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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 21, 2025 has been entered.
As directed by the amendment, claims 21, 23-26, 29, 33, 35 have been amended. As such, claims 21-39 remain under consideration in the instant application.
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.
Claims 21-39 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 21 and 33 recite the limitation “wherein the elongated body of the TPLO plate is curved such that the first portion is offset from the second portion in a second direction that is perpendicular to the first direction.” Applicant points to Figures 3-4B, 20, 22A for support (Applicant’s Remarks, page 7 of 8). However, the TPLO plate shown in these figures do not comprise first and second portions perpendicularly offset from one another. Perpendicular is defined as “being at right angles to a given line or plane” (Merriam-Webster) while the portions shown are at best at obtuse angles (see below).
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Figure: First and second directions of Applicant’s TPLO plate.
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.
Claim(s) 21-26, 29-37, 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan et al. (US 2017/0166377), hereinafter “Kaplan”, in view of West (US 2020/0405435), and further in view of Hilse et al. (US 8940026), hereinafter “Hilse”.
Regarding claim 21, Kaplan discloses an orthopedic implant kit (FIG. 7), comprising: a base (at 232); and a plurality of bone screws (52) received on the base, wherein one or more of the plurality of bone screws and the base are sterilized (¶36). However, Kaplan is silent regarding the plurality of bone screws comprising a plurality of cortical locking bone screws which each have threads in a head of the cortical locking bone screw, and a plurality of cortical bone screws which each are without threads in a head of the cortical bone screw. West teaches an orthopedic implant kit comprising an orthopedic implant (22) and a plurality of bone screws, wherein the plurality of bone screws comprises a plurality of cortical locking bone screws (50, FIGS. 5) which each have threads (56) in a head (56) of the cortical locking bone screw, and a plurality of cortical bone screws (102, FIGS. 7) which each are without threads in a head (104) of the cortical bone screw. It is well known in the orthopedic art to provide screws both with and without threading in the head, in order to complement the various types of apertures in an orthopedic implant. In this case, one would include screws with and without threaded heads in the kit of Kaplan. Additionally, Hilse teaches a tibial plateau leveling osteotomy (TPLO) plate comprising an elongated body comprising a first portion (8) and a second portion (6), wherein the length of the second portion is longer than that of the first portion and extends in a first direction (FIG. 1), wherein the second portion comprises two or more screw holes (11) spaced apart along the second portion, wherein the elongated body of the TPLO plate is curved such that the first portion is offset from the second portion in a second direction that is perpendicular to the first direction (FIG. 1), and wherein the first portion comprises a plurality of screw holes (11) arranged in a triangular pattern (FIG. 1). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to substitute the plate of Hilse in the kit of Kaplan to use in an alternative surgical procedure.
Regarding claim 22, Kaplan as modified by West and Hilse teach the orthopedic implant kit of claim 21, and Kaplan further discloses wherein each bone screw comprises a head and a threaded shaft having specified major and minor diameters, and a specified thread pitch (FIG. 7).
Regarding claim 23, Kaplan as modified by West and Hilse teach the orthopedic implant kit of claim 21, and Kaplan further discloses an orthopedic implant (242) secured on the base.
Regarding claim 24, Kaplan as modified by West and Hilse teach the orthopedic implant kit of claim 23, and Kaplan further discloses wherein the orthopedic implant is a bone plate (242).
Regarding claim 25, Kaplan as modified by West and Hilse teach the orthopedic implant kit of claim 23, and Kaplan further discloses wherein the orthopedic implant is a fixation member (242).
Regarding claim 26, Kaplan as modified by West and Hilse teach the orthopedic implant kit of claim 23, and Kaplan further discloses wherein the orthopedic implant is a tibial plateau leveling osteotomy (TPLO) plate. With regard to the statement of intended use and other functional statements, they do not impose any structural limitations on the claims distinguishable over Kaplan, which is capable of being used as claimed if one so desires to do so. Furthermore, the law of anticipation does not require that the reference “teach” what the subject patent teaches, but rather it is only necessary that the claims under attack “read on” something in the reference. Furthermore, the manner in which a device is intended to be employed does not differentiate the claimed apparatus from the prior art apparatus satisfying the claimed structural limitations.
Regarding claim 29, Kaplan as modified by West and Hilse teach the orthopedic implant kit of claim 21, and West further teaches wherein the plurality of cortical locking bone screws includes four cortical locking bone screws (FIGS. 1-2), and wherein the plurality of cortical bone screws includes two cortical bone screws (FIGS. 1-2).
Regarding claim 30, Kaplan as modified by West and Hilse teach the orthopedic implant kit of claim 21, except wherein the plurality of cortical locking bone screws includes cortical locking bone screws of different lengths, and wherein the plurality of cortical bone screws includes cortical bone screws of different lengths. It would have been an obvious matter of design choice to provide screws of various lengths in order to accommodate different anatomies, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art.
Regarding claim 31, Kaplan as modified by West and Hilse teach the orthopedic implant kit of claim 21, and Kaplan further discloses a package (250), wherein the orthopedic implant kit is sterilized and packaged inside the package.
Regarding claim 32, Kaplan as modified by West and Hilse teach the orthopedic implant kit of claim 31, and Kaplan further discloses wherein the package is a polymer pouch (¶42).
Regarding claims 33 and 39, Kaplan discloses an orthopedic implant kit (FIG. 7), comprising: a base (at 232); a plurality of bone screws (52) received on the base; and an orthopedic implant (242) secured on the base, wherein the orthopedic implant kit is sterilized (¶36). However, Kaplan is silent regarding the plurality of bone screws comprising a plurality of locking bone screws which each have threads in a head of the cortical locking bone screw, and a plurality of cortical screws which each are without threads in a head of the cortical bone screw. West teaches an orthopedic implant kit comprising an orthopedic implant (22) and a plurality of bone screws, wherein the plurality of bone screws comprises a plurality of cortical locking bone screws (50, FIGS. 5) which each have threads (56) in a head (56) of the cortical locking bone screw, and a plurality of cortical bone screws (102, FIGS. 7) which each are without threads in a head (104) of the cortical bone screw. It is well known in the orthopedic art to provide screws both with and without threading in the head, in order to complement the various types of apertures in an orthopedic implant. In this case, one would include screws with and without threaded heads in the kit of Kaplan. Additionally, Hilse teaches a tibial plateau leveling osteotomy (TPLO) plate comprising an elongated body comprising a first portion (8) and a second portion (6), wherein the length of the second portion is longer than that of the first portion and extends in a first direction (FIG. 1), wherein the second portion comprises two or more screw holes (11) spaced apart along the second portion, wherein the elongated body of the TPLO plate is curved such that the first portion is offset from the second portion in a second direction that is perpendicular to the first direction (FIG. 1), and wherein the first portion comprises a plurality of screw holes (11) arranged in a triangular pattern (FIG. 1). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to substitute the plate of Hilse in the kit of Kaplan to use in an alternative surgical procedure.
Regarding claim 34, Kaplan as modified by West and Hilse teach the orthopedic implant kit of claim 33, except wherein the plurality of locking screws have different lengths. It would have been an obvious matter of design choice to provide screws of various lengths in order to accommodate different anatomies, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art.
Regarding claim 35, Kaplan as modified by West and Hilse teach the orthopedic implant kit of claim 33, and Kaplan further discloses wherein the orthopedic implant is a bone plate (242).
Regarding claim 36, Kaplan as modified by West and Hilse teach the orthopedic implant kit of claim 33, and Kaplan further discloses a package (20), wherein the orthopedic implant kit is packaged inside the package (FIG. 2).
Regarding claim 37, Kaplan as modified by West and Hilse teach the orthopedic implant kit of claim 33, and Kaplan further discloses wherein the package containing the orthopedic implant kit, and the orthopedic implant kit, are sterilized (¶37).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan in view of West and Hilse, and further in view of Happonen et al. (US 2002/0170840), hereinafter “Happonen”.
Regarding claim 27, Kaplan as modified by West and Hilse teach the orthopedic implant kit of claim 21, except wherein the base is a sterilizable cardboard, paperboard, or cardstock base. Happonen teaches an orthopedic implant kit (FIGS. 1a-1b), comprising: a base (1); and a plurality of bone screws (5) secured on the base, wherein one or more of the plurality of bone screws and the base are sterilized (¶19), wherein the base is a sterilizable cardboard, paperboard, or cardstock base (“paper-based material” ¶19). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to form the base of a sterilizable cardboard, paperboard, or cardstock base, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan in view of West and Hilse, and further in view of Agarwal et al. (US 2021/0077242), hereinafter “Agarwal”.
Regarding claim 28, Kaplan as modified by West and Hilse teach the orthopedic implant kit of claim 21, except wherein the base comprises a plurality of tabs, each tab comprising an opening configured to receive a bone screw of the plurality of bone screws. Agarwal teaches an orthopedic implant kit (FIG. 7), comprising: a base (at 31); and a medical implant (MD) secured on the base, wherein the medical implant is sterilized (¶50). wherein the base comprises a plurality of tabs (32, 33), each tab comprising an opening (32a, 33a) configured to receive the medical implant. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention, to combine the tabs of Agarwal with the base of Kaplan, for the purpose of securing the fasteners in place within the base. In this case, one would form the base of Kaplan comprising such tabs wherein the bone screws are stored.
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan in view of West and Hilse, and further in view of Sweeney (US 2016/0228188).
Regarding claim 38, Kaplan as modified by West and Hilse teach the assembly of claim 36, except wherein the package is a polymer pouch. Sweeney teaches an orthopedic implant kit (10) comprising: a base (14); and a plurality of medical devices (12) secured on the base, and further comprising a package (16), wherein the orthopedic implant kit is packaged inside the package (FIG. 1), and wherein the package is a polymer pouch (¶32). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention, to substitute a polymer pouch for the packaging of Kaplan, since the two serve the same purpose of enclosing the base in a sterile environment. In this case, one would use a polymer pouch over the base of Kaplan to produce predictable results.
Response to Arguments
Applicant’s arguments with respect to claims 21 and 33 have been considered but are moot because the arguments do not apply to the combination of references being used in the current rejection. The newly presented rejection was necessitated by the amendments to the claims of July 23, 2025.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA C CHANG whose telephone number is (571) 270-5017. The examiner can normally be reached Monday-Friday, 7:30AM-5:00PM.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN TRUONG, 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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/OLIVIA C CHANG/Primary Examiner, Art Unit 3775