CTFR 17/671,071 CTFR 80696 DETAILED ACTION Receipt is acknowledged of applicant’s Amendment/Remarks filed 3/18/2026. Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Status of the Claims Claims 37 and 47 have been amended. Claims 1-33 are cancelled. No claims are newly added. Accordingly, claims 34-53 remain pending in the application. Claims 48-53 stand withdrawn from further consideration, without traverse. Claims 34-47 are currently under examination. Withdrawn Rejections Applicant’s amendment renders the rejection of claim 37 under 35 USC 112(b) moot. Specifically, the claim has been amended per the examiner’s suggestion to depend from claim 35. Thus, said rejection has been withdrawn. Applicant’s amendment renders the rejection of claim 47 under 35 USC 103 over Hossainy, Lam, Vonesh, Neff, Frendl and Humayun moot. Specifically, applicant’s argument regarding unexpected results for the particular peptide ligand, LXWY, are persuasive. See Remarks, page 8 and Fig. 12. Thus, said rejection has been withdrawn. Maintained Rejections Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim s 34, 35, 38, 39, 41 and 44 stand rejected under 35 U.S.C. 103 as being unpatentable over Hossainy et al. (US 2014/0370072 A1, Dec. 18, 2014, hereafter as “Hossainy”) in view of Lam et al. (WO 2011/079015 A1, Jun. 30, 2011, hereafter as “Lam”) as evidenced by Hao et al. (“Discovery and Characterization of a Potent and Specific Peptide Ligand Targeting Endothelial Progenitor Cells and Endothelial Cells for Tissue Regeneration”, Feb. 14, 2017, hereafter as “Hao”) . The instant claims are drawn to a medical device comprising: a scaffold; and a coating on a surface of the scaffold, wherein the coating comprises: a coating polymer, hydroxyapatite, or a combination thereof, and a peptide ligand selected from the group consisting of cGRGDdvc, cGRGDsfc, cGRGDdfc, cGRGDsec, cGRGDdsc, cGRGDd- D Bug-c, cGRGDd- D Bta-c, Ac-cGRGDdvc, (β-alanine)-cGRGDdvc, (Ebes)-cGRGDdvc, cGRGDd- D Agl-c, cGRGDd- D Pra-c, cGRGDd-D(NMe)Val-c, cGRGDd- D (CaMe)Val-c, cGRGDd- D Abu-c, cGRGDd- D Nal1-c, and cGRGDd- D Nal2-c. Regarding instant claims 34, 35, 38, 39 and 41 , Hossainy teaches coatings for implantable medical devices and a method of making the coated medical devices ([0003]; claim 16). Said coatings provide enhanced endothelialization of the coating and imparts to the coating enhanced prohealing properties ([0009]). Hossainy teaches the inclusion of piezoelectric polymers and biocompatible polymers in the coating ([0010], [0012] and [0044]). Hossainy teaches an implantable device can be any suitable medical substrate that can be implanted in a human or veterinary patient including, for example, stents, stent-grafts, vascular grafts, heart valves, shunts, and catheters and teaches that the medical device substrate (scaffold) can be made from polymers ([0068]). Hossainy also teaches chemo-attractants can be included in the coating including the particular chemo-attractant, a cyclic RGD peptide ([0013]; claims 14-15). Hossainy is silent to the particular cyclic RGD peptides claimed in instant claims 34 and 44 . Lam teaches cyclic RGD peptides that target αvβ3 integrin on tumor cells and neovasculatures and function as targeting agents for tumor diagnostic imaging and therapy (abstract). Lam teaches that said compounds have improved targeting efficacy and lower nonspecific binding to normal organs (abstract). Lam teaches the particular cyclic RGD peptides, cGRGDdvc (LXW7), cGRGDsfc, cGRGDdfc, cGRGDsec, cGRGDdsc, cGRGDd- D Bug-c, cGRGDd- D Bta-c, Ac-cGRGDdvc, (β-alanine)-cGRGDdvc, (Ebes)-cGRGDdvc, cGRGDd- D Agl-c, cGRGDd- D Pra-c, cGRGDd- D (NMe)Val-c, cGRGDd- D (CaMe)Val-c, cGRGDd- D Abu-c, cGRGDd- D Nal1-c ([0081], [0083]-[0084] and [0087]). Lam teaches that said compounds can be used in any suitable pharmaceutical composition, wherein said pharmaceutical composition comprises a pharmaceutically acceptable excipient such as polymers ([0090]-[0091]). Lam also teaches administering of the compounds includes administration via an implantable device ([0092]). It is noted that at least the particular RGD peptide, LXW7, was known as a potent and specific endothelial progenitor cell (EPC)/ endothelial cell (EC) targeting ligand as evidenced by Hao (abstract). EPCs and ECs were also known to play a vital role in endothelialization and vascularization for tissue engineering as evidenced by Hossainy ([0060]) and Hao (abstract). Both references are drawn to administration of cyclic RGD peptides, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the claimed cyclic RGD peptides such as LXW7 as suggested by Lam into the invention of Hossainy with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Hossainy generally teaches medical devices comprising a scaffold/substrate and a coating on the surface of said scaffold/substrate, wherein the coating comprises a coating polymer and a cyclic RGD peptide and Lam specifically teaches the claimed cyclic RGD peptides including LXW7, which can be combined with pharmaceutically acceptable polymers and can be administered via implantable devices, have improved targeting efficacy and lower nonspecific binding to normal organs for the purpose of tumor diagnostic imaging and therapy. Thus, the combined teachings of Hossainy and Lam render the instant claims prima facie obvious . Response to Arguments 07-37 AIA Applicant's arguments, filed 3/18/2026, regarding the 103 rejection over Hossainy and Lam have been fully considered but they are not persuasive. Applicant argues that the proposed combination of Hossainy and Lam is improper because Lam teaches away from the solution proposed in Hossainy and claimed in the present application. Applicant asserts that a person of ordinary skill in the art seeking to achieve the “prohealing” and cell growth-promoting objective of Hossainy would not select a peptide from Lam that is expressly designed to “induce apoptosis” in the very cell types Hossainy seeks to attract and cultivate. Applicant further asserts that the combination of Hossainy and Lam proposed by the Examiner lacks a reasonably expectation of success because a person of ordinary skill in the art would have no reasonable expectation that a peptide selected for its ability to target and facilitate the destruction of tumor neovasculature would successfully promote the healthy proliferation of endothelial cells on a vascular graft. Applicant further asserts the present application demonstrates in Figs. 12-14 that the claimed invention achieves unexpectedly superior results, that is, a significant increase in endothelial cell proliferation from activating key growth signaling pathways, and superior resistance to platelet adhesion when compared to other previously known RGD peptides. Remarks, pages 7-8. In response, it is respectfully submitted that Hossainy teaches that the coatings provide enhanced endothelialization and prohealing properties ([0009]). Hossainy also teaches that the prohealing drug or agent can be an endothelial cell (EDC)-binding agent and that RGD peptide sequences are EDC-binding agents ([0061] and [0063]). Lam is relied upon for the teaching of particular RGD peptide sequences such as LXW7 and the ability for said sequences to be formulated in combination with polymers and be administered via an implantable device ([0083] and [0090]-[0092]). Said RGD peptide, LXW7, was known as a potent and specific endothelial progenitor cell (EPC)/ endothelial cell (EC) targeting ligand as evidenced by Hao (abstract). It was also known that EPCs and ECs play a vital role in endothelialization and vascularization for tissue engineering as evidenced by Hossainy ([0060]) and Hao (abstract). While Lam teaches cyclic RGD peptides (including those claimed, e.g., LXW7) can be used to target αvβ3 integrin on tumor cells and neovasculatures and function as targeting agents for tumor diagnostic imaging and therapy, the teachings of Lam provide another use/function of at least some RGD peptides. Contrary to applicant’s assertions, it does not appear the Lam’s teachings contradict those of Hossainy but provide teachings of an additional function to that of Hossainy/Hao. It is noted that there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference (MPEP 2112 (II)). With respect to the unexpected results assertion, Figs. 12-14 and corresponding Examples 13-14 have been carefully considered. Said examples provide data of the particular peptide, cGRGDdvc (LXW7) whereas the broadest claim recites a peptide ligand Markush group of 17 peptide ligands (see claim 34). MPEP 716.02(d) states “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the ‘objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.’ In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range”. Accordingly, data provided on a single species does not provide the evidence required over the entire scope of the broader claimed invention (i.e., the 17 species claimed). However, in the case of claim 45 which is limited to LXW7, the data in Fig. 12 demonstrates that a LXW7 treated surface showed limited platelet adhesion whereas GRGD (SEQ ID NO: 1) treated surface allowed a significantly higher number of platelets to attach. Evidence of unobvious or unexpected advantageous properties, such as superiority in a property the claimed compound shares with the prior art, can rebut prima facie obviousness (MPEP 716.02(a)(II)). Thus, the data provided in Fig. 12 demonstrates unexpected results with respect to LXW7. Claim 45 is withdrawn from the rejection. It is further noted that the data provided in Figs. 13-14 compare LXW7 with a control (D-biotin). MPEP 716.02(e) states, that the evidence “must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness”. The evidence provided in Figs. 13-14 does not compare the claimed subject matter with the closest prior art because D-biotin is not representative of the closest prior art. Thus, for these reasons, Applicant’s arguments are found unpersuasive. Said rejection is maintained . 07-22-aia AIA Claim s 36 and 37 stand rejected under 35 U.S.C. 103 as being unpatentable over Hossainy et al. (US 2014/0370072 A1, Dec. 18, 2014, hereafter as “Hossainy”) in view of Lam et al. (WO 2011/079015 A1, Jun. 30, 2011, hereafter as “Lam”) as evidenced by Hao et al. (“Discovery and Characterization of a Potent and Specific Peptide Ligand Targeting Endothelial Progenitor Cells and Endothelial Cells for Tissue Regeneration”, Feb. 14, 2017, hereafter as “Hao”) , as applied to claim s 34 and 35 above, and further in view of Vonesh et al. (USPN 6,673,102 B1, Jan. 6, 2004, hereafter as “Vonesh”) . The instant claims are described above. Hossainy and Lam teach the elements discussed above. Hossainy and Lam are silent to the particular scaffold polymers, PLLA, PCL, PLGA, PLCL, PTFE, ePTFE, and combinations thereof (instant claim 36 ), and wherein the scaffold polymer comprises ePTFE (instant claim 37 ). Vonesh teaches an implantable endovascular device comprising a stent-graft construction (abstract; Fig. 1). Vonesh teaches that the stent can be formed of a variety of wire materials such as PTFE, PLLA, PGA (col. 6, lines 35-48). Vonesh also teaches that cover material comprises a fluoropolymer including expanded PTFE (paragraph bridging cols 7-8). Hossainy and Vonesh are both drawn to implantable devices, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a medical device (scaffold) composed of a polymer such as PLLA or PTFE as suggested by Vonesh with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Hossainy generally teaches implant substrate materials can be any suitable medical substrate that can be implanted in a human/animal such as polymers and Vonesh specifically teaches that medical device/scaffold materials including the particular polymers, PTFE, PLLA and PGA are suitable as medical device scaffold materials (MPEP 2144.07). Further, Vonesh effectively teaches that the medical device scaffold materials are functional equivalents and it is prima facie obvious to combine or substitute functional equivalents known for the same purpose (MPEP 2144.06). Thus, the combined teachings of Hossainy, Lam and Vonesh render the instant claims prima facie obvious . Response to Arguments 07-37 AIA Applicant's arguments, filed 3/18/2026, regarding the 103 rejection over Hossainy, Lam and Vonesh have been fully considered but they are not persuasive. Applicant relies on the same arguments as presented for the 103 rejection over Hossainy and Lam. No further arguments regarding claims 36 and 37 are presented. Remarks, pages 8-9. For the same reasons as discussed above, Applicant’s arguments are not persuasive. Thus, said rejection is maintained . 07-22-aia AIA Claim 40 stands rejected under 35 U.S.C. 103 as being unpatentable over Hossainy et al. (US 2014/0370072 A1, Dec. 18, 2014, hereafter as “Hossainy”) in view of Lam et al. (WO 2011/079015 A1, Jun. 30, 2011, hereafter as “Lam”) as evidenced by Hao et al. (“Discovery and Characterization of a Potent and Specific Peptide Ligand Targeting Endothelial Progenitor Cells and Endothelial Cells for Tissue Regeneration”, Feb. 14, 2017, hereafter as “Hao”) , as applied to claim s 34, 38 and 39 above, and further in view of Neff et al. (US 2009/0022888 A1, Jan. 22, 2009, hereafter as “Neff”) . The instant claims are described above. Hossainy and Lam teach the elements discussed above. Hossainy and Lam are silent to the limitation, the vascular graft is an arteriovenous dialysis graft (instant claim 40 ). Neff teaches medical devices comprising a polymeric coating that is functionalized with a peptide (abstract; [0023]). Neff teaches various medical devices including vascular access devices and names the particular vascular access devices, AV grafts ([0006] and [0069]). Hossainy, Lam and Neff are all drawn to compositions comprising a polymer and a peptide and Hossainy and Neff are drawn to medical devices including a vascular graft comprising a polymer coating comprising a peptide, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the particular medical device, an AV graft into the invention of Hossainy/Lam as suggested by Neff with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Hossainy teaches that implants (such as vascular implants, e.g., stents, grafts, valves) coated with a polymer bound to a bioactive such as a peptide can provide a therapeutic effect locally to the surrounding tissue and Neff teaches that implants including vascular implants such as AV grafts coated with a polymer bound to a bioactive such as a peptide can also provide a therapeutic effect locally to the surrounding tissue. Substitution of one vascular implant for another vascular implant for the same purpose, this is, to treat the vascular system or vascular tissue is prima facie obvious. Thus, the combined teachings of Hossainy, Lam and Neff render the instant claims prima facie obvious . Response to Arguments 07-37 AIA Applicant's arguments, filed 3/18/2026, regarding the 103 rejection over Hossainy, Lam and Neff have been fully considered but they are not persuasive. Applicant relies on the same arguments as presented for the 103 rejection over Hossainy and Lam. No further arguments regarding claim 40 are presented. Remarks, pages 8-9. For the same reasons as discussed above, Applicant’s arguments are not persuasive. Thus, said rejection is maintained . 07-22-aia AIA Claim 46 stands rejected under 35 U.S.C. 103 as being unpatentable over Hossainy et al. (US 2014/0370072 A1, Dec. 18, 2014, hereafter as “Hossainy”) in view of Lam et al. (WO 2011/079015 A1, Jun. 30, 2011, hereafter as “Lam”) as evidenced by Hao et al. (“Discovery and Characterization of a Potent and Specific Peptide Ligand Targeting Endothelial Progenitor Cells and Endothelial Cells for Tissue Regeneration”, Feb. 14, 2017, hereafter as “Hao”) , as applied to claim 34 above, and further in view of Frendl et al. (US 2014/0350671 A1, Nov. 27, 2014, hereafter as “Frendl”) . The instant claims are described above. Hossainy and Lam teach the elements discussed above. Hossainy also teaches recruiting endothelial cells or endothelial progenitor cells to the coating to promote healing ([0013], [0021], [0058] and [0060]). Hossainy and Lam are silent to endothelial cells or endothelial progenitor cells seeded on the medical device. Frendl teaches biomedical implants having a patterned surface having a plurality of cellular niches, wherein the implant has a plurality of cells seeded on at least a portion of the patterned surface of the biomedical implant (abstract; [0013]). Said cells include endothelial cells or progenitor cells ([0058]). Frendl also further teaches the incorporation of an “agent” such as a peptide ([0068]). Frendl teaches that endothelial cells line the cardiovascular system and naturally regulate the blood clotting cascade ([0008]). Frendl teaches that coating said implants with endothelial cells would prevent the need for anticoagulants as the pass blood would not be able to differentiate the endothelia coated implant from healthy vasculature ([0008]). All of the references are drawn to delivering peptides and Hossainy and Frendl are drawn to surface modifications to recruit/deliver endothelial cells to vasculature, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to seed endothelial cells or endothelial progenitor cells on a medical device such as the one advanced by Hossainy/Lam as suggested by Frendl with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Hossainy and Frendl both recognize that recruiting/delivering endothelial cells into the vasculature of a subject provides a therapeutic effect locally to the surrounding tissue and it is prima facie obvious to combine two compositions each of which is taught in the art to be useful for the same purpose, in order to for a third composition to be used for the same purpose (MPEP 2144.06(I)). Thus, the combined teachings of Hossainy, Lam and Frendl render the instant claim prima facie obvious . Response to Arguments 07-37 AIA Applicant's arguments, filed 3/18/2026, regarding the 103 rejection over Hossainy, Lam and Frendl have been fully considered but they are not persuasive. Applicant relies on the same arguments as presented for the 103 rejection over Hossainy and Lam. No further arguments regarding claim 46 are presented. Remarks, pages 8-9. For the same reasons as discussed above, Applicant’s arguments are not persuasive. Thus, said rejection is maintained . 07-22-aia AIA Claim s 42 and 43 stand rejected under 35 U.S.C. 103 as being unpatentable over Hossainy et al. (US 2014/0370072 A1, Dec. 18, 2014, hereafter as “Hossainy”) in view of Lam et al. (WO 2011/079015 A1, Jun. 30, 2011, hereafter as “Lam”) as evidenced by Hao et al. (“Discovery and Characterization of a Potent and Specific Peptide Ligand Targeting Endothelial Progenitor Cells and Endothelial Cells for Tissue Regeneration”, Feb. 14, 2017, hereafter as “Hao”) , as applied to claim s 34 and 41 above, and further in view of Frendl et al. (US 2014/0350671 A1, Nov. 27, 2014, hereafter as “Frendl”) and Humayun et al. (WO 2012/149468 A2, Nov. 1, 2012, hereafter as “Humayun”) . The instant claims are described above. Hossainy and Lam teach the elements discussed above. Hossainy also teaches recruiting endothelial cells or endothelial progenitor cells to the coating to promote healing ([0013], [0021], [0058] and [0060]). Hossainy also teaches polymer coating materials such as PLA, PLGA, PCL, etc. ([0044]). Hossainy and Lam are silent to the coating polymer comprising parylene (instant claim 42 ) and the peptide ligand is covalently attached to the coating polymer (instant claim 43 ). Frendl teaches biomedical implants having a patterned surface having a plurality of cellular niches, wherein the implant has a plurality of cells seeded on at least a portion of the patterned surface of the biomedical implant (abstract; [0013]). Said cells include endothelial cells or progenitor cells ([0058]). Frendl also further teaches the incorporation of an “agent” such as a peptide ([0068]). Frendl teaches that endothelial cells line the cardiovascular system and naturally regulate the blood clotting cascade ([0008]). Frendl teaches that coating said implants with endothelial cells would prevent the need for anticoagulants as the pass blood would not be able to differentiate the endothelia coated implant from healthy vasculature ([0008]). Humayun teaches implantable substrates seeded with cells (abstract). Humayun teaches functionalizing the surface of the substrate to promote cell viability and attachment and that materials to functionalize include the particular polymers, parylenes, PTFE, PLA, PLGA that contain cRGD peptides ([0175]). Humayun also teaches that the substrate can be coated with a layer comprising parylene and the layer can be reacted/covalently bound with cRGD peptides ([0153]-[0154] and [0266]). The references are all drawn to delivering peptides and Hossainy, Frendl and Humayun are drawn to surface modifications to recruit/deliver cells to tissue, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a functionalized parylene coating including a cyclic RGD peptide bound to said parylene on a medical device such as the one advanced by Hossainy/Lam as suggested by Frendl/Humayun with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Hossainy, Frendl and Humayun recognize that recruiting/delivering cells into tissue of a subject provides a therapeutic effect locally to the surrounding tissue and Humayun teaches that seeding cells on a medical device via a functionalized parylene coating covalently bound to cRGD peptides effectively promotes cell viability and attachment. Humayun also effectively teaches cRGD peptides can be functionalized on various polymer surfaces including parylenes, PTFE, PLA, PLGA and it is prima facie obvious to substitute equivalents known for the same purpose (MEP 2144.06(II)). Thus, the combined teachings of Hossainy, Lam, Frendl and Humayun render the instant claim prima facie obvious . Response to Arguments 07-37 AIA Applicant's arguments, filed 3/18/2026, regarding the 103 rejection over Hossainy, Lam, Frendl and Humayun have been fully considered but they are not persuasive. Applicant relies on the same arguments as presented for the 103 rejection over Hossainy and Lam. No further arguments regarding claims 42 and 43 are presented. Remarks, pages 8-9. For the same reasons as discussed above, Applicant’s arguments are not persuasive. Thus, said rejection is maintained . Double Patenting 08-33 AIA The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claim 34-39 and 41-46 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,246,961. Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the patent and the subject matter of the copending claims are significantly overlapping. The instant claims are drawn to a medical device comprising: a scaffold; and a coating on a surface of the scaffold, wherein the coating comprises: a coating polymer, hydroxyapatite, or a combination thereof, and a peptide ligand selected from the group consisting of cGRGDdvc, cGRGDsfc, cGRGDdfc, cGRGDsec, cGRGDdsc, cGRGDd- D Bug-c, cGRGDd- D Bta-c, Ac-cGRGDdvc, (β-alanine)-cGRGDdvc, (Ebes)-cGRGDdvc, cGRGDd- D Agl-c, cGRGDd- D Pra-c, cGRGDd-D(NMe)Val-c, cGRGDd- D (CaMe)Val-c, cGRGDd- D Abu-c, cGRGDd- D Nal1-c, cGRGDd- D Nal2-c, and functionalized derivatives thereof. The patented claims are drawn to a scaffold sculpted or molded into a form of at least a portion of a stent, a shunt, a vascular graft, a patch, a cardiac valve, or a catheter, the scaffold comprising: a biopolymer functionalized with chemical groups facilitating covalent attachment of the biopolymer to a peptide ligand; and the peptide ligand, wherein the peptide ligand is covalently immobilized on the surface of the biopolymer, wherein the peptide ligand increases a number of endothelial cells and/or endothelial progenitor cells attached to the scaffold relative to a number of endothelial cells and/or endothelial progenitor cells attached to a corresponding scaffold not comprising the peptide ligand, and wherein the peptide ligand is cGRGDdvc (LXW7) (SEQ ID No. 1). The patented claims further recite, wherein the biopolymer is selected from the group consisting of poly (L-lactic acid) (PLLA), polycaprolactone (PCL), poly (lactic-co-glycolic acid) (PLGA), poly(lactide-co-ε-caprolactone) (PLCL), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), and combinations thereof, wherein the biopolymer is a coating on at least a portion of a surface of the scaffold, wherein the coating polymer is a parylene polymer, and wherein endothelial cells, endothelial progenitor cells, and/or osteogenic cells are seeded on the scaffold. The patented subject matter anticipates the subject matter of the instant claims and, thus, the instant claims are unpatentable over the patented claims. 08-36 AIA Claim 40 and 47 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-10 of U.S. Patent No. 11,246,961 in view of Neff et al. (US 2009/0022888 A1, Jan. 22, 2009, hereafter as “Neff”) . Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the patent and the subject matter of the copending claims are significantly overlapping. The instant claims are described above. The patented claims are described above. While the patent recites, “a vascular graft”, the patent does not specifically recite, “an arteriovenous dialysis graft”. Neff teaches medical devices comprising a polymeric coating that is functionalized with a peptide (abstract; [0023]). Neff teaches various medical devices including vascular access devices and names the particular vascular access devices, AV grafts ([0006] and [0069]). The patent and Neff are drawn to medical devices comprising a polymer coating bound to a peptide, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the particular medical device, an AV graft, into the patented invention as suggested by Neff with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Neff teaches that implants including vascular implants such as AV grafts coated with a polymer bound to a bioactive such as a peptide can provide a therapeutic effect locally to the surrounding tissue. Substitution of one vascular implant for another vascular implant for the same purpose, this is, to treat the vascular system or vascular tissue is prima facie obvious. Thus, the instant claims are unpatentable over the patented claims in view of Neff . Response to Arguments 07-37 AIA Applicant's arguments, filed 3/18/2026, regarding the double patenting rejections have been fully considered but they are not persuasive. Applicant asserts that the current application is pending, allowable claim scope has yet to be determined, and requests the double patenting rejections to be held in abeyance until allowable subject matter is indicated. Remarks, page 6. In response, it is respectfully submitted that applicant’s request is acknowledged. The double patenting rejections remain applicable and, thus, maintained at this time. For these reasons, Applicant’s arguments are found unpersuasive. Said rejections are maintained. Allowable Subject Matter The data in Fig. 12 demonstrates that a LXW7 treated surface showed limited platelet adhesion whereas GRGD (SEQ ID NO: 1) treated surface allowed a significantly higher number of platelets to attach. Evidence of unobvious or unexpected advantageous properties, such as superiority in a property the claimed compound shares with the prior art, can rebut prima facie obviousness (MPEP 716.02(a)(II)). Thus, the data provided in Fig. 12 demonstrates unexpected results with respect to LXW7 and thereby claims 45 and 47 are free of the prior art. It is noted, however, that said claims remain rejected on the grounds of double patenting. Conclusion All claims have been rejected; no claims are allowed. 07-39 AIA 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. Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 5:00 pm. 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, Sue Liu can be reached on 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. Casey S. Hagopian Examiner, Art Unit 1617 /SUE X LIU/Supervisory Patent Examiner, Art Unit 1616 Application/Control Number: 17/671,071 Page 2 Art Unit: 1617 Application/Control Number: 17/671,071 Page 3 Art Unit: 1617 Application/Control Number: 17/671,071 Page 4 Art Unit: 1617 Application/Control Number: 17/671,071 Page 5 Art Unit: 1617 Application/Control Number: 17/671,071 Page 6 Art Unit: 1617 Application/Control Number: 17/671,071 Page 7 Art Unit: 1617 Application/Control Number: 17/671,071 Page 8 Art Unit: 1617 Application/Control Number: 17/671,071 Page 9 Art Unit: 1617 Application/Control Number: 17/671,071 Page 10 Art Unit: 1617 Application/Control Number: 17/671,071 Page 11 Art Unit: 1617 Application/Control Number: 17/671,071 Page 12 Art Unit: 1617 Application/Control Number: 17/671,071 Page 13 Art Unit: 1617 Application/Control Number: 17/671,071 Page 14 Art Unit: 1617 Application/Control Number: 17/671,071 Page 15 Art Unit: 1617 Application/Control Number: 17/671,071 Page 16 Art Unit: 1617 Application/Control Number: 17/671,071 Page 17 Art Unit: 1617 Application/Control Number: 17/671,071 Page 18 Art Unit: 1617 Application/Control Number: 17/671,071 Page 19 Art Unit: 1617 Application/Control Number: 17/671,071 Page 20 Art Unit: 1617 Application/Control Number: 17/671,071 Page 21 Art Unit: 1617 Application/Control Number: 17/671,071 Page 22 Art Unit: 1617 Application/Control Number: 17/671,071 Page 23 Art Unit: 1617
Prosecution Insights