DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
2. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosures of the prior-filed applications, Application No. 16/175,067, No. 16/783,615, No. 17/215,315, No. 17/564,565, No. 17/854,894, and No. 17/868,098 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The previous applications lack support for the current application because they lack mention of creating a surgical guide through finding geodesic line segments, slicing out the area bounded from the geodesic line segments, finding an insertion direction, and generating height maps.
Specifically, the specification and drawings fail to include any recitation or illustration in support of the system or method independent claim that includes "finding geodesic line segments… by applying an iterative flip-out operation…; slicing a part … bounded by the geodesic line segments; finding an insertion direction…; generating a height map…" as recited in claim 1, and "find, via a geodesic module, geodesic line segments … by applying an iterative flip-out operation…; slice, via a slicing module, a part … bounded by the geodesic line segments; find, via an insertion module, an insertion direction…; generate, via the insertion module, a height map…" as recited in claim 11 and 21.
Thus, claims 1-21 are not supported by the prior-filed applications.
Response to Amendment
3. The amendment filed December 5, 2025 has been entered. Claims 1-21 remain pending in the application. Applicant’s amendments to the Specification, Abstract, Drawings, and Claims have overcome most of the objections previously set forth. The amendments to the Claims have overcome the 35 U.S.C. 112(a) rejections, 35 U.S.C. 112(b) rejections, and 35 U.S.C. 101 rejections previously set forth in the Non-Final Office Action mailed February 25, 2025.
Response to Arguments
4. Applicant's arguments filed July 24, 2025 have been fully considered but some are not persuasive.
5. Applicant argues that the prior-filed application, Application No. 17/215,315, has sufficient disclosure and enablement for the subject matter claimed in the present application.
Examiner replies that the applicant cites the “segmentation is relevant for surgery planning and diagnostic”, “development of a module that creates 3-D model”, and “3-D printing a surgical template for drilling of the implant hole”. However, Application No. 17/215,315 nor the cited portions disclose creating the surgical guide through geodesic line segments, slicing out parts bounded by the geodesic line segments, finding an insertion direction, and generating a height map as claimed in the independent claims 1 and 21. Furthermore, the independent claims seem to primarily claim the process at outlaid in Figures 23-25. However, Figures 23-25 are not present in the prior-filled Application No. 17/215,315. Additionally, the applicant has not specifically pointed to a paragraph or figure that includes support for these features in the prior-filled applications.
Thus, the prior-filed Application No. 17/215,315 does not provide clear and adequate support for the subject matter claimed in the present application.
6. Applicant argues claims 11-21 are patent-eligible subject matter under 35 U.S.C. 101 for being directed to a statutory machine and a practical application. Furthermore, the Applicant argues that the invention provides technical improvements and that the claims recite significantly more than a judicial exception.
Examiner replies the amended claims overcome the 35 U.S.C. 101 rejection and will be withdrawn.
7. Applicant argues that Chen (“A Semi-Automatic Computer-Aided Method for Surgical Template Design”), Hansen (U.S. Patent Application Publication No. 2023/0162457 A1), and Sharp ("You Can Find Geodesic Paths in Triangle Meshes by Just Flipping Edges") do not teach “finding geodesic line segments, i.e., the shortest paths on the surface mesh-for boundary delineation” and do not teach performing edge flips “based on a tangent vector calculated for each edge”.
Examiner replies that Chen does teach geodesic line segments which are defined to be the shortest paths on the surface mesh for boundary delineation as defined by the Applicant. Chen in Page 3, ‘Mesh segmentation’ section, Paragraph 3 teaches that the mesh is segmented along the “shortest path generated from the vertex sequence”. The same section also teaches that the path is made to result in a “smoother segmentation border” which means the line segments are for boundary delineation on a mesh. Thus, the line segments which are the shortest path generated can be considered the geodesic line segments that are for boundary delineation on a surface mesh.
Hansen does not teach finding geodesic line segments using an iterative flip-out operation based on tangent vectors but Sharp does.
Sharp teaches the tangent vector used for the iterative flip-out operation. Sharp teaches in Section 6.5, Paragraph 3 that for each target vertex j, they locate a direction of the edge in the tangent space from the source vertex i. The direction located in the tangent space from the edge can be considered the tangent vector. Although Sharp does not talk about surgical guides, Sharp is in the same field of creating paths in a mesh and smoothing them. A person holding ordinary skill in the art would reasonably modify the method of creating a surgical guide taught by Chen with the flip out operations and tangent vectors taught by Sharp in order to have practical runtimes when computing geodesics on polyhedral surfaces as explained by Sharp in the Abstract. Sharp shows the algorithm being performed on multiple different 3-D models with triangle meshes objects as shown in Figure 1. The surgical guide model taught by Chen also has a surface triangle mesh, taught in Page 12-13 ‘Segmentation with Signed Distance’ section. It would not be unreasonable to perform Sharp’s algorithm on Chen’s surgical guide’s surface triangle mesh.
Thus, Chen in view of Sharp does teach the amended claim 1 limitation of “finding geodesic line segments on the mesh … based on a tangent vector calculated for each edge”.
8. Conclusion: The rejections set in the previous Office Action are shown to have been proper, and the claims are rejected below. New citations and parenthetical remarks can be considered new grounds of rejection and such new grounds of rejection are necessitated by the Applicant’s amendments to the claims. Therefore, the present Office Action is made final.
Drawings
9. The drawings were received on December 5, 2025. These drawings are acceptable.
10. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 2303d in Paragraph 129 and 131. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The edited Figure 23 on page 1 of the “Amendments to the Specification" is not entered since it is not part of the Replacement Drawings submitted.
11. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “208d” has been used to designate both a detection module and a classification layer in paragraph 67 of the specification. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The amended Specification filed December 5, 2025 does not include changes to paragraph 65 although the Remarks filed July 24, 2025 acknowledged that paragraph 65 should be amended. Thus, the objection for reference character “208d” still stands.
Specification
12. The amended specification was received on December 5, 2025. The amended specification is partially entered and objected to. Paragraph 137 will be entered but Paragraph 129 and 131 will not be entered for new matter.
13. The amendment filed December 5, 2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The
The “input mesh representing anatomical data” in the Paragraph 131 line 9 amendment is new matter. The initially filed claims and specification on February 27, 2023 do not specify the input mesh represents anatomical data.
The “surgical guide suitable for fabrication” in the Paragraph 131 line 17 amendment is new matter. The initially filed claims and specification on February 27, 2023 do not specify the surgical guide is suitable for fabrication. The specification and claims filed on February 27, 2023 only specifies the guide is fabricated.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
14. Claim 11 objected to because of the following informalities: Line 11, "an input event source" should be "the input event source" because it was already mentioned on line 2. Appropriate correction is required.
15. Claim 21 objected to because of the following informalities: Line 12, "an input event source" should be "the input event source" because it was already mentioned on line 2. Appropriate correction is required.
Claim Rejections - 35 USC § 112
16. 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.
17. Claims 1-21 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 line 13-14 has a new limitation that states “generate a height map of the sub-region in the insertion direction with configurable inner and outer surface offsets”. Although the specification discloses generating a height map in Paragraph 22, 129, 130, 135, 136, and 137, the specification does not disclose generating a height map of the sub-region and also does not disclose configurable inner and outer surface offsets. Thus, this new limitation is considered new matter.
Claim 1 line 15-16 has a new limitation that states “transmit the model to a fabrication module for 3-D printing of the surgical guide”. Although the specification discloses fabricating the surgical guide in Paragraph 22 and 137, it does not disclose transmitting the model to a fabrication module and does not disclose 3-D printing the surgical guide.
Claim 11 line 2 and 5 has a new limitation stating “a radiographic image gathering source.” Although the specification discloses in Paragraph 122 a “radiographic image input,” the specification does not disclose a radiographic image gathering source and only a general input event source.
Claim 11 line 3 has a new limitation stating “an input mesh representing anatomical data.” The specification and previously filed claims do not specify the input mesh represents anatomical data. The specification in Paragraph 16 only specifies the input mesh has a calculated sequence of points.
Claim 11 line 24 has a new limitation stating “the surgical guide suitable for on-site fabrication.” The initially filed claims and specification on February 27, 2023 do not specify the surgical guide is suitable for on-site fabrication and only specifies the guide is fabricated.
Claim 21 lines 2 and 5 has a new limitation stating “a radiographic image gathering source.” Although the specification discloses in Paragraph 122 a “radiographic image input,” the specification does not disclose a radiographic image gathering source and only a general input event source.
Claim 21 line 3 has a new limitation stating “an input mesh representing anatomical data.” The specification and previously filed claims also do not specify the input mesh represents anatomical data. The specification in Paragraph 16 only specifies the input mesh has a calculated sequence of points.
Claim 21 line 25 has a new limitation stating “the surgical guide suitable for fabrication.” The initially filed claims and specification on February 27, 2023 do not specify the surgical guide is suitable for fabrication and only specifies the guide is fabricated.
Claims 2-10 are rejected by dependency on claim 1.
Claims 12-20 are rejected by dependency on claim 11.
18. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
19. Claims 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the sub-region" in line 13. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-10 are rejected by dependency on claim 1.
Claim Rejections - 35 USC § 103
20. 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.
21. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
22. Claim(s) 1-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen ("A Semi-Automatic Computer-Aided Method for Surgical Template Design") in view of Sharp ("You Can Find Geodesic Paths in Triangle Meshes by Just Flipping Edges") and Hansen (United States Patent Application Publication No. 2023/0162457 A1).
23. Regarding claim 1, Chen teaches a method for surgical guide design, said method comprising of the steps of: receiving an input mesh with calculated sequence of points on the input mesh (Page 11, Methods section, Overview subsection mentions in step 1 and 2 receiving an input surface mesh with user generated points);
finding geodesic line segment on the mesh between the points (Page 11, Methods section, Overview subsection mentions in step 2 generating a curve between the user generated points; Figure 12 shows the points and line segments between each point);
slicing a part that is inside an area bounded by the geodesic line segments (Page 11, Methods section, Overview subsection mentions in step 2 that the curve from the user generated points is for cutting from the mesh);
generating a height map in the direction of the insertion with offsets a and b for an inner and outer surfaces for rendering a three-dimensional mask for triangulating and smoothing into the surgical guide (Page 11, Method section, Overview subsection mentions in step 3 and 4 an inner and outer surface generation which creates offsets and a distance field. The offsets and distance field can be considered the generation of the height map; Page 13, Outer Surface Generation subsection mentions having points projected to generate the outer surface and creating the distance field using points from the inner surface and expanded cuboid region. This can also be considered the generation of the height map; Page 12-13, Segmentation with Signed Distance section mentions segmenting the surface with triangles which can be considered the rendering of the mask for triangulating; Page 3, Offset Surface Generation Section mentions to have an outer surface as smooth as possible when creating the distance field which can be considered smoothing a surgical guide); generate a height map of the sub-region in the insertion direction with configurable inner and outer surface offsets (Page 11, Method section, Overview subsection teaches in step 3 and 4 an inner and outer surface generation which creates offsets and a distance field. The calculated offsets and distance field can be considered generation of the height map; Page 13, Outer Surface Generation subsection teaches having points projected to generate the outer surface and creating the distance field using points from the inner surface and expanded cuboid region. This teaches the generation of the height map. Page 13, ‘Offset surface’ section also teaches the distance field calculation which also determines the offsets is configurable through a specified value of thickness of the template. Thus, the offsets are configurable);
and transmit the model to a fabrication module for 3-D printing of the surgical guide (Page 2, paragraph 3 teaches that fabrication solutions include using software suppliers that have a manufacturing facility which would be off-site and another option which allows for local design and fabrication on-site; Page 9 step 3 teaches the method outputs a model which can be fabricated through 3D printing technology).
However, Chen fails to teach finding geodesic line segments on the mesh between the points by applying an iterative flip-out operation, the iterative flip-out operation comprising performing an intrinsic edge flip based on a tangent vector calculated for each edge; and finding an insertion direction that minimizes an undercut area.
Sharp teaches finding geodesic line segments on the mesh between the points by applying an iterative flip-out operation, the iterative flip-out operation comprising performing an intrinsic edge flip based on a tangent vector calculated for each edge (Page 1-2, Introduction section, paragraphs 2-4 teach repeatedly performing edge flips to obtain a geodesic; Section 6.5 teaches combining the flipping of the edge algorithm with Dijkstra’s algorithm. Section 6.5 Paragraph 3 also teaches finding the direction of each target vertex’s edge in the tangent space in order to execute the edge flips. The direction in the tangent space teaches a tangent vector).
Chen and Sharp are considered analogous to the claimed invention as because both are in the same field of smoothing lines in a mesh. Thus, it would have been obvious to a person holding ordinary skill in the art before the effective filing date to modify the method of generating a surgical guide in Chen with the edge flips taught by Sharp in order to find locally the shortest curves given the mesh model (Sharp, Page 1, Introduction section paragraph 1).
However, Chen and Sharp fail to teach finding an insertion direction that minimizes an undercut area.
Hansen teaches finding an insertion direction that minimizes an undercut area (Paragraph 101 mentions finding an insertion direction with a minimal to no undercut).
Chen and Hansen are considered analogous to the claimed invention as because both are in the same field of creating surgical guides. Sharp is considered analogous to the claimed invention because both are in the same field of connecting lines in a mesh and smoothing them. Thus, it would have been obvious to a person holding ordinary skill in the art before the effective filing date to modify the method of generating a surgical guide in Chen in view of Sharp with the additional insertion direction finding step in Hansen in order to minimize undercut areas and reduce the harm and undesired results caused by having undercut areas (Hansen Paragraph 91).
24. Regarding claim 2, Chen, Sharp, and Hansen teach the limitations of claim 1. Chen further teaches the method wherein the sequence of points is calculated by an user (Page 11, Methods section, Overview subsection mentions in step 2 that points are user generated; Page 13, Points for Segmentation section mentions that the user places control points to surround a target region).
25. Regarding claim 3, Chen, Sharp, and Hansen teach the limitations of claim 1. Chen further teaches the method wherein finding the geodesic line segments on the mesh (Page 3, Mesh Segmentation section mentions that the mesh is segmented along the shortest path generated from the vertex sequence which is specified by the user).
However, Chen and Hansen fail to teach applying the iterative flip-out to a rough Dijkstra path between initial points.
Sharp teaches applying the iterative flip-out to a rough Dijkstra path between initial points (Page 1-2, Introduction section, paragraph 2-4 mention repeatedly performing edge flips to obtain a geodesic; Page 10 mentions combining the flipping of the edge algorithm with Dijkstra’s algorithm).
Chen and Hansen are considered analogous to the claimed invention as because both are in the same field of creating surgical guides. Sharp is considered analogous to the claimed invention because both are in the same field of connecting lines in a mesh and smoothing them. Thus, it would have been obvious to a person holding ordinary skill in the art before the effective filing date to modify the method of creating a surgical guide and finding geodesic line segments in Chen and Hansen with the iterative flip-outs in Sharp in order to find locally the shortest curves given the mesh model (Sharp, Page 1, Introduction section paragraph 1).
26. Regarding claim 4, Chen, Sharp, and Hansen teach the limitations of claim 3. Chen further teaches the method wherein the geodesic line segments are smooth out by adding new points at a distance d tangent to and opposite to the tangent to the geodesic line segments at first and last points of the segments and for each segment a new line is generated passing through the new points; inserting a new control vertex at a midpoint between each pair of points; unmarking all the points except for the first and last points (working set); and passing the geodesic line segments through the first and last points representing a geodesic path (Page 13, Methods section, Points for Segmentation subsection mentions using a cardinal spline to create new points and to develop a smoother segmentation edge. The process is repeated after the next initial control point is placed. Assuming the first and last points are just the user placed points in each set, the additional points and control vertex added to create the cardinal spline are shown to be unmarked in Figure 12. Figure 12 only displays the first and last points of each geodesic path segment).
27. Regarding claim 5, Chen, Sharp, and Hansen teach the limitations of claim 4. Chen further teaches the method further comprising shrinking the working set to exclude the first and last points to resume generating the new line through the new points remaining in each segment, if there are more than 2 points remaining after unmarking (Page 13, Methods section, Points for Segmentation subsection mentions repeating and starting a new spline snippet when the user places another control point. Assuming the first and last points are just the user placed points in each set, the additional points and control vertex added to create the cardinal spline are shown to be unmarked in Figure 12. Figure 12 only displays the first and last points of each geodesic path segment).
28. Regarding claim 6, Chen, Sharp, and Hansen teach the limitations of claim 1. Chen fails to teach the method wherein the direction of insertion minimizes the undercut area and maximizes a contact surface.
Hansen teaches the method wherein the direction of insertion minimizes the undercut area and maximizes a contact surface (Paragraph 101 mentions finding an insertion direction with a minimal to no undercut. It also mentions that to do this, the method involves maximizing the area-normalized sum and finding the insertion direction which yields the largest value. This indicates the contact surface is maximized and undercut area minimized).
Chen and Hansen are considered analogous to the claimed invention as because both are in the same field of creating surgical guides. Sharp is considered analogous to the claimed invention because both are in the same field of connecting lines in a mesh and smoothing them. Thus, it would have been obvious to a person holding ordinary skill in the art before the effective filing date to modify the method of generating a surgical guide in Chen in view of Sharp with the additional insertion direction finding step in Hansen in order to minimize undercut areas and reduce the harm and undesired results caused by having undercut areas (Hansen Paragraph 91).
29. Regarding claim 7, Chen, Sharp, and Hansen teach the limitations of claim 6. Chen fails to teach the method wherein the undercut area is minimized by finding a plane that will be perpendicular to a first component; calculating an insertion vector lying in that plane for different insertion angles; and finding mesh triangles that are not undercut.
Hansen teaches the method wherein the undercut area is minimized by finding a plane that will be perpendicular to a first component; calculating an insertion vector lying in that plane for different insertion angles (Paragraph 92 mentions an orthographic projection from the preparation surface along the insertion direction and selecting an insertion direction. This indicates the insertion vector will lie in the orthogonal plane to the surface; Paragraph 101 mention calculating an insertion direction to minimize the undercut);
and finding mesh triangles that are not undercut (Paragraph 13 mentions the surface is a 3D digital model which may be based on meshes; Paragraph 101 mentions using the facet normal of each facet, which can be a mesh triangle, to find the best insertion direction. Thus, the facets can be mesh triangles that are not undercut and this inherently includes finding the not undercut mesh triangles to calculate their normals).
Chen and Hansen are considered analogous to the claimed invention as because both are in the same field of creating surgical guides. Sharp is considered analogous to the claimed invention because both are in the same field of connecting lines in a mesh and smoothing them. Thus, it would have been obvious to a person holding ordinary skill in the art before the effective filing date to modify the method of creating surgical guides in Chen in view of Sharp with the method of minimizing undercut areas in Hansen in order to minimize undercut areas and reduce the harm and undesired results caused by having undercut areas (Hansen Paragraph 91).
30. Regarding claim 8, Chen, Sharp, and Hansen teach the limitations of claim 7. Chen fails to teach the method wherein calculating an insertion direction corresponds to angles from -0.3 to 0.3 radians in 0.1 radian increments where 0 radians corresponds to a vertical direction; finding the contact surface area for these directions by finding mesh triangles that are not undercut; and approximating this set of pairs of values (angle and area) by smoothening and to find maximum around the angle equal to 0.
Hansen teaches the method wherein calculating an insertion direction corresponds to angles from -0.3 to 0.3 radians in 0.1 radian increments where 0 radians corresponds to a vertical direction (Paragraph 101 mentions finding an insertion direction with minimal to no undercut and does not mention any limits. Thus, the method disclosed allows for checking insertion angles from -0.3 to 0.3 radians in 0.1 radian increments);
finding the contact area for these directions by finding mesh triangles that are not undercut (Paragraph 13 mentions the surface is a 3D digital model which may be based on meshes; Paragraph 101 mentions using the facet normal of each facet, which can be a mesh triangle, to find the best insertion direction. Thus, the facets can be mesh triangles that are not undercut and this inherently includes finding the not undercut mesh triangles to calculate their normals);
and approximating this set of pairs of values (angle and area) by smoothening (Paragraph 35 mentions smoothing the mesh for more efficient processing) and to find maximum around the angle equal to 0 (Paragraph 101 mentions finding an insertion direction with minimal to no undercut and does not mention any limits. Thus, the method disclosed allows for finding an insertion angle around the angle equal to 0).
Chen and Hansen are considered analogous to the claimed invention as because both are in the same field of creating surgical guides. Sharp is considered analogous to the claimed invention because both are in the same field of connecting lines in a mesh and smoothing them. Thus, it would have been obvious to a person holding ordinary skill in the art before the effective filing date to modify the method of creating surgical guides in Chen in view of Sharp with the method of calculating the insertion direction and angle in Hansen in order to minimize undercut areas and reduce the harm and undesired results caused by having undercut areas (Hansen Paragraph 91).
31. Regarding claim 9, Chen, Sharp, and Hansen teach the limitations of claim 8. However, Chen fails to teach the method wherein finding the mesh triangles that are not undercut by extending a ray from all vertices of the triangle in a direction opposite to the insertion direction, and if the rays do not intersect with other triangles, then the triangle forms the contact surface and is not undercut.
Hansen teaches the method wherein finding the mesh triangles that are not undercut by extending a ray from all vertices of the triangle in the direction opposite to the insertion direction, and if the rays do not intersect with other triangles, then the triangle forms the contact surface and is not undercut (Paragraph 92 mentions using ray tracing to determine which portions of the preparation surface are undercut. Thus, if the surface is not undercut, it is known to be a contact surface; Paragraph 13 mentions the surface is a 3D digital model which may be based on meshes. This allows the ray tracing to be done with triangles in the mesh).
Chen and Hansen are considered analogous to the claimed invention as because both are in the same field of creating surgical guides. Sharp is considered analogous to the claimed invention because both are in the same field of connecting lines in a mesh and smoothing them. Thus, it would have been obvious to a person holding ordinary skill in the art before the effective filing date to modify the method of creating surgical guides in Chen in view of Sharp with the method of finding mesh triangles that are not undercut in Hansen in order to minimize undercut areas and reduce the harm and undesired results caused by having undercut areas (Hansen Paragraph 91).
32. Regarding claim 10, Chen, Sharp, and Hansen teach the limitations of claim 9. Chen further teaches the method further comprising building the 3D mask using the height map and contact surfaces bounding the model from below and sides (Page 11, Method section, Overview subsection step 3 and 4 mention inner and outer surface generation which creates offsets and a distance field which can be considered to be the generation of the height map; Page 13, Outer Surface Generation section mentions having points projected to generate the outer surface and creating the distance field using points from the inner surface and an expanded cuboid region; Page 13-15 Ruled Surface Section mentions closing the model using the inner and outer surfaces which can be considered to be bounding the model; Figure 15 shows the 3D mask);
inserting a sleeve support into this mask using a signed distance function (Page 15, Collision Detection and Merging section mentions adding drilling tubes which can be considered sleeve supports and merging it into the 3D model using the ruled surface method; Page 15, function 3 shows that part of the ruled surface method involves using the distance between the nodes in the mesh in order to connect surfaces; Figure 16 shows the insertion of the sleeve supports);
and triangulating and smooth the mesh (Page 3, Offset Surface Generation section mentions to have the outer surface as smooth as possible when creating the distance field; Page 12-13 Segmentation with Signed Distance section mentions segmenting the surface with triangles).
33. Regarding claim 11, Chen teaches a system for a surgical guide design, said system comprising:
an input event source or a radiographic image gathering source configured to provide an input mesh representing anatomical data (Figure 9 and Page 11, Methods section, Overview subsection teaches in step 1 importing and receiving an input surface mesh from a CT or CBCT scan data. The input mesh represent anatomical data like the teeth. The importing of the CT or CBCT scan data teaches an input event source); a memory element in communication with the input event source or the radiographic image gathering source, the memory element comprising a non-transitory computer-readable medium storing encoded instructions; a processor coupled to the memory element, wherein the stored instructions, when implemented by the processor, configures the system to (Page 5, ‘Osteotomy’ section, Paragraph 3 teaches the disclosed method is run on a Intel Core CPU with a 6GB memory. This runs the disclosed method as taught in Figure 9 and Page 11 which includes the importing of the CT or CBCT scan data which is the input event source):
receive the input mesh with a calculated sequence of points on the input mesh from an input event source (Page 11, Methods section, Overview subsection mentions in step 1 and 2 receiving an input surface mesh from a CT scan with user generated points. The CT scan input teaches the input event source);
find, via a geodesic module, a geodesic line segment on the mesh between the points (Page 11, Methods section, Overview subsection mentions in step 2 generating a curve between the user generated points; Figure 12 shows the points and line segments between each point)
slice, via a slicing module, a part that is inside an area bounded by the geodesic line segments (Page 11, Methods section, Overview subsection mentions in step 2 that the curve from the user generated points is for cutting from the mesh);
and generate, via the insertion module, a height map in the direction of the insertion with offsets a and b for an inner and outer surfaces of a three-dimensional mask; and rendering, via the insertion module, the three-dimensional mask for triangulating and smoothing into the surgical guide suitable for on-site fabrication (Page 11, Method section, Overview subsection mentions in step 3 and 4 an inner and outer surface generation which creates offsets and a distance field. The offsets and distance field can be considered generation of the height map; Page 13, Outer Surface Generation subsection mentions having points projected to generate the outer surface, or three-dimensional mask, and creating the distance field using points from the inner surface and expanded cuboid region. This can also be considered the generation of the height map; Page 12-13, Segmentation with Signed Distance section mentions segmenting the surface with triangles which can be considered the rendering of the mask for triangulating; Page 3, Offset Surface Generation Section mentions to have an outer surface as smooth as possible when creating the distance field which can be considered smoothing a surgical guide; Page 2, paragraph 3 teaches that fabrication solutions include using software suppliers that have an option which allows for local design and fabrication on-site; Page 9 step 3 teaches the method outputs a model which can be fabricated through 3D printing technology).
However, Chen fails to teach finding, via a geodesic module, a geodesic line segment on the mesh between the points by applying an iterative flip-out operation, the iterative flip-out operation comprising performing an intrinsic edge flip based on a tangent vector calculated for each edge; find, via an insertion module, an insertion direction that minimizes an undercut area.
Sharp teaches finding, via a geodesic module, a geodesic line segment on the mesh between the points by applying an iterative flip-out operation, the iterative flip-out operation comprising performing an intrinsic edge flip based on a tangent vector calculated for each edge (Page 1-2, Introduction section, paragraphs 2-4 teach repeatedly performing edge flips to obtain a geodesic. This operation executed by a processor taught in Section 5.1 teaches a geodesic module which are instructions executed by the processor; Section 6.5 teaches combining the flipping of the edge algorithm with Dijkstra’s algorithm. Section 6.5 Paragraph 3 also teaches finding the direction of each target vertex’s edge in the tangent space in order to execute the edge flips. The direction in the tangent space teaches a tangent vector).
Chen and Sharp are considered analogous to the claimed invention as because both are in the same field of smoothing lines in a mesh. Thus, it would have been obvious to a person holding ordinary skill in the art before the effective filing date to modify the system of generating a surgical guide in Chen with the edge flips taught by Sharp in order to find locally the shortest curves given the mesh model (Sharp, Page 1, Introduction section paragraph 1).
However, Chen and Sharp fail to teach finding, via an insertion module, an insertion direction that minimizes an undercut area.
Hansen teaches the system comprising an input event source or a radiographic image gathering source configured to provide an input mesh representing anatomical data; a memory element in communication with the input event source or the radiographic image gathering source, the memory element comprising a non-transitory computer-readable medium storing encoded instructions (Figure 7 and Paragraph 334-335 teaches a system comprising an input event source or radiographic image gathering source 101a or 101b which is connected to a memory element 104; Paragraph 345 teaches instructions are stored in the memory); finding, via an insertion module, an insertion direction that minimizes an undercut area (Paragraph 101 teaches finding an insertion direction with a minimal to no undercut. This execution by the processor 103 shown in Figure 7 can be considered to teach an insertion module).
Chen and Hansen are considered analogous to the claimed invention as because both are in the same field of creating surgical guides. Sharp is considered analogous to the claimed invention because both are in the same field of connecting lines in a mesh and smoothing them. Thus, it would have been obvious to a person holding ordinary skill in the art before the effective filing date to modify the system for generating a surgical guide in Chen in view of Sharp with the processor coupled to a memory element and additional insertion direction finding step in Hansen in order to minimize undercut areas and reduce the harm and undesired results caused by having undercut areas (Hansen Paragraph 91).
34. Regarding claim 12, Chen, Sharp, and Hansen teach the limitations of claim 11. Chen further teaches the system wherein the sequence of points is calculated by an user (Page 11, Methods section, Overview subsection mentions in step 2 that points are user generated; Page 13, Points for Segmentation section mentions that the user places control points to surround a target region).
35. Regarding claim 13, Chen, Sharp, and Hansen teach the limitations of claim 1. Chen further teaches the system wherein finding the geodesic line segments on the mesh (Page 3, Mesh Segmentation section teaches that the mesh is segmented along the shortest path generated from the vertex sequence which is specified by the user. This results in multiple geodesic line segments between the points in the vertex sequence).
However, Chen and Hansen fail to teach applying the iterative flip-out to a rough Dijkstra path between initial points.
Sharp teaches applying iterative flip-outs to a rough Dijkstra path between initial points (Page 1-2, Introduction section, paragraph 2-4 mention repeatedly performing edge flips to obtain a geodesic; Page 10 mentions combining the flipping of the edge algorithm with Dijkstra’s algorithm).
Chen and Hansen are considered analogous to the claimed invention as because both are in the same field of creating surgical guides. Sharp is considered analogous to the claimed invention because both are in the same field of connecting lines in a mesh and smoothing them. Thus, it would have been obvious to a person holding ordinary skill in the art before the effective filing date to modify the system of creating a surgical guide and finding geodesic line segments in Chen with the iterative flip-outs in Sharp in order to find locally the shortest curves given the mesh model (Sharp, Page 1, Introduction section paragraph 1).
36. Regarding claim 14, Chen, Hansen, and Sharp teach the limitations of claim 3. Chen further teaches the system wherein the geodesic line segments are smooth out by adding new points at a distance d tangent to and opposite to the tangent to the geodesic chain at first and last points of the segment and for each segment a new line is generated passing through the new points; inserting a new control vertex at a midpoint between each pair of points; unmarking all the points except for the first and last points (working set); and passing the geodesic line segments through the first and last points representing a geodesic path (Page 13, Methods section, Points for Segmentation subsection mentions using a cardinal spline to create new points and to develop a smoother segmentation edge. The process is repeated after the next initial control point is placed. Assuming the first and last points are just the user placed points in each set, the additional points and control vertex added to create the cardinal spline are shown to be unmarked in Figure 12. Figure 12 only displays the first and last points of that specific geodesic path).
37. Regarding claim 15, Chen, Sharp, and Hansen teach the limitations of claim 14. Chen further teaches the system further comprising shrinking the working set to exclude the first and last points to resume generating the new line through the new points remaining in each segment, if there are more than 2 points remaining after unmarking (Page 13, Methods section, Points for Segmentation subsection mentions repeating and starting a new spline snippet when the user places another control point).
38. Regarding claim 16, Chen, Sharp, and Hansen teach the limitations of claim 11. Chen fails to teach the system wherein the direction of insertion minimizes the undercut area and maximizes a contact surface.
Hansen teaches the system wherein the direction of insertion minimizes the undercut area and maximizes a contact surface (Paragraph 101 mentions finding an insertion direction with a minimal to no undercut. It also mentions that to do this, the method involves maximizing the area-normalized sum and finding the insertion direction which yields the largest value. This indicates the contact surface is maximized and undercut area minimized).
Chen and Hansen are considered analogous to the claimed invention as because both are in the same field of creating surgical guides. Sharp is considered analogous to the claimed invention because both are in the same field of connecting lines in a mesh and smoothing them. Thus, it would have been obvious to a person holding ordinary skill in the art before the effective filing date to modify the system for generating a surgical guide in Chen in view of Sharp with the additional insertion direction finding step in Hansen in order to minimize undercut areas and reduce the harm and undesired results caused by having undercut areas (Hansen Paragraph 91).
39. Regarding claim 17, Chen, Sharp, and Hansen teach the limitations of claim 16. Chen fails to teach the system wherein the undercut area is minimized by finding a plane that will be perpendicular to a first component; calculating an insertion vector lying in that plane for different insertion angles; and finding mesh triangles that are not undercut.
Hansen teaches the system wherein the undercut area is minimized by finding a plane that will be perpendicular to a first component; calculating an insertion vector lying in that plane for different insertion angles (Paragraph 92 mentions an orthographic projection from the preparation surface along the insertion direction and selecting an insertion direction. This indicates the insertion vector will lie in the orthogonal plane to the surface; Paragraph 101 mention calculating an insertion direction to minimize the undercut);
and finding mesh triangles that are not undercut (Paragraph 13 mentions the surface is a 3D digital model which may be based on meshes; Paragraph 101 mentions using the facet normal of each facet, which can be a mesh triangle, to find the best insertion direction which inherently includes finding those facets).
Chen and Hansen are considered analogous to the claimed invention as because both are in the same field of creating surgical guides. Sharp is considered analogous to the claimed invention because both are in the same field of connecting lines in a mesh and smoothing them. Thus, it would have been obvious to a person holding ordinary skill in the art before the effective filing date to modify the system for creating surgical guides in Chen in view of Sharp with the step of minimizing undercut areas in Hansen in order to minimize undercut areas and reduce the harm and undesired results caused by having undercut areas (Hansen Paragraph 91).
40. Regarding claim 18, Chen, Sharp, and Hansen teach the limitations of claim 17. Chen fails to teach the system wherein calculating an insertion direction corresponds to angles from -0.3 to 0.3 radians in 0.1 radian increments where 0 radians corresponds to a vertical direction; finding the contact surface area for these directions by finding mesh triangles that are not undercut; and approximating this set of pairs of values (angle and area) by smoothening and to find maximum around the angle equal to 0.
Hansen teaches the system wherein calculating an insertion direction corresponds to angles from -0.3 to 0.3 radians in 0.1 radian increments where 0 radians corresponds to a vertical direction (Paragraph 101 mentions finding an insertion direction with minimal to no undercut and does not mention any limits. Thus, the method disclosed allows for checking insertion angles from -0.3 to 0.3 radians in 0.1 radian increments);
finding the contact area for these directions by finding mesh triangles that are not undercut (Paragraph 13 mentions the surface is a 3D digital model which may be based on meshes; Paragraph 101 mentions using the facet normal of each facet, which can be a mesh triangle, to find the best insertion direction which inherently includes finding those facets);
and approximating this set of pairs of values (angle and area) by smoothening (Paragraph 35 mentions smoothing the mesh for more efficient processing) and to find maximum around the angle equal to 0 (Paragraph 101 mentions finding an insertion direction with minimal to no undercut and does not mention any limits. Thus, the method disclosed allows for finding an insertion angle around the angle equal to 0).
Chen and Hansen are considered analogous to the claimed invention as because both are in the same field of creating surgical guides. Sharp is considered analogous to the claimed invention because both are in the same field of connecting lines in a mesh and smoothing them. Thus, it would have been obvious to a person holding ordinary skill in the art before the effective filing date to modify the system for creating surgical guides in Chen in view of Sharp with the step of calculating the insertion direction and angle in Hansen in order to minimize undercut areas and reduce the harm and undesired results caused by having undercut areas (Hansen Paragraph 91).
Additionally, it has been held that where the general conditions of the claim are disclosed in the prior art, discovering an optimum workable range involves only routine skill in the art. In re Aller, 105 USPQ 233.
41. Regarding claim 19, Chen, Sharp, and Hansen teach the limitations of claim 18. Chen fails to teach the system wherein finding the mesh triangles that are not undercut by extending a ray from all vertices of the triangle in a direction opposite to the insertion direction, and if the rays do not intersect with other triangles, then the triangle forms the contact surface and is not undercut.
Hansen teaches the system wherein finding the mesh triangles that are not undercut by extending a ray from all vertices of the triangle in a direction opposite to the insertion direction, and if the rays do not intersect with other triangles, then the triangle forms the contact surface and is not undercut (Paragraph 92 mentions using ray tracing to determine which portions of the preparation surface are undercut. Thus, if the surface is not undercut, it is known to be a contact surface; Paragraph 13 mentions the surface is a 3D digital model which may be based on meshes. This allows the ray tracing to be done with triangles in the mesh).
Chen and Hansen are considered analogous to the claimed invention as because both are in the same field of creating surgical guides. Sharp is considered analogous to the claimed invention because both are in the same field of connecting lines in a mesh and smoothing them. Thus, it would have been obvious to a person holding ordinary skill in the art before the effective filing date to modify the system for creating surgical guides in Chen in view of Sharp with the step of finding mesh triangles that are not undercut in Hansen in order to minimize undercut areas and reduce the harm and undesired results caused by having undercut areas (Hansen Paragraph 91).
42. Regarding claim 20, Chen, Sharp, and Hansen teach the limitations of claim 19. Chen further teaches the system further comprising building the 3D mask using the height map and contact surfaces bounding the model from below and sides (Page 11, Method section, Overview subsection step 3 and 4 mention inner and outer surface generation which creates offsets and a distance field which can be considered to be the generation of the height map; Page 13, Outer Surface Generation section mentions having points projected to generate the outer surface and creating the distance field using points from the inner surface and an expanded cuboid region; Page 13-15 Ruled Surface Section mentions closing the model using the inner and outer surfaces which can be considered to be bounding the model; Figure 15 shows the 3D mask);
inserting a sleeve support into this mask using a signed distance function (Page 15, Collision Detection and Merging section mentions adding drilling tubes which can be considered sleeve supports and merging it into the 3D model using the ruled surface method; Page 15, function 3 shows that part of the ruled surface method involves using the distance between the nodes in the mesh in order to connect surfaces; Figure 16 shows the insertion of the sleeve supports);
and triangulating and smooth the mesh (Page 3, Offset Surface Generation section mentions to have the outer surface as smooth as possible when creating the distance field; Page 12-13 Segmentation with Signed Distance section mentions segmenting the surface with triangles).
43. Regarding claim 21, Chen teaches a system for a surgical guide design, said system comprising:
an input event source or radiographic image gathering source configured to provide an input mesh representing anatomical data (Figure 9 and Page 11, Methods section, Overview subsection teaches in step 1 importing and receiving an input surface mesh from a CT or CBCT scan data. The input mesh represent anatomical data like the teeth. The importing of the CT or CBCT scan data teaches an input event source);
a memory element in communication with the input event source or the radiographic image gathering source, the memory element comprising a non-transitory computer-readable medium storing encoded instructions; a processor coupled to the memory element wherein the stored instructions, when implemented by the processor, configures the system to (Page 5, ‘Osteotomy’ section, Paragraph 3 teaches the disclosed method is run on a Intel Core CPU with a 6GB memory. This runs the disclosed method as taught in Figure 9 and Page 11 which includes the importing of the CT or CBCT scan data which is the input event source):
receive the input mesh with a calculated sequence of points on the input mesh from an input event source (Page 11, Methods section, Overview subsection mentions in step 1 and 2 receiving an input surface mesh from a CT scan with user generated points. The CT scan input teaches the input event source);
find, via a geodesic module, a geodesic line segment on the mesh between the points (Page 11, Methods section, Overview subsection mentions in step 2 generating a curve between the user generated points; Figure 12 shows the points and line segments between each point)
slice, via a slicing module, a part that is inside an area bounded by the geodesic line segments (Page 11, Methods section, Overview subsection mentions in step 2 that the curve from the user generated points is for cutting from the mesh);
generate, via the insertion module, a height map in the direction of the insertion with offsets a and b for an inner and outer surfaces of a three-dimensional mask; rendering, via the insertion module, the three-dimensional mask for triangulating and smoothing into the surgical guide suitable for fabrication (Page 11, Method section, Overview subsection mentions in step 3 and 4 an inner and outer surface generation which creates offsets and a distance field. The offsets and distance field can be considered generation of the height map; Page 13, Outer Surface Generation subsection mentions having points projected to generate the outer surface, or three-dimensional mask, and creating the distance field using points from the inner surface and expanded cuboid region. This can also be considered the generation of the height map; Page 12-13, Segmentation with Signed Distance section mentions segmenting the surface with triangles which can be considered the rendering of the mask for triangulating; Page 3, Offset Surface Generation Section mentions to have an outer surface as smooth as possible when creating the distance field which can be considered smoothing a surgical guide; Page 9 step 3 teaches the method outputs a model which can be fabricated through 3D printing technology);
and fabricate, via a fabrication module, the designed guide on-site or off-site (Page 2, paragraph 3 teaches that fabrication solutions include using software suppliers that have a manufacturing facility which would be off-site and another option which allows for local design and fabrication on-site).
However, Chen fails to teach finding, via a geodesic module, a geodesic line segment on the mesh between the points by applying an iterative flip-out operation, the iterative flip-out operation comprising performing an intrinsic edge flip based on a tangent vector calculated for each edge; find, via an insertion module, an insertion direction that minimizes an undercut area.
Sharp teaches finding, via a geodesic module, a geodesic line segment on the mesh between the points by applying an iterative flip-out operation, the iterative flip-out operation comprising performing an intrinsic edge flip based on a tangent vector calculated for each edge (Page 1-2, Introduction section, paragraphs 2-4 teach repeatedly performing edge flips to obtain a geodesic. This operation executed by a processor taught in Section 5.1 teaches a geodesic module which are instructions executed by the processor; Section 6.5 teaches combining the flipping of the edge algorithm with Dijkstra’s algorithm. Section 6.5 Paragraph 3 also teaches finding the direction of each target vertex’s edge in the tangent space in order to execute the edge flips. The direction in the tangent space teaches a tangent vector).
Chen and Sharp are considered analogous to the claimed invention as because both are in the same field of smoothing lines in a mesh. Thus, it would have been obvious to a person holding ordinary skill in the art before the effective filing date to modify the system of generating a surgical guide in Chen with the edge flips taught by Sharp in order to find locally the shortest curves given the mesh model (Sharp, Page 1, Introduction section paragraph 1).
However, Chen and Sharp fail to teach finding, via an insertion module, an insertion direction that minimizes an undercut area.
Hansen teaches the system comprising an input event source or a radiographic image gathering source configured to provide an input mesh representing anatomical data; a memory element in communication with the input event source or the radiographic image gathering source, the memory element comprising a non-transitory computer-readable medium storing encoded instructions (Figure 7 and Paragraph 334-335 teaches a system comprising an input event source or radiographic image gathering source 101a or 101b which is connected to a memory element 104; Paragraph 345 teaches instructions are stored in the memory); finding, via an insertion module, an insertion direction that minimizes an undercut area (Paragraph 101 teaches finding an insertion direction with a minimal to no undercut. This execution by the processor 103 shown in Figure 7 can be considered to teach an insertion module).
Chen and Hansen are considered analogous to the claimed invention as because both are in the same field of creating surgical guides. Sharp is considered analogous to the claimed invention because both are in the same field of connecting lines in a mesh and smoothing them. Thus, it would have been obvious to a person holding ordinary skill in the art before the effective filing date to modify the system for generating a surgical guide in Chen in view of Sharp with the processor coupled to a memory element and additional insertion direction finding step in Hansen in order to minimize undercut areas and reduce the harm and undesired results caused by having undercut areas (Hansen Paragraph 91).
Conclusion
44. 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.
45. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE Y AHN whose telephone number is (571)272-0672. The examiner can normally be reached M-F 8-5pm.
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/CHRISTINE YERA AHN/Examiner, Art Unit 2615
/ALICIA M HARRINGTON/Supervisory Patent Examiner, Art Unit 2615