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 .
Response to Arguments
Applicant’s arguments with respect to the original claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 –
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 Rejections - 35 USC § 103
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 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, 6-9, 11-16 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by O’Neill et al (11,510,783), or, in the alternative, under 35 U.S.C. 103 as obvious over O’Neill et al in view of Servidio et al (2021/0307916).
O’Neill et al teaches an augmentation component (33:7-26) comprising
a first structure (102,104) adapted to allow passage or penetration of a biocompatible material being curable on contact with water or an aqueous liquid and/or being adapted to allow in-growth of bone tissue (see at least 2:50 et seq. teaching tissue ingrowth); and
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2:
a second structure surrounding the first structure at least in sections or being arranged at least in sections onto the first structure along a periphery of the first structure;
wherein the first structure comprises a planar structure having a distal surface extending in a plane and a proximal surface spaced from the distal surface in a proximal direction (inherent).
Under inherency: The first structure is arranged only at one side of the augmentation component. The second structure extends in the proximal direction from the proximal surface and only on one side of the plane.
Under obviousness:
If it is unclear that the first structure is arranged to extend through the augment and the second structure does not extend in the proximal direction from the proximal surface and only on one side of the plane, Servidio et al teaches this configuration.
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As shown, Servidio et al teaches a first structure (depicted) is arranged only at one side of the augmentation component and the second structure 14 extends in the proximal direction from the proximal surface and only on one side of the plane. The use of the transitional phrase “comprising” allows for additional structures.
It would have been obvious to one having ordinary skill in that the art to have used the configuration of Servido et al such that the first structure is arranged only at one side of the augmentation component and the second structure extends in the proximal direction from the proximal surface and only on one side of the plane to allow for attachment to a tibial tray or tibial insert(s).
Claim 2, wherein the first structure comprises a porous or lattice structure; see at least the title.
Claim 6, both anticipated by O’Neill et al (11,510,783), or, in the alternative, under 35 U.S.C. 103 as obvious over O’Neill et al in view of Servidio et al fulfill the wherein the second structure extends in the proximal direction from the distal surface.
Claim 7, both rejections teach the second structure comprises a wall element. The second structure of the anticipation rejection is solid with sides interpreted as wall element.
Claim 8, the second structure of the 102 rejection is solid. In the 103 rejection, the second structure is “H” shaped wherein the cross-bar. Both configurations do not adapted to allow passage or penetration of the biocompatible material being curable on contact with water or an aqueous liquid and/or is not adapted to allow in-growth of bone tissue.
Claim 9, see the summary of the invention teach the augmentation component comprises a metallic material.
Claim 11, see opening 103 adapted to receive a securing element for securing the augmentation component to the articular or joint implant.
Claim 12, all limitations are functional language and is fully capable thereof.
Claim 13-14, the augment is a single-piece manufactured by 3D printing; see at least the abstract.
Claim 15, an augmentation component according to claim 1; and at least one further kit or system component would have been obvious to one having ordinary skill in the art, such as orthopedic instruments to form the bone to receive the augment component. This is Official Notice.
Claim 16, the figure 50B shows the component photographed next to a ruler. It would have been obvious to one having ordinary skill in the art to have tried the first structure has a thickness in the proximal direction of 0.5 mm to 4 mm to bone ingrowth; and the second structure has a height in the proximal direction of 12 mm to 20 mm for a height of bone removed from the knee with a reasonable expectation of success.
Claim 18, see figure 50B showing the second structure entirely surrounds an outer perimeter of the first structure to define a receptacle for the biocompatible material.
Claim 19, see figure 50B showing the second structure comprises a continuous wall without openings.
Claim 20, see 103 defining a passage extending in the proximal direction from the at least one opening in the second structure.
Allowable Subject Matter
Claims 10 and 17 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 BRUCE EDWARD SNOW whose telephone number is (571)272-4759. The examiner can normally be reached 7:30 am - 5:00 pm Monday through Thursday.
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 Tyson can be reached at 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRUCE E SNOW/Primary Examiner, Art Unit 3774
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