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 6/12/26 have been fully considered but they are not persuasive. In response to applicant's argument that “configured to”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. When prior art discloses the same structure or meets the level of scope when elements are recited generically or with arbitrary structure, it must be assumed it is capable of performing a claimed function. However, when Applicant argues the prior art does not perform the function, yet the claim(s) argued have no different structures other than function, either the claim is lacking sufficient structure for the function to occur or some recitation to invoke means plus function should be used to limit the claims to distinguishing structure defined in the specification when invoked because if not invoked, limitations are not read into claims from the specification.
Applicant’s arguments, see page 4 of remarks (pg 10 of response), filed 6/12/26, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102 over Railey ‘730 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a teaching with Sutton ‘555 to modify Railey in addressing the amendment to claim 1.
Applicant’s arguments, see page 5 of remarks (pg 11 of response), filed 6/12/26, with respect to the rejection(s) of claim(s) 9 under 35 U.S.C. 102 over Erickson ‘350 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a teaching with Sutton ‘555 to modify Erickson in addressing the amendment to claim 9.
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 limitation “locking mechanism” in claim 1 has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the further limitation of “the articulating component is translatable relative to the baseplate along an axis” defines another function between the two cooperating components. It is not understood how some arbitrary structures (recitations of baseplate and articulating component imply no specific structure whatsoever) can permit two functions 1) translation 2) locking when cooperating together, thus it would be understood multiple different structures are needed to permit the translation and locking function(s), yet not recited. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Claim limitation “articulating component centering surface” in claim 9 has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the further limitation of “the baseplate centering surface and the articulating component centering surface cooperate to center the articulating component relative to the baseplate in a medial- lateral direction while the articulating component is moved along the baseplate” recite other generic features/elements to establish a function. It is not understood how some arbitrary surface “centers” itself, but other functional clauses were used, thus it appears multiple structures are needed potentially for the function, yet not recited. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
Claims 1-4,9-11,18-20 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.
Claims 5,6,8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: a first locking feature and a second locking feature which are slidably translatable in an anterior-posterior direction but captive in a medial-lateral direction and a cephalad-caudal direction. Claim 5 recites a baseplate with a surface that engages with an articulating component, however, no structural features define these surfaces other than they possibly contact one another. The limitation of “articulating component bone facing side configured to engage the baseplate joint facing side such that the articulating component is translatable relative to the baseplate only along an anterior-posterior direction” is a negative limitation. However, there is no feature in the claim that defines what prevents full movement or translation about any axis, thus how can one know what the structure is? Dependent claims are indefinite for depending from independent claims that are indefinite.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1,4,5,6,8 are rejected under 35 U.S.C. 103 as being unpatentable over Railey et al. (2006/0229730) in view of Sutton et al. (2005/0234555). Please note claims 1,5 are reciting two arbitrary elements, a baseplate and an articulating component with no specific shape or configurations required in any way. The recitations of “configured to be secured to a talus and prosthetic talar articular surface” are intended use limitations. It is noted that Railey et al. disclose (Figs. 7A-C) an adjustable system for ankle arthroplasty that allows the articulating component to be translatable relative to the baseplate along an axis. It is also noted that Railey disclose (Fig. 12A) a prosthetic ankle arthroplasty system that has a locking mechanism to secure the articulating component bone facing side to the baseplate joint facing side of two prosthetic components. However, Railey et al. did not disclose an embodiment having the articulating component translatable relative to the baseplate along an axis and 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 in any of a plurality of relative positions along the axis. Sutton et al. teach (Figs. 1C,3A) locking mechanisms that permit the baseplate and articulating component (Fig. 1D) to be secured in any of a plurality of relative positions along an axis, see paragraph 5. It would have been obvious to one of ordinary skill in the art to incorporate a locking mechanism that allows an articulating component to be adjusted relative to a baseplate such that it secures it in any of a plurality of positions along an axis as taught by Sutton et al. in the prosthetic ankle device of Railey et al. in order to provide a surgeon or orthopedic doctor to post-operatively reset the center of rotation of the device without a revision surgery. Regarding claim 4, it is noted Railey et al. disclose (paragraphs 31,64,120) that locking elements can be made of a polymer. Sutton et al. also teach components can be made of polymeric material. It would have been obvious to one of ordinary skill in the art to provide a locking mechanism with an anti-rotation component of polymer as taught by Sutton et al. in the prosthetic of Railey et al. since such a modification only involves routine skill in the art and selecting a known material based on properties is an obvious expedient. Regarding claim 5 and the limitation of “configured to engage the baseplate joint facing side such that the articulating component is translatable relative to the baseplate only along an anterior-posterior direction and be secured to the baseplate joint facing side at any of a plurality of positions relative to the baseplate along the anterior-posterior direction. Sutton et al. teach that a prosthetic having a baseplate and an articulating component can be provided with “arbitrary structure” since no limitations in claim 5 define any engagement elements, but only the ability of the “articulating component to be translatable relative to the baseplate only along an anterior-posterior direction” via the structure, see paragraph 67. Thus, Sutton teaches the claim limitation at the same level of scope as claim 5 and would have been obvious to one of ordinary skill in the art to utilize such a mechanical connection to provide an articulating component bone facing side configured to engage the baseplate joint facing side such that the articulating component is translatable relative to the baseplate only along an anterior-posterior direction and to be secured to the baseplate joint facing side at any of a plurality of positions relative to the baseplate along the anterior- posterior direction per the teaching of Sutton with the ankle prosthesis of Railey such that it provides an orthopedic doctor ability to adjust post-operatively the articulating component. Regarding claim 6, Sutton et al. disclose (abstract) 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) see paragraphs 4, 6 of Sutton. With respect to claim 8, it is noted that Railey et al. show numerous embodiments with a first example in fig. 10 illustrating a baseplate 20 that can have angled first surfaces 72 and the articulating component 24 can be provided with a plurality of second angled surfaces 68. Also a second example shown in Fig. 12C illustrates a baseplate 20 that can have angled first surfaces and the articulating component 24 can be provided with a plurality of second angled surfaces. Please note the claim (8) fails to limit any particular angle or location, thus claims are given their broadest reasonable interpretation in that any cooperative angles suffice to meet the scope of the claim in addition to any location between the engaging angled surfaces suffice to meet the scope of the claim.
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Railey et
al. (2006/0229730) in view of Sutton et al. (2005/0234555) as applied to claim 1 above, and further in view of Simoes et al. (2021/0369465). Railey et al. in view of Sutton 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 of Railey as modified with Sutton 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 Sutton et al. (2005/0234555) as applied to claim 1 above, and further in view of Valderrabano et al. (WO 2017/127067). Railey et al. in view of Sutton 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 ankle prosthesis of Railey as modified with Sutton in order to provide an articulating component enabled for both ankle sides such that a surgeon can treat either of the two of a patient with an injury.
Claim(s) 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Erickson et al. (6368350) in view of Sutton et al. (2005/0234555). 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. However, Erickson et al. did not disclose an articulating component joint facing side comprising a prosthetic articular surface; and an articulating component bone facing side comprising an articulating component centering surface; wherein the baseplate centering surface and the articulating component centering surface cooperate to center the articulating component relative to the baseplate in a medial- lateral direction while the articulating component is moved along the baseplate. Sutton et al. teach (paragraph 88) that adjust means are included with the baseplate and articulating component such that a baseplate centering surface and the articulating component centering surface cooperate to center the articulating component relative to the baseplate in a medial- lateral direction while the articulating component is moved along the baseplate. It would have been obvious to one of ordinary skill in the art to utilize a baseplate centering surface and an articulating component centering surface which cooperate to center the articulating component relative to the baseplate in a medial- lateral direction while the articulating component is moved along the baseplate as taught by Sutton et al. with the prosthetic of Erickson et al. so that the prosthetic can have the center of rotation desirably adjusted post implantation, see Sutton paragraphs 4,5. 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. With respect to claim 11, Sutton teaches (Fig. 7A) the baseplate and the articulating component cooperate to define a locking mechanism configured to secure the articulating component to the baseplate, the locking mechanism comprising: a plurality of baseplate locking features of the baseplate; and a plurality of articulating component locking features of the articulating component; and the plurality of articulating component locking features is configured to slidably mate with the plurality of baseplate locking features at any of a plurality of relative positions of the baseplate and the articulating component along an anterior-posterior direction.
Claim(s) 18,19 are rejected under 35 U.S.C. 103 as being unpatentable over Erickson et al. (6368350) in view of Sutton et al. (2005/0234555) as applied to claims 9,11 above, and further in view of Ferree (2005/0165484). Erickson et al. in view of Sutton et al. is explained supra. However, Erickson et al. as modified by Sutton did not disclose 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 recitations of "visualization ….when the plurality of baseplate locking features are in a locked position” or "visualization ….in a medial-lateral direction" are 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 in view of Sutton 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 Sutton et al. (2005/0234555) as applied to claim 9 above, and further in view of Librot et al. (2010/0121389). Erickson et al. in view of Sutton et al. is explained supra. However, Erickson et al. as modified by Sutton 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 as modified with Sutton 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 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
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 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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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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