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 III in the reply filed on February 9, 2026 is acknowledged. Claims 1-2, 4-21, 32-34, 36-38 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 9, 2026.
The requirement is still deemed proper and is therefore made FINAL.
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) 22-23, 25-27, and 29 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Blum et al (US 20160184080 A1) "Blum".
Regarding Claim 22, Blum discloses a vascular graft (endoluminal prosthesis 100 and graft body 120, par. [0034], Fig. 1) comprising one or more sheets or hollow tubes (support structure 110 defined by ring structures 112, graft body 120, pars. [0035] and [0038], Fig. 1) comprising a plurality of microfibers (graft body 120 made of various materials, par. [0039], Fig. 1) having one or more therapeutic agents (graft body 120 made of biocompatible materials, pars. [0039] and [0079], Fig. 1) embedded therein (par. [0009]).
Regarding Claim 23, Blum discloses the vascular graft of claim 22, wherein the one or more therapeutic agents: comprises a compound having at least one carboxyl group (par. [0079]);
and/or is selected from the group consisting of an anticoagulant, an antiplatelet, an antihistamine, an antihypertensive, a nonsteroidal anti-inflammatory drug (NSAID), a statin, an antibiotic, a growth factor, factor Xa inhibitors, direct thrombin inhibitors, an anti- proliferative drug, and combinations thereof (par. [0079]).
Regarding Claim 25, Blum discloses the vascular graft of claim 23, wherein the anticoagulant comprises heparin (par. [0102]).
Regarding Claim 26, Blum discloses the vascular graft of claim 25, wherein the heparin comprises a low molecular weight heparin (LMWH) (par. [0102]).
Regarding Claim 27, Blum discloses the vascular graft of claim 26, wherein the LMWH is selected from the group consisting of bemiparin, nadroparin, reviparin, enoxaparin, parnaparin, certoparin, dalteparin, tinzaparin, ardeparin, and pharmaceutically acceptable salts and combinations thereof (par. [0102]).
Regarding Claim 29, Blum discloses the vascular graft of claim 22, wherein the vascular graft comprises a tubular scaffold (support structure 110 and graft body 120, pars. [0034] and [0036], Fig. 1) comprising a hollow core (inside of support structure 110 defined by ring structures 112, path of lumen 122 extending from graft body 120, pars. [0035], [0038] and [0057], Fig. 1) surrounded by one or more sheets (layers 370 and 380 covering support structure 110, pars. [0056]-[0057], [0061]-[0063], Figs. 7-10) comprising a plurality of microfibers (layers 370 and 380 made of electrospun fibers, which consist of PET microfibers, pars. [0009], [0011], [0012], [0062], Figs. 7-10) having one or more therapeutic agents (layers 370 and 380 made of electrospun fibers, pars. [0078] and [0079], Figs. 7-10) embedded therein (pars. [0009], [0011], and [0073]).
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) 28, 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Blum et al (US 20160184080 A1) "Blum" in view of Menon et al (US 20190110883 A1) "Menon".
Regarding Claim 28, Blum does not disclose a plurality of microfibers comprising various proteins. However, Menon, in the same field of art, teaches a vascular graft with woven tubular nanotextiles (graft 300, Abstract, par. [0086], Fig. 3A), wherein the plurality of microfibers further comprise a protein selected from the group consisting of fibrinogen, collagen, elastin, gelatin, hyaluronic acid, and combinations thereof (par. [0011]). 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 structure disclosed by Blum to include a plurality of microfibers comprising various proteins, as taught by Menon, in order to maintain biocompatibility by using biodegradable polymers (Menon, pars. [0005] and [0006]).
Regarding Claim 30, Blum does not disclose a vascular graft with a hollow core and inner diameter between 0.1 mm to about 6 mm. However, Menon, in the same field of art, teaches a vascular graft with woven tubular nanotextiles (graft 300, Abstract, par. [0086], Fig. 3A), wherein the hollow core has an inner diameter having a range from about 0.1 mm to about 6 mm (par. [0011]). 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 structure disclosed by Blum to include a hollow core and inner diameter between 0.1 mm to about 6 mm, as taught by Menon, in order to have a small enough diameter to maintain or improve functionality (Menon, par. [0009]).
Regarding Claim 31, Blum does not disclose a vascular graft in which one or more sheets have a combined thickness having a range from about 5 nm to about 10,000 pm. However, Menon, in the same field of art, teaches a vascular graft with woven tubular nanotextiles (graft 300, Abstract, par. [0086], Fig. 3A), wherein the one or more sheets have a combined thickness having a range from about 5 nm to about 10,000 pm (par. [0011]). 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 structure disclosed by Blum to include a hollow core and inner diameter between 0.1 mm to about 6 mm, as taught by Menon, in order to have a small enough diameter to maintain or improve functionality (Menon, par. [0009]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE NICOLE THOMAS whose telephone number is (571)272-0004. The examiner can normally be reached Monday - Friday 8:30am-5pm.
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/NATALIE N THOMAS/Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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