DETAILED ACTION
Claims 1, 7, 9-11 are currently pending. Claims 1, 7 and 9-10 are currently under examination.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/31/2025 has been entered.
Examiner’s Note
Applicant's amendments and arguments filed 12/31/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 12/31/2025, it is noted that claim 1 has been amended and no new matter or claims have been added.
New Rejections:
The following rejections are newly applied based on Applicant’s claim amendments.
Claim Rejections - 35 USC § 112
Claims 1, 7 and 9-10 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 mixture" in the 14th line. There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites “heating the mixture”, wherein it is unclear which mixture it is referring back to, the mixture of smectite suspension including the polymeric suspending agent, low molecular weight suspending agent and smectite, or the mixed suspending agent containing the polymeric suspending agent and low molecular weight suspending agent.
Claim 1 additionally the combination of the use of dashes and the antecedent basis issue addressed above it is unclear if the heating and mixing time is in regards to the polymer suspending agent and low molecular suspending agent combination only or if the heating and mixing time is relating to the step of mixing the mixed suspending agent with the smectite dispersion.
Dependent claims 7 and 9-10 are rejected as being dependent on a rejected claim without clarifying the ambiguity of claim 1.
Modified Rejections:
The following rejections are modified based on Applicant’s claim amendment.
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.
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 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2002/0146455 (previously applied) in view of EP 2 386 289 (previously applied), US 4,942,042 (previously applied) and US 2013/0101645 (previously applied).
Regarding claim 1, the limitation of a suspension comprising a polymeric suspending agent and a low molecular suspending agent, wherein said polymer suspending agent is one or more selected form the group including xanthan gum in an amount from 0.05-0.45 w/v%, said low molecular suspending agent is glycerin and/or sorbitol and an amount of said low molecular suspending agent range from 8.5 to 14 w/v% with respect to the total amount of smectite suspension with a viscosity of the suspension ranges from 10 to 130 mPas is met by the ‘455 publication teaching an aqueous pharmaceutical composition suitable for oral delivery has insoluble active substance. The formulation has an excellent shelf life in which caking and sedimentation are inhibited (abstract). The ‘455 publication teaches suitable active agents include mineral supplements and gastrointestinal agents and antidiarrheal preparations [0018]. The active is present from 0.1 to 25% by weight (w/v) [0020]. Suspending agents are taught to include PEG or glycerol [0028] present at 5 to 50% [0029]. The second suspending agent is taught to include xanthan gum at 0.05 to 0.5 % [0031]. Sweetener is taught to include vanilla and strawberry at 0.005 to 20% [0034]. Preservatives are taught to include sodium benzoate at 0.01 to 1% [0035]. Buffers are taught to include citric acid and sodium citrate in an amount of 0.01 to about 0.5% [0036]. Example 1 includes
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. Assuming the composition is 100 ml with the solution being predominantly water the wt % would approximate the wt/vol%, thus the teachings of glycerol and xanthan gum overlap with claimed concentration ranges for the total polymer and low molecular weight suspending agent range and the low molecular weight suspending agent ranges. Additionally, it would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the amount of glycerol and xanthan gum in the compositions as both are taught to be suspending agents, making it obvious to optimize the concentration present to obtain the desired suspension of the active agent in the composition. As MPEP 2144.05 recites “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 optimization”.
Regarding the viscosity range, the ‘455 publication teaches the viscosity range of the suspension to be 75-300 cp (Table 7) which is equivalent to 75-300 mPas, thus overlapping with the claimed concentration range.
Regarding the limitation of wherein the smectite suspension does not cause layer separation is met by the ‘455 publication teaching the formulation has excellent shelf-life in which caking and sedimentation are inhibited (abstract).
Regarding the limitation of wherein the polymeric suspending agent is xanthan gum and the low molecular suspending agent is glycerin is met by the ‘455 publication teaching suspending agents are taught to include PEG or glycerol [0028] present at 5 to 50% [0029]. The second suspending agent is taught to include xanthan gum at 0.05 to 0.5 % [0031].
Regarding the limitation of “wherein the suspension is prepared by mixing a mixed suspending agent obtained by combining a polymer suspending agent and a low molecule suspending agent and heating the mixture at 90 degrees C to 95 degrees C for 25 minutes to 45 minutes with an aqueous smectite suspension is met by the ‘455 publication teaching two pot methods wherein the water-soluble polymer is melted, a hydrocolloid material, e.g. xanthan gum is added and mixed until thoroughly disposed in the melted polymer. Water is then added and mixed for an hour to ensure complete hydration of the hydrocolloid. The mixture is then cooled to about 25-30 degrees with mixing. A second vessel includes polymer, water at 70-75 degrees is mixed, active is added and mixed under high shear before combing phase I and II and mixing ([0039]-[0041]). A single pot method teaches mixing water, hydrocolloid (xanthan gum) and polymer at 60-70 degrees C [0041]. Thus the ‘455 publication teaches the steps of mixing for an extended period of time at elevated temperature of the polymeric suspending agents and low molecular weight suspending agent before addition of an aqueous active ingredient. MPEP 2113 - “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus the ‘455 publication teaches the steps of mixing for an extended period of time at elevated temperature of the polymeric suspending agents and low molecular weight suspending agent before addition of an aqueous active ingredient, wherein the suspension composition is taught as the final product, thus meeting the instant claim limitations absent factual evidence to the contrary.
Regarding claim 7, the limitation of wherein the suspension further comprises one or more ingredient selected from the group consisting of a sweetener, a preservative, a flavor, a pH adjusting agent and a colorant is met by the ‘455 publication teaching sweetener is taught to include vanilla and strawberry at 0.005 to 20% [0034]. Preservatives are taught to include sodium benzoate at 0.01 to 1% [0035]. Buffers are taught to include citric acid and sodium citrate in an amount of 0.01 to about 0.5% [0036].
Regarding claim 9, the limitation of said polymeric suspending agent is xanthan gum and in an amount that ranges from 0.1 to 0.4 w/v% and said low molecular suspending agent is glycerin ranging from 8.5 to 14 w/v% is met by the ‘455 publication teaching suspending agents are taught to include PEG or glycerol [0028] present at 5 to 50% [0029]. The second suspending agent is taught to include xanthan gum at 0.05 to 0.5 % [0031].
Regarding claim 10, the limitation of further comprising sucrose from 5 to 9 w/v%, sodium benzoate from 0.05 to 0.09 w/v, citric acid from 0.09 to 0.35 and sodium citrate from 0.055 to 0.095 w/v% is met by the ‘042 patent teaching Sweetener is taught to include vanilla and strawberry at 0.005 to 20% [0034]. Preservatives are taught to include sodium benzoate at 0.01 to 1% [0035]. Buffers are taught to include citric acid and sodium citrate in an amount of 0.01 to about 0.5% [0036]. Example 1 includes
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The ‘455 publication does not specifically teach smectite suspension wherein an amount of said smectite ranges 8-15 w/v% with respect to a total amount of the smectite suspension (claim 1) or 8-12 w/v% (claim 9).
The ‘455 publication does not specifically teach a sinking rate of the smectite suspension is 0.9 or higher (claim 1).
The ‘289 publication teaching an aqueous pharmaceutical suspension comprising natural mineral clays (abstract) wherein natural mineral clays may be chosen from the group including smectite [0002] wherein the specific smectites is taught to be dioctaedral species such as montmorillonite [0017]. The composition includes water and at least one viscosity agent [0007] wherein the viscosity agent is selected from the group including sugar xanthan gum [0009]. The ‘289 publication additionally teaches the composition including preservatives that are selected from the group including the elected glycerol [0022]. The ‘289 publication teaches a composition to treat acute and chronic diarrhea (abstract) which is administered orally [0005].
The ‘042 patent teaches an anti-diarrhea composition comprising smectite which is mixed with water, wherein smectite is in powder form (abstract), thus reading on particles. The composition includes suspending agents including xanthan gum and polyol such as glycerin (column 2, lines 1-15).
The ‘645 publication is directed to compositions for preventing mucositis by administering a clay to a subject in need (abstract). Mucositis is characterized by discomfort of mucosal linings such as the GI tract and can be a result of diarrhea [0003]. A clay composition is taught to include dioctahedral smectite in water in an amount of 10% w/v clay in water [0118]. The smectite may be specifically calcium montmorillonite clay particles which are non-swelling [0020].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use smectite in the composition taught by the ‘455 publication because the ‘455 publication teaches an oral drug delivery composition in the form of a suspension (abstract) which contains antidiarrheal pharmaceutical additives [0018] and the ‘289 publication is directed to an oral composition of the treatment of diarrhea which includes natural mineral clays such as smectite including specifically montmorillonite. Thus it would be obvious to one of ordinary skill in the art before the filing date of the claimed invention to use a specifically taught antidiarrhea agent in the composition taught by the ‘455 publication. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘289 publication and the ‘042 patent are directed to anti-diarrhea compositions which include smectite mixed with water and include xanthan gum and glycerin and the ‘455 publication is directed to an aqueous composition containing an antidiarrhea agents, xanthan gum and glycerol as suspending agents. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the concentration taught by the ‘645 publication in the composition taught by the ‘289 publication because the ‘645 publication and the ‘289 publication are both directed to smectite clay composition in water. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘289 publication and the ‘645 publication are both directed to the use of smectite in a water composition used to treat diarrhea. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘289 publication teaches a range of the smectite in the composition thus teaching an optimizable parameter.
Regarding the sinking rate of the smectite suspension is 0.9 or higher, the instant specification teaches the sinking rate is reliant on the amount of polymeric suspending agent and low molecular weight suspending agent ([0022], [0024], [0027]). As discussed above the ‘455 publication teaches the claimed amounts of the polymeric suspending agent and low molecular weight suspending agent. As the claimed concentrations of the ingredients are present, the composition of smectite in the compositions of the ‘455 publication would be expected to have the same sinking rate, absent factual evidence to the contrary.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
Applicant argues the ‘455 publication fails to address the specific formulation challenge presented by montmorillonite, an inorganic smectite exhibiting strong hydration and swelling properties upon contact with water. It is difficult to secure long-term suspension stability by simple dispersion methods. To objectively demonstrate the differences and isolate the effects of both active ingredient properties and process sequence Applicant conducted comparative experiments in which the preparation method and the active ingredient were cross-applied under identical excipient composition conditions. Specifically, suspensions were prepared using (A) preparation method of the present invention and (B) the preparation method of the ‘455 publication (single pot process).
In response, objective evidence must be factually supported by an appropriate affidavit or declaration (MPEP 716.01 (c)). “The reason for requiring evidence in declaration or affidavit form is to obtain the assurances that any statements or representations made are correct, as provided by 35 U.S.C. 25 and 18 U.S.C. 1001.” (MPEP 716.02(g)). In the instant case data is provided in a response and states “as described by the declarant” however no declaration is provided.
Applicant argues the present invention includes pre-swelling and fully hydrating a polymeric suspending agent in purified water, followed by mixing with a low molecular weight suspending agent and applying heat treatment under high temperature conditions to form a stable suspension matrix. Thereafter the active ingredient is added to the preformed mixed suspending agent followed by maintaining stirring at approximately 90 degrees for 45 minutes. This is not a mere mixing step, but a process step in which the active ingredient I integrated into an already formed suspension matrix. The mixing of montmorillonite addition in the form of an aqueous dispersion under high temperature stirring maintains the plate-like particles in a hydrated state and enable rearrangement and settling within the polymeric suspension network, a process distinguishable from the art single pot approach.
In response, the presented results are not commensurate in scope with the instant claims. See 112 (b) rejection above, newly applied, wherein amended claim 1 is directed to the polymeric suspending agent and low molecular suspending agent being combined, heated at 90 to 95 degrees for 25-45 minutes. Thus, the instant claim is directed to combining and heat, not requiring mixing and additionally the step of heating for a specific time is not at the time of aqueous smectite dispersion mixing, as Applicant states is required for the unexpected results. Therefore, the necessary step to obtain the results is not present in the instant claims. Additionally, the smectite dispersion is taught in water (aqueous) however is not required to be pre-swelled and fully hydrated as is stated in the provided data. Therefore, even if the results were presented in a declaration, they are not commensurate in scope with the instant claims. It is further noted the ‘455 publication teaches a two pot method as discussed in the modified rejection above. Regarding the limitation of “wherein the suspension is prepared by mixing a mixed suspending agent obtained by combining a polymer suspending agent and a low molecule suspending agent and heating the mixture at 90 degrees C to 95 degrees C for 25 minutes to 45 minutes with an aqueous smectite suspension is met by the ‘455 publication teaching two pot methods wherein the water-soluble polymer is melted, a hydrocolloid material, e.g. xanthan gum is added and mixed until thoroughly disposed in the melted polymer. Water is then added and mixed for an hour to ensure complete hydration of the hydrocolloid. The mixture is then cooled to about 25-30 degrees with mixing. A second vessel includes polymer, water at 70-75 degrees is mixed, active is added and mixed under high shear before combing phase I and II and mixing ([0039]-[0041]). A single pot method teaches mixing water, hydrocolloid (xanthan gum) and polymer at 60-70 degrees C [0041]. Thus the ‘455 publication teaches the steps of mixing for an extended period of time at elevated temperature of the polymeric suspending agents and low molecular weight suspending agent before addition of an aqueous active ingredient. MPEP 2113 - “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus the ‘455 publication teaches the steps of mixing for an extended period of time at elevated temperature of the polymeric suspending agents and low molecular weight suspending agent before addition of an aqueous active ingredient, wherein the suspension composition is taught as the final product, thus meeting the instant claim limitations absent factual evidence to the contrary.
Conclusion
No claims are allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613