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 .
Priority
This application claims priority from provisional application 62/265199, filed on 12/10/2021.
Status of Claims
Claims 1-16 are pending.
Information Disclosure Statement
The Information Disclosure Statements filed on 05/31/2024 and 10/21/2025 have been considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the 2 lines of symmetry of the base (Claim 9) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 13-16 are objected to because of undescriptive preambles. The claims merely define “a method”. They should be amended to at least describe what type of method. Is it a method of using? Making?
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 3 and 5-6 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 3 requires an axis to be perpendicular to a midpoint, which renders the claim indefinite. A line or axis cannot be parallel or perpendicular to a single point. The point has no dimensions so it is unclear how the axis can be oriented perpendicular to it.
Claim 5 requires a minimum radius of curvature of the first and second edges, which renders the claim indefinite. It is unclear what is meant by the minimum requirement. Does this mean that any radius larger than this value anticipates it? Does this mean the radius of curvature for each edge needs a portion with a value in the range? The applicant is advised to amend the claim to delete the minimum language and directly define the actual radius of curvature being within the range.
Claim 6 requires the edges to be substantially straight or curved when viewed from a top view, which renders the claims indefinite. The claims previously define the edges as 112 and 114 which both have a radius of curvature. Therefore the edges are not a single easily identifiable line or intersection between walls. The edges have both a length along the side wall and a width along their radius of curvature. Nothing that they have the curvature, there is no clear starting and stopping point for the edges vs the adjacent surfaces. Additionally there is no identified starting and stopping point for the lengths of the edges. For example, do the first and second edges contact each other? Are there additional edges between them? Where do they start and stop. Therefore it is unclear how one can identify the first edge as being substantially straight. Looking at Figure 2, the first edge 112 has multiple curves and surfaces extending along it. Additionally depending on where the applicant intends for it to start and stop, one could say a major portions is actually curved. The applicant is advised to better define the starting and stopping points of the edges. Then it may be helpful to say that the edge is substantially straight along the majority of its length when viewed from the top.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-7 and 9-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2019/166793 to Fitzbionics Limited (hereinafter, "Fitzbionics") (Cited in the applicant’s IDS).
Regarding Claim 1 Fitzbionics discloses a humeral implant (abstract; humeral component 40, Figs 3-5 and 8-9) comprising:
a base (51/63/64) having a first end (adjacent portion 51) and a second end (adjacent portion 64) opposite the first end (Figures3-4), wherein the base includes a sidewall coupling the first end to the second end (there is a side wall on the post 64 and a sidewall extending around portion 51 that both couple the upper ends to lower ends of the base); and
an articulating surface (52) positioned at the second end of the base (Figure 5), wherein the articulating surface includes a first edge (left side of Figure 4 near reference number 40) and a second edge (right side of Figure 4 extending from reference number 57) opposite the first edge (Figures 4-5), wherein a radius of curvature of the first edge is greater than a radius of curvature of the second edge (Figure 8 shows the first edge on the left side has a larger radius of curvature than the radius of curvature of the second edge on the extreme right side), and wherein the second edge of the articulating surface extends away from the sidewall of the base (the second edge of the articular surface upward and inward away from the sidewall of the base Figure 8) such that a surface area of the articulating surface is greater than a surface area of the first end of the base (the surface area of surface 52 is substantially greater than the surface area of the first end of the base near the bottom of the base near reference number 64).
Regarding Claim 2, Fitzbionics discloses the first edge of the articulating surface is aligned with the sidewall of the base (the first edge of the surface 52 is aligned with an end of the sidewall along reference number 51 of the base, see left side of Figure 7).
Regarding Claim 3, Fitzbionics discloses an axis perpendicular to a midpoint of the articulating surface is offset from a longitudinal axis of the base in a direction towards the second edge (see 112 rejection above with regards to axis being perpendicular to a point, additionally there are numerous midpoints along a midline of the articulating surface which can be identified as being offset towards the second edge due to the convex curved shape, and there are an infinite number of longitudinal axis that can be identified of the base, including those that are tilted at any angle or normal to the body).
Regarding Claim 4, Fitzbionics discloses the offset ranges from about 3 degrees to about 7 degrees (as explained above the axis are very broadly claimed and there are at least one example where they can be identified as having an offset in the range of about 3 degrees to about 7 degrees, which would also include angles reasonable above and below this range).
Regarding Claim 5, Fitzbionics discloses a minimum radius of curvature of the first edge ranges from about 1 mm to about 5 mm, and wherein a minimum radius of curvature of the second edge ranges from about 0.01 mm to about 3 mm (as explained in the 112 rejection above the minimum ranges are indefinite, based on the size of the overall implant the first and second edges are at least 1 mm and 0.01 mm so they are inherently above the minimum).
Regarding Claim 6, Fitzbionics discloses that from a top view the first edge is substantially straight (Figure 5 shows the left side forming the first edge is substantially straight) and the second edge is curved (the right side forming the second edge is considered to be curved because of the large curves at the top and bottom in Figure 5).
Regarding Claim 7, Fitzbionics discloses the articulating surface further includes first and second side edges (top and bottom sides of 52 shown in Figure 5) coupling the first edge to the second edge and a second side edge opposite the first side edge and coupling the first edge to the second edge (Figure 5).
Regarding Claim 9, Fitzbionics discloses the base is has two lines of symmetry (portion 64 of the base has at least two lines of symmetry because of the circular shape), and wherein the articulating surface has a single line of symmetry (the articulating surface has a single line of symmetry extending in a midplane left to right of Figure 5).
Regarding Claim 10, Fitzbionics discloses a height of the first edge with respect to the first end of the base is less than a height of the second edge with respect to the first end of the base (because the edges each have a variety of heights along their arcs, a lower height can be identified near the bottom of the first edge and a higher height near the top of the second edge can be identified).
Regarding Claim 11, Fitzbionics discloses the first end of the base comprises a first material, and wherein the second end of the base comprises a second material that is different than the first material (see claim 14 of Fitzbionics).
Regarding Claim 12, the claimed method of bonding the materials together amounts to a product by process. Whether a product is patentable depends on whether it is known in the art or it is obvious, and is not governed by whether the process by which it is made is patentable. Product by process claims are not construed as being limited to the product formed by the specific process recited. 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 product was made by a different process (see MPEP 2113). In this case the metal and polymer materials of Fitzbionics are fully capable of being diffusion bonded together.
Regarding Claim 13, Fitzbionics discloses a method comprising: forming a humeral trough (70) in a humeral condyle (Figure 10); and inserting the humeral implant of claim 1 into the humeral trough (Figures 1, 8, 10).
Regarding Claim 14, Fitzbionics discloses the humeral trough is formed in the humeral condyle to a depth about equal to a height of the base of the humeral implant (Figure 10 shows only the implant inserted so that only a portion of the articular surface rises above it, therefore the trough is inherently about equal to the height of the base).
Regarding Claim 15, Fitzbionics discloses the humeral trough is oval in shape (the cylindrical post of Fitzbionics is discloses as being in a portion of the trough 75, however it is not possible to form a perfectly circular bore in a bone, it will inherently have some portions larger or smaller due to the limits of human ability and the nature of bone, therefore it will have an oval shape in at least a portion).
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) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fitzbionics in view of Chibrac et al (hereinafter, "Chibrac") USPN 6,540,786 B2.
Fitzbionics discloses the invention substantially as claimed being described above. However, Fitzbionics does not disclose the step of removing a portion of an abaxial rim of the humeral trough to accommodate the second edge of the humeral implant..
Chibrac teaches the use of resurfacing implant that can be either be on just the tip of the condyle or extend to the edges of the condyle (Figures 1c vs 3b) in the same field of endeavor for the purpose of fully restoring the entire joint path of the condyle.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the implant of Fitzbionics to extend all the way across the condyle of the humerus and into the abaxial rim as taught by Chibrac in order to restore the entire articulation surface of the joint. By expanding the size of the implant, the trough will concurrently be expanded thereby meeting the requirement for removing at least a portion of the abaxial rim.
removing a portion of an abaxial rim of the humeral trough to accommodate the second edge of the humeral implant.
Allowable Subject Matter
Claim 8 is 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.
The prior art of record fails to discloses or render obvious the side edges each have a variable radius of curvature that decreases from the first edge to the second edge.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R 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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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774
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