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 08/25/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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, 2, 4, 8, 10-13, 16 and 17 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
On January 7, 2019, the USPTO released new examination guidelines setting forth a two-step inquiry for determining whether a claim is directed to non-statutory subject matter. According to the guidelines, a claim is directed to non-statutory subject matter if:
• STEP 1: the claim does not fall within one of the four statutory categories of invention (process, machine, manufacture or composition of matter), or
• STEP 2: the claim recites a judicial exception, e.g. an abstract idea, without reciting additional elements that amount to significantly more than the judicial exception, as determined using the following analysis:
o STEP 2A (PRONG 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
o STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
o STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Using the two-step inquiry, it is clear that claims 1 and 20 are directed toward non-statutory subject matter, as shown below:
STEP 1: Do claims 1, 9 and 18 fall within one of the statutory categories? Claims 1, 9 and 18 are directed towards an apparatus, and as such fall within one of the statutory categories.
STEP 2A (PRONG 1): Is the claim directed to a law of nature, a natural phenomenon or an abstract idea? Yes, claims 1, 9 and 18 are directed to mental processes.
With regard to STEP 2A (PRONG 1), the guidelines provide three groupings of subject matter that are considered abstract ideas:
1. Mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations;
2. Certain methods of organizing human activity – fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions); and
3. Mental processes – concepts that are practicably performed in the human mind (including an observation, evaluation, judgment, opinion).
NOTE: Claims 1, 9 and 18 recite limitations that are similar in scope, hence examiner will assess apparatus of claim 1.
The apparatus of claim 1 merely defines two volumes based on location of first and second anatomical elements. Based on location of the anatomical elements, a human can define a first and second volume by merely drawing it with aid of pen and paper. Therefore, the following limitations are directed towards an abstract idea:
define, based on the location of the first anatomical element, a first volume in the surgical environment that includes a first portion of the first anatomical element and that at least one of a robotic arm and one or more components attached to the robotic arm avoids passing through during a movement of the robotic arm; and
define, based on the location of the second anatomical element, a second volume different from the first volume in the surgical environment, wherein the second volume comprises a second portion of the first anatomical element different than the first portion of the first anatomical element, and wherein the second volume comprises an entirety of the second anatomical element
STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the judicial exception into a practical application? No, the claims do not recite additional elements that integrate the judicial exception into a practical application.
With regard to STEP 2A (prong 2), whether the claim recites additional elements that integrate the judicial exception into a practical application, the guidelines provide the following exemplary considerations that are indicative that an additional element (or combination of elements) may have integrated the judicial exception into a practical application:
• an additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
• an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
• an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
• an additional element effects a transformation or reduction of a particular article to a different state or thing; and
• an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
While the guidelines further state that the exemplary considerations are not an exhaustive list and that there may be other examples of integrating the exception into a practical application, the guidelines also list examples in which a judicial exception has not been integrated into a practical application:
• an additional element merely recites the words “apply it” (or an equivalent) with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea;
• an additional element adds insignificant extra-solution activity to the judicial exception; and
• an additional element does no more than generally link the use of a judicial exception to a particular technological environment or field of use.
Claims 1, 9 and 18 do not recite any of the exemplary considerations that are indicative of an abstract idea having been integrated into a practical application. Also, as noted above, merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea is indicative that the judicial exception has not been integrated into a practical application.
The steps of, ” a memory coupled with the processor and storing data thereon that, when processed by the processor, enable the processor to” indicates that abstract idea is performed by a computer. Thus, it is clear that the abstract idea is merely implemented on a computer, which is indicative of the abstract idea having not been integrated into a practical application. See MPEP 2106.05(f).
Furthermore, the steps performed by controller above are performed “receive information comprising a location of a first anatomical element in a surgical environment and a location of a second anatomical element in the surgical environment”, this is mere data gathering, hence an insignificant extra solution activity. See MPEP 2106.05(g).
Furthermore, in claim 9, system comprising a robotic arm is generally linking to a technological environment.
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? No, the claims do not recite additional elements that amount to significantly more than the judicial exception.
With regard to STEP 2B, whether the claims recite additional elements that provide significantly more than the recited judicial exception, the guidelines specify that the pre-guideline procedure is still in effect. Specifically, that examiners should continue to consider whether an additional element or combination of elements:
• adds a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; or
• simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Claims 1, 9 and 18 not recite any specific limitation or combination of limitations that are not well-understood, routine, conventional (WURC) activity in the field. Limitations identified as “apply it” and “generally linking” in step 2A qualify as apply it and generally linking in step 2B as well.
With respect to “receive information comprising a location of a first anatomical element in a surgical environment and a location of a second anatomical element in the surgical environment”, this is receiving or transmitting data. And as such has been recognized as well-understood routine and conventional. See MPEP 2106.05(d).
CONCLUSION
Thus, since claims 1, 9 and 18 are: (a) directed toward an abstract idea, (b) do not recite additional elements that integrate the judicial exception into a practical application, and (c) do not recite additional elements that amount to significantly more than the judicial exception, it is clear that claim 1 and 20 are directed towards non-statutory subject matter.
With respect to claims 2 and 12, the claims further limit information to be one or more of a computed tomography image, a magnetic resonance imaging image, and a fluoroscopic image. This is still part of insignificant data gathering. Therefore, does not amount to a practical application or significantly more.
With respect to claims 3, 5, 6, 7, 14, 15, 19 and 20, controlling/maneuvering robotic arm is not a mental process. Therefore, the claims are statutory.
With respect to claim 4, the claim further limits first anatomical element to comprise least one of a vertebra, a hard tissue, a soft tissue, an artery, and a nerve. As it is merely defining the first anatomical element, it does not integrate to abstract idea to a practical application or significantly more.
With respect to claims 8 and 11, the claims further limit first volume and second to be mutually exclusive. This does not amount to a practical application or significantly more.
With respect to claim 10, the claim further limits first volume to partially overlap second volume. As it is merely defining the first and second volume, it does not amount to a practical application or significantly more.
With respect to claim 13, the claim further limits robot arm to comprise an end effector couple to surgical tool. This is part of generally linking to a technological environment and is not considered a practical application or significantly more.
With respect to claim 16, receiving intraoperative image(s) is mere data gathering and , determining a second location of first anatomical element and updating first volume to third volume is still part of the abstract idea. Therefore, does not amount to a practical application or significantly more.
With respect to claim 17, the claim merely limits first volume to be different than third volume. This is still part of the abstract idea and not considered a practical application or significantly more.
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. 12,295,683. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim of Instant Application
Claim of US Patent 12295683
A system, comprising:
a processor; and
a memory coupled with the processor and storing data thereon that, when processed by the processor, enable the processor to:
receive information comprising a location of a first anatomical element in a surgical environment and a location of a second anatomical element in the surgical environment;
define, based on the location of the first anatomical element, a first volume in the surgical environment that includes a first portion of the first anatomical element and that at least one of a robotic arm and one or more components attached to the robotic arm avoids passing through during a movement of the robotic arm; and
define, based on the location of the second anatomical element, a second volume different from the first volume in the surgical environment, wherein the second volume comprises a second portion of the first anatomical element different than the first portion of the first anatomical element, and wherein the second volume comprises an entirety of the second anatomical element.
Claims 9 and 18 recite limitations similar in scope to claim 1, hence are similarly rejected.
A method, comprising:receiving first registration data including information about a location of a first anatomical element in a surgical environment;receiving second registration data including information about a location of a second anatomical element in the surgical environment;defining, based on the location of the first anatomical element, a first three-dimensional(3D) volume in the surgical environment including a first portion of the first anatomical element;defining, based on the location of the second anatomical element, a second 3D volume different from the first 3D volume in the surgical environment, wherein the second 3D volume comprises a second portion of the first anatomical element different than the first portion of the first anatomical element, and wherein the second 3D volume comprises an entirety of the second anatomical element; andcontrolling a robotic arm inside the surgical environment based on the first 3D volume and the second 3D volume such that at least one of the robotic arm and one or more components attached to the robotic arm avoids passing through the first 3D volume during a movement of the robotic arm
2.The system of claim 1, wherein the information comprises information from one or more of a computed tomography image, a magnetic resonance imaging image, and a fluoroscopic image
Claim 12 recites limitations similar in scope to claim 2, hence is similarly rejected
2. The method of claim 1, wherein the first registration data includes information from one or more of a Computed Tomography (CT) image, a Magnetic Resonance Image (MRI), and a fluoroscopic image
3. The system of claim 1, wherein the data, when processed by the processor, further enable the processor to:
register the first volume and the robotic arm;
define, based on a location of the second volume, a first sub-volume within the second volume; and
control the robotic arm based on the first sub-volume, such that at least one of the robotic arm and the one or more components attached to the robotic arm avoids passing through the first sub-volume.
3. The method of claim 1, further comprising:
registering the first 3D volume to the robotic arm;
defining, based on the location of the second anatomical element and a location of the second 3D volume, a first 3D sub-volume within the second 3D volume; and
controlling the robotic arm based on the first 3D sub-volume such that at least one of the robotic arm and the one or more components attached to the robotic arm passes through the second 3D volume and avoids passing through the first 3D sub-volume
4. The system of claim 1, wherein the first anatomical element comprises at least one of a vertebra, a hard tissue, a soft tissue, an artery, and a nerve.
4. The method of claim 1, wherein the first anatomical element comprises at least one of a vertebra, a hard tissue, a soft tissue, an artery, and a nerve, and wherein the second 3D volume is positioned a first distance away from the first 3D volume.
5. The system of claim 1, wherein the data, when processed by the processor, further enable the processor to:
control a second robotic arm based on the first volume, wherein at least one of the second robotic arm and a component attached to the second robotic arm passes through the first volume during a movement of the second robotic arm.
5. The method of claim 1, further comprising:
controlling a second robotic arm based on the first 3D volume, wherein at least one of the second robotic arm and components attached to the second robotic arm passes through the first 3D volume.
6. The system of claim 5, wherein the data, when processed by the processor, further enable the processor to:
determine, based on the first volume, a first navigation path of the robotic arm;
determine, based on at least one of the first volume and the first navigation path, a second navigation path of the second robotic arm; and
cause the second robotic arm to navigate along the second navigation path.
6. The method of claim 5, further comprising:
determining, based on the first 3D volume, a first navigation path of the robotic arm; and determining, based on at least one of the first 3D volume and the first navigation path, a second navigation path of the second robotic arm
7. The system of claim 5, wherein the data, when processed by the processor, further enable the processor to:
restrict, when the second robotic arm passes through the first volume, the movement of the robotic arm.
7.The method of claim 5, wherein the controlling of the second robotic arm further comprises:
restricting, when the second robotic arm passes through the first 3D volume, the movement of the robotic arm.
8. The system of claim 1, wherein the first volume and the second volume are mutually exclusive.
Claim 11 recites limitations similar in scope to claim 8, hence is similarly rejected
13. The system of claim 9, wherein the first 3D volume and the second 3D volume are mutually exclusive.
10. The system of claim 9, wherein the first volume at least partially overlaps the second volume.
10. The system of claim 9, wherein the first 3D volume at least partially overlaps the second 3D volume.
13. The system of claim 9, wherein the robotic arm comprises an end effector mechanically coupled to a surgical tool, and wherein the surgical tool comprises a drill, a reamer, a scalpel, a saw, a tap, an ultrasonic blade, a surgical burr, a surgical screw, or an interbody element.
14. The system of claim 13, wherein an end effector of the robotic arm is mechanically coupled to a first surgical tool, and wherein the first surgical tool comprises a drill, a reamer, a scalpel, a saw, a tap, an ultrasonic blade, a surgical burr, a surgical screw, or an interbody element.
14. The system of claim 9, wherein the data, when processed by the processor, further enable the processor to:
define a third volume that abuts at least one of the first volume and the second volume; and
control, based on the third volume, the movement of the robotic arm.
15. The system of claim 9, wherein the data further cause the processor to:
define a third 3D volume that abuts at least one of the first 3D volume and the second 3D volume; and
control the movement of the robotic arm based on the third 3D volume.
15. The system of claim 9, wherein the data, when processed by the processor, further enable the processor to:
register the robotic arm and at least one of the first volume and the second volume;
define, based on a location of the second volume, a first sub-volume within the second volume; and
control the robotic arm based on the first sub-volume such that at least one of the robotic arm and the one or more components attached to the robotic arm avoids passing through the first sub- volume.
3.The method of claim 1, further comprising:
registering the first 3D volume to the robotic arm;
defining, based on the location of the second anatomical element and a location of the second 3D volume, a first 3D sub-volume within the second 3D volume; and
controlling the robotic arm based on the first 3D sub-volume such that at least one of the robotic arm and the one or more components attached to the robotic arm passes through the second 3D volume and avoids passing through the first 3D sub-volume.
16. The system of claim 9, wherein the data, when processed by the processor, further enable the processor to:
receive one or more intraoperative images;
determine, based on the one or more intraoperative images, a second location of the first anatomical element in the surgical environment; and
update, based on the second location, the first volume to a third volume.
18. The apparatus of claim 17, wherein the data further cause the processor to:
receive one or more intraoperative images;
determine, based on the one or more intraoperative images, a second location of the first anatomical element in the surgical environment; and
change, based on the one or more intraoperative images, the first 3D volume to a third 3D volume.
17. The system of claim 16, wherein the third volume has a different volume than the first volume.
19. The apparatus of claim 18, wherein the third 3D volume has a volume that is different than the first 3D volume.
19. The apparatus of claim 18, wherein the data, when processed by the processor, further enable the processor to:
determine, based on the first volume, a first navigation path of the robotic arm; and
maneuver the robotic arm along the first navigation path.
6. The method of claim 5, further comprising:
determining, based on the first 3D volume, a first navigation path of the robotic arm; and determining, based on at least one of the first 3D volume and the first navigation path, a second navigation path of the second robotic arm.
20. The apparatus of claim 18, wherein the data, when processed by the processor, further enable the processor to:
register the first volume and the robotic arm;
define, based on a location of the second volume, a first sub-volume within the second volume; and
control the robotic arm based on the first sub-volume, such that at least one of the robotic arm and the end effector passes through a second sub-volume of the second volume and avoids passing through the first sub-volume.
3. The method of claim 1, further comprising:
registering the first 3D volume to the robotic arm;
defining, based on the location of the second anatomical element and a location of the second 3D volume, a first 3D sub-volume within the second 3D volume; and
controlling the robotic arm based on the first 3D sub-volume such that at least one of the robotic arm and the one or more components attached to the robotic arm passes through the second 3D volume and avoids passing through the first 3D sub-volume.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Atarot (US 20170202624), Sartor (US 20200035348) and Sexson (WO 2020236937) were pertinent to parent application 17590891 and the rejection. None of them alone or in combination teach or provide motivation for modification to teach:
the second volume comprises a second portion of the first anatomical element different than the first portion of the first anatomical element, and wherein the second volume comprises an entirety of the second anatomical element
Therefore, claims 1, 9 and 18 are deemed novel. Claims will be revaluated when amended to overcome rejections presented under 35 USC 101 and Non Statutory Double Patenting.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARSLAN AZHAR whose telephone number is (571)270-1703. The examiner can normally be reached Mon-Fri 7:30 - 5:30.
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, Wade Miles can be reached at (571) 270-7777. 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.
/ARSLAN AZHAR/Examiner, Art Unit 3656
Prosecution Insights