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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/02/2025 and 03/31/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group II including claims 2-8 and new claims 16-19 in the reply filed on 06/02/2026 is acknowledged. Claims 2-8 and new claims 16-19 are currently pending. Restriction/election requirement is hereby made final.
Claim Objections
Claims 2 is objected to because of the following informalities:
Regarding claim 2, the claim recites “wherein one or more of the steps is performed by a processor coupled to memory”.
Based on the claim language, the claim should read, “A method, comprising steps of: obtaining a digitized 3D dataset …. wherein one or more of the steps is performed by a processor coupled to memory”.
Appropriate correction is required.
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.
Claims 2-8, 16-19 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-4 of U.S. Patent No. US12193775B2.
Here is the claim-by-claim analysis provided in support of the nonstatutory double patenting rejection:
Instant application
Reference patent US12193775B2
Claim 2.
A method, comprising: obtaining a digitized 3D dataset of a procedural site where a surgical procedure is to be performed, the digitized 3D dataset including a surgical reference; identifying a spatial target in the digitized 3D dataset of the procedural site; accessing a remote robot disposed at a remote location relative to the procedural site; registering a replica reference associated with the remote robot to the surgical reference within the digitized 3D dataset; coupling a patient specific instrument relative to the remote robot, the patient specific instrument having a tool associated therewith; manipulating, with the remote robot, the tool to a replica spatial target based at least in part on the digitized 3D dataset and the replica reference, the replica spatial target corresponding to the spatial target within the procedural site;
Claim 1:
A method, comprising: obtaining a digitized 3D dataset of a procedural site
where a surgical procedure is to be performed, the digitized 3D dataset including a surgical reference; identifying a spatial target in the digitized 3D dataset of the procedural site; accessing a remote robot disposed at a remote location relative to the procedural site; registering a replica reference associated with the remote robot to the surgical reference within the digitized 3D dataset; coupling a patient specific instrument relative to the remote robot, the patient specific instrument having a tool associated therewith; manipulating, with the remote robot, the tool to a replica spatial target based at least in part on the digitized 3D dataset and the replica reference, the replica spatial target corresponding to the spatial target within the procedural site; securing the tool relative to the patient specific instrument;
removing the patient specific instrument from the remote robot and moving the patient specific instrument to the procedural site;
removing the patient specific instrument from the remote robot and moving the patient specific instrument to the procedural site;
configuring the patient specific instrument such that, when the patient specific instrument is coupled to the surgical reference at the procedural site, the tool is aligned with the spatial target
mounting the patient specific instrument relative to the surgical reference such that the tool is aligned with the spatial target
wherein one or more of the steps is performed by a processor coupled to memory.
and performing one or more operations with the tool; wherein the surgical reference includes a tissue mount, the tissue mount being represented in the digitized 3D dataset; wherein the replica reference includes a replica tissue mount, the replica tissue mount being secured relative to the remote robot; and wherein manipulating, with the remote robot, the tool includes maneuvering at least a surgical arm of the remote robot relative to the replica tissue mount to arrange the tool at the replica spatial target.
Claim 2 of the instant application comprises the limitations A and B that is taught by the reference patent limitations A and B.
Claim 2 of the instant application differs from the reference patent regarding limitations C and D. However, it is obvious to one of ordinary skill in the art that under BRI, “configuring the patient specific instrument such that, when the patient specific instrument is coupled to the surgical reference at the procedural site, the tool is aligned with the spatial target” can be interpreted as “mounting the patient specific instrument relative to the surgical reference such that the tool is aligned with the spatial target”.
Furthermore, it is obvious to one of ordinary skill in the art to perform at least one or more of the method steps provided using a processor. The reference patent also teaches to perform at least one or more of the method steps provided using a processor.
Regarding claim 3 of instant application, “including performing one of more operations with the tool at the procedural site by utilizing a second robot at the procedural site to control movement of the tool” is patentably indistinct from the limitation “wherein performing one of more operations includes utilizing a second robot at the procedural site to use the tool to perform the one or more operations” of claim 2 of the reference patent.
Regarding claim 4 of instant application, “wherein the procedural site includes tissue and the tool is a surgical tool” is considered to be obvious to one of ordinary skill in the art that under BRI over the limitations “wherein the surgical reference includes a tissue mount, the tissue mount being represented in the digitized 3D dataset” of claim 1 and “wherein the tool is a surgical tool” of claim 2 of the reference patent. In both cases, the procedure is conducted in/around the tissue.
Regarding claim 5 of instant application, the claim recites “The method of claim 4, including: imaging the surgical tool within the procedural site to obtain a first 3D data set of the surgical tool representative of at least one of location and orientation thereof to define the spatial target; obtaining a second 3D data set of at least the tissue; and registering the second 3D data set with the first 3D data set”. It is considered to be obvious to one of ordinary skill in the art that under BRI over the limitations “imaging the surgical tool within the procedural site to obtain a first 3D dataset of the surgical tool representative of at least one of location and orientation thereof to define the spatial target; obtaining a second 3D dataset of at least tissue adjacent the procedural site; and registering the second 3D dataset with the first 3D dataset” of claim 4 of the reference patent.
Regarding claim 6 of instant application, the claim recites “The method of claim 4, wherein the surgical reference includes a tissue mount, the tissue mount being represented in the digitized 3D dataset”. It is considered to be obvious to one of ordinary skill in the art that under BRI over the limitations “wherein the surgical reference includes a tissue mount, the tissue mount being represented in the digitized 3D dataset” of claim 1 of the reference patent.
Regarding claim 7 of instant application, the claim recites “The method of claim 6, wherein the replica reference includes a robot mount, and further including securing the robot mount relative to the remote robot”. It is considered to be obvious to one of ordinary skill in the art that under BRI over the limitations “wherein the replica reference includes a replica tissue mount, the replica tissue mount being secured relative to the remote robot” of claim 1 of the reference patent.
Regarding claim 8 of instant application, the claim recites “The method of claim 7, including maneuvering at least a surgical arm of the remote robot relative to the robot mount to arrange the surgical tool at the replica spatial target”. It is considered to be obvious to one of ordinary skill in the art that under BRI over the limitations “wherein manipulating, with the remote robot, the tool includes maneuvering at least a surgical arm of the remote robot relative to the replica tissue mount to arrange the tool at the replica spatial target” of claim 1 of the reference patent.
Regarding claim 16 of instant application, the claim recites “The method of claim 2, including performing one of more operations with the tool at the procedural site”. It is considered to be obvious to one of ordinary skill in the art that under BRI over the limitations “performing one or more operations with the tool” of claim 1 and “wherein performing one of more operations includes utilizing a second robot at the procedural site to use the tool to perform the one or more operations” of claim 2 of the reference patent.
Regarding claim 17 of instant application, the claim recites “The method of claim 7, wherein configuring the patient specific instrument includes mounting the patient specific instrument to the tissue mount”. It is considered to be obvious to one of ordinary skill in the art that under BRI over the limitations “mounting the patient specific instrument relative to the surgical reference such that the tool is aligned with the spatial target; and performing one or more operations with the tool; wherein the surgical reference includes a tissue mount” of claim 1 of the reference patent.
Regarding claim 18 of instant application, the claim recites “The method of claim 17 wherein the tissue mount is identical to the robot mount”. It is considered to be obvious to one of ordinary skill in the art that under BRI over the limitations “wherein the replica reference includes a replica tissue mount, the replica tissue mount being secured relative to the remote robot” of claim 1 of the reference patent. It is inherent that a replica tissue mount (the robot mount) is identical to the tissue mount.
Regarding claim 19 of instant application, the claim recites “The method of claim 5, wherein the surgical reference includes a tissue mount, the tissue mount being represented in the first 3D data set and the replica reference includes a robot mount, and further including: securing the robot mount relative to the remote robot; and maneuvering at least a surgical arm of the remote robot relative to the robot mount to arrange the surgical tool at the replica spatial target”. It is considered to be obvious to one of ordinary skill in the art that under BRI over the limitations “wherein the surgical reference includes a tissue mount, the tissue mount being represented in the digitized 3D dataset; wherein the replica reference includes a replica tissue mount, the replica tissue mount being secured relative to the remote robot; and wherein manipulating, with the remote robot, the tool includes maneuvering at least a surgical arm of the remote robot relative to the replica tissue mount to arrange the tool at the replica spatial target” of claim 1 of the reference patent.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bleunven (US 20220296302 A1) teaches a method, comprising: obtaining a digitized 3D dataset of a procedural site where a surgical procedure is to be performed, the digitized 3D dataset including a surgical reference ([¶18-25, 26-32 & 229-238] and Fig. 1-18); identifying a spatial target in the digitized 3D dataset of the procedural site ([¶ 21-32] and Fig. 1-18); accessing a remote robot disposed at a remote location relative to the procedural site ([¶ 18-28] and Fig. 1-18); registering a replica reference associated with the remote robot to the surgical reference within the digitized 3D dataset (03-10, 18-28, 69, 200 & 237-238] and Fig. 1 & 6); manipulating, with the remote robot, the tool to a replica spatial target based at least in part on the digitized 3D dataset and the replica reference, the replica spatial target corresponding to the spatial target within the procedural site ([¶ 26-32 & 39-45 & 229-238] Fig. 1-18).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAGAR KC whose telephone number is (571)272-7337. The examiner can normally be reached M-F 8:30 am - 5 pm.
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, Adam Mott can be reached at (571) 270-5376. 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.
/SAGAR KC/Examiner, Art Unit 3657
/ADAM R MOTT/Supervisory Patent Examiner, Art Unit 3657
Prosecution Insights