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
Claims 1-16 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Oct. 28, 2024 is in compliance with the
provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the
examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 13 is objected to because of the following informalities: “implantable the anastomotic” should be changed to --the implantable anastomotic--; and a comma should be added for clarity: --apical cuff, and deploy-- in line 9. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
"retention features configured to…" in claim 6;
"connector alignment module configured to…" in claim 13;
"implantation tool configured to…" in claim 13; and
"assembly tool configured to…" in claim 14.
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. For "retention features", in ¶[077] the specification discloses a “T-shape” or a flat head, and any equivalents thereof. For "connector alignment module", in ¶[086] the specification discloses a device as shown and described with reference to Fig. 8, and any equivalents thereof. For "implantation tool", the specification discloses the device in ¶[089]-[091] and depicted in Fig.'s 10A-10B, and any equivalents thereof. For "assembly tool", the specification does not disclose sufficient structural information and assembly tool is only mentioned in ¶[016].
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 14 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The recitation of "assembly tool" in claim 14 invokes 112(f) however fails to provide enough information in the specification for one skilled in the art to determine the structure necessary for the assembly tool.
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 5, 10-11, and 15-16 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.
The term “superelastic” in claim 5 is a relative term which renders the claim indefinite. The term “superelastic” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purposes of examination, "superelastic" will be interpreted as any material with elastic properties or a shape memory material, such as nitinol, beta titanium, or other medical grade material with superelastic and/or shape memory properties (¶[073]).
Claims 10-11 and 16 recite the limitation "the plurality of outer plates" in the first line. There is insufficient antecedent basis for this limitation in the claim. For examination, “the plurality of outer plates” will be interpreted as “the plurality of plates”.
Claim 15 recites the limitation "the connection interface" in the first line. There is insufficient antecedent basis for this limitation in the claim. For examination, “the connection interface” will be interpreted as “a connection interface”.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,070,216 (hereinafter referred to as “‘216”). Although the claims at issue are not identical, they are not patentably distinct from each other. Below is a reproduction of instant claim 1 (left) and Patent ‘216 (right).
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Patent ‘216 claim 1 differs from instant claim 1 indicated by the limitation indicated by the box above. The instant claims are fully encompassed by the subject matter of ‘216. Therefore, Patent ‘216 claim 1 is a “species” of the generic instant claim 1. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Independent claim 13 in the instant application and Patent ‘216 claim 13 differ in the same way as claim 1.
The specific claim correspondences are as follows:
Instant application [Wingdings font/0xE0] US Patent No. 12,070,216
Claim 1 [Wingdings font/0xE0] Claim 1
Claim 2 [Wingdings font/0xE0] Claim 2
Claim 3 [Wingdings font/0xE0] Claim 3
Claim 4 [Wingdings font/0xE0] Claim 4
Claim 5 [Wingdings font/0xE0] Claim 5
Claim 6 [Wingdings font/0xE0] Claim 6
Claim 7 [Wingdings font/0xE0] Claim 7
Claim 8 [Wingdings font/0xE0] Claim 8
Claim 9 [Wingdings font/0xE0] Claim 9
Claim 10 [Wingdings font/0xE0] Claim 10
Claim 11 [Wingdings font/0xE0] Claim 11
Claim 12 [Wingdings font/0xE0] Claim 12
Claim 13 [Wingdings font/0xE0] Claim 13
Claim 14 [Wingdings font/0xE0] Claim 14
Claim 15 [Wingdings font/0xE0] Claim 15
Claim 16 [Wingdings font/0xE0] Claim 16
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 11-13, and 15-16 are rejected under 102(a)(1) as being anticipated by Hoarau et al. (US 20130282026 A1, published Oct. 24, 2013, hereinafter referred to as "Hoarau").
Regarding claim 1, Hoarau teaches an implantable anastomotic assembly that is configured to be attached to cardiovascular tissue (Fig.'s 1-2 "Attachment ring 30 is a type of anastomotic prosthesis suitable for implantation within a human or animal body. Attachment ring 30 is a coupling for a conduit, graft, or other structure that is to be connected to a hollow anatomical organ." ¶[0043] and ""anastomosis" refers to the interconnection of two hollow structures, any of which can be an artificial tubular conduit, a blood vessel, a heart, or other hollow anatomical organ. For example and without limitation, anastomosis can be performed to connect an inflow conduit of a ventricular assist device (VAD) to the ventricular apex of the heart." ¶[0040]), the implantable anastomotic assembly comprising: an apical cuff (Fig.'s 1-2 "attachment ring 30" ¶[0043]); and at least one of a plurality of plates (Fig.'s 2-8, 10, & 14 "contact members 702" ¶[0048]) operably coupled to the apical cuff and configured to be attached to the cardiovascular tissue and compress the cardiovascular tissue with the apical cuff (Fig.'s 3-8 "configured to conform to curvature at the surface of biological tissue. Each contact member 702 is attached by flexible joint 708 to coupling member 706 to accommodate tissue surface curvature." ¶[0048] and "FIG. 1 is a disassembled, side view of an exemplary coupling system for securing an anastomotic prosthesis to biological tissue, showing an applicator tool, an attachment ring, and an engagement device." ¶[0028] the ring is connected to the contact members).
Regarding claim 2, Hoarau teaches the assembly further comprising a connection interface, the connection interface being either an integral part of the apical cuff or configured to couple to the apical cuff (Fig. 1 "top end 34 is configured to engage forward segment 12 of applicator tool 10" ¶[0044] and "attachment ring 30 is engaged to and carried by connector mechanism 26 at forward segment 12 of applicator tool 10." ¶[0045]).
Regarding claim 3, Hoarau teaches wherein the at least one of the plurality of plates couple to the connection interface ("FIGS. 6-8, coupling member 706 includes narrow portion 706a at rear end 710, flared portion 706b, and wide portion 706c at forward end 701. Flared portion 706b extends radially outward from narrow portion 706a. Flared portion 706b connects narrow portion 706a to wide portion 706c. In use, narrow portion 706a is attached to forward segment 12 of applicator tool 10." ¶[0052] and "FIGS. 7 and 8, the exterior surface of wide portion 706c is attached by flexible joints 708 to contact members 702." ¶[0053]).
Regarding claim 11, Hoarau teaches wherein each plate of the plurality of outer plates is an arcuate segment having a surface configured to engage the cardiovascular tissue (Fig.'s 3-8 "configured to conform to curvature at the surface of biological tissue. Each contact member 702 is attached by flexible joint 708 to coupling member 706 to accommodate tissue surface curvature." ¶[0048]).
Regarding claim 12, Hoarau teaches wherein a plate of the plurality of outer plates is configured to be engaged against the cardiovascular tissue ("Engagement device 700 is configured to selectively engage onto and disengage from the tissue with the application and removal of suction. Engagement device 700 is set to engage onto tissue, with application of suction, when clips are deployed and cinched by applicator tool 10" ¶[0047]).
Regarding claim 13, Hoarau teaches a ventricular assist system comprising: a. an implantable anastomotic assembly that is configured to be attached to a ventricle (Fig.'s 1-2 "Attachment ring 30 is a type of anastomotic prosthesis suitable for implantation within a human or animal body. Attachment ring 30 is a coupling for a conduit, graft, or other structure that is to be connected to a hollow anatomical organ." ¶[0043] and ""anastomosis" refers to the interconnection of two hollow structures, any of which can be an artificial tubular conduit, a blood vessel, a heart, or other hollow anatomical organ. For example and without limitation, anastomosis can be performed to connect an inflow conduit of a ventricular assist device (VAD) to the ventricular apex of the heart." ¶[0040]), the implantable anastomotic assembly comprising: 1. an apical cuff (Fig.'s 1-2 "attachment ring 30" ¶[0043]); 2. a plurality of plates (Fig.'s 2-8, 10, & 14 "contact members 702" ¶[0048]) configured to couple to the apical cuff ("FIG. 1 is a disassembled, side view of an exemplary coupling system for securing an anastomotic prosthesis to biological tissue, showing an applicator tool, an attachment ring, and an engagement device." ¶[0028] the ring is connected to the contact members); and b. a connector alignment module configured to hold the apical cuff and the plurality of plates in a pre-installed association with each other ("Forward segment 12 of applicator tool 10 is configured to engage attachment ring 30." ¶[0043] and "FIGS. 7 and 8, the exterior surface of wide portion 706c is attached by flexible joints 708 to contact members 702." ¶[0053]); and c. an implantation tool configured to at least one of successively approximate the plurality of plates relative to the apical cuff ("adjusting an axial position of the contact members by sliding the coupling member on the forward segment of the applicator tool" ¶[0022]; "coupling member 706" ¶[0048] or element 10 applicator tool).
Regarding claim 15, Hoarau teaches the system wherein a connection interface is separate from and non-contiguous with the plurality of plates (Fig. 1 "connector mechanism 26 at forward segment 12 of applicator tool 10." ¶[0045]).
Regarding claim 16, Hoarau teaches the system wherein a plate of the plurality of outer plates is configured to be engaged against the cardiovascular tissue (Fig.'s 3-8 "configured to conform to curvature at the surface of biological tissue. Each contact member 702 is attached by flexible joint 708 to coupling member 706 to accommodate tissue surface curvature." ¶[0048]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4-9 are rejected under 35 U.S.C. 103 as being unpatentable over Hoarau, as applied to claim 3 above, in further view of Karapetian et al. (EP 2720642 B1, published Oct. 25, 2017, hereinafter referred to as "Karapetian").
Regarding claim 4, Hoarau teaches the implantable assembly of claim 3. Hoarau does not disclose wherein the connection interface further comprises a plurality of apertures, each of the at least one of a plurality of plates has a receptacle; and further comprising a plurality of connectors, each being configured to be coupled between a respective aperture of the plurality of apertures of the connection interface and engage with a respective aperture of the plurality of apertures of the connection interface.
Karapetian's invention relates to heart valve surgery and more particularly to devices and methods for anchoring prostheses inside or near the heart. FIGS. 23-26 illustrate a further alternative knotless heart valve anchoring system 80 according to the invention that operates similarly to the system shown in FIG. 19. The system includes a prosthetic heart valve 82 having a leaflet supporting structure 84 and a contoured securing ring 86 around the inflow end thereof in the place and configuration where a sewing ring is usually found. The securing ring 86 has a series of through apertures 88 distributed around its periphery that receive elongated flexible connection members 90 therethrough. Each connection member 90 attaches at a distal end to a lower ring 92, formed in the illustrated embodiment by three ring segments 94a, 94b, 94c. The ring segments 94a, 94b, 94c are separate and may be joined with flexible links. The distal end of each connection member 90 preferably secures to the lower ring 92, but may simply pass downward through apertures 96 therein and have a bead or other such enlargement (not shown) that prevents the connection member from pulling upward through the aperture. In a preferred embodiment, the connection members 90 comprise elongate strips with ratcheting teeth. The apertures 88 on the securing ring 86 feature ratchet pawls (not shown) that engage the ratchet teeth on the connection members 90, much like cable ties. The ratcheting connection members 90 allow the lower ring 92 to be gradually pulled closer to the securing ring 86 so as to clamp a heart valve annulus therebetween and secure the device in place, as seen in FIG. 25 (¶[0064]-[0065]). Another implantable prosthesis anchor disclosed herein includes a first support ring with a plurality of receptacles in a facing surface, and a second support ring with a plurality of receptacles in a facing surface, wherein the facing surfaces of the first and second support rings may be brought together so that corresponding receptacles align. The prosthesis anchor further has a plurality of clips protruding from the facing surface of one of the first and second support rings and a plurality of mating opening in the other of the first and second support rings, the clips and openings holding the first and second support rings together. Furthermore, a plurality of compressible members are sized to fit between the aligned receptacles in the first and second support rings, the corresponding receptacles having a mutual size so as to compress the compressible members. A plurality of lengths of suture material passed through native tissue at least once and each pass through a pair of corresponding receptacles, wherein the compressible members each clamp a length of suture when the first support section mates to the second support section and engages the mating clips and openings (¶[0032]). (Apertures and receptacles are the same component as they serve the same function of securing the connector.)
Therefore, it would have been obvious for a person having ordinary skill in the art at the time of filing to have apertures and receptacles in the connection interface and plates with a connector to join them as taught by Karapetian in the implantable assembly of Hoarau since having a cable connect to holes in a structure allow separate components to be joined together.
Regarding claim 5, Hoarau and Karapetian do not explicitly disclose wherein the plurality of connectors comprise superelastic material.
Karapetian discloses the upper support section and the lower support section are made of a flexible material to allow either the upper support section or the lower support section to be elastically deformed and passed through the annulus of the heart (¶[0023]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to use a flexible elastic material as taught by Karapetian in the implantable assembly of Hoarau in order to allow the material to deform and return to normal in situations such as passing through the heart to its destination.
Regarding claim 6, Hoarau does not disclose wherein each connector of the plurality of connectors comprises a distal end comprising one or more retention features configured to engage the receptacle of a respective plate of the plurality of outer plates.
Karapetian teaches When the first support section mates to the second support section the protruding members each clamp a length of suture against the receptacle. The protruding members and receptacles may each comprise a cleat-style suture clamp or a button-style suture clamp (¶[0030]). a plurality of compressible members are sized to fit between the aligned receptacles in the first and second support rings, the corresponding receptacles having a mutual size so as to compress the compressible members (¶[0032]). Also, The distal end of each connection member 90 preferably secures to the lower ring 92, but may simply pass downward through apertures 96 therein and have a bead or other such enlargement (not shown) that prevents the connection member from pulling upward through the aperture (¶[0064]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have a distal end of the connector with one or more retention features as taught by Karapetian in the implantable assembly of Hoarau to engage the receptable of the component with a receptacle/aperture in order to prevent the connection member from pulling through the aperture.
Regarding claims 7 and 9, Hoarau does not teach wherein each connector of the plurality of connectors comprises a tab configured to engage the connection interface adjacent the respective aperture, and wherein each of the plurality of plates further comprises a ratcheting mechanism configured to receive a portion of the connection tab.
Karapetian teaches in a preferred embodiment, the connection members 90 comprise elongate strips with ratcheting teeth. The apertures 88 on the securing ring 86 feature ratchet pawls (not shown) that engage the ratchet teeth on the connection members 90, much like cable ties. The ratcheting connection members 90 allow the lower ring 92 to be gradually pulled closer to the securing ring 86 so as to clamp a heart valve annulus therebetween and secure the device in place, as seen in FIG. 25 (¶[0065]). The instant spec in ¶[010] defines a connection tab may comprise a ratcheting mechanism to receive a portion of the connection tab.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have the connectors comprise a tab to engage the apertures as taught by Karapetian in the implantable assembly of Hoarau in order to allow the components to be gradually pulled closer to each other so as to clamp a heart valve annulus therebetween and secure the device in place.
Regarding claim 8, Hoarau does not teach wherein the plurality of connectors are configured to extend into the cardiovascular tissue.
Karapetian teaches another implantable prosthesis anchor disclosed herein includes a first support ring with a plurality of receptacles in a facing surface, and a second support ring with a plurality of receptacles in a facing surface, wherein the facing surfaces of the first and second support rings may be brought together so that corresponding receptacles align. The prosthesis anchor further has a plurality of clips protruding from the facing surface of one of the first and second support rings and a plurality of mating opening in the other of the first and second support rings, the clips and openings holding the first and second support rings together. Furthermore, a plurality of compressible members are sized to fit between the aligned receptacles in the first and second support rings, the corresponding receptacles having a mutual size so as to compress the compressible members. A plurality of lengths of suture material passed through native tissue at least once and each pass through a pair of corresponding receptacles, wherein the compressible members each clamp a length of suture when the first support section mates to the second support section and engages the mating clips and openings (¶[0032]). (The suture material connects two components as well as connecting the tissue to the components).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to extend the connectors into the cardiovascular tissue as taught by Karapetian in the implantable assembly of Hoarau in order to secure the device to the target location.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hoarau.
Regarding claim 10, Hoarau teaches the implantable assembly of claim 1. In the above embodiment, Hoarau does not teach wherein each plate of the plurality of outer plates further comprises at least one tissue anchor configured to engage the cardiovascular tissue.
Hoarau does teach clips (tissue anchors) for anchoring attachment ring 30 to biological tissue that are contained within forward segment 12 of applicator tool 10. The configuration of each clip can be as shown in FIG. 9. Clip 36 is formed from a metal wire made of a nickel-titanium alloy, Nitinol, or other material having shape memory and/or superelastic properties. Clip 36 includes forward segment 40 and rear segment 42, both of which are substantially straight. Forward segment 40 has sharp tip 44 for piercing a portion of attachment ring 30 and underlying biological tissue. Catch 46 protrudes out from rear segment 42 and is pushed forward (deployment) and pulled backward (cinching) during operation of applicator tool 10. Curved segment 41 connects forward segment 40 to rear segment 42. Curved segment includes a plurality of studs or bumps 45 that protrude radially outward. After clips 36 are cinched, the bumps 45 prevent the clips moving forward due to tension. Each bump 45 allows for a different amount of cinching to accommodate variations in the thickness of biological tissue. Bumps 45 can be shaped and sized to engage one or more structural catch features of attachment ring 30 to inhibit or prevent clip 36 from loosening after being cinched (¶[0057]). Further, Hoarau does provide a method of securing the "plates" to the tissue by using suction. Engagement device 700 is configured to selectively engage onto and disengage from the tissue with the application and removal of suction. Engagement device 700 is set to engage onto tissue, with application of suction, when clips are deployed and cinched by applicator tool 10 (¶[0047]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to include tissue anchors to engage the cardiovascular tissue as this is a method of securing the plates to the tissue.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Hoarau, as applied to claim 13 above, in further view of Hoarau et al. (US 20140276986 A1, published Sept. 18, 2014, hereinafter referred to as "Hoarau '986").
Regarding claim 14, Hoarau teaches the system of claim 13. Hoarau also teaches the system further comprising a connection interface (Fig. 1 "connector mechanism 26 at forward segment 12 of applicator tool 10." ¶[0045]).
Hoarau does not teach the connection interface comprising a support ring, wherein the ventricular assist system further comprises an assembly tool configured to facilitate coupling the support ring to the apical cuff.
Hoarau '986's invention relates to a surgical device and method, and more particularly to anastomotic tools and methods for their use (¶[0003]). An engagement device can have an annular or ring-shaped contact member 750, as shown in FIGS. 34 and 35. Ring-shaped contact member 750 can be implemented as an alternative to or in combination with contact members 702 and/or suction cap 802. Contact member 750 is hollow and substantially circular, with a central opening 752 sized to receive coupling member 706 (FIG. 21) of the engagement device and attachment ring 30 carried by delivery tool 111 (¶[0108]). Delivery tool 29 of FIG. 6 can be modified to include contact members 702 and associated fluid conduits 704, which would surround vacuum cup 14. Also, vacuum cup 14 can be modified to have the configuration of ring-shaped contact member 750 (FIG. 34 and 35) or 750' (FIG. 36) (¶[0074]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have a support ring and an assembly tool to facilitate coupling the support ring to the apical cuff as taught by Hoarau '986 in the system of Hoarau in order to be sized to receive the coupling member.
Conclusion
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/E.N.C./ Patent Examiner, Art Unit 3792
/ALLEN PORTER/ Primary Examiner, Art Unit 3796
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