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
Claims 45 and 46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/8/25.
Applicant's election with traverse of Group I in the reply filed on 12/8/25 is acknowledged. The traversal is on the ground(s) that both groups recite a learning model and a surgical robot. This is not found persuasive. While Applicant has added new claim 47 that depends from claim 31 to recite a machine learning model, the inventions still have a different mode of operation. The learning model in Group I outputs a route based on locations of blood vessels, while the learning model in Group II is claimed to determine an anomalous condition. An anomalous condition is a condition such as a clot, hemorrhage, or aneurysm according to the instant specification and this is not the same as a learning model to output a route. It is further noted that the ‘route’ in claim 45 is not generated by a learning model.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claims 31-36, 38-41, 43, 44, and 47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thomas et al (US 9,600,138).
Re claim 31: Thomas discloses a computer-implemented digital image analysis method for navigating a surgical instrument in a patient using a surgical robot, comprising:
obtaining a route generated using an output of a trained model based on a plurality of locations of one or more blood vessels of the patient (col 12 lines 4-30, col 28 lines 39-47; see the setting or updating of a surgical path for a surgical tool in a vessel and see the adaptive learning paradigms to generate procedure specific outputs);
obtaining one or more images of an anatomy of the patient captured using one or more imaging devices (col 12, lines 4-30; see the imaging performed);
identifying, using the one or more images, a location of the surgical instrument (col 12, lines 4-30; see the sensor to track the surgical tool);
determining that the surgical instrument is on the route a particular distance from a treatment site (col 24 lines 39-52, col 26 lines 51-56; see the distance analysis that is dynamically manipulated and see the determining and updating of tissue and surgical device positions);
generating, based on the location of the surgical instrument, one or more instructions for advancing the surgical instrument along the route (col 26, lines 51-56; see the updated positions to guide the tool to the target); and
displaying, on a graphical display, the one or more instructions for advancing the surgical instrument (col 24, lines 53-56; see the displayed path that includes entry points to guide the tool).
Re claim 32: The instrument is at least one of a catheter or an end effector (col 5, lines 51-59; see the catheter).
Re claim 33: The method includes virtually simulating advancing of the surgical instrument (col 18, lines 63-67; see the visual simulation of the tool approaching the target along the path).
Re claims 34, 38, 40, 41, 43: The virtually simulating advancing of the surgical instrument is based on a minimum diameter and/or a maximum diameter of the one or more blood vessels, is based on narrowing of the blood vessels, is based on atherosclerosis-related parameters, and is based on lipoprotein-related markers or lipid levels (col 32, lines 14-32; see the overlay of blood vessels which indicate size/diameter including the narrowing of the blood vessel (i.e. an atherosclerosis-related parameter with heightened lipoprotein and lipid levels)).
Re claims 35, 36, 39: The simulating advancing of the surgical instrument is based on a predicted amount of elasticity of the one or more blood vessels, is based on risk scores for the one or more blood vessels that are narrowed or stiffened by plaque buildup, and is based on wall stress parameters of the blood vessels (col 18, lines 5-17; see the elasticity measurements and stiffness/rigidity properties of vessel wall stresses, wherein stiffness and the “metric” is a score that indicates plaque buildup).
Re claim 44: The method includes determining a position of the surgical instrument based on the one or more images; comparing a planned position of the surgical instrument in a surgical plan to the determined position of the surgical instrument; determining whether the surgical instrument is at an unacceptable position based on the comparison; and in response to determining the surgical instrument is at the unacceptable position, generating corrective instructions for repositioning the surgical instrument (col 34, lines 32-55; see the real-time instrument position determination that is compared with estimated positions wherein the quality of agreement is reported which is an instruction to reposition the surgical tool relative the desired path).
Re claim 47: The trained model is a machine learning model trained using data sets from historical surgical procedures, and wherein the robot positions the instrument in the patient (col 17, lines 34-47; see the data from previous surgeries; col 34 lines 45-47; see the robotic manipulator to position the instrument).
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 37 is rejected under 35 U.S.C. 103 as being unpatentable over Thomas, as applied to claim 33, in view of Bidne et al (US Pub 2015/0049083).
Re claim 37: Thomas discloses all features except virtually simulating advancing of the surgical instrument is based on eluting of medicants from implants. However, Bidne teaches virtually simulating advancing of the surgical instrument is based on eluting of medicants from implants [0051; see the simulation of moving the device through the anatomy based on modeling of a drug-eluting material]. It would have been obvious to the skilled artisan to modify Thomas, to include simulation based on eluting as taught by Bidne, in order to improve accuracy of the simulation.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Thomas, as applied to claim 33, in view of Shelton et al (US Pub 2019/0125357).
Re claim 42: Thomas discloses all features except wherein virtually simulating advancing of the surgical instrument is based on family history data of atherosclerosis. However, Shelton teaches virtually simulating advancing of the surgical instrument is based on family history data of atherosclerosis [0602; see the surgical system that takes into account contributing factors including family history of atherosclerosis]. It would have been obvious to the skilled artisan to modify Thomas, to include simulation based on family history as taught by Shelton, in order to improve accuracy of the simulation.
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 31-44 and 47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,950,851. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘851 features a computer implemented method including obtaining images of anatomy, generating a plurality of intravascular routes for navigating a surgical instrument, virtually simulating navigation and determining metrics for each route, and using machine learning with training sets that describe the routes. While the claims of ‘851 include additional limitations such as determining an anomalous condition, it would have been obvious to the skilled artisan to conclude that the instant claims are an obvious variant.
Claims 31-44 and 47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of copending Application No. 18/892,070. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘070 features a computer implemented method including obtaining images of anatomy, virtually simulating navigation and determining metrics for a plurality of intravascular routes, and using machine learning to perform the simulating of the catheter moving along the blood vessels. While the claims of ‘070 include additional limitations such as simulating a catheter, it would have been obvious to the skilled artisan to conclude that the instant claims are an obvious variant.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797