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 .
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Examiner notes the use of legal phraseology: “disclosed herein. “Examiner suggests removing this language from the abstract.
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.
Claim(s) 1-9 & 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bar et al. US 20210015476 A1, herein referred to as Bar.
RE. Claim 1, Bar discloses an anchoring system comprising (Fig 1, apparatus 20): a plurality of anchors (Fig 10, tissue anchors 60, [0154]; this element is interpreted under 112(f) as a “hook shape” see [0009] of the instant application, and equivalents thereof) each configured to anchor to tissue of a patient’s body (Abstract); one or more contraction members (Fig 3, thread 58, [0135]; this element is interpreted under 112(f) as “wires, lines, tethers, ropes, ribbons, contraction wires, contraction lines, tensioning wires, [or] tensioning lines” see [0011] of the instant application, and equivalents thereof) configured to couple the plurality of anchors to each other and to cinch the plurality of anchors [0165]; a plurality of spacer bodies (Fig 2, tube 34; this element is interpreted under 112(f) as a “bar”, “tube” or “rod” connected to anchoring element, see Fig 1 of the instant application, and equivalents thereof) engaging the one or more contraction members and configured to space the plurality of anchors from each other when the plurality of anchors are anchored to the tissue ([0006] & [0018]; and an anchor dispensing apparatus (Fig 1, a sheath 26) having a central portion (Fig 1, catheter 28) and including a plurality of dispenser arms (Fig 1, wire 38; meets definition of an arm as defined by Merriam Webster: “2: something like or corresponding to an arm: such as d: a slender part of a structure, machine, or an instrument projecting from a main part, axis, or fulcrum”) circumferentially spaced from each other and each configured to extend radially outward from the central portion to a distal end of the respective dispenser arm (Fig 4), each dispenser arm configured to dispense at least one of the plurality of anchors to the tissue of the patient’s body (Fig 4, [0121]).
RE. Claim 2, Bar discloses wherein the central portion (Fig 1, catheter 28) includes a central support (Fig 1, retaining tip 30), and each of the plurality of dispenser arms (Fig 1, wire 38) includes a proximal portion coupled to the central support (Fig 1, Proximal portion of dispenser arm located near the start of 26, distal end is located opposite to this end near the start of 36).
RE. Claim 3, Bar discloses wherein each of the plurality of dispenser arms (Fig 1, wire 38) is configured to pivot from an undeployed configuration (Fig 3, undeployed collapsed phase, [0155]) radially outward to a deployed configuration (Fig 4, deployed expanded phase, Abstract & [0018]).
RE. Claim 4, Bar discloses further comprising an actuation mechanism (guide wire advances anchoring system through sheath, causing expansion and pivoting [0126-0127]) configured to pivot each of the plurality of dispenser arms (Fig 1, wire 38) from the undeployed configuration radially outward to the deployed configuration ([0126-0127]).
RE. Claim 5, Bar discloses wherein the actuation mechanism (guide wire) includes: a plurality of support arms (Fig 2, annular structure 36) each coupled to one of the plurality of dispenser arms (Fig 2); a first shaft (Fig 2, first cylinder 67a) coupled to proximal portions of the plurality of dispenser arms (Fig 2); and a second shaft (Fig 2, second cylinder 67b) coupled to proximal portions of the plurality of support arms and configured to move relative to the first shaft to pivot each of the plurality of support arms radially outward (Fig 2).
RE. Claim 6, Bar discloses wherein the distal end of each of the dispenser arms (Fig 1, wire 38) is configured for the at least one of the plurality of anchors (Fig 10, tissue anchors 60) to be dispensed from (Fig 4).
RE. Claim 7, Bar discloses wherein the distal end of each of the dispenser arms includes an opening ([0147] and [0157], wire loop equivalent to opening) for the at least one of the plurality of anchors to be dispensed from (Fig 4, [0147] and [0157]).
RE. Claim 8, Bar discloses wherein each of the plurality of anchors (Fig 10, tissue anchors 60) is configured to move from an undeployed configuration to a deployed configuration and has a linearized shape (Fig 3, [0155]) in the undeployed configuration and an expanded shape in the deployed configuration (Fig 4, [0162]).
RE. Claim 9, Bar discloses wherein each of the plurality of anchors () is configured to self-expand from the undeployed configuration to the deployed configuration ([0018]).
RE. Claim 17, Bar discloses further comprising a lock (Fig 14, lock 80) for locking the one or more ([0183]) contraction members in a tensioned configuration.
RE. Claim 18, Bar discloses further comprising a cutting mechanism (Fig 16A, Device 118a: inner longitudinal element 122 comprises a sharp distal edge 126) for cutting the one or more contraction members in the tensioned configuration ([0214])
RE. Claim 19, Bar discloses further comprising a dispensing mechanism (Fig 1, a sheath 26) for dispensing each of the plurality of anchors (Fig 4 arced distal portion 66) from the plurality of dispenser arms (Fig 1, wire 38), the dispensing mechanism including one or more push bodies (anchor-pushing element 62 [0154]) configured to push the plurality of anchors distally from the plurality of dispenser arms (Fig 4).
RE. Claim 20, Bar discloses wherein the anchor dispensing apparatus (Fig 1, a sheath 26) is configured to dispense the plurality of anchors to tissue that surrounds a mitral heart valve [0121] or a tricuspid heart valve [0138].
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.
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.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bar.
RE. Claim 10, Bar discloses the invention substantially as claimed and as discussed above with respect to claim 1, but does not disclose wherein each of the plurality of anchors has at least two anchor arms coupled together at a central portion of the anchor and each extending to a tip of the respective anchor arm.
However, in another embodiment Bar discloses a similar anchoring system. Bar also teaches wherein the at least two anchor arms are (Fig 2, extendable arms 111, 112) configured to form curved hooks extending outward from each other (Fig 1).
Therefore, one of ordinary skill in the art would have known prior to the effective filling date of the claimed invention to modify the base invention of Bar to incorporate wherein each of the plurality of anchors has at least two anchor arms coupled together at a central portion of the anchor and each extending to a tip of the respective anchor arm as taught and suggested by Bar in order to compliment the placed protrusion [0205].
Claim(s) 11-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bar in view of Rafiee et al. US 20070066863 A1, herein referred to as Rafiee.
RE. claim 11, Bar discloses the invention substantially as claimed and as discussed above with respect to claim 1, but does not disclose wherein the at least two anchor arms are configured to form curved hooks extending outward from each other. But Rafiee a similar anchoring system for cardiovascular repair. Rafiee teaches wherein the at least two anchor arms are (Fig 2, extendable arms 111, 112) configured to form curved hooks extending outward from each other (Fig 1).
Therefore, one of ordinary skill in the art would have known prior to the effective filling date of the claimed invention to modify the base invention of Bar to incorporate wherein the at least two anchor arms are configured to form curved hooks extending outward from each other as taught and suggested by Rafiee in order to allow flexibility in the anchor [0205].
RE. Claim 12, the combination of Bar and Rafiee discloses the invention substantially as claimed as discussed above with respect to claim 11 and teaches wherein the plurality of spacer bodies (Fig 2, tube 34) are configured to extend over the one or more contraction members (Fig 3, thread 58; 34 and 58 are coaxially aligned, [0135]).
RE. Claim 13, the combination of Bar and Rafiee discloses the invention substantially as claimed as discussed above with respect to claim 11 and teaches wherein each of the plurality of spacer bodies (Fig 2, tube 34) are configured to pivotally couple to one of the plurality of anchors (Fig 2 collapse to Fig4 expanded states show pivoting, [0003-0004]).RE. Claim 14, the combination of Bar and Rafiee discloses the invention substantially as claimed as discussed above with respect to claim 11 and teaches wherein the plurality of spacer bodies (Fig 2, tube 34) are each configured to extend axially relative to one of the plurality of anchors when the respective one of the plurality of anchors is in an undeployed configuration (Fig 2 collapse to Fig4 expanded, [0135]).
RE. Claim 15, the combination of Bar and Rafiee discloses the invention substantially as claimed as discussed above with respect to claim 11 and teaches wherein each of the plurality of dispenser arms (Fig 1, wire 38) includes a channel (Fig 3, flexible tube guides 35) configured to retain the at least one of the plurality of anchors and at least one of the plurality of spacer bodies ([0132]).
RE. Claim 16, the combination of Bar and Rafiee discloses the invention substantially as claimed as discussed above with respect to claim 11 and teaches further comprising a tensioning mechanism (Fig 10, anchor-pushing element 62) for tensioning the one or more contraction members (Fig 3, thread 58, [0192]).
Conclusion
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/A.F./Patent Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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