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 . Claims 1-11 are pending and examined below.
Specification
The disclosure is objected to because of the following informalities: reference number “14” has been used to designate both walls and lateral surface. In addition, reference number “16” has been used to designate both “hemispherical protuberance” and “tips.” For reference 8, the reference is referred to as both a “perimetric frame” and a “perimetric containment frame”. For reference 15, the reference is referred to as “fixing elements” and “elements”.
Appropriate correction is required.
Claim Objections
Claim 1 objected to because of the following informalities: the claim recites "said at least one insert" instead of "said at least one protective insert” as previously recited. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 1-11 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 recites the limitation "complementary to those of said at least one protective insert" wherein no protective insert has been previously recited. There is insufficient antecedent basis for this limitation in the claim. The dependent claims are likewise rejected.
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)(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.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claims 1, 5, 7, and 9 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by US 4,207,627 A (“Cloutier et al").
Regarding claim 1, Cloutier et al. discloses a tibial component (Fig. 1, tibial component 5, col. 5, lines 56-60) of a total knee prosthesis, comprising:
a base element (see below, annotated Fig. 4, bridge section 33, in combination with elongated sections 37 and 39, B1, col. 6, lines 4-12)
provided with a medial portion (see below, annotated Fig. 4, M and S2, col. 6, lines 4-12)
and a lateral portion (see below, annotated Fig. 4, L and S1, col. 6, lines 4-12), configured to be fixed on the proximal surface of the tibia (Fig. 7, tibia, 81, col. 8, lines 55-61 ),
wherein said base element has a shape and dimensions that are complementary (see annotated Fig. 1, C1, col. 5, lines 50-54)
to those of said at least one protective insert (Fig. 1, bearing members, 7 and 9, col. 3, lines 51-55),
said medial portion being provided with coupling means configured for coupling by pressure (Fig. 1, internal locking lip, 69, col. 7, lines 55-61) to said at least one insert, the at least one insert resting on said lateral portion.
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Regarding claim 5, Cloutier et al. further discloses the tibial component (Fig. 1, tibial component 5, col. 5, lines 56-60) further comprising a recess (see above, annotated Fig. 4, R1)
between the lateral portion (see above, annotated Fig. 4, L and S1, col. 6, lines 4-12) and the medial portion (see above, annotated Fig. 4, M and S2, col. 6, lines 4-12)
which extends, in an anteroposterior direction (see above, annotated Fig. 4, AP),
from a rear end of said base element toward the front end of said base element (see above, annotated Fig. 4, bridge section 33, in combination with elongated sections 37 and 39, B1, col. 6, lines 4-12),
said recess having a progressively increasing width (see above, annotated Fig. 4, D1 and D2, where D2 is greater than D1).
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Regarding claim 7, Cloutier et al. further discloses the tibial component (Fig. 1, tibial component 5, col. 5, lines 56-60) of claim 1,
further comprising fixing elements (Fig. 5, studs, 77 and 79, col. 8, line 53-55)
for fixing to the proximal surface of the tibia (Fig. 7, tibia, 81, col. 8 lines 55-61 ),
which are defined at a lower face of said base element (see above, annotated Fig. 5, F1 and F2).
Regarding claim 9, Cloutier et al. further discloses the tibial component (Fig. 1, tibial component 5, col. 5, lines 56-60) of claim 7,
wherein said fixing elements comprise two pins (Fig. 5, studs, 77 and 79, col. 8, line 53-55) which are respectively defined at said lateral portion (see above, annotated Fig. 4, L and S1, col. 6, lines 4-12) and said medial portion (see above, annotated Fig. 4, M and S2, col. 6, lines 4-12) said pins having at least one row of spikes (see col. 8 lines 56-61, wherein the disclosed studs correspond to the recited pin, and the disclosed serrations correspond to the recited spikes) which are directed toward said lower face of said base element (bridge section 33, in combination with elongated sections 37 and 39, B1, col. 6, lines 4-12); configured to ensure optimum stability of said tibial component (col. 8, lines 56-61).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over US 4,207,627 A (“Cloutier et al.") in view of US 2014/0257506 A1 ("Sanford et al.”).
Regarding claim 2, Cloutier et al. discloses the tibial component (Fig. 1, tibial component, 5, col. 5, lines 56-60) of claim 1,
wherein said lateral portion (see below, annotated Fig. 4, L and S1, col. 6, lines 4-12) has,
at a boundary region (Fig. 1, bridge section, 33, col. 5, line 60)
with said medial portion (see below, annotated Fig. 4, M and S2, col. 6, lines 4-12)
However, Cloutier et al. does not disclose a guiding wall. Sanford et al. discloses a tibial component (Fig. 1, tibial tray, 14, para 0052) and
teaches the use of a guiding wall (Fig. 5, projecting rail, 66, 68, para 0055) configured to direct and drive the anteroposterior translational motion (Fig. 1, bearing component, 12, in combination with projecting rails 66/68, para 0055-0056, the bearing component and projecting rails would be capable of the recited function driving the anteroposterior translational motion)
of the at least one insert (Fig. 1 and 5, bearing component, 12, para 0055-0056).
Sanford et al. teaches that the guiding wall would be useful in order to prevent lift-off of the insert from the tibial component (Sanford et al., para 0084). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the tibial component of Cloutier et al. in view of the projecting rail of Sanford et al. in order to lock the protective insert to a final seated position on the tibial component.
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Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over US 4,207,627 A (“Cloutier et al.") in view of US 2021/0386553 A1 ("Catani et al.”).
Regarding claim 3, Cloutier et al. further teaches the tibial component (Fig. 1, tibial component 5, col. 5, lines 56-60) according to claim 1,
Cloutier et al. does not explicitly disclose wherein said coupling means comprise a perimeter containment frame which defines the contoured seat for the stable accommodation of a respective complementarily-shaped protrusion of the at least one insert. However, Catani et al. discloses the use of a tibial component (Fig. 1, tibial baseplate, 1, para 0107)
wherein said coupling means (Fig. 1, perimetric wall, 20 in combination with seat, 21, para 0112) comprise a perimeter containment frame (Fig. 1, perimetric wall, 20, para 0112)
which defines a contoured seat (Fig. 1, seat, 21, para 0112)
that would be able to provide for the stable accommodation of a respective complementarily-shaped protrusion (Fig. 1 and 9, proximally facing surface, 3, in combination with bearing element 100, para 0110) of the at least one insert (Fig. 9, bearing element, 100, para 0112).
Catani et al. teaches that the coupling means comprising the perimeter containment frame and contoured seat provides means for holding the protective insert in place (Catani et al., para 0114). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the tibial component of Cloutier et al. in view of the perimetric wall of Catani et al. to hold the bearing element into the seat (para 0114).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over US 4,207,627 A (“Cloutier et al.") in view of US 2021/0386553 A1 ("Catani et al.”) as applied to claim 3 above, and further in view of US 2003/0100953 A1 (“Rosa et. al.”).
Regarding claim 8, Cloutier et al. further discloses the tibial component (Fig. 1, tibial component, 5, col. 5, lines 56-60) of claim 7,
with a boundary portion (Fig. 4, bridge section, 33)
between said lateral (see below, annotated Fig. 4, L and S1, col. 6, lines 4-12) and said medial portion (see below, annotated Fig. 4, M and S2, col. 6, lines 4-12).
However, Cloutier et al. does not disclose wherein said fixing elements comprise a hemispherical protuberance which is defined at the boundary portion between said lateral and said medial portion of said base element.
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Catani et al. further discloses the use of a tibial component (Fig. 1, tibial baseplate, 1, para 0107)
wherein said fixing elements (Fig. 2, peg, 30, para 0134) comprise a protuberance (Fig. 6, spike, 40, para 0033-0034)
which is defined at the boundary position (Fig. 1, central region, 53, para 0113)
of said lateral portion (Fig. 1, first condylar region, 51, para 0109) and
said medial portion (Fig. 1, second condylar region, 52, para 0109) of said base element (Fig. 1, tibial baseplate, 1, para 0108)
is configured to increase prosthetic stability (para 0181, 0192) and prevent abnormal rotations of the tibial component during normal movements performed by a joint (para 0192).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the tibial component of Cloutier et al. in view of the spike of Catani et al. to reduce micromotion and avoid lift off (Catani et al., para 0033) to maintain optimal placement of the component.
Cloutier et al. in view of Catani et al. does not disclose a hemispherical protuberance. However, Rosa et al. teaches a tibial component (Fig. 1, tibial component, 14, para 0066),
wherein said fixing elements (Fig. 8, fixation pegs, 53, para 0081) comprises a hemispherical protuberance (Fig 8, fixation pegs, 53, para 0081). Rosa et al. further teaches that the fixation pegs may be reoriented to comprise of a posterior and anterior fixation peg (para 0081). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the shape of the spike of Cloutier et al. in view of Catani et al. to have a hemispherical shape as taught by Rosa et al. to provide enhanced fixation and bone conservation (Rosa et al., para 0081).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over US 4,207,627 A (“Cloutier et al.") in view of US 6,190,415 B1 (“Cooke et al.”)
Regarding claim 4, Cloutier et al. discloses the tibial component (Fig. 1, tibial component, 5, col. 5, lines 56-60) according to claim 1, where the convex surface of the tibial plateau allows for the lateral condyle to slide more than the medial condyle achieving flexion (col. 6, lines 45-55). However Cloutier et al. does not disclose a configuration
wherein an upper face of said lateral portion has a convex surface for accommodating one insert. However, Cooke et al. discloses a knee prosthesis including: a tibial component (Fig. 1, tibial baseplate, 8, col. 3 lines 15-20)
wherein an upper face of said lateral portion has a convex surface (Fig. 1, bearing’s distal surface, 13, and convex surface, 14, col. 3, lines 35-39)
for accommodating one insert (Fig. 1, bearing element, 4, col. 3 lines 23-26 and lines 35-45)
to minimize the risk of dislocation of said insert (col. 6, lines 17-25). Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the tibial component of Cloutier et al. with the lateral convex surface of Cooke et al. in order to most closely resemble the anatomic kinematic function.
Claims 6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over US 4,207,627 A (“Cloutier et al.") in view of US 2012/0022658 A1 (“Wentorf et al.”).
Regarding claim 6, Cloutier et al. discloses the tibial component (Fig. 1, 5, col. 5 line 56-60) according to claim 5, as well as a recess (see below, annotated, Fig. 4, R1) . However, Cloutier et al. does not explicitly disclose wherein walls of said recess are beveled/rounded. Wentorf et al. discloses a tibia component (Fig. 1A, tibial prosthesis, 10, para 0043)
wherein walls of said recess are beveled/rounded (see below, annotated Fig. 2A, E1 and E2, see also para 0114, 0117)
and mutually inclined toward said recess (Fig. 1B and Fig. 5, PCL cutouts, 28 and 30, para 0104) complementarily toward said recess configured to reduce a risk of prosthetic instability over time (Fig. 1B and Fig. 5, PCL cutouts, 28 and 30, para 0104, the adapted recess therein, would be capable of holding anatomical features in place decreasing instability). Wentorf et al. teaches these features are included to prevent chaffing or abrasion of any soft tissue that may come in contact with the surface (para 0117). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the tibial component of Cloutier et al. with the rounded/beveled recess walls of Wentorf et al. to protect anatomical structures after the tibial component is implanted.
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Regarding claim 10, Cloutier et al. discloses the tibial component according to claim 1 (Fig. 1, tibial component, 5, col. 5, lines 56-60), however, it does not disclose a base element with an asymmetrical atomical profile. Wentorf et al. further teaches that the tibia component (Fig. 1A, tibial prosthesis, 10, para 0043) has
an asymmetrical anatomical profile (Fig. 1, tibial plateau, 18, para 0050)
said medial portion having a greater width (Fig. 2B, DMPX, para 0089 ) than
said lateral portion (Fig. 2B, DMPLX, para 0089)
configured to maximize bone coverage and minimize a risk of tibial rotational misalignment (para 0011). Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the tibial component of Cloutier et al. in view of the asymmetrical profile of Wentorf et al. in order to maximize tibial coverage for increased support of tibial baseplate (Wentorf et al., para 0044).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over US 4,207,627 A (“Cloutier et al.") in view of US 2018/0206996 A1 (“Habeggar et al”).
Regarding claim 11, Cloutier et al. teaches the tibial component (Fig. 1, tibial component, 5, col. 5 line 56-60) according to claim 1, however it does not explicitly teach wherein said base element has a thickness comprised between 2.3 mm and 2.8 mm configured to minimize instability of the total knee prosthesis. Habeggar et al. teaches a tibial component (Fig. 1, tibial replacement system, 102, para 0037),
wherein said base element (Fig. 1, tibial tray, 104, para 0037)
has a thickness comprised between 2.3 mm and 2.8 mm (Fig. 5A-C, t’-t”’, para 0069-0071) configured to minimize instability of the total knee prosthesis (para 0034).
Habeggar discloses a range of various configurations of the tibial component thickness based on individual patient needs, for example 2 mm (para 0069). A reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness, see MPEP 2144.05. Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the tibial component of Cloutier et al. in view of the thicknesses disclosed by Habeggar because doing so would merely involve combining prior art elements according to known methods to yield predictable results; see MPEP 2143.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see US 2003/0060883 A1 (“Fell et al.”) , which discloses base element thickness and plateau convex configuration.
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/J.M.S./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774