet (the anchors are being placed at or below the native valve leaflet and extending generally toward the atrial side of the heart and therefore would be extending toward the anterior native leaflet); and
a valve body (Fig. 6 reproduced with annotation below) supported within the frame; wherein the first portion comprises an anchoring feature (Fig. 6 reproduced with annotation below) configured to contact the native valve on an atrial side of the native valve annulus; and
wherein the replacement heart valve is configured such that, after the replacement heart valve has been delivered to a native valve and expanded, the anchoring feature (Fig. 6 reproduced with annotation below) contacts tissue on the atrial side of the native valve annulus and at least some of the plurality of anchors contact tissue on a ventricular side of the native valve annulus (Fig. 8D shows the frame and valve placed in the native mitral valve where both frame with anchors in Fig. 6 below are engaging the native mitral valve at both atrial and ventricular sides, therefore, the anchors are engaging both the atrial and ventricular sides of the native mitral valve).
Claims 3 and 15: The plurality of anchors (Fig. 6 reproduced with annotation below) extend toward an atrial end of the expandable frame when the replacement heart valve is in an expanded configuration.
Claims 4 and 16: The expandable frame further comprises a third portion configured to be positioned in a ventricle of the heart (Fig. 6 reproduced with annotation below), wherein the plurality of anchors extend from the third portion of the expandable frame (Fig. 6 reproduced with annotation below).
Claims 5 and 17: The plurality of anchors (Fig. 6 reproduced with annotation below) extend radially outward from the third portion of the expandable frame and towards an atrial end of the expandable frame.
Claim 6: A portion of the expandable frame is flared to provide the anchoring feature (the 1st portion is flared).
Claim 7: The anchoring feature is a shoulder. (the flared end of the first portion is considered a shoulder, Fig. 6 below).
Claim 12: A replacement heart valve configured to be delivered to a native valve, the native valve positioned between an atrium and a ventricle, the replacement heart valve comprising:
an expandable frame (Fig. 6 reproduced with annotation below) comprising a first portion configured to be positioned in an atrium of the heart and a second portion configured to be positioned inside of a native valve annulus (Fig. 6 reproduced with annotation below), wherein the frame comprises a non-circular cross-section (D-shape, Abstract) to facilitate engagement with the native valve annulus;
a plurality of anchors (Fig. 6 reproduced with annotation below) extending from the frame, wherein each of the plurality of anchors extends generally toward the first portion of the frame when the frame is in an expanded configuration (Fig. 6 reproduced with annotation below), and wherein at least one anchor of the plurality of anchors extends towards an anterior native leaflet (the anchors are being placed at or below the native valve leaflet and extending generally toward the atrial side of the heart and therefore would be extending toward the anterior native leaflet); and
a valve body supported within the frame (Fig. 6 reproduced with annotation below);
wherein the first portion comprises an anchoring feature configured to contact the native valve on an atrial side of the native valve annulus (anchors, Fig. 6 reproduced with annotation below); and
wherein the replacement heart valve is configured such that, after the replacement heart valve has been delivered to a native valve and expanded, the anchoring feature contacts tissue on the atrial side of the native valve annulus and at least some of the plurality of anchors contact tissue on a ventricular side of the native valve annulus (Fig. 8D shows the frame and valve placed in the native mitral valve where both frame with anchors in Fig. 6 below are engaging the native mitral valve at both atrial and ventricular sides, therefore, the anchors are engaging both the atrial and ventricular sides of the native mitral valve).
Claim 13: The non-circular cross-section comprises a D-shape. (Abstract)
Claim 18: The plurality of anchors (104, Fig. 6) are approximately equally spaced around a perimeter of the expandable frame.
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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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2 and 14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rowe in view of US 2009/0216313 to Straubinger et al. (Straubinger).
Rowe teaches:
The replacement heart valve of claims 1 and 12 ( see rejection of claims 1 and 12 above).
Rowe fails to teach:
Claim 2: The plurality of anchors extend in a direction generally parallel to a longitudinal axis when the replacement heart valve is in a collapsed configuration.
Straubinger teaches:
In the same field as endeavor, stent for the positioning and anchoring of a valvular prosthesis, comprising a stent frame with positioning anchors (16a-c, 18a-c, Fig. 1b), that extend in a direction generally parallel to a longitudinal axis when the replacement heart valve is in a collapsed configuration.
It would have been obvious to one of ordinary skill in the art at the time of the invention as made to modify the anchors as taught by Straubinger into Rowe in order to enhance space saving and avoid hooking or scratching tissues before being deployed.
Claims 8-9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rowe in view of US 2010/0036479 to Hill et al. (Hill).
Rowe teaches:
The replacement heart valve of claim 1 (see rejection of claim 1 above).
Rowe fails to teach:
Claim 8: A liner covering at least part of the expandable frame.
Claim 9: A liner covering at least part of the plurality of anchors.
Hill teaches:
Claim 8: In the same field as endeavor, stented heart valve devices comprises stented frame (Fig. 1) including a liner covering (84, Fig. 14) at least part of the expandable frame (para. 0009).
Claim 9: A liner (84, Fig. 14) covering at least part of the plurality of anchors (the anchors is said to be covered by the liner material with respect to the view point from where the anchor is being view. The liner 84 in Fig. 14 covers all of the stented frame and the anchor in Fig. 22 is extending from the ends of the frame, looking from the inside of the stented frame outward, the anchor is being cover by the fabric material).
It would have been obvious to one of ordinary skill in the art at the time of the invention was made to modify a liner or covering material as taught by Hill into the stent frame of Rowe in order to enhance tissue ingrowth (para. 0055).
Claims 10 and 19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rowe in view of US 6,425,913 to Garrison et al. (Garrison).
Rowe teaches:
The replacement heart valve of claims 1 and 12 (see rejection of claims 1 and 12 above).
Rowe fails to teach:
The expandable frame comprises undulating struts.
Garrison teaches:
In the same field as endeavor, methods and devices for implanting cardiac valves comprises undulating stent frame (Figs. 9-10).
It would have been obvious to one of ordinary skill in the art at the time of the invention was made to modify the stent frame of Rowe with the undulating struts as taught by Garrison as an obvious matter of design choice because Applicant has not disclosed that the undulating struts provides an advantage, is used for a particular purpose, or solves a stated problem.
Claims 11 and 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rowe in view of US 2006/0052867 to Revuelta et al. (Revuelta).
Rowe teaches:
The replacement heart valve of claims 1 and 12 (see rejection of claims 1 and 12 above).
Rowe fails to teach:
Claims 11 and 20: An additional anchoring feature extending radially outward of the expandable frame in a ventricular direction.
Revuelta teaches:
In the same field as endeavor, replacement prosthetic heart valve comprises a stent frame (12, Fig. 1A) including anchors (40, Fig. 1A) that extending radially outward of the expandable frame in a ventricular direction.
It would have been obvious to one of ordinary skill in the art at the time of the invention was made to modify anchors as taught by Revuelta in to Rowe in order to enhance anchoring the stent frame of Rowe to valve annulus.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHONG SON DANG whose telephone number is (571)270-5809. The examiner can normally be reached Mon-Fri 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 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHONG SON H DANG/Primary Examiner, Art Unit 3771
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