Status under America Invents Act
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 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.
Drawings
Applicant’s replacement drawings filed February 23, 2026 are approved.
Rejections based on Prior Art
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.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alrumaih (US 2020/0315751).
Alrumaih discloses a model for pre-procedure verification of a dental treatment plan that includes a model main body (Figure 2) formed based on a jaw of a patient in a size and a shape identical to at least a part of a treatment objective site of the jaw of the patient and configured to model the at least a part of the treatment objective site (see e.g. paragraph [0028]: " printed 3D model of the maxillary jaw of the patient as shown for example by FIG 2").
The Alrumaih jaw model further includes an opening defining portion provided in the model main body and configured to define an opening corresponding to a recessed opening for embedding an embedded body in the treatment objective site (an “implant [/‘embedded body’] position is selected” paragraph [0086] and a “window”/opening and “cut through the gum/bone model and surgical guide” paragraph [0087]; note further Figure 4 illustrating the surgical guide in the bottom half of the figure mounted on a patient jaw model (upper half of the Figure) having a window opening extending through the surgical guide and into the jaw model).
The Alrumaih jaw model includes a target model portion configured to model a target adjacent to or embedded in an alveolar bone of the treatment objective site (the Alrumaih jaw model portion on the other side of the window/opening in Figure 4 is the targeted area/portion of the selected implant site (Figure 4, paragraphs [0086], [0087]). The target model portion of the Alrumaih jaw model seen through the window/opening is capable of allowing for the distal end of a procedural instrument used for a treatment to be out of contact with the target model portion under a condition that the procedural instrument passes through the opening defining portion in a positional relationship of the target model portion identical to a positional relationship of the target relative to the treatment objective site, or the target model portion allowing the distal end of the procedural instrument to be in contact with the target model portion under a condition that the procedural instrument passes through the opening defining portion in a positional relationship of the target model portion closer than the positional relationship of the target relative to the treatment objective site (see paragraph [0025]: "the outline of the osteotomy, as well as the depth of the bone to be removed without damaging the underlying the Schneiderian Membrane is created utilizing the surgical guide in conjunction with a proper depth bur permitting open access to the maxillary sinus cavity within the dimensions required for a sinus elevation. It provides a surgeon easy access to the Schneiderian Membrane without anatomical obstructions.").
Furthermore, the Alrumaih jaw model includes a space formed between the opening defining portion and the target model portion that allows for a visual recognition of a range present between the opening defining portion and the target model portion, the range including a reachable range of the distal end of the procedural instrument from the opening defining portion toward the target model portion and a reachable range of the distal end of the procedural instrument from the opening defining portion in a teeth alignment direction and a direction intersecting the teeth alignment direction (see Figure 4 wherein a space is formed in the jaw model between the opening and the target model portion which allows for visual observation of the distal end of a tool and its position with respect to the target portion). (Additionally, like applicant’s disclosed model, the Alrumaih jaw model illustrated in Figure 4 is 3D printed and includes spaced apart pillars in the body thereof that provides an open space between the window and the target position which would allow for visual observation of the distal end of a tool inserted through the window/opening).
Note annotated Figure 4 below (rotated 180 degrees to correspond with the orientation of applicant’s Figure 4A for comparison purposes).
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In regard to claim 2, note the 3D printed pillars illustrated by Alrumaih through the window in Figure 4. Any of the illustrated pillars could be named the “main pillar.” In regard to claim 3, the Alrumaih jaw model includes lingual and palatine side walls that model the patient’s bone surface (see Figure 2). In regard to claim 4, note the Alrumaih jaw model base portion at the top of Figure 4 from which pillars extend connecting the base portion to the rest of the jaw model. In regard to claim 5, the Alrumaih 3D printed guide that fits on and engages the jaw model (note Figure 4) meets the “adjunctive instrument” limitation.
Applicant’s Response
In response to the present rejection, applicant amended claim 1 to require that the broadly claimed “space” is “to allow recognition of whether the distal end of the procedural instrument is out of contact or in contact with the target model portion” and asserts that Alrumaih fails to disclose the feature. Applicant’s amendment and argument is not found persuasive. Alrumaih in Figure 4 illustrates a window that has been cut through the gum/bone model (paragraph [0087]) revealing a “space” within the model where a surgeon practitioner can visually evaluate the anatomical structure of a patient’s maxilla (paragraph [0063]). A practitioner/surgeon is capable of visually observing through the window when the distal end of a surgical drill (“procedural instrument”) approaches an undefined “target model portion.” Applicant’s claimed model fails to impose any objectively ascertainable structural distinctions from the model disclosed by Alrumaih.
It is noted that the present claims are directed solely to a “model” and not the combination of a “model” and a “procedural instrument.” It is immaterial whether or not Alrumaih specifically discloses a “procedural instrument” (i.e. a drill) because the present claims do not claim the “procedural instrument” as a required element of the model, but rather only that the model is capable of use with a “procedural instrument.” Additionally it is noted that the current claims are quite broad setting forth an “opening”, “target model portion”, and “space” without any defined structure or boundaries, and only vaguely locating the elements with respect to one another. With such breadth and lack of detail, the claims are subject to the broadest reasonable interpretation that is consistent with the specification (MPEP 2111).
Action Made Final
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 Ralph Lewis whose telephone number is (571)272-4712. The examiner can normally be reached Monday-Friday from 9AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Edelmira Bosques 571 270-5614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RALPH A LEWIS/Primary Examiner, Art Unit 3772 (571) 272-4712
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