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 1-2 and 4-12, filed 19 June 2026, are pending.
Declaration under 37 CFR 1.130(a)
The declarations under 37 CFR 1.130(a) filed 19 June 2026 are sufficient to overcome the rejections of claims 1-12 based upon US 2024/0024206 A1 and TW I809988 B.
Terminal Disclaimer
The terminal disclaimer filed on 19 June 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on Application Number 18/070,405 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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 1-2 and 4-12 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), Soliman et al. (US 2021/0008505 A1), Muthukrishnan (Colloid and Polymer Science, 2022) and Malekpour et al. (Biotechnology Progress, 2021).
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 the porosity ranging from 10% to 30%, 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 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 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]).
Muthukrishnan teaches electrospinning various polymers for tissue engineering, including bone regeneration, wherein the molecular weight of the polymers is a factor that affects the electrospinning. Lower molecular weight polymers (600 kDa) tend to form spherical shaped particles, while higher molecular weight polymers (1180 kDa) form smooth fibers suitable for tissue engineering applications (pg. 884, col. 1).
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. A person of ordinary skill in the art would have been motivated to select a polymer molecular weight that forms fibers that are suitable for use in the biomedical 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.
Malekpour et al. teach a method for coating PLGA electrospun nanofibers comprising immersing the nanofibers into a hyaluronic acid solution followed by drying (pg. 3, Section 3.1).
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, wherein the films are immersed in a coating solution comprising hyaluronic acid.
Response to Arguments
Applicant's arguments filed 19 June 2026 have been fully considered but they are not persuasive. Applicant argues that neither Liao '500 nor Soliman provides any teaching, suggestion, or motivation that would have led one of ordinary skill in the art to select the claimed low porosity range from 10% to 30%. Specifically, Liao '500 does not disclose any relationship between porosity and the performance of its anti-adhesion membrane. Moreover, although Soliman generally discloses membranes having small or large pore sizes and teaches that electrospinning allows precise control over the pore size and microstructure characteristics of the membranes generated, Soliman consistently teaches highly porous membranes rather than low porosity membranes. Applicant asserts that Soliman suggests that higher porosity provides better performance. Thus, the overall teachings of Soliman would lead one of ordinary skill in the art toward relatively high porosity membranes, not toward the claimed low porosity range of 10% to 30%. Therefore, one of ordinary skill in the art would lack motivation to modify the prior art membranes to achieve the claimed porosity range of 10% to 30%.
The examiner respectfully argues that Soliman et al. teach that electrospinning enables direct control of the microstructure of a scaffold, including characteristics such as the fiber diameter, orientation, pore size, and porosity ([0005], [0009], [0018]-[0021]). Soliman et al. teach that the membrane may be composed of at least two layers with different pore sizes. This may preferably enhance the functionality of the membrane as a barrier for soft tissue that promotes healing. The layer with the smaller pore size may preferably function as a barrier during gingival tissue healing, preventing soft tissue infiltration into a bone defect and also stabilizing one or more blood clots formed during healing. The layer with the larger pore size may preferably promote cell infiltration and guided bone healing ([0027]). Therefore, Soliman et al. teach that the pore size can be controlled with smaller pore sizes functioning as a barrier for soft tissue that promotes healing, and larger pore sizes promoting cell infiltration and guided bone healing. A person of ordinary skill in the art would have been motivated to determine through routine experimentation the optimum pore sizes and the porosity for separating membranes comprising a bone regeneration material.
Applicant further argues that the cited prior arts, whether taken alone or in combination, do not disclose, teach, or suggest the claimed, "a weight average molecular weight of the biodegradable polymer ranges from 250,000 g/mol to 600,000 g/mol." Applicant asserts that Kensho expressly teaches away from using polymers having molecular weights exceeding 200,000.
The examiner respectfully argues that Liao ‘500 teaches that the biodegradable polymers for electrospinning include polylactic acid, polycaprolactone, poly(lactide-co-glycolide), polyhydroxyalkanoate, polyglycolic acid, hyaluronic acid and gelatin ([0014], [0033]; Claim 5). A person of ordinary skill in the art would have been able to determine through routine experimentation the optimum molecular weight for use in the electrospinning according to Liao ‘500. Muthukrishnan teaches electrospinning various polymers for tissue engineering, including bone regeneration, wherein the molecular weight of the polymers is a factor that affects the electrospinning. Lower molecular weight polymers (600 kDa) tend to form spherical shaped particles, while higher molecular weight polymers (1180 kDa) form smooth fibers suitable for tissue engineering applications (pg. 884, col. 1).
Applicant further argues that the amended claim 9 is directed to a manufacturing method including a step of immersing the porous layer in a treatment solution. In contrast, although Soliman generally discloses coating hyaluronic acid on the surface of an electrospun membrane, Soliman does not disclose or suggest the step of immersing the porous layer in a treatment solution.
The examiner respectfully argues that Soliman et al. teach that a coating material may be physically coated on the surface of the electrospun membranes after electrospinning, wherein the surface of the electrospun membrane may be coated with a biodegradable synthetic polymer such as hyaluronic acid ([0035]-[0036]). Malekpour et al. teach a method for coating PLGA electrospun nanofibers comprising immersing the nanofibers into a hyaluronic acid solution followed by drying (pg. 3, Section 3.1).
Conclusion
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nathan W Schlientz whose telephone number is (571)272-9924. The examiner can normally be reached 10:00 AM to 6:00 PM, Monday through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571) 272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.W.S/Examiner, Art Unit 1616
/MONICA A SHIN/Primary Examiner, Art Unit 1616
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