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
Applicant elects Species 6 (FIGS. 6D and 6B), and claims 1, 3-5, 7, 10-18, 24, and 74 readable thereon, with at least claims 1, 24, and 74 being generic to the identified species. Applicant’s election without traverse is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/26/25 is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following terms were reviewed for proper antecedent basis:
(a) “the posterior segment” as compared to “an elongate curved posterior segment”;
(b) “the lateral segments” as compared to “first and second curved lateral segments”; and
(c) “the second axis” as compared to “the second posterior-anterior axis.”
Finding: Each of the above terms is properly introduced and subsequently referenced in the claim set. Independent claims 1 and 24 introduce the recited items (e.g., “an elongate curved posterior segment,” “first and second curved lateral segments,” and “a second posterior-anterior axis”), and dependent claims consistently reference those items as “the posterior segment,” “the lateral segments,” and “the second axis.” Accordingly, no rejection under 35 U.S.C. 112(b) for lack of antecedent basis (MPEP 2173.05(e)) is made on these specific term pairs.
Claim Objections
Claims 3 and 16 are objected to because of the following informalities:
Claim 3 and Claim 16: Current phrasing — “wherein the stiffness within the plane that is greater than the stiffness out of the plane.”
Objection: Missing verb; lacks clarity.
Suggested correction: “wherein the stiffness within the plane is greater than the stiffness out of the plane.” Appropriate correction is required.
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 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 –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 10, 11, 12, 14, 24, and 74 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lim et al. (US2005/0256569A1).
Regarding claim 1, Lim et al. disclose:
An annuloplasty device (Fig. 6), comprising:
a structure (10) comprising an elongate curved posterior segment (24a, 24b, 24c) and first (22a) and second (22c) curved lateral segments extending from opposite ends of the posterior segment, the posterior segment and lateral segments lying within a plane to define a C-shape (figs. 4 or 6), the structure (Figs. 4 or 6) inherently defining a first lateral axis extending between the lateral segments within the plane, and a second posterior-anterior axis perpendicular to the first axis intersecting a midpoint (between 24b) of the posterior segment,
the structure (10) having a stiffness such that the structure inherently resists anterior-posterior
motion along the second axis within the plane while allowing flexibility of the lateral segments
(22a and 22c) out of the plane about the second axis.
Regarding claim 10, Lim et al. disclose a substantially straight anterior segment (22b or 22d, fig. 4) extending between anterior ends of the lateral segments opposite the posterior segment and lying within the plane.
Regarding claims 11 and 24, Lim et al. disclose wherein the device defines a generally “D” shape within the plane (figs. 4 or 6).
Regarding claim 12, the anterior segment (flexible regions 22b or 22d) is formed from material having a durometer less than material of the posterior and lateral segment.
Regarding claim 14, Lim et al. discloses embodiments in which the central region of a segment has a larger/thicker cross-section than regions toward the ends, thereby making the central region less laterally flexible than the wing regions (FIGS. 5–6; ¶¶[0018], [0028]). This meets the limitation that the posterior segment includes a central region with greater cross-section than the regions of the posterior segment extending from the central region to the lateral segments.
Regarding claim 74, the method as claimed are inherently caried out when the annuloplasty device of Lim et al. being used.
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.
Claims 3, 4, 5, and 7 are rejected under 35 U.S.C. § 103 as unpatentable over Lim et al. (US 2005/0256569 A1), as previously cited for claim 1.
Lim discloses an annuloplasty ring having a non‑planar, saddle‑shaped form with annular segments of differing lateral flexibilities achieved by varying cross‑sectional geometry and/or material. Lim teaches using cross‑sectional size, shape, and material/durometer, as well as internal construction (e.g., wire spacing or number), to tune directional stiffness in and out of the plane (see, e.g., ¶¶ [0016]–[0019], [0023], [0026], [0028]–[0030]). Lim further provides that cross‑sections may be rectangular, circular, elliptical, etc., and that dimensions may be selected to achieve desired displacement/flexibility profiles (¶ [0023]).
Lim does not expressly recite, in the exact terms of the claims here, that: (i) the posterior segment has a cross‑section with a maximum width (parallel to the plan view) and a maximum height (perpendicular to that width) where the height is smaller than the width to provide directional stiffness (claim 3); (ii) the lateral segments have the same cross‑section as the posterior segment (claims 4 and 5); or (iii) the posterior and lateral segments have a substantially uniform cross‑section (claim 7). However, Lim explicitly teaches that cross‑sectional geometry and material/durometer are result‑effective variables for achieving target stiffness relationships (including greater in‑plane stiffness relative to out‑of‑plane flexibility) and invites the designer to select those parameters accordingly (¶¶ [0018]–[0019], [0023], [0026], [0028]–[0030]).
In view of these teachings, it would have been obvious to a person of ordinary skill in the art, at the time of the invention, to modify Lim’s device (e.g., the embodiment of Fig. 6) by:
selecting a posterior segment cross‑sectional aspect ratio with a height less than its width to provide the claimed directional stiffness (claim 3), as a routine application of Lim’s guidance to tune stiffness via cross‑sectional dimensions;
providing the lateral segments with the same cross‑section as the posterior segment (claims 4 and 5), as a predictable standardization to achieve a uniform stiffness profile consistent with the desired in‑plane vs. out‑of‑plane performance taught by Lim; and
implementing a substantially uniform cross‑section across the posterior and lateral segments (claim 7), as a straightforward design choice within Lim’s disclosed parameter space to produce consistent directional stiffness across segments, with a reasonable expectation of success.
These modifications constitute routine optimization and selection of known geometric and material parameters to achieve Lim’s expressly taught stiffness objectives. Accordingly, claims 3, 4, 5, and 7 are unpatentable under 35 U.S.C. § 103 over Lim et al. as modified as described above.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lim et al. (US 2005/0256569 A1), as previously cited for claim 12 above. Although, Lim fails to clearly teach the inelastic filament embedded in the embodiment which has a substantially straight anterior segment as claimed in claim 10 and specific material as claim in claim 12, Lim discloses embodiments with embedded structural members/wires within an elastomeric body (e.g., FIG. 7; ¶¶[0026]–[0031]) and teaches selecting materials such as elgiloy and stainless steel, which are conventional inelastic wire materials (¶[0030]). Lim also teaches using “substantially axially inflexible” structural members in segments (claim-style disclosure at ¶[0010]–[0011] and related discussion), and manipulating wire spacing/size/number to control directional stiffness and displacement (¶[0026]).
In view of these teachings, it would have been obvious to include an inelastic filament embedded in the anterior segment to constrain elongation along one axis (first axis) while permitting bending/flexibility along a transverse axis (second axis), as a predictable use of known inelastic wire elements within the elastomeric segment to achieve the directional stiffness/strain goals expressly taught by Lim (¶¶[0026], [0030]).
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lim et al. (US 2005/0256569 A1)
Claim 16: Lim discloses using cross‑sectional geometry and material selection to control directional stiffness and to obtain configurations where in‑plane stiffness differs from out‑of‑plane flexibility (¶¶ [0016]–[0019], [0023], [0026], [0028]–[0030]). Although Lim does not recite the exact phrase “maximum height smaller than maximum width,” Lim teaches selecting cross‑sectional dimensions and aspect ratios to achieve a desired saddle shape and directional stiffness (¶ [0023]). Therefore, it would have been an obvious design choice to select a posterior segment cross‑section whose height is smaller than its width to increase in‑plane stiffness relative to out‑of‑plane stiffness, because Lim teaches height/width ratios and explicitly identifies cross‑sectional dimensions as result‑effective variables for tuning stiffness (¶¶ [0023], [0028]). Such selection is a routine and predictable optimization of Lim’s disclosed parameters to achieve the expressly taught directional stiffness objective.
Claim 17: Lim discloses that cross‑sectional shapes may be circular, elliptical, rectangular, etc., and that the wing/lateral regions’ cross-sectional dimensions may differ from central/posterior regions to achieve different flexibilities (¶ [0023]; FIGS. 5–6 and ¶¶ [0018], [0028]). Although Lim does not explicitly recite lateral segments having a circular or oblong cross‑section with a maximum width greater than the posterior segment’s maximum width, Lim’s teaching that cross‑sectional size/shape is a selectable design parameter provides the motivation to increase the lateral segments’ maximum width relative to the posterior segment to enhance lateral segment flexibility out of plane while maintaining posterior in‑plane stiffness. Selecting larger lateral cross‑sectional width (circular or oblong) is therefore an obvious and predictable modification to achieve the claimed stiffness profile in light of Lim’s disclosures.
Lim provides both the motivation (explicit teaching to tune directional stiffness by cross‑section and material choice) and the means (disclosed cross‑sectional shapes, aspect ratios, examples of height-to-width considerations, and embedded structural members/wire options) to select posterior and lateral cross‑sectional aspect ratios and relative widths to obtain the claimed directional stiffness relationships (¶¶ [0016]–[0019], [0023], [0026], [0028]–[0030]) in order for the annuloplasty device to fit and support the body portion better. Therefore, it would have been obvious for a person of ordinary skill in the art to choose a posterior cross‑section with height less than width and to increase lateral segment width (circular/oblong cross‑section) as routine design optimization to achieve Lim’s expressly taught in‑plane stiffness greater than out‑of‑plane flexibility, with a reasonable expectation of success (KSR rationale).
Conclusion
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/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771