DETAILED ACTION
Claims 1-16 and 22-23 are currently pending. Claims 1-2, 5-8 and 23 are currently under examination.
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 .
Election/Restrictions
Newly submitted claim 22 is directed to a species that is independent or distinct from the invention originally claimed for the following reasons: Applicant has received an action on the merits directed to medical device comprises one or more metallic surfaces. The newly added claim 22 is directed to a medical device comprises one or more polymer or ceramic surfaces which is distinct from the previously examined and rejected metallic surfaces.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 22 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 07/22/2025 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
Examiner’s Note
Applicant's amendments and arguments filed 07/22/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 07/22/2025, it is noted that claim 23 is newly added and no new matter or claims have been added.
Modified Rejection:
The following rejections are modified based on Applicant’s newly added claim.
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.
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.
Claim(s) 1-2, 5-7 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0039441 (previously applied) in view of US 2008/0085946 (previously applied).
Regarding claim 1, the limitation of a method of coating one or more surfaces of a medical device comprising providing a mixture of PLGA, methacrylate, an organic solvent and one or more drugs, applying the mixture to one or more surfaces of the medical device is met by the ‘441 publication teaching a drug eluting medical device for implanting into vessels within the body. The coated medical device, such as a stent, comprises a coating consisting of a controlled release matrix of bioabsorbable, biocompatible material such as PLGA polymer, at least one pharmaceutical substance or bioactive agent incorporated within the matrix (abstract, [0020]). The coating is applied to the device using standard techniques such as spraying wherein a solution is applied [0021]. The coating composition may further comprise methyl methacrylate. The nonabsorbable polymer aids in the controlled release of the substance so as to increase the molecular weight of the composition thereby delaying or slowing the rate of release of the pharmaceutical substance ([0022], [0042]). The coating composition is taught to include a solvent such as methylene chloride [0048].
Regarding claim 2, the limitation of wherein the mixture is applied by spraying is met by the ‘441 publication teaching spraying [0021].
Regarding claim 5, the limitation of wherein the medical device comprises one or more metallic surfaces that are coated is met by the ‘441 publication teaching the structure of the device is biocompatible metals [0031].
Regarding claim 6, the limitation of wherein the medical device comprises one of an orthopedic implant, a spinal implant, a joint replacement device, a pacemaker, an insulin pump, a surgical pin, a screw or other surgical hardware is met by the ‘441 publication teaching stents, artificial hearts and fixates to connect the prosthetic organ to the vascular circulation [0032], meeting the limitation of surgical hardware.
Regarding claim 7, the limitation of wherein the one or more drugs, medicaments or pharmaceutical compounds comprises an antibiotic is met by the ‘441 publication teaching antibiotics [0044].
Regarding claim 23, the limitation of wherein the coating comprises a plurality of layers of photo-crosslinked PLGA dimethacrylate coating is met by the ‘441 publication teaching the coating comprising multiple layers of polymer and pharmaceutical substances (claims 22-23, abstract, [0020]).
The ‘946 publication does not specifically teach PLGA dimethacrylate and a photo initiator and irradiating the mixture with polymerizing light to form a photo crosslinked PLGA dimethacrylate coating (claim 1).
The ‘946 publication teaches a photo-tailored shape memory article. The article includes a photochemically cross linkable polymer composition, illuminating at least two different regions. Photo-chemically cross linkable polymer composition that include a di(meth)acrylate macromer, a multifunctional thiol and a photo initiator (abstract). Illuminating a first region of the article with a first ultraviolet light exposure to photochemically crosslink the photochemically crosslinkable polymer composition [0006]. Photocrosslinkable polymer compositions comprises a telechelic polymer, multifunctional crosslinking agent and a polymerization initiator. In some embodiments the polymer is bifunctional telechelic polymer wherein each of the two functional groups comprises an aliphatic carbon carbon double bond. Suitable telechelic biodegradable polymers include, for example, di(meth)acrylate esters of polycaprolactone, polylactide, polyglycolide ransom copolymers ([0039], [0050]). Poly(D,L-lactide-co-glycolide) dimethacrylate is taught [0063]. Although photochemical crosslinking reactions were used in the above experiments, thermal curing can also be used to form the thermoset networks. PLGA and POSS-PLGA macromers can be blended with a thermal initiator, and optionally with a pharmecuatially active ingredient to form a thermally curable composition. The curable composition can be electro sprayed onto a metallic stent and thermally cured. Thermal curing may be preferably to photochemical curing when the curable composition comprises a photochemically sensitive pharmaceutical active [0089]. Shape memory is taught to be tailored [0054].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use PLGA dimethacryate on the device taught by the ‘441 publication because the ‘441 publication teaches the use of PLGA and methacrylate as a stent coating and the ‘946 publication teaches lactide and glycolide dimethacrylic polymers which are photoinitiated and may be applied to medical devices such as stents. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use polymers taught by the ‘441 publication on a stent as a copolymer for photo initiator as the ‘946 publication teaches the use of photoinitiated polymers to be applied to a stent coating for curing. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘441 publication and the ‘946 publication both teach electrospraying of polymer coatings onto stents including an active agent. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to do so as the ‘946 publication teaches application of PLGA polymers and cross linkable macromomers wherein PLGA dimethacrylate is taught as a photoinitiated polymer and the ‘441 publication teaches the coating comprising PLGA and methacrylate polymers. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to do so as the ‘946 publication teaches phototailored shape memory articles which are useful for medical devices and the ‘441 publication teaches the inclusion of methacrylate for malleability of the matrix to be used on a medical device.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0039441 in view of US 2008/0085946 as applied to claims 1-2, 5-7 and 23 above, and further in view of Liu (Liu et al. Journal of Vascular Surgery Aug 2018, pgs. 597-606).
As mentioned in the above 103(a) rejection, all the limitations of claims 1-2 and 5-7 are taught by the combination of the ‘441 publication and the ‘946 publication.
The combination of references does not teach vancomycin (claim 8).
Liu teaches sustained local delivery of high concentration vancomycin from a hybrid biodegradable, antibiotic eluting prosthesis for treatment of mycotic aortic aneurysms (title). A stent graft is taught to be vancomycin-eluting prosthesis and evaluated antibiotic release form the endovascular prosthesis both in vitro and in vivo. Poly(D,L)-lactide-co-glycolide and vancomycin were dissolved in solvent. Antibiotic is taught as released form the hybrid stent graft. Sustained local delivery of antibiotics to the aneurysm sac and aortic wall were taught (abstract).
It would have been obvious to one of ordinary skill in the art to substitute a first antibiotic as taught by the ‘441 publication with a second antibiotic, i.e. vancomycin, as taught by Liu with a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). M.P.E.P. §2144.06.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the specifically named vancomycin as taught by Liu in the stent coating taught by the ‘441 publication because Liu teaches vancomycin to be a specific antibiotic to be used in PLGA coated stents and the ‘441 publication is directed to PLGA antibiotic coated stents.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
103: The ’441 publication and the ‘946 publication
Applicant argues the ‘441 publication teaches PLGA is not PLGA dimethacrylate and is not crosslinked together using light or any other initiator. Instead the ‘441 publication teaches that PLGA (not PLGA dimethacrylate) is dried on the stent and forms a lattice of channels in which pharmaceutical substances can be trapped for delivery to the tissue. There is not crosslinking of the PLGA disclosed in the ‘441 publication. The ‘441 publication merely discloses that PBMA or MMA may be added to a coating composition to increase the malleability of the matrix so that the device is more plastically deformable.
In response, the ‘441 publication teaches a drug eluting medical device containing a coating including PLGA polymer (abstract, [0020]) which may also contain methyl methacrylate ([0022], [0042]). The ‘946 publication teaches poly(D,L-lactide-co-glycolide) dimethacrylate [0063], wherein the composition include photochemically crosslinkable polymer compositions that include di(meth)acrylate macromer (abstract) wherein suitable telechelic biodegradable polymer include di(meth)acrylate esters of lactide polymers [0039]. Lactide di(meth)acrylate units are taught to be distinct from the di(meth)acrylate esters of polyhedral oligiosilsequioxane diol initiated lactide polymers ([0012]-[0013]). It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use PLGA dimethacryate on the device taught by the ‘441 publication because the ‘441 publication teaches the use of PLGA and methacrylate as a stent coating and the ‘946 publication teaches lactide and glycolide dimethacrylic polymers which are photoinitiated and may be applied to medical devices such as stents.
Applicant argues the ‘946 publication discloses a method of forming photo-tailored shape memory article. The ‘946 publication does not disclose the claimed mixture that includes PLGA dimethacryate, a photoinitiator, an organic solvent and one or more drugs, medicaments or pharmaceutical compounds. The ‘946 publication teaches POSS-PLGA. Applicant makes an on the record admission that the metes and bounds of claim 1 does not include POSS-PLGA molecule disclosed.
In response, the ‘946 publication teaches poly(D,L-lactide-co-glycolide) dimethacrylate [0063], wherein the composition include photochemically crosslinkable polymer compositions that include di(meth)acrylate macromer (abstract) wherein suitable telechelic biodegradable polymer include di(meth)acrylate esters of lactide polymers [0039]. Lactide di(meth)acrylate units are taught to be distinct form the di(meth)acrylate esters of polyhedral oligiosilsequioxane diol initiated lactide polymers ([0012]-[0013]). Additionally, the instant claims do not exclude POSS-PLGA-Dimethacrylate polymers as there is no closed language regarding the PLGA dimethacryate in the instant claims.
Applicant argues a person having ordinary skill in the art, when apprised of the disclosure and teachings of the ‘441 publication and the ’946 publication would not use the polymer taught by the ‘441 publication on a stent as a copolymer for photo-initiated curing as taught by the ‘946 publication. The ‘441 publication teaches to a person skilled in the art to use PLGA-based drug loaded coats that are to be crosslinked by any chemistry let alone by PLGA dimethacrylate. The ‘946 publication would not lead a person skilled in the art to crosslink PLGA dimethacrylate to form a drug loaded coating as it is directed to shape memory polymers that omits any discussion regarding coatings to control the release kinetics of drugs or therapeutics contained therein.
In response, the ‘946 publication teaches the curable composition to be electrosprayed onto a metallic stent and cured wherein the curable composition may include an active agent [0089]. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use PLGA dimethacryate on the device taught by the ‘441 publication because the ‘441 publication teaches the use of PLGA and methacrylate as a stent coating and the ‘946 publication teaches lactide and glycolide dimethacrylic polymers which are photoinitiated and may be applied to medical devices such as stents. The ‘411 publication teaches the coating composition may further comprise methyl methacrylate. The nonabsorbable polymer aids in the controlled release of the substance so as to increase the molecular weight of the composition thereby delaying or slowing the rate of release of the pharmaceutical substance ([0022], [0042]). Thus the ‘411 publication teaches the use of methacrylate to control the release of the pharmaceutical substance.
Applicant argues the Applicant found that photo-crosslinked PLGA dimethacrylate reduced the initial burst or release of antibiotic in a pin coated with vancomycin [0029]. The additional diffusion resistance created through crosslinking prevent easy diffusion of the drug into the surrounding media. There is nothing to suggest in either reference that would lead a person having ordinary skill in the art to use PLGA dimethacrylate to tune release kinetics of a drug loaded coating that is formed on medical devices. The ‘441 publication discusses increasing the molecular weight of the polymer coating to achieve slower release rates with not a hint or suggesting of tuning release kinetics via crosslinking. The ‘946 publication also does not teach or suggest anything in this regard as the material contemplated in this publication relates to adjusting the shape memory properties.
In response, the ‘441 publication teaches the inclusion of a nonabsorbable polymer such as methyl methacrylate controlled the lease of the substance by delaying or slowing the release of the pharmaceutical substance ([0022], [0042]). Thus the inclusion of an acrylate substance in the coating would be expected to slow the release rate compared to a PLGA coating only. The instant specification states that the release kinetics can be tuned by adjusting the degree of crosslinking. No data has been given regarding the release rate and the amount of crosslinking. Applicant’s arguments cannot take the place of factual evidence wherein factual evidence is required.
Applicant argues Liu is not PLGA dimethacrylate and is in the form of a nanofibrous membrane that is not crosslinked in any manner. Lue is particularly inapplicable to the claimed method.
In response, Applicant’s arguments regarding the ‘441 publication and the ‘946 publication are addressed above as first presented regarding PLGA dimethacrylate polymer. Liu teaches vancomycin on stents in combination of PLGA (abstract). It would have been obvious to one of ordinary skill in the art to substitute a first antibiotic as taught by the ‘441 publication with a second antibiotic, i.e. vancomycin, as taught by Liu with a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Conclusion
No claims are allowed.
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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613