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 .
Election/Restrictions
Applicants’ election without traverse of Group I, claims 1-3, 8-18, 20 and 22 in the reply filed on 07/07/2026 is acknowledged.
Claims 4-7 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/07/2026.
Status of the Claims
Claims 1-18, 20, and 22 are pending. Claims 4-7 have been withdrawn. Claims 19, 21, and 23-47 have been cancelled.
Claims 1-3, 8-18, 20, and 22 are currently under examination.
Information Disclosure Statement
Initialed and dated copies of Applicants’ information disclosure statements (IDS) filed on 05/22/2024 are attached to the instant Office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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.
The term “rigid” in claim 22 is a relative term which renders the claim indefinite. The term “rigid” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The Merriam-Webster dictionary define rigid as a: deficient in or devoid of flexibility; b: appearing stiff and unyielding.
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.
Claims 1-3, 8-17 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ryu et al. (Acta Biomaterialia, Volume 27, Published 11/2015, Pages 101-115).
The claims are drawn to a biocompatible adhesive for use in a subject having a tissue defect, wherein the biocompatible adhesive comprises an oxidized or crosslinked chitosan and optionally does not comprise an oxidizing agent or crosslinking agent.
Regarding claims 1-3, Ryu discloses the enhanced solubility maximizes the ability of catecholamine to behave similar to mussel adhesive proteins. Chitosan–catechol is biocompatible and exhibits excellent hemostatic ability and tissue adhesion, and thus, chitosan–catechol will be widely used in a variety of medical settings in the future. This review focuses on the various aspects of chitosan–catechol, including its (1) preparation methods, (2) physicochemical properties, and (3) current applications (abstract). Ryu also discloses Chitosan is a naturally occurring polysaccharide that has been used in numerous biomedical applications, such as wound dressings, hemostatic materials, drug/gene delivery depots and tissue engineering scaffolds. Ryu further discloses Through the deacetylation process under alkaline conditions or via enzymatic hydrolysis, the primary amine groups of chitosan are newly exposed, allowing tissue adhesion via electrostatic interactions or chemical modifications due to amine-involved bioconjugation. This conversion into chitosan readily permits physicochemical transitions to thin films (Introduction section). Ryu continues to disclose Chitosan–catechol (i.e., oxidized or crosslinked chitosan) has exhibited not only excellent solubility in neutral pH solutions but also strong adhesiveness on tissue surfaces. Additionally, it is biocompatible and shows enhanced mechanical properties (i.e., biocompatible adhesive) (Introduction section, third paragraph). The examiner points out that the limitation for use in a subject having a tissue defect does not limit the biocompatible adhesive and biocompatible film and is an intended use of the biocompatible adhesive and film.
Regarding claim 8, the examiner notes that the instant claim 8 wherein the oxidizing agent or the crosslinking agent has been removed by filtration, uses product by process language. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I).
Regarding claim 9, Ryu discloses Chitosan–catechol synthesis (i.e., HP-chitosan) based on electrochemistry has also been reported, particularly for the fabrication of chitosan films (2.2 Electrochemical synthesis section).
Regarding claim 10, the examiner notes that the instant claim 10 wherein gelation of the HP-chitosan is achieved using a filterable oxidizing crosslinking agent, uses product by process language. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I).
Regarding claim 11, the examiner notes that the instant claim 11 wherein the filterable oxidizing crosslinking agent is a periodate form of ionic exchange resins, uses product by process language. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I).
Regarding claim 12, the examiner notes that the instant claim 12 wherein the biocompatible adhesive is filtered to remove and/or recycle the oxidizing agent, wherein the oxidizing agent is immobilized onto resin beads, uses product by process language. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I).
Regarding claim 13, the examiner notes that the instant claim 13 wherein the oxidizing agent is immobilized onto a porous material, foam, fibrous material, or coated porous, foam, or fibrous material, uses product by process language. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I).
Regarding claim 14, the examiner notes that the instant claim 14 wherein a periodate-modified ion exchange resin-bead filtration system is used oxidize catechol moieties, uses product by process language. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I).
Regarding claims 15, 17 and 22, Ryu discloses Chitosan–catechol synthesis based on electrochemistry has also been reported, particularly for the fabrication of chitosan films. Chitosan–catechol was electrochemically synthesized in two steps (Fig. 1B, top). First, chitosan films were electro-deposited by immersing a gold electrode into the chitosan solution (pH ∼5.5), and the current density was retained at a constant level by applying a cathodic voltage. Chitosan was insolubilized by the deprotonation of amines due to the local pH increase at the cathode. Second, redox-active catechol groups were electro-grafted onto chitosan. The chitosan-coated electrode was immersed in catechol solutions, and an anodic voltage was applied to generate the catechol to o-quinone conversions. These oxidized o-quinones were covalently reacted with amine groups in chitosan (i.e., di- hydroxy phenyl-functionalized chitosan) (2.2 Electrochemical Synthesis section). The examiner points out that there is no oxidizing or crosslinking agent present when synthesizing the chitosan-catechol electrochemically, but the final product is a biocompatible adhesive film comprising crosslinked HP-Chitosan that is a crosslink of the catechol moiety to the oxidized o-quinones which is free off an oxidizing or crosslinking agent.
With regards to claim 22, wherein the biocompatible film comprises a rigid, dried HP-Chitosan sheet, Ryu discloses Materials, particularly films (i.e., sheet) prepared by chitosan–catechol provide excellent mechanical properties due to catecholamine crosslinking. The hardness (i.e., rigid, dried) value of chitosan–catechol films is similar to that of human fingernails (3.2.3. Mechanical strength). While Ryu does not explicitly teach that the electrochemically synthesized film was dried, Ryu suggest that the film was dried to have a hardness value, therefore, the preponderance of the evidence support the conclusion that the biocompatible film comprises a rigid, dried HP-chitosan sheet.
Regarding claim 16, the examiner notes that the instant claim 16 wherein the filtration filters off an activating agent and resin, uses product by process language. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I).
Accordingly, Ryu anticipated the claimed invention.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 8-17 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Ryu et al. (Acta Biomaterialia, Volume 27, Published 11/2015, Pages 101-115).
Applicant’s Invention
The Applicants claims are drawn to a biocompatible adhesive for use in a subject having a tissue defect, wherein the biocompatible adhesive comprises an oxidized or crosslinked chitosan and optionally does not comprise an oxidizing agent or crosslinking agent.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1-3, Ryu discloses the enhanced solubility maximizes the ability of catecholamine to behave similar to mussel adhesive proteins. Chitosan–catechol is biocompatible and exhibits excellent hemostatic ability and tissue adhesion, and thus, chitosan–catechol will be widely used in a variety of medical settings in the future. This review focuses on the various aspects of chitosan–catechol, including its (1) preparation methods, (2) physicochemical properties, and (3) current applications (abstract). Ryu also discloses Chitosan is a naturally occurring polysaccharide that has been used in numerous biomedical applications, such as wound dressings, hemostatic materials, drug/gene delivery depots and tissue engineering scaffolds. Ryu further discloses through the deacetylation process under alkaline conditions or via enzymatic hydrolysis, the primary amine groups of chitosan are newly exposed, allowing tissue adhesion via electrostatic interactions or chemical modifications due to amine-involved bioconjugation. This conversion into chitosan readily permits physicochemical transitions to thin films (Introduction section). Ryu continues to disclose Chitosan–catechol (i.e., oxidized or crosslinked chitosan) has exhibited not only excellent solubility in neutral pH solutions but also strong adhesiveness on tissue surfaces. Additionally, it is biocompatible and shows enhanced mechanical properties (i.e., biocompatible adhesive) (Introduction section, third paragraph). The examiner points out that the limitation for use in a subject having a tissue defect does not limit the biocompatible adhesive and biocompatible film and is an intended use of the biocompatible adhesive and film.
Regarding claim 8, the examiner notes that the instant claim 8 wherein the oxidizing agent or the crosslinking agent has been removed by filtration, uses product by process language. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I).
Regarding claim 9, Ryu discloses Chitosan–catechol synthesis (i.e., HP-chitosan) based on electrochemistry has also been reported, particularly for the fabrication of chitosan films (2.2 Electrochemical synthesis section).
Regarding claim 10, the examiner notes that the instant claim 10 wherein gelation of the HP-chitosan is achieved using a filterable oxidizing crosslinking agent, uses product by process language. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I).
Regarding claim 11, the examiner notes that the instant claim 11 wherein the filterable oxidizing crosslinking agent is a periodate form of ionic exchange resins, uses product by process language. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I).
Regarding claim 12, the examiner notes that the instant claim 12 wherein the biocompatible adhesive is filtered to remove and/or recycle the oxidizing agent, wherein the oxidizing agent is immobilized onto resin beads, uses product by process language. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I).
Regarding claim 13, the examiner notes that the instant claim 13 wherein the oxidizing agent is immobilized onto a porous material, foam, fibrous material, or coated porous, foam, or fibrous material, uses product by process language. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I).
Regarding claim 14, the examiner notes that the instant claim 14 wherein a periodate-modified ion exchange resin-bead filtration system is used oxidize catechol moieties, uses product by process language. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I).
Regarding claims 15, 17 and 22, Ryu discloses Chitosan–catechol synthesis based on electrochemistry has also been reported, particularly for the fabrication of chitosan films. Chitosan–catechol was electrochemically synthesized in two steps (Fig. 1B, top). First, chitosan films were electro-deposited by immersing a gold electrode into the chitosan solution (pH ∼5.5), and the current density was retained at a constant level by applying a cathodic voltage. Chitosan was insolubilized by the deprotonation of amines due to the local pH increase at the cathode. Second, redox-active catechol groups were electro-grafted onto chitosan. The chitosan-coated electrode was immersed in catechol solutions, and an anodic voltage was applied to generate the catechol to o-quinone conversions. These oxidized o-quinones were covalently reacted with amine groups in chitosan (i.e., di- hydroxy phenyl-functionalized chitosan) (2.2 Electrochemical Synthesis section). The examiner points out that there is no oxidizing or crosslinking agent present when synthesizing the chitosan-catechol electrochemically, but the final product is a biocompatible adhesive film comprising crosslinked HP-Chitosan that is a crosslink of the catechol moiety to the oxidized o-quinones which is free off an oxidizing or crosslinking agent.
Regarding claim 16, the examiner notes that the instant claim 16 wherein the filtration filters off an activating agent and resin, uses product by process language. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Ryu does not disclose a single embodiment or example where every limitation recited in the instant claims are taught.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The claims are considered prima facie obvious to one of ordinary skill in the art because
Ryu teaches all of the claimed elements. It would have been prima facie obvious at the time
of filing to have a biocompatible adhesive for use in a subject having a tissue defect, wherein the biocompatible adhesive comprises an oxidized or crosslinked chitosan and optionally does not comprise an oxidizing agent or crosslinking agent because Ryu teaches these elements as components of their invention.
With regards to claim 22, wherein the biocompatible film comprises a rigid, dried HP-Chitosan sheet, it would have been obvious to one of ordinary skill in the art to have the biocompatible film comprising a rigid, dried HP-chitosan. One would have understood that Ryu discloses Materials, particularly films (i.e., sheet) prepared by chitosan–catechol provide excellent mechanical properties due to catecholamine crosslinking. The hardness (i.e., rigid, dried) value of chitosan–catechol films is similar to that of human fingernails (3.2.3. Mechanical strength). It would have been obvious to have biocompatible film comprising a rigid, dried HP-chitosan because Ryu teaches that the film has a hardness value similar to that of human fingernails, therefore the film would have been dried and have a rigid form to have such a hardness value as taught by Ryu.
Claims 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ryu et al. (Acta Biomaterialia, Volume 27, Published 11/2015, Pages 101-115) as applied to claims 1-3, 8-17 and 22 above, in view of Lauto et al. (US20080132467A1, Published 06/05/2008).
Applicant’s Invention
Ryu renders obvious all the limitations of instant claim 1. Applicants claim 18 further adds the limitation wherein the biocompatible film has a shear modulus value between about 1MPa and about 5MPa. Applicants claim 20 further adds the limitation wherein the biocompatible film has a shear stress value between 0.1 MPa and about 0.45 MPa.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 18 and 20, Ryu teaches As previously discussed, the catecholamine composition abundant in chitosan–catechol inevitably results in strong adhesion to tissues despite the presence of body fluids (3.2.2 Tissue Adhesion section). Ryu also teaches the nanomechanical properties of the chitosan–catechol films were clearly increased compared with unmodified chitosan films. Regarding the elastic modulus (E) and hardness (H) values, chitosan–catechol films (E = 5.5 ± 0.4 GPa, H = 0.26 ± 0.03 GPa) have exhibited higher values than films composed of chitosan (E = 3.1 ± 0.4 GPa, H = 0.13 ± 0.02 GPa). The differences in the mechanical properties between dry and wet states were compared. The Ewet/Edry ratio was 0.37–0.48 for chitosan–catechol films, whereas it was 0.24 for chitosan films, indicating that the inter-chain chemical crosslinking of chitosan–catechol affects the retaining modulus (3.2.3. Mechanical strength section).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Ryu does not teach wherein the biocompatible film has a shear modulus value between about 1MPa and about 5MPa and wherein the biocompatible film has a shear stress value between 0.1 MPa and about 0.45 MPa. However, these deficiencies are cured by Lauto et al.
In the analogous art of bioadhesive films, Lauto teaches a bioadhesive composition comprising a polysaccharide and an energy converter, wherein the energy converter is activated by non-UV light, wherein the composition is in the form of a film, and may be used for repairing a discontinuity in an area of tissue or for joining tissue (abstract). Lauto also teaches that the polysaccharide may be selected from chitosan (paragraph [0017]). Lauto further teaches the resulting film or composition may display a maximum shear stress of greater than about 5 kPa (i.e., 5 kPa = 0.005 MPa) (paragraph [0057]). Lauto continues to teach A film according to the invention may have a Young's modulus of between about 1 and about 20 MPa (paragraph [0037]).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have the biocompatible film has a shear modulus value between about 1MPa and about 5 MPa, and has a shear stress value between about 0.1 MPa and about 0.45MPa in Ryu’s bioadhesive film by optimization. Ryu teaches the catecholamine composition abundant in chitosan–catechol inevitably results in strong adhesion to tissues despite the presence of body fluids (3.2.2 Tissue Adhesion section) and the nanomechanical properties of the chitosan–catechol films were clearly increased compared with unmodified chitosan films. Regarding the elastic modulus (E) and hardness (H) values, chitosan–catechol films (E = 5.5 ± 0.4 GPa, H = 0.26 ± 0.03 GPa) have exhibited higher values than films composed of chitosan (E = 3.1 ± 0.4 GPa, H = 0.13 ± 0.02 GPa). The differences in the mechanical properties between dry and wet states were compared. The Ewet/Edry ratio was 0.37–0.48 for chitosan–catechol films, whereas it was 0.24 for chitosan films, indicating that the inter-chain chemical crosslinking of chitosan–catechol affects the retaining modulus (3.2.3. Mechanical strength section). One would have understood in view of Lauto that a bioadhesive film used for the purpose of repairing a discontinuity in an area of tissue or for joining tissue, the resulting film or composition may display a maximum shear stress of greater than about 5 kPa (i.e., 5 kPa = 0.005 MPa) (paragraph [0057]); and that the film may have a Young's modulus of between about 1 and about 20 MPa (paragraph [0037]). It would have been obvious to optimize the shear modulus value and shear stress value by routine experimentation to adjust the biocompatible film because Lauto teaches the resulting film or composition may display a maximum shear stress of greater than about 5 kPa (i.e., 5 kPa = 0.005 MPa) (paragraph [0057]); and that the film may have a Young's modulus of between about 1 and about 20 MPa (paragraph [0037]), therefore, one of ordinary skill in the art can use the teachings of Lauto as a starting point using routine experimentation for the desired results of shear modulus and shear stress of the biocompatible film. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In addition, according to the MPEP, “It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments and adaptations, within the skill of the competent worker.” (MPEP 716.07).
Conclusion
No claims are allowed.
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AFUA BAMFOAA BOATENGExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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