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 .
Election/Restrictions
Applicant’s election without traverse of Species 2, claims 21-24, 29-32, 34-41, in the reply filed on 12/24/2025 is acknowledged. Applicant’s request for a rejoinder is acknowledged and will be considered at the time the withdrawn claims are dependent upon an allowable claim. Presently, none of withdrawn claims 25-27 and 33 depend from an allowable claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 22 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 recites “the driver anchors the anchor in the tissue”. It is unclear if Applicant is intending to claim the human tissue, as this would arise in a 35 U.S.C. 101 issue. Since claim 22 is directed to an apparatus claim, Applicant is advised to amend the claim to recite - - the driver is configured to anchor the anchor in the tissue”.
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) 21, 22, 24, 31, 32 and 40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lau (US 2021/0015475).
Lau discloses the following limitations:
Claim 21. A system for anchoring in a tissue ([0001]; mitral valve), the system comprising:
an anchor comprising:
a helical tissue-engaging element (helical member 150 of element 104);
a second tissue-engaging element (helical member 150 of element 102; wherein element 104 is described as being identical to element 102 in [0090]; Applicant has not claimed the relationship between the helical tissue-engaging element and the second tissue-engaging element and how they make up the claimed anchor other than their presence. Therefore, since the helical member 150 of element 102 and the helical member 150 of element 104 are connected together via suture 106, this together makes up the claimed anchor and thereby encompasses the claimed limitations); and
a head assembly, comprising:
a first head (drive portion 142 of element 104), fixed to a proximal end of the helical tissue-engaging element, and
a second head (drive portion 142 of element 102), fixed to a proximal end of the second tissue-engaging element ([0091], [0093]; Applicant has not claimed the relationship between the first head and the second head. The term ‘assembly’ as defined by www.dictonary.com in definition #6 in regards to machinery is “a group of machine parts”. Therefore, the drive portion 142 of element 102 and drive portion 142 of element 104 is a group of machine parts that together (as linked together in Fig. 1) to form the claimed assembly and thereby encompasses the claimed limitations); and
a driver (250) reversibly interfaces with the head assembly in a manner that drives both the helical tissue-engaging element and the second tissue-engaging element into engagement with the tissue by rotating the first head with respect to the second head (Figs. 7-8; [0061], [0062], [0114], [0116], [0130], [0132]; the single driver 250 is responsible for inserting both elements 102 and 104 into tissue, one at a time, and therefore engages both the helical tissue-engaging element and the second tissue-engaging element by rotating the first head with respect to the second head. In other words, when driver 250 is rotating and inserting element 104 (which contains the helical tissue engaging element 150 and first head 142), second head (drive portion 142 of element 102) is already inserted and remains substantially stationary (Fig. 8). Therefore, the first head is rotated with respect to the second head, as both the helical tissue-engaging element and the second tissue-engaging element are engaged with tissue).
Claim 22. The system according to claim 21, wherein the driver is configured to anchor the anchor in the tissue in a manner that the helical tissue-engaging element and the second tissue-engaging element enter the tissue asynchronously ([0130], [0132]; the second tissue-engaging element is entered into tissue first (Fig. 7), before the helical-tissue engaging element is entered into tissue (Fig. 8) and is therefore entered asynchronously).
Claim 24. The system according to claim 21, wherein the first head and the second head form a locking mechanism when the helical tissue-engaging element and the second tissue-engaging element are fully inserted into the tissue. Applicant has not claimed how the locking mechanism is form or what the locking mechanism is designed to lock. Therefore, the presence of the first head and the second head in Lau as cited in claim 21 inherently forms a locking mechanism when the helical tissue-engaging element and the second tissue-engaging element are fully inserted into tissue (Fig. 1) as the elements are not designed to not move once the elements are all in their final place in the tissue ([0084]).
Claim 31. The system according to claim 21, wherein:
the helical tissue-engaging element has a first handedness and a first pitch, and
the second tissue-engaging element is a second helical tissue-engaging element having a second handedness and a second pitch (Fig. 2; [0090]).
Claim 32. The system according to claim 31, wherein the first handedness is the same as the second handedness, and the first pitch is the same as the second pitch (Fig. 2; [0090]).
Claim 40. A system for anchoring in a tissue ([0001]; mitral valve), the system comprising:
an anchor comprising:
a helical tissue-engaging element (helical member 150 of element 104);
a second tissue-engaging element (helical member 150 of element 102; wherein element 104 is described as being identical to element 102 in [0090]; Applicant has not claimed the relationship between the helical tissue-engaging element and the second tissue-engaging element and how they make up the claimed anchor other than their presence. Therefore, since the helical member 150 of element 102 and the helical member 150 of element 104 are connected together via suture 106, this together makes up the claimed anchor and thereby encompasses the claimed limitations); and
a head assembly, comprising:
a first head (drive portion 142 of element 104), fixed to a proximal end of the helical tissue-engaging element, and
a second head (drive portion 142 of element 102), fixed to a proximal end of the second tissue-engaging element ([0091], [0093]; Applicant has not claimed the relationship between the first head and the second head. The term ‘assembly’ as defined by www.dictonary.com in definition #6 in regards to machinery is “a group of machine parts”. Therefore, the drive portion 142 of element 102 and drive portion 142 of element 104 is a group of machine parts that together (as linked together in Fig. 1) to form the claimed assembly and thereby encompasses the claimed limitations); and
a driver (250) that reversibly interfaces with the head assembly to anchor the anchor in the tissue:
such that the helical tissue-engaging element and the second tissue-engaging element are both in engagement with the tissue (Figs. 1 and 8 illustrate both in engagement with the mitral valve), and
by screwing the helical tissue-engaging element into the tissue independently of rotation of the second tissue-engaging element head (Figs. 7-8; [0061], [0062], [0114], [0116], [0130], [0132]; the single driver 250 independently inserts both elements 102 and 104 into tissue, one at a time and therefore screws the helical tissue-engaging element into the tissue independently of rotation of the second tissue-engaging element head and the second tissue-engaging element is not being manipulated when the helical tissue-engaging element is being inserted into tissue.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 21, 23, 24 and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jimenez et al (US 2015/0342602) in view of Lubbers et al (US 2004/0193217).
Claim 21. Jimenez et al discloses a system for anchoring in a tissue (Figs. 30A-30B), the system comprising:
an anchor comprising:
a helical tissue-engaging element (2355);
a second tissue-engaging element (2350); and
a head assembly, comprising:
a first head (see annotated figure below), fixed to a proximal end of the helical tissue-engaging element, and
a second head (see annotated figure below), fixed to a proximal end of the second tissue-engaging element.
Jimenez et al further discloses the helical tissue-engaging element and the second tissue-engaging element are inserted into tissue by rotating the first head with respect to the second head as the second tissue-engaging element is first rotated into the tissue wall (2300) before the helical tissue-engaging element is inserted. However, Jimenez et al fails to disclose a driver reversibly interfacing with the head assembly to drive both the helical tissue-engaging element and the second tissue-engaging element.
In a similar field of endeavor of a tissue anchor, Lubbers et al teaches an anchor having two helical tissue-engaging elements (12, 12a) (Figs. 3, 4), wherein a driver (insertion tool) is used reversibly engage and rotate both tissue-engaging elements into tissue by interfacing a head assembly (14) ([0097], [0098]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Jimenez et al with a driver for reversibly interfacing with the head assembly as claimed based upon the teachings of Lubber et al to provide a tool for controlled insertion of the anchor.
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Claim 23. The combination discloses the invention substantially as claimed above, wherein Jimenez et al further discloses the second head comprises an outer cylinder, and the first head comprises an independently moveable inner core that interfaces with the second head (see annotated figure from claim 21).
Claim 24. The combination discloses the invention substantially as claimed above, wherein the first head and the second head of Jimenez et al are configured to form a locking mechanism when the helical tissue-engaging element and the second tissue-engaging element are fully inserted into the tissue. Applicant has not claimed how the locking mechanism is form or what the locking mechanism is designed to lock. Therefore, the presence of the first head and the second head in Jimenez et al as cited in claim 21 inherently forms a locking mechanism when the helical tissue-engaging element and the second tissue-engaging element are fully inserted into tissue (Figs. 30A, 30B) as the elements are not designed to not move once the elements are all in their final place in the tissue.
Claim 40. Jimenez et al discloses system for anchoring in a tissue (Figs. 30, 30B), the system comprising:
an anchor comprising:
a helical tissue-engaging element (2355);
a second tissue-engaging element (2350); and
a head assembly, comprising:
a first head (see annotated figure from claim 21), fixed to a proximal end of the helical tissue-engaging element, and
a second head (see annotated figure from claim 21), fixed to a proximal end of the second tissue-engaging element.
Jimenez et al further discloses the helical tissue-engaging element and the second tissue-engaging element are inserted into tissue by rotating (screwing) the first head independently of the second head as the second tissue-engaging element is first rotated into the tissue wall (2300) before the helical tissue-engaging element is inserted. Therefore, the system of Jimenez et al results in the helical tissue-engaging element and the second tissue-engaging element both in engagement with the tissue. However, Jimenez et al fails to disclose a driver that reversibly interfaces with the head assembly to anchor the anchor in the tissue. In a similar field of endeavor of a tissue anchor, Lubbers et al teaches an anchor having two helical tissue-engaging elements (12, 12a) (Figs. 3, 4), wherein a driver (insertion tool) is used reversibly engage and rotate both tissue-engaging elements into tissue by interfacing a head assembly (14) ([0097], [0098]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Jimenez et al with a driver for reversibly interfacing with the head assembly as claimed based upon the teachings of Lubber et al to provide a tool for controlled insertion of the anchor.
Allowable Subject Matter
Claim 41 is allowed.
Claims 29, 30, 34-39 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.
The following is a statement of reasons for the indication of allowable subject matter:
In regards to claim 41, the closest prior art of record, Jimenez et al in view of Lubbers et al as applied to claim 40 above, discloses the invention substantially as claimed. The prior art of record does not disclose or fairly suggest either singly or in combination the claimed system for anchoring in a tissue comprising, inter alia, the first head comprising a runner fixed to the first tissue-engaging element, a driver that reversibly interfaces with the head assembly in a manner that drives both the first tissue-engaging element and the helical tissue-engaging element into engagement with the tissue by rotating the first head with respect to the second head such that the runner advances along turns of the helical tissue-engaging element. Instead, the first head is simply interfaced with the second head by being disposed within, without any further structures (runner) to advance along the turns of the helical tissue-engaging element.
In regards to claim 29, the closest prior art of record, Lau et al, or Jimenez et al in view of Lubbers et al, discloses the invention substantially as claimed above in claim 21. The prior art of record does not disclose or fairly suggest either singly or in combination the claimed system for anchoring in a tissue comprising, inter alia, the driver comprises a first component and a second component, the first component engaging the first head, and the second component engaging the second head. In Lau et al, the same component engages both the first head and the second head. Similarly, in Lubber et al, a single component (72) engages the anchor assembly.
In regards to claim 34, the closest prior art of record, Jimenez et al in view of Lubbers et al as applied to 21 above, discloses the invention substantially as claimed.
The prior art of record does not disclose or fairly suggest either singly or in combination the claimed system for anchoring in a tissue comprising, inter alia, the first head comprises a runner fixed to the helical tissue-engaging element. Instead, the first head is simply interfaced with the second head by being disposed within, without any further structures (runner) to advance along the turns of the helical tissue-engaging element.
Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771