3DETAILED 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 Objections
Claim 14 is objected to because of the following informalities:
Claim 14, line 1: “replacement valve” should recite “the replacement valve”. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“cutting feature” in claims 1-3, 10 and “cutting instrument” in claims 16, 18, and 20. The limitation describing the cutting feature/cutting instrument in claims 1 and 16 fail to include sufficient structure to perform the recited function of "cutting”. In the specification, the cutting feature/cutting instrument is described as “a sharp blade, tine, or other rigid feature” (para. 0024) or “The cutting feature can be an electrosurgical cutting feature. For example, a tine or anchor of the replacement valve 102 can be electrified to electrosurgically lacerate the leaflet” (para. 0025). Therefore, the cutting feature/cutting instrument is interpreted as the sharp blade, tine, other rigid feature, tine/anchor that can be electrified, or any structural equivalents thereof that can lacerate tissue.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1-3, 8, and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Realyvasquez et al. (US 20060271081) [hereinafter Realyvasquez].
Regarding claim 1, Realyvasquez discloses a method (Figs. 4A-4D, para. 0067), comprising:
positioning a replacement valve 500 at a target cardiac tissue location of a subject (Figs. 4A-B, para. 0079: “While in the generally collapsed state shown in FIG. 4A, valve prosthesis apparatus 300 with prosthetic valve 500 secured thereto is introduced through the aortotomy. The valve aligned with its natural location just below the two coronary arteries as is known in valve surgery”), the replacement valve 500 comprising a cutting feature (interpreted as “the sharp pointed distal end of each support tube 302” as described in para. 0072, see 112(f) interpretation above) (Fig. 5A, para. 0079: “The sliding member 318 is retracted to have the piercing ends of support tubes 302 penetrate into the aortic root tissue as shown in FIG. 5A. The piercing ends further penetrate through the aortic root of prosthesis 500 and penetrate into the natural aortic root surrounding aortic root 502 of valve prosthesis 500”);
cutting a cardiac tissue of the subject with the cutting feature (Fig. 5A, see quote from para. 0079 above); and
removing the cutting feature from the subject, wherein removing the cutting feature comprises decoupling the cutting feature from the replacement valve 500 (Figs. 5C-D, para. 0079: “After the clips are fully released and have moved or tended to move toward their memory shape to secure valve prosthesis 500 in place as diagrammatically shown in FIG. 5C and more particularly in FIG. 5F, valve prosthesis delivery apparatus 300 is removed leaving the replacement valve secured at the desired site (FIG. 5D)”).
Regarding claim 2, Realyvasquez discloses wherein the replacement valve 500 comprises an actuation arm (interpreted as tubular body of support tubes 302), wherein the cutting feature is coupled to the actuation arm (Fig. 5A, para. 0072: “Valve prosthesis 500 is then mounted on apparatus 300 so that the sharp pointed distal end of each support tube 302 extends through the lower wall portion or lower portion of root portion 502 of tissue valve prosthesis 500”).
Regarding claim 3, Realyvasquez discloses wherein removing the cutting feature from the subject comprises decoupling the actuation arm from the replacement valve (Figs. 5C-D, para. 0079: “After the clips are fully released and have moved or tended to move toward their memory shape to secure valve prosthesis 500 in place as diagrammatically shown in FIG. 5C and more particularly in FIG. 5F, valve prosthesis delivery apparatus 300 is removed leaving the replacement valve secured at the desired site (FIG. 5D)”).
Regarding claim 8, Realyvasquez discloses wherein the cutting feature comprises a blade (para. 0072: “the sharp pointed distal end of each support tube 302”),and wherein cutting the cardiac tissue comprises mechanically actuating the blade (para. 0079: “The sliding member 318 is retracted to have the piercing ends of support tubes 302 penetrate into the aortic root tissue as shown in FIG. 5A”).
Regarding claim 16, Realyvasquez discloses a method (Figs. 4A-4D, para. 0067), comprising:
deploying a medical device 500 at a target tissue location of a subject (Figs. 4A-B, para. 0079: “While in the generally collapsed state shown in FIG. 4A, valve prosthesis apparatus 300 with prosthetic valve 500 secured thereto is introduced through the aortotomy. The valve aligned with its natural location just below the two coronary arteries as is known in valve surgery”), the medical device 500 comprising a cutting instrument (interpreted as “the sharp pointed distal end of each support tube 302” as described in para. 0072, see 112(f) interpretation above) (Fig. 5A, para. 0079: “The sliding member 318 is retracted to have the piercing ends of support tubes 302 penetrate into the aortic root tissue as shown in FIG. 5A. The piercing ends further penetrate through the aortic root of prosthesis 500 and penetrate into the natural aortic root surrounding aortic root 502 of valve prosthesis 500”);
lacerating, with the cutting instrument 302 of the medical device 500, a tissue of the subject (Fig. 5A, see quote from para. 0079 above); and
removing the cutting instrument of the medical device from the subject (Figs. 5C-D, para. 0079: “After the clips are fully released and have moved or tended to move toward their memory shape to secure valve prosthesis 500 in place as diagrammatically shown in FIG. 5C and more particularly in FIG. 5F, valve prosthesis delivery apparatus 300 is removed leaving the replacement valve secured at the desired site (FIG. 5D)”).
Regarding claim 17, Realyvasquez discloses wherein lacerating the tissue comprises transecting a cardiac tissue of the subject (see quote from para. 0079 above which discloses that the tissue is cardiac tissue).
Regarding claim 18, Realyvasquez discloses wherein an actuation arm (interpreted as tubular body of support tubes 302) of the medical device comprises the cutting instrument (Fig. 5A, para. 0072: “Valve prosthesis 500 is then mounted on apparatus 300 so that the sharp pointed distal end of each support tube 302 extends through the lower wall portion or lower portion of root portion 502 of tissue valve prosthesis 500”), and wherein removing the cutting instrument from the subject comprises at least one of decoupling the actuation arm from the medical device (Figs. 5C-D, para. 0079: “After the clips are fully released and have moved or tended to move toward their memory shape to secure valve prosthesis 500 in place as diagrammatically shown in FIG. 5C and more particularly in FIG. 5F, valve prosthesis delivery apparatus 300 is removed leaving the replacement valve secured at the desired site (FIG. 5D)”).
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 (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 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.
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.
Alternative 103 rejection of claims 1 and 16
Claim(s) 1-9, 11, 12, 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Artof et al. (US 20060259137) [hereinafter Artof] in view of Al-Jilaihawi et al. (US 20160228241) [hereinafter Al-Jilaihawi] and Eidenschink (US 20140249621).
The examiner notes that the embodiment of the anchoring structure shown in Fig. 53 is relied upon in the rejection. However, the embodiments of Figs. 51, 52, and 54 are relied upon to refer to shared features that are not shown or described in Fig. 53.
Regarding claim 1, Artof discloses a method (Fig. 53, para. 0194), comprising:
positioning a replacement valve at a target cardiac tissue location of a subject (para. 0194: “a valve assembly made of an anchoring structure of the present invention and a collapsible valve, as described above,…the balloon means is pushed out of the protection cap and the valve assembly is positioned in the desired position”), the replacement valve comprising a cutting feature 621 (Fig. 53, para. 0191: “the anchoring structure comprises a set of sharp edge cutting elements (621) at the distal end portion of the cutting means (620) of the lower ring (602) of the anchoring structure, wherein each cutting element (621) has a cutting tip (622)”); and
cutting a cardiac tissue of the subject with the cutting feature (para. 0194: “the valve assembly is advanced with its cutting means cutting at least a portion of the native valve”).
Artof further discloses that the replacement valve comprises an anchoring structure 600 as a body of the replacement valve (see Fig. 51 for example, para. 0189: “the anchoring structure (600)) and the cutting feature 621 is located at a distal end portion of a lower ring 602 of the anchoring structure for cutting a native valve (Fig. 53, para. 0191: “the anchoring structure comprises a set of sharp edge cutting elements (621) at the distal end portion of the cutting means (620) of the lower ring (602) of the anchoring structure… wherein each cutting element (621) of the cutting means is sized and configured, optionally with radiofrequency energy, as cutting means for cutting a native valve)).
The reference further discloses that during implantation of the replacement valve, that an expansion/compression device may be used (para. 0157: “A preferred embodiment of an expansion and contraction device for implanting the valve assemblies of the present invention is illustrated in FIGS. 31-33”, para. 0159: “Pulling the grip handle (201) proximally contracts the anchoring structure (210) into a collapsed state for implantation whereas pushing the grip handle (201) distally expands the anchoring structure (210). When the anchoring structure (210) is positioned in a desirable location in the vessel and expanded to the desired dimensions, the sutures are severed and removed from the proximal end (203) of the wires (200) in order to disconnect the anchoring structure (210) from the device.”, and para. 0193: “passing the valve assembly through the vessel with the anchoring structure in a collapsed state”), wherein distal ends 204 of wires 200 of the expansion/compression device are attached to the anchoring structure (Fig. 33, para. 0159: “As shown in FIG. 33, a representative anchoring structure (210) of the present invention is attached to the distal ends (204) of the hollow wires (200)”).
However, Artof fails to disclose removing the cutting feature from the subject, wherein removing the cutting feature comprises decoupling the cutting feature from the replacement valve.
Eidenschink in the same field of endeavor of replacement valve devices teaches that it is known the art to attach distal ends 418 of wires 415 on a lower portion of the replacement valve 300 (Fig. 4, para. 0043: “The couplers 418 at the ends of wires 415 are adapted to mate with anchors 318 of heart valve 300. Each coupler 418 may be in the form of a metallic hook, clasp or pin that engages with an anchor 318”) for implantation of the replacement valve within the mitral valve (para. 0046: “To use delivery device 400 for delivering a prosthetic heart valve, such as mitral valve 300, the operator may advance the delivery catheter into the patient's heart using the transapical approach shown in FIG. 1...At this position, heart valve 300 may be partially expanded such that leaflets 308 are fully operational and the valve assembly 304 may be tested for proper functionality with each anchor 318 of the heart valve still mated with a coupler 418 of delivery device 400. ) or repositioning/removal (para. 0047: “If, however, the operator determines that an adjustment is necessary, he may pull on any one of the wires 415 to slightly reposition the heart valve within the native valve annulus…If the heart valve 300 is incapable of proper operation despite multiple repositioning attempts using wires 415, inner tube 450 and outer sheath 410 may be advanced over wires 415 to recapture heart valve 300 and remove it from the patient.”)
Al-Jilaihawi in the same field of endeavor of replacement valve devices teaches that it is known in the art to make replacement valves modular such that the replacement valve comprises a replacement valve portion 103 that remains in a subject (Fig. 2A, para. 0021: “The bottom module 103 comprises a replacement heart valve including, in some embodiments, leaflets 102 or other valve structures...The top module 101 is attached to the bottom module 103 prior to deployment of the device. In some embodiments, and as illustrated in FIG. 2B, the top module 101 may be detached from the bottom module 103 after deployment of the device”) and a detachable portion that is attached to a deployment device and removed from the subject after deployment of the replacement valve (Figs. 2A-B, see quote from para. 0021 above). The detachable portion is removed by retrieval cords 201 of the deployment device (para. 0021: “In this embodiment and as illustrated in FIG. 2A, the top module 101 includes retrieval cords 201 that may be connected to a guide wire, catheter or other structure that may be refracted, thereby removing the top module 101”).
The reference explains that providing the replacement valve device with a detachable portion is advantageous because it provides the device with a sufficient length for adequate delivery to a target site and minimizes the amount of metal and other foreign material in the subject’s body upon removal (para. 0004: “The longer the TAVR device, the easier it is to position in the canal of the aortic valve. However, the longer the TAVR device, the more metal that remains within the body, which may cause additional complications and reactions including thrombus formation. To solve these technical issues pertaining to the TAVR procedure, the inventors developed modular transcatheter valve replacement devices”).
Since Eidenschink teaches that the lower portion of the replacement valve may be directly attached to the deployment/removal device and Al-Jilaihawi teaches that the portion that is directly attached to the deployment device may be removed from the rest of the replacement valve device, one of ordinary skill in the art would recognize that a modular replacement valve that can be removed from the subject would be advantageous in the art. Thus, it would have been recognized by one of ordinary skill in the art before the effective filing date of the claimed invention to modify the replacement valve of Artof to be modular as taught by Al-Jilaihawi such that the lower ring of the replacement valve comprising the cutting means can be decoupled from the anchoring structure of the replacement valve by way of the wires of the deployment device and thereby removed from the subject. This modification would be advantageous for the replacement valve device of Artof because it would minimize the metal and other foreign material in a patient's body that could cause thrombosis or other reactions, as taught by Al-Jilaihawi above, but also minimize the risk of injury by making the cutting means removable from the rest of the device.
Regarding claim 2, modified Artof discloses wherein the replacement valve comprises an actuation arm (interpreted as one of the struts connected to the cutting element 621), wherein the cutting feature is coupled to the actuation arm (see annotated Fig. 53 of Artof below).
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Annotated Fig. 52 of Artof
Regarding claim 3, modified Artof results in a combination wherein removing the cutting feature 621 from the subject comprises decoupling the actuation arm from the replacement valve (The examiner notes that the actuation arm is one of a plurality of struts forming the lower ring 602 of the replacement valve which is modified to decouple from the replacement valve; see rejection of claim 1 above).
Regarding claim 4, modified Artof discloses wherein the cardiac tissue is a leaflet of a cardiac valve of the subject, and wherein cutting the cardiac valve comprises lacerating the leaflet (para. 0191 of Artof: “wherein each cutting element (621) of the cutting means is sized and configured, optionally with radiofrequency energy, as cutting means for cutting a native valve”).
Regarding claim 5, modified Artof discloses wherein positioning the replacement valve comprises deploying the replacement valve through a catheter (para. 0188 of Artof: “the valve anchoring structure is made from a radially collapsible and re-expandable cylindrical support means for folding and expanding together with the collapsible replacement valve for implantation in the body by means of catheterization or other minimally invasive procedure”).
Regarding claim 6, modified Artof discloses wherein the replacement valve comprises a shape memory alloy (para. 0155 of Artof: “The anchoring structures of the present invention may be constructed from superelastic memory metal alloys, such as Nitinol”), wherein positioning the replacement valve comprises collapsing the replacement valve prior to implantation at the target cardiac tissue location, and wherein the replacement valve expands following implantation (para. 0186 of Artof: “when passing the valve assembly comprising the valve and anchoring structure through the vessel with the anchoring structure in a collapsed state…the valve assembly is secured to the desired valve location with the anchoring structure in the expanded state”).
Regarding claim 7, modified Artof discloses further comprising determining a size of a constricted left ventricular outflow tract (LVOT) following positioning of the replacement valve (para. 0194 of Artof: “the valve assembly is positioned in the desired position if necessary by use of further imaging means to ensure accurate positioning; para. 0227 of Artof: “the imaging system may also be utilized in connection with other procedures in which visualization of the valve, vessel or other body cavity is desired, such as in valve removal, valve sizing, and valvuloplasty, to name a few”), wherein cutting the cardiac tissue is based at least in part on the size of the constricted LVOT (para. 0186 of Artof: “the cutting means can be advanced against the native valve with the anchoring structure in a partially expanded state. In this manner, the anchoring structure comprising the cutting means cuts at least a portion of the native valve by deploying the cutting means, before the valve assembly is secured to the desired valve location with the anchoring structure in the expanded state”).
Regarding claim 8, modified Artof discloses wherein the cutting feature 621 comprises a blade (Fig. 53, para. 0191 of Artof: “wherein each cutting element (621) has a cutting tip (622)”) and wherein cutting the cardiac tissue comprises mechanically actuating the blade (para. 0191 of Artof: “In one embodiment, sharp edge cutting means on the delivery apparatus is rotatable, enabling the cutting element (621) to cut through at least a portion of the native valve”; para. 0193 of Artof: “advancing the cutting means against the native valve with the anchoring structure in a partially expanded state, cutting at least a portion of the native valve by deploying the cutting means”).
Regarding claim 9, modified Artof discloses wherein the blade is actuated using wires 200 to cause a cutting motion with the blade to lacerate the cardiac tissue (Fig. 33, para. 0157 of Artof: “A preferred embodiment of an expansion and contraction device for implanting the valve assemblies of the present invention is illustrated in FIGS. 31-33. As seen in FIGS. 31 A and B, the device of the present embodiment comprises a group of bendable hollow tubes or wires (200)”; para. 0159 of Artof: “Attached to the distal ends (204) of the hollow wires, the anchoring structure (210) contracts and expands radially in response to the longitudinal motion of the wires (200). Pulling the grip handle (201) proximally contracts the anchoring structure (210) into a collapsed state for implantation whereas pushing the grip handle (201) distally expands the anchoring structure (210)”).
Regarding claim 11, modified Artof discloses wherein the cutting feature is an electrosurgical cutting feature (see Fig. 54 of Artof which illustrates a replacement valve with both sharp cutting means and RF cutting means, para. 0191 of Artof: “wherein each cutting element (621) of the cutting means is sized and configured, optionally with radiofrequency energy, as cutting means for cutting a native valve”), and wherein cutting the cardiac tissue comprises electrifying a portion of the replacement valve to activate the electrosurgical cutting feature (para. 0190 of Artof: “Radiofrequency energy is delivered through conductor means (611) to each electrode element (610) enabling the electrode element to cut through at least a portion of the native valve”).
Regarding claim 12, modified Artof discloses wherein the cutting feature comprises at least a first electrode (interpreted as one of the electrodes 610) to conduct a current to electrically cut the cardiac tissue, and wherein the replacement valve comprises a second electrode (interpreted as another electrode 610) to form a circuit with the first electrode through a portion of the cardiac tissue (Fig. 52, para. 0190 of Artof: “the anchoring structure comprises at least one radiofrequency electrode (610) at the distal end portion of the lower ring (602)…Radiofrequency energy is delivered through conductor means (611) to each electrode element (610) enabling the electrode element to cut through at least a portion of the native valve”).
Regarding claim 16, Artof discloses a method (Fig. 54, para. 0195), comprising:
deploying a medical device at a target tissue location of a subject (para. 0194: “a valve assembly made of an anchoring structure of the present invention and a collapsible valve, as described above,… the balloon means is pushed out of the protection cap and the valve assembly is positioned in the desired position”), the medical device comprising a cutting instrument 636, 638 (interpreted as sharp cutting means 636 or ultrasound/radiofrequency cutting means; see 112(f) interpretation above; Fig. 54, para. 0192: “the sharp end (636) of the cutting means of the valve anchoring structure (637) is advanced to cut and remove at least a portion of the native valve. In another embodiment, the valve anchoring structure (637) comprises an ultrasound or radiofrequency cutting means (638)”); and
lacerating, with the cutting instrument of the medical device, a tissue of the subject (para. 0194: “the valve assembly is advanced with its cutting means cutting at least a portion of the native valve”).
Artof further discloses that the medical device comprises an anchoring structure 600 as a body of the medical device and the cutting feature is located at a distal end portion of a lower ring 602 of the anchoring structure for cutting a native valve (see Fig. 51 for example, para. 0189: “the anchoring structure (600) comprises at least one ultrasound transducer (601) at the distal end portion of the lower ring (602), wherein each ultrasound transducer is sized and configured with ultrasound energy as cutting means for cutting a native valve”).
The reference further discloses that during implantation of the replacement valve, that an expansion/compression device may be used (para. 0157: “A preferred embodiment of an expansion and contraction device for implanting the valve assemblies of the present invention is illustrated in FIGS. 31-33”, para. 0159: “Pulling the grip handle (201) proximally contracts the anchoring structure (210) into a collapsed state for implantation whereas pushing the grip handle (201) distally expands the anchoring structure (210). When the anchoring structure (210) is positioned in a desirable location in the vessel and expanded to the desired dimensions, the sutures are severed and removed from the proximal end (203) of the wires (200) in order to disconnect the anchoring structure (210) from the device.”, and para. 0193: “passing the valve assembly through the vessel with the anchoring structure in a collapsed state”), wherein distal ends 204 of wires 200 of the expansion/compression device are attached to the anchoring structure (Fig. 33, para. 0159: “As shown in FIG. 33, a representative anchoring structure (210) of the present invention is attached to the distal ends (204) of the hollow wires (200)”).
However, Artof fails to disclose removing the cutting instrument of the medical device from the subject.
Eidenschink in the same field of endeavor of replacement valve devices teaches that it is known the art to attach distal ends 418 of wires 415 on a lower portion of the medical device 300 (Fig. 4, para. 0043: “The couplers 418 at the ends of wires 415 are adapted to mate with anchors 318 of heart valve 300. Each coupler 418 may be in the form of a metallic hook, clasp or pin that engages with an anchor 318”) for implantation of a replacement valve within the mitral valve (para. 0046: “To use delivery device 400 for delivering a prosthetic heart valve, such as mitral valve 300, the operator may advance the delivery catheter into the patient's heart using the transapical approach shown in FIG. 1...At this position, heart valve 300 may be partially expanded such that leaflets 308 are fully operational and the valve assembly 304 may be tested for proper functionality with each anchor 318 of the heart valve still mated with a coupler 418 of delivery device 400. ) or repositioning/removal (para. 0047: “If, however, the operator determines that an adjustment is necessary, he may pull on any one of the wires 415 to slightly reposition the heart valve within the native valve annulus…If the heart valve 300 is incapable of proper operation despite multiple repositioning attempts using wires 415, inner tube 450 and outer sheath 410 may be advanced over wires 415 to recapture heart valve 300 and remove it from the patient.”)
Al-Jilaihawi in the same field of endeavor of replacement valve devices teaches that it is known in the art to make replacement valves modular such that the replacement valve comprises a replacement valve portion 103 that remains in a subject (Fig. 2A, para. 0021: “The bottom module 103 comprises a replacement heart valve including, in some embodiments, leaflets 102 or other valve structures...The top module 101 is attached to the bottom module 103 prior to deployment of the device. In some embodiments, and as illustrated in FIG. 2B, the top module 101 may be detached from the bottom module 103 after deployment of the device”) and a detachable portion that is attached to a deployment device and removed from the subject after deployment of the replacement valve (Figs. 2A-B, see quote from para. 0021 above). The detachable portion is removed by retrieval cords 201 of the deployment device (para. 0021: “In this embodiment and as illustrated in FIG. 2A, the top module 101 includes retrieval cords 201 that may be connected to a guide wire, catheter or other structure that may be refracted, thereby removing the top module 101”).
The reference explains that providing the medical device with a detachable portion is advantageous because it provides the medical device with a sufficient length for adequate delivery to a target site and minimizes the amount of metal and other foreign material in the subject’s body upon removal (para. 0004: “The longer the TAVR device, the easier it is to position in the canal of the aortic valve. However, the longer the TAVR device, the more metal that remains within the body, which may cause additional complications and reactions including thrombus formation. To solve these technical issues pertaining to the TAVR procedure, the inventors developed modular transcatheter valve replacement devices”).
Since Eidenschink teaches that the lower portion of the replacement valve may be directly attached to the deployment/removal device and Al-Jilaihawi teaches that the portion that is directly attached to the deployment device may be removed from the rest of the replacement valve device, one of ordinary skill in the art would recognize that a modular replacement valve that can be removed from the subject would be advantageous in the art. Thus, it would have been recognized by one of ordinary skill in the art before the effective filing date of the claimed invention to modify the replacement valve of Artof to be modular as taught by Al-Jilaihawi such that the lower ring of the replacement valve comprising the cutting means can be removed from the anchoring structure of the replacement valve by way of the wires of the deployment device and thereby removed from the subject. This modification would be advantageous for the replacement valve device of Artof because it would minimize the metal and other foreign material in a patient's body that could cause thrombosis or other reactions, as taught by Al-Jilaihawi above, but also minimize the risk of injury by making the cutting means removable from the rest of the device.
Regarding claim 17, modified Artof discloses wherein lacerating the tissue comprises transecting a cardiac tissue of the subject (para. 0191 of Artof: “wherein each cutting element (621) of the cutting means is sized and configured, optionally with radiofrequency energy, as cutting means for cutting a native valve”).
Regarding claim 18, modified Artof discloses wherein an actuation arm (interpreted as one of the struts connected to the cutting element 621) of the medical device comprises the cutting instrument 621 (see annotated Fig. 53 above of Artof), and wherein removing the cutting instrument from the subject comprises at least one of decoupling the actuation arm from the medical device (The examiner notes that the actuation arm is one of a plurality of struts forming the lower ring 602 of the medical device which is modified to decouple from the medical device; see rejection of claim 16 above)
Regarding claim 19, modified Artof discloses wherein a leaflet of a cardiac valve of the subject is lacerated electrically or kinetically (para. 0191 of Artof: “wherein each cutting element (621) of the cutting means is sized and configured, optionally with radiofrequency energy, as cutting means for cutting a native valve. In one embodiment, sharp edge cutting means on the delivery apparatus is rotatable, enabling the cutting element (621) to cut through at least a portion of the native valve”).
Regarding claim 20, modified Artof discloses wherein the medical device is deployed via a catheter, and the cutting instrument is removed via the catheter (para. 0188 of Artof: “the valve anchoring structure is made from a radially collapsible and re-expandable cylindrical support means for folding and expanding together with the collapsible replacement valve for implantation in the body by means of catheterization or other minimally invasive procedure”).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Artof et al. (US 20060259137) [hereinafter Artof] in view of Al-Jilaihawi et al. (US 20160228241) [hereinafter Al-Jilaihawi], Eidenschink (US 20140249621) as applied to claim 1 above, and further in view of DiMatteo (US 6217600).
Regarding claim 10, modified Artof discloses all of the limitations set forth above in claim 1. However, modified Artof fails to disclose wherein the decoupling comprises applying a pulling force to release the cutting feature, wherein the replacement valve comprises a breakpoint configured to break when the pulling force is applied.
Al-Jilaihawi further teaches that it is known in the art to decouple portions of a replacement valve from one another by way of applying a pulling force to release a detachable portion 102 of the replacement valve (Figs. 2A-B, para. 0021: “the top module 101 includes retrieval cords 201 that may be connected to a guide wire, catheter or other structure that may be refracted, thereby removing the top module 101…Additionally, the device may contain detachable joint 203, that removably connects the top module 10 to the bottom module 103, and may be comprised of the various materials and devices disclosed herein”).
DiMatteo in the same field of endeavor of implantable devices teaches detachable connections can comprise a breakpoint 40 configured to break when a pulling force is applied (Fig. 2, col. 4 lines 34-35: “In the particular embodiment of FIG. 2 weakened portion 40 includes a plurality of divets 42”; Figs. 5-6, col. 6 lines 24-38: “Pulling force F may be applied and released repeatedly to induce fatigue cracking at weakened areas 40…After multiple applications of force F, the cross-sectional area of struts 24 at weakened areas 40 will be small enough that force F alone is sufficient to break struts 24 at weakened areas 40”).
Thus, one skilled in the art would have readily recognized that providing modified Artof with with frangible connections to decouple the cutting portion of the replacement valve with the rest of the device, as taught by DiMatteo, would provide the device with a known means for separation in the art and would yield predictable results, namely, a way for the cutting portion to break from the rest of the replacement valve to remove the cutting feature from the device (see quote from DiMatteo above).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Artof et al. (US 20060259137) [hereinafter Artof] in view of Al-Jilaihawi et al. (US 20160228241) [hereinafter Al-Jilaihawi], Eidenschink (US 20140249621) as applied to claim 1 above, and further in view of Asirvatham et al. (US 20160015410) [hereinafter Asirvatham].
Regarding claim 13, modified Artof discloses all of the limitations set forth above in claim 1. Modified Artof further discloses wherein cutting the cardiac tissue comprises radio frequency energy for lacerating the cardiac tissue (para. 0191: “wherein each cutting element (621) of the cutting means is sized and configured, optionally with radiofrequency energy, as cutting means for cutting a native valve”). However, modified Artof fails to disclose wherein cutting the cardiac tissue comprises cryogenically lacerating the cardiac tissue by cooling a portion of the replacement valve.
Asirvatham in the same field of endeavor of cutter configured for cutting a cardiac tissue (Fig. 1A, para. 0051: “In this manner, cutting device 134 can be in position to cut pericardium tent 24 created by grasping device”) teaches that cryogenically lacerating the cardiac tissue by cooling a portion of the cardiac tissue is a known alternative in the art to cutting with electrocautery devices (para. 0035: “In some embodiments, the devices provided herein are flexible catheter-based cutting devices (e.g., scissors, sheaths, knife, scapel, lasers, snares, cryogenic devices, and electrocautery devices)”).
The substitution of one known cutting energy (cryogenic energy as shown in Asirvatham) for another (radiofrequency energy as shown in modified Artof) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the cryogenic cutting energy shown in Asirvatham would have yielded predictable results, namely, an alternative way to cut the leaflet of the subject by way of cooling the tissue (see para. 0035 of Asirvatham above).
Claim(s) 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Artof et al. (US 20060259137) [hereinafter Artof] in view of Al-Jilaihawi et al. (US 20160228241) [hereinafter Al-Jilaihawi], Eidenschink (US 20140249621) as applied to claim 1 above, Morriss et al. (US 20150351903) [hereinafter Morriss].
Regarding claims 14 and 15, modified Artof discloses all of the limitations set forth above in claim 1. Modified Artof further disclose wherein replacement valve comprises: a stent body (interpreted as the anchoring structure; not labeled in Fig. 53; see anchoring structure 600 in Fig. 51 for example; para. 0191: “In one preferred embodiment, the anchoring structure comprises a set of sharp edge cutting elements”) comprising defining a lumen (see Fig. 53) and a prosthetic valve assembly coupled to the lumen (see Fig. 5, para. 0099 for example; para. 0193: “providing a collapsibly expandable valve assembly that comprises an anchoring structure according to the present invention with an annulus base and a collapsible valve connected to the anchoring structure”).
However, modified Artof fails to disclose a plurality of anchors extending from the stent body to anchor the stent body at the target cardiac tissue location.
Morriss in the same field of endeavor of prosthetic valve devices teaches that it is known in the art to provide a stent body 120 with a plurality of anchors 114 extending from the stent body 120 to anchor the stent body 120 at a target cardiac location (Figs. 10B-10C, para. 0115: “the retainer 110 can include a plurality of circumferentially positioned, resiliently deformable and flexible ribs 114 which are coupled at their downstream ends 116 to the valve support 120”; para. 0130: “the flexible ribs 114 can be configured to press radially outward against the native valve, ventricular and/or aortic structures so as to anchor the device 100 in a desired position”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the stent body in modified Artof to include the plurality of anchors, as taught by Morriss, in order to prevent upstream migration of the device after deployment and provide the device with additional axial stiffness to prevent longitudinal collapse of the device (para. 0130 of Morriss: “the flexible ribs 114 can have sufficient resilience and column strength (e.g., axial stiffness) to prevent longitudinal collapse of the retainer 110 and/or the device 100 and to resist movement of the device 100 in an upstream direction”).
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.
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Claims 1-4, 10-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, and 8-10 of U.S. Patent No. 12,329,637. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-4, 10-18 are under examination are anticipated, respectively, by claims 1, 2, 5, and 8-10 of the reference patent. Every limitation in the 19/239,415 application claims is recited in the conflicting 12,329,637 patent claims, and the differences between the claims are highlighted below by bolding all the limitations that differ and italicizing additional limitations (see table below).
Instant Application 19/239,415
U.S. Patent 12,329,637
A method, comprising:
[A] positioning a replacement valve at a target cardiac tissue location of a subject, the replacement valve comprising a cutting feature;
[B] cutting a cardiac tissue of the subject with the cutting feature; and
[C] removing the cutting feature from the subject, wherein removing the cutting feature comprises decoupling the cutting feature from the replacement valve.
1. A method, comprising:
[A] deploying a replacement valve through a cardiac valve of a subject, the replacement valve comprising:
a stent body comprising a first end and a second end and defining a lumen;
a prosthetic valve assembly coupled with an interior surface of the lumen;
a first set of anchors extending from the stent body to anchor the stent body to a target tissue location; and
at least one actuation arm extending from the stent body, the at least one actuation arm comprising a cutting feature to cut a portion of a heart;
[B] lacerating a leaflet of the cardiac valve of the subject with the cutting feature; and
[C] removing the cutting feature from the subject, wherein the removing the cutting feature comprises at least one of decoupling the actuation arm from the stent body or decoupling the cutting feature from the actuation arm.
2. The method of claim 1, wherein the replacement valve comprises an actuation arm, wherein the cutting feature is coupled to the actuation arm.
Encompassed in claim 1: “at least one actuation arm extending from the stent body, the at least one actuation arm comprising a cutting feature to cut a portion of a heart;”
3. The method of claim 2, wherein removing the cutting feature from the subject comprises decoupling the actuation arm from the replacement valve.
Encompassed in claim 1: “removing the cutting feature from the subject, wherein the removing the cutting feature comprises at least one of decoupling the actuation arm from the stent body or decoupling the cutting feature from the actuation arm.”
4. The method of claim 1, wherein the cardiac tissue is a leaflet of a cardiac valve of the subject, and wherein cutting the cardiac valve comprises lacerating the leaflet.
Encompassed in claim 1: “lacerating a leaflet of the cardiac valve of the subject with the cutting feature;”
10. The method of claim 1, wherein the decoupling comprises applying a pulling force to release the cutting feature, wherein the replacement valve comprises a breakpoint configured to break when the pulling force is applied.
10: The method of claim 1, wherein the decoupling comprises applying a pulling force to a first actuation arm of the at least one actuation arm to release the first actuation arm from the prosthetic valve assembly, wherein the first actuation arm comprises a score line configured to serve as a breakpoint for the first actuation arm.
11. The method of claim 1, wherein the cutting feature is an electrosurgical cutting feature, and wherein cutting the cardiac tissue comprises electrifying a portion of the replacement valve to activate the electrosurgical cutting feature.
8. The method of claim 1, wherein the cutting feature is an electrosurgical cutting feature, and wherein the leaflet is lacerated by activating a radio-frequency alternating current to electrosurgically cut the leaflet.
12. The method of claim 1, wherein the cutting feature comprises at least a first electrode to conduct a current to electrically cut the cardiac tissue, and wherein the replacement valve comprises a second electrode to form a circuit with the first electrode through a portion of the cardiac tissue.
2. The method of claim 1, wherein the cutting feature comprises at least a first electrode to conduct a current to electrically cut the leaflet of the cardiac valve of the subject, and wherein the at least one actuation arm comprises (i) a second electrode to form a circuit with the first electrode through a portion of tissue, and (ii) an insulator to electrically isolate the at least one actuation arm from the stent body.
13. The method of claim 1, wherein cutting the cardiac tissue comprises cryogenically lacerating the cardiac tissue by cooling a portion of the replacement valve.
9. The method of claim 1, wherein the leaflet is cryogenically lacerated by cooling the at least one actuation arm.
14. The method of claim 1, wherein replacement valve comprises:
a stent body comprising defining a lumen;
a prosthetic valve assembly coupled to the lumen; and
a plurality of anchors extending from the stent body to anchor the stent body at the target cardiac tissue location.
Encompassed in claim 1: “the replacement valve comprising:
a stent body comprising a first end and a second end and defining a lumen;
a prosthetic valve assembly coupled with an interior surface of the lumen;
a first set of anchors extending from the stent body to anchor the stent body to a target tissue location”
15. The method of claim 1, wherein the replacement valve comprises a plurality of anchors extending from a stent body of the replacement valve, to anchor the stent body at the target cardiac tissue location.
Encompassed in claim 1: “the replacement valve comprising…a first set of anchors extending from the stent body to anchor the stent body to a target tissue location”
A method, comprising:
[A] deploying a medical device at a target tissue location of a subject, the medical device comprising a cutting instrument;
[B] lacerating, with the cutting instrument of the medical device, a tissue of the subject; and
[C] removing the cutting instrument of the medical device from the subject.
1. A method, comprising:
[A] deploying a replacement valve through a cardiac valve of a subject, the replacement valve comprising:
a stent body comprising a first end and a second end and defining a lumen;
a prosthetic valve assembly coupled with an interior surface of the lumen;
a first set of anchors extending from the stent body to anchor the stent body to a target tissue location; and
at least one actuation arm extending from the stent body, the at least one actuation arm comprising a cutting feature to cut a portion of a heart;
[B] lacerating a leaflet of the cardiac valve of the subject with the cutting feature; and
[C] removing the cutting feature from the subject, wherein the removing the cutting feature comprises at least one of decoupling the actuation arm from the stent body or decoupling the cutting feature from the actuation arm.
17. The method of claim 16, wherein lacerating the tissue comprises transecting a cardiac tissue of the subject.
Encompassed in claim 1: “lacerating a leaflet of the cardiac valve of the subject with the cutting feature;”
18. The method of claim16, wherein an actuation arm of the medical device comprises the cutting instrument, and wherein removing the cutting instrument from the subject comprises at least one of decoupling the actuation arm from the medical device or decoupling the cutting instrument from the actuation arm.
Encompassed in claim 1: “at least one actuation arm extending from the stent body, the at least one actuation arm comprising a cutting feature to cut a portion of a heart… removing the cutting feature from the subject, wherein the removing the cutting feature comprises at least one of decoupling the actuation arm from the stent body or decoupling the cutting feature from the actuation arm.”
19. The method of claim 16, wherein a leaflet of a cardiac valve of the subject is lacerated electrically, kinetically, or cryogenically.
5. The method of claim 1, further comprising delivering at least one of electrical energy, radio-frequency energy, or cryogenic energy to the at least one actuation arm.
As shown in the mapping above, claims 1, 2, 5, and 8-10 of patent 12,329,637 includes all of the limitations of claims 1-4, 10-18 of the instant application, while also reciting further limitations.
Conclusion
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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