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 .
Status of Claims
Receipt of Arguments/Remarks filed on 7/9/2026 is acknowledged. Claims 1-30 are pending. Claims 1, 4, 5, 20, 24, 25, and 29 are amended. Claims 12-16, 18, and 19 are withdrawn from consideration as being directed to a non-elected invention.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 7/9/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement 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.
Claims 1-11, 17, and 20-30 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The disclosure does not enable one of ordinary skill in the art to practice the invention without access to the specific biological material, which is critical or essential to the practice of the invention but not included in the claims. See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976).
The invention appears to employ novel biological materials, specifically the bacterial strains Snodgrassella alvi wkB2, Lactobacillus "Firm-5" wkB10, Lactobacillus "Firm-5" wkB8, Gilliamella apicola wkB1, Gilliamella apicola wkB7, Gilliamella apicola PEB0154, Gilliamella apis PEB0162, Gilliamella apis PEB0183, Bartonella apis PEB0150, and Bifidobacterium asteroides LCep5. Since the biological materials are essential to the claimed invention, they must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the biological material is not so obtainable or available, the requirement of 35 U.S.C. 112 may be satisfied by a deposit of the biological materials.
The specification does not disclose a repeatable process to obtain the biological materials and it is not apparent if the biological materials are readily available to the public. If the deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by the applicants, or a statement by an attorney of record over his or her signature and registration number, stating that the specific strains have been deposited under the Budapest Treaty and that the strain will be irrevocably and without restriction or condition released to the public upon the issuance of a patent and a receipt showing that the appropriate biological material was received and entered into the depository, would satisfy the deposit requirement made herein.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. 1.801-1.809 applicants may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number indicating that:
a) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer;
d) a test of the viability of the biological material at the time the deposit was made and that such test result indicated that said biological material was viable (see 37 C.F.R. 1.807); and;
e) the deposit will be replaced if it should ever become inviable.
Applicant’s attention is directed to M.P.E.P. §2400 in general, and specifically to §2411.05, as well as to 37 C.F.R. § 1.809(d), wherein it is set forth that “the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination.” The specification should be amended to include this information; however, Applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
A statement regarding deposition and acceptance under the Budapest Treaty and a statement that the biological materials will be irrevocably and without restriction or condition released to the public upon issuance of a patent; or a statement including (a)-(e) above, is required to satisfy the conditions set forth in 35 U.S.C. § 112(a).
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 1-11, 17, and 26-27 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 at least two bacterial strains" in line 4. There is insufficient antecedent basis for this limitation in the claim. There is no prior reference to two bacterial strains, and the claim requires Snodgrassella alvi, Lactobacillus spp., and at least one other bacterial strain (i.e. at least three strains) to be present in the co-culture. Therefore, it is unclear what "the at least two bacterial strains" refers to.
Claim 6 recites that at least one bacterial strain is in a sporulated form. Claim 7 recites that at least one bacterial strain is provided in a lyophilized form. However, claim 1, upon which claims 6 and 7 depend, recites the limitation “wherein Snodgrassella alvi, Lactobacillus spp., and the at least one other bacterial strain in the co-culture are each stably growing”. Thus, it appears claim 1 is referring to a co-culture wherein the bacteria are in a state of growth. If bacteria are sporulated or lyophilized, they are not in a state of growth. Similarly, claims 26 and 27 recite a bacterial strain in sporulated or lyophilized form. Claim 20, upon which claims 26 and 27 depend, recites that the bacteria are stably growing. Therefore, it is unclear what is meant by the limitations in claims 6-7 and 26-27.
Claims 2-5, 8-11, and 17 are included in this rejection because they depend on a rejected claim and do not clarify the issue.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5, 8-11, 20-22, 24-25, and 28-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, a product of nature, without significantly more.
A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP § 2106:
Step (1): Is the claim directed to a process, machine, manufacture, or composition of matter?
Yes. The claims are directed to a composition of matter.
Step (2A):
Prong 1: Does the claim recite a law of nature, natural phenomenon, or an abstract idea?
Yes. Claims 1 and 29 and dependent claims are directed to a stable aerobic bacterial co-culture comprising Snodgrassella alvi, Lactobacillus spp., and at least one other bacterial strain selected from the group consisting of, Gilliamella apicola, Gilliamella apis, Bartonella apis, and Bifidobacterium spp. These bacterial species are all naturally occurring together within the honeybee gut (see Kwong et al. p. 3 para. 1; Fig. 1). “Bacterial co-culture” as set forth in the instant specification refers to a bacterial cell culture, which includes at least the two bacterial strains of the present invention (see instant specification p. 30). Thus, it is considered that the structural components of the co-culture are the bacteria recited in claim 1. Co-culture is not defined to indicate any other structural components that are required, and claim 1 does not recite any additional structural components of the co-culture product. For example, there is no requirement for any sort of contact between the strains, or that the strains are uniformly distributed in a particular medium. There is nothing to indicate that the strains as recited in claim 1 exhibit markedly different characteristics from their natural state.
Claim 20 and dependent claims are directed to an aerobic bacterial growth medium comprising a single culture aerobic propagation of a stable combination of Snodgrassella alvi, Lactobacillus spp., and at least one other bacterial strain. As set forth in the instant specification, “medium” includes a carbon source, a nitrogen source and inorganic salts as well as specially required substances such as vitamins, amino acids, nucleic acids and the like (see instant specification p. 31). Thus, the claims read on any setting wherein these components are present and the bacteria are capable of growth, i.e. the bee gut. Further, as claimed, the only required components of the growth medium are the bacterial strains. There is nothing to indicate that the strains as recited in claim 1 exhibit markedly different characteristics from their natural state.
Prong 2: If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application?
No. Claims 1 and 29 recite that the strains are “propagated together in aerobic conditions as a single culture prior to administration” and “inoculated individually and subsequently propagated together as a single culture prior to administration”. However, these are intended use limitations directed to how the strains can be cultured prior to administration. There is nothing to indicate that these intended use limitations result in a structural difference in the co-culture product, which requires the presence of the claimed bacterial strains. Similarly, claims 1, 20, and 29 recite that the strains in the co-culture or growth medium are each stably growing. However, this is a functional limitation of the claimed co-culture or growth medium product, which does not impact the structure of the co-culture or growth medium.
Claims 2-5, 9-10, 21, 24-25, and 30 specify the strains and amount of bacteria in the co-culture or growth medium product. However, these claims are still directed to a natural product.
Claims 8 and 28 recite that the co-culture or growth medium comprise an antibiotic. However, antibiotic is not defined in the specification and an example of an antibiotic includes natural plant-derived compounds (see instant specification p. 37). Further, antimicrobial compounds are produced by the honeybee gut bacteria (see Raymann et al., p. 101 para. 3) and therefore claims 8 and 28 read on a natural product.
Claim 11 recites that the ingestible composition comprises pollen feed, sucrose solution, or corn syrup solution. However, these compositions still read on the naturally occurring bacteria with another natural product, i.e. pollen or sucrose.
Claim 22 recites that the medium is a liquid medium or solid medium. However, this still reads on any medium that contains the required nutrients for bacterial growth, i.e. the honeybee gut.
Step (2B): If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly more than the judicial exception?
No. Claims 1-5, 8-11, 20-22, 24-25, and 28-30 are directed to naturally occurring bacterial strains and do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the intended use and functional limitations do not limit the product structurally and the claims read on a natural product.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 8-10, 20-22, 24-25, and 28-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kwong et al., Nature reviews microbiology. 2016 Jun;14(6):374-84, and as evidenced by Leonard et al., ACS synthetic biology. 2018 Apr 2;7(5):1279-90; Kwong et al. (hereinafter “Kwong 2014”) Genome announcements. 2014 Dec 24;2(6):10-128; and Raymann et al., Current opinion in insect science. 2018 Apr 1;26:97-104.
Regarding claims 1 and 29, the term “stable” and the limitation “wherein Snodgrassella alvi, Lactobacillus spp., and the at least one other bacterial strain in the co-culture are each stably growing” are directed to functional limitations of the claimed bacterial strains. Claims 1 and 29 are directed to a co-culture composition. “Bacterial co-culture” as set forth in the instant specification refers to a bacterial cell culture, which includes at least the two bacterial strains of the present invention (see instant specification p. 30). Thus, the required structural elements of the co-culture are the bacteria, i.e. Snodgrassella alvi, Lactobacillus spp., and at least one other bacterial strain. The limitations that the co-culture is stable, or that the strains are stably growing, do not alter the structure of the co-culture composition, but rather are directed to how the strains are growing during the process of culturing.
Regarding the limitations “wherein the at least two bacterial strains are propagated together in aerobic conditions as a single culture prior to administration”, and “inoculated individually and subsequently propagated together as a single culture prior to administration”, these are interpreted as intended use limitations directed to how the strains can be cultured prior to administration. The claims are directed to a co-culture product comprising the claimed bacterial strains, not to the use of the strains.
Regarding the term “aerobic”, this refers to the presence of oxygen during the culturing process. As discussed above, the required structural elements of the co-culture are the bacteria, i.e. Snodgrassella alvi, Lactobacillus spp., and at least one other bacterial strain. The growth in aerobic conditions does not alter the structure of the co-culture composition.
Kwong teaches that the guts of honeybees include the bacterial species Snodgrassella alvi, Gilliamella apicola, Lactobacillus Firm-4, Lactobacillus Firm-5, Bartonella apis, and Bifidobacterium (Kwong pp. 2-3 “Community Composition” para. 1-2 and 5). As discussed above, the structure of the co-culture product as claimed requires the presence of the recited bacteria. Kwong teaches that all of these bacteria are present together within the honeybee gut and thus reads on claims 1 and 29.
Regarding claims 3 and 9, an "effective amount" of a compound is that amount of a compound which is sufficient to provide a beneficial effect to the subject to which the compound is administered (instant specification p. 10 lines 4-6). Kwong teaches that microorganisms within animal guts can benefit their hosts, by helping to digest food, detoxifying harmful molecules, providing essential nutrients, protecting against invasion by pathogens and parasites, and modulating development and immunity (Kwong p. 1 para. 1). Thus, it is considered that the Snodgrassella alvi, Gilliamella apicola, Lactobacillus Firm-4, Lactobacillus Firm-5, Bartonella apis, and Bifidobacterium present together in the honeybee gut are present in an amount to provide a beneficial effect to the honeybee, constituting an “effective amount” of the strains.
Regarding claim 9, the structure of the ingestible composition or supplement is an effective amount of the bacteria as recited in claim 1. Therefore, the teachings of Kwong directed to these bacteria present together in the honeybee gut read on claim 9.
Regarding claim 20, as set forth in the instant specification, “medium” includes a carbon source, a nitrogen source and inorganic salts as well as specially required substances such as vitamins, amino acids, nucleic acids and the like (see instant specification p. 31). However, this is exemplary, and growth medium is not defined in the specification.
The growth medium product as claimed comprises a single culture aerobic propagation of a stable combination of Snodgrassella alvi, Lactobacillus spp., and at least one bacterial strain selected from the group consisting of Gilliamella apicola, Gilliamella apis, Bartonella apis, and Bifidobacterium spp., wherein Snodgrassella alvi, Lactobacillus spp., and the at least one bacterial strain in the propagation are each stably growing. As discussed above, “aerobic”, “stable”, and “stably growing” are limitations directed to conditions during the culturing process. Claim 20 is directed to a product, the components of which are the claimed bacterial strains. Kwong teaches that all of these bacteria are present together within the honeybee gut, and thus reads on claim 20.
Regarding claims 2, 10, 21, and 30, Snodgrassella alvi wkB2, Gilliamella apicola wkB7, and Bartonella apis PEB0150 are strains in the honeybee gut, as evidenced by Leonard (Leonard p. 1281 Fig. 2). Lactobacillus “Firm-5” wkB10 and “Firm-5” wkB8 are strains in the honeybee gut, as evidenced by Kwong 2014 (Kwong 2014 p. 1 para. 2). Therefore, it is expected that the honeybee gut as taught by Kwong would comprise these bacterial strains.
Regarding claims 4-5 and 24-25, Kwong teaches that the honeybee gut comprises between 108 and 109 cells (Kwong p. 3 para. 3).
Regarding claims 8 and 28, as evidenced by Raymann, the microbes in the honeybee gut produce antimicrobial compounds that inhibit pathogens (Raymann p. 101 para. 3). Thus, it is considered that the honeybee gut comprising the bacterial species as taught by Kwong would additionally include antibiotics.
Regarding claim 22, Kwong teaches that the bacteria recited in claim 1 are in the honeybee gut, with some on the gut wall (solid) and some in the lumen (liquid) (Kwong Fig. 1). Thus, the bacteria in the gut are in a solid or liquid medium.
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.
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 7, 11, 17, 23, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Kwong as applied to claims 1-5, 8-10, 20-22, 24-25, and 28-30 above, and further in view of Olofsson et al., US 2017/0226599 A1.
Kwong teaches the co-culture of claim 1 and the growth medium of claim 20, wherein Snodgrassella alvi, Gilliamella apicola, Lactobacillus Firm-4, Lactobacillus Firm-5, Bartonella apis, and Bifidobacterium are present together in the honeybee gut. Kwong teaches that in contrast to mammalian microbiomes, the species of bacteria in the bee gut can be cultured in the laboratory and used to inoculate bees, which allows for powerful experimental studies (Kwong p. 2 para. 2).
Kwong does not teach a composition wherein at least one of the bacterial strains is in a lyophilized form (claims 7, 27). Kwong does not teach an ingestible composition selected from a pollen feed, a sucrose solution and a corn syrup solution (claim 11). Kwong does not teach an article-of-manufacture comprising packaging material and a composition for treating or preventing a disease or disorder in a bee or bee colony being contained within said packaging material, said composition comprising a bacterial co-culture of claim 1 (claim 17). Kwong does not teach that the solid medium comprises a nutrient agar plate (claim 23).
Regarding claims 7 and 27, Olofsson teaches Lactobacillus strains isolated from honeybees and teaches that these bacterial strains are used in medically related products such as food, beverage, feed and wound care. (Olofsson p. 1 para. 1). Olofsson teaches probiotic feed products for bee and bee larvae comprising an effective amount of the bacterial strains from the honeybee gut to strengthen or re-establish the microbial flora within the bee or bee larvae and re-establish the inhibitory atmosphere inside the beehive (Olofsson p. 5 para. 67). Olofsson teaches that the feed product may be freeze-dried or lyophilized (Olofsson p. 5 para. 71).
Regarding claim 11, Olofsson teaches a feed product composition comprising an effective amount of bacteria, i.e. ingestible, and that the ingestible composition contains pollen or sucrose (Olofsson p. 5 para. 72 and 74). Therefore, the ingestible composition is a pollen feed or sucrose solution.
Regarding claim 17, Olofsson teaches a powdered feed product that is simple to
handle, transport, store, and has a more expanded to date of expiration (Olofsson p. 5 para. 71). Therefore, Olofsson teaches that the composition comprises or is contained in packaging material or stored in a package, i.e., is an article of manufacture.
Regarding claim 23, Olofsson teaches that the honeybee gut bacterial strains may be on agar plates (Olofsson p. 3 para. 40).
It would have been obvious to a skilled artisan, before the effective filing date, to combine the teachings of Kwong and Olofsson, arriving at a composition wherein at least one of the bacterial strains present in the honeybee gut is in a lyophilized form, is in a pollen feed or sucrose solution, is contained in packaging material, or on agar plates. Both Kwong and Olofsson are directed to honeybee gut bacteria and teach that the bacteria can be cultured and provided to honeybees, i.e. an ingestible feed product. Olofsson teaches various formulations comprising honeybee bacteria. Therefore, it would have been obvious for a skilled artisan to obtain a composition comprising the same strains in the honeybee gut as taught by Kwong, in the various formulations taught by Olofsson.
A person of ordinary skill in the art would have been motivated to obtain a composition comprising a lyophilized strain of the honeybee gut bacteria taught by Kwong because Olofsson teaches that lyophilized or freeze-dried bacterial products can be easily handled, transported, stored, and have expanded expiration dates (Olofsson para. 71). Therefore, it would be considered advantageous to formulate co-culture compositions comprising the bacteria taught by Kwong in lyophilized form. It would similarly be advantageous to create a composition of the co-culture that is packaged as an article of manufacture for extended storage purposes. As Kwong teaches that it is beneficial to culture the honeybee gut microbes to facilitate studies and to allow for inoculation of bees with the microbes, it would have been obvious to obtain a composition wherein the microbes are on a solid agar medium, or in a feed product, as taught by Olofsson.
A skilled artisan would have had a reasonable expectation of success in obtaining these co-culture compositions given the teachings of Kwong that the bacteria of the honeybee gut have the advantage of being culturable and can be provided to bees, and the teachings of Olofsson that honeybee gut-associated bacteria can be incorporated into an ingestible and commercial product comprising the components as recited in claims 7, 11, 17, 23, and 27.
Claims 6 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Kwong as applied to claims 1-5, 8-10, 20-22, 24-25, and 28-30 above, and further in view of Le et al., US 2018/0192668 A1.
Kwong teaches the co-culture of claim 1 and the growth medium of claim 20, wherein Snodgrassella alvi, Gilliamella apicola, Lactobacillus Firm-4, Lactobacillus Firm-5, Bartonella apis, and Bifidobacterium are present together in the honeybee gut. Kwong teaches that in contrast to mammalian microbiomes, the species of bacteria in the bee gut can be cultured in the laboratory and used to inoculate bees, which allows for powerful experimental studies (Kwong p. 2 para. 2).
Kwong does not teach a composition wherein at least one of the bacterial strains is in a sporulated form (claims 6, 26).
Regarding claims 6 and 26, Le teaches a method of making and using an animal feed containing strains of sporulated living microbes to stimulate local intestinal immunity with the microbes (Le Abstract). Le teaches selecting a plurality of strains of sporulated living microbes to form a microbial solution, wherein the ability to form spores allows germination in the upper digestive tract for nutrient absorption and stimulate local intestinal immunity (Le claim 1, para. 21 and 28).
It would have been obvious for a skilled artisan to obtain a composition comprising a sporulated strain of the honeybee gut bacteria taught by Kwong because Le teaches that sporulated forms of microbes can be used in feed products to stimulate local intestinal immunity. As Kwong teaches that it is beneficial to culture the honeybee gut microbes in vitro and provide these to honeybees, it would be obvious to formulate the bacteria taught by Kwong in a sporulated form which is used for feed products as taught by Le.
A skilled artisan would have been motivated to combine these teachings because Le
teaches that the sporulated bacterial strains display activity in the upper digestive tract helping
with nutrient absorption and stimulate local intestinal immunity (Le para. 28). Therefore, it would be considered advantageous to create a composition of honeybee bacteria in a sporulated formulation for use in a feed product.
The ordinary artisan would have reasonable expectation of success in combining these teachings to obtain a co-culture composition comprising a sporulated bacterial strain as taught by Kwong, given the successful use of sporulated bacterial strains by Le in compositions to improve the gut microbiome.
Response to Arguments
Applicant’s arguments with respect to claims rejected under 35 U.S.C. § 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. However, responses to pertinent arguments are set forth below.
Applicants submit that a skilled artisan will appreciate that a stable coculture should include species which do not suppress one another's growth. Applicants submit that a skilled person will appreciate that the prefix "co" is used in "stable co-culture" to indicate that the cultures grow with one-another, and further that the term "co" suggests that the cultures grow together with equal status or presence in the culture and certainly not wherein one species
is outgrown or suppressed by another.
Regarding the recitation of “stable” or “stably growing” in claims 1, 20, and 29, it is noted that the claims are directed to a co-culture composition. As pointed out in Applicant arguments, “stable” modifies the process of co-culturing, rather than the co-culture product itself, referring to the strains growing together without suppressing one another’s growth. The co-culture product as claimed represents a snapshot in time of a product obtained via a co-culturing technique. The process of stable growth does not influence the components of the co-culture product, which requires the presence of the claimed bacterial strains. As discussed above, the structural elements in a “co-culture” as defined in the specification are the at least the two bacterial strains of the present invention, i.e. Snodgrassella alvi, Lactobacillus spp., and at least one other bacterial strain as claimed. Therefore, any composition wherein the bacterial strains are present together reads on the co-culture product of claim 1.
It is noted that “co-culture” is not narrowly defined in the specification, and the claims do not limit the structure of what is considered a co-culture. It is additionally noted that in the honeybee gut, as taught by Kwong, the microbial species are not all found in the same location within the gut, for example some species are present in the ileum and others in the rectum (Kwong Fig. 1). However, given the broad definition of co-culture, it is not required that the strains be in contact with one another, and thus the gut environment which comprises all of these microbes reads on the claims. It is suggested that applicant amend the claims to include structural features which differentiate the co-culture composition from the naturally occurring bacterial strains. For example, applicant could amend the claims to indicate that the co-culture product comprises Snodgrassella alvi, Lactobacillus spp., and at least one other bacterial strain that are uniformly distributed and in contact with one another in a growth medium.
Applicants submit that a skilled artisan will appreciate that the term "aerobic" in reference to conditions for a culture, as used in the field, refers to a controlled laboratory environment in which a culture is grown with an oxygen source.
Regarding the recitation of “aerobic” in claims 1 and 20, it is noted that the claims are directed to a co-culture composition. As pointed out in Applicant arguments, “aerobic” modifies the process of co-culturing, rather than the co-culture product itself, referring to a culture being grown with an oxygen source. The aerobic conditions during the co-culturing process do not influence the components of the co-culture product, which requires the presence of the claimed bacterial strains. As discussed above, the structural elements in a “co-culture” as defined in the specification are the at least the two bacterial strains of the present invention, i.e. Snodgrassella alvi, Lactobacillus spp., and at least one other bacterial strain. Therefore, any composition wherein the bacterial strains are present together reads on the co-culture product of claim 1.
Applicants submit that Figures 1 and 2 of the specification demonstrate that the claimed product, produced by the co-culturing or propagation of Snodgrassella alvi, Lactobacillus spp., and at least one other bacterial strain selected from the group consisting of Gilliamella apicola, Gilliamella apis, Bartonella apis, and Bifidobacterium spp. together as a single culture prior to administration to the bee gut increases the stability and uniformity of the probiotic inoculation.
In response to this argument, it is again noted that the instant claims are directed to a co-culture or growth medium product, comprising the bacterial strains as recited in claims 1, 20, and 29. As discussed above, there is no indication that any of the functional or intended use limitations recited in the claims impact the structural features of the microbial strains, or anything to indicate that the claimed combination of strains differs from the combination of strains as taught by Kwong. The structure of the co-culture or growth medium product, comprising the strains as claimed, is anticipated by Kwong, as discussed above.
It is noted that the results referred to by applicant are experimental data measuring the bacterial abundance of bees that have been inoculated with the claimed composition. It is further noted that as claimed, the limitations “wherein the at least two bacterial strains are propagated together in aerobic conditions as a single culture prior to administration” or “are
inoculated individually and subsequently propagated together as a single culture prior to administration” are interpreted as an intended use of the claimed co-culture product, i.e. how the strains in the co-culture composition can be grown prior to administration to a bee. It is not considered that this wherein clause is directed to the process of obtaining the co-culture, but rather is directed to a way in which the composition comprising the claimed strains can be used, and thus does not structurally impact the claimed co-culture product.
Conclusion
Claims 1-11, 17, and 20-30 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY F EIX whose telephone number is (571)270-0808. The examiner can normally be reached M-F 8am-5pm ET.
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/EMILY F EIX/Examiner, Art Unit 1653
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
