DETAILED ACTION
This office action is responsive to the amendment filed December 2, 2025. By that response, claims 1, 14, 18 and 19 were amended; claim 21 was newly presented; and claim 17 was canceled. Claims 1-8, 14, 16, and 18-21 are pending.
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 .
Response to Arguments
The outstanding objection to claim 1 is overcome by the amendment of December 2, 2025.
Applicant’s arguments with respect to claim(s) 1-5, 7 and 8 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The newly presented rejection is necessitated by the amendments to the claims of December 2, 2025.
Claim Objections
Claim 21 is objected to because of the following informalities: The claim teaches “a tool” at line 1 and “a tool” at line 5. Examiner understands this to be the same tool, but as written, it is not necessarily clear if this is the same tool or a different tool. Appropriate correction is required. Examiner suggests the second instance refer to “the tool”.
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 2 is 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 2 teaches “at least one cut slot or a sharp…” at line 2. Examiner is unclear what “a sharp” is intended to be. “Sharp” is a commonly used word, generally understood to be an adjective – such as “a sharp blade”. “A sharp” is also known to examiner to be a name for a sharp object in a surgical setting (e.g. a scalpel blade or a needle being disposed of in a sharps container). However, that second interpretation does not appear to apply here – a scalpel blade or needle would not appear to be capable of use in the disclosed fashion. Examiner respectfully requests clarification on this matter.
Examiner notes instant [0051] provides a list of sharp objects: “a sharp (e.g. a bone saw, rasp rongeur, knife, bone cutter, osteotome, curette, chisel, bone lever, forceps, drill, k-wire, tap, etc.)”. If applicant wishes to treat the term “a sharp” as a ‘specially defined term’ from his specification, he is permitted to do so, but must state so on the record, since the term ‘a sharp’ has a standard meaning which is not generally understood by this examiner to encompass all of the items of that list.
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.
Claim(s) 1, 2 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wasielwski (US 2004/0243148 A1).
Regarding claim 1, Wasielwski teaches a system as in fig. 7 for positioning a tool 90 in surgery relative to a bone, the system comprising:
an implantable device 103 (at least temporarily implantable into the bone 106) having at least a first sensor 102 configured to collect first data regarding one or more characteristics of a bone of a patient [0064], wherein the implantable device 103 including the at least first sensor 102 is capable of being implanted in a medullary canal of the tibia with the at least first sensor 102 in the medullary canal (while demonstrated bone 106 is a femur, there is no reason that this device could not be inserted into a medullary canal of a properly sized and shaped tibia);
a tool 90/100;
a second sensor 92 configured to collect second data regarding at least an angle of the tool [0064]; and
a controller 96, communicatively coupled (via wireless receiver 98 and transmitters 94/104) to the first sensor 102 of the implantable device and the second sensor 92, the controller configured to [0064]:
determine a first position of the implantable device 103 from the first data;
determine an orientation of a landmark of the bone based at least in part on the first data (analysis of depth of the cut permits orientation of the tool 90 relative to a bone landmark – e.g. the area to be cut); and
determine an orientation for the tool 90/100 relative to the bone 106 based upon the second data and at least one of the orientation of the landmark and the first data [0064]. (It is noted that known position of 100 on the bone is also of importance in establishing the data to be derived about the relative positions of the components, and position of the landmark of the bone relative thereto).
Regarding claim 2, the tool 90/100 comprises at least one of a cut guide 100 having at least one cut slot (seen receiving the blade in fig. 7) configured to perform the resection of the proximal end portion of the bone 106.
Regarding claim 21, Wasielwski teaches a system at fig. 7 for positioning a tool 90 in surgery relative to a bone 106, the system comprising:
an implantable device 103 having a housing including at least a first sensor 102 configured to collect first data regarding one or more characteristics of a bone of a patient [0064], wherein the housing is configured for implantation in a medullary canal of the tibia (demonstrated in a femur in fig. 7; no reason it could not be implanted into a medullary canal of a properly sized and shaped tibia);
a tool 90;
a second sensor 92 configured to collect second data regarding at least an angle of the tool [0064]; and
a controller 96, communicatively coupled to the first sensor 102 of the implantable device and the second sensor 92 (through 98/104/94), the controller configured to:
determine a first position of the implantable device 103 from the first data;
determine an orientation of a landmark of the bone based at least in part on the first data (analysis of depth of the cut permits orientation of the tool 90 relative to a bone landmark – e.g. the area to be cut); and
determine an orientation for the tool 90 relative to the bone 106 based upon the second data and at least one of the orientation of the landmark and the first data [0064]. (It is noted that known position of 100 on the bone is also of importance in establishing the data to be derived about the relative positions of the components, and position of the landmark of the bone relative thereto).
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.
Claim(s) 3-5 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wasielwski in view of Gilhooley et al. (US 2019/0083191 A1).
Regarding claims 3-5 and 8, Wasielwski teaches the limitations of claim 1, but fails to teach an adjustment mechanism operably coupled to the controller and configured to orient the tool relative to the bone at the behest of the controller.
Gilhooley teaches a cutting tool 30 and a controller 32 (used with a navigation system 13). The cutting tool 30 is carried by an adjustment mechanism 20 which is operably coupled to the controller 32 and orients the cutting tool 30 at the behest of the controller 32. (Surgeon operates the robotic arm with a haptic control and tracks various portions [0032], [0033]) The system permits five or six degrees of freedom. The tool can be moved along any variety of paths (tracks) under control of the controller.
It would have been obvious to one with ordinary skill in the art at the time of the invention to move the tool portion 90 of Wasielwski with an adjustment mechanism in the form of a robotic arm based on the Gilhooley teaching. One could have controlled the position of the components using the trackers of Wasielwski. One would have done so to relieve the surgeon from manual operation of the tool 90, and prevent human error such as tremor or over-deep driving of the tool 90 permitted by manual manipulation of the tool.
Allowable Subject Matter
Claims 6 and 7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 14, 16, and 18-20 are allowed.
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 David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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, please contact the examiner’s supervisor, Kevin Truong, at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DAVID W BATES/Primary Examiner, Art Unit 3799