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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The disclosure is objected to because of the following informalities: paragraph [0013] recites “a fibre reinforced polyaryletherketone” and paragraph [0040] recites “reinforcement fibres (e.g. carbon fibres)” and paragraph [0043] recites “a fibre reinforced PAEK, preferably a carbon fibre reinforced PEEK.” The term fibre, fibres should be fiber or fibers.
Appropriate correction is required.
Claim Objections
Claim 6 is objected to because of the following informalities: the use of “fibre-reinforced polyaryletherketone” should be fiber-reinforced. It appears to be a misspelling of the word fiber. Appropriate 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.
Claim(s) 1-5 and 7-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hanson EP3287101 A1.
Regarding Claim 1, Hanson discloses a medical implant 100 comprising an implant body 102 comprising a polymer material (paragraph [0014] and [0036]) said implant body having a bone-facing interface 106 and an articulating interface 108, wherein a stiffening layer 104 is provided over at least a portion of the bone-facing interface 106, and wherein the stiffening layer 104 is porous (paragraphs [0019], [0021], [0028]) and is formed of a material having a higher stiffness than the polymer material of the underlying bone-facing interface (formed from titanium, metal versus a polymer such as peek, see paragraphs [0005], [0007], [0014] and [0042]).
Regarding Claim 2, Hanson discloses wherein the stiffening layer comprises a mesh (paragraph [0021-0022] and as incorporated by reference, see publications 2006/0147332; 20070142914, see paragraph [0042] describing successive layers forming a meshed structure).
Regarding Claim 3, Hanson discloses wherein the mesh comprises multiple overlying layers of mesh material (paragraph [0022]).
Regarding Claim 4, Hanson discloses wherein the openings of at least one layer of mesh material are partially offset with respect to the openings of at least one other layer of mesh material to provide channels through the thickness of the mesh (as incorporated by reference, see publications 2006/0147332; 20070142914, see paragraph [0042] describing successive layers forming a meshed structure that is offset to randomize the geometry of the unity cells and form a porous structure).
Regarding Claim 5, Hanson discloses wherein the mesh is formed of metal (paragraphs [0014], [0040] and [0042]).
Regarding Claim 7, Hanson discloses wherein the implant is a knee implant (paragraphs [0004], [0028]).
Regarding Claim 8, Hanson discloses wherein the polymer comprises a polyaryletherketone (paragraphs [0003], [0005], [0014], [0036] and [0040-0041]).
Regarding Claim 9, Hanson discloses wherein the polyaryletherketone is PEEK polyetheretherketone (paragraphs [0003], [0005], [0014], [0036] and [0040-0041]).
Regarding Claim 10, Hanson discloses wherein the stiffening layer 104 is provided over a selected region or selected regions of the bone-facing interface (see Figures 4B-4C, 7B-7C).
Regarding Claim 11, Hanson discloses wherein the stiffening layer is provided over substantially the entirety of the bone-facing interface (as seen in Figures 1-2 and 9).
Regarding Claim 12, Hanson discloses wherein the stiffening layer is formed of a first layer of material having a first stiffness and a second layer of material having a second stiffness to provide differing areas of stiffness in the stiffening layer (as incorporated by reference, see publications 20070142914, see paragraph [0042] of Hanson revealing Jones discloses the implant can have a porous bone ingrowth structure and a second bearing surface structure, wherein the porous bone ingrowth surface includes different layers having different gradients of porosity, as you move normal with regards to the bone ingrowth surface the porosity can alter, such that it can increase or decrease depending on desired purpose of the implant, see paragraph [0008] of Jones).
Regarding Claim 13, Hanson discloses wherein the first layer of material and/or the second layer of material is of a uniform thickness (as incorporated by reference, see publications 20070142914, see paragraph [0042] of Hanson describing successive layers forming a meshed structure, wherein successive layers of material can provide uniform thickness by controlling the layer thickness to crease consistent surface properties, see paragraph [0074] of Jones).
Regarding Claim 14, Hanson as incorporated by reference to Jones et al. discloses wherein either the first layer or second layer of material can includes uniform thickness or have a gradient, having different gradient porosity with each successive layer for the purpose of altering the porosity and surface properties of the implant. Jones’s disclosure reveals the surfaces can have one layer that has a porosity of almost zero while another layer can have a porosity of about 80% (see Jones, paragraph [0008]).
Regarding Claim 15, Hanson discloses wherein the first layer of material and/or the second layer of material is of a non-uniform thickness (as incorporated by reference, see publications 20070142914, see paragraph [0042] of Hanson revealing Jones discloses the implant can have a porous bone ingrowth structure and a second bearing surface structure, wherein the porous bone ingrowth surface includes different layers having different gradients of porosity, as you move normal with regards to the bone ingrowth surface the porosity can alter, such that it can increase or decrease depending on desired purpose of the implant, see paragraph [0008] of Jones).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanson EP3287101 A1 in view of Logan et al. EP3400912A1.
Regarding Claim 6, Hanson does not expressly disclose the mesh is formed from fiber-reinforced polyaryletherketone. Logan et al. teaches a prosthetic knee implant 10 in the same field of endeavor comprising a prosthetic femoral component 100 having a bone contacting surface 160 and an articulating surface 170, the articulating surface 170 and the bone-contacting surface 160 is formed from PAEK for creating a uniform material to allow for a porous structure with a desired gradient (paragraphs [0020] and [0025]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Hanson’s mesh to be formed from a polymer, such a fiber reinforced PAEK as taught by Logan for the purpose of having a biocompatible engineering polymer material that is relatively strong and have a modulus of elasticity similar to native bone and have significant resistance to allow the implant to be formed of a uniform material to allow for a porous structure with a desired gradient with enhanced performance (paragraph [0020]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson 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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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774