Prosecution Insights
Last updated: July 17, 2026
Application No. 18/785,098

METHOD AND SYSTEM TO FACILITATE INTRAOPERATIVE POSITIONING AND GUIDANCE

Final Rejection §112
Filed
Jul 26, 2024
Priority
Mar 15, 2013 — provisional 61/787,762 +3 more
Examiner
MOHAMMED, SHAHDEEP
Art Unit
3797
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
The Cleveland Clinic Foundation
OA Round
2 (Final)
51%
Grant Probability
Moderate
3-4
OA Rounds
2y 6m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 51% of resolved cases
51%
Career Allowance Rate
241 granted / 471 resolved
-18.8% vs TC avg
Strong +57% interview lift
Without
With
+56.9%
Interview Lift
resolved cases with interview
Typical timeline
4y 6m
Avg Prosecution
43 currently pending
Career history
530
Total Applications
across all art units

Statute-Specific Performance

§101
6.9%
-33.1% vs TC avg
§103
54.3%
+14.3% vs TC avg
§102
2.6%
-37.4% vs TC avg
§112
34.8%
-5.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 471 resolved cases

Office Action

§112
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 . Claim Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “tracking system” in claims 1, 12, and all dependent claims thereof; Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-28 of U.S. Patent No. US 10, 799, 145, in view of Liu (WO 2012/127353). Although the claims at issue are not identical, they are not patentably distinct from each other because both the current application and U.S. Patent No. US 10, 799, 145 are directed to intraoperative positioning and guidance of surgery instrument comprising a processor, computer readable memory, generating a patient specific model and object model, pre-operative and intraoperative image data, generating radiographic transformation matrix, image space transformation matrix, image marker transformation matrix, computing a registration matrix, common coordinate system, tracking sensor attached to an object, and generating a graphical visualization. Furthermore, U.S. Patent No. US 10, 799, 145 is narrower than the independent claims of present application, but fails to state that the intra operative image data is non-invasive. Liu discloses a multi-leg geometry reference tracker for multi-modality data fusion. Liu shows non-invasive imaging during procedure (see abstract and fig. 5; page 9-, lines 10-17). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of using non-invasive operative image data in the invention of US 10, 799, 145, as taught by Liu, to provide improve patient safety by avoiding invasive imaging which can cause risks. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of U.S. Patent No. US 12,048,523, in view of Liu (WO 2012/127353). Although the claims at issue are not identical, they are not patentably distinct from each other because both the current application and U.S. Patent No. US 12,048,523 are directed to intraoperative positioning and guidance of surgery instrument comprising a processor, computer readable memory, generating a patient specific model and object model, pre-operative and intraoperative image data, generating radiographic transformation matrix, image space transformation matrix, image marker transformation matrix, computing a registration matrix, common coordinate system, tracking sensor attached to an object, and generating a graphical visualization. Furthermore, U.S. Patent No. US 12,048,523 is narrower than the independent claims of present application, but fails to state that the intra operative image data is non-invasive. Liu discloses a multi-leg geometry reference tracker for multi-modality data fusion. Liu shows non-invasive imaging during procedure (see abstract and fig. 5; page 9-, lines 10-17). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of using non-invasive operative image data in the invention of US 12,048,523, as taught by Liu, to provide improve patient safety by avoiding invasive imaging which can cause risks. Response to Arguments The previous rejection under 35 USC 112 (b) to claims 1, 2, 5 and 12 has been withdrawn in view of Applicant’s amendments to the claims. Applicant’s arguments, filed 01/09/2026, with respect to prior art rejection of amended claims 1 and 12 have been fully considered and are persuasive. The previous prior art rejection of claims 1 and 12 has been withdrawn in view of Applicant’s amendments to claims 1 and 12 and Applicant’s arguments. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Labadie et al. (US 2006/0247517) disclose a system and method of using image guidance for providing an access to a region of interest of a living subject and discloses transformation matrix (see par. [0006]). 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 SHAHDEEP MOHAMMED whose telephone number is (571)270-3134. The examiner can normally be reached Monday to Friday, 9am to 5pm. 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, Anne M Kozak can be reached at (571)270-0552. 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. /SHAHDEEP MOHAMMED/Primary Examiner, Art Unit 3797
Read full office action

Prosecution Timeline

Jul 26, 2024
Application Filed
Sep 10, 2025
Non-Final Rejection mailed — §112
Jan 08, 2026
Applicant Interview (Telephonic)
Jan 09, 2026
Response Filed
Jan 10, 2026
Examiner Interview Summary
May 15, 2026
Final Rejection mailed — §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
51%
Grant Probability
99%
With Interview (+56.9%)
4y 6m (~2y 6m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 471 resolved cases by this examiner. Grant probability derived from career allowance rate.

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