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 .
Response to Amendment
This office action is responsive to the amendments presented on 03/16/2026. As directed by the response: claims 1, 3, 7-8, 11-13, 16, 18, 24 have been amended, claims 10, 14-15, 21 have been canceled and claims 31-33 are new. Thus, claims 1-9, 11-13, 16-20, 22-33 are presently pending in the application.
Response to Arguments
In light of the amendment to claim 11 to include “non-acute angle,” the examiner has withdrawn the previous 112(b) rejection.
In light of the cancelation of claim 15, the examiner has withdrawn the previous 112(b) rejection.
In light of the amendment to claim 1 to further include “at least a portion of each of the plurality of frame elements having a region of reduced cross section including a width in a circumferential direction radially disposed from the longitudinal axis of the tubular body, the width in the region of the reduced cross section being at least four times the thickness such that the second region exhibits a relatively higher degree of compressibility in the longitudinal direction than in the radial direction transverse to the longitudinal axis of the tubular body” has overcome the previous 102 rejection over Haung. However, upon further consideration, a new ground of rejection is made over Kumar et al. U.S. Publication 2016/0158004 A1.
Allowable Subject Matter
Claims 7-9, 11-13, 16-20, 22-29 and 31-33 are allowed. The prior art fails to teach nor render obvious wherein the obtuse angle defined by each longitudinal apex in the deployed configuration is greater than 150 degrees and wherein the obtuse angle defined by each longitudinal axis is greater than 180 degrees. In addition, the prior art fails to teach nor render obvious the second transverse deformation resistance is greater than the first transverse deformation resistance. Furthermore, the prior art fails to teach nor render obvious wherein the first and second sliding surfaces cause the first and second locking components to elastically deflect during collapse of the corresponding cell and wherein the securing portion is positioned at an acute angle relative to the body of the locking mechanism.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6 and 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kumar et al. U.S. Publication 2016/0158004 A1.
Regarding Claim 1, Kumar et al. discloses a support structure 300 for an implantable device, the support structure 300 including a tubular body having a longitudinal axis, the tubular body comprising: a first region 314 that is annular in shape and is characterized by a first transverse deformation resistance; and a second region 316 that is annular in shape and is characterized by a second transverse deformation resistance (see Figures 3A-3B and paragraphs [0038], [0048-0049]), the second region 316 including a plurality of frame elements 320D (e.g. struts) defining the annular shape of the second region 316, at least a portion of each of the plurality of frame elements 320D having a region of reduced cross section including a width DW1, DW2 in a circumferential radial direction transverse to radially disposed from the longitudinal axis of the tubular body and a thickness in a longitudinal direction parallel to the longitudinal axis of the tubular body (paragraphs [0038], [0048-0049]), the width DW2 in the region of reduced cross section being at least four times of the thickness such that the second region 316 exhibits a relatively higher degree of compressibility in the longitudinal direction than in the radial direction transverse to the longitudinal axis of the tubular body (as seen in Figure 3B, the width DW2 is 4 times the thickness of the strut, see paragraph [0038] the strut thickness is 0.8382 mm and the width DW2 is 9 mm to 16 mm).
Regarding Claim 2, Kumar et al. discloses wherein the second transverse deformation resistance (the cells in second region 316) is greater than the first transverse deformation resistance (paragraph [0036]).
Regarding Claim 3, Kumar et al. discloses wherein the first region 314 includes a plurality of frame elements defining the annular shape 330C (forming cells) of the first region, and further wherein at least a portion of each of the plurality of frame elements 320C of the first region 310 has a width in the circumferential radial direction transverse to radially disposed from the longitudinal axis of the tubular body and a thickness in the longitudinal direction parallel to the longitudinal axis of the tubular body (as seen in Figures 3A-3B), the width of each of the plurality of frame elements of the first region being less than 4 times of the thickness of each of the plurality of frame elements of the first region (the width of cells 330C is 1mm to 4 mm and the thickness of cells 330C 0.254 mm) .
Regarding Claim 4, Kumar et al. discloses further including one or more leaflets coupled to the first region (paragraphs [0025] and [0039]).
Regarding Claim 5, Kumar et al. discloses wherein the one or more leaflets are formed of a natural material (paragraphs [0026] and [0039]).
Regarding Claim 6, Kumar et al. discloses wherein the one or more leaflets are formed of a synthetic material (paragraphs [0026] and [0039]).
Regarding Claim 30, Kumar et al. discloses a method for treating a human patient with a diagnosed condition or disease associated with valve insufficiency or valve failure of a native valve (abstract and paragraph [0029]), the method comprising implanting a prosthetic valve of claim 1 (see claim 1 rejection above) at or adjacent to a location of the native valve (abstract and paragraph [0031]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
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