DETAILED ACTION
Status of the Claims
Claims 1-9 and 11-20 are pending in the instant application. Claims 11-15 have been withdrawn based upon Restriction/Election as discussed below. Claims 1-9 and 16-20 are being examined on the merits in the instant application.
Advisory Notice
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Restriction/Election
Applicant's election Group III drawn to methods of making, currently claims 1-9 and 16-20, in the reply filed on 01/05/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The requirement is still deemed proper and is therefore made FINAL.
Claims 11-15 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/05/2026.
Priority
The instant Application is a 371 of PCT/US2022/070918 filed 03/02/2021 which claims priority to US Provisional Application No. 63/159,523 filed 03/11/2021.
The U.S. effective filing date for claims 1-9 and 20 has been determined to be 03/02/2021, the filing date of PCT/US2022/070918. The U.S. effective filing date for claims 16-19 has been determined to be 03/11/2021, the filing date of 63/159,523.
Information Disclosure Statement
The information disclosure statements submitted on 09/012023 and 11/20/2023 were filed before the mailing date of the first office action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Specification
The abstract of the disclosure is objected to because the only Abstract on file is in the PCT, and is essentially instant claim 1 which is too long (> 150 words). Correction is required. See MPEP § 608.01(b). Additionally, the abstract of the disclosure does not commence on a separate sheet in accordance with 37 CFR 1.52(b)(4) and 1.72(b). A new abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text.
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
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 1-6 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 pre-AIA the applicant regards as the invention.
Claim 1 is rejected as being indefinite because the claim recites “(B) introducing the dispersed phase into a homogenization unit, wherein the time between the combining and the introducing consists of a predetermined contact time that is sufficiently short that the polymer does not undergo significant degradation attributable to contact with the API, and/or the API does not undergo significant degradation or morphologic changes attributable to contact with the polymer” (instant claim 1, item B) where the “contact time that is sufficiently short” is not clearly defined in the claim such that one of ordinary skill in the art would be appraised of the scope of the subject claimed, and particularly given the claim is not limited to any specific combination of polymer-API, “significant degradation” is unclear in the context of the claimed invention. Furthermore, no API morphology is recited in the claim such that “morphologic changes attributable to contact with the polymer” is unclear in the context of the claims. Appropriate clarification is required.
Claims 2-6 are rejected as inheriting the above discussed issue with claim 1 and doing nothing to clarify the same.
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 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 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, 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over KOSAKA (US 2019/0029969 A1; published January, 2019) in view of RICHEY (US 2016/0030351 A1; published February, 2016) and BRUNO (US 2003/0092652 A1; published May, 2003).
Applicants Claims
Applicant claims a method for preparing an active pharmaceutical ingredient ("API")-encapsulating polymer microsphere formulation, the method comprising: (A) preparing a dispersed phase, comprising the steps of: (1) dissolving and/or suspending an API in a first solvent in a first vessel to form an API solution; (2) dissolving a biodegradable polymer in a second solvent in a second vessel different from the first vessel to form a polymer solution; (3) combining the API solution and the polymer solution; and (4) mixing the combined solution to form the dispersed phase; (B) introducing the dispersed phase into a homogenization unit, wherein the time between the combining and the introducing consists of a predetermined contact time that is sufficiently short that the polymer does not undergo significant degradation attributable to contact with the API, and/or the API does not undergo significant degradation or morphologic changes attributable to contact with the polymer; (C) contacting the dispersed phase with a continuous phase in the homogenization unit; and (D) homogenizing the combined dispersed phase and continuous phase (instant claim 1).
Applicant claims a method for preparing an active pharmaceutical ingredient ("API")-encapsulating polymer microsphere formulation, the method comprising: (A) preparing a dispersed phase, comprising the steps of: (1) dissolving and/or suspending an API in a first solvent in a first vessel to form an API solution; (2) dissolving a biodegradable polymer in a second solvent in a second vessel different from the first vessel to form a polymer solution; (3) combining the API solution and the polymer solution by pumping both solutions into a Y connector; and (4) mixing the combined solution in a static mixer to form the dispersed phase; (B) introducing the dispersed phase into a homogenization unit, wherein the time between the combining and the introducing consists of a predetermined contact time of less than 15 seconds, less than 30 seconds, or less than one minute; (C) pumping a continuous phase into the homogenization unit such that the dispersed phase and continuous phase are in contact with each other; and (D) homogenizing the combined dispersed phase and continuous phase (instant claim 16).
Determination of the scope
and content of the prior art (MPEP 2141.01)
KOSAKA teaches risperidone-containing microcapsules and methods for preparing the same (title, see whole document), and particularly “A method of producing the microcapsule is also disclosed. The method of producing a microcapsule has (A) a step of preparing a first phase by mixing a solution of a biodegradable polymer and a solution of risperidone which are prepared separately, (B) a step of, immediately after the preparation of the first phase, mixing the first phase with a second phase being an aqueous phase to prepare an emulsion, and (C) a step of subjecting the resulting emulsion to in-water drying.” (abstract).
KOSAKA teaches that: “Further, it is described that from the viewpoint of preventing the active drug from being decomposed, a period of time for exposing the active drug to the polymer is as short as possible, that is, within 10 minutes, which, however, cannot be said to be satisfactory for the purpose of keeping a molecular weight of the biodegradable polymer during dissolution, dispersing and emulsification of the drug.” ([0006]). And that: “Further, in the case of obtaining a desired molecular weight by intentionally decomposing the polymer, there is a problem that it is difficult to control a decomposing process every time in the same manner, resulting in a large variation in a molecular weight between the preparation processes and leading to a large variation in a release behavior of a preparation.” ([0007]).
KOSAKA teaches that: “It is preferable to use the first phase obtained by mixing the solution of a biodegradable polymer and the solution of risperidone immediately after the preparation thereof. Therefore, it is preferable to prepare the second phase being an aqueous phase before the preparation of the first phase and prepare the first phase just before the emulsification of the step (B). Thus, an interaction between the biodegradable polymer and the risperidone can be inhibited to the utmost, and decomposition of the biodegradable polymer can be inhibited.” [emphasis added]([0040]). And that: “Herein, to use "immediately after the preparation" means that a time of exposure of risperidone to the biodegradable polymer is as short as possible in order to inhibit an interaction between the biodegradable polymer and the risperidone to the utmost. This means that the step (B) follows, for example, within at least 1.5 minutes, preferably within one minute, or more preferably the step from the preparation of the first phase up to the step (B) is performed continuously.” ([0041])(instant claims 1, 7-9 & 16, minimizing the time between combining and introducing; instant claim 18 – API is risperidone).
KOSAKA teaches that: “In the step (A), for the mixing of the solution of a
biodegradable polymer and the solution of risperidone, a usual mixing means can be used, and use of a Static Mixer is preferable since the step after the mixing up to the step (B) can be performed continuously.” ([0042])(instant claims 1, 3, 16, (4) mixing the combined solution in a static mixer to form the dispersed phase). And that: “The second phase in the step (B) is an aqueous phase, and it is preferable to add a hydrophilic colloid or a surfactant to stabilize the emulsion and adjust a size of the microcapsule in the emulsion.” ([0043])(instant claim 5). And further that: “Further in one embodiment of the present invention, it is preferable that the mixing in the step (B) is performed continuously after the above-mentioned step (A) by means of an emulsifier, for example, a Static Mixer, a homo-mixer or a high pressure homogenizer. By conducting the step (B) continuously, decomposition of the biodegradable polymer can be inhibited more effectively.” ([0046])(instant claims 1, 4, 16 – (B) introducing the dispersed phase into a homogenization unit).
KOSAKA teaches inclusion of polyvinyl alcohol (PVA) in a concentration of 0.01 to 10% ([0044]), and discloses a 1% by mass PVA solutions in Examples 1 & 2 ([0053] & [0056])(instant claim 6).
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of KOSAKA is that KOSAKA does not expressly teach (1) a y-connector into which the API solution and the polymer solution are pumped.
RICHEY teaches a process for production of sustained release microspheres (title, see whole document) including “method of making a sustained release microsphere formulation, wherein the release rate of a bioactive ingredient is manipulated by controlling the crystallinity of said bioactive ingredient, includes the steps of (a) sterilizing an active ingredient with either heat or gamma sterilization to form a sterilized active ingredient; (b) dissolving an encapsulating polymer in a second solvent or mixtures thereof; (c) filtering the result of step (b); wherein said filtering is accomplished with a hydrophobic or hydrophilic filter; (d) combining the results from step (a) and step (c) to form a dispersed phase, wherein the result of step (a) is not filtered before it is combined with the result of step (c); and (e) combining the dispersed phase with a continuous phase to form the microsphere formulation.” [emphasis added]([0005]). And particularly teaches: “Six batches of microsphere were made using the following method. Betamethasone microspheres were prepared using a continuous water in oil (W/O) emulsification/solvent extraction procedure. Generally, a dispersed phase, including a biodegradable polymer of polylactide or polylactide-co-glycolide, a suitable solvent, and a pharmaceutically effective amount of betamethasone is prepared to form a clear homogeneous solution. The dispersed phase is then pumped in to a homogenizer, such as an in-line Silverson Homogenizer, commercially available from Silverson Machines, Waterside, UK, at a defined flow rate. Simultaneously, an aqueous continuous phase, including polyvinyl alcohol, is also pumped in to the homogenizer at a defined flow rate. The speed of the homogenizer is generally fixed to achieve a desired microsphere size distribution.” ([0020])(instant claims 1 & 16, (A) preparing a disperse phase, and (C) contacting the disperse phase with a continuous phase in a homogenization unit).
BRUNO teaches a process including pumping two solutions through a Y-connector into a static mixer (Figure 1, see whole document). BRUNO teaches that: “The in-line mixer preferably is made up of two inlets in a Y-shaped configuration which join at an intersection to form a single outlet. In one embodiment of the invention, the in-line mixer includes a static mixer after the Y-shaped intersection.” ([0010]). BRUNO teaches including the step of mixing includes emulsions ([0068]).
Further regarding the claimed “predetermined contact time” that is less than 1 minute (claims 7 & 16), less that 30 seconds (claims 8 & 16), or less than 15 seconds (claims 9 & 16), one of ordinary skill would have been motivated to reduce the process time to the extent possible as reduced process time would have saved costs and/or increased production within a given time period. Therefore, it would have been prima facie obvious to reduce time to reduce costs and/or increased production within a given time period.
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
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 produce a method for the production of microspheres including a static mixer for combining an API solution/suspension and a solvent including a biodegradable polymer to forming a dispersed phase, and subsequently introducing the mixed dispersed phase into a homogenizer for the production of microcapsules, as suggested by, KOSAKA, the process including a dispersed phase and a continuous phase pumped into a homogenizer for production of microspheres, as suggested by RICHEY, and further to include a Y-connector for introducing the API solution/suspension and the solvent including the biodegradable polymer, as suggested by BRUNO, for introduction into a static mixer.
From the teachings of the references, it is apparent that 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 before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over KOSAKA in view of RICHEY and BRUNO as applied to claims 1-9, 16 and 18 above, and further in view of THANOO (US 2010/0143479 A1; published June, 2010).
Applicants Claims
Applicant claims a method for preparing an active pharmaceutical ingredient ("API")-encapsulating polymer microsphere formulation, the method comprising:
(A) preparing a dispersed phase, comprising the steps of: (1) dissolving and/or suspending an API in a first solvent in a first vessel to form an API solution; (2) dissolving a biodegradable polymer in a second solvent in a second vessel different from the first vessel to form a polymer solution; (3) combining the API solution and the polymer solution by pumping both solutions into a Y connector; and (4) mixing the combined solution in a static mixer to form the dispersed phase;
(B) introducing the dispersed phase into a homogenization unit, wherein the time between the combining and the introducing consists of a predetermined contact time of less than 15 seconds, less than 30 seconds, or less than one minute; (C) pumping a continuous phase into the homogenization unit such that the dispersed phase and continuous phase are in contact with each other; and (D) homogenizing the combined dispersed phase and continuous phase (instant claim 16). Applicant further claims the API is ondansetron (instant claim 17), nimodipine (instant claim 19) and olanzapine (instant claim 20).
Determination of the scope
and content of the prior art (MPEP 2141.01)
KOSAKA teaches risperidone-containing microcapsules and methods for preparing the same, as discussed above and incorporated herein by reference.
RICHEY teaches a process for production of sustained release microspheres, as discussed above and incorporated herein by reference.
BRUNO teaches a process including pumping two solutions through a Y-connector into a static mixer, as discussed above and incorporated herein by reference.
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of KOSAKA et al. is that KOSAKA et al. does not expressly teach the API is olanzapine.
THANOO teaches method of making sustained release microparticles (title, see whole document) including “the steps of forming a dispersed phase of an active agent in a polymer and combining the dispersed phase with a continuous phase to form a microparticle dispersion.” (abstract). THANOO teaches that: “Further examples of active agents whose release rate can be optimized to improve clinical effectiveness include […] olanzapine, risperidone, […], or pharmaceutically acceptable salts thereof.” ([0024]).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
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 produce a method for the production of microspheres, as discussed above, and further to substitute or combine the olanzapine API with the microspheres of KOSAKA et al., as per the teachings of THANOO.
From the teachings of the references, it is apparent that 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 before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over KOSAKA in view of RICHEY and BRUNO as applied to claims 1-9, 16 and 18 above, and further in view of LYONS (US 2003/0003156 A1; published January, 2003) and Gungor et al. (“Ondansetron-loaded biodegradable microspheres as a nasal sustained delivery system: In vitro/in vivo studies,” 2010, Infoma healthcare, Pharmaceutical Development and Technology, Vol. 15, No. 3, pp. 258–265).
Applicants Claims
Applicant claims a method for preparing an active pharmaceutical ingredient ("API")-encapsulating polymer microsphere formulation, the method comprising:
(A) preparing a dispersed phase, comprising the steps of: (1) dissolving and/or suspending an API in a first solvent in a first vessel to form an API solution; (2) dissolving a biodegradable polymer in a second solvent in a second vessel different from the first vessel to form a polymer solution; (3) combining the API solution and the polymer solution by pumping both solutions into a Y connector; and (4) mixing the combined solution in a static mixer to form the dispersed phase;
(B) introducing the dispersed phase into a homogenization unit, wherein the time between the combining and the introducing consists of a predetermined contact time of less than 15 seconds, less than 30 seconds, or less than one minute; (C) pumping a continuous phase into the homogenization unit such that the dispersed phase and continuous phase are in contact with each other; and (D) homogenizing the combined dispersed phase and continuous phase (instant claim 16). Applicant further claims the API is ondansetron (instant claim 17), nimodipine (instant claim 19) and olanzapine (instant claim 20).
Determination of the scope
and content of the prior art (MPEP 2141.01)
KOSAKA teaches risperidone-containing microcapsules and methods for preparing the same, as discussed above and incorporated herein by reference.
RICHEY teaches a process for production of sustained release microspheres, as discussed above and incorporated herein by reference.
BRUNO teaches a process including pumping two solutions through a Y-connector into a static mixer, as discussed above and incorporated herein by reference.
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of KOSAKA et al. is that KOSAKA et al. does not expressly teach the API is ondansetron.
LYONS teaches methods of for the production of microparticles that exhibit a controlled release of an effective amount of an active agent over an extended period of time (title, abstract, see whole document). LYONS teaches that: “The most preferred polymer for use in the practice of the invention is the copolymer, poly(d,1lactide-co-glycolide).” ([0042]). And the active agent includes risperidone ([0035]) or other biologically active agents such as anti-hypertensive compounds and anti-emetics, among others ([0036]).
Gungor et al. teaches ondansetron-loaded biodegradable microspheres (title, see whole document), and particularly that: “Ondansetron (OND) is a selective 5-HT3 receptor antagonist that is used for preventing nausea and vomiting caused by chemotherapy, radiotherapy and postoperative vomiting. […] One way to assess sustained drug delivery is to prepare microparticles by using biodegradable polymers. OND-loaded microspheres applied via nasal route could be considered as an alternative approach to obtain prolonged drug delivery.” (p. 259, col. 1, 3rd paragraph). The examiner notes that an anti-emetic, as suggested by LYONS, is a drug that prevents nausea and vomiting of which ondansetron was a known species.
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
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 produce a method for the production of microspheres, as discussed above, and further to substitute or combine the ondansetron API with the microspheres of KOSAKA et al., as per the teachings of LYONS and Gungor et al.
From the teachings of the references, it is apparent that 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 before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
Claims 19 is rejected under 35 U.S.C. 103 as being unpatentable over KOSAKA in view of RICHEY and BRUNO as applied to claims 1-9, 16 and 18 above, and further in view of LYONS (US 2003/0003156 A1; published January, 2003) and Yang et al. (“The application of novel nano-thermal and imaging techniques for monitoring drug microstructure and distribution within PLGA microspheres,” 2017, ELSEVIER, International Journal of Pharmaceutics, Vol. 522, pp. 34–49).
Applicants Claims
Applicant claims a method for preparing an active pharmaceutical ingredient ("API")-encapsulating polymer microsphere formulation, the method comprising:
(A) preparing a dispersed phase, comprising the steps of: (1) dissolving and/or suspending an API in a first solvent in a first vessel to form an API solution; (2) dissolving a biodegradable polymer in a second solvent in a second vessel different from the first vessel to form a polymer solution; (3) combining the API solution and the polymer solution by pumping both solutions into a Y connector; and (4) mixing the combined solution in a static mixer to form the dispersed phase;
(B) introducing the dispersed phase into a homogenization unit, wherein the time between the combining and the introducing consists of a predetermined contact time of less than 15 seconds, less than 30 seconds, or less than one minute; (C) pumping a continuous phase into the homogenization unit such that the dispersed phase and continuous phase are in contact with each other; and (D) homogenizing the combined dispersed phase and continuous phase (instant claim 16). Applicant further claims the API is ondansetron (instant claim 17), nimodipine (instant claim 19) and olanzapine (instant claim 20).
Determination of the scope
and content of the prior art (MPEP 2141.01)
KOSAKA teaches risperidone-containing microcapsules and methods for preparing the same, as discussed above and incorporated herein by reference.
RICHEY teaches a process for production of sustained release microspheres, as discussed above and incorporated herein by reference.
BRUNO teaches a process including pumping two solutions through a Y-connector into a static mixer, as discussed above and incorporated herein by reference.
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of KOSAKA et al. is that KOSAKA et al. does not expressly teach the API is nimodipine.
LYONS teaches methods of for the production of microparticles that exhibit a controlled release of an effective amount of an active agent over an extended period of time (title, abstract, see whole document). LYONS teaches that: “The most preferred polymer for use in the practice of the invention is the copolymer, poly(d,1lactide-co-glycolide).” ([0042]). And the active agent includes risperidone ([0035]) or other biologically active agents such as anti-hypertensive compounds and anti-emetics, among others ([0036]).
Yang et al. teaches PLGA microspheres loaded with nimodipine, an anti-hypertensive drug (see whole document).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
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 produce a method for the production of microspheres, as discussed above, and further to substitute or combine the olanzapine API with the microspheres of KOSAKA et al., as per the teachings of LYONS and Yang et al.
From the teachings of the references, it is apparent that 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 before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
Conclusion
Claims 1-9 and 16-20 are pending and have been examined on the merits. The abstract of the disclosure is objected to, and Applicant is required to file a now abstract. Claims 1-6 are rejected under 35 U.S.C. 112(b); and claims 1-9 and 16-20 are rejected under 35 U.S.C. 103. No claims allowed at this time.
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/IVAN A GREENE/Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619