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 Amendment
Applicant’s preliminary amendment, filed 11/19/2024, have been fully considered and reviewed by the examiner. Examiner notes the amendment to the claims, cancellation of claims 12 and 14, and the addition of new claims 15-17. Claims 1-11, 13 and 15-17 remain pending.
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.
Claim(s) 1-11, 13, 15, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over TR 201603358, hereinafter TR 358 taken collectively with US Patent Application Publication 20180064580 by Hussain et al.
Claim 1: TR 358 discloses a process for applying a polymer coating to a protein-containing biological material, comprising: providing a protein-containing biological material (biocompatible natural polymers, such as collagen, see claim 6, “The present invention relates to biomaterials which are obtained by coating biocompatible, biodegradable and natural polymer surfaces with silane / siloxane group polymers using plasma polymerization technique, and in particular used as wound dressings on wounded and / or burned tissue and their method of manufacture”),
wherein the protein-containing biological material is isolated from an organism or is an artificially produced protein-containing biological material (natural polymers such as collagen meets this requirement as evidenced by claim 6);
and depositing a polymer coating of at least one polymer by plasma-assisted chemical vapor deposition on a surface of the protein-containing biological material (“ producing biomaterials in which the silane / siloxane film is coated on the matrix of the natural polymer by plasma polymerization technique.”) wherein the polymer coating is covalently bonded to the surface of the protein-containing biological material (“The surface energies, antimicrobial properties, gas permeability, hydrophobicity of the surface, functional groups on the surface of these natural polymers can be varied using surface modification methods. Functional groups are introduced into the surfaces by covalent, ionic or cross-linking, or by adsorption, desorption, absorption.”) Here, while the reference fails to disclose the covalent bonding of the polymer coating to the collagen, the examiner notes the prior art discloses the same process steps and materials as claimed and thus would necessarily have the bonding as claimed unless the applicant is using specific process steps or materials that are neither claimed nor disclosed as required to achieve the claimed covalent bonding.
TR 358 discloses a collagen scaffold and wound dressing/implant; however, fails to disclose drying the protein-containing biological material. However, Hussain et al. in the art of forming wound dressings made from collagen (title) discloses the wound dressing after forming is dried (0068, abstract) and therefore taking the references collectively, it would have been obvious to have modified TR 358 to dry the collagen comprising wound dressing as Hussain discloses wound dressing from collagen can be dried after forming.
While the examiner maintains the position as set forth above, while the reference fails to disclose isolated from a species or artificially produced, the examiner notes such is met by the disclosure of Hussain, related to collagen derived from species (0050, “The collagen used in the process of the present invention may be fibrous or non-fibrous, or a mixture thereof. The term “collagen” refers to a group of naturally occurring proteins found in animals, especially in the flesh and connective tissues of vertebrates. It is the main component of connective tissue, and is the most abundant protein in mammals, making up about 25% to 35% of the protein content in a body. The collagen used in the process of the present invention may be derived from human, bovine, porcine, avian, equine or other tissue”) and therefore using such collagen would have been obvious as a known and suitable collagen for wound dressing forming.
Claim 2: TR 358 discloses depositing comprises introducing at least one monomer during the plasma-assisted chemical vapor deposition, wherein the at least one monomer is selected to be reactive in the plasma-assisted chemical vapor deposition to form the polymer coating. (“Another object of the invention is to realize a method of producing biomaterials in which the silane / siloxane film is coated on the matrix of the natural polymer by plasma polymerization technique”, “filling the monomer vapor into the reactor by adjusting the pressure within the reactor”, “providing plasma formation in the reactor”)
Claim 3, 15 and 16: TR 358 discloses siloxanes including HMDS as claimed (“As monomer materials, hexamethyl disilane, hexamethyl disiloxane, methyltrimethoxy silane or trimethyl vinyl silane monomers are used”)
Claim 4: TR 358 discloses a thickness within and overlapping the range as claimed (“ thickness of the film layer covering the matrix material is preferably in the range of 50nm to 300nm.”) and thus makes obvious the instant claims. Additionally, TR 358 discloses the thickness can be adjusted based on the application (The thickness of the silane / siloxane film layer covering the matrix can be adjusted according to the region where the product will be used.) and therefore illustrates such is a result effective variable based on where the product is used and determination of the optimum thickness would have been obvious through routine experimentation.
Claim 5: The siloxane polymer as taught by TR 358 does not include metal and therefore reads on the polymer coating is metal-free. Additionally, the prior art discloses the same materials and uses the same process as claimed and therefore deposition of such will necessarily have the same properties.
Claim 6: TR 358 discloses collagen.
Claim 7: Hussein discloses collagen can reasonably be considered biological tissue (0050), see collagen is “main component of connective tissue” and therefore using such would have been obvious as predictable.
Claim 8: While the references fail to disclose the protein-containing biological material is an autologous or xenogeneic protein-containing biological material (autologous is same species and xenogeneic is different species), such is a selection from a group of two alternatives. Additionally, the examiner notes Xenogeneic is met by the disclosure of Hussain, related to collagen derived from species (0050, “The collagen used in the process of the present invention may be derived from human, bovine, porcine, avian, equine or other tissue”) and therefore xenogeneic material would have been obvious as a known and suitable collagen for wound dressing forming.
Claim 9: Hussein discloses stabilizing the protein-containing biological material with a stabilizer before the drying or before the depositing (0058 related to crosslinking) and therefore applying a “stabilizer” would have been obvious to one of ordinary skill in the art see e.g. 0088 (“The crosslink density of the collagen articles of the present invention improves the mechanical and chemical stability of the collagen and provides the desired prolonged functional performance of the collagen articles.” )
Claim 10: Hussein discloses molding the protein-containing biological material into a predefined shape before the depositing (0070) and therefore molding to a shape would have been obvious to allow for cutting or stamping to desired shape.
Claim 11: TR 358 discloses the polymer coating is functionalized with an active substance (“ effect of the matrix on the controlled release of the drug and active substance loaded with the matrix”, “the amount of drug impregnated in each layer is different”)
Claim 13: TR 358 discloses forming the polymer-coated protein-containing biological material into an implant configured for implantation in a human or animal body (“biomaterial which is used as an implant as a tissue scaffold”, “dressing on wounded or burned tissue”)
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over TR 358 taken collectively with Hussain et al. and further with US Patent Application Publication 20060247667 by Ahern et al.
TR 358 with Hussain disclose all that is taught above and TR 358 discloses using natural biocompatible polymers including collagen, but fails to disclose pericardium. However, Ahern, discloses natural biocompatible polymers for forming a tissue scaffold including collagen based materials from pericardium (0054) and therefore taking the references collectively using pericardium would have been obvious as TR 358 discloses using biocompatible natural polymers and Ahern discloses such includes pericardium.
Conclusion
Pertinent Art cited on PTO 892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID P TUROCY whose telephone number is (571)272-2940. The examiner can normally be reached Mon, Tues, Thurs, and Friday, 7:00 a.m. to 5:30 p.m.
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/DAVID P TUROCY/Primary Examiner, Art Unit 1718
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