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 .
Receipt is acknowledged for amendment filed 12/18/2025 and IDS filed 12/30/2025.
Claims 3 is canceled.
Claims 1 and 21 are amended.
Original claims 1, 4-6, 8-10, 17-22, 28, 32, 36, 38, 40 and 42 are pending.
Priority
This application claims benefit of 63/318,275 filed 03/09/2022.
Information Disclosure Statement
He IDS filed 12/30/2025 has been considered by the examiner.
Response to Arguments
For the rejection of claims 1, 4-6, 8, 22, 28, 36, 38, 40 and 42 under 35 U.S.C. 102(a)(1) and 102(a)(b) as being anticipated by Wang et al. (US 20190092961 A1), the amendment to claim 1 incorporating the limitation of canceled claim 3 into claim 1 overcome Wang et al. (US 20190092961 A1).
For the rejection of claims 1, 3-6, 8-10, 17-20, 22, 28, 32, 36, 38, 40 and 42 under 35 U.S.C. 103 as being unpatentable over Stucke et al. (US 20060216324 A1) in combination with Bobcock (US 20130197433 A1), applicant argues that the skilled artisan would not be motivated to combine Stucke and Babcock because Stucke does not teach or suggest that lubricious topcoat layer could be added or would be beneficial, and one of skill in the art would likely believe that any topcoat put over the coating of Stucke could interfere with or prevent the heparin or bioactive agents from being effective or released as desired; that Babcock fails to teach or suggest that the disclosed lubricious coating could be disposed over the coating of Stucke.
Response: The examiner disagrees with applicant that Babcock cannot be combined with Stucke because in the rejection of record, Babcock was relied upon for teaching that lubricious coating applied to medical device reduces friction between medical device and the environment (see paragraph [0003]), such that disposing lubricious coating over the non-fouling basecoat would predictably reduce friction between the medical device and the environment. The motivation is the predictable reduction of friction between the medical device and the environment. There is no evidence that applying lubricious topcoat over the coating of Stucke interferes with effective release of heparin or bioactive agents.
For the rejection of claim(s) 1, 17, 20 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stucke et al. (US 20060216324 A1) in combination with Bobcock (US 20130197433 A1) and further in view of Yang et al., “Positively charged polyethylenimines enhance nasal absorption of the negatively charged drug, low molecular weight heparin” in Journal of Controlled Release 115 (2006) 289-297, applicant argues that the rejection should be withdrawn because of the reasons presented above. That Yang fails to cure the deficiencies of Stucke and Babcock.
Response: Yang was relied upon for teaching that polyethylenimine cationic polymer has been used in the delivery of heparin. Therefore, before the effective date of the invention the artisan looking to Yang would use cationic polymer to predictably deliver heparin.
The rejections are maintained below with modification to address the amendment whereby the hydrophobic component is limited to poly(butyl methacrylate) or poly(n-butyl methacrylate).
Modified Rejections
Necessitated by Amendment
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, 4-6, 8-10, 17-20, 22, 28, 32, 36, 38, 40 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stucke et al. (US 20060216324 A1) in combination with Bobcock (US 20130197433 A1) reiterated herein with modification to address the amendment.
Claim 1 is amended to recite the hydrophobic component of canceled claim 3.
Stucke discloses medical devices whose surfaces are coated with the disclosed compositions (paragraph [0078]) for providing biocompatible surfaces to the medical devices (paragraph [0012]). The medical devices named are stents, synthetic stents, vascular stents; other vascular devices ( e.g., grafts, catheters, valves, artificial hearts, heart assist devices); implantable defibrillators; blood oxygenator devices; surgical devices; tissue-related materials; membranes; cell culture devices; chromatographic support materials; biosensors; shunts for hydrocephalus; wound management devices; endoscopic devices; infection control devices; orthopedic devices; dental devices, urological devices; colostomy bag attachment devices; ophthalmic devices; glaucoma drain shunts; synthetic prostheses; intraocular lenses; respiratory, peripheral cardiovascular, spinal, neuro logical, dental, ear/nose/throat (e.g., ear drainage tubes); renal devices; and dialysis ( e.g., tubing, membranes, grafts); self-expanding stents ( e.g., made from nitinol), balloon-expanded stents (e.g., prepared from stainless steel), degradable coronary stents, non-degradable coronary stents, peripheral coronary stents, urinary catheters (e.g., surface-coated with antimicrobial agents), penile implants, sphincter devices, urethral devices, bladder devices, renal devices, vascular implants and grafts, intravenous catheters (e.g., treated with antithrombotic agents), small diameter grafts, artificial lung catheters, electrophysiology catheters, anastomosis devices, vertebral disks, bone pins, suture anchors, hemostatic barriers, clamps, surgical staples/sutures/screws/plates/clips, atrial septa! defect closures, electro-stimulation leads for cardiac rhythm management (e.g., pacer leads), glucose sensors (long-term and short-term), blood pressure and stent graft catheters, blood oxygenator tubing, blood oxygenator membranes, blood bags, birth control devices, breast implants; benign prostatic hyperplasia and prostate cancer implants, bone repair/augmentation devices, breast implants, cartilage repair devices, orthopedic joint implants, orthopedic fracture repairs, tissue adhesives, tissue sealants, tissue scaffolds, CSF shunts, dental implants, dental fracture repair devices, implanted drug infusion tubes, intravitreal drug delivery devices, nerve regeneration conduits, oncological implants, electrostimulation leads, pain management implants, spinal/orthopedic repair devices, wound dressings, embolic protection filters, abdominal aortic aneurysm grafts, heart valves (e.g., mechanical, polymeric, tissue, percutaneous, carbon, sewing cuff), valve annuloplasty devices, mitral valve repair devices, vascular intervention devices, left ventricle assist devices, neuro aneurysm treatment coils, neurological catheters, left atrial appendage filters, central venous access catheters, hemodialysis devices, catheter cuff, anastomotic closures, vascular access catheters, cardiac sensors, uterine bleeding patches, urological catheters/stents/implants, in vitro diagnostics, aneurysm exclusion devices, neuropatches, Vena cava filters, urinary dialators, endoscopic surgical tissue extractors, atherectomy catheters, clot extraction catheters, PTA catheters, PTCA catheters, stylets (vascular and non-vascular), coronary guidewires, drug infusion catheters, esophageal stents, circulatory support systems, angiographic catheters, transition sheaths and dialators, coronary and peripheral guidewires, hemodialysis catheters, neurovascular balloon catheters, tympanostomy vent tubes, cerebra-spinal fluid shunts, defibrillator leads, percutaneous closure devices, drainage tubes, thoracic cavity suction drainage catheters, electrophysiology catheters,
stroke therapy catheters, abscess drainage catheters, biliary drainage products, dialysis catheters, central venous access catheters, and parental feeding catheters (paragraphs [0073], [0078]).
In one embodiment, the biocompatible coated layer comprising of (i) a hydrophobic polymer namely poly(alkyl(meth)acrylate such as poly(butyl(meth)acrylate (pBMA) and which is present at 75-90%; (ii) heparin hydrophilic biocompatible polymer present at 5% to 15%; (iii) PVP polymer present at 5% to 15% (paragraph [0039]); in other embodiments, the coated layer is a bioactive agent-releasing layer that includes a bioactive agent, irradiated composition of heparin, photoreactive groups, polymeric material to activate the photo reactive group (paragraphs [0046], [0040]) and pBMA hydrophobic polymer (paragraph [0047]) and the pBMA mees the limitation of polybutylmethacrylate (pBMA) hydrophobic component of claim 1. The photoreactive moiety/group mis pendant from the polymer, the biocompatible agent, independent or combinations (paragraph [0018], [0162]). In another embodiment, the biocompatible coating comprises miscibility enhancer selected from the group consisting of polyvinylpyrrolidone (PVP), polyethylene glycol (PEG), PEG sulfonates, fatty acids, dextran, dextrin and cyclodextrin (paragraphs [0034]-[0037]); the miscibility enhancer is used to improve homogeneity of polymeric material and biocompatible agent in the coating composition and improve the overall coating composition (paragraph [0034]). Photo-heparin and photo-collagen are biocompatible agents having pendant photoreactive moiety (paragraph [0031]). A photoreactive moiety is a crosslinking agent having two or more photoreactive groups, (paragraphs [0041], [0178]), covalently bonded to the biocompatible polymer (paragraph [0071]), derivatizes PVP (paragraph [0158]). Benzophenone is a named photoreactive moiety (paragraph [0070])
Thus, for claim 1, the coating composition disposed over the medical device/substrate comprising (i) hydrophobic polymer namely poly(alkyl(meth)acrylate such as poly(butyl(meth)acrylate (pBMA) and which is present at 75-90%; (ii) heparin hydrophilic biocompatible polymer present at 5% to 15%; (iii) PVP polymer present at 5% to 15% (paragraph [0039]), bioactive agent-releasing layer that includes a bioactive agent, irradiated composition of heparin, photoreactive groups, polymeric material to activate the photo reactive group (paragraphs [0046], [0040]) and pBMA hydrophobic polymer (paragraph [0047]) meets the limitation of non-fouling basecoat.
Stucke does not disclose lubricious topcoat layer comprising a photo-reactive polyvinylpyrrolidone compound; and a cross-linking agent over the non-fouling base coat.
Babcock discloses a lubricious coating for a medical device comprising a first layer comprising polyvinylpyrrolidone derivatized with photoreactive group; and a first cross-linking agent comprising at least two photoreactive groups (abstract, paragraphs [0025]-[0027]); a second layer disposed on the first layer comprising polyvinylpyrrolidone derivatized with a photoreactive group; a second cross-linking agent comprising at least two photoreactive groups; and a polymer comprising polyacrylamide, the polymer derivatized with at least one photoreactive group (see the whole document with emphasis on the abstract, claim 1, paragraphs [0004]-[0005], [0028]). In some embodiments, polyvinylpyrrolidone, an underivatized PVP, is added to the first layer and to the topcoat (paragraphs [0027], [0029]). The first and second layers are considered as first and second layers of a lubricious topcoat. The photoreactive group is an aryl ketone, such as acetophenone, benzophenone, anthranone, anthranone-like heterocycles (paragraph [0036]) and ketones and quinones (paragraph [0035]).
The cross-linking agent can be bis(4-benzoylphenyl) phosphate (paragraph [0048]). Exemplary medical devices include biosensors, include vascular implants and grafts, surgical devices; synthetic prostheses; vascular prosthesis including endoprosthesis, stent-graft, and endovascular-stent combinations; small diameter grafts, abdominal aortic aneurysm grafts; wound dressings and wound management device; hemostatic barriers; mesh and hernia plugs; patches, including uterine bleeding patches, atrial septic defect (ASD) patches, patent foramen ovale (PFO) patches, ventricular septa defect (VSD) patches, and other generic cardiac patches; ASD, PFO, and VSD closures; percutaneous closure devices, mitral valve repair devices; left atrial appendage filters; valve annuloplasty devices, catheters; central venous access catheters, vascular access catheters, abscess drainage catheters, drug infusion catheters, parenteral feeding catheters, intravenous catheters ( e.g., treated with antithrombotic agents), stroke therapy catheters, blood pressure and stent graft catheters; interventional cardiology devices including guide wires and leads ( e.g. pacing, delivering electricity, defibrillation); anastomosis devices and anastomotic closures; aneurysm exclusion devices; biosensors, such as glucose sensors; cardiac sensors (and other sensors for analytical purposes); birth control devices; breast implants; infection control devices; membranes; tissue scaffolds; tissue-related materials; shunts including cerebral spinal fluid (CSF) shunts, glaucoma drain shunts; dental devices and dental implants; ear devices such as ear drainage tubes, tympanostomy vent tubes; ophthalmic devices; cuffs and cuff portions of devices including drainage tube cuffs, implanted drug infusion tube cuffs, catheter cuff; sewing cuff; spinal and neurological devices; nerve regeneration conduits; neurological catheters; neuropatches; orthopedic devices (paragraph [0083])
Substrates include polymers, oligomers, homopolymers such as methacrylate, polyurethanes, styrene-butadiene copolymers, isobutylene-isoprene copolymers (paragraph [0078]), polyacrylamide may be N-Acetylated poly[acrylamide-co-sodium-2-acrylamido-2-
methylpropanesulfonate-co-N-(3-(4-benzoylbenzamido)propyl)methacrylamide]-comethoxy poly(ethylene glycol) monomethacrylate (paragraph [0087]).
Bobcock teaches that lubricious coating is applied to medical device to reduce friction between medical device and the environment (see paragraph [0003]). Stucke does not disclose lubricious coating.
Thus, before the effective date of the invention, the artisan would look to Bobcock to use lubricious coating over the non-fouling basecoat with the expectation of predictably reducing friction between the medical device and the environment.
For claim 3, the polybutylmethacrylate of Bobcock meets the limitations.
For claims 4-5, the polyvinylpyrrolidone of Stucke and Bobcock meet the limitation,
For claim 6, the presence of crosslinking agent in the coating layers would lead to cross linking of the PVP and the acrylamide.
For claim 8, the hydrophobic polymer is at 75-90% and the hydrophilic component is 10 to 30% (5-15% and 5-15%) resulting in a point of 75:30 or 2.5 :1.
For claims 9, 10 and 17-18, the heparin, photo-heparin of Stucke meet the requirement of the claims.
For claim 19, the heparin is crosslinked with the photo reactive PVP of Stucke.
For claim 20, the coating composition of Stucke contains heparin and polyethylene glycol with the polyethylene glycol and the heparin complexed ionically.
For claim 22, in some embodiments in Bobcock, polyvinylpyrrolidone, an underivatized PVP, is added to the lubricious coating (the first layer and to the topcoat) (paragraphs [0027], [0029]).
For claim 28, the coating composition of Bobcock contains polyacrylamide (abstract).
For claim 32, acrylamido-2-methylpropanesulfonate groups (AMPS) is Bobcock (paragraph [0028]) is zwitterion.
For claim 36, the lubricious coating in Bobcock contains anionic agent (paragraph [0062]).
For claim 38, the lubricious coating of Bobcock has a first and second coating layers (abstract).
For claims 40 and 42, the lubricious coating layers contain polyethyleneglycol (claim 2) which meets the limitation of elutable platelet macromer, using applicant’s specification as a dictionary, polyethylene oxide is an elutable anti-platelet macromer as defined in applicant’s specification at page 23, lines 23-24) which is a non-prodrug anti-platelet agent.
Stucke in combination with Bobcock renders claims 1, 4-6, 8-10, 17-20, 22, 28, 32, 36, 38, 40 and 42 prima facies obvious.
Claim(s) 1, 17, 20 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stucke et al. (US 20060216324 A1) in combination with Bobcock (US 20130197433 A1) and further in view of Yang et al., “Positively charged polyethylenimines enhance nasal absorption of the negatively charged drug, low molecular weight heparin” in Journal of Controlled Release 115 (2006) 289-297 and reiterated herein.
Claim 17 depends on claim 1. Claim 20 depends on claim 17. Claim 21 depends on claim 20.
Stucke in combination with Bobcock has been described above to renders claims 1 and 17 prima facie obvious.
The combined teaching of Stucke and Bobcock does not teach the cationic polymers of claims 20 and 21. However, it is known in the art that polyethylenimine cationic polymer has been used in the delivery of heparin. Therefore, before the effective date of the invention the artisan looking to Yang would use cationic polymer to predictably deliver heparin.
Therefore, Stucke in combination with Bobcock and further in view of Yang renders claims 20 and 21 prima facie obvious.
No claim is allowed.
The 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.
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Yong Kwon can be reached at 5712720581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613