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 .
In view of the appeal brief filed on 05/06/26, PROSECUTION IS HEREBY REOPENED. A new ground of rejection is set forth below.
To avoid abandonment of the application, Applicant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then Applicant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/THOMAS C BARRETT/ SPE, Art Unit 3799
Response to Arguments
Applicant's arguments filed 05/06/26 have been fully considered, but they are not persuasive.
On pages 15-17 Applicant argues the embodiment of Figures 1a-b of Shoemaker describes leaflets which are formed by a cover and are “unbound” from the frame. Applicant then argues the embodiment of figures 2a-d also have this “unbound region 148” in order to “function as a valve leaflet”.
The Examiner respectfully registers confusion, pointing out that the “region 148 of the cover 104” which is described as being “unbound” or “unsupported” by the frame is very clearly shown and described as just being the leaflet free edges which open and close in order to form the moving part of the valve (Shoemaker [0034]: “region 148 of the cover 104 that can move relative to the frame 102…and extends between the first connection point 144 and the second connection point 146” which “permits the reversibly sealable opening 116 to open and close in response to the fluid pressure differential across the valve leaflets 132 and 134”.
The claim language in fact, even requires this: “the outlet edge of each leaflet is: attached only at opposed lateral ends to the inner wall of the outer tubular body so that the outlet edges remain open…and close…”). It appears Applicant is focusing on this part of Shoemaker in order to suggest that their leaflets are NOT attached to the surrounding tubular frame due to the word “unbound”.
It is unclear to the Examiner how a leaflet having free edges (Shoemaker figures 2a-d items 248/148) is an argument related to the claim language at all. Having free (or unbound) edges to open and close the leaflets does not appear to be related to the secured lateral edges in any way.
On pages 17-18 Applicant appears to summarize past arguments, which are not part of the rejection.
On page 18 Applicant argues that they cannot see how the lateral edges of the leaflets are attached to the surrounding valve along their length, and does not understand the Examiner’s reference to [0017] and [0022], which describe how the valve cover and leaflets work together to create a “reversibly sealable opening 216 for unidirectional flow of a liquid through the lumen 210”.
The Examiner respectfully notes the reference to [0017] and [0022] was made to point out that the valve of Shoemaker works. In other words, the leaflets, frame, and cover create a complete seal to create a one-way valve. Very basic reasoning along with at least figures 1a-b, and 2a-b tells/shows a person of ordinary skill that a valve which seals completely would inherently, or at the very least obviously, have their edges attached along the entire length of the leaflet (as is shown by Figures 1a-b and 2a-b of Shoemaker) in order to ensure that the seal functions and blood will not seep or leak through, as Shoemaker describes in those paragraphs. If the leaflets were unattached, the valve would leak. If there were openings where the leaflets are unattached, the valve would leak. If there were not an attachment along the entirety of the leaflets’ lateral and cusp (bottom) edges, they would leak, or simply not structurally form leaflets. If for example there were a location of unattachment or an opening instead of an attachment, there would be regurgitation or leaks. In other words, in order to form the valve, the leaflets must be attached to the valve body along their entire length except for where the leaflets have free edges to flap open and closed. The Examiner refers to the rejection below where this is clarified.
On pages 18-19 Applicant argues further that the leaflets only have two connection points (244, 246).
The Examiner respectfully agrees that on the outflow edge of the leaflets those connection points 244, 246 are the only place the leaflets are connected to the surrounding tubular body. This in fact, is a requirement of the claim: “the outlet edge of each leaflet is: attached only at opposed lateral edges to the inner wall of the tubular body”, which Shoemaker also discloses, as the rejection of record acknowledges. The Examiner maintains that if the lateral edges of the leaflets weren’t secured along their entire length, there would be no seal and thus the valve of Shoemaker would not function as the one-way valve they describe in [0017] and [0022]. This is also supported in the rejection of record (below) by Case, who teaches that leaflets are secured to their surrounding tubular body along the attachment pathway (Figure 16 item 74) for each leaflet lateral outer edge 87, 88 to seal. See Case [0042]: “the terms outer edge 39 and lateral outer edges 87, 88 being defined herein as the area or zone along the leaflet that comprises the sealing interface”.
On pages 19-20 Applicant again comments on the Examiner’s response to arguments or advisory action as opposed to the rejection of record.
On pages 20-21 Applicant argues Case fails to teach an outer tubular body.
The Examiner respectfully disagrees, noting first that Shoemaker already teaches this element of the claimed invention, making this argument moot. Second however, the Examiner points out that Case absolutely shows an outer tubular frame body (Figures 13-14 item 11). The claim defines an “outer tubular body” as being nothing other than “having an axial passage extending from an inlet end to an outlet end” and being “constructed of a flexible biocompatible material”. Case’s outer tubular frame absolutely extends along an axial passageway from an inlet to an outlet end (Figure 12 item 62) and is absolutely made of a flexible biocompatible material ([0008] Nitinol). Case even teaches their frame has a covering (Figure 12 item 44; [0053]). Applicant’s argument, which fails to detail why they believe there is no outer tubular body, is accordingly unpersuasive.
On page 21 Applicant copies the frame of figure 13 of Case, showing how the leaflets attach thereto, yet still arguing the leaflets do not attach thereto, despite figure 13 and [0042] of Case showing and describing this attachment in detail.
The Examiner respectfully disagrees, noting Case teaches that leaflets are secured to their surrounding tubular body along the attachment pathway (Figure 16 item 74) for each leaflet lateral outer edge 87, 88). See Case [0042]: “the terms outer edge 39 and lateral outer edges 87, 88 being defined herein as the area or zone along the leaflet that comprises the sealing interface)”. It is unclear to the Examiner where exactly Applicant believes the leaflets lateral edges 87, 88 are not “attached along their entire length”, since their sealing interface is described explicitly. Additionally, the rejection of record further clarifies that when Shoemaker is modified in light of Case, the liquid-casted coating/leaflet structure encapsulates the frame it is attached to, meaning even interstices are integrally formed and attached. Applicant’s argument is accordingly unclear and unpersuasive.
It is possible Applicant intends to argue that the outer tubular body of Case has a different composition or structure than that of Shoemaker, but this argument would be unclear since (1) the outer tubular structures of Case and Shoemaker do not need to be identical in order to be understood as congruent in the art, (2) Case teaches their frame can also include a cover ([0053] covering 44), (3) since Shoemaker already discloses the structure of the outer tubular body, and (4) since Case’s structure 11 actually meets the claim language related to the outer tubular body (“hav[e] an axial passage extending from an inlet end to an outlet end” and be “constructed of a flexible biocompatible material”). Case’s frame 11 accordingly meets this “outer tubular body” limitation (although it need not, since Shoemaker already does). See Case [0007]-[0008] a collapsible and expandable nitinol frame is understood to be flexible and biocompatible). This argument is accordingly unpersuasive.
On pages 22-25 Applicant copies paragraphs of Case and concludes Case has a focus on structures which maximizes coaptation distance, and then admits there is attachment between the outer tubular frame/body of Case and the leaflets, but states this is an inadequate teaching since it does not cover the entire length of the leaflet lateral edges and since this attachment is not continuous.
The Examiner respectfully disagrees, reminds Applicant that Case Figure 13 and [0042] explicitly describe and shows the attachment pathway of leaflet lateral edges 87, 88 to the surrounding tubular structure 11 along their entire length in a “sealing interface” ([0042]). Additionally, this fails to consider the rejection of record, which clarifies that the modification of Shoemaker in view of Case creates a valve which is liquid-casted to encapsulate a frame and form an integral tube/leaflet structure which is integrally formed along the entire length of the leaflet.
It is possible that Applicant’s main issue with Case is that the outer tubular body of Case takes the shape of a frame 11 with a covering 44 (as opposed to whatever else Applicant believes must be present to meet the limitation of an “outer tubular body”). However, this fails to account for the fact that Case’s frame 11 meets Applicant’s claim limitations regarding what the outer tubular body must be structurally (“having an axial passage extending from an inlet end to an outlet end” (Case figure 12 item 11 shows tubular passage 62) and “being constructed of a flexible biocompatible material”. (Case [0008] support structure is made of nitinol, which is both flexible and biocompatible)), and also for the fact that Shoemaker already teaches the outer tubular body. Thus, this argument fails on both levels.
Finally, as regards the suggestion that the attachment is done via fasteners and so the attachment is not continuous, the Examiner notes Applicant appears to be arguing features which are not present in the claim language. There is no part of the claim requiring a “continuous attachment” as is being argued. Case [0042] and Figures 13 and 16 item 74 shows the attachment pathway of the lateral outer edges 87, 88 of the leaflets, which forms the sealing interface. The Examiner reminds Applicant that a “seal” is “a tight and perfect closure (as against the passage of gas or water); a device to prevent the passage or return of gas or air into a pipe or container” according to Merriam-Webster. If the seal is present, as is described by Case [0042], and the seal interface occurs along the pathway Figure 16 item 74, which is shown to extend along the leaflets’ entire length and along their lateral ledges (Figure 13, 16 item 87, 88), the leaflets’ lateral edges are attached along their entire length to the inner wall of the outer tubular body as the claim requires. Additionally, the Combination of record is Shoemaker in view of Case, and since Shoemaker already teaches the leaflet/tubular body encapsulates the frame via a method of liquid casting to create the structure, the Shoemaker Case Combination creates a structure in which the leaflets are connected along their entire length to the frame and surrounding tubular body.
On pages 25-26 Applicant argues the shape of DiMatteo’s leaflets is a product of the shape of the frame and is not static, whereas the instant invention requires the recessed edge to the present in three states.
The Examiner respectfully notes it is unclear how this relates to the rejection of record, since it does not point out any supposed errors or flaws in the rejection.
On pages 26-27 Applicant argues further that the change in leaflet shape suggested by the Examiner is not predictable, and notes Shoemaker teaches an unsupported flexible membrane with no frame whereas DiMatteo teaches a valve with a rigid hinged system.
The Examiner respectfully notes this is incorrect. Shoemaker’s valve includes a frame (see figures 2a-d item 202), making it unclear why Applicant suggests there is no frame. Further, suggestions that the frames or leaflets of Shoemaker and DiMatteo are different or function differently are unsupported with evidence in the record. Attorney statements are not the same as evidence in the record, and to be of probative value, any objective evidence should be supported with actual proof. See MPEP 716.01(c)(I) and 716.01(c)(II). There is nothing in the record to support the suggestion that having a recessed leaflet would be unpredictable.
On page 27 Applicant argues the Examiner has not addressed whether a person of ordinary skill would have reasonable expectation of success in this modification, to have a “flexible, unsupported membrane leaflet” maintain “a recessed outlet edge geometry in the absence of the frame and hinge structure that produces that geometry in DiMatteo”.
The Examiner again points out there is no evidence in the record that the frames are distinct from one another in any way. The leaflets of both Shoemaker and DiMatteo are flexible (Shoemaker [0044] leaflet material is thin and pliable and can include ePTFE; DiMatteo [0009] the leaflet material is thin and pliable and comprises ePTFE), the frames of both Shoemaker and DiMatteo are both hinged (Shoemaker [0030] shape memory nitinol frame; DiMatteo [0018] shape memory trellis made of Nitinol). The Examiner is unclear exactly what the differences are that Applicant believes exist, and exactly how those differences would result in the leaflets of a Shoemaker DiMatteo Combination being “unpredictable” or “unsuccessful” in any way. Without proof or evidence in the record, these statements cannot be considered persuasive.
On page 27 Applicant suggests the Shoemaker DiMatteo “may well result in an inoperative or non-optimized valve”, and then provides no support or probative evidence for this statement.
As the Examiner explained above, the Examiner understands the equivalence of the structures of Shoemaker and DiMatteo and sees no reason for inoperability as Applicant suggests. The Examiner also notes no evidence in the record for the attorney statement regarding inoperability. See again MPEP 716.01(c)(I) and 716.01(c)(II).
On pages 27-28 Applicant describes various design considerations a person of ordinary skill understands when designing or manufacturing valves, and suggests (again without evidence in the record or proof provided) that the attachment of the leaflets’ lateral edges “may hinder the valve rotating around the pivot point or folding point” and “compromise valve leaflet coaptation sealing”.
The Examiner again refers Applicant to MPEP 716.01(c)(I) and 716.01(c)(II). Without proof in the record, attorney statements cannot be considered to be of probative value. Additionally, the Examiner points out that a person of ordinary skill is very able to consider these basic design considerations. "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." See MPEP 2141.03(I). There is nothing in the record to suggest a person of ordinary skill would not be able to design this combination, utilizing (or not utilizing) any specific frame geometry.
On pages 28-29 Applicant discusses the advisory action.
The Examiner respectfully notes the advisory action is not part of the pending rejection of record.
On pages 29-30 Applicant argues that Acosta [0024], [0028] is provided as “evidence” that venous valves have a normally open configuration, which is improper.
The Examiner respectfully notes confusion and disagreement. Acosta is and was positively recited as a modifying reference under 35 U.S.C. 103 and is not recited as evidentiary support.
On pages 30-31 Applicant argues the Examiner uses hindsight to piece together prior art references since the Examiner’s reason to modify is not present in the prior art references themselves.
The Examiner respectfully disagrees and reminds Applicant that “[t]he rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law.” See MPEP 2144(I).
On pages 32-34 Applicant argues remaining claims rise and fall with the above arguments.
Accordingly, no arguments are persuasive. The Examiner refers Applicant to the rejection below where the rejection is more thoroughly explained and clarified.
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) 1-2, 4-12, 23-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shoemaker et al. (US 20050137681 A1) hereinafter known as Shoemaker in view of Acosta et al. (US 20020177894 A1) hereinafter known as Acosta, further in view of DiMatteo et al. (US 20050065594 A1) hereinafter known as DiMatteo, further in view of Case et al. (US 20040260389 A1), hereinafter known as Case.
Regarding claim 1 Shoemaker discloses an implantable prosthetic valve (200) comprising:
an outer tubular body (Annotated Figure 2d) having an axial passage (210) extending from an inlet end (212) to an outlet end (214), the outer tubular body being constructed of a flexible biocompatible material ([0044], [0046] the leaflets and cover are made of a pliant material including those biocompatible materials listed); and
a pair of apposed valve leaflets (232, 234) disposed in the axial passage,
wherein the valve leaflets comprise the flexible material unsupported by a scaffold (see Figures 2a-d which show the leaflet material being unsupported on parts, along with Figures 4a-d which shows how the leaflets lack the frame/scaffold support which the outer tubular body has),
wherein each leaflet has a pair of lateral edges extending from an outlet edge and transitioning to an inlet edge (considered to be the left and right side edges of the extent of the valve leaflets seen in Figure 2b, where the leaflets follow the stent frame where they are attached thereto), the pair of lateral edges and inlet edge being attached to an inner wall of the outer tubular body (see Figure 2b, at attachment points 244, 246. Reference also Figures 1a-b item 144, 146; [0033]) and being attached along their entire length so the outlet edge of the leaflets are attached only at opposed lateral ends to the inner wall of the tubular body ([0045] and Figures 2a-d show the cover 104 can be located over the inner and outer surfaces of the frame and joined together through the openings to encase the frame 102, via folding the cover over the frame from the bottom of the figure, and extending upward where it is seen (Figure 2c) to deviate from the cylindrical form of the frame to skew inwardly and form the leaflets; [0046] the cover 104 can be coupled to the connection points 144, 146 to form the valve leaflets. The cover can be in the form of a sheet of material or in the form of a liquid that is case to cover the frame; [0048] the cover includes the valve leaflets 132, 134; [0049] the cover 104, forming the valve leaflets 132, 134. In other words, [0045]-[0046] and [0049] describe how the leaflets and outer tubular body are integrally formed of the same sheet or fluid casting of material that is (Figure 2c) folded from the outside of the frame, along the bottom of the figure, to the inside of the frame, where the cover extends upwards until it skews inwardly, detaching from the frame to form the leaflets 234 and 234 by connecting the outlet edges 256 to the frame only at connection points 244 and 246. Shoemaker accordingly discloses the integral formation of the outer tubular body and leaflets.), so the outlet edges remain open when fluid pressure is applied to the inlet end and close together when fluid pressure is applied to the outlet end ([0017], [0022] describe how the valve opens and closes with pressure), and
wherein the outlet edge of each leaflet is recessed along its length in a direction toward the inlet end when closed (Figure 2b),
but is silent with regards to whether or not the leaflets are recessed when open, or the leaflets’ position in an unstressed condition,
and whether the leaflets are attached to the outer tubular body along their entire length.
However, regarding claim 1 Shoemaker discloses their valve is a venous valve (Abstract) and Acosta teaches venous valves have a typically open configuration ([0024], [0028]). Shoemaker and Acosta are involved in the same field of endeavor, namely venous valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to ensure the venous valve of Shoemaker has a “normally” open configuration when stressed in order to ensure the valve remains typically open with minimal forward blood flow, such as is naturally present in biological venous environments, and/or under no forward flow, as may be present in a pathological leg to create a biomimetic valve.
However, regarding claim 1 DiMatteo teaches that venous valves can have leaflets which are recessed when open (Figure 25a) as well as closed (Figure 24a). Shoemaker and DiMatteo are involved in the same field of endeavor, namely venous 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 leaflets so that they are recessed when open as is taught by DiMatteo since the courts have held that choosing from a finite number of identified, predictable solutions (e.g. different/known shapes in the art) 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 shape of known valve when open/closed would have been obvious to one of ordinary skill to choose.
Further, regarding claim 1 Case teaches that leaflets forming venous valves can be attached to an outer tubular support structure (11) along a leaflet attachment pathway (Figure 16 item 74/75/76) to form a sealing interface therewith ([0042] “the terms outer edge 39 and lateral outer edges 87, 88 being defined herein as the area or zone along the leaflet that comprises the sealing interface”). Shoemaker and Case are involved in the same field of endeavor, namely venous 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 Shoemaker so that its leaflets and outer tubular body and support structure are connected to one another along a leaflet attachment pathway as is taught by Case, in order to ensure the leaflets have more support along their axial dimension, thus increasing valve durability over time so repeated opening/closing of the leaflets is less likely to dislodge the leaflets from the surrounding tubular body and support. This, when modified in light of Shoemaker, who teaches the leaflets/outer body are integrally formed (Shoemaker [0049]) by liquid casting/molding (Shoemaker [0046]) to encase the frame (Shoemaker [0045]), would result in the lateral edges of the leaflets being integrally cast along a leaflet attachment pathway (Case 74/754/76), so that the leaflets, frame, and both the inner and outer tubular covers are integrally attached to one another (Shoemaker [0056]) along the pathway that extends the leaflets’ entire length.
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Regarding claim 2 the Shoemaker Acosta DiMatteo Case Combination teaches the valve of claim 1 substantially as is claimed,
wherein Shoemaker further discloses the recessed outlet edges are curved away in the direction toward the inlet end (Figure 2b).
Regarding claim 4 the Shoemaker Acosta DiMatteo Combination teaches the valve of claim 3 substantially as is claimed,
wherein Shoemaker further discloses the leaflets have lateral edges that follow converging paths along the inner wall from their inlet ends to their outlet ends (see Figure 2d, or even Figure 5c).
Regarding claim 5 the Shoemaker Acosta DiMatteo Case Combination on teaches the valve of claim 1 substantially as is claimed,
wherein Shoemaker further discloses the leaflets and outer tubular body are formed from a biocompatible polymer ([0044] the leaflets are formed from one of these polymers; [0045]-[0047], [0049] the leaflets are integral with the outer tubular body meaning the outer tubular body is formed of the same material as the leaflets).
Regarding claim 6 S the Shoemaker Acosta DiMatteo Case Combination teaches the valve of claim 5 substantially as is claimed,
wherein Shoemaker further discloses the outer body and leaflets are integrally formed ([0045]-[0047], [0049] the cover is folded over the frame and integrally forms the leaflets via its connection to the frame up until it skews inwardly to form the leaflets by its attachment to the frame at connection points 244, 246) from the biocompatible polymer ([0044] describes the polymers the leaflets (and so outer body) are integrally formed of).
Regarding claim 7 the Shoemaker DiMatteo Acosta Case Combination teaches the valve of claim 6 substantially as is claimed,
wherein Shoemaker further discloses the outer body and leaflets are integrally formed ([0045]-[0047], [0049] the outer body forms the leaflets) by molding or welding (The applicant is advised that this is a product-by-process claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”. See MPEP 2113. In this case, the cited limitations failed to distinguish the claimed structure from Shoemaker, since all the structural limitations of the claim appear to be met. See for example, [0046] the cover (and so its integrally formed leaflets) are formed by liquid casting (molding)).
Regarding claim 8 the Shoemaker Acosta DiMatteo Case Combination teaches the valve of claim 1 substantially as is claimed,
wherein Shoemaker further discloses the outer tubular body is reinforced (Figure 2d item 202; [0030]).
Regarding claim 9 the Shoemaker Acosta DiMatteo Case Combination teaches the valve of claim 8 substantially as is claimed,
wherein Shoemaker further discloses a reinforcement scaffold coupled to the outer tubular body (Figure 2d item 202).
Regarding claim 10 the Shoemaker Acosta DiMatteo Case Combination teaches the valve of claim 9 substantially as is claimed,
wherein Shoemaker further discloses the scaffold is embedded within the outer tubular body (Figure 2d; [0045] the frame is encased within the outer tubular body 204).
Regarding claim 11 the Shoemaker Acosta DiMatteo Case Combination teaches the valve of claim 9 substantially as is claimed,
wherein Shoemaker further discloses the scaffold is self-expanding ([0030]).
Regarding claim 12 the Shoemaker Acosta DiMatteo Case Combination teaches the valve of claim 9 substantially as is claimed,
wherein Shoemaker further discloses the scaffold is balloon expandable ([0030]).
Claims 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shoemaker, DiMatteo, Acosta, and Case as is applied above, further in view of Patel et al. (US 20030014126 A1) hereinafter known as Patel.
Regarding claims 23-24 the Shoemaker DiMatteo Acosta Case Combination teaches the valve of claim 1 substantially as is claimed,
but is silent with regards to the leaflets’ ultimate tensile strength.
However, regarding claims 23-23 Patel teaches that leaflets for valves ([0050] valve structure forming leaflets to treat venous insufficiency) can include materials that have a tensile strength from 4-10 MPa ([0038]).
Claims 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shoemaker, DiMatteo, Acosta, Case as is applied above, further in view of Ku et al. (US 20120053676 A1) hereinafter known as Ku.
Regarding claim 25 the Shoemaker Acosta DiMatteo Case Combination teaches the valve of claim 1 substantially as is claimed,
but is silent with regards to the valve leaflets including a PVA.
However, regarding claim 25 Ku teaches that venous valve leaflets can include a PVA ([0061] ([0033])). Shoemaker and Ku are involved in the same field of endeavor, namely valve replacements. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the material of the valve leaflets of the Combination so that they included PVA as is taught by Ku it has been held by the courts that selection of a prior art material on the basis of its suitability for its intended purpose is within the level of ordinary skill. See MPEP 2144.07. In this case, the use of any biocompatible material known for use within leaflets would have been obvious to try.
Claims 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shoemaker, DiMatteo, Acosta, and Case as is applied above, further in view of Mathney et al. (WO 2014133543 A1) hereinafter known as Mathney and Ku as is applied above.
Regarding claims 26-27 the Shoemaker Acosta DiMatteo Case Combination teaches the valve of claim 1 substantially as is claimed,
but is silent with regards to the length of the outlet edge of each leaflet being 95-125% the width of the axial passage of the tubular outer body.
However, regarding claims 26-27 Mathney teaches that venous valves can have a leaflet free edge which ranges from approximately 0.5:1 to 3:1 the diameter of a target vessel ([000125]), and Ku teaches that a venous valve diameter can occupy 0.75-1.5 the inner diameter of the target vessel ([0057]). Shoemaker, Mathney and Ku are involved in the same field of endeavor, namely valve replacements. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the length of the free edge of the leaflets of the Combination so that they are 95-125% the width of the axial passage of the outer tubular body 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 identified edge length as it relates to the outer tubular body would have been obvious to try in order to optimize fit and leaflet coaptation.
Conclusion
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/Jacqueline Woznicki/ Primary Examiner, Art Unit 3774 06/09/26
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