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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: in Fig. 1, elements S30, S40, S50. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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 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: numerous elements and reference characters described in the specification from [page 15, line 3] to [page 16, line 20], including but not limited to P1, L1, vx, DP2, etc. 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.
Claim Objections
Claims 1, 4 are objected to because of the following informalities:
In claim 1, line 2 reads “guidance specific to a patent” but should read “guidance specific to a patient”.
In claim 4, “generating cutting planes n-1” should read “generating (n-1) cutting planes” for improved clarity as to the number of planes being generated.
Appropriate correction is required.
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.
Claims 4-6, 8 are 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.
Claims 4, 5, and 8 recite the limitations “the other region skeleton” or “the other area skeleton”. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 is additionally rejected due to its dependence on claim 4. Claim 8 is additionally rejected due to its dependence on claims 4 and 5.
Claim 4 recites the limitation “two minimum planes of the OBB”. The element “minimum planes” is unclear and confusing as to what applicant intends as the invention.
Claims 5, 8 are rejected due to their dependence on claim 4.
Claim 4 recites the limitation “the first line” in line 11, which seems to refer to one of the lines indicated in the recited element "first lines" (claim 4, line 5 and claim 4, line 7). It is unclear which of the recited “first lines” the element of line 11 is referring to, making it unclear as to what applicant intends as the invention.
Claims 5, 8 are rejected due to their dependence on claim 4.
Claim 6 recites the limitation “the coordinates of the vertex”. Regarding both “the coordinates” and “the vertex”, there is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because it is directed to a computer readable recording medium.
A "computer readable recording medium" as recited in claim 9 is defined in the specification on page 18, lines 1-10 and is not explicitly limited to non-transitory forms of computer-readable recording media. The broadest reasonable interpretation of a claim drawn to a computer readable medium (also called machine readable medium and other such variations) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media. See MPEP 2111.01. When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C 101 as covering non-statutory subject matter. The claims, as defined in the specification, cover both non-statutory subject matter and statutory subject matter. A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments by adding the limitation "non-transitory" to the claim.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 6-7, 9-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated Pissarenko (WO 2023086592 A2).
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 patent ([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 another region skeleton including the implant (Fig. 11B, [0278] specified fibula region of the patient's skeleton which contains the region which will become the implant);
calculating a number of at least one implant matching the first skeletal image (Fig. 15D-15E, [0806]-[0809] multiple pieces of fibula to become graft/implants are removed and tracked individually by the system);
cutting the second skeletal image according to the calculated number of implants such that the at least one implant matches the first skeletal image, and displaying the cut second skeletal image (Fig. 15E, [0809] displayed virtual model (i.e. image) of cut pieces of fibula (i.e. second skeleton image) into implant pieces); and
displaying the cut at least one implant to be 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)).
Regarding claim 2, Pissarenko 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 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 6, Pissarenko 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 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 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 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),
specify 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);
specify a second skeletal image of another region skeleton including the implant (Fig. 11B, [0278] specified fibula region of the patient's skeleton which contains the region which will become the implant);
calculate a number of at least one implant matching the first skeletal image (Fig. 15D-15E, [0806]-[0809] multiple pieces of fibula to become graft/implants are removed and tracked individually by the system);
cut the second skeletal image according to the calculated number of implants such that the at least one implant matches the first skeletal image, and display the cut second skeletal image (Fig. 15E, [0809] displayed virtual model (i.e. image) of cut pieces of fibula (i.e. second skeleton image) into implant pieces); and
display the cut at least one implant to be 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)).
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) 4 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.).
Regarding claim 4, Pissarenko discloses the design method of claim 3 as applied above. Pissarenko fails to disclose wherein the cutting of the second skeletal image according to the calculated number of implants such that the at least one implant material matches the first skeletal image, and the displaying of the cut second skeletal image includes: generating two cutting planes to remove the specific closed area; designating first lines passing through the two cutting planes; generating cutting planes n-1 from the coordinates of the vertices; aligning the first lines into a straight line; generating an oriented bounding box (OBB) for the other area skeleton including the second bone image, and connecting center points of two minimum planes of the OBB to designate a second line; matching the first line with the second line; and cutting the other region skeleton based on the first 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 to remove the specific closed area (See Fig. 1 below, also Timestamps 0:53-1:20: two cutting planes (Osteotomy plane 1 and Osteotomy plane 2) are shown and used to remove the region of the mandible that is between the two planes);
designating first lines passing through the two cutting planes (See Fig. 2 below, also Timestamps 2:00-2:45: lines (line segments 1 and 3) pass through the two cutting planes (osteotomy planes 1 and 2, respectively));
generating cutting planes n-1 from the coordinates of the vertices (See Fig. 3 below, also 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);
aligning the first lines into a straight line (See Fig. 4 below, also 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 other area skeleton including the second bone image, and connecting center points of two minimum planes of the OBB to designate a second line (See Fig. 5 below, also 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);
matching the first line with the second line (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)); and
cutting the other region skeleton based on 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).
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
958
1869
media_image4.png
Greyscale
Fig. 4, captured at 2:36
PNG
media_image5.png
961
1878
media_image5.png
Greyscale
Fig. 5, captured at 2:48
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).
Claim(s) 5, 8 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.
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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lu (Chuan Lu, Dongmei He, Chi Yang, Julian J. Wilson, Use of Computer-Assisted Templates for Placement of Osteotomies in Lateral Gap Arthroplasty, Journal of Oral and Maxillofacial Surgery, Volume 73, Issue 1, 2015, Pages 30-38, ISSN 0278-2391, https://doi.org/10.1016/j.joms.2014.08.030.) discloses generating surgical templates for precise bone cutting including generating osteotomy planes.
Poltaretskyi (US 20190380792 A1) discloses visualization via virtual model for planning of an orthopedic joint repair surgical procedure including specifying coordinates of vertices.
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 7:00am-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