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 .
Election/Restrictions
Claims 9-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/10/2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “P1” has been used to designate both point of central axis and posterior leaflet.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: C4 and S120.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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) 1-4, 6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burriesci (WO 2019/220365 A1).
Regarding claim 1, a first embodiment of Burriesci teaches an annuloplasty ring (1, annuloplasty prothesis device, fig. 6) comprising a core part (3, core, fig. 11) and an outer layer (36, fabric layer, fig. 11) made of a polymer material (¶ [001033]),
wherein the core part has a curved structure in which a band-shaped plate member (¶ [00107]) made of a spring material (¶ [00118]) defines an opening part in a shape along a mitral valve annulus,
the outer layer covers a surface of the core part (fig. 11),
the longitudinal axis of the cross section of the band-shaped plate member when the core part is cut along a flat plane containing the central axis passing through the opening part in the blood flow direction is inclined with respect to the central axis (fig. 8, segment 5), and
the inclination is such that the diameter of the opening part decreases as the central axis moves in the blood flow direction (fig. 8, segment 5).
The first embodiment of Burriesci fails to teach the annuloplasty ring is C-shaped. However, a second embodiment of Burriesci teaches the annuloplasty ring presents a C-shape (fig. 3, ¶ [00100]). Burriesci states embodiments are combinable (¶ [00144]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the annuloplasty ring shape of the first embodiment of Burriesci to include a C-shape as taught by the second embodiment of Burriesci in order to minimize unnecessary annular constraint.
Regarding claim 2, the first embodiment of Burriesci further teaches the annuloplasty ring is a mitral annuloplasty ring for application to a mitral valve annulus (¶ [0002-004]).
Regarding claim 3, the first embodiment of Burriesci further teaches a saddle shape (fig. 6), a shape along the mitral valve annulus (¶ [0062], the device is intended to be sutured to the mitral annulus, the device would present as the shape along the mitral valve annulus).
The first embodiment of Burriesci fails to teach the annuloplasty ring is C-shaped. However, a second embodiment of Burriesci teaches the annuloplasty ring presents a C-shape (fig. 3, ¶ [00100]). Burriesci states embodiments are combinable (¶ [00144]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the annuloplasty ring shape of the first embodiment of Burriesci to include a C-shape as taught by the second embodiment of Burriesci in order to minimize unnecessary annular constraint.
Regarding claim 4, the first embodiment of Burriesci further teaches the material of the band-shaped plate member is an Ni-Ti alloy which is a shape memory alloy (¶ [00118]).
Regarding claim 6, the first embodiment of Burriesci further teaches the longitudinal axis of the cross section of the band-shaped plate member is inclined at an elevation angle of 45 to 60 degrees with respect to a flat plane perpendicular to the central axis (¶ [0061]).
Regarding claim 8, the first embodiment of Burriesci further teaches the annuloplasty ring is used for treating a heart valve disease (¶ [0017-0019]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burriesci in view of Eigler (US 2022/0151784 A1).
Regarding claim 5, Burriesci fails to teach the Ni-Ti alloy has an Af point of not more than. However, Eigler teaches a cardiovascular implant made of nitinol that includes the Ni-Ti alloy has an Af point of not more than 15oC (¶ [0145]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the Af point of Burriesci to include it is not more than 15oC as taught by Eigler in order to remain superelastic at body temperature (¶ [0145], Eigler).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burriesci in view of Ryan (US 2011/0022169 A1).
Regarding claim 7, the first embodiment of Burriesci further teaches the outer layer is a layer made of cloth (¶ [00103]).
Burriesci fails to teach the cloth is a braid tube. However, Ryan teaches an annuloplasty device with a covering that includes a braid tube (¶ [0061]). Fig. 15 shows the covering 82 has the same shaped as the element inside it 87. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the outer layer of Burriesci to include a braid tube as taught by Ryan in order to provide a side for attachment of the device to the annulus (¶ [0061], Ryan).
Claim 7 is a product by process claim. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being a core part with a braid tube outer layer. Manufacturing steps such as weaving threads around a core material are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP 2113).”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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