DETAILED ACTION
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 .
Response to Amendment
The Amendment filed 22 July 2024 has been entered. Claims 1-93 are cancelled. Accordingly, claims 94-110 remain pending in the application.
Information Disclosure Statement
The Information Disclosure Statement filed 20 September 2024 has been considered.
Drawings
The drawings are objected to because Figures 4, 5, and 9 contain ineligible text. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Reference number 411 in Figure 4. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because "provided herein are apparatus and methods" should read "provided herein are an apparatus and methods". A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 94-110 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.
The term “about” in claims 94, 97, 99, 103-104, and 106-110 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The quantity associated with the percentage of purity, temperatures, concentrations, pH values, and masses of claims 94, 97, 99, 103-104, and 106-110 is therefore rendered indefinite by the use of the term "about".
Claim 98, line 1, recites “the filter is a 0.2 micro cartridge filter”. It is unclear if the filter of claim 98 is the filter of claim 94, line 5, and/or the filter of claim 94, line 14. This limitation is interpreted as requiring the filter of claim 94, line 5 is a 0.2 micro cartridge filter.
Claims 100-104 recites the limitation "the purified sodium chlorite" in line 1. There is insufficient antecedent basis for this limitation in the claim. This limitation is interpreted as requiring the crystalline sodium chlorite.
Claim 105 recites the limitation "the " in line-2. There is insufficient antecedent basis for this limitation in the claim. This limitation is interpreted as being dependent on claim 104.
Claim 110, lines 1-2, recite, “the solid phase comprises crystalline sodium chlorite in an amount of at least about 1 kg of purified sodium chlorite”. It is unclear what “purified sodium chlorite” requires. This limitation is interpreted as requiring the solid phase comprises crystalline sodium chlorite in an amount of at least about 1 kg of the crystalline sodium chlorite.
Claims 95-96 are indefinite as they depend from an indefinite base and fail to cure the deficiencies of the base claim.
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.
Claims 94-95, 97-110 are rejected under 35 U.S.C. 103 as being unpatentable over Boulanger (US 2007/0145328) in view of Desai (WO 2015181800) as evidenced by Science Insights (“What Is Vacuum Filtration and How Does It Work?”).
Regarding Claim 94, Boulanger discloses a method of preparing a formulation including chlorite comprising dissolving impure sodium chlorite (impure sodium chlorite meets the limitation of crude sodium chlorite) in a solvent (sodium chlorite dissolved in a solvent necessarily generates a sodium chlorite mixture), wherein the solvent is distilled water [0093] and the purity of the chlorite is between about any of 0.1% and about 5%; between about 1% and about 5%; between about 4% and about 10%; between about 1% and about 15%; between about 15% and about 25%; between about 5% and about 25%; between about 25% and about 50%; between about 50% and about 75%; between about 75% and about 85%; between about 85% to about 95%; between about 60% and about 90%; between about 95% and about 99% per weight of the starting material; at least about 50, at least about 60, at least about 70, at least about 80, at least about 90, or at least about 95% pure [0094], which overlaps the claimed range of up to about 80% pure such that the range taught by Boulanger obviates the claimed range. See MPEP 2144.05 (I).
Boulanger is silent to the temperature at which the sodium chlorite is dissolved.
Boulanger, however, further discloses concentrating the chlorite solution at a temperature between 60°C to about 100°C whereby impurities precipitate from the solution (60°C to about 100°C meets the limitation of 50°C to 100°C; [0023]). Boulanger further discloses the concentrating takes place in a rotary evaporator [0153], which necessarily provides agitation.
Desai discloses a method of purifying sodium chlorite [0002] comprising preheating a rotary evaporator water bath to 70°C, adding 750 g of sodium chlorite to a round bottom flask (RBF) with 1500 mL of USP grade water, and fixing the flask on the rotary evaporated, rotating in the hot bath until a solution was obtained [00150], such that the sodium chlorite of Desai is dissolved in a liquid at a temperature of 70°C (70°C meets the limitation of about 50°C to 100°C) with agitation thereby generating a sodium chlorite mixture.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boulanger to incorporate the teachings of Desai to dissolve the sodium chlorite at a temperature from about 50°C to 100°C with agitation, because combining the dissolving step with the rotary evaporator heating step of Boulanger is a process parameter well-known in the art of purifying sodium chlorite, as recognized by Desai.
Boulanger further discloses removing the impurities from the concentrated solution by filtration [0023], such that the sodium chlorite mixture is passed through a filter.
Boulanger is silent to filtering into a glass chamber, wherein the glass chamber is airtight and is substantially free of air, metal, acid, and organic chemicals.
Boulanger, however, discloses suction filtration using a coarse sintered glass funnel [0153].
Suction filtration (aka vacuum filtration) is a technique that separated solid particles from a liquid (pg. 1, par. 1), as recognized by Science Insights. The liquid is filtered into flask (pg. 4, par. 1) which is made of glass (glass flask meets the limitation of a glass chamber; pg. 6, par. 4). Science Insights further discloses using a rubber adapter between the funnel and the flask, creating an airtight seal (pg. 3, par. 2), such that the flask is airtight. The suction hose pulls air out of the filtration flask (pg. 2, par. 2), such that the glass chamber is substantially free of air. though a funnel comprising a filter into an Erlenmeyer flask (Erlenmeyer flasks are made of glass and therefore meet the limitation of a glass chamber). There is no disclosure in Boulanger or Science Insights that suggests the presence of a metal, acid, or organic chemicals in the filtration flask, such that the filtration flask of Boulanger is substantially free of metal, acid, and organic chemicals, absent a showing to the contrary.
Boulanger further discloses freezing the concentrated solution [0023], which necessarily provides a frozen sodium chlorite mixture. Boulanger further discloses the inducing crystallization of chlorite (aka freezing the concentrated solution) includes cooling the concentrated chlorite solution to a temperature no greater than about 10°C, or between about 20°C to about 30°C [0023], such that the frozen sodium chlorite mixture is within a range overlapping the claimed range of about 5°C to about 20°C such that the range taught by Boulanger obviates the claimed range. See MPEP 2144.05 (I). Therefore, generating a mixture of a solid phase and a liquid phase from the frozen sodium chlorite mixture is necessarily present.
Boulanger is silent to heating the frozen mixture.
Boulanger, however, discloses freezing the sodium chlorite mixture and a temperature range of the frozen mixture overlapping that of the present claim, such that the sodium chlorite mixture of Boulanger is exposed to substantially similar freezing and temperature conditions as that of the claim.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boulanger to freeze the sodium chlorite mixture to provide a frozen sodium chlorite mixture followed by heating the frozen sodium chlorite mixture to within a range of about 5°C to about 20°C, because selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results (MPEP 2144.04 IV C).
Boulanger further discloses harvesting the chlorite solids by filtration (such that the solid phase is separated from the liquid phase, wherein the solid phase comprises crystalline sodium chlorite) and dissolving the chlorite solids in an aqueous solvent [0023].
Regarding Claim 95, Boulanger discloses dissolving impure sodium chlorite in distilled water [0093].
Boulanger is silent to the water comprising pharma water.
Boulanger, however, discloses producing pharmaceutical compositions [0018].
Desai discloses a method of purifying sodium chlorite to prepare pharmaceutical-grade sodium chlorite [0002] comprising preheating a rotary evaporator water bath to 70°C, adding 750 g of sodium chlorite to a round bottom flask (RBF) with 1500 mL of USP (United States Pharmacopeia) grade water (USP grade water meets the limitation of pharma water), and fixing the flask on the rotary evaporated, rotating in the hot bath until a solution was obtained [00150], such that the sodium chlorite of Desai is dissolved in a liquid at a temperature of 70°C (70°C meets the limitation of about 50°C to 100°C) with agitation thereby generating a sodium chlorite mixture.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boulanger to incorporate the teachings of Desai to dissolve the sodium chlorite in pharma water, because both Boulanger [0018] and Desai [0002] aim to produce a purified pharmaceutical-grade sodium chlorite, and dissolving the crude sodium chlorite in pharma water is a process parameter well-known in the art of producing pharmaceutical-grade sodium chlorite, as recognized by Desai.
Regarding Claim 97, Boulanger discloses concentrating the chlorite solution at a temperature between 60°C to about 100°C whereby impurities precipitate from the solution (60°C to about 100°C meets the limitation of 50°C to 100°C; [0023]). Boulanger further discloses the concentrating takes place in a rotary evaporator [0153], which necessarily provides agitation.
Boulanger is silent to dissolving the sodium chlorite at a temperature of about 70°C.
Desai discloses a method of purifying sodium chlorite [0002] comprising preheating a rotary evaporator water bath to 70°C, adding 750 g of sodium chlorite to a round bottom flask (RBF) with 1500 mL of USP grade water, and fixing the flask on the rotary evaporated, rotating in the hot bath until a solution was obtained [00150], such that the sodium chlorite of Desai is dissolved in a liquid at a temperature of 70°C (70°C meets the limitation of about 70°C) with agitation thereby generating a sodium chlorite mixture.
Regarding Claim 98, Boulanger discloses the chlorite formulations described herein are sterile filtered, for example, through a sterile 0.22 micron filter (a micro cartridge filter is a type of micron filter, therefore, a 0.22 micron filter meets the limitation of a 0.2 micro cartridge filter; [0087]).
Boulanger is silent to the filter for suction filtration being a 0.2 micro cartridge filter.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boulanger to use a 0.2 micro cartridge filter for suction filtration, because selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results (MPEP 2144.04 IV C).
Regarding Claim 99, Boulanger discloses the inducing crystallization of chlorite (aka freezing the concentrated solution) includes cooling the concentrated chlorite solution to a temperature no greater than about 10°C, or between about 20°C to about 30°C [0023], such that the frozen sodium chlorite mixture is within a range overlapping the claimed range of about 10°C such that the range taught by Boulanger obviates the claimed range. See MPEP 2144.05 (I).
Regarding Claim 100, Boulanger discloses the chlorite may be recrystallized by the above or a different method, and in some variations the chlorite is recrystallized to give chlorite of increased purity relative to the first recrystallization [0104]. Boulanger further discloses an example wherein after the first crystallization, the chlorite purity was 91.9% (such that the purity of the purified sodium chlorite was measured; 91.9% does not meet the threshold purity of at least 96%); the crystallization step was repeated a second time, and after the second recrystallization the chlorite was 99.5% pure (99.5% meets the threshold purity of at least 96%; [0155]). Boulanger further discloses harvesting the chlorite solids by filtration and dissolving the chlorite solids in an aqueous solvent [0023], such that the sodium chlorite is collected, and the purified sodium chlorite is dissolved in a solvent prior to recrystallizing.
Regarding Claim 101, Boulanger discloses the formulations described herein are stable with respect to storage in a container that limits the amount of light to which the formulation is subjected [0064], such that the purified sodium chlorite is transferred to a container.
Regarding Claim 102, Boulanger discloses harvesting the chlorite solids by filtration and dissolving the chlorite solids in an aqueous solvent [0023], wherein the aqueous solvent is water [0057].
Regarding Claim 103, Boulanger discloses the concentration of chlorite in the formulations is between about 1 µM and about 1.5 M [0058], which is equivalent to between about 0.00009 mg/mL and 135 mg/mL, which overlaps the claimed range of about 100 mg/mL to about 125 mg/mL such that the range taught by Boulanger obviates the claimed range. See MPEP 2144.05 (I).
Regarding Claim 104, Boulanger discloses a unit dose form of a formulation, wherein the unit dose form comprises an effective amount of a pharmaceutical composition including: (a) chlorite; (b) a pH adjusting agent; and (c) a pharmaceutically acceptable excipient, and the pH of the unit dose is between about 7.1 and about 7.7 (between about 7.1 and about 7.7 meets the limitation of about 7 to about 11; [0021]). Boulanger further discloses the pH adjusting agent is monosodium phosphate (monosodium phosphate pH adjusting agent meets the limitation of a phosphate buffer; [0013]). Boulanger further discloses the chlorite is sodium chlorite [0051]. The unit dosage components of Boulanger are substantially similar to that of the claim such that the purified sodium chlorite is necessarily dissolved in the phosphate buffer of Boulanger. Boulanger further discloses a kit including one or more unit dose forms (one or more unit dose forms meets the limitation of processing the purified sodium chlorite into a plurality of unit dosage forms; [0022]).
Regarding Claim 105, Boulanger discloses a kit including one or more unit dose forms. Boulanger further discloses the kits comprise suitable packaging [0142], wherein the suitable packaging includes but is not limited to vials or vessels, including but not limited to sealed vials or vessels and sterile sealed vials or vessels (sterile sealed vials or vessels meets the limitation of pharmaceutically-acceptable packaging; [0150]).
Regarding Claim 106, Boulanger is silent to the mass of crude sodium chlorite used.
Desai discloses a method of purifying sodium chlorite [0002] comprising preheating a rotary evaporator water bath to 70°C, adding 750 g (750 g meets the limitation of at least about 100 g) of sodium chlorite to a round bottom flask (RBF) with 1500 mL of USP grade water, and fixing the flask on the rotary evaporated, rotating in the hot bath until a solution was obtained [00150].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boulanger to incorporate the teachings of Desai to dissolve at least 100 g of crude sodium chlorite, because dissolving at least 100 g of sodium chlorite is a process parameter well-known in the art of purifying sodium chlorite, as recognized by Desai.
Regarding Claim 107, Boulanger is silent to the mass of crude sodium chlorite used.
Desai discloses a method of purifying sodium chlorite [0002] comprising preheating a rotary evaporator water bath to 70°C, adding 750 g (750 g meets the limitation of at least about 500 g) of sodium chlorite to a round bottom flask (RBF) with 1500 mL of USP grade water, and fixing the flask on the rotary evaporated, rotating in the hot bath until a solution was obtained [00150].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boulanger to incorporate the teachings of Desai to dissolve at least 500 g of crude sodium chlorite, because dissolving at least 500 g of sodium chlorite is a process parameter well-known in the art of purifying sodium chlorite, as recognized by Desai.
Regarding Claim 108, Boulanger is silent to the mass of crude sodium chlorite used.
However, the mass of purified sodium chlorite is a variable that can be modified, among others, by adjusting the amount of crude sodium chlorite, the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of crude sodium chlorite dissolved in the liquid to obtain the desired amount of purified sodium chlorite, since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding Claim 109, Boulanger is silent to the mass of crude sodium chlorite used.
However, the mass of purified sodium chlorite is a variable that can be modified, among others, by adjusting the amount of crude sodium chlorite, the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of crude sodium chlorite dissolved in the liquid to obtain the desired amount of purified sodium chlorite, since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding Claim 110, Boulanger discloses harvesting the chlorite solids by filtration (such that the solid phase comprises crystalline sodium chlorite) [0023]. Boulanger further discloses providing a unit dose form of a formulation, wherein the unit dose form comprises an effective amount of a pharmaceutical composition including: (a) chlorite; (b) a pH adjusting agent; and (c) a pharmaceutically acceptable excipient, wherein the unit dose is ready for administration to a subject [0021].
Boulanger is silent to the amount of purified sodium chlorite in the solid phase.
However, the amount of unit dose forms for parenteral administration of the chlorite is a variable that can be modified, among others, by adjusting the amount of purified sodium chlorite in the solid phase, the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of purified sodium chlorite in the solid phase to obtain the desired unit dose form, since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Claim 96 is rejected under 35 U.S.C. 103 as being unpatentable over Boulanger (US 2007/0145328) in view of Desai (WO 2015181800) and U.S. Pharmacopeia (“Water for Injection”).
Regarding Claim 96, Boulanger and Desai teach the elements as described above with regards to claim 94.
Boulanger is silent to the water comprising water for injection.
Boulanger, however, discloses the chlorite formulations are formulated for parenteral administration (Abstract).
U.S. Pharmacopeia discloses water for injection is intended for use in the preparation of parenteral solutions in order to minimize microbial growth/contamination (par. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boulanger to incorporate the teachings of U.S. Pharmacopeia wherein the water comprises water for injection in order to minimize microbial growth/contamination, as recognized by U.S. Pharmacopeia (par. 2).
Conclusion
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/S.E.S./Examiner, Art Unit 1735
/PAUL A WARTALOWICZ/Primary Examiner, Art Unit 1735
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