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 .
Status of the Application
Applicant’s remarks and amendment submitted on 09/14/2026 are acknowledged.
Claims 2-11, 13-16, and 18-22 are pending.
Claims 12 and 17 are canceled.
Claims 2-11, 13-16, and 18-22 have been examined on the merits.
Applicant’s election of the species: 1) methanotrophic microorganisms capable of expressing pMMO and sMMO; 2) ethane; and 3) polyhydroxybutyrate, respectively, in response to the three species election requirements set forth in the prior office action is acknowledged.
Upon searching and further consideration, Examiner has withdrawn the species election 1 over pMMO and/or sMMO; and rejoined the species of oxygen in the species election 2 to be examined along with the elected ethane. The remaining of the species election requirements is maintained.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Priority
This application, U.S. Application number 18/759101, is a CON of U.S. Application No. 17/239,477 filed on 04/23/2021, now U.S. patent No. 12060597, which is a CIP of U.S. Application No. 16/710,516 filed on 12/11/2019, now U.S. patent No. 11459590, which is a CON of 15/849,193 filed on 12/20/2017, now U.S. patent No. 10538792, which is a CON of U.S. application No. 14/526,228 filed on 10/28/2014, now US patent No. 9850508, which a CON of 14/286,274 filed on 05/23/2014. now abandoned, which is a CON of 13/310,542 filed on 12/02/2011, now U.S. patent No. 8735113
Applicant’s claim for the benefit of prior-filed applications under 35 U.S.C. 120 has not complied with one or more conditions for receiving the benefit of an earlier filing date as follows.
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AlA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed applications, including applications Nos. 16/710,516, 15/849,193, 14/526,228, 14/286,274, and 13/310,542, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for the instant claims 2-11, 13-16, and 18-22 of this application. Specifically, the previous disclosure does not provide the support for microorganisms being initially overfed and then being underfed based on a gas concentration before being further cultured for depleting nitrogen and producing PHA, as recited in the base claims 2, 10, and 16. However, the disclosure of the prior-filed application No. 17/239,477 filed on 04/23/2021 provides adequate support for the claimed invention. Accordingly, instant claims 2-11, 13-16, and 18-22 receive the benefit of the filing date of the ‘477 application. Therefore, its filing date of 04/23/2021 is used for prior art purposes for the instant claims.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/13/2026 are acknowledged. The references where lined through have not been considered since their documents are either not provided, or not in English-translated version. The remainder of the submission is in compliance with the provisions of 37 CFR 1.97 and has been considered by the examiner.
Claim Objections
Claims 2, 10, and 16 are objected to due to the recitation of “the media”. The term should be corrected to “the medium” to be consistent with the “culture medium” previously recited in the claims. Appropriate correction is required.
Claim 5 is objected to due to the recitation of “one or more of … nickel, chromium, cobalt, or molybdenum”. To be consistent with the standard language of the Markush group, the phrase should be changed to “one or more of … nickel, chromium, cobalt, and molybdenum”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b), or 112, Second Paragraph
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 2-11, 13-16, and 8-22 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 pre-AIA the applicant regards as the invention.
Claims 2, 10, and 16 are indefinite due to the recitation of “… methanotrophic microorganisms is initially overfed based on the concentration of the gas followed by being underfed based on the same concentration of gas and growth of the … microorganisms”. There is no sufficient antecedent basis for the limitations “the concentration of the gas” and “the same concentration of gas” in the claims. The claims do not previously define any gas concentration. It is unclear which specific concentration the recited limitations refer to. In addition, it is unclear which nutrient(s) is(are) underfed or overfed for the microorganisms and whether the underfed or overfed nutrient(s) refer(s) to the methane and/or non-methane substances in the gas or to other nutrients (such as nitrogen) in the culture medium. Given the recited “underfed” and “overfed” are relative terms, a benchmark for comparison of levels of fed-nutrients is required for determining whether the microorganisms are overfed, underfed, or evenly-fed. It is unclear how an “overfed” or “underfed” state can be determined based on a concentration of the gas in view of the fact that the claims do not limit overfed/underfed nutrients to be the nutrients present in the gas (specifically methane and non-methane substances), rather they can be any other nutrients not present in the gas. In the case that underfed/overfed nutrients are not present in the gas, it is unclear how nutrients (e.g. soluble nitrogen) in the culture can be determined to be overfed or underfed based on a concentration of the gas.
Claim 2 is also indefinite due to the recitation of “in a second phase … allowing the culture of methanotrophic microorganisms to deplete the nitrogen … to create an underfeeding condition”. In the first phase, the microorganisms are initially overfed and then underfed with nutrients, which indicates there is a depletion/reduction of the nutrients and the underfed nutrients are not present at amounts sufficient to support the microorganisms, i.e. creating an underfeeding condition. It is noted that the underfed nutrients in the first stage can be or comprise nitrogen, as indicated above. As such, the first phase encompasses a process of depleting nitrogen from the culture medium to create an underfeeding condition, which is the same as the process of the second phase. It is unclear how the process of culturing microorganisms under depleted nitrogen in the second phase is different from that encompassed by the first phase; and it is unclear whether the recited second phase is simply a continuous process of the first phase by continuously culturing the microorganisms in the same culture medium with underfed nutrients/nitrogen, or it is a new phase which comprises culturing microorganisms harvested from the first phase in a new, fresh, or adjusted culture medium.
Claim 5 is indefinite due to the recitation of “wherein said culture medium further comprises … carbon … methane …”. The term “further” implies that the components defined in the claim are not present in the culture medium of the base claim 2 upon which the claim 5 depends. However, the base claim 2 recites “methane” as a carbon source in the gas (encompassed by “carbon”) provided to the culture medium (having cultured microorganisms). It is not clear how the culture medium can further comprise the methane/carbon which are already present in the medium.
Claims 8 and 11 are indefinite due to the recitation of “water, water vapor”. The claims recite “water” in addition to “water vapor” as the one or more non-methane substances in the gas, which implies the recited “water” can be in a form different from the “water vapor” (e.g. liquid or solid form). It is unclear how a gas can comprise a liquid or solid form of water. For the purpose of examination, the recited phrase is interpreted as “water vapor”.
Claim 20 is indefinite due to the recitation of “said molecular weight”. There are two different molecular weights recited in the claim 19 (one from first cycle and another from second cycle). It is unclear which molecular weight the recited term refers to.
Claim 22 is indefinite due to the recitation of “said polydispersity”. There are two different polydispersities are recited in the claim 21 (one from first cycle and another from second cycle). It is unclear which specific polydispersity the recited limitation refer to.
The remaining claims are rejected for depending from an indefinite claim.
Claim Rejections - 35 USC § 112(d), or 112, Fourth Paragraph
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends
Claim 5 defines the carbon and/or methane as carbon source further comprised in the culture medium (Note: the carbon encompasses any specifically defined carbon source, such as methane). Claim 2, upon which the claim 5 depends, defines that the methane is provided as a carbon source to the culture of the culture medium. Therefore, the scope of the claim 5 either fails to further limit or is broader than that of Claim 2.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
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 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.
Claims 2-3, 5, 8-11, and 13-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Asenjo et al. (J. Ferment. Technol.,1986, 64(4): 271-278, cited in IDS), as evidenced by Murrell et al. (Trends in Microbiology, 2000, 8(5):221-225, cited in IDS) and Wikipedia printout for Bacterial growth (retrieved on 9/28/2029 from https://en.wikipedia.org/wiki/Bacterial_growth).
Asenjo et al. teach a method for producing a polyhydroxyalkanoate (PHA), specifically poly-b-hydroxybutyrate (PHB) in a batch culture (abstract), comprising: a first stage of growing cells of methanotrophic microorganisms in a nitrogen-containing culture medium supplied with a gas mixture of methane and oxygen or air for a first period of time; and a second stage of obtaining cells from the first stage as an inoculum and then inoculating and culturing the cells in a nitrogen-containing culture medium in the presence of the gas under nitrogen-limited condition for a second period of time for producing and accumulating PHB in the late growth and stationary phases (see abstract; page 272/left col/paras 2-3 and right col/para 1 for conditions used for culturing in first and second stages; Figs. 2-5 for PHB accumulation under nitrogen-limited condition, see page 275/right col/para 2/lines 10-15 for obtaining inocula from cell cultures in rapid growth and late growth and stationary phases in the first stage and then culturing them in the second stage).
Regarding the limitations about pMMO and/or sMMO enzymes of the methanotrophic microorganisms in the claims 2 and 10, Asenjo et al. further teach that methanotrophic microorganisms are from Methylocystis parvus or Methylosinus trichosporium (page 272, left col/para 2/lines 1-2). These methanotrophic microorganisms are capable of expressing pMMO and/or sMMO enzymes and synthesize PHA/PHB via pMMO and/or sMMO, as evidenced by Murrell et al., who disclose that all methanotrophs examined possess pMMO (a particulate methane monooxygenase) (page 222/right col/para 2/lines 1-3); and expressively teach Methylocystis parvus possesses pMMO and Methylosinus trichosporium possesses both pMMO and sMMO (a soluble methane monooxygenase) and pMMO and/or sMMO are the first enzyme in the methane oxidation pathway for synthesize PHA/PHB (page 222/right col/para 1/lines 10-11, page 223/left col/para 2/lines 2-3, page 221/left col/last full para).
Regarding the limitations about “deplete nitrogen … to create an underfeeding condition” in the second phase or period of the claims 2, 10 and 16, Asenjo et al. teach nitrogen becomes limiting (i.e. nitrogen-depleting) in the later stages of the growth phase and there is no increase in cell growth in the downstream stationary phase, during which PHB is formed and accumulated (page 275, left col., para 2; Figs. 2-4). As such, the second stage of Asenjo et al. comprises depleting nitrogen from culture medium to create a nitrogen-underfeeding condition.
Regarding the limitations about “initially overfed … followed by being underfed” in the first phase or period of the claims 2 and 10, Asenjo et al. teach obtaining the inoculum/inocula from the first stage’s culture and inoculating and culturing them in the second stage, and the inoculum/inocula include: rapidly growing cells of rapid growth phase (12 hours) and cells of late growth or early stationary phases (72 hours); and further teach that the old-age inoculum (i.e. 70 hours) produces and accumulates higher levels of PHB (page 275/right col./para 2/lines 10-15, Table 1). As such, the cells of methanotrophic microorganisms in the first stage of Asenjo et al. go through a rapid growth phase with rapid cell growth (at early time, e.g. 12 hours) followed by a late growth phase with slower cell growth and a stationary phase with slow or substantially no cell growth (at late time, e.g. 70 hours). Although Asenjo et al. are silent about whether the cells are initially overfed followed by being underfed with nutrients, these features are respectively correlated with cell growth phases in a process of culturing bacterial cells, as evidenced by Wikipedia (see attached Wikipedia printout), which teaches that (i) in the Log/Exponential phase (i.e. rapid growth phase) bacteria rapidly grow with “both the number of cells and the rate of population increase doubles with each consecutive time period” when initially there are sufficient nutrients available to bacteria (i.e. bacteria being initially overfed); (ii) “Exponential growth cannot continue indefinitely, however, because the medium is soon depleted of nutrients” (i.e. bacteria are soon underfed with nutrients); and (iii) the bacteria enter the stationary phase due to the depletion of essential nutrient (i.e. being underfed with nutrient) and there is no increase in cell number because their growth rate is reduced to a level that equals to a cell death rate (see first page/last para, second page/paras 1-2, figures of bacterial growth curves in first page). As such, the cells of methanotrophic microorganisms in the first stage of Asenjo et al. are overfed initially (in the rapid growth phase) followed by being underfed (in late growth and stationary phases), meeting the claimed limitations.
Regarding the claims 3 and 11, Asenjo et al. teach the gas comprises oxygen as a non-methane substance.
Regarding the claim 5, Asenjo et al. teach the culture medium further comprises phosphorus, potassium, sodium, magnesium, copper, iron, sulfate, boron, zinc, nickel, cobalt, and molybdenum (page 272/left col./para 2).
Regarding the claims 8 and 15, the poly-b-hydroxybutyrate (PHB) taught by Asenjo et al. reads on the polyhydroxybutyrate recited in the claims.
Regarding the claim 9, Asenjo et al. are silent about molecular weights of the PHA/PHB. However, the limitation about PHA produced with a specific range of molecular weights is directed to an outcome, not to the steps, of the claimed method, i.e. the limitation is directed to what the method does, not to what the method is. Asenjo et al. teach a method having the same steps as the claimed method. In the absence of evidence to the contrary, it is presumed that a method having substantially the same steps is capable of generating substantially the same outcomes. Therefore, the teachings of Asenjo et al. meet the claimed limitation.
Regarding the claim 13, the methane in the gas taught by Asenjo et al. is quantifiable and monitored (see page 272/ the sentence spanning both cols, page 276/right column/last para).
Regarding the claim 14, Asenjo et al. teach harvesting PHA/PHB (page 272, right col, last full para/lines 1-2).
Regarding the claim 16, this claim is directed to a continuous process, in which the microorganisms are cultured in a medium with being initially overfed, then underfed with nutrients/nitrogen, and then being continuously cultured in the medium without additional nitrogen under nitrogen depletion condition for producing PHA. It is noted that the continuous process of Asenjo et al. meets all the steps and limitations in the claim 16. Specifically, see Figs 2-4, which show a continuous process of culturing the methanotrophic microorganisms in a medium having nitrogen and exposed to methane/O2, comprising: initially rapidly growing cells in a rapid growth phase/log phase (having a rapid increase in cell biomass/size of cell population and being overfed with nutrients), then culturing the cells in late growth and stationary phases (having slow or no increase of cell biomass and being underfed with nutrients), followed by continuously culturing the cells in the medium without additional nitrogen under nitrogen depletion condition in the stationary phase until 100 or 200 hours for producing PHA, as described above and evidenced by Wikipedia.
Therefore, in view of the teachings of Asenjo et al., the method of the instant claims is anticipated by the method of Asenjo et al.
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 of this title, 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.
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 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.
Claims 2-3, 5-11, 13-16, and 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Asenjo et al. (J. Ferment. Technol.,1986, 64(4): 271-278, cited in IDS), as evidenced by Murrell et al. (Trends in Microbiology, 2000, 8(5):221-225, cited in IDS) and Wikipedia printout for Bacterial growth (retrieved on 9/28/2029 from https://en.wikipedia.org/wiki/Bacterial_growth).
The teachings of Asenjo et al. are described above.
Regarding the claims 6 and 18, Asenjo et al. do not expressively teach repeating the culturing in first and second stages or time periods for a plurality of times. However, the process of first and second stages taught by Asenjo et al. is applied for producing PHA/PHB. It would have been obvious to modify the method of Asenjo et al. by repeating the first and second stages for a plurality of times for enhancing the production of PHB for being supplied as a plastic in the market, because Asenjo et al. teach PHB is a plastic having similar tensile and thermal properties to other industrial plastics, but with added advantage of being biodegradable when compared to other industrial plastics; and it shows great promise for biomedical applications and for biodegradable food packaging and encapsulation of agrochemicals. (page 271, right col., lines 9-16).
Regarding the claims 19-22, Asenjo et al. are silent about molecular weights and polydispersity of PHA/PHB. However, the limitations about PHA/PHB produced with a specific range of molecular weights or polydispersity are directed to an outcome, not to the steps, of the claimed method, i.e. the limitation is directed to what the method does, not to what the method is. Asenjo et al. suggest a method having the same steps as the claimed method. In the absence of evidence to the contrary, it is presumed that a method having substantially the same steps is capable of generating substantially the same outcomes. Therefore, the teachings of Asenjo et al. meet the claimed limitations.
Regarding the claim 7, Asenjo et al. teach harvesting PHA/PHB, as indicated above.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 2-11, 13-16, and 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Asenjo et al. (J. Ferment. Technol.,1986, 64(4): 271-278, cited in IDS), as applied to Claims 2-3, 5-11, 13-16, and 18-22, further in view of Herrema et al. (WO 2012/122343, 2012, effective filing date: 03/08/2011, cited in IDS), as evidenced by Murrell et al. (Trends in Microbiology, 2000, 8(5):221-225, cited in IDS) and Wikipedia printout for Bacterial growth (retrieved on 9/28/2029 from https://en.wikipedia.org/wiki/Bacterial_growth).
Examiner notes that this rejection further renders the “ethane”, a species of non-methane substance(s) Applicant elected from the claims 3 and 11, to be obvious in view of Asenjo et al. and Herrema et al.
The teachings of Asenjo et al. are described above.
Regarding Claims 3 and 11, Asenjo et al. teach the gas mixture comprises methane, but they do not teach the gas mixture comprises ethane as a non-methane substance.
It would have been obvious to further include ethane, along with methane, in the gas mixture in the method of Asenjo et al. for supporting the production of PHA/PHB, because it is known in the art to use a gas mixture comprising methane and ethane as carbon source to support production of PHA, specifically PHB, in methanotrophic microorganisms capable of expressing pMMO and/or sMMO. In support, Herrema et al. teach a method for enhancing polyhydroxyalkanoate (PHA) generation in a culture of methanotrophic microorganisms capable of expressing pMMO and/or sMMO, comprising: (i) contacting a culture of methanotrophic microorganisms with a medium comprising one or more nutrients comprising nitrogen, and a carbon-containing gas that can be metabolized by said culture, and incubating said culture in said medium for culturing methanotrophic microorganisms; (ii) reducing a concentration of one or more nutrients comprising nitrogen in said medium (e.g. nitrogen depletion to create an underfeeding condition) to cause said culture to generate PHA from said carbon-containing gas via pMMO and/or sMMO; and (iii) repeating the culturing and reducing (nitrogen depletion) steps for PHA production, wherein the carbon-containing gas comprises methane and ethane (abstract; paras 0013-14, 0015/lines 9-11, 0019/lines 6-7, 0129/lines 1-2, 0179/lines 1-2 and 3-4; the sentence spanning pages 38-39; claims 1, 8, 36 and 49), wherein said methanotrophic microorganisms are those of Methylosinus or Methylocystis (paras 0022/last line and 0181/line 6, claim 49); and wherein the PHA is polyhydroxybutyrate (PHB) (paras 0052/line 6, 0111, and 0185).
Regarding the claim 4, Asenjo et al. do not teach the culture comprises two or more species of methanotrophic microorganisms. However, it would have been obvious to further include additional species of methanotrophic microorganisms in the culture of the method of Asenjo et al. for producing PHA/PHB, because it is well known in the art to use mixed microbial cultures for producing PHA/PHB, as supported by Herrema et al., who further teach applying a culture of methanotrophic microorganisms comprising one or more microorganisms from the genera Methylocystis for producing PHA/PHB (claim 49).
Note: Herrema et al. teach repeating the growth and culturing with nitrogen depletion stages as required by the claims 6 and 18.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 2-11, 13-16, and 18-22 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12060597 in view of Asenjo et al. (J. Ferment. Technol.,1986, 64(4): 271-278, cited in IDS), as evidenced by Wikipedia printout for Bacterial growth (retrieved on 9/28/2029 from https://en.wikipedia.org/wiki/Bacterial_growth).
The claims of the ‘597 patent are directed in part to a method for producing a polyhydroxyalkanoate (PHA) in a culture of methanotrophic microorganisms, comprising: a) providing a gas comprising methane and one or more non-methane substances; b) providing a culture of methanotrophic microorganisms capable of expressing particulate methane monooxygenase (pMMO) and/or soluble methane monooxygenase (sMMO) in a culture medium comprising at least nitrogen as an essential nutrient; c) exposing said culture to said gas; d) inducing said culture to express pMMO and/or sMMO; and e) decreasing a concentration of nitrogen (i.e. depleting nitrogen to create an underfeeding condition) causing said methanotrophic microorganisms to produce the PHA; wherein said PHA is selected from polyhydroxybutyrate (PHB), polyhydroxybutyrate-covalerate (PHBV), poly-4-hydroxybutyrate (P4HB), polyhydroxyhexanoate (PHHx), and polyhydroxyoctanoate (PHO); wherein step d) is followed by step e), and followed by step d) comprises a production cycle; wherein the method further comprises repeating step d) followed by step e) one or more times, thereby resulting in at least a first production cycle and a second production cycle; wherein a molecular weight of said PHA produced in the first production cycle differs from the molecular weight of said PHA produced in the second production cycle by less than 50%; wherein molecular weights range from about 100 to about 5,000,000 Daltons, or from about 100,000 to about 2,500,000 Daltons; wherein a polydispersity of the PHA produced in the first production cycle differs from the polydispersity of said PHA produced in said second production cycle by less than 75% or less than 50%, and it ranges from about 0.1 to about 5.0; wherein said one or more non-methane substances comprise ethane; wherein said culture comprises two or more species of methanotrophic microorganisms; and wherein said culture medium further comprises one or more of hydrogen, oxygen, phosphorus, potassium, calcium, sodium, chlorine, carbon dioxide, magnesium, copper, iron, sulfate, manganese, boron, zinc, aluminum, nickel, chromium, cobalt, and molybdenum.
The teachings of Asenjo et al. and Wikipedia printout for bacterial growth are described above.
The claims of the ‘597 patent teach a nitrogen-depletion stage for stimulating PHA production via pMMO and/or sMMO, which is equivalent to the second phase or second period of culturing in the instant claims 2, 10, and 16. The claims of the ‘597 patent differ from the instant claims in that the patented claims are silent about whether the cells entered into the nitrogen-depletion stage, i.e. the step e), are previously cultured in a stage where the cells are initially overfed with nutrients followed by being underfed with nutrients. However, it would have been obvious to culture cells of methanotrophic microorganisms by initially overfeeding them with nutrients for rapidly growing the cells in a rapid growth phase and followed by underfeeding them after the cells consume most of the nutrients and enter a slow growth phase (late growth or stationary phase), thereby obtaining an inoculum of late growth or early stationary phase for being used in the nitrogen-depletion stage (i.e. the step e) in the method of the ‘597 patent for increasing production of PHA. This is because it is well known in the art that cells from the late growth or early stationary phase produce high levels of PHA/PHB when being stimulated by an underfeeding condition of nitrogen depletion, as supported by Asenjo et al. and evidenced by Wikipedia printout.
Therefore, in view of the cited prior art, the method of claims 2-11, 13-16, and 18-22 of the instant application is deemed obvious over the method of claims 1-18 of U.S. Patent No. 12060597.
Claims 2-11, 13-16, and 18-22 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10538792 in view of Asenjo et al. (J. Ferment. Technol.,1986, 64(4): 271-278, cited in IDS), as evidenced by Wikipedia printout for Bacterial growth (retrieved on 9/28/2029 from https://en.wikipedia.org/wiki/Bacterial_growth).
The claims of the ‘792 patent are directed in part to a method for producing a polyhydroxyalkanoate (PHA) in a culture of methanotrophic microorganisms, comprising: a) providing a gas comprising methane and one or more non-methane substances; b) providing a culture of methanotrophic microorganisms capable of expressing particulate methane monooxygenase (pMMO) and/or soluble methane monooxygenase (sMMO) in a culture medium comprising at least nitrogen as an essential nutrient; c) exposing said culture to said gas; d) inducing said culture to express particulate methane monooxygenase (pMMO) and/or soluble methane monooxygenase (sMMO); and e) decreasing the concentration of said nitrogen (i.e. depleting nitrogen to create an underfeeding condition) causing said methanotrophic microorganisms to produce said PHA; wherein said PHA is selected from the group consisting of polyhydroxybutyrate (PHB), polyhydroxybutyrate-covalerate (PHBV), poly-4-hydroxybutyrate (P4HB), polyhydroxyhexanoate (PHHx), and polyhydroxyoctanoate (PHO); wherein said step d) is followed by said step e), and wherein step e) followed by step d) comprises a production cycle; wherein the method further comprises repeating step d) followed by step e) one or more times, thereby resulting in at least a first production cycle and a second production cycle; wherein the molecular weight of said PHA produced in said first production cycle differs from the molecular weight of said PHA produced in said second production cycle by less than 50%; wherein said molecular weight ranges from about 100 to about 5,000,000 Daltons or from about 100,000 to about 2,500,000 Daltons; wherein the polydispersity of said PHA produced in said first production cycle differs from the polydispersity of said PHA produced in said second production cycle by less than 75% or less than 50%, and it ranges from about 0.1 to about 5.0; wherein said one or more non-methane substances comprise oxygen and/or ethane; wherein said culture comprises two or more species of methanotrophic microorganisms; and wherein said culture medium further comprises one or more of hydrogen, oxygen, phosphorus, potassium, calcium, sodium, chlorine, carbon dioxide, magnesium, copper, iron, sulfate, manganese, boron, zinc, aluminum, nickel, chromium, cobalt, and molybdenum.
The teachings of Asenjo et al. and Wikipedia printout for Bacterial growth are described above.
The claims of the ‘792 patent teach a nitrogen-depletion stage for stimulating PHA production via pMMO and/or sMMO, which is equivalent to the second phase or second period of culturing in the claims 2, 10, and 16. The claims of the ‘792 patent differ from the instant claims in that the patented claims are silent about whether the cells entered into the nitrogen-depletion stage, i.e. the step e), are previously cultured in a stage where the cells are initially overfed with nutrients followed by being underfed with nutrients. However, it would have been obvious to culture cells of methanotrophic microorganisms by initially overfeeding them with nutrients for rapidly growing the cells in a rapid growth phase and followed by underfeeding them after the cells consume most of the nutrients and enter a slow growth phase (late growth or stationary phase), thereby obtaining an inoculum of late growth or early stationary phase for being used in the nitrogen-depletion stage (i.e. the step e) in the method of the ‘792 patent for increasing production of PHA. This is because it is well known in the art that cells from the late growth or early stationary phase produce high levels of PHA/PHB when being stimulated by an underfeeding condition of nitrogen depletion, as supported by Asenjo et al. and evidenced by Wikipedia printout.
Therefore, in view of the cited prior art, the method of claims 2-11, 13-16, and 18-22 of the instant application is deemed obvious over the method of claims 1-18 of U.S. Patent No. 10538792.
Claims 2-11, 13-16, and 18-22 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9850508 in view of Asenjo et al. (J. Ferment. Technol.,1986, 64(4): 271-278, cited in IDS), as evidenced by Wikipedia printout for Bacterial growth (retrieved on 9/28/2029 from https://en.wikipedia.org/wiki/Bacterial_growth).
The claims of the ‘508 patent are directed in part to a method for producing a polyhydroxyalkanoate (PHA) in a culture of methanotrophic microorganisms, comprising: a) providing a gas comprising methane and one or more non-methane substances; b) providing a culture of methanotrophic microorganisms capable of expressing particulate methane monooxygenase (pMMO) and soluble methane monooxygenase (sMMO); c) providing a microorganism culture medium comprising at least a first essential nutrient copper and a second essential nutrient nitrogen; d) exposing said culture to said gas; e) manipulating a concentration of said copper in said culture medium for regulating expression of pMMO and sMMO; and f) decreasing a concentration of nitrogen (i.e. depleting nitrogen to create an underfeeding condition) causing said methanotrophic microorganisms to produce said PHA; wherein the PHA is selected from the group consisting of polyhydroxybutyrate (PHB), polyhydroxybutyrate-covalerate (PHBV), poly-4-hydroxybutyrate (P4HB), polyhydroxyhexanoate (PHHx), and polyhydroxyoctanoate (PHO); wherein said step e) is followed by said step f), and step e) followed by step f) comprises a production cycle; wherein the method further comprises repeating step e) followed by step f) one or more times, thereby resulting in at least a first production cycle and a second production cycle; wherein the molecular weight of said PHA produced in said first production cycle differs from the molecular weight of said PHA produced in said second production cycle by less than 50%, and it ranges from about 100 to about 5,000,000 Daltons or from about 100,000 to about 2,500,000 Daltons; wherein the polydispersity of said PHA produced in said first production cycle differs from the polydispersity of said PHA produced in said second production cycle by less than 50% or less than 75%, and it ranges from about 0.1 to about 5.0; wherein said one or more non-methane substances comprise oxygen and/or ethane; wherein said culture comprises two or more species of methanotrophic microorganisms; wherein said culture medium further comprises one or more of hydrogen, oxygen, phosphorus, potassium, calcium, sodium, chlorine, carbon dioxide, magnesium, iron, sulfate, manganese, boron, zinc, aluminum, nickel, chromium, cobalt, and molybdenum.
The teachings of Asenjo et al. and Wikipedia printout for Bacterial growth are described above.
The claims of the ‘508 patent teach a nitrogen-depletion stage for stimulating PHA production via pMMO and/or sMMO, which is equivalent to the second phase or second period of culturing in the claims 2, 10, and 16. The claims of the ‘508 patent differ from the instant claims in that the patented claims are silent about whether the cells entered into the nitrogen-depletion stage, i.e. the step e), are previously cultured in a stage where the cells are initially overfed with nutrients followed by being underfed with nutrients. However, it would have been obvious to culture cells of methanotrophic microorganisms by initially overfeeding them with nutrients for rapidly growing the cells in a rapid growth phase and followed by underfeeding them after the cells consume most of the nutrients and enter a slow growth phase (late growth or stationary phase), thereby obtaining an inoculum of late growth or early stationary phase for being used in the nitrogen-depletion stage (i.e. the step e) in the method of the ‘508 patent for increasing production of PHA. This is because it is well known in the art that cells from the late growth or early stationary phase produce high levels of PHA/PHB when being stimulated by an underfeeding condition of nitrogen depletion, as supported by Asenjo et al. and evidenced by Wikipedia printout.
Therefore, in view of the cited prior art, the method of claims 2-11, 13-16, and 18-22 of the instant application is deemed obvious over the method of claims 1-20 of U.S. Patent No. 9850508.
Conclusion
No claim is in condition for allowance.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Qing Xu, Ph.D., whose telephone number is (571) 272-3076. The examiner can normally be reached on Monday-Friday from 9:30 AM to 5:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao, can be reached at (571) 272-0939. Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to the receptionist whose telephone number is (571) 272-1600.
/Qing Xu/
Patent Examiner
Art Unit 1656
Prosecution Insights