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 .
Response to Arguments
Applicant's arguments filed 08/20/26 have been fully considered but they are not persuasive.
On pages 7-8 regarding prior art rejections Applicant argues amendments overcome the rejection of record since McLean shows the sleeve 146 being a form of the sealing member 140, and the sleeve 146 has “nothing to do with the coupling of the anchor 110 and the valve support 120”, but is rather used for sealing. Applicant argues the figures relied upon in the office action require the valve support 120 to be physically coupled to the anchoring member 210 which means the connection is not made of a “pliable material”.
The Examiner respectfully disagrees, pointing out Figure 25a-b and [0252] show and discuss the sleeve 146 bridging the gap 108 between the two supports 110, 120.
On pages 8-9 Applicant argues further that while McLean seeks to “ ‘mitigate’ the mechanical coupling, the coupling is still present” meaning “the connection isn’t non-existent, as required by claim 1”. Applicant refers to McLean [0236] where a potential connection between 120 and 210 can exist, and to Figures 16a-c, to Figure 10a and [0191], to [0195], [0200], [0206], [0208], and [0209] which all describe potential connections between the two members.
The Examiner respectfully agrees that a few embodiments of McLean have the supports 110, 120 connected together, but points out that many embodiments of McLean have the supports connected together indirectly as well. The recitation of a potential or optional connection does not require every embodiment to have the same connection as is appears Applicant is arguing. Additionally, suggesting the coupling between the two supports 110 and 120 of McLean is “still present” and “isn’t non-existent” as claim 1 requires is unclear, since the claim also requires the two to be literally connected together through the “interconnection”. The Examiner is unable to determine what Applicant intends by these amended claims. See the 112a and 112b rejections below for clarification.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the anchoring support structure being without any structural connection to the valvular support structure 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
Claim 18 is objected to because of the following informalities:
Claim 18 is objected to for referring to “a flow direction” when it is unclear how, if at all, this relates to the previously identified “antegrade flow direction” and “retrograde flow direction”.
Appropriate correction is required.
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 1-9, 11-18 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is rejected for having new matter for claiming there is an “anchoring support structure that is separate from and without any structural connection to the valvular support structure”, when there is no support for this in the originally filed disclosure. The original disclosure indicates that the “valvular support structure and the anchoring support structure are structurally separate from one another but are flexibly connected to each other” (page 13 lines 4-6). This is distinct from what is now required by claim 1, which is the anchoring support structure and valvular support structure being “without any structural connection”. The connection between the two support structures are clearly shown and described throughout as occurring through the leaflet and skirt. This is accordingly new matter. The Examiner notes that in order to have support for a negative limitation such as “without any structural connection”, there must be “basis in the original disclosure…The mere absence of a positive recitation is not basis for an exclusion.” See MPEP 2173.05(i).
Remaining claims are rejected for depending on a claim with 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.
Claims 1-9, 11-18 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 pre-AIA the applicant regards as the invention.
Claim 1 is indefinite for claiming there is an “anchoring support structure that is separate from and without any structural connection to the valvular support structure”, when the claim also requires the flexible skirt supported by the anchoring support structure, has a “pliable material interconnection” between it and the flexible leaflet arrangement supported by the valvular support structure. Notably, the valvular support structure and anchoring support structure are apparently required to be both connected by the flexible skirt/flexible leaflets, and also be “separate from and without any structural connection to” one another. It appears impossible to meet both of these claim limitations at the same time, since they claim opposite requirements.
Claim 16 is indefinite for claiming the lower and upper vertices define a “substantially curved shape” when it is unclear what it means to be “substantially” curved. The specification does not describe anywhere what it means to be “substantially curved” (for example, as opposed to being curved or not curved). Without understanding this, the boundaries of the claim cannot be determined.
Claim 17 is indefinite for claiming the pliable interconnection is formed by “crown-like shaped joining edges” when it is unclear what it means to be crown-shaped. The Examiner is unaware of what specific shape a crown has, and so the meaning of the claim cannot be determined.
Remaining claims are rejected for depending on an indefinite claim.
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, 11-13, 18 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 support structure (Figure 10a item 110) that is separate from and without any structural connection to the valvular support structure (as is best understood (See 112a and 112b rejections above): [0148] describes how the valve support and anchoring support structures are separate, and then connected together for use (indicating the two structures are separate before connection. See also Figures 25a-b, 22a-b, 22f-k, and 23a-b which show how the anchoring support structure and valvular support structure are not connected with a strut. See also [0242] the sealing member 140 is the element that couples the anchoring support structure 110 and valve support structure 120.),
a flexible skirt supported by the anchoring support structure (Figure 11b-c item 140; [0242] the skirt is made of Dacron, ePTFE, pericardium, polymer, polyester, Gore-tex, PET, etc. which are all considered flexible), 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),
a pliable material interconnection between the flexible leaflet arrangement and the flexible skirt ([0202], [0204] the skirt 140 can be attached directly to valve 130; see also [0240] adhesives, glues, or bonding materials can couple sealing members to components of the device 100),
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 18 the McLean Johnson Combination teaches the valve of claim 1 substantially as is claimed,
wherein McLean further teaches the anchoring support structure is separated from the valvular support structure along a flow direction through both support structures (see for example Figures 13a-b, 13e-f, 16b-d, 19b, 21a, 22i, 22k, 23a-b, 24c, 25a, 26a-d, 28-29, 45a-b, 53c, 57a-c, 59a, 61, etc. which all show how the anchoring support structure is separated from the valvular support structure along a flow direction.). 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 so that the anchoring support structure is separated along the flow direction as is taught by McLean in order to allow the valve 130 to be seated at any desirable location within the annulus, and thus optimize the treatment of a patient according to their particular need.
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 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over McLean and Johnson as is applied above, further in view of Yu et al. (US 20120316642 A1).
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 ([0204] the leaflets 130 and skirt 140 are connected to one another, which is understood to inherently include an attachment/joining edge),
but is silent with regards to the interconnection being a sewed seam.
However, regarding claim 14 Yu teaches a leaflet flexible arrangement (2) has a first joining edge which joins a flexible skirt (3) joining edge, wherein the pliable material interconnection between them is a sewed seam between the two edges (Figure 9 item 13; [0079]). McLean and Yu 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 so that the connection between the skirt 140 and leaflets 130 is a sewn seam as is taught by Yu since the courts have held that the use of a known technique or method to improve a known device results in a prima facie case of obviousness. See MPEP 2143 (I)(C). Additionally, the courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B). In this case, the use or substitution of any known method of connection between flexible materials is considered obvious to try.
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.
Claim 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over McLean and Johnson as is applied above, further in view of Oba et al. (US 20180055629 A1) hereinafter known as Oba.
Regarding claim 16 the McLean Johnson Combination teaches the valve of claim 1 substantially as is claimed,
wherein McLean further discloses the valvular support is formed by a ring which forms a circumferentially closed loop (Figure 11b-c item 120) and is elastically deformable to adapt to the shape of an implantation site ([0200] the valvular support 120 is formed of Nitinol, which is elastically deformable and so capable of deforming at an implantation site),
wherein the valvular support comprises a plurality of lower vertices and upper vertices (Figures 11b-c show how the support 120 includes zig-zag struts which comprise upper and lower vertices) that define a substantially curved shape (Figures 11a-b show how the vertices form an annular curved ring shape) and that alternate along a circumferential direction about the antegrade and retrograde flow directions (Figure 11a-b shows the zig-zags alternating circumferentially),
wherein the anchoring support structure comprises an elastically deformable anchor support ([0200] the support 110 is made of Nitinol, which is an elastically deformable material),
and the valvular support structure and anchoring support structure comprise no struts extending therebetween (See Figures 25a-b, 22a-b, 22f-k, and 23a-b which show how the anchoring support structure and valvular support structure are not connected with a strut. See also [0242] the sealing member 140 is the element that couples the anchoring support structure 110 and valve support structure 120.) and being only connected by the pliable material interconnection between the flexible leaflet arrangement and the flexible skirt (Figure 25a-b show how the only connection between the supports 110 and 120 include the sleeve 146; [0241] the sleeve 146 is just one of the forms the skirt 140 can take; [0242] the sealing member 140 is used to couple the valve support 120 to the valve 130) such that the anchoring support structure can elastically deform independently from the elastic deformation of the valvular support structure ([0143] the valve is mechanically isolated from its support),
but is silent with regards to the valvular support defining a conical shape that tapers in the retrograde flow direction toward the anchoring support structures.
However, regarding claim 16 Oba teaches the valvular support can define a conical shape that tapers in the retrograde flow direction towards the anchoring support structure (Figure 26 shows conical tapers of the inner valve support in both the antegrade and retrograde directions). McLean and Oba 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 so the valvular support is a conical taper as is taught by Oba 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, it would have been obvious to choose any shape for the valvular support known in the art. See also Oba [0373] which teaches how the inner frame body shape of Figure 46 can allow increased durability of the valve body 2460.
Claim 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over McLean, Johnson, and Oba as is applied above, further in view of Yu as is applied above.
Regarding claim 17 the McLean Johnson Oba Combination teaches the valve of claim 16 substantially as is claimed,
but is silent with regards to the pliable interconnection between the leaflets and skirt being meandering or crown-like shaped joining edges.
However, regarding claim 17 Yu teaches wherein flexible materials of a leaflet can be joined together via meandering or crown-like shaped joining edges of one of the flexible materials being received within complementary joining edges of the other flexible material (Figure 9 shows meandering and crown-shaped joining edges of leaflets and skirts interdigitating at seam 13). McLean and Yu 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 Combination so the connection between the leaflets and skirt form a meandering or crown-like shape as is taught by Yu 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.
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 extension fee 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 Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774
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