DETAILED ACTION
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 .
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.
MPEP 2114 States:
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.).
Claim(s) 1-2, 4-9, 9-11, 13-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gross et a. 2016/0310274.
Regarding claims 1-2, 4 and noting figures. 1A-2D, 3I, etc. Gross et al. discloses the invention as claimed comprising: A valve repair device for repairing a native valve of a patient, the valve repair device comprising: a pair of paddles (30/32a and 32b), wherein the paddles are movable between an open position and a closed position (this is functional language nevertheless, the paddles of Gross are capable of performing the functions as claimed. See MPEP 2114); an expanding spacer (this may be interpreted as support elements 60, 80) elements disposed between the pair of paddles (see figures as noted supra); wherein the expanding spacer is configured to be expanded between the paddles when the paddles are moved from the open position to the closed position; and wherein the expanding spacer is configured to fill at least a portion of a gap in the native valve of the patient when the valve repair device is attached to the native valve and the expanding spacer is expanded (this is all considered to be intended use/functional language. Nevertheless Gross et al. is capable of performing the functions as illustrate in figures 3G-6B. Also see [0066; 0111 etc.).
Regarding claims 5-8, Gross et al. further discloses a pair of gripping members (38) disposed between the pair of paddles and the expanding spacer (see fig. 1A and 1B and [0117]); wherein the pair of gripping members are integrally formed and extend from a common base and wherein each gripping member of the pair of gripping members is directly attached to a corresponding paddle of the pair of paddles (see illustration 1A); and wherein the griping members comprise a barbed portion (40 and see fig. 1D).
Regarding claims 9-11, 13-18, Gross et. al. disclose a shaft; a coupler (e.g. 132) movably attached to the shaft (130) such that the coupler can be moved along the shaft (functional); wherein the pair of paddles are pivotally attached to the coupler (see illustration below); and wherein movement of the coupler in a first direction along the shaft causes the pair of paddles to move to the closed position, and movement of the coupler in a second direction causes the pair of paddles to move to the open position.
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Further Gross discloses a catheter; a valve repair device coupled to the catheter (see illustration above and catheter [0015; 0168]), the valve repair device comprising: a pair of paddles, wherein the paddles are movable between an open position (see explanation supra) and a closed position; an expanding spacer disposed between the pair of paddles; wherein the expanding spacer is configured to be expanded between the paddles when the paddles are moved from the open position to the closed position; and wherein the expanding spacer is configured to fill at least a portion of a gap in the native valve of the patient when the valve repair device is attached to the native valve and the expanding spacer is expanded.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 5-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,076,415 (hereafter ‘415) and over claims 1-27 of U.S. Patent No. 10,123,873 (hereafter ‘873). Although the claims at issue are not identical, they are not patentably distinct from each other. For example, current claim 1-2 recite:
“1. A valve repair device for repairing a native valve of a patient, the valve repair device
comprising: a pair of paddles, wherein the paddles are movable between an open position and a closed position; an expanding spacer disposed between the pair of paddles; wherein the expanding spacer is configured to be expanded between the paddles when the paddles are moved from the open position to the closed position; and
wherein the expanding spacer is configured to fill at least a portion of a gap in
the native valve of the patient when the valve repair device is attached to the native valve and the expanding spacer is expanded.
2. The valve repair device of claim 1, wherein moving the pair of paddles from the open
position to the closed position causes the expanding spacer to expand.”
Pat. ‘415 claim 1 recites:
“1. A valve repair device for repairing a native valve of a patient, the valve repair device comprising: a base assembly comprising a plurality of pivoting links and a shaft, wherein the pivoting links are moved by the shaft; a pair of paddles attached to the base assembly, wherein the movement of the pivoting links moves the paddles between an open position and a closed position; a pair of gripping members attached to the base assembly, wherein the paddles and the gripping members are configured to attach to valve leaflets of the patient; at least one spacer element that surrounds the shaft and is disposed between the pair of gripping members; wherein the spacer element is made from at least one material selected from the group of materials consisting of braided mesh, fabric, biocompatible material, foam, and pericardial tissue; wherein the spacer element fills a space between the gripping members when the paddles are in the closed position.”
It is obvious to one having ordinary skill in the art that the subject matter of the current claim is broader in scope and worded in a varied manner. It is also obvious that because pat ‘415 recites that the material of the spacer may be a foam that it is capable of expansion.
Regarding claims 5-7, Pat. ‘873 claim 21 recites:
“21. A valve repair device for repairing a native valve of a patient, the valve repair device comprising: a pair of paddles, wherein the paddles are movable between an open position and a closed position; a pair of gripping members each having an attachment portion and a gripping portion, wherein the attachment portion of each gripping member of the pair of gripping members is directly attached to a corresponding paddle of the pair of paddles, and wherein the paddles and the gripping portions of the gripping members are configured to attach to the native valve of the patient.”
It is obvious to one having ordinary skill in the art that the limitations of claims 5-7 are reworded in a varied manner. Further, it would be obvious to one to integrally form and extend the gripping members from a common base because claim 21 recites that pair of gripping members is directly attached.
Regarding claim 8, pat. ‘873 claim 23 recites the use of barbs.
Regarding claim 9, see pat. ‘873 claim 22.
Claims 10-11, 14-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S Patent 12,090,052 (hereafter ‘052) in view of claims 1-27 of U.S. Patent No. 10,123,873 (hereafter ‘873).
Current application claims 10-11 recites:
“10. A valve repair system for repairing a native valve of a patient, the valve repair system comprising: a catheter; a valve repair device coupled to the catheter, the valve repair device comprising: a pair of paddles, wherein the paddles are movable between an open position and a closed position; an expanding spacer disposed between the pair of paddles; wherein the expanding spacer is configured to be expanded between the paddles when the paddles are moved from the open position to the closed position; and
wherein the expanding spacer is configured to fill at least a portion of a gap in
the native valve of the patient when the valve repair device is attached to the native valve and the expanding spacer is expanded.
11 The valve repair system of claim 10, wherein moving the pair of paddles from the open position to the closed position causes the expanding spacer to expand.”
Patent ‘052 claim 6 recites:
“6. A valve repair system for repairing a native valve of a patient, the valve repair system comprising: a catheter; and a valve repair device coupled to the catheter, the valve repair device comprising: a pair of paddles, wherein the paddles are movable between an open position and a closed position; a pair of gripping members that are configured to attach to the native valve of the patient; at least one spacer element that is disposed between the pair of gripping members, wherein the spacer element is configured to fill at least a portion of a gap in the native valve of the patient when the valve repair device is attached to the native valve; wherein each gripping member of the pair of gripping members is extendable in length to prevent tearing of the native valve of the patient when the gripping members are removed from the native valve.
It is obvious to one having ordinary skill in the art that the subject matter of the current claim is broader in scope and worded in a varied manner. It is also obvious that because pat. ‘052 claim 6 recites that the spacer is configured to fill at least a portion of a gap in the native valve that it is capable of expanding to fill the space.
Regarding claims 14-16, pat. ‘873 claim 21 it would be obvious to one to integrally form and extend the gripping members from a common base because claim 21 recites that pair of gripping members is directly attached.
Regarding claim 17, pat. ‘873 claim 23 recites the use of barbs.
Regarding claim 18, see pat. ‘873 claim 22.
Allowable Subject Matter
Claims 3-4 and 12-13 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.
Claims 19-20 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: The following is an examiner’s statement of reasons for allowance: The closest prior art has been provided supra however does not teach or disclose the method of repairing a native valve of a patient, comprising: positioning a leaflet of the native heart valve between a paddle and a spacer; closing the paddle to attach the leaflet between the paddle and the spacer; expanding the spacer; and wherein the spacer is configured to fill at least a portion of a gap in the native valve of the patient when the leaflet is attached between the paddle and the spacer.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
The closest prior art has been disclosed supra, however does not disclose in combination with independent claims 1 or 10 that the paddles curve around the expanding spacer.
Conclusion
19. 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 September 17, 2026
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