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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/18/2025 has been entered. Claims 1-5 have been cancelled, claims 6 and 10 have been amended and 11-14 are added in the current application. Claims 6-10 as presented on 12/20/2024 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 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.
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 6-14 are rejected under 35 U.S.C. 103 as being unpatentable over Frehner et al. (US 2009/000308 A1), 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), hereinafter Aristimunha, Virtanen et al (US 5876780), hereinafter Virtanen, Abdu-Rahman (WO 2004024151A1), hereinafter Rahman, Clark et al (US 3211610), hereinafter Clark and Rossi et al.(WO 9613175A with M. translation), hereinafter Rossi.
Claim subject matter interpretation
claim 6 as amended 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.”, is being interpreted as a 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).
Regardless of the specific method by which animal that has contracted coccidiosis, the composition remains unchanged, it is the composition and the method being claimed also remains the same “method of improving the health of an animal” that has contracted coccidiosis.
Applicant has not provided any details as to how the improvement in growth performance of the animal is being monitored, is it by checking the weight gain, or checking if the weight loss per day is reducing or feed consumption is increasing or some other measure is being adopted to check “improvement in growth performance”.
Regarding claims 6-14, 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 of claim 7, Frehner teaches the method of claim 6, wherein the animal is poultry selected from the group consisting of “turkeys, ducks and chickens, geese and pigeons”, (para 11 where turkeys, ducks and chickens are taught; also see para 3).
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 with respect to claim(s) 6-14 as amended on 8/18/2025 have been considered but are not found persuasive because applicant’s amendment amended claims 6 and 10 and added 11-14, which have been addressed above.
Applicant's arguments filed 8/18/2025 regarding Primary art to Frehner have been have been fully considered but they are not persuasive.
Applicant’s main argument against the primary art Frehner and also against the combination of references is that none of the prior art teach that the animals are infected with coccidiosis by “coccidiosis vaccine challenge”. This argument is not persuasive.
claim 6 as amended 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).
Applicant has not provided any details as to how the improvement in growth performance of the animal is being monitored, is it by checking the weight gain, or checking if the weight loss per day is reducing or feed consumption is increasing or some other measure is being adopted to check “improvement in growth performance”
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. 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 mixture of thymol, eugenol and piperine 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 two 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”.
On page 3 para 2 onwards, applicant presents argument that “the applied Frehner reference does not disclose a method for improving growth performance of an animal subjected to coccidiosis vaccine challenge.” This argument is not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case Frehner teaches a method of administering the composition comprising benzoic acid, derivatives or metabolites thereof (para 2) in combination with a mixture of at least two 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 and further teaches its utility for poultry (para 3, 11) and relative proportion of each of the components of the composition in the claimed range (Par 30-32) to correspond to the limitations of claims 6-14. Frehner is silent regarding its use for treatment of coccidiosis, however, prior art to Aristimunha, Rahman, Clark and Rossi as applied above teaches clearly that the claimed used of recited components separately as well as in combination was known for coccidiosis treatment and/or prevention. Thus, based on the combined teaching of prior art, 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 claimed (also taught by Frehner), when administered to animals in the claimed ranges as claimed (also taught in para 2 and 30-32 of Frehner) would be just as effective to improve growth performance of an animal subjected to coccidiosis vaccine challenge.
On page 3, last 2 paragraphs, applicant presents arguments against Rahman that “Rahman merely discloses that benzoic acid may be used as a potentiating agent of clopidol and its analogue in the treatment of coccidiosis. However, it does not disclose or teach that benzoic acid could be used alone or in combination with essential oils in the treatment of coccidiosis.” This argument is not persuasive. In response to applicant's argument that each element can be used alone or in combination, such 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). In the instant case, claims merely recite the coccidiosis challenged animals and the limitation of vaccine challenged, however, this limitation has been addressed in the rejection in the previous office action as well as in this office action.
Further, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).In the instant case the rejection clearly addresses use of benzoic acid, derivatives or metabolites thereof and at least one essential oil compounds as claimed either separately or in combination by prior art to Aristimunha, Rahman, Clark and Rossi (see rejection for full details) for management, treatment and/or improving growth performance of animals, in particular poultry.
Applicant’s argument starting page 2, para 5, “Aristimunha discloses that the feed product Crina® Poultry Plus which contains benzoic acid and essential oil decreased lesion scores of coccidiosis. However, as noted by the Examiner, the Aristimunha study utilized reused litter to facilitate the exposure of broilers to sporulated coccidia oocysts, which cannot ensure all the birds were infected and the infection was so bad as to negatively impact the growth performance of the broilers”, is moot as it has been addressed in view of Virtanen.
Claims 6-14 remain rejected for reasons of record.
Conclusion
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/JYOTI CHAWLA/Primary Examiner, Art Unit 1791