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 .
DETAILED OFFICE ACTION
This Office Action is in response to the papers filed on 20 February 2026.
CLAIMS UNDER EXAMINATION
Claims 1-2, 13-19, 21-27 and new claims 28-31 are pending.
The Applicant argues the product claims are in condition for allowance, and has requested rejoinder of method claims 13-19 and new method claims 29 and 31.
In response: the Applicant elected the claims drawn to a product in the Election received on 24 April 2023. While an SOD with greater than 96% sequence identity to SEQ ID:40 is free of the prior art (claims 23-27), none of the product claims recited in Independent claims 1, 28 and 30 are in condition for allowance. Claims 13-19, 29 and 31, directed to methods, require all the limitations of an allowable product claim, and have NOT been rejoined.
CLAIMS UNDER EXAMINATION
Claims 1-2, 21-28 and 30, drawn to a product, have been examined on their merits. Claims 13-19, 29 and 31, drawn to a non-elected method, have been withdrawn.
PRIORITY
Foreign document DKPA201900423, filed on 05 April 2019, is acknowledged.
REJECTIONS
Claim 1 has been amended to recite an isolated polypeptide. Claims 28 and 30 are new. New grounds of rejection have been necessitated by claim amendment.
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 1-2 and 22-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more as evidenced by
De Lima et al. (N-Acetylation of Aromatic Amines by the Soil Fungus Aspergillus japonicus (UFMS 48.136. Letters in Organic Chemistry. February 2017), Soil Science Society of America (Soils Overview, pages 1-4, 2012) and Grunow et al. (Purification of pro- and eukaryotic superoxide dismutases by charge-controlled hydrophobic chromatography. Journal of Chromatography, 590 (1992) 247-253).
Question 1: Are the claims directed to a process, machine manufacture or composition of matter? Yes, claim 1 is directed to a composition of matter.
Question 2A: Are the claims directed to a product of nature, a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions)?
Prong 1. Yes, claim 1 is directed to a nature-based product limitation. The limitation in the claim that sets forth a nature based product is: An isolated polypeptide of fungal origin having superoxide dismutase (SOD) activity and an amino acid sequence with at least 95% sequence identity to SEQ ID NO: 44 and a carrier. The closest naturally occurring counterparts are 1) an SOD produced by A. japonicus and 2) naturally occurring vitamins, minerals, amino acids and organic acids.
As evidenced by the specification, “SODs naturally occur in many organisms such as plants, insects, birds, reptiles and mammals” (PG Pub [0007]). SEQ ID NO: 44 is the amino acid sequence of a mature polypeptide having superoxide dismutase (SOD) activity from Aspergillus japonicus (PG Pub [0275] [1115]). The specification discloses the SOD is obtained from a naturally occurring fungus ([0499]). The specification does not disclose the claimed SOD and organism are genetically modified or markedly different from those that occur in nature. The claim recites the polypeptide is “isolated”. The specification defines isolated as “a substance in a form or environment that does not occur in nature”. The claimed polypeptide is naturally occurring. Separating it from its natural environment does not result in something markedly different than the naturally occurring polypeptide. As evidenced by the specification at (PG Pub 1768] [1771] [1737]), the carriers recited in claim 1 encompass naturally occurring components. Therefore each of the components is naturally occurring (judicial exceptions).
As evidenced by Lima et al, Aspergillus Japonicus is a filamentous fungus found in soil (second paragraph of Abstract; page 2, left column, first paragraph). As evidenced by Soil Science Society of America, soil is a mixture comprising minerals organic matter and organisms (first paragraph, page 1). Therefore A. japonicus, its SOD and minerals are found together in soil (a powder).
The nature based product lacks markedly different characteristics (and thus is a product of nature exception) because: When the claimed polypeptide and carriers are compared to their counterparts they do not have markedly different characteristics.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application? No. The claims are directed to a product (i.e. a composition) and not a method of administration to a subject.
Question 2B: Do the claims recite any additional elements that amount to significantly more than the judicial exception?
Are there any additional elements recited in the claim beyond the exception identified above? Yes.
Do the additional elements, taken individually and as a combination result in significantly more? No.
Regarding claim 1: the recitation of an animal feed is directed to the intended function of the claimed product. The intended use does not result in something significantly more than the judicial exceptions.
Claim 1 recites the composition is formulated as a powder or granule. The specification discloses a granule is composed of a core, and optionally one or more coatings (outer layers) surrounding the core ([1709]). The specification does not explicitly define “powder”. A powder is interpreted to be particulate matter (Merriam Webster). As evidenced by Grunow, pro- and eukaryotic SODs are extracted as crystals (see page 248, right column, second paragraph; hence, particulate matter; a powder). Formulation as a powder does not amount to something significantly more than the recited judicial exceptions.
Regarding claims 2 and 22: As evidenced by the Instant Specification, catalase is a naturally occurring enzyme ([0237]). Therefore it is also a judicial exception.
Regarding claims 23-27: As evidenced by the Specification, SEQ ID NO: 44 is the mature polypeptide from Aspergillus japonicus. Therefore the claims encompass naturally occurring SOD (a judicial exception).
Therefore, claims 1-2 and 22-27 are not eligible subject matter under 35 USC 101.
APPLICANT’S ARGUMENTS
The arguments made in the response filed on 20 February 2026 are acknowledged.
Argument 1: The Applicant argues the Office failed to compare the composition in claim 1 to its closest naturally occurring counterpart. The Applicant argues the claimed additive is an intentional, purified blend designed for stability and efficacy as an animal feed additive. The Applicant argues the claimed polypeptide is formulated as a powder or granule, and is not present in natural soil.
Response to Argument 1: The claim is a nature-based product, i.e., a combination of three naturally occurring substances. The nature-based product (the combination) is analyzed to determine whether it has markedly different characteristics from any naturally occurring counterpart(s) in their natural state. In the case where there is no naturally occurring counterpart to the claimed combination (the components do not occur together in nature), the closest counterpart may be the individual nature-based components of the combination. The analysis above compares each component individually. The analysis also compares the combination of components recited in claim 1.
As evidenced by the specification, SEQ ID NO: 44 is a naturally occurring SOD from A. japonicus. While the specification defines the term as “a substance in a form or environment that does not occur in nature”, it is naturally occurring SEQ ID 44 is the mature polypeptide from A. japonicus (supra). Isolation of an enzyme does not make the enzyme markedly different than A. japonicus. Claim 1 recites one or more vitamins, minerals, amino acids and organic acids. These all reach on naturally occurring components. A powder is composed of dried particles. The specification does not indicate dried components interact to produce something markedly different. Formulation as a dry powder does no add significantly more the recited judicial exceptions.
The rejection also notes soil reads on a powder. As evidenced by Lima et al., Aspergillus Japonicus is a filamentous fungus found in soil (second paragraph of Abstract; page 2, left column, first paragraph). As evidenced by Soil Science Society of America, soil is a mixture comprising minerals organic matter and organisms (first paragraph, page 1). Therefore A. japonicus, its SOD and minerals are found together in soil. Therefore the argument is not persuasive.
Argument 2: The arguments state the claimed animal feed has markedly different characteristics which give rise to markedly different functional characteristics useful for various performance parameters. The Applicant argues the claimed product is integrated into a practical application because it is useful as an animal feed additive for improving performance parameters, such as European Production Efficiency Factor, Feed Conversion Ratio, Growth Ratio, Body Weight Gain, Mortality Rate and Flock Uniformity.
Response to Argument 2: The claims are not directed to using the claimed product to improve the performance parameters cited by the Applicant. These are not claim limitations. The argument is not persuasive.
Argument 3: The Applicant argues the Office has not provided evidence catalase is found in soil.
Response to Argument 3: Catalase (recited in claim 2) is compared to its closest naturally occurring counterpart: catalase enzyme. The Specification does not indicate the “catalase” recited in claim 2 is markedly different from naturally occurring catalase. The argument is not persuasive.
Argument 4: Regarding claim 22: The Applicant argues the Office has not provided evidence of a soil containing an isolated polypeptide as claimed.
Response to Argument 4: While claim 1 recites an isolated polypeptide, the claimed product does not exclude any additional components. The rejection above compares the claimed SOD to naturally occurring SOD. Isolation does not result in a markedly different enzyme. While the claim recites formulation as a powder, the specification does not indicate a mixture of dried particles interact to produce something markedly different than a naturally occurring enzyme and a naturally occurring carrier. Therefore the argument is not persuasive.
Argument 5: The Applicant argues the claimed animal feed additive is man-made. The Applicant argues the product is a “purified blend” having markedly different physical characteristics which are distinct from soil.
Response to Argument 6: The claims are not directed to a purified blend. The claims recite an isolated polypeptide having SOD activity with the claimed sequence identity. This reads on a naturally occurring SOD. The claim comprises a naturally occurring carrier. The claim does not exclude any components. The specification does not indicate the combination of dried components (a powder) interact to produce something markedly different than the recited judicial exceptions.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 21-22 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Destaing (previously cited; Veterinary Composition Comprising Superoxide Dismutase and at Least One Hydrolysate of Proteins Rich in Bioassimilable Peptides. US 2021/0008174 A1 With benefit of PCT/ FR2019/050650 Mar. 21, 2019) in view of Uniprot (Accession Number A0A318ZDI4; submitted by Vesth et al. The genomes of Aspergillus section Nigri reveals drivers in fungal speciation. Submitted to GMBL/GenBank December 2016) and Hatzinikolaou et al. (An efficient and optimized purification procedure for the superoxide dismutase from Aspergillus niger. Partial characterization of the purified enzyme. Bioseparation 7: 39–46, 1997).
Claim 1 has been amended to recite an “isolated” polypeptide having SOD activity with the claimed sequence identity. The specification discloses the term “isolated” means a substance in a form or environment that does not occur in nature. Non-limiting examples of isolated substances include (1) any non-naturally occurring substance, (2) any substance that is at least partially removed from one or more or all of the naturally occurring constituents with which it is associated in nature ([0501]). As evidenced by the specification,. SEQ ID 44 is A. japonicus. Given its broadest reasonable interpretation, the claim is interpreted to mean an SOD isolated from the organism.
Destaing teaches a veterinary composition comprising superoxide dismutase and at least one protein hydrolysate rich in bioassimilable peptides (Abstract). It is noted that while the art teaches the SOD is preferably of plant origin ([0020]) this is not required. Destaing teaches a feed for animals comprising the veterinary composition ([0022]). The protein hydrolysate comprises the following amino acids: aspartic acid, threonine, serine, glutamic acid, proline, glycine, alanine, cystine, methionine, isoleucine, leucine, tyrosine, phenylalanine, lysine, histidine, arginine and tryptophan ([0106]). Destaing teaches formulation as mixtures of solid and divided particles (hence, granules) ([0058]). Destaing teaches the composition can be a powder ([0060]).
Destaing also teaches the following: due to the creation of abnormal biological molecules and the overexpression of certain genes, oxidative stress is the basic initial cause of numerous pathologies such as cancers, pulmonary oedema, acute pulmonary distress syndrome, amyotrophic lateral sclerosis, pro-inflammatory and cardiovascular diseases, neurological disorders, fibroses, diabetes, cellular aging, Alzheimer's disease, rheumatisms and also accelerated aging. Oxidative stress is also one of the factors which potentiate the genesis of plurifactorial diseases such as diabetes, Alzheimer's disease, rheumatisms and cardiovascular diseases. Similarly in numerous infection situations, the reduction in antioxidant capacities - thus facilitating oxidative stress—reduces immune defenses. See [0077]-[0079].
It is noted Destaing teaches SOD expressed in eukaryotic cells can be recovered from a supernatant and purified by chromatography ([0097]). Therefore the art suggests the cells can be isolated from a cell.
Destaing does not teach an SOD from fungal origin with the claimed sequence. The art does explicitly teach isolating an SOD with sufficient specificity.
Uniprot discloses a superoxide dismutase with the accession number A0A318ZDI4 (from Aspergillus saccharolyticus JOP 1030-1). A0A318ZDI4 has 95.8% similarity to SEQ ID NO: 44:
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Hatzinikolaou et al. teach an efficient and simple method yielding high specific activity preparations of superoxide dismutase from an Aspergillus (page 39, right column, second paragraph). Microorganisms are cultured, mycelia are collected and disrupted. The resulting supernatant is used as the enzyme source (page 40, left column “Liberation of cell-bound superoxide dismutase”). The SOD is extracted by ethanol chloroform extraction (page 40, left column, “Ethanol/chloroform extraction”). It is noted SOD has been purified from a variety of sources, spanning the whole spectrum of the animal and plant kingdom (page 39, left column, last paragraph).
It would have been obvious to try using the SOD disclosed by Uniprot in the composition taught by Destaing. One would have been motivated to do so since Destaing uses an SOD to enhance antioxidation and prevent oxidative stress and Uniprot discloses a fungal SOD that has the same function. KSR B teaches it is rational to substitute one known, equivalent element for another to obtain predictable results. One would have had a reasonable expectation of success since the SOD taught by Uniprot has the same function taught by Destaing. One would isolate the SOD from the cells of the microorganism since Hatzinikolaou et al. teach SOD can be easily and efficiently extracted from Aspergillus cells. One would have expected similar results since both references are directed to SODs. Therefore claim 1 is rendered obvious as claimed.
Destaing teaches formulation as mixtures of solid and divided particles (hence, granules) ([0058]). Therefore claim 21 is included in this rejection.
Destaing teaches the composition can be a powder ([0060]). Therefore claim 22 is included in this rejection.
Regarding claim 28: the art teaches formulation as a granule (supra). Therefore a granule comprising isolated SOD with the claimed sequence identity would have been obvious for the reasons set forth above. Claim 28 is included in this rejection.
Therefore Applicant’s Invention is rendered obvious as claimed.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Destaing in view of Uniprot and Hatzinikolaou as applied to claim 1 above, and further in view of Daoyou et al. (previously cited; Composite micro-ecological preparation for promoting animal digestion and absorption. CN104642749A 2015).
Claim 1 is rejected on the grounds set forth above. The teachings of cited references are reiterated.
Destaing teaches an animal feed comprising superoxide dismutase. The art does not teach catalase in an enzyme feed.
Daoyou teaches a composite micro-ecological preparation for promoting animal digestion and absorption. The composite micro-ecological preparation comprises catalase and superoxide dismutase. The micro-ecological preparation is capable of helping animal digestion and absorption, improving the utilization rate of a feed and improving the animal intestinal environment. See Abstract. The art teaches the composition is used in animal feed (see Embodiment 1).
It would have been obvious to combine superoxide dismutase and catalase in the animal feed taught by Destaing. One would have been motivated to do so since Daoyou teaches using both enzymes promote animal digestion. Applicants are referred to In re Kerkoven in which it was shown to be prima facia obvious to combine two compositions, each of which is taught by the prior art to be used for that very same purpose. One would have had a reasonable expectation of success since Daoyou teaches both enzymes can be used together in an animal feed. One would have expected similar results since Daoyou and Destaing are both directed to animal feeds comprising an SOD. Therefore claim 2 is rendered obvious as claimed.
Therefore Applicant’s Invention is rendered obvious as claimed.
RESPONSE TO APPLICANT’S ARGUMENTS
The arguments filed on 20 February 2026.
Argument 1: The Applicant argues Vesth is not enabling because it merely provides an amino acid sequence and does not describe any process for isolation. The Applicant argues Vesth does not provide any guidance on how one might formulate or dose the disclosed polypeptide.
Response to Argument 1: Vesth teaches a polypeptide with at least 95% sequence identity to SEQ ID NO:4. Vesth is not relied upon to teach an animal feed additive formulation. None of the claims recite a dose or administration. The arguments are not persuasive.
Argument 2: The Applicant argues there is no reason to combine Destaing and Vesth. The Applicant argues Destaing teaches a plant SODs are preferable and does not teach an SOD of fungal origin. The Applicant argues Vesth does not disclosed peptide can be used in an animal feed additive.
Response to Argument 2: Destaing teaches a veterinary composition comprising superoxide dismutase in bioassimilable peptide. It is noted that while the art teaches the SOD is preferably of plant origin ([0020]) this is not required. The art also teaches the SOD can be grown in prokaryotic cells (supra). It would have been obvious to try using the SOD disclosed by Uniprot in the composition taught by Destaing. One would have been motivated to do so since Destaing uses an SOD to enhance antioxidation and prevent oxidative stress and Uniprot discloses a fungal SOD that has the same function. KSR B teaches it is rational to substitute one known, equivalent element for another to obtain predictable results. One would have had a reasonable expectation of success since the SOD taught by Uniprot has the same function taught by Destaing.
Argument 3: The Applicant argues even if Dayou teaches an SOD and catalase, neither Destaing nor Vesth is concerned with animal digestion.
Response to Argument 3: Destaing teaches an animal feed comprising SOD. Dayou teaches an animal feed comprising an SOD and a catalase. Dayou teaches the composition comprising both enzymes promotes animal digestion and absorption. Vesth is relied upon because it teaches the SOD sequence.
UNEXPECTED RESULTS
Argument 1: Regarding claim 1: the Applicant argues Example 10 (pages 337-339) and 11 (pages 151-154, 329) disclose the isolated polypeptide recited in independent claim 1 exhibits unexpected and remarkable gastric stability.
Response to Argument: The cited examples compare gastric (Example 10) and heat (Example 11) stability of SODs to a commercially available SOD from E.coli and bovine (page 151, line 10). While the table discloses SEQ ID NO: 44 has higher gastric stability, none of the experiments use the compositions recited in claim 1. The experiments use “20 ul SOD with appropriate dilution”. None of the claims recite the amount of SOD in the claimed animal feeds. It is unclear what concentration of SOD produces the effect argued by the Applicant.
Argument 2: the Applicant argues Example 3 (pages 317-320) demonstrates combining an SOD and a catalase produces unexpected and remarkable weight gain in male piglets. The Applicant argues this is not taught by the cited prior art.
Response to Argument: Example 3 discloses the use of SOD SEQ ID NO 1 (see page 317). The specification discloses SEQ ID NO 1 is the amino acid sequence of a mature polypeptide having SOD activity from Trichoderma reesei [0232]. The claims are drawn to an SOD from Aspergillus japonicus. Therefore the unexpected results require the SOD from a different organism than the SOD required by the claims.
Example 3 discloses the use of “catalase B” (SEQ ID 7) and “catalase C” (SEQ ID NO 250) (see page 317, line 7). None of the claims recite these forms of catalase.
The specification discloses the greatest improvement is observed with the combination of 400 U/kg SOD and 100 U/kg “CAT B”. Claim 1 does not require any catalase. None of the claims recite any doses SOD and CAT. It is also noted none of the treatment groups disclosed in Table 9 (page 18) appear to produce synergistic results. The Applicant’s arguments are not commensurate with the scope of the claims.
DOUBLE PATENTING
Claims 1-2, 21-27 and new claims 28 and 30 of this application are patentably indistinct from claims 3, 12 and 21 of Application 18029590.
Regarding instant claim 1: Claim 3 of the ‘590 Application is directed to a granule comprising a polypeptide having superoxide dismutase and catalase. SEQ ID NO:2 recited in claim 21 reads on SEQ ID 44. Claim 12 of the ‘590 comprises the following salts which are minerals: ZnSO4, MgSO4 and CuSO4.
Regarding instant claim 2: Claim 2 of the ‘590 Application recites the granule comprises a polypeptide having catalase activity.
Regarding instant claim 21: Claim 3 of the ‘590 recites a granule.
Regarding instant claims 23-27: SEQ ID NO:2 recited in claim 21 reads on SEQ ID 44.
Regarding instant claims 28 and 30: Claim 3 of the ‘590 Application is directed to a granule comprising a polypeptide having superoxide dismutase and catalase. SEQ ID NO:2 recited in claim 21 reads on SEQ ID 44. Claim 12 of the ‘590 comprises the following salts which are minerals: ZnSO4, MgSO4 and CuSO4.
Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
APPLICANT’S ARGUMENTS
The Applicant argues the rejections are illegitimate because they lack statutory basis and are not supported by the Office’s limited rule-making authority. The Applicant argues Congress has never codified the judicially created doctrine of obviousness-type double patenting.
In response: A no-nstatutory 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). The claims in the co-pending application are directed to a granule comprising a polypeptide with superoxide dismutase activity. The claims encompass the claimed SEQ ID and minerals. The arguments are not persuasive.
CONCLUSION
No Claims Are Allowed
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/NATALIE M MOSS/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/ Supervisory Patent Examiner, Art Unit 1653
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