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 action is entered in response to Applicant's amendment and reply of 7/22/26. The claims 27-31, 33-45, and 48 are pending. The claim 27, 29, 31, 33, 34, 37, 38, 41, and 42 has been amended. Claim 48 is new.
Response to Arguments
Applicant’s response, filed 7/22/26 with respect to the rejections of claims 27-31, 33, 38-43, and 47 under 35 U.S.C. 102(a)(1) as being anticipated by Marchand (US2016/0331529) have been fully considered but are not persuasive.
Applicant argues with regard to claim 27, the interpretation of the cover 9 to correspond with the claimed fixation means. Applicant argues, the interpretation of the fixation means is not met by the cover 9, since there is no evidence the cover 9 is “connected with the inner stent and providing essentially for anchoring the prosthesis at the target site”. Examiner disagrees, Marchand states the cover 9 is connected, where cover 9 internally or externally covers inner wall 5 of anchoring device 1. Where the cover 9 lines the wall of the anchoring device 1 internally and therefore in order for proper function would be required to line the walls not merely just be internal to the anchoring device 1. An unconnected cover 9 would not allow for prevention of paravalvular leakage through the anchoring device 1 ([0145]).
Applicant argues, the cover 9 being made of fibers is not cited. Examiner disagrees, as clearly stated in paragraph [0202], the cover is a fabric and fabrics comprise fibers. Applicant further argues referring to fibers as “connecting arms” and “connecting arch” is unreasonably broad. Examiner disagrees, the claim language is broad and under broadest reasonable interpretation there is no reason why a fiber can’t be considered a connecting arch by having a curvature and being connected with the cover and a connecting arm by being a strand of fiber (arm) that is connected with the cover. Furthermore, the claim only requires a connecting arm or a connecting arch, where the individual fibers meet the claimed structure of both. "Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim. See MPEP 2111.01 (I).
Applicant argues Marchand fails to disclose “wherein the inflow area of the inner stent is directly connected to the outflow area of the outer stent by the at least one fixation means”. Examiner makes notice, the inflow area of the inner stent is directly connected to the outflow area of the outer stent by having the cover 9 external to the inner stent. Furthermore, the claim merely requires an area of the inner stent to be connected with an area of the outer stent. Where the inner stent 12 and the outer stent 1 are connected by interlacing or some other method ([0195]) and therefore there would be direct connection between the areas of the components. Where the at least one fixation means or cover 9 would connect of the assembly by being internal of the anchoring device 1 and external to the inner stent 9 and therefore by in between, assisting in connecting the components.
Applicant further argues, the heart valve support 12 and anchoring device 1 are mechanically coupled and not isolated as claimed. Examiner disagrees, the heart valve support 12 and anchoring device 1 are separated by the cover 9 that internally covers the anchoring device 1. Where the term “mechanically isolated” has been interpreted as the structures being separated and not directly touching. Where the claimed invention is disclosed by Marchand substantially, by having the heart valve support 12 and anchoring device 1 separated by the cover 9, where the cover 9 can totally cover the anchoring device 1 (see claim 26).
With regard to claim 28, Applicant argues, the interpretation of the strands of fabric to read on the quantities at the lower end (2, 3, etc.) is unreasonable. Examiner makes notice, the claim requires quantities are claimed optionally, with the higher end of the strands of fabric selected to read on the claim (36 or more).
Regarding claim 29, Applicant argues, connecting arms are interpreted as individual fibers of the mesh cover 9, but then in claim 29 the separate element of the anchoring loop is also interpreted as “any loop formed by fiber of the mesh 9”. Applicant states the interpretation is in error because two separately and distinctly claimed elements are said to correspond to the same element. Examiner disagrees, where a mesh is not made of a single fiber. Where individual fibers are interpreted as the claimed anchoring loop, which is separate from another individual fiber interpretated as connecting arms. Applicant further states the connecting arch is said to correspond to the groove 8, but the groove 8 is not a feature of cover 9. Examiner makes notice, the groove 8 would be on the cover 9 as well since the cover 9 lines the internal surface of the anchoring device 1. Furthermore, there would be fibers of the cover 9 at this groove 8 since the cover 9 can cover the entire internal surface of the anchoring device 1.
Applicant’s response, filed 7/22/26 with respect to the rejections of claims 34, 36, 37 under 35 U.S.C. 103 as being unpatentable over Marchand (US2016/0331529) have been fully considered but are not persuasive. Applicant argues with respect to claim 34, one having ordinary skill in the art would not rely on the teaching of interlacing different components- the outer wall and the flange 6 to teach interlacing the cover 9 and the anchoring device 1. Examiner disagrees, applying a known technique to a known device ready for improvement to yield predictable results would be within the scope of one of ordinary skill in art. MPEP 2143 (I)(D). Where Marchands cover 9 being interlaced to the anchoring device 1, would be taught by the technique of joining components by interlacing in Marchand ([0109]). Therefore, the rejection has been maintained.
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:
“fixation means” in claim 27 and 48. For examination purposes the “fixation means” is interpreted as “a component connected with the inner stent and providing essentially for anchoring the prosthesis at the target site” described in paragraph [0041] of the published application and its equivalents.
“connecting means” in claim 27 and 48. For examination purposes the “connecting means” is interpretated as “The connecting means can be by e.g. welding, gluing or any other known procedure or process or means” described in paragraph [0040] of the published application and its equivalents.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 48 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The last phrase of Claim 48 recites the limitation "wherein the atrial area and the ventricular area are separated by the annulus area". Previously in the claim the ventricular area and the atrial area are recited as optional features “an atrial or inflow area” and “a ventricular or outflow area.” It appears that the claim lacks proper antecedent basis for reciting the atrial area and the ventricular area, since they are previously recited as optional terms/ features.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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.
Claims 27-31, 33, and 38-43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marchand (US 2016/0331529).
Regarding claim 27, Marchand discloses a stent (entire device, where a “stent” is interpreted as any generally tubular structure with a passage for blood flow) comprising:
an inner stent (support 12), wherein the inner stent comprises an atrial or inflow area (area of support 12 near atrium of heart, see annotated Fig. 11, Examiner interprets “atrial area” broadly to mean any space near the atrium of the heart; Examiner interprets “inflow area” as an area at the end of the stent where blood flows into the device);
an outer stent (anchoring device 1), wherein the outer stent comprises a ventricular or outflow area (see annotated Fig. 11, Examiner interprets “outflow area” as an area at the end of the stent where blood flows out of the device); and
at least one fixation means (as interpreted under 112(f) the fixation means is “a component connected with the inner stent”; where fibers of the cover 9, which is made of a fabric to attach to tissue and is an equivalent structure by connecting with the inner stent, [0202]), wherein the at least one fixation means is connected with one or more connecting means (as interpreted under 112(f) the ”connecting means” is “e.g. welding, gluing or any other known procedure or process or means”; where the attachment/suture that connects the anchoring device 1 and support 12 is an equivalent structure, [0195]) from 2 to 36 connecting arms (each individual fiber of the mesh of cover 9 is interpreted as a connecting arm, [0202]) and a connecting arch (connecting arch is interpreted as the arch at the groove 8, see Fig. 7A, [0119]);
wherein the inner stent (12) and the at least one fixation means (fibers of cover 9) are connected to each other by the connecting means at the atrial or inflow area (the inner stent 12 and the fibers of cover 9 are connected to each other by the connecting means as described in paragraph [0195] at the inflow area, see annotated Fig. 11, the inflow area encompasses where the inner stent 12 is linked to the inner wall 5 of ventricular part 3 of anchoring device 1); and wherein the atrial or inflow area of the inner stent is directly connected to the ventricular or outflow area of the outer stent by the at least one fixation means (see annotated Fig. 11 where the direct connection occurs in the areas being directly adjacent, [0195]), thereby mechanically isolating the inner stent and the outer stent from each other (the inner stent 12 is mechanically isolated from the outer stent 1 by the cover 9 which may be on the external surface of inner stent 12, [0145], [0198]),
wherein the stent includes a groove in an annulus area (groove 8 at diameter D5 and Examiner interprets the area to include a length of 1-10 mm from both lengths of areas 2/3, see Fig. 2, see [0132]-[0139]); and
wherein the at least one fixation means provides a radial force in relation to anchoring the stent at a target site (fibers of the cover 9 would provide some radial force by expansion of the inner stent 12, which it is external of and outer stent 1 which it covers internally).
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Regarding claim 28, Marchand discloses the stent according to claim 27, wherein the inner stent is connected with 36 or more of the at least one fixation means (support is connected with all of the strands of fabric of cover 9, [0145]).
Regarding claim 29, Marchand discloses the stent according to claim 27, wherein:
the at least one fixation means comprises an anchoring loop (any loop formed by fiber of the mesh of 9, [0202]), the connecting arms, the connecting arch (defined by the fibers of the cover 8 at the arch at the groove 8), and an inner stent anchor (one of the fibers of cover 9 that attaches with a suture to connect support 12 to anchoring device 1, [0195]).
Regarding claim 30, Marchand discloses the stent according to claim 29, wherein the connecting means connects the inner stent anchor of the at least one fixation means with the inner stent (suture that connects support 12 to anchoring device 1 and therefore the cover 9, [0195]).
Regarding claim 31, Marchand discloses the stent according to claim 27, wherein the outer stent further comprises at least two loading loops (loops are interpreted as the loops of the wires forming the mesh of anchoring device 1, [0026]).
Regarding claim 33, Marchand discloses the stent according to claim 27, wherein the atrial area or inflow area has a diameter of 20 to 90 mm and a length of 2 to 30 mm, the annulus area has a diameter of 10 to 80 mm and a length of 2 to 20 mm, and the ventricular area or outflow area has a diameter of 20 to 90 mm and a length of 5 to 40 mm (see [0132]-[0139], where the atrial area encompasses a portion of D2, D5 and the diameter could be selected within the range claimed; where the ventricular area has not been selected as an option).
Regarding claim 38, Marchand discloses a replacement heart valve prosthesis the stent according to claim 27, wherein the inner stent comprise at least one seal (cover 14, [0198]) and a valve (valve 13) connected to the inner stent ([0179]).
Regarding claim 39, Marchand discloses a method for implanting the replacement heart valve prosthesis according to claim 38 comprising delivering the replacement heart valve prosthesis to a subject using a catheter based implantation and delivery system ([0142], [0150]).
Regarding claim 40, Marchand discloses the method according to claim 39, wherein the replacement heart valve prosthesis is delivered via trans-femoral, trans-atrial, trans-jugular, or trans-apical administration ([0150]).
Regarding claim 41, Marchand discloses a method for positioning the replacement heart valve prosthesis of claim 38, in a native tricuspid or mitral heart valve comprising:
delivering the prosthesis by a catheter based delivery system to a target site ([0205]), and releasing the prosthesis from the catheter based delivery system into a right or left heart chamber ([0152]), wherein the at least one fixation means comprises one or more anchoring loops, wherein the ventricular or outflow area of the stent including one or more anchoring loops is positioned in a ventricle (anchoring loops include loops of fibers of mesh 9 along the majority of the stent device and therefore would be positioned in a ventricle, [0198]; however the ventricular area has not been selected as an option), the annulus area is positioned in an area of an annulus ([0093]), and the atrial or inflow area of the stent is positioned in an atrium (where the atrial area is interpreted broadly to mean any space near the atrium of the heart encompasses the area that is within the atrium as described in paragraph [0093]).
Regarding claim 42, Marchand discloses the method according to claim 41, wherein the at least one fixation means are positioned with the one or more anchoring loops in the ventricular or outflow area ([0198], see Fig. 11, the ventricular area has not been selected as an option).
Regarding claim 43, Marchand discloses the stent according to claim 27, wherein the outer stent is composed of multiple parts (anchoring device 1 comprises a v shaped groove and optionally plurality of arms 16, [0169]; where Examiner makes notice “parts” doesn’t require the component to be separate, therefore “parts” is interpreted” as “sections” or “segments” of the component).
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 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 34, 36, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Marchand.
Regarding claim 34, Marchand discloses the stent according to claim 27, does not disclose wherein an area of the at least one fixation means is interwoven with the outer stent. Marchand teaches the fixation means or cover 9 may be the same material as the outer stent or anchoring device 1, which is a wire mesh ([0202]). Marchand further teaches interlacing two different components of the outer wall 4 with the flange 6 ([0109]). It would have been obvious to one having ordinary skill in the art to have the components be interwoven, as taught by Marchand, since interweaving different components is a known method of connection as taught by Marchand.
Regarding claim 36, Marchand discloses the stent according to claim 29; yet, does not explicitly disclose wherein the anchoring loop has a length of 3 to 20 mm. Marchand teaches the anchoring loop is a fiber of the mesh of 9 and fiber having some length ([0202]). However, Marchand does not explicitly disclose the length of the fiber. Marchand teaches the cover 14 that is essentially the same as cover 9 having some length that would encompass the fibers (length of cover is from 2 to 10 millimeters, [0198]). Thus, it would have been obvious to one of ordinary skill in the art to change the length of the fibers of the cover 9 to a length between 3 to 20 mm based on the desired length of the component. Therefore, the claimed limitation is considered at least obvious to one of ordinary skill in the art. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”).
Regarding claim 37, Marchand makes obvious the stent according to claim 36:
wherein the stent comprises at least one radial force wire (suture 10, [0146], the suture 10 is considered to be a radial force wire by being configured to be tied around the stent by passing through the mesh of the inner wall and applying a radial force), wherein the anchoring loop exhibits the angle equals 0 to 45 degrees (the anchoring loop is a fiber of the mesh of 9 and is curved and will exhibit this an angle in this range relative to some axis at some portion, [0202]). However, Marchand does not explicitly disclose wherein the stent further comprises 1 to 54 anchoring loops. Marchand discloses an anchoring loop (loop of at least one of the fibers of fabric, [0202]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the application to have modified the device of Marchand to comprise 1 to 54 anchor loops for the purpose of securing more of the tissue ([0202]), since it has been held that mere duplication of essential working parts of a device involve only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Further, Applicant has not disclosed that having 1 to 54 anchoring loops provides an advantage, solves any stated problem, or is used for any particular purpose and it appears that the device would perform equally well with either designs as stated in paragraph [0077] of the published application specification. Furthermore, absent a teaching as to criticality that having 1 to 54 anchoring loops provides a benefit, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Marchand in view of Faiyaz (US2015/0081000).
Regarding claim 35, Marchand discloses the stent according to claim 27, wherein the outer stent is braided ([0140]). However, Marchand is silent regarding the outer stent comprises from 1 to 108 wires. Faiyaz teaches a braided stent for an anatomical lumen such as a heart valve ([0003]). Faiyaz further teaches the number of wires of the braided stent is a result effective variable, selected based on the desired density of the braided structure ([0227]). Where Faiyaz lists ranges of picks per inch 10 to 80 which is the number of threads per inch of the braid ([0227]). Thus, it would have been obvious to one of ordinary skill in the art to change the number of wires of the outer stent (cover 9) of Marchland based on the desired density for the braided structure when implanted in anatomical lumen. As the it would have been obvious to modify the number of wires for the braid, the braided stent can be modified to have a certain number of wires longitudinally and circumferentially. Therefore, the claimed limitation is considered at least obvious to one of ordinary skill in the art. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”).
Claims 44 is rejected under 35 U.S.C. 103 as being unpatentable over Marchand in view of Peterson (US2018/0021129).
Regarding claim 44, Marchand discloses the stent according to claim 27, wherein the inner stent is a laser cut stent ([0196]) and the outer stent is a laser cut stent ([0140]); yet, does not disclose wherein the inner stent and the outer stent each comprise 6 to 48 cells circumferentially and 1 to 108 cells longitudinally. Peterson teaches a frame 300 for an implantable heart valve prosthesis 100 ([0180], [0182]). Peterson further teaches the frame is laser cut ([0245]) and the number of cells is a result effective variable ([0219]), selected based on the desired density amount of forshortening of the frame 300 ([0220]). Where Peterson lists ranges of cells, where any number of rows of cells can be used and any number of cells may be contained in the rows, and as an example lists three rows of cells with twelve cells in each row of cells ([0219]). Thus, it would have been obvious to one of ordinary skill in the art to change the number of circumferential and longitudinal cells of the outer stent and inner stent of Marchland based on the desired foreshortening when implanted in heart. As the it would have been obvious to modify the number of cells of the stent, the laser cut stent can be modified to have a certain number of cells longitudinally and circumferentially. Therefore, the claimed limitation is considered at least obvious to one of ordinary skill in the art. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”).
Claims 45 is rejected under 35 U.S.C. 103 as being unpatentable over Marchand in view of Peterson (US2018/0021129) and Faiyaz (US2015/0081000).
Regarding claim 45, Marchand discloses the stent according to claim 27, wherein:
the inner stent is a laser cut stent ([0196]) and the outer stent is a braided stent ([0140]); yet is silent regarding the inner stent comprises 6 to 48 cells circumferentially and 1 to 108 cells longitudinally, and the outer stent comprises 6 to 72 wires circumferentially and 1 to 180 wires longitudinally.
Peterson teaches a frame 300 for an implantable heart valve prosthesis 100 ([0180], [0182]). Peterson further teaches the frame is laser cut ([0245]) and the number of cells is a result effective variable ([0219]), selected based on the desired density amount of forshortening of the frame 300 ([0220]). Where Peterson lists ranges of cells, where any number of rows of cells can be used and any number of cells may be contained in the rows, and as an example lists three rows of cells with twelve cells in each row of cells ([0219]). Thus, it would have been obvious to one of ordinary skill in the art to change the number of circumferential and longitudinal cells of the inner stent of Marchland based on the desired foreshortening when implanted in heart. As the it would have been obvious to modify the number of cells of the stent, the laser cut stent can be modified to have a certain number of cells longitudinally and circumferentially. Therefore, the claimed limitation is considered at least obvious to one of ordinary skill in the art. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”).
Faiyaz teaches a braided stent for an anatomical lumen such as a heart valve ([0003]). Faiyaz further teaches the number of wires of the braided stent is a result effective variable, selected based on the desired density of the braided structure ([0227]), where Faiyaz lists ranges of picks per inch 10 to 80 which is the number of threads per inch of the braid ([0227]). Thus, it would have been obvious to one of ordinary skill in the art to change the number of wires of the outer stent of Marchland based on the desired density for the braided structure when implanted in anatomical lumen. As the it would have been obvious to modify the number of wires for the braid, the braided stent can be modified to have a certain number of wires longitudinally and circumferentially. Therefore, the claimed limitation is considered at least obvious to one of ordinary skill in the art. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”).
Claims 48 is rejected under 35 U.S.C. 103 as being unpatentable over Marchand in view of Noe (US2018/0206983).
Claim 48, Marchand discloses a stent comprising:
an inner stent (support 12), wherein the inner stent comprises an atrial or inflow area (area of support 12 near atrium of heart, see annotated Fig. 11, Examiner interprets “atrial area” broadly to mean any space near the atrium of the heart; Examiner interprets “inflow area” as an area at the end of the stent where blood flows into the device);
an outer stent (outer wall 4 of anchoring device 1, [0096]), wherein the outer stent comprises a ventricular or outflow area (see annotated Fig. 11, Examiner interprets “outflow area” as an area at the end of the stent where blood flows out of the device); and
at least one fixation means (as interpreted under 112(f) the fixation means is “a component connected with the inner stent”; the fibers of the cover 9, which is made of a fabric to attach to tissue and is an equivalent structure by connecting with the inner stent, [0202]; alternatively the fixation means includes struts that from the inner wall 5 anchoring loop 6 of the anchoring device 1 in combination with the fibers of the cover 9), wherein the at least one fixation means is connected with one or more connecting means (as interpreted under 112(f) the ”connecting means” is “e.g. welding, gluing or any other known procedure or process or means”; where the attachment/suture that connects the anchoring device 1 and support 12 is an equivalent structure, [0195]), wherein the at least one fixation means comprises an anchoring loop (loop around the inner wall 5 flange 6 , [0103]), from 2 to 36 connecting arms (each individual fiber of the mesh of cover 9 is interpreted as a connecting arm, [0202]; alternatively, fibers of the cover 9 and/or braided strand segments of inner wall 5), a connecting arch (connecting arch is interpreted as the arch at the groove 8, see Fig. 7A, [0119]; alternatively the connecting arch is the arms 16 that extend from an inner wall 5, [0123]),
wherein the inner stent and the at least one fixation means are connected to each other by the connecting means at the atrial or inflow area (the inner stent 12 and the fibers of cover 9 and/or inner wall 5 of anchoring device 1 are connected to each other by the connecting means as described in paragraph [0195] at the inflow area, see annotated Fig. 11, the inflow area encompasses where the inner stent 12 is linked to the inner wall 5 of ventricular part 3 of anchoring device 1); and
wherein the atrial or inflow area of the inner stent is directly connected to the ventricular or outflow area of the outer stent by the at least one fixation means (see annotated Fig. 11 where the direct connection occurs in the areas being directly adjacent, [0195]), thereby mechanically isolating the inner stent and the outer stent from each other (the inner stent 12 is mechanically isolated from the outer stent 1 by the cover 9 which may be on the external surface of inner stent 12, [0145], [0198]),
wherein the stent includes a groove (8) in an annulus area (annulus area is interpreted as the area between the atrial area and the ventricular area, see Fig. 2), wherein the atrial area and the ventricular area are separated by the annulus area.
Marchand does not explicitly disclose the at least one fixation means comprises an inner stent anchor. Noe teaches a valve carrying inner frame positioning radially inside an anchoring outer frame and attached to it at the atrial end ([0075], [0095]). The attachment is made at a plurality of discrete locations at atrial tips (interpreted as part of the connecting arms) connected by rivets (interpreted as the inner stent anchor) (strut frame 105 and anchor assembly 101 coupled together with rivets, [0079]). Where the rivets would also be interpreted as “a component connected with the inner stent” to meet the 112(f) interpretation.
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 Marchands attachment of support 12 to inner wall 5 to include plurality of rivets, as taught by Noe, in order to keep the cross-sectional shape of the prosthetic heart valve support 12 stable and the prosthetic heart valve competent when the anchoring device 1 is deformed ([0163] of Noe). Noe teaches attaching the valve frame at its atrial end at discrete points, accomplishes isolation and reduces torque on valve frame ([0166], [0169]).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/MIKAIL A MANNAN/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
