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 .
NOTE: Regarding claim 1, the Examiner has examined every single line of claim 1, however, the Examiner has interpreted lines 2-5 and 17-21 as functional language and the Examiner is not required to find a reference that discloses the above limitations. The Examiner is just required to find a reference that is capable of being used in the right and left knee joint of a patient.
See also independent claims 12 and 19 having the same issue.
Additionally, language such as, “configured to” has been identified as an intended use limitation because is typical of claim limitations which may not distinguish over prior art according to the principle. It has been held that the recitation that an element is “configured to” performing a function is not a positive limitation but only requires the ability to so perform.
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 1-20 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 independent claims 1, 12 and 19 disclose the following language: “the second side comprising the other of the right side and the left side,…” This statement is unclear. The Examiner does not understand what does the applicant’s representative is trying to say. Correction is required.
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.
Claims 1-8 and 10-20 are rejected under 35 U.S.C. 102(a0(1) as being anticipated by Wogoman et al US Patent Pub. 2021/0068966A1.
The following language positively claims the claimed structural limitations:
Claim 1 discloses a knee joint prosthesis system (10) comprising a tibial baseplate component (16) having an insert interface (60), a femoral component (12) having a femoral articulation surface and a tibial insert (18 or 20 or 22) comprising a baseplate interface (80) attachable to the insert interface (60) of the tibial baseplate component (16), the tibial insert (18 or 20 or 22) comprising a tibial articulation surface (106 and 108). The tibial articulation surface comprises a medial tibial compartment (106) and a lateral tibial compartment (108) that is asymmetrical to the medial tibial compartment (see paragraph 24 and 25).
Regarding claims 2, 3 and 13, the implantable system is capable of being used in both the left and right knee joints of a human patient. The first side is interpreted as the right leg and the second side has been interpreted as the left leg.
Regarding claims 4 and 14, as disclosed in paragraph 8, it is well known in the art that the tibia rotates relative to the femur, therefore, the invention discloses that the insert is free to rotate and translate (see paragraph 12), for the reasons above the reference clearly reads on the functional language of claim 4.
Regarding claims 5, 6, 15 and 16, the Wogoman et al reference is capable of increasing constraint on the LCL and decreases tension on the MCL of the knee joint.
Regarding claims 7 and 17, see Fig. 5 disclosing a lateral perimeter with a lateral high point (156) and a lateral low point (150). Regarding the medial perimeter, the medial perimeter, the high point and the low point are not shown (on the other side).
Regarding claims 8 and 18, the femoral articulating surfaces are congruent surfaces that match the surfaces of the tibial insert. Therefore, the articulating surfaces of the femoral component engages the articulating surfaces of the tibial insert. See the dwell point (120 and 150 in Figs. 4 and 5).
Regarding claim 10, see paragraph 121, the last line, disclosing that the contour of the condyles are substantially the same.
Regarding claim 11, see paragraph 11 disclosing that the implant can keep one of the cruciate ligaments, additionally, see Fig. 1 disclosing a posterior stabilizing insert (22) disclosing a post to stabilize the artificial joint.
Regarding claim 12, claim 1 (see above) discloses most of the structural limitations of the claim. However, does not mentions a right-side tibial insert and the left side tibial insert, both sides are attachable to the insert interface of the tibial baseplate. The Examiner interpreted the right side as the side opposite the medial side and the left side is the surface opposite side of the lateral surface.
Regarding claim 19, the difference between claims 1 and 12 is the method, the reference does not talks about a “condition”. The term “condition” is a very general term and can extends from a destructive accident to a tumor/cancer at the joint. Therefore, Wogoman et al reads on the term, since, is replacing a natural joint for a prosthetic joint.
Regarding claim 20, the reference does not disclose a valgus or varus condition, therefore, the condition of the patient has to have an inherent balance condition in order to replace the affected patient’s joint. For example, as disclosed in paragraphs 133, 134 discloses a procedure to rebalance balance the patient’s joint.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,911,280 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both cases disclose A knee joint prosthesis system for implantation in a first knee joint of a patient, the first knee joint comprising a femur and a tibia, the first knee joint having a condition, wherein the first knee joint is on a first side of the patient, selected from a right side and a left side, and is not on a second side of the patient, the second side comprising the other of the right side and the left side, the knee joint prosthesis system comprising a tibial baseplate component configured to be implanted on the tibia, the tibial baseplate component comprising an insert interface; a femoral component configured to be implanted on the femur, the femoral component comprising a femoral articulation surface; and a tibial insert comprising a baseplate interface attachable to the insert interface of the tibial baseplate component, the tibial insert comprising a tibial articulation surface configured to articulate with the femoral articulation surface; wherein: the tibial articulation surface comprises a medial tibial compartment and a lateral tibial compartment that is asymmetrical to the medial tibial compartment; the tibial articulation surface is shaped to cooperate with the femoral articulation surface to adapt kinematics of the first knee joint having the condition; and the tibial articulation surface is suitable for implantation in a second knee joint on the second side, the second knee joint lacking the condition.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 7/17/26
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