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 .
Election/Restrictions
Applicant’s election without traverse of (ii) base material: polyethylene oxide; and ratio of claim 4 (microcrystalline cellulose : maltitol is 0.5 to 7.5) in the reply filed on 5/8/2025 is acknowledged.
Claims 3, 5 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/8/2025.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 4, 8-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barkalow et al. (EP 1 621 080 A1; 2006; cited in a prior Office action).
Barkalow teaches edible films (abstract); comprising at least one film forming agent (claim 1); containing a sweetener (claim 7; wherein the sweetener is selected from a group containing inter alia, maltitol (claim 8). Wherein the edible film comprises a filler (claim 13); wherein the filler is selected from a group consisting of inter alia, microcrystalline cellulose (claim 14); the filler is present in the amount of 5% to 15% (claim 16); the filler can constitute 2% to 30% by dry weight of the film [0014]. The edible film further comprises a softener (claim 17); the softener is selected from a group including, inter alia, polyethylene glycol (a.k.a. polyethylene oxide; claim 18); the softener is present in an amount of 2% to 10% (claim 20). Exemplary microcrystalline cellulose amounts in tables range from 6.8-7.2%, reading on concentrations of claim 1, 5, 10 & 13. Note that concentrations are dry weight [0014], [0015], Table 1.
While the position might be adopted that the elected combination of ingredients are clearly taught (and claimed) and thus the edible film of claim 1 is anticipated; however, they are not all taught in the same embodiment; thus, in the interest of compact prosecution, the position is adopted that the edible film is not anticipated. It would have been obvious to combine the instant recited (and claimed) ingredients, for the purposes taught, giving the elected edible film of claim 1.
Regarding uniform dispersion of the microcrystalline cellulose, the uniform characteristic is taught (stir until appearance is uniform) [0029].
Regarding claim 4, the amount of maltitol is not explicitly taught. Other examples of sweetener would have been reviewed to evaluate an approximate amount for maltitol. Examples use sucralose in amounts ranging from about 2.6 to 3.1%. Adopting this sucralose range, when maltitol is used, would have rendered a ratio of about 7/3 for amounts of microcrystalline cellulose/maltitol, or a ratio of about 2.3 or similar ratios, would have been prima facie obvious, reading on the elected ratio of claim 4, as well as maltitol concentrations of claim 1, 8, 9, 11& 12. Other claimed ratios would also have been obvious as a result of routine optimization, using amounts named as starting points, which would have resulted in ratios within the scope of claim 4 & 8.
Note that concentrations are dry weight [0014], [0015], Table 1 (i.e., based on total weight of the edible film, prior to base solution formation, which is then dried to form films).
Regarding the maltitol being blended with base material prior to drying, [0024]- [0025] teaches the dry ingredients are added to water that is stirred, and the solution is stirred continuously and heated at a temperature ranging from 40 degrees C to 60 degrees C. This satisfies the blending of maltitol with base material prior to drying the edible film, thereby reducing an aggregation of microcrystalline cellulose during drying, absent evidence to the contrary.
The amendment to claims 1 and 8 add product by process limitations, where content of base material in the solution exhibits thixotropic behavior of a ratio range 2-10, which thereby reduces aggregation of MCC during dying and suppressing convection during the drying of the edible film. Reduction of aggregation is clearly taught by Barkalow.
Regarding product by process claims, these claims are not limited to the manipulations of the recited steps, only the structure implied by the steps (MPEP 2113(I)).
The Declaration of Masateru Chiyama filed 4/17/2026 provides some evidence of apparently hypothetical solutions 1-11, which are not limited to the claimed components, or any specific example, but include other components; MCC and corn starch amounts were varied and η0/ η100 ratios are reported. Examiner notes that there is some overlap between MCC amounts within the range taught by Barkalow and the η0/ η10 ratio being within the claimed 2-10 range of Solutions 8, 9 & 10. MCC amounts are taught including: Exemplary microcrystalline cellulose amounts in tables range from 6.8-7.2%; when filler is MCC (claim 14) and the range of filler is present 2% to 30%, the MCC amounts encompass the range for which η0/ η10 ratio is reported to be within the claimed 2-10 range in Solutions 8, 9 & 10. Thus, the product by process limitations of these claims do not appear to define a product different from that of Barkalow. Per MPEP 2113 (II), once a product appearing to be substantially identical is found and a prior art rejection is made, the burden shifts to the Applicant to show an unobvious difference.
Applicant previously argued that combination of microcrystalline cellulose (MCC) in an amount of 5-50% and maltitol in an amount of 1-35 wt% by total weight of the edible film prior to drying the edible film allegedly yields unexpected technical results, specifically a reduction in aggregation of the MCC during drying of the edible film, and further alleges that such results would not have been predictable or obtainable through routine experimentation by one of ordinary skill in the art. The range of amounts of MCC substantially overlap within the range of claim 1, permitting envisage of the specific ranges. Example amounts of MCC are within the narrower range 6.8-7.2%, within each recited MCC range. Sucralose ranges in examples range from 2.6 to 3.1%, rendering this range prima facie obvious when maltitol is utilized. This obvious amount range is also within each claimed maltitol range.
Thus, claimed combination, in amounts within claimed ranges are clearly suggested by Barkalow.
Applicant previously further argued that percentages of solution weight prior to drying the edible film, which includes a substantial amount of water and other volatile components, whereas Barkalow’s weight percentages are based on dried film weight; allegedly these are not interchangeable because the drying process significantly changes the total weight.
The examine disagrees that solution weight percent is indicated by the claims. Claim 1 recites MCC and maltitol wt% based on the total weight of the edible film prior to drying.
Review of Barkalow indicates initial mixture of dry ingredients are added to water, followed by stirring and stirring continuously, followed by drying. The measurement of dry ingredients, which clearly correspond to concentrations taught, occurs at the point of [0024], which is clearly before drying the edible film, which occurs at drying of the last line of [0025]. Thus, teachings of Barkalow render obvious the amended claims.
Examiner notes that if Applicant wishes to claim the content in a solution, then this should be clearly indicated in the claims. Examiner notes that Table 3 amounts do not include content of water; therefore, the argued meaning would not be construed from examples.
Examiner notes that Barkalow clearly teaches edible films without aggregation. Even if this requires considering amounts in an alternate manner, routine optimization of amounts to achieve the results taught would have been obvious, to resolve any aggregation and achieve the no aggregation embodiments taught, rendering obvious claimed amounts.
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY P THOMAS whose telephone number is (571)272-8994. The examiner can normally be reached M-Th 6:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TIMOTHY P. THOMAS
Primary Examiner
Art Unit 1614
/TIMOTHY P THOMAS/Primary Examiner, Art Unit 1614
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