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 .
Remarks
The amendments and remarks filed on 06/01/2026 have been entered and considered. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior office action. The rejections and/or objections presented herein are the only rejections and/or objections currently outstanding. Any previously presented objections or rejections that are not presented in this Office Action are withdrawn. Claims 1, 2, 4-12, 15, and 19-20 are pending; Claims 3, 13-14, and 16-18 are cancelled; Claims 1 and 15 are amended; Claims 4-9 and 19-20 are withdrawn; and Claims 1-2, 10-12, and 15 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/21/2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97 and is being considered by the examiner.
Withdrawal of Objections
The objection to Claim 15 in the previous office action is withdrawn due to the amendment to the claim.
Withdrawal of Rejections
The rejection of Claims 1, 2, 10-15 and 17 under 35 U.S.C. 112(a) as failing to comply with the written description requirement is withdrawn due to the amendment to or cancellation of the claims.
The rejection of Claim 1, 2, 10-15 and 17 under 35 U.S.C. 112(b) in the previous office action is withdrawn due to the amendment to or cancellation of the claims.
The rejection of claims 13-14 and 17 under 35 U.S.C. 102(d) is withdrawn due to the cancellation of the claims.
The provisional rejection of Claims 1, 2, 10-15 and 17 on the ground of nonstatutory obviousness-type double patenting over claims of copending Application No. 19/239599 is withdrawn due to the Terminal Disclaimer filed by Applicant on 6/01/2026.
The provisional rejection of Claims 1, 2, 10-15 and 17 on the ground of nonstatutory obviousness-type double patenting over claims of copending Application No. 19/002214 is withdrawn due to the Terminal Disclaimer filed by Applicant on 6/01/2026.
Claim Objections
Claim 1 is objected to because it recites the limitation “a broiler chicken an animal”. The limitation should be corrected to “a broiler chicken”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b), or 112, Second Paragraph
Claims 1, 2, 10-12, and 15 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 pre-AIA the applicant regards as the invention. This rejection is maintained.
Claim 1 is indefinite due to the recitation of “the bacterium being formulated with the composition before extraction or purification of the lipopolysaccharide”. This limitation seems to imply that after the bacterium is formulated with the composition, the resulting formulated composition is subjected to extraction or purification of the lipopolysaccharide. However, the claim previously defines that the lipopolysaccharide composition comprises a biomass extracted from a Gram-negative bacterial strain as an active agent, and such a lipopolysaccharide composition is directly fed to the broiler chicken. It is unclear how the extraction or purification of the lipopolysaccharide can be conducted on the formulated composition, given this formulated composition is directly used for feeding the broiler chicken. Furthermore, given a biomass extract from the bacterial strain is already present in the lipopolysaccharide composition as an active agent, it is unclear why the composition needs to be subjected to further extraction or purification of lipopolysaccharide. For the purpose of examination, the recited phrase is interpreted as “wherein the biomass extracted from the Gram-negative bacterial strain comprises lipopolysaccharides of the bacterial strain”, according to the disclosure of the specification.
Claim 15 is indefinite due to the recitation of “the bacterium being formulated with the composition before extraction or purification of the lipopolysaccharide” for the reason indicated above. For the purpose of examination, the recited phrase is interpreted as “wherein the biomass extracted from the Gram-negative bacterial strain comprises lipopolysaccharides of the bacterial strain”, according to the disclosure of the specification.
The remaining claims are rejected for depending from an indefinite claim.
Claim Rejections - 35 USC § 103
Claims 1, 2, 10-12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Komori et. al. (Anticancer Research, 35: 4461-4466, 2015, of record) in view of Lee et al. (Comparative Immunology, Microbiology & Infectious Diseases, 2008, 31:389–402, of record) and Winn (US 2006/0188550, 2006).
Komori et. al. teach a method for inducing innate immunity activation and priming effect in a broiler chicken, comprising a step of orally administering an effective amount of a lipopolysaccharide composition comprising lipopolysaccharides isolated/extracted from a Gram-negative bacterium Pantoea agglomerans (referred to as LPSp) to the boiler chicken (without use of antibiotics or hormones), wherein the LPS is mixed with a feed (feed ration portion) to form a finished feed for being administered to the broiler chicken at the age of 3-7 weeks, and also at the age from 10 to 34 days; wherein an oral dose of LPSp administered to treatment group of the chickens is 10 μg/kg of body weight (BW) per day; and wherein the oral LPSp administration reduces total mortality and prevents pathogenic infection in the broiler chickens on commercial farms, and it induces the innate immunity activation and priming effect in chickens, as demonstrated by infection prevention as well as increased phagocytic activity and enhanced gene expression (abstract; page 4462: col 1/paras 2-4, col 2/paras 1 and 5). Komori et al. states that the finding is promising and it may be applied in the activation of innate immunity and infection prevention in chickens from commercial farms (page 4465, Col. 2, para. 1/last 4 lines). Komori et. al. further teach LPS acts specifically through TLR4 (Toll-like receptor) signaling pathway, and the priming effect of LPSp demonstrated in their study is considered to be mediated through TLR4 (page 4465, right col., para 1).
Komori et al. do not explicitly teach administering the finished feed containing LPSp to the broiler chicken during the first week of life, specifically on Day 1 of broiler chicken’s life.
Lee et al. teach that enhanced protective immune responses (innate immunity activation and priming effect) and improved health condition were observed in one-day old chickens fed from the time of hatch with a plum extract supplement, wherein the chickens exhibited a greater spleen cell proliferation and an increase in expression of cytokines/IFN-𝛾 and IL-15 (indicating induced priming effects), and the chicken also show an increased body weight gain, a reduced fecal oocyst shedding rate, and increased protective immune response against coccidiosis after being orally challenged with oocysts of pathogenic Eimeria at day 12 post-hatch (indicating induced innate immunity activation) (abstract, page 399/para 4).
Winn teaches a method comprising a step of orally feeding a composition containing bacterial polysaccharides (i.e. polysaccharides extracted from a bacterium) to a young farm animal in the first 1-7 days of the young animal’s life for promoting growth and weight gain, increasing or stimulating natural immune response and function, and decreasing severity or mortality of diarrheal disease in the animal; wherein the composition is a nutritional composition (abstract; claims 1, 4, 15, and 36; paras 0013/lines 1-4, 0025/lines 1-3, 0026/lines 5-13, and 0028/lines 1-4) ; and wherein the bacterial polysaccharides are from a Gram-negative bacterium (para 0014/lines 8-10). Winn further teaches that the young animal is a newborn chicken, and the feeding begins on Day 1 or 2 of the newborn’s life (claims 4 and 36; para 0025/lines 5-6 and last 2 lines). It is noted that the natural immune response and function stimulated/induced by the method of Winn comprises innate immunity activation.
It would have been obvious to one of ordinary skill in the art to modify the method of Komori et al. by initially feeding a feed comprising an effective amount of LPS composition comprising LPSp to a broiler chicken during the first week of life, specifically to one-day old broiler chicken from the time of hatch, for inducing innate immunity activation and priming effect in chicken, thus preventing infection in chickens from commercial farms, because it had been well known in the art that preventive/natural immune response including innate immunity activation and priming effect can be induced in chicken for preventing infection by orally administration of bioactive substances to newly hatched chicken from Day one of birth, as supported by Lee et al. and Winn. Furthermore, Winn teaches that after being fed to a newborn chicken in the first week on Day 1 of life, the feed composition comprising bacterial polysaccharides stimulates and increases natural immune response and its function, reduces morality, and promotes growth and weight gain of the chicken. One of ordinary skill in the art would have recognized that orally administering LPSp to younger chicken, such as younger than 10 days old chicken, specifically on Day one of the first week of life, has obvious advantage of boosting immune response of chicken with younger ages for preventing pathogenic infection and reducing morality. It is noted that there are a limited number of ages with regard to chickens younger than 10 days old (e.g. one-day old chicken). One of ordinary skill in the art would have recognized that the model of boiler chicken established in the method of Komori et al. is readily appliable to test chickens with younger ages, especially newly hatched chicken from Day one of life, as taught by Lee et al. and Winn. As such, it would have been obvious to one of ordinary skill in the art to try oral administration of LPSp feed to younger chicken, specifically to a one-day old chicken, in the method of Komori et al. for inducing innate immunity activation/priming effect and boosting immune protection against pathogenic infection in younger chickens, specifically one day old chicken. See MPEP 2143 I.E., the rationale “obvious to try” supports a conclusion of obviousness when there is a finite number of identified and predictable solutions in the prior art, and choosing from such a finite number of identified and predictable solutions would have a reasonable expectation of success.
Regarding the limitations about promoting growth and experiencing an increase of at least 24% in breast meat yield recited in claims 1 and 15, these limitations are directed to what the method does to the chicken, i.e. an outcome of orally administering LPS composition to the chicken, not to what the method is. The method suggested by the cited prior art has all the steps of the claimed method. It is presumed that methods having substantially the same steps are capable of generating substantially the same outcomes. Furthermore, Komori et al. expressively teach that orally administering the LPS composition to chicken reduces total mortality, induces innate immunity activation and priming effect and prevents infection in chicken, which would improve the overall health of chickens, thus leading to promoting growth. Moreover, Winn expressively teaches that orally administering bacterial polysaccharides to newborn chickens in the first week on Day 1 of their life promotes growth and weight gain, reducing mortality of infectious diseases, as well as boosting natural immune response and function. Thus, the claims would have been obvious over the combined teachings of the cited prior art.
Regarding the limitations about an amount of LPS composition in finished feed as recited in the claims 1, 10-12, and 15, these limitations only define a concentration/amount of LPS composition in the finished feed, but do not define any specific amount or dose of the LPS composition fed to the chicken. Komori et al. teach that the LPSp was administered in feed in an amount/dose of 10 µg/kg of body weight per day. It is deemed merely a matter of design choice and routine optimization to provide a specific concentration/amount of LPS in the finished feed in the method suggested by Komori et al. for achieving a desired effect on inducing innate immunity activation and preventing infections in a broiler chicken. Given a concentration/amount of LPS in the finished feed is readily adjustable for providing an effective amount/dose of LPS to the chicken, the claims would be obvious over the cited prior art in the absence of evidence indicating the claimed concentration/amount is critical.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Response to Arguments
Applicant's arguments about the objection to claim 15 in the response filed on 06/01/2026 (page 6) have been fully considered but they are moot because the objection has been withdrawn, as indicated above.
Applicant's arguments about the claim rejection under 35 USC 112(b) in the response filed on 06/01/2026 (pages 7 and 8) have been fully considered and they are found to be persuasive in part. Specifically, Applicant’s arguments based on changing “bacteria” to “bacterium” in the claims 1 and 15 are not persuasive, while the remaining arguments are found persuasive. This is because the amendment to claims 1 and 15 filed on 6/1/2026 raises new issue and the changing “bacteria” to “bacterium” in the claims 1 and 15 is not sufficient to resolve indefinite issue (please see the rejection in pages 4 and 5 of this office action for details).
Applicant's arguments about the claim rejections under 35 USC 112(a) or 112(d) in the response filed on 06/01/2026 (pages 9 and 10) have been fully considered but they are moot because the rejections have been withdrawn, as indicated above.
Applicant's arguments about the double patenting rejections over the claims of copending application No. 19/239599 or No. 19/002214 in the 6/01/2026 response (page 10-11) have been fully considered but they are moot because the rejections have been withdrawn, as indicated above.
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 extension fee 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 date of this final action.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Qing Xu, Ph.D., whose telephone number is (571) 272-3076. The examiner can normally be reached on Monday-Friday from 9:30 AM to 5:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao, can be reached at (571) 272-0939. Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to the receptionist whose telephone number is (571) 272-1600.
/Qing Xu/
Patent Examiner
Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
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