DETAILED ACTION
Claims 1 and 3-20 are currently pending. Claims 1, 3-11, 13-17 and 20 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 .
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 02/20/2026 and 03/31/2026 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
Withdrawn Rejections
The prior rejection of claim 20 under 112(b) is withdrawn in light of Applicant’s amendment to add the transitional phrase comprising.
Examiner’s Note
Applicant's amendments and arguments filed 02/20/2026 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 02/20/2026, it is noted that claims 1 and 20 have been amended and no new matter or claims have been added.
Modified Rejections:
The following rejections are modified based on Applicant’s claim amendments.
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.
Claim(s) 1, 3-8, 10-11 and 13-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0093753 (Applicant provided).
Regarding claims 1 and 3, the limitation of a drug delivery coating comprising a polymeric layer, the polymeric layer comprising an hydrophilic outer surface, an active agent layer, wherein the active agent layer is disposed over the polymeric layer, the active agent layer comprising a microcrystalline active agent and a cationic agent is met by the ‘753 publication teaching composition includes an active agent a fibrin promoting vessel wall transfer agent wherein the ratio of active agent to fibrin promoting vessel wall transfer agent is at least 5:1 (abstract). Drug coated ballon catheters is taught [0026]. The medical device can include a substrate, a hydrophilic polymer layer disposed over the substrate and an active agent layer disposed over the hydrophilic polymer layer [0029]. The active agent includes sirolimus (rapamycin) ([0123], [0125]) specifically microcrystalline sirolimus [0152]. A cationic agent is taught as used [0134].
The limitation of wherein the microcrystalline active agent has an average particle size of less than 50 um, less than 20 um is met by the ‘753 publication teaching the active agent to have a particle size of 30um or less than about 10 um [0131] wherein the active agent is microcrystalline sirolimus [0152].
Regarding claims 4-6, the limitation of wherein the microcrystalline active agent is at least 95% crystalline and the total amount of amorphous active agent in the active agent layer is less than 5% by weight is met by the ‘753 publication teaching the therapeutic agent can be crystalline, combinations of crystalline an amorphous are also taught [0130] thus teaching embodiments of fully crystalline and not a mixture. Examples teach microcrystalline sirolimus [0156].
Regarding claim 7, the limitation of the cationic agent comprises at least the elected DOTAP is met by the ‘753 publication teaching DOTAP as the cationic agent [0136].
Regarding claims 8 and 10, the limitation of wherein the microcrystalline active agent is arranged leaving gaps between adjacent crystals; and wherein the cationic agent fills in at least some of the gaps is met by the ‘753 publication teaching the coating compristion include microcrystalline sirolimus, polyethyleneimine [0152] wherein the cationic agent wherein the fibrin promoting agent can be a cationic agent [0133]. Wherein the crystalline active agent and the cationic agent are used in the coating, the crystals would be separated and filled with said cationic agent.
Regarding claims 11 and 13-15, the limitation of wherein the polymeric layer further comprises a hydrophilic polymer, wherein the polymer is the elected hydrophilic polymer poly[N-3-aminopropyl)methacrylamide-co-N-(3-(4-benzoylbenazmido)propyl)methacrylamide] is met by the ‘753 publication teaching poly[N-3-aminopropyl)methacrylamide-co-N-(3-(4-benzoylbenazmido)propyl)methacrylamide] is the hydrophilic polymer forming the coating ([0074], [0077]).
Regarding claims 16-17, the limitation of the polymeric layer further comprising a photoreactive crosslinking agent is met by the ‘753 publication teaching photoactivatable crosslinking agents include ethylenebis(4-benzoylbenzyldimethyl-ammonium) bromide ([0086], [0108]).
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 (the elected hydrophilic polymer layer and a layer of the elected cationic agent with microcrystalline sirolimus) from within the prior art disclosure of the ‘753 publication, to arrive at the instantly claimed drug delivery coating “yielding no more than one would have expected from such an arrangement”.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0093753 as applied to claims 1, 3-8, 10-11 and 13-17 above, and further in view of US 5,443,498 (previously applied).
As mentioned in the above 103(a) rejection, all of the limitations of claims 1, 3-8, 10-11 and 13-17 are taught by the ‘753 publication.
The ‘753 publication teaches active agents can include many different types of activities [0122] and can include active agent such as anticoagulants [0123] and combinations of active agents ([0125]-[0126]).
The ‘753 publication does not specifically teach the active agent containing layer further comprising an additive, the additive comprising at least one selected from the group including dextran (claim 20).
The ‘498 patent teaches vascular stent (abstract). The stent may be coated with antithromblytic or anticoagulatory agents such as dextran, heparin, t-PA (column 5, lines 40-50).
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 a combination of active agents on the device taught by the ‘753 publication as the ‘753 publication teaches combination of active agents are known to be used as the stent coating on the device. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to include dextran on the stent coating as the ‘498 patent teaches dextran is a known coating to be applied to a stent. One of ordinary skill in the art before the filing date of the claimed invention would have a motivation to include dextran because the ‘498 patent teaches coated stents include e.g. dextran as an antithrombolytic or anticoagulatory agents to be used on a stent and the ‘753 publication teaches multiple active agents to be used on the stent coating wherein the active agent may include anticoagulants.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0093753 as applied to claims 1, 3-8, 10-11 and 13-17 above, and further in view of US 2015/0140107 (Applicant provided).
As mentioned in the above 103(a) rejection, all of the limitations of claims 1, 3-8, 10-11 and 13-17 are taught by the ‘753 publication.
The ‘753 publication does not specifically teach wherein at least some gaps remain unfilled.
The ‘107 publication teaches drug delivery coatings and devices including the same. The invention includes drug delivery coating including a polymeric layer that can include a hydrophilic surface. The matrix coating contacting the hydrophilic outer surface, the matrix includes hydrophobic therapeutic agent and a cationic agent (abstract). The therapeutic agents are taught to be coated and disposed on the hydrophilic surface. The hydrophobic therapeutic agent core and a cationic agent surrounding the particulate hydrophobic agent [0009] or embodiments wherein the cationic agent does not coated the particulate hydrophobic agent [0029]. The cationic agents can be disposed over a particulate hydrophobic therapeutic agent [0039]. The hydrophobic agent is taught to be crystalline [0069] wherein the particulate may be 30 um or less [0070].
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 cationic agent and the crystalline therapeutic agent as taught by the ‘753 publication to be applied with the cationic agent being disposed over the particulate therapeutic agent as the ‘107 publication teaches that it is known to apply a cationic agent over a crystalline therapeutic agent. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘753 publication and the ‘107 publication are both directed to hydrophilic coated medical devices to which a crystalline therapeutic agent and a cationic agent are applied. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success of unfilled gaps between the crystalline therapeutic agent as the ‘753 publication teaches the ratio of drug to fibrin promoting agent is 30:1 or greater, thus leading to a larger amount of therapeutic agent to that of cationic layer and the ‘107 publication demonstrates gaps between the particles and cationic agent (Fig 6-7). As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-6, 11 and 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9,861,727 in view of US 2021/0093753. The instant application and the ‘727 patent are directed to drug delivery coatings comprising a polymeric layer of hydrophilic polymer and a hydrophobic therapeutic agent with a cationic agent on the hydrophilic coating, wherein the hydrophobic agent is rapamycin. The ‘727 patent does not specifically teach microcrystalline therapeutic agent. The ‘753 publication teaching composition includes an active agent a fibrin promoting vessel wall transfer agent wherein the ratio of active agent to fibrin promoting vessel wall transfer agent is at least 5:1 (abstract). Drug coated ballon catheters is taught [0026]. The medical device can include a substrate, a hydrophilic polymer layer disposed over the substrate and an active agent layer disposed over the hydrophilic polymer layer [0029]. The active agent includes sirolimus (rapamycin) ([0123], [0125]) specifically microcrystalline sirolimus [0152]. A cationic agent is taught as used [0134]. The ‘753 publication teaching the active agent to have a particle size of 30um or less than about 10 um [0131] wherein the active agent is microcrystalline sirolimus [0152].
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 rapamycin in microcrystalline form in the claimed size range as the ‘753 publication teaches that it was known to use rapamycin in microcrystalline form to be applied on a hydrophilic polymeric coating and used in combination with a cationic agent and teaches known particle sizes to coat the device, thus it would have been prima facia obvious to use known forms and sizes of active agents as taught by the ‘753 publication on the device of the ‘727 patent.
Claims 1, 3-6, 11 and 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,213,528 in view of US 2021/0093753. The instant application and the ‘528 patent are directed to drug delivery coatings comprising a polymeric layer of hydrophilic polymer and a hydrophobic therapeutic agent with a cationic agent on the hydrophilic coating. The ‘528 patent does not specifically teach microcrystalline therapeutic agent is rapamycin. The ‘753 publication teaching composition includes an active agent a fibrin promoting vessel wall transfer agent wherein the ratio of active agent to fibrin promoting vessel wall transfer agent is at least 5:1 (abstract). Drug coated ballon catheters is taught [0026]. The medical device can include a substrate, a hydrophilic polymer layer disposed over the substrate and an active agent layer disposed over the hydrophilic polymer layer [0029]. The active agent includes sirolimus (rapamycin) ([0123], [0125]) specifically microcrystalline sirolimus [0152]. A cationic agent is taught as used [0134]. The ‘753 publication teaching the active agent to have a particle size of 30um or less than about 10 um [0131] wherein the active agent is microcrystalline sirolimus [0152].
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 rapamycin in microcrystalline form in the size range of less than 50 um as the ‘753 publication teaches that it was known to use rapamycin in microcrystalline form as a hydrophobic therapeutic agent to be applied on a hydrophilic polymeric coating and used in combination with a cationic agent, wherein the particle size range is taught and the ‘528 patent teaches the application of a hydrophobic agent on a hydrophilic polymeric coating. Thus it would have been prima facia obvious to use known forms and sizes of active agents as taught by the ‘753 publication on the device of the ‘528 patent.
Claims 1, 3-6, 11 and 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,529,440 in view of US 2021/0093753. The instant application and the ‘440 patent are directed to drug delivery coatings comprising a polymeric layer of hydrophilic polymer and a hydrophobic therapeutic agent with a cationic agent on the hydrophilic coating. The ‘440 patent does not specifically teach microcrystalline therapeutic agent is rapamycin. The ‘753 publication teaching composition includes an active agent a fibrin promoting vessel wall transfer agent wherein the ratio of active agent to fibrin promoting vessel wall transfer agent is at least 5:1 (abstract). Drug coated ballon catheters is taught [0026]. The medical device can include a substrate, a hydrophilic polymer layer disposed over the substrate and an active agent layer disposed over the hydrophilic polymer layer [0029]. The active agent includes sirolimus (rapamycin) ([0123], [0125]) specifically microcrystalline sirolimus [0152]. A cationic agent is taught as used [0134]. The ‘753 publication teaching the active agent to have a particle size of 30um or less than about 10 um [0131] wherein the active agent is microcrystalline sirolimus [0152].
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 rapamycin in microcrystalline form and in the claimed size range as the ‘753 publication teaches that it was known to use rapamycin in microcrystalline form as a hydrophobic therapeutic agent to be applied on a hydrophilic polymeric coating and used in combination with a cationic agent with a known size range and the ‘440 patent teaches the application of a hydrophobic agent on a hydrophilic polymeric coating. Thus it would have been prima facia obvious to use known forms and sizes of active agents as taught by the ‘753 publication on the device of the ‘440 patent.
Claims 1, 5-6, 11 and 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,083,249 in view of US 2021/0093753. The instant application and the ‘249 patent are directed to drug delivery coatings comprising a polymeric layer of hydrophilic polymer and a hydrophobic therapeutic agent with a cationic agent on the hydrophilic coating. The ‘249 patent does not specifically teach microcrystalline therapeutic agent is rapamycin. The ‘753 publication teaching composition includes an active agent a fibrin promoting vessel wall transfer agent wherein the ratio of active agent to fibrin promoting vessel wall transfer agent is at least 5:1 (abstract). Drug coated ballon catheters is taught [0026]. The medical device can include a substrate, a hydrophilic polymer layer disposed over the substrate and an active agent layer disposed over the hydrophilic polymer layer [0029]. The active agent includes sirolimus (rapamycin) ([0123], [0125]) specifically microcrystalline sirolimus [0152]. A cationic agent is taught as used [0134]. The ‘753 publication teaching the active agent to have a particle size of 30um or less than about 10 um [0131] wherein the active agent is microcrystalline sirolimus [0152].
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 rapamycin in microcrystalline form and claimed particle size as the ‘753 publication teaches that it was known to use rapamycin in microcrystalline form as a hydrophobic therapeutic agent to be applied on a hydrophilic polymeric coating and used in combination with a cationic agent in known particle sizes and the ‘249 patent teaches the application of a hydrophobic agent on a hydrophilic polymeric coating. Thus it would have been prima facia obvious to use known forms and sizes of active agents as taught by the ‘753 publication on the device of the ‘249 patent.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
103: The ‘753 publication (Slager)
Applicant argues that one of skill in the art would not be motivated to use microcrystalline active agents having particle sizes of less than 50 um because the ‘753 publication does not recognize any problems associated with crystal sizes of microcrystalline sirolimus or does it provide any benefits of selecting or controlling the particle size of microcrystalline active agents claimed. It fails to provide guidance that when microcrystalline sirolimus is utilized an average particle size of less than 50 um is desirable. Applicant argues there is no rationale as to why one of skill in the art reading the ‘753 publication would be motivated to use microcrystalline active agents having an average particle size of less than 50 um.
In response, it appears Applicant is arguing unexpected results. Attorney’s arguments may not take the place of factual evidence wherein factual evidence is required. The ‘753 publication teaching the active agent to have a particle size of 30um or less than about 10 um [0131] wherein the active agent is microcrystalline sirolimus [0152]. Thus it is obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the size range taught by the ‘753 publication for the microcrystalline sirolimus taught by the ‘753 publication.
Applicant argues the ‘498 patent and the ‘107 publication fail to cure the deficiencies of the ‘753 publication.
In response, Applicant’s arguments regarding the ‘753 publication are addressed as first presented.
Double Patenting:
Applicant argues they will file a terminal disclaimer if appropriate when there is an indication of allowable subject matter.
In response, Applicant has presented no substantive arguments thus the rejections are maintained for reasons of record.
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
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