DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee
set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since
this application is eligible for continued examination under 37 CFR 1.114, and the
fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous
Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's
submission filed on 01/08/2025 has been entered.
Response to Amendment
The amendment filed on 01/08/2025 has been entered. Claims 1-15 remain pending in the application.
Response to Arguments
Applicant's arguments filed 01/08/2025 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant argues that neither Antonyshyn et al. (US2012/0010711), Christopher et al. (US2019/0209328), Gordon (US2019/0231531), or Gordon et al. (US2019/0192298), nor a combination thereof teach or suggest, "manufacturing, pre-operatively, based on the pre-operative plan, an outer implant sized to be secured to the cranium at the second margin region; manufacturing, pre-operatively, based on the pre-operative plan, an inner implant sized to be secured to the cranium at the first margin region and sized to be secured to an inner edge of the outer implant" because “The fact that a certain result or characteristic may occur or be present in the prior art is not sufficient to establish the inherency of that result or characteristic."' And, "[i]n relying upon the theory of inherency, the examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art."
However, this argument is unpersuasive because the patient-specific cranial implant 300 comprising base 340 and augment 360 of Gordon (US2019/0231531) is manufactured based on a preoperatively planned position (Paragraph 0074), and the augment portion/ outer implant 360 protrudes outward from base portion/inner implant 340 in a medial-lateral direction, implicitly, to a second margin region larger than the preoperatively planned first margin region for the base/inner implant 340 (Paragraph 0075). Gordon additionally discloses that in different embodiments of the implant, an outer implant 420 is made to extend to a second larger margin defining a perimeter of a bone void, and an inner implant 500 designed to conform to a first smaller margin defining the pterion to counter the effects of temporal hollowing deformity (Figures 4A-4B; Paragraph 0083). Therefore, the inner and outer implants of Gordon are disclosed as extending to different margin regions to assume different functional purposes as claimed (See paragraphs 0078 and 0083 which describe the purpose of the inner and outer implants extending to different margins of the embodiments shown in Figs. 3A-4B).
Regarding claim 1, Applicant further argues that just because the second implant portion 360 is larger than portion 340, the second implant portion 360 is not “sized to be secured to the cranium at the second margin region”. However, since augment portion/ outer implant 360 protrudes outward from base portion/inner implant 340 in a medial-lateral direction, implicitly, to a second margin region larger than the preoperatively planned first margin region for the base/inner implant 340, and the second implant portion 360 is sized to be secured to the cranium at the second margin region, which is defined by the edge of the second implant portion 360, such that the outer surface 362 of the outer implant 360 is located on a line tangent to the most lateral portion of the zygomatic arch and terminates at a temporal trim line (Paragraphs 0074 and 0078; Figures 3A-3C), Gordon discloses that the second implant portion 360 is sized to be secured to the cranium at the second margin region.
Regarding amended claim 10, Applicant argues that none of the previously cited references disclose that “the outer implant is U-shaped and is open to one side”. However, this argument is unpersuasive because Gordon discloses an outer implant 420 that is U-shaped and is open to one side (Annotated Figure 4A).
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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.
Claims 1-8 and 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Antonyshyn et al. (US2012/0010711 cited in the Non-Final Rejection mailed 05/16/2024), hereinafter referred to as Antonyshyn, in view of Christopher et al. (US2019/0209328 cited in the Non-Final Rejection mailed 05/16/2024), hereinafter referred to as Christopher, Gordon (US2019/0231531 cited in the Non-Final Rejection mailed 05/16/2024), and Gordon et al. (US2019/0192298), hereinafter Gordon’298.
Regarding claim 1, Antonyshyn discloses a method of replacing a portion of a cranium with a hard tissue implant 365 (Paragraphs 0100-0102: titanium implant), the method comprising: resecting a first portion of the cranium at a first margin region; analyzing the first portion of the cranium to determine if the first margin region is free of cancerous cells (Paragraph 0110: tumor resection margin is unknown pre-operatively, therefore, implicitly, the cranium must be analyzed at a first margin to determine if it is free of cancer cells); and resecting a second portion of the cranium at a second margin region that is larger than the first margin region when it is determined that the first margin region is not free of cancerous cells (Paragraph 0100: Since “further removal of bone during the surgical procedure may be necessary to obtain clear margins free of infection” [0100], implicitly, if when they resect a first margin, infection is present, then a second or subsequent margins must be made). While Antonyshyn does not explicitly recite first and second margins, since Antonyshyn discloses that further removal of bone may be necessary to obtain clear margins, implicitly, there must be a first margin, and with further removal of bone, subsequent margins are established. Antonyshyn further discloses securing the outer edge of an implant 365 to the cranium at a margin (Figures 10d-10f shows that the implant is oversized to conform to any margin that is made and is then trimmed to conform to the shape of the margin when the final margin is determined; Paragraph 0110: tumor resection margin is unknown pre-operatively, therefore, implicitly, the cranium must be analyzed at a first margin to determine if it is free of cancer cells) and in instances when a second margin is required to achieve clear margins, it would be obvious to secure the implant at the second margin.
Antonyshyn fails to disclose that the implant comprises an outer implant and inner implant, and therefore does not disclose the steps of securing an outer implant to the cranium at the second margin region; and securing an inner implant to the outer implant. However, Christopher discloses a method of implanting a multi-piece cranial implant 214 (Paragraph 0074: made up of inner implant (made up of parts 217 and 219) and outer implant/mounting plate 12; Figure 19), and teaches the steps of securing an outer implant 12 to the cranium at a margin region; and securing an inner implant 217/219 (made up of parts 217 and 219) to the outer implant 12 (Paragraph 0074; Figure 21).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cranial implant of Antonyshyn to incorporate the teachings of Christopher and provide an outer implant and an inner implant secured to the outer implant, in order to allow for ready access to a functional neurosurgical implant without the need for complete removal of the multi-piece cranial implant (Paragraph 0073). It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to secure the outer implant of Antonyshyn in view of Christopher to the cranium at a second margin region when the second margin region is necessary to achieve clear margins as disclosed by Antonyshyn, since both Antonyshyn and Christopher disclose outer portions of the implant secured to the cranium at margin regions.
Antonyshyn in view of Christopher fails to disclose the steps of creating a pre-operative plan for resecting a first portion of the cranium at a first margin region of the cranium and for resecting a second portion of the cranium at a second margin region of the cranium; manufacturing, pre-operatively, based on the pre-operative plan, an outer implant sized to be secured to the cranium at the second margin region; manufacturing, pre-operatively, based on the pre-operative plan, an inner implant sized to be secured to the cranium at the first margin region and sized to be secured to an inner edge of the outer implant, however, Gordon discloses a patient-specific cranial implant 300 designed to fill a bone void in a skull of a patient (Figures 3A-3C) comprising an inner implant 340 and an outer implant 360 (Paragraph 0075) and teaches the steps of creating a pre-operative plan for resecting a first portion of the cranium at a first margin region of the cranium and for resecting a second portion of the cranium at a second margin region 220 of the cranium (Paragraph 0074: implant 300 is implanted in a preoperatively planned position; Paragraph 0075: augment portion/ outer implant 360 protrudes outward from base portion/inner implant 340 in a medial-lateral direction, implicitly, to a second margin region larger than the preoperatively planned first margin region for the base/inner implant 340); manufacturing, pre-operatively, based on the pre-operative plan, an outer implant 360 sized to be secured to the cranium at the second margin region (Paragraph 0074: patient-specific cranial implant 300 comprising base 340 and augment 360 is manufactured based on a preoperatively planned position); manufacturing, pre-operatively, based on the pre-operative plan, an inner implant 340 sized to be secured to the cranium at the first margin region and sized to be secured to an inner edge of the outer implant 360 (Paragraph 0075: augment/outer implant protrudes outwardly in medial-lateral direction with respect to the base/inner implant 340; Figures 3A-3C).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of manufacturing a cranial implant of Antonyshyn in view of Christopher to incorporate the teachings of Gordon and provide the steps of creating a pre-operative plan for resecting a first portion of the cranium at a first margin region of the cranium and for resecting a second portion of the cranium at a second margin region of the cranium; manufacturing, pre-operatively, based on the pre-operative plan, an outer implant sized to be secured to the cranium at the second margin region; manufacturing, pre-operatively, based on the pre-operative plan, an inner implant sized to be secured to the cranium at the first margin region and sized to be secured to an inner edge of the outer implant, in order to design the implants to contour to the resected bone, ensuring that the inner and outer implants have contact within the skull defect and complete 360-degree fixation (Paragraph 0074).
Antonyshyn in view of Christopher and Gordon fails to expressly disclose that the pre-operative plan includes that the first margin is likely to be free of cancerous cells and the second margin is more likely to be free of cancerous cells than the first margin region, however, Gordon’298 discloses methods of manufacturing a custom cranial implant 10 for replacing a skull tumor defect region (Paragraph 0053; Figures 3A-3G, 4A-4B, and 5), and teaches a pre-operative plan that includes that a first margin is likely to be free of cancerous cells and a second margin is more likely to be free of cancerous cells than the first margin region (Paragraph 0008: pre-operative CT scan images are used to virtually plan the surgical skull cuts/first margin region, and a more extensive resection/second margin up to 5 to 7 centimeters larger than the first margin, is established by the surgeon and visually confirmed to ensure that the final tumor and local disease extension are removed to completion prior to applying the implant to the skull, wherein the implant minimum size is the first margin size + 5 to 7 centimeters of excess implant material based on the probable second margin size). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of replacing a portion of a cranium of Antonyshyn in view of Christopher and Gordon to incorporate the teachings of Gordon’298 and provide that the pre-operative plan includes that the first margin is likely to be free of cancerous cells and the second margin is more likely to be free of cancerous cells than the first margin region, in order to account for possible tumor extension into neighboring regions and ensure that the resultant implant has the individual's exact craniofacial convexity and curvature equating to minimal-to-no deformity after surgery (Paragraph 0008).
Regarding claim 2, the cranial implant taught by Christopher further comprises that the cover of the inner implant 219 is secured to the base of the inner implant 217 using a plurality of fasteners 221 (Paragraph 0077; Figure 21) to keep the inner implant securely in place (Paragraph 0056: inner implant 18 is fixed by screws to cover 16, analogous to cover 219 secured to base of inner implant 217 to ensure that it is securely held in place).
Christopher does not expressly disclose that the outer implant 12 is secured to the inner implant (made of 217 and 219) using a plurality of fasteners. However, since the outer implant 12 is secured to the inner implant (made up of 217 and 219), it would be obvious to modify the attachment mechanism of the inner and outer implant of Antonyshyn in view of Christopher, Gordon, and Gordon’298 to include a plurality of fasteners 221 to secure the outer implant 12 to the inner implant 217/219 to ensure that the inner implant 217/219 is securely held in place (Christopher Paragraph 0056).
Regarding claim 3, the cranial implant taught by Christopher further comprises the steps of nesting the inner implant 217/219 in the outer implant 12 (Paragraphs 0074-0075; Figures 19-21).
Regarding claim 4, the cranial implant taught by Christopher further comprises that an inner edge of the outer implant 12 is beveled and an outer edge of the inner implant 217/219 is beveled complimentary to the beveled inner edge of the outer implant 12 to allow the inner implant 217/219 to nest in the outer implant 12 (See annotated Figure 22 below).
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Annotated Figure 22
Regarding claim 5, Antonyshyn further discloses the steps of: trimming the implant based on the analysis; and securing the trimmed implant to the cranium (Paragraph 0056; Figures 10d-10f). As discussed above, Antonyshyn as modified by Christopher, Gordon, and Gordon’298 includes an outer implant which is secured at the margin and an inner implant. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to trim the outer implant of Antonyshyn in view of Christopher, Gordon, and Gordon’298 and secure the trimmed outer implant to the cranium, in order to provide an implant conforming to the anatomy (Antonyshyn Paragraph 0056).
Regarding claim 6, the cranial implant taught by Christopher further comprises the steps of: securing the inner implant 217/219 to the outer implant 12 and to the cranium (Figures 20-22). While Christopher does not disclose trimming the outer implant, since the outer implant 12 is meant to fit the resected cranium (Christopher Paragraph 0077; Figures 21-22), and Antonyshyn teaches trimming the implant to conform to the anatomy, it would be obvious to trim the outer implant of Antonyshyn in view of Christopher, Gordon, and Gordon’298 and secure the inner implant 217/219 to the trimmed implant. Trimming the outer implant would not change that the inner implant is secured to the outer implant.
Regarding claim 7, the cranial implant taught by Christopher further comprises that the outer implant 12 is U-shaped (Figure 21: the outer implant 12 is implicitly u-shaped because it follows the curvature of the skull, which is dome shaped).
Regarding claim 8, the cranial implant taught by Christopher further comprises the steps of marking, using the outer implant 12 as a guide, the cranium for resecting the first portion of the cranium to the first margin region (Paragraphs 0086-0087: the dimensions of the cranial implant are determined preoperatively and CAD/CAM techniques are employed to develop the prosthesis. Therefore, implicitly, the prosthesis is used as a “guide” to make the first margin since the first margin must be equivalent in size to the manufactured prosthesis).
Regarding claim 10, Antonyshyn discloses a method of replacing a portion of a cranium with a hard tissue implant (Paragraphs 0100-0102: titanium implant), the method comprising: resecting a first portion of the cranium to define a first margin region; analyzing the first portion of the cranium to determine if the first margin region is free of cancerous cells (Paragraph 0100: further removal of bone may be necessary to obtain clear margins free of infection, or in cases like in paragraph 0110, free of tumor cells); and securing an implant 365 to the cranium when it is determined that the first margin region is free of cancerous cells (Figures 10d-10e shows that the implant is oversized to conform to any margin that is made and is then trimmed to conform to the shape of the margin when the final margin is determined); and resecting a second portion of the cranium at a second margin region when it is determined that the first margin region is not free of cancerous cells (Paragraph 0100: Since “further removal of bone during the surgical procedure may be necessary to obtain clear margins free of infection” [0100], implicitly, if when they resect a first margin, infection is present, then a second or subsequent margins must be made). While Antonyshyn does not explicitly recite first and second margins, since Antonyshyn discloses that further removal of bone may be necessary to obtain clear margins, implicitly, there must be a first margin, and with further removal of bone, subsequent margins can be established.
Antonyshyn fails to disclose the method comprising: marking the cranium for resecting a first portion of the cranium to define a first margin region using an inner edge of an outer implant as a guide; and resecting the first portion of the cranium to the first margin region, and does not disclose inner and outer implant portions, however, Christopher discloses a method of implanting a multi-piece cranial implant 214 (Paragraph 0074: made up of inner implant (made up of parts 217 and 219) and outer implant/mounting plate 12; Figure 19), and teaches the steps of marking the cranium for resecting a first portion of the cranium at a first margin region using an inner edge of an outer implant as a guide (Paragraph 0074; See annotated Figure 19 below: inner implant 217 substantially conforms to a resected portion, so the outer border 217p of inner implant 217, which is the inner edge of 12, is used to define the first margin, where the inner implant 217 is implanted) and resecting the first portion of the cranium to the first margin region (Figure 21).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the steps of implanting a cranial implant of Antonyshyn to incorporate the teachings of Christopher and provide the steps of marking the cranium for resecting a first portion of the cranium to define a first margin region using an inner edge of an outer implant as a guide; resecting the first portion of the cranium to the first margin region, and securing a multi-piece implant to the cranium, in order to allow for ready access to a functional neurosurgical implant without the need for complete removal of the multi-piece cranial implant (Paragraph 0073). The implant of Antonyshyn as modified by Christopher comprises an inner implant secured to the outer implant. Therefore, securing the inner and outer implants taught by Christopher to the cranium includes securing an inner implant to the cranium via the outer implant being directly secured to the cranium.
Antonyshyn in view of Christopher fails to disclose the steps of creating a pre-operative plan for resecting a first portion of the cranium at a first margin region of the cranium and for resecting a second portion of the cranium at a second margin region of the cranium; manufacturing, pre-operatively, based on the pre-operative plan, an outer implant sized to be secured to the cranium at the second margin region; manufacturing, pre-operatively, based on the pre-operative plan, an inner implant sized to be secured to the cranium at the first margin region and sized to be secured to an inner edge of the outer implant, wherein the outer implant is U- shaped and is open to one side, however, Gordon discloses a patient-specific cranial implant 300 designed to fill a bone void in a skull of a patient (Figures 3A-3C) comprising an inner implant 340 and an outer implant 360 (Paragraph 0075), and teaches the steps of creating a pre-operative plan for resecting a first portion of the cranium at a first margin region of the cranium and for resecting a second portion of the cranium at a second margin region 220 of the cranium that is larger than the first margin region (Paragraph 0074: implant 300 is implanted in a preoperatively planned position; Paragraph 0075: augment portion/ outer implant 360 protrudes outward from base portion/inner implant 340 in a medial-lateral direction, implicitly, to a second margin region larger than the preoperatively planned first margin region for the base/inner implant 340); manufacturing, pre-operatively, based on the pre-operative plan, an outer implant 360 sized to be secured to the cranium at the second margin region (Paragraph 0074: patient-specific cranial implant 300 comprising base 340 and augment 360 is manufactured based on a preoperatively planned position); manufacturing, pre-operatively, based on the pre-operative plan, an inner implant 340 sized to be secured to the cranium at the first margin region and sized to be secured to an inner edge of the outer implant 360 (Paragraph 0075: augment/outer implant protrudes outwardly in medial-lateral direction with respect to the base/inner implant 340; Figures 3A-3C), and that the outer implant 360 can be U-shaped and open to one side (Annotated Figure 4A: an alternative analogous embodiment of the cranial implant shows an outer implant 420 and inner implant 500, wherein the outer implant 420 can be U-shaped and open to one side depending on the application site of the implant; Paragraph 0083: implant can be shaped to conform to a temporal hollowing deformity, wherein a U-shaped outer implant is preferred to provide that the inner implant can be shaped to augment the pterion).
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Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of manufacturing a cranial implant of Antonyshyn in view of Christopher to incorporate the teachings of Gordon and provide the steps of creating a pre-operative plan for resecting a first portion of the cranium at a first margin region of the cranium and for resecting a second portion of the cranium at a second margin region of the cranium; manufacturing, pre-operatively, based on the pre-operative plan, an outer implant sized to be secured to the cranium at the second margin region; manufacturing, pre-operatively, based on the pre-operative plan, an inner implant sized to be secured to the cranium at the first margin region and sized to be secured to an inner edge of the outer implant, wherein the outer implant is U- shaped and is open to one side, in order to design the implants to contour to the resected bone, such that the inner and outer implants have contact within the skull defect and complete 360-degree fixation, and can be shaped to conform to a temporal hollowing deformity (Paragraph 0074).
Antonyshyn in view of Christopher and Gordon fails to expressly disclose that the pre-operative plan includes that the first margin is likely to be free of cancerous cells and the second margin is more likely to be free of cancerous cells than the first margin region, however, Gordon’298 discloses methods of manufacturing a custom cranial implant 10 for replacing a skull tumor defect region (Paragraph 0053; Figures 3A-3G, 4A-4B, and 5), and teaches a pre-operative plan that includes that a first margin is likely to be free of cancerous cells and a second margin is more likely to be free of cancerous cells than the first margin region (Paragraph 0008: pre-operative CT scan images are used to virtually plan the surgical skull cuts/first margin region, and a more extensive resection/second margin up to 5 to 7 centimeters larger than the first margin, is established by the surgeon and visually confirmed to ensure that the final tumor and local disease extension are removed to completion prior to applying the implant to the skull, wherein the implant minimum size is the first margin size + 5 to 7 centimeters of excess implant material based on the probable second margin size). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of replacing a portion of a cranium of Antonyshyn in view of Christopher and Gordon to incorporate the teachings of Gordon’298 and provide that the pre-operative plan includes that the first margin is likely to be free of cancerous cells and the second margin is more likely to be free of cancerous cells than the first margin region, in order to account for possible tumor extension into neighboring regions and ensure that the resultant implant has the individual's exact craniofacial convexity and curvature equating to minimal-to-no deformity after surgery (Paragraph 0008).
Regarding claim 11, Antonyshyn further discloses securing the outer edge of an implant 365 to the cranium at a margin (Figures 10d-10f shows that the implant is oversized to conform to any margin that is made and is then trimmed to conform to the shape of the margin when the final margin is determined; Paragraph 0110: tumor resection margin is unknown pre-operatively, therefore, implicitly, the cranium must be analyzed at a first margin to determine if it is free of cancer cells) and in instances when a second margin is required to achieve clear margins, it would be obvious to secure the implant at the second margin.
Regarding claim 12, Antonyshyn in view of Christopher discloses the invention essentially as claimed as discussed above. Antonyshyn further discloses trimming an oversized implant to any desired shape and size (Paragraph 0056; Figures 10d-10f).
However, Antonyshyn in view of Christopher does not expressly disclose securing an inner implant to the outer implant when the first margin region is not free of cancerous cells.
The device of Antonyshyn in view of Christopher would operate equally well with the claimed feature since the purpose of securing the inner implant to the outer implant when the first margin region is not free of cancerous cells appears to be to used for larger combinations of the invented implant, such as the inner implant with the middle implant, or the inner implant with the middle implant and outer implant, if larger margins need to be resected to obtain clear margins (Instant Specification Paragraph 0030).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of implanting the cranial implant of Antonyshyn in view of Christopher to include securing an inner implant to the outer implant when the first margin region is not free of cancerous cells because it appears to be an arbitrary design consideration which fails to patentably distinguish over Antonyshyn in view of Christopher, since the two-piece implant of Antonyshyn in view of Christopher is capable of being trimmed to any necessary size. Furthermore, the step “securing an inner implant to the outer implant when the first margin region is not free of cancerous cells” can include the inner implant being secured to the outer implant prior to implantation, such as the implants being pre-assembled.
Regarding claim 13, the cranial implant taught by Christopher further comprises that the cover of the inner implant 219 is secured to the base of the inner implant 217 using a plurality of fasteners 221 (Paragraph 0077; Figure 21) to keep the inner implant securely in place (Paragraph 0056: inner implant 18 is fixed by screws to cover 16, analogous to cover 219 secured to base of inner implant 217 to ensure that it is securely held in place).
Christopher does not expressly disclose that the outer implant 12 is secured to the inner implant (made of 217 and 219) using a plurality of fasteners. However, since the outer implant 12 is secured to the inner implant (made up of 217 and 219), it would be obvious to modify the attachment mechanism of the inner and outer implant of Antonyshyn in view of Christopher to include a plurality of fasteners 221 to secure the outer implant 12 to the inner implant 217/219 to ensure that the inner implant 217/219 is securely held in place (Christopher Paragraph 0056).
Regarding claim 14, the cranial implant taught by Christopher further comprises nesting the inner implant in the outer implant (Figures 21-22).
Regarding claim 15, the cranial implant taught by Christopher further comprises that an inner edge of the outer implant 12 is beveled and an outer edge of the inner implant 217/219 is beveled complimentary to the beveled inner edge of the outer implant 12 to allow the inner implant 217/219 to nest in the outer implant 12 (See annotated Figure 22 from the rejection of claim 4 above).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Antonyshyn in view of Christopher, Gordon, and Gordon’298 as applied to claim 1 above, and further in view of Ackerman et al. (US2017/0027629 cited in the Non-Final Rejection mailed 05/16/2024), hereinafter referred to as Ackerman.
Regarding claim 9, Antonyshyn in view of Christopher, Gordon, and Gordon’298 discloses the method of claim 1. Antonyshyn in view of Christopher, Gordon, and Gordon’298 fails to disclose that the inner implant and the outer implant are manufactured through selective laser sintering, however, Ackerman discloses a bone grafting implant 100 (Figure 2, with inner implant 210 and outer implant 220), and teaches that the inner implant 210 and the outer implant 220 are manufactured through selective laser sintering (Paragraph 0062).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of manufacturing the cranial implant of Antonyshyn in view of Christopher, Gordon, and Gordon’298 to incorporate the teachings of Ackerman and provide that the inner implant and the outer implant are manufactured through selective laser sintering, in order to employ a manufacturing technique that allows for high customization of the cranial implant based on patient CT scans or other medical imaging of the patient’s defect (Paragraph 0062).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASNIARY DE LA CARIDAD MORALES whose telephone number is (571)272-0821. The examiner can normally be reached M and W-Th 7:30am - 9:30pm EST and F 7:30am-11:30am EST.
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/YASNIARY DE LA CARIDAD MORALES/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774