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 .
Priority
This application claims priority from provisional application 62/874,327, filed 07/15/2019.
Status of Claims
Claims 1-20 are pending.
Claims 5 and 20 have been withdrawn from consideration.
Election/Restrictions
Applicant elected the following species with traverse on 09/19/2025.
Group 1 (Fixation Devices): Species 1 (Figures 3A-C).
Group 2 (Delivery Instrument): Species 2 (Figures 7A-14)
Group 3 (Proximal Line Handles): Species 1 (Figures 5AC1)
Group 4 (Coupling Mechanisms): Species 3 (Figures 15Y1-15Y3)
Group 5 (Flexible Cable Rods): Species 4 (Figures 32A-B)
Group 6 (Delivery Catheter Shafts): Species 3 (Figure 39)
Group 7 (Fixation Device Locking Mechanism): Species 1 (Figures 19-20)
Group 8 (Lock Line Arrangements): Species 2 (Figure 41B)
Group 9 (Proximal Element Line Arrangements): Species 2 (Figure 42B)
Group 10 (Catheter Steering Mechanisms): Species 1 (Figure 52A)
Group 11 (Steerable Catheter Construction): Species 4 (Figures 54A-C)
Group 12 (Handles): Species 2 (Figures 56-57)
Group 13 (End Caps): Species 1 (Figure 73)
Group 14 (Interlocks): Species 2 (Figures 76A-H)
Drawings
The objections to the drawings have been withdrawn in view of the applicant’s arguments/amendments to claim 13. With respect to the formatting the applicant argues that it would be too burdensome. Ultimately the formatting is up to the applicant and since there appears to be no missing figures the objection has been withdrawn. However, the applicant is on notice that further applications should have more consistent numbering for clarity of the record.
Specification
The objections to the specification have been withdrawn in view of the applicant’s arguments/amendments.
Claim Rejections - 35 USC § 112
The previous 112 rejections have been withdrawn in view of the applicant’s arguments/amendments.
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.
Claim(s) 1-4, 6, 8, and 11-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dell et al (Dell) US 2013/0066342 A1 in view of Muhlbauer et al (Muhlbauer) USPN 6,499,630 B2.
Dell discloses the invention substantially as claimed being:
1. Dell discloses a fixation system for fixation of tissue comprising:
an implantable fixation device 14 comprising: a first arm and a second arm (18 Figure 7), a first proximal element (16 Figure 7) moveable relative to the first arm between a first position and a second position, and a second proximal element (16 Figure 7) moveable relative to the second arm between a first position and a second position (Dell discloses the same figures as the applicant so they inherently move in the same manner); and
a delivery device (Figures 8A-9B) comprising: a catheter 86 having a proximal end portion and a distal end portion (top and bottom of catheter in Figures 8A-9B), the catheter defining at least one lumen extending between the proximal end portion and the distal end portion (inner lumen of 86 shown in Figures 8A and 9A), and the distal end portion being configured to releasably couple to the implantable fixation device (Figure 8A), a first proximal element line 90 extending through the at least one lumen (Figure 8A), the first proximal element line being configured to releasably couple to the first proximal element and to move the first proximal element between the first position and the second position upon the actuation of the first proximal element line (Dell discloses the same figures as the applicant so they inherently move in the same manner), a second proximal element line 90 extending through the at least one lumen (Figure 8A), the second proximal element line being configured to releasably couple to the second proximal element and to move the second proximal element between the first position and the second position upon the actuation of the second proximal element line (Dell discloses the same figures as the applicant so they inherently move in the same manner), and a handle (304 Figure 15AC1) coupled to the proximal end portion of the catheter (Figure 15AC1) and having: a first proximal element line handle 393A coupled to the first proximal element line and being actuatable to actuate the first proximal element line to move the first proximal element between the first position and the second position [0161], a second proximal element line handle 393B coupled to the second proximal element line and being actuatable to actuate the second proximal element line to move the second proximal element between the first position and second position [0161].
17. Dell discloses a fixation system for fixation of tissue comprising:
an implantable fixation device 14 comprising: a first arm and a second arm (18 Figure 7), a first proximal element (16 Figure 7) moveable relative to the first arm between a first position and a second position, and a second proximal element (16 Figure 7) moveable relative to the second arm between a first position and a second position (Dell discloses the same figures as the applicant so they inherently move in the same manner); and
a delivery device (Figures 8A-9B) comprising: a catheter 86 releasably coupled to the implantable fixation device (Figure 8A), and a handle (304 Figure 15AC1) coupled to the catheter and having a first proximal element actuator 393A operably coupled to the first proximal element and being actuatable to move the first proximal element between the first position and the second position [0161], a second proximal element actuator 393B operably coupled to the second proximal element and being actuatable to move the second proximal element between the first position and second position [0161].
However, with respect to both independent claims, Dell does not disclose the interlock component connecting the element line handles.
Muhlbauer teaches the use of an interlock (4’ Figures 4-5) connected to a first proximal element line handle 3’ and being moveable relative thereto between a first configuration and a second configuration (Figures 4-5), wherein in the first configuration, the interlock engages the second handle 13’ so as to couple the first and second proximal element line handles together for simultaneous actuation thereof (Figure 4), and a second configuration in which the interlock is disengaged from the second proximal element line handle while still being connected to the first proximal element line handle for independent actuation of the first and second proximal element line handles (Figure 5) in the same field of endeavor for the purpose of linking the actuation of each line handle so that they function in sync.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the interlock structure of Muhlbauer with the ends of the proximal element line handles of Dell in order to enable the two lines to be actuated simultaneously and uniformly.
2. Dell discloses the first and second proximal element line handles are each configured to move in a proximal-distal direction relative to a housing of the handle (Dell discloses the same implant and lines as the applicant so they inherently move in the same manner), and the first and second proximal element line handles are arranged parallel to each other (Figure 15AC1).
3. Dell discloses the first and second proximal element line handles are offset from each other (Figure 15AC1 shoes them offset because they are spaced apart ).
4. The combination discloses the interlock is rotatably connected to the first proximal element line handle (the interlock of Muhlbauer can be interpreted to be just portion 32 which is rotatably coupled to the first line element handle 3’ through portion 4’ Figures 4-5) and is rotatable between the first and second configurations (Figures 4-5 of Muhlbauer).
6. The combination discloses the interlock includes a latch 4’ and a locking lever 32 projecting outwardly from the latch for manipulation of the latch between the first and second configurations (Figures 4-5).
8. The combination discloses the interlock and the second proximal element line handle define a male-female connection (the interlock recess 35 or 31is considered the female portion and the rounded post surface of the handle is considered the male portion Figures 4-5).
11. The combination discloses the first proximal element line handle is translatable along a first axis thereof (into the page of Figure 4), and the interlock is moveable between the first and second configurations in a direction transverse to the first axis (along the plane of the page Figures 4-5).
12. The combination discloses the interlock projects outwardly from the first proximal element line handle (Figure 4 of Muhlbauer).
13. The combination discloses the interlock (Figures 4-5 of Muhlbauer) comprises a latch (32 swings to function as a latch as shown in Figures 4-5 of Muhlbauer) and a recess (31 is a recess in the main body that receives the protrusion adjacent 35 of the latch of Muhlbauer) that together define a male-female connection between the first and second proximal element line handles (as seen in Figures 4-5 of Muhlbauer the latch and recess act together to define a connection between the first and second line handles 3’/13’ because they directly secure the two handles together).
14. The combination discloses the first and second proximal element line handles are arranged adjacent to each other so as to form a gap therebetween (Figure 15AC1 of Dell), and the interlock is configured to span the gap when in the second configuration (Figures 4-5 of Muhlbauer show the interlock spanning the entire space between handles).
15. Dell discloses the first and second proximal element line handles each include a tube (393A/B Figure 15AC1 and ) that is configured to receive at least a portion of the first and second proximal element lines (Dell discloses the same implant and catheter as the applicant’s own invention so it inherently houses the lines within the tubes of the handles in the same manner as the current application), respectively, and to move relative to a housing of the handle during actuation of the respective first and second proximal element line handles (Dell discloses the same implant and catheter as the applicant’s own invention so it inherently houses the lines within the tubes of the handles in the same manner as the current application).
16. Dell discloses the delivery device includes an actuator rod (12 Figure 7) releasably coupled to the implantable fixation device and operable to move the first and second arms between an open position and a closed position, and the handle includes an actuator rod control knob configured to actuate the actuator rod upon rotation thereof relative to a housing of the handle (Dell discloses the same implant and catheter as the applicant’s own invention so it inherently has the same actuator rod as the current application rear portion of figure 15AC1 behind the handles).
18. The combination discloses the first proximal element actuator translates along a first axis (into the page of Figure 4 Muhlbauer), the second proximal element actuator translates along a second axis (into the page of Figure 4 Muhlbauer), and the interlock moves between the locked and unlocked positions in a direction transverse to the first and second axes (along the plane of the page Figures 4-5 Muhlbauer).
19. The combination discloses the first and second axes are parallel (both move into the page of Figure 4 Muhlbauer).
Claim(s) 7, 9, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dell and Muhlbauer (Combination 1) as applied to claims 1-4, 6, 8, and 11-19 above, and further in view of Martinez USPN 3,848,276.
Combination 1 discloses the invention substantially as claimed being described above. However, Combination 1 does not disclose the connection between the latch of the interlock and handle comprises a recess in the handle or that they have complementary male/female dovetail shapes.
Martinez teaches the use of a pivoting male dovetail shaped latch 105 that rotates to lock within a female dovetail shaped recess of housing 82 (Right side of Figure 7) in the same field of endeavor for the purpose of preventing axial movement upward along the pivot axis.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the latch connection of Combination 1 such that the handle comprises the female dovetail shaped recess and the interlock latch comprises the outer shape of a male dovetail projection as taught by Martinez in order to provide a locking connection that is more secure in the axial direction to prevent slippage when axial force is applied to the handles.
Response to Arguments
Applicant's arguments filed 04/21/2026 have been fully considered but they are not persuasive.
The applicant argues that the Muhlbauer reference is not analogous art. This is not persuasive because Muhlbauer meets the second prong of the analogous reference standard. Even though Muhlbauer is not in the art of heart implants it is reasonably pertinent to the particular problem with which the inventor was concerned. The applicant defines the problem they are concerned with as: “how to design an interlock for a cardiac catheter delivery handle that allows a surgeon to selectively couple two proximal element line handles such that, when engaged, the proximal elements move at the same angle relative to their respective distal elements, ensuring precise and symmetric leaflet coaptation during a live transcatheter cardiac repair procedure.” In other words, the applicant is concerned with interlocking two handles so that they move together. The applicant then points to Muhlbauer as addressing a fundamentally different problem identified as a “coupling mechanism connects two dental syringe pistons so that equal volumes of resin components are dispensed regardless of the relative fill levels of the syringes. In other words, Muhlbauer is concerned with interlocking two handles so that they move together. The over complication of the description does not change that both the applicant and Muhlbauer are merely connecting two handles that are normally independently movable and interlocking them such that they move uniformly. This is an old and extremely well-known approach to address the common issue of needing two handles moved simultaneously and to the same extent. Therefore, a person of ordinary skill in the art would look to Muhlbauer for the obvious teaching of locking the two handles together, which would provide the obvious benefit of linking their actions together.
The applicant further argues that this combination is based on hindsight and does not provide adequate motivation. As confirmed by the applicant, the office action clearly states the motivation as linking the two lines so that they move simultaneously and uniformly. This motivation is simple and clear there is no need for additional details. The modification links the two handles so that the user does not have to focus on each handle independently constantly ensuring that both are moving simultaneously and uniformly.
With respect to the claims 8 and 13 the applicant argues that Muhlbauer fails to disclose the claimed elements. Each element has been clearly identified and provided with additional explanation for clarity. The applicant argues that handle 13’ is just a rod and that there is no recess on it. This is not persuasive because the claims do not require the second element handle to have a recess. Claim 8 merely requires it to be part of a male-female connection. The combination discloses the interlock and the second proximal element line handle define a male-female connection (the interlock recess 35 or 31is considered the female portion and the rounded post surface of the handle is considered the male portion Figures 4-5). The rod acts as a protrusion which is received by multiple recesses in the latch, thereby allowing it to anticipate the broad male-female connection. Claim 13 requires the interlock to comprise the recess/latch and for it to form a connection between the handles. The combination discloses the interlock (Figures 4-5 of Muhlbauer) comprises a latch (32 swings to function as a latch as shown in Figures 4-5 of Muhlbauer) and a recess (31 is a recess in the main body that receives the protrusion adjacent 35 of the latch of Muhlbauer) that together define a male-female connection between the first and second proximal element line handles (as seen in Figures 4-5 of Muhlbauer the latch and recess act together to define a connection between the first and second line handles 3’/13’ because they directly secure the two handles together). Therefore there is no requirement for the second handle to have any additional recess/male structure.
With respect to claims 7, 9, and 10, the applicant uses the same reasoning as above to call Martinez non-analogous art outside of the field of endeavor. Again, Martinez satisfies the second prong of the analogous reference standard. Even though Martinez is not in the art of heart implants it is reasonably pertinent to the particular problem with which the inventor was concerned. The problem being forming a dovetail shaped recess that secures the latch to the second handle. As explained above the modification in view of Martinez addresses this problem by providing a locking connection that is more secure in the axial direction to prevent slippage when axial force is applied to the handles.
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 CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774
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