DETAILED ACTION
Claims 1, 3-6, 8-9, 11-12, 14-19 and 21-25 are currently pending. Claims 1, 3, 5-6, 8-9, 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 .
Withdrawn Rejections
The prior rejection of claim 11 under 112(b) is withdrawn in light of Applicant amended instant claim 11 to remove the term derivatives.
Examiner’s Note
Applicant's amendments and arguments filed 10/14/2025 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 10/14/2025, it is noted that claims 1, 3, 9, 11 are amended and claims 24-25 are newly added.
New Rejections:
The following rejections are newly applied based on Applicant’s claim amendments and newly added claims.
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, 8-9, 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, 9 and 24 contains the newly added limitation “the contrast agent and lycoprotectant is present at a weight ratio of 1:0.1 to 1:10” and “ratio of 1:05 to 1:5”. Support can be found for poloxamer and iopamidol present at a weight ratio of 1:0.1 to 1:10 (page 7) wherein poloxamer is a stabilizer and iopamidol is a contrast agent. Thus the instant specification discloses a ratio of the stabilizer to contrast agent however support cannot be found for the contrast agent to the lycoprotectant. No support in the instant specification has been alleged by Applicant for the broader instantly claimed embodiment.
Claims 1 and 9 contain the limitation of “the nanoparticle suspension is obtained from a mixed solution consisting of the stabilizer and the drug”. The nanoparticle suspension is obtained through mixing a first solution and second solution comprising solvents (page 8-9, page 18). The instant specification does not disclose forming a nanoparticulate suspension from a mixed solution consisting of stabilizer and the drug, which does not allow for additional ingredients such as solvents.
Alternatively, if Applicant believes that support for the ratio of contrast agent and lyoprotectant and the mixed solution consisting of the stabilizer and the drug, 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.
Claim Rejections - 35 USC § 112 (b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 5-6, 8-9, 11 and 24-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 9 contains the limitation of “drug coating formed by coating a nanoparticle suspension” and additionally contains the limitation of “drug coating is formed by coating a raw material of the drug containing on the surface of the drug-loaded medical device, the raw material for the drug coating is obtained by mixing the nanoparticle suspension”. The instant claim has unclear metes and bounds as the drug coating is formed by both coating the nanoparticle suspension and by mixing the nanoparticle suspension with the hydrophilic spacer. The instant claim defined forming the drug coating by two different methods and thus leads to unclear metes and bounds in the instant claim. Claim 1 defined the drug coating forming a nanoparticle suspension in water-soluble environment and additionally states the drug coating is obtained by mixing a nanoparticle suspension. It is unclear how the nanoparticle suspension both is formed by the drug coating and is used to form the drug coating.
Claims 1 and 9 contains the limitation of “nanoparticle suspension is obtained from a mixed solution consisting of the stabilizer and the drug”. It is unclear how a suspension can be formed with just the stabilizer and the drug, wherein no solvent is allowed, thus leading to unclear metes and bounds of the instant 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, 3, 5-6 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) and US 2005/0244456 (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”.
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 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 ‘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). 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]. The medical device may be a balloon catheter [0139].
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].
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.
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 by mixing the nanoparticle suspension with hydrophilic space, the nanoparticle suspension is obtained from mixed solution consisting of the stabilizer and the drug 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. 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).
Claim(s) 8-9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0255510 in view of US 2005/0095267 and US 2005/0244456 as applied to claims 1-3, 5-6 and 24-25 above, and further in view of US 2012/0143054 (previously applied).
As mentioned in the above 103(a) rejection, all of the limitations of claims 1, 3 and 5-6 are taught by the combination of the ‘510 publication and the ‘267 publication.
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).
The combination of references does not specifically teach a porous film layer covering the drug coating (claim 8-9).
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].
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 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 he release of the active agent during navigation of the balloon catheter. 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.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
Applicant argues the ‘510 publication (Wang) fails to teach the specific combination of a lyoprotectant with a contrast agent functioning together as a defined hydrophilic spacer. The additives are broadly categorized as surfactants to chemical compounds with certain moieties and are aimed at compatibility and release. The specific problem addressed by the lyoprotectant, enhancing stabilizing during storage and handling of the nanoparticle coating before deployment is not discussed by the ‘510 publication.
In response, 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).
Applicant argues the ‘267 publication (Campbell) and the ‘456 publication (Nilsson) are silent in regards to the combination of a contrast agent and lyprotectant.
In response, Applicant’s arguments regarding lyoprotectant are addressed as first presented regarding the ‘510 publication.
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 specific combination of the stabilizer (amphiphilic triblock polymer), the hydrophilic spacer (contrast agent + lyoprotectant) and the drug provides synergistic benefits. Benefits include improved coating stability, rapid and uniform drug release, preserved drug activity.
In response, Attorney’s arguments cannot take the place of factual evidence wherein factual evidence is required. Applicant has presented no factual data to support unexpected results and synergistic benefits, as is required for unexpected results.
Applicant argues the specific weigh ratio between the contrast agent and lyoprotectant and the molecular weight ratios of the polymeric blocks are critical for optimizing these synergistic effects and are not disclosed in the prior art.
In response, Applicant is referred to the modified rejection above. 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] 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”. 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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613