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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10 June 2025 has been entered.
Priority
The application was filed 27 July 2021 and is the national stage entry of PCT/GB2020/050193 filed 28 January 2020. The Applicant claims priority to foreign application GB1901137.8 filed 28 January 2019. An English copy of the foreign application has been provided; therefore, the effective filing date of the application is 28 January 2019.
Examiner’s Note
The Applicant's amendments and/or arguments filed 20 October 2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections not reiterated from previous office actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 20 October 2025, it is noted no claims have been amended or added. No new matter has been added.
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.
Claim(s) 41-60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oury et al. (US 2004/0247677 A1).
Oury et al. teach an orodispersible tablet (entire teaching; abs) with an uncoated active substance (para. 121). The active ingredient may be ibuprofen (para. 53) or 0.5-20% (para. 73) of malic acid (para. 70), and excipients include microcrystalline cellulose (para. 102) in an amount of 1-15% (para. 103), mannitol in an amount of up to 95% (para. 66), crospovidone (para. 100) in an amount of 1-20% (para. 101), colloidal silica in an amount of up to 10% (para. 67), or sodium stearyl fumarate in an amount of up to 10% (para. 88), addressing the disintegrant, binder, sugar alcohol filler, taste-masking agent, sweetener, glidant, lubricant (para. 88), and other excipients or fillers (para. 64), addressing claims 41, 47, 48, 50, 54, 58. The tablets may have a hardness of around 51.7 N and a friability of around 0.06% (para. 254), addressing claim 60. Oury also teaches that the friability is preferably less than 2% to provide a favorable disintegration time for the tablet (para. 168). The size of active substance may be 20-1000 µm (para. 58), addressing the particle size limitation in claims 41, 42, 47, 49, 51, 53, 55, 57, 59. The proportion of excipients to coated active substance is between 1 and 5 parts by weight (para. 121), addressing the ratio in claim 41. Malic acid may be in an amount of 0.5-20% (para. 73), addressing claims 43 and 44. Crospovidone may be in an amount of 1-20% (para. 101), addressing claims 45 and 46. Other general amounts include up to 15% of a binder (para. 65), up to 10% of a lubricant (para. 88), 1-20% of a disintegrant (para. 101), addressing claims 52 and 56.
Oury does not teach an exact combination of components in claims 41 and 47.
In regards to selecting a combination of ibuprofen, malic acid, mannitol, microcrystalline cellulose, crospovidone, sodium stearyl fumarate, colloidal silica, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various
combination of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Oury teaches an uncoated oral dispersible tablet that may comprise ibuprofen as an active ingredient and taste-masking agents where the active ingredient has an average particle size of 20-1000 µm. The claimed invention is directed towards a composition for an uncoated orodispersible tablet comprising ibuprofen, malic acid, a disintegrant, where ibuprofen has an average particle size of less than 100 µm. Since Oury teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
In regards to the friability % in claim 60, Oury teaches a friability of less than 2% for favorable disintegration properties. It is obvious to one of ordinary skill in the art to optimize the friability properties to adjust for the desired disintegration properties for the tablet composition. Additionally, in regards to the amounts of components and ratio of components in claim 47, Oury teaches 1-15% microcrystalline cellulose (para. 102), up to 95% mannitol (para. 66), 1-20% crospovidone (para. 101), 0.5-20% malic acid (para. 70, 73). Additionally, the proportion of excipients to coated active substance is between 1 and 5 parts by weight (para. 121). Therefore, the optimum or workable range of ratios, amounts, and friability % can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of friability % as nonobvious. In lieu of evidence of an unexpected result, the claimed excipients are obvious to use in the broad range amount taught by Huber and Oury. The claimed weight % and weight ratios would therefore be obvious from the ranges taught by the art.
Response to Arguments
Applicant's arguments filed 20 October 2025 have been fully considered but they are not persuasive.
The Applicant argues that Oury’s Examples teach that ibuprofen is coated (Remarks, pg. 3).
Applicant’s argument is not found persuasive. Oury’s composition may comprise an uncoated active substance (para. 121, claim 9) as well as malic acid (para. 70), where it is interpreted that malic acid will provide the effect of taste masking regardless of its intended use as an acidic agent. The Applicant is erroneously pointing to narrow embodiments expressly disclosed within the prior art reference as representing the sum total of information conveyed by each. Art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments (see MPEP § 2123).
The Applicant argues that a skilled artisan would not want to adjust acidic ibuprofen with another acidic component (Remarks, pgs. 3-4).
Applicant’s argument is not found persuasive. Ibuprofen is weakly acidic and a skilled artisan would have been easily led to adjust ibuprofen’s pH for drug delivery reasons, such as to control ionization, solubility, absorption, and interaction with different carriers.
The Applicant argues that Oury does not disclose the claimed ratio of uncoated ibuprofen to taste-masking agent being 4:1 by weight in claim 41.
Applicant’s argument is not found persuasive. The proportion of excipients to coated active substance is between 1 and 5 parts by weight (para. 121) and malic acid may be in an amount of 0.5-20% (para. 73). The ratio can be viewed as a variable that achieves the recognized result of successfully making the ibuprofen composition, which a skilled artisan would have been easily motivated to modify and adjust. The optimum or workable ratio can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration, such as unexpected results, that would render the optimized ratio of uncoated ibuprofen to taste-masking agent as nonobvious.
The Applicant argues that the hardness and friability values relate to a composition that is different from the claimed invention (Remarks, pg. 4).
Applicant’s argument is not found persuasive. In regards to the friability % in claim 60, Oury teaches a friability of less than 2% for favorable disintegration properties. The tablets may have a hardness of around 51.7 N and a friability of around 0.06% (para. 254) and the friability is preferably less than 2% to provide a favorable disintegration time for the tablet (para. 168). It is obvious to one of ordinary skill in the art to optimize the friability properties to adjust for the desired disintegration properties for the tablet composition. Furthermore, The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613