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 1-20 are pending and examined below.
Response to Arguments
Applicant's arguments filed on 05/18/2025 have been fully considered but they are not persuasive. The applicant argues on page 7, Chau et al fails to teach “a blocking component shaped conformingly to a shape of the aperture”, however the examiner respectfully disagrees. Chau et al discloses a prosthetic device (Fig. 24. (200)) that includes a parachute (Fig. 24. (206)) that is made of a flexible material which is capable of sealing the gap between the native leaflets, which can be interpreted as having the ability to conform to the shape of the aperture, paragraphs 0098-0099.
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.
Claims 1-20 are 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.
Regarding claims 1, 11, 18, and 20 the phrase "a bulky blocking component body shaped conformingly with a shape of the aperture " renders the claim indefinite because it is unclear whether the bulky body component is pre-shaped prior to implantation or if the material of the bulky body component allows the device to conform to the shape of the aperture. The dependent claims are likewise rejected.
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.
Claim 1-5, 7-8, 10-14, 16, 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chau et al (US 2014/0067048 A1).
Regarding claim 1, Chau et al discloses a blocking component for occlusion of a regurgitant aperture of a valve of a heart (abstract), the blocking component comprising: a bulky blocking component body shaped conformingly with a shape of the aperture (Fig. 24: prosthetic device (200) is placed within a heart valve, where the prosthetic device includes a parachute (206) that is made of a flexible material which is capable of sealing the gap between the native leaflets, which can be interpreted to conform to the shape of the aperture, paragraphs 0098-0099), and adapted to situate within the aperture such that the bulky blocking component body fills the aperture and mitigates regurgitant flow (blood flows into the device, specifically the lower end of the (208) of a parachute (206), paragraph 0099; also see MPEP 2114(II)); and wherein the bulky blocking component body is made of a flexible and conformable material such that when situated within the aperture (the device is made of a flexible, blood-impermeable material, paragraph 0098), the bulky blocking component body responds to the cycles of systole and diastole by expanding to fill the aperture responsively to decreasing local pressure at the valve mitigating regurgitant flow (the device fills with blood when the pressure in the left atrium is lower than the pressure within the device, which prevents or reduces mitral regurgitation, paragraph 0099; also see MPEP 2114(II)), and contracting responsively to increasing the local pressure at the valve is high, allowing the forward flow of blood (the device is then able to contract, releasing the blood within, in order to allow the blood to flow between the left atrium and left ventricle, paragraph 0100; also see MPEP 2114(II)).
Regarding claim 2, Chau et al discloses the blocking component according to claim 1, further comprising a fastener (Fig. 24: anchor (204), paragraph 0098); wherein, the fastener is adapted to anchor the blocking component within the aperture by securing the bulky blocking component body within the valve (the anchor attaches the device to one of the native mitral valves, by capturing the leaflet between the anchor and the structural portion (202) of the device, paragraph 0098; in addition, the claim language, “adapted to” does not limit a claim to a particular structure, see MPEP 2111.04).
Regarding claim 3, Chau et al discloses the blocking component according to claim 2, wherein the fastener is selected from a group consisting of: an adhesive, a set of one or more sutures, and a set of one or more clips (Fig. 24: anchor (204) is clipped onto the leaflets, paragraphs 0098).
Regarding claim 4, Chau et al discloses the blocking component according to claim 2, wherein the fastener anchors the bulky blocking component body to a set of one or more native leaflets of the valve (Fig. 24: anchor (204), which is attached to the device is attached onto the leaflets, paragraphs 0098; also see MPEP 2114(II)).
Regarding claim 5, Chau et al discloses the blocking component according to claim 2, wherein: the fastener is a clip that is secured onto the bulky blocking component body by a connective element selected from a group consisting of: sutures, adhesives, and staples (Fig. 24: the anchor (204) is coupled/adhered to the device (200), paragraphs 0098); and when the clip anchors the bulky blocking component body, the clip clips onto a set of one or more native leaflets of the valve such that the bulky blocking component body anchors within the aperture of the valve (Fig. 24: anchor (204), which is attached to the device, is then able to attach onto the leaflets, paragraphs 0098).
Regarding claim 7, Chau et al discloses the blocking component according to claim 2, wherein the bulky blocking component body and fastener are incorporated into a delivery system (the device is able to be implanted via a delivery sheath, paragraph 0075; also see Fig. 64-67 for the delivery of the device, paragraph 0142).
Regarding claim 8, Chau et al discloses the blocking component according to claim 7, wherein the delivery system is a transcatheter delivery system further comprising: a catheter housing the bulky blocking component body and fastener within (the device and the anchor are compressible to a radially compressed state inside the delivery sheath, paragraph 0075); and a guide wire that passes through and extends beyond the catheter and provides a means to guide the catheter through a patient's cardiovascular system (a guidewire can be used to guide the device into position, paragraphs 0075 and 0142).
Regarding claim 10, Chau et al discloses the blocking component according to claim 1, wherein the bulky blocking component body is formed from a material selected from a group consisting of: pericardium, expanded polytetrafluoroethylene (ePTFE), polyethylene terephthalate (PET), nylon, and polymer foam (the device is formed from a PET fabric, paragraph 0098).
Regarding claim 11, Chau et al discloses a blocking component for occlusion of a regurgitant aperture of a valve of a heart (abstract), the blocking component comprising: a blocking component body shaped conformingly with a shape of the aperture (Fig. 24: prosthetic device (200) is placed within a heart valve, where the prosthetic device includes a parachute (206) that is made of a flexible material which is capable of sealing the gap between the native leaflets, which can be interpreted to conform to the shape of the aperture, paragraphs 0098-0099);, and adapted to situate within the aperture (Fig. 24: the prosthetic device is placed within a aperture of a heart valve, paragraphs 0098-0099; also see MPEP 2114(II)); wherein the blocking component body has a pocket with upper perimeter dimensions (Fig. 24: parachute (206) has a closed upper end (210), paragraph 0098) such that when the blocking component body is situated within the aperture the upper perimeter of the pocket fills the aperture and mitigates regurgitant flow (Fig. 24: the closed upper end (210) of parachute (206) fills with blood, paragraphs 0098-0100); and wherein the blocking component body is made of a flexible and conformable material such that when situated within the aperture (the device is made of a flexible, blood-impermeable material, which is able to conform to the aperture of the valve, paragraphs 0098-0100), the blocking component body responds to the cycles of systole and diastole by expanding to fill the aperture responsively to decreasing local pressure at the valve mitigating regurgitant flow (the device fills with blood when the pressure in the left atrium is lower than the pressure within the device, which prevents or reduces mitral regurgitation, paragraph 0099; also see MPEP 2114(II)), and contracting responsively to increasing the local pressure at the valve is high, allowing the forward flow of blood (the device is then able to contract, releasing the blood within, in order to allow the blood to flow between the left atrium and left ventricle, paragraph 0100; also see MPEP 2114(II)).
Regarding claim 12, Chau et al discloses the blocking component according to claim 11 further comprising a fastener (Fig. 24: anchor (204), paragraph 0098); wherein, the fastener is adapted to anchor the blocking component body within the aperture by securing the blocking component body within the valve (the anchor attaches the device to one of the native mitral valves, by capturing the leaflet between the anchor and the structural portion (202) of the device, paragraph 0098; in addition, the claim language, “adapted to” does not limit a claim to a particular structure, see MPEP 2111.04).
Regarding claim 13, Chau et al discloses the blocking component according to claim 12, wherein the fastener anchors the blocking component body to a set of one or more native leaflets of the valve (Fig. 24: anchor (204) is clipped onto the leaflets, paragraphs 0098).
Regarding claim 14, Chau et al discloses the blocking component according to claim 12, wherein the fastener is a clip that is secured onto the blocking component body by a connective element selected from a group consisting of: sutures, adhesives, and staples (Fig. 24: the anchor (204) is coupled/adhered to the device (200), paragraphs 0098); and wherein when the clip anchors the blocking component body, the clip clips onto one or more native leaflets of the heart valve such that the blocking component body anchors within the aperture of the valve (Fig. 24: anchor (204), which is attached to the device, is then able to attach onto the leaflets, paragraphs 0098).
Regarding claim 16, Chau et al discloses the blocking component according to claim 12, wherein the blocking component body and fastener are incorporated into a transcatheter delivery system (the device is able to be implanted via a delivery sheath, paragraph 0075; also see Fig. 64-67 for the delivery of the device, paragraph 0142) comprising; a catheter housing the blocking component body and fastener within (the device and the anchor are compressible to a radially compressed state inside the delivery sheath, paragraph 0075); and a guide wire that passes through and extends beyond the catheter and provides a means to guide the catheter through a patient's cardiovascular system (a guidewire can be used to guide the device into position, paragraphs 0075 and 0142).
Regarding claim 18, Chau et al discloses a method for occlusion of a regurgitant aperture of a valve of a heart (abstract), the method comprising: situating a blocking component shaped conformingly with a shape of the aperture the aperture such that the blocking component fills the aperture and mitigates regurgitant flow (Fig. 24: prosthetic device (200) is placed within a heart valve, where the prosthetic device includes a parachute (206) that is made of a flexible material which is capable of sealing the gap between the native leaflets, which can be interpreted to conform to the shape of the aperture, paragraphs 0098-0099); wherein the blocking component is made of a flexible and conformable material (the device is made of a flexible, blood-impermeable material, paragraph 0098) that responds to the cycles of systole and diastole by expanding to fill the aperture responsively to decreasing local pressure at the valve mitigating regurgitant flow (the device fills with blood when the pressure in the left atrium is lower than the pressure within the device, which prevents or reduces mitral regurgitation, paragraph 0099), and contracting responsively to increasing the local pressure at the valve is high, allowing the forward flow of blood (the device is then able to contract, releasing the blood within, in order to allow the blood to flow between the left atrium and left ventricle, paragraph 0100); and wherein the blocking component comprises a blocking component body (Fig. 24: parachute (206), paragraph 0098-0100).
Regarding claim 19, Chau et al discloses the method according to claim 18, wherein the blocking component body has a pocket with upper perimeter dimensions configured to fill the aperture and mitigate regurgitant flow (Fig. 24: the closed upper end (210) of parachute (206) fills with blood, paragraphs 0098-0100).
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 6, 9, 15, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Chau et al (US 2014/0067048 A1).
Regarding claims 6 and 9, Chau et al discloses wherein the fastener is a clip that is secured onto the bulky blocking component body by a connective element selected from a group consisting of: sutures, adhesives, and staples (Fig. 24: the anchor (204) is coupled/adhered to the device (200), paragraphs 0098); however doesn’t specifically disclose, however doesn’t specifically disclose wherein the clip defines an eye that can accommodate a wire therethrough.
In another embodiment, Chau et al discloses a device that is deployed into a native mitral valve, wherein the clip defines an eye that can accommodate a wire therethrough, (Fig. 62: anchors (804 and 806) that are attached to expanders/levers (876) (paragraphs 0139-0142), and wherein the clip can be opened by tautening the wire and wherein the transcatheter delivery system further comprises an actuating wire that passes through the eye and is adapted to open the clip (the expanders/levers are able to move with manipulation/tautening by a physician (paragraph 0139).
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 taught by Chau et al to include the expander/levers taught by Chau et al in order to have way for the physician to control the expansion of the anchors onto the native leaflets by moving a control knob on a handle that is operatively connected to the expanders/levers, paragraph 0139.
Regarding claims 15 and 17, Chau et al discloses the blocking component according to claim 14, however doesn’t specifically disclose wherein the clip defines an eye that can accommodate a wire therethrough, and wherein the clip can be opened by tautening the wire and wherein the transcatheter delivery system further comprises an actuating wire that passes through the eye and is adapted to open the clip
In (Fig. 24: the anchor (204) is coupled/adhered to the device (200), paragraphs 0098); however doesn’t specifically disclose, however doesn’t specifically disclose wherein the clip defines an eye that can accommodate a wire therethrough.
In another embodiment, Chau et al discloses a device that is deployed into a native mitral valve, wherein the clip defines an eye that can accommodate a wire therethrough, (Fig. 62: anchors (804 and 806) that are attached to expanders/levers (876) (paragraphs 0139-0142), and wherein the clip can be opened by tautening the wire and wherein the transcatheter delivery system further comprises an actuating wire that passes through the eye and is adapted to open the clip (the expanders/levers are able to move with manipulation/tautening by a physician (paragraph 0139).
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 taught by Chau et al to include the expander/levers taught by Chau et al in order to have way for the physician to control the expansion of the anchors onto the native leaflets by moving a control knob on a handle that is operatively connected to the expanders/levers, paragraph 0139.
Regarding claim 20, Chau et al discloses a method for occlusion of a regurgitant gap of a valve of a heart (abstract), comprising: approaching, via a patient's circulatory system, the valve with a transcatheter delivery system (paragraph 0075); wherein the transcatheter delivery system comprises: a blocking component shaped conformingly with a shape of the gap Fig. 24: prosthetic device (200) is placed within a heart valve, where the prosthetic device includes a parachute (206) that is made of a flexible material which is capable of sealing the gap between the native leaflets, which can be interpreted to conform to the shape of the aperture, paragraphs 0098-0099), and adapted to situate within a gap (Fig. 24: prosthetic device (200) is placed within a heart valve, paragraphs 0098-0099) and configured such that, when situated within the gap, the blocking component mitigates regurgitation across the valve (paragraphs 0098-0101); a fastening clip secured to the blocking component (Fig. 24: anchor (204), paragraph 0098), and a catheter defining an internal volume into which the blocking component, the fastening clip, and the actuating wire are disposed (the device and the anchor are compressible to a radially compressed state inside the delivery sheath, paragraph 0075);; however doesn’t specifically disclose the fastening clip defining an eye.
In another embodiment, Chau et al discloses a device that is deployed into a native mitral valve that also includes the fastening clip defining an eye (Fig. 62: anchors (804 and 806), paragraphs 0139-0142), an actuating wire disposed through the eye (Fig. 62: expanders/levers (876), paragraphs 0139-0142). Chau et al further discloses advancing the blocking component and the clip with the actuating wire out of the catheter and towards a native leaflet proximate to the gap; opening the clip by tautening the actuating wire (the expanders/levers are able to move with manipulation by a physician by tautening a control wire, which is then able to attached/clip onto the leaflet (paragraph 0139)).
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 taught by Chau et al to include the expander/levers taught by Chau et al in order to have way for the physician to control the expansion of the anchors onto the native leaflets by moving a control knob on a handle that is operatively connected to the expanders/levers, paragraph 0139.
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
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774