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 .
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.
Claim 8 is 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.
Claim 8 recites the limitation "second intermediate implant" in line 2. There is insufficient antecedent basis for this limitation in the claim. The previous claims recite “second intermediate component.”
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reiley et al. U.S. Publication 2014/0296995 A1.
Regarding Claim 1, Reiley et al. discloses an implant system 10 (paragraph [0062]) as seen in Figure 7A-7B comprising: a tibial implant component 28 (paragraph [0105], see Figure 7A); a calcaneal implant component 26 (stem 26 extends into the calcaneus 17, see Figure 7B); and a talar implant component 22 (as seen in Figures 7A-7B).
Regarding Claim 1, Reiley et al. discloses a first intermediate component 12 disposed between the talar implant component 22 and the tibial implant component 28; and a second intermediate component 24 disposed between the talar implant 22 component and the calcaneal implant component 26 (as seen in Figures 7A-7B).
Regarding Claim 3, Reiley et al. discloses wherein the talar implant component comprises: a first articulating surface (top surface having an opening of talar implant 22) configured to engage with the first intermediate component 12; and a second articulating surface (the bottom surface that engages the top of 24) configured to engage with the second intermediate component 24 (as seen in Figures 7A-7B).
Regarding Claim 3, Reiley et al. discloses wherein the first articulating surface (top surface having an opening) is disposed on a superior surface of the talar implant component and the second articulating surface (the bottom surface that engages the top of 24) is disposed on an interior surface of the talar implant component.
Regarding Claim 5, Reiley et al. discloses wherein the tibial implant component 28 comprises a first engagement surface on a superior surface thereof configured to engage at least a portion of a tibia of a patient (as seen in Figure 7B).
Regarding Claim 6, Reiley et al. discloses wherein the tibial implant component 28 comprises a second engagement surface on an inferior surface thereof configured to engage with a superior surface of the first intermediate component 12 (the bottom surface as seen in Figure 7A engages the top opening of the intermediate component 12).
Regarding Claim 7, Reiley et al. discloses wherein the first articulating surface of the talar implant component 22 is configured to engage with an inferior surface of the first intermediate component 12 (as seen in Figures 7A-7B).
Regarding Claim 8, Reiley et al. discloses wherein the calcaneal implant component 26 comprises a first engagement surface on a superior surface thereof configured to engage with an inferior surface of the second intermediate component 24 (as seen in Figures 7A-7B).
Regarding Claim 9, Reiley et al. discloses wherein the calcaneal implant component 26 comprises a second engagement surface on an inferior portion thereof configured to engage with at least a portion of a calcaneus 17 of the patient (as seen in Figure 7A-7B).
Regarding Claim 10, Reiley et al. discloses wherein the second articulating surface of the talar implant component 22 is configured to engage with a superior surface of the second intermediate component 24.
Claim(s) 15-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goldberg et al. U.S. Publication 2017/0246004 A1.
Regarding Claim 15, Goldberg et al. discloses a subtalar arthroplasty system 20, comprising: an intermediate component 52; and a calcaneal implant component 24 (as seen in Figures 9, 11-12.
Regarding Claim 16, Goldberg et al. discloses wherein the intermediate component 52 comprises a superior surface, wherein the superior surface is configured to articulate with an articulating surface of a talar implant component 51 (as seen in Figure 12).
Regarding Claim 17, Goldberg et al. discloses wherein the superior surface is sized to be complementary to at least a portion of the articulating surface of the talar implant component 51 (as seen in Figures 9, 11-12).
Regarding Claim 18, Goldberg et al. discloses wherein the calcaneal implant component 24 comprises an inferior surface (as seen in Figures 11-14).
Regarding Claim 19, Goldberg et al. discloses wherein the inferior surface of the calcaneal implant component 24 comprises a plurality of surface features 74 to promote coupling of the inferior surface to a calcaneus bone (as seen in Figures 13-15, paragraph [0081]).
Regarding Claim 20, Goldberg et al. discloses wherein at least one of the plurality of surface features is a post 72 (as seen in Figure 14 and paragraph [0081]).
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.
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.
Claim(s) 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reiley et al. U.S. Publication 2014/0296995 A1 in view of Perler U.S. Publication 2015/0045902 A1.
Regarding Claims 11, 12, 13, Reiley et al. does not expressly disclose wherein the first articulating surface of the talar implant component comprises a plurality of radii, wherein the plurality of radii are different for an anterior-medial quadrant, an anterior-lateral quadrant, a posterior-medial quadrant and a posterior-lateral quadrant of the first articulating surface, wherein the radius of curvature of the anterior-medial quadrant is lesser than the radius of curvature of the anterior-lateral quadrant and the radius of curvature of the posterior-medial quadrant is greater than the radius of curvature of the posterior-lateral quadrants of the first articulating surface. Perler teaches an ankle implant system 10 in the same field of endeavor comprising a talar component 12 having a first articulating surface (top surface 24) having a plurality of radii (paragraphs [0009], [044-0045], [0053]), the radius of curvature is different at an anterior-medial quadrant, an anterior-lateral quadrant, posterior-medial quadrant and posterior-lateral quadrant 24a-24e, see Figures 3and 5 for the purpose of providing optimum implant positioning and loading to allow higher stress to be seen at contact points to allow for greater loads (paragraph [0009] and [0053]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Reiley’s first articulating surface of the talar component to comprise a plurality of radii, wherein the plurality of radii are different along an anterior and posterior medial quadrant and anterior and posterior lateral quadrant as taught by Perler for the purpose of providing optimum implant positioning and loading to allow higher stress to be seen at contact points to allow for greater loads.
Regarding Claim 14, Reiley et al. does not expressly disclose wherein the second articulating surface is comprised of at least one elongated protrusion, wherein the at least one elongated protrusion is configured to constrain movement of a subtalar arthroplasty component. Perler teaches an ankle implant system 10 in the same field of endeavor comprising a talar component 12 having a first articulating surface (top surface 24) and a second articulating surface 28 (paragraph [0046]) having a protrusion 32a to extend into the talus or calcaneus bone in order to help retain the talar component onto the talus or calcaneus and prevent or guard against twisting after implantation (paragraph [0046]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Reiley’s second articulating surface of the talar component to further include an elongated protrusion as taught by Perler for the purpose of retaining the talar component onto the talus or calcaneus and prevent or guard against twisting after implantation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
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