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
The applicant’s election of Group I directed towards a heart valve and delivery device, corresponding to claims 1-16 without traverse is acknowledged. Accordingly, claims 17-20 are withdrawn from examination.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stinson (2002/0099435A1) in view of Vaughn (2017/0348101).
In regard to claim 1, Stinson teaches a delivery device 11’ for a collapsible prosthetic heart valve (see fig 9; since the catheter delivers collapsible stent 31, also capable of delivering a valve stent), the delivery device 11’ comprising:
an inner shaft 13;
an outer shaft 51’;
a distal sheath 41 disposed distal to the outer shaft (distal to at least a portion of the outer shaft 51; see figure 9; the claim language does not require the entire distal sheath to be distal to the outer shaft) and about a portion of the inner shaft 13 to form a compartment with the inner shaft (see compartment within which 31 fits in figure 9), the compartment being sized to receive the prosthetic heart valve (fits stent 31, therefore also capable of fitting a stent valve), the inner shaft 13 and the distal sheath 41 being axially translatable relative to one another (see figs 8-9);
and a distal tip 17 disposed at a distal end of the delivery device 11’ (see fig 8-9);
wherein the distal sheath 41 is translatable between a proximal-most position and a distal- most position (see fig 8-9), the compartment being completely exposed [0063: catheter slides off stent, permitting to self expand; the compartment must be fully exposed for this to occur] when the distal sheath is in the proximal-most position (while figure 9 does not show the sheath being fully retracted, the compartment defined by the tip and 21 is capable of being completely exposed/open when the device is fully retracted to fully expose the stent in order for the catheter to release the stent as intended).
However, Stinson does not teach a gap between a distal end of the distal sheath and a proximal end of the distal tip when the sheath is in the distal most position.
Vaughn teaches a gap distance (window 310a) existing between a distal end of the distal sheath 300 and a proximal end of the distal tip when the distal sheath is in the distal-most position.(see fig 17C)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the distal windows in the outer sheath of Vaughn in the distal end of the outer sheath of Stinson because the windows impart an expandable or stretchable attribute to the outer sheath [0070].
It is noted the claim does not require the gap distance exists between the entire distal end of the distal sheath and proximal end of the distal tip or that the gap be uncovered or expose the device, only that a gap exists at a distal end of the distal sheath. It is recommended to further clarify the claim language.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stinson (2002/0099435A1) in view of Vaughn (2017/0348101) and further in view of Tremulis (2007/0219466A1).
In regard to claim 2, Stinson meets the claim limitations as discussed in the rejection of claim 1 and further teaches the distal tip includes a distal portion and a proximal portion.
However, Stinson does not teach the distal portion of the tip is less rigid than the proximal tip portion.
Tremulis teaches the distal portion of the tip having a rigidity that is less than a rigidity of the proximal portion. [0051: tip with varying flexibility; distal tip may be soft material, mid portion from a stiffer material, proximal tip from even stiffer material]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the graduated rigidity material of the catheter tip of Tremulis in the catheter tip of Stinson because this helps avoid perforation of the body lumen (abstract).
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stinson (2002/0099435A1) in view of Vaughn (2017/0348101) and further in view of Hijlkema (6858034B1).
In regard claim 3, Stinson meets the claim limitations as discussed in the rejection of claim 2, but does not teach the proximal portion of the distal tip is ring shaped.
Hijlkema teaches the proximal portion (at 44’, rim) of the distal tip 20’ is ring-shaped. (see figure 3, cross sections in fig 7A, 8A, catheter is cylindrical)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the ring-shaped proximal portion of the stent on the tip portion of Stinson because the ring allows the stent to be gripped and recaptured after partially deployed if needed (Col 5, lines 33-42)
In regard to claim 4, Stinson meets the claim limitations as discussed in the rejection of claim 3, but does not teach the distal tip shape as claimed.
Hijlkema further teaches the proximal portion (at 44’) of the distal tip 20’ has an outer diameter that is equal to an outer diameter of the distal sheath 12. Including the marker 46 on the proximal portion 44’ of the distal tip, the diameter is equal to a distal sheath diameter as shown in figure 3. When applied to the invention of Stinson, this arrangement will remain the same for the catheter to function as intended and not snag on a blood vessel.
In regard to claim 5, Stinson meets the claim limitations as discussed in the rejection of claim 3, but does not teach the distal tip shape as claimed.
As discussed in the rejection of claim 3, Hijlkema teaches the proximal portion of the distal tip 44’.
However, the combination of Stinson in view of Hijlkema does not teach the wall thickness of the proximal portion of the distal tip is equal to a wall thickness of the distal sheath.
It has been held that a mere optimization of the working parts of an invention, yielding a predictable result, requires no more than routine skill in the art. The wall thickness of the sheath is a result effective variable with a thicker sheath giving more strength and rigidity and a thinner sheath allowing for greater flexibility. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to optimize the thickness of the sheath of Stinson to match the thickness of the proximal portion of the distal tip so the catheter will have the same flexibility along its length for proper insertion. MPEP 2144.05II
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stinson (2002/0099435A1) in view of Vaughn (2017/0348101) and further in view of Anderson (2018/0153691A1).
In regard to claim 6, Stinson meets the claim limitations as discussed in the rejection of claim 1, but does not teach a retainer.
Anderson teaches a retainer (82 or 322) positioned at a proximal end of the compartment (see fig 6), the retainer (83 or 322) being configured to mate with retaining elements of the prosthetic heart valve. (see figure 6, 8-9), the retaining element pushes against all of the components within the catheter including retaining elements such as all of the sheaths. The claim does not actually positively recite or require any retaining elements. Since the retaining element is capable of mating with a retaining element [0033: valve retainer configured to receive a corresponding feature provided with a valve stent frame]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the retainer of Anderson in the stent of Stinson because the retainer assists in securing the stent within the catheter frame [0033].
In regard to claim 7, Stinson meets the claim limitations as discussed in the rejection of claim 6, but does not teach a retainer.
Anderson further teaches the distal tip is axially fixed relative to the retainer (322, or 82). The tip is fixed to retainer (322, or 82) via the inner shaft as shown in figure 6, figure 8)
In regard to claim 8, Stinson meets the claim limitations as discussed in the rejection of claim 6, but does not teach a retainer.
Anderson further teaches the distal tip is axially translatable relative to the retainer (82 or 322). As shown in figure 3, the retainer is slide onto the inner shaft during assembly and is therefore axially translatable relative to the retainer during assembly. The claim does not require the axial translation to occur during use of the catheter or after assembly.
Allowable Subject Matter
Claims 9-16 are allowed.
The closest prior art Anderson (2018/0153691A1) in view of Hoang (2019/0365530A1) teaches all of the claimed limitations except “wherein the system has a delivery condition in which the distal sheath is in a distal-most position in which the distal sheath overlies portions of the prosthetic heart valve but a distal end of the distal sheath leaves the outer cuff uncovered.”
Relevant prior art Tegels (2022/0015902A1) teaches an exposed stent valve in a delivery device but does not teach an axially translatable sheath.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIE BAHENA whose telephone number is (571)270-3206. The examiner can normally be reached M-F 9-3.
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
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