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 .
Priority
This application is a National Stage entry of PCT/US2021/053656, filed 10/5/2021.
Information Disclosure Statement
The IDS’s filed on 5/14/2026, 10/31/2025, 4/16/2025 have been considered. See the attached PTO 1449 form.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-16), hydrophobic material of the hydrophobic layer having the glass transition temperature of 37 C or lower, PLGA microparticle, Rapamycin (sirolimus) as the therapeutic agent and the medical device being a stent, in the reply filed on 4/20/2026 is acknowledged. The traversal is on the ground(s) that the examiner does not give the reasons why there would be serious search and/or examination burden on the examiner if restriction is not required and that there is overlap among various species. This is not found persuasive because as stated in the Restriction/Election of Species Requirement and as provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept ("requirement of unity of invention"). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression "special technical features" shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art. As discussed in the Restriction/Election of Species Requirement, Slager (EP2996735B1) teaches the common technical feature of a drug coating layer comprising a hydrophilic/hydrophobic layer and a hydrophobic/hydrophilic therapeutic or microparticle with therapeutic embedded therein. As the common technical feature was known in the art, this cannot be considered a common technical feature that would otherwise unify the groups. Accordingly, unity of invention is lacking and the requirement is still deemed proper and is therefore made FINAL.
Upon further search and consideration, the examiner has expanded the election of species and rejoined balloon catheter as the medical device since the prior art being relied upon teaches balloon catheter medical device and the search is coextensive. Accordingly, claims 1-15 are currently under examination.
Claims 16-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim.
Claim Status
Receipt of Remarks filed on 4/20/2026 is acknowledged. Claims 1-27 are currently pending. Claims 16-27 have been withdrawn. Accordingly, claims 1-15 are currently under examination.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
The specification recite “FIG. 5A” and “FIG. 5B” (see e.g. para 0047). Page 5 of drawings recites “FIG. 5” but there is no mention of specifically “FIG. 5A” and “FIG. 5B”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
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 1-15 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.
Claim 1 recites “a hydrophobic layer and a therapeutic agent or a polymer microparticle containing the therapeutic agent, embedded therein”. This recitation makes it unclear whether “embedded therein” refers to the therapeutic agent is embedded in the polymeric microparticle or whether it is the therapeutic agent or a polymer microparticle containing the therapeutic agent which are embedded in the hydrophobic layer. The recitation “embedded there” does not clarify exactly which component is embedded and into which part of the layer it is embedded.
Claim 4 recites “the hydrophobic material” in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 4 depends from claim 1 and claim 1 does not specifically recite a hydrophobic material. While claim 1 recites a hydrophobic layer, the claim also recites a therapeutic agent (e.g. rapamycin) which can be hydrophobic. Therefore, it is unclear which component the hydrophobic material of claim 4 is referring to.
Claim 7 recites “biolimus (biolimus A9)”. The recitation of “biolimus A9” in the parenthesis renders the claim indefinite because it is unclear whether the limitations in the parenthesis are part of the claimed invention. See MPEP § 2173.05(d).
Claims 2-3, 5-6, 8-15 are included in the rejection as they depend on a rejected base claim and do not clarify the issues discussed above.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 7-9, 12 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ahlering (WO2020081455A1).
Ahlering throughout the reference teaches coating for intraluminal expandable catheter providing contact transfer of drug micro-reservoirs.
Ahlering teaches a catheter and specifically a balloon catheter (medical device) comprising an expandable portion on an elongated body and a coating over an outer surface of the expandable portion wherein the coating comprises a lipophilic matrix, wherein the lipophilic matrix comprises at least one lipid (hydrophobic layer comprising hydrophobic material). The lipid include vegetable oil such as coconut oil or mono, di or tri- glycerides. Ahlering exemplifies DPPE-mPEG350 which reads on the claimed hydrophobic materials having a glass transition temperature of 37 C or lower. (see e.g. example 9). A plurality of micro-reservoirs dispersed in the lipophilic matrix, wherein the plurality of micro-reservoirs comprises an active agent. The active agent is crystalline and comprised of sirolimus. The micro-reservoirs may include microparticles or microspheres. Polylactic-co-glycolic acid (PLGA) microspheres are well suited for incorporation of the active agent for sustained release up to approximately 50% by weight of the active agent in the microsphere. In example 1, Ahlering specifically teaches drug containing microspheres made of PLGA comprising 39% sirolimus (rapamycin) by weight. In example 3, Ahlering teaches a coating formulation was prepared with stearic acid, cholesterol, and DPPE-mPEG350 mixed with heptane. Next the sirolimus loaded microsphere was added and the formulation was placed in ultrasonic bath to disperse and suspend the microspheres. The coating formulation was sprayed onto the balloon surface. As such, Ahlering anticipates claims 1-5, 7-9, 12 and 15. (see e.g. abstract; claims; para 0026; 0032; 0033; Examples; Specifically examples 1-9; entire document).
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 (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 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.
Claims 1-9 and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2021/0259976 A1).
Wang throughout the reference teaches polymer encapsulated drug particles for coating on to a medical device. Wang teaches polymer encapsulated drug particles comprising a therapeutic agent and one or more polymer that encapsulate the therapeutic agent. The therapeutic agent includes rapamycin (sirolimus). The polymer includes a polylactic acid/polyglycolic acid copolymer (PLGA). The polymer-encapsulated drug particles can include a first ionic or zwitterionic additive. The first ionic or zwitterionic additive can be homogeneously distributed within the particle (e.g., with the therapeutic agent within the encapsulating polymer). This reads on the therapeutic agent dispersed in the polymer. The polymer encapsulated drug particles are on a medical device including balloon catheter or drug eluting stent. Wang teaches the medical device includes a coating layer overlying an exterior surface of the medical device. Wang teaches the layer of coating that contains the therapeutic agent has at least one hydrophobic ingredient. The coating layer includes a drug-releasing coating including the polymer-encapsulated drug particles. The drug releasing coating comprises a release matrix comprising a second ionic or zwitterionic additive which include lipids/phospholipids (which also reads on hydrophobic material of hydrophobic layer). Wang in paragraph 0222-0224 discloses many hydrophobic polymeric surfactants which are biodegradable and have a glass transition temperature (Tg) of 37 C or lower, including semi-synthetic glycerides, PEGs, hydrogenated vegetable oils, etc. As such, Wang teaches the coating layer comprising a hydrophobic layer comprising a hydrophobic material with a Tg of 37 C or lower and specifically the hydrophobic materials recited in claims 3 and 4. Wang teaches the polymer-encapsulated drug particles can be homogeneously dispersed in the release matrix. Wang teaches the therapeutic agent can form any suitable proportion of the polymer-encapsulated drug particle, and specifically teaches 5-45 wt%, which overlaps the concentration recited in claim 9. Wang teaches wherein the therapeutic agent is crystalline and the therapeutic agent having a particle size of 0.2 micron to 10 microns, which reads on the crystalline particle size of claim 13. Regarding instant claim 6 which recites the polymer microparticle is a smooth microparticle, the instant specification disclose that the smooth polymer microparticles refer to polymer microparticles obtainable by emulsion evaporation and/or microfluidics mixing with solvents such as ethyl acetate (EtOAc) (para 0064 of instant specification). Wang also teaches the method of making the polymer-encapsulated drug particles include forming an organic premix comprising an organic solvent, the one or more polymers, the therapeutic agent, and wherein the organic solvent include esters/acetates such as ethyl acetate. As such, the polymer microparticle of Wang would be a smooth microparticle. (see e.g. abstract; claims; para 0037-0039; 0041; 0065; 0068; 0082; 0096-0098; 0162; 0215; 0222-0224; 0270; 0432; entire document).
The teachings of Wang have been set forth above.
Wang does not explicitly exemplify wherein the drug coating layer comprises a hydrophobic layer, wherein the hydrophobic layer comprises a hydrophobic material with a glass transition temperature of 37 C or lower. However, as discussed supra, Wang teaches the layer of coating that contains the therapeutic agent has at least one hydrophobic ingredient. The coating layer includes a drug-releasing coating including the polymer-encapsulated drug particles. The drug releasing coating comprises a release matrix comprising a second ionic or zwitterionic additive which include charged lipids and phospholipids (which also reads on hydrophobic material of hydrophobic layer). Wang in paragraph 0222-0224 discloses many hydrophobic polymeric surfactants which are biodegradable and have a glass transition temperature (Tg) of 37 C or lower, including semi-synthetic glycerides, PEGs, hydrogenated vegetable oils, etc. Therefore, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007). It would have been obvious to one of ordinary skill in the art to try and substitute the materials taught to be suitable for use in the coating layer and use the materials having glass transition temperature of 37 C or lower as a person with ordinary skill has good reason to pursue known options within his or her technical grasp. see MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
Further, Wang teaches the phase transition or softening temperature of the charged lipid can affect the properties of the coating, such as coating integrity, dry durability, the rate of drug release from the coating, rate and/or degree drug uptake into the tissue, or a combination thereof. Lipids and phospholipids that have a high phase transition temperature can lead to brittle coatings that crack and flake leading to inconsistent drug dosing. Lipids and phospholipids that have a low phase transition temperature can be hard to handle because they can be wet and sticky which leads to inconsistent drug dosing. The phase transition temperatures of charged lipids and phospholipids can range from −70° C to 80° C. The preferable range of phase transition temperatures is −30° C to 50° C. The most preferable range of phase transition temperatures is −20° C to 40° C. In some embodiments coatings can have a mixture of lipids and/or phospholipids that allow the phase transition temperature of the coating to be in the desirable range with desirable mechanical properties (e.g., para 0070; 0086). As discussed supra, Wang teaches the drug releasing coating comprises a release matrix comprising a second ionic or zwitterionic additive which include charged lipids and phospholipids. Thus, it would have been obvious to one skilled in the art to choose a hydrophobic material having a phase transition temperature or glass transition temperature which is suitable to provide the desired mechanical properties and drug dosing.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2021/0259976 A1) as applied to claims 1-9 and 12-15 above and further in view of Yoo et al. (ACS Biomater. Sci. Eng. 2020, 6, 6053-6062) and Flanagan et al. (US 2019/0358370 A1).
The teachings of Wang et al. have been set forth above.
Wang does not teach wherein the polymer microparticles are of a first size grouping and a second size grouping, wherein the first size grouping has an average size of 10 micron and second size grouping has an average size of 30, 35 or 40 micron. However, Yoo et al. and Flanagan et al. cure this deficiency.
Yoo teaches poly(lactic-co-glycolic acid) (PLGA) is a polymer drug delivery vehicle used in the form of microparticles. The primary role of PLGA is to control the kinetics of drug release toward achieving sustained release of the drug. Several factors are known to mainly affect the drug release kinetics of PLGA microparticles. They include particle size, porosity, and polymer molecular weight. Studies have shown that particle size is a primary determinant of drug release rate. Yoo discloses drug loaded PLGA microparticles of four size classes (>100, 50−100, 20−50, and <20 μm). The drug loading content (LC, defined as mass of drug per total mass of polymer and drug) was found to be significantly different among different size fractions. The LC of >100 μm-sized particles was >3× higher than that of <20 μm-sized particles. Different size particles exhibited remarkable differences in drug release kinetics. The drug was completely released from the 20-50 and <20 μm size fractions within 1 week, whereas the larger (>100 and 50−100 μm) size fractions exhibited a slow release over the first week. These larger microparticles showed a sigmoidal release profile, whereas the smaller ones showed a biphasic profile with a significant initial burst. Although the initial burst effect can be reduced by increasing the size of PLGA particles, optimal particle sizes must be determined in consideration of specific tissues to which PLGA particles are delivered. (see e.g. abstract; introduction; Section 2, 2.1; entire document).
Flanagan teaches drug delivery balloon having a drug thereon in the from of crystalline particles having predetermined size distribution. Multi-modal ranges, prepared, e.g by mixing two or more sets of different narrow size range may be used in some cases to provide a desired bioavailability profile over time. For example, 50% of the crystals can be of 1000 nm mean size and the other 50% could be 300 nm mean size. This embodiment enables a tailoring of the drug persistence in the vessel wall. The smaller crystals will more readily dissolve and enter the tissue for immediate effect and larger crystals will dissolve at a much slower rate enabling longer drug persistence. (see e.g. abstract; para 0023; entire document).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Wang, Yoo and Flanagan and make the polymer microparticle of Wang comprise of a first size grouping and a second size grouping, wherein the first size grouping has an average size of 10 micron and second size grouping has an average size of 30, 35 or 40 micron. As discussed supra, Wang teaches PLGA polymer comprising the therapeutic agent. Yoo teaches the primary role of PLGA is to control the kinetics of drug release toward achieving sustained release of the drug. Several factors are known to mainly affect the drug release kinetics of PLGA microparticles and particle size is a primary determinant of drug release rate. Yoo discloses that drug loading content was found to be significantly different among different size fractions. Different size particles exhibited remarkable differences in drug release kinetics. The drug was completely released from the 20-50 and <20 μm size fractions within 1 week, whereas the larger (>100 and 50−100 μm) size fractions exhibited a slow release over the first week. These larger microparticles showed a sigmoidal release profile, whereas the smaller ones showed a biphasic profile with a significant initial burst. Optimal particle sizes must be determined in consideration of specific tissues to which PLGA particles are delivered. Flanagan teaches multi-modal ranges, prepared, e.g by mixing two or more sets of different narrow size range may be used in some cases to provide a desired bioavailability profile over time. For example, 50% of the crystals can be of 1000 nm mean size and the other 50% could be 300 nm mean size. This embodiment enables a tailoring of the drug persistence in the vessel wall. The smaller crystals will more readily dissolve and enter the tissue for immediate effect and larger crystals will dissolve at a much slower rate enabling longer drug persistence. Therefore, it would have been obvious to one skilled in the art to determine the optimal size of the PLGA polymer of Wang based on the type of release desired for the therapeutic agent and also include two different size groupings wherein one size grouping can provide an immediate effect of the drug and the other can provide a slower and sustained release of the drug at the desired tissue. As such, the two different size grouping of the polymer microparticle and the specific sizes would have been prima facie obvious to one skilled in the art. Changes in size, shape, or sequence of adding ingredients generally have limited impact on patentability unless they produce unexpected results or solve a specific problem. See: MPEP 2144.04.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art.
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 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 14-24 of copending Application No. 18696272 (US20250041489A1) in view of Ahlering (WO2020081455A1).
‘272 claims a formulation for a balloon of a balloon catheter comprising a first group and a second group of polymer microparticles, each comprising PLGA and a therapeutic agent loaded therein, wherein the polymer microparticles of the first group have a smaller average size than the polymer microparticles of the second group. The therapeutic agent is sirolimus and is of 10 to 50% w/w. The polymer microparticles are smooth with even distribution of the therapeutic agent. The polymer microparticles of the second group is of an average size that is 20-30 micron larger than the first group. The first group have an average size of 10 micron. The second group have an average size of 30 to 40 micron.
‘272 does not teach the microparticles are embedded in hydrophobic layer coated on the balloon catheter, the claimed hydrophobic material, and wherein the therapeutic agent is crystalline.
However, Ahlering cures these deficiencies.
The teachings of Ahlering set forth above are incorporated herein. Ahlering teaches the microparticles are dispersed in a lipophilic matrix wherein the matrix configured to adhere to a luminal surface when balloon is expanded and transfer at least a portion of the plurality of microparticles (micro reservoir) to the liminal surface. (see e.g. claim 1; para 009).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of ‘272 and Ahlering and disperse/embed the microparticles in a lipophilic matrix (e.g., in the hydrophobic materials taught by Ahlering) coating on the balloon catheter because lipophilic matrix coating can adhere to a luminal surface when balloon is expanded and transfer at least a portion of the plurality of microparticles (micro reservoir) to the liminal surface. Further, Ahlering teaching PLGA microparticle containing sirolimus in crystalline form and one skilled in the art would have found it prima facie obvious to include crystalline form of sirolimus in the formulation of ‘272 because the prior art teaches crystalline form of sirolimus was known to be used in the PLGA microparticles coated on balloon catheter.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/ALI S SAEED/ Examiner, Art Unit 1616
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