DETAILED ACTION
Claims 1, 5-10 and 13-19 are currently pending and 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 .
Withdrawn Rejections
The prior rejection of claim(s) 1, 3, 5, 10-11 under 35 U.S.C. 102(a)(1) as being anticipated by EP 0331 392 and claim(s) 1, 3 and 5-14 under 35 U.S.C. 103 as being unpatentable over EP 0331 392 is withdrawn in light of Applicant’s amendment to specify a urinary catheter, which the art does not teach.
Examiner’s Note
Applicant's amendments and arguments filed 02/24/2026 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 02/24/2026, it is noted that claim 1 has been amended and no new matter or claims have been added.
Modified Rejection:
The following rejection has been modified based on Applicant’s claim amendment.
Claim(s) 1, 5-6, 7-10, 14-15 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0197455 (previously applied) in view of EP 0331 392 (Applicant provided).
Regarding claim 1, the limitation of the method comprising (a) providing a drug-eluting medical device containing the local anesthetic, the drug-eluting medical device being a urinary catheter comprising the local anesthetic within an elastomeric material and (b) administering the drug-eluting medical device to a subject such that it contacts a tissue and elutes the local anesthetic thereto; wherein the eluted local anesthetic provides an enhanced antimicrobial efficacy as compared to the same local anesthetic when not delivered by the drug-eluting medical device is met by the ‘455 publication teaches medical catheters, tubes and other medical devices where drugs can be loaded into the wall thereof with a loading solution (abstract). Catheters is taught to include urinary tract catheters [0008]. The catheter is taught to be formed of latex rubber or silicone and be immersed in lidocaine water solution wherein the lidocaine is adsorbed into the wall of the catheters. The catheter is taught to be placed in the mucosal tract and will continue to release lidocaine until the catheter wall is depleted ([0056]-[0059]). The ‘455 publication teaches providing the claimed medical device and administering it through application and thus would necessarily have the function of enhanced antimicrobial efficacy compared to the same local anesthetic when not delivered by the drug-eluting medical device, absent factual evidence to the contrary, as the ‘455 publication teaches the structure of the device and the method steps.
Regarding claims 5-9, the limitation of wherein the local anesthetic is hydrophobic, hydrophilic or lipophilic local anesthetic, specifically lidocaine free base or bupivacaine is met by the ‘455 publication teaching the local anesthetic includes lidocaine and bupivacaine and can be in its base form [0011].
Regarding claims 10, the ‘455 publication teaches contact with mucosal ([0056]-[0059]).
Regarding claims 14-15, the limitation of wherein the elastomeric material is a rubber or polymeric material selected from natural or elastomeric rubber, specifically latex rubber is met by the ‘455 publication teaching latex rubber [0057].
Regarding claims 18-19, the limitation of further contains an antimicrobial agent within the elastomeric material specifically high valency silver or silver sulphadiazine is met by the ‘455 publication teaching silver sulfadiazine ([0013]-[0014], [0066]).
The ‘455 publication does not specifically teach a tissue permeator, the drug eluting medical device comprising tissue permeator (claim 1) wherein the permeation enhancer is selected form a group including glycerol monooleate (claim 13).
The ‘392 publication teaching a device which occludes an area of skin has a self-adhering matrix containing a topical anesthetics of the amide or ester type wherein the anesthetic agents exhibit high activity against anaerobes as well as aerobes (abstract) where the anesthetic simultaneously serves as an antimicrobial agent (page 3, lines 1-8). In a preferred embodiment the matrix comprised of an anesthetic, preferably tetracaine)-polyisobutyene/mineral oil and a backing (page 4, lines 1-10). The drug is taught to be applied epidermis comprising tetracaine patches blended with poly(styrene-isoprene-styrene) block copolymer (Example 1-2). The ‘392 publication teaches providing the claimed medical device and administering it through application and thus would necessarily have the function of enhanced antimicrobial efficacy compared to the same local anesthetic when not delivered by the drug-eluting medical device, absent factual evidence to the contrary, as the ‘392 publication teaches the structure of the device and the method steps. The matrix may contain a permeation enhancer to facilitate the transdermal delivery of the anesthetic agent. Suitable permeation enhancer includes without limitations, glycerol monooleate and ethanol (page 3, lines 35-40).
It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of disclosed ingredients (a latex rubber catheter containing lidocaine and silver sulfadiazine administered to a subject in contact with tissue) from within the prior art disclosure of the ‘455 publication, to arrive at the instantly claimed medical device “yielding no more than one would have expected from such an arrangement”.
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 glycerol monooleate in the device taught by the ‘455 publication because the ‘392 publication teaches the use of glycerol monooleate to be a penetration enhancer for an anesthetic agent delivery to the body wherein the ‘455 publication is directed to delivery of an anesthetic agent to body. One of ordinary skill in the art before the filing date of the claimed invention would have reasonable expectation of success as the ‘455 publication and the ‘392 publication are both directed to medical devices to delivery local anesthetics to the body. One of ordinary skill in the art before the filing date of the claimed invention would have a motivation to use glycerol monooleate because it is taught as a penetration enhancer for the delivery of an anesthetic agent and the ‘455 publication desires the delivery of an anesthetic.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0197455 and EP 0331 392 as applied to claims 1, 5-6, 7-10, 14-15 and 18-19 above, and further in view of US 2008/0032935.
As mentioned in the above 103(a) rejection, all of the limitations of claims 1, 5-6, 7-10, 14-15 and 18-19 are taught by the ‘455 publication and the ‘392 publication.
The combination of references do not specifically teach the drug eluting medical device further contains vasoconstrictor within the elastomeric material, phenylephrine (claims 16-17).
The ‘935 publication teaches vasoconstrictors such as phenylephrine can be included to prolong the effect of local anesthesia. Anti-infective or antimicrobial agent may be added either systemic or local administration and may be administered at the site of catheter insertion [0085]. Combinations of anesthetics and vasoactive agents are taught ([0012], [0082], [0084]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use vasoconstrictors such as phenylephrine on the catheter taught by the ‘455 publication because the ‘935 publication teaches the use of vasoconstrictors in combination with local anesthesia. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use a vasoconstrictor in combination anesthetic agents because the ‘935 publication teaches the combination of local anesthesia with phenylephrine leads to prolonged effect of the local anesthesia.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
Applicant argues the ‘392 publication does not teach the subject matter of claim 4, now moved into claim 1.
In response the rejection over the ‘392 publication has been withdrawn.
Applicant argues the ‘455 publication does not teach the limitations of claim 12, now moved into claim 1.
In response, Applicant is referred to the modified rejections above wherein the ‘392 publication teaches the penetration enhancer of glycerol monooleate (page 3, lines 34-40).
Applicant argues the ‘935 publication does not cure the deficiencies of the ‘455 publication.
In response, the arguments regarding the ‘455 publication are addressed as first presented.
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
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613