RESPONSE TO AMENDMENT
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 .
WITHDRAWN REJECTIONS
The 35 U.S.C. §102 rejections of claims made of record in the office action mailed on 09/30/2025 have been withdrawn due to Applicant’s amendment in the response filed 12/23/2025.
The 35 U.S.C. §112 rejections of claims made of record in the office action mailed on 09/30/2025 have been withdrawn due to Applicant’s amendment in the response filed 12/23/2025
REJECTIONS
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 Rejections - 35 USC § 103
Claims 1-3, 5, 10, 13-17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Nishiumi et al. (WO 2020/262509).
Regarding claims 1-2, Nishiumi et al. discloses biodegradable resin particles of polyhydroxyalkanoates having volume average particle diameters in the range of 2-50 micrometers. (Abstract). Specific examples have particle less than 10 micrometers but greater than 0.2 as claimed, as shown in Fig. 1. The polyhydroxyalkanoate resin comprises repeating units of 3-hydroxybutyrate (i.e. polymerized form of 3-hydroxybutanoic acid). (page 3, 1st full paragraph). With respect to the limitation “the microparticle is porous”, the Examiner is interpreting this limitation are referring to the fact that the microparticles contain pores, however minute, on the surface or within the structure of the particle. As can be seen in Fig. 1-2, the microparticle contain small recesses (darker spots) on the surface thereof which would meet the limitation of pores. Therefore, the particles disclosed in Nishiumi et al. are porous as claimed.
Nishiumi et al. does not specifically disclose that the particle diameter measured using SEM observation or dynamic light scattering. However, the way in which the average particle diameter is measured would not result in a significant difference in the disclosed average particle size given the degree of overlap in the claimed range and the prior art range. As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claims 3 and 5, the resin may include repeating units of 3-hydroxyhexanoate (i.e. polymerized form of 3-hydroxyhexanoic acid) which may be copolymerized with 3-hydroxybutyrate. (page 3, 1st full paragraph).
Regarding claim 10, the melting point of the resin material is disclosed to be 142oC in example 1, which lies within the presently claimed range.
Regarding claims 13-14, the particles are disclosed to be spherical and can be porous. (page 5, 2nd full paragraph and page 3, 4th paragraph).
Regarding claim 15, the particles may contain therein Ca in amounts of 10 to 10,000 ppm. (Abstract)
Regarding claim 16, the particles have a 10% compressive strength in the range of 0.5 MPa or more (page 4, 2nd full paragraph) including specific example values which are included within the range claimed as shown in Table 1, par [0077] of the publication.
Regarding claim 17, the resin particles may be dispersible in water. (page 5, 2nd to last paragraph and page 18, first full paragraph).
Regarding claim 20, Nishiumi et al. teaches including a dispersion stabilizer including calcium carbonate (page 4, 3rd full paragraph) or coloring agents such as talc, mica or silica (page 8, 5th paragraph) or metal soaps such as magnesium/zinc stearate. (page 8, 1st full paragraph)
Claims 4-9 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Nishiumi et al. (WO 2020/262509) in view of Nishiyama et al. (U.S. App. Pub. No. 2021/0054191).
Nishiumi et al. is relied upon as described in the rejection of claim 1, above.
Regarding claim 4, Nishiumi et al. does not disclose the specific content of 3-hydroxyhexanoate.
Nishiyama et al. discloses polyhydroxyalkanoate (PHA) particles which have excellent dispersibility in aqueous medium which including units of 3-hydroxybutyrate which may be combine with other units including 3-hydroxyhexanoate. (Abstract and par. [0023]). Nishiyama et al. teaches that the content of 3-hydroxybutyrate should be in the range of 60-99 mol% when the PHA particles contain 3-hydroxybutyrate. This range is to optimize the balance of flexibility and strength of the composition. (par. [0023]). 3-hydroxybutyrate has a molecular weight of 104.1 and 3-hydroxyhexanoate has a molecular weight of 131.15 The mass content of each of the two monomers by weight on the low end of the 3-hydroxybutyrate mol content in one mole of copolymer would therefore be: 0.6 x 104.10 = 62.46 g for 3-hydroxybutyrate and 0.4 x 131.15 = 52.46 g for 3-hydroxyhexanoate. The relative proportions would therefore be: 62.46/(62.46 + 52.46) = 54.4% by weight for 3-hydroxybutyrate and 45.6% by weight for 3-hydroxyhexanoate. Therefore, the content of 3-hydroxyhexanoate should be at most 45.6% by weight (i.e. 45.6% or less), which overlaps with the presently claimed range. As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
It would have been obvious to one of ordinary skill in the art to use a 3-hydroxyhexanoate monomer content of 45.6% weight or less in Nishiumi et al. in view of the teachings of Nishiyama et al.
One of ordinary skill in the art would have found it obvious to use a 3-hydroxyhexanoate monomer content of 45.6% weight or less in Nishiumi et al. in view of the teachings in the secondary reference that a content of 3-hydroxybutyrate in the range of 60-99 mol% is optimal for balancing of flexibility and strength of the composition.
Regarding claim 6 and 8, Nishiumi et al. does not disclose the inclusion of 4-hydroxybutanoic acid repeat units.
Nishiyama et al. discloses that the polyhydroxyalkanoate (PHA) particles may include a copolymer of poly(3-hydroxybutyrate-co-4-hydroxybutyrate). (par. [0023]).
It would have been obvious to one of ordinary skill in the art to include a monomer of 4- hydroxybutyrate copolymerized with the 3-hydroxybutyrate units disclosed in Nishiyama et al.
One of ordinary skill in the art would have found it obvious to include 4-hydroxybutyrate repeat units in view of the teaching in Nishiyama et al. that copolymers including both 3-hydroxybutyrate and 4-hydroxybutyrate and known to be suitable for the formation of microparticles having improved properties with respect to dispersion in aqueous mediums, molded bodies and film compositions. (par. [0015]). The selection of a known material based on its suitability for its intended purpose is prima facie obvious. MPEP 2144.07. One of ordinary skill in the art would have a reasonable expectation of success that including 4-hydroxybutyrate monomers in the composition of Nishiumi et al. would result in a polymer having similar properties as disclosed in the secondary reference or capable of performing the intended uses designed in the prior art.
Regarding claim 7, the claim is rejected for substantially the same reasons as claim 7 above. Given that Nishiyama et al. discloses a content of 3-hydroxybutyrate in the range of 60-99 mol% is preferable from the standpoint of optimizing properties of the polymer, the relative mass content of the 4-hydroxybutyrate would therefore 1-40% mass or less.
Regarding claim 9, Nishiumi et al. does not disclose the molecular weight of the PHA resin.
Nishiyama et al. teaches that the molecular weight on average is 1.2 million (par. [0077]) which lies within the presently claimed range.
It would have been obvious to one of ordinary skill in the art to use a PHA polymer having a molecular weight of 1.2 million.
One of ordinary skill in the art would have found it obvious to use a molecular weight of 1.2 million in view of the teachings in Nishiyama et al. that such a molecular weight is suitable for forming PHA polymer microparticles and resins having mproved properties with respect to dispersion in aqueous mediums, molded bodies and film compositions. (par. [0015]). The selection of a known material based on its suitability for its intended purpose is prima facie obvious. MPEP 2144.07. One of ordinary skill in the art would have a reasonable expectation of success that the molecular weight of 1.2 million would be result in a polymer having similar properties as disclosed in the secondary reference would result in a polymer having similar properties as disclosed in the secondary reference or capable of performing the intended uses designed in the prior art.
Regarding claims 11-12, Nishiumi et al. does not disclose the inclusion of a resin separate from PHA in the particles thereof.
Nishiyama et al. teaches inclusion of peptidoglycan (a polymer of glycopeptide) which helps adjust the dispersibility of the particles and film formation capability thereof. (par. [0030]-[0033]). Peptidoglycan would be a biodegradable polymer. Nishiyama et al. further discloses inclusion of other materials such as impurities derived from microorganisms such as polysaccharides. (par. [0037]).
It would have been obvious to one of ordinary skill in the art to include other resin materials in the particle of Nishiumi et al. in view of the teachings of Nishiyama et al. such as peptidoglycan.
One of ordinary skill in the art would have found it obvious to include peptidoglycan in order to improve the dispersibility of the particles and film formation capability thereof as disclosed in Nishiyama et al.
ANSWERS TO APPLICANT’S ARGUMENTS
Applicant’s arguments in the response filed 12/23/2025 regarding the prior art rejections made of record have been carefully considered but are deemed unpersuasive.
Applicant argues that Nishiumi et al. is silent with respect to the claimed features of microparticles of 3-hydroxybutyrate having diameters of 0.2 to less than 10 micrometers as claimed. Applicant relies on the teachings in Nishiumi et al. regarding Comparative Example 5 of non-desirable porous particles. The Examiner disagrees.
Comparative Examples 5 refers to a non-preferred example wherein the particles on the reference lie outside the disclosed range of 2-50 microns, become brittle and porous. (see par. [0113], [0125], [0130]). However, the broadest reasonable interpretation of the term “porous” as presently claimed refers to a structure including recesses, however minute, in the surface/inside the particles. As shown in Fig. 1-2 of the Nishiumi et al. there are several pores present on the surface area of the of the particles which would therefore meet the limitation of “porous” as presently claimed. The excessively large and porous particles disclosed in Comparative Example 5 are therefore distinct from the inventive examples shown in Fig. 1-2, which would meet the presently claimed limitations.
The claims remain unpatentable over the cited prior art.
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.
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/ALEXANDRE F FERRE/Primary Examiner, Art Unit 1788 02/11/2026