DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This communication is responsive to the claim set and Response to Restriction filed 03/20/2026. Claims 1, 4-13 and 15-19 are pending. Claims 18-19 are withdrawn due to the Restriction Requirements.
Claims 1, 4-13 and 15-17 are rejected for the reasons set forth below.
Election/Restrictions
Applicant’s election without traverse of Claims 1, 4-13 and 15-16 in the reply filed on 03/20/2026 is acknowledged.
Drawings
Examiner objected FIG. 7, FIG. 10, FIG. 13 because the specification does not have explanation on PREFORM 1, PREFORM 2, PREFORM 3, PREFORM 4 and PREFORM 5.
DUPLICATE CLAIMS IN SINGLE CLAIM SET
Applicant is advised that should claim 16 be found allowable, claim 17 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. (See MPEP 706.03(k).)
In the Response to Restriction, Applicant elected Claims 1, 4-13 and 15-16. If Applicant intend to cancel Claim 17, the claim status identifier should be “Cancelled.”
Claim Objections
Claims 8 and 11 are objected to because of the following informalities:
Claims 1, 9. 10. 11, 16-17 recite “additional additives.” “additional” is redundant. The Examiner suggests deleting “additional.”
Claim 8 last line “and copolymers and blends thereof” should read – and copolymers of blends thereof—
Claim 11 the third line “and” should be deleted.
Appropriate correction is required.
Claim Interpretation
Claim 1 recites “a melt strength enhancer consisting essentially of a mixture of an organic peroxide and an oxazoline,” while it is recognized that the phrase “consisting essentially of” narrows the scope of the claims to the specified materials and those which do not materially affect the basic and novel characteristics of the claimed invention, absent a clear indication of what the basic and novel characteristics are, “consisting essentially of” is construed as equivalent to “comprising”. See MPEP 2111.03.
Instant claims recite values being modified by “about.” Nissenbaum et al. (US20160257098 A1) discloses a biodegradable sheet comprising polyhydroxyalkanoate (claim 1). Therefore, Nissenbaum is an analogous art of instant application. Nissenbaum defines “about” as 10% deviation of the value related to. Thus, “about” of instant claimed is interpreted as 10% deviation of the value related to, including the recited value.
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 1, 4-13 and 15-17 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.
Claim 1 recites “the preform comprises: … … from about 1 to about 60 wt.% additional additives, wherein the additional additives comprise from about 0.1 to about 10 weight percent of at least one nucleating agent, and from about 0.05 to about 3 weight percent of a melt strength enhancer consisting essentially of a mixture of an organic peroxide and an oxazoline, and wherein the preform has a body having a uniform wall thickness throughout the body of the preform.” It is not clear if the wt% of the nucleating agent and melt strength enhancer are based on the total weight of the preform or based on the total weight of additives. In view of the instant specification, wt% is interpreted as based on the total weight of preform.
Claim 7 recites “and the like,” the phrase "and the like" renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "and the like"), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d).
Claims 4-13 and 15-17 are rejected under 35 U.S.C. 112(b) for the dependency on Claim 1.
Claim Rejections - 35 USC§ 103
Claims 1, 4-13 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Rajendra et al. (EP3360927) in view of Garcia et al. (US20200002487).
Regarding Claims 1, 4-7 and 12, Rajendra teaches a resin composition comprising a nucleating agent (claim 5), 5 wt. % to 95 wt.% of PHA polymer (claim 6), an organic peroxide branching agent and a crosslinking agent ([0004]) and 0.05 wt.% to 20 wt.% additives ([0077]). Rajendra teaches reacting the PHA polymer with the branching agent and the crosslinking agent resulting in branched polymer with increased melt strength over the melt strength of the starting polymer ([0018]), therefore, the branching agent and crosslinking agent read on melt strength enhancer. Rajendra furthermore teaches the PHA polymer includes poly(3-hydroxybutyrate-co-3-hydroxyhexanoate) (P3HBco-P3HHx) with 3% to 15% 3-hydroxyhexanoate ( claim 10 ), which has the structure of:
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.
The structure reads on the claimed R1 consisting of CH3 and a C3 alkyl group, and wherein the monomeric units having =CH3 is from about 88 to 98 mol percent of the copolymer. (0.85/86/(0.85/86+0.15/114 )to 0.97/86/(0.97/86+0.03/114), 86 is the molecular weight of the R1=CH3 unit, 114 is the molecular weight of the R 1=C3 alkyl unit).
Rajendra exemplifies the nucleating agent being 3 wt. % , PHA polymer being 45 wt. %, peroxide and cross-linking agent being from 0.05 wt.% to 0.13 wt.% of a PHA polymer composition (page 28, Table 15). Therefore, Rajendra teaches a resin composition comprising a nucleating agent, the claimed PHA, melt strength enhancer and additives in the amounts falling within the claimed respective ranges.
Rajendra is silent on the resin composition adapted for forming a preform for a biodegradable container, however, the language directs to intended use which has no weight of patentability. It has been held "the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction." Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d.
The difference between Rajendra and instant Application is that Rejendra is silent that the melt enhancer includes an oxazoline.
However, Garcia teaches a composition comprising PHA ( claim 1) and 0.1 wt. % to 3 wt. % of at
least one crosslinking agent and/or chain extender, such as peroxide and oxazoline ([0088]; claim 11),
whereby Garcia teaches oxazoline is a crosslinking agent for PHA polymer and can form a PHA polymer composition with peroxide. In view of such teaching, one ordinary skilled artisan would have been motivated to using oxazoline taught by Garcia for the composition of Rajendra to obtain a modified PHA composition because using oxazoline replacing the crosslinking agent of Rajendra is a simple substitution of one known element for another (see MPEP § 2143 I. B.); and one ordinary skilled artisan would have had reasonable expectation of success because the teaching of Garcia suggests that PHA and peroxide and oxazoline compatible and the formed composition has good mechanical properties ([0006]).
Regarding the dimensions and shapes of the preform claimed in Claims 1, 4-7 and 12, the claims direct to intended use of the modified composition and manners of the preform. The intended use limitations do not require steps to be performed. These limitations do not limit the scope of the instant claims and need not be taught by the prior art in order to read on the claims. See MPEP 2114 II. It has been held that a recitation with respect to the manner in which a claim apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations (Ex Parte Masham, 2 USPQ2d 1647 (1987).
Regarding Claim 8, Rajendra teaches the resin composition comprising 20 wt.%
poly(butylene succinate) (page 18, table 3, formulation 2).
Regarding Claim 9, Rajendra teaches the resin composition comprising carbon black ([0096],
[0097]) or pigments ([0076], [0077]).
Regarding Claim 10, Rajendra teaches the resin composition comprising calcium carbonate as
filler (Page 20, Table 5, formulation 1, 2, 3, or 4).
Regarding Claim 11, Rajendra teaches the resin composition comprising 4.8% of plasticizer
(page 18, table 3, formulation 2), wherein the plasticizer is a citrate plasticizer ([0098]).
Regarding Claim 13, Rajendra teaches the nucleating agent is polyhydroxybutyrate ([0129]).
Regarding Claim 15, Rajendra teaches the PHA can be a) a poly(3-hydroxybutyrate-co-3-hydroxyhexanoate) with a 3% to 15% 3-hydroxyhexanoate content blended b) a poly(3-hydroxybutyrate-co-3-hydroxyhexanoate) having a 5%-50% 3-hydroxyhexanoate content, wherein the weight of polymer a) is 5% to 95% of the combined weight of polymer a) and polymer b) (claim 12). Poly(3-hydroxybutyrate-co-3-hydroxyhexanoate) having a 5%-50% 3-hydroxyhexanoate content, converting to mol%, the content of hydroxyhexanoate is 3.8 mol% to 43 mol%. Because Rajendra teaches the PHA is 5 wt.% to 95 wt.% of the composition, the wt% of poly(3-hydroxybutyrate-co-3-hydroxyhexanoate) having a 5%-50% 3-hydroxyhexanoate content is 0.25 wt.% to 90 wt.% of the composition. Thus, the wt% content of polymer b of the composition and mol% content of hydroxyhexanoate of poly(3-hydroxybutyrate-co-3-hydroxyhexanoate) overlapping the claimed 1 to 15 wt% and 25 mol% to 50 mol%, respectively. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists (See MPEP 2144.05 I). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected the overlapping portion of the range taught by Rajendra, i.e. it would have been obvious to have a modified composition containing 1 to 15 wt% of poly(3-hydroxybutyrate-co-3-hydroxyhexanoate with 25 mol% to 43 mol% of hydroxyhexanoate content.
Rajendra teaches the composition comprising 5 wt. % to 95 wt.% of PHA polymer, the overlapping portion with the instant claim 1 is 40 wt% to 95 wt%, therefore the wt.% of polymer a) poly(3-hydroxybutyrate-co-3-hydroxyhexanoate) with a 3% to 15% 3-hydroxyhexanoate is 25 wt% to 94 wt%. In polymer a), the mol% of hydroxybutyrate is 88 mol% to 98 mol%. In polymer b), the mol% of hydroxybutyrate is 57 mol% to 75 mol%. Consequently, the lowest mol% of hydroxybutyrate in such mixture of polymer a) and polymer b) is about 77 mol%, the highest mol% of hydroxybutyrate in such mixture of polymer a) and polymer b) is about 98 mol%. The mol% falls within the mol% of R1=CH3 of the instant claim 1.
Regarding Claims 16-17, Rajendra teaches the composition comprising slip agents ([0076]) and exemplifies that a composition comprises 5 wt% slip MB which contains 20% erucamide, whereby the composition comprises 1% of erucamide by weight.
Claims 1, 4-13 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (US 2004/0225269) in view of Yano et al. (US2006/0276617), as evidenced by Miyamoto et al. (US 2008/0108742).
Regarding claim 1, 4-7 and 12, Zhao discloses a biodegradable article comprising a moldable resin composition comprising at least 20 wt.% of PHA copolymer (claim 1), 0.01 wt.% to 5 wt.% of nucleating agent (claim 9 and [0053]) and 0.1 wt.% to 60 wt.% fillers ([0055]); wherein the PHA copolymer has a first monomer unit (I):
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the structure reads on the instant structure when R1=C1 alkyl, n=1 (claim 1). Zhao further teaches the first monomer units are at least 80% of the randomly repeating monomer units of the PHA copolymer (Id.), whereby Zhao discloses a PHA having the claimed structure wherein at least 80 mol% monomer units having R1 = CH3. Zhao exemplifies that a composition comprising 55 wt.% PHA copolymer which is poly(3-hydroxybutryate-co-3-hydroxhexanoate) resin comprising from 10 to 12 wt% of 3-hydroxyhexanoate [0084, Example 4]. The poly(3-hydroxybutryate-co-3-hydroxhexanoate) resin meets the structural limitations of the claimed PHA because the content of 3-hydroxyhexanoate in poly(3-hydroxybutryate-co-3-hydroxhexanoate) resin in lower of the highest amount of 3-hydroxyhexanoate in the PHA disclosed by Rajendra (see para. 11). In summary, Zhao teaches a resin composition comprising the claimed PHA copolymer, additives and nucleating agent in the amounts overlapping the respective claimed ranges.
Zhao further teaches that the composition can be molded into containers ([0059]).
The difference between Zhao and instant Claim 1 is that Zhao is silent on the composition comprising a melt strength enhancer consisting essentially of a mixture of an organic peroxide and an oxazoline.
However, Yano discloses an aliphatic polyester resin composition which exhibits excellent
heat resistance, moldability, and hydrolysis resistance [ abstract, 0001]. The resin composition comprises a biodegradable polyester resin which is crosslinked with a crosslinking agent wherein some or all of the terminal carboxyl groups in the polyester resin are blocked with a terminal blocking agent [abstract, 0001, 0024, 0028]. Yano teaches that from about 0.1 to 10 parts by mass (pbm) of an organic peroxide (relative
to 100 pbm of polyester resin) is added for increasing the degree of crosslinking [0026]. Yano also teaches that the terminal carboxyl groups of the polyester resin are blocked via a blocking agent which may be, inter alia, an oxazoline compound [0029, 0034]. The blocking agent is disclosed as being incorporated into the composition in a range of amounts of 0.1 to 20 pbm relative to 100 pbm of polyester resin [0038].
Zhao and Yano are both directed towards biodegradable polyester resin compositions comprising an aliphatic polyester resin.
It would have been obvious to one of ordinary skill in the art before the effective filing date of instant application to have modified the composition of Zhao with the teachings of Yano by incorporating a crosslinking agent, 0.1 to 10 pbm of an organic peroxide and 0.1 to 20 pbm of an oxazoline compound with the expectation of producing a biodegradable resin composition which exhibits excellent heat
resistance, moldability, and hydrolysis resistance.
The organic peroxide and oxazoline compound that would have been present in the resulting composition would have read on the claimed organic peroxide and oxazoline. The combined ranges of amounts of the organic peroxide and oxazoline compound in the resulting composition would have overlapped, and therefore rendered obvious, the claimed range of amounts (see MPEP 2144.05). While modified Zhao is silent regarding the organic peroxide and oxazoline compound being melt strength enhancers, it is noted that Yano teaches that the organic peroxide contributes to the crosslinking of polyester resin composition [0026] which would intrinsically increase the molecular weight and therefore the melt strength of the composition.
Regarding the terminal blocking agent, Miyamoto serves as objective evidence that end-capping (i.e. terminal blocking) of polyester resins inhibits the lowering of the resin's molecular weight by blocking the terminal carboxyl group [0063]. Since the melt strength of a resin is directly related to the resin's molecular weight, by inhibiting the lowering of a polyester resin's molecular weight, a terminal blocking agent effectively enhances the resin's melt strength. As such, the oxazoline compound taught by Yano reasonably reads on the melt strength enhancer as claimed.
Regarding the dimensions and shapes of the preform claimed in Claims 1, 4-7 and 12, the claims direct to intended use of the modified composition and manners of the preform. The intended use limitations do not require steps to be performed. These limitations do not limit the scope of the instant claims and need not be taught by the prior art in order to read on the claims. See MPEP 2114 II. It has been held that a recitation with respect to the manner in which a claim apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations (Ex Parte Masham, 2 USPQ2d 1647 (1987).
Regarding Claims 8-10, Zhao also discloses wherein the body of the biodegradable container resin further comprises from about 1 weight percent to about 60 weight percent of polymers selected from the group consisting of poly(lactic acid), poly(caprolactone), poly(ethylene sebacate sebicate), poly(butylene succinate), and poly(butylene succinate-co-adipate), and copolymers and blends thereof, wherein the resin composition further comprise from about 0.1 weight percent to about 5 weight percent of a reheat agent selected from the group consisting of carbon black, infrared absorbing pigments, and mixtures thereof, wherein the resin composition further comprises from about 0.1 weight percent to about 20 weight percent of a filler selected from the group consisting of calcium carbonate, talc, starch, zinc oxide, neutral alumina, and mixtures thereof (paragraphs [0001]. [0013-0021 ], [0025], [0031-0033],
[0047-0049], [0052-0059], [0084]).
Regarding Claim 11, Zhao discloses that the resin composition further comprising about 1wt.% to about 30 wt.% of a plasticizer selected from the group consisting of sebacates; citrates, etc. ([0052]).
Regarding Claim 13, Zhao discloses that the nucleating agent is selected from the group consisting of stearates, sorbitols, boron nitride, etc. ([0053]).
Regarding Claims 16-17, Zhao discloses the composition comprising a slip agent and exemplifies a composition comprising 1 wt% of euracamide [0084, Example 4].
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 11866606 (‘606) in view of Garcia et al. (US20200002487) and Rajendra et al. (EP3360927).
Claim 3 of ‘606 claims a biodegradable composition comprising from about 25 to about 65 wt.% of poly-3-hydroxybutyrate-co-3-hydroxyhexanoate (“P3HB-co-P3HHx”), from about 0.1 to about 5 wt.% of at least one nucleating agent; and from about 0.01 wt.% to about 5.0 wt.% of at least one rheology modifier, and the wetting and dispersing agent and biostatic agent reading on additives; wherein the P3HB-co-P3HHx comprises from about 75 to about 99 mol% hydroxybutyrate and from about 1 to about 25 mol% hydroxyhexanoate.
The difference between Claim 3 of ‘606 is silent that the rheology modifier is a mixture of an organic peroxide and an oxazoline.
However, Garcia teaches a composition comprising PHA ( claim 1) and 0.1 wt. % to 3 wt. % of at least one crosslinking agent and/or chain extender, such as peroxide and oxazoline ([0088]; claim 11). Crosslinking increases polymer molecular weight, thereby peroxide and oxazoline reading on rheology modifier. As discussed at paragraph 11, Rajendra teaches organic peroxide and oxazoline function as melt strength enhancer, in view of such benefit, one ordinary skilled artisan would have been motivated before the effective filing date of instant application, to use a mixture of an organic peroxide and an oxazoline as rheology modifier to obtain a modified biodegradable composition with a desirable melt strength.
Claims 1-8-11, 13 and 15-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4-5, 7,9, 10 and 13 of copending Application No. 18/408,788 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1,5, 4, 7, 9, 10, 13 of copending Application No. 18/408,788 encompass the scope of claims 1, 15, 13, 8, 9, 10, 16 and 11, respectively.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HUIHONG QIAO whose telephone number is (571)272-8315. The examiner can normally be reached 9AM - 5PM.
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/HUIHONG QIAO/ Examiner, Art Unit 1763
/JOSEPH S DEL SOLE/ Supervisory Patent Examiner, Art Unit 1763
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