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
In response to the Applicant’s response filed on 12/23/2025, no claim has been amended. Claims 1-30 are pending, and claims 1, 3-12, 25, 26, 29, and 30 are under examination.
Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered but they are not persuasive.
In response to the argument that Kerins does not disclose limitation “wherein the geometrical feature has parameters that are based on the surgical plan” because those “are merely patient-specific and would be the same regardless of which procedure was planned for the patient,” it is respectfully disagreed. Applicant’s response, pp 9-10. In particular, Kerins discloses “the simulation of such procedures may be achieved by providing a brain model that is suitable for simulating the surgical procedure.” Kerins, ¶41. For example, when “[s]uch a procedure may involve perforating, drilling, boring, punching, piercing, or any other suitable methods… some embodiments of the present disclosure provide brain models comprising an artificial skull layer that is suitable for simulating the process of penetrating a mammalian skull.” Id. Then, “The head component 210 is adapted or configured to maintain the training component 230 (located under skull component 300 in a relatively stable or fixed position throughout the performance of the medical procedure to be simulated.” Kerins, ¶49. Thus, Kerins discloses parameters specially planned for surgeries.
In response to the argument that Kerins does not disclose limitation “exposed to provide visual feedback about an accuracy of the surgical plan and/or an accuracy of the surgical instrument in carrying out the surgical plan [because] a brain model [of Kerins] does not include geometrical features having parameters that can be exposed to provide feedback about accuracy,” it is respectfully disagreed. Applicant’s response, pp 9-10. Kerins discloses a brain model “accurately simulat[ing] micro structures (e.g., axons) and macro structures (e.g., hematomas, ventricles) within the brain, vascularity, tumours, diseased white matter cartilage, bone, or neuro sub-anatomical structures.” ¶67. Kerins also discloses that “the product would enable surgical trainees to have a visual reference for anatomical regions of interest (e.g. fluid-filled vascularity) during their pre-operative trajectory planning as well as during navigation-guided surgical port cannulation, and tumour resection.” ¶73. Thus, such visual reference is exposed during navigation-guided surgical port cannulation, and tumour resection and would provide visual indication whether the navigation-guided surgery is performed as planned.
Thus, the rejections are maintained.
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 1, 3-8, 10-12, 25, 26, 29, and 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kerins et al (U.S. Patent Application Publication 2017/0291359), hereinafter Kerins.
Regarding claims 1, 29, and 30, Kerins discloses a physical model/system/method configured to be physically altered by a surgical instrument for providing feedback related to a surgical plan specific to an anatomy of a patient (Abstract), the physical model comprising:
a body (210, 220, 230) including:
a physical volume and a geometrical feature embedded within the physical volume wherein the geometrical feature is visually distinct from a remainder of the physical volume (FIG. 6 illustrates a volume and the geometrical feature, e.g., surface of the volume; ¶58: “Referring to FIGS. 6, there is shown an elevation view of a printed 3D volume printed in the shape and size of a human ventricle 22”) and wherein the geometrical feature has parameters that are based on the surgical plan (¶51: “the base and training components of the training model 100, and particularly the head component, may also include one or more external anatomic landmarks or fiducial locations 400, as shown in FIG. 4”; see also ¶47); and
wherein the physical volume is configured to be at least partially removed by the surgical instrument such that the geometrical feature is exposed to provide visual feedback about an accuracy of the surgical plan and/or an accuracy of the surgical instrument in carrying out the surgical plan (¶41: “the simulation of such procedures may be achieved by providing a brain model that is suitable for simulating the surgical procedure through one or more layers of the head. Such a procedure may involve perforating, drilling, boring, punching, piercing, or any other suitable methods, as necessary for an endo-nasal, port-based, or traditional craniotomy approach. For example, some embodiments of the present disclosure provide brain models comprising an artificial skull layer that is suitable for simulating the process of penetrating a mammalian skull. As described in further detail below, once the skull layer is penetrated, the medical procedure to be simulated using the training model may include further steps in the diagnosis and/or treatment of various medical conditions. Such conditions may involve normally occurring structures, aberrant or anomalous structures, and/or anatomical features underlying the skull and possibly embedded within the brain material.”).
Regarding claim 3, Kerins further discloses that the physical volume further comprises an outer surface that is shaped to correspond to the anatomy of the patient or shaped according to a generic geometry (¶52: “the training model, and particularly the simulated head, are sized, configured and shaped to approximate and closely resemble the size, configuration and shape of the head of a patient on which the medical procedure is to be performed”).
Regarding claim 4, Kerins further discloses that the physical volume and geometrical feature are formed by additive manufacturing (¶1: “The present disclosure relates to anatomical phantoms produced using three dimensional (3D) printing, and more particularly it relates to cerebrospinal diffusion phantoms produced using 3Dprinting techniques.”; ¶69: “the additive manufacturing (3D-printing) of UV-cured silicone sub-anatomical structures may be supplemented through addition of superparamagnetic/paramagnetic nanoparticles into the UV-curable silicone.”).
Regarding claim 5, Kerins further discloses that the physical volume is formed with regions of variable density correlating to density information of the anatomy based on the surgical plan (¶65: “integrating the capability of variable-density printing within these networks of sub-anatomical features enables high resolution simulation of tissue structures. This is useful because biomaterials do not typically exhibit consistent densities, thus creating a simulation tool that exhibits variable densities or variable diffusive properties such as commonly used to mimic the fluidic diffusion properties of brain tiisue such as grey matter or commonly found gloioblastomas or variable diffusive properties such as commonly used to mimic the fluidic diffusion properties of brain tiisue such as grey matter or commonly found gloioblastomas.”).
Regarding claim 6, Kerins further discloses that the geometrical feature comprises a boundary surface embedded within the physical volume (Abstract: “an outer surface of the one or more structures and an inner surface of the mold with a liquid precursor of a matrix material selected to mimic anatomical tissue and processing said liquid precursor to form a tissue mimic matrix material”).
Regarding claim 7, Kerins further discloses that the boundary surface is indicative of a region of the anatomy that should be avoided by the surgical instrument according to the surgical plan (¶45 discloses the anatomy includes tracks: “The training component may be comprised of a brain 230 with the following layers: dura, CSF (cerebrospinal fluid), vessels, white matter, grey matter, fiber bundles or tracks”; ¶43 further discloses that the tracks are the anatomy that should by avoided by the surgical instrument: “avoiding damaging the brain tracks”).
Regarding claim 8, Kerins further discloses that the boundary surface is indicative of a planned resection surface of the anatomy that is configured to receive an implant according to the surgical plan (¶73: “Incorporating this embodiment with the “SURGICAL TRAINING AND IMAGING BRAIN PHANTOM” disclosed in PCT WO 2015/003271 the product would enable surgical trainees to have a visual reference for anatomical regions of interest (e.g. fluid-filled vascularity) during their pre-operative trajectory planning as well as during navigation-guided surgical port cannulation, and tumour resection.”), and wherein the planned resection surface has parameters of shape, size and position based on the implant of the surgical plan and a geometry of the anatomy (¶47: “The base component may have any size, shape and configuration capable of maintaining the training component, mounted within the training component receptacle, in a position suitable for performing the medical procedure to be trained.”).
Regarding claim 10, Kerins further discloses that a 3D indicator having variable cross- sections is embedded within a thickness of the boundary surface, and wherein the boundary surface and the 3D indicator are configured to be at least partially removed by the surgical instrument such that a cross-section of the 3D indicator is configured to be exposed to provide visual feedback related to the thickness of the boundary surface removed or remaining (FIG. 10; ¶63: “FIG. 10 is a cross-section view of a sub-anatomical element found in the cerebrospinal simulator of FIG. 9. The sub-anatomical element 30 is connected to filling port 34 and is designed to include internal cavities and feature wall thicknesses appropriate to simulate the tactile response of respective tissues to surgical instrumentation. These features are constructed with linked tubular structures that link the internal cavity structures (or network thereof) to the exterior of the mold. For example, in another embodiment, a sub-anatomical element 30 may be linked to other sub-anatomical elements (e.g ventricles 22 as seen in FIG. 8) via a tubular structure similar to the filling port 34 to enable filling with various liquids. As a further example, constructed feature in FIG. 10 can be used to create a simulator with a network of sub-anatomical structures which can be filled with a multitude of materials (e.g., hematoma structure filled with simulated blood clotting material connected to a vein structure filled with simulated blood).”).
Regarding claim 11, Kerins further discloses that the geometrical feature comprises a first boundary surface, a second boundary surface, and a third boundary surface, wherein the first boundary surface is stacked on top of the second boundary surface, and the second boundary surface is stacked on top of the third boundary surface, and wherein each boundary surface is visually distinct from the other boundary surfaces (¶45: “The training component may be comprised of a brain 230 with the following layers: dura, CSF (cerebrospinal fluid), vessels, white matter, grey matter, fiber bundles or tracks, target tumors, or other anomalous structures.”).
Regarding claim 12, Kerins further discloses that the first, second, and third boundary surfaces are configured to be exposed to provide visual feedback related to a cutting accuracy of the surgical instrument, and wherein: the first boundary surface is configured to be exposed to indicate an undercut; the second boundary surface is configured to be exposed to indicate an accurate cut; and the third boundary surface is configured to be exposed to indicate an overcut (¶45 shows the dura layer represents undercut; the target tumor layer represents accurate cut; the track layer indicates the overcut, see supra rejection of claim 7; ).
Regarding claim 25, Kerins further discloses that the body further includes a first mounting interface coupled to the body, and the physical model is configured to couple to a base including a second mounting interface arranged to couple with the first mounting interface such that the body is configured to be detachably coupled to the base (¶55: “in order to permit the replacement or substitution of the training component 230, the training component is detachably or releasably mounted in the base component 210”).
Regarding claim 26, Kerins further discloses that the body is configured to be removed from the base after the physical volume has been at least partially removed by the surgical instrument, and a replacement body substantially similar to the body is configured to be coupled to the base (¶55: “Any detachable or releasable fastener or fastening mechanism may be used which is capable of securing the training component 230 in the receptacle, while also permitting the training component 230 to be readily detached, released or removed as desired or required.”).
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 (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.
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.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kerins.
Regarding claim 9, Kerins further discloses that the physical volume is representative of a bone/anatomical structure of the patient and the planned resection surface comprises a plurality of connected planar surfaces indicative of target surfaces of the bone/anatomical structure that are configured to receive a corresponding implant (¶67: “Using this combined methodology, one can accurately simulate micro structures (e.g., axons) and macro structures (e.g., hematomas, ventricles) within the brain, vascularity, tumours, diseased white matter cartilage, bone, or neuro sub-anatomical structures.”; ¶41: “Such a procedure may involve perforating, drilling, boring, punching, piercing, or any other suitable methods, as necessary for an endo-nasal, port-based, or traditional craniotomy approach”; ¶42: “the brain model is suitable for simulating a medical procedure involving a brain tumor that has been selected for resection. In such an example embodiment”).
Kerins does not explicitly disclose that the bone/anatomical structure comprises distal femur, tibia, pelvis and acetabulum, or scapula and a glenoid.
The following common knowledge or well-known in the art statement is taken to be admitted prior art because applicant either failed to traverse the examiner’s assertion of official notice or that the traverse was inadequate: manufacturing a simulated bone to specific bone/anatomical structure, such as distal femur, tibia, pelvis and acetabulum, or scapula and a glenoid, was old and well known in the art before the effective filing date, as it provides one of most demanding bone simulation parts and, therefore, enable to apply the known methods to familiar bone structure to yield predictable results, i.e., simulated specific bone/anatomical structure. See MPEP 2144.03 Section C.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to use well-known a comparison algorithm of video files based on a checksum because all the claimed elements were known in the art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one ordinary skill in the art at the time of the invention. "common sense teaches, however, that familiar items may have obvious uses beyond their primary purposes, and in many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." KSR Int'l Co. V. Teleflex Inc. 550 U.S.-,82USPQ2d 1385 (Supreme Court 2007) (KSR).
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 THOMAS J HONG whose telephone number is (571)272-0993. The examiner can normally be reached 9:30AM-6PM.
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, Sunil Singh can be reached at (571) 272-3460. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THOMAS J. HONG
Supervisory Patent Examiner
Art Unit 3729
/THOMAS J HONG/Supervisory Patent Examiner, Art Unit 3729
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