DETAILED CORRESPONDENCE
Application Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Support for the amendments are within the instant application specification.
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/16/2026 has been entered.
Applicant’s amendment to the claims filed on 2/16/2026 in response to the Final Rejection mailed on 11/17/2025 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 3-4, 6-9, 13, 16 are pending.
Claims 1-2, 5, 10-12, 14-15 are cancelled.
Applicants’ remarks filed on 2/16/2026 in response to the Final Rejection mailed on 11/17/2025 have been fully considered and deemed persuasive to overcome at least one of the rejections and/or objections as previously applied.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Applicant’s Affidavit under 37 CFR 1.132 filed 2/16/2026 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/19/2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Withdrawn Claim Rejections - 35 USC § 112(b) Rejection
The rejection of claim 9 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the phrase “or a culture” in view of Applicants’ amendment to the claim 9 add ‘…of the KH-1 strain, KH-1AL1 strain, KH-1AL2 strain, or KH-1AL3 strain.’
New Claim Rejections - 35 USC § 112a – Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3-4, 6-8, 13, 16 are newly rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. The new rejection is necessitated by Applicant’s declaration dated 2/16/2026 that not all bacterium in family Burkholderiaceae decompose and remove trans fatty acid and/or trans fatty acid-containing oil and fat in oil in a subject of treatment. The specification, while being enabling for KH-1 strains of Burkholderiaceae decomposing trans fatty acids, it does not reasonably provide enablement for all strains of Burkholderiaceae to decompose trans fatty acids as encompassed by the claims.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue.” In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 219 (CCPA 1976). Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands (858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)) as follows: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP § 2164.01(a). The Factors considered to be most relevant to the instant rejection are addressed in detail below.
(A)The breadth of the claims:
Claims 3-4, 6-8, 13, 16 are drawn to a method of decomposing and removing trans fatty acid and/or trans fatty acid-containing oil and fat in oil in a subject of treatment, the method comprising: adding a trans fatty acid or oil-decomposing agent comprising a bacterium in family Burkholderiaceae, having an ability to decompose trans fatty acid-containing oil and fat or trans fatty acid to the subject of treatment, wherein the subject of treatment comprises an oil comprising trans fatty acid and/or trans fatty acid-containing oil and fat wherein a total of the trans fatty acid and trans fatty acid-containing oil and fat is at a ratio of 1% by weight or greater in the oil; and treating the subject of treatment with the trans fatty acid or an oil-decomposing agent by decomposing the oil comprising trans fatty acid or trans fatty acid-containing oil and fat in the oil in the subject of treatment. The structure of a bacterium in family Burkholderiaceae are a large number of strains.
B) The nature of the invention; C) The state of the prior art; (D) The level of one of ordinary skill; and (E) The level of predictability in the art: As noted above, the scope of the claimed variants of guanine oxidase are unlimited. The structure of the claimed bacterium in family Burkholderiaceae able to decompose and remove trans fatty acid and/or trans fatty acid-containing oil and fat in oil in a subject of treatment is a large number of strains. (F) The amount of direction provided by the inventor and (G) The existence of working examples: The specification discloses the following working examples bacterium in family Burkholderiaceae able to decompose trans-fatty acids (i.e. a microorganism belonging to Burkholderia arboris, Burkholderia ambifaria, Burkholderia anthina, Burkholderia cenocepacia, Burkholderia cepacia, Burkholderia contaminans, Burkholderia diffusa, Burkholderia dolosa, Burkholderia lata, Burkholderia latens, Burkholderia metallica, Burkholderia multivorans, Burkholderia pseudomultivorans, Burkholderia puraquae, Burkholderia pyrrocinia, Burkholderia seminalis, Burkholderia stabilis, Burkholderia stagnalis, Burkholderia territorii, Burkholderia ubonensis, or Burkholderia vietnamiensis). Other than the above disclosed species, there is no prior-art or disclosed teaching as to the large number of claimed bacterium in family Burkholderiaceae able to decompose trans-fatty acids. Other than these working examples, the specification fails to disclose any other working examples of bacterium in family Burkholderiaceae able to decompose trans-fatty acids.
In view of the overly broad scope of the claims, the lack of guidance and working examples provided in the specification, the high level of unpredictability, and the state of the prior art, undue experimentation would be necessary for a skilled artisan to make and use the entire scope of the claimed invention. Applicants have not provided sufficient guidance to enable one of ordinary skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims. The scope of the claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without sufficient guidance, determination of having the desired biological characteristics is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988).
Maintained Claim Rejections - 35 USC § 102
The rejection of claims 3-4, 6-, 13, 16 under 35 U.S.C. 102(a)(1) as being anticipated by over (JP 5640211 B2, filed: 2009/03/27, published: 2014/12/17, cited on PTO-892 dated 11/1/2023) {herein ‘211} as evidenced by Matsuoka et al (2008, Journal of Biosciecne and Bioengineering, cited in PTO-892 dated 7/3/2025) {herein Matsuoka} is maintained.
Previously presented claims 3-4, 6-9, 13, 16 are drawn to a method of decomposing and removing trans fatty acid and/or trans fatty acid-containing oil and fat in oil in a subject of treatment, the method comprising: adding a trans fatty acid or oil-decomposing agent comprising a bacterium in family Burkholderiaceae, having an ability to decompose trans fatty acid-containing oil and fat or trans fatty acid to the subject of treatment, wherein the subject of treatment comprises an oil comprising trans fatty acid and/or trans fatty acid-containing oil and fat wherein a total of the trans fatty acid and trans fatty acid-containing oil and fat is at a ratio of 1% by weight or greater in the oil; and treating the subject of treatment with the trans fatty acid or an oil-decomposing agent by decomposing the oil comprising trans fatty acid or trans fatty acid-containing oil and fat in the oil in the subject of treatment.
With respect to claim 4, ‘211 teaches a method wherein examples of microorganisms that secrete lipase, decompose fats and oils into fatty acids and glycerol, and further assimilate and consume fatty acids include true bacteria, yeasts, and filamentous fungi (page 2, paragraph 2). Among said bacteria are Burkholderia bacteria (page 2, paragraph 2). Examiner is interpreting the teaching of fatty acids by ‘211 to include all fatty acids, including trans fatty acids. Furthermore, since the reference is disclosing the same bacterium as the instant application, Examiner takes the position that said reference bacteria would have the inherent characteristics to decompose trans fatty acid-containing oil and fat.
With respect to claim 6, ‘211 teaches a method wherein the lipase secreting bacterium Burkholderia arboris was cultured at 28C. Since the reference is disclosing the same bacterium as the instant application, here again Examiner takes the position that said reference bacteria would have the inherent characteristics to grow and assimilate/decompose trans-fat, oil and fats at 15C.
With respect to claim 7, ‘211 teaches a method wherein among the genus of true bacteria, Burkholderia bacteria are most preferable (page 2, paragraph 2). It is known by one of ordinary skill in the art that Burkholderia bacteria belong within the genus Burkholderia.
With respect to claim 8, ‘211 teaches a method wherein an example of a Burkholderia bacteria is Burkholderia arboris SL1B1 strain (page 2, paragraph 4).
With respect to claim 9, ‘211 teaches among the microorganisms that secrete lipases and microorganisms that assimilate and consume the hydrolysis products of oils and fats, Burkholderia bacteria is preferable (page 2, paragraph 4), wherein said Burkholderia bacteria is Burkholderia arboris SL1B1 strain within culture solution (page 2, paragraph 5). The term ‘culture’ is indefinite as it is unclear the limitations of the claim. As such, Examiner is interpreting the recited ‘culture’ to be Burkholderia arboris SL1B1 strain within culture.
With respect to claims 13 and 16, ‘211 teaches a composition comprising SLB1 and SLB2 strains that are able to hydrolyze fats and oils into glycerol and fatty acids along with assimilate and consume the hydrolysis product of fatty acids (page 1, para 7) for the increased degradation of fats and oils (page 2, para 2). The SL1B1 strain has a high ability to secrete lipase and hydrolyze fats and oils into glycerol and fatty acids (page 1, para 7), while the strain SLB2 is able to assimilate and consume the hydrolysis product of SLB1, fatty acids (page 1, para 7). Examiner is interpreting the teaching of fatty acids by ‘211 to include all fatty acids, including trans fatty acid within oil. As such, it is the Examiner’s position that said strain would inherently decompose and remove trans fatty acid and/or trans fatty acid-containing oil and fat in oil as ‘211 teaches said strain is able to hydrolyze fatty acids within fats and oils (page 1, para 7), of which Examiner is interpreting to include trans-fatty acids. MPEP 2112.I. states ‘“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that “just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel.” MPEP 2112.II states “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) (“[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention.”); Abbott Labs v. Geneva Pharms., Inc., 182 F.3d 1315, 1319, 51 USPQ2d 1307, 1310 (Fed. Cir. 1999) (“If a product that is offered for sale inherently possesses each of the limitations of the claims, then the invention is on sale, whether or not the parties to the transaction recognize that the product possesses the claimed characteristics.”); Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1348-49, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999) (“Because ‘sufficient aeration’ was inherent in the prior art, it is irrelevant that the prior art did not recognize the key aspect of [the] invention.... An inherent structure, composition, or function is not necessarily known.”); SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343-44, 74 USPQ2d 1398, 1406-07 (Fed. Cir. 2005) (holding that a prior art patent to an anhydrous form of a compound “inherently” anticipated the claimed hemihydrate form of the compound because practicing the process in the prior art to manufacture the anhydrous compound “inherently results in at least trace amounts of” the claimed hemihydrate even if the prior art did not discuss or recognize the hemihydrate); In re Omeprazole Patent Litigation, 483 F.3d 1364, 1373, 82 USPQ2d 1643, 1650 (Fed. Cir. 2007) (The court noted that although the inventors may not have recognized that a characteristic of the ingredients in the prior art method resulted in an in situ formation of a separating layer, the in situ formation was nevertheless inherent. “The record shows formation of the in situ separating layer in the prior art even though that process was not recognized at the time. The new realization alone does not render that necessary [sic] prior art patentable.”).” Evidentiary reference of Matsuoka is cited to demonstrate that the strain SL1B1 is Burkholderia arboris (abstract). As such, Examiner is interpreting the composition containing the strain SL1B1 and SLB2 as an oil-decomposing agent comprising a bacterium in the family Burkholderia. Said composition can be applied to the treatment of all wastewater as well as grease traps (page 2, para 15) found within the restaurant industry (page 1, para 2). Examiner is interpreting the wastewater produced by a restaurant will contain trans-fatty acids as the instant application specification states wastewater from restaurants as an example of the wastewater of the invention (Instant Application Specification: para 0068) (i.e. containing trans-fatty acid containing oil). ‘211 further teaches kitchen wastewater in the food service industry usually contains high concentrations of fats and oils of 10 g/ L or more (page 1, para 3). Examiner is interpreting said teaching to be as a ratio of 1% by weight of trans-fatty acid as encompassed by claim 13, as 1% by weight of trans-fatty acid is a relatively small amount of trans fatty-acids. ‘211 further teaches the total degradation of fatty acids by Burkholderia arboris. Absent evidence otherwise, it is the Examiner’s position that said teaching fits within the recited ‘wherein the total of the trans fatty acid and trans fatty acid-containing oil in the subject of treatment is reduced by 80% or greater by the method’ of claim 16 as ‘211 teaches the complete degradation of fatty-acids, of which Examiner is interpreting to include trans-fatty acids as 80% of 1% oil and fat is 0.008% which is a relatively small amount.
For the reasons stated herein, the teachings of ‘211 anticipate claims 3-4, 6-9, 13, 16.
RESPONSE TO REMARKS: Applicant’s remarks and Affidavit dated 2/16/2026 have been fully considered; however, they are not persuasive in view of the rejection set forth. In summary, beginning on page 4 of Applicant’s Remarks, Applicant contends the Examiner fails to show a basis for how SL 1B1 has an ability to decompose trans fatty acid-containing oil and fat or trans fatty acid. The Examiner merely alleges that the term "fatty acids" in '211 encompasses all fatty acids, including trans fatty acids, and that the Burkholderia arboris SL1B1 disclosed in '211 would inherently decompose trans fatty acids and trans fatty-acid-containing oils and fats. However, '211 is completely silent as to trans fatty acid-containing oil and fat or trans fatty acid, let alone that the oil used in the examples subjected to decomposition by SL1B1 contains any trans fatty acid-containing oil and fat or trans fatty acid.
These arguments are found to be not persuasive. Examiner contends that even by Applicant’s own admission in the response to remarks dated 10/1/2025, genetically unmodified Burkholderia arboris has the inherent property of being able to decompose and remove fatty-acid containing oil of which Examiner is interpreting as including both trans and non-trans fatty acids. Especially since ‘211 teaches the decomposition and removal of fatty acids from grease traps (page 1, para 1). The MPEP 2112.I. states “Something which is old does not become patentable upon the discovery of a new property. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.” As such, it is the Examiner’s position that the discovery of Burkholderia arboris ability to decompose or remove trans-fatty acid oil from compositions is an inherent property of Burkholderia arboris especially since ‘211 teaches its ability to decompose of remove fatty acids from compositions which encompasses trans-fatty acids. Although said characteristic was not recognized at the relevant time, MPEP 2112.II. states “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference.” Additionally, claim 13 of the instant application is sufficiently broad that it includes Applicant’s recited KH-1 strain. As such, said limitations are within claim 13 are taught by Applicant’s own Declaration dated 2/16/2026.
Applicant contends that although '211 describes a test result showing that canola oil (general oil) is decomposed by microorganisms described therein, this does not teach ability to decompose trans fatty acid or trans fatty acid-containing oil and fat. Applicant submits the enclosed Declaration under 37 CFR 1.132 by Katsutoshi Hori, the inventor of both '211 and the Present Application, showing, namely, that '211 does not teach that the disclosed microorganism can decompose or remove trans fatty acid and/or trans fatty acid-containing oil and fat, and Burkholderiaceae microorganism having such ability is first disclosed in the Present Application. '211 merely teaches that SL1B1 has ability to decompose general oil and fat, and the results in '211 do not teach that SL1B1 can also decompose trans fatty acid or trans fatty acid-containing oil and fat (which, if present at all, would only be too minor in amounts to evaluate its decomposition). Applicant contends that the Declaration demonstrates that the Burkholderia arboris SL1B1 strain disclosed in '211 does not, in fact, have the ability to decompose trans fatty acids or trans fatty acid-containing oils and fats. Therefore, even if the canola oil used in the examples of '211 contains trans fatty acids or trans fatty acid-containing fats and oils, the description in '211 that the oil has been completely removed does not disclose nor suggest bacteria that decompose trans fatty acids or trans fatty acid-containing fats and oils. Therefore, contrary to the Examiner's inherency assertion, decomposition of "fatty acids" in '211 does not inherently include decomposition of trans fatty acids.
These arguments are found to be not persuasive. Examiner appreciates Applicants Declaration dated 2/16/2026. However, Examiner contends that Applicant’s declaration specifies the degradation of an artificial trans fatty acid, elaidic acid (Declaration, page 2, para 1). Whereas, ‘211 teaches the degradation of oils found in grease traps (page 1, para 4) which are well-known in the art to be natural oils and fats (often referred to as FOG—Fats, Oils, and Grease) that are derived from cooking, baking, and food preparation. Said natural oils and fats contain natural trans-fatty acids, of which Applicant’s declaration does not disclose. As such, Examiner contends that Applicant has not shown the strain taught by ‘211 cannot degrade trans fatty acids, of which Applicant is claiming with the recitation ‘trans fatty acid and/or trans fatty acid-containing oil and fat in oil’ (instant application claim 13).
Applicant contends that '211 is completely silent as to any subject of treatment containing trans fatty acid-containing oil and fat or trans fatty acid, let alone that the total of the trans fatty acid and trans fatty acid-containing oil and fat is at a ratio of 1% by weight or greater in the oil. Applicant contends that although the present Application describes, as an example, that a subject of treatment can be wastewater from restaurants, it does not state that such wastewater necessarily contains trans fatty acid-containing oil and fat or trans fatty acid. Thus, there is no basis to equate any disclosure in '211 with the claim requirement that "total of the trans fatty acid and trans fatty acid-containing oil and fat is at ratio of 1 % by weight or greater in the oil'.
These arguments are found to be not persuasive. Examiner contends that said ‘211 teaches Burkholderiacea can be applied to the treatment of all wastewater as well as grease traps (page 2, para 15) found within the restaurant industry (page 1, para 2). Absent evidence otherwise, Examiner maintains that said grease traps contain trans-fatty acid containing oil. Especially since based on Applicant’s own disclosure that wastewater from restaurants are an example of the wastewater of the invention (Instant Application Specification: para 0068), of which contains trans-fatty acid containing oil. Examiner contends that ‘211 teaches kitchen wastewater in the food service industry usually contains high concentrations of fats and oils of 10 g/ L or more (page 1, para 3). Examiner is interpreting said teaching to be as a ratio of 1% by weight of trans-fatty acid as encompassed by claim 13, as 1% by weight of trans-fatty acid is a relatively small amount of trans fatty-acids.
Conclusion
Status of claims
Claims 3-4, 6-9, 13, 16 are pending.
Claims 1-2, 5, 10-12, 14-15 are cancelled.
Claims 3-4, 6-9, 13, 16 are rejected.
No claims are in condition for allowance
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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Ex Erica Jones-Foster
AU 1656
/MANJUNATH N RAO/ Supervisory Patent Examiner, Art Unit 1656 (n.r.)