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.
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Claims 2-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6 of U.S. Patent No. 11,337,808 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the Patent discloses:
Regarding Claim 2, the Patent discloses an annuloplasty ring for receiving a replacement heart valve comprising (column 8, lines 7-8): a core comprised of one continuous segment (the claim states a closed elongate core configured to establish a preferred perimeter of a human blood valve, therefore it is a continuous shape, see column 8, lines 9-11) with areas of increased stretchability along the one continuous segment (column 8, lines 18-22); a cover surrounding the core (column 8, line 26); the areas of increased stretchability configured for alignment with commissures of a target native heart valve (column 8, lines 21-22); the core being stretchable to a perimeter sufficient to receive a replacement valve but not so stretchable that the core separates into multiple segments the areas of increased stretchability (the claim states a closed elongate core, wherein said stretched state of the core has a perimeter larger than the preferred perimeter, therefore it is a continuous ring, not broken into multiple segments, see column 8, lines 9-17) configured to have a sufficient squeezing force on the replacement heart valve so as to prevent paravalvular leakage (column 8, lines 29-32).
Regarding Claim 3, the Patent discloses wherein said shape comprises an incomplete circle (column 8, lines 33-34).
Regarding Claim 4, the Patent discloses wherein said shape comprises a complete circle (column 8, lines 35-36).
Regarding Claim 5, the Patent discloses wherein said shape comprises an incomplete "D" shape that mimics a healthy mitral valve perimeter (column 8, lines 37-39).
Regarding Claim 6, the Patent discloses wherein said areas of increased stretchability comprises at least one tapered section of said core (column 8, lines 43-44).
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) 2, 4, 6-7, 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lim et al. U.S. Publication 2005/0256569 A1 in view of Bulman-Fleming et al. U.S. Publication 2006/0015179 A1.
Regarding Claim 2, Lim et al. discloses an annuloplasty ring for receiving a replacement heart valve comprising: a core 10 comprised of one continuous segment with areas of increased stretchability 22b, 22d, 24b, 24d along the one continuous segment (paragraph [0016-0017]); a cover surrounding the core (Lim discloses the ring may comprise fabric covers [0032]); the core being stretchable to a perimeter (Lim discloses increased flexibility, see paragraph [0014], [0016-0017]), but not so stretchable that the core separates into multiple segments the areas of increased stretchability configured to have a sufficient squeezing force (as seen in Figures 1-4). The limitation “sufficient to receive a replacement valve” and “the replacement heart valve so as to prevent paravalvular leakage” is considered a recitation of intended use, the replacement valve has not been positively claimed. However, Lim et al. does not expressly disclose the areas of increased stretchability configured for alignment with commissures of a target native heart valve. Bulman-Fleming et al. teaches an annuloplasty ring in the same field of endeavor comprising a core 400 and 208 having a continuous segment 205 (as seen in Figures 19C-19D and paragraphs [0052] and [0101]) with areas of increased stretchability 401(paragraphs [0086] and [0102]) aligned at the commissure of the ring for the purpose of allowing the areas of increased stretchability to stretch between the flexible and stiff portions (paragraph [0090] and [0093]) during the diastolic and systolic phase of the cardiac cycle (paragraph [0102]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Lim’s area of increased stretchability to be configured for alignment with commissures of a target native heart valve as taught by Bulman-Fleming et al. for the purpose of allowing the areas of increased stretchability to stretch between the flexible and stiff portions to accommodate the changes in diameter during systolic and diastolic phase of the cardiac cycle.
Regarding Claim 4, Lim et al. discloses wherein said shape comprises a complete circle (as seen in Figures 2 and 4).
Regarding Claim 6, Lim et al. discloses wherein said areas of increased stretchability 22b, 22d, 24b, 24d comprises at least one tapered section of said core (as seen in Figure 4).
Regarding Claim 7, Lim et al. discloses wherein said at least one tapered section comprises a cross section selected from the group including: circular, square, rectangular, coil-shaped (paragraph [0027]).
Regarding Claims 10, 11 in the embodiment used in the rejection above, Figures 1-4 of Lim et al. does not expressly disclose an inner wire extending through said core, wherein the inner wire is interrupted at locations of said areas of increased stretchability. However, in an alternative embodiment as seen in Figure 7, Lim teaches an annuloplasty ring 10 in the same field of endeavor comprising a core 40 and an inner wire 30a, 30b located along interrupted locations for the purpose of changing the structural strength of the various cross sections of the ring (paragraph [0020]). However, in an alternative embodiment as seen in Figure 7, Lim teaches an annuloplasty ring 10 in the same field of endeavor comprising a core 40 and an inner wire 30a, 30b located along interrupted locations, wherein the inner wire can be placed along the ring to change the cross-sectional size or strength of the ring (paragraph [0021]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Figures 1-4 to further include an inner wire to be placed along the core and having interrupted regions (such as the two wires 30a, 30b) as taught in Figure 7 for the purpose of changing the structural strength of the various cross sections of the ring.
Regarding Claim 12, in the embodiment used in the rejection above, Figures 1-4 of Lim et al. does not expressly disclose wherein said inner wire has areas of reduced diameter at locations of said areas of increased stretchability. However, in an alternative embodiment as seen in Figure 7, Lim teaches an annuloplasty ring 10 in the same field of endeavor comprising a core 40 and an inner wire 30a, 30b located along interrupted locations, wherein the inner wire can be placed along the ring to change the cross-sectional size or strength of the ring (paragraph [0021]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Figures 1-4 to further include an inner wire to be placed along the core, along the tapered regions having increased flexibility as taught in Figure 7 to provide additional strength along the smaller cross section of the ring.
Claim(s) 2-5 and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Perouse FR 3004334 A1 in view of Bulman-Fleming et al. U.S. Publication 2006/0015179 A1.
Regarding Claim 2, Perouse et al. discloses an annuloplasty ring 100 as seen in Figure 5 for receiving a replacement heart valve comprising: a core 110 comprised of one continuous segment with areas of increased stretchability 115 along the one continuous segment; a cover 105 surrounding the core; the core 110 being stretchable to a perimeter sufficient to receive a replacement valve but not so stretchable that the core separates into multiple segments the areas of increased stretchability configured to have a sufficient squeezing force on the replacement heart valve so as to prevent paravalvular leakage. However, Perouse et al. does not expressly disclose the areas of increased stretchability configured for alignment with commissures of a target native heart valve. Bulman-Fleming et al. teaches an annuloplasty ring in the same field of endeavor comprising a core 400 and 208 having a continuous segment 205 (as seen in Figures 19C-19D and paragraphs [0052] and [0101]) with areas of increased stretchability 401(paragraphs [0086] and [0102]) aligned at the commissure of the ring for the purpose of allowing the areas of increased stretchability to stretch between the flexible and stiff portions (paragraph [0090] and [0093]) during the diastolic and systolic phase of the cardiac cycle (paragraph [0102]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Perouse’s area of increased stretchability to be configured for alignment with commissures of a target native heart valve as taught by Bulman-Fleming et al. for the purpose of allowing the areas of increased stretchability to stretch between the flexible and stiff portions to accommodate the changes in diameter during systolic and diastolic phase of the cardiac cycle.
Regarding Claims 3, 5, In the embodiment used in the rejection above, Figure 5 of Perouse does not expressly disclose wherein said shape comprises an incomplete circle, wherein said shape comprises an incomplete "D" shape that mimics a healthy mitral valve perimeter. In an alternative embodiment as seen in Figure 7, the shape of the annuloplasty ring is discontinuous and forms an incomplete circle having a D-shape which can conform to the natural shape of a mitral valve (page 1, lines 1-16). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Perouse’s annuloplasty ring to be discontinuous as taught in Figure 7 for the purpose of forming an incomplete circle having a D-shape which can conform to the natural shape of the mitral valve.
Regarding Claim 4, Perouse et al. discloses wherein said shape comprises a complete circle (as seen in Figure 5).
Regarding Claim 8, Perouse et al. discloses wherein said areas of increased stretchability 115 comprise at least one accordion section of said core (the zig zag portions form accordion like sections).
Regarding Claim 9, Perouse et al. discloses wherein said accordion section extends along a substantial entirety of said core (the zig zag portions 115 and as seen in Figure 5).
Regarding Claim 10, in the embodiment used in the rejection above, Figure 5 does not expressly disclose an inner wire extending through said core. However, in an alternative embodiment as seen in Figures 9-10, Perouse et al. teaches an annuloplasty ring 300 with a core 310 and an increased stretchability area 315 and an inner wire 320 (the inner wire 320 includes a plurality of coiled turns) for the purpose of having a resorbable retaining means to allow the increased stretchability area to be in an elongate configuration (page 12, lines 1-20). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Perouse’s core to further include an inner wire as taught in Figures 9-10 for the purpose of having a resorbable retaining means to allow the increased stretchability area to be in an elongate configuration.
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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