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 .
The examiner acknowledges receipt of request for continued examination under 37 CFR 1.114, amendment and remarks filed 04/22/2026.
Claim 4 is canceled.
Claims 1 and 6 are amended.
New claim 82 is added.
Original claims 1, 5-6, 8-10, 17-22, 28, 32, 36, 38, 40, 42 and 82 are pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/22/2026 has been entered.
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, 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 Babcock (US 20130197433 A1), applicant argues that after argument or evidence is submitted by applicant in response to the office action, patentability is determined on the totality of the record.
Response: The examiner agrees. The totality of the record has been considered. The amendment to claim 1 moved elements of canceled claim 4 and polyacrylamide and combination in the alternative into claim 1. Claims 4 and 5 and 6 were previously rejected and the incorporation of the limitations of polyvinylpyrrolidone, polyacrylamide and combination in the alternative do not overcome the rejection of record. The argument that the incorporation of polyvinylpyrrolidone or polyacrylamide or combination into claim 1 overcome the rejection of record is not persuasive. The arguments are very similar to the arguments presented on 12/18/2025. Therefore, the response to those arguments would be similar to the response given on 01/26/2026.
On pages 7 of 10 to 8 of 10 of the remarks filed 04/22/2026, applicant argues that the skilled artisan would not be motivated to combine Stucke and Babcock to arrive at the claim 1 as currently amended because Stucke discloses forming "biocompatible surfaces to medical devices" in which "a biocompatible agent is coupled to the polymeric material to provide a biocompatible surface of the medical article." (citing paragraph [0012]). That the biocompatible surface coatings are directed to hemocompatibility and immobilized heparin activity (citing paragraphs [0007] and [0025]. That Stucke explains that "a biocompatible agent is utilized to provide a biocompatible surface to a medical device," and that "the biocompatible layer improves the function of the medical article in many ways," such as to "substantially reduce the accumulation of clotting components on the surface of the article." (paragraphs [0081] and [0055] are cited). That Stucke is silent on the on the biocompatible layer functioning as a rate limiter that controls the diffusion rate of a metabolite across the coating. Rather, Stucke explains that the biocompatible layer provides improved anti-adherence, mechanical function, and excellent biocompatible properties, particularly for heparin activity and reduced fouling (paragraphs [0055], [0058], and [0061]). Thus, applicant states, that Stucke is directed to release of drugs, such as heparin, from a drug-eluting coating, not to controlled diffusion of a physiological analyte through a barrier of a medical device. For example, Stucke discloses that "the bioactive agent can be released from or presented by the coating once the coating is formed on the medical article and implanted in a patient," and that "the bioactive agent is preferably released in a slow or controlled-release manner, to provide the desired elution profile to achieve the therapeutic effect." (paragraphs [0043] and [0115]). Thus, Stucke’s mention of both poly(butyl methacrylate) and polyvinylpyrrolidone is only in the context of a cross-linked, heparin-active biocompatible layer, with no teaching or suggestion that the polymer blend is configured to control diffusion of a metabolite across a coating.
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. Further, the claims have not excluded its coating from being biocompatible surface coatings and have not excluded its coatings as not having hemocompatibility properties and that immobilized heparin activity cannot be achieved. The claims have not also excluded the claimed coated implantable product from being biocompatible and from providing improved anti-adherence, mechanical function, and excellent biocompatible properties, particularly for heparin activity and reduced fouling. Non-fouling reads on reduction in fouling or anti-fouling. The claims do not exclude release or slow or controlled-release of bioactive agents. The teachings of Stucke would be reasonably expected to provide control diffusion of a metabolite across a coating. The examiner agrees with applicant that Stucke teaches/mentions both poly(butyl methacrylate) and polyvinylpyrrolidone.
In the first full paragraph of page 8 of 10 of the remarks filed 04/22/2026, argues that the present application teaches analyte diffusion across a coating sensor, that the coatings can combine a top coat with a basecoat having hydrophilic component and hydrophobic component where the topcoat provides lubricious surface that protects the coating and the basecoat ties the topcoat to a substrate (citing page 11, line 28 to page 12, line 2; page 12, lines 3-5 of the specification as filed).
Response: Applicant is attempting to import limitations into the claims. The claims have not claimed diffusion of analyte across coating sensor. Such a diffusion would be an inherent property of a coating composition that contains analyte.
From the last full paragraph of page 8 of 10 to the first and second full paragraphs of page 9 of 10, applicant argues that Babcock is silent on the topcoat being utilized as a rate limiting coating and that Stucke is silent on a topcoat and the office action relies on Babcock instead on topcoat. That Babcock is directed to lubricious medical device coatings with low particulate generation and medical devices and method relating to the same. That, there is no teaching or suggestion in Babcock or Stucke that would motivate the skilled artisan to modify the rate limiting basecoat of Stucke to include a topcoat of Babcock. That nothing in the disclosures of Stucke and Babcock teach or suggest a basecoat having hydrophilic components comprising polyvinylpyrrolidone and/or polyacrylamide polymer and hydrophobic components comprising poly(butyl methacrylate) or poly(n-butyl methacrylate) acting as a rate limiter controlling the diffusion rate of a metabolite across the coating. Nor does Babcock provide any teaching or suggestion to place its photo-reactive polyvinylpyrrolidone lubricious coating as a distinct topcoat over such a rate-limiting basecoat that itself already contains hydrophilic polyvinylpyrrolidone and/or polyacrylamide.
Response: The examiner agrees that Stucke is silent on a topcoat and the relied on Babcock instead for topcoat. The examiner also agrees that Babcock is directed to lubricious medical device coatings. The examiner however 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.
Therefore, Babcock is properly combined with Stucke to render the designated claims prima facies obvious and the rejection is maintained below with modification that address the moving of elements of claim 4 into claim 1.
For the rejection of claim(s) 1, 17, 20 and 21 under 35 U.S.C. 103 as being unpatentable over Stucke et al. (US 20060216324 A1) in combination with Babcock (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: The rejection is being maintained for the response presented above to applicant’s arguments above. 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, 5-6, 8-10, 17-20, 22, 28, 32, 36, 38, 40, 42 and 82 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stucke et al. (US 20060216324 A1) in combination with Babcock (US 20130197433 A1) reiterated herein with modification to address the amendment.
Claim 1 is amended to recite the polyvinylpyrrolidone, or polyacrylamide or combinations as the hydrophilic component. Claim 4 is canceled.
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]). Polybutylmethacrylate of Babcock meets the limitation of polybutyl methacrylate of claim 1.
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]).
Babcock 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 Babcock 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 5, the polyvinylpyrrolidone of Stucke and Babcock 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 Babcock, 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 Babcock contains polyacrylamide (abstract).
For claim 32, acrylamido-2-methylpropanesulfonate groups (AMPS) is Babcock (paragraph [0028]) is zwitterion.
For claim 36, the lubricious coating in Babcock contains anionic agent (paragraph [0062]).
For claim 38, the lubricious coating of Babcock 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.
For claim 82, Stucke teaches sensors (claim 26, paragraph [0078], [0079]).
Stucke in combination with Babcock renders claims 1, 4-6, 8-10, 17-20, 22, 28, 32, 36, 38, 40, 42 and 82 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 Babcock (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 Babcock has been described above to renders claims 1 and 17 prima facie obvious.
The combined teaching of Stucke and Babcock 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 Babcock 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.
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
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