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 A1, B2 in the reply filed on 11/7/2025 is acknowledged.
Claim(s) 6-7, 16-20 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/7/2025.
Claim Objections
Claim(s) 8 is/are objected to because of the following informalities:
Within claim 8, line 4: there should be a line break after “element;”
Appropriate correction is required.
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(s) 1-5, 8-15 is/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.
Within claim 1, line 3: Applicant claims, “one or more leaflets” (i.e. there could be one singular leaflet); additionally, within claim 1, line 7 (and claim 1, line 9; and claim 3, line 8): Applicant claims, “leaflets” (i.e. there must be more than one leaflet for leaflets to be plural); as such, it is unclear, and therefore indefinite how many leaflet(s) the anchors are configured to attach to? Claim(s) 2-5, which depend from claim 1, inherit all the problems associated with claim 1.
Within claim 2, line 4: Applicant claims, “the movable arm”; it is unclear, and therefore indefinite, which ONE moveable arm is being referred to as there maybe more than one (since each of the one or more anchors has a movable arm). Claim(s) 5, which depend from claim 2, inherit all the problems associated with claim 2.
Within claim 3, lines 5-6: Applicant claims, “the first portion”; it is unclear, and therefore indefinite, which ONE first portion is being referred to as there may be more than one (since each of the one anchors has a first portion).
Within claim 3, line 6: Applicant claims, “the second portion”; it is unclear, and therefore indefinite, which ONE second portion is being referred to as there may be more than one (since each of the one anchors has a second portion).
Within claim 3, line 6: Applicant claims, “the second visual marking”; it is unclear, and therefore indefinite, which ONE second visual marking is being referred to as there may be more than one (since each of the one anchors has a second visual marking).
Within claim 3, line 7: Applicant claims, “the first visual marking”; it is unclear, and therefore indefinite, which ONE first visual marking is being referred to as there may be more than one (since each of the one anchors has a first visual marking).
Within claim 5, lines 1-2: Applicant claims, “each clasp comprises the fixed arm that is attached to the anchor portion”; it is unclear, and therefore indefinite, how the fixed arm (of each clasp) can be ATTACHED to the anchor portion when the fixed arm/ clasp/ one or more anchors is a SUBSTRUCTURE (i.e. part of) the anchor portion (as required of claim 1, line 2 and claim 2, lines 1-2).
Within claim 5, line 3: Applicant claims, “a movable arm”; it is unclear, and therefore indefinite, if this is the same as OR in addition to the previous movable arm (within claim 2, line 2).
Within claim 8, lines 4-5: Applicant claims, “one or more leaflets” (i.e. there could be one singular leaflet); additionally, within claim 8, line 11 (and claim 8, line 13): Applicant claims, “leaflets” (i.e. there must be more than one leaflet for leaflets to be plural); as such, it is unclear, and therefore indefinite how many leaflet(s) the anchors are configured to attach to?
Within claim 9, line 7: Applicant claims, “one or more leaflets” (i.e. there could be one singular leaflet); additionally, within claim 9, line 14 (and claim 9, line 16; and claim 12, line 7): Applicant claims, “leaflets” (i.e. there must be more than one leaflet for leaflets to be plural); as such, it is unclear, and therefore indefinite how many leaflet(s) the anchors are configured to attach to? Claim(s) 10-15, which depend from claim 9, inherit all the problems associated with claim 9.
Within claim 10, lines 1-2: Applicant claims, “each of the one or more anchor comprises a clasp what comprises the indication feature”; it is unclear, and therefore indefinite, what defines the indication feature when that is more than one anchor – for example: if there are two anchors, then there would be two clasps in which case is there a single indication feature which is made up of a substructure of ALL of the clasps? Or would each clasp include it’s own indication feature? Claim(s) 11-12, 15, which depend from claim 10, inherit all the problems associated with claim 10.
Within claim 11, line 1: Applicant claims, “the clasp”; it is unclear, and therefore indefinite, which ONE clasp is being referred to as there may be more than one (since each of the one anchors has a clasp).
Within claim 11, lines 4-5: Applicant claims, “the indication feature is in a first tension position”; it is unclear, and therefore indefinite, if this is the same as OR different from either the allowable tension position or the exceeded tension portion (within claim 9, lines 12-13).
Within claim 11, lines 5-6: Applicant claims, “the indication feature is in a second tension position”; it is unclear, and therefore indefinite, if this is the same as OR different from either the allowable tension position or the exceeded tension portion (within claim 9, lines 12-13).
Within claim 12, line 1: Applicant claims, “the clasp”; it is unclear, and therefore indefinite, which ONE clasp is being referred to as there may be more than one (since each of the one anchors has a clasp).
Within claim 15, lines 1-2: Applicant claims, “each clasp comprises a fixed arm that is attached to the anchor portion”; it is unclear, and therefore indefinite, how a fixed arm (of each clasp) can be ATTACHED to the anchor portion when the fixed arm/ clasp/ one or more anchors is a SUBSTRUCTURE (i.e. part of) the anchor portion (as required of claim 9, line 5 and claim 10, lines 1-2).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 8-10, 12-13 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Goldfarb et al. (US 2007/0197858 A1).
With respect to claim 1:
Goldfarb et al. discloses a valve repair device (fixation device 14) (paragraph [0070]), as can be seen in fig. 3, comprising:
an anchor portion (made up of distal elements 18, and proximal elements 16) comprising one or more anchors (as can be seen in fig. 3, the fixation device 14 has two anchors where each anchor is made up of a proximal element and a respective distal element 18) (paragraphs [0070-0071]);
wherein the one or more anchors (each anchor is made up of a proximal element and a respective distal element 18) are configured to attach to one or more leaflets (a respective leaflet LF)
of a native heart valve (paragraphs [0070-0072]);
wherein the one or more anchors (each anchor is made up of a proximal element and a respective distal element 18) are configured to move between an open position (open position prior to gripping leaflets LF, as seen in figs. 5A-5B) and a closed position (after leaflets have been captured, as seen in figs. 7A-7B) (paragraphs [0076, 0081]); and
an indication feature (coatings on the segments proximal segments 16, 16’), as can be seen in fig. 30, that, when each of the one or more anchors (each anchor is made up of a proximal element and a respective distal element 18) are attached to respective leaflet (leaflet LF) of the native heart valve, indicates to a user when an amount of force applied to the anchor portion (made up of distal elements 18, and proximal elements 16) by the leaflets (leaflet LF) of the native heart valve exceeds a predetermined amount of force (please note: Applicant has not claimed what defines the “predetermined amount of force”, as such, the indication feature (coatings on the segments proximal segments 16, 16’) is capable of/ will indicate to a user (based on the location of segments proximal segments 16, 16’ with respect to each other) when an amount of force (causing the deflection in the flexible area 240) by the leaflets (leaflets LF) on the anchor portion (made up of distal elements 18, and proximal elements 16) exceeds a predetermined amount of force (the force required to create the deflection in the flexible area 240) (paragraph [0120]).
With respect to claim 3:
Wherein each of the one or more anchors (as can be seen in fig. 3, the fixation device 14 has two anchors where each anchor is made up of a proximal element 16 and a respective distal element 18) comprise a clasp (pairing of proximal element 16 and a respective distal element 18) with the indication feature (coatings on the segments proximal segments 16, 16’), wherein each of the clasps (pairing of proximal element 16 and a respective distal element 18) comprises a first portion (one of the segments of proximal segments 16, 16’ closer to stud 74) that includes a first visual marking (the coating on the one of the segments of proximal segments 16, 16’ closer to stud 74) of the indication feature (coatings on the segments proximal segments 16, 16’) and a second portion (one of the segments of proximal segments 16, 16’ closer to free end thereof) that includes a second visual marking (the coating on the one of the segments of proximal segments 16, 16’ closer to the free end thereof) of the indication feature (coatings on the segments proximal segments 16, 16’), and wherein the second portion (one of the segments of proximal segments 16, 16’ closer to free end thereof) of each clasp is movable relative to the first portion (one of the segments of proximal segments 16, 16’ closer to stud 74) such that movement of the second portion (one of the segments of proximal segments 16, 16’ closer to free end thereof) causes the second visual marking (the coating on the one of the segments of proximal segments 16, 16’ closer to the free end thereof) to move relative to the first visual marking (the coating on the one of the segments of proximal segments 16, 16’ closer to stud 74) to cause the indication feature (coatings on the segments proximal segments 16, 16’)to indicate to the user that the amount of force applied to the anchor portion (made up of distal elements 18, and proximal elements 16) by the leaflets (leaflet LF) of the native heart valve exceeds the predetermined amount of force (paragraph [0120]).
With respect to claim 8:
Goldfarb et al. discloses a valve repair device (fixation device 14) (paragraph [0070]), as can be seen in fig. 3, comprising:
an actuation element (actuation mechanism 58/ stud 74 and legs 68) (paragraph [0073]);
an anchor portion (made up of distal elements 18, and proximal elements 16) comprising one or more anchors (as can be seen in fig. 3, the fixation device 14 has two anchors where each anchor is made up of a proximal element and a respective distal element 18) (paragraphs [0070-0071]) coupled to the actuation element (actuation mechanism 58/ stud 74 and legs 68) (paragraph [0073]);
wherein the one or more anchors (each anchor is made up of a proximal element and a respective distal element 18) are configured to attach to one or more leaflets (a respective leaflet LF)
of a native heart valve (paragraphs [0070-0072]);
wherein the one or more anchors (each anchor is made up of a proximal element and a respective distal element 18) are configured to move between an open position (open position prior to gripping leaflets LF, as seen in figs. 5A-5B) and a closed position (after leaflets have been captured, as seen in figs. 7A-7B) (paragraphs [0076, 0081]) by movement of the actuation element (actuation mechanism 58/ stud 74 and legs 68) (paragraph [0073]);
wherein at least one of the actuation element (actuation mechanism 58/ stud 74 and legs 68), and the anchor portion (made up of distal elements 18, and proximal elements 16) comprise an indication feature (coatings on the segments proximal segments 16, 16’) that is movable between a first tension position (as can be seen in the proximal element 16 in fig. 30 OR prior to gripping leaflets LF) and a second tension position (as can be seen in the proximal element 16’ in fig. 30 OR after gripping leaflets LF); and
wherein, when each of the one or more anchors (each anchor is made up of a proximal element and a respective distal element 18) are attached to respective leaflet (leaflet LF) of the native heart valve, the indication feature (coatings on the segments proximal segments 16, 16’) indicates to a user when an amount of force applied to the anchor portion (made up of distal elements 18, and proximal elements 16) by the leaflets (leaflet LF) of the native heart valve exceeds a predetermined amount of force (please note: Applicant has not claimed what defines the “predetermined amount of force”, as such, the indication feature (coatings on the segments proximal segments 16, 16’) is capable of/ will indicate to a user (based on the location of segments proximal segments 16, 16’ with respect to each other) when an amount of force (causing the deflection in the flexible area 240) by the leaflets (leaflets LF) on the anchor portion (made up of distal elements 18, and proximal elements 16) exceeds a predetermined amount of force (the force required to create the deflection in the flexible area 240) (paragraph [0120]);
With respect to claim 9:
Goldfarb et al. discloses a valve repair system (interventional tool 10) for repairing a native heart valve of a patient during a non-open-heart procedure, the valve repair system (interventional tool 10) comprising:
a delivery device (sheath/ catheter 86) having at least one lumen (paragraphs [0024, 0075]);
an actuation element (actuation mechanism 58/ stud 74 and legs 68) that extends through the delivery device (sheath/ catheter 86) (paragraphs [0024, 0073]);
an anchor portion (made up of distal elements 18, and proximal elements 16) comprising one or more anchors (as can be seen in fig. 3, the fixation device 14 has two anchors where each anchor is made up of a proximal element and a respective distal element 18) (paragraphs [0070-0071]) coupled to the actuation element (actuation mechanism 58/ stud 74 and legs 68) (paragraph [0073]);
wherein the one or more anchors (each anchor is made up of a proximal element and a respective distal element 18) are configured to attach to one or more leaflets (a respective leaflet LF)
of a native heart valve (paragraphs [0070-0072]);
wherein the one or more anchors (each anchor is made up of a proximal element and a respective distal element 18) are configured to move between an open position (open position prior to gripping leaflets LF, as seen in figs. 5A-5B) and a closed position (after leaflets have been captured, as seen in figs. 7A-7B) (paragraphs [0076, 0081]) by movement of the actuation element (actuation mechanism 58/ stud 74 and legs 68) (paragraph [0073]);
wherein at least one of the actuation element (actuation mechanism 58/ stud 74 and legs 68), and the anchor portion (made up of distal elements 18, and proximal elements 16) comprise an indication feature (coatings on the segments proximal segments 16, 16’) that is movable between an allowable tension position (as can be seen in the proximal element 16 in fig. 30) and an exceeded tension position (as can be seen in the proximal element 16’ in fig. 30); and
wherein, when each of the one or more anchors (each anchor is made up of a proximal element and a respective distal element 18) are attached to respective leaflet (leaflet LF) of the native heart valve, the indication feature (coatings on the segments proximal segments 16, 16’) indicates to a user when an amount of force applied to the anchor portion (made up of distal elements 18, and proximal elements 16) by the leaflets (leaflet LF) of the native heart valve exceeds a predetermined amount of force (please note: Applicant has not claimed what defines the “predetermined amount of force”, as such, the indication feature (coatings on the segments proximal segments 16, 16’) is capable of/ will indicate to a user (based on the location of segments proximal segments 16, 16’ with respect to each other) when an amount of force (causing the deflection in the flexible area 240) by the leaflets (leaflets LF) on the anchor portion (made up of distal elements 18, and proximal elements 16) exceeds a predetermined amount of force (the force required to create the deflection in the flexible area 240) (paragraph [0120]).
With respect to claim 10:
Wherein each of the one or more anchors (as can be seen in fig. 3, the fixation device 14 has two anchors where each anchor is made up of a proximal element 16 and a respective distal element 18) comprise a clasp (pairing of proximal element 16 and a respective distal element 18) that comprises the indication feature (coatings on the segments proximal segments 16, 16’) (paragraph [0120]).
With respect to claim 12:
Wherein each of the clasps (pairing of proximal element 16 and a respective distal element 18) comprises a first portion (one of the segments of proximal segments 16, 16’ closer to stud 74) that includes a first visual marking (the coating on the one of the segments of proximal segments 16, 16’ closer to stud 74) of the indication feature (coatings on the segments proximal segments 16, 16’) and a second portion (one of the segments of proximal segments 16, 16’ closer to free end thereof) that includes a second visual marking (the coating on the one of the segments of proximal segments 16, 16’ closer to the free end thereof) of the indication feature (coatings on the segments proximal segments 16, 16’), and wherein the second portion (one of the segments of proximal segments 16, 16’ closer to free end thereof) of each clasp is movable relative to the first portion (one of the segments of proximal segments 16, 16’ closer to stud 74) such that movement of the second portion (one of the segments of proximal segments 16, 16’ closer to free end thereof) causes the second visual marking (the coating on the one of the segments of proximal segments 16, 16’ closer to the free end thereof) to move relative to the first visual marking (the coating on the one of the segments of proximal segments 16, 16’ closer to stud 74) to cause the indication feature (coatings on the segments proximal segments 16, 16’)to indicate to the user that the amount of force applied to the anchor portion (made up of distal elements 18, and proximal elements 16) by the leaflets (leaflet LF) of the native heart valve exceeds the predetermined amount of force (paragraph [0120]).
With respect to claim 13:
Wherein the one or more anchors (as can be seen in fig. 3, the fixation device 14 has two anchors where each anchor is made up of a proximal element 16 and a respective distal element 18) comprise the indication feature (coatings on the segments proximal segments 16, 16’) (paragraph [0120]).
Allowable Subject Matter
Claim(s) 2, 4-5, 11, 14-15 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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: Examiner can find no reference alone nor in combination which render obvious:
With respect to claim(s) 2 and 11:
A valve repair device (as required by claim 1) OR a valve repair system (as required by claim 10) wherein each of the one or more anchors comprise a clasp with a fixed arm and a movable arm that is pivotally connected to the fixed arm, wherein the indication feature comprises a flexible material of a respective movable arm that allows the respective movable arm to be in a non-extended position when the indication feature is in a first tension position and an extended position when the indication feature is in a second tension position, the second tension position indicating to the user when the amount of force exceeds the predetermined amount of force.
With respect to claim(s) 4 and 14:
A valve repair device (as required by claim 1) OR a valve repair system (as required by claim 9) wherein the indication feature comprises one or more components that allow the one or more anchors to have two positions – specifically: a non-extended position (when the indication feature is in an allowable tension position) AND an extended position (when the indication feature is in an exceeded tension position).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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/REBECCA S PRESTON/ Examiner, Art Unit 3774