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 . Claims 1-21 and 23-29 are pending and examined below.
Response to Arguments
Applicant's arguments filed on 09/18/2025 have been fully considered but they are not persuasive.
In response to applicant’s arguments that the primary reference Oba et al does not teach or disclose the amended limitations; where the valve segments are coupled to a frame structure and where the valve segments extend beyond the frame structure, as seen on page 7, the examiner respectfully disagrees. Oba et al discloses valve leaflets that are attached to a frame (Fig. 27: paragraph 0143) and where the valve leaflets extend beyond the frame (Fig. 27: leaflets (550), paragraph 0143), in addition, also see the §102 rejection of claim 1 below.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the valve segments not being coupled to an outer frame, as seen in page 8) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(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.
Claims 1, 3-5, 8-10, 13-16, 18-20, 23-24, 27-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oba et al (US 2016/0310268).
Regarding claim 1, Oba et al discloses a device for treating a diseased native valve in a patient (paragraphs 0009 and 0014), the device comprising: a frame structure having an unexpanded configuration and an expanded configuration (a prosthetic valve having a radially expandable and compressible support frame, where the compressible support frame is interpreted to be the unexpanded configuration, paragraph 0014), the frame structure in the expanded configuration comprising a first end portion (Fig 7: support structure (302), paragraph 0100; also see annotated fig 7 below), a central annular portion (Fig. 7: inner orifice (332), paragraph 0109), and a second end portion (Fig 7: support structure (302), paragraph 0100; also see annotated fig 7 below; and a valve segment coupled to the frame structure (Fig. 7: valve component (304), paragraph 0100) comprising a biocompatible one-way valve (the valve component has a plurality of leaflets that permit the blood though the valve component in one direction, which implicitly teaches the valve component is a one-way valve, paragraph 0019); wherein an inflow edge of the valve segment is completely unsupported by the first end portion of the frame structure (Fig 27 shows the valve segment is not attached, which can broadly be interpreted to be unsupported, to the first end portion of the frame, but rather partially attached to the inner orifice, paragraph 0143), extends beyond the frame structure (Fig. 27 show the valve leaflets (550) that are extending beyond the frame structure (546), paragraph 0143) and is spaced radially inwards from the first end portion when the frame structure is in the expanded configuration (Fig. 7: the inner orifice in positioned in the center of the frame, which is considered to be positioned radially inwards from the first end portion, paragraphs 0100-0101 and 0107).
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Regarding claim 3, Oba et al discloses the device of claim 1, wherein the valve segment comprises a plurality of leaflets (the valve component has a plurality of leaflets, paragraph 0019).
Regarding claim 4, Oba et al discloses the device of claim 3, wherein the valve segment further comprises a seal positioned radially between the frame structure and the plurality of leaflets (Fig. 7: sealing member (330), paragraph 0109).
Regarding claim 5, Oba et al discloses the device of claim 4, wherein the seal is attached to the central annular portion of the frame structure (Fig. 7: sealing member (315), paragraph 0103).
Regarding claim 8, Oba et al discloses the device of claim 1, wherein at least a portion of the inflow edge extends beyond the frame structure while an entire outflow edge of the valve segment is positioned within the frame structure (Fig. 7: show the inflow edge, the top of the valve, extends beyond the inner frame, while the outflow edge, the bottom of the valve, does not extend beyond the frame, paragraphs 0108-0110).
Regarding claim 9, Oba et al discloses the device of claim 1, wherein the first end portion flares radially outwards from the central annular portion (Fig. 13: angled struts (316), paragraph 0103)
Regarding claim 10, Oba et al discloses the device of claim 1, wherein the second end portion flares radially outwards from the central annular portion (Fig. 13: projections (318), paragraph 0103).
Regarding claim 13, Oba et al discloses the device of claim 1, wherein the frame structure is configured to self- expand from the unexpanded configuration to the expanded configuration (the prosthetic heart valve has a radially expandable and compressible support structure, paragraph 0014).
Regarding claim 14, Oba et al discloses the device of claim 1, wherein the frame structure is configured to couple to the native valve such that the first end portion is oriented toward an atrial side of the native valve and the second end portion is oriented toward a ventricular side of the native valve (Fig. 3: the frame couples to the native valve by penetrating the native leaflets while having the first end portion in the atrium (112) and the second in portion in the ventricle (114), paragraphs 0074-0075).
Regarding claim 15, Oba et al discloses the device of claim 1. wherein the diameter of the frame structure in the expanded configuration is between 25 mm and 35 mm (paragraph 0108).
Regarding claim 16, Oba et al discloses a device for treating a diseased native valve in a patient (paragraphs 0009 and 0014), the device comprising: a frame structure having an unexpanded configuration and an expanded configuration (a prosthetic valve having a radially expandable and compressible support frame, where the compressible support frame is interpreted to be the unexpanded configuration, paragraph 0014); and a valve segment coupled to the frame structure (Fig. 7: valve component (304), paragraph 0100), the valve segment comprising a biocompatible one-way valve (the valve component has a plurality of leaflets that permit the blood though the valve component in one direction, which implicitly teaches the valve component is a one-way valve, paragraph 0019), the valve segment further having an inflow edge and an outflow edge wherein a majority of the inflow edge of the valve segment is unsupported by the frame structure (Fig. 7 shows the valve segment is not attached, which can broadly be interpreted to be unsupported, to the first end portion of the frame, but rather partially attached to the inner orifice, paragraphs 0100-0101 and 0107; in addition the inflow edge would be when the blood enters the valve, while the outflow edge would be when the blood exits the valve, also see paragraph 0019); wherein an inflow end of the frame structure comprises a plurality of flared flanges extending radially therefrom (Fig. 13: angled struts (316), paragraph 0103), the inflow edge of the valve segment being positioned radially inwards of the plurality of flared flanges (Fig 27: the inner orifice in positioned in the center of the frame, which is considered to be positioned radially inwards from the first end portion, paragraphs 0100-0101 and 0107) and extending beyond the flared flanges when the frame structure is in the expanded configuration (Fig. 27 show the valve leaflets (550) that are extending beyond the frame structure (546), paragraph 0143).
Regarding claim 18, Oba et al discloses the device of claim 16, wherein the valve segment comprises a plurality of leaflets (the valve component has a plurality of leaflets, paragraph 0019).
Regarding claim 19, Oba et al discloses the device of claim 18, wherein the valve segment further comprises a seal positioned radially between the frame structure and the plurality of leaflets (Fig. 7: sealing member (315), paragraph 0103).
Regarding claim 20, Oba et al discloses the device of claim 19, wherein the seal is attached to a central portion of the frame structure (Fig. 7: sealing member (315), paragraph 0103).
Regarding claim 23, Oba et al discloses the device of claim 16, wherein at a least portion of the inflow edge extends beyond the frame structure while an entire outflow edge of the valve segment is positioned within the frame structure (Fig. 7: show the inflow edge, the top of the valve, extends beyond the inner frame, while the outflow edge, the bottom of the valve, does not extend beyond the frame, paragraphs 0108-0110).
Regarding claim 24, Oba et al discloses the device of claim 16, wherein an outflow end of the frame structure comprises a plurality of flared flanges extending radially therefrom (Fig. 13: projections (318), paragraph 0103).
Regarding claim 27, Oba et al discloses the device of claim 16, wherein the frame structure is configured to self- expand from the unexpanded configuration to the expanded configuration (the prosthetic heart valve has a radially expandable and compressible support structure, paragraph 0014).
Regarding claim 28, Oba et al discloses the device of claim 16, wherein the frame structure is configured to couple to the native valve such that the inflow edge is oriented toward an atrial side of the native valve and the outflow edge is oriented toward a ventricular side of the native valve (Fig. 3: the frame couples to the native valve by penetrating the native leaflets while having the first end portion in the atrium (112) and the second in portion in the ventricle (114), paragraphs 0074-0075).
Regarding claim 29, Oba et al discloses the device of claim 16, wherein the diameter of the frame structure in the expanded configuration is between 25 mm and 35 mm (paragraph 0108).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 6-7, 17, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Oba et al (US 2016/0310268), in view of Kovalsky et al (US 2012/0101572 A1).
Regarding claim 2, Oba et al discloses the device of claim 1, however doesn’t specifically disclose wherein the frame structure has a longitudinal length of less than 35 mm in the expanded configuration.
Kovalsky et al discloses a heart valve prosthesis having a frame structure that includes flares and leaflets (paragraph 0005). Kovalsky et al further discloses the frame structure has a length between 8 mm and 13 mm, which is less than 35 mm (paragraph 0029).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the heart valve taught by Oba et al to include the heart valve size taught by Kovalsky et al because courts have found prima facie obviousness where the modification requires combing prior art elements according to know method to yield predicable results (see MPEP 2143). Here, the predictable results are that heart valve would be sized to best fit within the native valve location of the patient, also see MPEP 2144.04(IV)(A).
Regarding claims 6-7, Oba et al discloses the device of claim 3, however doesn’t specifically disclose wherein the plurality of leaflets are attached to the frame structure only at commissures of the leaflets.
Kovalsky et al discloses a heart valve prosthesis having leaflets that are attached to the frame only at the commissures of the leaflets (Figs. 5A-B, also see paragraphs 0029 and 0032). In addition, using the broadest reasonably interpretation a nadir of each leaflet would be consider a low point of a leaflet, meaning any low point of the leaflets seen in Kovalsky et al can be interpreted to be the nadir of a leaflet, also see paragraph 0032.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the heart valve taught by Oba et al to include leaflets that are attached to a frame by the commissures of the leaflets taught by Kovalsky et al because courts have found prima facie obviousness where the modification requires combing prior art elements according to know method to yield predicable results (see MPEP 2143). Here, the predictable results are that the leaflets would be able to move as a native heart valve.
Regarding claim 17, Oba et al discloses the device of claim 16, however doesn’t specifically disclose wherein the frame structure has a longitudinal length of less than 35 mm in the expanded configuration.
Kovalsky et al discloses a heart valve prosthesis having a frame structure that includes flares and leaflets (paragraph 0005). Kovalsky et al further discloses the frame structure has a length between 8 mm and 13 mm, which is less than 35 mm (paragraph 0029).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the heart valve taught by Oba et al to include the heart valve size taught by Kovalsky et al because courts have found prima facie obviousness where the modification requires combing prior art elements according to know method to yield predicable results (see MPEP 2143). Here, the predictable results are that heart valve would be sized to best fit within the native valve location of the patient, also see MPEP 2144.04(IV)(A).
Regarding claims 21, Oba et al discloses the device of claim 18, however doesn’t specifically disclose wherein the plurality of leaflets are attached to the frame structure only at commissures of the leaflets.
Kovalsky et al discloses a heart valve prosthesis having leaflets that are attached to the frame only at the commissures of the leaflets (Figs. 5A-B, also see paragraphs 0029 and 0032). In addition, using the broadest reasonably interpretation a nadir of each leaflet would be consider a low point of a leaflet, meaning any low point of the leaflets seen in Kovalsky et al can be interpreted to be the nadir of a leaflet, also see paragraph 0032.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the heart valve taught by Oba et al to include leaflets that are attached to a frame by the commissures of the leaflets taught by Kovalsky et al because courts have found prima facie obviousness where the modification requires combing prior art elements according to know method to yield predicable results (see MPEP 2143). Here, the predictable results are that the leaflets would be able to move as a native heart valve.
Claims 11-12 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Oba et al (US 2016/0310268), in view of Chau et al (US 10,052,198 B2).
Regarding claims 11-12, Oba et al discloses the device of claim 1, however doesn’t specifically disclose wherein the first and second end portions are configured to engage an exterior anchor therebetween when the frame structure is in the expanded configuration.
Chau et al discloses a coiled anchor for docking a mitral valve prosthesis having a first end, second end, and a central axis (abstract). Chau et al also discloses the coiled anchor can engage with a mitral valve prosthesis in an expandable form (column 3, last paragraph). Chau et al further wherein the central annular portion is configured to apply outward radial pressure to engage with an exterior anchor discloses the central portion of the valve prosthesis (120), in the expanded configuration, can provide a radial force onto the anchor (72), (Fig. 7b, column 9, last paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the device for treating a diseased native valve as taught by Oba et al to include a coiled anchor as taught by Chau et al in order to provide an anchor that facilitates and maintain a positioning of the prosthetic heat valve (column 1, second paragraph).
Regarding claims 25-26, Oba et al discloses the device of claim 24, however doesn’t specifically disclose wherein the inflow end and the outflow end are configured to engage an exterior anchor therebetween when the frame structure is in the expanded configuration.
Chau et al discloses a coiled anchor for docking a mitral valve prosthesis having a first end, second end, and a central axis (abstract). Chau et al also discloses the coiled anchor can engage with a mitral valve prosthesis in an expandable form (column 3, last paragraph). Chau et al further wherein the central portion is configured to apply outward radial pressure to engage with an exterior anchor discloses the central portion of the valve prosthesis (120), in the expanded configuration, can provide a radial force onto the anchor (72), (Fig. 7b, column 9, last paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the device for treating a diseased native valve as taught by Oba et al to include a coiled anchor as taught by Chau et al in order to provide an anchor that facilitates and maintain a positioning of the prosthetic heat valve (column 1, second paragraph).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 JOSE H TREVINO III whose telephone number is (703)756-4678. The examiner can normally be reached Monday - Friday: 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.H.T./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774