DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt of the Response and Amendment after Non-Final Office Action filed 04/28/2026 is acknowledged.
Applicant has overcome the following rejections by cancellation of the claims: the 35 U.S.C. §103 of claims 23-24 over Porzio, Chen, and Toth as evidenced by Uhlemann has been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 23, 26
Withdrawn claims: None
Previously cancelled claims: 1-22, 25
Newly cancelled claims: 24
Amended claims: 23
New claims: 26
Claims currently under consideration: 23, 26
Currently rejected claims: 23, 26
Allowed claims: None
Claim Objections
Claim 23 is objected to because of the following informalities:
In line 11, “relativity” should be read as “relative”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 23 and 26 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 23 recites that the granule formulation contains 30-45 wt.% of a combination of maltodextrin and maltose, wherein the weight ratio of maltose to maltodextrin is from 3:1 to 1:2. Claim 23 also recites that the granule formulation is amorphous, stable at 40°C, exhibits a glass transition temperature (Tg) of 15-35°C and passes hygroscopicity testing for seven days at 30°C/65% relative humidity. However, the specification and claims as originally filed did not mention the formulation being amorphous or having stability, Tg, and hygroscopicity as now recited by present claim 23. The present specification only mentions these features in [0060] in relation to the formulation prepared from 15 wt.% maltose and 17-27 wt.% maltodextrin (i.e., [0063] of the present specification mentions hygroscopicity but does not mention stability at 40°C or Tg). The formulation of [0063] containing 15 wt.% maltose and 17-27 wt.% maltodextrin contains the combination of maltose and maltodextrin in amount of 32-42 wt.%, thereby providing a maltose to maltodextrin weight ratio of 1:1.13 to 1:1.8. Therefore, neither the specification nor claims as originally filed disclose an amorphous formulation having the claimed stability, Tg, and hygroscopicity wherein the formulation comprises: (A) a combination of maltose and maltodextrin in an amount of from 30 wt.% to an amount of less than 32 wt.%; or in an amount of from greater than 42 wt.% to an amount of 45 wt.%; and (B) a weight ratio of maltose to maltodextrin outside of the range of 1:1.13 to 1:1.8 (e.g., 3:1) as recited in present claim 23. Therefore, claim 23 recites new matter.
Claim 26 is rejected by reason of dependency from claim 23.
Response to Arguments
Claim Rejections – 35 U.S.C. §103 of claim 23 over Porzio and Chen as evidenced by Uhlemann; claim 24 over Porzio, Chen, and Toth as evidenced by Uhlemann: Applicant’s amendments with respect to claim(s) 23 have been considered and are considered to overcome the prior art rejection written in the previous Office Action. Therefore, the rejection of claim 23 is withdrawn.
The rejection of claim 24 is moot due to the cancelation of the claim.
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 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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/K.P.K./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
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