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 .
Applicant's submission filed on 2/24/26 has been entered. Claim 7 has been cancelled, claims 6 and 13 have been amended in the current response. Claims 6, 8-14 as presented on 2/24/2026 are pending and examined in the current application.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6 and 8-14 are rejected under 35 U.S.C. 103 as being unpatentable over Frehner et al. (US 2009/0004308 A1) of prior record, hereinafter Frehner, in view of NPL to Aristimunha et al . “A blend of benzoic acid and essential oil compounds as an alternative to antibiotic growth promoters in broiler diets” (NPL cited in search report and IDS of 11/30/2021) of prior record, hereinafter Aristimunha, Virtanen et al (US 5876780), hereinafter Virtanen, Abdu-Rahman (WO 2004024151A1) of prior record, hereinafter Rahman, Clark et al (US 3211610), hereinafter Clark and Rossi et al.(WO 9613175A with M. translation) of prior record, hereinafter Rossi.
Regarding claims 6 and 8-14, Frehner teaches a composition comprising benzoic acid, derivatives or metabolites thereof (para 2 discloses “benzoic acid, derivatives or metabolites thereof” in combination with “essential oil compounds”), optionally in combination with a mixture of essential oil compounds thymol, eugenol and piperine (abstract and para 2 of Frehner teaches at least two essential oil compounds selected from thymol, eugenol and piperine) for improving growth performance (such as “weight gain” described in para 2; or “growth promoter” – para 16) of an animal (para 3, especially first sentence). Frehner also teaches that a composition comprising benzoic acid, derivatives or metabolites thereof” in combination with “essential oil compounds” has antimicrobial activity, i.e., Frehner teaches composition as claimed which also is effective for "modulation of the gut flora of the animal and as antimicrobial agent" (Para 22, also see para 21 and 26 of Frehner). Frehner further teaches that antimicrobial activity of the claimed composition that includes bactericidal, bacteriostatic, fungicidal, fungistatic, and/or virucidal (Para 29). Claim 6 differs from Frehner in that claim recites “improving growth performance of an animal subjected to coccidiosis vaccine challenge”.
Regarding the limitation of “administering to the animal an effective amount” Frehner teaches administering benzoic acid, derivatives or metabolites thereof is administered in an amount of from 50 mg/kg to 1000 mg/kg feed, (para 31, which is also the dosage range recited in claim 8).
Regarding the limitation that the method is for increasing weight gain and/or increasing feed intake of a broiler chicken, see para 11 which describes “chickens” including “broiler chicks” and also see para 17 which describes “weight gain”.
Regarding the limitation of claim 8, Frehner teaches the method of claim 6, wherein benzoic acid, derivatives or metabolites thereof is administered in an amount of from 50 mg/kg to 1000 mg/kg feed, (para 31, where claimed range is taught).
Regarding the limitation of claim 9, Frehner teaches the method of claim 6, wherein benzoic acid, derivatives or metabolites thereof is administered in an amount sufficient to provide a daily dosage of 5 mg per kg body weight to about 80 mg per kg body weight, (see para 30 where claimed range is taught).
Regarding the limitation of claim 10, Frehner teaches the method of claim 6, wherein three active compounds thymol, eugenol and piperine are administered in amounts of 0.1 to 20 mg per kg feed (ppm) (para 32 where claimed range is taught).
Regarding the limitation of claim 11, Frehner as applied to claim 8 further teaches, wherein benzoic acid, derivatives or metabolites thereof is administered in an amount of from 100 mg/kg to 500 mg/kg feed (para 31, where claimed range is taught as preferred range).
Regarding the limitation of claim 12, Frehner as applied to claim 8 further teaches method of claim 6, wherein benzoic acid, derivatives or metabolites thereof is administered in an amount of from 200 mg/kg to 250 mg/kg feed (Para 31, where claimed range is taught as narrower preferred range).
Regarding the limitation of claim 13, Frehner teaches method of claim 6, wherein benzoic acid, derivatives or metabolites thereof is administered in an amount sufficient to provide a daily dosage of 10 mg per kg body weight to about 40 mg per kg body weight, of the animal (Para 30, where claimed range is taught as preferred range).
Regarding the limitation of claim 14, Frehner teaches method of claim 6, wherein the mixture of thymol, eugenol and piperine is administered in amounts in the range of 0.3 to 10 mg per kg feed (para 32 where claimed range is taught as preferred range)
Based on the above cited paragraphs Frehner teaches
a method of administering a composition comprising benzoic acid, derivatives or metabolites thereof (para 2 discloses “benzoic acid, derivatives or metabolites thereof” in combination with “essential oil compounds” wherein the essential oil compounds includes “at least two essential oil compounds selected from thymol, eugenol and piperine”), optionally in combination with a mixture of at least one essential oil compounds selected from the group consisting of thymol, eugenol and piperine (para 2) and abstract, para 13-14 and 31 as well as 72 of Frehner
a method of administering an effective amount of the claimed composition, i.e., a composition comprising benzoic acid, derivatives or metabolites thereof is administered in claimed range
an amount of from 50 mg/kg to 1000 mg/kg feed (claim 8), range of 100 to 500 mg/Kg (claim 11), most preferably in the range of 200 to 250 mg kg feed (claim 12) (para 31, which is also the dosage range recited in claim 8, abstract, para 13-14 and 31 as well as 72)
OR
where the effective daily dosage of 5 mg per kg body weight to about 80 mg per kg body weight (claim 9), and effective daily dosage of 10 mg per kg body weight to about 40 mg per kg body weight (claim 13 limitation), (see para 30 where claimed range is taught)
AND
essential oil compounds are administered in amounts of from 0.1 mg to 20 mg per kg feed (ppm) of claim 10, and from 0.3 mg to 10 mg per kg feed (ppm) (claim 14), see (para 32 where claimed range is taught)
wherein the composition as taught by Frehner when administered is effective for poultry and claim 7 limitations (para 11 where turkeys, ducks and chickens are taught; also see para 3) in
promoting growth performance of an animal (such as “weight gain” described in para 2; or “growth promoter” – para 16) by administering the claimed composition in claimed effective dosage;
antimicrobial activity of the claimed composition that includes bactericidal, bacteriostatic, fungicidal, fungistatic, and/or virucidal (Para 29)
Thus, Frehner teaches the claimed composition in claimed proportion to claimed intended animals and recognizes the antimicrobial benefit of the claimed composition.
Regarding the additional limitations of claim 6, Frehner is silent about the specific use of method for improving growth performance of an animal subjected to coccidiosis vaccine challenge , however, claim 6 recites “A method for improving growth performance of an animal subjected to coccidiosis vaccine challenge comprising administering to the animal an effective amount of a composition comprising benzoic acid, derivatives or metabolites thereof, in combination with a mixture of thymol, eugenol and piperine.”, i.e., the method being claimed is the method of “improving growth performance of animal with coccidiosis by administering to said animal an effective amount of a composition comprising benzoic acid, derivatives or metabolites thereof, in combination with a mixture of thymol, eugenol and piperine (emphasis added).
Regarding the limitation of “coccidiosis vaccine challenged” , as recited in claim 6, is being interpreted as animals/birds that are infected with coccidiosis regardless of the method of contracting the disease and the method being claimed also remains the same “method of improving the health of an animal” that has contracted coccidiosis.
Various methods of infecting animals were known, NPL to Aristimunha utilizes reused litter to expose broilers to coccidia study (page 457, column 1, para 1) as compared to vaccinating the animals, and Virtanen utilizes vaccination as method of deliberately inducing coccidiosis was also known as taught by Virtanen (column 7, lines 34-38). Thus, challenged with a vaccine, as instantly claimed and taught by Virtanen OR challenges by Eimeria species in normal housing setting methods as taught by Aristimunha both achieve the objective of leading to animals/ poultry/ broilers being infected with coccidiosis. It would have been a matter of routine determination for one of ordinary skill in the art at the time of effective filing date of the invention to choose a known method for infecting the animals with coccidiosis either by reused litter or vaccine challenge based at least on the resources available to the person of ordinary skill in the art including the housing facility, equipment, financial, man power and time resources to name a few. One of ordinary skill would have been motivated to choose vaccination challenge based at least on its advantage of repeatability and the ability to perform a controlled study with number of animals and various dosages of infective agent being introduced to infect the available animals.
Further, regarding the use of benzoic acid and essential oil compounds for treatment of coccidiosis in prior art:
coccidiosis is well-known as disease of intestinal lining of poultry, caused by protozoan coccidia parasite of Eimeria genus (as taught by Clark Column 1, lines 25-30; Rossi translation page 1, line 24-25 and Rahman, page 1, lines 5-10 and Aristimunha page 457);
feed product Crina® Poultry Plus (Aristimunha, Page 456, Column 2, para 2 of NPL article) which contains benzoic acid and optionally at least one essential oil, i.e., the instantly claimed invention) decreased lesion scores of coccidiosis (Aristimunha Page 457, column 1, para 1 and Experimental design para 3 AND conclusion section on page 462);
inclusion of benzoic acid or derivatives thereof as “potentiating component” enhance the activity of coccidiosis treatment (Rahman, Page 2, lines 1-2, 5-6 and 10-13). Thus, utility of benzoic acid and its derivatives as potentiators in compositions that have prophylactic effect on coccidiosis as well as an anti-coccidiocidal effect was known (See abstract and pages 1-2 of Rahman);
inclusion of benzoic acid ester derivative in feed or feed supplements for treatment and prevention of coccidiosis (Clark, Column 1, lines 10-21, 35-40, and at least column 9-10, Example 1 where effective dosage); and
essential oil compounds thymol, eugenol as active compounds as food or feed additive (Rossi, Page 3, line 95-99 of translation), reduce negative effects of coccidiosis in poultry (Rossi, Page 2, lines 80-81 of translation).
Therefore, as addressed above, composition comprising benzoic acid, derivatives thereof and in combination with essential oil compounds (Aristimunha, and Rahman) were known to have coccidiocidal effect (as taught by Rahman and Aristimunha). In addition, benzoic acid derivatives (Clark) and essential oil compounds including thymol and eugenol (Rossi translation) separately were also known to treat and/ or prevent coccidiosis. Thus, beneficial effect of benzoic acid derivatives and essential oil compounds either separately or in combination to treat and prevent coccidiosis in animals (As taught by Aristimunha, Rahman, Clark , Rossi) was known to one of ordinary skill in the art at the time of the effective filing date of the invention. One of ordinary skill in the art at the time of the effective filing date of the invention would have a reasonable expectation that a composition combining benzoic acid, derivatives or metabolites thereof with a mixture of at least one essential oil compounds (as is taught by Frehner), when administered to animals in the claimed ranges (as taught in para 2 and 30-32 of Frehner) in addition to being antimicrobial (para 29) would also be effective to improve growth performance of an animal subjected to coccidiosis vaccine challenge.
Further, the limitation “for improving growth performance of an animal subjected to coccidiosis vaccine challenge” of claim 6 is a recitation of the intended use of the claimed invention, which must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, the composition as taught by Frehner comprises benzoic acid, derivatives or metabolites thereof (para 2) in combination with a mixture of at least one essential oil compounds selected from the group consisting of thymol, eugenol and piperine (para 2) for improving growth performance (such as “weight gain” described in para 2; or “growth promoter” – para 16) of an animal (para 3) as is instantly claimed. Frehner also teaches all the dosage of essential oil components in claimed dosages, as recited in claims 7-14.Based at least on the above discussion, the prior art composition is substantially the same as the claimed composition, and it is capable of improving growth performance including in animals that have been “subjected to coccidiosis vaccine challenge”..
Response to Arguments
Applicant's arguments presented in applicant's response of 2/24/2026 have been fully considered but they are not persuasive. Applicant agrees with examiner's observation that teachings of Aristimunha and Virtanen results in "animals/poultry/broilers being infected with coccidiosis" but argues that "a challenge with a vaccine would cause a much more serious infection in animal, thereby inducing significantly more stress on the infected animals than a challenge by Eimeria species/reused litter in a normal housing setting". This argument is not persuasive.
First of all, Frehner teaches administering substantially the claimed composition which comprises "benzoic acid, derivatives or metabolites thereof, in combination with a
mixture of thymol, eugenol and piperine", The fact that the inventor has recognized another advantage (such as use in a more intense form of infection of a known form of infection; i.e. vaccine induced coccidiosis, as taught by Virtanen) which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya,227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Further, Virtanen specifically teaches vaccination as a method of deliberately inducing coccidiosis, as explained in the previous office action and claims do not recite a specific intensity of the infection. As such, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e. the infection induced by method taught by Virtanen is less severe) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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 JYOTI CHAWLA whose telephone number is (571)272-8212. The examiner can normally be reached M-F 9:30- 5:30.
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/JYOTI CHAWLA/Primary Examiner, Art Unit 1791
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