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. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/26/2026 has been entered.
Response to Arguments
Applicant’s arguments, see pages 6-7, filed 3/26/2026, with respect to the rejection(s) of claim(s) 10 under a combination of Jeckel and Rapaport, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a combination of Jeckel, Rapaport and Fibrothelium.
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.
Claim(s) 10-11 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over US 3,337,673 (Jeckel) in view of USPAP 2009/0227026 (Rapoport et al.), and further in view of WO 2020/109222 (Fibrothelium).
Jeckel discloses an artificial blood vessel graft (column 1, lines 16-20) with a corrugated structure. Jeckel discloses the corrugated pattern is achieved by placing a knitted tube (6) on a rod (7), wrapping a fiber (thread 8) in a helical pattern at 8 threads per inch (revolutions per inch), and the pushing the ends of the tube towards one another to cause the knitted tube (6) to bulge outwardly between turns of the fiber (column 2, lines 46-66). Jeckel explains this process allows the spacing and height of the corrugations to be controlled and have uniform dimensions (col 2, lines 10-24).
Jeckel fails to disclose the scaffold (knitted tube 6) is formed of electrospun fibers. Rapoport discloses another prosthetic blood vessel (abstract; [0071]) that may be corrugated [0113]. Rapaport teaches that a tubular element is formed of an electrospun fiber scaffold [0008], as electrospun fiber scaffolds provide suitable, long-lasting biomechanical properties for implants [0134]. By using electrospinning, various material properties of the scaffold can be tailored for a particular application [0157]. One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to substitute an electrospun fiber scaffold taught by Rapoport for the knitted tube of the Jeckel device, as the modification provides a scaffold for a prosthetic blood vessel with improved mechanical properties.
Rapoport further teaches that a second element applied over the first tubular element can be formed of a monofilament [0151]. It would have been further obvious to substitute a monofilament fiber taught by Rapoport for the thread of the Jeckel assembly in order to provide a prosthetic blood vessel with improved mechanical properties that more closely resemble those of a native vessel [0078].
Further in regards to claim 10, Jeckel and Rapoport fail to disclose that the fiber assembly is in a shape of a nerve conduit. Fibrothelium teaches that a tubular tissue scaffold can be shaped as a nerve conduit in order to fill a gap between injured nerve segments to facilitate regeneration of the nerve (page 18, lines 24-32; Figure 2). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to configure the electrospun fiber scaffold of the modified Jeckel device as a nerve conduit, as taught by Fibrothelium, as the modification merely involves a combination of known implantable tubular scaffolds that obtains a predictable result of a tubular nerve conduit for aiding in nerve regeneration.
The limitation “wherein the corrugated surface of the electrospun fiber scaffold is formed without the application of heat” is not given patentable weight. This is a product-by-process limitation directed towards a particular method by which the product is made, which is not germane to the issue of patentability of the device itself. Modified Jeckel meets all the claimed structural requirements of the final product.
In regards to claim 11, Jeckel discloses the fiber is wound at 8 threads per inch (column 2, lines 46-66), which falls within the claimed range of 2 TPI to about 20 TPI.
Regarding claim 13, the electrospun fiber scaffold may comprise polyurethane or PET [0027-0028; 0036; 0039].
Regarding claim 14, Jeckel fails to disclose the particular diameter of the thread (8). Rapoport teaches that a fiber diameter can be varied to achieve a desired mechanical behavior [0078; 0129] and the diameter of a fiber can be in the range of 0.05 - 20 micrometers (see Table 2; [0128]). 20 micrometers overlaps with the claimed range. Applicant appears to have placed no criticality on the claimed range (see claimed presented as a variety of options at [0060]), and it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to configure the monofilament fiber of modified Jeckel to have a diameter of about 20 micrometers, as taught by Rapoport, in order to achieve the desired mechanical behavior of the prosthetic blood vessel.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2019/0110883 (Menon et al.) discloses a nerve conduit formed by electrospinning [0005].
US Patent App. Pub. 2018/0237952 (Johnson et al.) discloses a nerve conduit formed of an electrospun fiber mold [0041].
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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