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 .
Response to Amendment
The amendment filed on January 13, 2026, has been entered. Claims 14 – 33 are pending and under examination. Claims 1 – 13 are cancelled. Applicant’s arguments have been considered and found unpersuasive (see the discussion of Applicant’s argument in the Response to Arguments section below). Therefore, the previously presented rejection to claims 14 – 33 are hereby reinstated in their entirety.
Claim Rejections - 35 USC § 103
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.
Claim(s) 14 – 21 are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0196071 A1 (Mentink et al.; of record), in view of Shi et al. (US 2009/0247036 A1).
Regarding claim 14. Mentink et al. teaches a method for producing a compound or film (e.g., see Mentink [0197, 0200, 0208]) comprising:
mixing a thermoplastic starch (e.g., “ester of starchy material” see [0038 – 0039, 0062, 0168], and e.g., [0072] could be water-soluble and “may advantageously be chosen from pregelatinized starches, extruded starches, spray-dried starches, dextrins, maltodextrins, functionalized starches or any mixtures of these products, optionally plasticized,” [0082] and could be prepared using an esterifying agent that “may be an organic acid anhydride, an organic acid, a mixed anhydride, an organic acid chloride or any mixture of these, the acid chosen from saturated or unsaturated acids having from 2 to 24 carbons”),
an alpha-hydroxycarboxylic acid ROHCOOH (e.g., Mentink [0147 – 0158] discloses that the composition may also comprise other additional products, such as [0157] “an agent which improves the durability of the material or an agent for controlling its (bio)degradability,” “preservatives such as in particular organic acids, in particular acetic acid or lactic acid” [analogous to the claimed “an alpha-hydroxycarboxylic acid ROHCOOH, wherein R is CH2 or CH3CH”], wherein R is CH2 or CH3CH (e.g., lactic acid “CH3CH(OH)COOH”), and
a thermoplastic polymer (e.g., “elastomeric non-starchy polymer,” “thermoplastic elastomers derived from polyolefins,” see [0105 - 0113]) to obtain a mixture [0119];
extruding the mixture to form a compound or a film (e.g., see [0197], [0223]); and
heating the compound or film to 40 – 140 °C (see [0222] discloses examples heated at different temperatures from 40 to 140 °C), during or after extrusion (e.g., see [0166] The optional incorporation of any additional product may be carried out by physical mixing under cold conditions or at low temperature, but preferably by kneading under hot conditions at a temperature greater than the glass transition temperature of the composition. This kneading temperature is advantageously between 60 and 200 °C, better still between 100 and 180 °C. This incorporation may be carried out by thermomechanical mixing, batchwise or continuously and in particular in line. In this case, the mixing time may be short, from a few seconds to a few minutes.”).
Mentink et al. does not specifically disclose the alpha-hydroxycarboxylic acid in an amount of 0.1 to 5% by weight in relation to the thermoplastic starch, and heating the compound or film to 100 – 140 °C.
Nonetheless, Mentink [0147 – 0158] teaches that the compound or film could have additional products/agents targeted at further improving the composition’s physicochemical properties, in particular its processing behavior and its durability, or else its mechanical, thermal, conductive, adhesive or organoleptic properties, e.g., a preservative agent such as lactic acid [0157], and Mentink further teaches examples heating the compound or film to 40 – 140 °C (e.g., see [0222]) – overlapping with the claimed heating range).
Overlapping ranges are prima facie evidence of obviousness.
Therefore, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected the portion of Mentink's temperature range that corresponds to the claimed range. In re Malagari, 184 USPQ 549 (CCPA 1974). See MPEP § 2144.05 (I).
Shi et al. teaches a method for forming a melt-extruded substrate that comprises a thermoplastic starch formed from about 30 wt. % to about 95 wt. % of at least one starch, from about 1 wt. % to about 35 wt. % of at least one plasticizer, and from about 1 wt. % to about 35 wt. % of at least one weak organic acid. [0003]-[0004], [0017], and discloses at [0023]-[0024] that suitable weak organic acids that may be use are, among others,
glycolic acid [“alpha-Hydroxyacetic acid”, Molecular Formula: C2H4O3 (HOCH2COOH)1, conforming to the claimed “an alpha-hydroxycarboxylic acid ROHCOOH, wherein R is CH2”], and/or
lactic acid [“alpha-Hydroxypropionic acid”, Molecular Formula: C3H6O3
(CH3CHOHCOOH)2, conforming to the claimed “an alpha-hydroxycarboxylic acid ROHCOOH, wherein R is CH3CH”].
Shi et al. at [0023] discloses that “the relative amount of starch, weak organic acid, and plasticizer employed in the thermoplastic starch may vary depending on a variety of factors, such as the desired molecular weight, the type of starch, the affinity of the plasticizer for the starch, etc.” But that “typically”, the native starch constitutes from about 30 wt. % to about 95 wt. %, in some embodiments from about 40 wt. % to about 90 wt. %, and in some embodiments, from about 50 wt. % to about 85 wt. % of the thermoplastic starch,
the weak organic acid may constitute from about 1 wt. % to about 35 wt. %, in some embodiments from about 2 wt. % to about 30 wt. %, and in some embodiments, from about 5 wt. % to about 25 wt. % of the thermoplastic starch [overlapping with the claimed range of from “0.1 to 5 % by weight in relation to the thermoplastic starch],
the plasticizer typically constitutes from about 1 wt. % to about 35 wt. %, in some embodiments from about 2 wt. % to about 30 wt. %, and in some embodiments, from about 5 wt. % to about 25 wt. % of the thermoplastic composition.
Overlapping ranges are prima facie evidence of obviousness.
Therefore, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected the portion of Shi's alpha-hydroxycarboxylic acid (e.g., glycolic acid or lactic acid) range that corresponds to the claimed range, for the purpose of, as suggested by Shi et al., hydrolyzing the starch in a highly efficient manner to form compositions having a comparably lower weight average molecular weight, polydispersity index, and viscosity, which are particularly suitable for use in the formation of melt-extruded substrates by selectively controlling certain parameters of the melt blending process (e.g., content of the components, such as glycolic acid or lactic acid; see Shi et al. [0017]). In re Malagari, 184 USPQ 549 (CCPA 1974). See MPEP § 2144.05 (I).
Regarding clam 15. Mentink/Shi. teaches method of claim 14, wherein the alpha-hydroxycarboxylic acid is lactic acid. (see the discussion of Mentink/Shi in claim 1 above, and Mentink et al. [0147 – 0158], Shi et al. [0017], [0023]-[0024]).
Regarding clam 16. Mentink/Shi teaches method of claim 14, wherein the compound or film contains the alpha-hydroxycarboxylic acid in an amount of 0.1 to 1% by weight in relation to the thermoplastic starch (e.g., Shi et al. [0023] “the weak organic acid may constitute from about 1 wt. % to about 35 wt. %”).
Regarding claim 17. Mentink/Shi teaches the method of claim 14, wherein the heating could be before or after extrusion (Mentink [0103]), except for specifically disclosing, the heating lasts at least 15 minutes for a compound or at least 2 minutes for a film.
However, Mentink discloses it could be “a few seconds to a few minutes,” overlapping with the claimed range) – see Mentink [0103, 0116, 0166] e.g., [0116] “This incorporation may be carried out by thermomechanical mixing (e.g., while being heated), in a batchwise manner or continuously and in particular in-line. In this case, the mixing time may be short, from a few seconds to a few minutes.” Overlapping ranges are prima facie evidence of obviousness.
Accordingly, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected the portion of Mentink/Shi’s heating time range for a compound or for a film, that corresponds to the claimed ranges. In re Malagari, 184 USPQ 549 (CCPA 1974). As per MPEP § 2144.05 (I).
Regarding claim 18. Mentink/Shi teaches the method of claim 14, wherein the thermoplastic polymer is a polyolefin (Mentink [0145]), polyamide (Mentink [0145]), polyurethane (Mentink [0145]; Shi [0056]), polyester (Mentink [0145]; Shi [0032]), or mixture thereof (see Mentink “functionalized variants thereof and any mixtures of the aforementioned polymers”; Shi [0034]).
Regarding claim 19. Mentink/Shi teaches the method of claim 14, wherein, the thermoplastic starch is obtained by: mixing a starch (Mentink [0062 – 0070]; Shi [0021]), a polyol (Mentink [0093], Shi [0021]), and an epoxidised plant oil (Mentink [0093] “The plasticizing agent may also be an epoxidized vegetable oil, a glycol or derivative such as an ethylene glycol polyester”) to form a mixture (Shi [0017]),
wherein the polyol is in an amount of 10 to 25 % by weight of the mixture (e.g., Mentink [0139] When said composition contains one or more additional polymer(s)… “between 5 and 35%, expressed relative to the total weight of the composition according to invention”), and the epoxidised plant oil is in an amount of 0.1 to 6% by weight of the mixture (noticed that Mentink discloses the epoxidized plant oil could be added as a plasticizing agent [0093], therefore, been at least 5% to 20% by weight of the composition [0046]) – overlapping the claimed ranges. Overlapping ranges are prima facie evidence of obviousness.
Therefore, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected the portion of Mentink/Shi’s a polyol (Mentink [0093]), and an epoxidised plant oil (Mentink [0093]) amounts range in relation to the weight of the mixture, that corresponds to the claimed ranges. In re Malagari, 184 USPQ 549 (CCPA 1974). As per MPEP § 2144.05 (I).
Regarding claim 20. Mentink/Shi teaches the method of claim 19, wherein the polyol is polyethylene glycol (e.g., Mentink discloses “a glycol or derivative such as an ethylene glycol polyester” [0093]; Shi [0026]), a monosaccharide (e.g., “sucrose” Mentink [0112]; Shi [0021]), or a sugar alcohol ([0263] e.g., sorbitol, mannitol, xylitol, sorbitol; Shi [0021]).
Regarding claim 21. Mentink/Shi. teaches the method of claim 20, wherein the polyol comprises glycerol (Mentink [0263]; Shi [0021]), sorbitol (Mentink [0263]; Shi [0026]), xylitol (Mentink [0263]; Shi [0021]), and/or or mannitol (Mentink [0263] ; Shi [0021]).
Claim(s) 22 – 33 are rejected under 35 U.S.C. 103 as being unpatentable over Mentink et al. in view of Shi et al., as applied to claim 19, and further in view of US 2006/009611 A1 (Hayes), US 2009/0110942 A1 (Henderson-Rutgers et al.), and US 2014/0296391 A1 (Bond et al.).
Regarding claim 22. Mentink/Shi teaches the method of claim 19, wherein the epoxidised plant oil comprises soybean oil, linseed oil, sunflower oil, and/or rapeseed oil (Mentink [0093] “epoxidised vegetable oil”), except for specifically disclosing, wherein the epoxidised plant oil comprises sunflower oil, and/or rapeseed oil.
In the same field of endeavor of copolyester compositions for the production of film, [0010], Hayes discloses that the aromatic copolyetheresters containing hydroxyalkanoic acid residues can also contain additives “conventional in the art,” preferably “nontoxic, biodegradable and biobenign,” further discloses examples of plasticizers “which can be added to improve processing, mechanical properties, or to reduce rattle or rustle of the films, coatings and laminates of the present invention, include soybean oil, epoxidized soybean oil, corn oil, caster oil, linseed oil, epoxidized linseed oil, mineral oil, alkyl phosphate esters.
In the same field of endeavor of compositions capable of being injection mouldable and able to be made into a transparent film or incorporated (by co-extrusion and/or lamination) into multi-layer film products (Abstract), Henderson, discloses “Molded articles formed from compositions comprising thermoplastic starch, thermoplastic polymers, and oils, waxes, or combinations thereof are disclosed, where the oil, wax, or combination is dispersed throughout the thermoplastic polymer” (Abstract), at [0052] discloses “An alternative plasticiser is epoxidized linseed oil or epoxidized soybean oil. Being hydrophobic these additives may improve moisture sensitivity of the material.”
In the same field of endeavor of molded articles formed from compositions comprising thermoplastic starch [0011], thermoplastic polymers, and oils, waxes, or combinations thereof, where the oil, wax, or combination is dispersed throughout the thermoplastic polymer (Abstract), Bond et al. discloses [0009] “The oil, wax, or combination thereof can be selected from the group consisting of soy bean oil, epoxidized soy bean oil, maleated soy bean oil, corn oil, cottonseed oil, canola oil, beef tallow, castor oil, coconut oil, coconut seed oil, corn germ oil, fish oil, linseed oil, olive oil, oiticica oil, palm kernel oil, palm oil, palm seed oil, peanut oil, rapeseed oil, safflower oil, sperm oil, sunflower seed oil…” and that they “can be present in the composition in an amount of about 5 wt. % to about 40 wt. % based upon the total weight of the composition.,” [0009], “plasticizer can comprised a polyol,” [0012];
“An additional plasticizer or diluent for the thermoplastic polymer may be present to lower the polymer's melting temperature and improve overall compatibility with the thermoplastic starch blend…” e.g., sugar alcohols such as erythritol, [0030];
Therefore, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select the epoxidised plant oil of Mentink/Shi to comprises soybean oil, linseed oil, sunflower oil, and/or rapeseed oil, as taught by Hayes, Henderson, and Bond, for the purpose of improve processing, mechanical properties, or to reduce rattle or rustle of the films, coatings and laminates, as taught by Hayes [0044], improve moisture sensitivity of the material, as taught by Henderson [0052], and/or lower the polymer's melting temperature and improve overall compatibility with the thermoplastic starch blend, as taught by Bond [0009]). Since, it have held to be within the ordinary skill of worker in the art to select a known material on the basis of its suitability for the intended use. See MPEP 2144.07:
Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination.
Regarding claim 23. Mentink/Shi/Hayes/Henderson/Bond teaches the method of claim 19, except for specifically disclosing, wherein the amount of epoxidised plant oil is 2.5 to 3.5% by weight of the mixture.
Nonetheless, Mentink discloses the composition could comprise one or more plasticizers, such as these epoxidized plant oils, and the composition may comprise a coupling agent, [0121]; the coupling agent being any organic molecule bearing at least two free or masked functional groups capable of reacting with molecules bearing functional groups having an active hydrogen such as, for e.g., those of the ester of the starchy material or the plasticizer, [0122], and added in order to enable the attachment, via covalent bonds, of at least one part of the plasticizer to the ester of the starchy material and/or to the non-starchy polymer added, and/or be added as a crosslinking or vulcanization agent, [0122]; and chosen from compounds bearing at least two identical or different, free or masked, functional groups chosen from e.g., epoxide, [0123]; said coupling agent is preferably present in an amount of 0.1 to 15 parts by dry weight, [0136].
As the glass transition temperature and the crystallinity of the composition are variables that can be modified, among others, by adjusting the amounts of plasticizer (e.g., the epoxidized plant oil), and the thermomechanical treatment temperatures, with said glass transition temperature and crystallinity both advantageously being reduce (Mentink [0091]), the precise amount of epoxidised plant oil in relation to the weight of the mixture would have been considered a result-effective variable by one having ordinary skill in the art at the time the invention was effectively filed.
Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of the epoxidised plant oil amount in the method of Mentink/Shi/Hayes/Henderson/Bond to obtain the desired balance between the glass transition temperature and crystallinity (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). See MPEP § 2144.05 (II) (B).
Regarding claim 24. Mentink/Shi/Hayes/Henderson/Bond teaches the method of claim 19, wherein the polyol comprises sorbitol or erythritol (Shi [0021]) in an amount of 10 to 15 % by weight of the mixture (Mentink discloses polyols “such as ethanol, diethylene glycol, glycerol or sorbitol,” [0093], could be use as plasticizers in the amount of from “5 to 30%, better still from 5 to 20%” [0101]). Overlapping the claimed range.
Bond discloses “An additional plasticizer or diluent for the thermoplastic polymer may be present to lower the polymer's melting temperature and improve overall compatibility with the thermoplastic starch blend…” e.g., sugar alcohols such as erythritol, Bond at [0030].
Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of the polyol comprising sorbitol amount in the method of Mentink/Shi to obtain the desired balance between the glass transition temperature and crystallinity (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). See MPEP § 2144.05 (II) (B).
Regarding claim 25. Mentink/Shi/Hayes/Henderson/Bond teaches the method of claim 19, except for, wherein the mixture comprises epoxidised plant oil to polyol ratio of 1:4 to 1:6.
Henderson at [0024] discloses the composition may comprise, “c) from 5 to 45% by weight of a non-crystallizing mixture of sorbitol (e.g., a polyol) and at least one other plasticizer selected from e.g., epoxidised linseed or soybean oil.
Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the epoxidised plant oil to polyol ratio in the method of Mentink/Shi/Hayes/Henderson/Bond to obtain the desired balance between the glass transition temperature and crystallinity (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). See MPEP § 2144.05 (II) (B).
Regarding claim 26. Mentink/Shi/Hayes/Henderson/Bond teaches the method of claim 19, wherein the mixture further comprises an acid in an amount of 0.1 to 1% by weight of the mixture (e.g., Shi [0035]-[0047]).
Mentink discloses at [0123] the additional product could be a coupling agent such as protonic acid, acid anhydride, “preferably present in an amount of 0.1 to 15 parts by dry weigh,” [0136], and at [0157] “The additional product may be an agent which improves the durability of the material or an agent for controlling its (bio)degradability, chosen in particular from hydrophobicizing or beading agents, such as oils and fats, corrosion inhibitors, preservatives such as in particular organic acids, in particular acetic acid or lactic acid.”
Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of a further acid (e.g., protonic acid, anhydride acid, organic acid such as acetic and/or lactic acids; Mentink [0123, 0136, 0157]), in the method of Mentink/Shi/Hayes/Henderson/Bond to obtain the desired balance between the glass transition temperature and crystallinity (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). See MPEP § 2144.05 (II) (B).
Regarding claim 27. Mentink/Shi/Hayes/Henderson/Bond teaches the method of claim 26, wherein the acid comprises citric acid (Mentink discloses citric acid in [0093]), acetic acid (Mentink [0157]), and/or tartaric acid (Henderson discloses the use of a diacetylated tartaric acid as emulsifier [0058]).
Regarding claim 28. Mentink/Shi/Hayes/Henderson/Bond teaches the method of claim 26, wherein the mixture comprises the acid in an amount of 0.1 to 0.5% by weight of the mixture – e.g., Henderson discloses composition comprising acids in the range of from 0.1% (e.g., ascorbic acid, Example 13 [0079]) to e.g., 5% (e.g., citric acid, Example 13, [0079]), and at [0078] discloses a formulation (Example 12) consisting of 50% hydroxypropylated high-amylose corn starch, 20% glycerol, 10.3% polyvinyl alcohol, 10% maltitol, 5% sorbitol, 1% GMS, 0.26% sodium stearoyl lactylate, 1.1% potassium bisulfite, 1.1% ascorbic acid, 0.7% stearic acid, 0.5% citric acid – overlapping with the claimed range.
Overlapping ranges are prima facie evidence of obviousness.
Therefore, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected the portion of Mentink/Shi/Hayes/Henderson/Bond’s acid range in relation to the weight of the mixture, that corresponds to the claimed ranges, for the purpose of provide emulsifying properties to the mixture, as taught by Henderson. In re Malagari, 184 USPQ 549 (CCPA 1974). As per MPEP § 2144.05 (I).
Regarding claim 29. Mentink/Shi/Hayes/Henderson/Bond teaches the method of claim 19, wherein the mixture is extruded at a temperature of 100-175°C (see “100 – 180°C” Mentink e.g., [0103]). Overlapping ranges are prima facie evidence of obviousness. See MPEP § 2144.05 (I).
Regarding claim 30. Mentink/Shi/Hayes/Henderson/Bond teaches the method of claim 29, wherein the mixture is extruded in a twin-screw extruder (e.g., Hayes discloses at [0050] “The intensive mixing can be done, for example, using static mixers, Brabender mixers, single screw extruders, twin screw extruders.”), with a separate vacuum zone in which degassing takes place by applying negative pressure (e.g., Hayes at [0213] “Werner and Pfleider twin screw extruder with a vacuum port maintained at house vacuum attached to a 10 inch wide film die with about a 0.010 inch gap.”).
Regarding claim 31. Mentink/Shi/Hayes/Henderson/Bond teaches the method of claim 14, wherein extruding the mixture comprises using blown or flat film extrusion to produce a transparent film (e.g., Henderson discloses at [0088] “The barrier layers of this invention are transparent and are ideally suited for multi-layer packaging items that allow visibility of the product.”; Hayes discloses [0143] “For some uses, the containers are clear and transparent, but can be modified to have color or to be opaque, rather than transparent, if desired, by adding colorants or dyes, or by causing crystallization of the polymer, which results in opaqueness.”; Mentink at [0182] discloses the composition’s “opacity, translucency or transparency which can be adjusted according to the use.”).
Regarding claim 32. Mentink/Shi/Hayes/Henderson/Bond teaches a method comprising: obtaining a compound produced by the method of claim 14; and using the compound to produce a transparent film. (e.g., see Henderson’s Abstract, and see the discussion of claim 31 above).
Regarding claim 33. Mentink/Shi/Hayes/Henderson/Bond teaches method of claim 32, wherein the transparent film is produced by blown or flat film extrusion of the compound (e.g., Henderson discloses at [0094] “Formulations of this invention may be readily blown into bottles on conventional stretch blow moulding lines,” Hayes discloses at [0242] “Bilayer films are produced on a 10 inch, two layer, Streamlined Coextrusion Die (SCD) blown film die manufactured by Brampton Engineering. Layer configuration of the die is as follows from outside to inside layers of the die, A/B. Two 31/2 inch David Standard extruders feed the A and B layers.”).
Response to Arguments
Applicant's arguments filed January 13, 2026, have been fully considered but they are not persuasive.
Regarding Applicant’s argument that “The prior art's alpha-hydroxycarboxylic acid amount overlaps with the presently claimed amount only in a minimum range” (Remarks pages 5 – 6). Applicant argues that the rejection in view of Shi’s disclosure is err, since Shi’s organic acid amount range in paragraph [0023] is from about 1wt. % to about 35 wt. %, and Shi does not disclose or suggest an organic acid amount upper limit of 5%. This assertion is not persuasive of error, since as a matter of fact, Shi’s paragraph [0023] disclosed organic acid amount range still overlaps with the claimed amount of 0.1 to 5 %, that is at least from 1 wt. % to about 5 wt. %, and would have suggested to one of ordinary skill in the art that said organic acid in an amount from 1 wt. % to 5 wt. % could be use, with good expectation of success in a method for producing a compound or film e.g., such as Mentink et al. method, an would reasonably be expected to lead to the same film performance as that of the instant application film comprising the organic acid in the amounts of 1% to 5%.
In response to applicant's argument that “Shi and Mentink use an organic acid for distinct and unrelated purposes” (Remarks pages 6 – 9), the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, as mentioned in the rejection of claim 14, Mentink et al. [0157] recognizes that the method could incorporate other additional products, such as “an agent which improves the durability of the material or an agent for controlling its (bio)degradability,” “preservatives such as in particular organic acids, in particular acetic acid or lactic acid” [analogous to the claimed “an alpha-hydroxycarboxylic acid ROHCOOH, wherein R is CH2 or CH3CH”]. Shi et al. [0029] discloses that “Due to the hydrolysis of the starch in the presence of the weak organic acid (e.g., lactic acid, Shi et al. Abstract, [0017]) and plasticizer during melt blending, the weight average molecular weight, polydispersity index, and viscosity of the resulting thermoplastic starch may be substantially reduced in comparison to native starches, thereby rending it more suitable for many applications.” – which suggests that the weak acid and weak acid amounts disclosed by Shi et al. could be within the skill set of one of ordinary skill in the art as the agent for controlling the material (bio)degradability in the method of Mentink et al. (e.g., lactic acid), since “The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). MPEP § 2144.07.
Moreover, the courts have held that where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) (See MPEP 2144.05(I)).
In response to applicant's argument regarding the criticality of the claimed organic acid amount range, that “the present inventors recognized the criticality of a maximum organic acid amount of 5%. Employing greater than 5% of organic acid and up to 35%, as disclosed by Shi, leads to film decomposition and deterioration of the film's physical properties” (Remarks pages 5 – 6). Applicant’s advantageous effects (i.e., restraining the film’s decomposition and deterioration) based on the alleged criticality of the claimed organic acid range are not unexpected. From the outset, Applicant’s criticality regarding deviations from an upper organic acid range amount of 5% wt. seems to disregard the fact that Shi discloses a portion of the range which still overlaps with the majority of the claimed range (i.e., the portion of from 1% to 5% wt. of Shi range of from 1% to 35% wt. for the weak inorganic acid e.g., lactic acid, overlapping with Applicant’s range of from 0.1% to 5% wt.).
Although Applicant’s range is narrower, it has been held where 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. See MPEP § 2144.05 (II). For example, one of ordinary skill in the art would have been motivated to consult Shi’s disclosure and to discover the organic acid optimum or workable ranges by routine experimentation e.g., to achieved the composition or film's optimal physical properties (e.g., good mechanical properties and is capable of water and/or biological degradation), since Shi is concerned with producing thermoplastic starches “manufacture of articles for which water or biological degradation are considered important” [0001], further disclosing at [0002] that “it has still proven problematic to form melt-extruded substrates (e.g., nonwoven webs, films, etc.) from thermoplastic starches. Films, for example, typically require polymers of appropriate molecular weights and suitable melt viscosity for processing. It is often difficult, however, to achieve both mechanical strength and water/biological degradation from such polymers. As such, a need currently exists for a thermoplastic starch that exhibits good mechanical properties and is capable of water and/or biological degradation.” See Shi [0017, 0023, 0029], for example. It is noted that the higher organic acid amount in any of Applicant’s disclosed examples is believed to be 5% wt., with the Tables and discussion of these being silent to any results obtained of any example comprising an organic acid amount above 5% wt.
Therefore, since the combination of teachings from Mentink and Shi render the particulars of the claimed method as obvious (see the discussion of claim 14 above), one of ordinary skill in the art would have reasonably and predictably anticipated that selecting the portion of Shi's weak organic acid range that corresponds to/overlaps with the claimed range (i.e., the overlap of from 1% to 5% wt.) would have implicitly achieved the claimed physical properties by the compound or film as claimed, and as a result, inherently achieving the same advantageous effects and rendered obvious. See MPEP § 2112.01. Furthermore, it appears that Applicant’s results are pointing towards a quality control assessment and not unexpected results, with the difference between the results achieved by the claimed organic acid 0.1-5% wt. range and those achieved by the ranges above 5%-35% wt. disclosed by Shi, being a difference in degree in the results and not a difference in the kind of results achieved. See MPEP § 2144.05 (III) (A). For these reasons, Applicant’s arguments are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention (Applicant’s argument that “Shi does not recognize, disclose, or suggest the deterioration in film properties that arises when including an organic acid in an amount of greater than 5%”, Remarks pages 5 – 6), it is noted that the features upon which applicant relies (i.e., “deterioration in film properties that arises when including an organic acid in an amount of greater than 5%”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Absent persuasive evidence or arguments, the examiner submits the claims would need to be further amended to overcome the prima facie case.
Conclusion
THIS ACTION IS MADE FINAL. 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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
a. Gruber et al. (US Pat. 5,484,881) discloses at Col. 6, ll. 55 – 67, Col. 7, ll. 1 – 10 “Polymers which may be useful for improving the film properties of poly(lactide) include aliphatic polyesters or polyamides made by both ring opening and condensation polymerization, esterified cellulose resins, derivitized starch, polyvinylacetate and any of its partially hydrolyzed products including polyvinylalcohol, polyethers including poly(ethylene oxide), polycarbonates, polyurethanes including those based on aliphatic isocyanates, polyanhydrides, natural rubber and its derivatives including epoxidized natural rubber, block copolymers of styrene and isoprene or butadiene and the hydrogenated version of those polymers, polyacrylates and methacrylates, polyolefins, and polystyrene.”
b. Mentink et al. (US 2010/0311905 A1) discloses [0070] The synthetic polymer obtained from monomers of fossil origin, preferably comprising functional groups having active hydrogen, may be chosen from synthetic polymers of polyester, polyacrylic, polyacetal, polycarbonate, polyamide, polyimide, polyurethane, polyolefin, functionalized polyolefin, styrene, functionalized styrene, vinyl, functionalized vinyl, functionalized fluoro, functionalized polysulfone, functionalized polyphenyl ether, functionalized polyphenyl sulfide, functionalized silicone and functionalized polyether type.
c. Mentink et al. (US 2010/0311874 A1) discloses [0096] The synthetic non-starchy polymer obtained from monomers of fossil origin, preferably comprising functional groups having active hydrogen, may be chosen from synthetic polymers of polyester, polyacrylic, polyacetal, polycarbonate, polyamide, polyimide, polyurethane, polyolefin, functionalized polyolefin, styrene, functionalized styrene, vinyl, functionalized vinyl, functionalized fluoro, functionalized polysulfone, functionalized polyphenyl ether, functionalized polyphenyl sulfide, functionalized silicone and functionalized polyether type.
d. Shi et al. (US 2009/0247036 A1, cited on IDS) discloses melt-extruded substrate (e.g., film, nonwoven web, etc.) that contains a thermoplastic starch formed from a starch and plasticizer.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDGAREDMANUEL TROCHE whose telephone number is (571)272-9766. The examiner can normally be reached M-F 7:30-5:30.
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/EDGAREDMANUEL TROCHE/ Examiner, Art Unit 1744
/JEFFREY M WOLLSCHLAGER/ Primary Examiner, Art Unit 1742
1 PubChem Glycolic Acid (Compound): https://pubchem.ncbi.nlm.nih.gov/compound/Glycolic-Acid#section=MeSH-Entry-Terms
2 PubChem Lactic Acid (Compound): https://pubchem.ncbi.nlm.nih.gov/compound/612
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