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 claim(s) 1-9, 11-21 and 25 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 § 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.
Claims 1-9, 11-21 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Myung et al US Patent Pub. 2012/0209396A1 in view of Nukavarapu et al US Patent 9,707,322 B2.
Myung et al a non-biodegradable implant comprising a base section (bone anchoring layer) configured for anchoring in bone tissue, and a top porous section having a top surface (lubricious surface layer)(see remarks above for the Examiner’s interpretation of the word porous). The top section comprises a porous thermoplastic elastomeric material (See paragraph 154 and 155 and Figs. 16A-16C), wherein the thermoplastic elastomeric material that extends to the top surface of the top section and has an average porosity of 20% to 80% by volume comprising a linear block copolymer comprising urethane and urea groups. Wherein the base section material comprises one of a biocompatible metal, ceramic, mineral, and polymer, a non-hydrogel polymer, and combinations thereof, wherein the thermoplastic elastomeric material further comprises carbonate groups (See paragraphs 154 and 155).
See below for the Examiner’s interpretation of the porous section and the non-hydrogel polymer:
1. Porous top section:
a. See Fig. 16B and paragraph, this embodiment discloses an implant having two parts: element (162) and element (164), as disclosed by this embodiment element 162 (the top section) comprises a porous section (163), therefore, the new limitations read on the claimed subject matter.
b. As disclosed in a different embodiment as shown in paragraphs 154 and 155, the composite graft is made of two regions: a bearing layer and the anchoring layer. The bearing layer is made of the Interpenetrating polymer network (IPN), wherein the top surface is capable of having a lubricious region and the anchoring layer can be made of porous carbonated apatite, non-resorbable thermoplastics, polyether urethane, PEEK, etc..
The Examiner believes that the lubricious layer can have certain porosity even though the word porosity or porous is not literally disclosed. For example, paragraphs 118, 119, 123 and 196 discloses that the IPN material in addition to the lubricious characteristics can produce also a material having permeability and absorbency characteristics. Paragraph 118 discloses that the IPN material can introduce hydrophilicity (water absorbency) characteristics to a otherwise hydrophobic material as disclosed in paragraphs 123 and 196 the IPN material is capable of absorbing water, therapeutic agents, drugs, Vitamin C, antibiotics, etc... Therefore, the IPN material must have some sort of porosity for the purpose of carrying these other materials.
2. Non-hydrogel polymer:
a. As disclosed in claim 1, the base section material can comprises from one of a group of selected materials, such as, metals, ceramics or polymers, see paragraphs 15 and 155.
However, Myung et al is silent regarding the percentage of the average porosity at the top surface (e.g. 20% to 80% by volume.
Nukavarapu et al discloses a gradient porous scaffold disclosing a plurality of layers. Some of the layers comprising a subchondral layer having a denser configuration having a porosity between 10% to 40%, a middle zone having a porosity between 55% to 65% and a superficial zone having a porosity between 65% to 75%, the superficial zone also comprises an increase amount of hydrogel resulting in cartilage tissue regeneration (See col. 5, lines 29-67 and col. 6, lines 1-27.
It would have been obvious to one ordinary skill in the art to modify the porosity of the Myung et al reference with the 65% to 75% porosity of the Nukavarapu et al reference in order to promote the growth of cartilage tissue around the implant.
Regarding claim 2, see paragraph 135 (‘396), the application does not mention the addition of any peptide.
Regarding claim 4, see paragraph 114 (‘396) disclosing aliphatic characteristics, see PEEK material.
Regarding claim 6, see Fig. 16B (‘396) disclosing that a core of the stem is not porous and the outer surfaces are porous.
Regarding claims 8, 9, 11 see paragraphs 155 and 260 (‘396) disclosing metals, polymers, minerals, etc..
Regarding claim 11, see paragraph 114 (‘396) disclosing the polyaryletherketone polymer.
Regarding claim 12, as disclosed above paragraph 114 (‘396) discloses a polyaryletherketone polymer, paragraph 114 discloses that the hydrophobic polymer can be made of polyaryletherketone. Additionally paragraph 144 discloses that the bone contacting layer can be made of a hydrophobic material and paragraph 154 discloses that the hydrophobic material (bone contacting layer) can have a porosity between 15% to 70%, therefore, the bone contacting layer can have a porosity of less than 20%. Regarding claim 13, see Fig. 16B (‘396).
Regarding claims 15 and 17 (‘396), the Examiner interpreted the pores as the irregularities.
Regarding claim 25 (‘396), the device is capable of being inserted below a top surface of the patient’s cartilage.
Regarding claims 3, 5, 14, 16, 20, 21, Myung et al discloses the invention substantially as claimed. However, Myung et al does not disclose a material made of poly-urethane-bisurea-alkylenecarbonate, a modulus of elasticity of less than 8MPa, a radiomarker, specific dimensions and reinforcing materials.
At the time the invention was made, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the material properties, add a radio marker element and add and make the implant a specific dimensions, since, it is well known in the art to modify those elements in order to design an implant with specific characteristics, since it has been held to be within the general skill of a worker in the art to select a known material, specific dimensions and reinforcing materials on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799
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