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 1/14/2026 have been fully considered. Regarding the claim interpretation under 35 U.S.C. 112(f), applicant argues the specification describes other fixation means beyond those listed by the examiner, specifically, “adhesive or otherwise”. The examiner agrees that adhesive should be included as a fixation element and now lists adhesive in the claim interpretation section.
Applicant’s arguments regarding the rejection of claims 1-13 under 35 U.S.C. 102(a)(2) as being anticipated by Tepic have been fully considered but they are not persuasive. Applicant argues the implant of Tepic fundamentally differs from the present meniscus prosthesis because Tepic requires surgical removal of the tibial condyle surface and replacement with the resurfacing implant, in contrast to the present application which provides a meniscus prosthesis designed to be placed on the preserved tibial plateau in the position normally occupied by the meniscus without requiring osteotomy of the tibia. This is not persuasive because the arguments are directed to an intended use of the prosthesis. The claims are not directed to a method of implanting a prosthesis and instead are directed to a prosthesis itself. The limitation “for implantation in a joint between a tibia and a femur of a mammal so that a dorsal surface faces a distal end of the femur and a ventral surface faces a tibial plateau at a proximal end of the tibia” is directed to an intended use of the prosthesis and the prosthesis of Tepic is capable of being implanted as intended by the claim. 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. In this case, since the structure of the prosthesis of Tepic is the same as the structure of claimed the prosthesis, the prosthesis of Tepic is capable of performing the intended use and meets the claim.
Applicant further argues that Tepic’s implant structure differs significantly from the claimed prosthesis because the prominent concave recess 20 is not “at the caudal edge” since there is a large portion of the implant (at numerals 19, 26) which separate the recess from the caudal edge of the prosthesis body. This is not persuasive because the dorsal surface of the prosthesis of Tepic includes the entire top surface, including at 19 and 26 (as shown in fig.4), not just the recess 20. The rejection relies on the raised caudalmost portion of the prosthesis of Tepic, located behind the recess 20 (near the 19, 26 reference numerals in fig.4) as the “rim at the caudal edge of the prosthesis body, wherein the rim is shaped to fit around and extend beyond at least part of an edge of the distal end of the femur”. See annotated fig.6a below.
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Applicant argues the claimed prosthesis provides stabilization through an inclined dorsal surface with a rim structure that extends beyond the femur edge, whereas Tepic provides articulation through a concave recess that receives the femur. This is not persuasive because Tepic also inherently provides stabilization through the inclined caudal rim that extends beyond the femur edge as clearly shown in at least fig.6a (shown above). Applicant argues the structure and shape of the claimed prosthesis can accommodate shape variations of the femur condyle which is in contrast to Tepic in which the concave recess has a standard shape in which the femur condyle has to be accommodated while being able to move and rotate which may give problems when there is no perfect fit. This argument is not based on any structure actually claimed. The claims do mention any structure that can accommodate shape variations of the femur condyle. Further, Tepic specifically teaches that the recess 20 matches the curvature of the femoral condyle in par.28 so applicant’s arguments regarding problems related to perfect fit are incorrect.
Applicant argues the claimed prosthesis achieves stabilization through a specific rim structure that provides a counter pressure to the distal end of the femur to protect the distal end of the femur from displacement in the caudal direction. Applicant argues this counter pressure mechanism using a rim that extends beyond the femur edge is not disclosed in Tepic. This is not persuasive because at least fig.6a of Tepic shows a caudal rim structure extending around the distal end of the femur which inherently provides a counter pressure to protect the distal end of the femur from displacement in the caudal direction.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “at least one fixation element for fixing the prosthesis body to a bone” in claim 1. The generic placeholder is “at least one fixation element” which is described in the specification as a through hole in the prosthesis body and may further comprise a screw, pin, cord, or nail to fit through the through hole, or an adhesive. Note that claims 7 and 8 recite sufficient structure and are not interpreted under 35 U.S.C. 112(f).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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)(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.
Claims 1-13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tepic et al. US 2022/0175540 (hereafter referred to as Tepic).
Regarding claim 1, Tepic discloses a prosthesis 100 capable of implantation in a joint between a tibia 1 and a femur 5, 6 of a mammal so that a dorsal surface faces a distal end of the femur and a ventral surface faces a tibial plateau at a proximal end of the tibia (fig.6a; the limitation “for implantation in a joint between a tibia and a femur of a mammal so that a dorsal surface faces a distal end of the femur and a ventral surface faces a tibial plateau at a proximal end of the tibia” is directed to an intended use of the prosthesis and the prosthesis of Tepic is capable of being placed in a joint as claimed), the prosthesis comprising a prosthesis body 100 with the dorsal surface 19 and the ventral surface 18 (fig.4); and at least one fixation element 25, 26, 27, and 28 for fixing the prosthesis body to a bone adjacent to the ventral surface (figs. 4-5), wherein the dorsal surface is inclined in a dorsal direction towards a caudal edge of the prosthesis body (figs. 4, 6a, and 6b show the caudal/right side of the prosthesis inclined upwardly), to stabilize the joint (par.13 discloses stabilizing the stifle in a human or non-human animal subject), wherein the dorsal surface comprises a rim at the caudal edge of the prosthesis body, wherein the rim is shaped to fit around and extend beyond at least part of an edge of the distal end of the femur, to provide a counter pressure to the distal end of the femur to protect the distal end of the femur from displacement in caudal direction (figs. 4, 6a, and 6b show the right/rear/caudal rim/edge of the prosthesis body being capable of fitting around and extending beyond at least part of an edge of the distal end of the femur which inherently provides some counter pressure to the distal end of the femur to protect the distal end of the femur from displacement in caudal direction).
Regarding claims 2 and 3, see fig.4 which shows the dorsal surface 19, including 20, inclined as claimed.
Regarding claim 4, see fig.4 for a minimal thickness at the center which increases outwardly.
Regarding claim 5, see par.9 for medial resurfacing a stifle/knee joint in humans or dogs.
Regarding claim 6, see figs.4-6 for through hole 25 being located at a cranial/anterior end of the prosthesis body.
Regarding claims 7 and 8, the fixation elements comprise through holes 25 and 26 and screws 27 and 28 as shown in figs. 4-6 and as discussed in par.30.
Regarding claims 9 and 10, no particular shape is required by the claims and the shape depends on an unclaimed surface of the tibia or meniscus. Accordingly, the ventral/bottom surface 18 is capable of matching a flat surface of a tibial plateau or meniscus. Note that “match” is interpreted to mean similar to and not exactly the same.
Regarding claim 11, see par.1 for the prosthesis of Tepic being capable of performing the intended use claimed.
Regarding claim 12, see figs. 4, 6a, and 6b for the thickness at the caudal edge being at least ¼ of the length of the prosthesis in the cranial-caudal direction.
Regarding claim 13, the prosthesis of Tepic is capable of being used to treat osteoarthritis since it resurfaces a surface of the joint.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fell US 2005/0033424 discloses a knee prosthesis comprising a raised posterior rim and fixation elements wherein the prosthesis is placed on a tibial plateau (fig. 10). Fitz et al. US 2009/0226068 discloses a knee prosthesis comprising a raised posterior rim and fixation elements, wherein the lower surface of the prosthesis matches the tibial plateau (figs. 2A-2G).
THIS ACTION IS MADE FINAL. 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 MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached 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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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774