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 .
Election/Restrictions
Applicant's election with traverse of Invention I (claims 1-11) in the reply filed on July 31, 2026 is acknowledged. The traversal is on the ground(s) that Invention II can be practiced with manual components in addition to the claimed robotic device (see pg. 6). This is not found persuasive because in Invention II, the creation of the implant placement plan is done by the circuitry of the robotic device (see claim 12), whereas in Invention I, the creation of the implant placement plan need not be done by a robotic device (see claim 1, which only requires the robot perform the step of preparing the bones).
The requirement is still deemed proper and is therefore made FINAL.
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on July 31, 2026.
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 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, 2, 4-6, and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Squires et al. (US 2003/0233094 A1) in view of Mire et al. (US 2009/0234217 A1) and Yapp et al. (US 5,549,612 A).
Claim 1. Squires discloses a method, comprising: tracking a plurality of bones of a patient (see step 200 in Fig. 2; see also para. 0018 referring to aligning reference mechanism 19 by the vertebral bodies themselves); creating an implant placement plan (see paras. 0029-0030 referring to contouring the perimeter surface of vertebral bodies 120 to mount a plate; see also Figs. 6-8), the implant placement plan comprising a placement of a plate across the plurality of bones (see para. 0030 referring to installing a plate; see also Fig. 8); and assisting preparation of the plurality of bones to receive the plate in accordance with the implant placement plan (see paras. 0029-0030 referring to contouring the perimeter surface of vertebral bodies 120 to mount a plate; see also Figs. 6-8).
Claim 2. Squires discloses wherein the plurality of bones comprise a plurality of vertebrae (vertebral bodies 120; see Figs. 6-8).
Claim 4. Squires discloses wherein creating the implant placement plan comprises planning a first cavity to be sculpted at a first bone (vertebra 120; see Fig. 8) of the plurality of bones and a second cavity to be sculpted at a second bone (vertebra 120; see Fig. 8) of the plurality of bones, the first cavity to receive a first portion of the plate and the second cavity to receive a second portion of the plate (see para. 0030 referring to the plate spanning the contoured surfaces of vertebral bodies 120).
Claim 5. Squires discloses wherein creating the implant placement plan comprises planning the first cavity and the second cavity such that a top surface (surface of the plate in contact with vertebral bodies 120) of the plate is planned to be substantially flush with surfaces of the first bone and the second bone (see para. 0030 referring to the plate spanning the contoured surfaces of vertebral bodies 120).
Squires fails to disclose wherein the plurality of bones are three or more bones, planning a planned alignment between the three or more bones, wherein the implant placement plan is based on the planned alignment, wherein the preparation of the bones is robotically assisted (claim 1), wherein the implant placement plan is created via circuitry of a surgical system (claim 4), wherein robotically assisting preparation of the three or more bones to receive the plate comprises tracking a pose of a robotic device relative to one or more of the three or more bones and controlling the robotic device based on the pose of the robotic device relative to the one or more of the three or more bones (claim 6), wherein creating the implant placement plan comprises defining a virtual cutting boundary and robotically assisting preparation of the three or more bones includes confining a pose of a robotic device based on the virtual cutting boundary (claim 8), wherein the virtual cutting boundary corresponds to one or more dimensions of the plate (claim 9), and wherein robotically assisting preparation of the three or more bones comprises creating a hole in a first bone of the three or more bones, the hole configured to receive an engagement member to engage the plate with the first bone (claim 10).
Yapp teaches that a plate (plate 12) can be configured to span two or three or more bones (see col. 5, ll. 58-64 referring to plate 12 spanning two to four vertebral bodies).
Mire teaches a method, comprising: tracking one or more of a plurality of bones of a patient (see the three fiducial markers 60 located on the patient’s vertebrae as shown in Fig. 1; see also sensors 58 positioned on vertebral bodies 200 and 202 as shown in Figs. 8A-G; see also para. 0069 regarding fiducial markers; see para. 0106 regarding sensors); planning a planned alignment between the plurality of bones (see para. 0106 regarding articulation centers and centers of rotation); creating an implant placement plan, via circuitry of a surgical system, based on the planned alignment (see para. 0110 regarding tracking the implant during insertion to ensure proper orientation of the spine), the implant placement plan comprising placement of a spinal implant (see implant 52 in Fig. 8G) at the plurality of bones (see para. 0108-0110 regarding centering the sagittal wedge, obtaining proper depth, and then burring for a proper oriented fit for the implant); and robotically preparing the plurality of bones to receive the spinal implant in accordance with the implant placement plan (see para. 0102 regarding a robotic device controlled by a user in cutting/drilling operations; see para. 0106 referencing milling) (Figs. 1 and 8A-G; paras. 0069, 0102, and 0105-0112). Tracking the one or more of the plurality of bones of the patient comprises collecting data indicative of positions of the plurality of bones (see para. 0108-0110 regarding centering the sagittal wedge, obtaining proper depth, and then burring for a proper oriented fit for the implant); and creating the implant placement plan comprises determining the adjusted relationship based on the data (see para. 0108-0110 regarding centering the sagittal wedge, obtaining proper depth, and then burring for a proper oriented fit for the implant). Collecting the alignment data is performed while one or more spacers (see distractor instrument 204 in Fig. 8B and sagittal wedge 206 in Fig. 8C) are positioned at the plurality of bones (see paras. 0107-0108 referencing the sensors, distractor instrument, and sagittal wedge). Robotically preparing the plurality of bones to receive the implant comprises: tracking a pose of a robotic device relative to the plurality of bones (note sensor 58 on burring hand piece 210 as shown in Fig. 8D and referenced in para. 0109; also note that para. 0102 refers to a robotic device controlled by a user in cutting/drilling operations); and controlling the robotic device based on the pose of the robotic device relative to the plurality of bones (see para. 0109 referencing safe zones). Creating the implant placement plan comprises defining a virtual cutting boundary (see para. 0109 referencing safe zones 112); and controlling the robotic device comprises confining the pose of the robotic device based on the virtual cutting boundary (see para. 0109 referencing burring within the safe zones). The virtual cutting boundary corresponds to a shape of the spinal implant (see para. 0109 referring to using information about implant 52 as the safe zones). Robotically preparing the plurality of bones to receive the implant comprises forming a sculpted cavity (ring portion 214 as shown in Fig. 8E; see also para. 0109 regarding ring portion) at a first bone of the plurality of bones (see Fig. 8D and burr 208; see also para. 0109 referring to burring an area between vertebrae 200 and 202 and the resulting milled vertebrae 200 and 202), the sculpted cavity corresponding to a surface of the spinal implant (para. 0109 states that ring portion 214 is milled to receive implant 52). Robotically preparing the plurality of bones comprises creating a hole (ring portion 214 as shown in Fig. 8E; see also para. 0109 regarding ring portion) in a first bone of the plurality of bones (see Fig. 8D and burr 208; see also para. 0109 referring to burring an area between vertebrae 200 and 202 and the resulting milled vertebrae 200 and 202), the hole configured to receive an engagement member (surface of implant 52 in contact with ring portion 214) of the spinal implant (see Figs. 8E and 8G). Such steps reduce surgical time and costs and increase surgical accuracy (see para. 0007) by planning the procedure and ensuring that the plan is performed (see para. 0002).
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 method of Squires such that the method is performed on three or more bones (claim 1), as suggested by Yapp, as a particular patient may have the need for multi-level fusion. 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 method of Squires by planning a planned alignment between the three or more bones, such that the implant placement plan is based on the planned alignment, wherein the preparation of the bones is robotically assisted (claim 1), such that the implant placement plan is created via circuitry of a surgical system (claim 4), such that robotically assisting preparation of the three or more bones to receive the plate comprises tracking a pose of a robotic device relative to one or more of the three or more bones and controlling the robotic device based on the pose of the robotic device relative to the one or more of the three or more bones (claim 6), such that creating the implant placement plan comprises defining a virtual cutting boundary and robotically assisting preparation of the three or more bones includes confining a pose of a robotic device based on the virtual cutting boundary (claim 8), such that the virtual cutting boundary corresponds to one or more dimensions of the plate (claim 9), and such that robotically assisting preparation of the three or more bones comprises creating a hole in a first bone of the three or more bones, the hole configured to receive an engagement member to engage the plate with the first bone (claim 10), as suggested by Mire, in order to reduce surgical time and costs and increase surgical accuracy by planning the procedure and ensuring that the plan is performed.
Claims 7 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Squires et al. (US 2003/0233094 A1) in view of Mire et al. (US 2009/0234217 A1) and Yapp et al. (US 5,549,612 A) as applied to claims 1 and 6 above, and further in view of Quaid et al. (US 8,010,180 B2).
Squires, Mire, and Yapp fail to teach wherein robotically assisting preparation of the three or more bones comprises providing force feedback via the robotic device (claim 7) and wherein creating the implant placement plan comprises selecting a plate model from a database of plate models, the plate model corresponding to a shape and a size of the plate to be used in the implant placement plan (claim 11).
Quaid teaches using a robotic device (haptic device 30 shown in Fig. 2A; see col. 14, ll. 6-8, which states that the haptic device may be robotic) that provides force feedback to the user (see col. 12, ll. 50-61) performing a procedure using the robotic device (see col. 12, ll. 40-42) based on a relationship between the tracked anatomy of the patient and the tracked position/orientation/velocity/acceleration of the robotic device (see col. 4, ll. 3-10). Quaid also teaches that a robotic system configured for planning (see col. 8, ll. 8-19) can include database libraries, including databases of various implants, to be used in the surgical procedure (see col. 8, ll. 20-30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Squires such that robotically assisting preparation of the three or more bones comprises providing force feedback via the robotic device (claim 7), as suggested by Quaid, in order to provide the user of the robotic system with real-time feedback during the surgical procedure, thereby minimizing the risk of excessive burring/milling of the vertebrae. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Squires such that creating the implant placement plan comprises selecting a plate model from a database of plate models (claim 11), as suggested by Quaid, in order to choose the most appropriate plate for that particular patient. It would have been further obvious for the plate model to correspond to a shape and a size of the plate to be used in the implant placement plan (claim 11) to ensure that the plate fits the cavities prepared in the vertebral bodies.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 11,523,867 B2 in view of Yapp et al. (US 5,549,612 A). Although the claims at issue are not identical, they are not patentably distinct from each other. The differences between claim 3 of the application and claim 9 of the patent are that (a) claim 9 of the application specifies that the bones are vertebrae (see claim 1, from which claim 9 depends) and (b) claim 3 of the application specifies three or more bones (see claim 1, from which claim 3 depends).
With regard to (a) above, the patent claim is more specific and thus the invention of claim 9 of the patent is in effect a species of the generic invention of claim 3. It has been held that the generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
With regard to (b) above, Yapp teaches that a plate (plate 12) can be configured to span two or three or more bones (see col. 5, ll. 58-64 referring to plate 12 spanning two to four vertebral bodies). 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 method of claim 9 such that the method is performed on three or more bones, as suggested by Yapp, as a particular patient may have the need for multi-level fusion.
Allowable Subject Matter
Claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable (a) if rewritten in independent form including all of the limitations of the base claim and any intervening claims and (b) upon the filing of a terminal disclaimer to overcome the double patenting rejection set forth above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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