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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 25 February 2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 25 February 2026. As directed by the amendment: claims 1-12 have been amended and claim 18 is cancelled. Claims 1-17 currently stand pending in the application.
The amendments to the claims are sufficient to overcome the previous claim objections, which are accordingly withdrawn.
Response to Arguments
Applicant's arguments filed 25 February 2026 have been fully considered but they are not persuasive. As to Wang et al. (US 9,949,837), Applicant contends that Wang does not disclose the now positively recited tibial implant including an underlying support member comprising one or more fins, keels, ridges, and/or pegs. Examiner respectfully submits that Wang does disclose a tibial implant including an underlying support member comprising one or more fins, keels, ridges, and/or pegs (one keel shown in FIG. 7 with fins extending from its sides), and a template (220) arranged and configured to assist with removing the orthopedic tibial implant during a revision surgery (the template assists with removing at least the tray 112 of the implant, which then allows for the support member to be removed; col. 4 / lines 16-34, col. 10 / lines 36-60). Wang’s template comprises a representation (upper/superior portion of 220, from which 230 extends) comprising a perimeter defined by one or more fins, keels, ridges, and/or pegs (the cylindrical upper/superior portion of 220 is a peg, or a short cylindrical piece). Wang’s template is a representation of a configuration of the tibial implant disclosed in Wang. The term “represent” is a broad term that means serving as a symbol of. The template could therefore serve as a representation of the configuration of the implant in various ways, including but not limited to proximal-distal extension.
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.
Claims 1-6, 8-10, and 12-16 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. US 9,949,837 to Wang et al. (hereinafter, “Wang”).
As to claim 1, Wang discloses an orthopedic template system, FIGS. 6-8, comprising: an orthopedic tibial implant (100) including an underlying support member (116) comprising one or more fins, keels, ridges, and/or pegs (one keel shown in FIG. 7 with fins extending from its sides); and a template (220) arranged and configured to assist with removing the orthopedic tibial implant during a revision surgery (the template assists with removing at least the tray 112 of the implant, which then allows for the support member to be removed; col. 4 / lines 16-34, col. 10 / lines 36-60), the template comprising: a superior surface (superior surface of lower/inferior portion of 220) and an inferior surface (surface that engages implant 100) opposite the superior surface, the superior surface including a footprint or representation (upper/superior portion of 220, from which 230 extends) comprising a perimeter defined by one or more fins, keels, ridges, and/or pegs (the cylindrical upper/superior portion of 220 is a peg, or a short cylindrical piece) to mimic a configuration of the underlying support member of the tibial implant (where “mimic” is commonly understood to mean imitate, and “configuration” is commonly understood to mean the particular arrangement, the representation perimeter imitates the particular arrangement of the underlying support member because both are arranged and extend along a proximal-distal direction, i.e. the arrangement or configuration).
As to claim 2, Wang discloses the system of claim 1, wherein the footprint or representation extends superiorly from the superior surface of the template (since the representation is the superior or upper portion of 220 which extends superiorly from the superior surface of the template which is taken at the inferior or lower portion of 220).
As to claim 3, Wang discloses the system of claim 2, wherein the footprint or representation is a three-dimensional structure extending from the superior surface of the template, FIG. 7.
As to claim 4, Wang discloses the system of claim 3, further comprising an instrument, FIGS. 6-8, wherein the footprint or representation is arranged and configured to interact with a first tip (230) of the instrument such that moving the first tip of the instrument relative to the footprint or representation (e.g. rotating the first tip about the representation, col. 10 / lines 36-60) is configured to cause a second tip (252) of the instrument to cut bone located inferiorly of the tibial implant (interpreted as language of intended use; the second tip is fully capable of cutting bone adjacent to the porous area 118, which is located inferiorly of the tray of the tibial implant).
As to claim 5, Wang discloses the system of claim 4, wherein the first tip of the instrument has a first length and the second tip of the instrument has a second length smaller than the first length (230 is longer than 252 or even 250).
As to claim 6, Wang discloses the system of claim 5, wherein the first and second lengths are configured so that when the first tip contacts the footprint or representation on the template (when 230 is engaged with the representation as in FIG. 7), the second tip approaches but does not contact the support member of the tibial implant (interpreted as language of intended use; the second tip can be moved away from the support member, to not contact it, via sliding of 240 on 230).
As to claim 8, Wang discloses the system of claim 1, wherein the template is arranged and configured to be positioned on a superior surface of the tibial implant (col. 10 / line 38), FIG. 7.
As to claim 9, Wang discloses the template of claim 8, wherein the template is coupled to the tibial implant (col. 10 / line 38), FIG. 7.
As to claim 10, Wang discloses the system of claim 1, wherein the template includes an outer shape that mimics an outer shape of the tibial implant (the template outer shape mimics the tibial implant outer shape as shown in FIG. 3 because they are both curved and convex).
As to claim 12, Wang discloses a system arranged and configured to assist with removing a previously implanted orthopedic tibial implant (100) during a revision surgery (the template assists with removing at least the tray 112 of the implant, which then allows for the support member to be removed; col. 4 / lines 16-34, col. 10 / lines 36-60), FIGS. 6-8, the tibial implant including a tibial tray (112) and a support member (116), the tibial tray including a superior surface and an inferior surface, the support member extending inferiorly from the inferior surface of the tibial tray, FIG. 7, the system comprising: the previously implanted orthopedic tibial implant (100); an orthopedic template (220) including a superior surface (superior surface of lower/inferior portion of 220) and an inferior surface (surface that engages implant 100) opposite the superior surface of the template, the template being arranged and configured to be positioned on the superior surface of the tibial tray (col. 10 / line 38), FIG. 7, the superior surface of the template including a footprint or representation (upper/superior portion of 220, from which 230 extends) comprising a perimeter defined by one or more fins, keels, ridges, and/or pegs (the cylindrical upper/superior portion of 220 is a peg, or a short cylindrical piece) to mimic a configuration of the support member of the tibial implant comprising one or more fins, keels, ridges, and/or pegs (the support member comprises one keel shown in FIG. 7 with fins extending from its sides; where “mimic” is commonly understood to mean imitate, and “configuration” is commonly understood to mean the particular arrangement, the representation perimeter imitates the particular arrangement of the underlying support member because both are arranged and extend along a proximal-distal direction, i.e. the arrangement or configuration); and an instrument including a distal end (distal to the proximal portion of 240, or the distal free ends of 230/250) having first (230) and second (252) tips; wherein the first tip is arranged and configured to interact with the footprint or representation formed on the superior surface of the template such that moving the first tip of the instrument relative to the footprint or representation (e.g. rotating the first tip about the representation, col. 10 / lines 36-60) is configured to cause the second tip to cut bone located inferiorly of the tibial tray (interpreted as language of intended use; the second tip is fully capable of cutting bone adjacent to the porous area 118, which is located inferiorly of the tibial tray).
As to claim 13, Wang discloses the system of claim 12, wherein the first tip has a first length and the second tip has a second length smaller than the first length (230 is longer than 252 or even 250).
As to claim 14, Wang discloses the system of claim 13, wherein the first and second lengths are configured so that when the first tip contacts the footprint or representation on the template (when 230 is engaged with the representation as in FIG. 7), the second tip approaches but does not contact the support member of the tibial implant (interpreted as language of intended use; the second tip can be moved away from the support member, to not contact it, via sliding of 240 on 230).
As to claim 15, Wang discloses the system of claim 12, wherein the footprint or representation extends superiorly from the superior surface of the template (since the representation is the superior or upper portion of 220 which extends superiorly from the superior surface of the template which is taken at the inferior or lower portion of 220).
As to claim 16, Wang discloses the system of claim 15, wherein the footprint or representation is a three-dimensional structure extending from the superior surface of the template, FIG. 7.
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.
Claims 7, 11, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of U.S. Patent Application Publication No. US 2010/0249943 to Bergin et al. (hereinafter, “Bergin”).
As to claims 7 and 17, Wang discloses the claimed invention except for wherein the footprint or representation is a printed image.
Bergin teaches indicia can be applied in the form of a sticker to a medical device in such a way that a user can only properly read it when the device is installed in its correct orientation (par. [0046]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide indicia on Wang’s template so that its orientation indicates to the user that the template is properly oriented on the implant, to ensure that the template and implant are correctly engaged with each other. The superior surface of the template may be interpreted as all of the surfaces of 220 superior to the tibial implant, i.e. all of the surfaces excluding the inferior surface that is positioned on the tibial implant. The superior surface includes the representation which also would include the indicia as taught by Bergin. Since the representation in Wang mimics the configuration of the underlying support member of the tibial implant, the indicia on the representation and as part of the representation would also be included in this mimicry. The indicia itself would also be a representation mimicking a configuration of the support member, since the indicia can only be properly read when it is properly oriented relative to the implant, therefore mimicking a configuration, e.g. upright or left/right, of the implant and its components such as the support member. The claimed phrase “a printed image” is being treated as a product by process limitation. 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. The indicia in the form of a sticker is viewable by the user and is thus an image; this image can be printed on the sticker, or at least is substantially the same or similar to an image printed on the sticker.
As to claim 11, Wang discloses the claimed invention except for wherein the template is a sticker arranged and configured to be adhered to a superior surface of the tibial implant.
Bergin teaches indicia can be applied in the form of a sticker to a medical device in such a way that a user can only properly read it when the device is installed in its correct orientation (par. [0046]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide indicia on Wang’s device so that its orientation indicates to the user that the component 220 of Wang is properly oriented on the component 100, to ensure proper engagement with each other. In this interpretation of claim 1, the implant comprises components 100 and 220, and the template comprises the sticker indicia that is a sticker arranged and configured to be adhered to a superior surface (outward facing surfaces of 220) of the tibial implant. Then, the sticker indicia as taught by Bergin is applied to the component 220 of the implant. The template/sticker indicia comprises a superior surface (outward facing surface of the sticker) and an inferior surface (sticky side) opposite the superior surface, the superior surface including a footprint or representation (the indicia) mimicking a configuration of an underlying support member of the tibial implant, since the indicia can only be properly read (on its outward facing superior surface) when it is properly oriented relative to the implant (when components 220 and 100 are properly oriented), therefore mimicking a configuration, e.g. upright or left/right, of the implant and its components such as the support member.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
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