DETAILED ACTION
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 Amendments
Applicant's amendments filed 7/29/2026 to claims 25 and 27 have been entered. Claims 10-24 and 28 are canceled. Claim 31 has been added. Claims 1-9, 25-27, and 29-31 remain pending, of which claims 25-27 and 29-31 are being considered on their merits. Claims 1-9 remain withdrawn from consideration. References not included with this Office action can be found in a prior action. Any rejections and/or objections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
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 25-27 and 29-31 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.
As amended, claim 25 now recites “wherein the microorganism cells that include a polyhydroxyalkanoate are obtained by culturing a microorganism that has a PHA production capacity” and “herein the crushing or solubilizing and/or the separating use recycled water”, which blurs the metes and bounds of the claim. Cultured microorganisms, as alleged by Applicant on page 9 of the reply, and recycled water are mutually exclusive sources of microorganisms. Therefore, it is unclear if claim 25 requires only cultured microorganisms, only recycled wastewater, or the combination of both. Correction is required.
In so much that claims 26, 27, and 29-31 depend from claim 25 and do not resolve the point of confusion, these claims must be rejected with claim 25 as indefinite.
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 nonobviousness.
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 25-27, 29, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Stufano et al. (US 2017/260390; provided in the IDS dated 5/28/2025) in view of Evans et al. (US 2012/00/85701), Williamson and Wilkinson (J Gen Microbiol (1958), 19, 198-209), Jiang et al. (Environ. Sci Technol. (2010), 44, 6642-6648), and Mantelatto et al. (US 2007/0161096).
Stufano teaches a method of producing a polyhydroxyalkanoate (PHA), the method comprising: A) subjecting waste water to an anaerobic treatment, pH adjusting the anaerobically treated waste water with ammonium hydroxide, and the aerobically treatment of the pH adjusted anaerobically treated waste water which are carried out by microorganisms to obtain first treated water, B) filtering the third treated water through an ion removal membrane (e.g. the reverse osmosis (RO) concentrate) and wherein each of the preceding steps is preferably subject to suitable pH controls and optionally combined with membrane ultrafiltered (UF) or membrane nanofiltered (NF) concentrate(s) (Fig. 1 and ¶0046-0049 and ¶0063-0070), C) lysing (e.g. crushing or solubilizing) the microorganisms, and then D) separating the PHAs from the microbial lysate by either solvent extraction or non-solvent digestion (¶0071-0072), reading in-part on claim 25 and reading on the embodiments of anaerobic and/or aerobic treatment for the generic culturing of claim 25 (see [0017] of Stufano; the microorganisms are reasonably construed as consuming sugar and nutrients and thus meeting the broadest reasonable interpretation of “obtained by culturing”. In a separate embodiment, Stufano teaches obtaining the waste water having been discharged during a continuous production process of a polyhydroxyalkanoate (¶0056, e.g. the waste stream), reading in-part on claim 25
Regarding claim 25, Stufano does not teach a single embodiment of a method of producing a polyhydroxyalkanoate combined with waste water obtained from a polyhydroxyalkanoate production process. However, it would have been obvious to a person of ordinary skill in the art before the invention was filed to the waste water obtained from a polyhydroxyalkanoate production process with the methods of producing a polyhydroxyalkanoate of Stufano. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Stufano expressly considers the combination. The skilled artisan would have been motivated to do so because Stufano teaches that waste water obtained from a polyhydroxyalkanoate production process is predictably advantageous as a starting source of (recycled) waste water in Stufano’s methods of a polyhydroxyalkanoate.
Regarding claim 25, Stufano does not teach a single embodiment of a method subjecting the second treated water to an alkali treatment to obtain third treated water. However, it would have been obvious to a person of ordinary skill in the art before the invention was filed to further treat the pH adjusted anaerobically and then aerobically treated waste water with the ammonium hydroxide of Stufano. A person of ordinary skill in the art would have had a reasonable expectation of success to do so and would have been motivated to do so because Stufano expressly considers the combination of any of the preceding steps being subject to suitable pH controls.
Stufano teaches alkali treatment to a pH range of 6-8 (¶0067), reading in-part on claim 26. Stufano further teaches centrifuging the waste water prior to microfiltration to remove coarse suspended solids and/or emulsions (¶0044), reading on the embodiment of centrifugation for the sedimentation of claim 30.
Regarding claim 25, Stufano does not teach subjecting the first treated water to pretreatment filtration by a membrane bioreactor. Regarding claim 25, Stufano does not teach the FI (i.e. fouling index) value of the third treated water is adjusted to not less than 4.5. Regarding claim 26, Stufano does not teach wherein the turbidity of the third treated water is adjusted to not less than 0.1. Regarding claim 27, Stufano does not teach wherein the FI value of the third treated water is adjusted to not less than 6.0. Regarding claims 28-30, Stufano does not teach wherein the producing of the recycled water further comprises precipitating a solid containing a polyvalent ion in the third treated water before the filtering, wherein polyvalent ion is at least one of Ca2+, SO42-, and PO42-.
Evans teaches a process for treating a water stream containing dissolved organic carbon and dissolved salts comprises subjecting the water stream to reverse osmosis after a pre-treatment step to reduce the amount of dissolved organic carbon directed in water to the reverse osmosis treatment step, and wherein the preferred pre-treatment step is a membrane treatment (Abstract). Evans teaches a pretreatment anaerobic process comprising a membrane bioreactor (MBR), and wherein the MBR is advantageous to remove a small portion of the dissolved organic carbon (DOC) and wherein the DOC is predominantly intractable to anaerobic and aerobic microbial digestion processes (¶0011), reading on claim 25. Evans teaches treating waste water streams (¶0020), reading on claim 25.
Williamson and Wilkinson teaches a method of measuring and estimating the poly-β-hydroxy-butyrate inclusions in Bacillus cereus (Abstract), the method comprising lysing the Bacillus cereus strain AC and then measuring the turbidity of lysate, wherein turbidity positively correlates to the number of (intracellular) poly-β-hydroxy-butyrate inclusions, and wherein turbidities of 0.158 and 0.262 are achieved (Table 1 and the paragraph spanning pages 202-203), reading on the turbidity of claim 26.
Jiang teaches a modified fouling index-ultrafiltration (MFI-UF) of 2.91 ± 105 for sludge water concentrate (SW), 4.27 ± 105 for biomass associated product (BAP), and 0.95 ± 105 for utilization associated products (UAP) in membrane bioreactors (Table 1), reading on the fouling index of claims 25 and 27. Jiang teaches that membrane fouling is mostly related to the organic colloidal and soluble components present in the sludge water (page 6642, right column, paragraph starting “MBR fouling…”), reading on claims 25 and 27 Jiang teaches the UAP comprises polyhydroxyalkanoate (PHA) stored within the (microbial) cells (page 6647, subheading “Characterization of UAP”), reading on claims 26 and 27.
Mantelatto teaches a process for recovering polyhydroxyalkanoates (PHAs)
from cellular biomass of bacteria (Abstract). Mantelatto teaches calcium hydroxide, sulfuric acid, and phosphoric acid as an exemplary alkalizing agents, respectively, in methods of flocculating/coagulating (e.g. precipitating) the cellular biomass by first acidifying the biomass to a pH of about 1.5-5.5 and then alkalizing the biomass to a pH of about 7-12 (¶0070), reading on the embodiments of Ca2+, SO42-, and PO42- for the polyvalent ions of claims 28-30. Mantelatto teaches that the addition of calcium and phosphate is advantageous to form bridges with the cell walls of the
microorganism containing the PHA, with a resulting positive charge and which are aggregated in a flake through the flocculating agent, leading to the formation of a stable flake presenting a density higher than that of the liquid that involves them and wherein said flakes are then easily separated from the fermented liquid culture (¶0072), reading on claims 28-30.
Regarding claim 25, It would have been obvious to a person of ordinary skill in the art before the invention was filed to add the membrane bioreactor pretreatment step of Evans to the methods of Stufano. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Stufano are both in-part directed towards methods of treating waste water streams. The skilled artisan would have been motivated to do so because Evans teaches that the addition would be predictably advantageous to remove dissolved organic carbon (DOC) from the waste water stream of Stufano and which would be intractable to anaerobic and aerobic microbial digestion processes of Stufano.
Regarding the (FI (i.e. fouling index) of claims 25 and 27, it would have been obvious to a person of ordinary skill in the art before the invention was filed to further adjust the fouling index of the third treated water of Stufano to not less than 4.5 or 6.0 in view of Jiang. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Stufano and Jiang are directed towards methods of producing polyhydroxyalkanoates from aqueous waste sources (e.g. waste water) and because Jiang teaches detailed methods for measuring fouling index. The skilled artisan would have been motivated to do so because Jiang teaches that operable fouling index values when producing microbial PHAs, and so measuring and achieving fouling index values not less than 4.5 and 6.0 in Stufano’s methods would predictably improve yield a method for producing PHAs; see M.P.E.P. § 2143(I)(A).
Regarding the turbidity of claim 26, it would have been obvious to a person of ordinary skill in the art before the invention was filed to further adjust the turbidity of the third treated water of Stufano to not less than 0.1 in view of Williamson and Wilkinson. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Stufano and Williamson and Wilkinson are directed towards methods of producing polyhydroxyalkanoates and because Williamson and Wilkinson teaches detailed methods for measuring turbidity. The skilled artisan would have been motivated to do so because Williamson and Wilkinson teach that turbidity positively correlates to the number of (intracellular) poly-β-hydroxy-butyrate inclusions and wherein turbidities of 0.158 and 0.262 are achieved, and so measuring and achieving turbidities not less than 0.1 in Stufano’s methods would predictably improve said methods by quantifying and maintaining a minimal PHA yield.
Regarding claims 28-30, it would have been obvious to a person of ordinary skill in the art before the invention was filed to further add the calcium hydroxide and either sulfuric or phosphoric acid flocculation/coagulation (e.g. precipitation) step of Mantelatto to the methods of Stufano. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Mantelatto and Stufano are in-part directed towards methods of producing PHAs from microbial biomass The skilled artisan would have been motivated to do so because Mantelatto teaches that the addition would be predictably advantageous to cause the formation of PHA flakes which are then easily separated from the fermented liquid culture and thus improving upon the PHA isolation methods of Stufano.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Stufano as applied to claim 25 above, and further in view of Horowitz (US 6,340,580; Reference A).
The teaches of Stufano, Evans, Williamson and Wilkinson, Jiang, and Mantelatto are relied upon as set forth above.
Regarding claim 31, Stufano, Evans, Williamson and Wilkinson, Jiang, and Mantelatto do not teach a transmembrane pressure difference range of 0.4-4.14 MPa.
Horowitz teaches methods of purifying PHA from microbial biomass (Abstract). Horowitz teaches recovering PHA from a bacterial cell slurry with a microfiltration apparatus operated at an average transmembrane pressure of 0.3-0.6 MPa (Col. 8, lines 15-52 and particularly lines 41-46), reading on claim 31.
Regarding claim 31, In the case where the claimed ranges "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 this case, both Horowitz and Stufano are directed towards methods of purifying/recovering PHAs from microbial biomass and Horowitz clearly teaches a transmembrane pressure range of 0.3-0.3 MPa is effective to purify said PHAs. Therefore, further modification of Stufano’s methods to utilize the transmembrane pressure range of Horowitz must be held prima facie obvious absent any showing to the contrary; see M.P.E.P. § 2144.05
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Response to Arguments
Applicant's arguments on pages 6-12 of the reply have been fully considered, but not found persuasive of error for the reasons given below.
Applicant’s specific remarks traversing the obviousness rejections of record begin on pages 9-10 of the reply, where Applicant alleges the instant amendments to claim 25 adding a wherein clause that the microorganisms were obtained by generic culturing overcomes the rejection of record over Stufano in view of Evans. This is not found persuasive of error, as notwithstanding the issues of indefinite caused by said amendment, the broadest reasonable interpretation of claim 25 does not exclude the embodiments of anaerobic and/or aerobic treatment of recycled water as species of the generic culturing of the claim. See [0017] of Stufano and as cited above, in that the microorganisms are reasonably construed as consuming sugar and nutrients and thus meeting the broadest reasonable interpretation of “obtained by culturing”. See M.P.E.P. § 2111.
On pages 10-11 of the reply, Applicant traverses the now rejection of claim 25 in-part over Jiang, wherein claim 25 was amended in-part to recite the prior limitation of claim 26 towards a “wherein FI value of the third treated water is adjusted to not less than 4.5.” This is not found persuasive, because the fouling index (FI) ranges of Jiang overlap with the claimed FI ranges and Applicant has yet to show criticality of the claimed FI ranges; see M.P.E.P. § 2144.05 (I) and (III). Similarly, Applicant has not yet shown by any preponderance of evidence that a FI range not less than 4.5 yields any unexpected result (See M.P.E.P. § 716 as a whole) nor that otherwise modifying the methods of Stufano with the transmembrane pressures of Jiang would proceed against accepted/conventional wisdom in this art (see M.P.E.P. § 2145(X)(D)(3).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the disclosed formula for calculated a fouling index (FI) value) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). At this time, claims 25 and 27 only recite a generic “fouling index”, and Jiang’s fouling index calculation are reasonably construed as the narrower embodiment and species of claimed “fouling index”.
Conclusion
No claims are allowed. No claims are free of the art.
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 SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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