DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-12, filed 8 March 2024, are pending.
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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being obvious over Liao ‘500 (US 2021/0332500 A1) in view of Kensho et al. (JP 2002-325830 A), Irie et al. (JP 2004-024706 A) and Soliman et al. (US 2021/0008505 A1).
Regarding instant claim 1, Liao ‘500 teach a method for manufacturing a porous anti-adhesive film for use in a biomedical-grade material comprising providing an electrospinning solution comprising a polymer and solvent, and performing an electrospinning process to form the porous anti-adhesive film (Abstract; [0008], [0010], [0032]-[0033]; Claims 1-10).
Liao ‘500 do not explicitly disclose a porous layer including a bone regeneration material attached on the porous structure, as instantly claimed.
However, Kensho et al. teach a bone tissue regeneration-inducing membrane comprising at least a bilayer membrane. The outer layer includes polylactic acid, and the inner layer includes calcium phosphate ([0008]). Examples of the calcium phosphate material contained in the material for the inner and outer layers include tricalcium phosphate, hydroxyapatite, dicalcium phosphate and the like. Among them, tricalcium phosphate, which has a good affinity with the copolymer and is absorbed and disintegrated in the living body to be replaced with a new tissue to promote bone tissue repair, is most preferable. Calcium phosphate having an average particle size of 200 μm or less is used. If the average particle size exceeds 200 μm, it is not suitable because it is difficult to form a thin film ([0015]).
Also, Irie et al. teach a living tissue regeneration guide sheet obtained by laminating a porous composite film made of β-tricalcium phosphate and a softer biodegradable material. Since each composite membrane is composed of a biodegradable material and β-tricalcium phosphate, it is absorbed into the living body as the tissue is regenerated by cell differentiation ([0005]). Irie et al. teach that the membrane can be used to regenerate and guide the alveolar bone in the defective portion of the alveolar bone ([0014]-[0016]; Figure 2). Irie et al. teach that the biodegradable material includes polylactic acid ([0016]).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare the porous film according to Liao ‘500 further comprising calcium phosphate as a bone regenerative material attached to the porous layer. Such would have been obvious because Kensho et al. and Irie et al. teach separating membranes comprising polylactic acid and calcium phosphate, wherein tricalcium phosphate, which has a good affinity with the copolymer and is absorbed and disintegrated in the living body to be replaced with a new tissue to promote bone tissue repair, is most preferable.
Regarding the concentration of porous structure and bone regeneration material, a person of ordinary skill in the art would have been motivated to determine through routine experimentation the optimum quantity of calcium phosphate to include in the porous layer of Liao ‘500 to effectively promote bone regeneration.
Liao ‘500 also do not explicitly disclose a hydrophilic layer encapsulating the porous layer, as instantly claimed.
Soliman et al. teach membranes suitable for guided bone regeneration (GBR) barrier membranes in dental applications composed of fibrous and highly porous biodegradable materials fabricated using electrospinning (Abstract; [0009], [0016]). The membranes may be fabricated using polylactic acid (PLA) and a solvent, such as acetone ([0022]-[0024]). Soliman et al. further teach that the surface of the electrospun membrane may be coated with an adhesive so that the membrane may be applied to a surgical site without suturing, wherein the adhesive may be hyaluronic acid ([0035]-[0036]; Claims 34, 40-41). Soliman et al. also teach that increasing surface hydrophilicity and controlling degradation rate of electrospun biodegradable materials is highly desirable ([0046]).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to further coat the porous film according to Liao ‘500 with an adhesive, such as hyaluronic acid, so that the membrane may be applied to a surgical site without suturing, as reasonably suggested by Soliman et al.
Regarding instant claim 2, Liao ‘500 teach that the porous anti-adhesive film has a thickness of greater than 20 µm, and greater than 200 µm ([0015], [0035]; Claim 6).
Regarding instant claim 3, Liao ‘500 do not explicitly disclose the porosity of the porous layer, as instantly claimed.
However, Liao ‘500 teach that the one or more polymer fibers can be closely stacked, wound or interlaced in specific directions by controlling the movement of the spinning device to form a porous anti-adhesive film having a uniform thickness ([0034]). The porous anti-adhesive film can reach a desired quality by setting control parameters of the electrospinning process ([0036]).
Soliman et al. teach that the membrane may comprise small pore size or large pore size ([0028]). Electrospinning allows precise control over the pore size and microstructure characteristics of the membranes generated ([0009], [0018]-[0021]).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to precisely control the electrospinning control parameters in order to achieve the desired degree of porosity.
Regarding instant claim 4, Liao ‘500 do not explicitly disclose a bone regeneration material including calcium phosphate.
However, Kensho et al. teach that examples of the calcium phosphate material contained in the material for the inner and outer layers include tricalcium phosphate, hydroxyapatite, dicalcium phosphate and the like. Among them, tricalcium phosphate, which has a good affinity with the copolymer and is absorbed and disintegrated in the living body to be replaced with a new tissue to promote bone tissue repair, is most preferable.
Also, Irie et al. teach a living tissue regeneration guide sheet obtained by laminating a porous composite film made of β-tricalcium phosphate and a softer biodegradable material. Since each composite membrane is composed of a biodegradable material and β-tricalcium phosphate, it is absorbed into the living body as the tissue is regenerated by cell differentiation ([0005]). Irie et al. teach that the membrane can be used to regenerate and guide the alveolar bone in the defective portion of the alveolar bone ([0014]-[0016]; Figure 2). Irie et al. teach that the biodegradable material includes polylactic acid ([0016]).
Regarding instant claim 5, Liao ‘500 do not explicitly disclose a particle size of the bone regeneration material, as instantly claimed.
Kensho et al. teach that calcium phosphate having an average particle size of 200 μm or less is used. If the average particle size exceeds 200 μm, it is not suitable because it is difficult to form a thin film ([0015]).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to include calcium phosphate having a particle size of less than 200 µm. A person of ordinary skill in the art would have been able to determine through routine experimentation the optimum particle size of calcium phosphate to include in the porous layer of Liao ‘500 to promote bone regeneration and be suitable for use in the electrospinning method.
Regarding instant claim 6, Liao ‘500 teach that the polymer material having biocompatibility and degradability includes polylactic acid ([0014], [0021], [0033], [0038]; Claim 5).
Regarding instant claim 7, Liao ‘500 do not explicitly disclose the molecular weight of the biodegradable polymer.
However, Liao ‘500 teach a polymer material suitable for electrospinning into a biomedical grade porous anti-adhesive film. Liao ‘500 further teach that the polymer includes polylactic acid, polycaprolactone, poly(lactide-co-glycolide), polyhydroxyalkanoate, polyglycolic acid, hyaluronic acid and gelatin ([0014]).
A person of ordinary skill in the art would have been motivated to determine through routine experimentation the optimal molecular weight for the polymer for use in electrospinning the films according to Liao ‘500.
Regarding instant claim 8, Liao ‘500 teach that in one embodiment the polymer material may include hyaluronic acid ([0014], [0033], [0038]; Claim 5).
Soliman et al. teach that the surface of the electrospun membrane may be coated with an adhesive so that the membrane may be applied to a surgical site without suturing, wherein the adhesive may be hyaluronic acid ([0035]-[0036]; Claims 34, 40-41).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to coat the biomedical-grade porous anti-adhesive film with hyaluronic acid so that the membrane may be applied to a surgical site without suturing, as reasonably suggested by Soliman et al.
Regarding instant claim 9, Liao ‘500 teach a method of manufacturing a porous anti-adhesive film, which includes the steps of providing an electrospinning solution comprising a polymer material and a solvent, and performing an electrospinning process by using the electrospinning solution to form the porous anti-adhesive film ([0010]; Claims 1-10).
As discussed above, it would have been obvious to include an effective amount of a bone generation material with the electrospinning solution as suggested by Kensho et al. and Irie et al., as well as coating the film with hyaluronic acid, as suggested by Soliman et al.
Regarding instant claim 10, Liao ‘500 teach that the solvent is selected from the group consisting of acetone, butanone, ethylene glycol, hexafluoroisopropanol (HFIP), isopropanol, deacetylated chitosan (DAC), N,N-dimethylformamide (DMF), dimethylacetamide (DMAC), dimethyl sulfoxide (DMSO), and ether (Claim 1).
Regarding instant claim 11, Liao ‘500 teach an ejection speed of the electrospinning solution can be from 0.1 cc/min to 5 cc/min. However, these details regarding the electrospinning process are merely exemplary, and are not intended to limit the present disclosure ([0036]).
Regarding instant claim 12, Liao ‘500 do not explicitly disclose the concentration of hyaluronic acid, as instantly claimed.
Soliman et al. teach that the surface of the electrospun membrane may be coated with an adhesive so that the membrane may be applied to a surgical site without suturing, wherein the adhesive may be hyaluronic acid ([0035]-[0036]; Claims 34, 40-41).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to determine through routine experimentation the appropriate concentration of hyaluronic acid to use in a treatment solution for coating the films according to Liao ‘500.
Claims 1-12 are rejected under 35 U.S.C. 103 as being obvious over Liao ‘206 (US 2024/0024206 A1, effective filing date 20 July 2022) in view of Kensho et al. (JP 2002-325830 A) and Irie et al. (JP 2004-024706 A).
The applied reference has a common assignee and joint inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Regarding instant claim 1, Liao ‘206 teach a separating membrane for dental surgeries, comprising a biodegradable porous base layer and a hydrophilic substance that is bonded to the biodegradable porous base layer, wherein in the step of treating the biodegradable porous base layer with the aqueous solution containing the hydrophilic substance, the biodegradable porous base layer is immersed in the aqueous solution ([0009], [0018]; Claims 1 and 12).
Liao ‘206 do not explicitly disclose a porous layer including a bone regeneration material attached on the porous structure, as instantly claimed.
However, Kensho et al. teach a bone tissue regeneration-inducing membrane comprising at least a bilayer membrane. The outer layer includes polylactic acid, and the inner layer includes calcium phosphate ([0008]). Examples of the calcium phosphate material contained in the material for the inner and outer layers include tricalcium phosphate, hydroxyapatite, dicalcium phosphate and the like. Among them, tricalcium phosphate, which has a good affinity with the copolymer and is absorbed and disintegrated in the living body to be replaced with a new tissue to promote bone tissue repair, is most preferable. Calcium phosphate having an average particle size of 200 μm or less is used. If the average particle size exceeds 200 μm, it is not suitable because it is difficult to form a thin film ([0015]).
Also, Irie et al. teach a living tissue regeneration guide sheet obtained by laminating a porous composite film made of β-tricalcium phosphate and a softer biodegradable material. Since each composite membrane is composed of a biodegradable material and β-tricalcium phosphate, it is absorbed into the living body as the tissue is regenerated by cell differentiation ([0005]). Irie et al. teach that the membrane can be used to regenerate and guide the alveolar bone in the defective portion of the alveolar bone ([0014]-[0016]; Figure 2). Irie et al. teach that the biodegradable material includes polylactic acid ([0016]).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare the separating material according to Liao ‘206 further comprising calcium phosphate as a bone regenerative material attached to the porous layer. Such would have been obvious because Kensho et al. and Irie et al. teach separating membranes comprising polylactic acid and calcium phosphate, wherein tricalcium phosphate, which has a good affinity with the copolymer and is absorbed and disintegrated in the living body to be replaced with a new tissue to promote bone tissue repair, is most preferable.
Regarding the concentration of porous structure and bone regeneration material, a person of ordinary skill in the art would have been motivated to determine through routine experimentation the optimum quantity of calcium phosphate to include in the porous layer of Liao ‘206 to effectively promote bone regeneration.
Regarding instant claim 2, Liao ‘206 teach a thickness of the biodegradable porous base layer is from 200 μm to 400 μm ([0011], [0044]; Table 1; Claims 3 and 10).
Regarding instant claim 3, Liao ‘206 do not explicitly disclose the porosity of the porous layer, as instantly claimed.
However, Liao ‘206 teach in the electrospinning process, the spinning solution can be sprayed from a nozzle and solidified to form the polylactic acid fibers in an electrostatic field, and then the polylactic acid fibers are deposited on a collecting board. Through adjusting a movement of the nozzle, the polylactic acid fibers can be tightly stacked, entangled, or interwoven along a specific direction, so as to form the biodegradable porous base layer with a uniform thickness. The aqueous solution containing the hydrophilic substance is used to treat the biodegradable porous base layer, such that the hydrophilic substance is bonded to the biodegradable porous base layer. The aqueous solution includes the hydrophilic substance and water. Specifically, the hydrophilic substance not only adheres to the outer surface of the biodegradable porous base layer, but also penetrates into the biodegradable porous base layer. Accordingly, the polylactic acid fibers are all adhered with the hydrophilic substance ([0049]-[0050]; Claims 8-14).
The method according to Liao ‘206 is the same as the method according to the instant specification at [0063]-[0068]. Therefore, absent evidence to the contrary, the method according to Liao ‘206 would also produce a porosity of 10% to 30%.
Regarding instant claim 4, Liao ‘206 do not explicitly disclose a bone regeneration material including calcium phosphate.
However, Kensho et al. teach that examples of the calcium phosphate material contained in the material for the inner and outer layers include tricalcium phosphate, hydroxyapatite, dicalcium phosphate and the like. Among them, tricalcium phosphate, which has a good affinity with the copolymer and is absorbed and disintegrated in the living body to be replaced with a new tissue to promote bone tissue repair, is most preferable.
Also, Irie et al. teach a living tissue regeneration guide sheet obtained by laminating a porous composite film made of β-tricalcium phosphate and a softer biodegradable material. Since each composite membrane is composed of a biodegradable material and β-tricalcium phosphate, it is absorbed into the living body as the tissue is regenerated by cell differentiation ([0005]). Irie et al. teach that the membrane can be used to regenerate and guide the alveolar bone in the defective portion of the alveolar bone ([0014]-[0016]; Figure 2). Irie et al. teach that the biodegradable material includes polylactic acid ([0016]).
Regarding instant claim 5, Liao ‘206 do not explicitly disclose a particle size of the bone regeneration material, as instantly claimed.
Kensho et al. teach that calcium phosphate having an average particle size of 200 μm or less is used. If the average particle size exceeds 200 μm, it is not suitable because it is difficult to form a thin film ([0015]).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to include calcium phosphate having a particle size of less than 200 µm. A person of ordinary skill in the art would have been able to determine through routine experimentation the optimum particle size of calcium phosphate to include in the porous layer of Liao ‘206 to promote bone regeneration and be suitable for use in the electrospinning method.
Regarding instant claim 6, Liao ‘206 teach that a material of the biodegradable porous base layer includes polylactic acid, wherein in certain embodiments, based on a total weight of the material of the biodegradable porous base layer being 100 wt %, a content of the polylactic acid can be greater than or equal to 50 wt %, and is preferably 100 wt % ([0010], [0012], [0043]; Claims 2 and 4).
Regarding instant claim 7, Liao ‘206 teach a material of the biodegradable porous base layer includes a biodegradable polymer that can have a molecular weight ranging from 100,000 g/mol to 600,000 g/mol (preferably ranging from 150,000 g/mol to 350,000 g/mol) ([0043]).
Regarding instant claim 8, Liao ‘206 teach that the hydrophilic substance is selected from the group consisting of hyaluronic acid ([0009]-[0010]; Claims 1-2).
Regarding instant claim 9, Liao ‘206 teach a method for manufacturing a separating membrane for dental surgeries, comprising: providing a biodegradable porous base layer; and treating the biodegradable porous base layer with an aqueous solution containing a hydrophilic substance, such that the hydrophilic substance is bonded to the biodegradable porous base layer, wherein in the step of treating the biodegradable porous base layer with the aqueous solution containing the hydrophilic substance, the biodegradable porous base layer is immersed in the aqueous solution for 30 seconds to 1 minute ([0016], [0018], [0038]; Figure 4; Claim 8). In one embodiment of the present disclosure, in the step of providing the biodegradable porous base layer, a plurality of polylactic acid fibers are provided and formed into a layered structure by electrospinning ([0020], [0045], [0047]-[0049]).
Regarding instant claim 10, Liao ‘206 teach that a spinning solution for electrospinning can include polylactic acid and a solvent. The solvent can be selected from the group consisting of acetone, butanone, ethylene glycol, isopropanol, deacetylated chitin (DAC), N,N-dimethylformamide (DMF), dimethylacetamide (DMAC), dimethyl sulfoxide (DMSO), and ether ([0048]).
Regarding instant claim 11, Liao ‘206 do not explicitly disclose the ejection speed of the polymer solution in the electrospinning process, as instantly claimed.
However, Liao ‘206 teach that in the electrospinning process, the spinning solution can be sprayed from a nozzle and solidified to form the polylactic acid fibers in an electrostatic field, and then the polylactic acid fibers are deposited on a collecting board. Through adjusting a movement of the nozzle, the polylactic acid fibers can be tightly stacked, entangled, or interwoven along a specific direction, so as to form the biodegradable porous base layer with a uniform thickness ([0049]).
Therefore, a person of ordinary skill in the art would have been motivated to optimize the ejection speed of the polymer from the electrospinning process in order to effectively form a tightly stacked, entangled or interwoven base layer with a uniform thickness.
Regarding instant claim 12, Liao ‘206 teach that in one embodiment of the present disclosure, based on a total weight of the aqueous solution being 100 wt %, a content of the hydrophilic substance is from 25 wt % to 40 wt% ([0017], [0038], [0051]; Claim 11).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Claims 1-12 are rejected under 35 U.S.C. 103 as being obvious over Liao ‘988 (TW I809988 B) in view of Kensho et al. (JP 2002-325830 A) and Irie et al. (JP 2004-024706 A).
The disclosure of TW I809988 B, which was published prior to the effective filing date of the instant claims, is the same as US 2024/0024206 A1, discussed above. Therefore, the claims are rejected for the same reasons as above.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 9-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-11 of copending Application No. 18/070,405 in view of Kensho et al. (JP 2002-325830 A) and Irie et al. (JP 2004-024706 A).
Regarding instant claim 9, the ‘405 Application claims a method for manufacturing a separating membrane for dental surgeries, comprising: providing a biodegradable porous base layer, wherein the biodegradable porous base layer is formed by a plurality of polylactic acid electrospun fibers; and immersing the biodegradable porous base layer in an aqueous solution containing a hydrophilic substance for 30 seconds to 1 minute, such that the hydrophilic substance is bonded to the biodegradable porous base layer; wherein the hydrophilic substance is hyaluronic acid, and the plurality of polylactic acid electrospun fibers are adhered with the hyaluronic acid; wherein an outer surface of the separating membrane has a water contact angle of less than 30° (Claim 8).
The ‘405 Application does not claim preparing a polymer solution including a solvent, a biodegradable polymer, and a bone regeneration material, as instantly claimed.
However, Kensho et al. teach a bone tissue regeneration-inducing membrane comprising at least a bilayer membrane. The outer layer includes polylactic acid, and the inner layer includes calcium phosphate ([0008]). Examples of the calcium phosphate material contained in the material for the inner and outer layers include tricalcium phosphate, hydroxyapatite, dicalcium phosphate and the like. Among them, tricalcium phosphate, which has a good affinity with the copolymer and is absorbed and disintegrated in the living body to be replaced with a new tissue to promote bone tissue repair, is most preferable. Calcium phosphate having an average particle size of 200 μm or less is used. If the average particle size exceeds 200 μm, it is not suitable because it is difficult to form a thin film ([0015]).
Also, Irie et al. teach a living tissue regeneration guide sheet obtained by laminating a porous composite film made of β-tricalcium phosphate and a softer biodegradable material. Since each composite membrane is composed of a biodegradable material and β-tricalcium phosphate, it is absorbed into the living body as the tissue is regenerated by cell differentiation ([0005]). Irie et al. teach that the membrane can be used to regenerate and guide the alveolar bone in the defective portion of the alveolar bone ([0014]-[0016]; Figure 2). Irie et al. teach that the biodegradable material includes polylactic acid ([0016]).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare the separating material according to the ‘405 Application further comprising calcium phosphate as a bone regenerative material attached to the porous layer. Such would have been obvious because Kensho et al. and Irie et al. teach separating membranes comprising polylactic acid and calcium phosphate, wherein tricalcium phosphate, which has a good affinity with the copolymer and is absorbed and disintegrated in the living body to be replaced with a new tissue to promote bone tissue repair, is most preferable.
Regarding the concentration of porous structure and bone regeneration material, a person of ordinary skill in the art would have been motivated to determine through routine experimentation the optimum quantity of calcium phosphate to include in the porous layer of the ‘405 Application to effectively promote bone regeneration.
Regarding instant claim 10, the ‘405 Application teaches that a spinning solution for electrospinning can include polylactic acid and a solvent. The solvent can be selected from the group consisting of acetone, butanone, ethylene glycol, isopropanol, deacetylated chitin (DAC), N,N-dimethylformamide (DMF), dimethylacetamide (DMAC), dimethyl sulfoxide (DMSO), and ether ([0048]). A person of ordinary skill in the art would have been motivated to use a suitable solvent for the electrospinning process, as taught by the ‘405 Application.
Regarding instant claim 11, the ‘405 Application does not claim the ejection speed of the polymer solution in the electrospinning process, as instantly claimed.
A person of ordinary skill in the art would have been motivated to determine through routine optimization the ejection speed of the polymer from the electrospinning process in order to effectively form the biodegradable porous base layer.
Regarding instant claim 12, the ‘405 Application claims that the hydrophilic substance is hyaluronic acid, and based on a total weight of the aqueous solution containing the hydrophilic substance being 100 wt.%, a content of the hydrophilic substance is from 25 wt.% to 40 wt.% (Claims 8 and 11).
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/N.W.S/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616