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 .
DETAILED ACTION
Final Rejection
NOTE TO APPLICANT:
The Examiner would like to request an Interview with Applicant to discuss technical features of the Instant Application, which may aid in the understanding of the technology.
Claim Status
Claims 1-20 were pending as of prior Office Action.
Upon amendment entry, no claims were amended or cancelled.
Claims 1-20 are pending examination.
Priority Status
PNG
media_image1.png
62
428
media_image1.png
Greyscale
Applicant has claimed NO foreign priority; effective filing date is 05/29/2020.
Examiner Responses to Arguments/Amendments
The issues raised in the Office Action mailed, are addressed below:
I. Response to Claim Interpretation–
Upon amendment entrance, Applicant stated: “a first concentration of the chlorthalidone in a first volume of the suspension differs from a second concentration in a second volume" as indicating "more than one type of liquid concentration within the composition." Applicant respectfully disagrees that this supports the addition of further components not materially affecting the essential characteristics of the composition.
Applicant submits that the disputed limitation pertains specifically to two different, arbitrarily selected sub-volumes within a larger volume of the suspension, where the larger volume itself maintains a specific overall concentration of chlorthalidone.”
In response to Applicant’s disagreement to the statement that the disputed limitation supports the addition of further components not materially affecting the essential characteristics of the composition. It is noted that the Claim 1 states “A chlorthalidone suspension for oral administration, comprising…”
According to MPEP 2111.03:
The transitional phrases "comprising", "consisting essentially of" and "consisting of" define the scope of a claim with respect to what unrecited additional components or steps, if any, are excluded from the scope of the claim. The determination of what is or is not excluded by a transitional phrase must be made on a case-by-case basis in light of the facts of each case.
I. COMPRISING
The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) ("[L]ike the term ‘comprising,’ the terms ‘containing’ and ‘mixture’ are open-ended."). Invitrogen Corp. v. Biocrest Manufacturing, L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003) ("The transition ‘comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.");
The transitional language “comprising” used within the claim is an open-ended term of what is or is not excluded within the claim. In light of this fact, clarification is needed as to the concentration of what liquid (Second volume of a less concentrated chlorthalidone? Second volume of a less concentrated excipient?). As this second concentration is a necessary limitation for the second volume in the suspension, clarification is requested, and/or a more defined naming of basic components of the suspension. As such, the Examiner maintains the claim interpretation as valid. Under BRI, and according to the Applicant’s election, the claim language reads to the understanding there are two dissimilar liquids within the suspension.
2. Applicant further states: “The limitation explicitly defines a quantitative low settling rate, which is a functional property tied to the structural elements of the suspension (e.g., specific viscosity, particle size). Under BRI consistent with the specification, this limitation requires a suspension that achieves the recited uniformity and stability, which the prior art does not teach, suggest, or provide reasoning for. Additionally, the Examiner interprets the claims as silent on the amount of undissolved chlorthalidone particles. However, the claims expressly recite "undissolved micronized particles consisting essentially of chlorthalidone" at a concentration of 1 to 20 mg/mL (claim 1) or 5 to 105.”
With respect to Applicant’s argument above that: the functional property is tied to the structural elements of the suspension, chlorthalidone as a thiazide-like diuretic is taught in the prior art and that diuretic is capable of treating high blood pressure (hypertension) and reducing edema (fluid retention) associated with heart, kidney, or liver disease, so this argument has been considered and is not found to be persuasive.
Further Examiner stated in regards to the "undissolved micronized particles consisting essentially of chlorthalidone," the amount of undissolved chlorthalidone particles is silent in the art but is understood as present in the art and addressed. The argument that undissolved solutes affect chlorthalidone suspension stability has been considered and found unpersuasive.
II. Claim Rejections 35 U.S.C. § 103 –
Claims 1-20 obvious over US 2009/0004262 Al (Shaw, hereinafter "App’262") in view of US 2007/0287690 Al (Solomon, hereinafter "App’690") and further in view of L. Newey-Keane in "Controlling the Stability of Medicinal Suspensions" (hereinafter "Newey").
Applicant' s arguments, filed 02/18/2026, with respect to the claims have been fully considered but they are not persuasive for the following reason(s):
Applicant argues in several sections the following: “The combination of references fails to teach or suggest all elements of the claims, lacks a proper motivation to combine, and relies on impermissible hindsight.
The Examiner disagrees. In response to the Applicant’s arguments have been considered and were not found to be persuasive.
Application '262 Does Not Teach or Suggest Key Elements of the Claims
App’262 is directed to nanoparticulate formulations of poorly soluble drugs, primarily for solid dosage forms, that maintain size stability in gastric and intestinal fluids and enhance bioavailability.
First, App’262 does teach the following “The pH of the aqueous dispersion media can be
adjusted by techniques known in the art. In this embodiment, the drug particles comprise a discrete phase having been admixed with a dispersing agent or wetting agent (para. [0106]).” With this suggestion, it is understood that these agents aid in changing the pH of the solution. As such, since chlorthalidone is poorly soluble in water, with a reported aqueous solubility this indicates that low solubility and low permeability, which limits its oral absorption and effectiveness.
This in combination, as seen in para. [0297]-[0298], does extend to making liquid formulations that include oral suspensions. Additionally, it is further elaborated that oral compositions need to maintain stability in gastric and intestinal fluids. Since the Applicant has noted that the Instant claims are geared towards an oral suspension, the art is good for the oral suspensions, “that at least some of the drug is released after entering the small intestine, rather than the acidic environment of the stomach.”
pH 5-7:
In response to Applicant statement, there is no phosphate buffer taught and that what is taught is the preparation of simulated intestinal fluid. As stated earlier, oral formulations which are enterically coated (which include suspensions). In para. [0269]-[0271], one of the reasons for the coating needed for oral administration is “intended to mean that some or most of the drug has been enterically coated to ensure that at least some of the drug is released after entering the small intestine, rather than the acidic environment of the stomach.” pH is a result-effective variable because adjusting it directly controls the outcome of chemical reactions and biological processes, such as solubility, stability, and enzymatic activity. It serves as a key, actionable parameter in scientific experimentation and industrial formulations (e.g., controlling acidity for product stability). If the prior art suggests that changing a specific parameter could produce beneficial or predictable results, it creates a motivation for a skilled practitioner to experiment with that parameter.
Viscosity (para. [0105]), particle size (Ex. 2A & 2B, paras. [0359]-[0360]), dispersion (Ex. 3A & 3B, paras. [0359]-[0360]),
In response to the above characteristics, Examiner maintains these physical characteristics are determined by several physical properties of the particles and the fluid, such as:
a) Particle Size and Shape: Smaller, more irregular particles have lower settling rates.
b) Particle Density: Particles with a lower density, especially those close to the fluid's density, settle more slowly.
c) Fluid Viscosity and Density: A more viscous fluid increases drag and reduces the settling rate.
d) Fluid Turbulence: High turbulence keep particles suspended longer, effectively lowering the settling rate.
e) Concentration: With high particle concentrations, the particles interfere with each other's movement, and the overall settling rate is lower than for individual particles in a dilute suspension.
Therefore, Examiner maintains points a-e above, are result-effective variables since it is connected to an increase in the overall concentration of distributed particles or the concentration of specific excipients (such as suspending agents), which leads to a higher viscosity of the dispersion medium. If the prior art suggests that changing a specific parameter could produce beneficial or predictable results, it creates a motivation for a skilled practitioner to experiment with that parameter.
Lastly, the combination of App’262 & App’690 are analogous art and though KSR - Prong A, “Combining prior art elements according to known methods to yield predictable results.” App’262 & App’690 discloses nanoparticulate formulations of drugs having an aqueous solubility which provide enhanced stability and pharmacokinetic properties. App’690 further discloses possible side effects of a thiazide diuretic (specifically chlorthalidone; para [0005]) and those properties are seen in the basic description of the molecule in a suspension in para. [0058] “Chlorothiazide… as an injection: 500 mg base/vial suspension or oral: 250 mg/5 ml.”
This statement indicates a suspension comprising: water containing a dissolved buffer, a dissolved solubilizing and/or wetting agent, and at least one dissolved suspending agent is in public use, on sale, or otherwise available to the public before the effective filing date of the Instant Application.
Applicant arguments against the references individually, cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. Therefore, App’262 & App’690 addresses the scope of the claims and reads on “a chlorthalidone suspension for oral administration, comprising: water containing a dissolved buffer, a dissolved solubilizing and/or wetting agent, and at least one dissolved suspending agent.” Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The features upon which Applicant relies is encompassed in Claim 1, a chlorthalidone suspension for oral administration, comprising: water containing a dissolved buffer, a dissolved solubilizing and/or wetting agent, and at least one dissolved suspending agent. In that context, the Applicant has not provided sufficient data as to indicate this is unexpected or surprising result in comparison as to what is known in the field. As such, the functional language is met for the claims. Both App’262 and App’690 teach the parameters stated within the independent claims.
Thus, for this reason as well, the argument/amendment is not persuasive.
III. Maintained Rejections –
Claim Interpretation
It is noted that the Claim 1 states “A chlorthalidone suspension for oral administration, comprising…”
According to MPEP 2111.03:
The transitional phrases "comprising", "consisting essentially of" and "consisting of" define the scope of a claim with respect to what unrecited additional components or steps, if any, are excluded from the scope of the claim. The determination of what is or is not excluded by a transitional phrase must be made on a case-by-case basis in light of the facts of each case.
I. COMPRISING
The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) ("[L]ike the term ‘comprising,’ the terms ‘containing’ and ‘mixture’ are open-ended."). Invitrogen Corp. v. Biocrest Manufacturing, L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003) ("The transition ‘comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.");
The transitional language “comprising” used within the claim is an open-ended term of what is or is not excluded within the claim. In light of this fact, clarification is needed as to the concentration of what liquid (Second volume of a less concentrated chlorthalidone? Second volume of a less concentrated excipient?). As this second concentration is a necessary limitation for the second volume in the suspension, clarification is requested, and/or a more defined naming of basic components of the suspension. As such, the Examiner maintains the claim interpretation as valid. Under BRI, and according to the Applicant’s election, the claim language reads to the understanding there are two dissimilar liquids within the suspension.
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.
Graham vs. Deere, Test for Obviousness
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.
Joint Inventors
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0004262 Al (hereinafter “App’262”) in view of US 2007/0287690 Al (hereinafter “App’690”) and as evidenced by and/or in view of L. Newey-Keane in “Controlling the Stability of Medicinal Suspensions” (Blog; hereinafter “Newey”).
With respect to Claim 1, 15 and 20, App’262 teaches detailed suspensions of drug-specific liquid nanoparticulate (para. [0163]; chlorthalidone) compositions comprising:
water containing a dissolved buffer, a dissolved solubilizing and/or wetting agent (para. [0070], solubilizers - glycerin), and at least one dissolved suspending agent (para. [0207], suspending agents for use xanthan gum);
wherein the buffer maintains a pH of the suspension between 5 and 7; wherein the dissolved solubilizing and/or wetting agent (para. [0070], solubilizers - glycerin) and/or the dissolved suspending agent are present in an amount to impart a viscosity of between 100-230 cps to the suspension and undissolved micronized particles consisting essentially of chlorthalidone having a particle size distribution d(0.9) of less than 90 µm (para. [0054]);
wherein the chlorthalidone is present in the suspension at a concentration of between 1 to 20 mg/mL (para. [0041]) and maintains, upon mixing to uniformity, a uniform dispersion in the suspension for at least 30 minutes and a low settling rate such that a first concentration of the chlorthalidone in a first volume of the suspension differs from a second concentration in a second volume of the suspension by 1% or less.
Examiner maintains (below in points a-e), that the variables mentioned (concentration, viscosity, low settling rate, etc) are result-effective variables since it is connected to an increase in the overall concentration of distributed particles or the concentration of specific excipients (such as suspending agents), which leads to a higher viscosity of the dispersion medium. pH is a result-effective variable because adjusting it directly controls the outcome of chemical reactions and biological processes, such as solubility, stability, and enzymatic activity. It serves as a key, actionable parameter in scientific experimentation and industrial formulations (e.g., controlling acidity for product stability). If the prior art suggests that changing a specific parameter could produce beneficial or predictable results, it creates a motivation for a skilled practitioner to experiment with that parameter.
In para. [0303], App’262 discloses “Dispersing/suspending agents and/or viscosity modulating agents include materials that control the diffusion and homogeneity of a drug through liquid media or a granulation method or blend method…Viscosity enhancing agents are agents which are typically added to a particulate dispersion to increase the viscosity and prevent or slow settling of the particles. Viscosity enhancing agents in solid dosage forms are used on occasion to form a gel matrix as water permeates the solid dosage form and can delay the release of the pharmaceutically active ingredient(s).”
In using Broadest Reasonable Interpretation, it is recognized the suspension’s “low settling rate” is a physical characteristic. This physical characteristic is known as settling velocity. This feature describes how quickly a particle moves through a fluid under the influence of gravity or other forces. As evidenced by Newey (pg. 1, para. 2), “settling behavior of a suspension is a function of the size of its suspended particles, the forces of attraction/repulsion between them, and the viscosity of the continuous liquid phase.…strategies for inducing stability in a pharmaceutical suspension, or alternatively, rapid redispersion in the event of settling, and explain how measurements of particle size, zeta potential and rheology support the associated formulation process.”
The settling rate is determined by several physical properties of the particles and the fluid, such as:
Particle Size and Shape: Smaller, more irregular particles have lower settling rates.
Particle Density: Particles with a lower density, especially those close to the fluid's density, settle more slowly.
Fluid Viscosity and Density: A more viscous fluid increases drag and reduces the settling rate.
Fluid Turbulence: High turbulence keep particles suspended longer, effectively lowering the settling rate.
Concentration: With high particle concentrations, the particles interfere with each other's movement, and the overall settling rate is lower than for individual particles in a dilute suspension. This is also known as hindered settling.
Therefore, a "low settling rate" is a considered an result-effective variable since it is a non-technical term for a slow rate of settling and is connected to an increase in the overall concentration. The concentration of distributed particles or the concentration of specific excipients, such as suspending agents, leads to a higher viscosity of the dispersion medium (i.e. hindered settling). One can use routine optimization to arrive at different concentrations of concentration of distributed particles through motivation and suggestion from the prior art. It would be obvious because such variables are routine optimization to the skilled chemist.
In the paras. [0352]-[0421], App’262 discloses embodiments, as well Examples 1-22, which detail nanoparticulate formulations of chlorthalidone including methods for treating, methods for formulating, and manufacturing, and pharmacokinetic strategies using nanoparticulates. In specific, within Examples 1-3A (paras. [0352]-[0361]), the drug compositions have formulated to desired specifications which contain the microencapsulation material, complexing agents, pH modifiers, anti-foaming agents, antioxidants, flavoring agents, and carrier materials such as binders, suspending agents, disintegration agents, filling agents, surfactants, solubilizers, stabilizers, lubricants, wetting agents, and diluents. In Examples 4-8 (paras. [0364]-[0372]), the suspension is complexed with varied nanoparticle suspensions.
With respect to Claim 15: App’262 discloses suspension, comprising: water containing a dissolved antimicrobial agent (abstract; methods and compositions for administering a thiazide diuretic, such as chlorthalidone), a dissolved phosphate buffer, dissolved glycerin (para. [0070], solubilizers - glycerin), and a dissolved xanthan gum (paras. [0207], [0306]); wherein the glycerin and the xanthan gum impart a viscosity of between 100-230cps to the suspension, and wherein the suspension has a pH of between 5 and 7 (para. [0352]; Example 1: Mono basic potassium phosphate (6.8 g) and sodium hydroxide (0.616 g) are added into 250 ml of distilled water in a 1000 ml volumetric flask and swirled until dissolved. 700 ml distilled water is added and the pH checked. The pH is adjusted to pH 6.8+/-0.1 by adding either 0.2N sodium hydroxide or 0.2N hydrochloric acid and the volume is brought to 1000 ml); undissolved milled or un-milled chlorthalidone particles having a particle size distribution d(0.9) of less than 90 µM, wherein the chlorthalidone is present in the suspension at a concentration of 5 mg/mL or 10 mg/mL (paras. [0174]-[0177]; para. [0354]-[0355])); and wherein the suspension maintains, upon mixing to uniformity, a uniform dispersion of the milled or un-milled micronized particles consisting essentially of chlorthalidone in the suspension for at least 30 minutes (para. [0207]) and undissolved chlorthalidone particles having a particle size distribution d(0.9) of less than 90 µM (paras. [0174]-[0177]; para. [0354]-[0355]).
App’262 fails to teach an embodiment of the chlorthalidone, with respect to Claim 1 and 20, in a suspension.
However, App’690 discloses a chlorthalidone suspension (’690: abstract; methods and compositions directed to administering a thiazide diuretic, such as chlorthalidone; under BRI this indicates that the API of choice is chlorthalidone) for oral administration (para. [0061]).
It would therefore be obvious to combine the teachings of App’262 with those of App’690 because using the formulations of App’262 lead to improved product specifically with the nanoparticulate formulations of chlorthalidone for easier administration. One skilled in the art would expect success because the chlorthalidone suspension is capable of functioning at the level needed to treat a patient in need thereof. Also, applying KSR prong B to substitute one drug-specific nanoparticulate formulations of chlorthalidone will act through the same mechanism of action.
With respect to Claim 2: App’262 teaches wherein the buffer comprises a phosphate buffer, and/or wherein the pH of the suspension is between 5 and 6 (according to para. [0271]: For example, suitable grades of hydroxypropylmethylcellulose acetate succinate include, but are not limited to, AS-LG (LF), which dissolves at pH 5, AS-MG (MF), which dissolves at pH 5.5, and AS-HG (HF), which dissolves at higher pH. These polymers are offered as granules, or as fine powders for aqueous dispersions; PolyVinyl Acetate Phthalate (PVAP). PVAP dissolves in pH>5 and it is much less permeable to water vapor and gastric fluids).
With respect to the following Claims 3-7 and 16, App’262 teaches the following:
Claim 3: App’262 teaches wherein the dissolved solubilizing and/or wetting agent is selected from the group consisting of glycerin (paras. [0070], [0194]).
Claim 4: App’262 teaches wherein the suspending agent is a polysaccharide suspending agent and/or a synthetic suspending agent (paras. [0207], [0306]; xanthan gum).
Claim 5: App’262 teaches wherein the suspending agent is a xanthan gum (paras. [0207], [0306]).
Claim 6: App’262 teaches wherein the suspending agent is a xanthan gum (paras. [0207], [0306]).
Claims 7 and 16: App’262 teaches further comprising a sweetener, an anti-foam agent, and/or a flavoring agent (para. [0193]).
With respect to the following Claims 8-14 and 17-18, App’262 teaches the following:
Claim 8, 10-11: App’262 teaches wherein the viscosity of the suspension is between 130- 190 cps (under BRI this reads as preference towards optimization because one in the art can choose parameters; “The apparent viscosity of the premix suspension is preferably less than about 1000 centipoise. The premix then can be transferred to the microfluidizer and circulated continuously first at low pressures, then at maximum capacity having a fluid pressure of from about 3,000 to 30,000 psi until the desired particle size reduction is achieved. The particles must be reduced in size at a temperature which does not significantly degrade the drug substance or cause significant particle size growth through solubilization).
App’262 continues in para. [0008], “In preparing drug nanoparticles via a wet ball milling process as described in the '684 patent, milling suspensions with drug concentrations of 5-30% are typically milled with a hard grinding media in a ball mill to obtain particles with a D50 in the 100-500 nm size range.”
Claim 9: App’262 teaches wherein the chlorthalidone particles are milled chlorthalidone particles (under BRI this reads as preference towards optimization because one in the art can choose parameters; “in preparing drug nanoparticles via a wet ball milling process as described in the '684 patent, milling suspensions with drug concentrations of 5-30% are typically milled with a hard grinding media in a ball mill to obtain particles with a D50 in the 100-500 nm size range. The literature teaches that particle size reduction using milling is conducted at a sufficient speed and time to obtain a desired particle size. The surface stabilizers are present or added to keep the particle size constant over a variety of stability indicating measurements as compared to the particle size (D50) obtained at the end of milling).
Claim 12 and 13: App’262 teaches wherein no less than 75% of all chlorthalidone particles dissolve within 60 minutes upon mixing with purified water (para. [0004], [0218]: “When this preferred "enteric-coated swelling plug device" is ingested orally, the enteric coat prevents release drug in the stomach. The enteric coat dissolves quickly, e.g., within about 15 minutes, in the duodenum”; this implies that with immediate disintegration that the rate at which it would dissolve 75% would indicate optimization was needed to find this percentage).
Claim 14, 17-18: App’262 teaches 1.2 wt. % total chlorthalidone degradation products of a total quantity of chlorthalidone in the suspension, (para. [0201]: In some embodiments of the invention, the solid dosage drug formulation has greater than about 1 w % of a disintegrant. In some embodiments, combinations of disintegrants provide superior dispersion characteristics compared to single disintegrant at a similar total weight percentage).
It would therefore be obvious to combine App’690 and App’262 because of the evidence that in providing a combination of a chlorthalidone suspension, would provide a beneficial effect of treatment, embodiments directed to liquid dosage forms, can include at least one excipient selected simethicone, sucralose and flavoring. Also the drug formulations described can be for immediate release, or can be further formulated to provide a modified or controlled release of drug. Compositions containing drug complexes may provide a more desirable pharmacokinetic performance (e.g., improved bioavailability, reduction in variability, etc.). One skilled in the art could have combined the elements by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 139.
Finally, concentration, viscosity of the suspension, and percentage of degraded product, are considered a result effective variable in this case because changes in concentration impact solubility. For example, the additional limitation of a "low settling rate" is a predictable result since it is a general, non-technical term for a slow rate of settling and is often connected to an increase in the overall concentration of distributed particles or the concentration of specific excipients, such as suspending agents, which leads to a higher viscosity of the dispersion medium (i.e. hindered settling). Thus, it would have been obvious to optimize a result-effective variable because it is routine optimization to a skilled artisan. See MPEP 2144.05 (incorporated by reference herein).
With respect to Claim 19, App’262 teaches wherein the chlorthalidone particles are milled particles and have a particle size distribution d(0.9) of less than 40 µM (paras. [0174]-[0177]; para. [0354]-[0355]). App’262 teaches in para. [0016], “the drug complexed particles exhibiting an increase in volume weighted median diameter (D50) of from 0% to not more than about 200% when the formulation is dispersed in simulated gastric fluid (SGF) or simulated intestinal fluid (SIF) at a concentration of 0.5 to 1 mg drug/mL and placed in a heated bath at 36° to 38° C. for 1 hour using a Type I or II dissolution apparatus and a stirring rate of 75 RPM, as compared to the D50 of the drug particles when the formulation is dispersed in distilled water under the same conditions” and in para. [0009], “The physiological media for dispersion stability is dependent on the route of administration (simulated gastric and/or intestinal fluid for oral products, saliva for buccal and sub-lingual products, etc). In general any parameter important to the performance or tolerability of a formulation must be monitored for stability.”
With respect to claim 20, based on the combination (see arguments above) If the structure of the suspension is met, it means that the suspension possesses the physical or chemical arrangement as described in the claim. As such, since the claim describes the suspension in purely structural terms, then meeting that structure inherently means that the suspension will possess the properties associated with that structure. Therefore the properties of the suspension are met if the structure of the suspension is met.
Conclusions
Claims 1-20 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Josmalen M. Ramos-Lewis whose telephone number is (571)272-0084. The examiner can normally be reached M-F 9:30-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A. Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Josmalen M. Ramos-Lewis, Ph.D.
Patent Examiner
Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621