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 .
Claim Status
The amendment submitted on January 2nd, 2026 has been entered. Claims 1, 3-7, 10, and 12-21, 23-25 are currently pending. Claim 25 has been newly added. Claims 2 and 22 have been newly cancelled. Claims 2, 8-9, 11, and 22 remain cancelled. Claims 1, 5-7, and 13 have been amended.
Response to Arguments
Applicant's arguments filed January 2nd, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments filed January 2nd, 2026 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. The applicant’s arguments pertain to the modification of Stamler in view of teaching references, however, Stamler is no longer utilized as the primary reference in the below rejection and Hossainy is no relied upon as the primary reference.
Furthermore, the arguments pertaining to the secondary references are considered moot as the secondary references in relation to the primary reference are not applied in the same manner as in the previous rejection in light of the new interpretation with primary reference Hossainy as detailed below in the Claim Rejections - 35 USC § 103 section
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, 16-17, 21 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hossainy et al. (U.S. Publication 2006/0246109) in view of Schwartz et al. (U.S. Publication 2017/0189654) and Soslau (U.S Publication 2002/0103107) and evidence by Walker (U.S. Publication 2010/0249044).
Regarding claim 1, Hossainy discloses a medical device (Fig. 2) comprising :a vascular device 201; and an anti-thrombogenic coating on a surface of the vascular device, wherein the anti-thrombogenic coating (¶0093 coating becomes non-thrombogenic) comprises: one or more peptides (¶0095 peptide sequences such as those comprising RGD) configured to interact fibrinogen and/or fibrinogen-derived proteins in blood (RGDs inherently interfere with platelet binding site and thus interacts with fibrinogen by preventing binding and interacts with fibrinogen-derived proteins by preventing polymerization of fibrinogen); and a bioabsorbable polymer matrix (¶0082 polymer matrix can comprise polymers that are biodegradable, compositions can be designed such that they can be broken down, absorbed, resorbed and eliminated by a mammal) configured to control availability of the one or more peptides at a surface of the anti-thrombogenic coating (¶0051 a polymeric matrix having a predetermined initial concentration gradient profile of agents within the matrix, designed to produce a controllable release rate of agents from a polymeric matrix, ¶0066 polymeric matrix releases agents during biodegradation of matrix, such that the agent-release design is at least partially dependent on biodegradation),wherein the one or more peptides are chemically bonded to the bioabsorbable polymer matrix (¶0089 polymers can be chemically connected to the agents by covalent bonds) and configured to release from the bioabsorbable polymer matrix upon degradation of the bioabsorbable polymer matrix (¶0066 polymeric matrix releases agents during biodegradation of the matrix).
Hossainy does not expressly disclose the one or more peptides being configured to bind to fibrinogen and/or fibrinogen-derived proteins in blood as the anti-thrombogenic agent disclosed by Stamler of RGD only interferes with the polymerization of fibrinogen and does not directly bind to fibrinogen itself.
However, Schwartz, in the same field of endeavor of anti-thrombotic agents (¶0124 agents are for anti-thrombotic; ¶0126 anti-thrombus) teaches utilizing GPRP-peptide as an injectable/infusible agent to provide anti-thrombotic affects (¶0126 anti-thrombus; ¶0129 GPRP-peptide) combined with other therapeutic agents to allow for synergistic enhanced efficacy (¶0131 therapeutic agents may be combined for synergistic enhanced efficacy).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included GPRP-peptide in the coating disclosed by Hossainy for the purpose of providing the therapeutic anti-thrombotic effect produced by GPRP.
Furthermore, Soslau, in the same field of endeavor of anti-thrombotic agents, discloses the use of RGDS in conjunction with GPRP (¶0010 addition of GPRP along with RGDS completely blocked platelet aggregation) for the purpose of completely block platelet aggregation (¶0010).
It would have been obvious to one of ordinary skill in the art to have modified the one or more peptides disclosed by Hossainy to have included both RGDS and GPRP used in conjunction with one another as taught by Soslau for the purpose of more thoroughly blocking platelet aggregation and fibrinogen interactions (¶0010 of Soslau) and providing two different peptides that are known to have synergistic enhanced efficacy as taught by Schwartz.
While Schwartz and Soslau do not expressly disclose GPRP binding to fibrinogen, the binding of fibrinogen is an inherent attribute of GPRP as evidenced in the disclosure of Walker in ¶0028 which describes GPRP as a fibrinogen binding moiety.
Regarding claim 16, Hossainy discloses a method comprising:
Forming (¶0033 formation) an antithrombogenic coating (¶0093 coating becomes non-thrombogenic) on a surface (Fig. 2 formed on outer surface of stent 202) of a vascular device 202, wherein the anti-thrombogenic coating comprises:
one or more peptides (¶0095 peptide sequences such as those comprising RGD) configured to interact fibrinogen and/or fibrinogen-derived proteins in blood (RGDs inherently interfere with platelet binding site and thus interacts with fibrinogen by preventing binding and interacts with fibrinogen-derived proteins by preventing polymerization of fibrinogen); and a bioabsorbable polymer matrix (¶0082 polymer matrix can comprise polymers that are biodegradable, compositions can be designed such that they can be broken down, absorbed, resorbed and eliminated by a mammal) configured to control availability of the one or more peptides at a surface of the anti-thrombogenic coating (¶0051 a polymeric matrix having a predetermined initial concentration gradient profile of agents within the matrix, designed to produce a controllable release rate of agents from a polymeric matrix, ¶0066 polymeric matrix releases agents during biodegradation of matrix, such that the agent-release design is at least partially dependent on biodegradation),wherein the one or more peptides are chemically bonded to the bioabsorbable polymer matrix (¶0089 polymers can be chemically connected to the agents by covalent bonds) and configured to release from the bioabsorbable polymer matrix upon degradation of the bioabsorbable polymer matrix (¶0066 polymeric matrix releases agents during biodegradation of the matrix).
Hossainy does not expressly disclose the one or more peptides being configured to bind to fibrinogen and/or fibrinogen-derived proteins in blood as the anti-thrombogenic agent disclosed by Stamler of RGD only interferes with the polymerization of fibrinogen and does not directly bind to fibrinogen itself.
However, Schwartz, in the same field of endeavor of anti-thrombotic agents (¶0124 agents are for anti-thrombotic; ¶0126 anti-thrombus) teaches utilizing GPRP-peptide as an injectable/infusible agent to provide anti-thrombotic affects (¶0126 anti-thrombus; ¶0129 GPRP-peptide) combined with other therapeutic agents to allow for synergistic enhanced efficacy (¶0131 therapeutic agents may be combined for synergistic enhanced efficacy).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included GPRP-peptide in the coating disclosed by Hossainy for the purpose of providing the therapeutic anti-thrombotic effect produced by GPRP.
Furthermore, Soslau, in the same field of endeavor of anti-thrombotic agents, discloses the use of RGDS in conjunction with GPRP (¶0010 addition of GPRP along with RGDS completely blocked platelet aggregation) for the purpose of completely block platelet aggregation (¶0010).
It would have been obvious to one of ordinary skill in the art to have modified the one or more peptides disclosed by Hossainy to have included both RGDS and GPRP used in conjunction with one another as taught by Soslau for the purpose of more thoroughly blocking platelet aggregation and fibrinogen interactions (¶0010 of Soslau) and providing two different peptides that are known to have synergistic enhanced efficacy as taught by Schwartz.
Regarding claim 17, Hossainy in view of Schwartz and Soslau suggest the method of claim 16. Hossainy further discloses applying (¶0150 applied) a mixture (¶0152 agent combined with polymer, biodegradable, as a matrix) to the surface of the vascular device (¶0150 formed on stent), wherein the mixture comprises the one or more peptides and the bioabsorbably polymer matrix (¶0152 agent combined with polymer, biodegradable, as a matrix); and curing the mixture to form the anti-thrombogenic coating (¶0181 any procedure for drying or curing known to one of skill in the art is within the scope of this invention).
Regarding claim 21, Hossainy in view of Schwartz and Soslau suggest the medical device of claim 1. Hossainy further discloses the one or more peptides being covalently bonded to the bioabsorbable polymer matrix (¶0089 polymers can be chemically connected to the agents by covalent bonds).
Hossainy in view of Schwartz and Soslau do not expressly disclose or suggest the bioabsorbable polymer matrix being configured to break covalent bonds in response to water migrated into the bioabsorbable polymer matrix to expose the one or more peptides to a surface of the antithrombogenic coating to maintain a minimum inhibitory concentration of the one or more peptides at the surface of the anti-thrombogenic coating.
However, the limitations of “configured to break covalent bonds in response to water migrated into the bioabsorbable polymer matrix to expose the one or more peptides to a surface of the antithrombogenic coating to maintain a minimum inhibitory concentration of the one or more peptides at the surface of the anti-thrombogenic coating” are considered functional language (based on ¶0040 which states that water is migrating into polymer matrix and reacting with polymer matrix to break covalent bonds and this being a function of the polymer including, but not limited to, poly(lactic acid), poly(glycolic acid) and the like. 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 Hossainy in view of Schwartz and Soslau suggests all the structure as claimed, comprises the bioabsorbable material listed by the applicant to provide the function of breaking covalent bonds in response to water, poly(lactic acid) (¶0086 poly(L-lactic acid) and is said to provide sustained release of the therapeutic peptides from the device. Furthermore, the biodegradable nature of poly(lactic acid) is known to occur due to hydrolysis of ester bonds (covalent) that occur between the monomers of the material and as such would inherently perform the function of breaking covalent bonds in response to water migrating into the bioabsorbable polymer matrix. As such, it is capable of performing the functions as claimed (i.e. it is capable of breaking covalent bonds in response to water migrated into the bioabsorbable polymer matrix to expose the one or more peptides to a surface of the antithrombogenic coating to maintain a minimum inhibitory concentration of the one or more peptides at the surface of the anti-thrombogenic coating).
Regarding claim 25, Hossainy in view of Schwartz and Soslau suggest the medical device of claim 1. Hossainy further discloses the anti-thrombogenic coating comprising one or more active anti-thrombogenic agents that consist essentially of the one or more peptides (¶0095 peptide sequences such as those comprising RGD)
Claim(s) 3-7, 19, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hossainy et al. (U.S. Publication 2006/0246109) in view of Schwartz et al. (U.S. Publication 2017/0189654) and Soslau (U.S Publication 2002/0103107) and evidence by Walker (U.S. Publication 2010/0249044) and Mosesson et al. (Mosesson et al. 2001, Ann. N.Y. Acad. Sci., 936, 11-30, page 22).
Regarding claims 3 and 5-7, Hossainy in view of Schwartz and Soslau suggest the medical device of claim 1. Hossainy in view of Schwartz and Soslau further suggest the one or more peptides comprising a first type of peptides configured to bind to the fibrinogen (GPRP binds to fibrinogen as evidence by Walker, see above rejection of claim 1) and 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 (RGDS inherently binds to platelets at polymerization site of fibrinogen and platelets thus binding to terminal polymerization sites of fibrinogen-derived polymerized protein structure of platelet polymerized with fibrinogen as evidenced by Mosesson et al. Page 22, binding of RGDS to platelet would inherently inhibit polymerization of the fibrinogen-derived protein; GPRP inherently binds to terminal polymerization sites of the fibrinogen-derived proteins to inhibit polymerization of the fibrinogen-derived proteins as fibrinogen-derived proteins terminal polymerization sites bind to GPRP in order to polymerize and are thus inhibited by GPRP as evidenced by Walker in ¶0028 which states that the sequence of GPRP is the sequence that becomes exposed on fibrinogen in order to allow for the polymerization reaction of fibrinogen-derived protein fibrin and would therefore presence of GPRP would inherently inhibit binding of exposed GPRP sequences of fibrinogen by binding to the fibrinogen prior to it being able to bind another fibrinogen GPRP sequence that would result in polymerization) (Claim 3 and 5) wherein at lest one of the peptides of the first type of peptides is different from at least one of the peptides of the second type of peptides (RGDS different from GPRP) (Claim 5), wherein the first type of peptides comprises GPRP (Claim 6) and the second type of peptides comprises GPRP (Claim 7).
Regarding claim 4, Hossainy in view of Schwartz and Soslau suggest the medical device of claim 3. Hossainy further discloses maintaining a concentration of the peptides at the surface of the anti-thrombogenic coating above a minimum inhibitory concentration (¶0051 a polymeric matrix having a predetermined initial concentration gradient profile of agents within the matrix, designed to produce a controllable release rate of agents from a polymeric matrix, ¶0066 polymeric matrix releases agents during biodegradation of matrix, such that the agent-release design is at least partially dependent on biodegradation; Abstract control over the release rate of agents provides control over the therapeutic…effects that are realized by a patient, ¶0129 design of a composition for the sustained release of agents can be dependent on…the therapeutic…needs of a patient).
Hossainy does not expressly disclose the minimum inhibitory concentration corresponding to inhibition of binding of fibrinogen to the surface of the anti-thrombogenic coating; or polymerization of the fibrinogen-derived proteins. However, the limitations of “corresponding to the inhibition of binding of fibrinogen to the surface of the anti-thrombogenic coating” and “corresponding to inhibition of polymerization of the fibrinogen-derived proteins” are considered functional language (describes the function of the peptide once released by the coating into the surrounding environment to interact with surrounding proteins to inhibit binding of fibrinogen to a separate moiety). 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 Hossainy in view of Schwartz and Soslau suggest all the structure as claimed, and is further used to release peptides in order to produce an antithrombic effect which is caused by the polymerization of the fibrinogen-derived proteins and incorporates a known inhibitor of fibrinogen binding and polymerization (GPRP) as evidenced by Walker (¶0028 fibrinogen binding peptide, GPRP). As such, it is capable of performing the functions as claimed (i.e., the GPRP released is capable of inhibiting polymerization of the fibrinogen-derived proteins by binding to fibrinogen).
Regarding claim 19, Hossainy in view of Schwartz and Soslau suggest the method of claim 16. Hossainy in view of Schwartz and Soslau further suggest the one or more peptides comprising a first type of peptides configured to bind to the fibrinogen (GPRP binds to fibrinogen as evidence by Walker, see above rejection of claim 1) and 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 (RGDS inherently binds to platelets at polymerization site of fibrinogen and platelets thus binding to terminal polymerization sites of fibrinogen-derived polymerized protein structure of platelet polymerized with fibrinogen as evidenced by Mosesson et al., binding of RGDS to platelet would inherently inhibit polymerization of the fibrinogen-derived protein; GPRP inherently binds to terminal polymerization sites of the fibrinogen-derived proteins to inhibit polymerization of the fibrinogen-derived proteins as fibrinogen-derived proteins terminal polymerization sites bind to GPRP in order to polymerize and are thus inhibited by GPRP as evidenced by Walker in ¶0028 which states that the sequence of GPRP is the sequence that becomes exposed on fibrinogen in order to allow for the polymerization reaction of fibrinogen-derived protein fibrin and would therefore presence of GPRP would inherently inhibit binding of exposed GPRP sequences of fibrinogen by binding to the fibrinogen prior to it being able to bind another fibrinogen GPRP sequence that would result in polymerization).
Regarding claim 23, Hossainy in view of Schwartz and Soslau suggest the device of claim 3. Hossainy further discloses the polymer matrix being configured to maintain a concentration of the one or more peptides that includes the first type and second type of peptides at the surface of the anti-thrombogenic coating above a minimum inhibitory concentration (¶0051 a polymeric matrix having a predetermined initial concentration gradient profile of agents within the matrix, designed to produce a controllable release rate of agents from a polymeric matrix, ¶0066 polymeric matrix releases agents during biodegradation of matrix, such that the agent-release design is at least partially dependent on biodegradation; Abstract control over the release rate of agents provides control over the therapeutic…effects that are realized by a patient, ¶0129 design of a composition for the sustained release of agents can be dependent on…the therapeutic…needs of a patient).
Hossainy does not expressly disclose the minimum inhibitory concentration comprising a first and second minimum inhibitory concentration corresponding to inhibition of binding of fibrinogen to the surface of the anti-thrombogenic coating for the first type of peptide and a second minimum inhibitory concentration corresponding to inhibition of polymerization of the fibrinogen-derived proteins for the second type of peptide.
However, the limitations of “corresponding to the inhibition of binding of fibrinogen to the surface of the anti-thrombogenic coating” and “corresponding to inhibition of polymerization of the fibrinogen-derived proteins” are considered functional language (describes the function of the peptide once released by the coating into the surrounding environment to interact with surrounding proteins to inhibit binding of fibrinogen to a separate moiety). 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 Hossainy in view of Schwartz and Soslau suggests all the structure as claimed, and is further used to release peptides in order to produce an antithrombic effect which is caused by the polymerization of the fibrinogen-derived proteins and incorporates a known inhibitor of fibrinogen binding and polymerization of fibrinogen into fibrinogen derived proteins (GPRP as taught by Soslau) as evidenced by Walker (¶0028 fibrinogen binding peptide, GPRP). As such, it is capable of performing the functions as claimed (i.e., the GPRP released is capable of inhibiting polymerization of the fibrinogen-derived proteins by binding to fibrinogen).
Regarding the concentration of the first and second type of peptides being at first and second minimum inhibitory concentrations, while Hossainy does not expressly disclose maintaining a minimum inhibitory concentration of the peptide, Hossainy does describe the release rate of agents being controlled to provide control over the therapeutic effects that are realized by a patient in need of such treatment (Abstract)
As such it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the GPRP peptide at a therapeutically effective amount for the purpose of accomplishing the intended therapy of antithrombosis which is achieved through the mechanism of GPRP that both inhibits the binding of fibrinogen to the surface of the anti-thrombogenic coating and inhibits polymerization of the fibrinogen-derived proteins as detailed in the functional language limitation above. As such, providing a controlled release rate of agents to provide the therapeutic effect realized by a patient in need of such treatment would have resulted in a minimum inhibitory concentration corresponding to inhibition of binding of fibrinogen to the surface of the anti-thrombogenic coating and a minimum inhibitory concentration corresponding to inhibition of polymerization of the fibrinogen-derived proteins as GPRP would have been provided at a concentration that is therapeutically effective and therefore above both of these concentrations.
Claim(s) 10 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hossainy et al. (U.S. Publication 2006/0246109) in view of Schwartz et al. (U.S. Publication 2017/0189654) and Soslau (U.S Publication 2002/0103107) as evidence by Walker (U.S. Publication 2010/0249044) and further in view of Stankus (U.S. Publication 2011/0143014).
Regarding claim 10, Hossainy in view of Schwartz and Soslau suggest the medical device of claim 1. Hossainy discloses the one or more peptides being encapsulated in the polymer matrix (¶0063 encapsulated within a polymer network) but does not disclose the one or more peptides being encapsulated in polymer shells as microspheres.
However, Stankus, in the same field of endeavor of coated catheters, teaches coating a medical device with antithrombic agents and peptides ¶0073 in the form of microcapsules formed in a surface of the medical device (¶0086 microcapsules formed in the wall of the balloon surface) for the purpose of releasing the therapeutic agent from the microcapsules through diffusion from the microcapsule ¶0086.
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 peptides suggested by Hossainy in view of Schwartz and Soslauto have been included in microcapsules for the purpose of being able to release the microcapsule from the polymer matrix into the surrounding environment and provide a controlled diffusion from the microcapsule after its initial release from the polymer matrix (¶0086 of Stankus).
Regarding claim 18, Hossainy in view of Schwartz and Soslau suggest the method of claim 17. Hossainy does not expressly disclose prior to applying the mixture to the surface encapsulating the one or more peptides into a bioabsorbable polymer shell as microspheres.
However, Stankus, in the same field of endeavor of coated catheters, teaches coating a medical device with antithrombic agents and peptides ¶0073 in the form of microcapsules formed in a surface of the medical device (¶0086 microcapsules formed in the wall of the balloon surface) for the purpose of releasing the therapeutic agent from the microcapsules through diffusion from the microcapsule ¶0086.
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 peptides suggested by Hossainy in view of Schwartz and Soslauto have been included in microcapsules for the purpose of being able to release the microcapsule from the polymer matrix into the surrounding environment and provide a controlled diffusion from the microcapsule after its initial release from the polymer matrix (¶0086 of Stankus).
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 Hossainy et al. (U.S. Publication 2006/0246109), Schwartz et al. (U.S. Publication 2017/0189654) and Soslau (U.S Publication 2002/0103107) as evidence by Walker (U.S. Publication 2010/0249044).
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 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, Hossainy, in the same field of endeavor of medical device coatings, teaches a medical device (Fig. 2) comprising :a vascular device 201; and an anti-thrombogenic coating on a surface of the vascular device, wherein the anti-thrombogenic coating (¶0093 coating becomes non-thrombogenic) comprises: one or more peptides (¶0095 peptide sequences such as those comprising RGD) configured to interact fibrinogen and/or fibrinogen-derived proteins in blood (RGDs inherently interfere with platelet binding site and thus interacts with fibrinogen by preventing binding and interacts with fibrinogen-derived proteins by preventing polymerization of fibrinogen); and a bioabsorbable polymer matrix (¶0082 polymer matrix can comprise polymers that are biodegradable, compositions can be designed such that they can be broken down, absorbed, resorbed and eliminated by a mammal) configured to control availability of the one or more peptides at a surface of the anti-thrombogenic coating (¶0051 a polymeric matrix having a predetermined initial concentration gradient profile of agents within the matrix, designed to produce a controllable release rate of agents from a polymeric matrix, ¶0066 polymeric matrix releases agents during biodegradation of matrix, such that the agent-release design is at least partially dependent on biodegradation),wherein the one or more peptides are chemically bonded to the bioabsorbable polymer matrix (¶0089 polymers can be chemically connected to the agents by covalent bonds) and configured to release from the bioabsorbable polymer matrix upon degradation of the bioabsorbable polymer matrix (¶0066 polymeric matrix releases agents during biodegradation of the matrix).
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 Hossainy 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.
Pruitt in view of Hossainy does not expressly disclose or suggest the one or more peptides being configured to bind to fibrinogen and/or fibrinogen-derived proteins in blood as the anti-thrombogenic agent disclosed by Stamler of RGD only interferes with the polymerization of fibrinogen and does not directly bind to fibrinogen itself.
However, Schwartz, in the same field of endeavor of anti-thrombotic agents (¶0124 agents are for anti-thrombotic; ¶0126 anti-thrombus) teaches utilizing GPRP-peptide as an injectable/infusible agent to provide anti-thrombotic affects (¶0126 anti-thrombus; ¶0129 GPRP-peptide) combined with other therapeutic agents to allow for synergistic enhanced efficacy (¶0131 therapeutic agents may be combined for synergistic enhanced efficacy).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included GPRP-peptide in the coating suggested by Pruitt in view of Hossainy for the purpose of providing the therapeutic anti-thrombotic effect produced by GPRP.
Furthermore, Soslau, in the same field of endeavor of anti-thrombotic agents, discloses the use of RGDS in conjunction with GPRP (¶0010 addition of GPRP along with RGDS completely blocked platelet aggregation) for the purpose of completely block platelet aggregation (¶0010).
It would have been obvious to one of ordinary skill in the art to have modified the one or more peptides suggested by Pruitt in view of Hossainy to have included both RGDS and GPRP used in conjunction with one another as taught by Soslau for the purpose of more thoroughly blocking platelet aggregation and fibrinogen interactions (¶0010 of Soslau) and providing two different peptides that are known to have synergistic enhanced efficacy as taught by Schwartz.
While Schwartz and Soslau do not expressly disclose GPRP binding to fibrinogen or terminal polymerization sites of the fibrinogen-derived proteins to inhibit polymerization of the fibrinogen-derived proteins, the binding of fibrinogen is an inherent attribute of GPRP as evidenced in the disclosure of Walker in ¶0028 which describes GPRP as a fibrinogen binding moiety and GPRP inherently binds to terminal polymerization sites of the fibrinogen-derived proteins to inhibit polymerization of the fibrinogen-derived proteins as fibrinogen-derived proteins terminal polymerization sites bind to GPRP in order to polymerize and are thus inhibited by GPRP as evidenced by Walker in ¶0028 which states that the sequence of GPRP is the sequence that becomes exposed on fibrinogen in order to allow for the polymerization reaction of fibrinogen-derived protein fibrin and would therefore presence of GPRP would inherently inhibit binding of exposed GPRP sequences of fibrinogen by binding to the fibrinogen prior to it being able to bind another fibrinogen GPRP sequence that would result in polymerization.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hossainy et al. (U.S. Publication 2006/0246109) in view of Schwartz et al. (U.S. Publication 2017/0189654) and Soslau (U.S Publication 2002/0103107) as evidence by Walker (U.S. Publication 2010/0249044) and further in view of Stamler et al. (U.S. Patent No. 6,255,277).
Regarding claim 24, Hossainy in view of Schwartz and Soslau suggest the device of claim 1. Hossainy further discloses the bioabsorbable polymer matrix being configured with a permeability (¶0048 porosity of a percolated-phase passage that has formed through the polymeric matrix), a molecular diffusivity (¶0048 effective diffusivity), a degradation rate (¶0079 control over the degradation rate), and a loading of the one or more peptides (¶0039 initial solid phase concentration distribution which includes the drug to polymer ratio) to maintain a concentration of the one or more peptides at the surface of the anti-thrombogenic coating above a minimum inhibitory concentration (¶0051 a polymeric matrix having a predetermined initial concentration gradient profile of agents within the matrix, designed to produce a controllable release rate of agents from a polymeric matrix, ¶0066 polymeric matrix releases agents during biodegradation of matrix, such that the agent-release design is at least partially dependent on biodegradation; Abstract control over the release rate of agents provides control over the therapeutic…effects that are realized by a patient, ¶0129 design of a composition for the sustained release of agents can be dependent on…the therapeutic…needs of a patient).
Hossainy is silent as to whether the minimum inhibitory concentration is related to 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, 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 a 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 Hossainy in view of Schwartz and Soslau 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 taught by Soslau and evidenced by Walker above. As such, the bioabsorbable polymer matrix suggested by Hossainy in view of Schwartz and Soslau 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 Hossainy in view of Schwartz and Soslau 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).
Furthermore, Stamler teaches the act of finding the optimal ranges for effective amounts of a drug being within the skill of the art which is further supported by MPEP section 2144.05 where it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine experimentation and is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Stamler teaches the necessity to optimize a drug dosage through adjustment of the dosage required for the purpose of providing an effective amount of the composition based on an individuals need in order to achieve a therapeutically effective amount that achieves the intended purpose of the drug.
As such it would have been obvious to one of ordinary skill in the art to have adjusted the concentration of GPRP provided by the bioabsorbable matrix to have been an amount sufficient to bind a concentration of fibrinogen in the patient’s blood between about 0.1 grams per liter (g/L) to about 10 g/L as it is within the skill of ordinary skill in the art to adjust the dosage of the therapeutic agent to be provided in a concentration that provides a therapeutic effect to the patient.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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