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 Status
Claims 1, 9, 15, and 16 have been amended. Claims 2-4, 8 and 10 have been canceled. Claims Claims 1, 5-7, 9, and 11-20 are pending.
Response to Arguments
Applicant's arguments filed 06/29/2026 have been fully considered but they are not persuasive.
Applicants argue, regarding the polyhydroxyalkanoic acid limitation of claim 1, that Mihara fails to disclose or suggest a polyhydroxyalkanoic acid wherein the monomer contains both 3-hydroxyhexanoic acid and 3-hydroxybutanoic acid, such as poly(3- hydroxybutyrate-co-3-hydroxyhexanoate) (PHBH).
Mihara teaches the polyhydroxycarboxylic acid (A) used in the present invention may be any material formed from a repeating unit of an aliphatic carboxylic acid with a hydroxyl group within the molecule, wherein suitable examples of (A) include PLA, polyhydroxybutyrate, polyhydroxyvalerate, polyhydroxybutyrate/valerate copolymers, and mixtures thereof [p. 0075]. The examiner agrees that Mihara is silent with respect to polyhydroxycarboxylic acid species comprising 3-hydroxyhexanoic acid, however, this limitation was previously presented in original claim 10, which was rejected as being obvious over Mihara in further view of Inagaki et al., US 2020/0384745 ("Inagaki").
Applicants argue, regarding the polyester resin viscosity limitation of claim 1, that the fact that a polyester is in a molten state does not establish that it has a viscosity of 4 Pa- s or less under the specific measurement conditions recited in the claims.
The general teachings of Mihara are that polyester (B), corresponding to the claimed polyester resin of (A-2), has a weight average molecular weight as low as 5000 Da and a melting temperature no higher than 150 °C, where in some instances polyester (B) is a liquid at room temperature [p. 0078, 0083, 0097]. Mihara teaches specific examples of polyester (B) with melting temperatures as low as -41°C [p. 0083]. Mihara teaches the reaction temperature ranges from 150 to 230 °C [p. 0095, 0099]. Furthermore, the examiner points to Mihara’s teaching that polyesters prepared from diethylene glycol and sebacic acid are suitable for use as polyester (B) [p. 0080, 0082]. Applicants exemplify the preparation and use of polyesters prepared from diethylene glycol and sebacic acid example 10, wherein the reported melt viscosities range from 0.167 Pa-s as measured at 10Hz and 135 °C [table 5]
A skilled artisan would appreciate that a polymers melt viscosity is influenced by the molecular weight of the polymer as well as the temperature in which the melt viscosity is measured. In light of this, one having ordinary skill in the art at the time the invention was filed would have expected the polyester(B) of Mihara to obviously satisfy, or at the very least, embrace embodiments capable of satisfying the claimed dynamic viscosity at reaction temperature as it satisfies all the material and chemical limitations of the claimed polyester.
Applicants further argue the polyester resin viscosity limitation, reciting, “In the molding resin field to which Mihara pertains, molten polyesters frequently have viscosities in the range of tens to hundreds of Pa- s”.
The polyester resin viscosity of amended claim 1 appears to be directed towards the polyester resin starting material of (A-2). The rejection is based on polyester (B) of Mihara, not the final polyester product used for molding.
Applicants argue the rejection on claims 10 and 20 as being obvious over Mihara in further view of Inagaki et al., US 2020/0384745 ("Inagaki"). Applicant submits that a person of ordinary skill in the art would not have been motivated to combine the teachings of Mihara and Inagaki. Mihara's technology is fundamentally directed to forming homogeneous copolymer structures via esterification/transesterification reaction between a polyhydroxycarboxylic acid (A) and a polyester (B). Mihara, paragraphs [0073], [0100]. In contrast, Inagaki's technology relies on phase separation structures and interfaces with inorganic fillers in physical blends to achieve desired properties. Inagaki, paragraphs [0066]-[0070].
The examiner agrees that Inagaki is directed towards a different final product (physical blend) than Mihara (homogenous copolymer). However, Ingnaki is relied on for the teaching that poly(3-hydroxybutyrate-co-3-hydroxyhexanoate) (PHBH) has superior biodegradability compared to PLA, which is used as the polyhydroxycarboxylic acid (A) in the examples of Mihara. The teaching of Ignaki is relevant to Mihara as Mihara is concerned with the biodegradability of the block copolymer formed from polyhydroxycarboxylic acid (A) and polyester (B) [p. 0001].
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 11-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 11-20 are unclear and indefinite as they depend on canceled claims.
For the purpose of compact prosecution, these claims would generally be interpreted as being dependent on claim 1, however:
If claims 11-16 were interpreted as dependent on claim 1, claims 11/12, 13/14, and 15/16 would be objected to as respective duplicates of claims 5, 6, and 7;
If claims 17-20 were interpreted as dependent on claim 1, claims 17-20 would be rejected for failing to further limit claim 1.
For clarity of the record, the examiner will refer to claims 1, 5, 6, 7, and 9 in the rejection below.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 limits the monomers configuring the polyhydroxyalkanoic acid to containing 3-hydroxyhexanoic acid and 3-hydroxybutanoic acid. These monomers satisfy claim 7, therefore, claim 7 fails to further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mihara (US 2006/0030690 A1) in further view of Inagaki (US 2020/0384745 A1). T
Mihara is directed towards a molding resin formed from a block copolymer comprising polyhydroxycarboxylic acid structural units (I), and polyester structural units (II) derived from a dicarboxylic acid and a diol [abstract].
Mihara is directed towards a production process for a molding resin wherein a molten mixture of a polyhydroxycarboxylic acid (A), and a polyester (B) with hydroxyl groups at both terminals, obtained by reacting a dicarboxylic acid and a diol, is subjected to an esterification reaction [p. 0073].
Mihara exemplifies the preparation of a molding resin (C-1) via esterification of a polylactic acid (PLA) and an aliphatic polyester (B-2) prepared from sebacic acid (SeA) and propylene glycol [p. 0176; example 1, reference example 2] [satisfying claimed conditions (A-2) and (B), see instant claims 1 and 3] [lactic acid corresponds to the hydroxyalkanoic acid, or lactide thereof, of claimed formula 2, wherein n=0 and R=Me; see instant claims 7 and 16].
Mihara discloses the reaction temperature of the esterification reaction conducted is sufficiently high to melt the polyhydroxycarboxylic acid (A) and the polyester (B), provided the temperature is low enough that the polyhydroxycarboxylic acid (A) is unlikely to undergo thermal decomposition [p. 0096]. Mihara teaches the temperature is preferably within a range from 150 to 230 °C. [p. 0103]. Mihara is silent with respect to methods used to determine the Td of the polyhydroxycarboxylic acid (A). It would have been obvious having ordinary skill in the art at the time the invention was filed that the temperature range taught by Mihara to be useful for the esterification reaction (above Tm- of (A) and (B), below Td of (A)) is below the thermal decomposition temperature as determined by method (I) or (II), and therefore obviously satisfies the limitation that the reaction temperature is lower than the decomposition temperature of the polyhydroxyalkanoic acid.
Mihara is directed towards a molding resin that shows excellent flexibility, transparency, impact resistance and biodegradability, which is particularly useful as a resin for molding purposes, as well as a production process for such a resin, and a polyester composition thereof comprising a polyhydroxycarboxylic acid (A) and a polyester (B) [p. 0001]. Mihara teaches the polyhydroxycarboxylic acid (A) used in the present invention may be any material formed from a repeat unit of an aliphatic carboxylic acid with a hydroxyl group within the molecule, wherein suitable examples of (A) include PLA, polyhydroxybutyrate, polyhydroxyvalerate, polyhydroxybutyrate/valerate copolymers, and mixtures thereof [p. 0075]. Mihara is silent with respect to polyhydroxycarboxylic acid species comprising 3-hydroxyhexanoic acid.
Inagaki is directed towards a tubular article obtained by molding an aliphatic polyester-based resin composition comprising an aliphatic polyester-based resin (A) having a repeat unit derived from an aliphatic diol and a repeat unit derived from an aliphatic dicarboxylic acid, and a polyhydroxyalkanoate (B), wherein the composition has excellent moldability, high biodegradability at room temperature [p. 0026].
Inagaki teaches, from the viewpoint of moldability, processability, and physical properties of the molded article to be obtained, the polyhydroxyalkanoate (B) is preferably a poly(3-hydroxybutyrate-co-3-hydroxyhexanoate) copolymer resin, that is PHBH [p. 0128].
Inagaki exemplifies a resin comprising aliphatic polyester-based resin (A) and poly(3-hydroxybutyrate-co-3-hydroxyhexanoate) (B) [example I-1] which has a high oxygen barrier property (low O2 permeability, < 100g/m2*day) and completely biodegrades in soil after 3 months [p. 0220-0222, 0225-0229, 0232; table 1]. In contrast, the resin composition exemplified by Inagaki comprising aliphatic polyester-based resin (A) and polylactic acid (B) [comparative example I-3] has a high oxygen permeability and achieves almost no biodegradation in soil after 3 months [p. 0231, table 1].
Considering the disclosure of Inagaki and the concern of Mihara towards the biodegradation of the molding resin — it would have been obvious to one having ordinary skill in the art at the time the invention was filed to prepare the composition of Mihara with poly(3-hydroxybutyrate-co-3-hydroxyhexanoate) as the polyhydroxycarboxylic acid (A), as Mihara teaches (A) may be a polyhydroxyalkanoates, and Inagaki demonstrate polyester resins comprising poly(3-hydroxybutyrate-co-3-hydroxyhexanoate) polyhydroxyalkanoate resins have superior biodegradation in soil after 3 months when compared to polyester resins comprising polylactic acid polyhydroxyalkanoate resins.
The general teachings of Mihara are that polyester (B), corresponding to the claimed polyester resin of (A-2), has a weight average molecular weight as low as 5000 Da and a melting temperature no higher than 150 °C, where in some instances polyester (B) is a liquid at room temperature [p. 0078, 0083, 0097]. Mihara teaches specific examples of polyester (B) with melting temperatures as low as -41°C [p. 0083]. Mihara teaches the reaction temperature ranges from 150 to 230 °C [p. 0095, 0099]. Furthermore, the examiner points to Mihara’s teaching that polyesters prepared from diethylene glycol and sebacic acid are suitable for use as polyester (B) [p. 0080, 0082]. Applicants exemplify the preparation and use of polyesters prepared from diethylene glycol and sebacic acid example 10, wherein the reported melt viscosities range from 0.167 Pa-s as measured at 10Hz and 135 °C [table 5]
A skilled artisan would appreciate that a polymers melt viscosity is influenced by the molecular weight of the polymer as well as the temperature in which the melt viscosity is measured. In light of this, one having ordinary skill in the art at the time the invention was filed would have expected the polyester(B) of Mihara to obviously satisfy, or at the very least, embrace embodiments capable of satisfying the claimed dynamic viscosity at reaction temperature as it satisfies all the material and chemical limitations of the claimed polyester.
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mihara (US 2006/0030690 A1) in view of Inagaki (US 2020/0384745 A1) and in further view of Li (Li, J., Yin, F., Li, D., Ma, X., and Zhou, J. (2019). "Mechanical, thermal, and barrier properties of PHBH/cellulose biocomposite films prepared by the solution casting method," BioRes. 14(1), 1219-1228.) The disclosure of Mihara and Inagaki is above and is applied here as such.
Mihara teaches the reaction temperature ranges from 150 to 230 °C and is selected to be high enough to melt (A) and (B) but low enough prevent thermal decomposition of (A) [p. 0095, 0099]. Inagaki teaches PHBH has a melting point of 140° C and is melt kneaded at 130 to 160° C in order to prevent polymer degradation or color deterioration [p. 0165, 0207] PHBH has a decomposition temperature of 225 °C as evidenced by [figure 4, table 1]. In light of this, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to select a temperature greater than 15 degrees lower than the degradation temperature of the polymer.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOLLEY GRACE HESTER whose telephone number is (703)756-5435. The examiner can normally be reached Monday - Friday 9:00AM -5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Randy Gulakowski can be reached at (571) 272-1302. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HOLLEY GRACE HESTER/Examiner, Art Unit 1766
/RANDY P GULAKOWSKI/Supervisory Patent Examiner, Art Unit 1766
