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 62/983,560 filed on 02/28/2020
Status of Claims
Claims 1, 2, 4, 6-11, 21-24, and 29-35 are pending.
Claims 3, 5, 12-20, and 25-28 have been cancelled.
Election/Restrictions
Applicant elected Species 1a (monoaxial joint) and Sub-Species 2b (magnetic extensor mechanism) without traverse on 02/28/2023
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Drawings
The previous objections to the drawings have been withdrawn in view of the applicant’s amendments.
Claim Objections
Claim 1 is objected to because line 3 should recite “canal of a femur”.
Claim Rejections - 35 USC § 112
The previous 112 rejections have been withdrawn in view of the applicant’s amendments.
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 2, 21-24, and 32-34 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 2 line two recites “co35mprising” which renders the claim indefinite. The applicant is advised to amend claim 2 to recite “comprising”.
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, 2, 4, 6, 8-11, 21-24, and 29-34 are rejected under 35 U.S.C. 103 as being unpatentable over Tavernetti et al (Tavernetti) USPN 3,813,700 in view of Janssen et al (Janssen) USPN 4,024,588.
1. Tavernetti discloses an implantable knee prosthesis (Figure 1), comprising:
a femoral component 19 comprising a first joint portion 20 and a first intermedullary stem portion 22, the first stem portion configured structured to be embedded in a medullary canal of the femur (tapered slim shape permits it to be embedded as shown in Figure 1), and the first joint portion configured structured to replace at least a portion of an end of the femur (rounded cylindrical shape permits it to replace end of femur);
a tibial component 11 comprising a second joint portion 12 and a second intermedullary stem portion 13, the second stem portion configured to be embedded in a medullary canal of a tibia associated with the femur (tapered slim shape permits it to be embedded as shown in Figure 1);
the first and second joint portions operatively coupled to create a monocentric axis flexion joint (Both the applicant’s and Tavernetti’s inventions have monoaxial hinges which read upon this limitation in the same manner) having a range of flexion of the tibia relative to the femur simulating natural knee movement (this limitation is extremely broad, a natural knee moves like a complicated hinge with translation and bending, any related movements like pivoting and translating is considered to read upon “simulating natural knee movement”, in this case Tavernetti discloses a standard knee hinge type movement);
The connecting structures between the tibial and femoral stems of Tavernetti are considered to be an extensor mechanism structure. However, they are not disclosed as comprising biasing features that provide constant friction.
Janssen discloses a prosthetic extensor mechanism operatively coupled to the flexion joint and biasing the implanted knee prothesis to an extended position (4:33-39) when the implantable knee prothesis has been implanted in a human body (mechanism of Janssen comprises opposing surfaces 15/16/17 and outer surface of 3, magnets 8/9 and material 13 which have no adhesive or other connections outside of a frictional engagement, but allow a level of simulated knee movement i.e. straightening and bending),
wherein the extensor mechanism comprises a constant friction joint supplying constant pressure against a rotation surface to resist knee flexion (the claims do not quantify how or when the force is applied, when stationary the magnets and material of Janssen have constant dimensions and are not configured to more or adjust so the attraction forces apply a constant pressure on the opposing surfaces forming the extensor mechanism).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the magnetic extensor mechanism and adjacent structures of Janssen to the femoral and tibial components of Tavernetti in order to provide an implant with biasing forces to aid the patient with their walking and reducing wear on the articulating surfaces.
2. Tavernetti as modified by Janssen discloses the a flexion resistance mechanism a magnet system (subcomponents 8/9/13 are considered to define the flexion resistance mechanism described in Janssen in 3:62-4:32).
6. Janssen discloses the flexion joint is a monocentric axis joint configured to operate as a simple hinge (Figure 1).
8-11. Tavernetti as modified by Janssen discloses the invention substantially as claimed being described above. However, the combination does not specifically disclose the removable/integral configurations of claims 8-11.
Tavernetti discloses integral stems, but it would have been obvious to one having ordinary skill in the art at the time the invention was filed to make the femoral and tibial stems removable from the base components, since it has been held that making an old device portable or movable without producing any new unexpected result involves only routine skill in the art (In re Lindberg 93 USPQ 12 CCPA 1952). This will allow for the implant to be inserted separately and to be partially removed if a revision or adjustment is later needed
Additionally, in regards to the claimed intended use of the implant, the modified components of the combination are fully capable of being implanted separately and then assembled or fully assembled then implanted. This only requires different preparation and modification techniques for the patient’s implant knee, not the implant of Janssen.
21. Janssen discloses the magnet system comprises one or more discrete magnets in the femoral component and one or more discrete magnets in the tibial component (Figure 1 2:15-50 discloses the components may use magnets in both components or a combination of magnet and material).
22. Janssen discloses the one or more discrete magnets in the femoral and tibial components are arranged and located so that the magnet system attracts the femoral component and the tibial component to a 0 degree flexion condition. (magnets 8, 9, 13 biased to straighten 4:33-39).
23. Janssen discloses the magnet system comprises a magnet in either the femoral component or the tibial component and magnetically attracted material in the component that does not include the magnet (Figure 1 2:15-50 discloses the components may use magnets in both components or a combination of magnet and material).
24. Janssen discloses the magnet and magnetically attracted material are arranged and located so that the magnet system attracts the femoral component and the tibial component to a 0 degree flexion condition (magnets 8, 9, 13 biased to straighten 4:33-39).
29. 32. Tavernetti discloses the flexion joint permits a range of rotation of the tibia relative to the femur (this recitation is very broad and does not define how big the range is or how it compares to the natural range, but Figure 1 of Tavernetti clearly discloses a range of rotation that reads upon the broad requirement).
30. 31. 33. 34. Tavernetti as modified by Janssen discloses a rotation resistance system comprising frictional surfaces providing an increasing amount of resistance to rotation in either direction from a centered orientation (Both Tavernetti and Janssen disclose opposing surfaces of the tibial and femoral components that are in contact with each other, these surfaces inherently encounter frictional forces which act to resist movement in any direction, thereby acting as rotational resistance systems).
Claim(s) 7 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tavernetti and Janssen (Combination 1) as applied to claims 1, 2, 4, 6, 8-11, 21-24, and 29-34 above, and further in view of Martinez USPN 3,848,276.
Combination 1 discloses the invention substantially as claimed being described above. However, Combination 1 does not disclose the use of a flexible bio sheath covering the moving parts.
Martinez teaches the use of a prosthetic knee implant comprising a flexible bio sheath (last sentence of abstract) in the same field of endeavor for the purpose of preventing damage to surrounding tissues and contamination of bodily fluids.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the flexible bio sheath of Martinez with the implant of Combination 1 in order to protect the surrounding tissue from the moving parts of the joint and vice versa.
35. Combination 1 as modified by Martinez discloses: the flexion joint is a monocentric axis joint configured to operate as a simple hinge (figure 1 of Tavernetti discloses the joint is a monocentric axis joint that moves as a simple hinge); wherein the flexion joint permits a range of rotation of the tibia relative to the femur (see response to claims 29 and 32 above); and further comprising a flexion resistance mechanism comprising a magnet system (see response to claim 2 above); a rotation resistance system providing an increasing amount of resistance to rotation in either direction from a centered orientation (see response to claims 30, 31, 33, and 34 above); and a biosheath encapsulating at least a portion of the prothesis (see modification incorporating the teachings of Martinez above).
Response to Arguments
Applicant's arguments filed 04/09/2026 have been fully considered but they are not persuasive.
As an initial note, the applicant appears to be moving towards claiming the extensor mechanism, a flexion resistance mechanism (magnets), the rotation resistance system as all independent components, but the original disclosure appears to have the flexion resistance mechanism and the rotation resistance system as subcomponents of the extensor mechanism. This is exacerbated by the fact that the only reference to the extensor mechanism is 656 Figure 6B, which is vaguely described as “structural and or operational components” and the “flexion resistance system” and “rotation resistance system” phrases are only recited in the claims of the original disclosure. It appears [0033] is describing the flexion resistance mechanism as a brake formed by surfaces or magnets, but this still seems to structurally be a sub component of the extensor mechanism. It appears [0039] is describing the rotation resistance system formed by the surfaces, but again this still seems to structurally be a sub component of the extensor mechanism. Clarification is required as to if these three systems are subcomponents of the extensor mechanism or if they are independent components, if so where they are depicted in the figures showing structural components and what reference numbers are identifying them.
With respect to the prior art rejection the applicant argues that Tavernetti does not disclose an extensor mechanism. This is not persuasive because Tavernetti discloses his knee implant comprising a plurality of components (opposing curved surfaces) that together act as an extensor mechanism.
The applicant further argues that the prosthesis of Janssen does not disclose a monocentric axis flexion joint. This is not persuasive because the prior art combination relies on Tavernetti as the base reference which clearly discloses a monocentric axis flexion joint (Figures 1-4).
The applicant further argues that the extensor mechanism of Janssen cannot apply constant pressure. This is not persuasive because the applicant is arguing a scope much narrower than the claims require. There is no description or requirement as to when or how the constant pressure is applied. It doesn’t need to be applied throughout every point of rotation. It just needs to apply pressure constantly in some configuration. The extensor mechanism of Tavernetti as modified by Janssen would apply constant pressure in a variety of configurations. For example when at 0 degrees shown in Figures 1-3 of Janssen, there is constant pressure applied. Additionally since there are multiple magnets and overlapping elongated uniform lengths shown in Figure 2, they will apply a constant pressure during at least some range of motion
Finally the applicant argues that the magnetic forces do not act against a surface but rather upon them. This is not persuasive because the magnets of the prior art combination are secured within the tibial and femoral implants so the forces from the magnets push them into contact with each other. The pushing is as explained above a constant force applied both upon the surfaces indirectly and against the surfaces directly because the forces are pulling opposing articulating surfaces into contact.
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 on (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
Prosecution Insights