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.
Claim(s) 98-104 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Braido 2011/0098802 or alternatively over Case et al. 2004/0260389.
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.).
Claims 98-104 are rejected under 35 U.S.C. 103 as being unpatentable over Braido 2011/0098802 or alternatively over Case et al. 2004/0260389.
Regarding claims 98-99, Braido discloses a valve replacement device (Abstract; Fig. 15), comprising: a valve frame defining an opening for passage of fluid (annulus section 30, defining an unmarked opening Fig. 16; para [0052]), the opening having a diameter along a largest dimension of the opening (annulus section 30 defines diameter along opening -Fig. 15; para [0052]), the valve frame being expandable to permit an increase in the diameter of the opening (flared region 40 of annulus 30 expands in diameter - Fig. 2; para [0052]); first and second leaflets (see fig. 1 and 10 element 70 of Braido) coupled to the valve frame (left leaflet 70 Fig. 15; para [0057]), the first leaflet having an open configuration in which the opening is exposed (leaflet 70 open to allow distal or antegrade flow of blood during systole - Fig. 15; para [0062]), and a closed configuration in which the first leaflet at least partially covers the opening (leaflet 70 close to block proximal or retrograde flow during diastole - Fig. 15;para [0062]), wherein the valve frame is expandable to permit an increase in the diameter of the opening (this is considered to be function language see MPEP 2114); and wherein the first leaflet is moveable between the open and closed configurations as the diameter of the opening expands (leaflet 70 moves between open and closed position which annulus section 40 expands - Fig. 2, 15; para [0052], [0062]).
Regarding claim 100, see MPEP 2114 supra. Regarding claim 101, (see stent 10 which is the frame). Regarding claims 102-104 (see [0064; 0080]).
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 88-93, 98-116 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-49 of U.S. Patent No. 12,004,948 (hereafter ‘948) and alternatively claims 1-21 of U.S. Patent No. 10,966,826 (‘826). Although the claims at issue are not identical, they are not patentably distinct from each other. For example, current claim 88 recites:
“88. A valve replacement device, comprising: a valve frame defining an opening for passage of fluid, the opening having a diameter along a largest dimension of the opening, the valve frame being expandable to permit an increase in the diameter of the opening; and a first leaflet coupled to the valve frame, the first leaflet having an open configuration in which the opening is exposed, and a closed configuration in which the first leaflet at least partially covers the opening; wherein the valve frame is configured to expand to permit an increase in the diameter of the opening, and wherein the first leaflet is configured to be moveable between the open and closed configurations as the diameter of the opening expands; wherein the valve frame comprises first and second frame sections configured to move laterally apart from each other as the valve frame expands; and wherein at least one of the first and second frame sections have a curve profile defined by an elliptical quadrant projected upon a cylinder.
Pat. ‘948 claims 1, 20 recite:
“1. A valve replacement device, comprising: a valve frame defining an opening for passage of fluid, the opening having a diameter along a largest dimension of the opening, the valve frame being expandable to permit an increase in the diameter of the opening from 5 mm to 50 mm; and a first leaflet coupled to the valve frame, the first leaflet having an open configuration in which the opening is exposed, and a closed configuration in which the first leaflet at least partially covers the opening, wherein the valve frame is expandable to permit an increase in the diameter of the opening, wherein the first leaflet is moveable between the open and closed configurations as the diameter of the opening expands from 5 mm to 50 mm, and wherein the opening expands while keeping a perimeter length of the valve frame constant.”
“20. The valve replacement device of claim 16, wherein the valve frame includes first and second frame sections configured to move laterally apart from each other as the valve frame expands.”
Pat. 826 claims 1-2 recites:
“1. A valve replacement device, comprising: a valve frame defining an opening for passage of fluid, the opening having a diameter along a largest dimension of the opening, the valve frame being expandable to permit an increase in the diameter of the opening from 5 mm to 50 mm; and a first leaflet coupled to the valve frame, the first leaflet having an open configuration in which the opening is exposed, and a closed configuration in which the first leaflet at least partially covers the opening, wherein the valve frame is configured to expand to permit an increase in the diameter of the opening, and wherein the first leaflet is configured to be moveable between the open and closed configurations as the diameter of the opening expands from 5 mm to 50 mm, wherein the first leaflet maintains a constant surface area with expansion or contraction of the valve frame, wherein the valve frame includes first and second frame sections configured to move laterally apart from each other as the valve frame expands, and wherein at least one of the first and second frame sections have a curve profile defined by an elliptical quadrant projected upon a cylinder.
2. The valve replacement device of claim 1, further comprising a second leaflet having an open configuration in which the opening is exposed, and a closed configuration in which the first and second leaflets contact one another to at least partially cover the opening, wherein the first leaflet and second leaflets are configured to be moveable between the open and closed configurations over the diameter size range of the opening, wherein in the closed configuration, the first and second leaflets permit a regurgitant fraction of no more than 0 to 20% over a diameter size range of the opening of 5 mm to 50 mm.”
It is obvious to one having ordinary skill in the art at the time the invention was made to that pat. ‘948 and pat. ‘826 are narrower in scope and includes the limitation of from 5 mm to 50 mm. Further the limitations as currently claimed are recited in pat. ‘948 claims 1 and 20.
Regarding claim 90, see pat. ‘948 claim 23; Regarding claim 91, see pat. ‘948 claims 20 and 30; Regarding claim 92, see pat. ‘948 claims 12, 26-27 and 35.
Regarding claims 93, see pat. ‘948 claims 1 and 13; Regarding claim 94, see pat. ‘948 claim 14; Regarding claim 98, see pat. ‘948 claim 1. Regarding claim 99, see pat. ‘948 claim 1; Regarding claim 100, see pat. ‘948 claim 7; Regarding claim 101, see pat. ‘948 clam 3; regarding claim 102 see claim 5; regarding claim 103 see claim 4see claim 29; regarding claim 104 see claim 6; regarding claim 105 see claim 8; regarding claim 106 see claim 12; regarding claim 107, see claim 13; regarding claim 108, see claim 15; regarding claim 109, see claim 22; regarding claim 110, see claim 23; regarding claim 111, see claim 26; regarding claim 112, see claim 27; regarding claim 113, see claim 28; regarding claim 114 see claim 29; regarding claim 115, see claim 35.
Regarding claim 116, see pat. ‘948 claims 1, 12, 26 and 27. Regarding claim 117 see pat. ‘948 claim 28; Regarding claim 118, see pat. ‘948 claim 29; Regarding claim 119, see pat. ‘948 claim 36; Regarding claim 120, see pat. ‘948 claim 37; Regarding claim 121, see pat. ‘948 claim 41; Regarding claim 122, see pat. ‘948 claim 42.
Allowable Subject Matter
Claims 94-97, 123-130 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.
The following is a statement of reasons for the indication of allowable subject matter: The prior art as indicated supra does not disclose or teach in combination with the independent claims the subject matter as recited in claims 94-97, 123-130.
Conclusion
11. 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https:/Awww.uspto.gov/patents/apply/patent- center for more information about Patent Center and https:/Awww.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197.
/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 October 6, 2026
Prosecution Insights