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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-4, 6-10, 22-26, and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan et al. US Patent Application Publication 2016/0279299 in view of Gravett et al. US Patent Application Publication 2010/0222863.
As to claim 1, Kaplan teaches a stent (para. 0054), the stent comprising: a plurality of silk particles (paras. 007, 0110); wherein the particles comprise a urological therapeutic agent (ibuprofen) (Kaplan paras. 0008, 0025, 140). Kaplan does not disclose a thermoplastic polyurethane (TPU) material and does not disclose the silk particles covalently attached to the TPU material. Gravett, from the same field of endeavor, teaches stents (Abstract) comprising silk particles (Gravett paras. 0058, 0079), where Gravett teaches the silk is affixed to either the stent or graft portion of the stent graft. Gravett teaches the silk-containing stent graft may include a polymer, comprising polyurethanes (paras. 0079, 0094 and 0095). Gravett teaches various methods of attaching the silk particles to the stent graft (Gravett para 0079) as well as the attachment of similar agents to the stent material including covalent attachments (para 0087). It would have been obvious for one of ordinary skill in the art before the invention was originally filed to prepare a stent, as disclosed by Kaplan, comprising silk particles attached to a polyurethane material, as disclosed by Gravett, comprising various methods of attachment, such as covalently attached since Gravett teaches covalent bonding is one of the known techniques of affixing particles to the stent and produce no new and unexpected result that is a silk-containing stent graft with a polyurethane sheath.
As to claim 2, wherein the stent is a catheter (Kaplan Abstract, paras. 0032, 0036, 0053).
As to claim 3, the stent has an elastic modulus of 1 MPa to 20 MPa (Kaplan para. 0076).
As to claim 4, Kaplan/Gravett teaches the TPU material comprises poly(tetrahydrofuran) (poly THF)– where Gravett teaches the silk-containing stent graft may include a polymer, such as a poly(tetramethylene ether glycol), also known as poly THF, and copolymers and blends thereof (para. 0094, col. 2). Gravett also teaches the silk-containing stent graft may be coated with a tetrahydrofuranyl compound (para. 0090, col. 2, line 2). Gravett does not teach the TPU material comprises 18 % by weight (wt%) to 48 wt% poly(tetrahydrofuran). However, one having ordinary skill in the art would be able to determine through routine experimentation the weight % of poly(tetrahydrofuran) needed to deliver therapeutic doses of fibrosis-inhibiting agents.
As to claim 6, Kaplan teaches the silk particles have an average diameter of 0.1 µm to 30 µm (Kaplan para. 0111).
As to claim 7, Kaplan teaches the loading of the urological therapeutic agent is 0.001 mg to 0.4 mg of urological therapeutic agent (Kaplan para. 0141), but does not specifically teach the loading amount per 1 mg of silk particles. However, it would have been obvious to one having ordinary skill in the art before the invention was originally filed to prepare the stent disclosed comprising various dosage loadings per desired amount of silk particles in order to deliver a desired dosage amount.
As to claims 8 and 9, Kaplan/Gravett teach the attachment of agents to the silk containing stent through covalent attachment (Gravett para. 0087). Kaplan/Gravett further teaches a urological the therapeutic agent may comprise a cell, a protein, a peptide, a nucleic acid, a nucleic acid analog, a nucleotide, an oligonucleotide, a peptide nucleic acid (PNA), an aptamer, an antibody, an antigen, an epitope, a hormone, a hormone antagonist, a growth factor, a recombinant growth factor, a cell attachment mediator, a cytokine, an enzyme, a small molecule, an antibiotic, an antimicrobial compound, a virus, an antiviral, or a combination thereof (Kaplan paras. 0025, 0064, 0140; Gravett para. 0088).
As to claim 10, Kaplan/Gravett teach the urological therapeutic agent comprises an alkylating agent, a platinum agent, an antimetabolite, a topoisomerase inhibitor, an antitumor antibiotic, an antimitotic agent, an aromatase inhibitor, a thymidylate synthase inhibitor, a DNA antagonist, a farnesyltransferase inhibitor, a pump inhibitor, a histone acetyltransferase inhibitor, a metalloproteinase inhibitor, a ribonucleoside reductase inhibitor, a TNF alpha agonist, a TNF alpha antagonist (Gravett paras. 0015,90, col. 2, line 2), an endothelin receptor antagonist, a retinoic acid receptor agonist, an immuno- modulator, a hormonal agent, an antihormonal agent, a photodynamic agent, or a tyrosine kinase inhibitor (Kaplan para. 140;Gravett paras. 0088, 0090).
As to claim 22, Kaplan/Gravett teaches the stent provides extended release of the urological therapeutic agent for up to 168 hours – where Kaplan the stent provides release of the therapeutic agent up to 8 days (192 hours) (Kaplan Figs. 7A, 7B; paras. 0033, 129, 130, 141; Gravett para. 0104).
As to claim 23, Kaplan teaches a stent (para. 0054). Kaplan teaches the stent is a catheter (Kaplan Abstract, paras. 0032, 0036, 0053).
The catheter comprising: a plurality of silk particles (paras. 007, 0110); wherein the particles comprise a urological therapeutic agent (ibuprofen) (Kaplan paras. 0008, 0025, 140). Kaplan does not disclose a thermoplastic polyurethane (TPU) material and does not disclose the silk particles attached to the TPU material. Gravett, from the same field of endeavor, teaches stents (Abstract) comprising silk particles (Gravett paras. 0058, 0079), where Gravett teaches the silk is affixed to either the stent or graft portion of the stent graft. Gravett teaches the silk-containing stent graft may include a polymer, comprising polyurethanes (paras. 0079, 0094 and 0095). Gravett teaches the silk-containing stent grafts may include a polymeric carrier that is adapted to contain and release a therapeutic agent (Gravett para. 0063). Gravett teaches the polymer can be blended or copolymerized in various compositions as required to deliver therapeutic doses of fibrosis-inhibiting agents (para. 0097). It would have been obvious to one having ordinary skill in the art to prepare a catheter, as disclosed by Kaplan, comprising silk particles attached to a polyurethane material, as disclosed by Gravett since both references are from the same field of endeavor and solve the same problem of providing a silk-containing catheter for the benefit of delivery of a therapeutic agent to repair or regenerate tissue in a subject. The catheter has an elastic modulus of 1 MPa to 20 MPa (Kaplan para. 0076).
As to claim 24, Kaplan teaches the loading of the urological therapeutic agent is 0.001 mg to 0.4 mg of urological therapeutic agent (Kaplan para. 0141), but does not specifically teach the loading amount per 1 mg of silk particles. However, it would have been obvious to one having ordinary skill in the art before the invention was originally filed to prepare the stent disclosed comprising various dosage loadings per desired amount of silk particles in order to deliver a desired dosage amount.
As to claim 25, Kaplan/Gravett teaches the catheter - Kaplan teaches the stent is a catheter (Kaplan Abstract, paras. 0032, 0036, 0053) - provides extended release of the urological therapeutic agent for up to 168 hours – where Kaplan the stent provides release of the therapeutic agent up to 8 days (192 hours) (Kaplan Figs. 7A, 7B; paras. 0033, 129, 130, 141; Gravett para. 0104).
As to claim 26, Kaplan/Gravett teach a method of manufacturing a stent, the method comprising: enriching a thermoplastic polyurethane (TPU) material with a plurality of carboxylic acid groups; and covalently coupling (Gravett para. 0087) a plurality of silk particles to the carboxylic acid groups (fatty acids) – where Gravett teaches the silk threads can be coated with fatty acids prior to attachment to the stent graft or they can be coated onto the silk threads once they have been attached to the stent graft, which includes the polyurethane material (Gravett paras. 0073-0074) - where, wherein the silk particles comprise a urological therapeutic agent (Kaplan paras. 0008, 0025, 140).
As to claims 29 and 30, Kaplan/Gravett teach the present invention substantially as claimed. Kaplan/Gravett teach functionalized and unfunctionalized silk – where Kaplan teaches the silk fibroin can be modified using a diazonium coupling reaction (Kaplan para. 0126). However, Kaplan/Gravett do not teach the claimed percentage of amine-functionalized or unfunctionalized silk. It would have been obvious to one having ordinary skill in the art to provide the claimed percentage through routine experimentation depending on the systems needed for fluid delivery of a therapeutic agent and the amount of agent needed for tissue repair and regeneration.
As to claim 31, Kaplan/Gravett teach a method for treating a urological disease or disorder, the method comprising: implanting or inserting the stent of claim 1 or the catheter of claim 23 into a subject in need thereof – where Kaplan teaches using a catheter to keep a passageway (urethra) open, to treat diseases or disorder, and/or to perform a surgical procedure (Kaplan paras. 0052-0053, Gravett paras. 0127-0128). Based on the teaching of Kaplan, it would have been obvious to use a urethral catheter to treat a urological disorder.
Claims 5 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan et al. US Patent Application Publication 2016/0279299 in view of Gravett et al. US Patent Application Publication 2010/0222863 and further in view of Pavlovic et al. US Patent Application Publication 2020/03582843.
Kaplan/Gravett teach the present invention substantially as claimed. With respect to claim 5, Kaplan/Gravett do not teach the silk particles are attached to the TPU material via an amide bond. Additionally, Kaplan teaches a chemical modification of the silk fibroin using a carbodiimide coupling reaction (Kaplan para. 0126), but Kaplan/Gravett do not teach the method of claim 28 wherein the stent is made by covalently coupling the silk particles to the carboxylic acid groups comprises: activating the carboxylic acid groups by reacting the groups with a carbodiimide; then reacting the silk particles with the activated carboxylic acid groups. Pavlovic teaches a silk-containing dermal filler where the composition comprises a silk crosslinked to a hyaluronic acid via amide bonding to a multiamine cross linker (Pavlovic claim 1), prepared by the process of: i)reacting at least one carboxylic acid group on a glucuronic acid residue of the hyaluronic acid with a carbodiimide coupling agent, where an activated hyaluronic acid is produced; and (ii) crosslinking the activated hyaluronic acid and the silk using a multiamine crosslinker (Abstract, Equivalent Abstract). Pavlovic teaches the composition is an injectable composition that reduces scar tissue as a result of the active vascularization and dissolution of scare tissue either as a preventative or post treatment procedure based on the delivery of viable fat-derived cells or stem or progenitor cells to the site (Pavlovic para. 0015). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to provide amide bonds for attaching the silk particles to the polyurethane, since amide bonding is a known method of covalent bonding which is taught in Gravett (Gravett para. 0087) and is a known technique of bonding materials (Pavlovic, claim 1). It would have been obvious to one having ordinary skill in the art to modify the method of Kaplan/Gravett with the method taught in Pavlovic since Pavlovic teaches the method is used to reduced scar tissue and Kaplan/Gravett also solves the same problem with methods for reducing scarring or fibrosis (Gravett paras. 0034, 0097, 0098).
Allowable Subject Matter
Claim 27 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter: The prior art references do not teach the method where the TPU material is enriched with carboxylic acid groups using photooxidation of the TPU material with an oxidizing agent.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Roth et al. US Patent Application Publication 2007/0123973 is cited to show a silk-containing stent. Lye et al. US Patent Application Publication 2006/0121080 is cited to show a silk-containing implantable device.
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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781
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