NON-FINAL REJECTION
This application is a 35 U.S.C. 371 (national stage) application of PCT/CN2023/089967, filed Apr. 23, 2023, which claims benefit of foreign priority to CN2022-10454188.1, filed Apr. 27, 2022.
Claims 1-19 are pending.
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 .
Priority
Acknowledgment is made of applicant's claim to foreign priority under 35 U.S.C. 119(a)-(d).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Aug. 23, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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.
Claims 1, 12, 13, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qu (CN111773191A, cited on the IDS dated 8/23/2023; English translation cited on PTO-892).
Qu discloses methods for preparing a phenylephrine hydrochloride-containing tablet, comprising preparation of tablets using both dry and wet granulation methods (para. [0013]). First, phenylephrine HCl is dry-granulated and sized. Acetaminophen and chlorpheniramine maleate are pulverized into fine powders, mixed with pulverized fillers, and then formed into a soft mass using a binder. After granulation, drying, and sizing, the phenylephrine HCl granules and a lubricant are added. After mixing and compression, the tablets are obtained (para. [0013]).
For example, the method of Qu comprises:
(1) dry granulating phenylephrine HCl as a single active pharmaceutical ingredient;
(2) wet granulating acetaminophen, chlorpheniramine maleate, and excipients;
(3) evenly mixing the granules obtained in (1) and (2) with magnesium stearate; and
(4) compressing into tablets (Example 1; paras. [0050]-[0052]; claim 10).
Thus, the methods of Qu read on the method for preparing a phenylephrine HCl-containing tablet as recited by claim 1, comprising:
(1) preparing granule A, containing phenylephrine HCl as a single active pharmaceutical ingredient, by dry granulation;
(2) preparing granule B, containing acetaminophen as an active pharmaceutical ingredient;
(3) mixing a granule A with at least one of granule B uniformly to obtain a mixture, and
(4) subjecting the mixture to tablet pressing to obtain the tablet.
Because Qu discloses methods for preparing the tablet of claim 1, the tablet prepared thereby, as recited by claim 12, is necessarily disclosed.
Further, it is implicit in their components that the tablets exemplified by Qu are oral tablets, as recited by claim 13.
The tablets of Qu contain other common excipients, e.g., filler, lubricant, and binder (paras. [0048], [0054], [0061]; claims 1-9), as recited by claim 19.
For the foregoing reasons, Qu anticipates claims 1, 12, 13, and 19.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
1. Claims 1, 5, 6, 8, 9, 12, 13, 18, and 19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Qu (CN 111773191A, cited on the IDS dated 8/23/2023; English translation cited on PTO-892) in view of Tsujimori et al. (JP 2004010611A, cited on PTO-892).
Qu discloses methods for preparing a phenylephrine hydrochloride-containing tablet, comprising preparation of tablets using both dry and wet granulation methods (para. [0013]). First, phenylephrine HCl is dry-granulated and sized. Acetaminophen and chlorpheniramine maleate are pulverized into fine powders, mixed with pulverized fillers, and then formed into a soft mass using a binder. After granulation, drying, and sizing, the phenylephrine HCl granules and a lubricant are added. After mixing and compression, the tablets are obtained (para. [0013]).
For example, the method of Qu comprises:
(1) dry granulating phenylephrine HCl as a single active pharmaceutical ingredient;
(2) wet granulating acetaminophen, chlorpheniramine maleate, and excipients;
(3) evenly mixing the granules obtained in (1) and (2) with magnesium stearate; and
(4) compressing into tablets (Example 1; paras. [0050]-[0052]; claim 10).
Thus, the methods of Qu read on the method for preparing a phenylephrine HCl-containing tablet as recited by claim 1, comprising:
(1) preparing granule A, containing phenylephrine HCl as a single active pharmaceutical ingredient, by dry granulation;
(2) preparing granule B, containing acetaminophen as an active pharmaceutical ingredient;
(3) mixing a granule A with at least one of granule B uniformly to obtain a mixture, and
(4) subjecting the mixture to tablet pressing to obtain the tablet.
Because Qu discloses methods for preparing the tablet of claim 1, the tablet prepared thereby, as recited by claim 12, is necessarily disclosed.
The tablets of Qu contain other common excipients, e.g., filler, lubricant, and binder (paras. [0048], [0054], [0061]; claims 1-9), as recited by claim 19.
It is implicit in these components that the tablets exemplified by Qu are oral tablets, as recited by claim 13. Further, it is implicit in the methods of Qu that the ambient humidity of the dry granulation is controlled at a relative humidity of 40% or less, as recited by claim 9.
Qu differs from claims 5, 6, 8, 9, and 18 in that the tablets of Qu are not disclosed to contain calcium silicate.
Tsujimori et al. claim masking compositions containing a drug having an unpleasant taste, together with, calcium silicate, and other common excipients (claim 1). The drug having an unpleasant taste is not particularly limited and can be selected from, e.g., dextromethorphan hydrobromide, chlorpheniramine maleate, and/or phenylephrine hydrochloride (claim 3), or a combination thereof (para. [0008]).
The masking compositions of Tsujimori et al. are disclosed to be mixed with excipients such as lactose, starch, dextrins, calcium silicate, celluloses, polyethylene glycol, magnesium stearate, and calcium stearate, which are commonly used in pharmaceutical formulations; lubricants; fragrances; sweeteners; and other components, and then compressed and molded to produce orally disintegrating tablets, chewable tablets, and lozenges (para. [0013]).
Furthermore, the masking composition can also be applied to solid preparations in which it is difficult to mask the unpleasant taste of the drug by methods such as film coating or sugar coating, such as oral dissolving tablets, granules, fine granules, and powders (para. [0014]).
Thus, Tsujimori et al. disclose methods of preparing oral tablets comprising calcium silicate and other common excipients, e.g., magnesium stearate as a lubricant, as recited by claims 5, 6, 8, 9 and 18.
Qu discloses tablets wherein the mass ratio of the excipient to phenylephrine HCl is 5-200:1. However, Qu and Tsujimori et al. do not exemplify tablets wherein the mass ratio of calcium silicate to phenylephrine HCl 1-10:1, as recited by claim 8.
However, it would have been predictable to one of ordinary skill in the art as of the filing date to modify the oral tablets of Qu by adding calcium silicate as taught by Tsujimori et al. with a reasonable expectation of success, because Qu exemplifies oral tablets comprising phenylephrine HCl, acetaminophen, and chlorpheniramine maleate, and Tsujimori et al. claim masking compositions comprising calcium silicate together with the active agents of Qu, having a bitter or unpleasant taste, with the advantage of improving the palatability of the formulation.
In addition, MPEP §2144.06 recognizes that “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
2. Claims 1, 5-9, 12, 13, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Qu (CN 111773191A) in view of Tsujimori et al. (JP2004-010611A) as applied to claims 1, 5, 6, 8, 9, 12, 13, 18, and 19 above, and further in view of Niazi, S.K. (Handbook of Pharmaceutical Manufacturing Formulations (2020), cited on PTO-892).
Qu exemplifies tablets comprising magnesium stearate (Example 1), the lubricant recited by claim 7. Tsujimori et al. disclose tablets comprising calcium silicate (claim 1), the stabilizer recited by claim 7; magnesium stearate, the lubricant recited by claim 7; and mannitol, the filler recited by claim 7.
While Qu and Tsujimori et al. disclose many types of excipients and specific examples thereof, Qu and Tsujimori et al. do not disclose the specific excipients recited by claim 7.
However, Niazi discloses the specific excipients recited by claim 7:
dimethicone 100 for use in oral tablets (p. 104), the defoamer recited by claim 7;
allura red (a.k.a. FD&C Red No. 40, pp. 478, 484; a.k.a. E129, p. 479) as a pigment or colorant approved for internal and external drug use, as recited by claim 7;
anhydrous citric acid for use in oral tablets (p. 92), the acid source recited by claim 7;
sucralose as a sweetener for use in oral tablets (pp. 41, 171), as recited by claim 7;
strawberry powder essence as a flavoring agent for use in oral tablets (p. 113), as recited by claim 7;
povidone K30 (p. 158-159), the binder recited by claim 7; and
potassium bicarbonate and sodium bicarbonate (pp. 57; 88; 158; 163-164) for use in oral tablets, the alkali sources recited by clam 7.
Therefore, it would have been predictable to one of ordinary skill in the art of pharmaceutical formulation as of the filing date to incorporate these common excipients into the oral tablets of Qu and Tsujimori et al. to arrive at the formulation of claim 7 with a reasonable expectation of success, because Niazi teaches that all of the claimed excipients were well-known and routinely employed and approved for use in oral tablet formulations.
3. Claims 1-4, 12, 13, and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Qu (CN 111773191A, "Qu 1") in view of Qu (CN111803452A, "Qu 2") (both cited on the IDS dated 8/23/2023; English translations cited on PTO-892).
Qu 1 discloses methods for preparing a phenylephrine HCl-containing tablet, comprising preparation of tablets using both dry and wet granulation methods (para. [0013]). First, phenylephrine HCl is dry-granulated and sized. Acetaminophen and chlorpheniramine maleate are pulverized into fine powders, mixed with pulverized fillers, and then formed into a soft mass using a binder. After granulation, drying, and sizing, the phenylephrine HCl granules and a lubricant are added. After mixing and compression, the tablets are obtained (para. [0013]).
For example, the method of Qu 1 comprises:
(1) dry granulating phenylephrine HCl as a single active pharmaceutical ingredient;
(2) wet granulating acetaminophen, chlorpheniramine maleate, and excipients;
(3) evenly mixing the granules obtained in (1) and (2) with magnesium stearate; and
(4) compressing into tablets (Example 1; paras. [0050]-[0052]; claim 10).
Thus, the methods of Qu 1 read on the method for preparing a phenylephrine hydrochloride-containing tablet as recited by claim 1, comprising:
(1) preparing granule A, containing phenylephrine hydrochloride as a single active pharmaceutical ingredient, by dry granulation;
(2) preparing granule B, containing acetaminophen as an active pharmaceutical ingredient;
(3) mixing a granule A with at least one of granule B or granule C uniformly to obtain a mixture, and
(4) subjecting the mixture to tablet pressing to obtain the tablet.
Because Qu discloses methods for preparing the tablet of claim 1, the tablet prepared by the method of claim 1 is necessarily disclosed, as recited by claim 12.
Further, it is implicit in their components and formulation that the tablets exemplified by Qu are for oral administration, as recited by claim 13.
Qu 1 differs from claims 1-4, 12, 13, and 17 in that the tablets of Qu 1 are not disclosed to include a third granule C containing dextromethorphan hydrobromide (HBr).
Qu 2 discloses methods of preparing oral tablets comprising effervescent granules containing a phenylephrine HCl composition and further comprising acetaminophen, chlorpheniramine maleate, and dextromethorphan HBr (abstract; claims 2, 3, and 14).
It would have been predictable to one of ordinary skill in the art as of the filing date to modify the oral tablets of Qu 1 by including dextromethorphan HBr in the granules as taught by Qu 2 with a reasonable expectation of success, because, as recognized by MPEP §2144.06, "it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Qu 1 and Qu 2 do not disclose methods of preparing oral tablets comprising a granule A containing phenylephrine HCl, a granule B containing acetaminophen, and a third granule C containing dextromethorphan HBr and chlorpheniramine maleate.
However, the tablets of Qu 1 comprise a large amount of acetaminophen (30-60% w/w) relative to the small amount of chlorpheniramine maleate (0-0.5% w/w) (claim 1); and the tablets of Qu 2 similarly comprise a larger amount of acetaminophen (1-5% w/w) relative to the small amounts of chlorpheniramine maleate (0-0.05% w/w) and dextromethorphan HBr (0-0.05% w/w) (claims 2-3). Formulating a high-bulk active pharmaceutical ingredient (API) together with a low-dose API was known to result in segregation and non-uniform distribution.
Thus, those of ordinary skill in the art of pharmaceutical formulation would have recognized the advantages of granulating acetaminophen separately from chlorpheniramine maleate and dextromethorphan HBr, including content uniformity. Separating the two low-dose APIs was a standard technique to avoid variability in the final compressed tablet. In addition, process optimization by parallel wet-granulation of granule B (acetaminophen) and granule C (chlorpheniramine maleate and dextromethorphan HBr) allows parameters to be tailored separately for each API while avoiding the compromises when combining them.
Therefore, it would have been predictable to one of ordinary skill in the art as of the filing date to prepare oral tablets comprising dry-granulated granule A (comprising phenylephrine HCl) and wet-granulated granule B (comprising acetaminophen) and separately wet-granulated granule C (comprising chlorpheniramine maleate and dextromethorphan HBr) as taught by Qu 1 and Qu 2 to arrive at the tripartite oral tablets recited by claims 1-4, 12, 13, and 17 with a reasonable expectation of success, because it was known that low-dose APIs fail to distribute uniformly when co-granulated with a high-dose bulk component, a disadvantage that could be avoided by granulating low-dose components separately to avoid dose-to-dose variability.
As to the amounts and mass ratios of each component recited by claims 2-4 and 17, Qu 1 claims oral tablet solid dosage forms comprising:
phenylephrine hydrochloride 0.5% (w/w);
acetaminophen 32.5% (w/w);
chlorpheniramine maleate 0.2% (w/w);
and excipients including filler 47%; encapsulating agent 8%; binder 8%; antioxidant 3.5%; and lubricant 0.3% (claim 2).
These amounts result in a mass ratio of active pharmaceutical ingredient contained in the granule B (acetaminophen 32.5% (w/w) + chlorpheniramine maleate 0.2% (w/w) = 32.7% (w/w) to phenylephrine hydrochloride (0.5% (w/w) = 32.7/0.5 = 65.4:1, which falls within the range of 20-80:1, as recited by claims 2 and 17.
Qu 1 does not exemplify tablets wherein the mass ratio of the active pharmaceutical ingredient contained in the granule B to phenylephrine hydrochloride is in a range of 40-60:1, as recited by claim 3; or 50:1, as recited by claim 4.
However, Qu 1 discloses and claims solid dosage forms containing phenylephrine hydrochloride and its preparation method thereof, comprising the following components by weight percentage: acetaminophen 30-60%; chlorpheniramine maleate 0-0.5%; phenylephrine hydrochloride 0-0.6%; filler 30-55%; encapsulating agent 0-10%; binder 2-10%; antioxidant 1-5%; and lubricant 0-0.5% (claim 1).
Thus, the tablets of Qu encompass, e.g., 50% (w/w) acetaminophen and 1% (w/w) phenylephrine hydrochloride, such that the mass ratio of the active pharmaceutical ingredient contained in the granule B to phenylephrine hydrochloride is 50:1, as recited by claims 3-4.
Similarly, Qu 2 claims oral tablet effervescent granules containing a composition of
phenylephrine HCl 0-0.1% (w/w),
acetaminophen 1-5% (w/w),
chlorpheniramine maleate 0-0.05% (w/w),
dextromethorphan hydrobromide 0-0.05% (w/w), and
excipients including acid source 10-25%, alkali source 10-20%, antioxidant 1-8%, binder 1-10%, filler 30-65%, lubricant 1-5%, fragrance 0-0.5%, flavoring agent 0.5-5%, and pigment 0.1-0.5% (claims 2-3).
Qu 2 does not exemplify tablets wherein the mass ratio of chlorpheniramine maleate and dextromethorphan HBr in granule C to phenylephrine HCl is in a range of 1.2-4.8:1, as recited by claims 2 and 17; in the range of 2-2.8:1, as recited by claim 3, or in the range of 2.4:1, as recited by claim 4. However, Qu 2 claims compositions which encompass the ranges of these components (claims 2-3).
As recognized by MPEP § 2144.05 (I), in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575,16 USPQ2d 1934 (Fed. Cir. 1990).
MPEP § 2144.05 further recognizes that
Generally, differences in concentration or tempera-ture will not support the patentability of subject mat-ter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Therefore, it would have been predictable to one of ordinary skill in the art as of the filing date to modify the amounts of the active pharmaceutical ingredients within the ranges disclosed and claimed by Qu 1 and Qu 2 to arrive at the claimed mass ratios with a reasonable expectation of success, because optimizing drug dosage depending on the specific condition to be treated and/or patient-specific variables amounts to routine experimentation. Furthermore, "the normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." In re Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382.
4. Claims 1-6 and 8-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Qu (CN 111773191A, "Qu 1") in view of Qu (CN111803452A, "Qu 2") (both cited on the IDS dated 8/23/2023; English translations cited on PTO-892) as applied to claims 1-4, 12, 13, and 17 above, and further in view of Tsujimori et al. (JP 2004-010611A, cited on PTO-892).
As set forth in detail above, the combination of Qu 1 and Qu 2 disclose, teach, and suggest methods for preparing a tablet comprising uniformly mixing
granule A containing phenylephrine HCl,
granule B containing acetaminophen, and
granule C containing dextromethorphan HBr and chlorpheniramine maleate, and
subjecting the mixture to tablet pressing,
wherein the mass ratio of the acetaminophen in granule B to phenylephrine HCl is in a range of 20-80:1, as recited by claim 2, in a range of 40-60:1, as recited by claim 3, and 50:1, as recited by claim 4; and the mass ratio of the APIs in granule C to phenylephrine HCl is in a range of 1.2-4.8:1, as recited by claim 2, in a range of 2-2.8:1, as recited by claim 3, and, 2.4:1, as recited by claim 4.
Qu 1 and Qu 2 differ from claims 5, 6, 8-11, 14-16, and 18 in that the references do not disclose the step of adding calcium silicate during the preparation of the tablet.
Tsujimori et al. claim masking compositions containing a drug having an unpleasant taste, together with, calcium silicate, and other common excipients (claim 1). The drug having an unpleasant taste is selected from, e.g., dextromethorphan hydrobromide, chlorpheniramine maleate, and/or phenylephrine hydrochloride (claim 3), or a combination thereof (para. [0008]).
The masking compositions of Tsujimori et al. are disclosed to be mixed with excipients such as lactose, starch, dextrins, calcium silicate, celluloses, polyethylene glycol, magnesium stearate, and calcium stearate, which are commonly used in pharmaceutical formulations; lubricants; fragrances; sweeteners; and other components, and then compressed and molded to produce orally disintegrating tablets, chewable tablets, and lozenges (para. [0013]).
Furthermore, the masking composition can also be applied to solid preparations in which it is difficult to mask the unpleasant taste of the drug by methods such as film coating or sugar coating, such as oral dissolving tablets, granules, fine granules, and powders (para. [0014]).
Thus, Tsujimori et al. disclose methods of preparing oral tablets comprising calcium silicate and other common excipients, e.g., magnesium stearate as a lubricant, as recited by claims 5, 6, 8-11, 14-16, and 18.
It would have been predictable to one of ordinary skill in the art as of the filing date to modify the oral tablets of Qu 1 and Qu 2 by adding calcium silicate as taught by Tsujimori et al. with a reasonable expectation of success, because Tsujimori et al. claim masking compositions comprising calcium silicate together with the active agents of Qu 1 and Qu 2, having a bitter or unpleasant taste, with the advantage of improving the palatability of the formulation.
In addition, MPEP §2144.06 recognizes that “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
5. Claims 1-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Qu (CN 111773191A, "Qu 1") in view of Qu (CN111803452A, "Qu 2") (both cited on the IDS dated 8/23/2023) and Tsujimori et al. (JP 2004-010611A) as applied to claims 1-6 and 8-19 above, and further in view of Niazi, S.K. (Handbook of Pharmaceutical Manufacturing Formulations (2020)).
As discussed in detail above, Qu 1, Qu 2, and Tsujimori et al. disclose, teach, and suggest methods for preparing a tablet comprising uniformly mixing
granule A containing phenylephrine HCl,
granule B containing acetaminophen, and
granule C containing dextromethorphan HBr and chlorpheniramine maleate,
adding calcium silicate, and
subjecting the mixture to tablet pressing.
While Qu 1, Qu 2, and Tsujimori et al. disclose many types of excipients and specific examples thereof, the cited references do not disclose the specific excipients recited by claim 7.
However, Niazi discloses the specific excipients recited by claim 7:
dimethicone 100 for use in oral tablets (p. 104), the defoamer recited by claim 7;
allura red (a.k.a. FD&C Red No. 40, pp. 478, 484; a.k.a. E129, p. 479) as a pigment or colorant approved for internal and external drug use, as recited by claim 7;
anhydrous citric acid for use in oral tablets (p. 92), the acid source recited by claim 7;
sucralose as a sweetener for use in oral tablets (pp. 41, 171), as recited by claim 7;
strawberry powder essence as a flavoring agent for use in oral tablets (p. 113), as recited by claim 7;
povidone K30 (p. 158-159), the binder recited by claim 7; and
potassium bicarbonate and sodium bicarbonate (pp. 57; 88; 158; 163-164) for use in oral tablets, the alkali sources recited by clam 7.
Therefore, it would have been predictable to one of ordinary skill in the art of pharmaceutical formulation as of the filing date to incorporate these common excipients into the oral tablets of Qu 1, Qu 2, and Tsujimori et al. to arrive at the formulation of claim 7 with a reasonable expectation of success, because Niazi teaches that all of the claimed excipients were well-known and routinely employed and approved for use in oral tablet formulations.
Citation of Additional Prior Art
Additional references made of record are considered pertinent to applicant's disclosure:
CN 102018712A; CN 103768060A (all cited on PTO-892).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 9:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA ELIZABETH TOWNSLEY/Examiner, Art Unit 1629
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