DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed 12/30/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Rejections - 35 USC § 103 - Obviousness
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.
Claim(s) 1-2, 7, 17 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over KR 2008/0015550A, in view of KR 2007/0049962 A.
KR 2008/0015550A taught an oral formulation comprising ibuprofen, an antacid selected from the group consisting of sodium hydrogen carbonate or magnesium oxide, and at least one selected from the group consisting of hydroxypropyl cellulose, carmellose, croscarmellose sodium, carboxymethyl starch sodium, crospovidone, crystalline cellulose and carmellose sodium [abstract]; wherein the formulation masked the unpleasant taste of the drug [page 3/16, first paragraph]. The ibuprofen and antacid were contained in one granule [abstract]; the antacid was especially preferably magnesium oxide [page 3, 7th paragraph].
The amount of the ibuprofen was 1 to 95 mass % [page 3/16; 9th paragraph]; the amount of the magnesium oxide (e.g., antacid) was 1 to 95 mass %; page 3/16, 11th paragraph]. The formulation was obtained by wet granulation [abstract], then dried [page 2/16, last paragraph] and manufactured as tablets [page 5/16, paragraph preceding Example 1].
KR 2008/0015550A generally taught drying, as discussed, but was silent drying at a temperature of 60-75 ºC for 0.5 to 96 hours, as recited in claim 1.
KR 2007/0049962A taught a method of providing an oral solid formulation in which the bitter taste and mucosal irritability of ibuprofen was concealed. Specifically, was disclosed an oral solid preparation concealing the bitter taste and mucosal irritability of ibuprofen (and other active agents), which was obtained by wet granulation of ibuprofen, followed by drying [abstract]. The drying temperature, which could be adjusted, was 25-60 ºC [page 6/18, 1st full paragraph] for 1 hour [Example 1]. Magnesium oxide was taught as an active agent, further added to the solid oral formulation [page 6/18, penultimate paragraph].
Since KR 2008/0015550A generally taught formulations that masked the unpleasant taste of ibuprofen, and formulations that were dried, it would have been prima facie obvious to one of ordinary skill in the art to dry the formulation at 25-60 ºC for 1 hour, as taught by KR 2007/0049962A. The ordinarily skilled artisan would have been so motivated, because KR 2007/0049962A taught that drying formulations at 25-60 ºC for 1 hour, wherein the formulations comprised ibuprofen and magnesium oxide, concealed the bitter taste [abstract].
The instant claim 1 recites a magnesium oxide to ibuprofen mass ratio in a range from 1.25 to 1.5; a drying temperature of 60-70 ºC for 0.5 to 96 hours.
The instant claim 2 recites a magnesium oxide to ibuprofen mass ratio in a range from 1.25 to 1.5.
The instant claim 21 recites a magnesium oxide to ibuprofen mass ratio in a range from 1.25-1.5 and a drying temperature of 60-67.5 ºC.
KR 2008/0015550A taught: the amount of the magnesium oxide at 1 to 95 mass %; the amount of ibuprofen at 1 to 95 mass %. KR 2007/0049962A taught drying at 25-60 ºC for one hour. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A.
KR 2008/0015550A, in view of KR 2007/0049962A, reads on claims 1-2, 7 and 21.
Further regarding the instant claims 1 and 21, the claim limitations of “obtaining the composition and then drying the composition at a temperature of 60-75 ºC for 0.5 to 96 hours” or “obtaining the formulation by drying at a temperature of 60-67.5 ºC” (claim 21) are interpreted as a product-by-process limitations. Product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.
Even though product-by-process claims are limited by, and defined by, the process, the 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, then the claim is unpatentable even though the prior product was made by a different process. In the instant case, the formulation of the combined teachings of the prior art (ibuprofen and magnesium oxide, combined in a mass ratio, and dried at 25-60 ºC for 1 hour) reads on the claimed formulation (ibuprofen and magnesium oxide, combined in a mass ratio, and dried at 60-75 ºC for 0.5 to 96 hours; dried at 60-67.5 ºC). As such, the patentability of the instant composition does not depend on its method of production, and the Applicant’s limitation regarding the process of obtaining the formulation by drying the composition to reduce an unpleasant taste is not patentable, in view of the combined teachings of the prior art. MPEP 2113.
Further regarding claims 1-2 and 22, the instant claims recite “wherein the amount of magnesium oxide in the formulation is sufficient to reduce an unpleasant taste of the ibuprofen”.
The instant specification [0045] disclosed that from the viewpoint of reducing the unpleasant taste, the magnesium oxide content with respect to the total mass of the oral pharmaceutical formulation is 0.1-95 % by mass.
It appears that the compositions of the instant claims (e.g., oral pharmaceutical of ibuprofen and magnesium oxide, wherein the magnesium oxide content is 0.1-95 %) and those of the prior art (e.g., oral formulation comprising ibuprofen and magnesium oxide, with the amount of the magnesium oxide at 1 to 95 mass %) would reasonably be expected to have substantially the same physical and chemical properties (e.g., reduce an unpleasant taste of the ibuprofen). Inherent features need not be recognized at the time of the invention. There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. MPEP 2112 II. It should be noted that a chemical composition and its properties are inseparable. If the prior art teaches the identical chemical compounds, the properties applicant discloses and/or claims are necessarily present (see MPEP 2112).
Further regarding claim 2, the instant claim recites reduction of an unpleasant taste of the ibuprofen for at least two minutes when in the mouth of a patient. The instant Specification [0006] disclosed that it is possible to reduce the unpleasant taste of ibuprofen by incorporating ibuprofen and magnesium oxide into an oral formulation at a ratio of the magnesium oxide to ibuprofen at 0.2-1.5.
It appears that the compositions of the instant claims (e.g., oral pharmaceutical of ibuprofen and magnesium oxide at a ratio of magnesium oxide to ibuprofen from 0.125 to 1.5 as claimed in instant claim 2) and those of the prior art (e.g., oral formulation comprising ibuprofen, magnesium oxide, and at least one selected from the group consisting of hydroxypropyl cellulose, carmellose, croscarmellose sodium, carboxymethyl starch sodium, crospovidone, crystalline cellulose and carmellose sodium; the amount of the ibuprofen was 1 to 95 mass %; the amount of the magnesium oxide was 1 to 95 mass %) would reasonably be expected to have substantially the same physical and chemical properties (e.g., reduce an unpleasant taste for at least two minutes).
Inherent features need not be recognized at the time of the invention. There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. MPEP 2112 II. It should be noted that a chemical composition and its properties are inseparable. If the prior art teaches the identical chemical compounds, the properties applicant discloses and/or claims are necessarily present (see MPEP 2112).
Claim 17 is rendered prima facie obvious over the teachings of KR 2008/0015550A. The instant claim 17 recites that the magnesium oxide is present in an amount sufficient to inhibit discoloration.
The instant Specification, at ¶ [0045] disclosed that:
“from the viewpoint of reducing the unpleasant taste and inhibiting discoloration in the production step, the magnesium oxide content with respect to the total mass of the inventive oral pharmaceutical formulation is preferably 0.1-95% by mass, more preferably 0.25-85% by mass, even more preferably 0.5-75% by mass, and even more preferably 1-65% by mass. If the inventive oral pharmaceutical formulation is a solid formulation or semi-solid formulation, from the viewpoint of reducing the unpleasant taste and inhibiting discoloration in the production step it is even more preferably 1-55% by mass, and particularly preferably 1-40% by mass….”
KR 2008/0015550A taught: the amount of the magnesium oxide at 1 to 95 mass %; the amount of ibuprofen at 1 to 95 mass %.
Regarding the prior art formulation inhibiting discoloration, it appears that the compositions of the instant claims (tablet comprising magnesium oxide and ibuprofen) and those of the prior art (tablet comprising magnesium oxide and ibuprofen) would reasonably be expected to have substantially the same physical and chemical properties (inhibition of discoloration). This is because the instant Specification disclosed that the inventive formulation inhibits discoloration when magnesium oxide is present at preferably 1-40 mass %; and, the prior art taught formulations containing magnesium oxide present at 1-95 mass %.
Inherent features need not be recognized at the time of the invention. There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. MPEP 2112 II. It should be noted that a chemical composition (magnesium oxide) and its properties (inhibition of discoloration) are inseparable. If the prior art teaches the identical chemical compounds, then the properties that the Applicant discloses and/or claims are necessarily present (see MPEP 2112).
Response to Arguments
Applicant's arguments filed 12/30/2025 have been fully considered but they are not persuasive.
Applicant argued that the cited prior art, alone or in combination, would not lead to the claimed invention. Applicant argued that the product-by-process limitations of claim 1 should be considered because the skilled artisan, upon reviewing the specification, would recognize that the process parameters recited in claim 1 impart the claimed structural characteristics.
The Examiner disagrees. The Applicant has not identified any distinctive structural characteristics between the claimed pharmaceutical, and the pharmaceutical of the combined prior art. It does not appear that the claimed composition of ibuprofen and magnesium, dried at 60-75 ºC for 0.5 to 96 hours, with magnesium oxide and ibuprofen at a mass ratio of 1.25-1.5, and with an amount of magnesium oxide sufficient to reduce an unpleasant taste of ibuprofen, differ by structural characteristics, and the Applicant has not shown as much. In the instant case, the combined cited prior art taught the claimed composition of magnesium oxide and ibuprofen at amounts of each ingredient that overlap the claimed ratio, and at amounts of magnesium oxide (e.g., 1 to 95 mass % taught by KR 2008/0015550A) that are similar to and overlap the amount as disclosed by the Specification as the amount (0.1-95 %) of magnesium oxide sufficient to reduce an unpleasant taste of the ibuprofen.
The Examiner disagrees that the instant claims are patentably different than the combined teachings of the prior art, and the Examiner maintains that the Invention and the combined prior art are not structurally different. The Examiner maintains that the product-by-process claims instantly recited in claims 1-2 do not receive patentable weight over the combined teachings of the cited art. The Obviousness rejection over KR 2008/0015550A, in view of KR 2007/0049962 A, is maintained.
Applicant argued that: KR’550 does not demonstrate taste masking formulations; KR’962 and KR’550 mention taste masking of ibuprofen, but do not disclose or suggest that other bitter agents in the formulations are also taste masked; a reasoned motivation to combine the secondary references does not exist.
The Examiner disagrees. The Examiner cautions the Applicant against attacking references individually, where the rejection was based upon a combination of references. See MPEP 2145(V). In the instant case, KR’550 is not required to demonstrate taste masking formulations. Regarding KR’550, the art is presumed to be operable/enabling. The burden is on the Applicant to rebut the presumption of operability. See MPEP 2121. Regarding the other ingredients of KR’962 and KR’550, a multitude of combinations does not necessarily render any particular formulation (taste masking of ibuprofen) as less obvious. Furthermore, a motivation of obviousness exists to combine the secondary references with the primary references (see the Obviousness rejection).
Applicant argued that there is no teaching or suggestion in KR’550 as to how to specifically generate a taste masking formulation out of its formulations designed to prevent a color change.
The Examiner reminds the Applicant that the instant invention is drawn to formulation claims, rather than to method claims. In the instant case, the instant claims recite that the magnesium oxide is present in an amount sufficient to inhibit discoloration.
The instant Specification, at ¶ [0045] disclosed that:
“from the viewpoint of reducing the unpleasant taste and inhibiting discoloration in the production step, the magnesium oxide content with respect to the total mass of the inventive oral pharmaceutical formulation is preferably 0.1-95% by mass, more preferably 0.25-85% by mass, even more preferably 0.5-75% by mass, and even more preferably 1-65% by mass. If the inventive oral pharmaceutical formulation is a solid formulation or semi-solid formulation, from the viewpoint of reducing the unpleasant taste and inhibiting discoloration in the production step it is even more preferably 1-55% by mass, and particularly preferably 1-40% by mass….”
KR 2008/0015550A taught: the amount of the magnesium oxide at 1 to 95 mass %; the amount of ibuprofen at 1 to 95 mass %.
Regarding the prior art formulation inhibiting discoloration, it appears that the compositions of the instant claims (tablet comprising magnesium oxide and ibuprofen) and those of the prior art (tablet comprising magnesium oxide and ibuprofen) would reasonably be expected to have substantially the same physical and chemical properties (inhibition of discoloration). This is because the instant Specification disclosed that the inventive formulation inhibits discoloration when magnesium oxide is present at preferably 1-40 mass %; and, the prior art taught formulations containing magnesium oxide present at 1-95 mass %.
Inherent features need not be recognized at the time of the invention. There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. MPEP 2112 II. It should be noted that a chemical composition (magnesium oxide) and its properties (inhibition of discoloration) are inseparable. If the prior art teaches the identical chemical compounds, then the properties that the Applicant discloses and/or claims are necessarily present (see MPEP 2112).
Applicant maintained that KR’550 does not establish that it is possible to generate taste masking formulations, as claimed.
The Examiner maintains that the burden is upon the Applicant to rebut the presumption of enablement of KR’550.
Applicant argued that KR’550 disclosed 15-85 % swelling agent; 1-95 % antacid; and, 1-95 % ibuprofen, which is insufficient to render obvious the claimed invention. Applicant argued that Patent Document 2, as cited in KR’550, disclosed that taste masking formulations of drugs such as ibuprofen contain 30 % by weight or more of low-substituted hydroxypropylcellulose as a masking agent, preferably 50-90 % by weight.
The Examiner responds that the rejection was not relied upon by the disclosure of KR’550’s citation to Patent Document 2; and, the teachings of KR’550 are not excluded by the present claims.
Applicant argued that all of the formulations of KR’550 are not taste-masking.
The Examiner responds that KR’550 is relevant as prior art for all that it contains, as a broad disclosure, rather than the formulations picked by the Applicant. The use of KR’550 is not limited to what the Applicant describes as problems with which they are concerned. See MPEP 2123I.
Applicant argued that KR 2008/0015550A disclosed that its compositions are obtained by drying without specifying drying conditions. Applicant argued that KR’962 taught that a lower temperature should be used which may be adjusted based on thermal stability of ibuprofen.
The Examiner responds that KR 2008/0015550A was not relied upon to teach the drying conditions. The Applicant is reminded that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See MPEP 2145 IV. In the instant case, KR 2008/0015550A generally taught drying; KR 2007/0049962A taught an adjustable drying temperature of 25-60 ºC for one hour; Furthermore, the passage of KR’962 pointed to by the Applicant disclosed a preferable temperature of 50 ºC; however, the Examiner reminds the Applicant that KR’962 is not limited to preferred examples, where nonpreferred and alternative embodiments also constitute prior art. See MPEP 2123II.
Applicant argued that the combined teachings of the cited art do not teach the claimed B:A mass ratio. Applicant argued that there is no express teaching in KR’550 of the claimed ratio, or to increase the amounts therein to obtain the claimed ratio. Applicant argued that the prior art formulations did not disclose taste masking reductions.
The Examiner disagrees. KR 2008/0015550A taught an oral formulation containing ibuprofen and an antacid in one granule, where the antacid was preferably magnesium oxide, as previously discussed. KR 2008/0015550A taught ranges of ibuprofen and magnesium oxide that overlap the claimed ratio of magnesium oxide to ibuprofen. Furthermore, KR 2008/0015550A taught an amount of magnesium oxide sufficient to reduce an unpleasant taste of ibuprofen. As discussed in the body of the rejection, KR 2008/0015550A taught 1-95 % each of ibuprofen and magnesium oxide, which overlaps the claimed ratio of magnesium oxide to ibuprofen at 1.25-1.5. Additionally, and as previously discussed, the Specification defines an amount of magnesium oxide that reduces an unpleasant taste of ibuprofen at 0.1-95 %; meanwhile, KR 2008/0015550A taught 1-95 % magnesium oxide. Given that the amounts were disclosed within a range, the skilled artisan would understand that the amounts were adjustable.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over KR 2008/0015550A, in view of KR 2007/0049962 A, and further in view of JP 2007/023026A.
The 35 U.S.C. 103 rejection over KR 2008/0015550A and KR 2007/0049962 A was previously described.
The English translation of KR 2008/0015550A does not make clear the amount of ibuprofen in mg, as recited in the instant claim 8.
Nevertheless, JP 2007/023026A taught ibuprofen and magnesium oxide administered simultaneously as a formulation, where the dose of ibuprofen is usually 50 mg to 250 mg [page 6/18, 4th and 5th paragraphs]. Tablets were taught at page 7/18, 1st full paragraph.
It would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of KR 2008/0015550A, ibuprofen in a range of 50 to 250 mg, as taught by JP 2007/023026A. The ordinarily skilled artisan would have been so motivated, because the dose of ibuprofen is usually 50 mg to 250 mg, as known in the art [JP 2007/023026A at page 6/18, 4th and 5th paragraphs].
Response to Arguments
Applicant's arguments filed 12/30/2025 have been fully considered but they are not persuasive.
Applicant argued that JP 2007/023026A does not cure the deficiencies of the combination of the cited prior art.
The Examiner disagrees that the combination of the cited prior art is deficient.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over KR 2008/0015550A, in view of KR 2007/0049962 A and further in view of Reddy et al (WO 2006/134611 A1).
The 35 U.S.C. 103 rejection over KR 2008/0015550A and KR 2007/0049962 A was previously described.
Additionally, KR 2008/0015550A disclosed the antacid (e.g., magnesium oxide) as stabilizing the ibuprofen [page 3, last paragraph bridging to page 4].
KR 2008/0015550A taught magnesium oxide, however, was silent heavy magnesium oxide, as recited in claim 16.
Nevertheless, Reddy taught heavy magnesium oxide as a stabilizer conventionally used in dosage forms manufactured as pharmaceutical tablets [page 3, lines 31-21; page 4, lines 13-14; claim 151; abstract].
Since KR 2008/0015550A generally taught magnesium oxide as a stabilizer, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of KR 2008/0015550A, heavy magnesium oxide, as taught by Reddy et al. The ordinarily skilled artisan would have been motivated to include a conventional stabilizer used in dosage forms manufactured as pharmaceutical tablets, as taught by Reddy [page 3, lines 31-21; page 4, lines 13-14; claim 151; abstract]. 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. In the instant case, it is prima facie obvious to select heavy magnesium oxide for incorporation into a composition, based on its recognized suitability for its intended use as a conventional stabilizer, as taught by Reddy et al.
Response to Arguments
Applicant's arguments filed 12/30/2025 have been fully considered but they are not persuasive.
Applicant argued that Reddy does not cure the deficiencies of the combination of the cited prior art.
The Examiner disagrees that the combination of the cited prior art is deficient.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over KR 2008/0015550A, in view of KR 2007/0049962 A and further in view of Catania et al (USP 5,633,006 A).
The 35 U.S.C. 103 rejection over KR 2008/0015550A and KR 2007/0049962 A was previously described.
Although KR 2008/0015550A generally taught tablets, where an unpleasant taste of the drug (ibuprofen) was known in the art, as previously discussed, KR 2008/0015550A was not specific chewable tablets, as recited in claim 20.
Catania taught a pharmaceutical composition having reduced bitterness, comprising a bitter pharmaceutical agent (e.g., ibuprofen, at [col 4, line 54]), a taste-masking component and a pharmaceutically acceptable carrier. The taste-masking component was an alkaline earth oxide (e.g., magnesium oxide, at [col 2, line 59]), [abstract]. The compositions were capable of being chewed without the production of a bitter taste or aftertaste [col 1, lines 13-15], in order to increase patient compliance [col 1, lines 52-64], since ibuprofen is known in the art as one of the most bitter pharmaceutical agents [col 1, lines 17-27].
Since KR 2008/0015550A generally taught ibuprofen tablets, where an unpleasant taste of ibuprofen was known in the art, it would have been prima facie obvious to one of ordinary skill in the art to include, within KR 2008/0015550A’s general teaching of tablets, chewable tablets, as taught by Catania. The ordinarily skilled artisan would have been so motivated, because Catania’s ibuprofen tablets were capable of being chewed without the production of a bitter taste or aftertaste, in order to increase patient compliance [Catania, at col 1, lines 13-15; 17-27; 52-64].
Response to Arguments
Applicant's arguments filed 09/02/2025 have been fully considered but they are not persuasive.
Applicant argued that Catania does not cure the deficiencies of the combination of the cited prior art.
The Examiner disagrees that the combination of the cited prior art is deficient.
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612