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 .
Applicant’s amendment and accompanying remarks filed January 6, 2026 are acknowledged.
Examiner acknowledges amended claims 1, 9, 14 and 18.
Examiner acknowledges cancelled claims 2-4, 15 and 17.
The rejection of claims 1, 5-8, 12, 14, 16 and 19 under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Ladet et al., U.S. Pre Grant Publication 2009/0004239 is overcome by Applicant’s amendment.
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.
Claims 1, 5-9, 12-14, 16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rocco et al., U.S. Pre Grant Publication 2020/0253713 in view of Suzuki et al., JP 2002-200176
Regarding claims 1, 9, 12 and 18, Rocco discloses composite scaffold devices coated with PEG 400 [0101]. Paragraph 0161 discloses that the that the textile support structure comprises PLLA fibers. Paragraph 0020 discloses that composite scaffold comprises a textile support structure [0160]. Paragraph 0125 discloses that the composite scaffold can include additives including biologics such as seeded cells and bioactive agents wherein the bioactive agents can include growth factors, therapeutics and extracellular matrices. With the bioactive agents being added to the textile structure that is coated with PEG 400, the bioactive agents are combined with the PEG 400. Paragraph 0210 and Figure 2D disclose a surgical mesh. The abstract of Rocco discloses that the reinforcement is used for repair of tissues. Rocco illustrates a 3D mesh in Figure 1A. The manner in which the 3D mesh is manufactured is given minimal patentable weight. Rocco discloses a planar 3D mesh as claimed by Applicant. The manner in which the 3D mesh in Rocco is manufactured has the same structure as claimed by Applicant.
Rocco is silent to the PLLA fibers being fused. Suzuki discloses a 3D net structure in Figure 1. Paragraph 0006 discloses a fabric formed of bioabsorbable fibers such as PLLA fibers. Paragraph 0010 discloses that the fabric is coated with polyethylene glycol wherein the coating can further include a drug [pharmaceutical compound]. Paragraph 0012 discloses that the intersections of the fibers may be joined or bonded at one or more points by using heat fusion [0015]. Suzuki discloses body tissue [0001]. Additionally, Suzuki discloses that the fabric made of bioabsorbable material has large expansion force and high flexibility. Rocco and Suzuki are analogous art in that both references discloses fabrics of PLLA fibers coated with PEG for tissue repair. One of ordinary skill in the art before the effective filing date of the invention would utilize the fused PLLA fibers of Suzuki as the fabric/;textile composite structure of Rocco for the benefit of obtaining a coated fabric or textile having enhanced large expansion force and high flexibility.
The combination of Rocco and Suzuki teach the claimed invention but fails to teach wherein the PEG coated on fused PLLA fibers improves flexibility and decreases the crystallinity of the 3D printed mesh as compared to a corresponding uncoated 3D printed mesh mat. It is reasonable to presume that the wherein the PEG coated on fused PLLA fibers improves flexibility and decreases the crystallinity of the 3D printed mesh as compared to a corresponding uncoated 3D printed mesh mat is inherent to the combination of Rocco and Suzuki. Said presumption is based upon Rocco’s disclosure of a composite scaffold devices coated with PEG 400 [0101]. Paragraph 0161 discloses that the that the textile support structure comprises PLLA fibers. Paragraph 0020 discloses that composite scaffold comprises a textile support structure [0160]. Paragraph 0125 discloses that the composite scaffold can include additives including biologics such as seeded cells and bioactive agents wherein the bioactive agents can include growth factors, therapeutics and extracellular matrices. With the bioactive agents being added to the textile structure that is coated with PEG 400, the bioactive agents are combined with the PEG 400. Paragraph 0210 and Figure 2D disclose a surgical mesh. The abstract of Rocco discloses that the reinforcement is used for repair of tissues. Rocco illustrates a 3D mesh in Figure 1A. The manner in which the 3D mesh is manufactured is given minimal patentable weight. Rocco discloses a planar 3D mesh as claimed by Applicant. The manner in which the 3D mesh in Rocco is manufactured has the same structure as claimed by Applicant.
Rocco is silent to the PLLA fibers being fused. Suzuki discloses a 3D net structure in Figure 1. Paragraph 0006 discloses a fabric formed of bioabsorbable fibers such as PLLA fibers. Paragraph 0010 discloses that the fabric is coated with polyethylene glycol wherein the coating can further include a drug [pharmaceutical compound]. Paragraph 0012 discloses that the intersections of the fibers may be joined or bonded at one or more points by using heat fusion [0015]. Suzuki discloses body tissue [0001]. Additionally, Suzuki discloses that the fabric made of bioabsorbable material has large expansion force and high flexibility. Rocco and Suzuki are analogous art in that both references discloses fabrics of PLLA fibers coated with PEG for tissue repair. One of ordinary skill in the art before the effective filing date of the invention would utilize the fused PLLA fibers of Suzuki as the fabric/;textile composite structure of Rocco for the benefit of obtaining a coated fabric or textile having enhanced large expansion force and high flexibility. Burden is upon Applicant to prove otherwise. Fitzgerald, In re, 619 F.2d 67, 205 USPQ 594 (CCPA 1980).
Regarding claims 5-8, 16, 19, paragraphs 0125-0129 of Rocco disclose that the that the composite scaffold can be combined with additives to enhance various characteristics of the scaffold including biologics including seeded cells and bioactive agents. Paragraph 0126 discloses that the bioactive agents such as growth factors, therapeutics and extracellular matrices can be added to the scaffold either before or after the formation of the microporous matrix [combined with the microporous matrix]. Paragraph 0135 discloses that PEG [polyethylene glycol] can be used for the microporous matrix. Paragraph 0127 discloses that suitable growth factors include fibroblast growth factor, vascular endothelial growth factor and epidermal growth factor. Paragraph 0129 discloses therapeutics such as antibiotics and anti-inflammatories. Claim 6 depends upon claim 5 which recites growth factor. Rocco discloses growth factors in paragraph 0126. Rocco satisfies the limitation of claim 6 as it depends on claim 5 which recites growth factors.
Regarding claims 13 and 19-20, paragraph 0125 of Rocco discloses that the composite scaffold can be combined with additives to enhance various characteristics of the scaffold including biologics including seeded cells. Also, paragraph 0125 discloses suitable seeded cells such as mesenchyn stem cells.
Regarding claim 14, the preamble “skin graft” is intended use. See MPEP 2111.02.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Rocco et al., U.S. Pre Grant Publication 2020/0253713 in view of Suzuki et al., JP 2002-200176 as evidenced by Polysciences, Poly-L-lactic Acid.
Regarding claim 10, Polysciences, Poly-L-lactic acid provides evidence that PLLA has a molecular weight of about 100,000 g/mol [100 kDa]. 1 kDa = 1000 g/mol.
Regarding claim 11, Polysciences, Poly-L-lactic acid provides evidence that PLLA has a melting temperature ranging from 173 °C to 178 °C.
Response to Arguments
Applicant’s arguments with respect to the present claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAMIE S THOMPSON whose telephone number is (571)272-1530. The examiner can normally be reached 8:30 am - 5:30 pm.
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/CAMIE S THOMPSON/Primary Examiner, Art Unit 1786
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