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Claims 5 and 20 have been withdrawn from consideration.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's election with traverse of the following species in the reply filed on 09/19/2025 is acknowledged. As an initial note, there are no provisional elections, so the applicant’s election have been accepted as a standard election with traverse.
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)
The traversal is on the ground(s) that argues that the species election creates challenges rather than facilitating examination. This argument is not persuasive because the species election focuses the examination process to a single invention which allows for more efficient searching and examination. Especially due to the complex nature of the applicant’s invention and the field of endeavor, species requirements may be more common in this field compared to other fields of endeavor. The applicant then contends that the requirement is improper because it contains excessive species. The number of species is based on the disclosure by the applicant. The examiner has no control over the number of species the applicant provides within their application. As previously explained numerous times to the applicant, this application discloses the different species in overlapping figures and disclosures. The applicant has provided over 100 pages of drawings including over 150 Figures described throughout over 80 pages of specification. This is why the examiner reached out to the applicant for help numerous times in identifying the different species and which aspects they wanted to pursue. Since the applicant would not identify their disclosed species and changed their mind on identifying which embodiments are obvious variants the examiner grouped the species as best understood. Since the disclosure is so inclusive the examiner created the species requirements to be as complete as possible in order to prevent introduction of conflicting subject matter of species that could be later claimed. The applicant further argues that species 1 and 2 of group 12 are not different embodiments. However, the original disclosure specifically states in [0070] that Figure 56 discloses embodiments of handles. Since the plural was used the examiner lets this open for the applicant to clarify. Additionally, it is unclear then why the applicant elected species 2 for group 12 if species 1 is not a different embodiment because no clarification was provided.
Upon further review claims 5 and 20 have been withdrawn as being directed at non-elected embodiments. The applicant elected the interlock of Figures 76A-H, which clearly shows the movement as a rotation because it turns. A slide requires additional movement across a surface and a combination of rotation and sliding would require both turning and movement (such as a cylinder rolling down an incline). There is no explanation or depiction of a sliding interlock within the original disclosure outside of a general statement in [0018] and original claims. Therefore, the elected embodiment is considered to be directed at just a rotating interlock.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The Information Disclosure Statements filed on 06/27/2024 (x3) and 09/16/2024 has been considered by the examiner.
Applicant should note that the large number of references (90 pages) in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). It appears that not all of the cited references are relevant to the patentability of the claims. For example cited references include:
WO 99/66967 is directed at a process for preparing soft tissue.
WO2015/057289 is directed at a pressure measuring guidewire.
3874338 is directed at a milking cup.
4641366 is directed at a portable radio.
Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Additionally, a major portion many of the foreign documents are incomplete with numerous missing pages marked “not available”. The applicant must provide the missing parts of these documents so that they can be properly reviewed
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the interlock comprising a male/female connection of Claim 13 (the interlock is disclosed as only having one part of the male/female connection not both as required by claim 8) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are further objected to for inconsistent and illogical numbering. For example sometimes the drawings will have Figure 40, Figure 40A, and Figure 40B, but other times the drawings only have Figure 28A and Figure 28B. It is unclear why they are skipping the base number with no characters sometimes but not others. Additionally, it is unnecessary for the drawings to continue to use the same base reference number and modify it with numerous characters rather than just changing the base number. For example, there is no Figure 15, but there are Figures 15A-Figure 15AC4. The application must be consistent with the numbering pattern.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: missing/outdated priority information. Since the filing of this application at least one of the parent applications have been issued patent numbers. The priority information within the first line of the specification must be amended to disclose these patent numbers.
Appropriate correction is required.
Additionally, since the applicant did not address the issues pointed out previously, the disclosure is objected to under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, which requires the specification to be written in “full, clear, concise, and exact terms.” The specification is replete with terms which are not clear, concise and exact. The specification should be revised carefully in order to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112. Examples of some unclear, inexact or verbose terms used in the specification are: repeating the same reference number twice when referring to multiple components (90 is used to refer to proximal element actuators and proximal element lines), using the wrong character A when B is intended, describing the same reference number with different phrases (90 is described as proximal element lines sometime and just lines other times) describing a figure by referring to a reference number only shown in other figures ([0119] described Figure 8B with reference number 58 which is not shown), the brief description of the drawings is not properly broken down (Fig. 2B should have its own paragraph), failing to briefly describe all drawings by referring to the wrong drawing number ([0046] should say Figures 29A-29B not 29A-28B). The applicant is requested to do a complete review of all Figures and Drawings.
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.
Claims 1-16 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.
Lines 31-32 of claim 1 refer to “the second handle” but there are no previous references to a second handle. There is only a single handle or a second proximal element line handle. The applicant is advised to amend this recitation to read “the second proximal line handle”.
Line 33 of claim 1 refers to “a second configuration”, but this configuration has already been defined in lines 30-31. The applicant is advised to amend this recitation to read “the second configuration”.
Claim 13 is rendered indefinite by the requirement for the interlock to comprise the male/female connection. The connection is described properly in claim 8 where the interlock only has a portion of the connection. It is unclear how a single portion of a connection can be claimed to comprise the entire connection. The applicant is advised to cancel claim 13 because this limitation is sufficiently addressed in claim 8.
Line 2 of claim 16 refers to “the fixation device”, but the device has already been defined in line 2 of claim 1 as “an implantable fixation device”. Additionally it was referenced in the body of claim 1 as “the implantable fixation device”. Therefore claim 16 is either improperly referring back to this device or introducing a new fixation device. The applicant is advised to amend this recitation to read “the implantable fixation device”.
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.
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, 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 is 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 comprises a male-female connection (In view of the 112 rejection the combination discloses the structure that reads upon this limitation as much as the applicant’s own invention).
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 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.
Martinex 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 Martinex 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.
Examiner’s Comment
In order to advance prosecution the applicant is advised to amend the claims to better define the shape and structure of the interlock.
Conclusion
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).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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