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 .
Status of Claims
This office action is responsive to the amendment filed on 11/17/2022. As directed by the amendment: claims 1-17 have been cancelled and new claims 18-38 have been added. Thus, claims 18-38 are presently pending in this application, and examined in the current Office Action.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the backbone element being covered by a sheath (claim 28), and a spring means arranged between segments arranged in the distal end section of the backbone element, to resiliently press segments of the backbone element against the distal region of the native leaflet (claim 30) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18-38 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 18, which sets forth the limitations of “one of replace and support”, on line 4, “at least one of the first and second native leaflets”, on lines 4-5, and “one of the annulus and the at least one of the first and second native leaflets”, on lines 6-7; these limitations are found to be indefinite since it is not clear if only one of the options in each limitation needs to be met or both. For example the limitation of line 4 does the artificial leaflet need to replace or support, or does it need to replace and support; the limitation on lines 6-7, is the implant to be fixed to the annulus and the first native leaflets and second native leaflet, or is it to be fixed to the annulus and the first native leaflets or second native leaflet, or fixed to the annulus or the first native leaflets and second native leaflet, or fixed to the annulus or the first native leaflets or second native leaflet. For the purpose of examination, as can be gleaned from the originally filed disclosure, the above mentioned limitations shall be interpreted as the word “and” meaning or; similar and appropriate amendment to the limitations to clarify is suggested. Furthermore, line 9 sets forth “the retention means one of comprise and consist of a backbone element” (emphasis added), in addition to the confusion created by using the term “one of” and then using “and” between the options (same issue set forth above, i.e. is the intention to have it “comprise and consist”, or “comprise or consist”), the terms “comprise” and “consist” and two very different and distinct means in claim language (the term “comprising” is an inclusive or open-ended term, and does not exclude additional/unrecited elements, while the term “consisting” is closed to unrecited elements) and thereby further made the limitation set forth on line 9 indefinite since it is not clear what the meets an bounds of the limitation actually are. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 21, which recites the limitation “the proximal end”, on line 2; there is insufficient antecedent basis for this limitation in the claim. In order to overcome this rejection, it is suggested the word “the” be deleted and replaced with the word “a”.
Regarding claim 22, which depends from claim 21, and sets forth the parameter of “the resting element comprises a support element aligned with the backbone element and configured to rest against the wall of the atrium adjacent the valve”; however, it is not clear what, if any, additional structural limitation(s) this claim imparts on the final structure of the inventive device. Instead, claim 22 just merely seems to be recited the same limitation/structure, just in different words, as set forth in claim 21, but does not include any new or additional structural features/limitations to the final device.
Regarding claim 23, which sets forth the parameter of “the artificial leaflet comprises one of a mesh, a flexible net, a plurality of flexible wires, a plurality of yarns, a fabric, and a sheet” (emphasis added); however, this parameter is found to be confusing since it is not clear if all the options/limitations must be included to meet the claim, based on the use of the word “and”, or only one would be needed to meet the claim, based on the use of the words “one of”. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 24, which sets forth the parameter of “the sheet comprises one of a PTFE sheet and a PTFE matrix” (emphasis added); however, this parameter is found to be confusing since it is not clear if both the options must be included to meet the claim, based on the use of the word “and”, or only one would be needed to meet the claim, based on the use of the words “one of”. Additionally, it is not clear what exactly, structurally, the difference is between “a PTFE sheet” and “a PTFE matrix”, if both are considered “a sheet” as set forth on line 2 of the claim, i.e. “the artificial leaflet comprises the sheet”. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 27, which recites the limitation “the side”, on lines 1 and 2; there is insufficient antecedent basis for this limitation in the claim. In order to overcome this issue, it is suggested the above mentioned limitation be amended by deleting the word “the”, on both lines 1 and 2, and replaced it with the word “a”. Furthermore, the claim sets forth the parameter of one side of the artificial leaflet “has an anticoagulant surface”; however, this parameter is found to be confusing since it is not clear what exactly, structurally, is meant by the leaflet have “an anticoagulant surface”. Does this mean that side of the leaflet is coated/imbedded with an anticoagulant drug and/or therapeutic, or does it have to do with the physical structure/texture of that side, or of a specific material used to make the leaflet/that side of the leaflet, or does it mean something else completely different. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 29, which sets forth the parameter of the u-bend clamping “a distal region of one of the first and second native leaflets” (emphasis added); however, this parameter is found to be confusing since it is not clear if both the options must be included to meet the claim, based on the use of the word “and”, or only one would be needed to meet the claim, based on the use of the words “one of”. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 30, which sets forth the parameter of “spring means are arranged between segments arranged in the distal end section of the backbone element”; however, this parameter is found to the confusing since it is not clear what exactly, structurally, is mean by the limitation of “spring means” and/or how exactly these “spring means” are mean to be placed/arranged in the distal end second of the backbone element. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 31, which recites the limitation “the proximal end region”, on line 2; there is insufficient antecedent basis for this limitation in the claim. In order to overcome this issue, it is suggested the word “the” be deleted and replaced with the word “a”. Furthermore, lines 3-4 set forth the parameter of the needle unit being configured to penetrate “one of the annulus and at least one of the first and second native leaflets” (emphasis added); however, this parameter is found to be confusing since it is not clear which options/limitations must be included to meet the claim based on the use of the words “one of” as well as “and” (same as detailed above in the rejection of claim 18 lines 6-7). Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 33, which recites the limitation “the needle unit”, twice on line 2; there is insufficient antecedent basis for this limitation in the claim. In order to overcome this rejection, and keep claim terminology consistent, it is suggested the word “central” be added between the words “the” and “needle” both times the limitation appears on line 2.
Regarding claim 37, which recites the limitation “the anchor units”, on line 5; there is insufficient antecedent basis for this limitation in the claim. In order to overcome this rejection, and keep claim terminology consistent, it is suggested the words “first and second” be added between the words “the” and “anchor” on line 2. Furthermore, the phrase “such as”, on line 3, renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention (see MPEP § 2173.05(d)).
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 limitations are: “fixing means”, “retention means” and “limiting means” in claim 18; “spring means”, in claim 30; and “anchor means”, in claim 37.
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.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 18-23, 25, 28 and 31-36 are rejected under 35 U.S.C. 103 as being unpatentable over Kuck et al. (WO 2018/142217), as disclosed in the IDS dated 11/17/2022, hereinafter Kuck.
Regarding claims 18-20, Kuck discloses an implant (2200/3100), illustrated in Figures 22 and 31A-31D, comprising an artificial leaflet (2202), configured to replace/support at least one native leaflet; fixing means (2238/1400) for fixing the implant to an annulus/native leaflet; and retention means, for preventing prolapse of the artificial leaflet, comprising a backbone element (3110) extending along the artificial leaflet and towards a distal end of the artificial leaflet and being connected to the artificial leaflet; wherein the backbone element (3110) is configured to be bendable between a first state of bending and a second state of bending, and comprises a plurality of segments (3120), pivotably connected to each other; and limiting means (LM) comprising an abutment element on each segment (3120) for limiting the pivoting angle of one segment relative to an adjacent segment for limiting the degree of bending, illustrated in Figures 22, 31A-31D an modified figure 31C, below ([085] & [093]); and though it does not specifically state the backbone element/flexural stiffener is connected to the artificial leaflet at at-least two attachment points, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate way/location(s) to connect/attach the backbone element/flexural stiffener to the artificial leaflet, including in at-least two attachment points; and it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to, the parameter of the backbone element being connected to the artificial leaflet at at-least two attachment points, as opposed to having any other kind of connection type/number of locations.
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Regarding claims 21 and 22, Kuck discloses the implant according to claim 18, wherein the implant comprises a resting element/strap (2211/RE) comprising a support element, aligned with, and fixed to the proximal end of the backbone element, and configured to rest against the wall of the atrium adjacent the valve, illustrated in Figure 22, 31A, 31B and modified figure 31A, below.
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Regarding claim 23, Kuck discloses the implant according to claim 18, wherein the artificial leaflet/device body (2202) comprises a sheet, illustrated in Figure 22 ([008]).
Regarding claim 25, Kuck discloses the implant according to claim 18, wherein the artificial leaflet/device body (2202) comprises a wire frame (2230) extending along a periphery of the artificial leaflet/device body (2202), illustrated in Figure 22 ([085], Lines 1-2).
Regarding claim 28, Kuck discloses the implant according to claim 18, wherein it is taught that it is known for a biasing material to cover a backbone/stiffening element ([089], Line 5); therefore, it would have been obvious and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to cover the backbone element (3110) with a sheath/biasing material, in order to protect the structure of the backbone element.
Regarding claims 31 and 32, Kuck discloses the implant according to claim 18, wherein: the fixing means (2238/1400) are arranged in the proximal end region of the artificial leaflet (2202) and aligned with the backbone element (3110), illustrated in Figures 22 and 31A; the fixing means (1400) comprise a central needle unit (1419), configured to penetrate the annulus/native leaflet (1721), and a stabilization platform (SP) having an abutment surface (at portion 1417) for abutting the annulus/native leaflet (1721); the central needle unit (1419) and the stabilization platform (SP) are movably arranged in a housing (1420) in an axial direction of the needle (1419), illustrated in Figures 17A, 17B and modified figure 17A, below ([079]).
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Regarding claim 33, Kuck discloses the implant according to claim 31, wherein the fixing means comprise first means (1418) acting on the needle unit (1419) to displace it relative to the housing (1420) and second means (1416) acting on the stabilization platform (SP) to displace it relative to the housing (1420), illustrated in Figures 17A, 17B and modified figure 17A, above ([079]); and though it is not specifically disclosed that the first and second means are “spring” means, this parameter is deemed to be a mere matter of normal design choice not involving a novel, inventive step. It would have been obvious and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine appropriate means/mechanism for displacing the needle unit and the stabilization platform, including modifying the mechanical push force means, as disclosed by Kuck, with a spring means, since both art equivalent means/mechanisms for displacing components of an anchoring/fixing means. Furthermore, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the means/mechanism for displacing the needle unit and the stabilization platform be a spring means, as opposed to any other means of displacement known in the art.
Regarding claim 34, Kuck discloses the implant according to claim 33, and though it is not directly disclosed that the fixing means comprises first and second releasable locking means to hold the central needle unit and the stabilization platform, respectively, in a spring-loaded position, this parameter is indirectly taught since a pushing force is required to move/displace the central needle unit and the stabilization platform ([079]); therefore, would have been obvious to one having ordinary skill in the art before the effective filing date of the invention that the fixing means, of the implant of Kuck, comprises first and second releasable locking means to hold the central needle unit and the stabilization platform, respectively, in an initial/spring-loaded position, since a push force is required to overcome the first and second releasable locking means, holding the central needle unit and the stabilization platform in the initial/spring-loaded position, to achieve a deployed/final position of the central needle unit and the stabilization platform.
Regarding claim 35, Kuck discloses the implant according to claim 31, wherein the central needle unit (1419) comprises anchoring elements (portion 1417) on its distal end; and the anchoring elements (1417) are movable relative to the central needle unit (1419) between a first position in which the anchoring elements (1417) are positioned against a needle shaft (1419), illustrated in Figure 17A, and a second position in which the anchoring elements (1417) are tilted away from the needle shaft (1419), illustrated in Figure 17B.
Regarding claim 36, Kuck discloses the implant according to claim 21, wherein the artificial leaflet/device body (2202/2502) and the resting element/strap (2211/2511) are deployable from a first position, in which the artificial leaflet and the resting element are folded for being arranged within a tubular housing/catheter (2513) of a delivery device, illustrated in Figure 25 ([088]), and into a second position, in which the artificial leaflet/device body (2202) and the resting element/strap (2211) are deployed, illustrated in Figure 22.
Claims 24, 26, 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Kuck as applied to claims 18, 23 and 25 above, and in view of Khairkhahan et al. (US PG Pub. 2015/0366666), hereinafter Khairkhahan.
Regarding claim 24, Kuck discloses the implant according to claim 23, wherein the artificial leaflet/device body (2202) comprises the sheet, illustrated in Figure 22 ([008]); but does not specifically disclose the sheet comprises PTFE, but does state the artificial leaflet/device body can be an artificial/synthetic material ([008] & [011], Line 1).
However, Khairkhahan teaches an implant (500), in the same field of endeavor, comprising an artificial leaflet/coaptation assistance body (515) which comprises PTFE, illustrated in Figure 5A ([0110], Lines 1-4).
In view of the teachings of Khairkhahan, it would have been obvious and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate material, for the sheet of the artificial leaflet of the implant of Kuck, including PTFE, as taught by Khairkhahan; since this is a known material used for implants in the field of endeavor, and it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (see MPEP 2144.07).
Regarding claim 26, Kuck discloses the implant according to claim 25, but does not specifically teach the wire frame being connected to at least two ribs extending perpendicularly from the backbone element.
However, Khairkhahan teaches an implant (500), in the same field of endeavor, comprising ribs/support structures (505/505.2) which extend horizontally across an artificial leaflet/coaptation assistance body (515) entirely between the lateral edges, illustrated in Figure 5A; the ribs/support structures act as a spine to aid in supporting the artificial leaflet/coaptation assistance body ([0094] & [0098], Lines 1-5).
In view of the teachings of Khairkhahan, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the implant of Kuck to further comprise at least two ribs, connected to the wire frame and extending perpendicularly from the backbone element, acting as spines to aid in supporting the artificial leaflet, as taught by Khairkhahan.
Regarding claim 29, Kuck discloses the implant according to claim 18, but does not disclose a distal end section of the backbone element comprising a u-bend configured to clamp the native leaflet between segments of the backbone element.
However, Khairkhahan teaches an implant (500), in the same field of endeavor, comprising a distal end section (525) having a u-bend configured to clamp a native leaflet (14), thereby keeping the implant in position, illustrated in Figure 5G ([0103] & [0104]).
In view of the teachings of Khairkhahan, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for a distal end section of the backbone element, of the implant of Kuck, to comprise a u-bend configured to clamp the native leaflet between segments of the backbone element, in order to provide an additional means of securing the implant/keeping the implant in position, as taught by Khairkhahan.
Regarding claim 30, Kuck in view of Khairkhahan disclose the implant according to claim 29, and though Khairkhahan does not specifically disclose spring means are arranged between segments of the distal end section of the backbone element, to resiliently press segments of the backbone element against the native leaflet; Khairkhahan does disclose the u-bend distal end section (525) can comprise shape memory material, which is known to have a spring-like effect/means, to clamp and retain the native leaflet and keep the implant in position ([0104], Last 6 Lines). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the u-bend distal end section of the backbone element, of the implant of Kuck in view of Khairkhahan, such that it has spring means are arranged between segments of the distal end section of the backbone element, as opposed to being made entirely of a spring means, since the backbone element of Kuck in view of Khairkhahan comprises a plurality of segments; the spring means allowing the u-bend distal end section to clamp and retain the native leaflet and keep the implant in position, as taught by Khairkhahan.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Kuck as applied to claim 18 above, and in view of Khairkhahan et al. (US PG Pub. 2019/0076249), hereinafter Khairkhahan’249.
Regarding claim 27, Kuck discloses the implant according to claim 18, but does not specifically disclose the side of the artificial leaflet which faces towards the atrium has an anticoagulant surface and the side of the artificial leaflet which faces towards the native leaflet, has a porous surface.
However, Khairkhahan’249 teaches an implant (500), in the same field of endeavor, comprising an artificial leaflet/body covering (550) which is made of/comprises ePTFE and has a coating of heparin, to inhibit thrombosis, illustrated in Figure 5A ([0149], Lines 1-2 & 7th to Last Line).
In view of the teachings of Khairkhahan’249, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the artificial leaflet, of the implant of Kuck, to be made of ePTFE, which is known to be a porous material and would result the surface that faces the native leaflets to be porous, in order to enhance attachment by tissue ingrowth; and for the surface, of the artificial leaflet, which faces the atrium to be coated with an anticoagulant, i.e. heparin, in order to inhibit thrombosis, as taught by Khairkhahan’249.
Claims 37 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Kuck as applied to claim 18 above, and in view of Gross et al. (US Patent No. 9,192,472), hereinafter Gross.
Regarding claims 37 and 38, Kuck discloses the implant according to claim 18, wherein the implant/leaflet assist or repair device can further be used with/comprise an annuloplasty device (APR), illustrated in Figure 30 ([091]); but does not disclose the specific parameters set forth in the claims regarding the annuloplasty device.
However, Gross teaches an annuloplasty device (100), illustrated in Figure 1, comprising more than two anchor units (461), deployable by a vascular delivery device/catheter and positionable in a row along the annulus, comprising anchor means (740) arranged on each of the first and second anchor units, whereby the anchor units are arranged to be movable towards one another, so that the anchor means engage with the annulus thereby pulling the annulus together when the first and second anchor units are moved, illustrated in Figure 1 (Column 20, Lines 9-32; Column 21, Lines 37-38 & Column 24, Lines 1-11).
In view of the teachings of Gross, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the annuloplasty device, of the implant of Kuck, to comprise more than two anchor units comprising anchor means arranged on each of the anchor units, whereby the anchor units are arranged to be movable towards one another, so that the anchor means engage with the annulus thereby pulling the annulus together when the first and second anchor units are moved, as taught by Gross, since these are well-known attachment and adjusting mechanisms of an annuloplasty device, in order to attach to and adjust a malformed heart annulus.
Conclusion
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/DINAH BARIA/Primary Examiner, Art Unit 3774