DETAILED OFFICIAL 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 .
Examiner Note
It is noted that all references hereinafter to Applicant’s specification (“spec”) are to the published application US 2024/0301151, unless stated otherwise. Further, any italicized text utilized hereinafter is to be interpreted as emphasis placed thereupon.
Information Disclosure Statement
The information disclosure statements (IDS) filed 20 November 2023 and 02 May 2025 are in compliance with 37 CFR 1.97 and have been considered.
Claim Status
Claims 47-66 are pending and under consideration on the merits.
Claim Objections
Claims 60 and 66 are objected to because of the following informalities.
[claim 60] – “metre2” constitutes improper unit formatting, and the alternative abbreviation of the unit recited in parenthesis “(gsm)” constitutes a redundancy which detracts from the readability of the claim; the following amendments are respectfully suggested for correction of the issues
“…of at least 5 g/m2.”
[claim 66] – improper unit formatting and redundant recitations in the same manner set forth above in the objection to claim 66; the following amendments are respectfully suggested for correction of the issues
“…is less than or equal to 30 cm3/m2·day, at 23° C, 50% relative humidity.”
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.
Claims 47-66 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 47, the limitation “wherein the at least one layer is formed to a thickness that is efficacious in providing a barrier to transmission of oxygen and/or water vapor to the carrying surface of the substrate” renders the claim indefinite. The metes and bounds of the scope of the claimed term “efficacious” and phrase “a thickness that is efficacious” are unclear, as the requisite/minimum degree of oxygen and/or water vapor transmission barrier provided thereby (i.e. resultant therefrom, i.e. dependent thereupon, i.e. associated with the thickness being ‘effective’), and the conditions/methods of measurement of said oxygen and water vapor transmissions, are unclear. As such, the metes and bounds cannot be ascertained or readily determined by one of ordinary skill in the art – the public would not be informed of the boundaries of what constitutes infringement thereupon (MPEP 2173).
The oxygen transmission (rate) and water vapor transmission (rate) of a material are dependent upon the temperature and relative humidity – and corresponding standardized method – at which the reported value is determined, of which are not defined in the claim. As such, it is unclear what thickness or range thereof constitutes “efficacious” in providing a barrier to transmission of oxygen and/or water vapor, as claimed – phrased inquisitively, does a water vapor transmission rate(s) of, e.g. 30,000 g/m2·day, measured at 90° C and 90% RH resultant from a 1 nm thick layer constitute an “effective” barrier thickness; does an oxygen transmission rate(s) of, e.g. 9,000 cm3/m2·day, measured at 23° C and 60% RH resultant from a layer thickness of 1 µm constitute an effective barrier thickness? Simply put, because the measurement conditions at which the oxygen and water vapor transmissions are determined are unclear, one of ordinary skill in the art would not be able to readily determine whether a transmission value at a given thickness is within the metes and bounds of the scope of the claimed thickness which is “efficacious in providing a barrier to transmission of oxygen and/or water vapor…”
For examination on the merits, claim 47 is given the broadest reasonable interpretation in view of the spec (MPEP 2111; MPEP 2111.01(II)) – in particular, claim 47 is interpreted wherein any thickness (of the at least one layer) which provides any barrier to transmission of oxygen and/or water vapor, measured at any temperature and relative humidity determined in accordance with any standard, reads on (i.e. is encompassed within) the claimed “thickness that is efficacious in providing a barrier to transmission of oxygen and/or water vapor to the carrying surface of the substrate”.
In order to overcome the indefiniteness issue identified above, the following amendment is respectfully suggested, of which finds support in claim 66 and in the spec at [0150, 0250-0252; Tables 1 and 5]:
“wherein the at least one layer is formed to a thickness such that the oxygen transmission rate of the packaging material is less than or equal to 30 cm3/m2·day, at 23° C and 50% RH and/or the water vapor transmission rate of the packaging material is less than or equal to about 132 g/m2·day and greater than or equal to about 53 g/m2·day, at 23°C and 50% RH.”
Regarding claims 62-63 and 65-66, the phrase “the layer of the film material” renders each claim indefinite, as it is unclear if the “at least one layer that is formed of a film material” recited in claim 47 is being further limited to only a single layer formed of the film material, or if Applicant intended to utilize the language recited in claim 47 which encompasses a plurality of the [at least one] layer[s] formed of [the] film material (i.e. unclear if Applicant intended to utilize the language of claim 47 or, e.g. the language utilized in claim 60 of “wherein the, or each layer of film material…”).
Also regarding claims 62-63, each claim constitutes a grammatically incorrect incomplete sentence; and the phrases “the layer of the film material that defines an external surface of the packaging material” and “the layer of the film material that defines an internal surface of the packaging material” lack sufficient antecedent basis, as there is no prior recitation of (i.e. claim 47 does not recite) a layer of the film material that defines an external surface, or that defines an internal surface, of the packaging material.
For examination on the merits, claim 62 is interpreted to read as follows: “wherein the at least one layer of the film material
For examination on the merits, claim 63 is interpreted to read as follows: “wherein the at least one layer of the film material
For examination on the merits, claim 65 is interpreted to read as follows: “…wherein the packaging material is arranged with the at least one layer of the film material being between the substrate and the concave portion.”
For examination on the merits, claim 66 is interpreted to read as follows: “wherein the at least one layer of the film material is formed…”
The foregoing interpretations of claims 62-63 and 65-66 are respectfully suggested as amendments for correction of the indefiniteness issues identified above.
Claims 48-66 are indefinite and rejected under 35 U.S.C. 112(b) as they are directly or ultimately dependent upon claim 47 and therefore include, and do not fully remedy the indefiniteness issues of claim 47 identified above.
Appropriate action is required.
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.
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.
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.
Claims 47-50 and 52-66 are rejected under 35 U.S.C. 103 as being unpatentable over Kuiper et al. (US 2021/0009327; “Kuiper”), in view of Buchanan et al. (US 5,446,079; “Buchanan”) and Lewandowski et al. (US 2016/0257802; “Lewandowski”).
Regarding claim 47, Kuiper discloses a biodegradable food packaging container (2), e.g. food tray [Fig. 1A], said container (2) formed from moulded (and bonded/fused) pulp fibers and defining a compartment (via bottom (4) and side walls (6)) – and corresponding food-contact surface – for receiving/carrying foods or other products [Abstract; 0001-0002, 0006-0007, 0046-0049, 0052, 0060, 0067-0068, 0070].
The food-contact surface (interior surfaces of compartment defined by bottom (4) and side walls (6)) comprises a layer (film) of biodegradable aliphatic polyester, such as (nonlimiting) polyhydroxyalkanoates (PHA), polyhydroxybutyrate (PHB), polybutylene succinate (PBS), polycaprolactone (PCL), or polylactic acid (PLA), formed thereon and having a thickness of 1-100 µm [0019, 0025-0027, 0068]. The aforesaid layer of biodegradable aliphatic polyester functions as an intermediate connection/adhesive layer between the moulded pulp and an overlying “peelable laminate layer” based on polyethylene terephthalate (PET) [0006, 0008, 0011, 0025-0027, 0067-0068].
The aforesaid compartment/food-contact surface (moulded pulp fibers) reads on the claimed substrate, and the layer of biodegradable aliphatic polyester reads on the claimed at least one layer that is formed of a film material, the at least one layer being assembled into a substantially continuous film on a carrying surface of the substrate.
The layer thickness of 1-100 µm reads on the claimed thickness that is efficacious in providing a barrier to transmission of oxygen and/or water vapor to the carrying surface of the substrate, in view of the spec which indicates that the layer of film material (for provision of said barrier to oxygen and/or water vapor) is formed to an average thickness of at least 2.5 µm, preferably in the range of 5-50 µm [0057-0059, 0063, 0084], and in accordance with the interpretation set forth in the rejection of claim 47 under 112(b) above.
With respect to the difference(s) relative to the claimed invention, Kuiper is silent regarding (i) said layer comprising an aliphatic polyester blended with a carbohydrate or functionalized carbohydrate (hereinafter “carbohydrate”), regarding (ii) the aliphatic polyester having a molecular weight less than or equal to 60 kilodaltons (60,000 g/mol), and regarding (iii) the weight ratio of the aliphatic polyester to the carbohydrate being at least 25:75 (i.e. at least 1:3, i.e. 0.33 or greater).
Buchanan is directed to biodegradable, binary blends of aliphatic polyesters and cellulose esters, and films or other molded/extruded articles formed from said blends [Abstract; col. 1 ln. 18-30, col. 5 ln. 15-35, 38-40]. The aforesaid blend comprises about 5-98 wt.% (preferably about 40-90 wt.%) of, inter alia cellulose acetate (CA) having a degree of substitution (DS) of about 1.7-2.75 [col. 5 ln 60-65, col. 6 ln. 13-43, 52-55], and about 2-95 wt.% (preferably about 10-60 wt.%) of an aliphatic polyester [col. 5 ln. 67–col. 6 ln. 5, col. 10 ln. 12–col. 11 ln. 2, col. 13 ln. 23–col. 14 ln. 17, col. 17 ln. 31-40]. The aliphatic polyester is not necessarily limited, and the aforecited disclosure of Buchanan encompasses polyesters formed solely from hydroxy acids, said hydroxy acids including, inter alia lactic acid, glycolic acid, ester forming derivatives thereof, and combinations thereof [col. 13 ln. 23-33], wherein said aliphatic polyester is suitably derived from biological sources [col. 10 ln. 68–col. 11 ln. 2, col. 13 ln. 23–col. 14 ln. 17]. The aforecited disclosure of Buchanan reasonably encompasses embodiment(s) of the binary blend wherein said aliphatic polyester may be, inter alia a copolymer of lactic acid and glycolic acid, i.e. poly(lactic-co-glycolic acid) (PLGA).
Buchanan teaches that the blends and films formed therefrom: suitably include optional additives, such as plasticizers [col. 14 ln. 18-40]; are biodegradable, flexible, and substantially clear/non-hazy [col. 14 ln. 41-60]; are useful in packaging applications where thin (e.g. about 25-500 µm) barrier and/or biodegradable films are desired and may exhibit water vapor transmission rates of less than about 500 g·mil/m2·day [col. 15 ln. 38-54]; and have melting temperatures between about 120-280° C, preferably 150-190° C [col. 16 ln. 46-50] (noted that Kuiper discloses subjecting the container (2) to a heating step at a temperature which is about the melting temperature of the biodegradable aliphatic polyester, e.g. in the range of 145-195° C [Kuiper, 0052]).
Lewandowski is directed to biodegradable/environmentally-friendly/renewably-derived polymeric compositions including a polymer(s) and a specific plasticizer(s), and articles, e.g. films or adhesives/adhesive layers formed from said compositions [Abstract; 0002-0004, 0012-0015, 0039, 0042, 0050-0054]. The films/adhesive layers are suitably formed on substrates by, e.g. melt extrusion, can have any desired thickness, and are often visually clear (haze less than 5%) [0050-0053]. See MPEP 2144.07.
Lewandowski teaches that the polymer of the composition, which is compatible with the plasticizer(s), is suitably, inter alia an aliphatic polyester copolymer formed from L- and/or D-lactic acid and glycolic acid, i.e. PLGA [0024-0027], or a cellulose ester such as cellulose acetate [0032, 0054]. The PLGA exhibits a weight average molecular weight (MW) of at least 1,000 g/mol (at least 1 kilodalton) [0038]; and contains at least 50 wt.% lactic acid units, e.g. at least 60 wt.% lactic acid units (i.e. 60:40 by weight lactic acid:glycolic acid) [0027, 0029].
As such, Lewandowski reasonably teaches that the aforecited PLGA is suitable for use as the aliphatic polyester utilized in plasticized compositions which are intended for use as films/adhesive layers formed on substrates to form biodegradable articles (MPEP 2144.07), and reasonably teaches that CA is also suitable for use in said compositions for said intended use. Additionally, Lewandowski teaches that the aliphatic polyester (PLGA) may be combined with other polymeric material in the composition, wherein the composition can include 50-95 wt.% of the PLGA [0031].
Kuiper, Buchanan, and Lewandowski each constitute prior art which is directly analogous to the claimed invention – packaging articles and/or polymeric compositions including an aliphatic polyester and/or cellulose ester, e.g. CA. In view of the combined teachings of the foregoing prior art, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the food packaging container of Kuiper by utilizing a blend (as taught by Buchanan) of PLGA (as the aliphatic polyester, as taught by Lewandowski and reasonably taught/encompassed by Buchanan) and CA to form the thin biodegradable layer disposed on the food-contact surface of the moulded pulp, as the blend would have been readily recognized as: (i) suitable for use in thin film packaging applications requiring biodegradability and/or barrier properties, (ii) inclusive of a biodegradable aliphatic polyester as disclosed by Kuiper, (iii) capable of providing the requisite adhesion between the moulded pulp and overlying peelable laminate layer, (iv) suitable for/capable of melting at the temperature disclosed by Kuiper to bond/fuse the moulded pulp fibers, and (v) capable of film formation at the requisite thickness of Kuiper (MPEP 2144.07); and/or (vi) in order to increase the barrier properties or biodegradability of the container without use of additional materials/additives. The PLGA would have been readily recognized as (vii) a biodegradable, aliphatic polyester suitable for the intended use disclosed/required by Kuiper, and (viii) suitable for use as the aliphatic polyester component of said blend.
In accordance with the aforesaid modification, the layer formed on the food-contact surface (interior surfaces of compartment defined by bottom (4) and side walls (6)) of the container (2) of Kuiper would have been formed from a blend of about 2-95 wt.% (preferably 10-60 wt.%) PLGA and about 5-98 wt.% (preferably 40-90 wt.%) CA (aforesaid amounts relative to the total amount of PLGA and CA). The CA would have exhibited a DS of about 1.7-2.75 as taught by Buchanan, and the PLGA would have exhibited a MW of at least 1,000 g/mol and comprised at least 50 wt.% lactic acid units (e.g. 50:50 lactic acid:glycolic acid), or at least 60 wt.% lactic acid units (e.g. 60:40) as taught by Lewandowski. The layer would have exhibited a thickness of 1-100 µm (as disclosed by Kuiper, set forth/cited above).
The container (2) of Kuiper, as modified above (hereinafter interchangeably “modified Kuiper”) reads on the packaging material defined by each and every limitation of claim 47. That is, in addition to ¶28-29 above, and with regard to ¶30 above, the PLGA (of the blend) reads on the claimed first polymer (synthesized from one or more bio-based monomers; copolymers of lactic acid and glycolic acid). The MW of the PLGA of at least 1,000 g/mol overlaps with, and thereby renders prima facie obvious the claimed range of less than or equal to 60 kilodaltons (MPEP 2144.05(I)). The CA (of the blend) reads on the claimed second polymer (one of a carbohydrate and a functionalized carbohydrate derived from one or more bio-based materials). The weight ratio of 2:98 to 95:5 of PLGA:CA, or the preferred weight ratio of 10:90 to 60:40 of PLGA:CA, reads on the claimed ratio of first polymer to second polymer within the film material being at least 25:75 by weight – each of the aforesaid ratio and preferred ratio overlap with, and thereby render prima facie obvious the claimed weight ratio (MPEP 2144.05(I)).
Regarding claims 48-50, the rejection of claim 47 above reads on each packaging material defined by claims 448-50 – the PLGA MW of at least 1,000 g/mol (at least 1 kilodalton) overlaps with, and thereby renders prima facie obvious, the claimed ranges “less than or equal to 30 kilodaltons” (claim 48) and “less than or equal to 15 kilodaltons” (claim 49). The MW of at least 1,000 g/mol encompasses, and thereby renders prima facie obvious the claimed range “4.5 kilodaltons to 7.5 kilodaltons” (claim 50). See MPEP 2144.05(I).
Regarding claim 52, the rejection of claim 47 above reads on the packaging material defined by claim 52. The weight ratio of 2:98 to 95:5, or preferred weight ratio of 10:90 to 60:40 (PLGA:CA), encompasses and thereby renders prima facie obvious the claimed weight ratio of approximately 50:50 first polymer:second polymer (MPEP 2144.05(I)).
Regarding claims 53-54, the rejection of claim 47 above reads on each packaging material defined by claims 53-54 – the biodegradable aliphatic polyester of the blend is PLGA.
Regarding claim 55, in view of the rejection of claim 54 above, the rejection of claim 47 above reads on the packaging material defined by claim 55. The PLGA of the blend comprises at least 50 wt.%, or at least 60 wt.% lactic acid units, of which correspond to weight ratios of 50:50 and 60:40 lactic acid units:glycolic acid units, wherein the latter reads on the claimed “lactic and glycolic units at a ratio of approximately 60:40”.
Regarding claims 56-58, the rejection of claim 47 above reads on each packaging material defined by claims 56-57. Cellulose acetate (CA) of the blend reads on the claimed second polymer being an acetylated cellulose derivative (claim 56), specifically cellulose acetate (claims 57 and 58).
Regarding claim 59, in view of the rejection of claim 57 above, the rejection of claim 47 above reads on the packaging material defined by claim 58. The CA exhibits a DS (degree of substitution per anhydroglucose unit) of 1.7-2.75 (degree of acetyl group substituents), of which is within the claimed range of 1 to 3.
Regarding claims 60-61, as set forth above in the rejection of claim 47, the layer (formed from the blend) of modified Kuiper exhibits a thickness of 1-100 µm, of which overlaps with (encompasses lower bound of, and is within the open upper bound of) the claimed average thickness range of at least 2.5 µm (claim 61), thereby rendering the range prima facie obvious (MPEP 2144.05(I)), wherein the spec indicates that the preferred thickness (coat weight) of at least 20 g/m2 corresponds to an average thickness of at least 5 µm [0058-0059], up to 100 µm and preferably up to 50 µm [0084].Given that the thickness range of the layer of modified Kuiper encompasses layers formed to a thickness of, e.g. 50 µm, up to 100 µm, it stands to reason that modified Kuiper reasonably encompasses embodiments of the layer (e.g. thickness of 50 µm, e.g. thickness of 100 µm) which would have necessarily exhibited (corresponded to) a coat weight [thickness] of at least 5 g/m2 as claimed (claim 60), absent a showing of factually supported objective evidence to the contrary. See MPEP 2112(V); MPEP 2112.01(I) and (II); MPEP 2144.05(I); MPEP 2145; and MPEP 2145(I).
Regarding claim 62, in view of the rejection of claim 47 above, Kuiper discloses that the container includes a circumferential edge comprising a connecting surface (34) (flange) to which a transparent seal/foil/film/sheet/liner is sealed to close the opening (compartment) of the container [0028-0030, 0044, 0072; Figs. 1C-1D]. The peelable laminate layer is not present on the connecting surface (34), however the thin biodegradable layer is disposed on said connecting surface (34) (over width W1 of said surface (34)) [Fig. 1D; 0030, 0044]. The thin biodegradable layer, formed from the blend of PLGA and CA set forth above and disposed on the moulded pulp at the connecting surface (34), in the absence of the peelable laminate layer, reads on the claimed layer of film material that defines an external surface of the packaging material.
Regarding claim 63, as set forth above in the rejection of claim 47, the layer of the container of modified Kuiper is disposed on the moulded pulp (substrate) and is overlaid by the peelable laminate layer. However, Kuiper discloses that the peelable laminate layer is peeled away (separated) from the container and subsequently discarded (treated as waste), whereby the resultant container consisting of the moulded pulp (substrate) and thin film layer (formed from PLGA and CA blend) thereon can be recycled together, or can be reused to prepare another container having a (new) peelable laminate layer [0026, 0075]. The container, subsequent removal of the peelable laminate layer/prior to recycling or reuse, defines an intermediate product (i.e. intermediate food packaging container) wherein the layer (formed from PLGA/CA blend) defines the internal surface of the container. The aforesaid intermediate food packaging container reads on the packaging material defined by claim 63, wherein the layer of the film material defines an internal surface of the packaging material.
Regarding claims 64-65, the rejection of claim 47 above reads on each packaging material defined by claims 64-65. The moulded pulp (substrate) fibers, formed into the container shape including the bottom and sidewalls which define the compartment/food-contact surface, and subject to heat treatment (set forth/cited above), read on the claimed substrate formed of pulp fibers that have been processed so as to be assembled into a predetermined shape and treated to form bonds between the pulp fibers within the substrate, whereby the substrate is able to at least partially retain its shape in an unsupported condition (claim 64), as well as wherein the packaging material is shaped to define a concave portion within which a consumable good is to be packaged, and wherein the packaging material is arranged within the layer of film material being between the substrate and the concave portion (claim 65). Additionally/alternatively, Kuiper discloses that the container may exhibit alternative shapes to that depicted in Fig. 1A, such as a bowl shape including a concave portion [Fig. 2; 0007], of which reads on the packaging material defined by claim 65.
Regarding claim 66, in view of the rejection of claim 47 above, modified Kuiper is silent regarding the oxygen transmission rate (OTR) of the container being less than or equal to 30 cm3/m2·day at 23° C, 50% RH based on the thickness of the layer. However, the thickness of the layer of modified Kuiper is 1-100 µm, of which is substantially identical or identical to the claimed and disclosed thickness ranges (2.5-100 µm [spec, 0084]) of the layer formed of film material; further, the layer of modified Kuiper is identical to the claimed/disclosed layer formed of film material in terms of polymeric blend components including first polymer species (PLGA), molecular weight thereof, monomer unit ratio thereof, in terms of second polymer species (CA) and DS thereof, and in terms of the weight ratio of first to second polymer in the blend/film material. As such, it stands to reason, and there is a strong and reasonable expectation, that the container of modified Kuiper – inclusive of the aforesaid layer and corresponding thickness – would have necessarily exhibited an OTR of less than or equal to 30 cm3/m2·day at 23° C, 50% RH as claimed, absent a showing of factually supported objective evidence to the contrary. See MPEP 2112(V); MPEP 2112.01(I) and (II); MPEP 2145; and MPEP 2145(I).
Claims 48-51 are rejected under 35 U.S.C. 103 as being unpatentable over Kuiper in view of Buchanan and Lewandowski as applied to claim 47 above, further in view of Doornheim (US 2023/0119820; “Doornheim”) and Oh et al. (KR 2014-0038158; “Oh”) (copy and machine translation provided herewith; translation relied upon).
Regarding claim 51, as set forth above in the rejection of claim 47 (incorporated herein by reference; not repeated for sake of brevity), the PLGA of the PLGA/CA blend which forms the layer disposed on the moulded pulp (substrate) of the container of modified Kuiper exhibits a weight average molecular weight (MW) of at least 1,000 g/mol [Lewandowski, 0038], and contains 50% or greater of lactic acid-based units, such as 60:40 lactic acid:glycolic acid units. Further, Lewandowski teaches that the MW may be from 10,000 g/mol to 1,000,000 g/mol [0038], and reasonably encompasses (i.e. implicitly discloses based on aforecited paragraph) the ranges of 1,000-100,000 g/mol and 1,000-10,000 g/mol [0038].
Kuiper, as modified, is silent regarding the PDI of the PLGA (aliphatic polyester of the blend) being less than or equal to 3 (claim 51).
Doornheim is directed to multilayer films/sheets (“films”) for use in packaging applications, e.g. thermoformed packaging containers, said films/sheets based on polylactide [Abstract; Figs. 3A-3C; 0001-0002, 0008-0009, 0104]. Doornheim teaches that the films include a layer comprising a poly(lactide-co-glycolide) polymer (PLGA) having more than 30 mol% lactide units, such as 35-75 mol% lactide units, said layer functioning as a tie/adhesive layer within the multilayer structure [0018, 0027, 0051, 0056, 0105, 0110, 0161-0164] – the use of the “lactide rich” PLGA significantly reduces layer delamination [0027, 0163]. Doornheim teaches that the polydispersity of the lactide rich PLGA is between about 1.0 and 5.0, such as 1.0-3.0 and preferably 1.0-2.0 [0169], wherein the MW of the lactide-rich PLGA is preferably from 30,000 g/mol to 500,000 g/mol (30-500 kilodaltons) [0168].
Oh is directed to PLGA copolymers, and teaches that to reduce PLGA production costs and synthesize lactide rich PLGA having increased purity at an increased yield, the molecular weight distribution (polydispersity) thereof is preferably reduced to about 1.5-2.4 while controlling the MW to within the range of 8,000-15,000 g/mol [pp. 1-3, p. 5, p. 9].
Doornheim and Oh each constitute prior art which is directly analogous to the claimed invention, the former being directed to packaging materials inclusive of layers based on PLGA, and the latter being directed to PLGA copolymers and control of the MW and PDI thereof. In view of the combined teachings of the foregoing prior art – and given that the PLGA of the blend of modified Kuiper suitably exhibits a MW of at least 1,000 g/mol and would have been readily recognized as lactide rich – it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the layer of the container of modified Kuiper (as set forth above in the rejection of claim 47) by utilizing a lactide rich PLGA having a polydispersity of from 1.0-3.0, such as 1.5-2.4, and a corresponding MW of at least about 8,000 g/mol, in order to reduce or prevent undesired delamination of the peelable laminate layer from the container, e.g. prior to the time at which a user desires or intends to peel the laminate layer therefrom, and/or to reduce the overall cost of manufacturing the container through use of lower-cost PLGA.
In accordance with the aforesaid modification(s), the PLGA of the PLGA/CA blend which forms the thin biodegradable layer of the container of modified Kuiper – in addition to the other features/elements and properties set forth above in the rejection of claim 47 – would have exhibited a weight average molecular weight MW of at least about 8,000 g/mol and a corresponding PDI of 1.0-3.0, such as 1.5-2.4. The aforesaid MW range of the PLGA of modified Kuiper overlaps with the claimed range of less than or equal to 60 kilodaltons (claim 47) (MPEP 2144.05(I)), and the corresponding PDI range of 1.0-3.0 (e.g. 1.5-2.4) of said PLGA is within the claimed range of less than or equal to 3 (claim 51). As such, the container of modified Kuiper set forth above reads on the packaging material defined by claim 51 as dependent upon claim 47.
Regarding claims 48-49, the rejection of claim 51 above is incorporated herein by reference and reads on each packaging material defined by claims 48-49. Specifically, the MW of the PLGA of the blend being at least 8,000 g/mol overlaps with, and thereby renders prima facie obvious each of the claimed ranges “less than or equal to 30 kilodaltons” (claim 48) and “less than or equal to 15 kilodaltons” (claim 49) (MPEP 2144.05(I)).
Regarding claims 48-50, in the alternative to the rejection of claims 48-49 set forth immediately hereinabove (¶57), the rejection of claim 51 above (incorporated herein) reads on each packaging material defined by claims 48-50. Specifically, the MW of the PLGA being at least 8,000 g/mol, in view of the PDI being from 1.0-3.0, such as 1.5-2.4, encompasses/defines embodiments of the PLGA which – through simple calculation – would have necessarily exhibited a number average molecular weight (MN) of at least about 2,666 g/mol (8,000/3), e.g. about 2,666 to 8,000 g/mol (8,000/1.0) or greater, such as (or preferably) about 3,333 (8,000/2.4) to 5,333 g/mol (8,000/1.5) or greater. The aforesaid MN ranges (at least 2,666 g/mol, about 2,666-8,000 g/mol, and about 3,333-5,333 g/mol) overlap with, or are within, the molecular weight range defined by claim 47 (less than or equal to 60 kilodaltons), as well as each of the molecular weight ranges defined in claims 48-49, i.e. “less than or equal to 30 kilodaltons” (claim 48) and “less than or equal to 15 kilodaltons” (claim 49).
Further, each of the aforesaid MN ranges “at least 2,666 g/mol” and “about 2,666-8,000 g/mol” encompasses, and thereby renders prima facie obvious the claimed range of “4.5 kilodaltons to 7.5 kilodaltons” (claim 50); furthermore, the aforesaid range of “about 3,333-5,333 g/mol” encompasses the lower bound of, and is within the upper bound of the claimed range of “4.5 kilodaltons to 7.5 kilodaltons” (claim 50), thereby also rendering said range prima facie obvious (MPEP 2144.05(I)). It is noted that each of claims 47-50 does not require the molecular weight be based on the number average or weight average molecular weight of the first polymer, and as such the broadest reasonable interpretation thereof is such that either the MN or MW of the PLGA reads on the claimed ranges.
Pertinent Prior Art
The following constitutes a list of prior art which are not relied upon herein, but are considered pertinent to the claimed invention and/or written description thereof. The prior art are purposely made of record hereinafter to facilitate compact/expedient prosecution, and consideration thereof is respectfully suggested.
US 2014/0004330 to Yoo et al. – teaches that the polydispersity of PLA-based resins may be from 1.60 to 2.20, in order to tailor the melt viscosity/melt properties of the resin so that it may be extruded into a film, as well as to achieve high physical strength [0043]
US 2019/0276637 to Yao et al. – discloses a resin composition including a blend of cellulose acetate with a copolymer of L- and/or D-lactic acid and glycolic acid [Abstract; 0026, 0039, 0046, 0051-0061, 0065-0066, 0070, 0166-0173, 0194, 0197-0198]
US 2018/0002835 to Kumbar et al. – discloses fibers, and matrices inclusive thereof, formed from a blend of cellulose acetate and PLGA [Abstract; 0004, 0021-0027, 0046-0047]
US 2010/0112252 to Ito et al. – discloses a plastic-formed article comprising a substrate layer which may comprise PLGA copolymer, further blended with CA [Abstract; 0036-0040]
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Michael C. Romanowski whose telephone number is (571)270-1387. The Examiner can normally be reached M-F, 09:30-17:30.
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/MICHAEL C. ROMANOWSKI/Primary Examiner, Art Unit 1782