DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of t/e previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/11/2026 has been entered.
Status of Application
The Examiner acknowledges receipt of the amendments filed on 3/11/2026 wherein claim 1 has been amended.
Claims 1 and 2 are presented for examination on the merits. The following rejections are made.
Response to Applicants’ Arguments & Response to 1.132 Declaration
Applicant’s arguments/amendments filed 3/11/2026 overcome the rejection of claims 1-2 made by the Examiner under 35 USC 103 over Boit et al. (US 2012/0156496) in view of Scott (US 3341415). This rejection has been withdrawn.
The declaration under 37 CFR 1.132 filed 3/11/2026 is sufficient to overcome the rejection of claims 1 and 2 based upon Boit et al. (US 2012/0156496) in view of Scott (US 3341415).
New Rejections, Necessitated by Amendment
Claim Rejections - 35 USC § 103
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 Schwarz et al. (US 2003/0188679).
Schwarz teaches a powdered mannitol composition, wherein the powdered mannitol particles are to have a size distribution of between 1-200 microns (preferably 20-125 microns) (see [0023]). It is presumed that 100% of the mannitol particles are encompassed within this range. Schwarz’s mannitol has an apparent (i.e. bulk) density of 20-70g/100mL (0.2-0.7 g/mL) with 60 g/100mL (0.60 g/mL) being specifically enumerated (see [0023, 0033]). It is taught that particles present in the powder having the aforementioned properties exhibit good fluidizing properties, a better flowability, an excellent dispersibility and improved solubility (see [0034]). Mannitol filled capsules are described wherein mannitol is present together with a therapeutic (salbutamol) such that mannitol comprises about 96wt% of the fill (see Table II). The blend of mannitol and the therapeutic agent is considered overlapping with instant claim 2’s requirement that the composition be “devoid of excipients and/or pyrogenic substances” as the drug used in combination with mannitol is neither an excipient or a pyrogenic substance. Capsules comprising about 30 mg of mannitol fill are described.
Although Schwarz teaches filling capsules with about 30 mg mannitol, Schwarz fails to teach a capsule the comprises between 50-200 gram of mannitol. However, such a difference in capsule fill is nothing more than a change in the size/proportion of an old, already described prior art composition. Limitations relating to the size (i.e. mass) of mannitol in the final capsule product are insufficient to distinguish the claimed invention over the prior art because the nature of the composition is the same. See MPEP 2143.03(IV)(A).
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
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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