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 62/428858, filed 12/01/2016. However, the elected embodiment is not supported earlier than the filing date of this application. Any claims directed solely at the elected embodiment will only being given the priority date of 04/10/2023.
Status of Claims
Claims 1-20 are pending.
Claims 6, 7, and 16 have been withdrawn from consideration.
Election/Restrictions
Applicant’s election without traverse of Species 10 (Figures 15A-16) in the reply filed on 01/28/2026 is acknowledged. Upon further review claim 7 has also been withdrawn as being directed at non-elected species for having multiple spikes which is disclosed as being part of the species shown in figures 9A and 10 A.
Information Disclosure Statement
The Information Disclosure Statements filed on 04/10/2023 and 02/11/2025 have been considered by the examiner.
Claim Objections
Claim 12 is objected to because of the following informalities: improper capitalization and punctuation. The first word of line two should not be capitalized. Additionally the colon at the end of line three should be deleted.
Appropriate correction is required.
Drawings
It is noted that the applicant failed to provide the updated/amended drawings from parent application 16/463891. The amendments were made to non-elected embodiments but they still corrected issues with the originally filed drawings and must be made to the drawings of the current application as well. Therefore the drawings are objected to for all the reasons outlined in the parent application and the applicant is required to review all drawings for any consistency/accuracy issues.
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 convex outer surface with side surfaces comprising notches ( there are no side surfaces that are part of the outer convex surface; Claim 12) and an axis of the cannulation that is parallel to and offset from the longitudinal axis (it is unclear how the axis of the cannulation can be offset from the longitudinal axis when they both extend through the center of the stem as shown in Figure 15B; Claim 19) 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 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 5, 7-9, 12, and 15-17 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.
The phrase “generally parallel” renders claims 5, 15, and 17 indefinite because a person of ordinary skill in the art of medical implants would not be able to determine the scope of this phrase. The term “generally” is a term of degree with an undefined range. Based on the current language of the claims, the drawings, and the specification a person of ordinary skill in the art would not be able to determine what degree of alignment reads upon and what degree of misalignment would not read upon the generally parallel claim language.
Additionally, the term parallel is not a term of degree open for broad interpretation. Parallel is a simple term which two objects either meet or do not. If a line is “substantially parallel” to a base line, then it by definition is not parallel to the base line because they will eventually intersect. Therefore the spike of the applicant's invention cannot be “generally parallel” to the longitudinal axis, it would either be parallel or not parallel.
Claim 8 is rendered indefinite by the requirement for each of the one or more radial grooves to be configured to resist removal of the first spike from the metatarsus. It is unclear how a groove which is an open space can resist removal of the spike. The surrounding structure of the spike outlining the groove is what would dig in and resist removal. An empty space cannot perform this function. The applicant is advised to amend this recitation to define the surrounding portions of the spike as performing the resistance.
Claim 12 is rendered indefinite by the requirement for the convex outer surface comprises one or more side surfaces comprising one or more notches. It appears that the convex outer surface is a single surface that extends all the way to the flat lower surface. There are no separate side surfaces disclosed as part of the convex outer surface. It is unclear if the applicant is referring to the side portion of the convex outer surface or referring to the lower flat surface. That applicant is advised to amend the claim to read “the convex outer surface comprises one or more notches”.
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) 1-4, 11, and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beckendorf et al (Beckendorf) US 2011/0184528.
1. Beckendorf discloses an implant 200 (Figures 3-4) configured to replace an articular surface on a distal end of a metatarsus [0005], the implant comprising:
a convex outer surface 208 overlaying a concave inner surface 206, wherein the convex outer surface is shaped to replace the articular surface (abstract);
a stem 202 configured to be inserted into an intramedullary canal of the metatarsus [0024], the stem extending from the concave inner surface along a longitudinal axis of the implant (Figure 4 shows stem connected to the concave inner surface by ring 226), the stem comprising:
an outward-facing surface (exterior most surface 220 of stem 202) disposed at a first angle relative to the longitudinal axis (portions of the surface are parallel to the axis meaning a 0 degree angle);
at least one flute 222 extending along a length of the stem (Figures 3-4); and
at least one radial groove (lower most groove 232) formed in the outward-facing surface (Figures 3-4); and
a plurality of rib members (portion 228) distributed about the stem to connect the stem to the inner concave surface (228 and 226 combine to connect the stem to the concave inner surface);
wherein: each of the rib members comprises a distally-facing surface (angled surface extending into the upper radial groove) disposed at a second angle relative to the longitudinal axis (the angle appears to be between 30 and 45 degrees); and the second angle is greater than the first angle (the second angle is not parallel to the longitudinal axis making it inherently greater than the 0 degree value for the first angle).
2. Beckendorf discloses second angle is within a range of 35 degrees to 65 degrees (the outer surface of the rib 228 extends along a steep angle the curves up along a second angle, there is inherently a portion along this path that is angled between 35 and 65 degrees on either the two flatter surfaces or on a portion of the curve).
3. Beckendorf discloses rib members are configured to prevent rotation of the implant after implantation in the metatarsus (both the rib and flutes prevent rotation [0037]).
4. Beckendorf discloses the rib members are configured to provide structural support between the concave inner surface and the stem (the ribs of Beckendorf act in the same manner as the current invention and provide rigid support to the stem while connecting to the concave inner surface).
11. Beckendorf discloses the convex outer surface comprises an asymmetrical shape such that the longitudinal axis does not pass through a location on the convex outer surface that is furthest from a distal end of the stem ([0033] discloses the curvature at 204a is different than the curvature at 204b, which provides the asymmetrical shape and moves the furthest location towards to off center away from the central longitudinal axis).
13. Beckendorf discloses the convex outer surface comprises a first radius and a second radius different from the first radius; and the first radius is on a dorsal side of the implant and the second radius is on a plantar side of the implant [0033].
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) 5, 8, 9, 15, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beckendorf in view of Wyss 2008/0015691 A1.
Beckendorf discloses the invention substantially as claimed being described above. However, Beckendorf does not disclose the use of an additional spike.
Wyss teaches the use of a articulation surface implant comprising a concave inner surface with a central post 30 combined with an offset spike 30’ in the same field of endeavor for the purpose of providing additional anchoring and stability through a smaller spike because the edges have less natural bone.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the offset post of Wyss to the concave inner surface of Beckendorf in order to provide additional anchoring force that aids in the prevention of rotation after insertion.
5. Wyss discloses a first spike 30’ spaced apart from the stem and extending from the inner concave surface generally parallel to the longitudinal axis (Figure 2).
8. Wyss discloses the first spike comprises one or more radial grooves (extending circumferentially between the fins of spike 30’); and each of the one or more radial grooves comprises a barb shape (Figures 4-6) configured to resist removal of the first spike from the metatarsus (the barb shape of the area surrounding the grooves would dig into surrounding bone to resist withdrawal of the implant in the same manner as the applicant’s invention).
9. Wyss discloses the first spike is generally straight and comprises a sharp distal tip (Figure 2 shows the spike30’ is straight with a sharp pointed tip).
15. Beckendorf discloses an implant 200 (Figures 3-4) configured to replace an articular surface on a distal end of a metatarsus [0005], the implant comprising:
a convex outer surface 208 overlaying a concave inner surface 206, wherein the convex outer surface is shaped to replace the articular surface (abstract);
a stem 202 configured to be inserted into an intramedullary canal of the metatarsus [0024], the stem extending from the concave inner surface along a longitudinal axis of the implant (Figure 4 shows stem connected to the concave inner surface by ring 226), the stem comprising:
at least one flute 222 extending along a length of the stem (Figures 3-4); and
at least one radial groove (lower most groove 232); and
a first spike spaced apart from the stem and extending from the inner concave surface generally parallel to the longitudinal axis (as modified in the same manner as above in view of Wyss above to include spike 30’).
17. Wyss discloses the first spike comprises one or more radial grooves (extending circumferentially between the fins of spike 30’); and each of the one or more radial grooves comprises a barb shape (Figures 4-6) configured to resist removal of the first spike from the metatarsus (the barb shape of the area surrounding the grooves would dig into surrounding bone to resist withdrawal of the implant in the same manner as the applicant’s invention).
Claim(s) 10 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beckendorf in view of Tallarida 2002/0055783 A1.
Beckendorf discloses the invention substantially as claimed being described above. However, Beckendorf does not disclose the implant is cannulated.
Tallarida teaches the use of an articulation surface implant comprising an upper portion with convex/concave surfaces and a stem that are cannulated ([0102] discloses openings 46 and 16 may be aligned) in the same field of endeavor for the purpose of providing the surgeon the ability to precisely guide the implant along a guidewire to the implant site.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the entire implant of Beckendorf to have a central cannulation as taught by Tallarida in order to provide the surgeon the ability to precisely guide the implant along a guidewire to the implant site.
10. Tallarida discloses the convex outer surface, the concave inner surface, and the stem cooperate to define a cannulation extending along the longitudinal axis; and the cannulation is configured to receive a guidewire to guide insertion of the implant onto the distal end of the metatarsus [0102].
18. Beckendorf discloses an implant 200 (Figures 3-4) configured to replace an articular surface on a distal end of a metatarsus [0005], the implant comprising:
a convex outer surface 208 overlaying a concave inner surface 206, wherein the convex outer surface is shaped to replace the articular surface (abstract); and
a stem 202 configured to be inserted into an intramedullary canal of the metatarsus [0024], the stem extending from the concave inner surface along a longitudinal axis of the implant (Figure 4 shows stem connected to the concave inner surface by ring 226), the stem comprising:
at least one flute 222 extending along a length of the stem (Figures 3-4); and
at least one radial groove (lower most groove 232);
wherein: the convex outer surface, the concave inner surface, and the stem cooperate to define a cannulation extending along the longitudinal axis; and the cannulation is configured to receive a guidewire to guide insertion of the implant onto the distal end of the metatarsus (as modified in the same manner as above in view of Tallarida above to include the central cannulation).
19. The combination of Beckendorf and Tallarida disclose the same parallel overlapping axis of the cannulation and longitudinal axis as the elected embodiment, therefore it reads upon this claim as much as the applicant’s own invention.
20. The combination of Beckendorf and Tallarida disclose the convex outer surface comprises an asymmetrical shape such that the cannulation does not pass through a location on the convex outer surface that is furthest from a distal end of the stem ([0033] of Beckendorf discloses the curvature at 204a is different than the curvature at 204b, which provides the asymmetrical shape and moves the furthest location towards to off center away from the central longitudinal axis and cannulation ).
.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beckendorf in view of Dreyfus 2008/0249577 A1.
Beckendorf discloses the invention substantially as claimed being described above. However, Beckendorf does not disclose the use of notches for engaging an instrument.
Dreyfus teaches the use of a articulation surface implant comprising a an upper convex surfaces with a plurality of notches 55 each including undercut surface (upper flat surface in each notch) in the same field of endeavor for the purpose of providing the surgeon the ability to secure an insertion instrument to notches around the implant.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the outer convex surface of Beckendorf to have the notches of Dreyfus in order to provide the surgeon the ability to precisely guide the implant with instruments secured to the outer surface.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beckendorf in view of Vitale 5,683,466.
Beckendorf discloses the invention substantially as claimed being described above including a thickness of 1mm or less. However, Beckendorf does not disclose different thicknesses.
Vitale teaches the use of a articulation surface implant comprising a an upper convex surfaces and opposing concave surface with varied thickness (Figure 3) in the same field of endeavor for the purpose of providing the implant with thinner edges that better blend into the articulating surface of the natural bone.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the thickness between the outer and inner surfaces of Beckendorf to have reduced thickness at the edges in order to better blend into the remaining articulating surface of the surrounding natural bone.
14. Beckendorf as modified by Vitale includes multiple thicknesses between the convex outer surface and the concave inner surface on both the dorsal and plantar sides of the implant. This allows for selection of a more radially inward portion with a greater thickness in the dorsal side and a more radially outward portion with a reduced thickness in the plantar side.
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