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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/07/2025 has been entered.
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, and 19-28 are pending.
Claims 3, 5, and 12-18 have been cancelled.
Election/Restrictions
Applicant elected Species 1a (monoaxial joint) and Sub-Species 2b (magnetic extensor mechanism) without traverse on 02/28/2023
.
Drawings
The previous objections to the drawings have been withdrawn in view of the applicant’s amendments.
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 single hinge points (Claims 1 and 28) 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
Claim 1 is objected to because “and” was added to line 9 but the applicant failed to provide the proper indications.
Claim 24 remains objected to for the following issues. Line 1 should recite “wherein the magnet and”.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 4, 6-11, and 19-28 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claims 1 and 28 have been amended to define single hinge points, which is considered to be new matter. The original disclosure clearly describes monoaxial or single axis hinges not single hinge points. The applicant is advised to amend the claims to define monoaxial hinges to be consistent with the original disclosure.
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, 2, 4, 6-11, and 19-28 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.
Independent claims 1 and 28 have been amended to define single hinge points, which renders the claims indefinite. It is unclear how any knee joint implant could hinge about a single point. Hinges are clearly understood to rotate about an axis not a single point. As seen throughout the applicant’s drawings they all include multiple points along an axis for hinging. See above rejection for recommended amendment.
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, and 21-24 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 hinged flexion joint having a single hinge point (as explained in the 112 rejections above the applicant’s own invention does not meet this requirement, both the applicant’s and Tavernetti’s inventions have monoaxial hinges which read upon this limitation in the same manner) 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);
However, Tavernetti does not disclose the claimed extensor mechanism structure.
Janssen discloses a prosthetic extensor mechanism operatively coupled to the flexion joint and biasing the implanted knee prothesis to an extended position when the implantable knee prothesis has been implanted in a human body (mechanism of Janssen comprises 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 friction joint supplying pressure against a rotating surface to resist knee flexion (the magnets and material of Janssen have constant dimensions and are not adjustable so the attraction forces apply a constant pressure).
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 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. Janssen discloses the extensor mechanism comprises a magnet system (8, 9, 13 3:62-4:32).
4. Janssen discloses support for multiple configurations including: Figure 1 shows constant pressure and friction with uniform shaped magnets and materials, but Janssen further discloses an enlarged base material portion in Figure 3 which will provide the friction contact surfaces to have more attraction thereby increasing resistance to flexion.
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 rotate toward 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 rotate toward a 00 flexion condition (magnets 8, 9, 13 biased to straighten 4:33-39).
Claim(s) 7, 19-20, and 25-28 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, and 21-24 above, and further in view of Martinez USPN 3,848,276.
Janssen discloses the invention substantially as claimed being described above. However, Janssen 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.
19. Tavernetti discloses the flexion joint is a monocentric axis joint configured to operate as a simple hinge (Figure 1).
20. As explained above with respect to claims 8-11, it would have been obvious to provide the stems of the implant of Tavernetti such that they are removably coupled to the other components so that the device can be inserted separately or partially removed for revision surgeries.
25. 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).
26. 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 rotate toward a 0 degree flexion condition. (Figure 1 shows multiple magnets 8, 9, 2:15-50 discloses the components may both use magnets, and they are biased to straighten 4:33-39).
27. 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).
28. Tavernetti discloses an implantable knee prosthesis (Figures 1), comprising:
a femoral component 19 comprising a first joint portion 20 and a first intermedullary stem portion 22, the first stem portion 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 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);
the first and second joint portions operatively coupled to create a flexion joint having a single hinge point (see 112 rejection above, Tavernetti discloses this feature in the same manner as the applicant’s own invention) and simulating a natural range of flexion (the applicant has failed to define what qualifies as natural, does this mean natural for that patient? Does it account for age, condition, or health of the structures? In this case Tavernetti clearly discloses a natural range of motion for an average patient) of the tibia relative to the femur (Figure 1);
a prosthetic extensor mechanism operatively coupled to the flexion joint and biasing the implanted knee prothesis to simulate a level of natural knee movement for individuals with compromised extensor mechanisms when the implantable knee prothesis is implanted in a human body (see 103 modification above, mechanism of Janssen comprises 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), the extensor mechanism comprising a constant friction joint supplying constant pressure against a rotating surface to resist knee flexion (the magnets and material of Janssen have constant dimensions and are not adjustable so the attraction forces apply a constant pressure);
wherein the prosthetic extensor mechanism comprises a magnet system (8, 9, 13); and
wherein at least a portion of the flexion joint is encapsulated in a bio sheath (see modification in view of Martinez).
Response to Arguments
Applicant's arguments filed 07/07/2025 have been fully considered but they are not persuasive.
As an initial note, the applicant’s statement on page 1 of their arguments that they will only be choosing which factual and legal issues to respond to is not proper. A proper response shall address all objections and rejections made in the office action. There will be no delaying or holding off on addressing current issues. Any response that fails to address all outstanding issues will be considered non-responsive.
The applicants arguments on page 8 state that the claims are directed at an embodiment with a single hinge point with a constant friction joint. However claim 1 has been amended to remove the term constant and claim 4 defines it as a variable friction joint. Clarification of the claims to be directed at a single embodiment is required.
With respect to the prior art rejection the applicant argues that Janssen does not disclose a hinge because it is described as a ball and socket. The examiner recognizes that Janssen does call it a ball and socket but the figures clearly disclose a hinge which is supported by Figures 2-3. Figure 3 is a cross-section of Figure 2, which would require rounded sides for the joint to actually be a ball and socket. However, in order to advance prosecution the rejection has been modified to include a new base reference which clearly discloses a simple hinge joint with a monoaxial structure. The magnetic extensor mechanism as shown in Figures 2-3 can be readily applied to the similar looking tibial and femoral structures of Tavernetti.
The applicant further argues, that there has been no reasoned analysis of how any prior art reads upon claims 26-28. This argument is not true because the previous office action clearly addressed claims 26-28 on pages 10-12. These rejections have been updated above in view of Tavernetti.
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 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