DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of claims
Claims 1, 5-13, 17-19 and 22 as amended on 9/17/2025 are pending and under examination.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1, 5-13, 17-19 and 22 as amended are/remain rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 7,579,176 (Herrema et al), Wendlandt et al (“The potential of methane-oxidizing bacteria for applications in environmental biotechnology”. Eng. Life Sci., 2010, No. 2, pages 87-102), Alber et al (“Biotechnological potential of the ethylmalonyl-CoA pathway”. Appl Microbiol Biotechnol. 2011, 89, pages 17-25), Asenjo et al. (“Microbial conversion of methane into poly-beta-hydroxybutyrate (PHB): growth and intracellular product accumulation in a type II methanotroph”. J. Ferment. Technol., 1986, Vol. 64, No. 4, pages 271-278) and US 8,535,399 (Chen et al).
First with regard to claims 1, 5, 6, 13, 17, 18, and 19:
Claims are directed to a product-obtained by a method; and the product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. MPEP 2113.
In the instant case the final product is a composition comprising methanotrophic microorganisms that are: 1) having or capable to produce intracellular PHA content greater than 85%; 2) express EMC pathway; and 3) express pMMO at a greater level than sMMO when placed in a medium with copper concentration below 1 µM.
The cited US 7,579,176 (Herrema et al) disclose a composition with carbon- utilizing and PHA producing methanotrophic microorganisms that are:
1) capable to accumulate intracellular PHA content up to 80% by weight; for example: see col. 5, lines 10-11. The disclosed PHA amount is less than claimed; and the final product of the cited reference does not explicitly meet the final feature 1 as claimed.
2) Although US 7,579,176 (Herrema et al) is silent about EMC pathway, the EMC pathway genetic material is inherently present in the microorganisms of Asenjo because the EMC pathway is central to the carbon metabolism of proteobacteria including C1 carbon-utilizing bacteria (see Alber at abstract and page 17, col. 2). Thus, expression of EMC pathway is an inherent feature of the final product of the cited US 7,579,176 (Herrema et al). The cited product meets the required feature 2 as claimed.
3) the cited US 7,579,176 (Herrema et al) explicitly teaches that altering or increasing concentration of copper in culture media results in greater level of expression of pMMO over sMMO (col. 5, lines 25-35; col.10, lines 13-23). The cited US 7,579,176 (Herrema et al) teaches that the threshold of copper concentration is below 0.005 µM (col. 10, line 22) which falls within the claimed range. Thus, the final product has more of pMMO than sMMO when copper concentration is altered, for example: either reduced (claimed limitation ii) or returned to elevated concentration (claimed limitation iii). Therefore, the cited product meets relative requirement for feature 3 within the broadest reasonable meaning of the claims.
Now with regard to the claimed feature 1 or a limitation drawn to intracellular PHA concentration 85-95%:
In particular embodiment the cited US 7,579,176 (Herrema et al) discloses a composition with carbon utilizing and PHA producing methanotrophic microorganisms that are capable to accumulate intracellular PHA content up to 80% by weight; for example: see col. 5, lines 10-11; which is less than claimed.
But the prior art teaches and suggests various culture condition manipulations that lead to increase of PHA accumulation.
For example: the cited reference by Asenjo et al teaches that PHA/PHB accumulation in methanotrophic microorganisms depends on several conditions and that it can be increased by selecting a particular biological species (page 274, col. 2, par. 1), by imposing nitrogen limitation (abstract), by increasing age of inoculum (table 1), by increasing period of time for accumulation of PHA in biomass (page 274, col. 2, par. 1), etc.
For example: the cited reference by Wendlandt also teaches that PHB or PHA accumulation in methanotrophic microorganisms in increased by various conditions including excess of carbon nutrient source and deficiency of non-carbon nutrient sources including nitrogen, phosphorous, sulfur, Fe, etc. (page 96-97).
For example: US 8,535,399 (Chen et al) teaches that organic solvent extraction of PHA from PHA-producing biomass could make PHA yield more than 95% of the intracellular content (col. 7, lines 25 and 43-45).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to optimize culture conditions of methanotrophic microorganisms capable to produce PHA and/or to use organic solvent for PHA extraction with a reasonable expectation of success in providing a composition comprising methanotrophic microorganisms having intracellular PHA concentration greater than 70% or 85-95% because prior art teaches and suggests that using organic solvent for PHA extraction and/or using various culture conditions including excess of carbon source, deficiency of non-carbon nutrient sources, increasing age of inoculum, increasing period of time for accumulation of PHA in biomass as well as selection of most beneficial biological species provide for increasing of PHA content in the final product. Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Further, as applied to claims 7-12 and 22:
The cited reference by Asenjo clearly teaches the use of methane as a carbon-containing gas that is a source of carbon for PHA/PHB production as well as carbon dioxide gas that is involved in biosynthesis of PHA/PHB (page 274, col.1, equation 6). With respect to claim-recited “PHA-reduced biomass as a source of carbon” it is noted that specification defines content of this claimed carbon source as being carbon dioxide or methane (par. 0108 of PG publication). In alternative, it is not a carbon source of methanotrophic microorganisms of pending claims but for autotrophic microorganism (par. 0187 of PG publication) which is not recited in the claims as a component of the claimed composition.
Thus, the claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 5-13, 17-19 and 22 as amended remain/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature or a natural phenomenon without significantly more.
The claims recite a composition with methanotrophic microorganism(s) having intracellular PBH content 85% by weight and more, wherein the microorganisms have EMC pathway genetic material and enzymes pMMO and sMMO in relative amounts. The specific amounts of copper are not required as a component of claimed product.
The methanotrophic microorganisms capable to accumulate intracellular PHB are natural bacteria and the amounts of accumulated PHA are regulated by their natural biological function or by a natural phenomenon as a natural microbial response to surrounding conditions.
It is known that enzyme methane monooxygenase (MMO) is universally found in methanotrophs as evidenced by Bourne (page 3802, col.1, lines 8-9) including sMMO and pMMO ( see Wendlandt, page 88, col. 2). Thus, accumulation of PHA in methanotrophic cultures is regulated by their natural biological function or by a natural phenomenon as a natural microbial response to surrounding conditions including excess of carbon nutrient source (methane as a natural gas) and/or deficiencies of natural non-carbon nutrients including nitrogen, phosphorous, sulfur, etc. as acknowledged by Wendlandt (page 96, col. 2, par. 3).
Further, the EMC pathway is central to the carbon metabolism of proteobacteria including C1 carbon-utilizing bacteria (see Alber at abstract and page 17, col. 2). Thus, a presence of EMC pathway as claimed and as disclosed in the as-filed specification (par. 0023, 0193) is a natural characteristics of naturally occurring bacteria.
The as-filed specification does not appear to describe that the claimed microorganisms are genetically engineered bacteria. Therefore, as a whole claimed product is a product of nature and/or a natural phenomenon without significantly more.
This judicial exception is not integrated into a practical application because claimed natural components do not add a meaningful limitation or extra-solution; and it is nothing more than an attempt to generally link the product of nature to a particular technological environment.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as a whole the claimed product is a simple combination of natural products which is not markedly different from their naturally occurring counterparts by structure or function.
Response to Arguments
Applicant's arguments filed on 9/17/2025 have been fully considered but they are not found persuasive.
With regard to claim rejection under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 7,579,176 (Herrema et al), Wendlandt et al., Alber et a, Asenjo et al. and US 8,535,399 (Chen et al) Applicant argues that the cited prior art discloses the PHA producing methanotrophic microorganisms that are capable to accumulate intracellular PHA content up to 80% by weight but not greater than 85% or 90-95% as required for the claimed product and that the cited prior art does not teach or recognize that PHA accumulation is due to a greater level of pMMO expression that sMMO expression as result of repeated concentration changes of copper and additional nutrients.
The first argument is not found persuasive because, for example, the cited US 8,535,399 (Chen et al) teaches that organic solvent extraction of PHA from PHA-producing biomass could make data for PHA yield more than 95% of the intracellular content (col. 7, lines 25 and 43-45).
With regard to second argument: the cited US 7,579,176 (Herrema et al) explicitly teaches that altering or increasing concentration of copper in culture media results in greater level of expression of pMMO over sMMO (col. 5, lines 25-35; col.10, lines 13-23). The cited US 7,579,176 (Herrema et al) the threshold of copper concentration is below 0.005 µM (col. 10, line 22) which falls within the claimed range. Thus, the final product has more of pMMO than sMMO when copper concentration is altered.
Applicant also argue that the claimed product unexpectedly generate a greater amount of PHA through enzyme pMMO (response pages 7-8) as result of repeated changes in conditions and/or concentrations.
This arguments is not persuasive with respect to the claimed invention which is not a method of making as argued.
Moreover, the cited US 7,579,176 (Herrema et al) teaches that the threshold of copper concentration is below 0.005 µM (col. 10, line 22) which falls within the claimed range. Thus, the disclosed alterations (which broadly mean repeated changes of conditions) are taught/suggested to take place under same condition of copper concentration below claimed 1 µM.
Furthermore, limitation (iii) is drawn to “one or more additional nutrients” which is a generic condition and does not indicate conditions leading to unexpected results as argued. Moreover, the cited US 7,579,176 (Herrema et al) clearly teaches that sMMO has a wider range of nutrient substrates than pMMO (col. 3, lines 25-28). Thus, it would be obvious to one of skill in the art to change nutrient substrates to favor expression of either sMMO or pMMO depending on nutrient substrates.
With regard to claim rejection under 35 U.S.C. 101 Applicants argue that the claimed composition is not a natural product because the product is obtained by repeated specific manipulations leading to accumulation higher amount of intracellular PHB than in natural cells.
This argument is found persuasive because adaption of cells or modification of phenotype cells upon exposure to a changing or repeated culture environment is a natural process of adaptation, thus, a natural phenomenon. The amounts of accumulated PHA in the claimed product are regulated by the natural biological function or by a natural phenomenon as a natural microbial response to surrounding conditions.
The as-filed specification does not describe that the claimed microorganisms are stable mutants and/or genetically engineered bacteria. Therefore, as a whole claimed product is a product of nature and/or a natural phenomenon without significantly more.
No claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Vera Afremova
January 15, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653