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
This Office Action is responsive to Applicant’s remarks received on May 26, 2026. Claims 1-22 are pending.
Claim Notes
Claims 6, 13 and 19 recite a limitation of the form “at least one of A, B, C, D, E and F”. In accordance with the U.S. Court of Appeals for the Federal Circuit in SuperGuide Corp v. DirecTV Enterprises, Inc., these limitations are conjunctive in nature and to be construed as “at least one of A, at least one of B, at least one of C, at least one of D, at least one of E and at least one of F”. Therefore, these claims are addressed herein as requiring each of these steps rather than the alternative of A or B or C or D or E or F.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “a finite number of time deformation scenes that are two-dimensional (2D) or higher” in line 5. While the specification has clear written description for a 4D or so-called 5D time deformation, there is no explicit description providing support for a 2D or 3D time deformation. Looking at paragraph 0058, for example, it is stated “The scenes generated a priori are unique because each individual scene is a 4D data set (or 5D or more if healing is also modeled), with the ability to represent the time deformation of the tissue being manipulated.” As such, it is not clear that there is support for 2D or 3D time deformations. The same reasoning applies to claim 9, line 8 and claim 16, line 6.
Response to Arguments
Summary of Remarks (@ response page labeled 7): “Claims 6, 13, and 19 have been amended to clarify that the recited analysis techniques are alternatives rather than conjunctive requirements. In particular, "one of" has been replaced with "at least one of" to reflect the intended scop consistent with the specification (see, e.g., para. [0059] and [0116]). Accordingly, the claims do not require the use of all listed techniques, but rather one or more thereof.”
Examiner’s Response: Applicant’s amendment to the claim language keeps the claim in the form of “at least one of A, B, C, D, E and F”. As Applicant has not changed “and” to “or”, the previous interpretation requiring one of each remains.
Summary of Remarks (@ response pages labeled 7-8): “The specification describes a modeling framework that begins with imaging data and generates spatial models for simulation. For example, the method includes "receiving 3D imaging" and "generating 3D models based on the 3D imaging" (see, e.g., para. [0009]-[0011]). These disclosures establish hat the system operates on spatial representations of anatomical structures, which form the basis for the claimed "time deformation scenes." A person of ordinary skill in the art would understand that such modeling frameworks are not limited to a single spatial dimensionality, but are applicable to 2D representations (e.g., image slices or projections), 3D models, and higher-dimensional datasets.
The specification further describes generating time-dependent deformation of anatomical structures, stating that "the simulation generates the time-deformation of the organ/tissue (4D data)" para. [0057], and that scenes may be "4D data set (or 5D or more if healing is also modeled)" para. [0058]. These disclosures demonstrate that the invention encompasses time-evolving spatial data, where the dimensionality depends on the underlying spatial representation. A person of ordinary skill in the art would understand that time-based deformation can likewise be applied to 2D spatial data (resulting in 3D space-time representations) or 3D spatial data (resulting in 4D representations), and thus the reference to 4D dimensional datasets reflects
exemplary implementations, not a limiting excluding lower-dimensional spatial embodiments.
The computational modeling techniques (see para. [0059]) are well understood to be
dimension-agnostic and applicable to both 2D and 3D domains. This also illustrates that the disclosed system operates on spatial models that can be generalized across dimensions.
Accordingly, the specification, when read from the perspective of a person of ordinary
skill in the art, reasonably conveys possession of time deformation scenes that are 2D or higher. The Office's interpretation that the disclosure is limited to 4D or higher datasets is therefore incorrect.”
Examiner’s Response: While it is necessary to consider what one of ordinary skill in the art understands of the subject matter, this does not preclude the step of determining whether a limitation as a whole is conventional enough to omit its detailed description. Applicant argues that computational modeling is well-known to use 2D domains. The Examiner agrees but notes that in the context of the limitation, it is not well-known to generate a finite number of 2D time-deformation scenes for each pre-determined surgical step associated with the 3D models. If Applicant can provide evidence that this is indeed well-known in the art, the Examiner will reconsider the rejection.
Furthermore, as discussed in MPEP 2163(II)(A)(3)(b), “To comply with the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, or to be entitled to an earlier priority date or filing date under 35 U.S.C. 119, 120, 365, or 386, each claim limitation must be expressly, implicitly, or inherently supported in the originally filed disclosure.” The specification does not expressly disclose these elements and they are neither implicit nor inherent to the principles of modeling.
Terminal Disclaimer
The terminal disclaimer filed on May 26, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 11,931,109 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Conclusion
THIS ACTION IS MADE FINAL. 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 KATRINA R FUJITA whose telephone number is (571)270-1574. The examiner can normally be reached Monday - Friday 9:30-5:30 pm ET.
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, Sumati Lefkowitz can be reached at 5712723638. 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.
/KATRINA R FUJITA/ Primary Examiner, Art Unit 2672
Prosecution Insights