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
Applicant's election with traverse of Group I (claims 1-15 and 25-27) in the reply filed on 05/01/2026 is acknowledged. The traversal is on the grounds that claim 15 (from Group II) has been amended to depend on claim 1 and thus claim 15 should be examined together with the claims of Group I. This is found persuasive. Claim 15 has been added to Group I and Group II has been removed. Applicant further argues that claims 19-22 and 22-24 have been amended to require the segmented keel wing and notch feature of claim 1 and that because the claims share a technical feature with the elected invention of Group I they don’t impose a serious burden, and they should be examined together. This is not found persuasive because the test for requiring a restriction is not if the claims share a technical feature, it is if they are independent or distinct, each from the other.
Now (after applicant’s amendment to the claims), we have three Groups, i.e. Group I (claims 1-15 and 25-27, directed to a tibial implant, classified in A61F 2/389); Group II (claims 19-22, directed to a prosthetic implant, classified in A61F 2/02); and Group III (claims 23-24, directed to a method of manufacturing a stemmed prosthetic component, classified in A61F 2240/00). Group II and I are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself on in other combinations (MPEP 806.05 (C)). In the instant case, the combination (Group II) does not require the particulars of the subcombination (Group I) as claimed because the combination does not need a tibial tray component comprising a tray plate, or having a stem extending from the distal surface of a tray plate. The subcombination has separate utility by itself, i.e. as a tibial prosthesis.
Group I and III are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP 806.05(f)). In the instance case the product as claimed (Group I) can be made by another and materially different process, e.g. 3D-printing process or from a non-metallic material.
Group II and III are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP 806.05(f)). In the instance case the product (Group II) as claimed can be made by another and materially different process, e.g. 3D-prining or from a non-metallic material.
Regarding applicant’s argument that there is no serious burden on examining the distinct inventions together, it is noted, contrary to applicant’s opinion, each of the inventions (Groups) has attained recognition in the art as a separate subject shown by their separate classification. Also, the field of search of each of the inventions will be different from each other, e.g. searching different classes/subclasses and different text searches.
Claims 19-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/01/2026.
The requirement is still deemed proper and is therefore made FINAL.
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 1-15 and 25-27 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.
Claim 1 recites: “a first taper extending along the stem in a first axial position axially aligned with the segmented keel.”
The phrase “axially aligned with the segmented keel” is unclear because the claim does not identify what it means for the taper to be “axially aligned” with the segmented keel or what portion of the segmented keel defines the relevant axial position. The claim recites that the segmented keel extends from the distal surface of the tray plate and includes a first wing having a first notch proximate the stem. However, the claim does not specify:
whether “axially aligned” requires the first taper to overlap axially with the segmented keel;
whether the taper must overlap the entire segmented keel, only the first wing, or only the first notch;
the axial boundaries of the segmented keel or first wing;
whether the first axial position refers to the beginning, end, center, or any portion of the taper; or
whether mere positioning along the same stem axis is sufficient.
As a result, it is unclear what structural relationship is required between the first taper and the segmented keel. For example, it is unclear whether an implant in which the taper is entirely distal to the keel, partially overlapping the keel, or located at the same general axial level as the keel would fall within the scope of claim 1.
The specification does not cure the deficiency because it uses the expressions “axially aligned with,” “same axial space,” and “axial position” without defining the axial extent or boundaries of the segmented keel or explaining the required degree of alignment. Figures 3B, 5, 6A–6B, and 9A–9D depict various portions of the stem, keel wings, notches, and sleeve, but do not establish a clear axial boundary for the segmented keel or a definite relationship between the claimed first taper and the segmented keel.
Accordingly, claim 1 does not provide reasonable notice of the metes and bounds of the claimed invention and is indefinite under § 112(b).
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.
Claims 1-7, 9-15, 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Matyas, et al. (Pub. No.: US2015/0202056 A1, cited by applicant in IDS filed 05/01/2026) in view of Walker, et al. (US Patent 4822362, cited by applicant in IDS filed 08/12/2024).
Matyas, et al. disclose a tibial implant comprising a tibial tray component 20 having a tray plate 24 with a proximal surface and a distal surface (see Figures 1 and 2). The tray component 20 further includes a stem 26 extending from the distal surface; and a segmented keel (grey shade area in annotated Figure 2 below) extending from the distal surface. The segmented keel includes two wings. The tray component also includes a first taper (which is part of the stem 26) extending along the stem in an axial position axially aligned with the segmented keel. Matyas, et la. further discloses that the wings can have any shape and can include additional or fewer wings (see Paragraph [0035]).
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Matyas, et al. disclose the claimed invention except for the segmented keel wings having notches.
Walker, et al. discloses a tibial implant (see Figures 1-5) comprising a tibial tray component with a tray plate having proximal and distal surfaces. The tibial tray component further includes a stem, a segmented keel with wings 14, 16. The wings include notches formed by the webs/troughs 18, 20 (which are part of the wings), see Figure 4. Walker et al. discloses that these wings help further secure the tibial implant against shear, tipping and torque forces (see column 4, lines 57-60).
It would have been obvious to one skilled in the art at the time the invention was made to construct the implant of Matyas, et al. having wings with notches in view of Walker, et al., in order to further secure the implant against shear, tipping and torque forces.
Regarding claim 2, it is noted that the notches/troughs of the combination of Matyas, et al. and Walker, et al. extend from the stem and a sidewall extends from the webs/trough along the wings, wherein the trough comprises a lowest point of the first notch that is adjacent the stem (see Walker, et al. Figure 4).
Regarding claim 3, the wings of the combination of Matyas, et al. and Walker, et al. include a first height from the distal surface at the notches and a second height from the distal surface away from the notches, wherein the second height is greater than the first height (see Walker, et al. Figure 4).
Regarding claim 4, the combination of Matyas, et al. and Walker, et al. disclose two wings apart from each other.
Regarding claim 5, the combination of Matyas, et al. and Walker, et al. shows wherein the first taper extends into the notches to be in opposition to the sidewall.
Regarding claim 6, the combination of Matyas, et al. and Walker, et a. discloses the first taper is spaced from the distal surface of the tray plate by a portion of the wings in the notches (see Walker, et al. Figure 4).
Regarding claim 7, the combination of Matyas, et al. and Walker, et al. disclose the taper is a Morse taper (see for example Matyas, et al. paragraph [0034]).
Regarding claims 9-13, the combination of Matyas, et al, and Walker, et al. disclose a sleeve couplable to the stem, the sleeve comprising slots to accommodate the wings (see Matyas, et al. figure 2). It is noted that the wings fit into the slots to allow a proximal surface of the sleeve to come into close proximity to the distal surface of the tray plate (see for example, Matyas, et al. figure 1). The sleeve further comprises lobes protruding from an exterior surface of the sleeve at the slots (see Matyas, et al. figure 2). Channels extend into the lobes to form an extension of the slots (see Matyas, et al. figure 2). The sleeve is configured to fit into the notches spaced apart from the distal surface of the tray plate (see Matyas, et al. figure 1).
Regarding claim 14, the combination of Matyas, et a. and Walker, et al. discloses a sleeve couplable to the stem, the sleeve comprising sleeve wings configured to be received in the notches.
Regarding claim 15, the combination of Matyas, et al. and Walker, et al. sleeve for the stem of a prosthetic implant, the sleeve comprising: an annular body; an inner passage extending through the annular body, wherein the inner passage comprises a Morse taper; and the slots extend into the annular body to intersect the inner passage and the Morse taper.
Regarding claim 25, the notches are proximate to the stem to open toward the stem. Regarding claim 26, the first taper extends along the stem to a lowest point of the notches.
Regarding claim 27, the second height extends completely along the stem.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Matyas, et al. (Pub. No.: US2015/0202056 A1, cited by applicant in IDS filed 05/01/2026) in view of Walker, et al. (US Patent 4822362, cited by applicant in IDS filed 08/12/2024) and further in view of Landon (Pub. NO.: US 2018/0333267 A1, cited by applicant in IDS filed 09/23/2025).
The combination of Matyas, et al. and Walker, et al. discloses the claimed invention except for the stem including a second taper in a second axial position at a distal tip of the stem, the second taper comprising a necked-down portion of the stem.
Landon discloses a tibial implant comprising a tibial tray component which includes a tray plate, a stem, a segmented keel and a first taper (see for example figure 2). The stem further includes a second taper at the distal tip of the stem (see Figure 2), which is considered a necked-down portion of the stem.
It would have been obvious to one skill in the art at the time the invention was made to construct the implant of the combination of Matyas, et al. and Walker, et al. including a second taper at the distal tip of the stem in view of Landon, in order to facilitate introduction of the stem into the hole receiving the stem.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for prior art of interest.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eduardo C Robert whose telephone number is (571)272-4719. The examiner can normally be reached M-F: 8 AM-4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Marivelisse Santiago-Cordero can be reached at 571-272-7839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
