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 .
Claim Interpretation
With respect to ASTM standards utilized in the claims following are ISO and JIS equivalents:
ASTM D638 V has equivalent in ISO 527-2 Type 5B and JIS K7161
ASTM D3985 has equivalent in ISO 15105-2 and JIS K7126-2-B
ASTM D1003 has equivalent in ISO 14782 and JIS K7136
JIS B0601 has equivalent in ISO 4287:1997 and ASTM : ASME B46.1
With respect to the Equation 1:
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78
314
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While applicants can be their own lexicographers, the extent of which should not contradict the definitions already established in the art. Dispersion Index of a filler is measured by quantifying the spatial distribution, size and uniformity of a filler particles within matrix is accomplished using microscopic imaging, light scattering or spectroscopic techniques. Dispersity of the filler cannot be directly measured from the equation 1, because tensile strength and oxygen permeability are composite performance indicator influenced by many factors such as particle shape, interfacial adhesion, loading dispersion as such they do not represent a direct physical measurement of the particle size distribution. Consequently, the prior art of record will encompass claimed dispersion index as long as the properties of tensile strength and oxygen permeability are within the same range.
With respect to equation 2:
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76
408
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Similarly with the discussion of Formula 1, by definition the measuring the processability reduction index in polymers index involves assessing changes in viscosity, glow behavior, and thermal stability, often quantified by the melt flow index of capillary rheometry. A decrease in processability indicates higher viscosity or degradation is reflected by reduction in MFI at a specific temperature and load. It should be noted that this type of measurement has its own ASTM D1238 standard that is not utilized in the instant invention. While surface roughness is major contributor to total haze, it is not the only contributor. Surface roughness is further influenced by include high melt elasticity or crystallization. It is important to note that total haze includes both surface haze (due to roughness) and internal bulk has (due to crystallization /density changed. Consequently surface roughness is not reflective of the entirety of the haze. Consequently, if the prior art of record meets the limitation of surface roughness and haze, the prior art will meet the limitation of processability reduction index.
With respect to of recitation of ring opening process in the composition claims, the limitation is viewed as product by process. Consequently the patentable weight is given to the product and not to the process by which it was made.
With respect to the limitation of monomers and/or prepolymers utilized in making polymerizable composition, the aliphatic-aromatic component is selected from a monomer composition comprising diol component and dicarboxylic acid component and a prepolymer of part or all of the monomer composition. As such, under broadest reasonable interpretation, the prepolymer comprising all of the monomers reads on fully polymerized polymer.
Claim Objections
Claim 1 is objected to because of the following informalities:
With respect to claim 1, applicants claim viscosity of 5,000 to 15,000 poise at 240oC as the viscosity of the composition. The limitation if confusing in the light of the specification. Page 1 of the instant specification defines viscosity as dynamic viscosity. The same range of viscosity also in poise is reported as intrinsic viscosity. It should be noted that dynamic viscosity and melt viscosities are the only viscosities that can be measured in poise. Intrinsic viscosity is measured in dL/g. Appropriate clarification and discussion of the viscosities is requested.
It should also be noted, that the examples disclose number average molecular weights for prepolymer which is required by the instant claim 1, however the viscosity of the polymerizable composition does not support the claims. The viscosity that is supported by the examples, is the viscosity of already polymerized composition. Further clarification is required.
The examiner would like to note, if the clarification of the viscosity of the composition of claim 1 is not provided, the objection will be changed to a rejection under 35 U.S.C paragraph 112, without affecting the finality of the rejection. The objection hereby puts applicants on notice.
For more prompt prosecution of this application, the examiner will interpret the viscosity as dynamic viscosity of the composition before it is polymerized. Having said that if the prior art does not explicitly recite dynamic viscosity, the polymer will meet the limitations if, for example, polymer such as polylactic acid has number average molecular weight of at least 40,000 as it is described in the specification. More specific number average molecular weight of the biodegradable polymer in the application as filed originally is in a range of 30,000-100,000 g/mole. Molecular weight of the same polymer is directly related to the viscosities as well as the content of filler, particle size of the filler and type of the filler. All these aspect have to be met to meet the viscosity of the composition.
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.
Claim 5, 7, 11 and 13 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.
Claims 5, 11 and 13 contains the trademark/trade name OX-Tran 702. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify a product of the Ametek Mocon company as analyzer, accordingly, the identification/description is indefinite.
It should also be noted that the use of trademarks and tradenames in the claims is improper because the manufacturer is under no obligation to continue making the same material under given trademark nor continue to selling anything under given trademark. The discontinued use of trademarks or changing of the material sold under the trademark renders the claim meaningless.
Instant claim 7 requires intrinsic viscosity to be 5,000 poise or more. Intrinsic viscosity is not a dynamic it is not measured in poise. It is calculated from relative viscosity and expressed dL/g or mL/g because intrinsic viscosity itself represents dimensionless concentration limit extrapolated to zero concentration. As such it is not clear what type of the viscosity the applicants are claiming. For more prompt prosecution, if the polymer meets the dynamic viscosity and molecular weight and has the same structural make up the polymer will meet claimed intrinsic viscosity as well.
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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Coszach (US 2006/0014975) in view of Nyun (KR 2005-0056020 translation attached).
With respect to claim 1, Coszach discloses a method of polymerizing polylactic acid in situ with fillers and additives in order to make a biodegradable composition [0072] and with optical quality [0022, 0153]. The composition is utilized to make packaging [0109]The composition Specifically [0144] of Coszach discloses following composition:
Purified lactide as monomer in presence,
Catalyst (tin octanoate, triphenylphosphine)
A prepolymer having molecular weight in a range of 10,000-50,000,
Additives which includes fillers, stabilizers and if required catalytic deactivators are added with lactide monomer.
Consistent with broadest reasonable interpretation above, a prepolymer having molecular weight in a range of 10,000-50,000, the molecular weight of the prepolymer produced is encompassed by a range of disclosed in the specification. Once polymerized the molecular weight of the polymer of Coszach is 40,000 up to 350,000 which also encompasses the molecular weight of the instant invention.
While Coszach discloses use of fillers, the jest of his invention lies in the polymerization process and when the additives can be incorporated into polymeric composition in order to form a product having good optical quality. As it is well understood in the art the type of the filler and the content in which such filler can be utilized depends on the intended use of the polymeric composition [0106].
Nyun discloses a composition which also requires optical transparency and is also utilized in the making of packaging materials just like the composition of Coszach.
The majority of the composition of Nyun is also polylactic acid (PLA) in order to maintain transparency (p. 3 of the translation, last sentence. Nyun also discloses use of aliphatic-aromatic polyester that is blended with the PLA to further improve not only transparency but also elongation, tensile strength and release property.
Nyun discloses use of fillers such as silica, in amount of 0.05-3 % by weight (claim 3). The content of silica as disclosed by Nyun is utilized in order to aid in release properties of the film (page 4 of the translation).
Consequently it would have been obvious to one having ordinary skill in the art at the time instant invention is filed to utilize the silica of Nyun in the composition of Coszach and thereby obtain the claimed invention. Use of silica of Nyun in the claimed amount will not adversely affect transparency of the composition and such composition can still be utilized to make packaging in food industry. Consequently using silica in such amounts would therefore also result in the composition having claimed viscosity, because not only PLA is the same but also type and content of the filler, including particle size and BET.
With respect to claims 2 and 3, as it was disclosed above the Nyun discloses use of no more than 3%,wherein silica is defined particle size in a range of 2-20 microns and surface area of 100-600 m2/g (page 4 of translation). The specific tradename of the silica utilized by Nyun is FPS-11 by Shionogi Co, which has BET of 175-225 m2/g (page 5 of translation, experimental section).
With respect to claim 4, the silica of Nyun is wet processed by extruder, which encompasses the definition of homogenizer as it acts as high shear mixer. Wet processed silica is then added to the composition.
It should also be noted that the composition of Nyun is subject to ASTM D1003 and results in haze value of less than 10% (page 4).
Claims 5-8 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Coszach (US 2006/0014975) in view of Nyun (KR 2005-0056020 translation attached) as applied to claims 1-4 above, and further in view of Gui (WO 2021/185339) US 2023/0193021 is used as translation.
Discussion of Coszach and Nyun from paragraph 1 of this office action is incorporated here by reference. In summary, Coszach discloses process of making biodegradable polymer composition having optical properties and transparency. The composition of Coszach discloses use additives utilized in the second condensation reaction added with lactide stream to the prepolymer, wherein additives include fillers. Nyun is utilized to supplement the type and amount of filler that can be utilized in the composition of Coszach without negatively affecting the transparency and processability of the composition. The composition of Coszach is utilized as packaging material in food industry.
While Coszach discloses composition his invention is directed mainly to the process in which the lactide is polymerized. Gui who also teaches composition that includes PLA biodegradable polymer in the same packaging industry and what properties are required for the composition to make good product and at the same time be compostable at the end of service life (Abstract).
Gui discloses composition comprising at least 70%, most preferably at least 85% of polylactic acid [0013] because its use helps to improve the processing properties and the usability such as mechanical properties and thermal properties [0014]. The polylactic acid of Gui has number average molecular weight of 50,000 or more [0015] which is within the range of the molecular weight of the Coszach, Nyuen and instant invention. The optical purity of PLA is at least 97%, which is also the purity required by Coszach [0016].
In order to speed up the biodegradation process and improve the properties such as flexibility, elongation, thickness deviation of film products the composition may comprise aliphatic-aromatic copolyester in amount of 10-30 wt.% [0027].
The fillers of Gui also include silica as well as calcium carbonate, titania, alumina. Organic fillers include cellulose [0033]. The silica is the filler disclosed in the Coszach and Nyun, wherein physical properties are already met by Nyun.
Gui discloses that the content of metallic element is 50-500 ppm [0030, 0055-0056] which is equivalent to 0.005-0.05% which range encompasses claimed range. Addition of such metal is also utilize to increase biodegradation and improve mechanical properties, because metallic element facilitated reactions such as ester exchange and chain expansion between PLA and other resins of additives. The properties of the composition of Gui are as follows:
Intrinsic viscosity of 1.0 dL/g or more [0007], and since the PLA has the same number average molecular weight as consulted with instant specification, as well as exactly the same monomer make up as both instant invention and Coszach, the PLA of Gui will also meet the viscosity.
Oxygen Permeability according to a standard ASTM D3952 [0125] is less than 500 cc/m2 [0129].
Tensile strength of 60 MPa or more (claim 34) while the ASTM methos was not disclosed the sample was subject to tensile speed of 100 mm/min which is the same tensile speed as ASTM D638 V [0122].
Haze and transparency, the article of Gui has transparency of at least 90%, haze of 40% or less and internal haze of 8%. While claims do not distinguish which haze measurement is claimed, both values of Gui meet the claimed range [0064]. While Gui does not disclose the ASTM method, such method is disclosed in Nyun and results in the same overlapping ranges as that of instant invention and Gui.
Roughness of 0.05-0.5 microns [0066], wherein 0.05 microns meets the claimed amount. While the roughness method is not defined, and Gui does not specify if the roughness measurement is a centerline measurements, the following is well established in the art: Centerline roughness is commonly known as average roughness or arithmetic average. It measures the arithmetic average of the absolute values of surface height and deviation (peaks and valleys) within specified sampling length.
Gui discloses that the film produced therein is uniform and the variation of the film thickness is 10% or less [0068]. In fact the examples disclosed in Table 3 have variation in thickness of less than that. Consequently for the film that is uniform is viewed as an average measurement with the +/- 10% or less variation.
While coefficient of friction is not disclosed, this property depends on material composition, surface roughness and surface contaminants, which for purpose of this rejection will be viewed as negligible or none. Since all disclosures of record disclose PLA composition comprising filler such as silica, and the content of silica is what influences surface roughness and since roughness influences coefficient of friction, the composition as disclosed in Gui will meet the instantly claimed coefficient of friction.
With respect to claim 5, based on the summary of the properties in Gui above, the dispersion index as claimed by the applicants has tensile strength is 60 MPa or more oxygen permeability of 500 or less and metal content of 0.005-0.05%. The dispersion index value is 12.
With respect to claim 6, Ra is 50 nm and haze is 48% or less (including both surface haze and internal haze) the processability index will be less than 100.
With respect to claim 7, please refer to all the properties disclosed in Gui as discussed above.
With respect to claim 8, the biodegradable polymer of references utilized in the rejection is PLA, aliphatic-aromatic polyesters when blended with PLA include PBAT (See discussions above).
With respect to claim 10, the limitation is not viewed as limitation that would narrow down the scope of the polymer composition, but operational condition of the filter within the extruder. Having said that, the applicants defined the claims filter pressure difference in instant specification as dependent on inorganic filler dispersion. Specifically, instant specification stated that if filler is well dispersed during the condensation of the polyester, the filter pressure difference is small. If the inorganic filler particles are not well dispersed, aggregation may take place and cause filter clogging.
In all references applied in this rejection uniform distribution of the filler is a must. Coszach as disclosed in paragraph 1 of this rejection adds filler during the polymerization of the lactic acid, in order to obtain product having good optical properties. It is well established fact in the art that aggregated particles will affect transparency of the film and increase opacity. Nyun pretreats silica to homogenize it, wherein it is another well established knowledge that homogenizing filler is done to break up aggregates and allow uniform dispersion of the filler. Resulting sheet of Nyun as disclosed in paragraph 1 of this rejection has the same haze and transparency as instant invention. Gui discloses importance of uniformly dispersed filler so that uniform surface roughness can be obtain which in turn will directly affect the permeability of the film or a sheet. Since all these properties as disclosed by the prior art of record meet the claimed properties the change in pressure applied to the filter will also be within the same range.
With respect to claims 11-13, primary reference of Coszach disclosed multi-step condensation of polylactic acid first by ring opening and forming prepolymer and the adding monomers and additives to complete condensation of monomers and provide composition for making packaging material for food industry. This topic is presented in detail in paragraph 1 of this rejection. Gui was utilized to supplement the properties of the same type of polylactic polymer (molecular weight and viscosity) necessary for the composition to be suitable as food packaging product. These properties are defined in rejection of instant claim 5 and claim 7 respectively. Polymerization of the PLA is disclosed in rejection of claim 1.
In the light of the above disclosure, at the time instant invention was filed, it would have been obvious to one having ordinary skill in the art to utilize known process of Coszach to polymerize polylactic acid for the production of the transparent food packaging articles. It would have been obvious to one having ordinary skill in the art at the time instant invention was filed, to adjust the properties of the polymer composition of Coszach as it is shown in Gui, since the properties of Gui are necessary to form efficient packaging material that is also compostable thereby minimizing impact on the environment.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Coszach (US 2006/0014975) in view of Nyun (KR 2005-0056020 translation attached) and Gui [(WO 2021/185339) US 2023/0193021 is used as translation] as applied to claims 1-8 and 10-13 above, and further in view of Nelson (US 2018/0118936.
Discussion of Coszach and Nyun from paragraph 1 of this rejection is incorporated here by reference. The discussion of Gui from paragraph 2 of this rejection is also incorporated here by reference.
Coszach in his polymerization process discloses purification and melt processing which are require crystallization and utilize various ways to promote nucleation and the grown of crystals by seeding pure lactide crystals [0166]. The additives include dispersants. Gui further teaches use of nucleating agents and dispersants (WO document). While Gui discloses cellulose, reference lacks the description of the cellulose.
Nelson discloses composition comprising transparent polylactic acid, which is also utilized to make food packaging, wherein nucleating agents are specifically preferred for biodegradable polymer such as polylactic acid (Abstract). Nelson teaches that in order to improve heat resistance of PLA one of ordinary skill in the art can partially crystalize it [0005] and there are two ways to do it. First by annealing which can negatively impact the final product (for example, by shrinking), and second process is by slow crystallization which takes a long time [0006] not very economical on industrial scale).
Nelson therefore provides solution where polylactic acid polymer can have improved crystallization much faster than slow crystallization and one that does not deteriorate the physical properties of the composition. Nelson achieves this by adding nucleating agent which is based on nanocellulose.
Nanocellulose is added to the polylactic acid along with an additive such as silica [0023, 0072], wherein content of the nanocellulose is 0.1-10 % by weight which functions as a dispersant nucleating agent [0017] or a dispersant [0051]. The length-to-width aspect ratio of nanocellulose particles is from 10-1000, wherein the length is 10-500 nm [0161].
It would have been obvious to one having ordinary skill in the art at the time instant invention was filed to utilize nanocellulose of Nelson in the composition of Coszach and thereby obtain the claimed invention. Use of nanocellulose will also result in a composition having improved thermal stability for processing the composition into an article, wherein the resulting article is also a food packaging [0134] while maintaining transparency [0195], oxygen permeability [0104], tensile strength [0103].
Correspondence
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/KATARZYNA I KOLB/Primary Examiner, Art Unit 1767 January 29, 2026