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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/06/26 has been entered.
Response to Arguments
Applicant's arguments filed 04/06/26 have been fully considered but they are not persuasive.
On pages 6-7 regarding prior art rejections Applicant amendments overcome the rejection of record.
The Examiner respectfully refers to the rejection below regarding amended claims.
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.
Claims 21-24, 26-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boudjemline (US 20090198315 A1) in view of Shokoohi (US 20090182404 A1), further in view of Johnson et al. (US 20200121456 A1) hereinafter known as Johnson, and further in view of Quadri et al. (US 8403983 B2) hereinafter known as Quadri, further in view of Stinson et al. (US 6251135 B1) hereinafter known as Stinson.
Regarding claim 21 Boudjemline discloses a replacement mitral heart valve ([0103] cardiac, [0128] AV valves, [0126] mitral) comprising:
a collapsible and expandable ([0129]; [0033], [0022]) tubular braided frame (Figures 13-14, 18-19, 31, etc. which show a tubular frame which is partly cylindrical) comprising at least one wire braided in a pattern (Figures 1-5; ; [0021]) comprising 12 or less apices on at least one end of the frame (Figure 5 shows 12 apices in the frame), a braid angle of about 45 degrees in a fully self-expanded configuration (Figures 1-5),
wherein the wire(s) of the braided frame intersect at crossing points such that portions of the wire are configured to move independent of each other to define sliding crossing points (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 Boudjemline 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 [0018], [0087]),
a valve assembly being connected to an inside portion of the frame (for example, see Figure 29d which shows valve 2906 inside stent); and
but is silent with regards to the angle being between 15-45 degrees,
and the valve assembly including leaflets which are configured to provide a one-way flow control through the valve,
and a base stitch connecting the leaflet assembly to the inside portion of the frame along the crossing points,
and a portion of the crossing points being lashed so they constrain motion of intersecting portions of the wire.
However, regarding claim 21 Shokoohi teaches that braid angles within self-expanding frames can be 15-45 degrees ([0099]). Boudjemline and Shokoohi are involved in the same field of endeavor, namely implantable valve prostheses (Shokoohi [0086]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the angle of the braid of Boudjemline so that it is 15-45 degrees as is taught by Shokoohi since 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, since the angles shown by Boudjemline appear to lie somewhere between 0-90 degrees, any angle lying therebetween is considered obvious to try.
Further, regarding claim 21 Johnson teaches that valves are known to include leaflets (Figure 1a item 24; [0032]) for one-way flow (the limitation of one-way flow is understood to be a “functional limitation” (see the explanation above). See also [0010]). Boudjemline and Johnson are involved in the same field of endeavor, namely 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 Boudjemline Shokoohi Combination to ensure their valve includes leaflets that are capable of allowing one-way flow as is taught by Johnson in order to mimic the native leaflets of the heart and ensure the failing valve can be replaced and function as intended.
Further, regarding claim 21 Quadri teaches that heart valves can include a base stitch (Figure 16a item 820) to connect a leaflet assembly (330) to an inside portion of a frame (500). Boudjemline and Quadri 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 Boudjemline Shokoohi Johnson Combination so that there is a base stitch to connect the leaflet to the inside of the frame as is taught by Quadri in order to ensure the secure connection between the frame and leaflet assembly, which still enables expansion. The Examiner notes that when applied to the Combination, this base stitch would obviously be located along the crossing points of Boudjemline.
Further, regarding claim 21 Stinson teaches wherein a portion of crossing points of braided frames can be lashed so that they are capable of constraining motion of intersecting portions of the wire(s) (Figure 14 item 24; Column 14 lines 49-56 the described markers are understood to be capable of achieving the functional limitation of constraining motion of the intersections at least slightly since they are looped, enclosed, welded, etc.). Boudjemline and Stinson are involved in the same field of endeavor, namely braided endoprostheses. 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 that there are lashed crossing points as is taught by Stinson 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). Accordingly, it would have been obvious to one of ordinary skill to modify Boudjemline’s markers’ shapes and attachment method so they are formed as is taught by Stinson, since this is a known shape and attachment method for radiopaque markers within the art.
Regarding claim 22 the Boudjemline Shokoohi Johnson Quadri Stinson Combination teaches the valve of claim 21 substantially as is claimed,
wherein Boudjemline further discloses the wire of the frame has four crossing points per circumference (see Figures 1-5 where four crossing points are shown).
Regarding claim 23 the Boudjemline Shokoohi Johnson Quadri Stinson Combination teaches the valve of claim 21 substantially as is claimed,
wherein Boudjemline further discloses the wire of the frame has six crossing points per circumference (see Figures 1-5 where six crossing points are shown).
Regarding claim 24 the Boudjemline Shokoohi Johnson Quadri Stinson Combination teaches the valve of claim 21 substantially as is claimed,
wherein Shokoohi further teaches the braid angle is between 20-30 degrees in the fully self-expanded configuration ([0099]; 15-45 degrees before crimping).
Regarding claim 26 the Boudjemline Shokoohi Johnson Quadri Stinson Combination teaches the valve of claim 21 substantially as is claimed,
wherein Boudjemline further discloses looping structures formed at one or more of the apices of the frame (Figure 5 item 12), wherein a radial force created at the looping structures is capable of contributing to the valve being self-expandable (this is stated as a functional limitation (see the explanation in the rejection to claim 21 above). Since the structure of Boudjemline is the same as Applicant’s, it is understood to perform in the same way).
Regarding claim 27 the Boudjemline Shokoohi Johnson Quadri Stinson Combination teaches the valve of claim 21 substantially as is claimed,
wherein Boudjemline further discloses the braid is a zig-zag or over-under braid (Figures 1-4; [0021]).
Regarding claim 28 the Boudjemline Shokoohi Johnson Quadri Stinson Combination teaches the valve of claim 21 substantially as is claimed,
wherein Boudjemline further discloses the braid consists of one or more wires of Nitinol ([0022]).
Regarding claim 29 the Boudjemline Shokoohi Johnson Quadri Stinson Combination teaches the valve of claim 21 substantially as is claimed,
wherein Boudjemline further discloses the frame diameter is 2-3 cm ([0129]).
Regarding claim 30 the Boudjemline Shokoohi Johnson Quadri Stinson Combination teaches the valve of claim 21 substantially as is claimed,
wherein Boudjemline further discloses the frame is 1.5 cm in length ([0129] 15 mm),
but is silent with regards to the length being 2 cm in length.
However, regarding claim 30 a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05 (I). In this case, it is accordingly considered obvious to have the length be 2 cm in length, since this is close to 1.5 cm.
Regarding claim 31 the Boudjemline Shokoohi Johnson Quadri Stinson Combination teaches the valve of claim 21 substantially as is claimed,
wherein Boudjemline further discloses there are commissure posts ([0023]),
and Johnson further teaches there can be three commissure posts at apices a valve (Figures 2-4).
Regarding claim 32 the Boudjemline Shokoohi Johnson Quadri Stinson Combination teaches the valve of claim 21 substantially as is claimed,
wherein Johnson further teaches the leaflet assembly is connected to commissure posts formed at three apices on the frame (Figures 1-4).
Regarding claim 33 the Boudjemline Shokoohi Johnson Quadri Stinson Combination teaches the valve of claim 26 substantially as is claimed,
wherein Boudjemline further discloses the looping structures are configured to reduce peak stress and strains at the apices (this is stated as a functional limitation (see explanation in the rejection to claim 21 above). Since the looping structures of Boudjemline are structurally the same as Applicant’s they are understood to perform the same way. See also [0087]).
Claim 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boudjemline, Shokoohi, Johnson, Quadri, and Stinson as is applied above, further in view of Clerc et al. (US 20080300673 A1) hereinafter known as Clerc.
Regarding claim 34 the Boudjemline Shokoohi Johnson Quadri Stinson Combination teaches the valve of claim 26 substantially as is claimed,
wherein Boudjemline further discloses the frame includes radiopaque markers ([0023]) which are configured for visibility under fluoroscopy (this is stated as a functional limitation of the markers (see the explanation above regarding functional limitations). The markers are considered capable of visibility under fluoroscopy (see [0023]).),
but is silent with regards to them being specifically located on looping structures.
However, regarding claim 34 Clerc teaches that woven endovascular devices can include radiopaque markers on looped ends ([0054]). Boujermline and Clerc are involved in the same field of endeavor, namely braided endovascular implants. 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 Boudjemline Shokoohi Johnson Quadri Stinson Combination so that the looping structures on one end of the stent include a radiopaque marker in order to enhance visibility of the frame, thus ensuring the implanting physician can visualize the positioning of the device within the patient.
Claim 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boudjemline, Shokoohi, Johnson, Quadri, and Stinson as is applied above, further in view of Haug et al. (US 20050283231 A1) hereinafter known as Haug.
Regarding claim 37 the Boudjemline Shokoohi Johnson Quadri Stinson Combination teaches the valve of claim 21 substantially as is claimed,
but is silent with regards to the apices comprising a lock suture threaded therebetween.
However, regarding claim 37 Haug teaches a valve that includes apices with a lock suture threaded therebetween, so that during delivery to the native valve, tension at the lock suture is configured to pull the lock suture radially inward and the valve can be held in a diametrically compact form (this is stated as a functional limitation (see the explanation above regarding functional limitations). See also [0075], [0067] Figure 1a-b, 2a-b, and 12a-b shows a valve which includes openings in apices 42 which are connected to a lock suture 50. Limitations of this lock suture being used in a specific way during delivery is an intended use of the system (see the explanation in the rejection to claim 21 above). See also [0067] which directly indicates suture 50 can be used during delivery to change the valve’s shape). Boudjemline and Haug are involved in the same field of endeavor, namely 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 Boudjemline Shokoohi Johnson Quadri Stinson Combination so that there is a suture lock between apices as is taught by Haug in order to provide a thread to aid in either delivery, retrieval, and/or repositioning of the valve. Such inclusions are a very common element for valve systems. 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).
Conclusion
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 04/22/26
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