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 . Claims 18-23 are pending and examined below. Claims 1-17 is/are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group II: claims 18-23 in the reply filed on 05/01/2026 is acknowledged. The requirement is therefore made FINAL.
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 18-23 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.
Claim 18 recites the limitation “an implantable tether lock” in lines 1 & 4. It is unclear if these are the same or different part. For the purpose of examination, they are regarded as the same.
Claim 18 recites the limitation “the instrument” in lines 6, 7, 10, 12, & 13. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this “instrument” is the same or different from the “tensioning and locking instrument”. For the purpose of examination, they are regarded as the same.
Claim 18 recites the limitation “the tether lock” in lines 7,10, and 13-14. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this “tether lock” is the same or different from the “implantable tether lock”. For the purpose of examination, they are regarded as the same.
Claim 18 recites the limitation “the lock” in line 7. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this “lock” is the same or different from the “implantable tether lock”. For the purpose of examination, they are regarded as the same.
Claim 18 recites the limitation “the implantable lock” in lines 12-13. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this “implantable lock” is the same or different from the “implantable tether lock”. For the purpose of examination, they are regarded as the same
Claim 20 recites the limitation “the instrument” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this “instrument” is the same or different from the “tensioning and locking instrument”. For the purpose of examination, they are regarded as the same.
Claim 20 recites the limitation “the tether lock” in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this “tether lock” is the same or different from the “implantable tether lock”. For the purpose of examination, they are regarded as the same.
Claim 22 recites the limitation “the instrument” in line 3. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this “instrument” is the same or different from the “tensioning and locking instrument”. For the purpose of examination, they are regarded as the same.
Claim 23 recites the limitation “the tether lock” in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this “tether lock” is the same or different from the “implantable tether lock”. For the purpose of examination, they are regarded as the same.
Claim 23 recites the limitation “the instrument” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this “instrument” is the same or different from the “tensioning and locking instrument”. For the purpose of examination, they are regarded as the same.
All dependent claims are likewise rejected.
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) 18-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dahlgren et al. (US 20110082538 A1) hereinafter, Dahlgren, in view of Goldfarb et al. (US 20040049207 A1) hereinafter, Goldfarb.
Regarding claim 18, Dahlgren teaches a method of installing (abstract, Dahlgren) an implantable tether lock (2334, Fig. 23U, Dahlgren), the method comprising:
threading a tether (2330, Fig. 23U, Dahlgren) through an implantable device (2332, Fig. 23U, Dahlgren);
implanting the implantable device (2332, Fig. 23U, ¶0250-0251, Dahlgren);
providing an implantable tether lock (2334, Fig. 23U, Dahlgren) located on a distal end of a tensioning and locking instrument (100, Fig. 1, Dahlgren);
threading the tether (2330, Fig. 23U, Dahlgren) through the implantable tether lock (2334, Fig. 23U, Dahlgren) and the instrument (2302, Fig, 23U, Dahlgren);
advancing the tether lock (2334, Fig. 23U, par. 0251, Dahlgren) along the tether using the instrument until the lock contacts the implantable device (2332, Fig. 23U, Dahlgren).
Dahlgren teaches a device system to deploy the implantable device (100, Fig. 1, ¶0120) but he does not disclose explicitly a trigger on the instrument (device system) to move a pull wire.
Dahlgren does not disclose a tensioning clamp located on the instrument to clamp onto the tether and activating a trigger on the instrument. However, Goldfarb teaches systems and methods for tissue approximation (abstract, Goldfarb)
using a tensioning clamp (392, Fig. 57, Goldfarb) located on the instrument (300, Fig. 47, Goldfarb) to clamp onto the tether (serrations 394 of wing 392 are used to apply tension to the lock lines 92, Fig. 57, ¶0221, Goldfarb) and draw it in a proximal direction relative to the tether lock (106, Fig. 18, Goldfarb), thereby increasing tension in the tether (apply tension to the lock lines, ¶0221, Goldfarb); and
activating a trigger (386, Fig. 57, Goldfarb) on the instrument (300, Fig. 47, Goldfarb) to move a pull wire (108, Fig. 18, Goldfarb) spanning between the implantable lock (106, Fig. 18, Goldfarb) and the instrument (300, Fig. 47, Goldfarb) in a proximal direction, thereby locking the tether lock (106, Fig. 18, Goldfarb) against the tether (92, Fig. 57, Goldfarb).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Dahlgren by incorporating the teachings above as taught by Goldfarb in order to apply or release tension in the lock lines (tether) (¶0221, Goldfarb).
Regarding claim 19, Dahlgren does not teach a trigger pull lock. However, Goldfarb teaches
further comprising disengaging a trigger pull lock (383, Fig. 57, Goldfarb) before activating the trigger to move the pull wire in the proximal direction (¶0221, Goldfarb).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Dahlgren by incorporating the teachings above as taught by Goldfarb in order to manipulated independently or jointly, allow various amounts of tension to be applied and vary the force required for removal of the lock lines when the fixation device is to be left behind (¶0208, Goldfarb).
Regarding claim 20, Dahlgren does not disclose activating the trigger on the instrument. However, Goldfarb teaches
further comprising activating the trigger (386, Fig. 57, Goldfarb) on the instrument to move the pull wire (108, Fig. 18, Goldfarb) in a distal direction to disengage the pull wire from the tether lock (106, Fig. 18, ¶0163, Goldfarb).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Dahlgren by incorporating the teachings above as taught by Goldfarb in order to manipulated independently or jointly, allow various amounts of tension to be applied and vary the force required for removal of the lock lines when the fixation device is to be left behind (¶0208, Goldfarb).
Regarding claim 21, Dahlgren does not teach a trigger push lock. However, Goldfarb teaches
further comprising disengaging a trigger push lock (383 rotated to disengage the serrations, Fig. 57, Goldfarb) before activating the trigger to move the pull wire in the distal direction (¶0221, Goldfarb).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Dahlgren by incorporating the teachings above as taught by Goldfarb in order to manipulated independently or jointly, allow various amounts of tension to be applied and vary the force required for removal of the lock lines when the fixation device is to be left behind (¶0208, Goldfarb).
Regarding claim 22, Dahlgren teaches
wherein moving the pull wire (2330 is used as both a tether and pull wire depending on the step of installation, Fig. 23U, Dahlgren) in the proximal direction comprising pulling a proximal end of the tether lock (2334, Fig. 23U, Dahlgren) further into a collar (distal portion of 2314, Fig. 23D, Dahlgren) located on the distal end of the instrument (2302, Fig. 23U, Dahlgren), the collar serving to move a movable member on the tether lock (2334, Fig. 23M, Dahlgren) in a distal direction against the tether.
Regarding claim 23, Dahlgren teaches
wherein moving the pull wire (2330 is used as both a tether and pull wire depending on the step of installation, Fig. 23U, Dahlgren) in the distal direction serves to push a proximal end of the tether lock out (2334, Fig. 23U, Dahlgren) of a collar (distal portion of 2314, Fig. 23D, Dahlgren) located on the distal end of the instrument (2302, Fig. 23U, Dahlgren).
Conclusion
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/K.X.W./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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