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 .
Response to Amendment
This office action is in response to the amendments filed on 10/4/2024. Claims 21 and 28-32 are amended. Claim 33 is canceled. Claims 21-32 are pending and addressed below.
Response to Arguments
Applicant’s arguments, filed on 10/4/2024, with respect to claim 21 have been considered but are moot because the arguments do not apply to the new interpretations of the prior art of record being used in the current rejection. Applicant’s arguments are only directed to the amended claims, therefore the arguments are addressed in the body of the rejection below.
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 21-32 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 pre-AIA the applicant regards as the invention.
Regarding claim 21, the claim recited the limitation “a second commissure” in line 12. It is not clear to the examiner if the second commissure in line 12 is the same as or different from the second commissure previously recited in lines 7-8. Therefore, the scope of the claim in unclear. For examination purposes, the limitation of “a second commissure” in line 12 will be interpreted as “the second commissure”. Appropriate correction is required.
Claims 22-32 are rejected due to being dependent on the rejected claim as discussed above.
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 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)(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 21, 23 and 27 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chau (US Pub No. 2014/0067054).
Regarding claim 21 as best understood, Chau discloses (Figures 3-8) a valve prosthesis (20), comprising a generally tubular body (Figures 6-8) adapted for placement proximate a mitral annulus (Figure 3) (Paragraph 0080), the tubular body having: a) a supra annular frame portion (top portion of the tubular body) that includes (i) a left atrial posterior loop (see annotated figure below) that is configured to rest above the mitral annulus in the left atrium (Figure 3), the left atrial posterior loop extending from a first end (see annotated figure below) at a location corresponding to a first commissure of a patient’s mitral annulus along a pathway corresponding a location of a posterior portion of the patient’s mitral annulus to a second end (see annotated figure below) at a location corresponding to a second commissure of the patient’s mitral annulus [The first end of the posterior loop corresponds or has a close similarity to a location of the first commissure of a patient’s mitral annulus since the valve prosthesis can be manipulated in any direction to get the first end of the posterior loop to correspond or have a close similarity to a location of the first commissure. Also, the second end of the posterior loop corresponds or has a close similarity to a location of the second commissure of a patient’s mitral annulus since the valve prosthesis can be manipulated in any direction to get the second end of the posterior loop to correspond or have a close similarity to a location of the second commissure. The examiner wants to note that the term “corresponding” is broad and the claim does not specifically state that the valve prosthesis needs to be in an implanted state within the heart for the first and seconds ends of the posterior loop to correspond to the different anatomical locations of the heart] (ii) an anterior left atrial loop (see annotated figure below) configured to expand into the left atrium above the mitral annulus (Figure 3), the anterior left atrial loop extending from a first end (see annotated figure below) at a location corresponding to the first commissure of the patient’s mitral annulus along a pathway corresponding to an anterior region of the patient’s atrium to a second end (see annotated figure below) in a location corresponding to the second commissure of the patient’s mitral annulus [The first end of the anterior loop corresponds or has a close similarity to a location of the first commissure of a patient’s mitral annulus since the valve prosthesis can be manipulated in any direction to get the first end of the anterior loop to correspond or have a close similarity to a location of the first commissure. Also, the second end of the anterior loop corresponds or has a close similarity to a location of the second commissure of a patient’s mitral annulus since the valve prosthesis can be manipulated in any direction to get the second end of the anterior loop to correspond or have a close similarity to a location of the second commissure. The examiner wants to note that the term “corresponding” is broad and the claim does not specifically state that the valve prosthesis needs to be in an implanted state within the heart for the first and seconds ends of the anterior loop to correspond to the different anatomical locations of the heart]; and b) a sub annular frame portion (bottom portion of the tubular body) configured to extend downwardly from the supra annular frame portion through a main opening of a patient’s mitral valve into a posterior region of a native left ventricle of the patient (Figure 3) (Paragraphs 0079-0080), the sub annular frame portion being configured to not extend into the patient’s left ventricle in the region of an anterior native mitral valve leaflet (6) of the patient when deployed such that the sub annular frame portion does not interfere with the opening and closing of the native anterior mitral valve leaflet (Figure 3) (Paragraphs 0079-0080), the sub annular frame portion being configured to form a surface that replaces a native posterior mitral valve leaflet (8) of the patient to coapt with the native anterior mitral valve leaflet (6) of the
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patient to permit the mitral valve to open and close (Figure 3) (Paragraphs 0079-0080).
Regarding claim 23, wherein the surface includes a fabric (28) operably coupled to the sub annular frame portion (Figures 6-8) (Paragraph 0084).
Regarding claim 27, wherein the sub annular frame portion includes a generally circumferential wall (Figure 8) configured to traverse a posterior wall of the left ventricle at a location posterior of commissures of the patient’s mitral valve [Fully configured in doing this since Chau discloses all of the structural elements in the same arrangement as claimed].
Claim Rejections - 35 USC § 103
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 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 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 of this title, 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.
Claims 22, 25, 26, 28 and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Chau (US Pub No. 2014/0067054) as applied to claim 21 above.
Regarding claims 22, 25 and 26, Chau discloses the invention of claim 21 above except for wherein the surface includes biological cells residing on prosthetic material, wherein the surface includes living tissue operably coupled to the sub annular frame portion and wherein the surface includes pericardial tissue operably coupled to the sub annular frame portion.
Chau’s alternative embodiment teaches (Figures 35-36) valve prosthetic devices (460, 470) that includes surfaces (462, 472) that comprise biological cells residing on prosthetic material (pericardial tissue) (Paragraph 0115), wherein the surfaces includes living tissue (pericardial tissue) (Paragraph 0115) and wherein the surface includes pericardial tissue (Paragraph 0115). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Chau to have the surface to include biological cells residing on prosthetic material, wherein the surface includes living tissue operably coupled to the sub annular frame portion and wherein the surface includes pericardial tissue operably coupled to the sub annular frame portion as taught by Chau’s alternative embodiment, in order to provide a material which is stiff enough to reduce the chance of leaflet prolapse, and flexible enough to increase the extend of leaflet coaptation (Paragraph 0115).
Regarding claims 28, 31 and 32, Chau discloses the invention of claim 21 above including a surface (28) extending from a first lateral portion of the prosthesis to an opposing, second lateral portion of the prosthesis (Figure 8) but fails to disclose surface prevent prolapse of an anterior native leaflet during systole, wherein the surface includes biological tissue and wherein the at least transverse support includes pericardial tissue.
Chau’s alternative embodiment teaches (Figures 35-36) valve prosthetic devices (460, 470) that includes a surface (462, 472) that prevent prolapse of an anterior native leaflet during systole (Paragraph 0115), wherein the surface includes biological tissue (pericardial tissue) (Paragraph 0115) and wherein the surface includes pericardial tissue (Paragraph 0115). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Chau to have the surface to prevent prolapse of an anterior native leaflet during systole, wherein the surface includes biological tissue and wherein the surface includes pericardial tissue as taught by Chau’s alternative embodiment, in order to provide a material which is stiff enough to reduce the chance of leaflet prolapse, and flexible enough to increase the extend of leaflet coaptation (Paragraph 0115).
Claims 24, 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Chau (US Pub No. 2014/0067054) as applied to claims 23 and 28 above, and further in view of Hill (US Pub No. 2010/0036479).
Regarding claim 24, Chau discloses the invention of claim 23 above except for wherein the fabric includes at least one of expanded PTFE, Dacron, and polyester material.
Hill, in the same field of endeavor, teaches (Figure 5) a valve prosthetic device (30) that includes a fabric of polyester material (Paragraph 0055). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Chau to have the fabric to include a polyester material as taught by Hill, in order to provide a material that includes a medium for tissue ingrowth, and the ability for the fabric to stretch to conform to a curved surface (Hill, Paragraph 0055).
Regarding claims 29 and 30, Chau discloses the invention of claim 28 above except for wherein the surface includes polyester material or an expanded PTFE material.
Hill, in the same field of endeavor, teaches (Figure 5) a valve prosthetic device (30) that includes a surfaace (34) that includes a polyester material or an expanded PTFE material (Paragraph 0055). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Chau to have the surface to include a polyester material or an expanded PTFE material as taught by Hill, in order to provide a material that includes a medium for tissue ingrowth, and the ability for the fabric to stretch to conform to a curved surface (Hill, Paragraph 0055).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAJID JAMIALAHMADI whose telephone number is (571) 270-0172. The examiner can normally be reached on Monday-Friday 7am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAJID JAMIALAHMADI/Primary Examiner, Art Unit 3771