DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the amendments/arguments filed on 6/12/2025 wherein claim 29 has been added.
Claims 1, 2 and 29 are presented for examination on the merits. The following rejections are made.
Response to Applicants’ Arguments
Applicant’s arguments filed 6/12/2025 regarding the rejection of claims 1 and 2 made by the Examiner under 35 USC 103 over Boit et al. (US 2012/0156496) in view of Scott et al. (US 3341415) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 12/13/2024.
In regards to the 103 rejection, Applicant asserts the following:
A) Boit and Scott’s composition are fundamentally different in structure, form and components as well in process of manufacturing. Scott’s composition is to be that of a melt of sugar and mannitol whereas Boit’s composition is a powder that is stable and has good flow characteristics.
In response to A, Boit describes an invention which obviates that claimed. Boit teaches a composition that may comprise pure mannitol powder wherein between 0.1-60% of the mannitol powder particles have a particle size greater than 200 nm, a mean diameter of between 100-300 microns and a bulk density between 0.540-.0700 g/mL. These particles properties are overlapping with the properties claimed.
Applicant argues that there are too many variables within Boit’s ranges to select from and that overlap with the instant claims would not be obvious. The Examiner respectfully disagrees. Skilled artisans are more than capable of working within prior art ranges to identify conditions which best suit their need. Again, as noted before, the physical properties of Boit’s mannitol powder overlap with the physical properties claimed. MPEP 2144.05(I)(A) states that where overlapping ranges are described by the prior art a prima facie case of obviousness exists. The Examiner is not persuaded that working within known ranges of the prior art would be burdensome and inventive.
Applicant provides dissolution data as evidence of unexpected results wherein mannitol particles with a size distribution less than 500 microns dissolve more readily than mannitol particles with a size distribution greater than 500 microns. Applicant’s assertion appears to be that the improved dissolution is a feature of the reduced mannitol particle size. While the identified outcome is interesting, it is not considered sufficient to overcome the rejection because Boit teaches mannitol powder particles having a mean diameter of between 100-300 microns which is within the range identified having improved dissolution kinetics. Therefore because Boit’s mannitol particle size distribution is less than 500 microns, the particles would be expected to share the observed dissolution kinetics albeit being unrecognized by the reference.
Regarding the combination of Boit and Smith, although Boit’s mannitol powder overlaps with the mannitol powder of the instant claims Boit does not teach a dosage form that comprises mannitol in an amount of 50-200 grams.
As noted in the Office Action mailed 12/13/2024, determining an amount of mannitol to be included in a dosage form would be an obvious modification of the prior art. MPEP 2144.05(II)(A) states that where the general conditions of a claim are described by the prior art (see Boit), determining optimum or workable ranges by routine experimentation is not considered invention. Regarding the combination of Boit with Scott, Scott is cited to demonstrate that dosage forms comprising 80 grams of mannitol are known and the Examiner maintains that use of such an amount in Boit’s teaching would have been obvious. The Examiner is not persuaded that Scott being in the form of a melt would render the teaching that 80 grams of mannitol could be provided in a dosage form unworkable because the reference still provides the claimed agent in a dosage form for administration in an amount which overlaps with that claimed. At the very minimum it would provide a staring point for which one could branch out from to identify other suitable amounts.
The Examiner agrees that Scott’s composition is different from that of Boit as Boit is directed to a powder mannitol composition whereas Scott is directed to a solid solution of sugar and mannitol. However, the differences between Boit and Scott are not considered sufficient to mitigate the rejection because Scott is only relied on to show that dosage forms comprising overlapping amounts of mannitol were known in the art at the time of filing. Applicant’s argument is not considered persuasive.
Rejections
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 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.
Claims 1 and 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boit et al. (US 2012/0156496; of record) in view of Scott (US 3341415).
Boit teaches a mannitol powder having mannitol particles wherein 99.9% volume of the particles have a particle size greater than 75 microns, from 0.1-60% of volume having particles greater than 200 microns and a mean diameter of between 100-300 microns (see abstract and claim 1) (see instant claims 1 and 2). Thus, it would have been obvious to formulate a mannitol powder having a size distribution wherein 90-100% of the particles have a size ranging between 1-500 microns (or 90-100% having a size distribution from 1-250 microns). See MPEP 2144.05(I) regarding obviousness of overlapping/similar ranges.
Boit’s particles are described as having a mannitol richness (content) of 96-100% by weight of the composition (see claim 3) (see instant claim 2). In the obvious circumstance that the powder comprises 100% mannitol, the composition would be devoid of excipients and/or pyrogenic substances (see instant claim 2).
The mannitol particles are to have a bulk density of between 0.540-0.700 g/mL which overlaps with the instantly claimed range of 0.50-0.62 g/mL. See MPEP 2144.05(I) regarding the obviousness of overlapping ranges.
Boit’s particles may be compressed in to a dosage form (e.g. tablet) or provided as a sachet or filled in to a capsule (see [0031]). Boit teaches that dosage form can contain 1300 grams of mannitol (see [0090]).
Boit fails to teach the amount of mannitol in the composition as being from 50-200 grams.
Scott is directed to tablets comprising mannitol as an excipient. It is taught by Scott that mannitol can be present in a tablet in an amount of 80 grams (see Examples 4 and 5). Thus, as it was known that mannitol could be included into a dosage form in an amount of 80 grams, it would have been obvious to manipulate Boit’s dosage form to include mannitol in such an amount.
However, even without Scott’s teaching, the claimed invention would be obvious as differences in concentration do not support patentability of subject matter described by the prior art absent evidence that such concentration is critical. MPEP 2144.05(II)(A) states that when the general conditions of a claimed invention are described by the prior art (such as here), it is not inventive to discover optimum or workable ranges by routine experimentation. The mere carrying forward of a known conception involving only changing the proportion of the material amounts to doing the same thing as the original invention.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611
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