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 .
Response to Arguments/ Amendments
Applicant presented no arguments, within the response dated 4/14/2026, 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 4/14/2026, have overcome:
The rejection of claim(s) 1-5, 8-11, 13, 15-17, 20 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) based on Fodor et al. (US 2020/0108173 A1 – as previously cited);
The aforementioned rejection(s) has/have been withdrawn.
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 § 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.
Claim(s) 1-5, 8-11, 13, 15-17, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sostek et al. (US 2014/0141152 A1) in view of Fodor et al. (US 2020/0108173 A1 – as previously cited).
With respect to claim 1:
Sostek et al. discloses the invention substantially as claimed. Specifically, Sostek et al. discloses a tubular construct (tubular scaffold) comprising a tube (frame) having a first end and a second end, wherein the tube (frame) is enclosed within a polymeric outer tube (second layer of material) (paragraph [0060]), wherein the polymeric outer tube (second layer of material) is formed by an electrospinning process (paragraphs [0050, 0066]), wherein the electrospinning process comprises a step of electrospinning a polymer solution (polymer) (paragraphs [0050, 0066]), wherein the polymeric outer tube (second layer of material) has a uniform outer diameter (the scaffold is cylindrical with a uniform diameter) (paragraph [0107]), and wherein the tube (frame) is held under tension from the first and second ends during at least a part of the step of electrospinning the polymer solution-process (maintained under stress/ elongation as the scaffold layers are electrospun) (paragraph [0112]). However, Sostek et al. does not disclose the tube (frame) to be braided (as required by claim 1).
Fodor et al. teaches 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]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to replace the tube (frame), as disclosed by Sostek et al., with the braided tube (braided layer 20), as taught by Fodor et al., as the two structures are functional/ structural equivalents for each other (both are used as stent supports enclosed within electrospun graft layers intended to be used within the respiratory system of a patient) and as such would be obvious substitutes for each other.
With respect to claim 2:
Wherein the application of tension (elongation stress), as disclosed by Sostek et al., is computer-controlled and is based on data collected during the electrospinning process (paragraph [0112]).
With respect to claim 3:
Wherein the braided tube (braided layer 20), as disclosed by Sostek et al. as modified by Fodor et al., is held under tension from the first and second ends during the entire duration of the step of electrospinning the polymer solution process (as the release of stress is not until subsequent of the end of the fabrication process) (Sostek et al. paragraph [0112]).
With respect to claim 4:
Wherein the tubular construct (tubular scaffold), as disclosed by Sostek et al., further comprises an inner layer (first layer), and wherein the tube (frame) is embedded between the polymeric outer tube (second layer of material) and inner layer (first layer) of the tubular construct (tubular scaffold) (paragraphs [0060, 0066]).
With respect to claim 5:
Wherein the braided tube (braided layer 20), as disclosed by Sostek et al. as modified by Fodor et al., is positioned flush with an inside surface of the tubular construct (tubular scaffold) (in situations in which there is no inner layer (first layer) - the tube (frame) will define (and thereby be flush with) an inside surface of the tubular construct (tubular scaffold)).
With respect to claim 8:
Wherein the braided tube braided tube (braided layer 20), as disclosed by Sostek et al. as modified by Fodor et al., is fabricated to be substantially circular (Fodor et al. paragraph [0053]). (Please note: In making the aforementioned combination of Sostek et al. as modified by Fodor et al. (as discussed above with respect to claim 1), Examiner replacing the tube (frame), as disclosed by Sostek et al., with the braided tube (braided layer 20), as taught by Fodor et al., which is inclusive of the shape of the braided tube (braided layer 20), as taught by Fodor et al..)
With respect to claim 9:
Wherein the braided tube (braided layer 20), as disclosed by Sostek et al. as modified by Fodor et al., is fabricated to be substantially D-shaped (Fodor et al. paragraph [0053]). (Please note: In making the aforementioned combination of Sostek et al. as modified by Fodor et al. (as discussed above with respect to claim 1), Examiner replacing the tube (frame), as disclosed by Sostek et al., with the braided tube (braided layer 20), as taught by Fodor et al., which is inclusive of the shape of the braided tube (braided layer 20), as taught by Fodor et al..)
With respect to claim 10:
Wherein the braided tube (braided layer 20), as disclosed by Sostek et al. as modified by Fodor et al., is formed from metal (nitinol) (Fodor et al. paragraph [0064]). (Please note: In making the aforementioned combination of Sostek et al. as modified by Fodor et al. (as discussed above with respect to claim 1), Examiner replacing the tube (frame), as disclosed by Sostek et al., with the braided tube (braided layer 20), as taught by Fodor et al., which is inclusive of the material of the braided tube (braided layer 20), as taught by Fodor et al..)
With respect to claim 11:
Wherein the braided tube (braided layer 20), as disclosed by Sostek et al. as modified by Fodor et al., is formed from a polymer (PET) (Fodor et al. paragraph [0064]). (Please note: In making the aforementioned combination of Sostek et al. as modified by Fodor et al. (as discussed above with respect to claim 1), Examiner replacing the tube (frame), as disclosed by Sostek et al., with the braided tube (braided layer 20), as taught by Fodor et al., which is inclusive of the material of the braided tube (braided layer 20), as taught by Fodor et al..)
With respect to claim 13:
Wherein the mechanical integrity and binding forces between layers of the polymeric outer tube (second layer of material), as disclosed by Sostek et al., are enhanced by electrospraying short fibers (short fibers intermittently streamed) prior to electrospinning a subsequent layer of the polymeric outer tube (second layer of material) (paragraph [0076]).
With respect to claim 15:
Wherein the mechanical integrity and binding forces between layers of the polymeric outer tube (second layer of material), as disclosed by Sostek et al., are enhanced by electrospinning wet fibers (short 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 (second layer of material) (paragraph [0076]). (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 (tubular scaffold) with a polymeric outer tube of one or more layers (second layer of material). 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), as disclosed by Sostek et al. as modified by Fodor et al., is coated (with an organic solvent) (Fodor et al. paragraph [0064]). (Please note: In making the aforementioned combination of Sostek et al. as modified by Fodor et al. (as discussed above with respect to claim 1), Examiner replacing the tube (frame), as disclosed by Sostek et al., with the braided tube (braided layer 20), as taught by Fodor et al., which is inclusive of the materials/ coatings of the braided tube (braided layer 20), as taught by Fodor et al..).
With respect to claim 17:
Wherein the braided tube (braided layer 20), as disclosed by Sostek et al. as modified by Fodor et al., is uncoated (when the electrospun layer is in direct contact with the braid layer 20) (Fodor et al. paragraph [0058]). (Please note: In making the aforementioned combination of Sostek et al. as modified by Fodor et al. (as discussed above with respect to claim 1), Examiner replacing the tube (frame), as disclosed by Sostek et al., with the braided tube (braided layer 20), as taught by Fodor et al., which is inclusive of the coatings/ lack of coatings of the braided tube (braided layer 20), as taught by Fodor et al..).
With respect to claim 20:
Wherein the tubular construct (tubular scaffold) is resorbable in vivo (Please note: In making the aforementioned combination of Sostek et al. as modified by Fodor et al. (as discussed above with respect to claim 1), Examiner replacing the tube (frame), as disclosed by Sostek et al., with the braided tube (braided layer 20), as taught by Fodor et al., which is inclusive of the resorbable material of the braided tube (braided layer 20), as taught by Fodor et al.. As such, the braided tube (braided layer 20), as taught by Fodor et al., is resorbable (Fodor et al. paragraphs [0041, 0097]) and the polymeric outer tube (second layer of material), as disclosed by Sostek et al., is resorbable (Sostek et al. paragraphs [0114, 0116]).
Conclusion
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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA S PRESTON/ Examiner, Art Unit 3774
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