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 .
DETAILED ACTION
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4-7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 4-7 are in a form of improper multiple dependent claims and a multiple dependent claim cannot depend on another multiple dependent claims.
Claim 5 recites many additives in a form of Markush Group including talc, but claim 5 further recites the talc as optional component which is confusing.
Claim 6 recites “less than 5 wt% of epoxidized soybean oil and/or less than 5 wt% of a polylactic acid”, but claim 6 further recites “optionally essentially free of epoxidized soybean oil and/or polylactic acid is which is confusing since the recited “less than 5 wt%” would encompass an amount down to 0 wt% encompassing the “essentially free of”.
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.
Claims 1 -11 are rejected under 35 U.S.C. 103 as being unpatentable over Koyama (Jan. 3, 2023) in view of EP 2285901 B1 (July 22, 2020) equivalent to US 2011/0189414 A1 (Aug, 4, 2011).
Koyama teaches biodegradable film comprising a poly(3-hydroxybutylate-co-3-hydroxyhexanoate (P3HB3HH) A-1 having a 3-hydroxyhexanote content of 11.2 mol % (see a lower section of col. 9) and 15-45 parts by weight of aromatic/aliphatic polyester in examples 1-4 of Table 1 and the parts by weight is almost same as the instantly recited weight %. Koyama teaches that the aromatic/aliphatic polyester is Ecoflex C1200 (poly(butylene adipate-co-butylene terephthalate below the Table 1 meeting the instant biodegradable aromatic/aliphatic polyester.
The instant invention further recites a blend of the poly(3-hydroxybutylate-co-3-hydroxyhexanoate having a different mol % of 3-hydroxyhexanote over the examples 1-4 of Koyama.
Koyama teaches biodegradable film comprising a poly(3-hydroxybutylate-co-3-hydroxyhexanoate (P3HB3HH) A-2 having a 3-hydroxyhexanote content of 5.4 mol % in lines 5-11 of col. 9 and an amount of the biodegradable aliphatic polyester being 20 to 99% by weight of the total amount in lines 23-31 of col. 9 overlapping the instant amounts recited in claim 1.
Koyama further teaches utilization of two or more PHA in lines 18-22 of col. 5. See In re Mills, 477 F.2d 649, 176 USPQ 196 (CCPA), In re Lamberti, 545 F.2d 747, 750 (CCPA 1976): Reference must be considered for all that it discloses and must not be limited to preferred embodiments or working examples. MPEP 2123.
Utilization of two or more poly(3-hydroxybutylate-co-3-hydroxyhexanoate (P3HB3HH) is known in the art.
EP teaches a composition comprising a blend of two or more linear biologically-produced polyhydroxyalkanoate polymer, a biodegradable aromatic/aliphatic polyester and a nucleating agent in claim 1. EP further teaches a blend (iii) of a poly(3-hydroxybutylate-co-3-hydroxyhexanoate with 3%-15% 3-hydroxyhexanoate content and a poly(3-hydroxybutylate-co-3-hydroxyhexanoate with 5%-50% 3-hydroxyhexanoate content in the claim 1.
Thus, it would have been obvious to one skilled in the art before the effective filing date of invention further to utilize a mixture of the A-1 (the instant second polyhydroxyalkanote) and A-2 (the instant first polyhydroxyalkanote) in the examples of Koyama since Koyama teaches utilization of two or more PHA I and since utilization of two or more poly(3-hydroxybutylate-co-3-hydroxyhexanoate (P3HB3HH) is known in the art as taught by EP absent showing otherwise.
Regarding amounts of the instant first and second polyhydroxyalkanote resins, Google search of Glass Transition Temperature of Poly(3-hydroxyhexanoate) has yielded the following.
Poly(3-hydroxyhexanoate) (P3HHx) is a biodegradable polyhydroxyalkanoate (PHA) homopolymer. In its pure form, P3HHx has a glass transition temperature (Tg) in the range of about –5 °C to –3.2 °C pdf.benchchem.com. This low Tg reflects the flexibility of the long hexanoate side chain, which reduces chain packing and increases free volume compared to shorter-chain PHAs like poly(3-hydroxybutyrate) (P3HB).
Context and comparison
P3HB (homopolymer): Tg ≈ 4–5 °C pdf.benchchem.com
P3HHx (homopolymer): Tg ≈ –5 °C to –3.2 °C pdf.benchchem.com
P(3HB-co-3HHx) copolymers: As 3HHx content increases, Tg generally decreases further due to chain stiffness reduction and disruption of crystallinity.
The poly(3-hydroxybutylate-co-3-hydroxyhexanoate (P3HB3HH) A-1 having a 3-hydroxyhexanote content of 11.2 mol % would be expected have a Tg lower than the poly(3-hydroxybutylate-co-3-hydroxyhexanoate (P3HB3HH) A-2 having a 3-hydroxyhexanote content of 5.4 mol % inherently. Thus, utilization of a higher amount of the P3HB3HH (A-1) would be expected to yield a film having a lower Tg having a higher flexibility/softness.
Thus, it would have been obvious to one skilled in the art before the effective filing date of invention further to utilize the instant amount of the first and second polyhydroxyalkanote resins in Koyama in order to adjust flexibility/softness of the film depending a desired application absent showing otherwise. Such blend would make claim 3 obvious. When patentability is predicated upon a change in a condition of a prior art composition, such as a change in concentration or in temperature, or both, the burden is on Applicant to establish with objective evidence that the change is critical, i.e., it leads to a new unexpected result. It is not inventive to discover the optimum or workable ranges by routine experimentation when the general conditions of a claim are disclosed in the prior art. See In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990); In re Aller, 220 F.2d 454, 456 (CCPA 1955). MPEP 2144.05.
Regarding claim 2, (P3HB3HH) A-1 having a 3-hydroxyhexanote content of 11.2 mol % and poly(3-hydroxybutylate-co-3-hydroxyhexanoate (P3HB3HH) A-2 having a 3-hydroxyhexanote content of 5.4 mol % would meet claim 2.
Regarding claim 4, the examples 1, 2 and 4 taught in the Table1 of Koyama would meet claim 4.
Regarding claim 5, Koyama teaches employing other additives including inorganic fillers in lines 16-29 of col. 7 and EP teaches employing a nucleating agent such as mica, silica talc and calcium carbonate in [0104]. Thus, further utilization of the nucleating agent (i.e. inorganic filler) of EP in Koyama would have been obvious to one skilled in the art since the nucleating agent (i.e. inorganic filler) would increase crystallinity and physical and mechanical properties thereof inherently. When patentability is predicated upon a change in a condition of a prior art composition, such as a change in concentration or in temperature, or both, the burden is on Applicant to establish with objective evidence that the change is critical, i.e., it leads to a new unexpected result. It is not inventive to discover the optimum or workable ranges by routine experimentation when the general conditions of a claim are disclosed in the prior art. See In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990); In re Aller, 220 F.2d 454, 456 (CCPA 1955). MPEP 2144.05.
Regarding claim 6, EP teaches employing a plasticizer such as epoxidized soy bean oil in [0107] and thus further utilization of a small amount of the epoxidized soy bean oil taught in EP would have been obvious to one skilled in the art since EP teaches the plasticizer would change the glass transition temperature and modulus of the composition in [0105]. Further, the recite less than 5 wt% would encompass 0 wt%.
Selection of a known material based on its suitability for its intended use is prima facie obvious, see Sinclair & Carroll Co. v. Interchemical Corp., 325 US 327, 65 USPQ 297 (1945). MPEP 2144.07.
The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. KSR Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). MPEP 2141.
Regarding claim 7, Koyama teaches a 20 µm-thick film in Example 1 as well as 5-100 µm in lines 38-41 of col. 9. Further, EP teaches a film having a thickness of 100-120 microns in [0137] and Young’s modulus (i.e., flexural modulus) of 137.5 MPa to 860.4 MPa in table 6.
Regarding claim 8, EP teaches utilization of 5% to 50% of the nucleating agent (inorganic filler) in the liquid carrier in [0099] which would make claim 8 obvious.
Regarding claims 9 and 10, the above discussed obvious modification to components and amounts thereof would make claims 9 and 10 obvious.
When patentability is predicated upon a change in a condition of a prior art composition, such as a change in concentration or in temperature, or both, the burden is on Applicant to establish with objective evidence that the change is critical, i.e., it leads to a new unexpected result. It is not inventive to discover the optimum or workable ranges by routine experimentation when the general conditions of a claim are disclosed in the prior art. See In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990); In re Aller, 220 F.2d 454, 456 (CCPA 1955). MPEP 2144.05.
Regarding claim 11, Koyama teaches utilization of an extruder and a blow molding for obtaining the film in Example 1 which would make claim 11 obvious.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over EP 2285901 B1 (July 22, 2020) equivalent to US 2011/0189414 A1 (Aug, 4, 2011).
EP teaches a composition comprising a blend of two or more linear biologically-produced polyhydroxyalkanoate polymer, a biodegradable aromatic/aliphatic polyester and a nucleating agent in claim 1.
EP further teaches a blend (iii) of a poly(3-hydroxybutylate-co-3-hydroxyhexanoate with 3%-15% 3-hydroxyhexanoate content and a poly(3-hydroxybutylate-co-3-hydroxyhexanoate with 5%-50% 3-hydroxyhexanoate content in the claim 1.
EP teaches 10 to 50 percent by weight of the total polymer components of the composition is the biodegradable aromatic/aliphatic polyester in claim 4 overlapping the recited amount of 5 wt% to 48 w% for a component (C) of claim 1.
The instant invention further recites amounts of the first and second polyhydroxyalkanote resins over EP.
Google search of Glass Transition Temperature of Poly(3-hydroxyhexanoate) has yielded the following.
Poly(3-hydroxyhexanoate) (P3HHx) is a biodegradable polyhydroxyalkanoate (PHA) homopolymer. In its pure form, P3HHx has a glass transition temperature (Tg) in the range of about –5 °C to –3.2 °C pdf.benchchem.com. This low Tg reflects the flexibility of the long hexanoate side chain, which reduces chain packing and increases free volume compared to shorter-chain PHAs like poly(3-hydroxybutyrate) (P3HB).
Context and comparison
P3HB (homopolymer): Tg ≈ 4–5 °C pdf.benchchem.com
P3HHx (homopolymer): Tg ≈ –5 °C to –3.2 °C pdf.benchchem.com
P(3HB-co-3HHx) copolymers: As 3HHx content increases, Tg generally decreases further due to chain stiffness reduction and disruption of crystallinity.
The poly(3-hydroxybutylate-co-3-hydroxyhexanoate having a 3-hydroxyhexanote content of 5%-50% would be expected have a Tg lower than the poly(3-hydroxybutylate-co-3-hydroxyhexanoate having a 3-hydroxyhexanote content of 3%-15% inherently. Thus, utilization of a higher amount of the poly(3-hydroxybutylate-co-3-hydroxyhexanoate having a 3-hydroxyhexanote content of 5%-50% would be expected to yield a film having a lower Tg having a higher flexibility/softness.
Thus, it would have been obvious to one skilled in the art before the effective filing date of invention further to utilize the instant amount of the first and second polyhydroxyalkanote resins in EP in order to adjust flexibility/softness of the film depending a desired application.
Thus, it would have been obvious to one skilled in the art before the effective filing date of invention further to utilize the instant higher amount of the second polyhydroxyalkanote (i.e., the poly(3-hydroxybutylate-co-3-hydroxyhexanoate with 5%-50% 3-hydroxyhexanoate content) in EP in order to adjust flexibility/softness of the film depending a desired application absent showing otherwise. Such blend would make claim 3 obvious. When patentability is predicated upon a change in a condition of a prior art composition, such as a change in concentration or in temperature, or both, the burden is on Applicant to establish with objective evidence that the change is critical, i.e., it leads to a new unexpected result. It is not inventive to discover the optimum or workable ranges by routine experimentation when the general conditions of a claim are disclosed in the prior art. See In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990); In re Aller, 220 F.2d 454, 456 (CCPA 1955). MPEP 2144.05.
Regarding claim 2, a blend (iii) of a poly(3-hydroxybutylate-co-3-hydroxyhexanoate with 3%-15% 3-hydroxyhexanoate content and a poly(3-hydroxybutylate-co-3-hydroxyhexanoate with 5%-50% 3-hydroxyhexanoate content would make claim 2 obvious.
Regarding claim 4, EP teaches 10 to 50 percent by weight of the total polymer components of the composition is the biodegradable aromatic/aliphatic polyester in claim 4 overlapping the recited amount of 8 wt% to 40 wt% of claim 4. EP further teaches polybutylene adipate terephthalate (PBAT) in [0080].
Regarding claim 5, EP teaches employing a nucleating agent such as mica, silica talc and calcium carbonate and cyanuric acid in [0104]. EP teaches 4 parts by weight of 25% cyanuric acid compounded in PHB carrier in Table 1 which would yield a lttle less that 1 wt.% based on a total amount.
Thus, further utilization of the nucleating agent (i.e. inorganic filler) would have been obvious to one skilled in the art since the nucleating agent (i.e. inorganic filler) would increase crystallinity and physical and mechanical properties thereof inherently and since EP teaches and equates the inorganic filler and cyanuric acid. See In re Mills, 477 F.2d 649, 176 USPQ 196 (CCPA), In re Lamberti, 545 F.2d 747, 750 (CCPA 1976): Reference must be considered for all that it discloses and must not be limited to preferred embodiments or working examples. MPEP 2123. A prima facie case of obviousness exists when the claimed range and the prior art range do not overlap but are close enough such that one skilled in the art would have expected them to have the same properties, Titanium Metals Corp. v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed, Cir. 1985). MPEP 2144.05.
Regarding claim 6, EP teaches employing a plasticizer such as epoxidized soy bean oil in [0107] and thus further utilization of a small amount of the epoxidized soy bean oil taught by EP in Koyama would have been obvious to one skilled in the art since EP teaches the plasticizer would change the glass transition temperature and modulus of the composition in [0105]. Further, the recite less than 5 wt% would encompass 0 wt%.
Regarding claim 7, EP teaches a film having a thickness of 100-120 microns in [0137] and Young’s modulus (i.e., flexural modulus) of 137.5 MPa to 860.4 MPa in table 6.
Regarding claims 9 and 10, the above discussed obvious modification to components and amounts thereof would make claims 9 and 10 obvious.
When patentability is predicated upon a change in a condition of a prior art composition, such as a change in concentration or in temperature, or both, the burden is on Applicant to establish with objective evidence that the change is critical, i.e., it leads to a new unexpected result. It is not inventive to discover the optimum or workable ranges by routine experimentation when the general conditions of a claim are disclosed in the prior art. See In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990); In re Aller, 220 F.2d 454, 456 (CCPA 1955). MPEP 2144.05.
Regarding claim 11, EP teaches films in examples and Koyama teaches utilization of an extruder and a blow molding for obtaining the film in Example 1. Thus, the recited method of claim 11 of EP in view of Koyama would have been obvious. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. KSR Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). MPEP 2141.
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/TAE H YOON/Primary Examiner, Art Unit 1762
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