DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed 06/23/2026 has been entered. Claims 1-18 and 20 remain pending in the application and claim 19 has been canceled. Applicant’s amendments to the claims have overcome each the 112(b) rejection and prior art rejection previously set forth in the Non-Final Office Action mailed 01/30/2026 with respect to claim 11, however has not overcome the prior art rejection with respect to claim 6 (see rejection below).
Response to Arguments
Applicant's arguments filed 06/23/2026 have been fully considered but they are not persuasive.
Applicant argues on pages 6-7 that Orlov’s alleged support frame 54 does not include prosthetic leaflets; instead, the prosthetic leaflets 350 are disposed inside the alleged valve anchor 52. The Office respectfully disagrees. Col 9 lines 35-46 discloses that “Alternatively, the valve mechanism is attached to the ventricle part.” Therefore, the prosthetic leaflets 350 are also able to be coupled to the support frame 54, and the rejection is maintained.
Applicant also argues that the distal ends of the filament 72 are fixed to the ventricle part 54 by tying, gluing, or crimping; and thus if the ventricle part 54 is considered to be the valve anchor, Orlov does not satisfy claim 6 because filament 72 is not slidable along the ventricle part. The Office respectfully disagrees. Col 18 lines 25-33 discloses that “Optionally, filament 72 loops around a portion of annulus part 54 (e.g., through perforations in tabs 58, around and/or through struts).” Therefore, the filaments, by looping around the perforations in tabs 58, are slidable around the ventricle part; and the rejection is maintained.
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6 line 4 “the support” is suggested to read “the support frame” for better claim language consistency.
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 pre-AIA 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 –
Claims 6-7 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Orlov et al. (US Patent 10,500,038), hereinafter known as “Orlov.”
With regards to claim 6, Orlov discloses (Figures 2A-4H) a method of assembly for valve prosthesis delivery (Abstract), the method comprising:
coupling at least one suture 72 to a support frame 54 (figure 2B; Col 18 lines 25-33 and Col 19 lines 25-36), wherein a plurality of prosthetic leaflets 350 are disposed inside of and coupled to the support 54 (Col 9 lines 35-46 – “Alternatively, the valve mechanism is attached to the ventricle part”); and
looping the at least one suture 72 to an anchoring leg 58 of a valve anchor 52 so that the at least one suture 72 is slidable along the anchoring leg 58 (figure 2B; Col 18 lines 25-33 and Col 19 lines 25-36).
With regards to claim 7, Orlov discloses further comprising:
compacting the support frame 54 and the valve anchor 52 (figure 3); and
housing the compacted support frame 54 and the compacted valve anchor 52 within a sheath 76 with the support frame 54 coupled to the valve anchor 52 via the at least one suture 72 (figure 3; Col 18 lines 34-49).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 8-10 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Orlov in view of Li et al. (WO 2015/090188), hereinafter known as “Li.”
With regards to claims 8-10, Orlov discloses the method as claimed in claim 8. Orlov is silent to further comprising inserting a pin through a connection aperture of the anchoring leg to constrain a portion of the anchoring leg (claim 8); further comprising sliding the pin through the connection aperture and through a lock aperture (claim 9); and further comprising positioning the portion of the anchoring leg between a first flange and a second flange (claim 10).
However, in a similar field of endeavor of valve delivery, Li teaches (Figures 1-4 and 6-10) further comprising inserting a pin 3a through a connection aperture 7a of the anchoring leg 7 to constrain a portion of the anchoring leg 7 (figures 1 and 4; page 4 paragraphs 6-10);
further comprising sliding the pin 3a through the connection aperture 7a and through a lock aperture 2b (figure 1; page 4 paragraphs 6-10); and
further comprising positioning the portion of the anchoring leg 7 between a first flange and a second flange (figure 3 - proximal and distal sides are represented as the first and second flange, respectively; lock apertures 2b extend through both sides).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Orlov to include inserting a pin through a connection aperture of the anchoring leg to constrain a portion of the anchoring leg as taught by Li for the purpose of facilitating the alignment and avoiding crossing or bending (page 2 paragraph 7 of Li) of the valve anchor.
Allowable Subject Matter
Claims 1-5, 11-18 and 20 are allowed.
The following is an examiner’s statement of reasons for allowance:
With regards to claims 1-5, the allowable subject matter is in the context of the claims. Specifically, the prior art of records fails to disclose or make obvious the claimed method, comprising, inter alia,
“coupling a plurality of sutures to an end of a support frame;
looping the plurality of sutures to a plurality of anchoring legs of a valve anchor so that the plurality of sutures is slidable along the plurality of anchoring legs, wherein each of the anchoring legs is interconnected between a pair of U-shaped members of the valve anchor, and wherein each of the plurality of sutures are looped in a respective longitudinal slot extending along a length of the respective anchoring leg.”
The closest prior art of Orlov discloses a suture 72 slidable along a circular slot (perforations) in the anchoring leg 58, however does not slide along a longitudinal slot extending along a length of the anchoring leg. The prior art fails to disclose or make obvious the claimed subject matter of this coupling feature. Therefore, the claims are allowable over all prior art.
With regards to claims 11-18 and 20, the allowable subject matter is in the context of the claims. Specifically, the prior art of records fails to disclose or make obvious the claimed method, comprising, inter alia,
“slidably coupling a pin assembly around a core member so that the pin assembly is slidable longitudinally along the core member; and
inserting a plurality of pins of the pin assembly through the plurality of connection apertures of the valve anchor and a plurality of lock apertures of the delivery system to engage the plurality of anchoring legs of the valve anchor;
coupling the valve anchor to the support frame via at least one suture slidably coupled along a longitudinal slot extending along a length of one of the plurality of anchoring legs.”
The closest prior art of Li (WO 2015/090188) discloses (Figures 1-4 and 6-10) slidably coupling a pin assembly 3a/3b around a core member 8 so that the pin assembly 3a/3b is slidable longitudinally along the core member 8 (page 4, paragraphs 6-8); and
inserting a plurality of pins 3a of the pin assembly 3a/3b through the plurality of connection apertures 7a of the valve anchor 7 and a plurality of lock apertures 2b of the delivery system to engage the plurality of anchoring legs of the valve anchor 7 (page 4, paragraphs 6-8).
Li et al. does not disclose coupling the valve anchor to the support frame via at least one suture slidably coupled along a longitudinal slot extending along a length of one of the plurality of anchoring legs. The prior art fails to disclose or make obvious the claimed subject matter of the coupling feature. Therefore, the claims are allowable over all prior art.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
THIS ACTION IS MADE FINAL. 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 MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached 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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/MOHAMMED S ADAM/Examiner, Art Unit 3771 08/19/2026
/KATHERINE M SHI/Primary Examiner, Art Unit 3771
