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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-11) in the reply filed on 2/4/26 is acknowledged. Claims 12-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART
"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (The preamble of claim 1 recited that the apparatus was "for mixing flowing developer material" and the body of the claim recited "means for mixing ..., said mixing means being stationary and completely submerged in the developer material." The claim was rejected over a reference which taught all the structural limitations of the claim for the intended use of mixing flowing developer. However, the mixer was only partially submerged in the developer material. The Board held that the amount of submersion is immaterial to the structure of the mixer and thus the claim was properly rejected.).
4. The italicized below will point out the functional/intended use language of the claims.
5. Claim(s) 1-2, 4-5 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Meiri et al. (hereafter Meiri) 2011/0218620.
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6. Regarding claim 1 and noting figures 19-22 Meiri discloses a medical device (THV 480); and a delivery catheter (430) that is configured deliver the medical device to a portion of a body of a subject (see MPEP 2114 supra), the delivery catheter comprising:
an overtube (this may be considered to be sheath 420 and 422) configured, during delivery of the medical device to the portion of the subject's body, to maintain a proximal portion of the medical device in a radially-constrained configuration by covering the proximal portion of the medical device (see MPEP 2114 supra);
and a string-rod constraining mechanism comprising (see [0130]) a rod (this is interpreted to be the guidewire) disposed at least partially within the overtube (420 and 422); and at least one string (the string is interpreted to be the cord. 0130 states “…The guidewire can then be attached to another cord of biocompatible material used to form the support band and pulled through the interior of the first and the second loop delivery catheters 430…), the string-rod mechanism being configured to maintain a distal portion of the medical device in a radially-constrained configuration, when the overtube is not covering the distal portion of the medical device, by the at least one string extending from the distal portion of the medical device to the rod (see MPEP 2114 supra).
Regarding claim 2 “…wherein the delivery catheter is configured to release the distal portion of the medical device from being maintained in the radially-constrained configuration by the rod being retracted such as to release the at least one string..” is functional language. The structure of Meiri is capable of performing the function. See MPEP 2114 supra.
Regarding claim 4, “…delivery catheter is configured to maintain the distal portion of the medical device in the radially-constrained configuration when the overtube is not covering the distal portion of the medical device, without using a nose cone to maintain the distal portion of the medical device in the radially-constrained configuration” is functional language. The structure of Meiri is capable of performing the function. See MPEP 2114 supra. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
Regarding claim 5, Meiri discloses “…wherein the medical device comprises a stent (310).
Claim Rejection - 35 USC § 103
8. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
9. Claim(s) 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Meiri et al. (hereafter Meiri) 2011/0218620 in view of Chau et al. 2011/0137397.
10. Meiri has been disclosed supra and further disclose that the implant may include a support stent (310) for a mitral valve. However Meiri et al. does not disclose that the medical device comprises a prosthetic tricuspid valve; a plurality of leaflets that are coupled to the valve frame body; and a plurality of chord-recruiting arms that are configured to extend radially from the ventricular portion of the valve frame body.
Chau et al. teaches a tricuspid valve ([0088]) with a plurality of leaflets that are coupled to the valve frame body (see 106) and a stent frame (e.g. 102); and a plurality of chord-recruiting arms (426) that are configured to extend radially from the ventricular portion of the valve frame body. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Meiri et al. and implant a stent/frame valve with leaflets into a tricuspid region and chord anchors in order to provide proper flow through valves with deficient or calcified leaflets and to utilize tension from the chordae tendineae to retain the frame.
The following is considered intended use language (claim 7) “..the prosthetic tricuspid valve comprising: a valve-frame body that defines a ventricular portion that is configured to de disposed within a right ventricle of the subject, and atrial portion that is configured to be disposed inside a right atrium of the subject”…(claim 8); Regarding claims 10 and 11 limitations are functional.
Allowable Subject Matter
11. Claims 3 and 9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
12. The following is a statement of reasons for the indication of allowable subject matter: The closet prior art is considered to be Meiri et al. (hereafter Meiri) 2011/0218620 which discloses a medical device, a delivery catheter, and a string rod mechanism within an overtube as disclosed supra.
The prior art fails to teach or disclose that the at least one string comprises a
plurality of loops extending from the distal portion of the medical device and that are
configured to maintain the distal portion of the medical device in the radially-constrained
configuration by looping around the rod.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http:/Avww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Melanie Tyson can be reached on 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 March 3, 2026