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 .
Claim Status
Claims 1 – 2, 4 – 9, 12 – 22 and 24 are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 22 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 22 is being interpreted as being dependent on claim 17, instead of claim 1. Claim 1 does not disclose a pressure compensation layer.
Claim Rejections - 35 USC § 103
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, 2, 4, 5 – 9, 12 – 15 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Alexander et al. (E.P. Patent Application Publication No. 3156083 A1; cited on IDS, hereinafter Alexander), Lehenberger et al. (U.S. Patent Application Publication No. 2019/0374680; hereinafter Lehenberger), Johnson et al. (W.O. Patent Application Publication No. 2009/155600 A3; hereinafter Johnson), and Rikleen et al. (T.W. Patent Application Publication No. 201731674; hereinafter Rikleen). The references are mapped to the machine translation.
Regarding claims 1 and 2, Alexander discloses a method for impressing a 3D shape on a biological tissue, preferably collagen-rich pericardial tissue, using a molding tool that has a first 3D abutment surface for abutment against a top surface of the tissue and a second 3D abutment surface for surface abutment on an underside of the fabric, wherein the fabric between the two contact surfaces is arranged or clamped on both sides of the contact surfaces (p. 2 bottom of page). Regarding claim 4, Alexander discloses that the preferred tissue can be dura mater (p. 4, Middle of page). Alexander does not disclose adding the tissue water replacement before placing the tissue in the mold with the fabric.
Regarding claims 1 and 5, Lehenberger discloses a method of preparing biological tissue for use as a component of an implant, in which the biological tissue is exposed to a solution comprising glycerol and to one or more solutions comprising polyethylene glycol (para. [0019]; Fig. 10) for improving the stabilization of the tissue. Lehenberger further discloses motivation for stabilizing the structure by stating that the microscopic (para. [0020]) tissue structures are protected and maintained from stabilization by means of the stabilization of the hydrogen bridges, in addition to specific protection of the biological tissue to be dried is obtained by means of the combination.
Regarding claim 1, Johnson discloses, in an invention directed to collagenous materials useful in hemostatic applications, that the collagenous material can be wholly encapsulated into a biodegradable capsule (p. 25, line 13 – 14). For an optional decellularized tissue embodiment, Johnson discloses a submucosa extract (claim 6), in which it is prepared by mixing submucosa tissue with PBS and adding a physical pressure (p. 10, line 15).
Regarding claims 1, 12 and 13, Rikleen discloses an insulating structure comprising a stent and a monolithic aerogel structure within the stent (p. 1, Description). In some embodiments, the insulating structure comprise a multi-layered agglomerate of monolithic aerogel structures present in the multilayer support (p. 1, Description). In some embodiments, at least one of the layers of the stent is a microwell. Rikleen further teaches the limitations of claims 12 and 13, by disclosing that the continuous matrix of aerogel within the microwell scaffold can be created with mesh polyester polyurethane foam (p. 11, Bottom of page). Also, Rikleen teaches applying a pressure (autoclave, p. 9, Middle of page) to produce a dry aerogel material.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the layered tissue (dura mater)/fabric mold assembly of Alexander, with the glycerol/ polyethylene glycol tissue stabilization/(protection before drying) step of Lehenberger and the biodegradable capsule of Johnson, with Rikleen’s pressurized-drying (Autoclave) step and also replacing the fabric of Alexander with the permeable material layer(s) of Rikleen under the motivation described by Lehenberger above to generate a structurally-stabilized dried durable biodegradable biological tissue.
Regarding claims 6, Lehenberger discloses a method of preparing biological tissue for use as a component of an implant, in which the biological tissue is exposed to a solution comprising glycerol and to one or more solutions comprising polyethylene glycol (para. [0019]; Fig. 10). Regarding claims 7 and 8, Lehenberger discloses exposing the biological tissue to a solution comprising glycerol and to two or more solutions comprising polyethylene glycol having a different average molecular weight (para. [0021]) and the limitations of claim 8 (para. [0026]). Lehenberger discloses that the motivation for the targeted use of polyethylene glycol in combination with glycerol results in a marked reduction of the risk of calcification of the implanted tissue (para. [0020]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the impure form of glycerol (glycerin) as a substitute in an effort to reduce the risk of calcification of the “implanted” biological tissue as taught by Lehenberger.
Regarding claim 9, Lehenberger discloses using a solution containing surfactin and deoxycholic acid (Abstract) for the decellularization of biological tissue.
Regarding claims 14 and 15, Rikleen discloses in one embodiment, that the microporous layer comprises an expanded polyethylene (ePE) membrane (permeable material layer), comprising a pore size from 0.03 µm to 210 µm (p. 1, 4th para.).
Regarding claim 24, Lehenberger discloses drying the tissue and reducing the relative humidity over 12 hours at 37 ⁰ C (P. 21, Claim 38).
Claims 22 is rejected under 35 U.S.C. 103 as being unpatentable over Alexander, Lehenberger, Johnson, and Rikleen as applied to claims 1, 2, 4, 5 – 9, 12 – 15 and 24 above, and in further view of Trudell (U.S. Patent No. 5,207,705; hereinafter Trudell).
Regarding claim 22, Trudell discloses a composition for a medical prosthesis comprising foam polyurethane and collagen, of one or more layers. The medical prosthesis was engineered for strength and pliancy (Col. 2, lines 50 – 65). Trudell discloses a motivation for engineering the prosthesis was so that it can be shaped into biocompatible units useful as soft-tissue replacements or as matrices for sustained-release vehicles (Abstract).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the pressure compensation layer of Trudell to the layered tissue/fabric mold assembly of Alexander, with the glycerol/polyethylene glycol tissue stabilization step of Lehenberger and the biodegradable capsule of Johnson, with Rikleen’s pressurized-drying step and also replacing the fabric of Alexander with the permeable material layer(s) of Rikleen. Doing so would add a strong and pliant layer to the biological tissue, according to Trudell.
Allowable Subject Matter
Claims 16 – 21 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.
Regarding claims 16 – 21, the limitation ranges of claims 16 – 21 are free of the art. The dimensions of the pressure compensation layer are novel and a person of ordinary skill in the art would not find those specific dimensions obvious over the previous art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER JACKSON III whose telephone number is (571)272-0247. The examiner can normally be reached M-F 9:00A - 5:00P.
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/WALTER JACKSON III/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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