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 Arguments
Applicant's arguments filed 11/7/2025 have been fully considered but they are not persuasive. Claim 1 was amended to essentially incorporate some features of claim 3 which was rejected under 35 U.S.C. 103 as being unpatentable over Pontius in view of Parry. Applicant argues the Office’s characterization of Parry is incorrect because Parry does not describe or suggest that interlocking of any sub-component or scaffold may form a full size implant. Applicant argues the spacer of Parry does not form a part of what Parry considers to be a prosthesis or implant let alone a full sized one and Parry does not describe interlocking scaffolding may form the spacer in full. These are arguments are not persuasive because applicant appears to be focused on the term scaffold as opposed to implant, and disregards the relevant teachings of Parry as they relate to the instant application. The method of installing an implant and the orthopedic implant of Pontius are identical to the claimed method and disclosed orthopedic implant except for the connection mechanism between the modular parts. Parry specifically teaches a modular implant that uses a dovetail shaped connection for the purpose of securely connecting sub-units together to form a full size implant. The arguments regarding whether the scaffold of Parry is a full size implant are unpersuasive because the rejection refers to the assembled scaffold 1400 as the full size implant/scaffold. The rejection never refers a combination of the tibial implant and scaffold. The rejection specifically refers to the scaffold/implant 1400 in fig.14. The scaffold of Parry is implanted and is therefore an implant. The sub-units coupled together form a full size implant/unit 1400 as shown in fig.14 of Parry. Parry is relied upon in the rejection to teach the well-known dovetail connection mechanism for joining modular implant parts to form an implant. Parry specifically says “Two connectable half sizes may be provided in a left and right configuration that may be assembled to form a full size assembled scaffold, or fractional sizes may be provided that allow for two or more units to be linked together” in col.17, lines 62-65. It is clear that Parry teaches modular implant components that can be assembled to form a full-size assembled implant. Even though Parry refers to a “scaffold”, a scaffold is an implant and is therefore applicable to teaching the connection mechanism claimed. Parry further specifically discloses each of a dovetail shaped connection, a snap-fit connection, or a puzzle piece interlock as functionally equivalent means for connecting modular components, which is why the examiner relied upon the teachings of Parry.
Applicant further argues Parry is better characterized as teaching a non-load bearing scaffold which forms part of a spacer made with cement. This is not persuasive because Parry was not relied upon for teaching a load bearing component and was simply applied to teach a dovetail type connection between modular parts of an implant. The connection mechanisms of modular parts of an implant as taught by Parry are relevant to both load bearing implants and non-load bearing implants since the connection mechanism is used for connecting parts and not providing load bearing capability. Pontius discloses the invention substantially as claimed except for the dovetail shaped connection, which is commonplace in the art of prosthetics. Parry was relied upon to teach well-known coupling mechanisms (i.e. a dovetail shaped connection, a snap-fit connection, or a puzzle piece interlock) useful for connecting modular components of an implant.
Terminal Disclaimer
The terminal disclaimer filed on 11/7/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Pat. No. 12,370,049 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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, 3, 6-11, and 38-43 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, claim 1 is indefinite because it is unclear what is meant by “within a nominally lateral plane” as recited in line 12. The term nominal is defined by Merriam-Webster online dictionary to mean “existing or being something in name or form only”. The lateral plane of the body typically refers to the sagittal plane and is a vertical, anteroposterior plane that divides the body or its parts into left and right portions. The orthopedic implant of the invention does not appear to lie in a lateral/sagittal plane and instead appears to extend in a mediolateral direction, approximately in a transverse plane. What is meant by “nominally lateral plane”? A literal interpretation would be a lateral/sagittal plane in name only which is unclear. In par.93 of the instant application, the specification recites “It will be appreciated that when implant 180 is assembled as shown in Fig. 24, each of the subunits 182, 184, 186, 188 is substantially prevented from moving in any direction, with respect to each other, within the nominally lateral plane in which implant 180 is installed”. Therefore, for the purpose of examination, the examiner interprets “a nominally lateral plane” to mean a plane in which the implant is installed.
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, 3, 6-11, and 38-43 are rejected under 35 U.S.C. 103 as being unpatentable over Pontius US 2020/0107934 (hereafter referred to as Pontius; cited in IDS; Pontius was published more than one year before the effective filing date of the instant application) in view of Parry et al. US 9,241,801 (hereafter referred to as Parry).
Regarding claim 1, Pontius discloses a method of installing an orthopedic implant comprising creating an opening in a patient's tissue in order to expose a portion of the patient's tibia (par.11), cutting a portion of the patient's tibia to create a wedge-shaped void 10 in the patient's tibia (par.11; fig.1), individually inserting each of a plurality of implant subunits through the opening in the patient's tissue (par.11; fig.2), and positioning the plurality of implant subunits within the wedge-shaped void (par.11; figs.2 and 10) such that at least two 64, 70 of the plurality of implant subunits are mechanically interlocked together with each other such that the at least two subunits are substantially prevented from moving in any direction with respect to each other within a nominally lateral plane (interpreted to mean a plane in which the implant is installed) by projections 66 and recesses 68 when the plurality of implant subunits are in an assembled condition (fig.10; par.61 discloses complementary features help guide the surface to abut together in a correct orientation; when the projections are within the recesses and the cable and/or screws or pins are installed, the sub-units are substantially prevented from moving in any direction within the plane in which the implant is installed). While Pontius discloses the invention substantially as claimed, Pontius does not disclose that the subunits are substantially prevented from moving in any direction with respect to each other within a nominally lateral plane by acute angles of the projections and recesses.
Parry teaches a method of installing an orthopedic implant, in the same field of endeavor, wherein subunits of an implant 1400 are connected by a dovetail shaped connection (fig.14), wherein two subunits 1410, 1420 are substantially prevented from moving in any direction with respect to each other within a plane in which the implant is installed by acute angles of projections 1450 and recesses 1460 (fig.14, col.18, lines 26-41) for the purpose of rapidly and securely interlocking sub-components together (col.18, lines 37-40). Parry teaches that the attachment features 1450 and 1460 may interlock such that they can only be detached from each other by moving the subunit 1420 out of plane relative to the first subunit 1410 (col.18, lines 33-37) which shows that the subunits are substantially prevented from moving in any direction within the plane in which the implant is installed (e.g. right/left and front/back).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the dovetail shaped connection, comprising acute angles of projections and recesses, as taught by Parry for the complementary shaped features of Pontius in order to rapidly and securely interlock the subunits together to form the full size implant.
Regarding claim 3, Parry teaches the acute angles of projections comprise a dovetail shape as discussed above. Pontius discloses the implant subunits form a load bearing implant substantially filling the wedge-shaped void in the assembled position (fig.2 shows the implant substantially filling the wedge-shaped void; par.8 discloses the implant is constructed to withstand loads associated with patient’s who may be obese). Pontius further teaches secondary subunits may be made from one or more highly porous materials and may be configured to promote osteogenesis (par.60), therefore the implant as a whole is considered a load bearing osseo-integrative implant.
Regarding claim 6, see Pontius figs.2, 11-13, and 19-22 for the subunits being arranged in wedge-shaped configuration.
Regarding claims 7 and 8, see Pontius par.61 for the subunits comprising the mechanical interlocking configuration being pulled together using one or more cables and/or one or more screws or pins.
Regarding claim 9, see Pontius fig.2 for a plate 30 installed to assist in maintaining the positioning of the plurality of implant subunits.
Regarding claim 10, par.45 of Pontius discloses a plate “may” be secured to the tibia, therefore the orthopedic implant of Pontius in view of Parry is capable of use without a compression plate.
Regarding claim 11, see Pontius par.67 for titanium alloy which is a conventional orthopedic implant material.
Regarding claim 38, see fig.10 of Pontius which shows each of the lateral 64, medial (opposite 64), anterior 70, and posterior (opposite 70) implant subunits.
Regarding claims 39 and 40, Pontius as modified by Parry to include the dovetail shaped projections/recesses connecting each of the subunits results in each of the subunits being inhibited from movement in both a medial-lateral direction and anterior-posterior direction. Parry specifically says the subunits can only be separated by moving them out of plane with each other (col.18, lines 33-37).
Regarding claim 41, see Pontius par.7 for a smaller opening in light of the modular components.
Regarding claims 42 and 43, see fig.14 of Parry for projection 1450 and recess 1460 as claimed, wherein each of the projection and recess extend across only a portion of the outer wall in which they are formed (they extend for less than the entire width of the subunits). Parry teaches the projection and recess can only be detached from each other by moving a subunit out of plane relative to another subunit (col.18, lines 33-37). This means in order to engage a first implant subunit with a second implant subunit of the implant of Pontius in view of Parry, the subunits must be first aligned in offset vertical planes and then slid vertically relative each other so that the projection 1450 engages with the recess 1460.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Pierce US 2015/0216669 discloses a modular implant formed of subunits which have dovetail shaped connections (figs.13A-13B) or a snap-connection (fig.13C).
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 MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm EST.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774