DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 “tension limiting mechanism” in claims 13 and 24 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 13 and 24 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 13 and 24 recite “a tension limiting mechanism” but lack support in the written specification for this limitation.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 10-12, 18-23, 27, 29 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 6,117,160 to Bonutti in view of US 3,959,960 to Santos and further in view of US 6,475,230 to Bonutti et al. (Bonutti 2).
Bonutti teaches:
Claim 10: A system for securing body tissue comprising:
a first fastener (52e, Fig. 8) configured to contact a first tissue portion (bone, 20e, Fig. 8);
a second fastener (50e, Fig. 8) configured to contact a second tissue portion (fragment 154, Fig. 8);
a suture (38e, Fig. 8) configured to pass through the first fastener and the second fastener; and
a tensioning device (98e, Fig. 8) configured to apply tension to the suture, wherein the tensioning device includes an elongate member (98e, Fig. 8) having opposite distal and proximal end margins (98e distal is shown in figure 8, there inherently a proximal end margin on the opposite side) and a longitudinal axis extending between the distal and proximal end margins, the distal end margin of the elongate member is configured to receive the suture (similar to Fig. 3), wherein the elongate member is configured to enable the suture to extend along elongate member from the distal end margin toward the proximal end margin of the elongate member (functional limitation, Fig. 3 is showing the suture being extending through 98).
Claim 11: The distal end margin of the elongate member (98e, Fig. 8) defines an opening configured to receive the suture (similar to Fig. 3).
Claim 18: The system is configured to be operated with a surgical robotic mechanism (functional limitation, the surgical robotic mechanism has not positively claimed and the tensioning system of Bonutti is capable of operating with such device).
Claim 19: The first tissue portion and the second tissue portion are at least one of bone (20e and fragment 154, Fig. 8), ligament, tendon, cartilage, muscle, skin, joint, capsule, organ, nerve, vessel, fascia, or a combination thereof.
Claim 20: A method for securing body tissue using the system of claim 11 (see rejection of claim 11 above), the method comprising: passing the suture (38e) through the first fastener (52e, Fig. 8); positioning the first fastener in contact with the first tissue portion (20e); passing the suture through the second fastener (50e); positioning the second fastener in contact with the second tissue portion (154); and securing the first fastener (52e) to the first tissue portion (20e) and the second fastener (50e) to the second tissue portion (154) with the tension applied to the suture (Col. 13, II. 32-36 described tension applied to suture limbs, Figs. 8-9 show the fasteners being secured and suture tensioned to hold the bone fragments).
Claim 21: A tensioning device (98e, Fig. 8) configured to apply tension to the suture (suture not positively recited) comprising an elongate member (98e, Fig. 8) having opposite distal and proximal end margins (98e distal is shown in figure 8, there inherently a proximal end margin on the opposite side) and a longitudinal axis extending between the distal and proximal end margins, the distal end margin of the elongate member is configured to receive the suture (similar to Fig. 3), wherein the elongate member is configured to enable the suture to extend along elongate member from the distal end margin toward the proximal end margin of the elongate member (functional limitation, Fig. 3 is showing the suture being extending through 98).
Claim 22: The distal end margin of the elongate member (98e, Fig. 8) defines an opening configured to receive the suture (similar to Fig. 3).
Claim 27: In combination with the suture (38e, Fig. 8).
Bonutti fails to teach:
Claim 10: A handle attached to the proximal end margin of the elongate member, wherein the handle is configured to be held by a user. Rotatable shaft operatively coupled to the handle, the rotatable shaft having a rotation axis extending generally transverse to the longitudinal axis of the elongate member, wherein the rotatable shaft is rotatably coupled to the handle and configured to be selectively rotatable about its rotation axis relative to the handle, wherein the rotatable shaft defines a slot configured to receive the suture to enable the suture to wrap around the rotatable shaft as the rotatable shaft rotates about its rotation axis to apply tension to the suture.
Claim 12: The tensioning device further includes a locking assembly, wherein the locking assembly is configured to at least one of maintain the tension applied to the suture or prevent reversal of the rotatable shaft.
Claim 20: Positioning the suture in the slot defined by the rotatable shaft; tensioning, the suture with the tensioning device by rotating the rotatable shaft, with the suture positioned in the slot, about its rotation axis.
Claim 29: The rotatable shaft is manually rotatable about its rotation axis.
Santos teaches:
Claim 10: Tensioning, twisting and cutting device for suture comprises a handle (40, Fig. 8) attached to the proximal end margin of the elongate member (33, Fig. 7), rotatable shaft (spool 36, Fig. 7) operatively coupled to the handle (40, Fig. 7, coupled via tube 33), the rotatable shaft having a rotation axis extending generally transverse to the longitudinal axis of the elongate member (33, Fig. 7), wherein the rotatable shaft is rotatably coupled to the handle and configured to be selectively rotatable about its rotation axis relative to the handle, wherein the rotatable shaft defines a slot (37, Fig. 7) configured to receive the suture (as shown in Figs. 9A-9D) to enable the suture to wrap around the rotatable shaft as the rotatable shaft rotates about its rotation axis to apply tension to the suture.
Claim 12: The tensioning device further includes a locking assembly, wherein the locking assembly is configured to at least one of maintain the tension applied to the suture or prevent reversal of the rotatable shaft. (Col. 1, II. 49-56, the ratchet mechanism prevents reversal/unwinding of the suture, hence prevent reversal of the rotatable shaft).
Claim 20: Positioning the suture (as shown in Figs. 9A-9D) in the slot (37, Fig. 7) defined by the rotatable shaft; tensioning, the suture with the tensioning device by rotating the rotatable shaft, with the suture positioned in the slot, about its rotation axis (Figs. 9A-9D shown the suture being tensioned by rotating spool 36 to wrap the suture onto the spool).
Claim 29: The rotatable shaft (36) is manually rotatable about its rotation axis (functional limitation, the shaft 36 is capable of manually rotating).
It would have been obvious to one of ordinary skill in the art at the time of the invention was filed to employ the tensioning device as taught by Santos into Bonutti as a known substitution of one known device and method for another that would yield predictable result for tensioning suture.
Bonutti in view of Santos fails to teach:
Claims 10 and 21: The tensioning device further includes an indicator configured to indicate tension being applied to the suture during tensioning, wherein the indicator includes a spring through which tension is transmitted to the suture.
Bonutti 2 teaches:
In the same field as endeavor, method and apparatus for securing a suture, comprising a suture retainer (180, Fig. 9) comprises a force (220, Fig. 9) for tensioning suture (52). The force (220) being measured with a suitable transducer or a force measuring device having a spring (Col. 14, ll. 24-28).
It would have been obvious to one of ordinary skills in the art at the time of the invention was made to modify a force measuring device having a spring as taught by Bonutti 2 into Bonutti in order to monitor suture tension to avoid damaging body tissue.
Claim 16-17, 28 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bonutti in view of Santos and Bonutti 2 and further in view of US 5,133,738 to Korthoff et al. (Korthoff).
Bonutti in view of Santos and Bonutti 2 teaches:
The system of claim 10 (see rejection of claim 10 above).
Bonutti in view of Santos and Bonutti 2 fails to teach:
Claim 16: The suture comprises polyethylene.
Claims 17, 28: The suture is at least one of a multifilament, braided, or interlaced suture.
Korthoff teaches:
Surgical suture made from braided suture (30, Fig. 1) formed from polyethylene (Col. 9, II. 25-35). Bonutti teaches suture can be made from any known suture material but fails to explicitly teach the suture is polyethylene. Korthoff teaches this limitation.
It would have been obvious to one of ordinary skill in the art at the time of the invention was filed to modify the suture as taught by Korthoff into Bonutti since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use; MPEP 2144.07 Art Recognized Suitability for an Intended Purpose, In re Leshin, * > 277 < F.2d 197, 125 USPQ 416 (CCPA 1960).
Response to Arguments
Applicant’s arguments with respect to claim(s) 10-13, 16-24 and 27-29 have been considered but are moot because of the new ground of rejection. The applicant argued that Bonutti, Santos or Korthoff failed to disclose the spring as amended. A new ground of rejection is inserted with Bonutti 2 disclosing a force measuring device having a spring as stated in the above rejection paragraph.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHONG SON DANG whose telephone number is (571)270-5809. The examiner can normally be reached Mon-Fri 8-5.
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/PHONG SON H DANG/Primary Examiner, Art Unit 3771
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