DETAILED ACTION
Formal Matters
Claims 1-34 are pending and under examination.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a national stage entry of PCT/GB2022/052777 filed on 11/3/2022, which claims priority from GB2115813.4 filed on 11/3/2021.
Information Disclosure Statements
The information disclosure statements filed on 5/1/2024, 5/21/2024, 10/4/2024, 4/25/2025 and 6/9/2026 have been considered by the examiner.
Claim Objection
Claims 14 and 26 are objected to for the phrase “by weight by weight” where it should only say “by weight”.
Claims 28 and 29 are objected to as being an improper dependent claim as it uses “and/or” which allows for both limitations of claims 1 and 16 and not just the alternatives as with “or”. A dependent claim must provide the multiple claims it depends on as alternatives. Applicant could import the limitations of each of claims 1 and 16 into claims 28 and 29, so that they will be complete independent claims. Alternatively, they can change the “and/or” to just being “or”. (MPEP 608.01(n)).
Claim 32 is objected to as being improperly dependent as it both is a multiply dependent claim that can depend on other multiply dependent claims (e.g. claims 28 and 29) and is improper for including both dependency to composition and method claims where a claim should be dependent to a claim of only one category of invention.
Claims 33 and 34 are objection to for being improper for including both dependency to composition and method claims where a claim should be dependent to a claim of only one category of invention.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112(a) – Written Description
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 1-34 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. Applicant claims in claims 1, 16 and 29, polymeric compounds based on having hydrophobic or hydrophilic ends and a center that is hydrophilic or hydrophobic respectively. However, in applicant’s specification including its description with examples, the applicant only describes polymers with hydrophobic blocks that are polypropylene oxide and hydrophilic blocks that are polyethylene oxide (pages 3-4 and examples of specification). Here, hydrophilic and hydrophobic are to a chemical property of the unit and do not present a particular structure. It is noted that the specification does allow alternatives of the hydrophobic portion to also include fatty acid derivatives and polybutylene oxide (close structurally to polypropylene oxide). It does not provide any compound species that have fatty acid “derivatives” as the hydrophobic portion. The specification also does not teach the use of polymers with replacements for ethylene oxide hydrophilic molecules. As the breadth of polymers and blocks therefor is very broad and applicant namely supports this through its alternatives for polymer blocks and examples, it does not provide enough species of different hydrophobic and hydrophilic blocks that would properly describe this genus. Additionally, the polymer is not closed off to having various other subunits as long as the central region is hydrophilic or hydrophobic and the ends of the polymer are hydrophobic or hydrophilic, respectively. Again, this increases the size of the genus that would need proper description. Only claims 8 and 20 would limit to triblock copolymer (three blocks). Furthermore, claims 10 and 22 provide for poloxamer derivative without describing what “derivatives” would encompass or providing a sufficient number of species that would allow ownership of all possible poloxamer derivatives that could have varying changes in atoms, groups, new polymer blocks, and properties. Alshammari et al (Scientific Reports, 2025, volume 15, pages 1-20) teaches molecular design of amphiphilic triblock copolymers with polystyrene ends and a central PEG block with considerations to molecular weights (abstract). As this was after applicant’s filing and the applicant does not describe such a block copolymer with polystyrene units, this would be just one example of a polymer with hydrophobic ends and a hydrophilic center that applicant did not have possession of at their filing. For these reasons, applicant might have reasonable support for triblock copolymers with the hydrophobic portion being fatty acid, polypropylene oxide or polybutylene oxide and the hydrophilic portion being polyethylene oxide, but does not have support for the full genus encompassed by the claims for these polymers and derivatives. Note MPEP 2163 II 3 (a) ii) regarding original claims to genus - “The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 “merely by clearly describing one embodiment of the thing claimed.” LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). The issue is whether a person skilled in the art would understand inventor to have invented, and been in possession of, the invention as broadly claimed” and “Satisfactory disclosure of a “representative number” depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are “representative of the full variety or scope of the genus,” or by the establishment of “a reasonable structure-function correlation.”
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 1-34 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 5 recites the limitation "the active agent" or “the active agents” in the claims where the first recitation in claim 1 is “at least one active agent”. There is insufficient antecedent basis for this limitation in the claim. Applicant should amend these recitations to “the at least one active agent”
Claims 3-4. 6-15 and 28-34 are rejected as being dependent on indefinite claims.
Claims 1, 2 and 16 are indefinite for the recitations of “wherein use the at least one active agent” or “wherein use the first active agent” or “wherein use the second active agent” as it is unclear if applicant means these to be intended use recitations, if applicant means them to occur conditionally during a use, or if applicant means these to be limitations to those active agents as recited earlier in the claim. For the purpose of compact prosecution, the examiner is considering these limitations to be part of the composition or system.
Claims 3-15 and 17-34 are rejected as being dependent on indefinite claims.
Claims 3 and 4 are indefinite for “an active agent” as it is unclear if this is meant to refer to “the at least one active agent” presented in claim 1 or if this is a further/additional active agent that is being included. For the purpose of compact prosecution, the examiner will consider these as “wherein the at least one active agent is…”
Claim 7 is indefinite for “at least one active agent” as it is unclear if this is meant to refer to “the at least one active agent” presented in claim 1 or if this is a further/additional at least one active agent that is being included. For the purpose of compact prosecution, the examiner will consider these as “wherein the at least one active agent is…”
Claims 11-12 are indefinite for “each active agent” as it is unclear if this is meant to refer to each of “the at least one active agent” presented in claim 1 or if this is to a further/additional active agent that is being included. For the purpose of compact prosecution, the examiner will consider these as “wherein each of the at least one active agent is present…”
Claim 10 recites the limitation "the triblock copolymer" in the claim with dependence to claim 1 that does not introduce a triblock copolymer. There is insufficient antecedent basis for this limitation in the claim. Applicant may change the dependency of this claim to claim 8.
Regarding claim 17, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 18 is rejected as being dependent on an indefinite claim.
Claims 10 and 22 are indefinite for the recitation of “poloxamer derivative” as it is unclear what the metes and bounds “derivative” provides to the poloxamer. Derivatives could include a number of salts, solvates, isomerisms, addition groups and other structural changes that can potentially affect the properties and function of the poloxamer. The specification does not define “derivatives” or provide a sufficient number of species of different poloxamer derivatives of enough varying types that would define this genus. Applicant may simply recite that “…the triblock copolymer is a poloxamer.”
Claims 23-24 are indefinite for “each active agent” as it is unclear if this is meant to refer to each of “the first and second active agents” presented in claim 16 or if this is to a further/additional active agent that is being included. For the purpose of compact prosecution, the examiner will consider these as “wherein each of the first and second active agents is present…”
Claims 25-27 are indefinite for “the polymeric compound” with the claim dependent on claim 16, which provides for “a first polymeric compound” and “a second polymeric compound”. It is unclear which of these applicant intends to place the limitation on or if it should apply to both or whether applicant intends this to be a different polymeric compound. For the purpose of compact prosecution, the examiner will consider the limitation as “wherein each of the first and second polymeric compounds is present…”
Claim 28 is indefinite for “derived from” as it makes it unclear if applicant desires what comes after “derived from” or if applicant is extending the coating composition or coating system to be other derivations of these items. It is unclear what the metes and bounds of the claims are with the recitations of “derived from”. Applicant may delete “derived from” for these recitations to correct the issue.
Claim 31 recites the limitation "The method of delivering" with this being an independent claim as claim 28 is toward an expandable medical device. There is insufficient antecedent basis for this limitation in the claim. The recitation should be “A method of delivering….”
Claims 32-34 are indefinite for the preambles introducing a composition, system, device and a method as alternatives in the preamble for the limitation. It is unclear if in terms of the composition or coating composition system, this will introduce a new feature that has to be a part of the composition or system or if this will remain as part of the intended use of “…for application to an expandable medical device” where it does not receive patentable weight. For the purpose of compact prosecution, in terms of dependence to claims 1 or 16, the examiner will only consider it as part of the intended use recitation.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 2 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lebouille WO 2010136604 A1.
Lebouille teaches “a transfer matrix comprising (i) microparticles comprising a bioactive agent and (ii) at least one matrix compound selected from the group of hydrophilic polymers having a weight average molecular mass of at least 10 000 g/mol and amphiphilic macromolecular compounds, for medical use wherein the transfer matrix is to be transferred from an exterior surface of a medical device to an inner surface of a body vessel of a human or another vertebrate animal” (abstract). Lebouille teaches poloxamers as an amphiphilic macromolecular compound (claims 1 and 4 of Lebouille). Lebouille teaches formulation ID7 that has rapamycin, ethanol (solvent), and pluronic F127 to make the nanoparticles (example 4). Formulation ID8 is made with rapamycin, acetone and Pluronic 127F. Also see example 1. Lebouille teaches poloxamers such as Pluronic 127F as polypropyleneoxide-polyethylene oxide block copolymers (page 6, lines 31-34). Pluronic F127 is a triblock copolymer that has PEO-PPO-PEO structure, central hydrophobic block with two flanking hydrophilic blocks. Lebouille teaches various agents that can be included including those that are antiplatelet (page 8). Lebouille teaches dipyridamole among other bioactive agents (page 8, line 27). Lebouille teaches rapamycin as an anti-proliferative agent (page 8, lines 14-16 and claim 8 of Lebouille). Rapamycin is also known as sirolimus and is hydrophobic. Lebouille teaches “Balloon application, multiple dips, formulation concentration dependent, in the formulation were used and after each dip the balloon was dried with 5O C air.” (paragraph 34). Lebouille teaches “After dipping the layer may be dried. Thereafter, this procedure of dipping and drying may be repeated at least one more time to provide another layer of interest.” And “This method is in particular suitable for applying a transfer matrix comprising a layered structure wherein different layers comprise a different bioactive agent and/or the same bioactive agent in a different concentration.” (page 19). As Lebouille teaches a number of bioactive agents that can be utilized and using different bioactives, its disclosure anticipates using a plurality of bioactive compounds. As the drugs in Lebouille are within the matrix, they are encapsulated in (enclosed inside) it.
Claim 1-2, 4-5, 7-8, 10, 13, 14, and 28-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoffmann US20150011492A1 as evidenced by Gordish et al (American Journal of Physiology – Renal physiology, 2014, volume 306, page F542-F550).
In regards to claims 32-34, these can depend on the composition claim of claim 1 where the device is part of the intended use of the composition in claim 1, and not a limitation to the coating composition itself. Therefore, a teaching of the composition of claim 1 is sufficient to teach these claims.
Hoffmann teaches “For perivascular drug delivery, resveratrol (500 μg) or halofuginone (30 μg) or DMSO dissolved in 200 μL of 25% F127 pluronic gel (Sigma-Aldrich) in PBS was evenly applied, immediately after reestablishment of flow, around the injured segment of the carotid artery (5 animals in each group).” (example 4). Hoffmann also teaches “perivascular drug delivery composition is prepared by dissolving 0.08 mg/mL idarubicin and 500 μg resveratrol or 30 μg halofuginone in 200 μL of 25% F127 pluronic gel. The composition is applied to a stent to form a drug layer on the stent” (paragraph 70). Paragraph 70 provides for dipping or spraying of the stent into the composition to form the drug layer. F127 is a poloxamer with PEO-PPO-PEO structure and molecular weight of 12,600 g/mol (daltons). Resveratrol and halofuginone have vasodilatory actions and resveratrol and idarubicin are hydrophobic active agents. Hoffmann also teaches “at least one of rapamycin, resveratrol and halofuginone (claim 13 of Hoffmann and paragraphs 6 and 26). Hoffmann teaches a drug delivery balloon (paragraph 21). Hoffman teaches “For coatings comprising one or more active agents, the agent will be retained on the medical device during delivery and expansion of the device, and released at a desired rate and for a predetermined duration of time at that position within the blood vessel. For example, a stent coated by a formulation comprising idarubicin or an analog thereof and, in some cases, one or more additional agents, can be expanded at a desired position for treatment” (paragraphs 32 and 71). As the drugs in Hoffmann are within the pluronic gel, they are encapsulated in (enclosed inside) it. Gordish teaches resveratrol is able to induce vasodilation through increased NO production (abstract and introduction). Thus, a vasodilator is included in the product of Hoffmann.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-34 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hoffmann US20150011492A1 and Lebouille WO 2010136604 A1 as evidenced by Gordish et al (cited above).
Hoffmann teaches “For perivascular drug delivery, resveratrol (500 μg) or halofuginone (30 μg) or DMSO dissolved in 200 μL of 25% F127 pluronic gel (Sigma-Aldrich) in PBS was evenly applied, immediately after reestablishment of flow, around the injured segment of the carotid artery (5 animals in each group).” (example 4). Hoffmann also teaches “perivascular drug delivery composition is prepared by dissolving 0.08 mg/mL idarubicin and 500 μg resveratrol or 30 μg halofuginone in 200 μL of 25% F127 pluronic gel. The composition is applied to a stent to form a drug layer on the stent” (paragraph 70). Paragraph 70 provides for dipping or spraying of the stent into the composition to form the drug layer. F127 is a poloxamer with PEO-PPO-PEO structure and molecular weight of 12,600 g/mol (daltons). Resveratrol and halofuginone have vasodilatory actions and resveratrol and idarubicin are hydrophobic active agents. Hoffmann also teaches “at least one of rapamycin, resveratrol and halofuginone (claim 13 of Hoffmann and paragraphs 6 and 26). Hoffmann teaches a drug delivery balloon (paragraph 21). Hoffman teaches “For coatings comprising one or more active agents, the agent will be retained on the medical device during delivery and expansion of the device, and released at a desired rate and for a predetermined duration of time at that position within the blood vessel. For example, a stent coated by a formulation comprising idarubicin or an analog thereof and, in some cases, one or more additional agents, can be expanded at a desired position for treatment” (paragraphs 32 and 71). As the drugs in Hoffmann are within the pluronic gel, they are encapsulated in (enclosed inside) it. Hoffmann teaches pluronic gel (paragraphs 6, 14 and 26).
Hoffman teaches much of the claims, but does not provide lowering amount of its polymer for claims 15 and 27, amounts of each drug as in claims 11, 12, 23 and 24, the molecular weight of 13,000 to 50,000 Da for the polymeric compound in claims 9 and 21, dipyridamole as in claims 3, 6, and 18, and providing a second drug coating as in claim 16. Hoffmann provides for balloons and stents but does not indicate balloon catheter as a device being coated.
Lebouille teaches “a transfer matrix comprising (i) microparticles comprising a bioactive agent and (ii) at least one matrix compound selected from the group of hydrophilic polymers having a weight average molecular mass of at least 10 000 g/mol and amphiphilic macromolecular compounds, for medical use wherein the transfer matrix is to be transferred from an exterior surface of a medical device to an inner surface of a body vessel of a human or another vertebrate animal” (abstract). Lebouille teaches poloxamers as an amphiphilic macromolecular compound (claims 1 and 4 of Lebouille). Lebouille teaches formulation ID7 that has rapamycin, ethanol (solvent), and pluronic F127 to make the nanoparticles (example 4). Formulation ID8 is made with rapamycin, acetone and Pluronic 127F. Also see example 1. Lebouille teaches poloxamers such as Pluronic 127F as polypropyleneoxide-polyethylene oxide block copolymers (page 6, lines 31-34). Pluronic F127 is a triblock copolymer that has PEO-PPO-PEO structure, central hydrophobic block with two flanking hydrophilic blocks. Lebouille’s broader teachings provide for “polypropyleneoxide-polyethylene oxide block-copolymers, such as poloxamers” (page 6), which covers the genre of poloxamers that are compounds with polypropylene oxide and polyethylene oxide blocks. Lebouille teaches various agents that can be included including those that are antiplatelet (page 8). Lebouille teaches dipyridamole among options of bioactive agents that can be used (page 8, line 27). Lebouille teaches rapamycin as an anti-proliferative agent (page 8, lines 14-16 and claim 8 of Lebouille). Rapamycin is also known as sirolimus and is hydrophobic. Lebouille teaches “Balloon application, multiple dips, formulation concentration dependent, in the formulation were used and after each dip the balloon was dried with 5O C air.” (paragraph 34). Lebouille teaches “After dipping the layer may be dried. Thereafter, this procedure of dipping and drying may be repeated at least one more time to provide another layer of interest.” And “This method is in particular suitable for applying a transfer matrix comprising a layered structure wherein different layers comprise a different bioactive agent and/or the same bioactive agent in a different concentration.” (page 19). As Lebouille teaches a number of bioactive agents that can be utilized and using different bioactives, its disclosure anticipates using a plurality of bioactive compounds. As the drugs in Lebouille are within the matrix, they are encapsulated in (enclosed inside) it. Lebouille teaches “The weight average molecular mass of the amphiphilic macromolecular compound usually is 1000 g/mol or more. In a specific embodiment weight average molecular mass may be 3000 g/mol or more, 5000 g/mol or more, or 10.000 g/mol or more”. Lebouille teaches “As mentioned above the transfer matrix may comprise a hydrophilic polymer, an amphiphilic macromolecular compound or both. The weight to weight ratio of hydrophilic polymer to amphiphilic macromolecular compound may be in the range of 100:0 to 0:100. If both are present, said ratio is usually in the range of 0.1 :99.9 to 99:1 , in particular in the range of 0.4:99.6 to 95:5” while teachings a combined amount of hydrophilic polymer and amphiphilic polymer is usually 30 wt% or more (pages 6 and 7). On page 7, poloxamers (pluronic) is provided as an amphiphilic macromolecular compound/polymer. In example 1, there is 1-250 mg rapamycin (drug) in 1 ml of solvent with about 5% of Pluronic F-127. This would represent 0.1-25% w/v of drug. Thus, both polymer and drug are adjustable and provided with overlap with applicant’s claimed amounts in teachings of Lebouille. Lebouille teaches balloon catheters known in the art and teaches nylon-12 (a hydrophobic polyamide) as a surface material (page 16 of Lebouille). Other surface materials can include PET (hydrophobic), silicon polymers (mainly hydrophobic) and polyurethanes (page 16).
One of ordinary skill in the art before the time of filing would have made routine adjustments in polymer and drug amounts in products of Hoffmann based on the teachings of Lebouille as it recognizes also making a coating material with Pluronic/poloxamer and drug for coating a device with a drug and allows for amounts and ratios that allow for overlapping amounts where adjustments would be made by one of ordinary skill in the art (MPEP 2144.05). One of ordinary skill in the art before the time of filing would have considered coating of balloon catheters as this is another suitable cardiovascular device suitable for such drug coatings in teachings of Lebouille. One of ordinary skill in the art before the time of filing would have utilized poloxamers of other molecular weights in the range of applicant as Hoffmann’s poloxamer (12,600 daltons) is very near 13,000 and Lebouille also provides for using molecular weights of its amphiphilic polymer (that includes poloxamer) to above 10,000 daltons (MPEP 2144.05). One of ordinary skill in the art before the time of filing would have included other drugs or modified coatings to contain drugs including dipyridamole as this drug is recognized in teachings of Lebouille for its materials. In regards to rearrangement of poloxamers to have the option having hydrophobic ends and a hydrophilic center, the prior art teaches poloxamers are made up of polypropylene oxide and polypropylene oxide blocks, and so, this is a rearrangement of the units known in the art that would make other poloxamer compounds. The prior art of Lebouille also teaches a range of different bioactive agents to include besides the ones used in the examples. Therefore, there was a reasonable expectation of success in using the techniques, components, polymer molecular weights, and concentrations/ratios of the prior art to produce devices such as stents, balloons and balloon catheters with coatings having poloxamer polymers, solvent and drugs of claim hydrophilic or hydrophobic natures and providing a coated device for drug release in a blood vessel.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached on M-F 9:00 am to 6:00 pm EST.
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/MARK V STEVENS/
Examiner, Art Unit 1613
Prosecution Insights