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 .
Response to Amendment
Applicant's amendment and argument filed 02/17/2026, in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-3 and 5-17 are pending of which claims 12-15 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/18/2025.
Claims 1-3, 5-11 and 16-17 are being examined on the merits.
Claim Rejections - 35 USC § 112
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.
This rejection is maintained with added claim 10 due to the arguments and amendments filed on 01/17/2026.
Claims 10-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Claims 10 recites a composition comprising Southern Ocean mackerel oil and a preservative for treating arthritis, irritated skin, swollen gums, allergy, asthma, autoimmune diseases, coeliac disease, glomerulonephritis, hepatitis, inflammatory bowel disease, reperfusion injury, transplant rejection, gout, myositis, scleroderma, systemic lupus erythematosus, vasculitis, psoriasis. Claim 11 is rejected because the claim recites “the composition can treat a member selected from the group consisting of: cancer, heart disease, diabetes, renal disorders, and cognitive disorders” without any support or written description for any of these diseases. The applicant merely describes that the composition can treat these diseases but it would not be expected that any amount of a pet food composition having only a Southern Ocean Mackerel oil and preservative would be able to treat any of these claimed diseases.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The Applicant's attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Nature of the invention: Claims 10 recites a composition comprising southern ocean mackerel oil and a preservative for treating arthritis, irritated skin, swollen gums, allergy, asthma, autoimmune diseases, coeliac disease, glomerulonephritis, hepatitis, inflammatory bowel disease, reperfusion injury, transplant rejection, gout, myositis, scleroderma, systemic lupus erythematosus, vasculitis, psoriasis, and claim 11 recites a composition comprising southern ocean mackerel oil and a preservative for treating cancer heart disease, diabetes, renal disorders, and cognitive disorders. First of all the claims are directed to a composition and not to a method of treatment. There is no required administration route nor dose required for the treatment to be effective for any of the claimed diseases and there are no patient populations which are in need of any pet food composition for treating those diseases.
The state of the prior art: The state of the art for treating any of these diseases would at least require administration of a specific amount of a drug, compound, herb, extract etc. for treatment of one of these diseases. On the other hand the state of the instant art of a pet food composition is limited in such that pet foods are able to treat diseases such as cancer, heart disease, renal disorders and cognitive disorders. The applicant does not define what treatment would include or not include within the limited term and so treatment is given its broadest reasonable interpretation. Treatment in this context would mean medical care given to a patient for an illness or injury. In this case the patient is a companion animal however the pet food composition claimed is generally regarded as food for consumption and not as medical treatment unless prescribed by a veterinarian.
The relative skill of those in the art: The relative skill of those in the art is high.
The predictability or unpredictability of the art: The art is unpredictable as there are not many recorded pet food compositions known to treat cancer or any of the other disease claimed. It cannot be predicted what amount of the components within the pet food composition would need to be at to be an effective means of treatment.
The amount of direction or guidance presented and the presence or absence of working examples: The applicant does not show any evidence or data to support this claim. There is no testing of the pet food composition to show any effective treatment or relief of symptoms. The pet food was not even fed to any animal let alone any animal with the claimed diseases.
The quantity of experimentation necessary: There would be an excessive amount of testing to determine if at all the pet food composition could indeed be used as a means of treating cancer, heart disease, diabetes, renal disorders, and cognitive disorders. First of all one would need to create multiple groups of companion animals each having or being representative of each disease state and then creating control groups. Next it would need to be determined if indeed Southern Ocean mackerel oil and a preservative could at any range be beneficial for a specific symptom. Then it would have to be determined what amount or range the beneficial property is effective at and then administered to the companion animal. Determining how long the administration would last would also need to be determined and the route of most effective administration and formulation, assuming the pet food composition can be taken other routes besides being ingested as food would imply. Other factors to consider are pharmacokinetics of the food composition such as absorption, distribution, metabolism, and excretion of the active components of the pet food. The dosage would be expected to be different for each disease.
Therefore, in view of the Wands factors, as discussed above, Applicants fail to provide information sufficient to practice the claimed invention for treating cancer, heart disease, diabetes, renal disorders, and cognitive disorders.
Response to Arguments
Applicant's arguments filed 02/17/2026 have been fully considered but they are not persuasive. The applicant argues that inflammation significantly affects cancer by promoting its development, spread and resistance to treatment. Inflammation plays a critical role in development of heart disease and progression of heart attacks, while driving atherosclerosis and leads to clots and blockages, while directly affecting heart structures. Diabetes is significantly affected by inflammation with chronic low-grade inflammation driving insulin resistance and autoimmune destruction of insulin producing cells. Lastly the applicant argues that inflammation affects cognitive disorders acting as a key driver in Alzheimer’s, Parkinson’s, depression and age-related cognitive decline. While inflammation may have roles in many diseases these mere conclusory statements do not show any evidence as to pet food being able to treat any of the claimed diseases. The applicant argues that the standard for determining whether the specification meets the enablement requirement is whether the experimentation needed to practice the invention is undue or unreasonable. In this case there is much undue experimentation necessary as described in the above rejection. Merely claiming “wherein the pet food comprises an amount of the southern mackerel oil effective to treat” one of the claimed diseases does not change the basis of the previous and current rejections. One would need to undertake much undue experimentation to figure out if pet food comprised of southern mackerel can treat any of the diseases. Just because mackerel is known for having beneficial fatty acids does not mean it is equivalent as a treatment for these different diseases. What are the effective amounts and how does one test to arrive at those amounts for each disease? Mackerel oil is not a known treatment for any of these diseases so pet food comprising it would not be expected as a means of treatment and determining how to incorporate it into a means of successful treatment warrants more than undue experimentation.
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 1-3, 5-11 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Dennis Jewell and Mathew Jackson (WO2022140211A1) hereinafter Jackson and Mirja Kaizer Ahmmed et. al. (Omega-3 phospholipids in Pacific blue mackerel (Scomber australasicus) processing by-products, Food Chemistry 353 (2021) 129451). This is a new rejection based on the amendments filed on 02/17/2026.
Regarding claims 1 and 10, Jackson teaches of a pet food composition which shows that the test food composition decreases various inflammatory cytokine levels (see 0075). Jackson teaches wherein the composition can comprise of omega-3 fatty acids found from mackerel (see 0041) and teaches the composition can also comprise of additives such as preservatives (see 0062).
Jackson teaches the omega-3 fatty acid may comprise linolenic acid, stearidonic acid, eicosatetraenoic acid, eicosapentaenoic acid, docosapentaenoic acid, docosahexaenoic acid, or a combination of two or more thereof (see 0035).
Regarding claim 5, Jackson teaches the composition can contain protein, fat, carbohydrates (see 0049) and protein in an amount from about 20 wt.% to 45 wt.% (see 0051 and 0053).
Regarding claim 6, Jackson teaches the composition can contain carbohydrates in an amount from about 10 to about 70 weight % (see 0056).
Regarding claim 7, Jackson teaches the composition can contain fat in an amount from 10 wt% to 20 wt% (see 0059).
Jackson does not specifically teach that the mackerel oil is from a Southern Ocean mackerel derived from waters south of 20 degrees south latitude and the Southern Ocean mackerel oil comprises at least 3% of eicosatetraenoic acid, at least 1% of stearidonic acid, at least 8% of eicosapentanaeoic acid, at least 15% of docosahexaenoic acid, and at least 2% of docosapentaenoic acid.
Ahmmed’s general disclosure is about omega-3 phospholipids in Pacific blue mackerel (see abstract).
Ahmmed teaches “Blue mackerel is a pelagic and moderately oily fish mostly found to a depth of 200 m in the ocean. Mackerel is considered as a sustainable fish species and is commercially harvested and processed all over the world. This fish is one of the major processed fish species that is used in a wide range of canned, dried and smoked products. As a result, the fish processing industry generates a massive amount of by-product material, including head, skin, roe, viscera, male gonad, and frame bone, corresponding to ~50% of the body weight of the whole fish (Zuta, Simpson, Chan, & Phillips, 2003). The co-product material is utilized in products that have low revenue, such as animal feed and plant fertilizers. Fish processing by-products have an oil content of between 1.4 and 40.1% (Zuta et al., 2003) depending on the organ and species” (see page 2, 3rd para.).
Ahmmed teaches that parts of the Pacific blue mackerel oil contain eicosatetraenoic acid (ETA), stearidonic acid (SDA), eicosapentanaeoic acid (EPA), docosahesaenoic acid (DHA) and docosapentanoic acid (DPA) and shows their distributions in different parts of the fish (see table 3) and teaches it is a high protein source (see table 1).
Ahmmed teaches that “marine polyunsaturated fatty acids (PUFA), especially n3-PUFA, eicosapentaenoic acid (C20:5, EPA), docosapentanoic acid (C22:5, DPA) and docosahexanoic acid (C22:6, DHA) play an important role in human health, including in cardiovascular health, non-alcoholic fatty liver disease, brain development and neuroprotection, and respiratory tract (Yalagala, Sugasini, Dasarathi, Pahan, & Subbaiah, 2019; Zhang, Xu, Wang, & Xue, 2019). These diseases are closely related to oxidative stress. Hippocampal neurons can be damaged due to the accumulation of free radicals generated during lipid metabolism. The n3-PUFA has the ability to prevent oxidative deterioration and neural apoptosis of brain (Zhang, Xu, Wang, & Xue, 2019). de Godoy et al. (2018) investigated the effect of n-3 phospholipid on hydrogen peroxide (H2O2) induced oxidative stress in PC12 cells and the result found decreasing trend of oxidative stress as a result of increasing total antioxidant capacity (T- AOC) and superoxide dismutase (SOD) levels. Phospholipids with n3- PUFA act as natural antioxidants, which inhibit lipid peroxidation (Ahmmed, Ahmmed, Tian, Carne, & Bekhit, 2020). In nature, n-3 fatty acids are found in both triacylglycerol (TAG) and phospholipid form, of which the phospholipid form has attracted considerable attention due to its potential involvement in brain health (Ahmmed, Ahmmed, Tian, Carne, & Bekhit, 2020; Echeverría, Valenzuela, Catalina Hernandez- Rodas, & Valenzuela, 2017).
Therefore it would have been obvious to persons having ordinary skill in the art to use Pacific blue mackerel (Scomber australasicus) in the composition taught by Jackson because it is a sustainable mackerel source with high nutritional value due to high protein contents and many nutrients and healthy fatty acids which can contribute to a healthy diet.
It would have also been obvious to create a pet food composition with mackerel oil and to optimize the omega-3 fatty acids and omega-6 fatty acid content to be at the recited amounts because the mackerel oil already is already high in omega-3 fatty acids and low in omega-6 fatty acids. It is known to those skilled in the art and from what can be appreciated from that of Jackson’s teachings that omega-3 fatty acids can help against pro-inflammatory cytokines whereas omega-6 fatty acids are usually increase these which would only exacerbate inflammatory conditions. Thus increasing the omega-3 fatty acids to at least 30% and the omega-6 to no more than 5% is prima facie obvious. Optimizing the amount of mackerel oil would have also been obvious as mackerel fish oils are known for being high in beneficial omega-3 fatty acids which is described by Ahmmed for having many beneficial properties because of the high EPA and DHA content. Also one could combine each fish part listed in table 1 of Ahmmed’s teaching to arrive at the number of fatty acids in the mackerel oil.
Additionally, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” The references teach the use of each of the ingredients in a food composition. Varying the concentration of ingredients within a pet food composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
Regarding claims 8-9, pertaining to wherein the composition is a main meal or supplement would have been obvious given the prior art especially since the art is directed to pet food compositions intended for having the same anti-inflammatory effects. Regarding claims 10-11, pertaining to wherein the composition is intended to treat a disease, these limitations are merely intended uses for the composition and do not structurally or functionally change the composition in any meaningful way.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Dennis Jewell and Mathew Jackson (WO2022140211A1) hereinafter Jackson and Mirja Kaizer Ahmmed et. al. (Omega-3 phospholipids in Pacific blue mackerel (Scomber australasicus) processing by-products, Food Chemistry 353 (2021) 129451) as applied to claims 1-11 and 16 above, and further in view of Ferreira et. al. (The chemical composition and lipid profile of the chub mackerel (Scomber colias) show a strong seasonal dependence: Contribution to a nutritional evaluation, Biochimie 178 (2020) 181-189). This is a new rejection based on the amendments filed on 02/17/2026.
Jackson and Ahmmed teach the claimed invention however do not teach wherein the Southern Ocean mackerel oil is derived from mackerel farmed from waters south of 40 degrees latitude.
Ferreira teaches that “Chub mackerel (Scomber colias) is known as a privileged source of important fatty acids, particularly DHA [12], and other nutrients, such as vitamin B12 and Se, that are critical to the maintenance of a healthy brain activity [13,14]. As such, the consumption of this pelagic fish contributes to ensure the adequate levels of these compounds and to the preservation of a healthy neuronal tissue and a normal cognitive activity. In fact, chub mackerel is already considered a food of high nutritional value due to high protein contents, but also because its composition includes multiple compounds with major physiological roles. These include, for example, vitamin D that regulates calcium and phosphorus absorption and promotes the normal immune system function, and other nutrients, like potassium, phosphorous and zinc, as well as other n-3 PUFA other than DHA, including EPA, 18:3n-3, 18:4n-3, 22:5n-3 [12]”.
“In view of this, chub mackerel has a huge upgrading potential, not only because it has a high nutritional value, but also because it is currently considered as a sustainable marine resource (see page 182, left column).
Additionally, Ferreira teaches that the omega-3 content is very high when compared to omega-6 content (see table 4 specifically 18:2, 18:3, 20:4, 20:5, 22:6) and that chub mackerel lipid profile may ensure multiple important health benefits (see conclusions, page 187).
Therefore it would have been obvious to persons having ordinary skill in the art to use Chub mackerel (Scomber colias) in the composition taught by Jackson because it is a sustainable mackerel source with high nutritional value due to high protein contents and many nutrients and healthy fatty acids which can contribute to a healthy diet. The applicant recites in instant paragraph 0014 that the other mackerel species to be included in the term “Southern Ocean Mackerel” can be representatives of the Scomber, Grammatorcynus, Acanthocybium and Trachurus genus. Additionally, Scomber colias are typically found in waters from 46 degrees North to 65 degrees South and this would be below 40 degrees South as claimed. The fish coming from farmed waters would have been obvious given the prior art.
Response to Arguments
Applicant's arguments filed 02/17/2026 have been fully considered but they are not persuasive. The applicant argues that the relied upon art does not teach each limitation wherein the mackerel is from water below 40 degrees South latitude or that the oil has at least 3% of eicosatetraenoic acid, at least 1% of stearidonic acid, at least 8% of eicosapentanaeoic acid, at least 15% of docosahexaenoic acid, and at least 2% of docosapentaenoic acid. The art teaches of Scomber colias which is known to be found in waters from 46°N - 65°S. Also the art teaches that mackerel indeed contains each specific fatty acid near similar amounts as claimed and modifying those amounts to meet the instantly claimed amounts would have been prima facie obvious and a skill any artisan poses. Also one could combine each fish part listed in table 1 of Ahmmed’s teaching to arrive at the concentration of fatty acids in the mackerel oil.
Conclusion
Currently 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 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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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655