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 10/17/25 have been fully considered but they are not persuasive.
On page 6 Applicant argues amendments overcome the rejections of record.
The Examiner respectfully refers to the rejection below regarding amended claims.
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 heart valve comprising receive frame, 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 21 is objected to because of the following informalities:
Claim 21 is objected to for missing a word after “self-expanded configuration”.
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 36, 38 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 36 is rejected for having new matter for claiming the replacement mitral heart valve comprises “a receiver frame”, when the originally filed disclosure makes it clear that the “receiver frame” is not actually a part of the claimed heart valve, but rather a component of a system which the mitral valve and receiver frame can be a part of.
Claim 38 is additionally rejected for having new matter for claiming the valve relies on “a receiver frame” which appears to also positively claim the “receiver frame” as being a part of the claimed “heart valve” (however, see the 112b rejection below, since this is not clear), when this is not supported by the originally filed disclosure.
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 38 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 38 is indefinite for claiming “the valve relies on a receiver frame” when it is unclear whether or not this “receiver frame” is a positively claimed part of the “heart valve” or not. The specification appears to claim that it is not a part of the “heart valve”, which would make the “receiver frame” not positively claimed, but amendments (e.g. the amendment to claim 36) and arguments filed 10/17/25 appear to indicate the Applicant believes the receiver frame might be a part of the claimed “heart valve”. However, clarification is required.
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.
Claims 21-24, 26-33, 38 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.
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),
independent movement of the wire at 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.
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.
Regarding claim 22 the Boudjemline Shokoohi Johnson Quadri 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 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 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 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 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 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 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 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 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 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 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]).
Regarding claim 38 the Boudjemline Shokoohi Johnson Quadri Combination teaches the valve of claim 21 substantially as is claimed,
wherein Boudjemline further discloses the valve is configured to rely on a receiver frame for secure anchoring to the native heart tissue when implanted in a native valve (this does not materially alter the structure of the claimed valve, as it appears to be drawn towards an intended method of implantation or a system which involves the claimed valve).
Claim 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boudjemline, Shokoohi, Johnson, and Quadri 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 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 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.
Claims 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boudjemline, Shokoohi, Johnson, and Quadri as is applied above, further in view of Haug et al. (US 20050283231 A1) hereinafter known as Haug.
Regarding claim 36 the Boudjemline Shokoohi Johnson Quadri Combination teaches the valve of claim 21 substantially as is claimed,
but is silent with regards to the frame comprising a retrieval system with a leash connecting to one of the looping structures.
However, regarding claim 36, as is best understood, Haug teaches a valve which includes a retrieval system for removal of the valve from the receiver after being implanted and fully deployed in the native valve (this is stated as an “intended use” of the retrieval system – see the explanation regarding these statements in the rejection to claim 21 above), the retrieval system comprises at least one retrieval leash connected to the tubular braided frame, wherein inward radial tension created by pulling on the leash is configured to partially compress the frame and allow it to be removed from the receiver (This is recited as a “functional limitation” of the retrieval system (see the explanation above regarding these limitations). See also [0075], Figure 1a-b, 2a-b, and 12a-b shows a valve which includes openings 42 which extend through parts of a frame which are connected to a leash 50. Limitations of this system/leash being “for removal” after being “fully deployed” is recited as an intended use (e.g. intended method of implantation) of the system (see the explanation in the rejection to claim 21 above). See also [0075] which directly indicates the forces of the control wires 50 can be used for retrieval of the valve as well as for deployment). 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 Combination so that there is a retrieval system between ends of the valve 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).
Regarding claim 37 the Boudjemline Shokoohi Johnson Quadri 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 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
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 11/04/25