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 Amendment
The claim amendments filed on 04/10/2025 have been entered. Claims 1-8 remain pending in the application.
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: “locking mechanism” in claim 1.
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.
Response to Arguments
Applicant's arguments filed 10/10/2025 have been fully considered and are persuasive in part. Examiner agrees Hodorek et al (US Patent No. 4,795,468) in view of Fell (US 2003/0055500 A1) fails to disclose “wherein the first component comprises a first tissue interface and the second component comprises a second tissue interface surface, engaging a locking mechanism that secures the first component within the cavity of the second component to form an assembled joint replacement device; introducing the assembled joint replacement device between opposing tissue surfaces at a joint having damaged soft tissue without removing or penetrating bone tissue at the joint, wherein the assembled joint replacement device is free-floating such that the assembled joint replacement device is not mechanically fixed to the first bone structure or the second bone structure; and positioning the assembled joint replacement device; and wherein the assembled joint replacement device is configured to translate and rotate between the first bone structure and the second bone structure during articulation of the joint.” as now required by amended claim 1. Therefore, the 35 USC 103 rejection has been withdrawn and a new ground(s) of rejection is made infra in view of Fell (US 2009/0118830 A1) addressing all of the claim limitations as necessitated by amendment.
In response to applicant’s argument regarding the 112(f) claim interpretation, claim 1 recites the term “locking mechanism”. MPEP 2181.1.A states “When the claim limitation does not use the term "means," examiners should determine whether the presumption that 35 U.S.C. 112(f) does not apply is overcome. The presumption may be overcome if the claim limitation uses a generic placeholder (a term that is simply a substitute for the term "means"). The following is a list of non-structural generic placeholders that may invoke 35 U.S.C. 112(f): "mechanism for," "module for," "device for," "unit for," "component for," "element for," "member for," "apparatus for," "machine for," or "system for." Welker Bearing Co., v. PHD, Inc., 550 F.3d 1090, 1096, 89 USPQ2d 1289, 1293-94 (Fed. Cir. 2008); Mass. Inst. of Tech. v. Abacus Software, 462 F.3d 1344, 1354, 80 USPQ2d 1225, 1228 (Fed. Cir. 2006); Personalized Media, 161 F.3d at 704, 48 USPQ2d at 1886–87; Mas-Hamilton Group v. LaGard, Inc., 156 F.3d 1206, 1214-1215, 48 USPQ2d 1010, 1017 (Fed. Cir. 1998). The terming locking mechanism is essentially “mechanism for locking” and does not provide structure as to what the structure is that performs the locking function without referring to the applicant’s specification, therefore, the 112(f) claim interpretation rejection is maintained.
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.
(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 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fell (US 2009/0118830 A1).
Regarding claim 1, Fell discloses a method of implantation between a first bone structure and an adjacent second bone structure (Figure 9; paragraph 0017), the method comprising:
introducing a first component (Figure 9, item 106) into a cavity (Figure 9, item 144) of a second component (Figure 9, item 104; paragraph 0049),
comprising applying a downward force to the first component such that the first component is moved in a vertical direction into the cavity of the second component (paragraph 0049 “a second mating component 144 affixed to an interior side of top surface 106 and arranged to be securely received by first mating component 142.”),
wherein the first component (Figure 9, item 106) comprises a first tissue interface (Figure 9, paragraph 0042 discloses that 106 comprises a femoral surface) and the second component (Figure 9, item 104) comprises a second tissue interface surface (Figure 9, paragraph 0042 discloses that 104 comprises a tibial surface; paragraph 0079;
engaging a locking mechanism (Figure 9, item 140) that secures the first component within the cavity of the second component to form an assembled joint replacement device (paragraph 0049);
introducing the assembled joint replacement device between opposing tissue surfaces at a joint having damaged soft tissue without removing or penetrating bone tissue at the joint (paragraph 0081),
wherein the assembled joint replacement device is free-floating such that the assembled joint replacement device is not mechanically fixed to the first bone structure or the second bone structure (paragraph 0021 states “The body is preferably free of any means of fixation within the knee joint compartment, but can alternatively be arranged to be constrained within the knee joint compartment.”);
and positioning the assembled joint replacement device so that the first tissue interface surface receives a portion of the first bone structure and the second tissue interface surface receives a portion of the second bone structure (paragraph 0079),
wherein the assembled joint replacement device is configured to translate and rotate between the first bone structure and the second bone structure during articulation of the joint (paragraphs 0039-0040).
Regarding claim 2, Fell discloses further comprising selecting the first component from a plurality of first components each arranged to fit within the second component and each having a differently contoured first tissue interface surface (paragraph 0078 discloses a library of prostheses which would include a first component from a plurality of first components arranged to fit within the second component having a differently contoured first tissue interface surface).
Regarding claim 3, Fell discloses further comprising closing an incision (paragraph 0110) without mechanically fixing the assembled joint replacement device to the first bone structure or the second bone structure (paragraph 0108; paragraph 0021 states “The body is preferably free of any means of fixation within the knee joint compartment, but can alternatively be arranged to be constrained within the knee joint compartment.”).
Regarding claim 4, Fell discloses further comprising positioning a bone-relief recess area (Figures 1-2, item 124 “indentation) formed on the first tissue interface surface (Figures 1-2, item 106) of the first component over the portion of the first bone structure to limit contact between the portion of the first bone structure and the joint replacement device (paragraph 0044 discloses an indentation to limit contact or to be positioned proximate to the tibial spine and the joint replacement device 100; Figure 10).
Regarding claim 5, Fell discloses wherein the first tissue interface surface of the first component is molded to fit a shape of a medial femoral condyle (Figure 9, paragraph 0042 discloses that 106 comprises a femoral surface; the limitation “molded” is being treated as a product by process limitation; that is the first tissue interface surface is made by molding. Even though product-by-process claims are limited and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior art was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, even though Fell is silent as to the process used to make the first tissue interface surface, it appears that first tissue interface surface would be the same as that claimed; especially since both applicant’s first tissue interface surface and the prior art first tissue interface surface is made to fit the shape of a medial femoral condyle. See MPEP 2113).
Regarding claim 6, Fell discloses wherein the second tissue interface surface of the second component is molded to fit a shape of a natural tibia plateau (Figure 9, paragraph 0042 discloses that 104 comprises a tibial surface; the limitation “molded” is being treated as a product by process limitation; that is the first tissue interface surface is made by molding. Even though product-by-process claims are limited and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior art was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, even though Fell is silent as to the process used to make the second tissue interface surface, it appears that second tissue interface surface would be the same as that claimed; especially since both applicant’s first tissue interface surface and the prior art second tissue interface surface is made to fit the shape of a natural tibia plateau. See MPEP 2113).
Regarding claim 7, Fell discloses wherein positioning the assembled joint replacement device comprises manipulating the first component so that the first bone structure fits within contours of the first component (paragraphs 0078-0079 discloses wherein each patient receives one or more devices that are custom tailored for the individual by producing a contour plot of the femoral and tibial mating surfaces and the size of the meniscal cavity. From the contour plot, the correct surface geometry of the device is determined from the shape of the respective tibial plateau and femoral condyle and the orientation between the two surfaces in extension, therefore, the first component has been manipulated such that the first bone structure will fit within the contours of the first component, paragraphs 0101-0109 discloses that a check for the implant’s stability and fit was performed, and the implant was inserted into the joint. Paragraph 0073 discloses that that proper tensioning of the collateral ligaments is also important to maintain positioning of the prosthesis.).
Regarding claim 8, Fell discloses wherein positioning the assembled joint replacement device comprises manipulating the second component so that the second bone structure fits within contours of the second component (paragraphs 0078-0079 discloses wherein each patient receives one or more devices that are custom tailored for the individual by producing a contour plot of the femoral and tibial mating surfaces and the size of the meniscal cavity. From the contour plot, the correct surface geometry of the device is determined from the shape of the respective tibial plateau and femoral condyle and the orientation between the two surfaces in extension, therefore, the second component has been manipulated such that the second bone structure will fit within the contours of the second component, paragraphs 0101-0109 discloses that a check for the implant’s stability and fit was performed, and the implant was inserted into the joint. Paragraph 0073 discloses that that proper tensioning of the collateral ligaments is also important to maintain positioning of the prosthesis.).
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 REBECCA LYNEE ZIMMERMAN whose telephone number is (313)446-4864. The examiner can normally be reached Mon. 8:30 AM-6:30 PM, Tues. - Fri. 8:30-4:00 PM.
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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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/REBECCA LYNEE ZIMMERMAN/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774