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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-5, 7, 10-16 and 20) in the reply filed on 12/02/2025 is acknowledged.
Claims 8-9 and 17-19 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/02/2025.
Claim Interpretation
Claim 1 recites the open transitional phrase comprising such that the methods of the claims are open to unrecited steps. Claim 1, part (a), states adjusting pH to 8.0 to 12.0 an maintaining the same for 4-30 hours as stated in the wherein clause. Step (b) of claim 1 is understood as open to the following act, wherein the unrecited elements that claim 1 reads upon due to recitation of the “comprising” are unlined:
(b) adjusting the pH of the culture solution obtained in (a), and adding an aqueous alkaline solution to the culture solution obtained in step (a) to subject the microbial cells to an enzyme treatment.
Claim Objections
Claims 1 and 4 objected to because of the following informalities:
In claim 1, units are required for the recited weight average molecular weight, which is understood to be Daltons.
In claim 1, last line, reference is made to “a reaction time in (a).” However, (a) does not recite a reaction per se but rather an adjustment of pH. As such, stating “incubation” would be more appropriate since no specific “reaction” is required to take place.
Claim 4 references “the enzyme” in the plural wherein the antecedent basis for the same is “an enzyme” in the singular in claim 1. Consistent singular/plural terminology should be employed or clarification that a second enzyme is present.
Appropriate correction is required.
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.
Claim 4 is 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 4 contains the trademark/trade name Alcalase. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a product being an enzyme positively employed in the methods of the claims and, accordingly, the identification/description is indefinite. Alcalase® is registered trademark number 0808294.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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.
Claim(s) 1, 7, 10-12, and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yanagita et al. (WO 2010/116681 A1) further in view of Maruyama (WO 2008/010296 A1). Machine translations of WO 2010/116681 A1 and WO 2008/010296 A1 are provided and cited herein.
Yanagita, abstract, states:
A high-purity PHA (polyhydroxyalkanoate) is separated from PHA-containing microbial cells by a commercially suitable, simple and low-cost method with a reduced number of processes, without causing a significant decrease in the molecular weight. Specifically disclosed is a method for collecting a polyhydroxyalkanoate, which comprises: (a) a step wherein an enzymatic treatment is performed by adding an enzyme and an alkali and/or a surfactant into an aqueous suspension of polyhydroxyalkanoate-containing microbial cells, thereby obtaining an enzymatic treatment liquid; (b) a step wherein the enzymatic treatment liquid is subjected to a physical crushing process under basic conditions in the presence of a surfactant, so that the cells are crushed and cell substances other than polyhydroxyalkanoate in the cells are solubilized or emulsified, thereby obtaining a polyhydroxyalkanoate suspension; and (c) a step wherein the polyhydroxyalkanoate is separated from the polyhydroxyalkanoate suspension.
Example 1 of Yanagita states:
Ralstonia eutropha KNK-005 described in [0049] of WO 08/010296 A1 is cultured by the method described in [0050] to [0053], and 3-hydroxybutyrate and 3-hydroxyhexanoate are cultured. A cell culture broth containing polyhydroxyalkanoate (PHBH) composed of an ate copolymer was obtained. The weight average molecular weight of PHBH at the end of the culture was 1,840,000. Ralstonia and Eutropha are now classified as Capriavidas Necka.
1000 g of the obtained bacterial cell culture solution was sterilized at 70 to 75 ° C. for 1 hour, cooled to 50 ° C., 4.0 g of sodium dodecyl sulfate was added, and sodium hydroxide was added so that the pH was 8.5 [i.e. (a) adding sodium hydroxide to a culture solution comprising microbial cells comprising poly(3-hydroxybutyrate-co-3-hydroxyhexanote) to adjust the pH of the culture solution to pH 8.5]. Alcalase 2.5L (Novozymes) was added to 1.0 wt% of the amount of PHBH contained in the cell culture solution, and the mixture was stirred for 4 hours while controlling the pH at 8.5 [i.e. (b) adding an alkaline proteolytic enzyme being Alcalase™ to the culture solution obtained in (a) to subject the microbial cells to an enzyme treatment]. Then, after cooling to 25 ° C and adding sodium hydroxide to pH 12.0, the temperature was adjusted to 25 with a high-pressure crusher (high-pressure homogenizer model “PA2K type” manufactured by Nirosoavi) at a pressure of 45 to 55 MPa [i.e. (c) adding sodium hydroxide to the culture solution obtained in (b) to adjust the pH of the culture solution to 12]. While controlling at ~ 35 ° C, high-pressure crushing was performed three times. The crushed liquid was adjusted to a temperature of 30 ° C. and a pH of 12.0 and stirred for about 10 minutes, and then PHBH was recovered by centrifugation, and water was added to suspend PHBH. The operation from pH adjustment of the crushed liquid to suspension of PHBH was repeated three times. Thereafter, the pH of the suspension was adjusted to 4.5 to 5.0 and stirred for about 1 hour. PHBH was recovered from this adjusted solution by centrifugation. The obtained PHBH was dried under reduced pressure at 40 ° C. for 12 hours to obtain purified PHBH. The recovery rate of PHBH was 98%.
“As shown in Examples, the microbial strain obtained by substituting the polyhydroxyalkanoic acid synthase gene on the chromosome of the Ralstonia ′ Urea H16 strain with the polyhydroxyalkanoic acid synthase mutant gene derived from s was cultured for 48 hours to produce P (3 HB-co -3HH) having a bacterial cell production amount of 10.10 g/L and a polyester content of 733.8 Wt %. This productivity greatly exceeded the productivity of P (3 HB-co -3 HH) reported so far. It was also found that this strain does not require an antibiotic or any other selected pressure in all the steps of culture, and the cells in the base substantially accumulate P (3 HB-co -3 HH) at the end of the culture.” WO 08//010296, para. [0020]. Ralstonia eutropha KNK-005 described in [0049] of WO 08/010296 A1 produces P (3 HB-co -3 HH), which is poly(3-hydroxybutyrate-co-3-hydroxyhexanoate).
Regarding that recitation that sodium hydroxide is added as an aqueous solution, Yanagita, page 5, states “Alkali means a substance whose aqueous solution is basic when dissolved in water.” An ordinarily skilled artisan at the time of filing would have recognized that sodium hydroxide is a solid (at room temperature and atmospheric pressure) such that “sodium hydroxide was added” is suggestive of adding sodium hydroxide as an aqueous alkaline solution. Regardless, since sodium hydroxide is added to an aqueous cell culture/solution, an ordinarily skilled artisan at time of filing would have been motivated to add sodium hydroxide as taught by Yanagita as an aqueous alkaline solution as a convenient means of adding a controlled or specific amount of sodium hydroxide wherein Yanagita, page 5, directly teaches that alkali including sodium hydroxide as taught therein is a “substance whose aqueous solution is basic,” which directly teaches that it is appropriate to formulate such alkali/sodium hydroxide as an aqueous basic solution.
Regarding recitation in claim 1 of producing a poly(3-hydroxyalkanoate) (e.g. poly(3-hydroxybutyrate-co-3-hydroxyhexanote)) having a weight average molecular weight from 100,000 to 700,000 (presumed to be in units of daltons or g/mol), “In order to put PHA into practical use, it is necessary to show the physical properties that the processed product can withstand. From this point of view, the weight average molecular weight of PHA using polystyrene as a molecular weight standard is required to be 10,000 or more by gel chromatography. It is preferably 50,000 or more, more preferably 100,000 or more, further preferably 200,000 or more.” Yanagita, page 4.
Yanagita does not make it clear whether the molecular weight of PHA (poly(3-hydroxyalkanoate)) referenced is weight average molecular weight before or after extraction from cells by the process of Yanagita, wherein it is understood that extraction will decrease molecular weight to some degree. “In particular, since the copolymer tends to decrease in molecular weight due to hydrolysis due to heating or the like, the present invention having the advantage that the molecular weight hardly decreases as will be described later is significant in recovering the copolymer.” Yanagita, page 4.
“In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.” MPEP 2144.05(I). Here, Yanagita teaches that PHA polymers with a weight average molecular weight of 100,000 or more or 200,000 or more are particular understood to be desirable and functional within the methods of Yanagita. Even in view of the possibility that “the molecular weight hardly decreases” by purification/extraction as taught by Yanagita, there is substantial overlap between the ranges of weight average molecular weight taught by Yanagita and the broad range of 100,000 to 700,000 recited in claim 1 such that a prima facie case of obviousness exists.
Regarding recitation in claim 1 of “wherein a reaction time in (a) is form 4 hours to 30 hours,” the cited claim language is understood as reference to a time period that the solution of microbial cells are maintained at a pH of 8.0 to 12.0 prior to addition of any enzyme as stated in part (b) of claim 1. The same interpretation is applied to claims 12 and 14. Example 1 of Yanagita is silent regarding any time period or reaction time between adjustment of solution of microbial cells to pH to 8.5 and addition of Alcalase® enzyme. “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP 2144.05(II)(A). There is no apparent technical reasoning in the specification nor evidence of record why a time period between adding sodium hydroxide to adjust the solution of microbial cells to a pH of 8.5 (or pH 8) and addition of Alcalase® enzyme (or any other further enzymes) will have any specific technical effect. More specifically, there is no evidence that incubation at pH of 8 or 8.5 has any effect on molecular weight of PHA. Some elapse of time must occur between adjustment to pH 8.5 with sodium hydroxide and later addition of Alcalase® enzyme (or any other further enzymes), which is a disclosure of general conditions. In view of the guidance of MPEP 2144.05(II)(A), it is not inventive to discover a time period of 4 hours or 8 hours as a workable time period between adjustment of pH 8.5 with sodium hydroxide and later addition of Alcalase® enzyme (or any other further enzymes) such that the same is obvious to a person having ordinary skill in the prior art at the time of filing. Regarding claim 12, Example 1 of Yanagita, Example 1, as discussed, teaches that 4 hours is an appropriate time period for enzyme treatment with Alcalase®.
Regarding claim 10, Example 1 of Yanagita, Example 1, as discussed, teaches that 4 hours is an appropriate time period for enzyme treatment with Alcalase®.
Regarding claim 11, “Particularly, a copolymer having 3HH [3-hydroxyhexanoate] as a monomer unit is preferable, and PHBH is more preferable from the viewpoint of degradability as a biodegradable polymer and soft properties. At this time, the composition ratio of each monomer unit constituting PHBH is not particularly limited, but from the viewpoint of showing good processability, the content of 3HH units with respect to the total units is preferably 1 to 99 mol%, more preferably. 3 to 30 mol%.” Yanagita, page 4. As discussed above, Yanagita directly cites WO 08/010296 A1 producing poly(3-hydroxybutyrate-co-3-hydroxyhexanote). The content of 3HH units with respect to the total units is preferably 1 to 99 mol% is a ratio from 1/99 to 99/1 of 3-hydroxyhexanoate to remaining copolymer monomer, which is illustrated to specifically be 3-hydroxybutyrate. “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.” MPEP 2144.05(I). Here, Yanagita teaches that the fraction of a copolymer that is 3-hydroxyhexanoate substantially overlaps the recited range in claim 11 wherein the balance of monomers in a copolymer is or can be specifically 3-hydroxybutyrate such that a prima facie case of obviousness exits.
Regarding claim 15, Yanagita, in Example 1, reports “rate [i.e. yield] of PHBH was 98%,” wherein an ordinarily skilled artisan at time of filing would expect a similar yield (i.e. at least 95%) regardless of the weight average molecular weight of polymer recovered, or in the alternative Yanagita teach an active expectation to an ordinarily skilled artisan that yields greater than 95% are obtainable by the methods of Yanagita.
Regarding claim 16, “the basic condition is more preferably pH 8.5 to 12.5, and still more preferably pH 9.0 to The basic condition is 12.5, and the basic condition is particularly preferably pH 10.0 to 12.5.” Yanagita, pages 7-8. As discussed, Yanagita, Example 1, exemplifies a basic condition of 12 for step (c) as recited in claim 1. “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.” MPEP 2144.05(I). Here, Yanagita teaches that the pH can be adjusted to greater than 10 including up to 12.5. The same is a substantial overlap with the pH range recited in claim 16 such that a prima facie case of obviousness exits.
Claim(s) 1-5, 7, 10-16 and 20 (all non-withdrawn claims) is/are rejected under 35 U.S.C. 103 as being unpatentable over Yanagita et al. (WO 2010/116681 A1) and Maruyama (WO 08/010296 A1) as applied to claims 1, 7, 10-12, and 14-16 above, and further in view of Yasotha et al. (Recovery of medium-chain-length polyhydroxyalkanoates (PHAs) through enzymatic digestion treatments and ultrafiltration, Biochem. Eng. J. 30, 2006, 260-68).
Regarding claims 2-5, 13 and 20, Yanagita, page 5, teaches: “The enzyme used in the step (a) is not particularly limited as long as it can be used for industrial products, but for the purpose of degrading the cell wall to obtain a higher crushing effect, a proteolytic enzyme (protease) Cell wall degrading enzymes are preferred. In terms of supply stability and cost, industrially, a proteolytic enzyme is more preferable. Only one type of enzyme may be used, or two or more types may be used in combination. One of proteolytic enzymes and cell wall degrading enzymes may be used, or both enzyme may be used in combination. Examples of proteolytic enzymes include alcalase, pepsin, trypsin, papain, chymotrypsin, aminopeptidase, carboxypeptidase and the like. Examples of cell wall degrading enzymes include lysozyme, amylase, cellulase, maltase, saccharase, α and β-glycosinase.” From Yanagita, page 6: The enzyme treatment is preferably performed at the optimum temperature and pH of the enzyme used. For example, when using Alcalase (manufactured by Novozymes), temperature: 50-60 ° C. and pH: 8-9 are preferable . . . Preferably, when lysozyme is used, the temperature is preferably 40-50 ° C. and the pH is 6-7.
As discussed, Yanagita, Example 1, teach the application of Alcalase® without an additional enzyme. However, as discussed, Yanagita teaches that a proteolytic enzyme such as Alcalase can be used in combination with a cell wall degrading enzyme such as lysozyme. Yasotha et al. demonstrates how Alcalase and lysozyme can be applied for recovery of PHA from cells.
“Medium-chain-length (mcl) polyhydroxyalkanoates (PHAs) are biodegradable polyesters accumulated intracellularly as energy resources by bacterial species such as Pseudomonas putida. The most popular method for PHA recovery in the downstream processing is solvent extraction using chloroform and methanol. An alternate method is bioseparation using enzymatic digestion process which eliminates the need for hazardous solvents. This research focuses on an attempt to optimize the recovery of PHAs by solubilisation of non-PHA granules through enzymatic treatments such as; Alcalase (to digest the denatured proteins), sodium dodecyl sulfate (SDS) to assist solubilisation, ethylene diamine tetra acetic acid (EDTA) to complex divalent cations and lysozyme to digest the peptidoglycan wall enveloping the cell.” Yasotha, abstract.
“In this study, shake flask experiments were conducted with
P. putida as the bacterial species. P. putida was cultivated in
nutrient-rich medium for 24 h in a shaker incubator at 30 ◦C
at 240 rpm. The culture 0.5% (v/v) were then transferred into
a 1000mL Erlenmeyer flask containing 300mL modified-R
medium plus 10 g/L of oleic acid as the carbon source. The
flask was incubated at 30 ◦C with a shaker speed of 240 rpm
for a fermentation period of 48 h. Cells were harvested by
centrifuging the broth and re-suspending the cells in water. This
suspension was then subjected to heat treatment by autoclaving
at 121 ◦C for 1 min prior to enzymatic treatments. The cell
weight was predetermined by drying a portion of cells at 80 ◦C
until constant weight was achieved. The harvested suspension
was initially subjected to digestion with Alcalase and SDS at pH
8.5 and temperature of 55 ◦C at the time duration, which was
optimized through Taguchi’s method (refer to Section 3). This
was followed by further treatments with EDTA and lysozyme
at pH 7 and temperature of 30 ◦C for 15 min.” Yasotha, page 261, right col.
As discussed, Yanagita teaches that it is appropriate to apply both Alcalase and lysozyme, wherein Yanagita directly teaches that Alcalase and lysozyme have different pH preferences. Yasotha teaches that in lysing cells with Alcalase and lysozyme to recover PHA, it is appropriate to first apply Alcalase at a time and at a pH appropriate for alcalase (e.g. pH 8.5), and then follow with a separate treatment at a different pH of 7.0 for treatment of lysozyme, which is consist with the pH preferences for Alcalase and lysozyme directly taught by Yanagita.
Since Yanagita directly teaches that it is appropriate to treat R. eutropha cells as taught therein with Alcalase and lysozyme, an ordinarily skilled artisan would have been motivated to do the same as directly suggested by Yanagita. Although Yasotha is directed towards a different cell type, Yasotha in confirmation and reinforcing the teachings of Yangita teaches that a combination of Alcalase and lysozyme is particularly effective for cell lysis to recover PHA such that an ordinarily skilled artisan at the time of filing would have been motivated to apply the same to R. eutropha cells as taught by Yanagita. As emphasized above, Yanagita teaches that Alcalase is preferably applied at pH 8-9 and lysozyme is preferably applied at pH 6-7. Yasotha teaches that the different pH preferences of Alcalase and lysozyme can be accommodated by a treatment with Alcalase at a pH 8.5 as also taught by Yanagita. Yasotha then teaches that pH can be separately adjusted lower to pH 7.0 for a separate enzymatic treatment with lysozyme. At the time of filing an ordinarily skilled artisan would have been motivated to modify the methods of Yanagita to have an additional step of adding lysozyme enzyme (after treatment with Alcalase at pH 8.5) by adjusting pH of the culture solution to 7 for a separate treatment with lysozyme in view of Yanagita directly teaching that it is appropriate to treat R. eutropha cells as taught therein with Alcalase and lysozyme.
Regarding claims 2, 3, 4 and 13, “[S]election of any order of performing process steps is prima facie obvious in the absence of new or unexpected results.” 2144.04(IV)(C). Performance of the following meets the features of claim 3:
-Alcalase treatment of the culture solution at pH 8.5;
-adjustment of pH to 7.0 and lytic enzyme/lysozyme treatment of the culture solution;
-adjustment of the culture solution back to pH 8.5 and a second Alcalase treatment of the culture solution; and
-adjustment of pH to 7.0 and a second lytic enzyme/lysozyme treatment of the culture solution.
Again, as discussed, the methods recite an open transitional phrase comprising such that the claims encompass performing (b) of claim 1 more than one time. As indicated, Yanagita and Yasotha teaches the application of separate Alcalase and lysozyme treatments with pH adjustment to the appropriate pH of 8.5 or 7.0 prior to each treatment as to suggest at least one cycle of Alcalase treatment at pH 8.5 followed by lysozyme treatment at pH 7, which meets the features of claims 4 and 13. Simply repeating this cycle is prima facie obvious in the absence of new or unexpected results as a selection of order of steps by selecting performing an enzymatic treatment more than one time. In the alternative, an ordinarily skilled artisan at the time of filing would have been motivated to repeat enzymatic treatment with alcalase followed lysozyme (such that four steps of enzymatic treatment are done) if the first round of treatment with alcalase followed by lysozyme did not yield complete enough cell lysis or PHA recovery wherein additional treatment with alcalase followed by lysozyme would be expected to yield additional PHA recovery.
Regarding claim 3 specifically, recitation of “further comprising between (a) and (b), (a’) adjusting the pH of the culture solution obtained in (a) to form 6.0 to 8.0” is met if such pH adjustment is done prior to at least one enzyme treatment if plural enzyme treatments are performed. “Carrying out a lytic enzyme treatment and an alkaline proteolytic enzyme treatment in this order” does not preclude the performance other additional enzyme treatments wherein claim 3 recites “further comprising.” For example, claim 13 recites carrying out proteolytic enzyme treatment and a lytic enzyme treatment “at least one each,” such that claim 1 and all claims depending therefrom are understood as encompassing an enzyme treatment as in (b) in claim 1 multiple times in the absence of specific negative claim limitations excluding the same, wherein such a negative claim limitation is not recited. The first performed lytic enzyme treatment followed by a second Alcalase enzyme treatment (wherein four total enzyme treatments are performed) as outlined above is “carrying out a lytic enzyme treatment and an alkaline proteolytic enzyme treatment in this order” as recited in claim 3. Regarding claim 2, performance of four enzymatic treatments as outlined above also satisfies the features of claim 2.
Regarding claims 5 and 20, Example 1 of Yanagita, Yanagita describes addition of SDS (sodium dodecyl sulfate/surfactant prior to addition of enzyme. “The use of anionic detergent such as sodium dodecyl sulfate (SDS) can decompose any insoluble matters such as protein and lipids and solubilise the components by incorporation in micelles. [A reference] found in their research that reaction of Alcalase and SDS simultaneously bore no synergistic effect at the optimum pH and temperature condition of Alcalase, and as such this leads to considerable time savings since the reactions can be carried out simultaneously.” Yasotha, page 261, left col. As such, addition of SDS (a surfactant) at some point in recovery of PHA is beneficial for solubilizing insoluble material. “[S]election of any order of performing process steps is prima facie obvious in the absence of new or unexpected results.” Addition of SDS after the pH adjustment of step (c) of claim 1 [as taught by Yanagita as discussed above), either instead of at the beginning of the process or as and additional addition of SDS, is selection of performing process steps that is prima facie obvious in the absence of new or unexpected results. That is, the prior art cited teaches the addition of SDS wherein the point of addition of SDS in the process is selection of performing process steps that is prima facie obvious in the absence of new or unexpected results. Regarding claim 20, Example 1 of Yanagita, Example 1, states: 1000 g of the obtained bacterial cell culture solution was sterilized at 70 to 75 ° C. for 1 hour, cooled to 50 ° C., 4.0 g of sodium dodecyl sulfate was added. 4 g SDS in 1000 g of cell culture solution is 0.4% by weight relative to the culture solution. Regardless of at what point in the process SDS is added, an ordinarily skilled artisan at the time of filing would have been motivated to utilize the amount of SDS specifically taught by Yanagita, or stated in other words, Yanagita directly indicates 0.4% weight relative to the culture solution is an appropriate amount of surfactant.
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.
Claims 1-5, 7, 10-16 and 20 (all non-withdrawn claims) are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-13 of copending Application No. 18/681,441 in view of Yanagita et al. (WO 2010/116681 A1), Maruyama (WO 08/010296 A1) and Yasotha et al. (Recovery of medium-chain-length polyhydroxyalkanoates (PHAs) through enzymatic digestion treatments and ultrafiltration, Biochem. Eng. J. 30, 2006, 260-68). Machine translations are provided and cited as indicated above.
The rejections under 35 U.S.C. 103 stated above are incorporated herein by reference.
The copending (i.e. reference) claims state:
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The maintaining the culture solution a pH of 10.5 as in reference claim 1 meets step (a) of claim 1; however, the reference claims does not state a time for maintaining. Regardless, maintain must be performed for a period of time wherein it is not inventive to discover that a maintenance time of, for example, 4 hours is effective or operative. See MPEP 2144.05(II)(A). As explained in MPEP 2144.05(II)(A), since the general condition of maintaining at pH 10.5 is recited it is not inventive to discover that 4 hours is a workable time period.
Reference claim 3 indicates enzymatic treatment of cells for recovery of PHA including with a lytic enzyme and an alkaline proteolytic enzyme (reference claim 8), including later adjustment to pH 10 and addition of surfactant as recited in claim 1, part(c). The reasons one having skill in the art at time of filing would have performed such enzymatic treatment is the manner recited in the rejected claims and to meet all limitations of the rejected claims are set forth above in the rejections under 35 USC 103 over Yanagita et al. (WO 2010/116681 A1), Maruyama (WO 08/010296 A1) and Yasotha et al.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/TODD M EPSTEIN/Primary Examiner, Art Unit 1652