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 .
Priority
This application claims priority from provisional application 62/923,657 filed 10/21/2019.
Status of Claims
Claims 1-19 and 21 are pending.
Claim 20 has been cancelled.
Election/Restrictions
It is noted that all claims are directed at the species shown in Figure 2, because the claims all require the commissure posts to longitudinally extend from a crown of the inflow end. Only Figure 2 reads upon the claims as originally presented.
Drawings
The drawings remain objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims.
Therefore the drawings must show the following features of the features must be cancelled from the claims:
the commissure post longitudinally extending from and connected to a single crown of the inflow portion. It appears the first end is coupled directly to a crown of the outflow end 216 (independent claims 1, 11, 17, and 19)
a commissure post both longitudinally extending and connected to a single crown of the inflow portion and having a length greater than struts of the inflow end (claims 11 and 19), and must be shown or the feature(s) canceled from the claim(s).
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
The previous claim objections have been withdrawn in view of the applicant’s amendments.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-16 and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The independent claims and claim 21 have been amended to require the commissure posts to longitudinally extend from and connect to a single crown of the inflow portion. As explained in the response to arguments section and drawing objections previously, only Figure 2 shows an inflow portion proximate the inflow end with a crown longitudinally extending from the posts. However, they are not connected to each other. The posts are connected to crowns of the outflow end. Furthermore even if the applicant intended for this language to allow for intermediate structures establishing the connection, then the posts cannot be described as being connected to a single crown. The posts would then be connected to every crown of the device. At best the applicant’s disclosure supports the posts longitudinally aligned with the crowns of the outflow end and crowns of an intermediate portion. The posts only longitudinally extend from the outflow end and are only directly connected to a single crown of the outflow portion. Therefore the requirement for the posts to longitudinally extend from and be connected to a single crown of the inflow portion is considered to be new matter.
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.
Claim 14 is 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 14 is rendered indefinite by the requirement for each commissure post to have “a strength that is greater than a strength of each strut of the inflow portion.” A person of ordinary skill in the art would not be able to determine what does and does not qualify as a strength. What is the strength relative to? What qualifies as a strength? Does it have to be a material property of the portions? Can it be based on a dimension? Does the strength need to be the same type of strength? Can one be resistance to bending and the other strength is resistance to compression? The applicant is advised to amend this claim to clarify the material properties of dimensions that define the strengths.
Claim Rejections - 35 USC § 103
In view of the numerous drawing and 112 issues, the claims are being interpreted as best understood. Any component longitudinally downstream from another is considered to be longitudinally extending from, connected to a single crown is being interpreted to mean connected to at least a single crown and allows for intermediate connecting structures. This is interpretation is consistent with the applicant’s disclosure and any art that reads upon it inherently reads upon it as much as the applicant’s own invention.
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) 1-5, 8-19, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuval et al (Tuval) US 2008/0071369 A1 in view of Drasler et al (Drasler) USPN 6,245,101 B1.
1. Tuval discloses a transcatheter valve prosthesis (10 Figures 1-2B) comprising:
a stent 12 having a crimped configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve [0547]-[0549], the stent having
an inflow portion (bottom half of Figure 1) formed proximate to an inflow end of the stent (bottom most edge of Figure 1), the inflow portion including a plurality of crowns (V-shaped portions directly above and between 120 Figure 1) and a plurality of struts with each crown being formed between a pair of opposing struts (shown best in Figure 2B), a plurality of side openings being defined by the plurality of crowns and the plurality of struts (diamond shaped openings Figure 1), and
an outflow portion (top half of Figure 1) formed proximate to an outflow end of the stent (top most edge of Figure 1) and coupled to the inflow portion (the entire stent of the device is coupled together), wherein the outflow portion of the stent has exactly three commissure posts (30 Figure 2B), each commissure post longitudinally extending from and connected to a single crown of the inflow portion (Figure 2B shows each post longitudinally aligned and extending from crowns on the opposite side of the stent, directly longitudinally extending from crowns of the second zigzag row of the inflow portion, longitudinally extending diagonally from crowns at the inflow end’s edge crowns which all read upon the claims in the same manner as the applicant’s invention)(the posts all are connected to a single crown of the outflow end in the same manner as the applicant’s invention, they are also connected to every other crown of the device in the same manner as the applicant’s invention) and the three commissure posts being circumferentially spaced apart (Figure 2B), and a first end (bottom of post 30) and a second end (top of post 30), the first end being coupled to the crown of the inflow portion (the entire stent is coupled together, so the invention of Tuval reads upon this as much as the applicant’s own invention see 112 above); and
a prosthetic valve 104 disposed within and secured to at least the outflow portion of the stent (Figure 1), the prosthetic valve being configured to block blood flow in one direction to regulate blood flow through a central lumen of the tubular stent (this is how all heart valves function).
However, Tuval does not disclose the thickness of each commissure post varies along a length thereof such that a first end is relatively thicker than a second end.
Drasler teaches the use of a stent comprising thicker crowns 100 and adjacent portions of struts 23 that are thicker than the strut portions 25/10 extending away therefrom (Figures 4-5) in the same field of endeavor for the purpose of allowing for more flexibility away from the crown.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the hinges of the stent of Tuval such that the posts have thicker first ends adjacent the crowns and thinner second ends extending away from there as taught by Drasler in order for the posts to maintain a secure connection to the rest of the stent but have increased flexibility in the radial direction.
2. 12. 18. Tuval discloses the prosthetic valve includes three leaflets and three commissures (Figures 1-2B), each commissure being formed by attached adjacent lateral ends of an adjoining pair of the three leaflets (Figure 1), and wherein the three commissure posts are aligned with and attached to a respective commissure of the three leaflets of the prosthetic valve (Figure 1) (The method for attaching the leaflets to the posts is considered to be a product by process limitation and given limited weight, In this case the prosthesis of Tuval is fully capable of having the leaflets attached to the posts in any known manner including having to commissures of the leaflets).
3. 13. Tuval discloses each commissure post is a planar bar (30 Figure 2B).
4. Tuval discloses the thickness of each commissure post is configured to permit each commissure post to flex radially inward during loading of the transcatheter valve prosthesis (Tuval discloses the entire device is compressed radially inward to be loaded into a catheter prior to delivery. Therefore the entire device permits radially inward flexing).
In regards to claim 5, it would have been obvious to modify all of the hinges of the entire stent of Tuval to include the increased thickness, this would provide stronger hinges with more resistance to failure from flexing. This results in each strut of the inflow portion having a thickness along a length thereof (the ends adjacent to the crowns) and the thickness of each commissure post at the first end (see modification with respect to claim 1) thereof is not greater than the thickness of the strut of the inflow portion (both thicknesses are identical).
8. Tuval discloses each strut of the inflow portion has a first width along a length thereof and each commissure post has a second width along a length thereof, the first width being less than the second width (Figure 2B clearly shows the posts with more than double the width of the struts).
9. Tuval as modified comprises the different materials (See explanation with respect to claim 17 below).
10. Tuval as modified comprises the different materials (See explanation with respect to claim 17 below).
11. Tuval discloses a transcatheter valve prosthesis (10 Figures 1-2B) comprising:
a stent 12 having a crimped configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve [0547]-[0549], the stent having
an inflow portion (bottom half of Figure 1) formed proximate to an inflow end of the stent (bottom most edge of Figure 1), the inflow portion including a plurality of crowns and a plurality of struts with each crown being formed between a pair of opposing struts (V-shaped portions directly above and between 120 Figure 2B), a plurality of side openings being defined by the plurality of crowns and the plurality of struts (diamond shaped openings Figure 1), and
an outflow portion (top half of Figure 1) formed proximate to an outflow end of the stent (top most edge of Figure 1) and coupled to the inflow portion (the entire stent of the device is coupled together), wherein the outflow portion of the stent has exactly three commissure posts (30 Figure 2B), each commissure post longitudinally extending from and connected to a single crown of the inflow portion (See explanation with respect to claim 1) and the three commissure posts being circumferentially spaced apart (Figure 2B), and wherein each commissure post has a length that is greater than a length of each strut of the inflow portion (the struts are considered to be one angled portion of each diamond shaped cell, Figure 2B shows the posts are longer than each strut), each commissure post has a thickness along the length thereof that is less than a thickness of each strut of the inflow portion along the length thereof (modification in view of Drasler results in each strut having a thick portion and the posts having an upper thin portion), and each commissure post has a width that is greater than a width of each strut of the inflow portion (30 is much wider than the struts of the stent); and
a prosthetic valve 104 disposed within and secured to at least the outflow portion of the stent (Figure 1), the prosthetic valve being configured to block blood flow in one direction to regulate blood flow through a central lumen of the stent (this is how all heart valves function).
14. Tuval as modified (see claim 5 above) discloses wherein each commissure post and strut of the inflow portions have a variety of thicknesses. Each thickness point has varied strength for resistance to bending. By selecting thicker and thinner points, there is inherently a portion of the post with a strength that is greater than a strength of each strut of the inflow portion.
15. 16. Tuval as modified comprises the different materials (See explanation with respect to claim 17 below).
17. Tuval discloses a transcatheter valve prosthesis (10 Figures 1-2B) comprising:
a stent 12 having a crimped configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve [0547]-[0549], the stent having
an inflow portion (bottom half of Figure 1) formed proximate to an inflow end of the stent (bottom most edge of Figure 1), the inflow portion including a plurality of crowns and a plurality of struts with each crown being formed between a pair of opposing struts (V-shaped portions directly above and between 120 Figure 1), a plurality of side openings being defined by the plurality of crowns and the plurality of struts (diamond shaped openings Figure 1), wherein the inflow portion is formed from a first material [0581], and
an outflow portion (top half of Figure 1) formed proximate to an outflow end (top most edge of Figure 1) of the stent and coupled to the inflow portion (the entire stent of the device is coupled together), wherein the outflow portion of the tubular stent has exactly three commissure posts (30 Figure 2B), each commissure post longitudinally extending from a crown of the inflow portion (Figure 2B) and the three commissure posts being circumferentially spaced apart (Figure 2B), and wherein each commissure post is formed from a second material [0581]; and
a prosthetic valve 104 disposed within and secured to at least the outflow portion of the stent (Figure 1), the prosthetic valve being configured to block blood flow in one direction to regulate blood flow through a central lumen of the tubular stent (this is how all heart valves function).
Tuval does not disclose the inflow portion and posts comprise different materials or that the first material is plastically deformable and the second material is superelastic.
However, Tuval discloses the support post portion of the stent 14 in Figure 2A comprises flexible materials such as superelastic nitinol material for the inflow end [0579] and other support structures comprise different materials such as other biocompatible metals [0581]. Stainless steel is one of the oldest and readily used materials for making stents and medical support structures, that is plastically deformable.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to form the posts of Tuval out of the flexible superelastic nitinol and the rest of the support frame from plastically deformable stainless steel in order for the posts better flex and seal with the valve movement while the rest of the support frame rigidly anchors to the implant site thereby resisting compression.
19. Tuval discloses each commissure post is a planar bar (Figure 2B) and wherein each commissure post has a length that is greater than a length of each strut of the inflow portion (see explanation with respect to claim 1 above), each commissure post has a thickness along the length thereof that is less than a thickness of each strut of the inflow portion along the length thereof (see modification with respect to Drasler above), and each commissure post has a width that is greater than a width of each strut of the inflow portion (Figure 2B).
21. Tuval discloses each commissure post is longitudinally extending from and connected to a single crown of the inflow portion (see 112 rejections and further explanation with respect to claim 1 above).
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuval and Drasler (Combination 1) as applied to claims 1-5, 8-19, and 21 above, and further in view of Conklin US 2012/0078357 A1.
Combination 1 discloses the invention substantially as claimed being described above. However, Combination 1 does not disclose the preset curves of the posts.
Conklin teaches the use of a frame supported heart valve comprising commissure posts 1216 Figure 26 having a preset inward curve in the same field of endeavor for the purpose of aiding with insertion and relieving forces from the implant site during opening and closing of the valve.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the preset radially inward commissure post curve shape as taught by Conklin with the posts of Tuval in order to aid with insertion and relieving forces from the implant site during opening and closing of the valve.
In regards to claim 7, the applicant’s original disclosure failed to provide any indication of criticality for the claimed range of inward bend. The range is simply defined in the specification as an example for some embodiments with no additional explanation. Furthermore, there is no factual evidence in the record to support any unexpected results. The disclosure of these ranges is consistent with a routine optimization. Therefore it would have been obvious to a person of ordinary skill in the art to take the teaching of Conklin and to apply it to Tuval such that the posts extend radially inward about 1 to 2 mm. Finally, since the claims do not disclose what part of the post is measured for the curve there is inherently a portion of the curved post of Conklin that would curve in from 1 to 2 mm.
Response to Arguments
Applicant's arguments filed 09/11/2025 have been fully considered but they are not persuasive.
The applicant argues that all embodiments depict commissure posts longitudinally extending from a crown of the inflow portion not just Figure 2. This is not persuasive because only Figure 2 shows the posts longitudinally extending from a crown that is proximate the inflow end as required by the claims. The claims define the inflow portion as proximate the inflow end which the examiner has interpreted to mean the bottom of the implant proximate 106/206. The other embodiments all show the posts extending from valleys between the crowns. The other embodiments all disclose the crowns offset making the posts extending diagonally not longitudinally from the crowns of the inflow end.
With respect to the drawing objections the applicant argues that all of their embodiments disclose the posts longitudinally extending from a crown of the inflow portion. As explained above this is not true because only Figure 2 shows the posts longitudinally extending from the crowns of the inflow end. The applicant further contends that the inflow portion is defined by the specification as the plurality of rows between the posts and inflow end of the stent. This argument brings further ambiguity into the claims. How is the inflow portion not a part of the inflow end? The inflow end is considered to be the end 106 or 206, and the claims require the inflow portion to be proximate the inflow end. The outflow end is considered to be the end adjacent 102 and the outflow portion comprises the posts which are within the outflow end. How can all the middle rows of struts be appropriately called the inflow portion when they are spaced between the inflow and outflow ends and are then proximate to both ends? The applicant is advised to amend the claims to define the posts as longitudinally extending from crows of an intermediate portion.
Additionally, the claims have now been amended to require the posts to be longitudinally extending from “and connected to a single crown of the inflow portion”. It is unclear how the applicant’s invention can read upon this and how it is shown in the drawings. As explained in the 112 rejection above, the posts can only reasonable be interpreted to be connected to crowns of the outflow end or connected to every crown of the device.
Finally with respect to the objection that the drawings fail to show the combination of a commissure post both longitudinally extending and connected to a single crown of the inflow portion and having a length greater than struts of the inflow end the applicant points to Figure 21. This is not persuasive because Figure 21 only shows the post aligned/connected to a crown of the outflow and the struts of the outflow end. If the applicant intended for the struts of Figure 21 to be the inflow end then the crowns of the inflow portion are all offset diagonally and not connected to the posts.
With respect to the prior art rejection the applicant argues that the posts of Tuval extend from and are connected to multiple crowns of the “inflow portion”. The applicant provided a marked up Figure two with a reference arrow for support of the argument. However, this argument is moot because the applicant is referring to and pointing at the outflow portion not the inflow portion. (Tuval discloses the inlet is adjacent 32 in [0585]) Both the applicant’s invention and Tuval discloses the same general shapes with upper posts for supporting the leaflets at the outflow end and lower zigzag struts defining the inflow end. Therefore both the prior art and the applicant’s own invention have posts that read upon the requirement for posts to longitudinally extend from and are connected to a single crown of the inflow portion in the same manner.
Examiner’s Comments
In order to advance the application close to allowance the applicant is advised to amend the claims so that the posts are directly connected to a single crown of the outflow end, axially aligned not extending from crowns of the inflow end, and to describe an intermediate portion in place of the inflow portion.
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 CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached 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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/Christopher D. Prone/Primary Examiner, Art Unit 3774
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