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 .
Claim Status
Claims 8-11 are pending.
Claim 8 is currently amended.
Claims 1-7 and 12-14 have been canceled.
Claims 8-11 are currently under consideration.
Claims 8-11 are rejected.
Acknowledgement of Receipt
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/24/2025 has been entered.
Priority
This application claims benefit to Taiwan Patent Application No. 111127113, filed on 07/20/2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. § 102 and § 103 (or as subject to pre-AIA 35 U.S.C. § 102 and § 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. § 103 (a) are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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. Applicants are 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 8-11 are rejected under 35 U.S.C. § 103 as being unpatentable over Litvin (WO2024/075118A1, priority to 10/03/2022) herein referenced Litvin’118, in view of Lee (WO2011/081328A2, WIPO, MT), Niu (Colloids and Surfaces B: Biointerfaces 206, 111970, pg. 1-10, 07/07/2021) and Kurusu (International Material Reviews 64:5, pg. 249–287, 2019). Citations from Lee are from the translation provided.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Litvin’118 discloses an effective and stable method for implanting dental implants and subperiosteal implants that are versatile thereby reducing technical complexity, whilst being bio-stable and biocompatible thereby enhancing sustainable outcomes by facilitating an effective integration with the jaw and dental tissue ([003]). Litvin’118 discloses a synthetic biocompatible graft for use in periodontal and/or dental surgery ([0036]). In Figure 2, said graft covers the root implanted part (106) wherein the abutment (105) and the external tooth part (104) remain uncoated ([007]). As such, osseointegration is advantageously facilitated ([008]).
Litvin’118 discloses teaches that the graft has a porous polymeric structure (claim 1) and is biocompatible (claim 4), and further comprises at least one non-porous layer (claim 16). The porous polymeric structure comprises at least one porous electrospun polymer ([0017], [0082], [0084], claim 12) and comprises at least one polymer selected from a group including polylactic acid (PLA) and hyaluronic acid (HA) ([0018], [0032], claim 13).
Litvin’118 does not teach immersing the base layer with an aqueous solution containing a hydrophilic substance for 30 seconds to 1 minute.
Litvin’118 does not teach an outer surface of the separating membrane has a water contact angle (WCA) of less than 30°.
Lee teaches that a challenge with supports having hydrophobic properties e.g., PLA, relates to low cell and tissue suitability when transplanted ([4]). Lee provides a method of surface modification of the support as an answer to these issues ([4]). Lee teaches that the term "construct for tissue-reconstruction" refers to a structure that is implanted in a damaged tissue in the body or around the damaged tissue to regenerate the damaged tissue and then is separated again or completely decomposed ([23]).
Lee provides a construct for tissue regeneration comprising a coating layer formed by coating hyaluronic acid or a salt thereof and fibrinogen on a surface of a frame of a polymer support having pores, wherein (i) the coating layer includes cells, a cell growth factor, or cells and cell growth factors, (ii) the coating layer is crosslinked by thrombin, and (iii) the structure has pores of 10 μm to 1,000 μm. ([25], claim 1). The polymer support may be preferably formed from a biodegradable polymer and the biodegradable polymer may be a biodegradable polymer commonly used in the pharmaceutical or pharmaceutical field, e.g., poly (D, L-lactic acid-co-glycolic acid, PLGA) ] (i.e., polylactic acid based) ([26], claim 2).
Lee discloses that the coating of hyaluronic acid or a salt thereof and fibrinogen on the surface of the structural frame of the polymer support may be performed by immersing the support in an aqueous solution containing hyaluronic acid and fibrinogen, and then taking out the support from the aqueous solution and freeze-drying the same at least once ([29], [56], claim 8). The freeze-drying may be repeatedly performed, for example, 2 to 20 times, but is not limited thereto ([29], claim 9). The immersion may be carried out at 4 to 50° C, preferably 4 to 20° C ([29], [56], claim 10). The immersion time is not particularly limited, and may be performed for a short time of about 30 seconds or may be performed for a longer period of time, for example, 12 to 48 hours as needed ([29], [56]). In addition, if necessary, it is further included to dry the support taken out from the aqueous solution at room temperature (about 25° C.) before freeze-drying after the immersion, thereby preventing pores from being clogged in the preparation process ([29], [56]). Exemplary embodiments of preparation of a scaffold for tissue regeneration are provided in Examples 1-5 ([64]-[88]).
Lee does not teach WCA.
Niu teaches HA/PLA microfibers with hierarchical architecture is that they can bio-mimic the bulk properties of natural blood vessels and that the HA microfibers film coating of the scaffold (i.e., base layer) can provide contact guidance for vascular endothelial cells (ECs), and the architecture and porous microfiber network of the outer wall can promote the infiltration and migration of vascular r smooth muscle cells (SMCs) (pg. 9, col. 1, para. 3). Niu’s studies revealed that vascular ECs prefer to establish natural behavior patterns on the surface of HA/PLA microfibers with hydrophilicity, relatively low surface energy, and roughness (pg. 9, col. 1, para. 5).
Niu teaches that the linear molecular chain of HA contains a large number of carboxyl and hydroxyl groups, and that an aqueous solution thereof has significant viscoelasticity due to the complex tertiary network structure formed by intermolecular interaction at high concentration (pg. 4, col. 2, para. 3.1). Niu performed static water contact angle tests confirmed both the successful incorporation of HA microfibers in the inner wall surface of tubular HA/PLA microfibers and its decoration coating on the inner wall surface to show a 75.2° for HA/PLA and 97.8° for PLA (pg. 5, Table 1).
Niu shows that the pure PLA microfibers did not absorb water within 6 seconds, indicating hydrophobicity, while the HA/PLA microfibers absorbed water within 6 seconds, which showed the hydrophilicity of anisotropic wettability; surface energy analyses show that HA/PLA microfibers have relatively lower surface energy than PLA (pg. 4, col. 2, para. 4; Fig. 1d).
Kurusu discloses surface modification techniques used to change the water wettability of mats produced by electrospinning (abstract). Kurusu teaches and teaches PLGA and PLA as the polymer and hyaluronic acid solution as a coating (pg. 267, Table 4). Kurusu provides water wettability characterization showing water contact angles (WCA) at 0° after surface modification by coating or adsorption with hyaluronic acid where the polymer is PLGA (pg. 267, Table 4) to read on the less than 30° WCA limitation.
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, combine the teachings of Lee, Niu and Kurusu with those of Litvin’118 with expected results. One would be motivated to do so with a reasonable expectation of success for several reasons. Litvin’118 teaches that enhancing hydrophilicity in the coating of dental implants provides high flexibility ([0085]). Litvin’118 further discloses that at least one synthetic biocompatible graft coats at least a part of said implant ([0010], claim 6). Lee discloses hyaluronic acid as enabling the introduction of therapeutically beneficial cells and/or cell growth factors onto the polymer support ([30]). Niu’s surface energy analyses show HA/PLA microfibers having relatively lower surface energy (pg. 9, col. 1, para. 4). In the context of HA/PLA and PLA scaffolds, this is an advantage since vascular endothelial cells prefer to establish natural behavior patterns on the surface of HA/PLA microfibers having hydrophilicity, relatively low surface energy, and roughness (pg. 9, col. 1, para. 4). Kurusu reinforces surface modification for hydrophilization or hydrophilization as necessary to obtain the ideal water wetting behavior (pg. 250, col. 2, para. 2).
Regarding claim 9 (i.e., HA, 10,000–700,000 Daltons), Lee discloses that the average molecular weight of hyaluronic acid or a salt thereof may be 1,000 to 4,000,000 Daltons ([0027], claim 5).
Regarding claim 10, Litvin’118 teaches that the non-porous layer has a thickness of between 100-1000 µm ([0015], [0030], claim 7).
Regarding claim 11, Lee discloses that the content of hyaluronic acid or a salt thereof in the coating layer is in the range of 10 to 90% by weight ([28], claims 6, 33).
Claims 8-11 are rejected under 35 U.S.C. § 103 as being unpatentable over Litvin (US 2022/0313872A1, filed 08/12/2020) herein referenced Litvin’872, in view of Lee (WO2011/081328A2, WIPO, MT), Niu (Colloids and Surfaces B: Biointerfaces 206, 111970, pg. 1-10, 07/07/2021) and Kurusu (International Material Reviews 64:5, pg. 249–287, 2019). Citations from Lee are from the translation provided.
Litvin’872 discloses a synthetic gingival patch graft having a porous polymeric structure and uses thereof in the treatment of periodontal diseases (abstract). Litvin’872 discloses that in some embodiments, the patch graft is a biodegradable patch ([0011], [0025]). Litvin’872 teaches that the porous polymeric structure comprises at least one polymer, nanofibers and at least one porous electrospun polymer ([0014], claims 8-10). The porous polymeric structure comprises at least one polymer selected from polylactic acid (PLA) and hyaluronic acid (HA) ([0015], [0028]). Litvin’872 teaches that in the manufacturing of electrospun fibers, parameters can be optimized and highly porous fibers can be obtained ([0016]). In Figure 2, in addition to the porous layer, a non-porous (film) layer is shown ([0049]).
Litvin’872 does not teach immersing with HA for 30 seconds to 1 minute; and a water contact angle (WCA) of less than 30°.
Lee teaches that a challenge with supports having hydrophobic properties e.g., PLA, relates to low cell and tissue suitability when transplanted ([4]). Lee provides a method of surface modification of the support as an answer to these issues ([4]). Lee teaches that the term "construct for tissue-reconstruction" refers to a structure that is implanted in a damaged tissue in the body or around the damaged tissue to regenerate the damaged tissue and then is separated again or completely decomposed ([23]).
Lee provides a construct for tissue regeneration comprising a coating layer formed by coating hyaluronic acid or a salt thereof and fibrinogen on a surface of a frame of a polymer support having pores, wherein (i) the coating layer includes cells, a cell growth factor, or cells and cell growth factors, (ii) the coating layer is crosslinked by thrombin, and (iii) the structure has pores of 10 μm to 1,000 μm. ([25], claim 1). The polymer support may be preferably formed from a biodegradable polymer and the biodegradable polymer may be a biodegradable polymer commonly used in the pharmaceutical or pharmaceutical field, e.g., poly (D, L-lactic acid-co-glycolic acid, PLGA) ] (i.e., polylactic acid based) ([26], claim 2).
Lee discloses that the coating of hyaluronic acid or a salt thereof and fibrinogen on the surface of the structural frame of the polymer support may be performed by immersing the support in an aqueous solution containing hyaluronic acid and fibrinogen, and then taking out the support from the aqueous solution and freeze-drying the same at least once ([29], [56], claim 8). The freeze-drying may be repeatedly performed, for example, 2 to 20 times, but is not limited thereto ([29], claim 9). The immersion may be carried out at 4 to 50° C, preferably 4 to 20° C ([29], [56], claim 10). The immersion time is not particularly limited, and may be performed for a short time of about 30 seconds or may be performed for a longer period of time, for example, 12 to 48 hours as needed ([29], [56]). In addition, if necessary, it is further included to dry the support taken out from the aqueous solution at room temperature (about 25° C.) before freeze-drying after the immersion, thereby preventing pores from being clogged in the preparation process ([29], [56]). Exemplary embodiments of preparation of a scaffold for tissue regeneration are provided in Examples 1-5 ([64]-[88]).
Lee does not teach WCA.
Niu teaches HA/PLA microfibers with hierarchical architecture is that they can bio-mimic the bulk properties of natural blood vessels and that the HA microfibers film coating of the scaffold (i.e., base layer) can provide contact guidance for vascular endothelial cells (ECs), and the architecture and porous microfiber network of the outer wall can promote the infiltration and migration of vascular r smooth muscle cells (SMCs) (pg. 9, col. 1, para. 3). Niu’s studies revealed that vascular ECs prefer to establish natural behavior patterns on the surface of HA/PLA microfibers with hydrophilicity, relatively low surface energy, and roughness (pg. 9, col. 1, para. 5).
Niu teaches that the linear molecular chain of HA contains a large number of carboxyl and hydroxyl groups, and that an aqueous solution thereof has significant viscoelasticity due to the complex tertiary network structure formed by intermolecular interaction at high concentration (pg. 4, col. 2, para. 3.1). Niu performed static water contact angle tests confirmed both the successful incorporation of HA microfibers in the inner wall surface of tubular HA/PLA microfibers and its decoration coating on the inner wall surface to show a 75.2° for HA/PLA and 97.8° for PLA (pg. 5, Table 1).
Niu shows that the pure PLA microfibers did not absorb water within 6 seconds, indicating hydrophobicity, while the HA/PLA microfibers absorbed water within 6 seconds, which showed the hydrophilicity of anisotropic wettability; surface energy analyses show that HA/PLA microfibers have relatively lower surface energy than PLA (pg. 4, col. 2, para. 4; Fig. 1d).
Kurusu discloses surface modification techniques used to change the water wettability of mats produced by electrospinning (abstract). Kurusu teaches and teaches PLGA and PLA as the polymer and hyaluronic acid solution as a coating (pg. 267, Table 4). Kurusu provides water wettability characterization showing water contact angles (WCA) at 0° after surface modification by coating or adsorption with hyaluronic acid where the polymer is PLGA (pg. 267, Table 4) to read on the less than 30° WCA limitation.
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, combine the teachings of Lee, Niu, and Kurusu with those of Litvin’872’s with expected results. One would be motivated to do so with a reasonable expectation of success for several reasons. Litvin’872 provides an effective and stable solution for gingival recession that is versatile, making the procedure simple to perform, and bio-stable, having an improved and lasting effect ([0007]). Litvin’872’s disclosure of at least one non-porous layer in the form of a film, thus not penetrable ([0023]-[0024], Fig. 2) welcomes HA. Lee discloses hyaluronic acid as enabling the introduction of therapeutically beneficial cells and/or cell growth factors onto the polymer support ([30]). Niu’s surface energy analyses show HA/PLA microfibers having relatively lower surface energy (pg. 9, col. 1, para. 4). In the context of HA/PLA and PLA scaffolds, this is an advantage since vascular endothelial cells prefer to establish natural behavior patterns on the surface of HA/PLA microfibers having hydrophilicity, relatively low surface energy, and roughness (pg. 9, col. 1, para. 4). Kurusu reinforces surface modification for hydrophilization or hydrophilization as necessary to obtain the ideal water wetting behavior (pg. 250, col. 2, para. 2).
Regarding claim 9 (i.e., HA, 10,000–700,000 Daltons), Lee discloses that the average molecular weight of hyaluronic acid or a salt thereof may be 1,000 to 4,000,000 Daltons ([0027], claim 5).
Regarding claim 10, Litvin’872 teaches that the patch graft has a thickness of between 100-1000 µm ([0012], [0026], claim 5).
Regarding claim 11, Lee discloses that the content of hyaluronic acid or a salt thereof in the coating layer is in the range of 10 to 90% by weight ([28], claims 6, 33).
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.
Claim 8 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9 and 12 of copending application no. 18/599,375 herein referenced ‘375 in view of Lee (WO2011/081328A2, WIPO, MT), Niu (Colloids and Surfaces B: Biointerfaces 206, 111970, pg. 1-10, 07/07/2021) and Kurusu (International Material Reviews 64:5, pg. 249–287, 2019). Citations from Lee are from the translation provided.
Claim 9 of ‘375 recites “A method for manufacturing a separating membrane, comprising: preparing a polymer solution including a solvent, a biodegradable polymer, and a bone generation material; wherein, based on a solid content of the polymer solution being 100 wt%, an amount of the biodegradable polymer ranges from 22 wt% to 50 wt%, and an amount of the bone generation material ranges from 50 wt% to 78 wt%; using the polymer solution for an electrospinning process to form a porous layer; and immersing the porous layer into a treatment solution, so as to form a hydrophilic layer encapsulating the porous layer.”
Claim 12 of ‘375 recites, “The method according to claim 9, wherein the treatment solution contains 10 wt% to 30 wt% hyaluronic acid.”
The claims of ‘375 do not recite immersing for 30 seconds to 1 minute; and water contact angle of less than 30°.
Lee discloses immersion time performed in an aqueous solution of HA of about 30 seconds ([29], [56], claim 8). Niu discloses HA microfibers film coating of the scaffold (i.e., base layer) (pg. 9, col. 1, para. 3). Kurusu provides water wettability characterization showing water contact angles (WCA) at 0° after surface modification by coating or adsorption with hyaluronic acid where the polymer is PLGA (pg. 267, Table 4).
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to incorporate the teachings of Lee, Niu and Kurusu in the method for manufacturing a separating membrane of ‘375 with expected results. One would be motivated to do so with a reasonable expectation of success because Lee discloses hyaluronic acid as enabling the introduction of therapeutically beneficial cells and/or cell growth factors onto the polymer support ([30]). Niu’s surface energy analyses show HA/PLA microfibers having relatively lower surface energy (pg. 9, col. 1, para. 4). In the context of HA/PLA and PLA scaffolds, this is an advantage since vascular endothelial cells prefer to establish natural behavior patterns on the surface of HA/PLA microfibers having hydrophilicity, relatively low surface energy, and roughness (pg. 9, col. 1, para. 4). Kurusu reinforces surface modification for hydrophilization or hydrophilization as necessary to obtain the ideal water wetting behavior (pg. 250, col. 2, para. 2).
Claims 9 and 12 of ‘375 recite separating membrane comprising a biodegradable polymer, using the polymer solution for an electrospinning process to form a porous layer; and immersing the porous layer into a solution of hyaluronic acid overlapping with instant claim 8.
Response to Arguments
With respect to Applicants’ outlined declaration filed 06/24/2025 regarding the primary cited reference, as mentioned above,
Applicant's arguments filed 06/24/2025 have been fully considered but they are not persuasive and/or are based on newly amended limitations which have been addressed by the new grounds of rejection above.
Liao is no longer relied upon.
Specifically regarding the technical feature "immersing the biodegradable porous base layer in an aqueous solution containing a hydrophilic substance for 30 seconds to 1 minute, the above rejections include prior art that was not relied upon in the prior rejection of record.
For these reasons, Applicants’ arguments are found unpersuasive.
Conclusion
Claims 8-11 are rejected; no claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Karen Ketcham whose telephone number is (571)270-5896. The examiner can normally be reached 900-500 ET.
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/Karen Ketcham/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614