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 .
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any specific references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this 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 docking device comprising a frame having first and second sub-frames, one or more linking struts extending from a first end to a second end of the frame and coupling the first and second sub-frames, a first actuator having first and second members connected to the frame at first and second locations, respectively, axially spaced from one another, and a second actuator comprising a first member coupled to the first sub-frame at a location adjacent an inflow end portion of the first sub-frame and a second member coupled to the first sub-frame at a location adjacent an outflow end portion of the first sub-frame (claim 3), the docking device comprising a frame having first and second sub-frames, one or more linking struts extending from a first end to a second end of the frame and coupling the first and second sub-frames, and an actuator having first and second members connected to the frame at first and second locations, respectively, axially spaced from one another; and wherein the first and second sub-frames are radially expandable independently from one another. (claim 4), the docking device comprising a frame having first and second sub-frames, one or more linking struts extending from a first end to a second end of the frame and coupling the first and second sub-frames, and an actuator having a first member, coupled to a first location/junction on the first sub-frame comprising a first linking strut, and a second member, coupled to a second location/junction on the first sub-frame comprising a second linking strut, wherein the first and second members are axially spaced from one another (claim 7), the docking device comprising a frame having first and second sub-frames, one or more linking struts extending from a first end to a second end of the frame and coupling the first and second sub-frames, and an actuator having first and second members connected to the frame at first and second locations, respectively, axially spaced from one another, wherein the first member extends at least partially into the second member (claim 8), the docking device comprising a frame having first and second sub-frames, one or more linking struts extending from a first end to a second end of the frame and coupling the first and second sub-frames, and an actuator having first and second members connected to the frame at first and second locations, respectively, axially spaced from one another; and wherein first and second subsets of linking struts extend in a first and second direction, respectively, such that one or more struts of the first and second subsets overlap at one or more inflow apices of the first sub-frame (claim 13), the docking device comprising a frame having first and second sub-frames, one or more linking struts extending from a first end to a second end of the frame and coupling the first and second sub-frames, and an actuator having first and second members connected to the frame at first and second locations, respectively, axially spaced from one another; and a valvular structure disposed within and coupled to at least one of the first and second sub-frame (claim 14), the docking device comprising a frame having first and second sub-frames, one or more linking struts extending from a first end to a second end of the frame and coupling the first and second sub-frames, and an actuator having first and second members connected to the frame at first and second locations, respectively, axially spaced from one another; and a prosthetic valve disposed within the second sub-frame, the prosthetic valve comprising a radially expandable and compressible frame and a valvular structure disposed within and coupled to the frame (claim 15), the docking device comprising a frame having first and second sub-frames, one or more linking struts extending from a first end to a second end of the frame and coupling the first and second sub-frames, and an actuator having first and second members connected to the frame at first and second locations, respectively, axially spaced from one another; and a prosthetic valve disposed within the first sub-frame, the prosthetic valve comprising a radially expandable and compressible frame and a valvular structure disposed within and coupled to the frame (claim 16), the docking device comprising a frame having first and second sub-frames, one or more linking struts extending from a first end to a second end of the frame and coupling the first and second sub-frames, and an actuator having first and second members connected to the frame at first and second locations, respectively, axially spaced from one another; and a sealing member disposed on an outer surface of at least one of the first and second sub-frames (claim 17), the docking device comprising a frame having first and second sub-frames each comprising a plurality of pivotably coupled struts defining a single row of cells extending circumferentially around the frame, one or more linking struts extending from a first end to a second end of the frame and coupling the first and second sub-frames, and at least one expansion and locking mechanism comprising an outer member coupled to the second sub-frame at a first junction and an inner member coupled to the second sub-frame at a second junction axially spaced from the first junction; and a prosthetic valve disposed within at least one of the first sub-frame and the second sub-frame, the prosthetic valve comprising a radially expandable and compressible frame and a valvular structure disposed within and coupled to the frame (claim 22), and the docking device comprising a frame having first and second sub-frames each comprising a plurality of pivotably coupled struts defining a single row of cells extending circumferentially around the frame, one or more linking struts extending from a first end to a second end of the frame and coupling the first and second sub-frames, and at least one expansion and locking mechanism comprising an outer member coupled to the second sub-frame at a first junction and an inner member coupled to the second sub-frame at a second junction axially spaced from the first junction; and a sealing member disposed on an outer surface of at least one of the first or second sub-frames (claim 23) 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.
Examiner’s Notes
It is to be noted that the claimed invention is “A docking device”, and only the claimed structure of the invention, i.e. the docking device, bears patentable weight; structure of other devices/components, i.e. “a valvular structure”/“a prosthetic valve” does not hold patentable weight, and will only be considered to the extent that it/they further define(s) the structure of the claimed invention, i.e. the docking device.
It is further 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 § 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 11, 13-16 and 22 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 11, which depends from claim 1 which sets forth, in part, that the docking device comprises “an actuator”, and claim 11 further sets forth the parameter of “the docking device comprises three actuators disposed circumferentially around the frame”; however, this parameter is found to be confusing since it is not clear if the final structure of the docking device has three actuators total, or three actuators in addition to the first actuator set forth in claim 1, thereby having a total of four actuators. 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 13, which sets forth the parameter of first and second subsets of linking struts extending in a first and second direction, respectively, wherein “one or more struts of the first and second subsets overlap at one or more inflow apices of the first sub-frame”; however, this parameter is found to be confusing for a few reasons. Firstly, the location of the inflow apices of the first sub-frame is not clear due to discrepancies in the originally filed disclosure. Specifically, throughout the originally filed disclosure it is stated, and illustrated, that the first sub-frame is denoted by reference numeral “210”, the second sub-frame is denoted by reference numeral “212”, the inflow end of each sub-frames is denoted by reference numeral “204”, and paragraph [0062], of the originally filed specification of the current application at hand, denotes the inflow apices of the first sub-frame (210) by reference numeral “223”, while the inflow apices of the second sub-frame (212) are denoted by reference numeral “222”; however paragraph [0064], of the originally filed specification of the current application at hand, denotes the inflow apices of the first sub-frame (210) by reference numeral “222”. Additionally, paragraph [0064] is the only place, in the originally filed specification, where the above mentioned parameter is described, specifically stating “first and second sets 228a, 228b can overlap one another at selected inflow apices 222 of the first sub-frame 210” (emphasis added). Secondly, if the location of the inflow apices, of the first sub-frame 210, is taken to be at location “223” (which seems to be the most consistent with the originally field disclosure), it is unclear how, structurally, the first and second subsets of linking struts can overlap at the “inflow apices of the first sub-frame”, as set forth in the claim; and the originally filed disclosure does not aid in explaining, clarifying, or properly illustrating how exactly such a structure could occur. 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 claims 14-16 and 22, it is not clear what, if any, additional structural limitation(s) the parameters of these claims impart on the final structure of the claimed invention, i.e. the docking station; the parameters seem to merely be recited an intended use/function of the docking station to be used with other component(s), and include structural limitations directed towards the other component(s). However, there does not seem to be any additional structural limitations, directly or indirectly, set forth by the parameters of the claims to further limit the final structure of the claimed invention of a “docking device”. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claims indefinite.
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 1, 5, 6, 8, 9, 11, 12, 14, 17 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maimon et al. (US PG Pub. 2018/0153689), as disclosed in the IDS dated 07/19/2023, hereinafter Maimon.
Regarding claims 1, 5, 6, 9 and 18, Maimon discloses a docking device, illustrated in Figures 27-29C, comprising a radially expandable and compressible frame (604), illustrated in Figures 27 and 28, comprising a first sub-frame (S1) comprising a first plurality of struts pivotably coupled to one another, a second sub-frame (S2) comprising a second plurality of struts pivotably coupled to one another, wherein the first and second sub-frames (S1&S2) are spaced axially apart from one another, and one or more linking struts (LS) extending from a first end of the frame to a second end of the frame and coupling the first sub-frame (S1) and the second sub-frame (S2) to one another; and an actuator/locking member (800) comprising a first member (802/808/810) coupled to the frame at a first location/junction (J1) comprising a first linking strut (LS1) and a second member (812/814) coupled to the frame at a second location/junction (J2) comprising a second linking strut (LS2), wherein the second location/junction (J2) is axially spaced from the first location/junction (J1), wherein movement of the first member relative to the second member in a first direction causes simultaneous radial expansion of the first and second sub-frames, and the locking member is configured to lock the frame in an expanded configuration, illustrated in Figures 27-29C and modified figure 29C-1, below ([0233] – [0237] & [0239]).
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Regarding claims 1, 9, 12 and 18, Maimon discloses a docking device, illustrated in Figures 27-29C, comprising a radially expandable and compressible frame (604), illustrated in Figures 27 and 28, comprising a first sub-frame (S1) comprising a first plurality of struts pivotably coupled to one another, a second sub-frame (S2) comprising a second plurality of struts pivotably coupled to one another, wherein the first and second sub-frames (S1&S2) are spaced axially apart from one another and each sub-frame (S1&S2) comprises a single row of cells extending circumferentially around the frame, and one or more linking struts (LS) extending from a first end of the frame to a second end of the frame and coupling the first sub-frame (S1) and the second sub-frame (S2) to one another; and an actuator/locking member (800) comprising a first member (802/808/810) coupled to the frame at a first location (J1) and a second member (812/814) coupled to the frame at a second location (J2) axially spaced from the first location, wherein the locking member configured to lock the frame in an expanded configuration, illustrated in Figures 27-29C and modified figure 29C-2, below ([0233] – [0237] & [0239]).
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Regarding claim 8, Maimon discloses the docking device of claim 1, wherein the first member (802) extends at least partially into the second member (812), illustrated in Figures 28, 29B and 29C ([0236]).
Regarding claim 11, Maimon discloses the docking device of claim 1, wherein the docking device comprises three actuators (800) disposed circumferentially around the frame (604), illustrated in Figures 28 and 29C ([0233]).
Regarding claim 14, Maimon discloses the docking device of claim 1, further comprising a valvular structure disposed within and coupled to at least one of the first and second sub-frame ([0233], Lines 1-4 – to clarify, it is stated frame 604 is illustrated with the leaflets/soft tissue components removed; thus, teaching that the device/frame does/is capable of comprising a valvular structure).
Regarding claim 17, Maimon discloses the docking device of claim 1, further comprising a sealing member/skirt (266) disposed on an outer surface of at least one of the first and second sub-frames, example illustrated in Figure 7, the sealing member configured to expand radially to secure the docking device at a selected implantation site ([0135] & [0233], Lines 1-4 – to clarify, Figure 7 illustrates a frame with a sealing member/skirt, which frame 604 does/is capable of comprising, since it is stated that frame 604 is illustrated with the soft tissue components removed).
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 2, 3, 15, 16, 19 and 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over Maimon.
Regarding claim 2, Maimon discloses the docking device of claim 1, wherein the first member (802/808/810) is coupled to the frame at a location, and wherein the second member (812/814) is coupled to the second sub-frame (S2) at a location (622) adjacent an inflow end portion of the second sub-frame (S2), illustrated in Figures 28, 29C and modified figure 29C-2, above ([0235] & [0237]); and though it is not specifically disclosed that the first member is coupled adjacent an outflow end portion (J2) of the second sub-frame, it is stated that the connectors/inner & outer members “need not be connected to opposite ends of the frame” and that the connectors/inner & outer members can function properly being placed at any location as long as they are “connected to respective junctions on the frame that are axially spaced from each other” ([0238]). 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 determine an appropriate coupling location for the first member, including coupling adjacent an outflow end portion (J2) of the second sub-frame (S2), which is axially spaced from the coupling location (662) of the second member, example illustrated in modified figure 29C-2, above.
Regarding claim 3, Maimon discloses the docking device of claim 1, wherein the actuator is a first actuator (800) and wherein the docking device further comprises a second actuator (800-2) comprising a first member (802/808/810) coupled to the first sub-frame (S1) at a location (652) adjacent an inflow end portion of the first sub-frame, and a second member (812/814) coupled to the frame, illustrated in Figures 28, 29C and modified figure 29C-2, above ([0235] & [0237]); and though it is not specifically disclosed that the second member is coupled adjacent an outflow end portion (J2-2) of the first sub-frame, it is stated that the connectors/inner & outer members “need not be connected to opposite ends of the frame” and that the connectors/inner & outer members can function properly being placed at any location as long as they are “connected to respective junctions on the frame that are axially spaced from each other” ([0238]). 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 determine an appropriate coupling location for the second member, including coupling adjacent an outflow end portion (J2-2) of the first sub-frame (S1), which is axially spaced from the coupling location (652) of the first member, example illustrated in modified figure 29C-2, above.
Regarding claims 15 and 16, Maimon discloses the docking device of claim 1, and inasmuch as only the final structure of the claimed invention, i.e. a/the “docking device” bears patentable weight, Maimon discloses all the structural limitations of the final docking device as set forth in the claims, and the docking device has the capability, i.e. has the physical, structural ability, to comprise a prosthetic valve within the first/second sub-frame, wherein the prosthetic valve comprises a radially expandable/compressible frame and a valvular structure; thus, reading on the claims.
Regarding claims 19 and 24, Maimon discloses a docking device, illustrated in Figures 27-29C, comprising a radially expandable and compressible frame (604), illustrated in Figures 27 and 28, including first and second sub-frames (S1&S2) spaced axially apart from one another, each sub-frame (S1&S2) comprising a plurality of struts pivotably coupled to one another at a plurality of junctions defining a single row of cells extending circumferentially around the frame, wherein the plurality of struts comprises one or more linking struts (LS) extending from a first end of the frame to a second end of the frame and coupling the first and second sub-frames (S1&S2) to one another; and three expansion and locking mechanisms (800) each comprising an outer member (812/814) coupled to the second sub-frame (S2) at a first junction (662), an inner member (802/808/810) coupled to the frame a second junction axially spaced from the first junction, and a locking member (816) configured to retain the second sub-frame in an expanded configuration, illustrated in Figures 27-29C and modified figure 29C-2, above ([0233] – [0237] & [0239]); and though it is not specifically disclosed that the second junction is at the second sub-frame/the inner member is coupled, at the second junction, to the second sub-frame, it is stated that the connectors/inner & outer members “need not be connected to opposite ends of the frame” and that the connectors/inner & outer members can function properly being placed at any location as long as they are “connected to respective junctions on the frame that are axially spaced from each other” ([0238]). 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 determine appropriate junction locations, including the second junction (J2) being on/at the second sub-frame (S2) axially spaced from the first junction (662), example illustrated in modified figure 29C-2, above.
Regarding claim 22, Maimon discloses the docking device of claim 19, and inasmuch as only the final structure of the claimed invention, i.e. a/the “docking device” bears patentable weight, Maimon discloses all the structural limitations of the final docking device as set forth in the claims, and the docking device has the capability, i.e. has the physical, structural ability, to comprise a prosthetic valve within the first/second sub-frame, wherein the prosthetic valve comprises a radially expandable/compressible frame and a valvular structure; thus, reading on the claim.
Regarding claim 23, Maimon discloses the docking device of claim 19, further comprising a sealing member/skirt (266) disposed on an outer surface of at least one of the first and second sub-frames, example illustrated in Figure 7, the sealing member configured to expand radially to secure the docking device at a selected implantation site ([0135] & [0233], Lines 1-4 – to clarify, Figure 7 illustrates a frame with a sealing member/skirt, which frame 604 does/is capable of comprising, since it is stated that frame 604 is illustrated with the soft tissue components removed).
Regarding claim 25, Maimon discloses the docking device of claim 19, wherein a first subset of linking struts (LSS1) extends in a first direction and a second subset of linking struts (LSS2) extends in a second direction such that one or more struts of the first and second subsets (LSS1&LSS2) overlap at one or more outflow apices (IA) of the first sub-frame (S1), illustrated in Figures 28, 29C and modified figure 29C-2, above.
Allowable Subject Matter
Claims 4, 7, 10 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 02/21/2026