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 . This action is in response to Applicant Arguments/Remarks Made in an Amendment received on October 2,2025. Claims 1-15 are currently pending. Claims 5-15 are withdrawn.
Response to Arguments
Applicant's arguments filed October 2,2025 have been fully considered but they are not persuasive. Applicant’s amendments specifically “the at least one control unit is configured to perform a plurality of controlled loops, each loop…” seeks to introduce new matter. There is lack of written support for a plurality of controlled loops, each loop performing updates for controlling the dispersion of cement in a region of interest through an injection needle.
Applicant argues that the prior art fails to disclose a plurality of controlled loops, comprising, imaging that results in obtaining an updated set of imaging data and using that updated data to calculate updated parameters for a subsequent dispense within the same procedure. This is not found persuasive because in as much as applicant describes a plurality of controlled loops, Metz (US Publication 2019/0254750) describes the ability to update or modify the procedure. The procedure can be adjusted to include imaging, calculating injection parameters, and injection parameters. This occurs by selecting a different simulation, as executed by the return of the method algorithm to step 54 [paragraphs 0059-0060]. Once the acceptable preferred entry point is accepted based on changes or updates that can be made, then the resulting parameters may be translated into instructions for transfer directly to a robotic guidance system to mechanically guide the trajectory of bone cement insertion device to the correct pre-selected and pre-planned location [paragraph 0060].
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 1-4 are 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. Applicant’s amendments specifically “the at least one control unit is configured to perform a plurality of controlled loops, each loop…” seeks to introduce new matter. There is lack of written support for a plurality of controlled loops, each loop performing updates for controlling the dispersion of cement in a region of interest through an injection needle.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Metz (US Publication 2019/0254750) in view of Timperley et al. (US Publication 2019/0021796), hereinafter “Timperley”.
Regarding claim 1, Metz discloses a surgical robotic system [paragraph 0060], comprising: a robotic arm (i.e., robotic guidance system); an injection needle (15, Figure 1B) with a tip having an orifice capable of dispensing a quantity of cement (16, Figure 1B) contained in the injection needle [paragraph 0048], the injection needle being supported by the robotic arm [paragraphs 0060-0064; an imaging system (i.e. CT scan [paragraphs 0050-0051]); and at least one control unit (i.e. robotic control system [paragraphs 0064-0066], wherein: the at least one control unit is configured to perform at least one controlled loop comprising: imaging a region of interest with the imaging system, the imaging providing an updated set of imaging data, the updated set of imaging data being updated for each loop [paragraphs 0050 and 0053, steps 51-52];using at least partially the updated set of imaging data for calculating an updated set of injection parameters, the updated set of injection parameters being updated for each loop [paragraphs 0051 and 055-056 and steps 52-53]; and using, at each loop, at least one parameter of the updated set of injection parameters for controlling dispense of the cement in the region of interest through the injection needle [paragraphs 0052 and 055, steps 54-57].
Metz fails to disclose a localization system configured for providing data relating to a position of a patient reference configured for being rigidly fixed to a patient body, relative to a robot tracker supported by the robotic arm and whose spatial relationship with the injection needle is known.
Timperley, however, discloses a localization system (10 [paragraph 0048]} configured for providing data relating to a position of a patient reference configured for being rigidly fixed to a patient body (provides data via trackers 54,56,58), relative to a robot tracker supported by the robotic arm [paragraph 0044] and whose spatial relationship with the injection needle is known.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the system of Metz with a localization system as taught my Timperley in order to communication with a computer processor to effect the actions of the robotic system.
Regarding claim 2, the modified Metz’s system discloses wherein the updated set of injection parameters comprises at least one parameter from a list comprising: a withdrawal trajectory, a location of the tip of the injection needle in the region of interest for a subsequent dispense of a volume of cement [paragraphs 0054-0056 of Metz], a volume of the cement to be dispensed in the region of interest before carrying out a subsequent controlled loop [paragraphs 0054-0058 of Metz], an injection flow rate of the cement to be injected through the tip of the injection needle in the region of interest, a configuration of the robotic arm for supporting the injection needle during the subsequent dispense of the volume of the cement, a configuration of the robotic arm for supporting the injection needle during a subsequent step of imaging, and a distance between the tip of the injection needle and the cement already dispensed in the region of interest.
Regarding claim 3, the modified Metz’s system further comprising injection activation (i.e. robotic control system and pre-operative planning software of Metz) means for controlling the dispense of the cement contained in the injection needle, in the region of interest.
Regarding claim 4, the modified Metz’s system wherein the injection activation i.e. robotic control system and pre-operative planning software of Metz) means for controlling the dispense of the cement contained in the injection needle is itself controlled by the at least one control unit.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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 DIANA S JONES whose telephone number is (571)270-5963. The examiner can normally be reached Monday to Friday (8am to 4pm EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at 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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/Diana Jones/Examiner, Art Unit 3775
/KEVIN T TRUONG/Supervisory Patent Examiner, Art Unit 3775