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 .
DETAILED ACTION
This is a non-final Office Action on the merits. Claims 1-20 are currently pending and are addressed below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/10/2024 is being considered by the examiner.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,226,302. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims contain all limitations of the pending claims, thereby anticipating the pending claims.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,234,774. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims contain all limitations of the pending claims, thereby anticipating the pending claims.
Claims 1-2, 4, and 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,059,217. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims contain all limitations of the pending claims, thereby anticipating the pending claims.
Claims 7-9, and 13-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No. 12,059,217. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims contain all limitations of the pending claims, thereby anticipating the pending claims.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1:
A computer-implemented method for generating and presenting an electronic display of guidance for performing a robotic medical procedure, comprising:
receiving, by one or more processors, a plurality of prior procedure data sets, wherein each prior procedure data set: i) corresponds to an instance of the robotic medical procedure performed by using a robotic tool on a patient within a population, and ii) defines one or more of a location or a movement of the patient, a medical device, or the robotic tool involved in the robotic medical procedure; a force applied by the robotic tool; or a timing of a step of the robotic medical procedure;
receiving or identifying, by the one or more processors, objective data defining one or more of a duration or a patient outcome of the robotic medical procedure;
executing an algorithm, stored in a non-transitory computer-readable storage medium, to identify a pattern across the plurality of prior procedure data sets, the pattern describing one or more of a location or a movement of a patient, medical device, or robotic tool involved in the robotic medical procedure, a force applied by the robotic tool, or a timing of a step of the robotic medical procedure that achieves the duration or the patient outcome defined by the objective data;
receiving, by the one or more processors, information about an instance of the robotic medical procedure to be performed in the future for a patient outside the population;
automatically generating, by the one or more processors, guidance for performing the robotic medical procedure, the guidance comprising a recommended location or movement of a patient, medical device, or robotic tool involved in the robotic medical procedure, force applied by the robotic tool, or timing of a step of the robotic medical procedure based on evaluating the pattern identified across the plurality of prior procedure data sets and the information received about the instance of the robotic medical procedure to be performed; and
generating and presenting an electronic display of the guidance for performing the robotic medical procedure.
Step 1: Statutory Category – Yes
The claim recites a method including at least one step. The claim falls within one of the four statutory categories. MPEP 2106.03.
Step 2A prong one evaluation: Judicial Exception – Yes
The Office submits that the foregoing bolded limitation(s) constitutes judicial exceptions in terms of “mental processes” because under its broadest reasonable interpretation, the claim covers performance using mental processes.
The claim recites “executing an algorithm... to identify a pattern”. This limitation, as drafted, is a simple process that, under its broadest reasonable interpretation per the specification, covers performance of the limitation in the mind, but for the limitation that a computer can be programed to perform the task. That is, other than reciting “stored in a non-transitory computer-readable storage medium”, nothing in the claim precludes the element being done in the mind. For example, a person could mentally analyze data and determine a pattern. This step is directed to a mental process.
The claim recites “automatically generating... guidance for performing the robotic medical procedure”. This limitation, as drafted, is a simple process that, under its broadest reasonable interpretation per the specification, covers performance of the limitation in the mind, but for the limitation that a computer can be programed to perform the task. That is, other than reciting “by the one or more processors”, nothing in the claim precludes the element being done in the mind. For example, a person could determine guidance for optimizing or improving a medical procedure based on previous procedures. This step is directed to a mental process.
Step 2A Prong Two evaluations – Practical Application – No
Claim 1 is evaluated whether as a whole it integrates the recited judicial exception into a practical application. As noted in the 2019 PEG, it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.”
In the present case, the additional limitations beyond the above-noted abstract idea are as follows (where the underlined portions are the “additional limitations” while the bolded portions continue to represent the “abstract idea”).
Claim 1 recites the additional element of “a computer-implemented method” and being performed by “one or more processors”. According to the specification, the computer is identified as a general purpose computer such that it represents no more than mere instructions to apply the judicial exceptions on a generic computer. The computer is recited at a high level of generality and merely automates the receiving, identifying, and generating steps. The generically recited computer merely describes how to generally “apply” the otherwise mental processes and business transaction using a generic or general-purpose processor.
The claim limitation of “receiving a plurality of prior procedure data sets”, “receiving or identifying objective data”, and “receiving information” are directed to extra-solution activity of receiving data. This step amounts to mere data gathering/receiving which is a form of insignificant extra-solution activity, see MPEP2106.05(g).
The claim limitation of “presenting an electronic display” are directed to extra-solution activity of displaying data. This step amounts to mere data presentation which is a form of insignificant extra-solution activity, see MPEP2106.05(g).
The claim limitation of “for performing a robotic medical procedure” is described at a high level of generality. This amounts to insignificant application of the identified abstraction per MPEP 2106.05(g). Additionally, the limitation of “performing a robotic medical procedure” does no more than generally link the identified judicial exceptions to a particular technological environment or field of use. This type of limitation merely confines the use of the abstract idea to a particular technological environment and thus fails to add an inventive concept to the claims, see MPEP2106.05(h).
Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limit on practicing the abstract idea. The claim is ineligible.
2B Evaluation: Inventive Concept – No
Claim 1 is evaluated as to whether the claims as a whole amount to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim.
As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Per the evaluation in step 2A, general linking the use of the judicial exception to a particular technological environment or filed of use is not indicative of an inventive concept (significantly more).
Under the 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be reevaluated in Step 2B. Here, the steps of receiving information and presenting an electronic display were considered to be extra-solution activities in Step 2A, and thus they are reevaluated in Step 2B to determine if they are more than what is well-understood, routine, conventional activity in the field. The specification and background therein does not provide any indication that the processor and network are anything other than possible generic, off the-shelf computer components, and the Symantec, TLI, and OIP Techs, court decisions cited in MPEP 2106.05(d)(ll) indicate that mere collection or receipt of data over a network is a well-understood, routine, and conventional function when it is claimed in a merely generic manner (as it is here), see MPEP 2106.05(g).
For these reasons, there is no inventive concept in the claim, and thus it is ineligible.
Claims 2-6 merely recite additional details of the data being received and processed, and therefore does not provide an inventive step, or otherwise render the claims eligible.
Claims 7-20 are ineligible based on a similar analysis, with the exception of the differing statutory categories.
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 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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as obvious over Nawana et al. (US 2014/0081659) in view of Coste-Maniere et al. (US 2003/0109780).
Regarding claims 1, 4, 7, 8, and 14:
Nawana discloses a system and computer storage medium for performing a computer-implemented method for generating and presenting an electronic display of guidance for performing a robotic medical procedure, comprising (see at least abstract, [0101-0105]):
receiving, by one or more processors, a plurality of prior procedure data sets, wherein each prior procedure data set: i) corresponds to an instance of the robotic medical procedure performed by using a tool on a patient within a population (see at least [0021], [0032] accessing historical patient data, historical outcomes of treatment), and ii) defines one or more of a location or a movement of the patient, a medical device, or the robotic tool involved in the robotic medical procedure; a force applied by the robotic tool; or a timing of a step of the robotic medical procedure (see at least [0026] performance data including at least surgical instrument used, duration of tissue retraction, implant type, etc.);
receiving or identifying, by the one or more processors, objective data defining one or more of a duration or a patient outcome of the robotic medical procedure (see at least [0032] accessing historical patient data, historical outcomes of treatment);
executing an algorithm, stored in a non-transitory computer-readable storage medium, to identify a pattern across the plurality of prior procedure data sets, the pattern describing one or more of a location or a movement of a patient, medical device, or robotic tool involved in the robotic medical procedure, a force applied by the robotic tool, or a timing of a step of the robotic medical procedure that achieves the duration or the patient outcome defined by the objective data (collating variances of planned data from performance data, wherein variance includes movement of instrument, tissue retraction times, etc. see at least [0026]);
receiving, by the one or more processors, information about an instance of the robotic medical procedure to be performed in the future for a patient outside the population (recommending and planning future surgeries involving other patients, see at least [0199], [0220]);
automatically generating, by the one or more processors, guidance for performing the robotic medical procedure, the guidance comprising a recommended location or movement of a patient, medical device, or a robotic tool involved in the robotic medical procedure, force applied by the robotic tool, or timing of a step of the robotic medical procedure based on evaluating the pattern identified across the plurality of prior procedure data sets and the information received about the instance of the robotic medical procedure to be performed (providing recommended surgical strategies, see at least [0199]); and
generating and presenting an electronic display of the guidance for performing the robotic medical procedure (displaying suggested plan, see at least [0022], [0038], [0200]).
Nawana further teaches the guidance including at least a pre-op simulation and moving image data of all or a portion of a surgical procedure (see at least [0287]). Nawana also further teaches guidance including feedback of trajectory angles (see at least [0289]) and tracking motion of an instrument relative to the patient as well as tracking personnel motion and/or posture (see at least [0258]). The Examiner notes that all of the above example data at least partially defines at least a location or movement of at least surgical tools during the surgical procedure, meeting the claim limitations regarding the guidance comprising tool movement or location.
Nawana does not explicitly teach the tool being robotic or providing instructions to the robotic tool during a medical procedure. Nawana does teach, however that any number of conventional technologies may be integrated into the system and method, including navigating instruments via robotic control, which at least suggests some of the data relating to a robotic tool. Additionally, the Examiner notes that “robotic tool” in the surgical arts need not describe a robotic manipulator system, but may be broadly interpreted to encompass robotic hand tools, or hand tools with some control/actuation.
Coste-Maniere teaches a system and method for enhancing robotic surgical planning, wherein data, including movement of tools and robotic arms from past procedures (see at least [0112]) are collected and processed to create and modify a surgical plan and wherein instructions are provided to a surgical tool during a robotic surgical procedure for moving the tool (see at least abstract, [0022], [0104-0110]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the surgical planning system as taught by Nawana, by integrating it with the robotic surgical planning system as taught by Coste-Maniere, as suggested by Nawana in order to utilize past robotic surgical procedures to simulate and ensure feasibility of selected port placements and/or robot positions.
Regarding claims 2 and 15, Nawana further discloses wherein the duration defined by the objective data is a duration of a portion of the robotic medical procedure (at least duration of retraction of tissue, [0026] durations of steps in a surgical procedure, [0287]).
The Examiner further notes that the limitations of claim 2 are not required for the claim combination, since they further limit an optional limitation of the claim from which they depend.
Regarding claims 3, 11, and 17, Nawana further discloses wherein identifying the pattern across the plurality of prior procedure data sets includes identifying an occurrence level of at least one of the location or the movement of the patient, medical device, or robotic tool across the plurality of prior procedure data sets (comparing movement of the surgical instrument, see at least [0026] [0042], determining optimal position of the patient, see at least [0034], comparing parameters for future surgeries [0199]).
Regarding claims 4 and 18 Nawana further discloses wherein identifying the pattern across the plurality of prior procedure data sets includes describing a movement of the robotic tool during a portion of a procedure that achieves the duration defined by the objective data, wherein the duration is of the portion of the robotic medical procedure (comparing movement of the surgical instrument, see at least [0026] [0042], comparing parameters for future surgeries [0199] durations of steps in a surgical procedure, [0287]. The Examiner notes that the instant claim language is met by the teaching of tracking tool movement in general, since at least some of the movement will be during a procedure as claimed.).
Regarding claims 5, 13, and 19, Nawana further discloses wherein the information about the instance of the robotic medical procedure to be performed includes information about at least one of: a patient, a type of procedure, an operating room characteristic, or a user's prior experience (recommending and planning future surgeries involving other patients, see at least [0199]).
Regarding claims 6, 9 and 12, Nawana further discloses wherein the guidance comprises a recommended timing of a step of the robotic medical procedure, and the recommendation includes a recommended order of steps of the robotic medical procedure (timing of surgical steps, see at least [0214]).
Regarding claims 10 and 16. Nawana further discloses wherein the robot data includes information gathered by the robotic device during the corresponding instance of the robotic medical procedure (operation module 204, see at least [0199], [0026]).
Regarding claim 20:
Nawana further teaches wherein the medical device is a table supporting the patient (the Examiner notes that the instant claim language further limits an optional limitation of claim 14 and is therefore optional, see at least [0211], [0220]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN J RINK whose telephone number is (571)272-4863. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anna Momper can be reached on (571) 270-5788. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Ryan Rink/ Primary Examiner, Art Unit 3619