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 .
Election/Restrictions
This application contains claims directed to the following patentably distinct species of ankle prostheses.
Specie 1) Fig. 1
Specie 2) Fig. 6B
Specie 3) Fig. 7
Specie 4 ) Fig. 11A
Specie 5) Fig. 18
The species are independent or distinct because each have a different structural design. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, none are generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply: each of the species require varying or differing search queries.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with David Meibos on 1/30/2026 a provisional election was made without traverse to prosecute the invention of Specie 1, claims 1-20 was said to read on the specie elected. Affirmation of this election must be made by applicant in replying to this Office action.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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 5-8, 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.
The term “relative” in claims 5 is a relational term which renders the claim indefinite. The term “relative” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Since the claim(s) fail to define any specific structure for the baseplate or the articulating component, it is impossible to know how the elements can be “secured….at any of a plurality of relative positions” as recited in claim 5 because no limits are set forth in the configurations or connection, thus the scope implies an unlimited number of orientations. No shape, configuration, dimension or boundaries that permit various positions is recited in the claim(s) to allow the function of securing, thus making the claim(s) indefinite. Dependent claims fail to clarify and are indefinite for the same reason.
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.
Claim(s) 1,4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Railey et al. (2006/0229730). Fig. 12A shows an adjustable system for ankle arthroplasty, the adjustable system comprising: a baseplate 20 comprising: a baseplate bone facing side configured to be secured to a talus 15; and a baseplate joint facing side; and an articulating component comprising: an articulating component joint facing side comprising a prosthetic talar articular surface 24; and an articulating component bone facing side configured to adjustably engage the baseplate joint facing side; wherein the baseplate and the articulating component cooperate to define a locking mechanism configured to be actuated to secure the articulating component bone facing side to the baseplate joint facing side, paragraph 119. Regarding claim 4, Railey et al. further disclose (paragraphs 31,64,120) the locking mechanism includes a polymer anti-rotation component 60.
Claim(s) 5-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Luna et al. (2022/0395378). Fig. 3 shows an adjustable system 100 for ankle arthroplasty, the adjustable system comprising: a baseplate 102 comprising: a baseplate joint facing side 106b and a baseplate bone facing side 106a configured to be secured to a talus; and an articulating component 104 comprising: an articulating component joint facing side comprising a prosthetic talar articular surface 120; and an articulating component bone facing side 123 configured to be secured to the baseplate joint facing side at any of a plurality of relative positions, paragraph 26. Regarding claim 6, Luna et al. disclose (paragraphs 21,26,43) the articulating component bone facing side is configured to be secured to the baseplate joint facing side at any of a plurality of relative positions in-vivo and in-vitro (please note these are intended uses and the assembly is fully capable of being placed in the correct orientation in an in-vitro setting and not needing adjustment, but the assembly could also be implanted and the surgeon determine an adjustment is needed and the articulating component needs to be reoriented in-vivo). With respect to claim 7, Figs. 5A,B show the articulating component bone facing side is configured to be secured to the baseplate joint facing side at any of a plurality of relative positions along an anterior-posterior direction, paragraph 30.
Claim(s) 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Erickson et al. (6368350). Please note the recitation of “for ankle arthroplasty” is an intended use and has minimal patentable weight, as the body of the claim has no structural limits as to its particular construction, other than a surface can engage bone. Erickson et al. disclose (Fig. 23) an adjustable system comprising: a baseplate 260 comprising: a baseplate bone facing side configured to be secured to one of a talus and a tibia, note this an intended use as the plate has spikes to penetrate bone thus it is fully capable of the function; and a baseplate joint facing side; and an articulating component 270 configured to be secured to the baseplate via peg 271 such that the articulating component can be moved along the baseplate in track 265 (see Fig. 20) without detaching the articulating component from the baseplate, the articulating component comprising: an articulating component joint facing side comprising a prosthetic articular surface; and an articulating component bone facing side. Regarding claim 10, it can be seen Fig. 23 the baseplate bone facing side further comprises one or more protrusions configured to engage a bone.
Claim(s) 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bernard et al. (FR 2865629). Please note the recitation of “for ankle arthroplasty” is an intended use and has minimal patentable weight, as the body of the claim has no structural limits as to its particular construction, other than a surface can engage bone. Bernard et al. disclose (Figs. 1C,1D) an adjustable system comprising: a baseplate 2 comprising: a baseplate bone facing side configured to be secured to one of a talus and a tibia, note this an intended use as the plate has spikes to penetrate bone thus it is fully capable of the function; and a baseplate joint facing side; and an articulating component 3 configured to be secured to the baseplate via groove such that the articulating component can be moved along the baseplate (page 6 of translation) in enclosed area (see Fig. 1D) without detaching the articulating component from the baseplate, the articulating component comprising: an articulating component joint facing side comprising a prosthetic articular surface 32; and an articulating component bone facing side. Regarding claim 10, it can be seen Fig. 1D the baseplate bone facing side further comprises one or more protrusions 21 configured to engage a bone.
Claim(s) 9-11,18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nichols et al. (2016/0089247). Please note the recitation of “for ankle arthroplasty” is an intended use and has minimal patentable weight, as the body of the claim has no structural limits as to its particular construction, other than a surface can engage bone. Nichols et al. disclose (Figs. 1,2) an adjustable system comprising: a baseplate 110 comprising: a baseplate bone facing side 104 configured to be secured to one of a talus and a tibia, note this an intended use as the plate has teeth to penetrate bone (paragraph 55) thus it is fully capable of the function; and a baseplate joint facing side; and an articulating component 130 configured to be secured to the baseplate via pin 139 such that the articulating component can be moved along the baseplate surface 124 (see Figs. 1,2 how pivoting occurs) without detaching the articulating component from the baseplate, the articulating component comprising: an articulating component joint facing side comprising a prosthetic articular surface 136; and an articulating component bone facing side 104. Regarding claim 10, Nichols et al. disclose (paragraph 55) the baseplate bone facing side further comprises one or more protrusions (teeth) configured to engage a bone. With respect to claim 11, Nichols et al. further illustrate (Fig. 9) the baseplate and the articulating component cooperate to define a locking mechanism (paragraph 65) configured to secure the articulating component to the baseplate, the locking mechanism comprising: a plurality of baseplate locking features 150 of the baseplate; and a plurality of articulating component locking features 160 of the articulating component; and the plurality of articulating component locking features is configured to slidably mate via rotation of threads against the plurality of baseplate locking features’ threads at any of a plurality of relative positions of the baseplate and the articulating component along an anterior-posterior direction and with drive element 192 once inserted will lock the articulating component at the position needed. Regarding claim 18, Fig. 9 shows the baseplate comprises one or more apertures 114 configured to facilitate visualization of the plurality of baseplate locking features when the plurality of baseplate locking features are in a locked position.
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) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Railey et al. (2006/0229730) in view of Simoes et al. (2021/0369465). Railey et al. is explained supra. However, Railey et al. did not disclose the baseplate bone facing side is additively manufactured with integrated porous features configured for bone integration. Simoes et al. teach (Fig. 13) a baseplate 1300 with its bone facing side having porous features configured for bone integration, paragraph 59. Please note the recitation of “additively manufactured” is a product-by-process limitation and only requires the ability for a feature to be produced as such. It is noted that Simoes et al. does teach (paragraph 4) additive manufacturing can be used for producing an implant structure. It would have been obvious to one of ordinary skill in the art to utilize additive manufacturing and provide integrated porous features configured for bone integration on the bone facing surface of a baseplate as taught by Simoes et al. and incorporate with the talar adjustable implant system baseplate in order to improve stabilization.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Railey et al. (2006/0229730) in view of Valderrabano et al. (WO 2017/127067). Railey et al. is explained supra. However, Railey et al. did not disclose the articulating component is configured for both right ankle arthroplasty and left ankle arthroplasty. Valderrabano et al. teach (paragraph 67) that a talar implant can be provided with a component that allows for use in both right ankle and left ankle arthroplasty. It would have been obvious to one of ordinary skill in the art to provide a talar adjustable system with a component that is configured for both right ankle arthroplasty and left ankle arthroplasty as taught by Valderrabano et al. with the adjustable system of Railey et al. and provide an articulating component enabled for both such that a surgeon can treat either foot of a patient with an injury.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Luna et al. (2022/0395378) in view of Winslow et al. (2018/0193150). Luna et al. is explained supra. However, Luna et al. did not disclose the baseplate joint facing side comprises a plurality of first angled surfaces; and the articulating component bone facing side comprises a plurality of second angled surfaces configured to slidably engage the plurality of first angled surfaces such that the articulating component is centered on the baseplate in a medial-lateral direction. Winslow et al. teach (Fig. 12) a baseplate 141 comprising a plurality of first angled surfaces 144’. It can also be seen (Fig. 12) that articulating component 148 has a plurality of second angled surfaces (see Fig. 4A illustration) configured to slidably engage the plurality of first angled surfaces. It would have been obvious to one of ordinary skill in the art to alternatively use slidably engaging first and second angled surfaces as taught by Winslow et al. in the adjustable arthroplasty system of Luna et al. such that it provides a removably locking connecting structure between the components with angled surfaces, see abstract of Winslow
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Erickson et al. (6368350) in view of Ferree (2005/0165484). Erickson et al. is explained supra. However, Erickson et al. did not disclose the articulating component comprises one or more apertures configured to facilitate visualization through the articulating component in a medial-lateral direction. Ferree teaches an articulating implant in which articulating component comprises one or more apertures 1280 configured to facilitate visualization through the articulating component, see paragraph 85. Please note the recited “visualization…in a medial-lateral direction” is an intended use in how one could orient the implant for the visualization to be permitted, thus with the placement of holes throughout the component as seen by Ferree, one is fully capable of using the implant of Erickson as modified by Ferree to permit such a function. One of ordinary skill in the art would have been motivated to incorporate such reference holes per Ferree’s teaching with the articulating component of Erickson to assure the joint is oriented appropriately for the proper placement of the apparatus.
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Erickson et al. (6368350) in view of Librot et al. (2010/0121389). Erickson et al. is explained supra. However, Erickson et al. did not disclose a size trial comprising a plurality of apertures configured to receive a cutting instrument. Librot et al. teach (Fig. 4) a size trial 10 with a plurality of apertures 18,20 configured to receive an instrument. It would have been obvious to one of ordinary skill in the art to utilize a size trial with a plurality of apertures configured to receive a drill or boring instrument that cuts into bone as taught by Librot et al. for preparing the bone sites for the implant of Erickson in order to secure the plate element to bone with a fastener by forming a hole to receive it where appropriate.
Allowable Subject Matter
Claims 12-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E PELLEGRINO/ Primary Examiner, Art Unit 3799