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 63/139,911 filed 01/21/2021.
Status of Claims
Claims 1-3 and 6-19 are pending.
Claims 4-5 have been cancelled.
Information Disclosure Statement
The Information Disclosure Statement filed on 03/03/2026 has been considered by the examiner.
Drawings
The drawing objections have been withdrawn in view of the applicant’s amendments.
Specification
The objection to the specification has been withdrawn in view of the applicant’s amendments.
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.
Claim(s) 1-3, 8, 11-14, and 16-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wadsworth GB 2022422 A.
1. Wadsworth discloses an ulnar implant 8 (Figure 3) comprising:
a curved body (adjacent reference number 8 Figure 3) having a first end and a second end (left and right sides of Figure 3), the curved body comprising:
a first surface (top curved surface near 44 Figure 3); and
a second surface (bottom curved surface near 50 Figure 3),
wherein the first surface and the second surface are on opposing sides of the curved body (Figure 2); wherein the first surface has a concave curvature in a cross-sectional view when a section is taken along a first plane that intersects both S-I axis and A-P axis (concave upper surface shown in Figures 2-3), wherein the S-I axis is an axis that extends in superior-inferior direction with respect to the curved body of the ulnar implant and the A-P axis is an axis that extends in antero-posterior direction with respect to the curved body of the ulnar implant (Figures 2-3);
wherein the second surface has a convex curvature in a cross-sectional view when a section is taken along the first plane (convex lower surface shown in Figures 1-3),
wherein the first surface and the second surface are continuous (both extend from one end to the other end of the implant in Figure 3), opposing concave and convex surfaces configured to engage corresponding articular and bone engaging surfaces of an ulna and a humerus (Figures 1-2) such that, when the ulnar implant is configured to be positioned between the ulna and the humerus, the ulnar implant is configured to be constrained in position by the patient’s anatomy (the inner and outer surfaces are designed to directly engage the bones of the ulna and humerus as seen in Figures 1-2), and
wherein when the ulnar implant is implanted at an end portion of the ulna, the first surface of the ulnar implant articulates with a portion of the humerus (Figures 1-2).
2. Wadsworth discloses the first surface has a convex curvature in a cross-sectional view when a section is taken along a second plane that intersects both the A-P axis and L-M axis (Figure 3 shows the upper surface comprises a convex extending left to right), wherein the L-M axis is an axis that extends in latero-medial direction with respect to the curved body of the ulnar implant.
3. Wadsworth discloses the second surface has a concave curvature in a cross-sectional view when a section is taken along a second plane that intersects both the A-P axis and L-M axis (Figure 3 shows the bottom surface comprises a concave cross-section shape extending left to right near reference number 50), wherein the L-M axis is an axis that extends in latero- medial direction with respect to the curved body of the ulnar implant.
8. Wadsworth discloses the first surface is smooth and the second surface is smooth (Figures 1-3 show the smooth surfaces with no texture).
11-14. As explained in the drawing objections above the applicant’s invention is only depicted with one configuration for thickness. As seen in Figure 2 the thickness of the implant is substantially constant for both the first and second surfaces, this allows for symmetrical curvatures. However, the tips each taper which allows for some change in thickness this may be disclosing support for asymmetrical curves. Wadsworth is considered to read on these 4 claimed configurations as much as the applicant’s own invention. Wadsworth has the same uniform thickness and constant curves through the majority of the middle section shown in Figures 2-3, which reads upon the symmetrical curvature in the same manner as the applicants invention. Additionally, Wadsworth discloses tips with different shapes and varied thicknesses shown in Figures 2-3, which reads upon the asymmetrical curvature in the same manner as the applicants invention.
16. Wadsworth discloses a method for treating an elbow joint (Figures 1-17), comprising:
accessing an end portion of an ulna (Figure 17);
positioning an ulnar implant comprising a curved body at the end portion of the ulna (Figures 2, 3, and 17), wherein the curved body having a first end and a second end, the curved body comprising:
a first surface; and a second surface, wherein the first surface and the second surface are on opposing sides of the curved body;
wherein the first surface has a concave curvature in a cross-sectional view when a section is taken along a first plane that intersects both S-I axis and A-P axis, wherein the S-I axis is an axis that extends in superior-inferior direction with respect to the curved body of the ulnar implant and the A-P axis is an axis that extends in antero-posterior direction with respect to the curved body of the ulnar implant;
wherein the second surface has a convex curvature in a cross-sectional view when a section is taken along the first plane,
wherein the first surface and the second surface are continuous (both extend from one end to the other end of the implant in Figure 3), opposing concave and convex surfaces configured to engage corresponding articular and bone engaging surfaces of an ulna and a humerus (Figures 1-2) such that, when the ulnar implant is configured to be positioned between the ulna and the humerus, the ulnar implant is configured to be constrained in position by the patient’s anatomy (the inner and outer surfaces are designed to directly engage the bones of the ulna and humerus to be constrained within the joint as seen in Figures 1-2),
wherein when the ulnar implant is implanted at the end portion of the ulna, the first surface of the ulnar implant articulates with a portion of the humerus; (Figures 1-3, See rejection of claim 1 for specifics), and
positioning the first surface of the ulnar implant at the end portion of the ulna to articulate with a portion of the humerus (Figures 2 and 17).
17. Wadsworth discloses forming a recess shaped to receive the ulnar implant in the end portion of the ulna (Figures 1-2 show the recess in the end of the Ulnar that receives the stem portion).
18. Wadsworth discloses positioning the ulnar implant at the end portion of the ulna (Figures 1-2), such that a trochlea of the humerus at least partially constrains the ulnar implant in place (Figure 1 shows the left portion of the Trochlea extends around the implant which partially constrains the implant in place).
19. Wadsworth discloses positioning the ulnar implant at the end portion of the ulna (Figures 1-2), such that soft tissues of the elbow joint at least partially constrains the ulnar implant in place (there is inherently soft tissue surrounding the entire elbow joint of every patient, which together function to help to keep the entire joint in place, including the newly inserted implant, and moving in the natural range of motion).
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) 6, 7, 9, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wadsworth.
Wadsworth discloses the invention substantially as claimed being described above. However, Wadsworth does not disclose the specific radius of curvature, thickness, or lengths of the implant.
In regards to the radius of curvature, in [0062] discloses about 20 mm radius of curvature can be used to match the natural humerus. Figure 2 of Wadsworth shows the first and second surfaces having radius of curvature matching that of the natural humerus.
Therefore, it would have been obvious to one of ordinary skill in the art to provide the first and second surfaces with curvatures of 20 mm or more to allow for lubrication growth.
In regards to the length and thickness, the claims do not specify how these measurements are taken. They could be taken as a straight line from one end to another, along a curve, straight through the thickness, from an intermediate point to a tip, and many other ways. Depending on how the device is oriented the length and thickness can be varied. Additionally, the dimensions of the implant would depend on the needs of each patient, specifically the size and condition of their bones within the implant site.
Therefore, it would have been obvious to one of ordinary skill in the art to provide the implant of Wadsworth with a length between 30 mm and 40 mm taking into account the different patient sizes and the numerous ways a length could be measured.
Additionally, it would have been obvious to one of ordinary skill in the art to provide the implant of Wadsworth with a maximum thickness between 20 mm and 30 mm taking into account the different patient sizes and the numerous ways a length could be measured.
Claims 15 is rejected under 35 U.S.C. 103 as being unpatentable over Wadsworth in view of Katrana et al (Katrana) US 2019/0105163 A1.
Wadsworth discloses the invention substantially as claimed being described above. However, Wadsworth does not disclose the use of pyrocarbon.
Katrana teaches the use of elbow implants formed with articulating surfaces and stems comprising pyrocarbon [0074] in the same field of endeavor for the purpose of providing a more biocompatible material with strong endurance to the movement of the joint.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the pyrocarbon taught by Katrana with the implant of Wadsworth in order to provide a more biocompatible material with strong endurance to the movement of the joint and a feel very similar to natural bone.
Response to Arguments
Applicant's arguments filed 03/31/2026 have been fully considered but they are not persuasive.
The applicant argues that the opposing concave and convex surfaces of Wadsworth are not configured to engage articular and bone engaging surfaces of the ulna and humerus. This is not persuasive because Wadsworth discloses the surfaces configured in the same manner as the applicant’s invention and are fully capable of engaging surfaces of a patients ulna and humerus in the same manner. The additional keel and extension have no limiting effect preventing them from doing so.
The applicant further argues that when positioned between the ulna and humerus the implant of Wadsworth is not configured to be constrained in position by the patient’s anatomy. This argument is misplaced because regardless of the additional anchoring features the implant is still constrained within the joint, which is clearly seen in the remaining figures of Wadsworth. The implant of Wadsworth is constrained by the patient’s anatomy as well as being constrained by the additional anchoring features. Having the additional features does not eliminate the other constraining forces experienced by the implant due to the configuration of the joint.
The applicant then argues that modifying the implant of Wadsworth to delete the stem and keel would destroy the principle operation of the implant. This argument is moot because the claims do not require there to be no stem or keel and the prior art rejection does not propose such a modification.
The applicant argues that the examiner has failed to provide rational underpinning to support the optimization of dimensions. This argument is not persuasive because as previously explained, in regards to the radius of curvature of the first surface, in [0062] discloses about 20 mm radius of curvature can be used to match the natural humerus. Figure 2 of Wadsworth shows the first and second surfaces having radius of curvature matching that of the natural humerus. Therefore, it would have been obvious to one of ordinary skill in the art to provide the first and second surfaces with curvatures of 20 mm in order to restore the natural range of motion. It is old and extremely well known in the art of medical implants to provide components with surface dimensions that mimic and substantially match the natural dimensions. In regards to the length and thickness, as confirmed by the claims do not specify how these measurements are taken. They could be taken as a straight line from one end to another, along a curve, straight through the thickness, from an intermediate point to a tip, and many other ways. Depending on how the device is oriented the length and thickness can be varied. Additionally, the dimensions of the implant would depend on the needs of each patient, specifically the size and condition of their bones within the implant site. Therefore, it would have been obvious to one of ordinary skill in the art to provide the implant of Wadsworth with a length between 30 mm and 40 mm taking into account the different patient sizes and the numerous ways a length could be measured. Additionally, it would have been obvious to one of ordinary skill in the art to provide the implant of Wadsworth with a maximum thickness between 20 mm and 30 mm taking into account the different patient sizes and the numerous ways a length could be measured. The applicant further contends that these conclusions are “at best speculation of what a person of ordinary skill in the art would consider”. It is unclear how the fact that people come in all shapes and sizes (i.e. children, adults, males, females, large males, small females, etc.) would be only speculation. The mere fact that the applicant provided a range of values seems to justify that there is not a single one size fits all when it comes to ulnar implants. The size of patients is generally one of the first consideration during every medical appointment.
The applicant goes on to argues that examiner has taken the position that the claimed dimensions indefinite. Again this argument is misplaced because the examiner has not made a 112 indefinite rejection. As previously explained the dimensions are broad and allow for a variety of different mechanisms to achieve those dimensions. There are no defined starting points or ending points. In view of the multiplicity of complex curves and blended surfaces the length and thickness can be measured in a plethora of manners achieving a huge variety of results.
The applicant then argues that the rejection is based on hindsight and based on obvious design choices. Again this argument is misplaced because the examiner never contends that the ranges are obvious design choices and modifying the dimensions of an implant to match those of the body that it is replacing is not a new concept invented by the applicant. These concepts are old and well known within the art as optimizing and achieved by routine experimentation. Taking all of this into account, it is also worth noting that the applicant has not disclosed that having these claimed dimensions solves any stated problem or is for any particular purpose. The applicant’s original disclosure failed to provide any indication of criticality for the claimed elasticity ranges. In fact the original disclosure merely provides plethora of interchangeable ranges which support the conclusion that the values are not critical. Furthermore, there is no factual evidence in the record to support any unexpected results. The disclosure of these ranges is consistent with a routine optimization.
The applicant then argues that the modification of Wadsworth to remove the stem and keel would have no expectation of success. This modification was not proposed by the examiner and is not part of the prior art rejection. Furthermore it is not required by the claims because there are no recitations saying these structures cannot be present.
The applicant’s arguments with respect to claim 15 are a repetition of the above addressed arguments. The implant of Wadsworth on its own is inherently constrained by the patients anatomy regardless of the additional anchoring features. After implantation the implant is compressed by the natural forces of the joint.
Conclusion
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 CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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