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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/27/2025 has been entered.
Response to Arguments/ Amendments
Applicant presented no arguments, within the response dated 9/27/2025, concerning Examiner’s previous objections to fig. 3. Instead Applicant stated the intention of submitted corrected drawing at a later date. As such, the previous objection to fig. 3 is maintained.
The arguments/ amendments, dated 9/27/2025, have overcome:
The objection to the specifications;
The rejection of claim(s) 4, 6-7, 12-13, 15 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph;
The rejection of claim(s) 18-19 is/are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph;
The rejection of claim(s) 1-6, 8-17, 20 under 35 U.S.C. 103 based on Fodor et al. (US 2020/0108173 A1 – as previously cited) and Grewe et al. (US 2012/0259170 A1 – as previously cited);
The rejection of claim(s) 7 under 35 U.S.C. 103 based on Fodor et al. (US 2020/0108173 A1 – as previously cited) and Grewe et al. (US 2012/0259170 A1 -as previously cited) and further in view of Zaver et al. (US 2012/0158124 A1 – as previously cited);
The aforementioned rejection(s) has/have been withdrawn.
With respect to the rejection of claim(s) 1-6, 8-17, 20 under 35 U.S.C. 103 based on Fodor et al. (US 2020/0108173 A1 – as previously cited) and Grewe et al. (US 2012/0259170 A1 – as previously cited) Applicant argues: in making the combination of Fodor et al. and Grewe et al. - Grewe et al. teaches the tensioning (axially stretching) of the tube (stent 10) during the electrospinning of the polymeric outer tube (graft layer 18) thereon forming a polymeric outer tube (graft layer 18) with wrinkling (thus creating a more flexible tubular construct (stent graft 16) which is less likely to crack after implantation) (paragraphs [0010, 0013, 0050]). This method (tensioning the tube (stent 10) during the application of the polymeric outer tube (graft layer 18)), when used to create the tubular construct (scaffold 10), as disclosed by Fodor et al., would result in the polymeric outer tube (outer tube 18), as disclosed by Fodor et al., having the same wrinkled shape, as taught by Grewe et al.. This “wrinkling” creates/ results in a variable outer diameter polymeric outer tube (outer tube 18) (due to the folds in the material) which does not meet the requirements of amended claim 1 (which require the polymeric outer tube having a uniform outer diameter). While Examiner agrees with this argument. Examiner has reconsidered the amount of patentable weight to give to the claim limitation of “wherein the braided tube is held under tension from the first and second ends during at least a part of the electrospinning process”. First, the aforementioned claim requirement is a product by process claim requirement. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered an electrospun polymeric outer tube on a braided tube. Manufacturing steps such as tensioning the braided tube during the electrospinning process are not given patentable weight in the claim (as the tensioning of the braided tube during the electrospinning process do not appear to impart distinctive structural characteristics to the final product (such as: a specific measurable kink resistance as argued by Applicant in the interview dated 9/16/2025)). “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113. As such, Examiner is reapplying the Fodor et al. reference under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2), as discussed below. Second, the within the claim language “wherein the braided tube is held under tension from the first and second ends during at least a part of the electrospinning process” the “at least a part of the electrospinning process” is open ended and can be more broadly interpreted by Examiner – as what is considered part of the electrospinning process? Examiner argues the electrospinning process extends longer than just the step of electrospraying the polymeric material on the braided tube – such as, during the transition/ prepping of the braided tube prior to the actual electrospraying. For example, the braided tube could be tensioned after being attached to a mandrel (to ensure the braided tube is properly attached and will not become dislodged from the mandrel during spraying) and then the tension could be released prior to the actual step of electrospraying, thereby resulting in a braided tube that is electrosprayed while untensioned but that has been tensioned during another portion of the part of the electrospinning process; thus resulting in a tubular construct which has no distinctive structural characteristics from a tubular construct (scaffold 10), as disclosed by Fodor et al., which is not tensioned during the actual spraying of the electrospun polymeric outer tube (outer tube 18).
Drawings
The following is a quotation of the appropriate paragraphs of 37 CFR 1.84 that form the basis for the rejections under this section made in this Office action:
(b) Photographs.—
(1) Black and white. Photographs, including photocopies of photographs, are not ordinarily
permitted in utility and design patent applications. The Office will accept photographs in utility
and design patent applications, however, if photographs are the only practicable medium for
illustrating the claimed invention. For example, photographs or photomicrographs of:
electrophoresis gels, blots (e.g., immunological, western, Southern, and northern), auto-
radiographs, cell cultures (stained and unstained), histological tissue cross sections (stained and
unstained), animals, plants, in vivo imaging, thin layer chromatography plates, crystalline
structures, and, in a design patent application, ornamental effects, are acceptable. If the subject
matter of the application admits of illustration by a drawing, the examiner may require a
drawing in place of the photograph. The photographs must be of sufficient quality so that all
details in the photographs are reproducible in the printed patent.
(2) Color photographs. Color photographs will be accepted in utility and design patent
applications if the conditions for accepting color drawings and black and white photographs
have been satisfied. See paragraphs (a)(2) and (b)(1) of this section.
Figure 3 is rejected under 37 CFR 1.84(b)(1) as a black and white photograph is not ordinarily permitted. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 8-11, 13, 15-17, 20 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Fodor et al. (US 2020/0108173 A1 – as previously cited).
With respect to claim 1:
Fodor et al. discloses a tubular construct (scaffold 10), as can be seen in fig. 11, comprising a braided tube (braided layer 20) having a first end and a second end (paragraph [0056]), wherein the braided tube (braided layer 20) is enclosed (covered) within a polymeric outer tube (outer tube 18) (paragraph [0056]), wherein the polymeric outer tube (outer tube 18) is formed by an electrospinning process (paragraphs [0058, 0066, 0070, 0077]), wherein the polymeric outer tube (outer tube 18) has a uniform outer diameter (the scaffold 10 has a cylindrical uniform diameter and the scaffold 10 has a uniform wall thickness) (paragraphs [0057, 0084]), and wherein the braided tube (braided layer 20) is held under tension from the first and second ends during at least a part of the electrospinning process (during the electrospinning of the outer tube 18). (PLEASE NOTE: “wherein the braided tube is held under tension from the first and second ends during at least a part of the electrospinning process is a product by process claim requirement. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered an electrospun polymeric outer tube on a braided tube. Manufacturing steps such as tensioning the braided tube during the electrospinning process are not given patentable weight in the claim (as the tensioning of the braided tube during the electrospinning process do not appear to impart distinctive structural characteristics to the final product (such as: a specific measurable kink resistance as argued by Applicant in the interview dated 9/16/2025)). “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113. Additionally, the within the claim language “wherein the braided tube is held under tension from the first and second ends during at least a part of the electrospinning process” the “at least a part of the electrospinning process” is open ended and can be more broadly interpreted by Examiner – as what is considered part of the electrospinning process? Examiner argues the electrospinning process extends longer than just the step of electrospraying the polymeric material on the braided tube – such as, during the transition/ prepping of the braided tube prior to the actual electrospraying. For example, the braided tube could be tensioned after being attached to a mandrel (to ensure the braided tube is properly attached and will not become dislodged from the mandrel during spraying) and then the tension could be released prior to the actual step of electrospraying, thereby resulting in a braided tube that is electrosprayed while untensioned but that has been tensioned during another portion of the part of the electrospinning process; thus resulting in a tubular construct which has no distinctive structural characteristics from a tubular construct (scaffold 10), as disclosed by Fodor et al., which is not tensioned during the actual spraying of the electrospun polymeric outer tube (outer tube 18).)
With respect to claim 2:
Wherein the application of tension is computer-controlled and is based on data collected during the electrospinning process. (PLEASE NOTE: the aforementioned claim is a product by process claim. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered an electrospun polymeric outer tube on a braided tube. Manufacturing steps such tensioning via a computer controlled system are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.)
With respect to claim 3:
Wherein the braided tube (braided layer 20) is held under tension rom the first and second ends during the entire duration of the electrospinning process. (PLEASE NOTE: the aforementioned claim is a product by process claim. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered an electrospun polymeric outer tube on a braided tube. Manufacturing steps such as the duration of tensioning during electrospinning are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.)
With respect to claim 4:
Wherein the tubular construct (scaffold 10) further comprises an inner layer (interior layer 22) (paragraph [0056]), and wherein the braided tube (braided layer 20) is embedded (completely surrounded) between the polymeric outer tube (graft layer 18) and inner layer (interior layer 22) of the tubular construct (scaffold 10).
With respect to claim 5:
Wherein the braided tube (braided layer 20) is positioned flush with an inside surface of the tubular construct (scaffold 10) (in situations in which there is no interior layer (22) - the braided tube (braided layer 20) will define (and thereby be flush with) an inside surface of the tubular construct (scaffold 10)).
With respect to claim 8:
Wherein the braided tube (braided layer 20) is fabricated to be substantially circular (paragraph [0053]).
With respect to claim 9:
Wherein the braided tube (braided layer 20) is fabricated to be substantially D-shaped (paragraph [0053]).
With respect to claim 10:
Wherein the braided tube (braided layer 20) is formed from metal (nitinol) (paragraph [0064]).
With respect to claim 11:
Wherein the braided tube (braided layer 20) is formed from a polymer (PET) (paragraph [0064]).
With respect to claim 13:
Wherein the mechanical integrity and binding forces between layers of the polymeric outer tube (when there are multiple graft layers 18) are enhanced by electrospraying short fibers prior to electrospinning a subsequent layer of the polymeric outer tube (when there are multiple graft layers 18). (PLEASE NOTE: the aforementioned claim is a product by process claim. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a tubular construct (scaffold 10) with a polymeric outer tube of one or more layers (graft layer 18 maybe multilayered) and a braided tube (braided layer 20). Manufacturing steps such using specific lengths of fibers for different layers making up the electrospun structure are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.)
With respect to claim 15:
Wherein the mechanical integrity and binding forces between layers of the polymeric outer tube (when there are multiple graft layers 18) are enhanced by electrospinning wet fibers by decreasing a screen distance during electrospinning to generate a “tacky surface” prior to electrospinning a subsequent layer of the polymeric outer tube (when there are multiple graft layers 18). (PLEASE NOTE: the aforementioned claim is a product by process claim. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a tubular construct (scaffold 10) with a polymeric outer tube of one or more layers (graft layer 18 maybe multilayered) and a braided tube (braided layer 20). Manufacturing steps such using specific distances to between structures to electrospun wet fibers are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.)
With respect to claim 16:
Wherein the braided tube (braided layer 20) is coated (with an organic solvent) (paragraph [0064]).
With respect to claim 17:
Wherein the braided tube (braided layer 20) is uncoated (when the electrospun layer is in direct contact with the braid layer 20) (paragraph [0058]).
With respect to claim 20:
Wherein the tubular construct (scaffold 10) is resorbable in vivo (paragraphs [0041, 0097]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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/REBECCA S PRESTON/ Examiner, Art Unit 3774