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 .
Status
Applicant’s response dated 03 February 2026 to the previous Office action dated 04 November 2025 is acknowledged. Pursuant to amendments therein, claims 1-3, 5-6, 8, 10-14, 16-17, 22-23, 26, 32, 36, and 39-42 are pending in the application.
The claim objections made in the previous Office action are withdrawn in view of applicant’s claim amendments.
The rejections under 35 U.S.C. 103 made in the previous Office action are maintained.
Election/Restrictions
Claims 39-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 28 July 2025.
Claims 1-3, 5-6, 8, 10-14, 16-17, 22-23, 26, 32, and 36 are under current consideration.
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.
Claim(s) 1-3, 5-6, 8, 12, 16-17, 22-23, 26, 32, and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lelkes et al. (US 2015/0359619 A1; published 17 December 2015; of record).
Regarding claim 1, Lelkes et al. discloses a hybrid graft comprising a micropattern of grooves to which cells adhere and orient along, and electrospun microfibers (abstract; paragraph [0009]) wherein the graft is produced using electrocasting/electrospraying and electrospinning (paragraph [0010]) wherein each groove has a depth of about 1 µm and a width of about 5 µm and positioned 5 µm away from each other (paragraphs [0011], [0023]), reading on the claimed periodicity of alternating ridges or valleys is optionally 500 µm or less or a repeated three-dimensional pattern or tessellation of raised shapes with a periodicity of less than 500 µm, wherein the graft / luminal surface comprises polymeric material such as polydimethylsiloxane (paragraphs [0014], [0170]), reading on the claimed polymer matrix structure and surface of a siloxane target comprising a siloxane composition, wherein an elastomeric polymer is electrocast/electrosprayed on a micropatterned mandrel thereby generating a casted graft, followed by electrospinning an elastomeric polymer on the casted graft to produce electrospun fibers on the graft (paragraph [0021]) wherein luminal surface and mandrel have complementary micropattern features (paragraph [0100]), reading on the claimed electrodepositing polymer fibers onto a surface of a target, wherein the micropattern / grooves are parallel or perpendicular to the direction of the lumen (paragraph [0105]) wherein the electrodepositing mechanism includes a nozzle (paragraph [0120]), reading on the claimed electrodeposition nozzle, wherein microfibers are oriented helically along the graft length (paragraph [0194]), reading on the claimed controlled fiber alignment and a non-homogenous pattern of alternating ridges and valleys extending generally perpendicularly to a fiber alignment direction, wherein the target may be electrically charged to create an electrical field for electrodeposition (paragraph [0121]), reading on producing an aligned electrical field for depositing the polymer fibers in the fiber alignment direction.
Further regarding claim 1, although a single example in Lelkes et al. does not disclose all such steps and elements as discussed above, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Lelkes et al. as discussed above and to perform the method of Lelkes et al. as discussed above including all the steps and elements as discussed above, with a reasonable expectation of success.
Regarding claim 2, as discussed above with respect to claim 1, Lelkes et al. discloses that the target may be electrically charged to create an electrical field for electrodeposition (paragraph [0121]), reading on the claimed target and/or surface of the target being conductive.
Regarding claim 3, as discussed above with respect to claim 1, Lelkes et al. discloses that the graft / luminal surface comprises polymeric material such as polydimethylsiloxane (paragraphs [0014], [0170]), reading on the claimed target comprising a siloxane composition, and discloses each groove has a depth of about 1 µm and a width of about 5 µm and positioned 5 µm away from each other (paragraphs [0011], [0023]), reading on the claimed plurality of alternating ridges and valleys.
Regarding claim 5, as discussed above with respect to claim 1, Lelkes et al. discloses that the graft / luminal surface comprises polymeric material such as polydimethylsiloxane (paragraphs [0014], [0170]), reading on the claimed target comprising a siloxane composition. Further regarding claim 5, Lelkes et al. discloses that the polymer can be one or more polymers such as polyaniline (paragraph [0131]) and can contain nanoparticles (paragraph [0119]), reading on the claimed conductor. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Lelkes et al. as discussed above and to perform the method of Lelkes et al. as discussed above using as polymer therein polydimethylsiloxane with polyaniline or polyaniline nanoparticles, with a reasonable expectation of success.
Regarding claim 6, see above regarding claim 5, which reads on the claimed conductor comprising conductive particles or siloxane doped with a conductive material.
Regarding claim 8, see above regarding claim 5, which reads on the claimed conductor comprising polyaniline.
Regarding claim 12, Lelkes et al. discloses that the graft grooves can have square or rectangular cross-sectional geometries (paragraph [0099]), reading on the claimed pair of adjacent ridges having polygonal cross-sections. It would have been prima face obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Lelkes et al. as discussed above and to practice the method of Lelkes et al. as discussed above wherein the graft grooves have square or rectangular cross-sectional geometries, with a reasonable expectation of success.
Regarding claim 16, Lelkes et al. discloses that heart leaflets have been fabricated using electrospinning (paragraph [0005]), reading on the claimed heart valve leaflet. It would have been prima face obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Lelkes et al. as discussed above and to practice the method of Lelkes et al. as discussed above wherein the graft is a heart leaflet, with a reasonable expectation of success. Such method necessarily/inherently has a target comprising a pattern of ridges and valleys configured to produce a fiber matrix in the size and shape of a heart valve leaflet having a base edge and an apex wherein the ridges and valleys are arranged to produce a convex arrangement of fibers with respect to the base edge as claimed.
Regarding claim 17, Lelkes et al. discloses a tubular mandrel (paragraph [0128], which reads on the claimed target being non-planar. It would have been prima face obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Lelkes et al. as discussed above and to practice the method of Lelkes et al. as discussed above wherein the mandrel / target is tubular, with a reasonable expectation of success.
Regarding claims 22-23, see the discussion above regarding claim 16.
Regarding claim 26, see the discussion above regarding claims 1-3, 5, and 10.
Regarding claim 32, see the discussion above regarding claim 1.
Further regarding claim 32, Lelkes et al. discloses that the graft grooves can have semi-circular, semi-oval, or v-shaped cross-sectional geometries (paragraph [0099]), reading on the claimed shapes of the repeated three-dimensional pattern or tessellation being not square or rectangular. It would have been prima face obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Lelkes et al. as discussed above and to practice the method of Lelkes et al. as discussed above wherein the graft grooves have semi-circular, semi-oval, or v-shaped cross-sectional geometries, with a reasonable expectation of success.
Regarding claim 36, Lelkes et al. discloses that the polymers can comprise biodegradable polymers (paragraphs [0119], [0134]), reading on the claimed polymer fibers prepared from a bioerodable polymer. It would have been prima face obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Lelkes et al. as discussed above and to practice the method of Lelkes et al. as discussed above wherein the polymer therein comprises a biodegradable polymer, with a reasonable expectation of success.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lelkes et al. as applied to claims 1-3, 5-6, 8, 12, 16-17, 22-23, 26, 32, and 36 above, and further in view of Krieger et al. (US 2018/0245243 A1; published 30 August 2018; of record).
Lelkes et al. is relied upon as discussed above.
Lelkes et al. does not disclose a conductive layer deposited over at least a portion of the surface of the target as in claim 10
Regarding claim 10, Krieger et al. discloses a method for generating a electro spun fiber medical implant (abstract) wherein a mandrel may have conductive coating such as silver, chrome, or gold thereon (paragraph [0057]).
Further regarding claim 10, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Lelkes et al. and Krieger et al. by using a conductive coating such as silver, chrome, or gold as suggested by Krieger et al. on the mandrel/target in the method of Lelkes et al. as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to use a material known for use as/on mandrels/targets for electrospinning as suggested by Krieger et al., given that it is prima facie obvious to select a known material based on its suitability for its intended use per MPEP 2144.07.
Regarding claim 11, see the discussion above regarding claim 1 for the claimed target comprising a pattern of alternating ridges and valleys, and see the discussion above regarding claim 10 for the claimed target being metallic such as silver, chrome, or gold.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lelkes et al. as applied to claims 1-3, 5-6, 8, 12, 16-17, 22-23, 26, 32, and 36 above, and further in view of Johnson et al. (US 2017/0071607 A1; published 16 March 2017; of record).
Lelkes et al. is relied upon as discussed above.
Lelkes et al. does not disclose movement as in claims 13-14.
Regarding claims 13-14, Johnson et al. discloses polymeric electrospun devices and methods (title) wherein during electrospinning the mandrel may move with respect to the polymer injection system and/or the polymer injection system may move with respect to the mandrel wherein movement may be rotational and/or translational wherein the pattern of the electrospun fiber deposited on the mandrel may depend upon such motion (paragraph [0070]), which reads on the claimed target and/or electrodeposition nozzle moving in a direction relative to each other during the electrodeposition, and which reads on the claimed electrodeposition nozzle moving relative to the target.
Further regarding claims 13-14, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Lelkes et al. and Johnson et al. by during electrospinning in the method of Lelkes et al. as discussed above moving the mandrel with respect to the polymer injection system / nozzle and/or moving the polymer injection system / nozzle with respect to the mandrel wherein the movement may be rotational and/or translational wherein the pattern of the electrospun fiber deposited on the mandrel depends upon such motion as suggested by Johnson et al. as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to achieve a desired pattern of electrospun fiber and to use a material and method known for use as/on mandrels/targets for electrospinning as suggested by Johnson et al., given that it is prima facie obvious to select a known material based on its suitability for its intended use per MPEP 2144.07.
Further regarding claims 13-14, Lelkes et al. discloses that the mandrel may rotate (paragraph [0094]), reading on the claimed rotating mandrel, and it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Lelkes et al. as discussed above and to rotate the mandrel in the method of Lelkes et al. in view of Johnson et al. as discussed above, with a reasonable expectation of success.
Further regarding claim 13, such movement as discussed above with respect to claims 13-14 necessarily/inherently results in the claimed portion of ridges and valleys of the target not being longitudinally extended perpendicular to a direction of relative movement of the target and the electrodeposition nozzle, thereby depositing a fiber in a direction not parallel to the direction of the relative movement of the target and the electrodeposition nozzle.
Response to Arguments
Applicant's arguments filed 03 February 2026 have been fully considered but they are not persuasive.
Applicant argues that the microfibers of Lelkes are not deposited onto the surface of the micropatterned polydimethylsiloxane sheet but rather are deposited onto the non-patterned portion of the spin-casted polyether polyurethane portion (remarks pages 9-10). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., depositing microfibers onto the surface of the micropatterned polydimethylsiloxane sheet) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claims merely recite (in part) that the fibers are deposited onto a surface of a siloxane target comprising a siloxane composition, and thus fiber deposition onto any surface of a target that comprises a siloxane composition, including deposition onto a surface of the target regardless of whether such particular surface contains the siloxane composition present on/in the target, e.g., Lelkes et al., satisfies the claim limitations.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617