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 .
Claim Rejections - 35 USC § 103
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.
Claims 1-3, 5-8, 10-11, 13-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Morriss et al. (US 2013/0310928) in view of Seguin (US 2012/0016464).
Regarding claim 1, an invention relating to prosthetic heart valve, Morriss discloses (Figs. 2A1, 2A4, 2F3-A) a prosthetic implant assembly (Abstract) comprising: a prosthetic valve (100) comprising a frame (110) and a plurality of leaflets (152) coupled to an interior portion of the frame (Par. 0205), wherein the frame comprises an atrial portion (163) and one or more arms (120), wherein the atrial portion extends radially outwardly from an inflow end portion of the frame, and wherein the one or more arms extend radially outwardly from an outflow end portion of the frame (Par. 0084-0085, 0150, 0209). However, Morriss fails to disclose an anchoring device comprising a coil configuration configured to extend around native heart valve leaflets and to define an inner space for receiving the frame of the prosthetic valve, wherein the atrial portion and the one or more arms of the prosthetic valve extend radially outwardly beyond the anchoring device.
In the same field of endeavor, which is prosthetic heart valve, Seguin teaches (Fig. 1A) an anchoring device (40) comprising a coil configuration configured to extend around native heart valve leaflets and to define an inner space for receiving a frame (30) of the prosthetic valve (10; Par. 0025 & 0028), wherein an atrial portion [i.e. upper flared end (32)] and one or more arms [i.e. woven wire making cell pattern of the end of the lower flared end (32)] of the prosthetic valve extend radially outwardly beyond the anchoring device (Figs. 7-8).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Morriss to have an anchoring device comprising a coil configuration configured to extend around native heart valve leaflets and to define an inner space for receiving the frame of the prosthetic valve, wherein the atrial portion and the one or more arms of the prosthetic valve extend radially outwardly beyond the anchoring device. Doing so would reduce the risk that the replacement cardiac valve will obstruct the outflow tract of an adjacent cardiac valve, ensure that the replacement valve body cannot overexpand during deployment, and reduce the risk of perivalvular leaks arising around the replacement cardiac valve (Par. 0028), as taught by Seguin.
Regarding claim 2, Morriss, as modified by Seguin, discloses the prosthetic implant assembly of claim 1. Morriss further discloses (Fig. 2A1) wherein the one or more arms is a plurality of arms comprising a first arm (120A) and a second arm (120B), and wherein the entire first arm and the entire second arm are shaped differently from one another (Par. 0187 & 0189).
Regarding claim 3, Morriss, as modified by Seguin, discloses the prosthetic implant assembly of claim 2. Morriss further discloses wherein the first arm differs from the second arm in that the first arm comprises a closed annulus that defines an opening [i.e. tube or eyelet] through which an anchoring device is guided (Par. 0189 & 0193).
Regarding claim 5, Morriss, as modified by Seguin, discloses the prosthetic implant assembly of claim 2. Morriss further discloses wherein the first arm is of a heavier construction [i.e. a larger size and shape] than the second arm (Par. 0189).
Regarding claim 6, Morriss, as modified by Seguin, discloses the prosthetic implant assembly of claim 2. Morriss discloses (Fig. 2A1) further comprising a third arm having a same shape as the second arm [i.e. another arm from the second plurality of arms (120B; Par. 0149)].
Regarding claim 7, Morriss, as modified by Seguin, further discloses wherein prosthetic valve and the anchoring device are configured such that the native heart valve leaflets are disposed between the prosthetic valve and the coils of the anchoring device upon deployment of the prosthetic implant assembly in a native heart valve [i.e. see Seguin Paragraphs 0028 and 0033-0035].
Regarding claim 8, Morriss discloses (Figs. 2A1, 2A4, 2F3-A) a prosthetic implant assembly (Abstract) comprising: a prosthetic valve (100) comprising a frame (110) and a plurality of leaflets (152) coupled to an interior portion of the frame (Par. 0205), wherein the frame comprises a flange portion (163) and a plurality of arms (120), wherein the flange portion extends radially outwardly from a first end portion of the frame, and wherein the arms extend radially outwardly from a second end portion of the frame (Par. 0084-0085, 0150, 0209). However, Morriss fails to disclose a helical anchoring device configured to extend around native heart valve leaflets and to define an inner space for receiving the frame of the prosthetic valve, wherein the flange portion and the arms of the prosthetic valve extend radially outwardly beyond the anchoring device.
In the same field of endeavor, which is prosthetic heart valve, Seguin teaches (Fig. 1A) a helical anchoring device (40) configured to extend around native heart valve leaflets and to define an inner space for receiving a frame (30) of a prosthetic valve (10; Par. 0025 & 0028), wherein a flange portion [i.e. upper flared end (32)] and the arms [i.e. woven wire making pattern of cells at the end of the lower flared end (32)] of the prosthetic valve extend radially outwardly beyond the anchoring device (Figs. 7-8).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Morriss to have a helical anchoring device configured to extend around native heart valve leaflets and to define an inner space for receiving the frame of the prosthetic valve, wherein the flange portion and the arms of the prosthetic valve extend radially outwardly beyond the anchoring device. Doing so would reduce the risk that the replacement cardiac valve will obstruct the outflow tract of an adjacent cardiac valve, ensure that the replacement valve body cannot overexpand during deployment, and reduce the risk of perivalvular leaks arising around the replacement cardiac valve (Par. 0028), as taught by Seguin.
Regarding claim 10, Morriss, as modified by Seguin, discloses the prosthetic implant assembly of claim 8. Morriss further discloses (Fig. 2A1) wherein the plurality of arms comprises a first arm (120A) and a second arm (120B), and wherein the entire first arm and the entire second arm are shaped differently from one another (Par. 0187 & 0189).
Regarding claim 11, Morriss, as modified by Seguin, discloses the prosthetic implant assembly of claim 10. Morriss further discloses wherein the first arm differs from the second arm in that the first arm comprises a closed annulus that defines an opening [i.e. tube or eyelet] through which an anchoring device is guided (Par. 0189 & 0193).
Regarding claim 13, Morriss, as modified by Seguin, discloses the prosthetic implant assembly of claim 10. Morriss further discloses wherein the first arm is of a heavier construction [i.e. a larger size and shape] than the second arm (Par. 0189).
Regarding claim 14, Morriss, as modified by Seguin, discloses the prosthetic implant assembly of claim 10. Morriss discloses further comprising a third arm having a same shape as the second arm [i.e. another arm from the second plurality of arms (120B; Par. 0149)].
Regarding claim 15, Morriss, as modified by Seguin, discloses further wherein prosthetic valve and the anchoring device are configured such that the native heart valve leaflets are disposed between the prosthetic valve and the coils of the anchoring device upon deployment of the prosthetic implant assembly in a native heart valve [i.e. see Seguin Paragraphs 0028 and 0033-0035].
Regarding claim 16, Morriss discloses (Figs. 2A1, 2A4, 2F3-A) a prosthetic implant assembly for implantation at a native mitral valve (Abstract), comprising: a prosthetic mitral valve (100) comprising a frame (110) and a plurality of leaflets (152) coupled to an interior portion of the frame (Par. 0205), wherein the frame comprises an atrial portion (163) and one or more arms (120), wherein the atrial portion extends radially outwardly from an inflow end portion of the frame and is configured to engage native tissue in a patient’s left atrium, and wherein the one or more arms extend radially outwardly from an outflow end portion of the frame and are configured to engage native mitral valve leaflets (Par. 0084-0086, 0150, 0209). However, Morriss fails to disclose an anchoring device comprising a coil configuration configured to extend around the native mitral valve leaflets on a ventricular side of the native mitral valve leaflets, wherein the anchor device defines an inner space for receiving the frame of the prosthetic mitral valve, wherein the atrial portion and the one or more arms of the prosthetic mitral valve extend radially outwardly beyond an outer diameter of the anchoring device.
In the same field of endeavor, which is prosthetic heart valve, Seguin teaches (Fig. 1A) an anchoring device (40) comprising a coil configuration configured to extend around the native mitral valve leaflets on a ventricular side of the native mitral valve leaflets, wherein the anchor device defines an inner space for receiving a frame (30) of a prosthetic mitral valve (10; Par. 0025 & 0028), wherein an atrial portion [i.e. upper flared end (32)] and one or more arms [i.e. woven wire making cell pattern of the end of the lower flared end (32)] of the prosthetic mitral valve extend radially outwardly beyond an outer diameter of the anchoring device (Figs. 7-8).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Morriss to have an anchoring device comprising a coil configuration configured to extend around the native mitral valve leaflets on a ventricular side of the native mitral valve leaflets, wherein the anchor device defines an inner space for receiving the frame of the prosthetic mitral valve, wherein the atrial portion and the one or more arms of the prosthetic mitral valve extend radially outwardly beyond an outer diameter of the anchoring device. Doing so would reduce the risk that the replacement cardiac valve will obstruct the outflow tract of an adjacent cardiac valve, ensure that the replacement valve body cannot overexpand during deployment, and reduce the risk of perivalvular leaks arising around the replacement cardiac valve (Par. 0028), as taught by Seguin.
Regarding claim 17, Morriss, as modified by Seguin, discloses the prosthetic implant assembly of claim 16. Morriss discloses (Fig. 2A1) wherein the one or more arms is a plurality of arms comprising a first arm (120A) and a second arm (120B), and wherein the entire first arm and the entire second arm are shaped differently from one another (Par. 0187 & 0189).
Regarding claim 18, Morriss, as modified by Seguin, discloses the prosthetic implant assembly of claim 17. Morriss further discloses wherein the first arm differs from the second arm in that the first arm comprises a closed annulus that defines an opening [i.e. tube or eyelet] through which an anchoring device is guided (Par. 0189 & 0193).
Regarding claim 20, Morriss, as modified by Seguin, discloses the prosthetic implant assembly of claim 17. Morriss further discloses wherein the first arm is of a heavier construction [i.e. a larger size and shape] than the second arm (Par. 0189).
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 1-5, 7-8, 10-13, and 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7, 9, and 11 of U.S. Patent No. 10,052,199. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are fully contained within the claim of the patent application.
Claims 18/624,452
1
2
3
4
5
7
8
10
Claims US Patent No.
10,052,199
1 & 9
1 & 9
1 & 9
4 & 11
7
1 & 9
1 & 9
1 & 9
Claims 18/624,452
11
12
13
15
16
17
18
19
20
Claims US Patent No.
10,052,199
1 & 9
4 & 11
7
1 & 9
1 & 9
1 & 9
1 & 9
4 & 11
7
Claims 1-2, 4-5, 7-8, 10, 12-13, 15-17, and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7, 9, and 10 of U.S. Patent No. 10,898,320. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are fully contained within the claim of the patent application.
Claims 18/624,452
1
2
4
5
7
8
10
Claims US Patent No.
10,898,320
1, 9, 10
2
1 & 10
7
1 & 10
1, 9, 10
2
Claims 18/624,452
12
13
15
16
17
19
20
Claims US Patent No.
10,898,320
1 & 10
7
1 & 10
1, 9, 10
2
1 & 10
7
Claims 1-5, 7-8, 10-13, and 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7, 9, and 11 of U.S. Patent No. 11,974, 914. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are fully contained within the claim of the patent application.
Claims 18/624,452
1
2
3
4
5
6
8
9
10
Claims US Patent No.
11,974, 914
1 & 7
1
2 & 9
3
4 & 11
5
1 & 7
1 & 7
1
Claims 18/624,452
11
12
13
14
16
17
18
19
20
Claims US Patent No.
11,974, 914
2 & 9
3
4 & 11
5
1 & 7
1
2 & 9
3
4 & 11
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.U.I/ Examiner, Art Unit 3771
/ROBERT A LYNCH/Primary Examiner, Art Unit 3771