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 .
Response to Arguments
Applicant’s arguments and amendments have persuasively overcome the claim objections, the 112a rejections, and the 112b rejections. The remaining issues are addressed below.
101
Applicant argues:
The reason for this inconsistency is that surgeons had no indication of which osteophytes to remove or how much to remove them (e.g., when to stop osteophyte removal).
Examiner responds:
This is attorney argument, unsupported by evidence. Fundamentally, a surgeon looks at an osteophyte and uses this visual information to decide where to cut. The decision where to cut is a mental version of the graphical indicator (because the surgeon cuts the osteophyte and not another part of the body).
The surgeon has an indicator of where to cut because they are a surgeon. For example, they know to cut the osteophyte and not healthy bone and they distinguish these visually (as opposed to by touch or hearing).
Applicant argues:
The Office Action made no effort to explain how updating one or more graphical visual indications is a mental step.
Examiner responds:
For example, the surgeon looks at a patient, and sees an osteophyte, and decides to cut it. This decision is a mental version of a first graphical indicator. Then, the surgeon sees that they have removed the osteophyte, and decides to stop cutting. This decision is a mental version of an updated graphical indicator.
Applicant argues:
For instance, the Office Action made no explanation how it is a mental step to "virtually remov[e], by one or more processors, one or more areas.... [now amended to one or more osteophytes]."
Examiner responds:
The surgeon looks at the osteophyte, and imagines what the patient will look like once the osteophyte is gone.
102
Applicant argues:
For instance, the derive surfaces being done during surgery provides no disclosure related to generating...one or more updated graphical visual indications, much less as set forth by updating...the one or more graphical visual indications based on how much of the one or more osteophytes are removed relative to one or more thresholds during the surgery," as set forth in claim 1 and similar features of claims 10 and 19.
Examiner responds:
The live surface is during surgery. The point of the surgery is to remove the osteophytes. Thus, at the beginning of the surgery, the derived surfaces have the osteophyte, and towards the end of the surgery, the osteophytes are removed, and thus the derived surfaces are updated as well because this is a live surface.
Double Patenting
Applicant argues:
However, as described above, Lang does not disclose or suggest the features of the amended claims. Therefore, Applicant respectfully requests withdrawal of obviousness-type double patenting rejection of the pending claims.
Examiner responds:
The rejection is maintained because the rejection over Lang is also maintained.
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, 3, 4, 6, 7, 10, 12, 13, 15, 16, 19, 21, 22, 24, and 25 (all claims) are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Pat. Nos. 10987176, 11439469, 11478310, 11571263, 11589923, 11645531, 11657287, 12020801, 12070272, and 12266440 in view of the prior art as applied below.
Both the pending claims and the conflicting patents are all directed to using virtual reality to guide surgery. Therefore, all of the conflicting patents are directed to the same problem as the present application. Further, any differences between the present claims and the claims in any of the conflicting patents are obvious in view of the prior art as applied below. It would have been obvious to one of ordinary skill in the art, before the effective filing date, to combine Lang with any of the conflicting patents for implementation details (in part because only claims of the conflicting patents are available). Based on the findings herein, this is an example of “combining prior art elements according to known methods to yield predictable results.”
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, 3, 4, 6, 7, 10, 12, 13, 15, 16, 19, 21, 22, 24, and 25 (all claims) are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process) without significantly more.
Step 1: Claim 1 (and its dependents) recite a method, and processes are eligible subject matter.
Claim 10 (and its dependents) recite a system, and machines are eligible subject matter.
Claim 19 (and its dependents) recite a non-transitory computer-readable storage medium, and manufactures are eligible subject matter.
Step 2A, prong one: All of the elements of the claims are a mental process. For example, obtaining image data can be performed by looking around, or at a photo. The specification identifies a practical application at [0044], “The example techniques provide a practical application whereby the example techniques generate information indicative of the shape, size and/or location of the one or more areas (or volumes) to remove during the surgical procedure. Using this information, the surgeon can better plan and execute a repair or replacement surgery to address the patient injury or disease.” However, the examiner has not identified techniques that differ from performing these steps manually (other than being performed with generic computer components).
MPEP 2106.04(a)(2)(III)(C) explains that use of a generic computer or in a computer environment is still a mental process. For example, the memory of claim 10, the processor of claims 1 and 10, and the non-transitory computer-readable storage medium are each generic computer components. In particular, this section begins by citing Gottschalk v. Benson, 409 US 63 (1972). “The Supreme Court recognized this in Benson, determining that a mathematical algorithm for converting binary coded decimal to pure binary within a computer’s shift register was an abstract idea.” In Benson the Supreme Court did not separately analyze the computer hardware at issue; the specifics of what hardware was claimed is only included in an appendix to the decision.
Because there are no additional elements, no further analysis is required for Step 2A, prong two or Step 2B.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 4, 6, 7, 10, 12, 13, 15, 16, 19, 21, 22, 24 and 25 (all claims) are rejected under 35 U.S.C. 102(a)(2) as being anticipated by LANG (USPAP 2017/0258526).
Referring to claim 1, Lang teaches a method comprising: obtaining, by one or more processors, first image data of a bone before a surgery; ([see para. 0023, virtual data of a patient can be superimposed onto live data seen through the optical head [i.e. obtaining means] mounted display, the virtual data can be raw data in unprocessed form, e.g. preoperative images of a patient, or they can be processed data, e.g. filtered data or segmented data], see para.0203);
virtually removing, by one or more processors, one or more osteophytes on the bone from the first image data to form a virtual model of the bone before the surgery; (Fig. 3, step 57. See also, [0275] listing various osteophytes);
obtaining, by one or more processors, second image data of the bone during the surgery; (Fig. 3, step 61)
generating information of the virtual model for overlay on or for displaying proximate to the bone based on the second image data; ([see para [0711], tissue deformation, a shape change or removal of tissue caused by the surgery or surgical instruments can be simulated in the virtual data, the resultant simulated virtual data can then be registered related to the live patient data (i.e. 2nd image data), either before and/or after deformation, alteration of shape or removal of tissue of the live patient]);
generating, by one or more processors and prior to removal of the one or more osteophytes, one or more graphical visual indications graphically located on the one or more osteophytes, wherein the one or more osteophytes are the one or more osteophytes that are virtually removed from the first image data; (para.0395] the registration virtual patient data and live patient data using the methods described herein including anatomic landmarks can be repeated after one or more surgical steps have been performed. In this case, the surgically altered tissue or tissue surface or tissue contour or tissue perimeter in the live patient can be matched to, superimposed onto and/or registered with the surgically altered tissue features in the virtual data of the patient, e.g. in a virtual surgical plan developed for the patient]);
generating, in real-time or near real-time and by the one or more processors and during the surgery, one or more updated graphical visual indicators by updating, in real-time or near real-time and by the one or more processors and during the surgery, the one or more graphical visual indications based on how much of the one or more osteophytes are removed relative to one or more thresholds during the surgery; (para. [0405] “In this embodiment, the live anatomic surface can be derived, for example, using a light scanning, infrared scanning or ultrasound technique, or ultrasonic scanning technique during the surgery.”)
outputting, by the one or more processors and based on the information, the virtual model for overlay on or for displaying proximate to the bone during the surgery; and (Fig. 4C)
outputting, by the one or more processors, the one or more updated graphical visual indications in real-time or near real-time, as the one or more indications are updated, during the surgery. [see para. 0405] “The live surfaces of the patient that are detected and generated in this manner can be matched or aligned with virtual surfaces of the patient, for example obtained preoperatively using an imaging test such as x-ray imaging, ultrasound, CT or MRI or any other technique known in the art.”).
Referring to claim 3, Lang teaches wherein generating the one or more graphical visual indications comprises:
determining differences between the virtual model and the bone in the second image data, the differences indicating at least what bone areas to remove or amount of bone areas to remove or have been removed; and (para. [0405] “The live surfaces of the patient that are detected and generated in this manner can be matched or aligned with virtual surfaces of the patient”)
determining a size or shape for the one or more graphical visual indications based on the differences; and (para. [0405] “Virtual and live data and anatomic surfaces can include an osteophyte or bone spur or other bony anatomy or deformity.” Being an osteophyte teaches the claimed shape.)
the method further comprising outputting information of the one or more indications having the size or shape during the surgery in a first color. (Fig. 3, step 60)
Referring to claim 4, Lang teaches wherein generating the one or more updated graphical visual indications comprises:
generating updated differences by updating the differences between the virtual model and how much of the one or more osteophytes are removed; and (para. [0406] “In some embodiments of the invention, the registration of virtual patient data and live patient data using the methods described herein can be repeated after one or more surgical steps have been performed.”)
generating an updated size or shape by updating the size or shape of the one or more graphical visual indications based on the updated differences, and (para. [0406] “The matching, superimposing and/or registering of the live data of the patient and the virtual data of the patient after the surgical tissue alteration can be performed using the same methods described in the foregoing or any of the other registration methods described in the specification or any other registration method known in the art.”)
wherein outputting information of the one or more updated graphical visual indications comprises outputting the one or more graphical visual indications having the updated size or shape during the surgery in a second color. (para. [0218] “If combinations of virtual data are displayed simultaneously with the live data, the different types of virtual data can be displayed with different colors.”)
Referring to claim 6, Lang teaches wherein updating the one or more characteristics comprises updating the size of the one or more graphical visual indications based on the updated differences. (para. [0406] “the surgically altered tissue or tissue surface or tissue contour or tissue perimeter or tissue volume or other tissue features in the live patient can be matched to, superimposed onto and/or registered with the surgically altered tissue or tissue surface or tissue contour or tissue perimeter or tissue volume or other tissue features in the virtual data of the patient, e.g. in a virtual surgical plan developed for the patient.”)
Referring to claim 7, Lang teaches wherein generating the updated size or shape comprises updating the shape of the one or more graphical visual indications based on the updated differences. (para. [0406] “the surgically altered tissue or tissue surface or tissue contour or tissue perimeter or tissue volume or other tissue features in the live patient can be matched to, superimposed onto and/or registered with the surgically altered tissue or tissue surface or tissue contour or tissue perimeter or tissue volume or other tissue features in the virtual data of the patient, e.g. in a virtual surgical plan developed for the patient.”)
The system and computer readable medium claims are rejected under the same reasoning as the counterpart method claims.
Claims 1, 3, 4, 6, 7, 10, 12, 13, 15, 16, 19, 21, 22, 24 and 25 (all claims) are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US20190380792A1 (“Poltaretskyi”).
Availability of Poltaretskyi
The examiner believes that the current application and Poltaretskyi are presently commonly owned by the Stryker Corporation. However, Poltaretskyi is available as prior art under 35 U.S.C. 102(a)(2) because it was not commonly owned or subject to an obligation of assignment until after the effective filing date. The present application has an effective filing date of June 3, 2020 because it claims priority to provisional 63/034,092, which appears to have the same figures and written description as the present application (and thus the present application is entitled to the date). However, Poltaretskyi was not assigned to Howmedica (which the examiner understands to be a Stryker subsidiary) until May 21, 2021. The examiner’s understanding is that Tornier (the original assignee of Poltaretskyi) was acquired by Wright Medical Group on October 1, 2015, and that Wright Medical Group was acquired by Stryker on November 11, 2020 – after the effective filing date.
Referring to claim 1, Poltaretskyi teaches a method comprising: obtaining, by one or more processors, first image data of a bone before a surgery; (Poltaretskyi, Fig. 4, Medical Image Acquisition 406. See also, [0003] “Today, virtual visualization tools are available to surgeons that use three-dimensional modeling of bone shapes to facilitate preoperative planning for joint repairs and replacements.”)
virtually removing, by one or more processors, one or more osteophytes on the bone from the first image data to form a virtual model of the bone before the surgery; (Poltaretskyi, [0254] “In response to selection of other items on menu 1510 on this page, visualization device 213 can remove the 3D model of the humeral implant components 1506 from the presented imagery and provide images of the humeral head before and after cutting, as examples.” See also, [0256] providing ostephytes as an option and [0773] “a step of removing osteophytes during the surgery for a first patient”)
obtaining, by one or more processors, second image data of the bone during the surgery; (Poltaretskyi, Fig. 4, Generate Intraoperative Guidance 414. See also, Fig. 5, optical cameras 530.)
generating information of the virtual model for overlay on or for displaying proximate to the bone based on the second image data; (Poltaretskyi, Fig. 27 and [0033] “FIG. 27 illustrates an image perceptible to a user when in an augment surgery mode of a mixed reality (MR) system”)
generating, by one or more processors and prior to removal of the one or more osteophytes, one or more graphical visual indications graphically located on the one or more osteophytes, wherein the one or more osteophytes are the one or more osteophytes that are virtually removed from the first image data; (Poltaretskyi, [0254] “In response to selection of other items on menu 1510 on this page, visualization device 213 can remove the 3D model of the humeral implant components 1506 from the presented imagery and provide images of the humeral head before and after cutting, as examples.” See above that this also applies to osteophytes.)
generating, in real-time or near real-time and by the one or more processors and during the surgery, one or more updated graphical visual indicators by updating, in real-time or near real-time and by the one or more processors and during the surgery, the one or more graphical visual indications based on how much of the one or more osteophytes are removed relative to one or more thresholds during the surgery; (Polaretskyi, Figs. 36A-D, see also, [0380] “As one example, MR system 212 may display any of the virtual markers described above to assist the surgeon in performing any work on humerus 3200.” See also, [0502] “computing systems 11706 (FIG. 117), etc.) may mark steps of the surgical workflow as complete as the surgeon progresses through the surgical workflow.”)
outputting, by the one or more processors and based on the information, the virtual model for overlay on or for displaying proximate to the bone during the surgery; and (Poltaretskyi, Fig. 4, surgical procedure with guidance 418. See also, abstract, “An example method includes displaying, via a visualization device and overlaid on a portion of an anatomy of a patient viewable via the visualization device”)
outputting, by the one or more processors, the one or more updated graphical visual indications in real-time or near real-time, as the one or more indications are updated, during the surgery. (Polaretskyi, Figs. 36A-D, see also, [0380] “As one example, MR system 212 may display any of the virtual markers described above to assist the surgeon in performing any work on humerus 3200.” See also, [0502] “computing systems 11706 (FIG. 117), etc.) may mark steps of the surgical workflow as complete as the surgeon progresses through the surgical workflow.”)
Referring to claim 3, Poltaretskyi teaches wherein generating the one or more graphical visual indications comprises:
determining differences between the virtual model and the bone in the second image data, the differences indicating at least what bone areas to remove or amount of bone areas to remove or have been removed; and (Poltaretskyi, Fig. 31)
determining a size or shape for the one or more graphical visual indications based on the differences; and (Poltaretskyi, [0362] “For example, the virtual guides may be 3D virtual objects that appear to reside within the real-world environment with the actual, real anatomical object.” “Reside within” teaches the claimed size or shape.)
the method further comprising outputting information of the one or more indications having the size or shape during the surgery in a first color. (Poltaretskyi, [0361] “Example parameters for the virtual guides include, but are not necessarily limited to: guide location, guide orientation, guide type, guide color, etc.”)
Referring to claim 4, Poltaretskyi teaches wherein generating the one or more updated graphical visual indications comprises:
generating updated differences by updating the differences between the virtual model and how much of the one or more osteophytes are removed; and (Poltaretskyi, [0494] “For instance, in the example of FIG. 67, the surgeon may use secondary view window 6704 to determine how far a bit of drill 6600 has penetrated scapula 5100.” See also, Fig. 67.)
generating an updated size or shape by updating the size or shape of the one or more graphical visual indications based on the updated differences, and (Poltaretskyi, [0494] “For instance, in the example of FIG. 67, the surgeon may use secondary view window 6704 to determine how far a bit of drill 6600 has penetrated scapula 5100.” See also, Fig. 67.)
wherein outputting information of the one or more updated graphical visual indications comprises outputting the one or more graphical visual indications having the updated size or shape during the surgery in a second color. (Poltaretskyi, [0526] “For example, visualization device 213 may provide or issue alerts to a user, and such alerts may be indicative of depth. The alerts may be graphical, color-based, color changing, symbols, shape or size-changing symbols, textual, visual, audible, tactile, or other types of alerts.”)
Referring to claim 6, Poltaretskyi teaches wherein updating the one or more characteristics comprises updating the size of the one or more graphical visual indications based on the updated differences. (Poltaretskyi, [0526] “For example, visualization device 213 may provide or issue alerts to a user, and such alerts may be indicative of depth. The alerts may be graphical, color-based, color changing, symbols, shape or size-changing symbols, textual, visual, audible, tactile, or other types of alerts.”)
Referring to claim 7, Poltaretskyi teaches wherein generating the updated size or shape comprises updating the shape of the one or more graphical visual indications based on the updated differences. (Poltaretskyi, [0526] “For example, visualization device 213 may provide or issue alerts to a user, and such alerts may be indicative of depth. The alerts may be graphical, color-based, color changing, symbols, shape or size-changing symbols, textual, visual, audible, tactile, or other types of alerts.”)
The system and computer readable medium claims are rejected under the same reasoning as the counterpart method claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
In addition to the reference applied above, Philipp K. Lang has a wide variety of other relevant references, such as US9861446B2 (see, e.g., claim 1, including “so as to superimpose the virtual surgical guide onto the surface of the physical joint … wherein the physical surgical guide is configured to guide a bone cut of the physical joint”)
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID ORANGE whose telephone number is (571)270-1799. The examiner can normally be reached Mon-Fri, 9-5.
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, Gregory Morse can be reached at 571-272-3838. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID ORANGE/ Primary Examiner, Art Unit 2663
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