Election/Restrictions
Applicant's election with traverse of Group II, claims 6-14 and 18-20 in the reply filed on 08/16/2026 is acknowledged. The traversal is on the ground(s) that the claims make a contribution over the prior art Rao. This is not found persuasive because the claims to not make a contribution over the cited art Lin et al. in view of Erickson et al.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 20 is objected to because of the following informalities: Claim 20 contains a typographical error “biodgradable”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7, 19 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation “the amount of polymer is 10 to 66 wt%” and “the amount of amyloid fibrils is 33 to 90 wt% and “an amount of additives ranges from 0 – 40 wt%, and the claim also recites “preferably ranges from ranges from 20 to < 50 wt%;”, “preferably ranges from > 50 - 80 wt%” and “preferably 5 - 35 wt%,in each case based on dry wt%” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 19 depends from claim 6. Claim 6 is limited to “water soluble biodegradable polymer”. Claim 19 recites water insoluble polymer which broadens and therefore does not further limit claim 6 and is therefore indefinite.
Claim 20 depends form claim 6 which recites “wherein said amyloid fibrils (i) are obtained from the group of plant-based proteins and/or obtained from whey”. Claim 20 recites “biodgradable polymer and amyloid fibrils obtained from feather”. Claim 20 is indefinite because a feather is not plant based or whey.
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) 6-14, 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al (U.S. Pat. No. 5,320,669) in view of Erickson et al. (Corn zein undergoes conformational changes to higher β-sheet content during its self-assembly in an increasingly hydrophilic solvent; International Journal of Biological Macromolecules 157; 232–239; 2020).
Regarding claims 6 and 14, Lin et al. teaches a biodegradeable thermoplastic composition made of cereal grain that is treated with organic solvent, cross-linking agent such as an acid anhydride to link together the starch and protein which meets a broad and reasonable interpretation of a composite material obtained from the group of plant-based proteins and/or obtained from whey (abstract). Lin et al. teaches polyvinyl acetate, methyl cellulose which meets the limitation of a water soluble biodegradable polymer (column 6, lines 25-50). Lin et al. teaches a cereal protein such as zein is treated with an acid anhydride cross-linking agent (column 3, lines 15-25; column 3, lines 50—65). Lin et al. teaches a cross-linked thermoplastic molded composition comprising cereal starch and protein which meets a broad and reasonable interpretation of wherein said amyloid fibrils are distributed within said water soluble biodegradable polymer (column 8, lines 1-67). Lin et al. does specify amyloid fibrils i.e. the conformation of the protein structure after acid treatment or heating.
Erickson et al. teaches zein have also shown increases in β-sheet contents under conditions which result in protein self-assembly such as elevated temperature, evaporation and ethanol concentration (page 232). Erickson et al. detection of β-sheet structure in amyloid fibril systems (page 233). It would have been obvious to one of ordinary skill in the art at the time of filing the treated zein proteins taught by Lin et al. would be comprised of amyloid fibrils because the zein protein taught by Lin et al. are treated with acid solutions and heat.
Regarding claim 7, Lin et al. teaches cereal grain comprises about 60 to 95% starch, and about 5 to 40% water-insoluble proteins such as gluten and zein (column 3, lines 50-65).
Regarding claim 8, Lin et al. teaches a biodegradeable composition wherein the articles made from the composition of the invention will degrade over time when exposed to moisture, such as from the atmosphere and the package contents, or from submersion in water or other direct contact with water, the articles of the invention, particularly those that include a cross-linking agent, have a higher resistance to such disintegration and will remain substantially intact for a more extended period of time than articles made from other starch-based thermoplastics (column 9, lines 1-50). Lin et al. teaches a biodegradeable compositions wherein the composition may be comprised entirely of components that are edible by a mammal including humans, or other animal, so that articles molded from such compositions may be safely consumed by the animal (column 9, lines 1-50). It is clear that the biodegradeable composition taught by Lin et al. would necessarily meet the claimed ISO standard.
Regarding claim 9, Lin et al. teaches starch and natural cellulose which meets the limitation of the group of natural polymers and modified natural polymers (columns 5 and 6).
Regarding claim 10, Lin et al. teaches flour, meal and grits which meets the limitation are obtained from the group of plant based proteins (column 2).
Regarding claim 11, Lin et al. teaches plasticizers, crosslinkers and acids (column 5 and 6).
Regarding claim 12, Lin et al. teaches 211 kg/mm2, 2.07 gigapascal, which is encompassed by the composite material has a Young's modulus in the range of 0.01-4 GPa (column 11, Table 2).
Regarding claim 13, Lin et al. teaches composition of the invention may be molded to provide articles of varying shapes, sizes and dimensions, that are useful in a variety of applications and may be molded into an article such as a sheet, film, capsule, tray, bottle, tubing or the like which encompasses in the form of a self-supporting film, a coating on a substrate or on an article or granules or pellets or blocks (column 9, lines 1-40).
Regarding claim 18, Lin et al. teaches plasticizers, crosslinkers and acids (column 5 and 6).
Regarding claim 19, Lin et al. teaches PVA, methyl cellulose, etc (column 6).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. in view of Erickson et al. as applied to claim 6 above, and further in view of Azevedo et al. (Effect of replacement of corn starch by whey protein isolate in biodegradable film blends obtained by extrusion; Carbohydrate Polymers 157 971–980; 2017).
Lin et al. in view of Erickson et al. teaches a biodegradable thermoplastic composition made of cereal grain such as corn that is treated with organic solvent, cross-linking agent to link together the starch and protein. Lin et al. does not teach whey.
Azevedo et al. teaches the effect of replacing corn starch by whey protein isolated (WPI) in biodegradable polymer blends (abstract). Azevedo et al. teaches an increase in tensile strength for the TPS70/WPI30 film (page 977). Azevedo et al. teaches the TPS70/WPI30 film presented as more resistant, less flexible and with low elongation compared to the TPS film (page 979). Azevedo et al. teaches the addition of WPI in the TPS matrix made the films more stable to thermal decomposition (page 979). It would have been obvious to on of ordinary skill in the art to add whey proteins to the starch/ amyloid blend taught by Lin et al. in view of Erickson et al. because the addition of whey makes the biodegradable composite more resistant, less flexible and with low elongation and more stable to thermal decomposition.
Conclusion
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/GUINEVER S GREGORIO/Primary Examiner, Art Unit 1732 10/10/2026
