DETAILED ACTION
Claims 1, 3-6, 9, 11-12, 14-19 and 21-25 are currently pending. Claims 1, 3, 5-6, 9, 11 and 24-25 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/22/2026 has been entered.
Withdrawn Rejections
The prior rejection of claims 1, 3, 5-6, 8-9, 11 and 24-25 under 112(a) new matter is withdrawn as a result of Applicant amending the claims to remove the contrast agent and lycoprotetant ratio.
The prior rejection of claim 1, 3, 5-6, 8-9, 11 and 24-25 under 112(b) is withdrawn based on Applicant amending the instant claims to clarify the nanoparticle suspension and method of obtaining the nanoparticle suspension.
Examiner’s Note
Applicant's amendments and arguments filed 04/22/2026 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 04/22/2026, it is noted that claims 1 and 9 are amended.
New Rejection:
The following rejections are newly applied based on Applicant’s claim amendments.
Claim Rejections - 35 USC § 112 (New Matter)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 5-6, 9, 11 and 24-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 9 contains the newly added limitation “a polydispersity index (PDI) not greater than 0.208”. Support can be found for specific PDI found in Table 1, however does not provide support the range of not greater than 0.208. Specific numerical amounts do not provide support for a range and additionally the not more than 0.208 embraces amounts of PDI below the lowest exemplified PDI by Table 1. No support in the instant specification has been alleged by Applicant for the broader instantly claimed embodiment.
Alternatively, if Applicant believes that support for PDI range of not greater than 0.208, is present and clearly envisaged in the instant application or earlier filed priority documents, applicant must, in responding to this Office Action, point out with particularity, where such support may be found.
Applicant does not indicate where these limitations are supported by the original specification, or how, as is Applicant's burden. See MPEP §714.02, last sentence of the third paragraph from the end and MPEP §2163.06 (I) last sentence.
Modified Rejection:
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.
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, 3, 5-6, 9, 11 and 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0255510 (previously applied) in view of US 2005/0095267 (previously applied), US 2005/0244456 (previously applied) and US 2012/0143054 (previously applied) as evidenced by CI Guide (CI Guide, Poloxamer 124, pgs. 1-2, accessed 11/25/2025).
Regarding claims 1, 3 and 24, the limitation of a drug-loaded medical device, wherein a surface of the drug-loaded medical device has a drug coating, the drug coating comprising a stabilizer and a drug, the stabilizer comprising an amphiphilic triblock polymer with hydrophilic segments at both terminals, the drug coating forming a suspension in water-soluble environment is met by the ‘510 publication teaches a coated medical device for rapid delivery of a therapeutic agent to a tissue. The medical device as a layer overlying the exterior surface of the medical device. The layer contains a therapeutic agent, a contrast agent and an additive (abstract). The contrast agent is taught to be iopromide which is used with paclitaxel ([0018], claims 1-3 and 7). Suitable additives are taught to include surfactants ([0138]-[0140]) which includes polyoxyethylene-polyoxypropylene (POE-POP) block copolymer such as the elected poloxamer ([0165]-[0168]). The additive is taught for delivering a therapeutic agent to the tissue, the device comprising a layer overlying an exterior surface of the medical device comprising a therapeutic agent, a contrast agent and an additive, wherein the additive comprises a hydrophilic part and a drug affinity part which is hydrophobic. The additives include block copolymer of polyethylene glycol and polypropylene glycol (claim 9). The additive is additional taught to include amino acids ([0038], [0059], [0079]), a claimed lyoprotectant, and wherein combination of additives is taught by the ‘510 publication [0235] and the additives are taught to be from 1 to 10 um/mm2 [0069] and the contrast agent is present at 1-20 ug/mm2 [0051]. 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”. The ‘510 publication teaches the elimination of the drug crystal particles in the polymeric matrix to create a uniform drug distribution [0008] and wherein the drug can be in various physical states [0220], thus teaching amorphous form.
Regarding claims 5-6 are directed to the polymeric block copolymer including the elected poloxamer is met by the ‘510 publication teaching suitable additives are taught to include surfactants ([0138]-[0140]) which includes polyoxyethylene-polyoxypropylene (POE-POP) block copolymer such as the elected poloxamer ([0165]-[0168]). The additive is taught for delivering a therapeutic agent to the tissue, the device comprising a layer overlying an exterior surface of the medical device comprising a therapeutic agent, a contrast agent and an additive, wherein the additive comprises a hydrophilic part and a drug affinity part which is hydrophobic. The additives include block copolymer of polyethylene glycol and polypropylene glycol (claim 9).
Regarding claims 9 and 11, the limitation of a drug balloon, comprising a balloon body and provided on a surface of the balloon body, a drug coating, the drug coating comprising a stabilizer and a drug, the stabilizer comprising an amphiphilic triblock polymer with hydrophilic segments at both terminal the drug coating forming a nanodrug particle suspension in a water-soluble environment is met by the ‘510 publication teaching applying the coating solution to the balloon catheter [0097]. The ‘510 publication teaches a coated medical device for rapid delivery of a therapeutic agent to a tissue. The medical device as a layer overlying the exterior surface of the medical device. The layer contains a therapeutic agent, a contrast agent and an additive (abstract). The contrast agent is taught to be iopromide which is used with paclitaxel ([0018], claims 1-3 and 7). Suitable additives are taught to include surfactants ([0138]-[0140]) which includes polyoxyethylene-polyoxypropylene (POE-POP) block copolymer such as the elected poloxamer ([0165]-[0168]). The additive is taught for delivering a therapeutic agent to the tissue, the device comprising a layer overlying an exterior surface of the medical device comprising a therapeutic agent, a contrast agent and an additive, wherein the additive comprises a hydrophilic part and a drug affinity part which is hydrophobic. The additives include block copolymer of polyethylene glycol and polypropylene glycol (claim 9). The ‘267 publication teaches implantable medical devices having a nanoparticle coating applied thereon (abstract).
Regarding claim 25, the limitation of wherein a molecular weight ratio of the polymer block components A, B and C in the ABC-type amphiphilic triblock polymer is (0.5-3):1:(0.5-3) is met by the ‘510 publication teaching poloxamers are selected from a group including poloxamer 124 [0168]. CI Guide teaches poloxamer 124 contains 11:21:11 ratio of monomers (page 1), reading on the claimed ratio.
The ’510 publication does not specifically teach nanoparticles (claim 1).
The ‘510 publication does not specifically teach a porous film layer covering the drug coating, the porous film layer being a two-layer porous film structure and having a pore size in the range of 1 um to 50 um.
The ‘267 publication teaches implantable medical devices having a nanoparticle coating applied thereon. The nanoparticle coating comprises nanopulverized antiproliferative compounds, specifically nanoparticulate antiproliferative compounds comprise particle less than 500 nm in size (abstract), overlapping with the claimed particle size. Controlled drug release rate is used by a combination of the drug nanoparticle size, nanoparticle distribution, drug in polymer solubility, polymer stability, coating thickness [0028]. The nanopulverized pounds have substantially the same particle size [0038], reading on PDI range claimed. The medical device may be a balloon catheter [0139]. The ‘267 publication teaches a barrier coat comprises a porous network where the coating acts as a molecular sieve. The larger the pores relative to the size of the drug, the faster the drug will elute. Persons having ordinary skill in the art of material science in combination with the teaching herein will readily understand that many variations on the cap coat and drug eluting coatings can be made to tune the target diffusivity of the present invention [0079].
The ‘456 publication teaches surface coating comprising bioactive compound (title) wherein the device is a balloon catheter (claim 2). The coating is taught to contain hydrophilic and hydrophobic portions and is specifically desired to be Pluronic block copolymer (claims 6-80) such as the elected poloxamers [0071].
The ‘054 publication teaches catheter balloons for delivering a bioactive to a body vessel. The bioactive is disposed on a portion of at least one outer balloon surface (abstract). The coating is taught to include paclitaxel and iopamidol and the coating may include a barrier layer [0010]. The barrier layer is the outermost layer and does not include a bioactive agent [0030]. The barrier layer is taught to be useful when duration of the navigation of the balloon catheter is unknown or difficult and it is desirable to control the release of the bioactive [0074]. The barrier layer is taught to include a porosity to obtain the desired release rate [0077]. One or more barrier layers are taught as overcoated [0076].
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 nanoparticles as taught by the ‘267 publication in the coating as taught by the ‘510 publication because the ‘267 publication and the ‘510 publication are both directed to coatings on medical devices such as balloon catheters wherein the coating include paclitaxel. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use the particles of the ’267 publication in the coating of the ‘510 publication as the ‘510 publication teaches the active agent may be in the form of particulate and the ‘267 publication specifically teaches nanoparticles. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use the nanoparticle form of the paclitaxel as the ’267 publication teaches the particle size and distribution can be used to control the drug release rate from the coated medical device. It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to select a known preferred balloon catheter polymer containing hydrophilic and hydrophobic section such as the poloxamer polymer taught by the ‘456 publication.
It would have been prima facie obvious for one of ordinary skill in the art before the filing date of the claimed invention to use a one or more porous barrier coating layer as taught by the ’054 publication for the medical device taught by the ‘510 publication as the ‘510 publication teaches the coating layer to contain a top coat layer to prevent the loss of drug before brought in contact with the target tissue [0114] and the ‘054 publication teaches a specific barrier layer which is useful to control the release of the active agent during navigation of the balloon catheter and may be one or more barrier layers. One of ordinary skill in the art would be motivated to use the barrier layer of the ‘054 publication as it is known to be used over catheters containing paclitaxel and iopamidol to control the release during navigation and the ‘510 publication is directed to a catheter containing paclitaxel and iopamidol which contains a top coat layer to control the drug release until reaching the desired location. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to optimize the number and pore size of the barrier coating layer as the ‘267 publication teaches that the pore size relates to the elution rate of the drug and that persons of ordinary skill in the art would readily understand many variations of the cap and drug eluting coatings may be used to tune the drug release rate, thus rending it obvious to optimize the one or more porous barrier coatings taught by the ‘054 publication in pore size and number to obtain the desired drug release from the drug containing layer taught by the ‘510 publication. 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”.
Regarding the limitation of the drug coating forming a nano-drug particle suspension in water soluble environment, the combination of references teaches the elected poloxamer and paclitaxel wherein the drug is in nanoparticulate form. Further the ‘510 teaches the coating to include hydrophilic and hydrophobic portions in the coating polymer and method of making the coating to include forming a solution in an organic solvent containing the polymer, therapeutic agent, additive and applying to the device before drying [0096]. Thus the combination of references teaches the elected components being applied to the device in a homogenous manner, and thus would react by forming a suspension upon exposure to water soluble environment, absent factual evidence to the contrary. “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding the limitation of “formed by coating a raw material of the drug coating is obtained comprising the nanoparticle suspension with hydrophilic space, the nanoparticle suspension is obtained from a process composing dissolving the stabilizer in a first solvent to form a first solution, dissolving the drug in a second solvent to form a second solution and mixing the first solution with the second solution is met by the ‘510 publication teaches a coating comprising the drug, contrast agent and additives which includes amino acids and surfactants such as PEO-POP block copolymers. The ‘510 publication teaches solvents for preparing the coating layer wherein therapeutic agent, contrast agent and additive may be dispersed in solubilized or otherwise mixed in the solvent ([0233]-[0235]) wherein the amount of solvent affects the uniformity the drug coating when evaporated and two or more solvents may be used ([0236]-[0238]). MPEP 2113 - “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
Applicant argues the ‘510 publication (Wang) provides no modification to select a specific amphiphilic triblock polymer with two terminal hydrophilic segments to function as a stylizer for nanoparticles nor does it teach containing both the contrast agent and lycoprotectant, which is critical for enabling a coating to reform a nanoparticle suspension with specific controlled size and PDI characteristics.
In response, it appears Applicant is arguing unexpected results however has not presented factual data wherein factual data is required. The medical device comprising a therapeutic agent, a contrast agent and an additive, wherein the additive comprises a hydrophilic part and a drug affinity part which is hydrophobic. The additives include block copolymer of polyethylene glycol and polypropylene glycol (claim 9). The additive is additionally taught to include amino acids ([0038], [0059], [0079]), a claimed lyoprotectant, and wherein combination of additives is taught by the ‘510 publication [0235]. Thus the ‘510 publication teaches the coating comprising a drug and a contrast agent named specifically wherein additives may be a combination and include poloxamers and amino acids, rending the combination of ingredient obvious. The ‘510 publication teaches a lyoprotectant agent, the amino acid, per instant claim 3, and thus would meet the claim limitation of lyoprotectant. “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
The ‘267 publication (Campbell) does not teach formulating the nanoparticle in situ via the chemical solvent based process with specific stabilizer to create an amorphous monodispersed nanoparticle suspension from a dried coating.
In response, Applicant is arguing limitations not present in the instant claims. The instant claims do not require in situ formation of nanoparticles, which further would be product by process limitations, wherein the instant claims are directed to a product the medical device. Regarding the limitation of the drug coating forming a nano-drug particle suspension in water soluble environment, the combination of references teaches the elected poloxamer and paclitaxel wherein the drug is in nanoparticulate form. Further the ‘510 teaches the coating to include hydrophilic and hydrophobic portions in the coating polymer and method of making the coating to include forming a solution in an organic solvent containing the polymer, therapeutic agent, additive and applying to the device before drying [0096]. Thus the combination of references teaches the elected components being applied to the device in a homogenous manner, and thus would react by forming a suspension upon exposure to water soluble environment, absent factual evidence to the contrary. “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Applicant argues the ‘456 publication the purpose is entirely different from the present invention’s technical problem of preventing particle aggregation and embolism from a drug coating.
In response, Applicant is arguing limitations not present in the instant claims. The instant claims contain no limitations directed to aggregation and embolisms.
Applicant argues hindsight construction. Applicant argues the distinguishing features are not common general knowledge of the art and are not disclosed by the prior art.
In response, as for the assertion that the rejection is based on hindsight, as noted in MPEP 2145, any obviousness rejection is in a sense necessarily a reconstruction based on hindsight reasoning and is not improper if it takes into account only knowledge within the level of ordinary skill in the art at the time the claimed invention was made. Applicants have provided no evidence that the rejection is not based on knowledge available to those of ordinary skill in the art.
Applicant argues the synergistic combination of a stabilizer with two terminal hydrophilic blocks, a hydrophilic spacer. The combination is critical for achieving the amorphous particle with tightly controlled small size and narrow distribution PDI.
In response, it appears Applicant is arguing unexpected results however has not presented factual data. Further the examples provided in the instant specification are to a specific combination of ingredient wherein the instant claims are broadly directed to drug, stabilizer, hydrophilic spacer, and thus are not commensurate in scope with the instant claims.
Conclusion
No claims are allowed.
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
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