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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 20th, 2026 has been entered.
Claim Status
The amendment submitted on July 20th, 2026 has been entered. Claims 1, 3-7, 12-16, 19-20, and 23-29 are currently pending and under consideration. Claim 26-29 have been newly added. Claims 2, 8-11, 17-18, and 21-22 have been cancelled. Claims 1, 13, and 16 have been amended.
Response to Arguments
Applicant's arguments filed July 20th, 2026 have been fully considered but they are not persuasive. Applicant’s arguments with respect to claim(s) 1, 3-7, 12-16, 19-20, and 23-29 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3-7, 16, 19, 23 and 25-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tan (U.S. Publication 2006/0009839) in view of Hunter et al. (U.S. Publication 2007/0299043) and Barker (U.S. Publication 2012/0114682) and further in view of Shebuski et al. (U.S. Publication 2006/0286063).
Regarding claim 1, Tan discloses a medical device 10 comprising: a vascular device (¶0031 vascular graft 10 Fig. 2) and an anti-thrombogenic coating 14,18 (¶0058 coating layer combined with…anti-thrombogenic agents…RGD peptide) on a surface 12 of the vascular device (¶0031 coating layer covers the graft member), wherein the anti-thrombogenic coating comprises: one or more peptide (¶0058 can be combined with any of the following…RGD peptide…anti-platelet peptides); and a bioabsorbable polymer matrix (14,18 acts as matrix comprising 16; ¶0031 biodegradable coating layer; biodegradable sheath 18; ¶0066 biodegradable polymeric matrix of the sheath) configured to control availability of the one or more peptides at a surface of the anti-thrombogenic coating (¶0031 permits controlled delivery of bioactive agents associated with coating layer), wherein the one or more peptides are encapsulated in microspheres (¶0066 bioactive agent or dug may be encapsulated in microparticles, such as microspheres) wherein the microspheres are dispersed in the bioabsorbable polymer matrix (¶0066 microsphere contained within the biodegradable polymeric matrix), and wherein the bioabsorbable polymer shells are configured to degrade to release the one or more peptides.
Tan does not expressly disclose the one or more peptides being configured to bind to fibrinogen and/or fibrinogen-derived proteins in blood, or the microspheres being bioabsorbable polymer shells.
Regarding the microspheres being bioabsorbable polymer shells, Hunter, in the same field of endeavor of drug delivery coatings, teaches drug encapsulating microspheres that are made of degradable polymers (¶1749 drug incorporated into secondary carrier microspheres, microsphere may include degradable polymers).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the microsphere material of Tan that performs the function of containing and release a therapeutic to a patient for the microsphere material of Hunter since these elements perform the same function of containing and releasing therapeutics to a patient. Simply substituting one microsphere therapeutic delivery means for another would yield the predictable result of allowing a(n) drug to be contained and released from a microsphere format. See MPEP 2143.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the microsphere of Tan out of the biodegradable material of Hunter, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding the one or more peptides being configured to bind to fibrinogen and/or fibrinogen-derived proteins in blood, Barker, in the same field of endeavor of fibrinogen binding peptides, teaches providing fibrin knob peptides conjugated to inert carriers to block the self-binding pockets of fibrinogen through binding to fibrinogen and fibrin monomers and preventing self-binding to the polymerization pocket of fibrinogen for the purpose of diminishing the formation of fibrin following injuries (¶0114 a conjugate of a fibrin know peptide and an inert carrier can bind to fibrinogen and fibrin monomers and prevent self-binding to the polymerization pocket of fibrinogen. This interaction can inhibit fibrin formation in a dose dependent fashion. Consequently, this conjugate can be used to diminish the formation of fibrin following injuries).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microsphere encapsulated therapeutic of Hunter to have been the fibrin binding peptide therapeutic taught by Barker for the purpose of diminishing the formation of fibrin in the patient.
Furthermore, one of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to perform this modification of Tan with the teachings of Barker in view of the teaching provided by Shebuski, in the same field of endeavor of antithrombotic coatings for medical devices, teaching in ¶0139 that platelets and white blood cells respond to foreign substances in much the same way as an injured tissue, through fibrin deposition and encapsulation of the foreign substance resulting in the formation of fibrin sheaths on intravascular devices.
As such, one of ordinary skill in the art before the effective filing date of the claimed invention would have been properly motivated to have modified Tan with the teachings of Barker for the purpose of preventing complications resulting from fibrin sheath formation on the intravascular medical device as taught by Shebuski (¶0139).
Regarding claims 3-5 and 23, Tan in view of Hunter, Barker and Shebuski suggest the medical device of claim 1. Tan in view of Barker and Shebuski further suggest the peptides (peptides suggested by Barker) configured to bind fibrinogen and bind to terminal polymerization sites of the fibrinogen-derived proteins to inhibit polymerization of the fibrinogen-derived proteins (¶0114 of Barker; a conjugate of a fibrin knob peptide and an inert carrier can bind to fibrinogen and fibrin monomers and prevent self-binding to the polymerization pocket of fibrinogen. This interaction can inhibit fibrin formation in a dose dependent fashion. Consequently, this conjugate can be used to diminish the formation of fibrin following injuries) and thus suggests the peptide constituting both the first and second type of peptide as claimed (claim 3).
Tan further discloses the bioabsorbable matrix being configured to maintain a concentration of the first type/second type of peptides at the surface of the anti-thrombogenic coating (¶0054 controllably released from the biodegradable coating layer to the site of implantation by hydrolysis of chemical bonds in the biodegradable layer),
Barker further suggests providing the concentration of the first/second peptides above a first/second minimum inhibitory concentration corresponding inhibition of fibrin formation/prevention of polymerization as Barker states that this interaction is occurs in a dose dependent fashion and thus is provided at a tailored dose with the dose corresponding to inhibition response and thus providing a minimum (Claim 4 and claim 23 with claim 4 only requiring one and 23 requiring both).
Tan in view of Barker do not expressly disclose the inhibition of binding of fibrinogen being to the surface of the anti-thrombogenic coating, however, by inhibiting binding of fibrinogen, this would inherently inhibit the binding to the surface as the fibrinogen binding sites have been bound to the inhibitor and therefore would be prevented from binding to another substance.
Tan in view of Barker further fail to suggest at least one of the peptides of the first type of peptides being different from at least one of the peptides of the second type of peptides (Claim 5), however, Barker, in the same field of endeavor of fibrinogen binding peptides, further teaches the ability to conjugate the peptides to different domains to provide additional effects targeted to fibrin(ogen) molecules such as proteases (¶0104 proteases) or serum proteins (¶0106) as well as selecting the peptide (¶0067) for the purpose of providing additional therapeutic effects targeted to fibrin(ogen) (¶0104 proteases incorporated as an X domain may influence fibrin degradation rate; ¶0106 enhance the pharmacokinetics) and selecting the affinity to fibrin that is desired (¶0067 depend on the affinity to fibrin that is desired).
It would have been obvious to one of ordinary skill in the art to have modified the peptides of Tan in view of Barker to have provided the peptides with different domains for the purpose of providing additional therapeutic effects targeted to fibrin(ogen) and selecting the affinity to fibrin that is desired as taught by Barker.
Regarding claims 6 and 7, Tan in view of Hunter, Barker and Shebuski suggest the medical device of claim 5. Barker further suggests the first/second type of peptides comprising GPRP (¶0063; sequence 1). As such it would have been obvious for the fibrin binding peptide to have been GPRP as taught by Barker for the reasons applied to the rejection of claim 1 above.
Regarding claim 16, Tan discloses a method comprising:
forming (Abstract disposed over the graft member) an anti-thrombogenic coating 14,18 (¶0058 coating layer combined with…anti-thrombogenic agents…RGD peptide) on a surface 12 of a vascular device (vascular graft 10, Fig. 2, ¶0031 coating layer covers the graft member), wherein the anti-thrombogenic coating comprises: wherein the anti-thrombogenic coating comprises: one or more peptide (¶0058 can be combined with any of the following…RGD peptide…anti-platelet peptides); and a bioabsorbable polymer matrix (14,18 acts as matrix comprising 16; ¶0031 biodegradable coating layer; biodegradable sheath 18; ¶0066 biodegradable polymeric matrix of the sheath) configured to control availability of the one or more peptides at a surface of the anti-thrombogenic coating (¶0031 permits controlled delivery of bioactive agents associated with coating layer), wherein the one or more peptides are encapsulated in microspheres (¶0066 bioactive agent or dug may be encapsulated in microparticles, such as microspheres) wherein the microspheres are dispersed in the bioabsorbable polymer matrix (¶0066 microsphere contained within the biodegradable polymeric matrix), and wherein the bioabsorbable polymer shells are configured to degrade to release the one or more peptides.
Tan does not expressly disclose the one or more peptides being configured to bind to fibrinogen and/or fibrinogen-derived proteins in blood, or the microspheres being bioabsorbable polymer shells.
Regarding the microspheres being bioabsorbable polymer shells, Hunter, in the same field of endeavor of drug delivery coatings, teaches drug encapsulating microspheres that are made of degradable polymers (¶1749 drug incorporated into secondary carrier microspheres, microsphere may include degradable polymers).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the microsphere material of Tan that performs the function of containing and release a therapeutic to a patient for the microsphere material of Hunter since these elements perform the same function of containing and releasing therapeutics to a patient. Simply substituting one microsphere therapeutic delivery means for another would yield the predictable result of allowing a(n) drug to be contained and released from a microsphere format. See MPEP 2143.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the microsphere of Tan out of the biodegradable material of Hunter, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding the one or more peptides being configured to bind to fibrinogen and/or fibrinogen-derived proteins in blood, Barker, in the same field of endeavor of fibrinogen binding peptides, teaches providing fibrin knob peptides conjugated to inert carriers to block the self-binding pockets of fibrinogen through binding to fibrinogen and fibrin monomers and preventing self-binding to the polymerization pocket of fibrinogen for the purpose of diminishing the formation of fibrin following injuries (¶0114 a conjugate of a fibrin know peptide and an inert carrier can bind to fibrinogen and fibrin monomers and prevent self-binding to the polymerization pocket of fibrinogen. This interaction can inhibit fibrin formation in a dose dependent fashion. Consequently, this conjugate can be used to diminish the formation of fibrin following injuries).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microsphere encapsulated therapeutic of Hunter to have been the fibrin binding peptide therapeutic taught by Barker for the purpose of diminishing the formation of fibrin in the patient.
Furthermore, one of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to perform this modification of Tan with the teachings of Barker in view of the teaching provided by Shebuski, in the same field of endeavor of antithrombotic coatings for medical devices, teaching in ¶0139 that platelets and white blood cells respond to foreign substances in much the same way as an injured tissue, through fibrin deposition and encapsulation of the foreign substance resulting in the formation of fibrin sheaths on intravascular devices.
As such, one of ordinary skill in the art before the effective filing date of the claimed invention would have been properly motivated to have modified Tan with the teachings of Barker for the purpose of preventing complications resulting from fibrin sheath formation on the intravascular medical device as taught by Shebuski (¶0139).
Regarding claim 19, Tan in view of Hunter, Barker and Shebuski suggest the medical device of claim 16. Tan in view of Barker and Shebuski further suggest the peptides (peptides suggested by Barker) configured to bind fibrinogen and bind to terminal polymerization sites of the fibrinogen-derived proteins to inhibit polymerization of the fibrinogen-derived proteins (¶0114 of Barker; a conjugate of a fibrin knob peptide and an inert carrier can bind to fibrinogen and fibrin monomers and prevent self-binding to the polymerization pocket of fibrinogen. This interaction can inhibit fibrin formation in a dose dependent fashion. Consequently, this conjugate can be used to diminish the formation of fibrin following injuries) and thus suggests the peptide constituting both the first and second type of peptide as claimed.
Regarding claim 25, Tan in view of Hunter, Barker and Shebuski suggest the medical device of claim 11. Tan in view of Barker and Shebuski further suggest the thrombogenic coating comprising one or more active anti-thrombogenic agents that consist essentially of the one or more peptides (GPRP peptide binds to fibrin/fibrinogen which would inherently perform anti-thrombogenic properties).
Regarding claim 26, Tan in view of Hunter, Barker and Shebuski suggest the medical device of claim 1. Tan further discloses the bioabsorbable polymer matrix comprising a hydrocolloid polymer matrix (¶0049 suitable biodegradable polymers or polymer classes include alginates) configured to swell in response to water absorbed from blood (swelling inherent characteristic of alginates when exposed to water).
Regarding claims 27 and 28, Tan in view of Hunter, Barker and Shebuski suggest the medical device of claim 1. Tan further discloses the bioabsorbable polymer matrix being formed from a selection of bioabsorbable polymers comprising fibrin, collagen, elastin, celluloses, gelatin, vitronectin, fibronectin, laminin, reconstituted basement membrane matrices, starches, dextrans, alginates, hyaluronic acid, poly(lactic acid), poly(glycolic acid), polypeptides, glycosaminoglycans, their derivatives and mixtures thereof ¶0049 and stereopolymers of L- and D-lactic acid, copolymers of bis(p-carboxyphenoxy) propane acid and sebacic acid, sebacic acid copolymers, copolymers of caprolactone, poly(lactic acid)/poly(glycolic acid)/polyethyleneglycol copolymers, copolymers of polyurethane and (poly(lactic acid), copolymers of polyurethane and poly(lactic acid), copolymers of .alpha.-amino acids, copolymers of .alpha.-amino acids and caproic acid, copolymers of .alpha.-benzyl glutamate and polyethylene glycol, copolymers of succinate and poly(glycols), polyphosphazene, polyhydroxy-alkanoates and mixtures thereof ¶0051.
Tan further discloses that actors affecting the mechanical performance of in vivo biodegradable polymers are well known to the polymer scientist, and include monomer selection, initial process conditions, and the presence of additives ¶0052, as well as microparticles having the potential to provide an additional mechanism for controlling the release of a therapeutic agent ¶0066.
Hunter similarly suggests that the bioabsorbable polymer shells bioabsorbable polymer can be formed of degradable polymers including poly(hydroxyl esters) (e.g., PLGA, PLA, PCL, and the like) as well as polyanhydrides, polyorthoesters and polysaccharides (e.g., chitosan and alginates).
Hunter, in the same field of endeavor of biodegradable coatings, further teaches different polymer coatings releasing drugs at differing rates, and selecting dosing parameters with the release rate of the drug from surface/coating such that a minimum concentration is maintained ¶2222,
While neither Tan nor Hunter suggest the bioabsorbable polymer shells and the bioabsorbable polymer matrix being formed of different bioabsorbable polymers or these polymers having different degradation rates such that a degradation rate of the bioabsorbable polymer shells are different from a release rate of the bioabsorbable polymer matrix, Tan, in the same field of endeavor of biodegradable coatings, teaches that the mechanical performance of in vivo biodegradable polymers is well known to one of ordinary skill in the art, i.e. polymer scientist, and includes the selection of the polymer; and that the material properties of the microsphere can be utilized to provide an additional mechanism of controlling the release. As such it is found that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have varied the polymer compositions of the bioabsorbable polymer and bioabsorbable polymer shells such that they were different and had different degradation rates for the purpose of selecting the dosing parameters and release rates to maintain a minimum concentration at the surface as taught by Hunter ¶2222
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have performed the above modification of polymer material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 29, Tan in view of Hunter, Barker and Shebuski suggest the medical device of claim 1. Tan further discloses the bioabsorbable polymer matrix comprising a solvent-activated polymer matrix comprising alginate (¶0049 suitable biodegradable polymers or polymer classes include alginates; solvent-activated inherent to alginates which is activated by the solvent water to perform hydrolysis of alginate bonds ¶0054 hydrolysis of chemical bonds in the biodegradable polymer).
Claim(s) 12-15 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pruitt et al. (U.S. Publication 2012/0330231) in view of Tan (U.S. Publication 2006/0009839) and further in view of in view of Hunter et al. (U.S. Publication 2007/0299043) and Barker (U.S. Publication 2012/0114682) and Shebuski et al. (U.S. Publication 2006/0286063).
Regarding claims 12-15 and 20, Pruitt discloses a hemodialysis (¶0005 hemodialysis) medical assembly comprising: a hemodialysis catheter (¶0005 hemodialysis catheter, element 10, Fig. 1) assembly configured to fluidically couple to a hemodialysis machine (¶0006, placement of catheter, blood withdrawn through aspiration lumen directed to hemodialysis unit), wherein the hemodialysis catheter assembly comprises: a catheter 10 comprising an elongated body and defining an aspiration lumen 3 and a perfusion lumen 3; and an anti-thrombogenic coating formed (method step of 16) on a surface of the catheter (¶0058 balloon coated with anti-thrombogenic material) the surface of the catheter comprising an outer surface of the elongated body, an inner surface of the aspiration lumen, and an inner surface of the perfusion lumen (all of these areas inherently have surfaces formed by the walls of the catheter) (Claim 15).
Pruitt does not expressly disclose the anti-thrombogenic coating comprising: one or more peptides configured to interact with fibrinogen or fibrinogen-derived proteins in blood; and a bioabsorbable polymer matrix configured to control availability of the one or more peptides at a surface of the anti-thrombogenic coating, wherein the one or more peptides are chemically bonded to the bioabsorbable polymer matrix; wherein the one or more peptides comprise at least one of: a first type of peptides configured to bind to the fibrinogen; or a second type of peptides configured to bind to terminal polymerization sites of the fibrinogen-derived proteins to inhibit polymerization of the fibrinogen-derived proteins.
However, Tan, in the same field of endeavor of medical device coatings, teaches a medical device 10 comprising: a vascular device (¶0031 vascular graft 10 Fig. 2) and an anti-thrombogenic coating 14,18 (¶0058 coating layer combined with…anti-thrombogenic agents…RGD peptide) on a surface 12 of the vascular device (¶0031 coating layer covers the graft member), wherein the anti-thrombogenic coating comprises: one or more peptide (¶0058 can be combined with any of the following…RGD peptide…anti-platelet peptides); and a bioabsorbable polymer matrix (14,18 acts as matrix comprising 16; ¶0031 biodegradable coating layer; biodegradable sheath 18; ¶0066 biodegradable polymeric matrix of the sheath) configured to control availability of the one or more peptides at a surface of the anti-thrombogenic coating (¶0031 permits controlled delivery of bioactive agents associated with coating layer), wherein the one or more peptides are encapsulated in microspheres (¶0066 bioactive agent or dug may be encapsulated in microparticles, such as microspheres) wherein the microspheres are dispersed in the bioabsorbable polymer matrix (¶0066 microsphere contained within the biodegradable polymeric matrix), and wherein the bioabsorbable polymer shells are configured to degrade to release the one or more peptides.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the coating of Pruitt that performs the function of providing an antithrombogenic agent for the coating of Tan since these elements perform the same function of providing the therapeutic effect of an anti-thrombogenic agent to a medical device inserted into the vasculature of a patient. Simply substituting one anti-thrombogenic coating means for another would yield the predictable result of allowing a(n) medical device inserted into the vasculature of a patient to have anti-thrombogenic therapeutic effects. See MPEP 2143.
Tan does not expressly suggest the one or more peptides being configured to bind to fibrinogen and/or fibrinogen-derived proteins in blood, or the microspheres being bioabsorbable polymer shells.
Regarding the microspheres being bioabsorbable polymer shells, Hunter, in the same field of endeavor of drug delivery coatings, teaches drug encapsulating microspheres that are made of degradable polymers (¶1749 drug incorporated into secondary carrier microspheres, microsphere may include degradable polymers).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the microsphere material of Tan that performs the function of containing and release a therapeutic to a patient for the microsphere material of Hunter since these elements perform the same function of containing and releasing therapeutics to a patient. Simply substituting one microsphere therapeutic delivery means for another would yield the predictable result of allowing a(n) drug to be contained and released from a microsphere format. See MPEP 2143.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the microsphere of Tan out of the biodegradable material of Hunter, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding the one or more peptides being configured to bind to fibrinogen and/or fibrinogen-derived proteins in blood, Barker, in the same field of endeavor of fibrinogen binding peptides, teaches providing fibrin knob peptides conjugated to inert carriers to block the self-binding pockets of fibrinogen through binding to fibrinogen and fibrin monomers and preventing self-binding to the polymerization pocket of fibrinogen for the purpose of diminishing the formation of fibrin following injuries (¶0114 a conjugate of a fibrin know peptide and an inert carrier can bind to fibrinogen and fibrin monomers and prevent self-binding to the polymerization pocket of fibrinogen. This interaction can inhibit fibrin formation in a dose dependent fashion. Consequently, this conjugate can be used to diminish the formation of fibrin following injuries).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microsphere encapsulated therapeutic of Hunter to have been the fibrin binding peptide therapeutic taught by Barker for the purpose of diminishing the formation of fibrin in the patient.
Furthermore, one of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to perform this modification of Tan with the teachings of Barker in view of the teaching provided by Shebuski, in the same field of endeavor of antithrombotic coatings for medical devices, teaching in ¶0139 that platelets and white blood cells respond to foreign substances in much the same way as an injured tissue, through fibrin deposition and encapsulation of the foreign substance resulting in the formation of fibrin sheaths on intravascular devices.
As such, one of ordinary skill in the art before the effective filing date of the claimed invention would have been properly motivated to have modified Tan with the teachings of Barker for the purpose of preventing complications resulting from fibrin sheath formation on the intravascular medical device as taught by Shebuski (¶0139).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tan (U.S. Publication 2006/0009839) in view of Hunter et al. (U.S. Publication 2007/0299043) and Barker (U.S. Publication 2012/0114682) and Shebuski et al. (U.S. Publication 2006/0286063) as applied to above claim 1 and further in view of Stamler et al. (U.S. Patent No. 6,255,277).
Regarding claim 24, Tan in view of Hunter, Barker and Shebuski suggest the medical device of claim 1. Tan does not expressly disclose the bioabsorbable matrix being configured with a permeability, a molecular diffusivity, a degradation rate, and a loading of the one or more peptides that is sufficient to maintain a concentration of the one or more peptides at the surface of the anti-thrombogenic coating above a minimum inhibitory concentration for inhibition of polymerization of fibrinogen-derived proteins for blood having a concentration of fibrinogen between about 0.1 grams per liter (g/L) to about 10 g/L.
However, the limitation of “configured with a permeability, a molecular diffusivity, a degradation rate, and a loading of the one or more peptides that is sufficient to maintain a concentration of the one or more peptides at the surface of the anti-thrombogenic coating above a minimum inhibitory concentration for inhibition of polymerization of fibrinogen-derived proteins for blood having a concentration of fibrinogen between about 0.1 grams per liter (g/L) to about 10 g/L” is considered functional language as the limitation is requiring that the device exist in such a state of permeability, molecular diffusivity, degradation rate, and a loading of the one or more peptides that when in use is capable of sufficiently maintaining a concentration of the one or more peptides at the surface to maintain inhibition of polymerization of fibrinogen-derived proteins. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Tan in view of Hunter, Barker and Shebuski suggests all the structure as claimed, and is further made of a bioabsorbable material that would inherently have a permeability, a molecular diffusivity, and a degradation rate, and is loaded with peptides in such a way as to allow for sustained release from the biodegrading polymer matrix in order to control a therapeutically effective action, and whose therapeutic effective of antithrombosis would inherently occur through the inhibition of polymerization of fibrinogen-derived proteins as is the effect of the peptide of GPRP. As such, the bioabsorbable polymer matrix suggested by Tan in view of Hunter, Barker and Shebuski is seen to be capable of maintaining a sufficient concentration of the one or more peptides at the surface of the anti-thrombogenic coating above a minimum inhibitory concentration for inhibition of polymerization of fibrinogen-derived proteins for blood having a concentration of fibrinogen as the bioabsorbable polymer matrix is configured to provide sustained release of the therapeutic drug at a level required to have a therapeutic effect and this rate of release would inherently be caused by a permeability, molecular diffusivity, and degradation rate of the matrix as well as an amount of peptide loaded.
Regarding the limitation of for blood having a concentration of fibrinogen between about 0.1 grams per liter (g/L) to about 10 g/L, Stamler, in the same field of endeavor of coatings for medical devices, teaches utilizing a “therapeutically effective amount” of a peptide which refers to the amount of a drug which is effective to achieve its intended purpose and the ability to determine optimal ranges for effective amounts of the drug and adjust dosage required to provide an effective amount of the composition based on individual needs (Col. 22 lines 1-15).
As such it would have been obvious to one of ordinary skill in the art to have modified the dosage of the GPRP peptide of Tan in view of Barker to have been provided in an amount to provide a therapeutic effect based on the individual patient in which the device is to be used and as such based on the fibrinogen value of the blood for the purpose of achieving the intended purpose of antithrombosis as taught by Stamler (Col. 22 lines 1-15).
Conclusion
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781
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