Detailed Action
This is the first office action on the merits for US application number 19/238,875.
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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim(s) 13 is/are unclear with regards to “reattaching the third handle to the second handle of the delivery device after the tension of the flexible segment is adjusted via the second handle” in lines 1-2 and what “is adjusted via the second handle” and how that relates to the reattaching step. Examiner is interpreting this as referring to the tensioning being adjusted via the second handle and suggests amending to clarify, i.e. “ the tension of the flexible segment is adjusted via the second handle”.
Claim(s) 14 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for its/their dependence on one or more rejected base claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Duquesnel et al. (US 2023/0320838, hereinafter “Duquesnel”).
As to claim 1, Duquesnel discloses a system (Figs. 1-7 and 10A-10D, ¶71 discloses that 102 may be loosely positioned within 100 and 90 used only to tighten 102 after a desired suture tension has been obtained) capable of use for approximation of two bones (Figs. 7 and 10A-10D, ¶7), the system comprising: an implant (100, 102, S, Figs. 4A-7 and 10B-10D) comprising a first anchor (100, Figs. 4A, 4B, 7, and 10B-10D), a flexible segment (S, Figs. 7 and 10B-10D), and a second anchor (102, Figs. 5A-7), the first anchor comprising a distal end (lower end as shown in Fig. 7, Fig. 7) capable of insertion into a first hole in a first bone (Fig. 7), the second anchor being capable of engaging with a second bone (if so positioned due to the structure shown in Figs. 5A-7, Figs. 5A-7), and the flexible segment extending between the first and second anchors (Fig. 7); and a delivery device (10, 90, Figs. 1-3, 6A, 6B, and 10A-10D) capable of engaging the implant with the first and second bones (if so positioned due to the structure shown in Figs. 1-7, Figs. 1-7 and 10A-10D), the delivery device comprising: a first handle (portion of 12 to the left of 20, 22 as shown in Fig. 1, Fig. 1); a second handle (50, 32, 70) coupled to the first handle (Figs. 1 and 2); and a third handle (structure labeled as 92 in Fig. 3, Fig. 3) removably coupled to the second handle (Fig. 10), wherein the first, second, and third handles are capable of being rotated simultaneously thereby facilitating the insertion of the first anchor into the first hole of the first bone (Fig. 10B, ¶s 64 and 71; where ¶64 discloses that notches 110 of 100 engage corresponding features of 14 to aid in aligning and stabilizing 100 during tensioning and ¶71 discloses that 102 may be loosely positioned within 100 and 90 used only to tighten 102 after a desired suture tension has been obtained; thus, the handles are capable of simultaneously rotating in order to align the device with 100), wherein the second handle is capable of increasing tension on the flexible segment with the third handle disengaged from the second handle (as shown in Fig. 10C, ¶70 discloses rotating 50 to tension the suture and that 90 can be inserted into 10 after tensioning the suture; thus the second handle is capable of increasing tension while disengaged from the third handle) by pulling one or more proximal ends of the flexible segment in a proximal direction (Fig. 10C, ¶70); and wherein the third handle is capable of being reattached to the second handle after the second handle increases the tension on the flexible segment (Fig. 10D, ¶70), thereby attaching the flexible segment to the second anchor (¶70).
As to claim 2, Duquesnel discloses that the second handle comprises a suture carriage (32, 70) disposed within the delivery device (Fig. 2), the suture carriage capable of rotating (relative to 50, Fig. 2, ¶s 59 and 60) and moving along a longitudinal axis of the delivery device as the second handle is rotated (Fig. 2, ¶s 59 and 60).
As to claim 3, Duquesnel discloses that the suture carriage aids in adjusting the tension on the flexible segment (Fig. 2, ¶s 59 and 60).
As to claim 4, Duquesnel discloses that the second handle is capable of rotating independent of the first handle (Fig. 2, ¶s 59 and 60) after the third handle is disengaged from the second handle (Fig. 10C, ¶70 discloses rotating 50 to tension the suture and that 90 can be inserted into 10 after tensioning the suture; thus the second handle is capable of increasing tension while disengaged from the third handle).
As to claim 5, Duquesnel discloses an internal shaft (structure labeled as 96 in Fig. 3) and a locking component (94).
As to claim 6, Duquesnel discloses that rotation of the third handle is capable of rotating the internal shaft (Fig. 3) capable of engaging the locking component with the flexible segment and the second anchor (Figs. 6A-7), thereby attaching the flexible segment to the second anchor (Fig. 7).
Claim(s) 15, 17, 18, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fallin et al. (US 2022/0000470, hereinafter “Fallin”).
As to claim 15, Fallin discloses a method (Figs. 93-104) of constructing a system (Figs. 52-65 and 66-92) capable of use for approximation of two bones (when 704 and 702 are separated as disclosed in ¶142, ¶s 2, 94, 142, 197, 198, and 205), the method comprising: coupling a locking component (770) to a third handle (1130, 1088, ¶198) of a delivery device (Figs. 66-104); feeding a flexible segment (1034) through a second anchor (702) of an implant (702, 704, Fig. 93); configuring the delivery device such that rotation of the third handle couples the locking component to the flexible segment and the second anchor (Figs. 102-104, ¶s 201-204); coupling a proximal end of the flexible segment (left end as shown in Figs. 95 and 96, Figs. 95 and 96) to a second handle of the delivery device (1040, 1036, 1038, 1002, Fig. 95, ¶182) such that a distal end of the flexible segment is coupled to a first anchor of the implant (704, Figs. 91, 95, and 96); configuring the delivery device such that rotation of the second handle (relative to 1004, Figs. 77 and 78, ¶s 182 and 183) adjusts tension on the flexible segment (¶183); configuring the delivery device such that simultaneous rotation of a first handle (1004), the second handle, and the third handle rotates the first anchor (Fig. 101); and configuring the delivery device such that the third handle is capable of being disengaged from the first and second handles and the first anchor while the flexible segment remains coupled to the second handle and the first anchor (Figs. 100 and 101, ).
As to claim 17, Fallin discloses that the second handle comprises a suture carriage (1046) disposed within the delivery device (Fig. 91), the method further comprising: rotating the suture carriage and moving the suture carriage along a longitudinal axis of the delivery device as the second handle is rotated (relative to 1004, Figs. 77, 78, 95, and 96, ¶s 182 and 183).
As to claim 18, Fallin discloses that the suture carriage aids in adjusting the tension on the flexible segment (Figs. 77, 78, 95, and 96, ¶s 182 and 183).
As to claim 20, Fallin discloses the third handle comprises an internal shaft (1160, 1082, ¶198), the method further comprising: rotating the third handle to rotate the internal shaft thereby coupling the locking component to the flexible segment and the second anchor (¶s 191, 198, and 204).
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 of this title, 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) 7-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duquesnel.
As to claim 7, Duquesnel discloses a method (Figs. 1-7 and 10A-10D, ¶s 70 and 71 ¶70 discloses inserting 90 after tensioning, ¶71 discloses that 102 may be loosely positioned within 100 and 90 used only to tighten 102 after a desired suture tension has been obtained) capable of use for approximation of two bones (Figs. 7 and 10A-10D, ¶7), the method comprising: delivering, via a delivery device (10, 90, Figs. 1-3, 6A, 6B, and 10A-10D) that comprises a first handle (portion of 12 to the left of 20, 22 as shown in Fig. 1, Fig. 1), a second handle (50, 32, 70), and a third handle (structure labeled as 92 in Fig. 3, Fig. 3), a first anchor (100, Figs. 4A, 4B, 7, and 10B-10D) into a first bone (Fig. 7); engaging the first anchor with a distal end of a flexible segment (S, Figs. 7 and 10B-10D, ¶69); rotating the second handle independently from the first handle (Fig. 2, ¶s 59 and 60); adjusting, via the second handle while the disengaged from the third handle, tension of the flexible segment by pulling one or more proximal ends of the flexible segment in a proximal direction (as shown in Fig. 10C, ¶70 discloses rotating 50 to tension the suture and that 90 can be inserted into 10 after tensioning the suture); attaching the third handle to the second handle of the delivery device (Fig. 10D, ¶70); and attaching, via the third handle of the delivery device, the flexible segment to a second anchor (102, Figs. 5A-7 and 10D, ¶70). As to claim 8, Duquesnel discloses that the third handle comprises an internal shaft (structure labeled as 96 in Fig. 3) and a locking component (94), the method further comprising: rotating the third handle to engage the locking component with the flexible segment and the second anchor (Figs. 6A-7), thereby attaching the flexible segment to the second anchor (Fig. 7). As to claim 9, Duquesnel discloses that rotating the third handle rotates the internal shaft (Figs. 6A-7) capable of engaging the locking component (Fig. 3). As to claim 10, Duquesnel discloses that adjusting the tension of the flexible segment comprises rotating the second handle (¶70). As to claim 11, Duquesnel discloses that the second handle comprises a suture carriage (32, 70) disposed within the delivery device (Fig. 2), the method further comprising: rotating the suture carriage (relative to 50, Fig. 2, ¶s 59 and 60) and moving the suture carriage along a longitudinal axis of the delivery device as the second handle is rotated (Fig. 2, ¶s 59 and 60). As to claim 12, Duquesnel discloses that the suture carriage aids in adjusting the tension on the flexible segment (Fig. 2, ¶s 59 and 60). As to claim 13, Duquesnel discloses that the tension of the flexible segment is adjusted via the second handle (¶70). As to claim 14, Duquesnel discloses that attaching, via the third handle of the delivery device, the flexible segment to the second anchor after the third handle is attached to the second handle of the delivery device (Fig. 10D).
Duquesnel is silent to disengaging the third handle from the delivery device, the adjusting of tension occurring after the third handle is disengaged from the delivery device, and attaching the third handle to the second handle of the delivery device includes reattaching the third handle to the second handle of the delivery device.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method that includes inserting the third handle into the delivery device before or after tensioning as disclosed by Duquesnel to include disengaging the third handle from the delivery device, the adjusting of tension occurring after the third handle is disengaged from the delivery device, and attaching the third handle to the second handle of the delivery device includes reattaching the third handle to the second handle of the delivery device, since rearranging parts/steps of an invention involves only routine skill in the art and would be one a finite number of steps for achieving the disclosed third handle positioning within the delivery device and operating as desired by a particular surgeon in a particular surgery.
Claim(s) 16 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fallin.
As to claim 16, Fallin discloses the invention of claim 15 as well as rotating the second handle to adjust the tension on the flexible segment (Figs. 95, 96, 98, and 100, ¶196 discloses that Figs. 100 and 101 occur after Fig. 98).
Fallin is silent to rotating the second handle to adjust the tension on the flexible segment after disengaging the third handle from the first and second handles.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method that includes rotating the second handle to adjust the tension on the flexible segment as disclosed by Fallin to do so after disengaging the third handle from the first and second handles, since rearranging parts/steps of an invention involves only routine skill in the art and would be one a finite number of steps for achieving the disclosed third handle positioning within the delivery device and operating as desired by a particular surgeon in a particular surgery.
As to claim 19, Fallin discloses the invention of claim 15 as well as rotating the second handle independently from the first handle (Figs. 95, 96, 98, and 100, ¶196 discloses that Figs. 100 and 101 occur after Fig. 98).
Fallin is silent to rotating the second handle independently from the first handle after disengaging the third handle from the first and second handles.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method that includes rotating the second handle independently from the first handle as disclosed by Fallin to do so after disengaging the third handle from the first and second handles, since rearranging parts/steps of an invention involves only routine skill in the art and would be one a finite number of steps for achieving the disclosed third handle positioning within the delivery device and operating as desired by a particular surgeon in a particular surgery.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY R SIPP/Primary Examiner, Art Unit 3775
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