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 .
DETAILED ACTION
Applicant filed a claim amendment on 16 March 2026. Claims 1, 6-10, 14-16, and 21-23 are amended; claims 24-25 are canceled; and claim 26 is new. Claims 1-2 and 4-25 are pending. Claims 17-20 are withdrawn.
Claims 1-2, 4-16, 21-23, and 26 are under examination.
Amendments to the claims filed on or after July 30, 2003 must comply with 37 CFR 1.121(c) which states:
(c) Claims. Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
(1) Claim listing. All of the claims presented in a claim listing shall be presented in ascending numerical order. Consecutive claims having the same status of “canceled” or “not entered” may be aggregated into one statement (e.g., Claims 1–5 (canceled)). The claim listing shall commence on a separate sheet of the amendment document and the sheet(s) that contain the text of any part of the claims shall not contain any other part of the amendment.
(2) When claim text with markings is required. All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of “currently amended,” and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. Only claims having the status of “currently amended,” or “withdrawn” if also being amended, shall include markings. If a withdrawn claim is currently amended, its status in the claim listing may be identified as “withdrawn—currently amended.”
(3) When claim text in clean version is required. The text of all pending claims not being currently amended shall be presented in the claim listing in clean version, i.e., without any markings in the presentation of text. The presentation of a clean version of any claim having the status of “original,” “withdrawn” or “previously presented” will constitute an assertion that it has not been changed relative to the immediate prior version, except to omit markings that may have been present in the immediate prior version of the claims of the status of “withdrawn” or “previously presented.” Any claim added by amendment must be indicated with the status of “new” and presented in clean version, i.e., without any underlining.
(4) When claim text shall not be presented; canceling a claim.
(i) No claim text shall be presented for any claim in the claim listing with the status of “canceled” or “not entered.”
(ii) Cancellation of a claim shall be effected by an instruction to cancel a particular claim number. Identifying the status of a claim in the claim listing as “canceled” will constitute an instruction to cancel the claim.
(5) Reinstatement of previously canceled claim. A claim which was previously canceled may be reinstated only by adding the claim as a “new” claim with a new claim number.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06 March 2026 is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
(Maintained and extended to new claim) Claims 1-2, 4-16, 21-23, and 26 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 claims contain 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The specification lacks sufficient written description for the full genus of compounds derived from Gram-negative bacteria Algoriphagus aquaticus, Bosea sp., Brevundimonas sp., Desulfovibrio sp., Microbacterium testaceum, Sphingomonas sp., and Variovorax paradoxus. The broadest reasonable interpretation of these compounds includes any compound that is present in or produced by Gram-negative bacteria Algoriphagus aquaticus, Bosea sp., Brevundimonas sp., Desulfovibrio sp., Microbacterium testaceum, Sphingomonas sp., and Variovorax paradoxus, which includes ubiquitous compounds such as water, sugars, and minerals.
MPEP §2163.02 states “[a]n applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention.”
The instant specification only describes the Gram-negative bacteria Algoriphaqus aquaticus, Bosea sp., Brevundimonas diminuta, Brevundimonas vesicularis, Desulfovibrio sp., Microbacterium testaceum, Sphingomonas sp., Variovorax paradoxus themselves and the specific Gram-negative bacteria derived compounds lipopolysaccharide and lipid-A (specification [0034] and [0038]). The specification merely repeats the claims’ limitation “Gram-negative bacteria Algoriphaqus aquaticus, Bosea sp., Brevundimonas diminuta, Brevundimonas vesicularis, Desulfovibrio sp., Microbacterium testaceum, Sphingomonas sp., Variovorax paradoxus, or compounds derived therefrom”, but does not further describe or limit the scope of the term “compounds derived therefrom” (specification [0053]). The working examples in the specification describe the administration of an animal feed comprising corn-soy diet, algae, and symbiont Gram-negative bacteria Algoriphaqus aquaticus, Bosea sp., Brevundimonas diminuta, Brevundimonas vesicularis, Desulfovibrio sp., Microbacterium testaceum, Sphingomonas sp., Variovorax paradoxus, and Ochrobactrum pseudogrignonense (specification [0049]-[0053]). There is no description or working examples demonstrating any specific compounds of these Gram-negative bacteria being used to practice the instant invention other than the lipopolysaccharide/Lipid-A outer membrane compounds of the bacteria. As such, the disclosure as a whole fails to sufficiently describe the entire genus of compounds derived from Gram-negative bacteria Algoriphaqus aquaticus, Bosea sp., Brevundimonas diminuta, Brevundimonas vesicularis, Desulfovibrio sp., Microbacterium testaceum, Sphingomonas sp., Variovorax paradoxus.
Zhang et al. (alpha-Lipoic acid attenuates LPS-induced inflammatory responses by activating the phosphoinositide 3-kinase/Akt signaling pathway, PNAS, March 6, 2007, vol. 104, no. 10, pg. 4077–4082) teaches that Gram-negative bacteria derived lipopolysaccharides induce (alter) the AKT signaling pathway, which is an immune-related signaling pathway (Zhang pg. 4077 left col. para. 2). Embree et al. (US 9993507 B2 published 12 June 2018) teaches a composition comprising Gram-negative bacteria Algoriphaqus sp., Bosea sp., Brevundimonas sp., Desulfovibrio sp., Microbacterium sp., or Sphingomonas sp. (Embree col. 2 lns. 29-36 and Table 3) that may also comprise compounds such as lipopolysaccharides (Embree col. 86 lns. 52-56) is mixed with livestock feed, and orally administered to animals (Embree col. 4 lns. 8-9 and 25-26). Thus, both Zhang and Embree teach the use of Gram-negative bacteria derived lipopolysaccharides and the claimed Gram-negative bacteria themselves to practice the instant invention, but does not teach any other compound derived from Gram-negative bacteria with the functional activity to alter signaling in growth or immune-related pathways, nor promote growth or prime the immune system of an animal.
The prior art lacks any guidance that directs one of ordinary skill in the art to what specific compounds, components, or structures of the compounds derived from Gram-negative bacteria, Algoriphaqus aquaticus, Bosea sp., Brevundimonas diminuta, Brevundimonas vesicularis, Desulfovibrio sp., Microbacterium testaceum, Sphingomonas sp., or Variovorax paradoxus, that correlate to the function of altering signaling in growth or immune-related pathways, and promoting growth or priming the immune system of an animal. The prior art lacks any sufficient description of the entire scope of the claimed compounds derived from Gram-negative bacteria Gram-negative bacteria Algoriphaqus aquaticus, Bosea sp., Brevundimonas diminuta, Brevundimonas vesicularis, Desulfovibrio sp., Microbacterium testaceum, Sphingomonas sp., or Variovorax paradoxus.
Lacking sufficient prior art knowledge of the structure-function relationship for the claimed genus of compounds derived from Gram-negative bacteria Gram-negative bacteria Algoriphaqus aquaticus, Bosea sp., Brevundimonas diminuta, Brevundimonas vesicularis, Desulfovibrio sp., Microbacterium testaceum, Sphingomonas sp., or Variovorax paradoxus, the specification does not provide sufficient description of these derived compounds such that one of ordinary skill in the art would be able to reasonably predict the entire scope of the genus. Thus, one of ordinary skill in the art would conclude that Applicant was not in possession of the entire genus of compounds derived from Gram-negative bacteria Gram-negative bacteria Algoriphaqus aquaticus, Bosea sp., Brevundimonas diminuta, Brevundimonas vesicularis, Desulfovibrio sp., Microbacterium testaceum, Sphingomonas sp., or Variovorax paradoxus as claimed.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4-16, 21-23, and 26 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the symbiotic Gram-negative bacteria" in line 13. There is insufficient antecedent basis for this limitation in the claim.
(Maintained) Claim 10 recites the Gram-negative bacteria being selected from the group consisting of Algoriphaqus aquaticus, Bosea sp., Brevundimonas sp., Desulfovibrio sp., Microbacterium testaceum, Sphingomonas sp., and Variovorax paradoxus or compounds derived therefrom. It is unclear how “compounds derived therefrom” is considered to be a Gram-negative bacteria because the compounds themselves are not bacteria.
(Maintained and extended to new claim) Claim 1 recites the composition is capable of both growth induction and attenuating inflammatory signaling while maintaining innate immune responsiveness during early immune development, thereby promoting immune priming and muscle growth in the animal by Day 14, claim 10 recites whereby by Day 14 enhanced priming and muscle growth are experienced by modulation of, and claim 26 recites modulating the broiler chicken's neuronal pathway via neurotrophic tropomyosin-related kinase (NTRK) signaling leading to cell differentiation and MAPK-related growth as well as being modulated by TRAF6- mediated signaling leading to an improved innate response in the gut by Day 14. It is unclear if the timepoint “Day 14” is intended to be measured from the day of the broiler chicken’s birth, or from the day the composition was first fed to the broiler chicken.
Although claims 1 and 26 recite the method includes the step of initially administering to the broiler chicken the effective amount of the composition during the first and second week of the life of the broiler chicken, the claims never limit the composition to being administered at a specific time, nor the length of administration. It is uncertain whether the day of birth and the day of first administration are the same because the claim does not limit the feed to being administered on day one of the broiler chicken being alive. It is also uncertain if “by Day 14” in line 18 means 14 days after initial administration, after second administration, or after birth.
Claims 2 and 4-9 and 21-23 depend from claim 1 and claims 11-16 depend from claim 10, and so are indefinite for the same reasons.
(Maintained) Regarding claims 2 and 11, the phrase "may also be" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The phrase “may also be” can be replaced by the word “is” to obviate this indefiniteness.
Claim 4 recites wherein the alteration is caused by modulation of one or more of the growth-related pathways. It is unclear whether the claim is merely describing a molecular property that the signal alteration is a consequence of modulating one or more growth-related pathways, or the claim is further requiring an active step of modulating growth-related pathways to cause the signal alteration.
(New) Claim 9 recites the composition of claim 1 is administered in a manner that establishes maturation of immune and metabolic processes. It is unclear by what means or manner the composition of claim 1 should be administered to achieve the claimed result of establishing maturation of immune and metabolic processes. Neither the claims nor the specification provides sufficient direction to one of ordinary skill in the art for them to reasonably determine the administration manner that achieves the claimed result. Claim 9 further recites “a manner that establishes maturation of immune and metabolic processes in poultry processes in poultry during early development”. It is unclear if the claim limits the maturation of immune and metabolic processes to just being processes during early development, or if the maturation of immune and metabolic processes is broader and includes non-early development processes.
(Maintained) Claim 11 recites, in the preamble, the method for promoting growth of claim 10. However, claim 10 recites a method for promoting growth and priming the immune system in an animal. It is unclear whether claim 11 is limiting the result of the claimed method to promoting growth in an animal. Further regarding claim 11, the limitation “altered pathway” lacks sufficient antecedent basis in the claim.
(Maintained) Claims 12 and 13 recite the method for altering signaling of Claim 10, but claim 10 is drawn to a method for promoting growth and priming the immune system in an animal. Therefore, this limitation lacks sufficient antecedent basis.
Claims 14-16 depend from claim 13, and so are indefinite for the same reasons.
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.
(Maintained) Claim 2 is 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.
Claim 2 recites the method for altering signaling of Claim 1, wherein the altered pathway may also be selected from the group consisting of the pathway associated with the vascular endothelial growth factor (VEGF) and Ak strain transforming (Akt).
Claim 2 does not limit the “multiple growth-related pathways” limitation in claim 1 to be the pathways selected from VEGF and AKT. Rather, claim 2 means that the signaling of the pathways associated with VEGF and/or AKT may be altered in addition to the pathways whose signaling is altered by practicing the method of claim 1. However, in one embodiment of claim 1, the method alters the signaling in the pathways associated with VEGF and/or AKT because both the VEGF and AKT associated pathways are encompassed in the “growth-related pathways” limitation of claim 1 (specification pg. 19 [0091]). Thus, in this embodiment of claim 1, the limitations of claim 2 do not further limit claim 1 because the VEGF and/or AKT associated pathways’ signaling is already altered by this embodiment of claim 1.
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.
Claim Rejections - 35 USC § 103
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.
(Maintained and extended to new claim) Claims 1-2, 4-9, 21-23, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Levine et al. (US 20150181909 A1, published 02 July 2015) in view of Guo et al. (Immune activation of murine RAW264.7 macrophages by sonicated and alkalized paramylon from Euglena gracilis, BMC Microbiology (2020) 20:171), Embree et al. (US 9993507 B2 published 12 June 2018), and Zhang et al. (alpha-Lipoic acid attenuates LPS-induced inflammatory responses by activating the phosphoinositide 3-kinase/Akt signaling pathway, PNAS, March 6, 2007, vol. 104, no. 10, pg. 4077–4082), and as evidenced by Erridge et al. (Structure and function of lipopolysaccharides, Microbes and Infection 4 (2002) 837–851).
The claim 1 limitation of “whereby by Day 14 the broiler chicken’s neuronal pathway is modulated via neurotrophic tropomyosin-related kinase (NTRK) signaling which leads to cell differentiation and MAPK-related growth as well as being modulated by TRAF6-mediated signaling leading to an improved innate response in the gut” is interpreted as an intended result of practicing the invention, and not an active step. Thus, if the instant method and its active steps would have been prima facie obvious in view of prior art, the intended result that the broiler chicken's neuronal pathway is modulated via neurotrophic tropomyosin-related kinase (NTRK) signaling which leads to cell differentiation and MAPK-related growth as well as being modulated by TRAF6-mediated signaling leading to an improved innate response in the gut by Day 14 is considered to be necessarily met.
Regarding claims 1-2, 4-7, and 21-23, Levine teaches an animal feed composition for increasing growth rate of the animal comprising Euglena algal biomass (Levine claim 1). Levine demonstrates the administration of this animal feed to newly hatched broiler chicken “Ross x Ross” chicks, so teaches the administration of the composition within the first and second week of the life of a broiler chicken (Levine [0033]). The algal biomass is added to animal feed (Levine claim 5) in an amount ranging from about 10g to about 1000g per ton of feed, or 0.001 to 0.1 wt.% (Levine [0010]), which covers the ranges of biomass in animal feed recited in the instant dependent claims 6-7 and 21-23.
Levine does not teach the broiler chicken animal feed comprising the Euglena algal biomass alters the signaling in growth-related or immune-related pathways, nor that the Euglena biomass broiler chicken animal feed further comprises a Gram-negative bacteria selected from the group consisting of: Algoriphaqus aquaticus, Bosea sp., Brevundimonas sp., Desulfovibrio sp., Microbacterium testaceum, Sphingomonas sp., and Variovorax paradoxus.
Guo teaches that Euglena algal biomass is capable of activating (thereby altering) the mitogen-activated protein kinase (MAPK) growth-related signaling pathway in an animal, and also can activate (alter) the NF-kB immune system signaling pathway (Guo abstract and page 4 “Paramylon activates MAPK signaling” and Figure 5).
Levine and Guo do not teach that the Euglena biomass animal feed further comprises a Gram-negative bacteria selected from the group consisting of: Algoriphaqus aquaticus, Bosea sp., Brevundimonas sp., Desulfovibrio sp., Microbacterium testaceum, Sphingomonas sp., and Variovorax paradoxus or compounds derived therefrom.
Embree teaches a composition comprising Gram-negative bacteria Algoriphaqus sp., Bosea sp., Brevundimonas sp., Desulfovibrio sp., Microbacterium sp., or Sphingomonas sp. (Embree col. 2 lns. 29-36 and Table 3). Embree teaches that the microbial compositions may also comprise compounds such as lipopolysaccharides (Embree col. 86 lns. 52-56). Lipopolysaccharides are ubiquitously expressed by Gram-negative bacteria, as evidenced by Erridge (Erridge pg. 1 Intro. sentence 2), thus the Gram-negative bacteria Algoriphaqus sp., Bosea sp., Brevundimonas sp., Desulfovibrio sp., Microbacterium sp., or Sphingomonas sp. naturally comprise lipopolysaccharides. Embree also teaches that the composition may be mixed with livestock feed, and orally administered to animals (Embree col. 4 lns. 8-9 and 25-26).
Embree does not teach that the animal feed composition alters the signaling in growth-related or immune-related pathways.
Zhang teaches that lipopolysaccharides induce (alter) the AKT signaling pathway, which is an immune-related signaling pathway (Zhang pg. 4077 left col. para. 2).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to combine Levine’s animal feed comprising a Euglena biomass with Embree’s animal feed comprising Gram-negative bacteria Algoriphaqus sp., Bosea sp., Brevundimonas sp., Desulfovibrio sp., Microbacterium sp., or Sphingomonas sp. in an amount ranging from about 10g to about 1000g per ton of feed, or 0.001 to 0.1 wt.%, and administered that combined composition to a broiler chicken in order to alter the signaling in growth-related and immune-related pathways of the broiler chicken, which would promote the growth and immune systems of the broiler chicken. One of ordinary skill in the art would have been motivated to do so in order to increase broiler chicken facility throughput by increasing the broiler chicken growth rates, improving the overall health of the broiler chickens, and improving the target market weights of the broiler chickens quickly, which would reduce overall costs (Levine [0004]-[0008]). One of ordinary skill in the art would have had reasonable expectations of success because both the broiler chicken animal feed comprising a Euglena biomass, as taught by Levine, and the animal feed comprising Gram-negative bacteria Algoriphaqus sp., Bosea sp., Brevundimonas sp., Desulfovibrio sp., Microbacterium sp., or Sphingomonas sp., as taught by Embree, are known to be able to alter the signaling of growth and immune-related pathways, as taught by Guo and Zhang. Thus, one of ordinary skill in the art would have understood that administering a broiler chicken animal feed comprising both a Euglena biomass and a Gram-negative bacteria Algoriphaqus sp., Bosea sp., Brevundimonas sp., Desulfovibrio sp., Microbacterium sp., or Sphingomonas sp., to a broiler chicken would alter the signaling of growth and immune-related pathways, thereby enhancing its growth and immunity.
Regarding claim 8, Levine, Guo, Embree, and Zhang do not teach that the a broiler chicken animal feed comprising a Euglena algal biomass and a Gram-negative bacteria comprises an amount from about 3.0-4.0 lbs. of composition per ton of finished feed, which equates to a weight percent range of about 0.15 wt.% to about 0.2 wt.%.
MPEP §2144.05(I) recites “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.").
Levine teaches the broiler chicken animal feed composition to comprise up to about 0.1wt.%, which does not overlap with the about 0.15 wt.% to about 0.2 wt.% range of instant claim 8, but is indeed merely close. Therefore, a prima facie case of obviousness exists because one of ordinary skill in the art would not have expected an increase of at least 0.05 wt.% to have disabled the growth and immune enhancing characteristics of the composition of Levine in view of Guo.
Regarding claim 9, the limitation “wherein the composition is administered in a manner that establishes maturation of immune and metabolic processes in poultry” recited in claim 9 does not recite any differences in the administration step of claim 1, thus the administration steps of the method of Levine, Guo, Embree, and Zhang as discussed above encompass the scope of claim 9’s limitation. Furthermore, the limitation “establishes maturation of immune and metabolic processes in poultry” is interpreted as a desired outcome of administering the composition, and is not an active step by itself. Thus, if the instant method and its active steps would have been prima facie obvious in view of prior art, the matured immune and metabolic processes in poultry is considered to be necessarily met.
Regarding claim 26, the claim does not limit the species of bacterial strain in the administered composition comprising a lipopolysaccharide-Lipid A compound derived from a bacterial strain, a cellular component, fraction, or extract derived from a bacterial strain. As discussed above, Levine, Guo, Embree, and Zhang teach the administration of a composition comprising a lipopolysaccharide-Lipid A compound derived from a bacterial strain, a cellular component, fraction, or extract derived from a bacterial strain in a method of altering signaling in multiple growth-related pathways and immune-related pathways in broiler chickens.
(Maintained) Claims 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over Levine et al. (US 20150181909 A1, published 02 July 2015) in view of Guo et al. (Immune activation of murine RAW264.7 macrophages by sonicated and alkalized paramylon from Euglena gracilis, BMC Microbiology (2020) 20:171).
The limitation “wherein the composition is capable of both growth induction and attenuating inflammatory signaling while maintaining innate immune responsiveness during early immune development, thereby promoting immune priming and muscle growth in the animal by Day 14” recited in claim 10 is interpreted as an intended capability of the administered composition, and is not an active step. Thus, if the instant method and its active steps would have been prima facie obvious in view of prior art, the composition’s intended capability of inducing growth and attenuating inflammatory signaling while maintaining innate immune responsiveness during early immune development, thereby promoting immune priming and muscle growth in the animal by Day 14 is considered met.
Regarding claims 10-16, Levine teaches a broiler chicken animal feed composition for increasing growth rate of the broiler chicken comprising Euglena algal biomass (Levine claim 1). Levine demonstrates the administration of this animal feed to newly hatched broiler chicken chicks (Levine [0033]). The algal biomass is added to animal feed (Levine claim 5) in an amount ranging from about 10g to about 1000g per ton of feed, or 0.001 to 0.1 wt.% (Levine [0010]), which covers the ranges of biomass in animal feed recited in the instant dependent claims 14-16.
Levine does not teach the broiler chicken animal feed comprising the Euglena algal biomass primes the immune system of a broiler chicken, nor that it modulates growth-related pathways, like vascular endothelial growth factor (VEGF), the mitogen-activated protein kinase (MAPK or MAP kinase), Ak strain transforming (Akt).
However, Guo teaches that Euglena algal biomass is capable of activating the mitogen-activated protein kinase (MAPK) growth-related signaling pathway in an animal, and also can activate the NF-kB immune system signaling pathway (Guo abstract and page 4 “Paramylon activates MAPK signaling” and Figure 5).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to have administered a broiler chicken animal feed comprising Euglena algal biomass in an amount ranging from about 10g to about 1000g per ton of feed, or 0.001 to 0.1 wt.%, in order to promote the growth of a broiler chicken as taught by Levine, and activating its growth-related and immune system signaling pathways as taught by Guo. One of ordinary skill in the art would have been motivated to do so in order to increase broiler chicken facility throughput by increasing the broiler chicken’s growth rates, improving the overall health of the broiler chickens, and improving the target market weights of the broiler chickens quickly, which would reduce overall costs (Levine [0004]-[0008]). One of ordinary skill in the art would have had reasonable expectations of success because Levine taught a broiler chicken animal feed composition comprising Euglena algal biomass for increasing growth rate of a broiler chicken, and Guo further teaches that Euglena algal biomass activates the important mitogen-activated protein kinase (MAPK) growth-related signaling pathway in an animal, and has the added benefit of also activating the NF-kB immune system signaling pathway. Thus, one of ordinary skill in the art would have understood that administering an animal feed comprising a Euglena biomass to a broiler chicken animal would enhance its growth and immunity.
Response to Arguments
Applicant's arguments filed 16 March 2026 have been fully considered but they are not persuasive.
In response to applicant's argument that the examiner has combined an excessive number of references, reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. See In re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Regarding Applicant’s argument that the broadest reasonable interpretation of compounds in the amended claims now more narrowly defines the features of the composition to those capable of both growth induction and attenuating inflammatory signaling while maintaining innate immune responsiveness during early development, thus the rejection under 35 USC §112(a) should be withdrawn (Remarks pg. 12), the new limitation that the composition is capable of both growth induction and attenuating inflammatory signaling while maintaining innate immune responsiveness during early immune development does not limit the number of compounds in the claimed composition to just those described in the instant disclosure, nor does it adequately describe the full scope of claimed compounds which are included in the broadest reasonable scope of the claimed composition. The limitation merely limits the composition’s capabilities without any further description or limitation as to what compounds fit within that claimed scope.
Regarding Applicant’s argument that Guo uses processed purified beta-glucan applied directly to cells, rather than administered as an animal feed as in the claimed invention (Remarks pg. 14 para. 1), the Euglena gracilis biomass taught by Guo fits within the claimed scope of algal biomass. Furthermore, when Guo is considered in light of Levine, Embree, and Zhang, it would have been reasonable to one of ordinary skill in the art that an algal biomass would be suitable to be added into a broiler chicken animal feed, and still be reasonably expected to provide the benefits as described by Guo.
Regarding Applicant’s argument that Levine discourages administering whole algae based on the lack of dose response observed with the algae, thus one of ordinary skill in the art would not have chosen the inclusion level range that Applicant uses based on Levine’s data (Remarks pg. 14 para. 1), Levine’s disclosure fully demonstrates a response of the broiler chicken chicks to different doses of the algae containing feed composition, thus one of ordinary skill in the art would reasonably conclude that the ranges of algae in the feed as taught in Levine would be sufficient to provide the benefits to the broiler chickens as discussed in the rejection above.
Regarding Applicant’s argument that Levine and Guo teach activation and not attenuation as set forth in the claims (Remarks pg. 14 para. 1 and pg. 15 para. 1), the claimed methods are directed to altering signaling in multiple growth related pathways and immune related pathways. The claims do not limit the alteration to be attenuation only.
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).
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 Alexander M Duryee whose telephone number is (571)272-9377. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/LOUISE W HUMPHREY/ Supervisory Patent Examiner, Art Unit 1657
/Alexander M Duryee/Examiner, Art Unit 1657
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