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Claims 3, 5 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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.
Applicant argues 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 further argues 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.
Conclusion
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