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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-10, in the reply filed on 15 December 2025 is acknowledged. Claims 23-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 8 is objected to because of the following informalities: in line 2 and again in line 4, “concentric” should apparently be deleted for consistency with the rest of the claims. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8 and 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites the limitation “prior to pulling over the concentric bioink tube” in line 2. However, claim 1 does not recite a step of pulling the braid tube over the bioink tube (by contrast, claim 2 does recite such a step). It is not clear if this limitation is intended to positively recite such a step, if the claim should be dependent upon claim 2, or something else.
Claim 9 recites the limitation “wherein the stabilization tube is polytetrafluoroethylene, poloxamer, and combinations thereof.” It is not clear if this is intended to mean that the tube must comprise (i) PTFE, (ii) poloxamer, and (iii) combinations of PTFE and poloxamer; or if the tube only must comprise at least one of these. For sake of compact prosecution, the latter interpretation has been adopted herein.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 4-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Rapoport et al. (U.S. Pub. No. 2018/0369451 A1; hereinafter known as “Rapoport”), in view of Scheglova et al. (RU 187447 U1; hereinafter known as “Scheglova”).
Regarding claim 1, Rapoport discloses a method for forming a tissue engineered vascular graft (Abstract; [0006]-[0007]), comprising the step of: forming the vascular graft by depositing a bioink layer on a rotating mandrel ([0009]-[0015]). Rapoport fails to disclose positioning a braid tube concentrically over the bioink tube. Scheglova discloses a similar method (Abstract) comprising positioning a braid tube concentrically over a vascular prosthesis tube in order to improve the elastic-deformative properties and the biocompatibility of the apparatus (p. 6, lines 7-11 & lines 33-48). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Rapoport by positioning a braid tube concentrically over the bioink tube, as taught by Scheglova, in order to improve the elastic-deformative properties and the biocompatibility of the apparatus.
Regarding claim 2, the combination of Rapoport and Scheglova discloses the invention as claimed, see rejection supra, and Scheglova further discloses pulling the braid tube over the bioink tube on the mandrel (Fig. 4; p. 8, lines 25-34).
Regarding claim 4, the combination of Rapoport and Scheglova discloses the invention as claimed, see rejection supra, and Scheglova further discloses that the braid tube is expandable to a first diameter and contractible to a second diameter under axial loading (e.g., such a braided nitinol tube has such elastic-deformative properties).
Regarding claims 5 and 6, the combination of Rapoport and Scheglova discloses the invention as claimed, see rejection supra, and Scheglova further discloses that the braid tube is any one of a woven, knitted, braided, or non-woven textile and is made of nitinol (p. 7, lines 1-14; knitted nitinol filaments into tubular mesh).
Regarding claim 7, the combination of Rapoport and Scheglova discloses the invention as claimed, see rejection supra, and Rapoport further discloses that the bioink is deposited on the rotating mandrel using 3D printing, dip casting, or slot casting ([0169]-[0170]; [0179]-[0180]).
Regarding claim 8, the combination of Rapoport and Scheglova discloses the invention as claimed, see rejection supra, and Scheglova further discloses a stabilization tube 8 and the step of pulling out the stabilization tube once positioned on the bioink tube and leaving the braid tube behind over the concentric bioink tube to form the vascular graft (p. 8, lines 25-34). While the combination of Rapoport and Scheglova does not expressly disclose that the braid tube is positioned concentrically over the stabilization tube prior to pulling over the concentric bioink tube, this would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as obvious to try. With the use of such a stabilization tube that is positioned between the bioink tube and the braid tube (and then removed), there are two ways to couple the recited components: (i) place the stabilization tube over the bioink tube and then place the braid tube over the stabilization tube, or (ii) place the braid tube over the stabilization tube and then place both the braid tube and the stabilization tube over the bioink tube. Both provide identical functionality and results.
Regarding claim 10, the combination of Rapoport and Scheglova discloses the invention as claimed, see rejection supra, and Rapoport further discloses that a sacrificial layer is deposited on the rotating mandrel prior to the bioink layer being deposited on the rotating mandrel ([0025]; [0068]-[0069]; [0216]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Rapoport and Scheglova as applied to claim 1 above, and further in view of Greenhalgh (U.S. Pub. No. 2002/0087176 A1). The combination of Rapoport and Scheglova discloses the invention as claimed, see rejection supra, but fails to disclose that the step of positioning the braid tube is comprised of interlacing filaments concentrically over the bioink tube on the mandrel. Greenhalgh discloses a similar method (Abstract) comprising positioning a braid tube by interlacing filaments concentrically over a mandrel in order to best control the nominal diameter of the braid tube ([0039]; [0049]; [0055]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Rapoport and Scheglova by interlacing filaments concentrically over the bioink tube on the mandrel, as taught by Greenhalgh, in order to best control the nominal diameter of the braid tube.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Rapoport and Scheglova as applied to claim 8 above, and further in view of Kolbel et al. (U.S. Pub. No. 2020/0038211 A1; hereinafter known as “Kolbel”). The combination of Rapoport and Scheglova discloses the invention as claimed, see rejection supra, but fails to expressly disclose that the stabilization tube is polytetrafluoroethylene, poloxamer, and combinations thereof; Scheglova does teach that the stabilization tube is plastic. Kolbel discloses a similar method (Abstract) comprising a removable tube that is made of PTFE in order to provide a physiologically benign low friction material ([0032]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Rapoport and Scheglova by using a stabilization tube made of PTFE, as taught by Kolbel, in order to provide a physiologically benign low friction material.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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, Jason M. Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THADDEUS B COX/Primary Examiner, Art Unit 3791