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
The amendment filed 03/16/2026 has been entered. Claims 1-12, 14 and 16-25 remain pending in the application, claims 13 and 15 are cancelled, claims 21-25 are withdrawn, and claim 26 is added. Applicant’s amendments to the claims have overcome each claim objection, however has not overcome the interpretation of the rejection previously set forth in the Non-Final Office Action mailed 09/18/2025.
Response to Arguments
Applicant's arguments filed 03/16/2026 have been fully considered but they are not persuasive.
Applicant argues on pages 9-10 that the Office is misapplying the law and that the Office errors in replying on its assertion that the alleged distal and proximal parts of Dahlgren are capable of being a housing as somehow providing its missing rationale for the specific placement of the flexible join located in the combination of Hiorth, and that the Office is still missing a motivation to combine the references to insert the flexible joint between anchors as it alleged in the combination in the first place. The Office respectfully disagrees. The anchors are only functionally recited, and thus the proximal part and distal part only needs to be capable of housing its respective anchor. The prior art of Hiorth clearly discloses such features in figures 1-14; paragraphs 76-78. The relationship between the flexible joint and the papillary anchor/leaflet anchor needs only to be functional since the papillary anchor/leaflet anchor are never positively recited. Thus, the secondary reference of Dahlgren who teaches a flexible joint between a distal part and a proximal part may be combined to the catheter device of Hiorth in between Hiorth’s proximal part 4 and distal part 8. Although Dahlgren does not explicitly show a flexible joint between a proximal part housing a leaflet anchor and a distal part housing a papillary anchor, the anchors are only functionally claimed and Dahlgren’s flexible joint is shown between a proximal part and distal part.
Applicant argues on pages 10-12 that the Office lacks a motivation to combine Hiorth and Dahlgren as the Office’s mapping is not correct in that the alleged proximal and distal parts are arbitrary distal and proximal parts of the flexible joint itself and the arbitrary portions do not house multiple anchors. The flexible joint 1107 of Dahlgren includes the most proximal articulation link or joint 1115, and includes all of the articulation links or joints 1102-1116. Therefore, because the articulation mechanism 1107 includes articulation link or joint 1115, articulation mechanism cannot be between articulation link or joint 1115. The Office respectfully disagrees. The proximal part of Dahlgren is never cited to as element 1115, it is cited as the element that is proximal to joint 1115. The Applicant may be incorrectly mapping Dahlgren’s proximal part to element 1115, however that is not the case. The rejection is maintained.
Applicant argues on page 12 that Dahlgren’s flexible joint does not enable “a centreline of the distal part to be angled relative to a centreline of the proximal part such that the papillary anchor housed in the distal part can be angled relative to the proximal part arranged to house the leaflet anchor during deployment of the papillary anchor for attachment to the papillary muscle.” As stated above, the anchors are functionally recited and thus do not need to be disclosed as part of the structural combination. In any case, the anchors are still recited as being part of the two-part housing of Hiorth. Dahlgren teaches the flexible joint between a proximal part and a distal part, the distal part 1112 is shown to house an anchor 1109 as well (although this is not a requirement since it is a functional limitation). The rejection is maintained.
Applicant argues on pages 13-15 that the distal portion does not house an anchor and the proximal portion does not house an anchor, and then cites to Dahlgren who does not disclose such features. However, the Office relies on Hiorth to disclose such features, not Dahlgren. Dahlgren teaches the flexible joint between a proximal part and a distal part, and therefore the rejection is maintained.
Applicant argues on pages 15-16 that assuming arguendo a hypothetical combination could be made, a different configuration would result, specifically the articulation mechanism 1107 of Dahlgren would be proximal to the two-part housing and both anchors of Hiorth. The Office respectfully disagrees. The distal part of Dahlgren is element 1112 that extends from the flexible joint 1107. The proximal part is the element that is proximal to the most proximal link 1115. This configuration is similar to that of Hiorth, where the distal part 8 and the proximal part 4 are separated from each other. Thus, applying the flexible joint of Dahlgren in between the proximal part and distal part of Hiorth would have been obvious to one of ordinary skill in the art, especially when the motivation is taught in Dahlgren’s paragraph 25 to be manipulable to a size and dimension to be deliverable via a catheter and in an deployed configuration the segments form a structure sufficiently rigid to affect a shape of the orifice in the tissue when the implant member is positioned to physically couple with the embedded tissue anchors. Therefore, the rejection is maintained.
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: “leaflet anchor deployment mechanism” in claim 1; “papillary anchor deployment mechanism” in claim 1.
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.
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 § 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.
Claims 1-12, 14, 16, 18-20, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Hiorth et al. (US PGPub 2017/0252032) in view of Dahlgren et al. (US PGPub 2011/0082538), hereinafter known as “Hiorth” and “Dahlgren,” respectively.
With regards to claim 1, Hiorth discloses (Figures 1-36) a catheter device (figures 1-3) for implanting a leaflet anchor 10 and a papillary anchor 9 into a heart as part of a procedure for implanting an artificial chordae line 14 that extends between the leaflet anchor 10 and the papillary anchor 9 (Abstract; paragraphs 32-35), the catheter device comprising:
a two-part housing section 4/8 extending from a distal end of the catheter device along a length of the catheter device toward a proximal end of the catheter device (figures 1-3), the two-part housing section 4/8 being arranged to be placed between a papillary muscle 26 and a leaflet 12 of the heart during use of the catheter device, and the two-part housing section 4/8 comprising a distal part 8 at the distal end of the catheter device and a proximal part 4 located on a proximal side of the distal part 8 (paragraph 76), wherein the proximal part 4 is arranged to house the leaflet anchor 10 and the distal part 8 is arranged to house the papillary anchor 9 (figures 1-14; paragraphs 76-78);
a leaflet anchor deployment mechanism 6 (see Note below) at the proximal part 4 of the two-part housing section 4/8 for deploying the leaflet anchor 10 for attachment to the leaflet 12 of the heart (paragraph 78);
a papillary anchor deployment mechanism 20 (see Note below) at the distal part 8 of the two-part housing section 4/8 for deployment of the papillary anchor 9 for attachment to the papillary muscle 26, wherein the papillary anchor deployment mechanism 20 is arranged for deployment of the papillary anchor 9 by moving it outward in a distal direction relative to the distal part 8 (paragraph 85).
Note – 112(f) interpretation – Applicant’s leaflet anchor deployment mechanism is a mechanical gripper for gripping the leaflet during deployment of the leaflet anchor (page 38 lines 20-23); Hiorth’s leaflet anchor deployment mechanism is a gripper arm that grips the leaflet and pushes out the leaflet anchor (paragraphs 78 and 81-82 of Hiorth); therefore both leaflet anchor deployment mechanisms are equivalent in gripping the leaflet during deployment of the leaflet anchor.
Note – 112(f) interpretation – Applicant’s papillary anchor deployment mechanism is a wire or rod for pushing the papillary anchor in the distal direction (page 16 lines 25-30); Hiorth’s papillary anchor deployment mechanism is a catheter that pushes out the papillary anchor in the distal direction (paragraph 85 of Hiorth); therefore both papillary anchor deployment mechanisms are equivalent in pushing out the papillary anchor in the distal direction.
Hiorth is silent to a flexible joint located between the proximal part arranged to house the leaflet anchor and the distal part arranged to house the papillary anchor, wherein the flexible joint allows a centreline of the distal part to be angled relative to a centreline of the proximal part such that the papillary anchor housed in the distal part can be angled relative to the proximal part arranged to house the leaflet anchor during deployment of the papillary anchor for attachment to the papillary muscle.
However, in a similar field of endeavor of implanting anchors, Dahlgren teaches (Figure 11) a flexible joint 1107 located between the proximal part (proximal of link 1115) and the distal part 1112, wherein the flexible joint 1107 allows a centreline of the distal part 1112 to be angled relative to a centreline of the proximal part (see figure 11; paragraphs 161-162).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter device of Hiorth to include a flexible joint as taught by Dahlgren for the purpose of being manipulable to a size and dimension to be deliverable via a catheter and in an deployed configuration the segments form a structure sufficiently rigid to affect a shape of the orifice in the tissue when the implant member is positioned to physically couple with the embedded tissue anchors (paragraph 25 of Dahlgren).
The combination of Hiorth in view of Dahlgren results in wherein the flexible joint (1107 of Dahlgren) allows a centreline of the distal part (8 of Hiorth) to be angled relative to a centreline of the proximal part (4 of Hiorth) such that the papillary anchor (9 of Hiorth) housed in the distal part (8 of Hiorth) can be angled relative to the proximal part (4 of Hiorth) arranged to house the leaflet anchor (10 of Hiorth) during deployment of the papillary anchor (9 of Hiorth) for attachment to the papillary muscle (26 of Hiorth).
With regards to claim 2, it would be obvious to modify the catheter device of Hiorth to include a flexible joint as taught by Dahlgren. Dahlgren further discloses wherein the flexible joint 1107 is also an extendable joint (paragraph 162 – “when inserting articulation mechanism 1107 into the left atrium, it may be preferable to cause the distal links, such as articulation link or joint 1113 and articulation link or joint 1114, to separate or bend” – separation causes an extension). Thus, when incorporating the flexible joint of Dahlgren, the claimed limitation is considered obvious.
With regards to claim 3, it would be obvious to modify the catheter device of Hiorth to include a flexible joint as taught by Dahlgren. Dahlgren further discloses wherein the flexible joint 1107 allows the distal part 1112 to be moved away from the proximal part to thereby extend the distal end of the catheter device further into the heart (paragraph 162 – “when inserting articulation mechanism 1107 into the left atrium, it may be preferable to cause the distal links, such as articulation link or joint 1113 and articulation link or joint 1114, to separate or bend” – separation causes an extension and would thus extend further into the heart). Thus, when incorporating the flexible joint of Dahlgren, the claimed limitation is considered obvious.
With regards to claim 4, it would be obvious to modify the catheter device of Hiorth to include a flexible joint as taught by Dahlgren. Dahlgren further discloses wherein the flexible joint 1107 consists of a single part (any one of the distal links/joints 1113 or 1114) providing both the flexing and extending functions (paragraph 162 – “when inserting articulation mechanism 1107 into the left atrium, it may be preferable to cause the distal links, such as articulation link or joint 1113 and articulation link or joint 1114, to separate or bend” – separation causes an extension, bending causes flexing). Thus, when incorporating the flexible joint of Dahlgren, the claimed limitation is considered obvious.
With regards to claim 5, it would be obvious to modify the catheter device of Hiorth to include a flexible joint as taught by Dahlgren. Dahlgren further discloses wherein the flexible joint 1107 is configured to bend independently of its extending; and/or
wherein the flexible joint 1107 is configured to extend independently of its bending (paragraph 162 – “when inserting articulation mechanism 1107 into the left atrium, it may be preferable to cause the distal links, such as articulation link or joint 1113 and articulation link or joint 1114, to separate or bend” (emphasis added) – separation causes an extension, bending causes flexing). Thus, when incorporating the flexible joint of Dahlgren, the claimed limitation is considered obvious.
With regards to claim 6, it would be obvious to modify the catheter device of Hiorth to include a flexible joint as taught by Dahlgren. Dahlgren further discloses wherein the flexible joint 1107 is provided with mechanical shielding internally (paragraph 162 – springs 1108 and 1102 between the links/joints) for preventing wires, chordaes or tissue from getting pinched by the joint 1107 (functional limitation – mechanical springs located internally assists in the bending/extending of the joint 1107 so as to navigate the distal part and prevent wires, chordaes or tissue from getting pinched by the joint 1107). Thus, when incorporating the flexible joint of Dahlgren, the claimed limitation is considered obvious.
With regards to claim 7, it would be obvious to modify the catheter device of Hiorth to include a flexible joint as taught by Dahlgren. Dahlgren further discloses wherein the flexible joint 1107 includes a hinge element (distal link/joint 1114), the hinge element 1114 coupling the distal part 1112 to the proximal part (proximal of link 1115; figure 11). Thus, when incorporating the flexible joint of Dahlgren, the claimed limitation is considered obvious.
With regards to claim 8, it would be obvious to modify the catheter device of Hiorth to include a flexible joint as taught by Dahlgren. Dahlgren further discloses wherein the hinge element 1114 is controlled via one or more hinge pullwires, the one or more hinge pullwires are configured to control actuation of the hinge element 1114 such that the distal part 1112 bends relative to the proximal part (paragraph 162 – “Articulation mechanism 1107 may be curved using wires (not shown) that are carried on opposing sides relative to a longitudinal axis of the articulation mechanism and fixed to the distal end of the articulation mechanism 1107” – wires on opposite sides attached to the distal end of flexible joint 1107 (which is link 1114 according to figure 11) are used to curve the distal part 1112). Thus, when incorporating the flexible joint of Dahlgren, the claimed limitation is considered obvious.
With regards to claim 9, it would be obvious to modify the catheter device of Hiorth to include a flexible joint as taught by Dahlgren. Dahlgren further discloses wherein the one or more hinge pullwires are radially offset from a central axis of the catheter device (paragraph 162 – “Articulation mechanism 1107 may be curved using wires (not shown) that are carried on opposing sides relative to a longitudinal axis of the articulation mechanism and fixed to the distal end of the articulation mechanism 1107” – wires on opposite sides relative to a longitudinal axis means the wires are radially offset from the central axis, wires are attached to the distal end of flexible joint 1107 (which is link 1114 according to figure 11)). Thus, when incorporating the flexible joint of Dahlgren, the claimed limitation is considered obvious.
With regards to claim 10, it would be obvious to modify the catheter device of Hiorth to include a flexible joint as taught by Dahlgren. Dahlgren further discloses wherein the one or more hinge pullwires are arranged such that, when in use, actuation of the one or more hinge pullwires bends the distal part 1112 of the two-part housing section and deflects a device shaft of the catheter device in the same direction as the bending of the distal part 1112 (paragraph 162 – “Articulation mechanism 1107 may be curved using wires (not shown) that are carried on opposing sides relative to a longitudinal axis of the articulation mechanism and fixed to the distal end of the articulation mechanism 1107” – wires on opposite sides attached to the distal end of flexible joint 1107 (which is link 1114 according to figure 11) are used to curve the distal part 1112. The distal part 1112 is akin to the distal part 8 of Hiorth and thus would also deflect the device shaft of Hiorth in order to deflect anything that is distal of the flexible joint 1107 that is between the proximal part and distal part). Thus, when incorporating the flexible joint of Dahlgren, the claimed limitation is considered obvious.
With regards to claim 11, Hiorth further discloses wherein the papillary anchor 9 is housed within the distal part 8 of the two-part housing section 4/8 before its deployment (paragraph 76), and further comprising:
a steerable catheter 2 located proximal to the two-part housing section 4/8, wherein all anchors 9/10 to be implanted are distal to the steerable catheter 2 (figures 5-14; paragraph 76).
With regards to claim 12, Hiorth further discloses wherein the papillary anchor 9 has the chordae line 14 attached to it and includes a locking mechanism 28 for clamping the chordae line 14 when no force is applied to the locking mechanism 28 (paragraph 87; figures 15-18), and wherein the locking mechanism 28 comprises a locking segment 28 that is able to be elastically deformed to release the chordae line 14 from the locking mechanism 28 for adjustment of a length of the chordae line 14 (paragraphs 22-23 and 87; figures 15-18).
With regards to claim 14, Hiorth further discloses wherein the papillary anchor deployment mechanism 20 includes a piston 18 comprising a piston wedge 44 for holding the locking segment 28 in its elastically deformed position (figure 36), with the papillary anchor deployment mechanism 20 being arranged to selectively withdraw the piston wedge 44 from the locking segment 28 so that the chordae line 14 can be locked in place after deployment of the papillary anchor 9 and after any required adjustment of the length of the chordae line 14 (paragraphs 87 and 107-111; figures 33-36).
With regards to claim 16, Hiorth further discloses wherein:
the leaflet anchor deployment mechanism 6 allows for retraction and repositioning of the leaflet anchor 10 after deployment of the leaflet anchor 10 into the leaflet 12 via an ejector unit 30 having a grasping device (distal end of ejector unit 30 that pushes the leaflet anchor 10) with a first configuration (figure 25) arranged to permit deployment of the leaflet anchor 10 into the leaflet 12 without disengagement of the leaflet anchor 10 from the ejector unit 30 (paragraph 93), and a second configuration (figure 26) in which the leaflet anchor 10 is reversibly released from the ejector unit 30 (paragraph 95 – “If both anchors 9, 10 have been placed and the position is not ideal, the procedure can be reversed”);
in the first configuration (figure 25), the grasping device (distal end of 30) of the ejector unit 30 grasps a proximal end of the leaflet anchor 10, whilst a distal end of the leaflet anchor 10 is unimpeded by the grasping device (distal end of 30) to enable it to be implanted in the leaflet 12 (paragraph 93 – “The U-rod 30 pushes the leaflet anchor 10 when the U-rod wire is pulled”); and
in the second configuration (figure 26), the grasping device (distal end of 30) of the ejector unit 30 is disengaged from the leaflet anchor 10 (paragraph 93).
With regards to claim 18, Hiorth further discloses wherein the leaflet anchor 10 and the papillary anchor 9 comprise a number of hooks (figures 28-32) for engagement with body tissue and having a folded position (figures 28 and 30) and an unfolded position (figures 29 and 31-32; paragraphs 13-14 and 19), wherein the anchor leaflet anchor 10 and the papillary anchor 9 is made of an elastic material such that it can be elastically deformed into the folded position (figures 28 and 30) by application of a constraining force, and will return to the unfolded position (figures 29 and 31-32) when no constraining force is applied, and wherein the hooks are formed with openings along their length (paragraphs 13-14 and 19).
With regards to claim 19, Hiorth further discloses wherein the leaflet anchor 10 can be pushed out of the leaflet anchor deployment mechanism 6 in a direction extending from the distal end of the catheter device toward the proximal end of the catheter device (figures 6-11).
With regards to claim 20, Hiorth further discloses comprising a U-shaped rod 30 for deployment of the leaflet anchor 10 (paragraphs 91 and 93; figures 22-26).
With regards to claim 26, the combination of Hiorth/Dahlgren disclose wherein the one or more hinge pullwires (Dahlgren: paragraph 162) pass through a front of the catheter device proximate the leaflet anchor deployment mechanism (Hiorth: 6) (Dahlgren: paragraph 162 – “Articulation mechanism 1107 may be curved using wires (not shown) that are carried on opposing sides relative to a longitudinal axis of the articulation mechanism and fixed to the distal end of the articulation mechanism 1107” – wires on opposite sides relative to a longitudinal axis means the wires pass through a front of the catheter device (front of the catheter device as described in Applicant’s specification (page 17 lines 20-24) refers to the side of the catheter device shaft where the leaflet anchor deployment mechanism may be located) as the wires pass on opposite sides of the central longitudinal axis to the distal end of the flexible joint 1107. Since the wires pass through the flexible joint 1107, it is interpreted that the wires would also pass through a location that is proximate, or near, the leaflet anchor deployment mechanism 6 of Hiorth).
With regards to claim 27, Hiorth further discloses wherein the proximal part 4 arranged to house the leaflet anchor 10 and the distal part 8 arranged to house the papillary anchor 9 are substantially enclosed (figures 1-2, 5, and 7).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Hiorth in view of Dahlgren, and further in view of Schaffner et al. (US PGPub 2019/0175346), hereinafter known as “Schaffner.”
With regards to claim 17, Hiorth/Dahlgren disclose the catheter device as claimed in claim 1. Hiorth further discloses wherein:
the leaflet anchor deployment mechanism 6 comprises a mechanical gripper device 6 for grasping the leaflet 12 of the heart, wherein the gripper device 6 comprises a leaflet anchor tube (paragraph 12 – “leaflet anchor channel may take the form of a generally cylindrical channel”) for housing the leaflet anchor 10 in a folded configuration (figures 23-24 and 28);
the gripper device 6 and the leaflet anchor 10 being arranged such that when, in use, the gripper device 6 grasps the leaflet 12, the leaflet anchor 10 can be pushed out of the leaflet anchor tube to pierce the leaflet 12 and form the leaflet anchor 10 into an unfolded configuration (figures 26 and 29) so that hooked formations of the leaflet anchor 10 can, in use, secure the leaflet anchor 10 in the leaflet 12 (paragraph 93);
the mechanical gripper device 6 includes a first gripper arm 6 rotatably coupled to a main body of the catheter device so that the first gripper arm can rotate relative to the catheter device to move an outer end of the first gripper arm 6 away from the main body of the catheter device (figure 23).
Hiorth/Dahlgren are silent to a second gripper arm rotatably and/or slideably coupled to the main body of the catheter device so that the second gripper arm can rotate and/or slide relative to the main body of the catheter device to move an outer end of the second gripper arm away from the main body of the catheter device; and
the first and second gripper arms are arranged so that they can move to come into contact with one another at a point spaced apart from the main body of the catheter device.
However, in a similar field of endeavor of implanting anchors, Schaffner teaches (Figures 1-12) a first gripper arm 111/112 and a second gripper arm 80 slidably coupled to the main body 101 of the catheter device so that the second gripper arm 80 can slide relative to the main body 101 of the catheter device to move an outer end of the second gripper arm 80 away from the main body 101 of the catheter device (paragraph 87; figure 12); and
the first 111/112 and second 80 gripper arms are arranged so that they can move to come into contact with one another at a point spaced apart from the main body 101 of the catheter device (figure 12; paragraph 87).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mechanical gripper device of Hiorth/Dahlgren to include a second gripper arm as taught by Schaffner for the purpose of clamping the leaflet between two elements (paragraph 87 of Schaffner) and providing a stronger grip than using a single gripper arm as Hiorth discloses.
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 MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 04/24/2026
/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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