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 .
Continued Examination Under 37 CFR 1.114
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 on July 21, 2025. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 18, 2025 has been entered.
Response to Amendment
Applicant’s amendment filed on June 18, 2025 has been entered. Claims 1 and 16 have been amended. As such, Claims 1-16 are currently pending in the application, with Claim 16 withdrawn from consideration.
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, 2, 6-8, 12, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2013/0338791 to McCullen et al. (“McCullen”).
With regard to Claim 1, 2, 8, and 15, McCullen discloses a multilayered fibrous construct for use as a scaffold for repairing or replacing cartilage or cartilage-like tissue. See, e.g., Abstract, entire document. McCullen discloses that the multilayered fibrous construct comprises first, second, and third layers of polymer fibers that are biocompatible and biodegradable, and that the first, second, and third layers can be formed using the same polymer. Paragraph [0022]. It would have been obvious to a person having ordinary skill in the art at the time of filing the invention to provide the first fibrous layer disclosed by McCullen with a synthetic polymer having identical properties to the polymer of the second fibrous layer, since McCullen teaches that it is preferable to use the same polymer for both of these layers, and because McCullen does not suggest that the polymer need to be modified in any sufficient manner to change the polymer properties. Rather, McCullen teaches that layers of material possess different properties from the physical construction of the fibers making up those layers instead of modification of the polymer, itself. McCullen discloses that non-identical properties exist across multiple layers of the multilayered fibrous construct, noting that “the average diameter of fibres within the third layer is greater than the average diameter of fibres within the second layer. Fibre diameter not only changes the tensile properties but also the physical properties such as pore size.” Paragraph [0011]. McCullen also notes that “[t]he first layer of fibres has the strongest mechanical properties” compared to the second and third layers. Paragraph [0013]. With regard to Claims 6 and 12, McCullen discloses that “the average diameter of fibres within the first, second and third layers are: first layer 0.1-5 µm; second layer: 0.1-5 µm; and third layer: 0.5-25 µm.” Paragraph [0012]. With regard to Claims 7 and 13, McCullen discloses that “the first, second and third layers of the construct are formed by sequential electrospinning.” Paragraph [0028].
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over McCullen in view of U.S. Patent Application Publication No. 2008/0051881 to Feng et al. (“Feng”).
With regard to Claim 3, McCullen teaches that a base layer can be utilized in the multilayered construct of their invention. Paragraph [0025]. However, McCullen does not disclose using a non-porous sheet base layer. Feng is also related medical devices comprising porous layers useful in tissue scaffolding. See, e.g., Abstract, paragraph [0018], entire document. Feng teaches that a non-porous sheet layer can be included in the structure to provide stability to the product after packaging. Paragraph [0062]. It would have been obvious to a person having ordinary skill in the art at the time of filing the invention to utilize a non-porous base layer in the multilayered construct disclosed by McCullen in order to provide stability to the product after packaging, but prior to use, as shown to be known in the art by Feng.
Claims 4, 9-11, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over McCullen in view of U.S. Patent Application Publication No. 2010/0233115 to Patel et al. (“Patel”).
With regard to Claim 9, McCullen discloses that preferred polymers for forming the fibers include polycaprolactone and polylactic acid. Paragraph [0022]. However, McCullen does not disclose that the layers are elastomeric. Patel is also related to fibrous polymer scaffolds comprising multiple layers for use in cartilage replacement or repair. See, e.g., Abstract, entire document. Patel teaches that “[s]caffolds of multiple layers of polymer fibers may have multiple differential alignments for each layer, providing tensile strength, suture retention strength, elasticity, flexibility, and rigidity while minimizing delamination of the layers of fibers.” Paragraph [0088]. Patel teaches that polycarprolactone and polylactic acid polymers are elastomeric polymers that provide flexibility for the resulting scaffold. Paragraphs [0154] and [0219]. It would have been obvious to a person having ordinary skill in the art at the time of filing the invention to use elastomeric polymer in the multiple layers of the multilayered fibrous construct disclosed by McCullen in order to provide a flexible cartilage material, as shown to be known by Patel. With regard to Claims 4 and 10, Patel does not specifically disclose the strain-at-break property of 100-2500% for the elastomeric material used to form the layers or that the deforming load of 100% strain-at-break does not cause delamination of the base layer from the first layer. However, Patel does teach that properties such as elasticity, tensile strength, and resistance to delamination can be varied and controlled well within the purview of the skilled artisan. See, e.g., paragraphs [0088] and [0219]. As such, it would have been obvious to a person having ordinary skill in the art at the time of filing the invention to provide the multilayered fibrous construct taught by the combination of McCullen with Patel with a strain-at-break of 100% to 2500%, without delamination, in order to provide a durable material that will maintain its structure upon implantation into a body, as such properties are entirely foreseeable with the use of elastomeric polymers in tissue scaffolding, and because “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, 456 (CCPA 1955). With regard to Claims 11 and 14, Patel discloses that copolyesters comprising caprolactone and/or lactic acid units are suitable for use in the multilayered scaffolding. Paragraph [0139].
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over McCullen in view of U.S. Patent Application Publication No. 2009/0039565 to Reneker et al. (“Reneker”).
With regard to Claim 5, McCullen does not disclose using a colorant. Reneker is also related to electrospun fibrous constructions for use in medical devices. See, e.g., Abstract, entire document. Reneker discloses that polymer solutions can be provided with dyes or colorants for visual discernment. Paragraph [0071]. It would have been obvious to a person having ordinary skill in the art at the time of filing the invention to provide colorant to the multilayered construct disclosed by McCullen in order to provide visual discernment to the product, as shown to be generally known in the art by Reneker.
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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,549,197 (“the ‘197 Patent”) in view of McCullen. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘197 Patent also claims a multilayer construct comprising an elastomeric base layer, a first electrospun fibrous layer, and a second electrospun fibrous layer. The ‘197 Patent claims, in Claim 2, that the base layer and the first layer each comprise polyester. The ‘197 Patent further recites dependent claim limitations with overlapping scope to that which is presently claimed. Although the ‘197 Patent does not recite the synthetic polymer in the base layer has identical properties to the synthetic polymer in the first layer, such a modification is rendered obvious by the teachings of McCullen, which discloses that a multilayered fibrous construct comprising first, second, and third layers of polymer fibers that are biocompatible and biodegradable can be provided with first, second, and third layers formed using the same polymer. Paragraph [0022].
Response to Arguments
Applicant’s arguments with respect to Claims 1-15 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. For example, Patel is no longer relied upon as a primary reference in the rejection, nor is Patel cited for the proposition that the same polymer with identical properties is used in a base layer and a first fibrous layer.
Conclusion
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JEREMY R. PIERCE
Primary Examiner
Art Unit 1789
/JEREMY R PIERCE/Primary Examiner, Art Unit 1789