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 .
Claim Rejections - 35 USC § 102
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 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.
Claims 1-4 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zahiri et al. (US 8187276 B1).
Regarding claim 1, Zahiri teaches a tether (14) for an implantable bone device (see Col. 6, ll. 49-67), the tether comprising:
a retention portion (387) for holding an implantable bone device in place (see Col. 6, ll. 49-67),
wherein the retention portion (38) comprises a recess (42) configured to receive a proximate end of the implantable bone device (see Col. 6, ll. 12-35) when the implantable bone device is positioned inside a bone with the proximate end protruding from the bone (see Col. 6, ll. 12-35), wherein the recess (42) is closed at a top (38), open opposite the top (46), open at a first end (42), closed at a second end (44), and
contoured to approximate or to match a shape of the proximate end of the implantable bone device (see Fig. 1 and Col. 6, ll. 13-35); and
a fastening portion (30) for affixing the tether to the bone (see Col. 5, ll. 32-46), wherein the fastening portion comprises one or more through fastener openings (33),
wherein each through fastener opening (33) is configured to receive a bone fastener (see Col. 5, ll. 63-64),
wherein the fastening portion (30) is adjustable, and wherein the fastening portion (30) is shaped to be less thick than a height of the retention portion (see Col. 5, ll. 47-64 and Fig. 3).
Regarding claim 2, Zahiri teaches the tether of claim 1, wherein the implantable bone device is a percutaneous screw (see Col. 7, ll. 29-31).
Regarding claim 3, Zahiri teaches the tether of claim 1, wherein the tether (14) comprises a bone-side contour to approximate a contour of the bone to which it is to be affixed (see Col. 7, ll. 50-54).
Regarding claim 4, Zahiri teaches the tether of claim 1, wherein the tether (14) comprises a smooth outside contour to reduce irritation of tissue when implanted (see Col. 6, ll. 12-13 and Fig. 3).
Regarding claim 6, Zahiri teaches the tether of claim 1, further comprising one or more bone-side spikes (35a-35d) protruding from a bone-side surface (34) of the tether (14) and configured to penetrate the bone when the tether is affixed to the bone (see Col. 7, ll. 15-19).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Zahiri as applied to claim 1 above, and further in view of Iott et al. (WO 2005006948 A2) (hereon referred to as Iott).
Zahiri teaches a tether for an implantable bone device as outlined in the rejection of claim 1 above, however fails to teach the device further comprising a clamp for manipulating a tether for the implantable bone device, the clamp comprising: two clamp arms joined at their proximal ends or between their proximal and distal ends and configured such that their distal ends can be brought together, wherein the distal ends of the two clamp arms are configured to grip the tether.
Iott teaches a tether (20’, see Fig. 8A) configured to be implanted with a clamp (450), the clamp comprising: two clamp arms (451, 454) joined between their proximal and distal ends (at 453) and configured such that their distal ends can be brought together (see P. 25, ll. 19-34), wherein the distal ends (458, 460) of the two clamp arms are configured to grip the tether (see P. 25, ll. 19-34).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tool of Zahiri to be a clamp as taught by Iott, as such a tool would enable better control and manipulation of the device, while only requiring the practitioner to use one hand (see P. 2, ll. 16-21).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Zahiri as applied to claim 1 above, and further in view of Chapolini et al. (US 20060111723 A1) (hereon referred to as Chapolini).
Zahiri teaches a tether for an implantable bone device as outlined in the rejection of claim 1 above, however fails to teach a keyless chuck for an implantable bone device, the keyless chuck comprising: a receptacle configured to receive a proximal end of the implantable bone device, wherein no key is required to secure the implantable bone device, and wherein the receptacle is configured to rotate the implantable bone device or the implantable bone device tamp when the keyless chuck is rotated.
Chapolini teaches a keyless chuck (see Para. [0048]) for an implantable bone device (note that this is a functional limitation, and the keyless chuck of Chapolini may satisfy this requirement if the two devices are oriented accordingly), the keyless chuck comprising:
a receptacle (distal end of chuck described in Para. [0048]) configured to receive a proximal end of the implantable bone device (note that this is a functional limitation; depending on the relative size of the two devices, such a configuration may be possible), wherein no key is required to secure the implantable bone device (note that the disclosure elaborates on the use of a keyless chuck, see Para. [0048]), and wherein the receptacle is configured to rotate the implantable bone device or the implantable bone device tamp when the keyless chuck is rotated (see Para. [0071]).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tether device of Zahiri to have the keyless chuck configuration as taught by Chapolini, as this would enable the use of exemplary couplers for drill devices (see Para. [0071] of Chapolini).
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Zahiri in view of Chapolini as applied to claim 22 above, and further in view of Weinstein et al. (US 20160242771 A1) (hereon referred to as Weinstein).
Zahiri teaches a tether for an implantable bone device as outlined in the rejection of claim 1 above, and Chapolini teaches a keyless chuck as outlined in the rejection of claim 22 above, however the combination of the two fails to teach the device further comprising a bone tamp with an impact anvil surface (claim 23), further comprising an implantable bone device tamp, wherein the tamp is detachably engageable with the receptacle (claim 24).
Weinstein teaches a bone tamp with (196) an impact anvil surface (200) (claim 23), further comprising an implantable bone device tamp (196), wherein the tamp is detachably engageable with the receptacle (via 202, see Para. [0075], noting that the distal end of the tamp is configured for engagement with an implant) (claim 24).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implantable bone device of Zahiri to further include a bone tamp with an anvil impact surface as taught by Weinstein, as this would enable punching of the device into bone, improving ease of fixation thereto (see Para. [0071] of Weinstein).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 HOLLY J LANE whose telephone number is (703)756-4702. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/H.J.L./Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
Prosecution Insights