DETAILED ACTION
Comments
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Claims 1-2, 5-12, 14-17, 20-21, 23-24, 26, and 40 are pending and examined in the instant Office action.
Information Disclosure Statement
The IDS of 9/6/2022 has been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Paragraph 128 and 183 of the specification contain hyperlinks.
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.
35 U.S.C. 103 Rejection #1:
Claim 40 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter. In view of a lack of a limiting description of a computer readable storage media, the term “computer readable storage media” is broadly construed to comprise transitory subject matter such as carrier waves, which are not subject matter eligible
35 U.S.C. 103 Rejection #2:
Claim(s) 1-2, 5-12, 14-17, 20-21, 23-24, 26, and 40 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea/law of nature/natural phenomenon without significantly more. Claims 1-2, 5-12, 14-17, and 20-21 are drawn to systems comprising processors, and claims 23-24 and 26 are drawn to methods.
In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1 : YES; except for claim 40) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea:
The independent claims recite the mental step of storing a surgical plan comprising a digital three-dimensional model.
The independent claims recite the mental step of receiving the digital X-ray image of the joint and the localization object during the total replacement surgery.
The independent claims recite the mental step of determining a pose of the localization object relative to the bone or joint.
The independent claims recite the mental step of assessing the pose of the localization object against the surgical plan.
The independent claims recite the mental step of providing an indication of a clinal consequence of the pose in relation to the surgical plan to the surgeon
Claims 2 and 24 recite the mental step of constraining the types of poses.
Claims 5 and 26 recite the mental step of receiving an updated surgical plan.
Claim 6 recites the mental step of receiving an updated three-dimensional model.
Claim 7 recites the mental step of determining a preoperative simulated performance metric by simulating movement of the digital three-dimensional model.
Claim 8 recites the mental step of determining an intraoperative simulated performance metric by simulating movement of the updated digital three-dimensional model.
Claim 9 recites the mental step of requiring the indication to comprise an intraoperative simulated performance metric.
Claim 10 recites the mental step of comparing the intraoperative simulated performance metric and the preoperative simulated performance metric.
Claim 11 recites the mental step of requiring the intraoperative performance metric to be an indication of risk stratification.
Claim 12 recites the mental step of requiring the risk stratification to be indicative of a risk associated with multiple predicted postoperative movements of the patient.
Claim 14 recites the mental steps of detecting objects in the digital image and fitting an object model to the objects.
Claim 15 recites the mental step of associating a pose with an X-ray opaque two-dimensional code.
Claims 16-17 recite the mental step of storing the surgical plan.
Claims 16-17 recite the mental step of receiving the digital X-ray image of the joint and the localization object during the total joint replacement surgery.
Claims 16-17 recite the mental step of determining the pose of the localization object relative to the bone or the joint based on the digital X-ray image.
Claims 16-17 recite the mental step of assessing the pose of the localization object against the surgical plan.
Claim 21 recites the mental step of identifying edges of the localization object in the digital X-ray image.
These recitations are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind or mathematical relationships. Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas. Merely reciting that a mental process is being performed in a generic computer environment does not preclude the steps from being performed practically in the human mind or with pen and paper as claimed. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then if falls within the “Mental processes” grouping of abstract ideas. As such, claim(s) 1-2, 5-12, 14-17, 20-21, 23-24, 26, and 40 recite(s) an abstract idea/law of nature/natural phenomenon (Step 2A, Prong 1 : YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). This judicial exception is not integrated into a practical application because the claims do not recite an additional element that reflects an improvement to technology or applies or uses the recited judicial exception to affect a particular treatment for a condition. Rather, the instant claims recite additional elements that amount to mere instructions to implement the abstract idea in a generic computing environment or mere instructions to apply the recited judicial exception via a generic treatment.
There are no limitations that indicate that the claimed analysis engine or the formats of the provided data require anything other than generic computing systems. As such, these limitations equate to mere instructions to implement the abstract idea on a generic computer that the courts have stated does not render an abstract idea eligible in Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. As such, claims 1-2, 5-12, 14-17, 20-21, 23-24, 26, and 40 is/are directed to an abstract idea/law of nature/natural phenomenon (Step 2A, Prong 2 : NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that equate to mere instructions to apply the recited exception in a generic way or in a generic computing environment.
The prior art of Sakaguchi et al. [US PGPUB 2017/0027533 A1; on attached 892 form] teaches that an using an X-ray apparatus controlled by processors with a display to present results is routine and conventional in the prior art.
Claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. MPEP 2106.05(f) discloses that mere instructions to apply the judicial exception cannot provide an inventive concept to the claims. The additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B : No). As such, claims 1-2, 5-12, 14-17, 20-21, 23-24, 26, and 40 is/are not patent eligible.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claim(s) 1-2, 5-6, 14, 16-17, 20-21, 23-24, 26, and 40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mahfouz [US PGPUB 2019/0133693 A1; on IDS].
Claim(s) 1-2, 5-6, 14, 16-17, 20-21, 23-24, 26, and 40 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mahfouz [US PGPUB 2019/0133693 A1; on IDS].
Claim 23 is drawn to a method for assisting a surgeon in total joint replacement of a joint of a patient. The method comprises storing a surgical plan comprising a digital three-dimensional model. The method comprises receiving a digital X-ray image of the joint and a localization object during a total joint replacement surgery. The method comprises determining a pose of the localization object against the surgical plan. The method comprises providing an indication of a clinical consequence of the pose in relation to the surgical plan to the surgeon.
Claim 1 is drawn to similar subject matter as claim 23, except claim 1 is drawn to a system.
Claim 40 is drawn to similar subject matter as claim 23, except claim 40 is drawn to a computer readable storage medium.
The document of Mahfouz studies surgical navigation of the hip using fluoroscopy and tracking sensors [title]. Paragraph 106 and Figure 3 of Mahfouz teach the X-ray imaging device wherein the cover figure of Mahfouz illustrate receiving actual X-ray imaging of bones and joints. Paragraph 106 and Figures 3 and 40 of Mahfouz teach intraoperative imaging wherein the “image targets” are interpreted to be localization objects. Paragraph 109 and Figure 3 (“pre-operative reconstruction) of Mahfouz teach storing a surgical plan comprising a digital three-dimensional object. Paragraph 183 of Mahfouz teaches determining a pose of the localization object relative to the bone or joint. Paragraph 188 of Mahfouz teaches assessing the pose of the localization object relative against a surgical plan and providing an indication of a clinical consequence of the pose in relation to the surgical plan of the surgeon.
With regard to claims 2 and 24, Figure 40 of Mahfouz teaches the pose is associated with a bone pose and comprises the localization object.
With regard to claims 5 and 26, paragraph 191 of Mahfouz teaches updating a surgical plan and three dimensional model based on indication.
With regard to claim 14, paragraph 184 of Mahfouz teaches that determining a pose involves fitting and detecting objects in the image.
With regard to claims 16-17 and 20, paragraphs 105 and 188 teach details regarding the computer system and display (e.g. a computer, phone, or tablet).
With regard to claim 21, Figure 64, step 4 and paragraph 162 of Mahfouz teach edge detection and calculating edge scores.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
35 U.S.C. 103 Rejection #1:
Claim(s) 1-2, 5-12, 14, 16-17, 20-21, 23-24, 26, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahfouz [US PGPUB 2019/0133693 A1; on IDS] in view of Barsoum et al. [US PGPUB 2018/0161101 A1; on IDS].
The document of Mahfouz studies surgical navigation of the hip using fluoroscopy and tracking sensors [title]. Paragraph 106 and Figure 3 of Mahfouz teach the X-ray imaging device wherein the cover figure of Mahfouz illustrate receiving actual X-ray imaging of bones and joints. Paragraph 106 and Figures 3 and 40 of Mahfouz teach intraoperative imaging wherein the “image targets” are interpreted to be localization objects. Paragraph 109 and Figure 3 (“pre-operative reconstruction) of Mahfouz teach storing a surgical plan comprising a digital three-dimensional object. Paragraph 183 of Mahfouz teaches determining a pose of the localization object relative to the bone or joint. Paragraph 188 of Mahfouz teaches assessing the pose of the localization object relative against a surgical plan and providing an indication of a clinical consequence of the pose in relation to the surgical plan of the surgeon. Paragraphs 106, 188, and 194 of Mahfouz teach determining an intraoperative performance metric and providing the indication based on a preoperative to postoperative comparison.
Mahfouz does not teach the recited guidance system for total joint replacement with risk calculations.
The document of Barsoum et al. studies model-based surgical planning and implant placement [title]. Figures 2 and 4 and paragraphs 48-51 of Barsoum et al. teach a guidance system for total joint replacement wherein a simulated performance metric is calculated and provided to the surgeon for an assessment of a planned orientation of a joint implant. Paragraphs 27 and 49 of Barsoum et al. teach that the performance metric is indicative of a risk of dislocation.
It would have been obvious at the time of the filing date of the instant application to modify the X-ray image analysis of Mahfouz by use of the guidance system for joint replacement of Barsoum et al. wherein the motivation would have been that the modeling techniques of Barsoum et al. facilitate the imaging analysis of Mahfouz [Figures 2 and 4 and paragraphs 48-51 of Barsoum et al.]. There would have been a reasonable expectation of success in combining Mahfouz and Barsoum et al. because both studies are analogously applicable of analyzing the mechanics of joint replacements.
35 U.S.C. 103 Rejection #2:
Claim(s) 1-2, 5-6, 14-17, 20-21, 23-24, 26, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahfouz [US PGPUB 2019/0133693 A1; on IDS].
Claim 15 is further limiting wherein the localization object comprises an X-ray opaque two-dimensional code, and wherein determining the pose of the localization object comprises determining a pose associated with the X-ray opaque two-dimensional code.
The document of Mahfouz studies surgical navigation of the hip using fluoroscopy and tracking sensors [title]. Paragraph 106 and Figure 3 of Mahfouz teach the X-ray imaging device wherein the cover figure of Mahfouz illustrate receiving actual X-ray imaging of bones and joints. Paragraph 106 and Figures 3 and 40 of Mahfouz teach intraoperative imaging wherein the “image targets” are interpreted to be localization objects. Paragraph 109 and Figure 3 (“pre-operative reconstruction) of Mahfouz teach storing a surgical plan comprising a digital three-dimensional object. Paragraph 183 of Mahfouz teaches determining a pose of the localization object relative to the bone or joint. Paragraph 188 of Mahfouz teaches assessing the pose of the localization object relative against a surgical plan and providing an indication of a clinical consequence of the pose in relation to the surgical plan of the surgeon. Paragraphs 106, 188, and 194 of Mahfouz teach determining an intraoperative performance metric and providing the indication based on a preoperative to postoperative comparison.
Mahfouz does not teach an X-ray opaque two-dimensional code.
It would have been obvious at the time of the filing date of the instant application to modify the X-ray image analysis of Mahfouz by use of and X-ray opaque two-dimensional code because it is obvious to try alternative design choices to associate with a pose.
E-mail Communications Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Russell Negin, whose telephone number is (571) 272-1083. This Examiner can normally be reached from Monday through Thursday from 8 am to 3 pm and variable hours on Fridays.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s Supervisor, Larry Riggs, Supervisory Patent Examiner, can be reached at (571) 270-3062.
/RUSSELL S NEGIN/ Primary Examiner, Art Unit 1686 1 March 2026