Detailed Action
This is the final office action for US application number 18/748,828. Claims are evaluated as filed on May 19, 2026.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed May 19, 2026 have been fully considered but they are not persuasive. The rejections in this office action have been amended to address the amended claims. Examiner asserts that Moos, Bassett, Kubiak, Carchidi, and Toranto teach all the newly-amended limitations and are capable of performing the functions as claimed. Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
With regards to Applicant’s argument that the “C-shaped” cross-section feature of claim 9 is shown in Fig. 4E if breakaway regions 970a and 970b were omitted (Remarks p. 8), Examiner notes that Fig. 4E hasn’t been shown with portions omitted nor has an unshown species been elected. No view has been shown that fully enables one to determine what the disclosed structure is in a plane perpendicular to that of Fig. 4E to determine if such would be C-shaped or if the portions labeled as 970a and 970b were removed how the structure shown in Fig. 4E would connect the portions above and below 970a and 970b. Further, it is not shown how the C-shaped first reconstruction template is configured to engage a donor bone via a push fit as claimed.
With regards to Applicant’s argument that the dashed lines in Fig. 4E represent the joining point of two “split semicircles” and therefore the features of claim 10 are shown (Remarks p. 8-9), Examiner notes that no view has been shown that fully enables one to determine what the disclosed structure is in a plane perpendicular to that of Fig. 4E to determine if such is circular with split semicircles. Further, how such are “split” has not been shown as well as how and the reconstruction template is configured to engage a donor bone by opening the reconstruction template and arranging the reconstruction template on the donor bone as claimed.
With regards to Applicant’s argument that the provisional application and the specification disclose the first plantar plate protruding orthogonally from the main bracket in paragraph 64 of the specification and paragraph 5 of the provisional application as well as Fig. 3C shows the plates 935 extending orthogonally to the bracket 930 (Remarks p. 9), Examiner notes that there is no scale or indicator shown in Fig. 3C to enable one to determine that the plates 935 are orthogonal to bracket 930. Further, review of paragraph 64 of the specification and paragraph 5 of the provisional application shown that such are silent as to what species is being described. Additional review of the specification shows no disclosure of the elected species having plates orthogonal to the bracket. Thus, Examiner suggests amending to claim that the plates are substantially/generally orthogonal to the bracket as supported by Figs. 3C and 6A.
With regards to Applicant’s argument that in claim 4 the claimed feature is the positioning pin is not created by drilling through the template to create and opening as the pin already exists and is simply not a product-by-process limitation (Remarks p. 10), Examiner notes that this argument appears to be completely arbitrary and unfounded in the non-final office action dated February 19, 2026. Instead, as indicated below and on pages 8-9 of the non-final office action dated February 19, 2026, “formed” has been treaded as a product by process limitation, i.e. as something being formed or forming something is indeed a process. However, it has not been asserted that the positioning pin is created by drilling, such has not been claimed, and Examiner can find nothing in the non-final office action dated February 19, 2026 that can be reasonably construed to be making such an assertion or any mention of the pin being created by drilling. Instead, claim 4 provides the positioning pin configured to be inserted through “an opening in a bone formed using the first implant opening”, claim 5 provides a dental implant configured to be inserted through “an opening in a bone formed using the first implant opening”, and claim 10 provides “the reconstruction plate is formed via additive manufacturing”, i.e. the bone opening created using the first implant opening in claim 4, the bone opening created using the first implant opening in claim 5, and the reconstruction plate created via additive manufacturing in claim 15.
With regards to Applicant’s argument that Bassett does not disclose the plate 202 extending from a main bracket (Remarks p. 10-12), Examiner notes that such has not been asserted and is therefore moot. Instead, as detailed below and on pages 11-16 of the non-final office action dated February 19, 2026, Kubiak teaches that the plate connects to and extends from the main bracket.
Priority
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 disclosure of the prior-filed application, Application No. 63/556,156, fails 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. Application No. 63/556,156 fails to provide adequate support for “a first plantar plate protruding orthogonally from the main bracket” in claim 1 line 17 for the elected species, “a first plantar plate protruding orthogonally from the main bracket” in claim 17 line 3 for the elected species, and “a second plantar plate protruding orthogonally from the main bracket” in claim 17 line 5 for the elected species.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
As to claim 1, the specification appears to lack proper antecedent basis for “a first plantar plate protruding orthogonally from the main bracket” in line 16 as there does not appear to be any description of the plate being orthogonal to the bracket for the elected species. Thus, the specification fails to provide proper antecedent basis for “a first plantar plate protruding orthogonally from the main bracket” in line 17.
As to claim 17, the specification appears to lack proper antecedent basis for “a first plantar plate protruding orthogonally from the main bracket” in line 16 as there does not appear to be any description of the plate being orthogonal to the bracket for the elected species. Thus, the specification fails to provide proper antecedent basis for “a first plantar plate protruding orthogonally from the main bracket” in line 3.
As to claim 17, the specification appears to lack proper antecedent basis for “a second plantar plate protruding orthogonally from the main bracket t” in line 16 as there does not appear to be any description of the plate being orthogonal to the bracket for the elected species. Thus, the specification fails to provide proper antecedent basis for “a second plantar plate protruding orthogonally from the main bracket” in line 5.
As to claim 17, the specification appears to lack proper antecedent basis for “the first plantar plate and the second plantar plate are configured to protrude into a mandible” of lines 9-10. That is, the specification is silent to the plantar plates 935 protruding into the mandible, such is not shown, and such was not originally claimed. Instead, Fig. 5 and paragraph 56 show that the plates protrude into the donor bone and that “the reconstruction plate 999 can be fixated to the flanking mandible stumps via multiple of the fastener 955 disposed at various locations along the main bracket 930 of the reconstruction plate 999” (¶56). Thus, the specification fails to provide proper antecedent basis for “the first plantar plate and the second plantar plate are configured to protrude into a mandible” of lines 9-10.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “a cross-sectional shape of the first reconstruction template is C-shaped and the first reconstruction template is configured to engage a donor bone via a push fit” of claim 9, “a cross-sectional shape of the reconstruction template is circular with split semicircles, and the reconstruction template is configured to engage a donor bone by opening the reconstruction template and arranging the reconstruction template on the donor bone” of claim 10, and “the first plantar plate and the second plantar plate are configured to protrude into a mandible” of claim 17 lines 9-10 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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
Claim(s) 1 and 17 is/are objected to because of the following informalities:
Claim 1 line 1 should read “implant system[[,]] comprising:”.
Claim 17 line 1 should read “A reconstruction template apparatus[[,]] comprising:”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim(s) 17-20 is/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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to claims 17-20, “the first plantar plate and the second plantar plate are configured to protrude into a mandible” of claim 17 lines 9-10 appears to be new matter. That is, the specification is silent to the plantar plates 935 protruding into the mandible, such is not shown, and such was not originally claimed. Instead, Fig. 5 and paragraph 56 show that the plates protrude into the donor bone and that “the reconstruction plate 999 can be fixated to the flanking mandible stumps via multiple of the fastener 955 disposed at various locations along the main bracket 930 of the reconstruction plate 999” (¶56). Thus, “the first plantar plate and the second plantar plate are configured to protrude into a mandible” of claim 17 lines 9-10 constitutes new matter.
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(s) 19 is/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 pre-AIA the applicant regards as the invention.
Claim(s) 19 recites/recite the limitation "the aperture includes threading" in line 1 and is unclear as to if such is intended to refer to the first aperture of claim 17 line 4 of the second aperture of claim 17 line 6. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “the first aperture includes threading”.
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 of this title, 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.
Claim(s) 1-3, 5, and 8-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moos et al. (WO 2022/164943, hereinafter “Moos”) in view of Bassett et al. (US 2011/0008754, hereinafter “Bassett”), further in view of Kubiak et al. (US 2013/0267955, hereinafter “Kubiak”).
The claimed phrase “formed” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claims 1-3, 5, and 8-16, Moos discloses a mandible reconstruction and dental implant system (Figs. 1-4B and 20) comprising: a first reconstruction template (11, Figs. 1-4B) including: a body (Figs 1-4B), a first cutting guide (surface as left 32 as shown in Fig. 1, Fig. 1) disposed at a first edge of the body (as defined, Fig. 1) and a second cutting guide (surface as left 31 as shown in Fig. 1, Fig. 1) disposed at a second edge of the body (as defined, Fig. 1), a first bone fastener opening (generally circular openings shown in 11 in Figs. 1-3, Figs. 1-3) disposed along the body (Figs. 1-3) and capable of receiving a drill therein (due to the shown structure, such is capable of receiving an appropriately sized drill/drill bit, Figs. 1-3, page 14 lines 1-5, page 11 lines 23-25), and a reconstruction plate (Fig. 20) including: a main bracket (Fig. 20), wherein the reconstruction plate comprises titanium (page 14 lines 2-3). As to claim 2, Moos discloses that the main bracket includes at least one opening (Fig. 20) capable of receiving a fastener (“screw” of page 14 line 2) therein to attach the main bracket to an abutting bone segment (page 14 lines 1-5). As to claim 9, Moos discloses that a cross-sectional shape of the first reconstruction template is C-shaped (Figs. 4A and 4B) and the first reconstruction template is capable of engaging a donor bone via a push fit (Figs. 4A and 4B). As to claim 10, Moos discloses that a cross-sectional shape of the reconstruction template is circular with split semicircles (Figs. 1-4B), and the reconstruction template is capable of engaging a donor bone by opening the reconstruction template and arranging the reconstruction template on the donor bone (Figs. 1-4B). As to claim 11, Moos discloses a second reconstruction template (12, Figs. 1-4B), the first reconstruction template and the second reconstruction template being attached to one another via a template segment connector (13, Figs. 1-4B). As to claim 15, Moos discloses that a material of the reconstruction plate is titanium (page 14 lines 2-3) and the reconstruction plate is formed via additive manufacturing (Fig. 20). As to claim 16, Moos discloses that a first side of the main bracket is capable of being fixated to a first mandible stump (Fig. 20) and a second side of the main bracket is capable of being fixated to a second mandible stump (Fig. 20).
Moos is silent to a first plantar plate slot disposed along the body, the first plantar plate slot being an opening configured to receive a drill therein, a first implant opening disposed along the body and aligned with the first plantar plate slot, the first implant opening being configured to receive a drill therein, an axis through the first implant opening being orthogonal to an axis through the first plantar plate slot; and a first plantar plate protruding orthogonally from the main bracket, the first plantar plate including an aperture. As to claim 3, Moos is silent to the aperture includes threading for receiving and frictionally securing a complementary threading inserted therein. As to claim 5, Moos is silent to a dental implant configured to be inserted through an opening in a bone formed using the first implant opening and coupled to the first plantar plate. As to claim 8, Moos is silent to a cross-sectional shape of the first plantar plate slot is rectangular, and a cross-sectional shape of the first plantar plate is a complementary rectangular shape to the plantar plate slot. As to claim 12, Moos is silent to an arrangement of the first plantar plate is aligned with the first bone fastener opening along a length of the body. As to claim 13, Moos is silent to the arrangement of the first bone fastener opening is not aligned with the first implant opening along the length of the body. As to claim 14, Moos is silent to the reconstruction plate includes a second plantar plate disposed proximal to the first plantar plate and the first reconstruction template includes a second plantar plate slot arranged at a location relative to the first plantar plate slot.
Bassett teaches a similar mandible reconstruction and dental implant system (Fig. 17, ¶72) comprising: a first plantar plate (202) protruding orthogonally from a surface (208, Fig. 17, ¶72) within a porous material (200, Fig. 17, ¶72), the first plantar plate including an aperture (212, Fig. 17, ¶72) capable of receiving a dental implant (204, Fig. 17, ¶72 discloses 204 is a post on which a tooth crown may be fastened or supported), and a dental implant (204, Fig. 17, ¶72 discloses 204 is a post on which a tooth crown may be fastened or supported). As to claim 3, Bassett teaches the aperture includes threading (female threads of 212 as disclosed in ¶72, Fig. 17, ¶72) capable of receiving and frictionally securing a complementary threading (male threads mating with 212 as disclosed in ¶72, Fig. 17, ¶72) inserted therein (Fig. 17, ¶72). As to claim 5, Bassett teaches a dental implant (204, Fig. 17, ¶72 discloses 204 is a post on which a tooth crown may be fastened or supported) capable of being inserted through an opening in a bone (Fig. 17). As to claim 8, Bassett teaches that a cross-sectional shape of the first plantar plate is a rectangular shape (Fig. 17). As to claim 13, Bassett teaches that the arrangement of the first plantar plate is aligned with the implant bone opening along a length of the body (vertically spaced as shown in Fig. 17, Fig. 17).
Kubiak teaches a similar bone repair system (Figs. 1A-1C, abstract) comprising: a bone plate (10) including: a main bracket (12) comprising openings (30s) capable of receiving fasteners (fasteners of ¶74, ¶74) capable of fastening the plate to bone portions (¶74), and a first plantar plate (16 and 18 of 14, Fig. 1A, ¶72) protruding substantially orthogonally from the main bracket (Figs. 1A-1C, ¶81); wherein the bone plate comprises titanium (¶s 81 and 82). As to claim 12, Kubiak teaches an arrangement of the first plantar plate is aligned with the main bracket fastener opening along a length of the body (vertically aligned as shown in Fig. 1B, Fig. 1B). As to claim 13, Kubiak teaches that the arrangement of the main bracket fastener opening is not aligned with a surface orthogonal to the first plantar plate along the length of the body (vertically spaced as shown in Fig. 1B, Fig. 1B). As to claim 14, Kubiak teaches that the reconstruction plate includes a second plantar plate (the other of 16, 18, Fig. 1A) disposed proximal to the first plantar plate (Fig. 1A).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the system as disclosed by Moos by adding a first plantar plate and dental implant as taught by Bassett in order to aid in joining multiple sections of porous material (Bassett ¶72) and permit immediate restoration of dental surfaces (Bassett ¶65). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the orthogonally oriented main bracket and the first plantar plate as disclosed by Moos and Bassett to be connected such that the first plate is part of the bracket and there is a second plate connected to another part of the bracket as taught by Kubiak in order to increase torsional stiffness as compared with traditional plates (Kubiak ¶83) and may allow the main bracket to have a thinner profile (Kubiak ¶83) and thereby improve the facial appearance following post-operative healing.
In forming the combination, it would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to construct the template of Moos with appropriately sized and positioned openings corresponding to the plantar plate and dental implant taught by Bassett as connected to the main bracket as taught by Kubiak, since Applicant has not disclosed that such is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a cutting guide (Moos page 14 lines 1-5) that allows drilling of bone segments (Moos page 14 lines 1-5) to fix them to the reconstruction plate (Moos Fig. 20) to quickly and accurately take bone segments from a patient’s fibula with correct positioning on the mandible (Moos page 3 lines 10-20).
Thus, as to claim 1, the combination of Moos, Bassett, and Kubiak discloses a first plantar plate slot (to create the bone opening for Bassett 202, Fig. 17, ¶72 when connected to the main bracket as taught by Kubiak 16, 18, Figs. 1A-1C) disposed along the body (between fastener openings of Moos Figs. 1 and 20 as modified with the plantar plate of Bassett connected to the main bracket as taught by Kubiak), the first plantar plate slot being an opening (as defined) capable of receiving a drill therein (Moos Figs. 1-3, page 14 lines 1-5, page 11 lines 23-25), a first implant opening (to create the bone opening for Bassett 204, Fig. 17, ¶72) disposed along the body (between fastener openings of Moos Figs. 1 and 20 as modified with the plantar plate of Bassett connected to the main bracket as taught by Kubiak) and aligned with the first plantar plate slot (to achieve the positioning necessary for the alignment of Bassett Fig. 17 between the plantar plate and the implant), the first implant opening being capable of receiving a drill therein (Moos Figs. 1-3, page 14 lines 1-5, page 11 lines 23-25), an axis through the first implant opening being orthogonal to an axis through the first plantar plate slot (to achieve the positioning necessary for the alignment of Bassett Fig. 17 between the plantar plate and the implant). As to claim 5, the combination of Moos, Bassett, and Kubiak teaches a dental implant (Bassett 204, Fig. 17, ¶72 discloses 204 is a post on which a tooth crown may be fastened or supported) capable of being inserted through an opening in a bone (Bassett Fig. 17) formed using the first implant opening and coupled to the first plantar plate (to create the bone opening for Bassett 202, Fig. 17, ¶72 when connected to the main bracket as taught by Kubiak 16, 18, Figs. 1A-1C). As to claim 8, the combination of Moos, Bassett, and Kubiak discloses a cross-sectional shape of the first plantar plate slot is rectangular (to create the bone opening for Bassett 202, Fig. 17, ¶72 when connected to the main bracket as taught by Kubiak 16, 18, Figs. 1A-1C), and a cross-sectional shape of the first plantar plate is a complementary rectangular shape (as defined, Fig. 17) to the first plantar plate slot (as defined). As to claim 12, the combination of Moos, Bassett, and Kubiak discloses an arrangement of the first plantar plate slot is aligned with the first bone fastener opening along a length of the body (as defined, Moos Fig. 1; Bassett Fig. 17; Kubiak Fig. 1B). As to claim 13, the combination of Moos, Bassett, and Kubiak discloses the arrangement of the first bone fastener opening is not aligned with the first implant opening along the length of the body (as defined, Moos Fig. 1; Bassett Fig. 17; Kubiak Fig. 1B). As to claim 14, the combination of Moos, Bassett, and Kubiak discloses that the reconstruction plate includes a second plantar plate (Moos Fig. 1; Bassett Fig. 17; Kubiak the other of 16, 18, Fig. 1A) disposed proximal to the first plantar plate (Fig. 1A) and the reconstruction template includes a second plantar plate slot (as defined, Moos Fig. 1; Bassett Fig. 17; Kubiak Fig. 1B) arranged at a location relative to the first plantar plate slot (as defined, Moos Fig. 1; Bassett Fig. 17; Kubiak Fig. 1B).
As to claims 17-20, Moos discloses reconstruction plate apparatus (Fig. 20) comprising: a main bracket (Fig. 20), wherein the reconstruction plate comprises titanium (page 14 lines 2-3). As to claim 18, Moos discloses that the main bracket includes at least one opening (Fig. 20) capable of receiving a fastener (“screw” of page 14 line 2) therein to attach the main bracket to an abutting bone segment (page 14 lines 1-5). As to claim 20, Moos discloses that a first side of the main bracket is capable of being fixated to a first mandible stump (Fig. 20) and a second side of the main bracket is capable of being fixated to a second mandible stump (Fig. 20).
Moos is silent to a first plantar plate protruding orthogonally from the main bracket, the first plantar plate including a first aperture; and a second plantar plate protruding orthogonally from the main bracket, the second plantar plate including a second aperture, wherein the first plantar plate and the second plantar plate are disposed on opposing sides of the main bracket, and the first plantar plate and the second plantar plate are configured to protrude into a mandible. As to claim 19, Moos is silent to the first aperture includes threading for receiving and frictionally securing a complementary threading inserted therein.
Bassett teaches a similar reconstruction plate system (Fig. 17, ¶72) comprising: a first plantar plate (202) protruding orthogonally from a surface (208, Fig. 17, ¶72) within a porous material (200, Fig. 17, ¶72), the first plantar plate including a first aperture (212, Fig. 17, ¶72) capable of receiving a dental implant (204, Fig. 17, ¶72 discloses 204 is a post on which a tooth crown may be fastened or supported), and a dental implant (204, Fig. 17, ¶72 discloses 204 is a post on which a tooth crown may be fastened or supported). As to claim 19, Bassett teaches the first aperture includes threading (female threads of 212 as disclosed in ¶72, Fig. 17, ¶72) capable of receiving and frictionally securing a complementary threading (male threads mating with 212 as disclosed in ¶72, Fig. 17, ¶72) inserted therein (Fig. 17, ¶72).
Kubiak teaches a similar bone repair system (Figs. 1A-1C, abstract) comprising: a bone plate (10) including: a main bracket (12) comprising openings (30s) capable of receiving fasteners (fasteners of ¶74, ¶74) capable of fastening the plate to bone portions (¶74), a first plantar plate (16 of 14, Fig. 1A, ¶72) protruding substantially orthogonally from the main bracket (Figs. 1A-1C, ¶81), a second plantar plate (18 of 14, Fig. 1A) substantially orthogonally from the main bracket (Figs. 1A-1C, ¶81); wherein the first plantar plate and the second plantar plate are disposed on opposing sides of the main bracket (left and right sides as show in Fig. 1B, Fig. 1B), and the first plantar plate and the second plantar plate are capable of protruding into a mandible/bone (due to the structure shown in Figs. 1A-1C, Figs. 1A-1C, abstract discloses that the keel extends from the plate and into the bone); wherein the bone plate comprises titanium (¶s 81 and 82).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the system as disclosed by Moos by adding a plantar plate and dental implant as taught by Bassett in order to aid in joining multiple sections of porous material (Bassett ¶72) and permit immediate restoration of dental surfaces (Bassett ¶65). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the orthogonally oriented main bracket and the plantar plate as disclosed by Moos and Bassett to be connected such that the first plate is part of the bracket and there is a second plate connected to another part of the bracket as taught by Kubiak in order to increase torsional stiffness as compared with traditional plates (Kubiak ¶83) and may allow the main bracket to have a thinner profile (Kubiak ¶83) and thereby improve the facial appearance following post-operative healing.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moos, Bassett, and Kubiak in view of Carchidi et al. (US 5,971,985, hereinafter “Carchidi”).
As to claim 4, the combination of Moos, Bassett, and Kubiak discloses the invention of claim 1.
The combination of Moos, Bassett, and Kubiak is silent to a positioning pin configured to be inserted through an opening in a bone formed using the first implant opening and coupled to the first plantar plate.
Carchidi teaches a positioning pin (10) capable of being inserted through an opening in a bone (abstract) for fixing and retaining tissue grafts and synthetic membranes directly to a maxillofacial bone graft site (abstract).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to the system as disclosed by the combination of Moos, Bassett, and Kubiak by adding the positioning pin as taught by Carchidi in order to fix and retain grafts directly to a maxillofacial bone graft site (Carchidi abstract) while being easily inserted and removed from the graft site without compromising its fixation (Carchidi abstract).
In forming the combination, it would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to specify that the positioning pin of the combination of Moos, Bassett, Kubiak, and Carchidi is appropriately sized for insertion in the first implant opening and coupling to the first plantar plate, since Applicant has not disclosed that such is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for temporarily fixing and retaining the plate within the bone graft (Moos Fig. 1; Bassett Fig. 17; Kubiak Fig. 1B; Carchidi Fig. 1, abstract) to fix them to the reconstruction plate (Moos Fig. 20) to aid in quickly and accurately taking bone segments from a patient’s fibula with correct positioning on the mandible (Moos page 3 lines 10-20).
Thus, as to claim 4, the combination of Moos, Bassett, Kubiak, and Carchidi discloses a positioning pin (Carchidi Fig. 1) capable of being inserted through an opening in a bone formed using the first implant opening and coupled to the first plantar plate (Moos Fig. 1; Bassett Fig. 17; Kubiak Fig. 1B; Carchidi Fig. 1, abstract).
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moos, Bassett, and Kubiak in view of Toranto (US 2022/0362023).
As to claims 6 and 7, the combination of Moos, Bassett, and Kubiak discloses the invention of claim 1.
The combination of Moos, Bassett, and Kubiak is silent to an angle of a plane of the first cutting guide is based on an obtained medical image. As to claim 7, the combination of Moos, Bassett, and Kubiak is silent to an angle of a plane of the second cutting guide is based on the obtained medical image.
Toranto teaches a similar mandible reconstruction and dental implant system (Figs. 3 and 22C) comprising: a first reconstruction template (300, Fig. 3) including: a body (Fig. 3), a first cutting guide (left slot of 310/410 as shown in Figs. 3 and 4, Figs. 3 and 4) disposed at a first edge of the body (Figs. 3 and 4) and a second cutting guide (right edge surface of 310/410 as shown in Figs. 3 and 4, Figs. 3 and 4) disposed at a second edge of the body (Figs. 3 and 4); and a reconstruction plate (Fig. 22C) including: a main bracket (Fig. 22C) that is 3D printed out of titanium alloy (¶101); wherein an angle of a plane of the first cutting guide is based on an obtained medical image (112, 124/128, Fig. 1, ¶s 93-95). As to claim 7, Toranto teaches an angle of a plane of the second cutting guide is based on the obtained medical image (112, 124/128, Fig. 1, ¶s 93-95).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the template and plate as disclosed by the combination of Moos, Bassett, and Kubiak to be based on obtained medical images as taught by Toranto in order to provide a patient specific template and plate (Toranto ¶s 92-95) to precisely cut fibular bone grafts at predetermined locations and then conform grafts into a final orientation to construct a neo-mandible (Toranto ¶s 3 and 98).
Conclusion
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 extension fee 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 date of this final action.
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/AMY R SIPP/Primary Examiner, Art Unit 3775
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