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 .
Claims 1-17 are pending.
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 1-2 and 8-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 18/954,195 in view of Long (U.S. Pub. No. 2017/0193160 A1), which teaches the organ and stone aspects of limitations (Paragraphs [0045-0047] discuss figure 6, which shows the stones shape and size, including dimensions that highlight the anatomical structures and features which is used for the decision support. Paragraphs [0051-0052] discuss identifying one or more access plans based on the processed data including the location, depth and trajectory angle of the needle required to remove the stone.) not found in the reference application. Long further teaches the generating a visual indication of the decision context information associated with selecting the surgical option limitation (Paragraphs [0045], [0048] and [0051] discuss the system displaying the processed image with the location, depth and trajectory angle of the needle required to remove the stone.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify the instant application to include an organ, a stone, and generating a visual related to removing the stone from the organ, as taught by Long, in order to “improve the efficacy and safety of minimally-invasive surgeries (Long, Paragraph [0020]).”
This is a provisional nonstatutory double patenting rejection.
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 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
Claims 1-7 and 15-17 are drawn to system for surgery which is within the four statutory categories (i.e. machine). Claims 8-14 are drawn to a method for a surgical system which is within the four statutory categories (i.e. process).
Step 2A | Prong One
Claims 1-7 (Group I) recite: a surgical system comprising:
a processor (apply it, MPEP § 2106.05(f)) configured to:
receive an external data stream from a source external to the surgical system (insignificant extra-solution activity, MPEP § 2106.05(g));
derive, based at least on the external data stream, decision contextual information;
select a surgical option associated with a surgical instrument based on the decision context information;
generate a visual indication of the decision context information associated with selecting the surgical option; and
generate a control signal associated with the surgical instrument based on the selected surgical option (insignificant extra-solution activity, MPEP § 2106.05(g)).
The bolded limitations, given the broadest reasonable interpretation, cover a certain method of organizing human activity because it recites fundamental economic practices, commercial or legal interactions, and/or managing personal behavior or relationships or interactions between people. Any limitations not identified above as part of the abstract idea are underlined and are deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for Claims 8-14 and 15-17 is substantially as the abstract idea for Claims 1-7 (Group I), because the only difference is they are directed towards different statutory categories or are in a different order.
Dependent Claims 2-7, 9-14 and 16-17 include other limitations, for example Claims 2 and 9 recite wherein the surgical option is associated with stone removal, and the external data stream comprises a visualization of a patient’s organ, and the processor is further configured to: identify, based on the visualization of the patient’s organ, a potential perimeter of a stone in the patient's organ, wherein the decision context information comprises the identified potential perimeter of the stone in the patient's organ, and the visual indication of the decision context information comprises a visual indication of the identified potential perimeter of the stone in the patient’s organ, Claims 3 and 10 recite wherein the surgical option is associated with stone removal, and the external data stream comprises a visualization of a patient’s organ, and the processor is further configured to: identify, based on the visualization of the patient’s organ, a potential perimeter of a stone in the patient's organ; and select a stone removal treatment location based on the identified potential perimeter of the stone in the patient's organ, wherein the control signal associated with the surgical instrument is generated based on the selected stone removal treatment location, and the visual indication of the decision context information comprises a visual indication of the identified potential perimeter of the stone in the patient’s organ, Claims 4 and 11 recite wherein the processor is further configured to: obtain a plurality of surgical options associated with the surgical instrument; and determine, based at least on the external data stream, respective system confidence assessments that correspond to the plurality of surgical options, wherein the decision context information comprises the respective system confidence assessments that correspond to the plurality of surgical options, and the visual indication of the decision context information comprises the system confidence assessment that corresponds to the selected surgical option, Claims 5 and 12 recite wherein the external data stream comprises a visualization of a patient’s organ, and the processor is further configured to: determine, based on the external data stream and the selected surgical option, a resultant visualization of the patient’s organ, wherein the visual indication of the decision context information comprises a visualization of the patient's organ pre-therapy and the resultant visualization of the patient’s organ post-therapy, Claims 6, 13 and 17 recite wherein the surgical option is associated with stone removal, and the external data stream comprises a visualization of a patient’s organ, and the processor is further configured to: identify, based on the visualization of the patient’s organ, a first potential perimeter of a stone in the patient's organ and a second potential perimeter of the stone in the patient's organ, the second potential perimeter encompassing the first potential perimeter; and calculate a first system confidence percentage associated with the first potential perimeter and a second system confidence percentage associated with the second potential perimeter, wherein the decision context information comprises the first system confidence percentage and the second system confidence percentage, and wherein the visual indication of the decision context information comprises a visual indication of the first potential perimeter of the stone and its associated first system confidence percentage, and a visual indication of the first potential perimeter of the stone and its associated second system confidence percentage, Claims 7, 14 and 16 recite wherein the surgical option is associated with stone removal, and the external data stream comprises a visualization of a patient’s organ, and the processor is further configured to:
identify, based on the visualization of the patient’s organ, a potential perimeter of a stone in the patient's organ; identify a plurality of potential stone removal treatment locations; determine, based on the potential perimeter of the stone in the patient's organ, respective confidence assessments that correspond to the plurality of potential stone removal treatment locations; and select a stone removal treatment location from the potential stone removal treatment locations based on their respective confidence assessments, wherein the control signal associated with the surgical instrument is generated based on the selected stone removal treatment location, and the visual indication of the decision context information comprises a visual indication of the potential perimeter of the stone in the patient’s organ, but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent Claims 1, 8 and 15.
Step 2A | Prong Two
Furthermore, Claims 1-17 are not integrated into a practical application because the additional elements (i.e. the limitations not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of a processor, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see paragraph [0048] of the present Specification, see MPEP 2106.05(f)
add insignificant extra-solution activity to the abstract idea – for example, the recitation of receiving an external data stream from a source external to the surgical system, which amounts to mere data gathering and/or the recitation of generating a control signal associated with the surgical instrument based on the selected surgical option, which amounts to an insignificant application, see MPEP 2106.05(g).
Step 2B
Furthermore, the Claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e. the elements other than the abstract idea) amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
paragraphs [0048] of the Specification discloses that the additional elements (i.e. a processor) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions (i.e. receiving data, generating signals) that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. healthcare);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention receives external stream data;
The following State of the Art Publication that demonstrates the well-understood, routine, and conventional nature of the additional elements:
generating a control signal associated with the surgical instrument based on the selected surgical option, e.g. see Long (U.S. Pub. No. 2017/0193160 A1) (Paragraphs [0031] and [0052] discuss controlling using instructions received over the network to a c-arm to adjust a needle.), Altshuler (U.S. Pub. No. 2024/0329202 A1), (Paragraphs [0126] and [0305] discuss generating signals to control instruments, such as a treatment laser, and Mino (U.S. Pub. No. 2025/0288186 A1) (Paragraphs [0063] and [0097] discuss generating control signals to one or more actuators of a robot arm used in robot-assisted procedures.).
Dependent Claims 2-7, 9-14 and 16-17 include other limitations, but they do not recite any additional elements beyond those recited in independent claims 1, 10 and 15.
Thus, taken alone, the additional elements do not amount to “significantly more” than the above-identified abstract idea. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, Claims 1-17 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
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 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 1-3, 5, and 8-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Long (U.S. Pub. No. 2017/0193160 A1).
Regarding claim 1, Long discloses a surgical system comprising:
a processor (Paragraph [0032] discusses the servers including a processor.) configured to:
receive an external data stream from a source external to the surgical system (Paragraphs [0026] and [0028] discuss the imaging devices being able to send and receive data over the network to the system.);
derive, based at least on the external data stream, decision contextual information (Paragraph [0038] discusses processing the received data to automatically identify different features of the kidney or surrounding tissues.);
select a surgical option associated with a surgical instrument based on the decision context information (Paragraphs [0051-0052] discuss identifying one or more access plans based on the processed data including the location, depth and trajectory angle of the needle required to remove the stone.);
generate a visual indication of the decision context information associated with selecting the surgical option (Paragraphs [0045], [0048] and [0051] discuss the system displaying the processed image with the location, depth and trajectory angle of the needle required to remove the stone.); and
generate a control signal associated with the surgical instrument based on the selected surgical option (Paragraphs [0031] and [0052] discuss the C-arm including a light source to identify a specific target or region of a patient based on the processing.).
Regarding claim 2, Long discloses wherein the surgical option is associated with stone removal (Paragraphs [0051-0052] discuss identifying one or more access plans based on the processed data including the location, depth and trajectory angle of the needle required to remove the stone.), and the external data stream comprises a visualization of a patient’s organ (Paragraphs [0024], [0026] and [0028] discuss the imaging devices being able to send and receive data over the network to the system including images of stones in a kidney.), and wherein the processor is further configured to:
identify, based on the visualization of the patient’s organ, a potential perimeter of a stone in the patient's organ, wherein the decision context information comprises the identified potential perimeter of the stone in the patient's organ, and the visual indication of the decision context information comprises a visual indication of the identified potential perimeter of the stone in the patient’s organ (Paragraphs [0045-0047] discuss figure 6, which shows the stones shape and size, including dimensions that highlight the anatomical structures and features which is used for the decision support.).
Regarding claim 3, Long discloses wherein the surgical option is associated with stone removal, and the external data stream comprises a visualization of a patient’s organ, and the processor is further configured to:
identify, based on the visualization of the patient’s organ, a potential perimeter of a stone in the patient's organ (Paragraphs [0024] and [0045] (which discusses figure 6) shows the stones shape and size, including dimensions that highlight the anatomical structures and features which is used for the decision support.); and
select a stone removal treatment location based on the identified potential perimeter of the stone in the patient's organ, wherein the control signal associated with the surgical instrument is generated based on the selected stone removal treatment location, and the visual indication of the decision context information comprises a visual indication of the identified potential perimeter of the stone in the patient’s organ (Paragraphs [0024], [0045] and [0051-0053] discuss planning a route of access to remove the stone and using that information to adjust the mobile c-arm device which adjusts the location/position of the needle.).
Regarding claim 5, Long discloses wherein the external data stream comprises a visualization of a patient’s organ, and the processor is further configured to:
determine, based on the external data stream and the selected surgical option, a resultant visualization of the patient’s organ, wherein the visual indication of the decision context information comprises a visualization of the patient's organ pre-therapy and the resultant visualization of the patient’s organ post-therapy (Paragraph [0024] discusses images before, during and after the procedure.).
2025Attorney Docket No. 317EP.001US01
Claim 8 recites substantially similar limitations as those already addressed in claim 1, and, as such, is rejected for similar reasons as given above.
Claim 9 recites substantially similar limitations as those already addressed in claim 2, and, as such, is rejected for similar reasons as given above.
Claim 10 recites substantially similar limitations as those already addressed in claim 3, and, as such, is rejected for similar reasons as given above.
Claim 11 recites substantially similar limitations as those already addressed in claim 4, and, as such, is rejected for similar reasons as given above.
Claim 12 recites substantially similar limitations as those already addressed in claim 5, and, as such, is rejected for similar reasons as given above.
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.
Claims 4 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Long in view Buschle (U.S. Pub. No. 2025/0166796 A1).
Regarding claim 4, Long discloses wherein the processor is further configured to:
obtain a plurality of surgical options associated with the surgical instrument (Paragraphs [0036] and [0051-0052] discuss identifying one or more access plans based on the processed data including the location, depth and trajectory angle of the needle required to remove the stone by accessing relevant data from medical case studies and/or comparison to the patient data.);
but Long does not appear to explicitly disclose:
determining, based at least on the external data stream, respective system confidence assessments that correspond to the plurality of surgical options, wherein the decision context information comprises the respective system confidence assessments that correspond to the plurality of surgical options, and the visual indication of the decision context information comprises the system confidence assessment that corresponds to the selected surgical option.
Buschle teaches determine, based at least on the external data stream, respective system confidence assessments that correspond to the plurality of surgical options, wherein the decision context information comprises the respective system confidence assessments that correspond to the plurality of surgical options, and the visual indication of the decision context information comprises the system confidence assessment that corresponds to the selected surgical option (Paragraphs [0027-0028], [0048] and 90075] discuss sorting recommended actions according to a recommended ranking based on the received imaging data.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify Long to identify a potential perimeter of a stone in the patient’s organ and a visual indication of the identified potential perimeter, as taught by Buschle, in order to provide “an imaging device and an imaging method by means of which the safety, quality and/or efficiency of diagnostic and/or therapeutic activities can be increased (Buschle, Paragraph [0006]).”
Claim 15 recites substantially similar limitations as those already addressed in claims 1 and 4, and, as such, is rejected for similar reasons as given above.
Subject Matter Free from Prior Art
The prior art of record does not appear to disclose or render obvious the limitations of claims 6-7, 13-14 and 16-17. Specifically, the prior art of record does not disclose or render obvious the limitations of claim 6 “wherein the surgical option is associated with stone removal, and the external data stream comprises a visualization of a patient’s organ, and the processor is further configured to: identify, based on the visualization of the patient’s organ, a first potential perimeter of a stone in the patient's organ and a second potential perimeter of the stone in the patient's organ, the second potential perimeter encompassing the first potential perimeter; and calculate a first system confidence percentage associated with the first potential perimeter and a second system confidence percentage associated with the second potential perimeter, wherein the decision context information comprises the first system confidence percentage and the second system confidence percentage, and wherein the visual indication of the decision context information comprises a visual indication of the first potential perimeter of the stone and its associated first system confidence percentage, and a visual indication of the first potential perimeter of the stone and its associated second system confidence percentage” and of claim 7 “wherein the surgical option is associated with stone removal, and the external data stream comprises a visualization of a patient’s organ, and the processor is further configured to: identify, based on the visualization of the patient’s organ, a potential perimeter of a stone in the patient's organ; identify a plurality of potential stone removal treatment locations; determine, based on the potential perimeter of the stone in the patient's organ, respective confidence assessments that correspond to the plurality of potential stone removal treatment locations; and select a stone removal treatment location from the potential stone removal treatment locations based on their respective confidence assessments, wherein the control signal associated with the surgical instrument is generated based on the selected stone removal treatment location, and the visual indication of the decision context information comprises a visual indication of the potential perimeter of the stone in the patient’s organ” in combination with the limitations of claim 1. Claims 13-14 and 16-17 are free from prior art for the same reasons as claims 6-7.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachelle Reichert whose telephone number is (303)297-4782. The examiner can normally be reached M-F 9-5 MT.
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/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686