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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 12 August 2026. As directed by the amendment: claims 1 and 12 have been amended and claim 18 is cancelled. Claims 1-17 currently stand pending in the application.
Response to Arguments
Applicant's arguments filed 12 August 2026 have been fully considered but they are not persuasive. As to Wang et al. (US 9,949,837), Applicant contends that Wang’s adaptor 220 is cylindrical and therefore does not have a non-uniform perimeter with multiple branches. Examiner respectfully submits that Wang’s adaptor 220 has a perimeter that is non-uniform, or not perfectly cylindrical, as seen in FIG. 7 where there are various indents/protrusions around the circumference of adaptor 220 which result in a non-uniform perimeter. The perimeter or circumferential surface around the upper/superior portion of 220 is formed by and includes branches such as the tip and the wider middle portion, both of which jut superiorly out from the lower/inferior portion of 220; in addition or alternatively, there are superior and inferior branches that jut superiorly/inferiorly from the smallest diameter portion near the tip; in addition or alternatively, there are branches shown in FIG. 8 jutting out above and below the recess in the wider middle portion; each of these branches provides part of the perimeter or circumferential surface around adaptor 220.
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 1-17 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim 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.
As to claims 1 and 12, the limitation “a non-uniform perimeter” renders the claims indefinite, because the scope of the limitation is unascertainable. It is unclear if the term “non-uniform” refers to an irregular or non-symmetrical shape of the perimeter; or that the perimeter is not consistent with or identical to another feature, i.e. that the perimeter is not uniform with another feature; or that the perimeter has some surface irregularities. For examination purposes, the limitation will be interpreted as the perimeter being non-circular.
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, including larger diameter portion) comprising a non-uniform perimeter (the perimeter, defined as the outermost boundary of an area, is the circumferential surface around the upper/superior portion of 220; see FIG. 7 for various indents/protrusions around the circumference of 220 which results in a non-uniform perimeter, at least as much as the instant invention) comprising a multi-branched geometry (a branch is a part that juts out from a main part; the perimeter or circumferential surface around the upper/superior portion of 220 is formed by/includes branches such as the tip and the wider middle portion, both of which jut superiorly out from the lower/inferior portion of 220; in addition or alternatively, there are superior and inferior branches that jut superiorly/inferiorly from the smallest diameter portion near the tip; in addition or alternatively, there are branches shown in FIG. 8 jutting out above and below the recess in the wider middle portion; each of these branches provides part of the perimeter or circumferential surface around 220) defined by one or more fins, keels, ridges, and/or pegs (the 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, including larger diameter portion) comprising a non-uniform perimeter (the perimeter, defined as the outermost boundary of an area, is the circumferential surface around the upper/superior portion of 220; see FIG. 7 for various indents/protrusions around the circumference of 220 which results in a non-uniform perimeter, at least as much as the instant invention) comprising a multi-branched geometry (a branch is a part that juts out from a main part; the perimeter or circumferential surface around the upper/superior portion of 220 is formed by/includes branches such as the tip and the wider middle portion, both of which jut superiorly out from the lower/inferior portion of 220; in addition or alternatively, there are superior and inferior branches that jut superiorly/inferiorly from the smallest diameter portion near the tip; in addition or alternatively, there are branches shown in FIG. 8 jutting out above and below the recess in the wider middle portion; each of these branches provides part of the perimeter or circumferential surface around 220) defined by one or more fins, keels, ridges, and/or pegs (the 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. Since the sticker overlies the component 220, the sticker would comprise the shape of the underlying component 220, including the non-uniform perimeter comprising a multi-branched geometry, as described above, and/or the sticker conveys information that represents or indicates the presence of the non-uniform perimeter comprising a multi-branched geometry.
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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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, Kevin Truong, can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
