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 .
Response to Amendment
In response to the amendment filed on 7/10/2026, no claims have been cancelled, claims 13-20 are newly added and claims 1-12 are pending.
Response to Arguments
Applicant's arguments filed 7/10/2026 have been fully considered but they are not persuasive. Applicant argues that “Sheps does not disclose that stiffening element 1926 is a stiffening element of manipulator 61, or of any other anchor driver.”, however, Examiner respectfully disagrees. Sheps discloses in paragraph 647 that for other applications, stiffening element 1926 is coupled to the anchor driver 61 or a component that is slidable within a lumen of the anchor driver 61, and thus the stiffening element 1926 is a stiffening element of the anchor driver 61 as it would still impart a level of stiffness to the anchor driver 61. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zipory with the teachings of Sheps in order to modify the stiffness of the anchor driver and provide variable levels of driver reinforcement when driving the anchor.
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 1-8, 13, 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 20160262755 Zipory et al. (hereinafter Zipory) in view of US 20150272734 Sheps et al. (hereinafter Sheps).
Regarding claim 1, Zipory discloses an apparatus for use with a tissue anchor (40, Fig. 1a-f) at a heart of a subject (Fig. 1a-f, 3a-c, paragraph 3, 154-155) comprising:
an anchor driver (60), transluminally advanceable to the heart (Fig. 3a-c, paragraph 137-138, 154-155), and comprising:
a shaft (64);
a head (62), coupled to the shaft at a distal part of the anchor driver (as seen in Fig. 1a-f, paragraph 138), and configured to engage the tissue anchor (paragraph 139-141).
Zipory is silent on a stiffening element that, while the head remains engaged with the tissue anchor within the subject, is repositionable from outside of the subject in a manner that transitions the anchor driver between (i) a first state, and (ii) a second state in which the distal part of the anchor driver is stiffer than in the first state.
However, Sheps teaches a similar apparatus for use with a tissue anchor (32, Fig. 2) at a heart of a subject (paragraph 11) comprising an anchor driver (61, Fig. 2) having a stiffening element (1926, Fig. 16a-b) that is repositionable from outside of the subject in a manner that transitions the anchor driver between (i) a first state, and (ii) a second state in which the distal part of the anchor driver is stiffer than in the first state (paragraph 645-649, stiffening element (1926) is slidable within a lumen of the anchor driver (61), the presence of the stiffening element (1926) stiffens the anchor driver (61) and removal of the stiffening element by the operating physician pulling it out causes the anchor driver (61) to become less stiff) while the head of the anchor driver remains engaged with the tissue anchor within the subject (Fig. 2, 8a-9b, 10g, anchor driver 61 has a head 38 that is engaged with the tissue anchor 32 within the heart of the subject, paragraph 573, 645-649).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zipory with the teachings of Sheps in order to modify the stiffness of the anchor driver and provide variable levels of driver reinforcement when driving the anchor.
Regarding claim 2, the combination of Zipory and Sheps teaches the limitations of claim 1, and the combination further teaches wherein: in the first state, the head is articulatable with respect to the shaft (modified anchor driver of Zipory with the teachings of Sheps allows the head (62) to articulate with respect to the shaft (64) since the stiffening element (1926) taught by Sheps is removed by the operating physician allowing the shaft to be flexible), and the manner that transitions the anchor driver from the first state to the second state is inhibition articulation of the head with respect to the shaft (when the stiffening element (1926) of Sheps is slidably moved towards the head (62) of Zipory, the shaft (64) becomes stiffer therefore inhibiting movement of the head).
Regarding claim 3, the combination of Zipory and Sheps teaches the limitations of claim 1, and the combination further teaches wherein the manner that transitions the anchor driver from the first state to the second state is stiffening of the shaft (when the stiffening element (1926) of Sheps is slidably moved distally toward the head (62) of Zipory, the shaft (64) becomes stiffer).
Regarding claim 4, the combination of Zipory and Sheps teaches the limitations of claim 1, and the combination further teaches wherein the anchor driver is transitionable between the first state and the second state via axial repositioning of the stiffening element (the stiffening element (1926) of Sheps is slidably moved to adjust stiffness as taught in paragraph 647-648).
Regarding claim 5, to claim 1, wherein the anchor driver is transitionable between the first state and the second state via rotational repositioning of the stiffening element (paragraph 472, 647, the anchor driver (61) of Sheps comprises a rotating component 36 as seen in Fig. 2, thus rotating the rotating component 36 rotates the stiffening element (1926) as it is within the lumen of the anchor driver (61)).
Regarding claim 6, the combination of Zipory and Sheps teaches the limitations of claim 1, and Zipory further discloses further comprising the tissue anchor (40, Fig. 1a-f).
Regarding claim 7, the combination of Zipory and Sheps teaches the limitations of claim 1, and the combination further teaches wherein:
the shaft is a first shaft, and defines a tube (as seen in Fig. 1a-e of Zipory, shaft (64) has a lumen and therefore is tubular), and
the stiffening element comprises a second shaft (paragraph 645, 648, stiffening element (1926) of Sheps can be a wire (which is a shaft) or a flexible tube with a stiff rod within the tube), movable within the first shaft to transition the anchor driver between the first state and the second state (modified anchor driver of Zipory with the teachings of Sheps would place the second shaft (stiffening element 1926 of Sheps) within the lumen of the first shaft (64) of Zipory to transition the anchor driver of Zipory between the first state and the second state).
Regarding claim 8, the combination of Zipory and Sheps teaches the limitations of claim 7, and the combination further teaches wherein the anchor driver is configured such that (i) distalward advancement of the second shaft into the first shaft transitions the anchor driver into the second state (modified anchor driver of Zipory with the teachings of Sheps would place the second shaft (stiffening element 1926 of Sheps) within the lumen of the first shaft (64) of Zipory, wherein distalward advancement of the second shaft into the first shaft transitions the anchor driver from a more flexible state to a less flexible state), and (ii) proximalward retraction of the second shaft from the first shaft transitions the anchor driver into the first state (modified anchor driver of Zipory with the teachings of Sheps allows for proximalward advancement of the second shaft into the first shaft that transitions the anchor driver from a less flexible state to a more flexible state).
Regarding claim 13, the combination of Zipory and Sheps teaches the limitations to claim 1, and Sheps teaches wherein the anchor driver is configured such that, while the head remains engaged with the tissue anchor within the subject, the stiffening element is repositionable from outside of the subject in a manner that transitions the anchor driver from the first state to the second state (Fig. 2, 8a-9b, 10g, head 38 is engaged with the tissue anchor 32 within the heart of the subject, and stiffening element 1926 is slidable within a lumen of the anchor driver 61, the presence of the stiffening element 1926 stiffens the anchor driver 61 and removal of the stiffening element by the operating physician pulling it out causes the anchor driver 61 to become less stiff, paragraph 573, 645-649).
Regarding claim 16, Zipory discloses a system for use at a heart of a subject (Fig. 1a-f, 3a-c, paragraph 3, 154-155), comprising:
an implantable device (140, Fig. 3a-c) comprising a tissue anchor (40, Fig. 1a-f, 3c);
an anchor driver (60), transluminally advanceable to the heart (Fig. 3a-c, paragraph 137-138, 154-155), and comprising:
a shaft (64);
a head (62), coupled to the shaft at a distal part of the anchor driver (as seen in Fig. 1a-f, paragraph 138), and configured to engage the tissue anchor (paragraph 139-141); and
Zipory is silent on a stiffening element that, while the head remains engaged with the tissue anchor within the subject, is repositionable from outside of the subject in a manner that transitions the anchor driver between (i) a first state, and (ii) a second state in which the distal part of the anchor driver is stiffer than in the first state.
However, Sheps teaches a similar apparatus for use with a tissue anchor (32, Fig. 2) at a heart of a subject (paragraph 11) comprising an anchor driver (61, Fig. 2) having a stiffening element (1926, Fig. 16a-b) that is repositionable from outside of the subject in a manner that transitions the anchor driver between (i) a first state, and (ii) a second state in which the distal part of the anchor driver is stiffer than in the first state (paragraph 645-649, stiffening element (1926) is slidable within a lumen of the anchor driver (61), the presence of the stiffening element (1926) stiffens the anchor driver (61) and removal of the stiffening element by the operating physician pulling it out causes the anchor driver (61) to become less stiff) while the head of the anchor driver remains engaged with the tissue anchor within the subject (Fig. 2, 8a-9b, 10g, anchor driver 61 has a head 38 that is engaged with the tissue anchor 32 within the heart of the subject, paragraph 573, 645-649).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zipory with the teachings of Sheps in order to modify the stiffness of the anchor driver and provide variable levels of driver reinforcement when driving the anchor.
Regarding claim 17, the combination of Zipory and Sheps teaches the limitations of claim 16, and the combination further teaches wherein: in the first state, the head is articulatable with respect to the shaft (modified anchor driver of Zipory with the teachings of Sheps allows the head (62) to articulate with respect to the shaft (64) since the stiffening element (1926) taught by Sheps is removed by the operating physician allowing the shaft to be flexible), and the manner that transitions the anchor driver from the first state to the second state is inhibition articulation of the head with respect to the shaft (when the stiffening element (1926) of Sheps is slidably moved towards the head (62) of Zipory, the shaft (64) becomes stiffer therefore inhibiting movement of the head).
Regarding claim 18, the combination of Zipory and Sheps teaches the limitations to claim 16, and the combination further teaches wherein the manner that transitions the anchor driver from the first state to the second state is stiffening of the shaft (when the stiffening element (1926) of Sheps is slidably moved distally toward the head (62) of Zipory, the shaft (64) becomes stiffer).
Regarding claim 19, the combination of Zipory and Sheps teaches the limitations to claim 16, and the combination further teaches wherein the anchor driver is transitionable between the first state and the second state via axial repositioning of the stiffening element (the stiffening element (1926) of Sheps is slidably moved to adjust stiffness as taught in paragraph 647-648).
Regarding claim 20, the combination of Zipory and Sheps teaches the limitations to claim 16, and the combination further teaches wherein the anchor driver is transitionable between the first state and the second state via rotational repositioning of the stiffening element (paragraph 472, 647, the anchor driver (61) of Sheps comprises a rotating component 36 as seen in Fig. 2, thus rotating the rotating component 36 rotates the stiffening element (1926) as it is within the lumen of the anchor driver (61)).
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Zipory and Sheps as applied to claim 1 above, and further in view of US 20100305475 Hinchliffe (hereinafter Hinchliffe).
Regarding claim 9, the combination of Zipory and Sheps teaches the limitations of claim 1.
The combination is silent on wherein the head is shaped so as to define at least one slotted opening, the slotted opening defining a wider main section and a narrower extreme section.
However, Hinchliffe teaches a medical guidewire system with slidable inner and outer members for adjusting stiffness of the guidewire system (abstract, paragraph 14-23) having a distal end head shaped to define a slotted opening (228, Fig. 13, 13b, paragraph 97), the slotted opening defining a wider main section (228a, Fig. 14-16, paragraph 97) and a narrower extreme section (228b, Fig. 14-16, paragraph 97), the slotted opening configured to receive a pin (233, Fig. 14-16) of a stiffening element (230, Fig. 13-16, paragraph 97).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention modify the modification of Zipory with Sheps with the teachings of Hinchliffe to have wherein the head is shaped so as to define at least one slotted opening, the slotted opening defining a wider main section and a narrower extreme section in order to provide a secure locking mechanism that fixes axial positioning of the stiffening element as disclosed by Hinchcliffe (paragraph 97).
Regarding claim 10, the combination of Zipory, Sheps and Hinchliffe teaches the limitations of claim 9, and Hinchliffe further teaches wherein the stiffening element (230, Fig. 13-16) comprises a coupling pin (233, Fig. 14-16) coupled to the shaft and disposed within the at least one slotted opening (as seen in Fig. 15-16, paragraph 97).
Regarding claim 11, the combination of Zipory, Sheps and Hinchliffe teaches the limitations of claim 10, and the combination further teaches wherein the anchor driver is configured to, via rotation of the shaft, transition: into the first state by the coupling pin becoming disposed within the wider main section (modified anchor driver of Zipory with the teachings of Sheps and further modified with the teachings of Hinchliffe has the coupling pin 233 of Hinchliffe disposed within the wider main section 228, paragraph 97, as seen in Fig. 15), and into the second state by the coupling pin becoming disposed within the narrower extreme section (paragraph 97, as seen in Fig. 16, the coupling pin 233 of Hinchliffe disposed within the narrower extreme section 228b).
Regarding claim 12, the combination of Zipory, Sheps and Hinchliffe teaches the limitations of claim 10, and Hinchliffe further teaches wherein the shaft is rotatable about a longitudinal axis thereof with respect to the head so as to transition the coupling pin between the wider main section and the narrower extreme section (paragraph 97, Fig. 15-16, rotation of stiffening element 230 rotates the pin 233 from the wider main section 228a into the narrower extreme section 228b).
Allowable Subject Matter
Claims 14-15 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: No prior art references alone or in combination with other references teaches each and every limitation of the independent claims. The closest art of record is Zipory and Sheps.
Regarding claim 14, the combination of Zipory and Sheps teaches the limitations of claim 1, however does not teach wherein the anchor driver is configured to be stiffened by the stiffening element being advanced distally toward the head while the head remains engaged with the tissue anchor within the subject.
Regarding claim 15, the combination of Zipory and Sheps teaches the limitations of claim 1, however does not teach wherein the stiffening element is repeatedly repositionable to repeatedly transition the anchor driver between the first state the second state while the head remains engaged with the tissue anchor within the subject.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KHOA TAN LE/Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771
