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 .
Status of the Claims
Claims 1-10 were pending. Claims 1, 4, 6, 9-10 have been amended. No claims have been canceled. Claims 11-12 have been newly added. Thus claims 1-12 are currently pending including independent claims 1, 10.
Drawings
The objections to the drawings are removed in light of the remarks and amendments filed 04/15/2026.
Claim Objections
The objections to the claims have removed in light of the remarks and amendments filed 04/15/2026.
Claim Rejections - 35 USC § 112
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.
Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 8 recites the limitation “the other region skeleton”. There is insufficient antecedent basis for this limitation in the claim.
The rejections under 35 U.S.C. 112(b) of claims 4-6 have removed in light of the remarks and amendments filed 04/15/2026.
Claim Rejections - 35 USC § 101
The rejection of claim 9 under 35 U.S.C. 101 is removed in light of the remarks and amendments filed 04/15/2026.
Claim Rejections - 35 USC § 102
The rejections under 35 U.S.C. 102 are removed in light of the remarks and amendments filed 04/15/2026.
Claim Rejections - 35 USC § 103
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) 1-4, 6-7, 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pissarenko (WO 2023086592 A2) in view of Materialise (Materialise medical, "Mandible Reconstruction Tutorial PROPLAN CMF", YouTube, Jul 6 2020. www.youtube.com/watch?v=KYZlEP9mHvw.) Figures relating to specific timestamps from Materialise are included in the table below.
Regarding claim 1, Pissarenko discloses a design method, which is a method performed by an apparatus for designing an implant and a guidance specific to a patient ([0014], [0177] method performed by a computing system (i.e. apparatus) for designing patient-specific implants, surgical plans, and guide devices), the design method comprising:
specifying a first skeletal image of a skeleton of a patient in which an affected region to which an implant is to be implanted is located ([0161], Fig. 11C, [0288] 3D image model of a specified mandible region of a patient's skeleton in which an implant is to be implanted);
specifying a second skeletal image of a donor region comprising a candidate implant portion (Fig. 11B, [0278] specified fibula region of the patient's skeleton which contains the region which will become the implant);
receiving user-selected coordinates of n vertices inside or outside the first skeletal image ([0130] landmarks may be points (i.e. vertex); [0160] landmark points (i.e. including their coordinates) may be determined (i.e. moved) manually by a user using the input/output interface);
cutting the second skeletal image with the cutting planes to yield implant segments and moving the segments onto the first skeletal image according to the alignment; and displaying the cut segments overlaid on the first skeletal image (Fig. 11C, [0288] displayed overlaid implant pieces on the 3D image model of the mandible region of the patient (i.e. first skeletal image), the user may position the implant on the actual bone (i.e. first skeletal image) by using the visual reference of the virtual bone fragments (i.e. implant segments)).
Pissarenko fails to disclose calculating n - 1 cutting planes from the coordinates, thereby determining the number of implant segments; generating a first line by connecting two initial cutting planes in the first skeletal image, and rotating the first line and associated cutting planes until the first line is straight; computing an oriented bounding box (OBB) for the second skeletal image, defining a second line by connecting centers of two smallest planes of the OBB and matching the straight first line to the OBB second line to align the donor region with the patient's skeleton.
Materialise, in a related system from the same field of endeavor of developing patient-specific surgical guidances based on skeletal images (Timestamps 0:08-0:14), discloses calculating n - 1 cutting planes from the coordinates, thereby determining the number of implant segments (See Fig. 3 below. Timestamps 2:07-2:25: cut edges (i.e. cutting planes) of the fibula implant segments are determined based on the locations of the vertices (see particularly, the vertices indicated by the user at 2:13 and the osteotomy planes indicated by the colored segments 1-3 at 2:20; i.e. for n=vertices, at least (n-1)=3 cutting planes are calculated, which will generate (n-1)=3 implant segments));
generating a first line by connecting two initial cutting planes in the first skeletal image, and rotating the first line and associated cutting planes until the first line is straight (See Fig. 2-5 below. Timestamps 2:00-2:45: line segments (i.e. segments of a first line; see line segments 1-3) pass through the cutting planes (osteotomy planes 1 and 2); Timestamps 2:27-2:41: aligning the implant segments which are along the first line segments into a straight linear arrangement (see particularly, at 2:32 the user rotates the lines around the end vertices and the angles of associated planes are similarly adjusted, the user rotates the lines until the line segments form a visually straight line at 2:41);
computing an oriented bounding box (OBB) for the second skeletal image, defining a second line by connecting centers of two smallest planes of the OBB and matching the straight first line to the OBB second line to align the donor region with the patient's skeleton (See Fig. 6 below. Timestamps 2:46-3:14: the fibula (i.e. second skeletal image region) has segments and corresponding bounding boxes, of which two of each of their sides are connected by a straight line which passes through all of the segments; Timestamps 2:46-3:14: the line which passes through the fibula segments in the fibula image (i.e. second line) corresponds to the lines passing through the fibula implant segments in the mandible image (i.e. first lines) (See particularly, the red lines and colored regions on the fibula at 2:48, which are connected by a straight black line and aligned in the upper region (overlaid on the mandible) to match the first line)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine Materialise with Pissarenko and calculate cutting planes from coordinates, generate a first line, compute bounding boxes and align the donor region, as disclosed by Materialise, as part of a design method for designing an implant and a guidance specific to a patient, as disclosed by Pissarenko, for the purpose of efficiently planning a surgical procedure that is customized to a patient (See Materialise, timestamps 3:03-3:21).
Regarding claim 2, Pissarenko in view of Materialise discloses the design method of claim 1 as applied above. Pissarenko further discloses wherein the specifying of the first skeletal image includes: generating one or more planes around the affected region ([0284]-[0285] planes for performing osteotomy are specified; [0399] the planes indicating boundaries of a region to be removed (i.e. affected region)); and
specifying, as the first skeletal image, a specific closed area corresponding to a cutting target area among one or more closed areas defined in the first skeletal image by the one or more planes ([0399] the region to be removed (i.e. cutting target) is specified as being between the cutting planes and indicated with a contrasting color/transparency; Fig. 11C, [0288] wherein the region is a closed area between mandible bone regions (i.e. first skeletal image)).
Regarding claim 3, Pissarenko in view of Materialise discloses the design method of claim 1 as applied above. Pissarenko further discloses wherein the calculating of the number of the at least one implants matching the first skeletal image includes specifying, by a user, coordinates of n vertices inside or outside the first skeletal image ([0130] landmarks may be points (i.e. vertex); [0160] landmark points (i.e. including their coordinates) may be determined (i.e. moved) manually by a user using the input/output interface;).
Regarding claim 4, Pissarenko in view of Materialise discloses the design method of claim 3 as applied above. Pissarenko fails to disclose generating two cutting planes for removing the affected region of the first skeletal image; designating respective reference lines passing through the two cutting planes; aligning the reference lines to form a single straight reference line; generating an oriented bounding box (OBB) for the second skeletal image and defining a second reference line by connecting center points of two smallest planes of the OBB; aligning the straight reference line with the second reference line; and cutting the second skeletal image according to the aligned reference line.
Materialise, in a related system from the same field of endeavor of developing patient-specific surgical guidances based on skeletal images (Timestamps 0:08-0:14), discloses generating two cutting planes for removing the affected region of the first skeletal image; designating respective reference lines passing through the two cutting planes (See Fig. 1-3. Timestamps 2:00-2:45: lines (line segments 1 and 3) pass through the two cutting planes (osteotomy planes 1 and 2, respectively));
aligning the reference lines to form a single straight reference line (See Fig. 3-4. Timestamps 2:27-2:41: aligning the fibula segments which are along the first lines into a linear arrangement);
generating an oriented bounding box (OBB) for the second skeletal image and defining a second reference line by connecting center points of two smallest planes of the OBB; aligning the straight reference line with the second reference line; and cutting the second skeletal image according to the aligned reference line (See Fig. 6-7. Timestamps 2:46-3:14: the fibula (i.e. second skeletal image region) has segments and corresponding bounding boxes, of which two of each of their sides are connected by a straight line which passes through all of the segments; Timestamps 2:46-3:14: the line which passes through the fibula segments in the fibula image (i.e. second line) corresponds to the lines passing through the fibula implant segments in the mandible image (i.e. first lines) (See particularly, the red lines and colored regions on the fibula at 2:48, which are connected by a straight black line and aligned in the upper region (overlaid on the mandible) to match the first line); Timestamps 2:46-3:14: the fibula segments in the fibula image (i.e. second skeletal image) are shown to be cut out and arranged along the first lines in the mandible image; Timestamps 3:32-3:40: the cut segments are shown moved onto the mandible region according to the straightened line segments).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine Materialise with Pissarenko and perform the limitations of claim 4, as disclosed by Materialise, as part of a design method for designing an implant and a guidance specific to a patient, as disclosed by Pissarenko, for the purpose of efficiently planning a surgical procedure that is customized to a patient (See Materialise, timestamps 3:03-3:21).
Regarding claim 6, Pissarenko in view of Materialise discloses the design method of claim 1 as applied above. Pissarenko further discloses wherein the displaying of the cut at least one implant to be overlaid on the first skeletal image includes when a user arbitrarily moves the coordinates of the vertex, performing the cutting of the second skeletal image according to the calculated number of implants such that the at least one implant matches the first skeletal image and the displaying of the cut second skeletal image again ([0130] landmarks may be points (i.e. vertex); [0160] landmark points (i.e. including their coordinates) may be determined (i.e. moved) manually by a user using the input/output interface; Fig. 14B, [0787] a user may edit arbitrarily the cutting locations of the implant within the second skeletal image region and cut the number of implant regions out; Fig. 11C, [0288] displayed overlaid implant pieces on the 3D image model of the mandible region of the patient (i.e. first skeletal image) wherein the implant fits into (i.e. matches) the first skeletal image region).
Regarding claim 7, Pissarenko in view of Materialise discloses the design method of claim 1 as applied above. Pissarenko further discloses wherein the displaying of the cut at least one implant to be overlaid on the first skeletal image includes allowing a user to arbitrarily perform coordinate change, turning, or spinning on the cut at least one implant displayed to be overlaid on the first skeletal image (Fig. 11B, 14B, [0787] virtual interface displaying the implant regions and second skeletal region allow the user to arbitrarily rotate and move the viewed regions).
Regarding claim 9, Pissarenko in view of Materialise discloses the design method of claim 1 as applied above. Pissarenko further discloses a computer readable recording medium on which a program for performing a method is recorded ([0034] non-transitory computer readable-medium storing instructions for performing the method).
Regarding claim 10, Pissarenko in view of Materialise discloses everything claimed as applied above (see rejection of claim 1), and Pissarenko further discloses a discloses apparatus for designing an implant and a guidance specific to a patent ([0014], [0177] method performed by a computing system (i.e. apparatus) for designing patient-specific implants, surgical plans, and guide devices), the apparatus comprising: an input/output interface, a memory in which an instruction is stored, and a processor, wherein the processor is configured to, in connection with the memory ([0034] a memory and a processor configured to perform the methods including stored instructions; [0013], [0518] including an interface for input/output).
PNG
media_image1.png
831
1449
media_image1.png
Greyscale
Fig. 1, captured at 1:18
PNG
media_image2.png
953
1885
media_image2.png
Greyscale
Fig. 2, captured at 2:13
PNG
media_image3.png
948
1875
media_image3.png
Greyscale
Fig. 3, captured at 2:20
PNG
media_image4.png
943
1903
media_image4.png
Greyscale
Fig. 4, captured at 2:32
PNG
media_image5.png
958
1869
media_image5.png
Greyscale
Fig. 5, captured at 2:36
PNG
media_image6.png
961
1878
media_image6.png
Greyscale
Fig. 6, captured at 2:48
PNG
media_image7.png
914
1878
media_image7.png
Greyscale
Fig. 7, captured at 3:34
Claim(s) 5, 8, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pissarenko (WO 2023086592 A2) in view of Materialise (Materialise medical, "Mandible Reconstruction Tutorial PROPLAN CMF", YouTube, Jul 6 2020. www.youtube.com/watch?v=KYZlEP9mHvw.) in further view of Numajiri (Numajiri, Toshiaki MD, PhD; Nakamura, Hiroko MD; Sowa, Yoshihiro MD, PhD; Nishino, Kenichi MD, PhD. Low-cost Design and Manufacturing of Surgical Guides for Mandibular Reconstruction Using a Fibula. Plastic and Reconstructive Surgery - Global Open 4(7):p e805, July 2016.).
Regarding claim 5, Pissarenko in view of Materialise discloses the design method of claim 4 as applied above. Pissarenko fails to disclose generating cutting guide pieces based on the OBB for the second skeletal image; generating a bridge structure connecting the cutting guide pieces; and generating a guidance by combining the cutting guide pieces and the bridge structure.
Numajiri, in a related system from the same field of endeavor of producing patient-specific surgical guidance tools based on skeletal images (Page 2, left column), discloses generating cutting guide pieces based on the OBB for the second skeletal image; generating a bridge structure connecting the cutting guide pieces; and generating a guidance by combining the cutting guide pieces and the bridge structure (Figs. 4-6; Page 2, right column: Guides design: generate cutting guides including bridge structure connecting pieces and generating a physical guidance device including both the pieces and the bridge structure).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine Numajiri with Pissarenko in view of Materialise and generate cutting guide pieces, a bridge structure, and a guidance, as disclosed by Numajiri, as part of a design method for designing an implant and a guidance specific to a patient, as disclosed by Pissarenko, for the purpose of improving efficiency and cost-effectiveness of patient-specific surgical procedures (See Numajiri page 8).
Regarding claim 8, Pissarenko in view of Materialise in further view of Numajiri discloses the design method of claim 5 as applied above. Pissarenko fails to disclose wherein the displaying of the cut at least one implant to be overlaid on the first skeletal image includes: displaying the at least one implant to be overlaid on the first skeletal image while displaying the at least one implant with respect to the other region skeleton including the second skeletal image.
Materialise, in a related system from the same field of endeavor of developing patient-specific surgical guidances based on skeletal images (Timestamps 0:08-0:14), discloses wherein the displaying of the cut at least one implant to be overlaid on the first skeletal image includes: displaying the at least one implant to be overlaid on the first skeletal image while displaying the at least one implant with respect to the other region skeleton including the second skeletal image (Timestamps 2:46-3:14: displaying the fibula implant segments overlaid on the mandible image (i.e. first skeletal image) while simultaneously displaying on the screen the fibula image containing the fibula implant segments (i.e. second skeletal image)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine Materialise with Pissarenko in view of Materialise and Numajiri and display the implant overlaid on the first skeletal image while displaying the implant with respect to the second skeletal image region, as disclosed by Materialise, as part of a design method for designing an implant and a guidance specific to a patient, as disclosed by Pissarenko, for the purpose of efficiently planning a surgical procedure that is customized to a patient (See Materialise, timestamps 3:03-3:21).
Regarding claim 11, Pissarenko in view of Materialise discloses the design method of claim 1 as applied above. Pissarenko fails to disclose generating cutting guide pieces based on the oriented bounding box, generating a bridge structure that connects the cutting guide pieces, and combining the cutting guide pieces and the bridge structure into a single guidance to assist in cutting the donor bone.
Numajiri, in a related system from the same field of endeavor of producing patient-specific surgical guidance tools based on skeletal images (Page 2, left column), discloses generating cutting guide pieces based on the oriented bounding box, generating a bridge structure that connects the cutting guide pieces, and combining the cutting guide pieces and the bridge structure into a single guidance to assist in cutting the donor bone (Figs. 4-6; Page 2, right column: Guides design: generate cutting guides including bridge structure connecting pieces and generating a physical guidance device including both the pieces and the bridge structure (I.e. bridge and guide components for the fibula osteotomy planes are assembled to form a single guidance tool to aid in cutting the fibula segments).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine Numajiri with Pissarenko in view of Materialise and generate cutting guide pieces, a bridge structure, and a single guidance, as disclosed by Numajiri, as part of a design method for designing an implant and a guidance specific to a patient, as disclosed by Pissarenko, for the purpose of improving efficiency and cost-effectiveness of patient-specific surgical procedures (See Numajiri page 8).
Allowable Subject Matter
Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 12, Pissarenko in view of Materialise discloses the method of claim 1 as applied above. Pissarenko fails to disclose further comprising, after cutting the second skeletal image and aligning the implant segments, moving and rotating the implant segments based on transformation matrices derived from the alignment step and applying inverse transformation matrices to place the implant segments into the affected region of the first skeletal image.
Response to Arguments
Applicant's arguments filed 04/15/2026 have been fully considered but they are not persuasive.
Applicant asserts on page 11 that “Materialise merely illustrates general surgical planning steps and does not disclose the claimed coordinated process of deriving a first reference line from cutting planes, computing an OBB-based second line, and matching these lines to align skeletal regions." Examiner disagrees.
As stated in the rejection of amended claim 1 above, Materialise does disclose the claimed limitations of deriving a first reference line from cutting planes (see in particular Figs. 2-5 of Materialise above), computing an OBB-based second line (see in particular Fig. 6 above), and matching the lines to align skeletal regions (see in particular Figs. 6-7 above). Materialise discloses a detailed method of determining cutting planes based on user-specified points on a first skeletal region (the mandible) and connecting the points with line segments which form a first line. Materialise further discloses an OBB-based second line (which is particularly similar to the present disclosure’s figures 3E-4H) and matching the regions connected by the second line along the fibula with the first line by arranging the fibula segments along the segments of the first line on the mandible display (Fig. 6, 7 of Materialise above). Thus, amended claim 1 is rejected under 35 U.S.C. 103 under Pissarenko in view of Materialise as applied above.
Applicant further asserts on page 11 that “neither Pissarenko alone nor the combination of Pissarenko with Materialise and Numajiri discloses or suggests the amended features of independent claim 1." Examiner disagrees. For similar reasons to those stated above, amended claim 1 is rejected under 35 U.S.C. 103 under Pissarenko in view of Materialise as applied above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Huang (CN 113855234 A) discloses a reconstruction method for repairing a mandible using fibular segments, including implementing oriented bounding boxes over segments of the mandible which are to be removed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLINE DEPALMA whose telephone number is (571)270-0769. The examiner can normally be reached Mon-Thurs 9:00am-4pm Eastern Time.
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, Andrew Moyer can be reached at 571-272-9523. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CAROLINE E. DEPALMA/Examiner, Art Unit 2675
/SJ Park/Primary Examiner, Art Unit 2675
Prosecution Insights