DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Status of the Claims
Claims 1-22 are pending. Claims 20-22 are withdrawn. Claims 1-19 are under consideration in this action.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-19) in the reply filed on January 27, 2026 is acknowledged.
Claims 20-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 27, 2026.
Claim Objections
Claim 1 is objected to because of the following informalities: the comma between “EGFRI” and “and” in line 7 should be deleted.
Claims 3 and 9 are objected to because of the following informalities: “plural polymers” should be “plurality of polymers” to be consistent with how it is written in claims 1 and 2.
Claim 8 is objected to because of the following informalities: “a weight ratio” should be “the weight ratio” for improved readability as the weight ratio is inherently present.
Claim 9 is objected to because of the following informalities: “a ratio” should be “the ratio” for improved readability as the ratio is inherently present.
Claim 12 is objected to because of the following informalities: “a projected area equivalent diameter” should be “the projected area equivalent diameter” for improved readability as the projected area equivalent diameter is inherently present.
Appropriate correction is required.
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 1-6 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 the limitation "the polymer shell" in lines 7-8. There is insufficient antecedent basis for this limitation in the claim. It is noted that the previous introduction is noted as “a shell”. For improved clarity and consistency, it is suggested “the polymer shell” is amended to “the shell” or that the previous mention of the “shell” in line 6 be amended to “a polymer shell”.
Claim 2 recites the limitation "the low molecular weight polymer" in line 7. There is insufficient antecedent basis for this limitation in the claim. It is noted that there is previous introduction of “a lower molecular weight polymer” in line 3. For improved clarity and consistency, it is suggested “the low molecular weight polymer” be amended to “the lower molecular weight polymer.
Further regarding claims 2 and 6, “the low molecular weight polymer” is indefinite because the term “low” is subjective. The instant specification does not appear to define what molecular weights are considered “low”. The instant specification appears to give examples of the “lowest molecular weight polymer”, but such as only examples and not a set definition (e.g., P.G. Pub., para.0051) Thus, the full scope of the term is unclear as to what molecular weights are and are not encompassed by the term.
With regards to claim 3, “low solubility in water” is indefinite because the term “low” is subjective. The instant specification appears to give various examples of what solubilities are considered “low”, but those are merely exemplary and not a comprehensive, set definition (e.g., P.G. Pub., para.0053). Thus, the full scope of the term is unclear as to what solubilities are and are not encompassed by the term. Claims 4 and 5 are subsequently rejected as they incorporate the limitation discussed above and do not remedy the issue discussed above.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 4 recites that the higher molecular weight polymer (one of the plurality of polymers) is PLGA. Claim 4 depends from claim 3, which recites that the polymers used are soluble in ethanol. However, as evidenced by Garner et al. (International Journal of Pharmaceutics; published 2021), ethanol is a non-solvent (poor solvent) that does not dissolve PLGA at any lactide content (p.1, col.2, para.2 to p.2, col.1, para.1). Thus, claim 4 fails to include all the limitation of claim 3 or fails to further limit the subject matter of claim 3 by allowing for a polymer that is not soluble in ethanol.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-7 and 9-18 are rejected under 35 U.S.C. 103 as being unpatentable over Rhodes et al. (Rhodes) (US 2017/0354611 A1; published Dec. 14, 2017), Yulai et al. (Yulai) (US 2010/0173002 A1; published Jul. 8, 2010), Liggins et al. (Liggins) (US 2008/0124400 A1; published May 29, 2008), and Lavik et al. (Lavik) (US 2011/0206773 A1; published Aug. 25, 2011).
With regards to Claim 1, Rhodes discloses multi-layer microparticles for sustained release of therapeutic agents and compositions comprising multilayer microparticles (para.0002). The method includes:
(a) forming a layer comprising a first polymer on a solid surface by depositing a first composition one or more times on the solid surface, wherein the first composition comprises the first polymer and a first solvent, and evaporating the first solvent in the first composition;
(b) forming one or more layers comprising a second polymer and a therapeutic agent by depositing a second composition on all or part of the layer formed in step (a), wherein the second composition comprises the second polymer, the therapeutic agent, and a second solvent; and evaporating the second solvent in the second composition; and
(c) forming an additional layer comprising a third polymer by depositing a third composition one or more times on a previously formed layer, wherein the third composition comprises the third polymer and a third solvent; and evaporating the third solvent in the third composition (para.0004).
When adjacent layers are formed using compositions that differ with respect to solvent and/or polymer, there is less tendency for material from the two adjacent layers to intermingle during layer formation. In some embodiments, the first and third compositions do not contain a therapeutic agent, thus in some cases, the layers formed by the first and the third compositions contain only polymer or only polymer and non-therapeutic components. The polymer outer layers can act as barriers in controlling the initial burst release of the therapeutic agent and further reduce its subsequent release rate from the inner layer of the microparticle. Thus, the methods of forming microparticles are useful for achieving sustained release of therapeutic agents with reduced or no burst release (para.0004, 0039).
A wide variety of polymers can be used to form the microparticles and the identity and concentration of polymer can vary in the various layers of the microparticles to provide particles with desirable drug release characteristics. Among the suitable polymers include poly(lactic-co-glycolic acid) (PLGA) and other natural biodegradable polymers (para.0029, 0039). The third (outer) layer may be PLGA (para.0029).
Various therapeutic agents can be delivered using the multilayer microparticles, including small molecule drug, peptide drug, protein drug, polysaccharide drug, oligonucleotide, or an antibody (para.0031).
A variety of solvents can be used in the microparticle fabrication based on the type of therapeutic agent, the polymer, and the formulation. Among the suitable solvents include ethanol (para.0031).
The microparticles have outer layers which can act as barriers in controlling the initial burst release of the therapeutic agent contained in the inner layer or layers and can lower the subsequent release rate from the inner layers of the microparticle. Thus, the methods of forming the microparticles are useful for achieving sustained release of therapeutic agents over an extended duration (para.0023).
With regards to Claim 2, in some cases, the molecular weight of the first and third polymers is greater than the molecular weight of the second polymer. In some cases, the first and third polymers have different molecular weight (para.0004). In some cases, the solvent used in the compositions used to form adjacent layers I the same, but the difference in polymer or polymer molecular weight reduced the tendency of a subsequently applied solvent containing composition to dissolve or partially dissolve previously formed layer (para.0025-0026). The molecular weight of a polymer affects its solubility in a given solvent: higher molecular weight of a polymer lowers its solubility (para.0028).
With regards to Claims 12 and 13, the microparticles have an average diameter less than 60 microns (para.0010, 0040, 0041).
With regards to Claim 14, the therapeutic agent constitutes 1-30 wt.% of the total solids of the formulation for the microparticle (par.0051).
With regards to Claim 17, with regards to the configuration of the layers of the multilayer microparticles, the microparticles may have simple flat layers that are layered on top of each other (para.0033, 0041). The multilayer microparticles can contain layers of uniform flat layers or layers of different thicknesses (para.0041).
Rhodes does not appear to explicitly disclose (i) wherein the microparticles are in a suspension (Claims 1 and 16); (ii) the inclusion of a stabilizing sugar (Claims 1 and 9-11); (iii) wherein the drug is an EGFRI (Claims 1, 7, and 14); or (iv) wherein the plurality of polymers include PLGA, CAB, and EC (Claims 4-6 and 18). Yulai, Liggins, and Lavik are relied upon for these disclosures. Their teachings are set forth herein below.
Yulai discloses microcapsules and methods for improving various properties of microcapsules like impermeability (abstract). The microcapsules are loaded with pharmaceutical composition (e.g., a drug) (para.0058).
Yulai discloses that the shells of many microcapsules are often “porous”, which can allow oxygen in air or dissolved in water to diffuse into the loading substance core(s). Oxidation of the loading substance can cause stability and sensory problems (para.0030). To overcome these problems, Yulai discloses microcapsules with improved shells and methods for preparing them. In general, disclosed are methods for preparing microcapsules that involve the use of saccharides to block the pores of a microcapsule shell and/or to increase the number of crosslinks in a microcapsule shell. Thus, the microcapsules disclosed herein generally have a combination of structural strength, impermeability, and high payload (para.0030).
The microcapsules comprise an agglomeration of primary microcapsules and a loading substance, each individual primary microcapsule having a primary shell, wherein the loading substance is encapsulated by the primary shell, wherein the agglomeration is encapsulated by an outer shell, wherein the primary shell, the outer shell, or both comprise a residue of one or more composition comprising an amino acid, protein, saccharide, wax, or combination thereof (Yulai claim 1). Figure 3, for example, discloses wherein the residue is encapsulated in the polymer shell.
In an embodiment, the composition comprises saccharide (Yulai claim 27). Among the suitable saccharides include mannose and trehalose (par.0125, 0260, 0273; Yulai claim 27). The composition can comprise the saccharide and the ratio of saccharide to the total shell material can be from about 1:0.2 to about 1:5 (para.0272).
Liggins discloses microparticles loaded with a drug (abstract). Among the suitable drugs that may be loaded into the microparticles include anti-fibrotic agents, such as gefitinib (para.0083). The microparticles provides sustained and/or controlled release of the drug present in the composition (para.0051).
Liggins also discloses compositions comprising the microparticles. The compositions further comprise a carrier. The microparticles may be dispersed throughout the carrier. The carrier may be in the form of a gel (para.0128).
Lavik discloses biodegradable polymeric microparticle compositions containing one or more active agents (abstract). An objective is to provide sustained release polymeric microparticulate compositions which have been optimized to maximize drug loading and release an effective amount of drug(s) for a desired period of time (para.0013).
Among the suitable drugs to be loaded in the microparticles include gefitinib (para.0052).
The percent loading of the drug in the microspheres is from about 1% to about 80% by weight, most preferably from about 1% to about 10% by weight. The percent loading is dependent on the drug to be encapsulated, the polymer(s) used to form the microparticles, and/or the procedure used to prepare the microparticles (para.0021).
The microparticles can be made from a variety of bioerodible polymers. PLGA is preferred copolymer. Among the additional suitable polymers include ethyl cellulose and cellulose acetate butyrate (para.0066-0068, 0072).
With regards to Claims 1-6, and 18, as discussed above, Rhodes discloses sustained-release multilayer microparticles containing an inner, intermediate, and outer polymeric layer, making up the shell of the microparticle. Each layer may be made of a different polymer of varying molecular weights, and contains a therapeutic agent or a non-therapeutic agent. Among the suitable polymers for the outer layer is PLGA. The microparticles are useful for achieving sustained release of therapeutic agents with reduced or no burst release. In light of Lavik’s disclosure of biodegradable polymers known to be used to form microparticles for sustained release of therapeutic agents, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to combine the teachings of Rhodes and Lavik and try Lavik’s disclosed polymers (e.g., PLGA, ethyl cellulose, and cellulose acetate butyrate) as the plurality of polymers for Rhode’s microparticles. One of ordinary skill in the art would have been motivated with a reasonable expectation of success in doing so as ethyl cellulose and cellulose acetate butyrate, like PLGA, are conventional biodegradable polymeric materials used in the formation of microparticles used for controlled release of therapeutic agents.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to engage in routine experimentation to determine the optimal combination of polymers, the order of polymer layering, and the molecular weight of each polymer to use to produced expected results. In particular, one of ordinary skill in the art would have found it prima facie obvious and would have been motivated to engage in routine optimization to optimize the aforementioned variables in order to obtain the optimal or desired timing and/or release rate of the encapsulated drug.
Further, with regards to Claims 1, 7, 14, and 16, as discussed above, the combined teachings of Rhodes and Lavik are directed to multilayered microparticles that provide controlled, sustained release of therapeutic agents that are encapsulated within the multilayered shell. In light of Lavik’s and Liggins’s disclosures that gefitinib is a therapeutic agent known to be delivered by microparticles that provide sustained and/or controlled release of drugs and that such microparticles are known to be dispersed throughout a carrier, such as those in the form of a gel, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to further combine the teachings of Rhodes and Lavik with the teachings of Liggins and encapsulate gefitinib as the therapeutic agent in the multilayered shell and disperse the microparticles in the desired carrier, e.g., a gel. One of ordinary skill in the art would have been motivated to do so in order to provide controlled and/or sustained delivery of gefitinib with reduced or no initial burst, thus providing potential art recognized benefits, e.g., ensuring predictable and steady dosing and minimizing unintended side effects throughout the treatment; and being able to provide the microparticles in a desired dosage form. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as gefitinib is known to be delivered via controlled and/or sustained-release polymeric microparticles and such microparticles known to be dispersed in carriers of various forms, e.g., gels.
Further regarding the amount of gefitinib loaded in the microparticles, as discussed above, Rhodes discloses that the therapeutic agent constitutes 1-30 wt.% of the total solids of the formulation for the microparticle, and Lavik discloses that microparticles most preferably have loaded from about 1-10% by weight the drug. It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. In the present case, one of ordinary skill in the art would have found it prima facie obvious and would have been motivated to engage in routine experimentation to determine optimal or workable amount of gefitinib (therapeutic agent) from the disclosed conventional drug loading amounts to incorporate into the microparticle based on art recognized factors such as the condition to be treated, the severity of the treatment, the treatment duration, and dosage needed. 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 experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955).
With regards to Claims 1 and 9-11, as discussed above, Yulai discloses that shells of many microparticles are often “porous”, which can allow oxygen in air or dissolved in water to diffuse into the loading substance core. In light of Yulai’s disclosure that saccharides such as mannose and trehalose are known to be incorporated into the polymeric shell to provide improved such shells, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to further combine the teachings of Rhodes, Lavik, and Liggins with the teachings of Yulai, and further encapsulate mannose or trehalose into the polymeric shells in amounts so that the ratio of saccharide to the total shell material can be from about 1:0.2 to about 1:5. One of ordinary skill in the art would have been motivated to do so in order to provide microparticles with improved structural strength and impermeability to improve the stability of the encapsulated active agent (drug). One of ordinary skill in the art would have had a reasonable expectation of success in doing so as mannose and trehalose are disclosed as conventional additives for inclusion into polymeric shells of microparticles used for drug delivery.
With regards to Claim 15, the instant Specification discloses that formulations that included three polymers were found to provide slow release of gefitinib over extended periods compared to formulations that included only two polymers. For example, microparticles made by spray drying the formulations PLGA/CAB/EC and CAB/EC/PLGA, released gefitinib slowly enough that it took more than 350 hours to release 95% of the gefitinib in the microparticle in both the saliva and cell culture medium (P.G. Pub., para.0148). The instant Specification also discloses that the formulation containing trehalose appeared to release gefitinib more slowly into saliva and cell culture liquid than the other tested formulations (P.G. Pub., para.0123). Because the combined teachings of Rhodes, Lavik, Liggins, and Yulai as discussed above are fairly suggestive of microparticles made of three polymers (PLGA, EC, and CAB) and trehalose, absent evidence to the contrary, the pharmaceutical composition of the combined teachings of the cited prior art references as discussed above will also demonstrate the property recited in the instant claim 15.
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, because the combined teachings of the prior art references is fairly suggestive of the claimed invention.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Rhodes et al. (Rhodes) (US 2017/0354611 A1; published Dec. 14, 2017), Yulai et al. (Yulai) (US 2010/0173002 A1; published Jul. 8, 2010), Liggins et al. (Liggins) (US 2008/0124400 A1; published May 29, 2008), and Lavik et al. (Lavik) (US 2011/0206773 A1; published Aug. 25, 2011) as applied to Claims 1-7 and 9-18 set forth above, further in view of Visaveliya et al. (Visaveliya) (Adv. Mater. Interfaces; published 2017).
The teachings of Rhodes, Yulai, Liggins, and Lavik, and the motivation for their combination as they apply to Claims 1-7 and 9-18 are set forth above and incorporated herein.
The combined teachings of Rhodes, Yulai, Liggins, and Lavik do not appear to explicitly disclose wherein the microparticles have a surface morphology that is folded and crumpled. Visaveliya is relied upon for this disclosure. The teachings of Visaveliya are set forth herein below.
Visaveliya discloses the polymer particles are promising particulate materials for renowned biomedical applications such as targeted drug delivery. Surface properties of the polymer particles are of key importance for biomedical applications because they directly interact with biological systems. Particularly, wrinkled as well as porous surfaces possess an enhanced ability for cell attachment without any additional chemical modification. Therefore, a key objective is to fabricate the particles with desired degree of wrinkles and porosity (abstract).
Visaveliya discloses that wrinkling, folding, and creasing are surface structures that can be generated upon different types of morphological instabilities. A folding type effect can also be generated in cases when two pores are closer on the surface of particles. It can be imagined that two pores merged together during drying process and create one pore which finally folds and creases (p.4, col.2, para.2; p.5, Fig.3; p.11, col.2, para.2; p.12, Fig. 12). Visaveliya discloses that tailored surface textures and topology are driving forces for real impact because surfaces are in direct contact with biological systems during applications. Microparticles possess high surface to volume ratio compared to their bulk counterparts. Surface area is further enhanced when wrinkled patterns are applied on the surface. Surface roughness of particles can enhance drug-loading efficiency and a release rate of the encapsulated hydrophobic active compounds. Also, wrinkle-like surface-textured polymer particles can exhibit enhanced cell viability and biocompatibility (p.5, col.2, para.1).
Visaveliya discloses that cells interaction with wrinkled particles is of particular importance for biomedical purposes. Compared to smooth particles, a greater amount of wrinkled particles were attached by cells. Cells attachment to the wrinkled surface can occupy large surface area of particles and can be attributed to the surface topology of wrinkles which cannot be observed on the smooth surfaced particles. The wrinkled surface without any additional chemical processing can be advantageous for different biomedical applications. For example, wrinkled particles can be potentially used as microcarriers for drug delivery and performance can significantly can be enhanced with increased drug carrying efficiency because of the enhanced surface area (p.12, col.1, para.1-col.2, para.1). Visaveliya concludes that wrinkled and porous polymer particles have significant impact in targeted drug delivery due to their enhanced surface structure (p.13, col.1, para.1).
With regards to Claim 19, as discussed above, the combined teachings of Rhodes, Yulai, Liggins, and Lavik are directed to sustained and controlled-release microparticles used for drug delivery. In light of Visaveliya’s disclosure of the advantages of surface-textured polymer particles, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to further combine the teachings of Rhodes, Yulai, Liggins, and Lavik with the teachings of Visaveliya and provide polymeric microparticles with a textured surface that is wrinkled, folded, and/or creased. One of ordinary skill in the art would have been motivated to do so as such surface modification to the microparticles provide enhanced surface area, thus providing enhanced drug carrying efficiency and localized delivery. One of ordinary skill in the art would have had are reasonable expectation of success in doing so as Visaveliya discloses that such surface morphology, through providing wrinkles and/or porosity, is known for microparticles used for drug delivery.
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, because the combined teachings of the prior art references is fairly suggestive of the claimed invention.
Allowable Subject Matter
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art references, alone or in combination do not teach or fairly suggest the limitation of the instant claim 8. The closest prior art teachings are the combined teachings of the prior art references cited in the rejections set forth above, in particular Rhodes et al. (Rhodes) (US 2017/0354611 A1; published Dec. 14, 2017) and Lavik et al. (Lavik) (US 2011/0206773 A1; published Aug. 25, 2011). The teachings of Rhodes and Lavik are set forth above in detailed and incorporated herein.
While Rhodes discloses the use of a plurality of polymers with varying molecular weights for forming sustained-release microparticles, and Lavik discloses conventional polymers used for such microparticles, including PLGA, ethyl cellulose, and cellulose acetate butyrate, the prior art, alone or in combination, do not disclose, fairly suggest, or direct one of ordinary skill in the art to the specifically claimed ratio for the specifically selected polymers, wherein the PLGA is the higher molecular weight polymer, cellulose acetate butyrate is the intermediate molecular weight polymer, and the ethyl cellulose is the lower molecular weight polymer.
Conclusion
Claims 1-7 and 9-19 are rejected. Claim 8 is objected to. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MONICA A. SHIN whose telephone number is (571)272-7138. The examiner can normally be reached Monday-Friday (9:00AM-5:00PM EST).
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/MONICA A SHIN/Primary Examiner, Art Unit 1616
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