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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Remarks
The amendments and remarks filed on 10/06/2025 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 Any previously presented objections or rejections that are not presented in this Office Action are withdrawn.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, 4-15, 17, 19, and 20 are pending.
Claims 1, 2, and 15 are amended.
Claims 3, 16, and 18 are canceled.
Claims 4-9 and 19-20 are withdrawn.
Claims 1, 2, 10-15, and 17 have been examined on the merits.
Priority
Acknowledgment is made of a claim for domestic priority under 35 U.S.C. 119(e) to provisional application No. 63/056993 filed on 07/27/2020.
Rejections - Withdrawn
The rejection of claims 15 and 17 under 35 U.S.C. 112(b) in the previous office action is withdrawn due to the amendment to the claim filed on 10/06/2025.
The rejection of Claims 1, 2, 10-15 and 17 under 35 U.S.C. 103 over Komori in view of Lee, Kutuzova and Li is withdrawn due to the amendment to the claims filed on 10/06/2025.
Claim Objections
Claim 15 is objected to the recitation of “feeding the broiler chicken … of the broiler’s life”. The phrase should be corrected to “feeding the broiler chicken … of the broiler chicken’s life”. Appropriate correction is required.
Claim Rejections - 35 USC § 112, Second Paragraph
Claim 1, 2, 10-15 and 17 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.
Claim 1 is indefinite due to the recitation of “a lipopolysaccharide composition derived from a biomass consisting essentially of an algal culture and a Gram-negative bacterial strain selected from the group consisting of Rhodobacter sphaeroides and Variovorax paradoxus, the bacteria being formulated with the composition before extraction or purification of the lipopolysaccharide”. There is no sufficient antecedent basis for the term “the bacteria” in the claim. The recited term, bacteria, is in a plural form, which indicates more than one bacterium are referred by this term, it is unclear how the recited bacteria are related to a singular form of “a Gram-negative bacterial strain” previously recited in the claim. In addition, it is unclear how the recited “algal culture” is related to “a Gram-negative bacterial strain” recited in the claim and whether the recited algal culture is a culture of the recited Gram-negative bacterial strain or a culture of a different bacterial strain. Furthermore, there is no sufficient antecedent basis for the limitation “extraction or purification of the lipopolysaccharide” in the claim. Given the lipopolysaccharide composition is generated/derived from lipopolysaccharides of the claimed bacterial strain, it is unclear how the bacteria can be formulated with the lipopolysaccharide composition before lipopolysaccharides are extracted or purified from the bacterial strain to obtain the lipopolysaccharide composition. Moreover, the claim recites the limitation “initially feeding the broiler chicken … the composition beginning on Day 0 of the broiler chicken’s life”. It is noted that the first 24 hours right after a chicken hatches out its egg shell are considered as Day 1 of the chicken’s life. It appears the broiler chicken on Day 0 refers to a broiler chicken that has not hatched out of egg shell. It is unclear how the lipopolysaccharide composition can be feed to a broiler chicken still in the egg shell.
Claim 15 is indefinite due to the recitation of “feeding to the animal an effective amount of a composition … consisting essentially of an algal culture and a lipopolysaccharide derived from the … bacteria selected from the group consisting of Rhodobacter sphaeroides and Variovorax paradoxus, the bacteria being formulated with the composition before extraction or purification of the lipopolysaccharide”. It is unclear how the recited “algal culture” is related to the bacteria recited in the claim and whether the recited algal culture is a culture of the recited bacteria or a culture from different bacteria. Furthermore, given the claimed composition is a lipopolysaccharide composition and generated from the lipopolysaccharide of the claimed bacteria, it is unclear how the bacteria can be formulated with this lipopolysaccharide composition before the lipopolysaccharide is extracted or purified from the bacteria to obtain the lipopolysaccharide composition. Moreover, the claim recites the limitation “feeding the broiler chicken … the composition beginning on Day 0 of the broiler chicken’s life”. This limitation renders the claim to be indefinite for the reasons indicated above.
The remaining claims are rejected for depending from an indefinite claim.
Claim Rejections - 35 USC § 112, First Paragraph
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 1, 2, 10-15 and 17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
The base claims 1 and 15 are directed to a method for promoting growth of a broiler chicken, comprising the step of initially feeding the chicken a lipopolysaccharide composition on Day 0 of the chicken’s life. Support for initially feeding the chicken on Day 0 of the chicken’s life has not been found in the disclosure of the originally filed application. It is noted that the specification of the instant specification (para 0032 and claim 1 of the PGPUB) only provides support for feeding the chicken the lipopolysaccharide composition on Day 1 or in the first week (comprising Day 1 – Day 7) of the chicken’s life.
Therefore, the base claims 1 and 15 as well as their dependent claims 2, 10-14 and 17 are directed to new matter.
Claim Rejections - 35 USC § 112(d), or 112, Fourth Paragraph
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 13-14 and 17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends
Claims 1 and 15 are directed to a method for promoting growth of a broiler chicken, comprising the step of feeding the broiler chicken a lipopolysaccharide composition; whereas the dependent claims 14 and 17 define the composition is for feeding bovine, porcine, avian, equine, ovine, leporidae, and caprine species, and the dependent claim 13 defines using the composition for promoting growth of poultry. Therefore, the scope of Claims 13-14 and 17 is broader than that of Claims 1 and 15, respectively.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting
Claims 1, 2, 10-15 and 17 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 13-20 of copending Application No. 19/239599. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Claims 13-20 of copending ‘599 Application are directed in part to a method for improving gut morphology in an animal, comprising the steps of: forming a biomass-based compound derived from a Gram-negative bacteria at amounts efficacious for the prevention and treatment of disease in the animal; mixing the compound with an amount of basal feed to create a pre-mix; adding the premix to finished feed; and administering the finished feed to the animal from the earliest stage of development; wherein the premix is administered at the concentration range of between about 0.5 lbs. per ton and about 11.0 lbs. per ton of finished feed; wherein the premix is administered at the concentration range of between about 3.5 lbs. per ton of finished feed; wherein the biomass-based compound derived from a Gram-negative bacteria is a lipopolysaccharide; wherein said Gram-negative bacteria is a member of the group Variovorax; and wherein said member of the group Variovorax is Variovorax paradoxus.
It is noted that the claims 1-8 of the ‘599 Application define the animal is poultry, which encompasses broiler chicken, thus rendering the broiler chicken recited in the instant claims to be obvious. It is also noted that the claims of the ‘599 Application define the administering starts from the earliest stage of development, thus rendering the limitation “Day 0 of the broiler chicken’s life” in the instant claims to be obvious. It is further noted that improving gut morphology and preventing/treating diseases delivered by the method of the ‘599 Application lead to the promoting growth of the animals/chicken, thus meeting the claimed limitations in the instant claims.
Therefore, the method of Claims 1, 2, 10-15 and 17 of the instant application is deemed obvious over the method of Claims 13-20 of copending Application No. 19/239599.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 1, 2, 10-15 and 17 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 21-38 of copending Application No. 19/002214. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims 21-38 of copending ‘214 Application are directed in part to a method for improving gut health in poultry by altering conversion rates, body weight gain, and gut microbes, and for activating the TLR4 signaling pathway or minimizing coccidial, comprising the steps: orally administering to the animal an effective amount of a composition consisting essentially of a lipopolysaccharide of Gram-negative bacteria derived from a bacterial biomass, the bacteria being formulated with the composition before extraction or purification of the lipopolysaccharide, the feeding protocol commencing on Day 0 of the animal's life, whereby the composition is mixed with a feed ration portion prior to feeding the animal; where the Gram-negative bacteria is from the genus Rhodobacter or Variovorax, or from Variovorax paradoxus; wherein the composition is formulated to be fed to the animal in an amount providing from about 0.022% finished feed to about 0.275% finished feed, or providing from about 0.138% of finished feed to about 0.193% of finished feed, or providing from about 0.11% of finished feed to about 0.165% of finished feed; wherein the compound is formulated to be fed to the animal in an amount up to 0.551% of finished feed; and wherein the composition is adapted for use in poultry.
It is noted that the claims 21-38 of the ‘214 Application define the animal is poultry, which encompasses broiler chicken, thus rendering the broiler chicken recited in the instant claims to be obvious.
Therefore, the method of Claims 1, 2, 10-15 and 17 of the instant application is deemed obvious over the method of claims 21-38 of copending Application No. 19/002214.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Response to Arguments
Applicant's arguments about the rejection of claims 15 and 17 under 35 U.S.C 112(b) in the response filed on 10/06/2025 (page 6) have been fully considered but they are moot because the rejection has been withdrawn, as indicated above. However, newly amended claims raise new issues and they are rejected under 35 U.S.C. 112(b) for the reasons indicated above (see pages 3-5 for details).
Applicant's arguments about the rejection of claims 1, 2, 10-15, and 17 under 35 U.S.C 103 in the response filed on 10/06/2025 (pages 6-8) have been fully considered but they are moot because the rejection has been withdrawn for the reasons indicated above.
Conclusion
No claim is in condition for allowance.
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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