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 .
Applicant's election with traverse of group I, claims 1-13 in the reply filed on 3/23/23 is acknowledged. The traversal is on the ground(s) that no support has been provided for the assumption that the methylcellulose of Suzuki is a water-dispersible fine cellulose. This is not found persuasive. The instant specification teaches that the term “"water-dispersible fine cellulose composition" means a composition containing microcrystalline cellulose that easily disperses in water. Given the broadest reasonable interpretation, methylcellulose meets the requirements of the term “water-dispersible fine cellulose”. Thus, the special technical feature of a does not make a contribution over the prior art.
The requirement is still deemed proper and is therefore made FINAL.
Claims 14-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/12/26.
Claims 1-13 are under examination.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention.”
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicants were in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
The instant claims are drawn to a pharmaceutical composition for otic administration, comprising one, or two or more drugs and a water-dispersible fine cellulose composition.
The specification teaches the term "water-dispersible fine cellulose composition" as used herein means a composition containing microcrystalline cellulose that easily disperses in water. Examples of the water-dispersible fine cellulose composition used in the present invention include, typically, a composition comprising a mixture in which a water-soluble polymer is attached to or coated on microcrystalline cellulose, but are not limited thereto. The specification teaches that the water-soluble fine cellulose is preferably microcrystalline cellulose-carmellose sodium.
The claims broadly encompass a genus of compositions comprising components that are not adequately described. Although the claims are inclusive of compositions comprising heparin binding epidermal growth protein and microcrystalline cellulose-carmellose sodium (MCC-CMNA) as the water-dispersible fine cellulose composition, the claims are not limited to these compositions. The claims broadly encompass compositions comprising any drug and any water dispersible cellulose that disperses in water. The specification provides no guidance regarding any other agent that is a “water-dispersible fine cellulose composition. Further, there is inadequate guidance regarding the specific drugs that can be combined with the water-dispersible cellulose composition for otic administration. Although the specification attempts to define “water dispersible fine cellulose, the specification provides a functional definition and does not provide the structure that has the claimed function. Thus, the claims encompass a vast genus of compositions comprising components that are described only in functional terms. These compositions have no correlation between their structure and function.
Furthermore, the specification does not disclose a representative number of species. As noted above, the specification discloses a single “water dispersible fine cellulose composition”. Although the specification clearly sets forth a correlation between microcrystalline cellulose-carmellose sodium (MCC-CMNA) and the function of being a water dispersible fine cellulose composition, this correlation does not appear to be clearly present in the breadth of the claims. The claims set forth a broad genus of compositions and specify no particular drug or water dispersible fine cellulose composition. Given the breadth of the claims, the claims encompass compositions that can differ substantially from the single species disclosed. However, these species are not representative of the genus because there is no indication in the specification that other species encompassed by the genus that differ from these species disclosed will have the same functional characteristics and one of skill in the art would not be able to predict the operability of any species other than the one disclosed. When there is substantial variation within the genus, the specification must describe a sufficient variety of species to reflect the variation within the genus. Thus, the specification does not adequately reflect the structural diversity of the claimed genus, either by the establishment of "a reasonable structure-function correlation or through the disclosure of sufficient number of species that are "representative of the full variety or scope of the genus”. Therefore, the specification provides insufficient written description to support the genus of compositions encompassed by the claim. Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
With the exception of the compositions comprising heparin0binding epidermal growth factor and microcrystalline cellulose-carmellose sodium (MCC-CMNA), the skilled artisan cannot envision the detailed chemical structure of the encompassed agents, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The nucleic acid and/or protein itself is required. See Fiers v. Revel, 25 USPQ2d 1601,1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481,1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence.
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held that: ...To fulfill the written description requirement, a patent specification must describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines Inc., 107 F.3d 1565, 1572, 41 USPQ2dl961,1966 (1997); In re Gosteli, 872 F.2dl008,1012,10 USPQ2dl614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d 1966.
Berglin et al. ((2015). Local treatment of the inner ear: A study of three different polymers aimed for middle ear administration. Acta Oto-Laryngologica, 135(10), 985–994) discuss three different polymers aimed for middle ear administration. Berglin et al. teach that recent advances in inner ear research support the idea of using the middle ear cavity for drug administration to target the inner ear. Berglin et al. teach that formulations comprising sodium carboxymethyl cellulose (NaCMC), sodium hyaluronate (NaHYA), and poloxamer 407 (POL) were tested (See abstract). Berglin et al. teach that results favor NaHYA, since it did not cause prolonged hearing threshold elevations (See pages 989-990). Berglin et al. teach that the results of the elimination and morphological investigations support the conclusion of NaHYA being the most promising candidate for intra-tympanic administration (See abstract and page 990-991). Antonelli et al. (Otolaryngology-Head and Neck Surgery (2010) 142, 405-408) teach that carboxymethylcellulose (CMC) was evaluated for efficacy and safety for use in middle ear surgery (See page 405). Antonelli et al. teach that all tympanic membrane treated with CMC healed by week eight (See page 405). Antonelli et al. teach that less postoperative bleeding was observed with CMC than HA or GS (See abstract and page 407). Antonelli et al. teach that CMC was associated with greater auditory threshold elevation at eight weeks across all test frequencies relative to HA or GS (See abstract and page 407). Antonelli et al. teach that residual CMC and screening were not found in the middle ear, indicating that hearing loss was sensorineural. Antonelli et al. teach that CMC was associated with hearing loss and may be ototoxic. Antonelli et al. should not be used in human middle ears given the presence of several nontoxic alternative materials (See abstract).
Adequate written description requires more than a mere statement that is part of the invention. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chungai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence.
The University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that: ...To fulfill the written description requirement, a patent specification must describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines Inc. 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[The description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.").
Thus an Applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2datl966.
MPEP § 2163.02 states, "[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow person of ordinary skill in the art to recognize that he or she invented what is claimed"1. The courts have decided: the purpose of the "written description" requirement is broader than to merely explain how to "make and use"; the Applicant must convey with reasonable clarity to those skilled in the art, that as of the filing date sought, he or she was in possession of the invention. The invention is for purposes of the "written description" inquiry, whatever is now claimed. See Vas-Cath, Inc v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991).
Furthermore, the written description provision of 35 USC §112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. Fiers v. Revel, 25 USPQ2d 1601,1606 (CAFC 1993). And Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. The Guidelines for Examination of Patent Applications under the 35 USC §112 paragraph 1, "Revision 1" of Written Description Requirement (66 FR 1099-1111, March 25, 2008) state, "[possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the Applicant was in possession of the claimed invention (Id. At 1104). Moreover, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was "ready for patenting" by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has the Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed.
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 9 and 12 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 9 is indefinite because the preamble of the claim is drawn to a pharmaceutical composition; however, the body of the claim recites active method steps for using the composition. Since claim 9 encompasses both a product and the method of using the product, it is indefinite under 35 U.S.C. 112(b). The claim is considered indefinite because one of ordinary skill in the art would not be able to ascertain whether the claim is directed to a pharmaceutical composition or a method of using the composition.
Claim 12 is indefinite because it is unclear what drug(s) would provide a biological activity of a heparin-binding epidermal growth factor. The term is not defined in the specification, and one of skill in the art would not be apprised of the compounds that are encompassed by the claims. Thus, the metes and bounds of the claim are unclear. Clarification and/or correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Lichter et al. (WO 2010/008995 A2, published January 21, 2010).
The instant claims are drawn to a pharmaceutical composition for otic administration, comprising one, or two or more drugs and a water-dispersible fine cellulose composition.
Lichter et al. teach a composition for delivering an anti-apoptotic agent or pro-apoptotic agent to the ear (See page 1). Lichter et al. teach the composition comprises an excipient that is auris-acceptable polymers that gel at body temperature and remain in contact with the target auditory surface (See paragraph 0012-0015). Lichter et al. teach that the composition comprises a dispersing agent and/or viscosity modulating agent that control the diffusion and homogeneity of the anti-apoptotic agent or pro-apoptotic agent through liquid media and the dispersing agent and/or viscosity modulating agent is carboxymethylcellulose sodium (See paragraph 0080). Lichter et al. teach that the auris-acceptable viscosity agent includes microcrystalline cellulose (MCC) and sodium carboxymethylcellulose (CMC), which are interpreted as the “water dispersible fine cellulose composition (See paragraph 00311). Lichter et al. teach a solution comprising CMC in PBS buffer, prepared by dissolving 178.35 mg of sodium chloride, 300.5 mg of sodium phosphate dibasic anhydrous, 126.6 mg of sodium phosphate monobasic anhydrous dissolved with 78.4 of sterile filtered DI water, then 1 g of Blanose 7M65 CMC is sprinkled. into the buffer T solution and heated to aid dissolution, and the solution is then cooled down (See paragraph 00463). Lichter et al. teach that the amount of thickening agent (e.g., a gelling agent) in any composition described herein is about 1%, about 5%, about 10%, or about 15% of the total weight of the composition (See paragraph 00275). Regarding the limitation of claim 9, the claim recites a limitation directed to the use of the product. A recitation of the intended use of a composition or a product will not further limit claims drawn to a composition or a product. See See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In Re Hack 114, USPQ 161. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Lichter et al. teach that the composition comprises an auris-acceptable round window membrane penetration enhancer selected from DMSO, ethanol, and glycerol, each of which meet the limitation of a solubilizer (See paragraph 00380). Lichter et al. teach that the drug is a protein or a small molecule (See paragraphs 0020-0022 and claim 7). Lichter et al. teach that the anti-apoptotic agent is a growth factor (See paragraph 00155). Thus, Lichter et al. anticipate the claims.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lichter et al. (WO 2010/008995 A2, published January 21, 2010).in view of Santa Maria et al. (WO 2014/186075, published November 20, 2014).
The instant claims are drawn to a pharmaceutical composition for otic administration, comprising one, or two or more drugs and a water-dispersible fine cellulose composition.
Lichter et al. teach a composition for delivering an anti-apoptotic agent or pro-apoptotic agent to the ear (See page 1). Lichter et al. teach the composition comprises an excipient that is auris-acceptable polymers that gel at body temperature and remain in contact with the target auditory surface (See paragraph 0012-0015). Lichter et al. teach that the composition comprises a dispersing agent and/or viscosity modulating agent that control the diffusion and homogeneity of the anti-apoptotic agent or pro-apoptotic agent through liquid media and the dispersing agent and/or viscosity modulating agent is carboxymethylcellulose sodium (See paragraph 0080). Lichter et al. teach that the auris-acceptable viscosity agent includes microcrystalline cellulose (MCC) and sodium carboxymethylcellulose (CMC), which are interpreted as the “water dispersible fine cellulose composition (See paragraph 00311). Lichter et al. teach a solution comprising CMC in PBS buffer, prepared by dissolving 178.35 mg of sodium chloride, 300.5 mg of sodium phosphate dibasic anhydrous, 126.6 mg of sodium phosphate monobasic anhydrous dissolved with 78.4 of sterile filtered DI water, then 1 g of Blanose 7M65 CMC is sprinkled. into the buffer T solution and heated to aid dissolution, and the solution is then cooled down (See paragraph 00463). Lichter et al. teach that the amount of thickening agent (e.g., a gelling agent) in any composition described herein is about 1%, about 5%, about 10%, or about 15% of the total weight of the composition (See paragraph 00275). Regarding the limitation of claim 9, the claim recites a limitation directed to the use of the product. A recitation of the intended use of a composition or a product will not further limit claims drawn to a composition or a product. See See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In Re Hack 114, USPQ 161. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Lichter et al. teach that the composition comprises an auris-acceptable round window membrane penetration enhancer selected from DMSO, ethanol, and glycerol, each of which meet the limitation of a solubilizer (See paragraph 00380). Lichter et al. teach that the drug is a protein or a small molecule (See paragraphs 0020-0022 and claim 7). Lichter et al. teach that the anti-apoptotic agent is a growth factor (See paragraph 00155).
Lichter et al. do not teach wherein the drug is heparin-binding epidermal growth factor.
Santa Maria et al. teach a method of treating chronic tympanic membrane perforation comprising administering an agent that has heparin binding epidermal growth factor activity (See claim 1). Santa Maria et al. teach that the agent having heparin binding epidermal growth activity is human heparin binding epidermal growth factor (See claims 1-3). It should be noted that the sequence set forth in SEQ ID NO: 1 is that of human heparin binding epidermal growth factor. Given that Santa Maria et al. teach that the agent having heparin binding epidermal growth activity is human heparin binding epidermal growth factor, the human heparin binding epidermal growth factor of the prior art would inherently have the amino acid sequence set forth in SEQ ID NO: 1.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Lichter et al. to include heparin-binding epidermal growth factor because Santa Maria et al. teach that heparin-binding epidermal growth factor can be used for otic administration and Lichter et al. teach that the formulation is specifically for otic administration. One of skill in the art would be motivated to formulate heparin-binding epidermal growth factor with an auris-acceptable viscosity agent comprising microcrystalline cellulose (MCC) and sodium carboxymethylcellulose (CMC) because doing so would advantageously allow for controlled release of the agent to at least one structure of the ear and further, the composition would be biodegradable, dispersible, and non-toxic to the inner ear environments. One of ordinary skill in the art would have a reasonable expectation of success because Lichter et al. teach that the composition is for use with many types of drugs, including growth factors.
Claim Status
No claims are allowed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Takeo et al. (US Patent No. 4159345, issued June 26, 1979) teach a pharmaceutical composition comprising a pharmaceutically active ingredient and an excipient which consists essentially of microcrystalline cellulose having an average degree of polymerization of 60 to 375 and obtained through acid hydrolysis or alkaline oxidative degradation of a cellulosic substance selected from linters, pulps and regenerated fibers, said microcrystalline cellulose being a white cellulosic powder having an apparent specific volume of 1.6 to 3.1 cc/g, and a repose angle of 35 to 42° (See claim 4). Takeo et al. teach wherein said excipient is present in an amount of 2 to 40% by weight based on the pharmaceutical composition (See claim 5). Takeo et al. teach the composition comprises further additives (See claim 10).
Dickerson et al. (US Patent Application Publication 2014/0142187 A1, published May 22, 2014) teach an oral liquid pharmaceutical composition comprising a suspending system which comprises in a preferred embodiment an aqueous composition, which includes about 0.1 g/100 mL to about 1.0 g/100 mL xanthan gum and about 0.5 g/100 mL to about 3.0 g/100 mL microcrystalline cellulose/carboxymethylcellulose sodium in an aqueous base (or “aqueous medium”) and at least one pharmaceutical active (also referred to herein as “at least one pharmaceutical active compound” or “at least one first pharmaceutical active”), that is substantially insoluble in water (or the aqueous base) (See paragraph 0005).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANDRA CARTER whose telephone number is (571)272-2932. The examiner can normally be reached 8:00-5:00 pm.
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/SANDRA CARTER/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
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