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 Amendment
The rejection under 35 U.S.C. 112(b) has been withdrawn in light of the amendment to the claims filed on 30 October 2025.
The rejection under 35 U.S.C. 112(d) has been withdrawn in light of the arguments filed on 30 October 2025.
The rejection under 35 U.S.C. 102(a)(1) has been withdrawn in light of the arguments to the claims filed on 30 October 2025.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 12, & 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Chaoui (US PGPUB 20220039868) in view of Britton et al. (US PGPUB 20170007330; hereinafter "Britton").
With regards to Claim 1, a system for computer-assisted guidance in glenohumeral joint surgery (mixed reality (MR) system 212 for pre-operatively displaying anatomical structures such as the humerus and/or glenoid {i.e. surface of the scapula}; see Chaoui ¶ [0084]) comprising:
a processor unit, and a non-transitory computer-readable memory communicatively coupled to the processor and comprising computer-readable program instructions executable by the processor unit (processing circuitry 542 which executes instructions stored on storage devices 554; see Chaoui ¶ [0112 & FIG. 6]) for:
obtaining a natural range of motion profile for the glenohumeral joint by tracking movement of a humerus relative to a scapula of the glenohumeral joint in a non-invasive natural state (the range of motion (RoM) may be one or more specific angles for respective movements {i.e. profile} of the joint or a metric or other composite value that represents overall range of motion for the joint, e.g. the range of motion of the humerus with respect to the glenoid surface or rest of the scapula; see Chaoui ¶ [0119]; it should be appreciated that Chaoui’s specific angles for respective movements amount to a non-invasive natural state; furthermore, Chaoui discloses performing the RoM analysis {i.e. profile} on the current damaged joint and bones {non-invasive natural state} and use this calculation for identifying which type of treatment is appropriate for the patient; see ¶ [0180]);
registering pre-operatively the humerus and the scapula to a referential system (mixed reality (MR) system 212 for pre-operatively displaying anatomical structures such as the humerus and/or glenoid {i.e. surface of the scapula}, wherein the axes are in alignment; see Chaoui ¶ [0084]; the scapula and humerus are registered to the initial shape of the patients bones; see Chaoui ¶ [0121] and see also [0116, 0160-0168, 0121, 0182, 0186, 0193] for various descriptions of the registration process; it should be appreciated that is notoriously well known in the art that registering various imaging modalities and models are registered to the same referential space otherwise the corresponding surgical would be a catastrophic failure);
pre-operatively fitting the natural range of motion profile to the humerus and the scapula in the referential system (establishing RoM axes; see Chaoui ¶ [0180]);
creating an pre-operative range of motion profile for the glenohumeral joint by tracking movement of the humerus relative to the scapula of the glenohumeral joint pre-operatively in the referential system (the range of motion may be one or more specific angles for respective movements of the joint or a metric or other composite value that represents overall range of motion for the joint; see Chaoui ¶ [0119]; patient range of motion information may be generated using a motion tracking device, i.e. intraoperatively tracking movement; see Chaoui ¶ [0272]); and
outputting the pre-operative range of motion for the glenohumeral joint as a function of the natural range of motion (Processing circuitry 542 may present the analysis for each type of treatment to the user, e.g. RoM analysis; see Chaoui ¶ [0180]; Processing circuitry 542 then outputs the atrophy ratio for display to a user or for further use in additional calculations during pre-operative planning (868). For example, processing circuitry 542 may output the present tissue or patient-specific shape overlaid on the pre-morbid, or healthy {i.e. natural RoM}, estimate of the same soft tissue structure; see Chaoui ¶ [0200]).
While Chaoui discloses that the surgical system 100 maybe “used in one or more of preoperative phase 302, the manufacturing and delivery phase 304, the intraoperative phase 306, and the postoperative phase 308” and that “[S]ome of the systems of FIG. 1 may be used in multiple phases of FIG. 3” (see Chaoui ¶ [0087]), it appears that Chaoui may be silent to the struck-through limitations above. However, Britton teaches of a system of method of providing graphical feedback visualizing forces within a joint through a range of motion of the joint (see Britton Abstract). More specifically, Britton teaches of “surgical planning software can be useful in adding another element to the pre-operative/intraoperative/post-operative comparison capabilities discussed herein”; “standards for joint tension over a joint range of motion can be developed to allow for intraoperative comparison to standards that are known to have resulted in positive outcomes”; and “The predicted range of motion graph can be used intraoperatively, with the systems and methods discussed herein, to provide quantitative comparison-based feedback to the surgeon during the replacement procedure. Further, the predicted range of motion graph is optionally used to evaluate outcomes post-procedure” (see Britton ¶ [0018, 0040, 0047]).
Chaoui and Britton are both considered to be analogous to the claimed invention because they are in the same field of computer aided planning of shoulder operations. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chaoui to incorporate the above teachings of Britton to provide at least the method steps intra-operatively. Doing so would aid in evaluating outcomes post-procedure (see Britton ¶ [0047]).
Claim 21 recites similar limitations and are rejected under the same rationale as Claim 1 with the addition of computer readable medium for performing various method steps (see Chaoui ¶ [0516]).
With regards to Claim 21, modified Chaoui teaches of wherein obtaining the natural range of motion profile includes creating the natural range of motion profile for the glenohumeral joint (Processing circuitry 542 may perform this atrophy ratio calculation for each muscle of interest when performing pre-operative planning for the joint of interest (e.g., rotator cuff muscles for a shoulder joint of interest), i.e. glenohumeral joint; see Chaoui ¶ [0200]).
With regards to Claim 32, modified Chaoui teaches of wherein creating the natural range of motion profile for the glenohumeral joint includes tracking movement of the humerus relative to the scapula of the glenohumeral joint in the non-invasive natural state (the range of motion value or values may be determined from analysis of the patient-specific image data, such as pre-operative ultrasound imaging, i.e. tracking the movement of the humerus relative to the scapula; see Chaoui ¶ [0091 & 0272]).
With regards to Claim 43, modified Chaoui teaches of wherein tracking movement of the humerus relative to the scapula of the glenohumeral joint in the non-invasive natural state includes tracking the movement pre-operatively without disrupting a soft-tissue envelope covering the glenohumeral joint (virtual planning system 102 {i.e. pre-operative} for determining various characteristics such as RoM for the joint which includes RoM of the humerus with respect to the scapula for treatment determination; see Chaoui ¶ [0103 & 0119]).
With regards to Claim 53, modified Chaoui teaches of wherein tracking movement of the humerus relative to the scapula of the glenohumeral joint in the non-invasive natural state includes tracking the humerus and the scapula using at least one ultrasound imaging device (medical images can include ultrasound images; see Chaoui ¶ [0083]).
With regards to Claim 122, modified Chaoui teaches of wherein creating the natural range of motion profile for the glenohumeral joint includes creating the natural range of motion profile pre-operatively or peri- operatively, prior to soft-tissue incisions being made to access the glenohumeral joint (Processing circuitry 542 then outputs the atrophy ratio for display to a user or for further use in additional calculations during pre-operative planning (868). For example, processing circuitry 542 may output the present tissue or patient-specific shape overlaid on the pre-morbid, or healthy {i.e. natural RoM}, estimate of the same soft tissue structure; see Chaoui ¶ [0200]).
With regards to Claim 201, modified Chaoui teaches of wherein outputting the intraoperative range of motion includes outputting a gain or loss of range of motion relative to the natural range of motion (a pre-morbid prediction, it may be informative when selecting a type of joint treatment to understand how the muscle has changed from a healthy or pre-morbid state {i.e. loss of natural range of motion from a healthy state, natural, to a diseased state}; see Chaoui ¶ [0174]).
Claims 6-7 & 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Chaoui in view of Britton, as applied to Claim 1 above, and in further view of Wilk et al. (US PGPUB 20050020918; hereinafter "Wilk").
With regards to Claim 65, while modified Chaoui discloses ultrasound imaging to track the humerus and scapula (see Chaoui ¶ [0083, 0091, 0272]), it appears that Chaoui may be silent to tracking the scapula with a vest on soft-tissue covering the scapula, the vest including a plurality of ultrasound probe units. However, Wilk teaches of a flexible web of ultrasonic sensors in the form of a coverlet or blanket {i.e. vest or band as illustrated in FIGS. 22A-22B} which deforms to the movement of the shoulder joint during motion to facilitate a diagnostic appraisal of the shoulder joint (see Wilk ¶ [0149]).
Modified Chaoui and Wilk are both considered to be analogous to the claimed invention because they are in the same field of ultrasound imaging of the shoulder joint. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Chaoui to incorporate the above teachings of Wilk to provide at least tracking the scapula with a vest on soft-tissue covering the scapula, the vest including a plurality of ultrasound probe units. Doing so would aid in imaging the shoulder joint while in motion (see Wilk ¶ [0149]).
Claims 9-10 recite similar limitations and are rejected under the same rationale as claim 6.
With regards to Claim 76, modified Chaoui teaches including the vest with the plurality of ultrasound probe units (flexible web of ultrasonic sensors in the form of a coverlet or blanket {i.e. vest} which deforms to the movement of the shoulder joint during motion; see Wilk ¶ [0149]).
Claim 10 recite similar limitations and are rejected under the same rationale as claim 6.
Claims 8 & 11 are rejected under 35 U.S.C. 103 as being unpatentable over Chaoui in view of Britton & Wilk as applied to claim 6 above, and further in view of Kruse et al. (US PGPUB 20170100092; hereinafter "Kruse").
With regards to Claim 85, while modified Chaoui teaches of wherein tracking movement of the scapula with the vest (a flexible web of ultrasonic sensors in the form of a coverlet or blanket {i.e. vest or band as illustrated in FIGS. 22A-22B} which deforms to the movement of the shoulder joint during motion to facilitate a diagnostic appraisal of the shoulder joint; see Wilk ¶ [0149]), it appears that modified Chaoui may be silent to optically tracking the vest. However, Kruse teaches of an acoustic orthopedic tracking system (see Kruse Abstract) which includes a flexible transducer array structure 110 with a sleeve {i.e. band or vest} of transducers attached to a flexible material configured to conform to a torso {i.e. conforming to a torso amounts to a vest} and/or arm such as the shoulder in order to track bone (see Kruse ¶ [0059, 0069, 0073-0074, & 0079]). Kruse also teaches that the structure can be measured dynamically with respect to external spatial reference points via optical tracking (see Kruse ¶ [0077-0078]).
Modified Chaoui and Kruse are both considered to be analogous to the claimed invention because they are in the same field of ultrasound imaging of the shoulder joint bones. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Chaoui to incorporate the above teachings of Kruse to provide at least optically tracking the vest. Doing so would aid in tracking bone positions before surgery (see Kruse ¶ [0225]).
Claim 11 recites similar limitations and is rejected under the same rationale as claim 8.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-12 & 20-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In particular, Applicant successfully argues that Chaoui does not teach of performing the various claimed steps intra-operatively. The Office agrees. As noted above, Chaoui may implicitly teach of performing the various steps intra-operatively because Chaoui teaches that the system can be used intra-operatively; however, Chaoui does not explicitly teach of performing the registering, fitting, creating a RoM profile all intra-operatively. The Office relies on Britton to remedy the shortcomings of Chaoui as detailed above.
Conclusion
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHISH S. JASANI whose telephone number is (571)272-6402. The examiner can normally be reached M-F 8:00 am - 4:00 pm (CST).
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, Keith M. Raymond can be reached on (571) 270-1790. 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.
/ASHISH S. JASANI/Examiner, Art Unit 3798
/KEITH M RAYMOND/ Supervisory Patent Examiner, Art Unit 3798