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 Claims
Acknowledgement is made of the response filed on October 29, 2025. In that response, claims 1-15 were amended. Claims 1-15 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Specification
The disclosure is objected to because of the following informalities: “large pepper” of Example 2 should be “Piper longum”. Note that in English “pepper” could generally refer to black pepper, chili pepper, sweet bell pepper, etc. which do not all comprise active agents such as piperine or capsaicin.
Consistent amendments should be made where necessary to avoid confusion.
Appropriate correction is required.
Claim Objections
Claims 1, 12, and 13 are objected to because of the following informalities: “pepper” should be “Piper longum” based on correct translation of “pimiento larga” in the PCT publication (Example 2).
Claims 6, 14, and 15 are objected to because of the following informalities: “fishes” should be “fish”, for consistency.
Claim 10 is objected to because of the following informalities: “said such”.
Claim 12 is objected to because of the following informalities: “is ranging” should be “ranges from”.
Claim 14 is objected to because of the following informalities: an “a” should precede “method”, a comma or a word is needed between “parasitosis” and “limiting”, “the” before “larvae” should be deleted, and “the fishes” lacks antecedent basis.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112
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 3-5 and 7 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites “fish food…comprising the additive of claim 1 in a fish food at a dose ranging 200-4000 grams(g) of food per ton(t)”. First the underlined “a” appears it should be “the” or “said”. Secondly “grams of food per ton” is confusing because no word comes after “ton (t)”, i.e., a ton of what substance. Generally “per” is followed by something, e.g., “2 hydrogen atoms per molecule of water”. Here “200-4000 grams of food” is present per ton of something, which is not recited. The other component in the claim is the “food additive”. Therefore “200-4000 grams(g) of food per ton(t)” could be per ton of the food additive, meaning only 200-4000 grams of food is added to one ton of the food additive. However an “additive” by definition should be something marginal relative to the main component of a food product. Claims 4 and 5 depend from claim 3 and recite narrower ranges of “g of food per t” and therefore are also rejected on this ground.
Applicant’s remarks regarding this issue (Remarks, 6, second-last para., October 29, 2025) has been reviewed, but they concern the claim language prior to the current amendment.
It appears claim 3 should recite “200-4000 grams(g) of the additive per ton of the fish food”. It is also recommended to remove “in a fish food” which is redundant, so it is recommended that claim 3 recite “fish food…comprising the additive of claim 1 at a dose ranging 200-4000 grams(g) of the additive per ton(t) of the fish food”. Claims 4 and 5 should be amended accordingly. The “ton” is interpreted as metric ton based on the metric system used throughout the disclosure.
Claim 7 recites “said fish food is a fish food powder premix”. “Fish food” and “fish food powder premix” are contradictory, because a “premix” indicates a mixture that is ready to be made into a final product. Yet here they are identical according to the underlined “is”. Also it is ambiguous whether “fish food powder premix” means (i) a premix that can be made into a “fish food powder”, or (ii) the premix is a powder and the final product fish food could be in a non-powder form.
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 6, 14, and 15 are rejected under 35 U.S.C. 112, 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 6 recites a method of “preventing caligidosis”, claim 14 recites a method of “sterilizing parasite adult stages”, and claim 15 recites a method of “eliminating Caligus infestations…including sterilizing Caligus”. While Applicant’s disclosure may be enabling for methods of treating caligidosis or Caligus infestations, it does not enable prevention or inhibition, or elimination of caligidosis or any parasitosis, or sterilizing Caligus via supplying the food additive as recited.
In re Wands, 858 F.2d 731, 736-40, 8 USPQ2d 1400, 1403-07 (Fed. Cir. 1988), set forth eight factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." (MPEP § 2164.01)
a. The breadth of the claim: The rejected claims are drawn to methods of preventing or inhibiting caligidosis in fish, “sterilizing parasite adult stages” of any parasite species, and “eliminating Caligus infestations…including sterilizing Caligus”. The claim terms "preventing", “eliminating” and “sterilizing” imply that the caligidosis or parasitosis (claim 14), and Caligus is completely absent in fish treated according to the methods claimed.
b. Nature of the invention: The nature of the invention is methods of preventing caligidosis, sterilizing parasite adult stages, and eliminating Caligus including sterilizing Caligus, in fish via administration of a fish food additive comprising an extract of Azadirachta indica or the neem tree, an extract of pepper, and a taste masking agent comprising a seaweed extract.
c. The state of the prior art: Mason, Rho, and Wan (see rejection under 35 U.S.C. 103 below for citations) teach each of extract of Azadirachta indica, Piper longum, and Palmaria palmata is taught as treating Caligus infestation in fish aquaculture, effective against parasitic infection and bioprotective to cultured fish, or confer antifungal , antibacterial , and/or antiparasitic properties. However prevention, elimination, or sterilizing as the terms would be generally understood as complete absence caligidosis, parasite adult stages, and Caligus, was not attained or reported in these studies.
d. Level of one of ordinary skill in the art: the level of ordinary skill would be high as trained aquaculturist would practice prevention, elimination, or sterilizing of or for caligidosis or parasitosis.
e. Level of predictability in the art: the level of predictability in caligidosis or parasitosis management would be low because susceptibility would differ widely among fish species, climate, and aquaculture practices, among others.
f. Amount of direction provided by the inventor: Applicant does not disclose guidance or methods of how to specifically prevent or eliminate caligidosis, sterilize parasite adult stages, and eliminate Caligus including sterilize Caligus.
g. Existence of working examples: The disclosure does not include any animal models or in vitro data tending to support any clinical attainment of preventing caligidosis, sterilizing parasite adult stages, and eliminating Caligus including sterilizing Caligus. Example 6 studied “efficacy in Caligus control and elimination”. The percent mortality of Caligus rogercresseyi at 13 days post application was 72.1 and 73.8% (Table 10; see para.0076), not elimination or 100%. Furthermore “[a]t the end of the assay, predominant stages were adult in 4 tanks, including ovigerous females” (para.0075). It therefore appears the additive reduced the population of Caligus rogercresseyi that reach maturity; however it did not sterilize them.
Example 8 studied effects of a supernatant ultimately resulting from mixing the additive, dimethylsulfoxide, and sea water, on ovigerous sac maturity of Caligus rogercresseyi (Specification, para.0099). The disclosure states, “at the end[ ] of the study, 83% females have immature sacs, 17% having a medium sac maturity, and matured ovigerous sacs are observed in females treated at day 4 (Table 12)” (id. (emphasis added)). The bolded text contradicts sterilization of Caligus rogercresseyi. (However it is noted that Table 12 shows “0” under the Mature/Phytogenic column for all “Day” lines including Day 4.)
h. Quantity or experimentation needed to make or use the invention based on the content of the disclosure: considering the state of the art as discussed by the references above, particularly regarding the unpredictability of preventing or inhibiting caligidosis in fish, “sterilizing parasite adult stages”, and “eliminating Caligus infestations…including sterilizing Caligus”, and the lack of guidance provided in the specification, the person of ordinary skill would have to engage in significant amount experimentation and ingenuity to practice the invention commensurate in the scope of the claims.
In conclusion, 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 claims 6, 14, and 15.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-10, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Mason (WO 2014/140623A1) in view of Rho (KR 20160067612 A; the attached machine translation is relied on for citations) and Wan (Wan, A.H., et al., The inclusion of Palmaria palmata macroalgae in Atlantic salmon (Salmo salar) diets: effects on growth, haematology, immunity and liver function, J Appl Phycol 28, 3091–3100 (2016)).
Mason teaches a “supplemented fish feed” comprising extracts of the neem tree or Azadirachta indica, also known as Indian margosa (title; abstract; p.7 third para.-p.12 second para.; claims 1-6, 8-21). The supplemented fish feed comprising the neem extract is useful for controlling, among other things, a Caligus infestation in fish aquaculture (p.5 first two paras.). The dose of agent administered to fish depends on the agent and may be approximately 1-100 mg per kg body weight per day (p.14 third para.), or coated over the fish feed at about 0.1-100 g per kilogram of feed (p.15 second and third paras.). Mason teaches antiparasitic “in-feed” treatment where the agent is mixed with, or coated onto, the fish food (p.1 lines 14-16).
Mason does not teach including a Piper longum extract or a seaweed extract as in claim 1.
Rho teaches “composition for preventing or treating parasitic infection in fish, containing, as an active ingredient, a Piper longum extract and a compound isolated from Piper longum” (abstract; see title; claims 1-3). The “composition can be effective as an agent for preventing and treating parasitic infection in cultured fish”, specifically including by Miamiensis avidus (abstract).
Furthermore Wan teaches that including Palmaria palmata into formulated Atlantic salmon diet improves the fish’s hepatic function and “also had positive effect on body lipid content” (abstract; p.3092 Diet Preparation; Tables 2, 4 and accompanying text). Also a “wide range of bioactivities have been described from macroalgal extracts…, including antifungal…, antibacterial, and/or antiparasitic…properties” (p.3091-92). Although Wan does not refer to Palmaria palmata as a “taste masking agent”, a “chemical composition and its properties are inseparable”. MPEP § 2112.01D. Therefore it would have had taste-masking effect.
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Mason, Rho, and Wan, and devise a supplemental fish feed comprising an extract of Azadirachta indica, Piper longum, and Palmaria palmata for treating parasitosis or infestations of Caligus as recited in the instant claims. The skilled person would have been motivated to do so because all references are drawn to fish feed in aquaculture, and each of extract of Azadirachta indica, Piper longum, and Palmaria palmata is taught as treating Caligus infestation in fish aquaculture, effective against parasitic infection and bioprotective to cultured fish, or confer antifungal , antibacterial , and/or antiparasitic properties. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” MPEP §2144.06 (I) (citations omitted). Also it would have been prima facie obvious for the skilled person to include one or more palatant to a feed additive in order to make it more palatable to the animal.
Regarding claims 3-5, Mason teaches a range of neem active agent concentration of about 1-100 mg per kg body weight per day (p.14 third para.), or coated over the fish feed at about 0.1-100 g per kilogram of feed (p.15 second and third paras.). Mason further teaches adjusting the dosage depending on the pest control effect desired (p.14 second para.). Based on these guidelines the skilled person could have optimized the total dose of their combination. For result-effective variables, in the case where claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP § 2144.05 (citations omitted). Furthermore, optimization within prior art conditions or through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. See MPEP § 2144.05 (II) (citations omitted).
Regarding claims 8-10, a widely known and representative extract of neem tree is the neem oil. Mason teaches adding the pest control agent to either solid or liquid feed (p.3 lines 13-14, p.20 lines 15-18). Therefore the agent could be in either powder or liquid form, to be applied onto fish pellet or flake or mixed with a liquid feed (Mason pp.12-13). Mason further teaches providing a “form which is edible by fish” using pharmaceutically acceptable excipients (p.13 second para.). Official notice is taken that capsules are known dosage forms to the skilled person. Mason teaches bath treatment or topical administration (p.13 last para.).
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Mason (WO 2014/140623A1) in view of Rho (KR 20160067612 A; the attached machine translation is relied on for citations), Wan (Wan, A.H., et al., The inclusion of Palmaria palmata macroalgae in Atlantic salmon (Salmo salar) diets: effects on growth, haematology, immunity and liver function, J Appl Phycol 28, 3091–3100 (2016)), and Baik (KR 100984217 B1; the attached machine translation is relied on for citations).
Regarding claims 12 and 13 Mason, Rho, and Wan do not specifically teach a ratio comprising Azadirachta indica extract, Piper longum extract, and a taste masking agent including a seaweed extract.
Baik teaches composition for repelling wild animals and birds in agricultural and “fish farms”, comprising 50-55 weight% of neem extract, 2-7 weight% of black pepper extract, and 10-15 weight% of seaweed extract (title; abstract; claim 1, p.2 second para., fourth-last para., p.3 fourth-twelfth paras. and last three paras., p.4 third-last para.). In addition to repelling wild animals and birds, “application after encapsulation or packing in bags “also has the effect of suppressing the penetration and reproduction of pests and bacteria” (p.2 fourth-last para.; see also p.3 sixth para., p.4 third-last para.). Both black pepper and Piper longum belong in the Piper genus and have similar taste and active agents including piperine. The ratio of 50-55: 2-7: 10-15 overlaps that in claim 12. For example 49:7:14 is within this range as well as the range in claim 12.
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Mason, Rho, Wan, and Baik and devise a combination of Azadirachta indica extract, Piper longum extract, and seaweed extract in a relative concentration using Baik’s ranges. The skilled person would have been motivated to do so because all are drawn to aquacultural pest management, and Baik teaches appropriate relative concentration for achieving prey animal repulsion as well as pest and bacteria suppression. For result-effective variables, in the case where claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP § 2144.05 (citations omitted). Furthermore, optimization within prior art conditions or through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. See MPEP § 2144.05 (II) (citations omitted).
Response to Arguments
Although new rejections are made above Applicant’s arguments are addressed now to the extent they have not been rendered moot and are relevant to the above rejections.
Applicant's arguments filed October 29, 2025 have been fully considered but they are not persuasive. Applicant relies on the information in Appendix A to argue that a synergistic effect shown in Table 2 establishes non-obviousness. (Remarks, 7-9, October 29, 2025.)
In response it is noted that evidence of non-obviousness must be reasonably commensurate in scope with the claimed invention. MPEP § 2145 (citations omitted). Here the data in Table 2 does establish synergistic increase in reducing the count of hatched Caligus rogercresseyi egg by applying Azadirachta indica extract at 5 mg/L combined with Piper longum extract at 3 mg/L. However it does not establish, and there is no basis to extrapolate the data in Table 2 to any and all other parasites (claims 1-5, 7-14), or to a combination of Azadirachta indica extract and Piper longum extract in any ratio (claims 1-15). The A2-1+P1 in Table 2 comprised a ratio of 5:3, which is outside the range in claim 12 and not covered by claim 13.
CONCLUSION
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614