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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3 March 2026 has been entered.
Claim Status
Applicant’s remarks and amendments, filed 5 March 2026 in response to the final rejection mailed 3 November 2025, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 5 March 2026 replaces all prior versions and listings of the claims.
Claims 13-17 and 19-31 are pending. Claims 13, 19, and 22 are amended. Claims 27-31 are newly added. Claims 13-17 and 19-31 are being examined on the merits.
Specification
The disclosure is objected to because on page 26, paragraph 4, line 1, “antiprotoxoal” should instead read --antiprotozoal-- and on page 43 at “Example 7-1,” the word “favility” should instead be spelled --facility--.
Please note that these objections address necessary grammatical corrections and formal matters in the claims and specification; however, is not exhaustive of all possible informalities, as examination is not made for the purpose of securing grammatical perfection (See MPEP 601.01(g)).
Appropriate correction is required.
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 13-17, 19, 20, and 22-31 are rejected under 35 U.S.C. 103 as being unpatentable over Sunarso et al. (Drug Invent Today, 2019, 558-564) in view of Ricketts & Pfefferkorn (Antimicrob Agents Chemother, 1993, 2358-2363).
The instant claims are drawn to a method for treating coccidiosis, specifically infection with Eimeria sp., comprising administering a composition comprising mangosteen to poultry.
Sunarso et al. teach administration of mangosteen peel (pericarp; flesh, see e.g., instant specification, page 26) extract to mice (animal) for the reduction of Toxoplasma gondii (coccidiosis) parasite burden and reduction of kidney damage (reduction of lesion score; treating; Sunarso et al., Abstract, page 558; as required for instant Claims 13-15, 17, 19, 22-24, and 26-31). The mangosteen peel extract was prepared using ethanol (linear or branched chain alcohol having 1 to 4 carbon atoms; Sunarso et al., Methods, page 559; as required for instant Claims 16 and 25). The mangosteen peel extract was fed orally (feed composition; as required for instant Claim 20) to mice at a dose of 200 mg/kg – 400 mg/kg of body weight (Sunarso et al., Treatment of laboratory animals, page 559). While Sunarso et al. do not explicitly mention that the parasites are killed or that cell invasion or propagation are inhibited, a reduction in the number of parasites (Sunarso et al., Abstract, page 558) implies that they are affected at some point in their life cycle, such as outright killing or prevention of cell invasion and further propagation (as required for instant Claim 22).
Sunarso et al. do not teach wherein the coccidiosis is Eimeria sp. and that the animal is poultry.
Ricketts & Pfefferkorn, however, teach that Eimeria, which cause coccidiosis, are significant parasites in intensive poultry operations (Ricketts & Pfefferkorn, page 2358; as required for instant Claims 13, 22, and 31).
Sunarso et al. are relied upon for the reasons discussed above. If not expressly taught by the art, based upon the overall beneficial teaching provided by this reference with respect to appropriate dosage of mangosteen peel extract in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable concentrations (as required for instant Claim 20) with which to perform such a method), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the teachings of Sunarso et al. and Ricketts & Pfefferkorn in order to arrive at the instantly claimed invention. A skilled artisan would know that anticoccidial drugs such as salinomycin, (e.g., instant specification, Tables 8-10), monensin, and decoquinate are effective against both Eimeria sp. and T. gondii (Ricketts & Pfefferkorn, Figure 3, page 2362). Additionally, a skilled artisan would know that coccidiosis is highly contagious and spreads extensively in intensive poultry operations (Ricketts & Pfefferkorn, page 2361). A skilled artisan would therefore not only be motivated to try a treatment that was previously shown to be successful against T. gondii in rats as taught by Sunarso et al. in poultry, but would also have a reasonable expectation of success because it is known in the art that many drugs which are effective against T. gondii are also effective against Eimeria sp.
Claims 13-17 and 19-31 are rejected under 35 U.S.C. 103 as being unpatentable over Sunarso et al. (Drug Invent Today, 2019, 558-564) in view of Ricketts & Pfefferkorn (Antimicrob Agents Chemother, 1993, 2358-2363) as applied to Claims 13-17, 19, 20, and 22-31 above, and further in view of Vermeulen et al. (Adv Drug Deliv Rev, 2002, 795-803).
The instant claims and teachings of Sunarso et al. and Ricketts & Pfefferkorn are as of record.
Sunarso et al. and Ricketts & Pfefferkorn do not explicitly mention a feed additive, however, Vermeulen et al. teach that therapeutically and prophylactically active substances, including coccidiostatics, can be incorporated into bird feed (Vermeulen et al., Feed medication, page 800; as required for instant Claim 21).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the teachings of Sunarso et al., Vermeulen et al., and Ricketts & Pfefferkorn in order to arrive at the instantly claimed invention. A skilled artisan could reasonably expect to provide the treatment of Sunarso et al. as a feed additive because administration of drugs through feed, including coccidiostatics, is considered reliable, safe, and ensures maximum performance of feed producing animals (e.g., broilers; Vermeulen et al., Feed medication, page 800). A skilled artisan could therefore apply the method of Sunarso et al. to an animal as the feed additive to Vermeulen at al. in order to treat various coccidian parasite infections, including Eimeria sp., with a reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 5 March 2026 have been fully considered but they are not persuasive.
Applicant argues that a skilled artisan would have no reasonable expectation of success in treating coccidiosis induced by Eimeria sp. using a composition known to be effective against T. gondii because the Keyloun and Choi references indicate that for a specific mechanism of action targeting CDPKs in coccidian parasites, compounds which were effective against T. gondii were less effective against E. tenella. This argument is not persuasive, however, because as discussed in the rejection above, it is well known in the art that there are drugs which are effective against both T. gondii and Eimeria sp., which provides both motivation and a reasonable expectation of success for a skilled artisan to try a composition which is effective against T. gondii for treatment of coccidiosis caused by Eimeria sp. Additionally, Keyloun concludes that the highly conserved nature of the ATP binding domain shared by apicomplexan CDPK homologues could be exploited for the development of broad spectrum inhibitors, indicating that there is potential for development of a drug that would be effective against both T. gondii and Eimeria sp. (Keyloun et al., Parasitol, 2014, Conclusion, page 1508).
Conclusion
No claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 11:00am to 5:00pm EST.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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