DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claim 10 is objected to because of the following informalities:
Claim 10 line 1 repeats “further comprising” and is suggested to remove one instance of this phrase.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18 recites in lines 1-3 “further comprising positioning a pushing block at a second end of the support frame opposite to the first end of the support frame so that the second end can contact the support frame” and is unclear if the second end is to contact the support frame or if the pushing block is to contact the support frame. For the purposes of examination, the Office will interpret the claim to mean either the second end, or the pushing block.
Claim 19 recites in line 2 “at least one suture slidably coupled along a plurality of longitudinal slots” and is unclear how one suture is to be coupled along a plurality of longitudinal slots. It appears that each of a plurality of sutures is to be coupled along a respective longitudinal slot of a plurality of longitudinal slots, however for the purposes of examination, the Office will interpret the claim to mean “at least one suture slidably coupled along at least one longitudinal slot.”
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); 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).
Claims 11-13 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (WO 2015/090188), hereinafter known as “Li.”
With regards to claim 11, Li discloses (Figures 1-4 and 6-10) a method of assembly for a valve prosthesis delivery (Abstract), the method comprising:
housing a valve prosthesis 7 in a compacted state (figure 8) within a sheath 10 of a delivery system, the valve prosthesis 7 comprising a valve anchor 7 and a support frame (see graft extending from valve anchor 7 in figures 9-10) coupled to the valve anchor 7, the valve anchor 7 comprising a plurality of anchoring legs having a plurality of connection apertures 7a (figure 7);
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).
With regards to claim 12, Li discloses further comprising positioning the plurality of connection apertures 7a of the valve anchor 7 between a first flange and a second flange, wherein the lock apertures 2b of the delivery system extend through both the first flange and the second flange (figure 3 - proximal and distal sides are represented as the first and second flange, respectively; lock apertures 2b extend through both sides).
With regards to claim 13, Li discloses further comprising positioning an annular component 3b of the pin assembly 3a/3b within a cavity of the delivery system (within the sheath 10) so that the pin assembly 3a/3b is reciprocal within the cavity between an engaged configuration (when locked with the valve anchor 7 through the connection apertures 7a) and a disengaged configuration (figure 10 – when unlocked from the valve anchor 7), wherein the plurality of pins 3a extends longitudinally from the annular component 3b (figure 4; page 4, paragraphs 6-10).
Claims 11, 14-18, and 20 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Fargahi (US PGPub 2014/0067037).
With regards to claim 11, Fargahi discloses (Figures 1-8) a method of assembly for a valve prosthesis delivery (Abstract; paragraph 99), the method comprising:
housing a valve prosthesis 102 in a compacted state (figure 7) within a sheath (paragraph 83 – outer sleeve) of a delivery system, the valve prosthesis 102 comprising a valve anchor 102 and a support frame 86 coupled to the valve anchor 102 (figure 5), the valve anchor 102 comprising a plurality of anchoring legs having a plurality of connection apertures (see where extensions 16 extend into on implant 102 in figure 7);
slidably coupling a pin assembly 16/84 around a core member 62 so that the pin assembly 16/84 is slidable longitudinally along the core member 62 (paragraphs 85 and 94-95); and
inserting a plurality of pins 16 of the pin assembly through the plurality of connection apertures of the valve anchor 102 and a plurality of lock apertures 78 of the delivery system to engage the plurality of anchoring legs of the valve anchor 102 (figures 1, 5, 7, and 8; paragraphs 95 and 101).
With regards to claim 14, Fargahi discloses further comprising slidably coupling a pusher component 64 around the core member 62 so that the pusher component 64 is slidable longitudinally along the core member 62 (paragraphs 94-95 and 103).
With regards to claim 15, Fargahi discloses further comprising positioning a tubular component 84 of the pin assembly 16/84 to extend along the core member 62 towards the pusher component 64 so that the pusher component 64 can contact an end of the tubular component 84 (figures 2-3).
With regards to claim 16, Fargahi discloses further comprising positioning a tubular component 64 of the pusher component 64 to extend along the core member 62 towards the pin assembly 16/84 so that the tubular component 64 can contact the pin assembly 84 (figures 2-3).
With regards to claim 17, Fargahi discloses further comprising positioning the pusher component 64 at a first end of the support frame 86 so that the first end of the support frame 86 can contact the pusher component 64 (figure 5 – in contact via 84).
With regards to claim 18, Fargahi discloses further comprising positioning a pushing block 88 at a second end of the support frame 86 opposite to the first end of the support frame 86 so that the second end can contact the support frame 86 (see 112(b) rejection above; figure 5 – support frame 86 is in contact with the pushing block 88).
With regards to claim 20, Fargahi discloses further comprising positioning the valve anchor 102 and the support frame 86 coupled to the valve anchor 102 serially within the sheath (paragraph 83 - outer sleeve, not shown however the serial coupling is shown in figure 7).
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.
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 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.
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
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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/MOHAMMED S ADAM/Examiner, Art Unit 3771 01/26/2026
/KATHERINE M SHI/Primary Examiner, Art Unit 3771