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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of the Application
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-30
Withdrawn claims: 21-26 and 28-30
Previously canceled claims: None
Newly canceled claims: 27
Amended claims: 1-20, 23, 26, and 30
New claims: 31
Claims currently under consideration: 1-20 and 31
Currently rejected claims: 1-20 and 31
Allowed claims: None
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-20, in the reply filed on 03/25/2026 is acknowledged.
Claims 21-26 and 28-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Regarding the election of species, Applicant elected separate layers for protein and starch and argued that species groups B and C were moot in light of the election of Group 1, claims 1-20 and 31. Applicant’s argument is persuasive, and the requirement for election of a species is withdrawn.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 8-12, 19, 20, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (Chen et al., “Development and characterization of a hydroxypropyl starch/zein bilayer edible film,” International Journal of Biological Macromolecules, 141 (2019) 1175-1182).
Regarding claim 1, Chen et al. discloses a film comprising greater than or equal to 50 wt% of a combination of a plant protein (zein) and a starch (“HPS”, i.e., hydroxypropyl starch), based upon the total weight of the film (where no other solids are taught as being present), wherein a weight ratio of the starch to the plant protein is in the range of 0.5:1 to 30:1 (i.e., 6.25 mL of 6% w/v HPS and 2.5 ml of 15% w/v zein, which would equate to 0.375 g HPS:0.375 g zein, or 1:1), and wherein the plant protein has been pretreated with organic acid (i.e., acetic acid) (p. 1176, § 2.2 Films preparation, ¶1-¶2).
Chen et al. does not explicitly disclose the total weight of the film as being measured at 55% relative humidity and 22°C.
However, Chen et al. does disclose the films as being maintained at 53 ± 1% relative humidity and at 25 ± 0.5 °C, which is considered close enough to the claimed conditions to be obvious, since no appreciable difference in component attributes would be expected between the disclosed conditions and those claimed. MPEP 2144.05 I (“a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”).
As for claim 2, Chen et al. discloses a first layer comprising at least a portion of the starch and a second layer comprising at least a portion of the plant protein, wherein the second layer is in contact with a first surface of the first layer (p. 1176, § 2.2 Films preparation, ¶2).
As for claims 3 and 4, no method is required for the production of the film, such that the designation between the first layer and the second layer is arbitrary. The “first layer” of the film of Chen et al. may be deemed to include more or less than the first material that is poured, such that the “first layer” (i.e., the first poured layer plus some additional portion of the second poured layer that may be arbitrarily deemed to comprise part of the “first layer”) may be said to comprise a portion of the plant protein (claim 3) or the “second layer” (i.e., the first poured layer minus some portion of the first poured layer that may be arbitrarily deemed to comprise part of the “second layer”) may be said to comprise a portion of the starch (claim 4).
As for claim 5, Chen et al. discloses the weight ratio of the starch to the plant protein in the bilayer film is 1:1 (i.e., 6.25 mL of 6% w/v HPS and 2.5 ml of 15% w/v zein, which would equate to 0.375 g HPS:0.375 g zein, or 1:1), and further discloses films comprised only of starch (S) or plant protein (Z) (p. 1176, § 2.2 Films preparation, ¶2; p. 1178, Table 1). MPEP 2144.05 II A indicates that “differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’” The disclosed films comprising only either component individually thus effectively render obvious all intermediate relative concentrations of starch and plant protein due to involving merely the modification of concentrations, which renders the claimed ratio of starch to plant protein of 2:1 to 27.5:1 obvious.
As for claim 6, Chen et al. discloses the weight ratio of the starch to the plant protein as being within the range of 1:2 to 3:1 (i.e., 6.25 mL of 6% w/v HPS and 2.5 ml of 15% w/v zein, which would equate to 0.375 g HPS:0.375 g zein, or 1:1) (p. 1176, § 2.2 Films preparation, ¶2).
As for claim 8, Chen et al. discloses the plant protein as comprising 50 wt% in the bilayer film (i.e., 6.25 mL of 6% w/v HPS and 2.5 ml of 15% w/v zein, which would equate to 0.375 g HPS:0.375 g zein), and further discloses films comprised only of starch (S) or plant protein (Z) (p. 1176, § 2.2 Films preparation, ¶2; p. 1178, Table 1). MPEP 2144.05 II A indicates that “differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’” The disclosed films comprising only either component individually thus effectively render obvious all intermediate relative concentrations of starch and plant protein due to involving merely the modification of concentrations, which renders the claimed concentration of 2.0 to 40 wt.% of the plant protein based on the total weight of the film obvious.
As for claim 9, Chen et al. discloses the starch as being maize starch (i.e., corn starch) (p. 1176, § 2.1 Materials).
As for claim 10, Chen et al. discloses the film as comprising 30-70 wt.% of the starch based on the total weight of the film (i.e., 6.25 mL of 6% w/v HPS and 2.5 ml of 15% w/v zein, which would equate to 0.375 g HPS:0.375 g zein, or 50 wt.% starch) (p. 1176, § 2.2 Films preparation, ¶2).
As for claim 11, Chen et al. discloses the film initially comprised water in an amount that is presumed to exceed the claimed range and that the film was dried, which is presumed to result in a moisture content approaching 0 wt% of water (p. 1176, § 2.2 Films preparation, ¶2). Chen et al. is thus interpreted as implicitly disclosing the film as comprising an amount of water of 8-20% based on the total weight of the film at some point between the preparation and cessation of drying, which renders the claimed water content obvious to a skilled practitioner.
As for claim 12, Chen et al. discloses the film as comprising glycerol (p. 1176, § 2.2 Films preparation, ¶1).
As for claim 19, Chen et al. discloses the organic acid is acetic acid (p. 1176, § 2.2 Films preparation, ¶1).
As for claim 20, the present specification indicates that “[t]he pre-treatment of the plant protein with an organic acid results in the plant protein having a protein secondary structure with at least 40% intermolecular β-sheet” (p. 6, ¶2). Chen et al. discloses pre-treatment of zein with acetic acid (p. 1176, § 2.2 Films preparation, ¶1). The treated plant protein of Chen et al. is thus presumed to have a protein secondary structure with at least 40% intermolecular β-sheet. MPEP 2112.01 I (“Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.”).
As for claim 31, Chen et al. discloses the film is edible (Abstract).
Claims 7 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (Chen et al., “Development and characterization of a hydroxypropyl starch/zein bilayer edible film,” International Journal of Biological Macromolecules, 141 (2019) 1175-1182) in view of Ninomiya et al. (U.S. 5,089,307).
Regarding claim 7, Chen et al. discloses the film of claim 1.
Chen et al. does not disclose the plant protein as being from among the selected group.
However, Ninomiya et al. discloses an edible film comprising soybean protein (C2, L41-L47).
It would have been obvious to one having ordinary skill in the art to produce a film according to Chen et al. comprising soybean protein. Although Chen et al. incorporates zein as the protein of the bilayer film (p. 1175, column 2, ¶2), the reference earlier suggests more broadly that edible packaging materials made from proteins are known in the art (p. 1175, column 1, ¶1), which would prompt a skilled practitioner to consult Ninomiya et al. for such types of suitable proteins. Since Ninomiya et al. discloses soybean protein as suitable for use in an edible film, the incorporation of soybean protein into the film of Chen et al. would be obvious to a skilled practitioner.
As for claim 13, Chen et al. discloses the film of claim 12.
Chen et al. does not disclose the plasticizer (glycerol) as being at a concentration of 5-30 wt.%.
However, Ninomiya et al. discloses an edible film comprising a polyhydric alcohol (C2, L31-L47) that may be glycerol (C5, L1-L5) in amount effectively ranging from 0-50% by weight (C4, L45-L57).
It would have been obvious to one having ordinary skill in the art to produce a film according to Chen et al. comprising glycerol in an amount of 5-30 wt%. Although Chen et al. incorporates glycerol in amounts that appear to be below 50 wt% (p. 1176, § 2.2 Films preparation, column 1), it is unclear what the glycerol concentration would be following formation of the bilayer film and drying. A skilled practitioner would be motivated to consult Ninomiya et al. for clarification regarding the component. Since Ninomiya et al. disclose broadly that glycerol may be included in amounts that merely remain below the concentration of the principal component (C4, L45-L57), a skilled practitioner would find the formation of a film according to Chen et al. comprising from 5-30 wt.% glycerol to be obvious.
As for claim 14, Ninomiya et al. discloses the inclusion of a dye in an edible film (C4, L54-L60), which renders its inclusion in the film of Chen et al. obvious. A skilled practitioner would be motivated to consult Ninomiya et al. for broader instruction regarding suitable film ingredients than merely those used in the exemplary formation of Chen et al.
As for claim 15, Ninomiya et al. discloses the inclusion of water-soluble cellulose in an edible film (C3, L60 – C4, L2), which renders the inclusion of cellulose fibers extracted from the pulp of citrus fruits in the film of Chen et al. obvious. A skilled practitioner would be motivated to consult Ninomiya et al. for broader instruction regarding suitable film ingredients than merely those used in the exemplary formation of Chen et al.
As for claim 16, Ninomiya et al. discloses the cellulose component may used in combination with other components (C3, L60 – C4, L2), which indicates any individual components may be present in amounts ranging from 0 wt.% to essentially 50 wt.%. The claimed concentration range of 0.5-5 wt.% of the structural reinforcement agent would thus be obvious to a skilled practitioner.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (Chen et al., “Development and characterization of a hydroxypropyl starch/zein bilayer edible film,” International Journal of Biological Macromolecules, 141 (2019) 1175-1182) in view of Kitamura et al. (U.S. 2005/0233048 A1).
As for claim 17, Chen et al. discloses the film of claim 1.
Chen et al. does not disclose film as comprising a hydrophobic agent.
However, Kitamura et al. discloses an edible film ([0015]) that may comprise a fat or oil ([0060]).
It would have been obvious to one having ordinary skill in the art to include a fat/oil in the film of Chen et al. A skilled practitioner would be motivated to consult Kitamura et al. for broader instruction regarding suitable film ingredients than merely those used in the exemplary formation of Chen et al. Since Kitamura et al. disclose the inclusion of a fat/oil in an edible film as an optional component ([0060]), a skilled practitioner would find the incorporation of a fat/oil (which would constitute a hydrophobic agent) into the film of Chen et al. to be obvious in order to impart characteristics of such components, such as flavor or organoleptic properties.
As for claim 18, Kitamura et al. discloses the fat/oil may be added “in a suitable manner depending on the use of the film” ([0060]), which indicates the fat/oil concentration would be a result-effective variable subject to optimization depending on the aim of the film. Incorporation into the film of Chen et al. a fat/oil in an amount of 0.3-2.5 wt% would thus be obvious to a skilled practitioner. MPEP 2144.05 II A.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY P MORNHINWEG whose telephone number is (571)270-5272. The examiner can normally be reached 8:30AM-5:00PM.
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/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793
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