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 amendment, filed 7/30/2026, have been fully considered and reviewed by the examiner. Examiner notes the amendment to the claims, cancellation of claims 9, and the addition of new claims 19-23. Claims 1-8, 10-11, 13 and 15-23 remain pending.
Response to Arguments
Applicant's arguments filed 7/30/2026 have been fully considered but they are not persuasive as they are directed to newly added claim requirements that are specifically addressed hereinafter.
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) 1-8, 10-11, 13, 15-20 and 22-23 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 20150282930 by Lehenberger et al. and 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 stabilizing the implant with the claimed stabilizer and thereafter drying to reduce water content to less than 10 wt% as claimed. However, Lehenberger, also in providing a collagen implant (example 1) discloses subjecting the implant to a stabilization process, by exposing the biological implant to a stabilizing agent and thereafter drying (abstract) so as to provide dimensional and structural stabilization (abstract) and high level of dimensional stability is achieved as well as targeted protection of the tissue structure, coupled with a lower risk of calcification (0012). Lehenberger discloses the stabilization using a biological non-volatile hygroscopic exchange substrate (see 0013 “ the tissue is subjected to a dimensional and structural stabilization step in which the tissue is exposed to a first solution, which contains polyethylene glycol, and is exposed to a second solution, which contains glycerol, wherein the tissue is exposed either to the two solutions one after the other in any order, or is exposed to both solutions simultaneously, as the first solution mixture”). Lehenberger discloses after stabilization, drying the protein-containing biological material to prepare for further processing by removal of water (0029, “the drying of the tissue is designed such that a slow and gentle withdrawal of the water, in the liquid state, from the tissue is ensured.” And 0040 “The thusly stabilized biological tissue is then dried in a desiccator for 24 hours, using a silical gel as the desiccant. The thusly obtained, dried, biological tissue can either be further processed or stored in the desiccator.”). While Lehenberger fails to disclose the degree of water removal, the reference discloses the tissue is “dried” to remove water and therefore, taking the level on one of ordinary skill in the art at the time of the invention, it would have been obvious to one of ordinary skill in the art to determine the optimum amount of drying to reap the benefits as outlined by Lehenberger, including that as within the range as claimed, or completely dried, which would include a water content that overlaps the range as claimed.
The cited prior art references fail 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. See also Lehenberger at 0004 (“which are often made of pericardial tissue, which is usually obtained from animal sources (e.g. swine or cattle).”)
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 and 23: TR 358 discloses siloxanes including HMDS as claimed (“As monomer materials, hexamethyl disilane, hexamethyl disiloxane, methyltrimethoxy silane or trimethyl vinyl silane monomers are used”) and discloses plasma polymerization technique (see abstract) and thus reads on these claims as drafted.
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 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 17: Lehenberger discloses a pericardium tissue as claimed and thus using such would have been obvious (see e.g. 0004, or 0031“a porcine pericardial tissue”).
Claim 18-20: Lehenberger discloses the stabilization using a biological non-volatile hygroscopic exchange substance, including glycerol; polyethylene glycol, in either order (see 0013 “ the tissue is subjected to a dimensional and structural stabilization step in which the tissue is exposed to a first solution, which contains polyethylene glycol, and is exposed to a second solution, which contains glycerol, wherein the tissue is exposed either to the two solutions one after the other in any order, or is exposed to both solutions simultaneously, as the first solution mixture”).
Claim 22: Hussein discloses drying at what can reasonably be considered ambient pressure and humidity (0069, where ambient would encompass ambient pressure and humidity) and further drying under a reduced pressure (0069, see vacuum) and therefore using this stepped drying method would have been obvious to one of ordinary skill in the art at the time of the invention. A predictable use of prior art elements according to their established functions to achieve a predictable result is prima facie obvious. See KSR Int’l Inc. v. Teleflex Inc., 127 S Ct. 1727, 1741, 82 USPQ2d 1385, 1396 (2007).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over TR 358 taken collectively with Lehenberger and Hussain et al. and further with US Patent Application Publication 20060247667 by Ahern et al.
TR 358 with Lehenberger and 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.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over TR 358 taken collectively with Lehenberger and Hussain et al. and further with US Patent Application Publication 20170296709 by Bunge et al.
TR 358 taken collectively with Lehenberger and Hussain et al. discloses all that is taught above; however, fails to disclose removing stabilizer prior to coating. However, Bunge, also in the art of plasma polymerization onto a medical device discloses selective removal of the stabilizer prior to deposition (0062-0063) from the surface, including removal of known stabilizers (e.g. glycerol) and therefore taking the references collectively, it would have been obvious to have modified TR 358 taken collectively with Lehenberger and Hussain et al. to remove the stabilizer from the surface prior to plasma polymerization deposition as suggested by Bunge, as TR 358 taken collectively with Lehenberger and Hussain et al. makes obvious using stabilizers for implants and TR 358 discloses plasma polymerization and Bunge discloses the benefits of removing stabilizer prior to plasma polyermization deposition and one would desire to reap the benefits of such.
Conclusion
Pertinent Art cited on PTO 892.
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 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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