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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/13/26 has been entered.
Response to Arguments
Applicant's arguments filed 01/13/26 have been fully considered but they are not persuasive.
On page 7 regarding prior art rejections, Applicant argues Kupumbati teaches away from the amended claims that require a separate stent frame and valve leaflets simply because they teach a stent frame with portions that are not structurally separate.
The Examiner respectfully disagrees. A references disclosing or teaching a construction is not the same thing as teaching away from a different construction. Applicant should point to where in Kupumbati they teach separate stent frame/valve leaflets is undesirable in order to provide proof of teaching away. Until then, this argument is unpersuasive and the rejection is maintained.
On page 9 Applicant suggests the Examiner’s statement that references are in the same field of endeavor equates to a rationale to combine.
The Examiner respectfully points out the rationale to combine is provided on page 7 after the statement that the inventions are in the same field of endeavor. The Examiner refers Applicant to MPEP 2141.01(a) which describes why the Examiner has established the prior art is in the same field of endeavor.
On pages 9-10 Applicant suggests the Examiner fails to notice neither reference mentions an “anchor portion”, and that Johnson fails to discuss a skirt.
The Examiner respectfully points out no requirement by the claimed invention for there to be an “anchor portion” making this unclear. Suggestions about Johnson not discussing a skirt are equally unclear since this is discussed in-depth in the rejection of record on pages 6-8.
On page 10 Applicant argues Johnson does not have a separate anchor and thus teaches away from “the anchoring support structure are structurally separate from one another”.
The Examiner respectfully notes this argument is unclear since, as before, disclosing or teaching two elements are integral is not the same as teaching away. Further, the claims do not appear to require the language quoted by Applicant, making this further unclear.
On page 10 Applicant argues Bruchman does not teach a connection between the flexible leaflet arrangement and skirt, but instead teaches a connection between leaflets and frames. Applicant then expresses confusion regarding Bruchman’s inner and outer frames and how they could be used with either Johnson or Kupumbati since these references do not use “two frames”.
The Examiner respectfully refers to the rejection below regarding amended claims.
Election/Restrictions
Newly submitted claims 16-17 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the originally filed and examined invention was drawn towards a combination of the newly claimed subcombination. The combination does not require the particulars of the subcombination, since it does not require a valvular support which is elastically deformable, or formed by a ring that forms a circumferentially closed loop. The subcombination also has separate utility by itself, acting as a heart valve prosthesis which does not require an anchoring member.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 16-17 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-5, 7-9, 11-14, is/are rejected under 35 U.S.C. 103 as being unpatentable over McLean et al. (US 20130304200 A1) hereinafter known as McLean in view of Johnson (US 20070050021 A1).
Regarding claim 1 McLean discloses a heart valve prosthesis comprising:
a valve support structure (Figure 10a item 120),
a plurality of flexible leaflets (Figure 10a item 130 (132)) defining a flexible leaflet arrangement ([0202] the valve 130/leaflets 132 are made of flexible materials) supported by the valve support structure (Figure 10a-e) which are moveable between an open position to permit blood flow in an antegrade flow direction and a closed position to block blood flow in a retrograde flow direction (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of Johnson discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus. See, for example [0202]), wherein each leaflet forms a free edge which abut one another in the closed position (Figure 10e shows leaflets 132 abutting at free edges), and
an anchoring member (Figure 10a item 110) comprising a flexible skirt (Figure 11b-c item 140) wherein the flexible skirt is formed from a separate unit of flexible material than the flexible leaflets ([0204] the valve 130 is attached to the flexible skirt 140, indicating they are made of distinct units of material), wherein the valvular support structure (120) and anchoring support structure (110) are structurally separate from one another ([0148] the valve support and anchoring member are connected together for use, indicating their structural separation before connection. See also many of the figures. For example, Figures 25a-b shows how the two can stay separate structurally being connected only thorough a sleeve 146; Figures 22a-b show how the two structures are separate and joined together via a filament 310; Figures 22f-k, 23a-b, etc.) but flexibly connected to each other through an interconnection of the flexible leaflet arrangement and the flexible skirt (Figures 11b-c, [0204] valve 130 is attached to the sealing skirt 140),
but is silent with regards to the leaflets extending across two different angles and having two different curvatures when viewed in a cross-sectional plane transverse to the antegrade flow direction..
However, regarding claim 1 Johnson teaches a heart valve prosthesis comprising a valve support structure (Figure 3a, 4a item 50), a plurality of flexible leaflets (Figure 3b items 34a-d) defining a flexible leaflet arrangement (considered to be the four leaflets 34a-d) supported by the valve support structure (Figure 3b, [0012]) which are moveable between an open position to permit blood flow in an antegrade flow direction and a closed position to block blood flow in a retrograde flow direction ([0012]), wherein each leaflet forms a free edge which abut one another in the closed position (Figures 3a-b; [0012], [0035]), and
wherein when viewed in a cross-sectional plane transverse to the antegrade flow direction, a first of the leaflets extends across a first angle (Figure 4b item α) and a second of the leaflets extends across a second angle which is different from the first angle (Figure 4b item Ɛ), wherein the free edge of the first leaflet comprises a first convex curvature and the free edge of the second leaflet comprises a second, different convex curvature (Figures 3a-b, 4a show the two leaflets with different curvatures around the annulus). McLean and Johnson are involved in the same field of endeavor, namely heart valve prostheses. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the prosthesis of McLean so that the leaflets have different angular extends and curvatures as is taught by Johnson since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the use of any number and configuration of leaflets to assist in mitral valve replacement would have been obvious to one of ordinary skill to try.
Regarding claim 2 the McLean Johnson Combination teaches the valve of claim 1 substantially as is claimed,
wherein Johnson further teaches the second angle is smaller than the first angle (Figure 4b).
Regarding claim 3 the McLean Johnson Combination teaches the valve of claim 1 substantially as is claimed,
wherein Johnson further teaches the plurality of leaflets comprise a third leaflet extending across a third opening angle that is equal to the first opening angle (Figure 4b item ẟ).
Regarding claim 4 the McLean Johnson Combination teaches the valve of claim 1 substantially as is claimed,
wherein Johnson further teaches the second curvature is smaller than the first (see Figure 4b where the curvature of the first angle is larger than that of the second).
Regarding claim 5 the McLean Johnson Combination teaches the valve of claim 1 substantially as is claimed,
wherein Johnson further teaches the leaflets are formed from separate pieces of material ([0007] flexible leaflets can be made of a whole valve or separate leaflets; see also [0012] flexible leaflets are each separately mounted),
and wherein a geometric shape of a first piece of material forming the first leaflet differs from the shape of a second piece of material forming the second leaflet (see Figures 3b and 4b the shape of the materials differ when attaching to the frame to form the leaflets). It would have been obvious to one of ordinary skill at the time the invention was filed to modify the method of manufacture of the Combination so that the leaflets are formed from the same piece of material or separate pieces material as is taught by Johnson as two equally obvious manufacturing methods known in the art, each with their known benefits and drawbacks and otherwise considered equivalents in the art.
Regarding claim 7 the McLean Johnson Combination teaches the valve of claim 1 substantially as is claimed,
wherein McLean further discloses the valve support structure comprises a ring (see Figures 11b-c which show multiple rings of struts comprising the valve support structure 120).
Regarding claim 8 the McLean Johnson Combination teaches the valve of claim 7 substantially as is claimed,
wherein McLean further discloses the ring comprises a plurality of curved sections (see Figure 11d where at least three curved sections exist around the circumference of the ring), each curved section being associated with one of the leaflets to define a bending line about which the leaflet is flexibly bendable to permit movement between the open and closed positions (This is stated as a “functional limitation” of the curved section in relation to the leaflets (see the explanation in the rejection to claim 1 above). See also Figure 11d where it is seen the leaflets attach around the curved sections and around which they open/closed).
Regarding claim 9 the McLean Johnson Combination teaches the valve of claim 1 substantially as is claimed,
wherein McLean further discloses the valve support structure forms a plurality of tip sections (Figure 11d item 128) that fix the leaflets to the valvular support structure ([0203]).
Regarding claim 12 the McLean Johnson Combination teaches the valve of claim 1 substantially as is claimed,
wherein McLean further discloses the anchoring support structure comprises a ring (Figure 10a shows how the anchoring support 110 is formed of multiple rings).
Regarding claim 13 the McLean Johnson Combination teaches the valve of claim 12 substantially as is claimed,
wherein McLean further discloses the ring has a meandering shape (Figure 10a shows the struts of 110 meander in a zigzag fashion).
Regarding claim 14 the McLean Johnson Combination teaches the valve of claim 1 substantially as is claimed,
wherein McLean further discloses the leaflet arrangement (130) comprises a first joining edge, and the skirt (140) comprises a second joining edge wherein the first and second joining edges are connected to each other by a seam that forms the interconnection ([0204] the leaflets 130 and skirt 140 are connected to one another, which is understood to inherently include an attachment/joining edge at the connection seam).
Claim 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over McLean and Johnson as is applied above, further in view of Cai et al. (US 20030055496 A1) hereinafter known as Cai.
Regarding claim 6 the McLean Johnson Combination teaches the valve of claim 1 substantially as is claimed,
but is silent with regards to the leaflet arrangement being conically tapered in the retrograde flow direction,
However, regarding claim 6 Cai teaches leaflets from a heart valve can be tapered in either the antegrade or the retrograde flow direction as a result of its support structure ([0039]. McLean and Cai are involved in the same field of endeavor, namely heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the shape of the wireform of the McLean Johnson Combination so the leaflet arrangement tapers in the retrograde flow direction as is taught by Cai in order to adjust the dynamics of the leaflets and orifice of the heart valve when opening/closing, so the amount of speed, turbulence, and surface area of the opening can be optimized according to the desires of the cardiac interventionalist.
Claim 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over McLean and Johnson as is applied above, further in view of Thambar et al. (US 20120101571 A1) hereinafter known as Thambar.
Regarding claim 11 the McLean Johnson Combination teaches the valve of claim 1 substantially as is claimed,
wherein McLean further discloses the skirt forms an inflow edge (Figure 11d item 121),
but is silent with regards to the skirt being conically tapered in the antegrade direction beyond the inflow edge.
However, regarding claim 11 Thambar teaches a prosthetic heart valve which includes a valvular support member (131) which has at least a portion beyond the inflow edge which is conically tapered in an antegrade flow direction (Figures 3-4). McLean and Thambar are involved in the same field of endeavor, namely prosthetic heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of the McLean Johnson Combination to have the valvular support member (and so also the attached skirt) to be conically tapered in the antegrade direction beyond the inflow edge as is taught by Thambar since it has been held by the courts that a change in shape or configuration, without any criticality in operation of the device, is nothing more than one of numerous shapes that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See MPEP 2144.04 (IV)(B). It appears that the disclosed device would perform equally well shaped as disclosed by McLean. See also Thambar [0098] which describes how the shape of the valvular support member being cylindrical or hourglass are obvious alternatives.
Claim 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over McLean and Johnson as is applied above, further in view of Levi (US 20190053895 A1).
Regarding claim 15 the McLean Johnson Combination teaches the valve of claim 14 substantially as is claimed,
but is silent with regards to the leaflet arrangement forming a first joining flap OR the skirt forming a second joining flap.
However, regarding claim 15 Levi teaches Levi teaches a heart valve where a leaflet arrangement comprises a first joining edge (Figures 17 and 20, bottom of leaflets 41) and a skirt comprises a second joining edge (Figure 20, top of skirt 16), wherein the two joining edges are connected to each other by a seam (Figure 20 item 154) at first/second flaps (see Figures 20-21 in which arc-shaped flaps can be seen which follow the lower edge shape of the leaflets). McLean and Levi are involved in the same field of endeavor, namely heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of the McLean Johnson Combination by having the leaflets and skirt join together as is taught by Levi with flaps, since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the joining of the leaflets and skirt via any known method would have been obvious to try as it would be considered reasonable for it to succeed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 04/08/26
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