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 § 112
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.
Claim 7 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the limitation "the axial height”. There is insufficient antecedent basis for this limitation in the claim.
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 1-10, 15-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,179,043 (hereafter ‘043). The current application claim 1 recites:
“1. An implantable prosthetic valve comprising: an annular frame; a leaflet structure positioned within the frame; and two or more annular outer skirts extending continuously and completely around an outer surface of the frame, the two or more outer skirts each comprising an inflow edge secured to the frame and an outflow edge, wherein the outflow edges of the two or more outer skirts define one or more upper openings allowing retrograde blood to flow between the outer surface of the frame and the two or more skirts to create a plurality of regions of turbulent blood flow along the prosthetic valve.”
Patent ‘043 claim 1 recites:
“1. An implantable prosthetic valve comprising: an annular frame; a leaflet structure positioned within the frame; and an annular outer skirt positioned around an outer surface of the frame, the outer skirt comprising an inflow edge secured to the frame and an outflow edge, wherein the outflow edge defines one or more upper openings allowing retrograde blood to flow between the outer surface of the frame and the outer skirt to create a plurality of regions of turbulent blood flow along the outside of the prosthetic valve; and wherein the outer skirt comprises a fabric formed with fringes that perturb the flow of blood along the outside of the prosthetic valve.”
The phrase “extending continuously and completely” is interpreted as positioned around an outer surface which is broader. The patent is narrower in scope and includes more limitations than the current application claim 1, thereby patent claim 1 anticipates application claim 1.
Regarding claim 2 see Pat. ‘043 claim 2. Regarding claim 3 see pat. ‘043 claim 2. Regarding claim 4 see pat. ‘043 claim 4. Regarding claim 5, see pat. ‘043 claim 5. Regarding claim 6, see pat. ‘043 claim 6. Regarding claim 7, see pat. ‘043 claim 7. Regarding claim 8, see pat. ‘043 claim 8. Regarding claim 9, see pat. ‘043 claim 9.
Regarding 10 it recites:
“10. An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the prosthetic valve
comprising: an annular frame; a leaflet structure positioned within the frame; and a plurality of outer skirts positioned around an outer surface of the frame, each outer skirt
comprising an inflow edge secured to and extending completely around the frame and an outflow edge unsecured to the frame along its entire length and extending completely around the frame to form an upper opening extending continuously around the frame to receive retrograde blood, the plurality of outer skirts including at least a first outer skirt and a second outer skirt.”
Patent ‘043, claim 10 recites:
“10. An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the prosthetic valve comprising: an annular frame; a leaflet structure positioned within the frame; a plurality of outer skirts positioned around an outer surface of the frame, each outer skirt extending continuously around the entire extent of a circumference of the frame, each outer skirt comprising an inflow edge secured to the frame and an outflow edge; and wherein the outflow edge of each outer skirt comprises alternating projections and notches, the projections being secured to the frame and the notches being unsecured to the frame such that each notch defines an opening.”
The phrase “extending continuously around the entire extent of a circumference of the frame” is synonymous to “extending completely around the frame” as claimed because the patent recites that the notches are on the outflow end and are unsecured. Therefore, patent claim 10 anticipates application claim 10.
Regarding claim 15, see pat. ‘043 claim12; Regarding claims 16 and 17, Patent ‘043 claim 7 recites the axial spacing between the two or more outer skirts is less than the axial height of a least one of the two or more outer skirts. It is obvious to one having ordinary skill in the art that this meeting the limitation of claim 16 which requires that the skirts are positioned in a series along the length of the frame between and inflow edge and an outflow edge.
Claims 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S Patent No. 11,744,700 (hereafter ‘700).
Claims 18 and 19 recite:
“18. An implantable prosthetic valve comprising: an annular frame having an inflow end and an outflow end; a leaflet structure positioned within the frame; an annular skirt mounted on the frame; and a plurality of discrete radiopaque markings positioned at a plurality of circumferentially spaced locations on the skirt, wherein the radiopaque markings are positioned to indicate an orientation of the prosthetic valve relative to a native heart valve under fluoroscopy.”
“19. The prosthetic valve of claim 18, wherein the radiopaque markings comprise
radiopaque sutures.
Patent ‘700 claim 1 recites:
“1. An implantable prosthetic valve, comprising: a radially expandable and compressible annular frame; a valvular structure disposed within the frame and coupled to the frame; and an outer skirt positioned around an outer surface of the frame; and a plurality of radiopaque sutures forming a plurality of discrete radiopaque markings arranged on the outer skirt at a plurality of circumferentially spaced locations; wherein the radiopaque sutures are positioned to indicate an orientation of the prosthetic valve relative to a delivery apparatus and a native heart valve under fluoroscopy, and wherein the radiopaque marking formed by the radiopaque sutures are in the form of vertical lines.”
The patent claim is narrow in scope and requires more limitations than current claim 18 and that application claims 18 and 19 are recited within patent claim 1. Therefore, patent claim 1 anticipates application claims 18-19.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S Patent No. 11,744,700 (hereafter ‘700) in view of Wirtel et al. 2007/0288095.
Patent ‘700 has been disclosed supra however does not recite the use of a radiopaque dye. Wirtel et al. teaches that implantable devices my incorporate radiopaque dyes [0075]. It would have been obvious to one having ordinary skill in the art to utilize a radiopaque dye as the marker in order help determine if the implant is properly positioned within the patient's heart and a dye would not disrupt the structural integrity of the implant.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4-5, 8, 10, 16-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Braido et al. 2018/0008402.
Regarding claims 1 and 10 and noting figures 5F and 3A, 3C and 9D, Braido et al. ‘402 discloses:
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An implantable prosthetic valve (e.g. 300) comprising: an annular frame (e.g. 306); a leaflet structure (308; 310) positioned within the frame; and two or more annular outer skirts extending continuously and completely around an outer surface of the frame (It is inherent that the term "skirts" as used in the applicants disclosure is synonymous with the term "sealing ring" as used by Braido et al.; see fig. 5F and [0078-0086; 0135] which states that the prosthetic heart valve may include two or more sealing rings which therefore includes three sealing rings as recited in claim 12) , the two or more outer skirts each comprising an inflow edge secured to the frame and an outflow edge, wherein the outflow edges of the two or more outer skirts define one or more upper openings (see for example 00079 which states that the sealing rings may have any number of openings of any shape) allowing retrograde blood to flow between the outer surface of the frame and the two or more skirts to create a plurality of regions of turbulent blood flow along the prosthetic valve (this is considered to be functional language, see MPEP 2114).
Regarding claim 4, Braido et al. further discloses that the two or more outer skirts are secured at intervals and include openings between the intervals.
Regarding claim 5 Braido et a. discloses that the one or more openings do not lie flat against the outer surface (see e.g. 820 and [0120] which state that parachute-like members billow open when blood flows in the retrograde direction... If retrograde flow occurs on the abluminal side of prosthetic heart valve 800, the blood may enter one or more sealing members 820, causing the sealing members to billow open and facilitating the sealing of gap spaces between the patient's anatomy and the valve.)
The intended use recitation language "allowing retrograde blood to flow between the outer surface of the frame and the two or more skirts to create a plurality of regions of turbulent blood flow along the prosthetic valve." carries no weight in the absence of any distinguishing structure. Braido et al. discloses the structure as claimed and is thus capable of performing the functions. See MPEP 2114.
Regarding claims 8 and 16-17 see fig. 5F supra where the skirts may be positioned in a series axially along the length of the frame..
Claim Rejections - 35 USC § 103
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.
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Braido et al. 2018/0008402 (hereafter ‘402) in view of Braido et al. 2014/0277389 (hereafter ‘389).
Braido et al. 2018/0008402 has been disclosed however does not specify the use of sutures with radiopaque material. Braido et al. '389 teaches a heart valve implant that utilizes radiopaque sutures (see [0030; 0050]). It would have been obvious to modify the invention of '0008402 and provide radiopaque sutures and features in order to help facilitate proper placement of prosthetic valves during valve repair or replacement surgery by more accurately and easily determining the location of components of the valve assembly with respect to anatomical landmarks.
Claims 3 is rejected under 35 U.S.C. 103 as being unpatentable over Braido et al. 2018/0008402 in view of Lee et al. 2016/0346105 or alternatively in view of Jose et al. 2017/0218228.
Braido et al. has been disclosed however does not disclose the use if radiopaque dye (e.g. lines printed using radiopaque dye as disclosed by applicant [0061]). Lee teaches the use markers that can be present in the form of radiopaque dye. Jose et al. teaches the use of radiopaque printed bio-in for which can be utilized
with implants (see [0454] and [0447]). It would have been obvious to modify the invention of '0008402 and provide radiopaque dye as a marker in order the assist and allow for better position during implantation as Braido et al. already utilized radiopaque markers and is deemed a design modification.
Allowable Subject Matter
Claims 11-14 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 (indicated by bold/italicized):
An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the prosthetic valve comprising: an annular frame; a leaflet structure positioned within the frame; and a plurality of outer skirts positioned around an outer surface of the frame, each outer skirt comprising an inflow edge secured to and extending completely around the frame and an outflow edge unsecured to the frame along its entire length and extending completely around the frame to form an upper opening extending continuously around the frame to receive retrograde blood, the plurality of outer skirts including at least a first outer skirt and a second outer skirt; wherein when the prosthetic valve is radially expanded, each of the outer skirts flares outwardly away from the frame in a direction from the inflow edge to the outflow edge is novel over prior art.
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 January 23, 2026