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 .
Response to Amendment
Applicant’s claim amendments and remarks filed 2/13/2026 are entered and have
been fully considered. Applicant has cancelled claims 2, 6, 8, 10-13 and 17, therefore the 112b rejection over claim 17 is withdrawn. Applicant has amended claim 4, therefore the 112b rejection is withdrawn. Applicant has amended the specification to provide support for claims 3 and 4.
Priority
Applicant claims priority to PRO 63/266,702 but the claims lack support in the PRO specification. The subject matter of claims 3 and 4 are not found in the PRO specification, and therefore only claims 1, 5, 7, 9, and 14-16 will have the filing date of 1/12/2022 associated with the PRO, while claims 3 and 4 will have a filing date of 1/12/2023, the current application filing date. Claims 3 and 4 lack support because there is no description of what the inventive PHA is comprised of.
Claim Objections
Claim 9 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 5. 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 § 608.01(m). According to the remarks filed 2/13/2026, page 2, applicant meant to cancel claim 5 and states claim 9 is favored, which implies the dry mass of claim 5 refers to the PHA content, therefore they are duplicate claims.
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 5, 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.
Regarding claim 5, the claim states a “dry mass content”, which is unclear if this is the same as a solids content or only refers to powdered ingredients and not additional liquid ingredients, such as surfactants, therefore the scope of the claim is unclear.
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 non-obviousness.
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, 3-5, 7, 9, 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Nishiyama et al, US20210054191.
Regarding claims 1, 5, 7, and 9, Nishiyama teaches a method for producing a dispersion of PHA particles where the PHA particles are produced by bacterial microbes, ¶¶[0021, 0025], and a fermentation process, ¶[0075], which reads on step (a) of claim 1 and claim 7. Nishiyama further teaches cell wall degradation with a proteolytic enzyme, ¶¶[0048-0049], which reads on step (b) of claim 1. It is then preferable to carry out a dehydration step to separate the PHA particles from the water with impurities, ¶[0063]. The dehydration step may be performed by filtration, centrifugal separation or precipitation separation, ¶[0062], and may be performed alone or in combination, ¶[0065]. These separation techniques read on step (c) of claim 1. Nishiyama further teaches washing the PHA particles with water and an organic solvent such as ethanol, ¶[0066], it is exemplified in example 1 the PHA particles are washed and centrifuged six times, where in centrifugal separation the impurities can be decanted, ¶[0064], which reads on the alternate washings with pressing or decanting between washings in step (d) of claim 1.
Nishiyama does not explicitly teach partially drying the purified PHA using a flow of gas at room temperature without external heat, but does teach the use of filtration methods that do not require heat, such as Nutsche filtration, suction filtration, or pressure filtration, and membrane separation such as cloth flow, ¶[0063]. Heat is not mentioned as a requirement; therefore it would be obvious the filtration can be performed at room temperature, and exemplifies filtering without use of heat in ¶[0079]. Any pressure or suction filtration involves the flow of a gas to filter the slurry, which reads on step (e) of claim 1.
Although Nishiyama teaches the washing step occurs after the filtration ¶[0066], the claim is directed to a process comprising the steps (a)-(e), and does not require that they be performed in the exact order listed. Moreover, Nishiyama does not explicitly state another filtration step follows the washing, but it would be obvious to the skilled artisan to perform another filtration to further separate the impurities from the PHA.
Additionally, Nishiyama teaches only partially drying the PHA particles, i.e. used in a wet state, for ease of production of an aqueous dispersion, ¶[0068], and exemplifies a dispersion of 50% PHA particles after washing and centrifugal separation, ¶¶[0089, 0092, 0094], which reads on the ranges of claims 5 and 9, and the moisture content of claim 1.
Additionally Nishiyama teaches the PHA has an average particle size of 0.05-10 µm ¶[0014], Nishiyama does not teach the D90 particle size, but with the smallest average particle size disclosed as 0.05 µm, which is more than 100 times smaller than the claimed D90 of 8 µm, the skilled artisan has a reasonable expectation that the D90 for that same dispersion is inherently less than 8 µm. Therefore the D90 particle size limitation of the claim is rendered obvious to one of ordinary skill in the art.
Nishiyama does not use the term “cake” to describe the PHA dispersion, but applicant does not fully define “cake” in the instant specification other than to state it is the product derived from the method of making, and it is a dispersion of PHA in a liquid (¶¶[0005-0006] of the instant specification). Therefore because Nishiyama’s method to produce the PHA dispersion reads on the claimed method and it also reads on the PHA cake produced by the method.
Regarding claims 3-4, Nishiyama teaches the PHAs comprise butyrate, valerate, and hexanoate units ¶[0023, 0026] and are in the form of copolymers, ¶[0026].
Regarding claims 14-16, these claims are directed to the future intended use of the product made from the method of claim 1. The PHA dispersion of Nishiyama inherently satisfies the intended use of these claims because it matches the structural limitations of the product and is made by the same method of claim 1. The Courts have held that if the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967); and In re Otto, 136 USPQ 458, 459 (CCPA 1963).
Furthermore, Nishiyama teaches that the PHA dispersion is for film formation, such as coatings on substrates, ¶[0069].
Response to Arguments
Applicant’s arguments, see pages 2-5, filed 2/13/2026, with respect to the rejection(s) of claim(s) 1-17 under 103 over Capello and Eggink have been fully considered and are persuasive. Therefore, the rejections have been withdrawn.
Applicant’s argument with respect to the 103 rejection over Nishiyama has been fully considered but is not persuasive. As explained above in the rejection, Nishiyama teaches steps a-d. Furthermore, Nishiyama teaches different methods of filtration for separating the PHA particles from the impurities in the solution, none of which require heat, and filtration methods such as pressure and suction filtration use the flow of gas to aid in filtering the slurry, which reads on step (e). Nishiyama teaches using the PHA particles as a wet product, not fully dried, for ease of production of the aqueous dispersion, which reads on the partially drying of step (e). Although Nishiyama teaches the washing step occurs after the filtration ¶[0066], the claim is directed to a process comprising the steps (a)-(e), and does not require that they be performed in the exact order listed. Nishiyama does not explicitly state another filtration step follows the washing, but it would be obvious to the skilled artisan to perform another filtration to further separate the impurities from the PHA.
For the reasons above, the 103 rejection over Nishiyama is maintained.
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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/V.L.S./Examiner, Art Unit 1766
/MARC S ZIMMER/Primary Patent Examiner, Art Unit 1765
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