DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09 January 2026 has been entered.
Status of the Application
Claims 1-20 are pending. Claim 21 has been cancelled. The previous claim objections have been withdrawn in view of applicant’s amendments to the claims. The previous 112 rejections have been withdrawn in view of applicant’s amendments to the claims. The previous 103 rejections have been modified in view of applicant’s amendments to the claims.
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.
Claims 1-2, 7 and 10-19 are rejected under 35 U.S.C. 103 as being unpatentable over Bicalho (US 2015/0044172 A1) in view of Sokol (US 2018/0092949 A1) as evidenced by Bircher (Effect of cryopreservation and lyophilization on viability and growth of strict anaerobic human gut microbes, Lea Bircher, et al. Microbial Biotechnology (2018) 11(4), 721–733).
Regarding claims 1 and 2, Bicalho discloses a composition comprising one or more Faecalibacterium spp. including, but not limited to Faecalibacterium prausnitzii [0006]. Bicalho discloses the composition can be administered to an animal and the animal may be poultry [0006].
Bicalho discloses the bacteria can be freeze dried cells [0055]. As evidenced by Bircher, when Faecalibacterium prausnitzii is lyophilized in anaerobic conditions the number of intact cells in the sample goes from about 85% for the Fresh, un-lyophilized cells, down to 27% for the lyophilized cells (Figure 2 (F), p725, RH column p725 and pp729-730 “Cryopreservation, lyophilization and storage” section). The non-intact cells of Faecalibacterium prausnitzii will be non-viable, or killed, in the freeze drying process. Therefore the freeze dried Faecalibacterium prausnitzii of Bicalho will also comprise Faecalibacterium prausnitzii which have been killed during the freeze drying process.
Bicalho does not disclose the Faecalibacterium prausnitzii comprises cell components and supernatant from the culture.
Sokol, in the field of administering bacteria based compositions to poultry, discloses a composition comprising Bacteroides thetaiotaomicron and at most five other bacterial species and/or an extract thereof [0043], where the other bacteria can be Faecalibacterium prausnitzii [0026] and the composition may be a functional food or a dietary supplement [0023] and where the subject of the invention can be hens and chickens [0021]. Sokol further discloses the term "extract" refers to any fraction obtained from the bacterial cell, notably a cell supernatant or a component there of, cell debris, a cell wall or a component thereof [0041]. Sokol also discloses the composition is appropriate for effectively controlling infections while preserving the intestinal microflora [0010].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the Faecalibacterium prausnitzii based composition of Bicalho with the cell components and supernatant of Sokol because Sokol discloses it is appropriate to include the cell components and supernatant of Faecalibacterium prausnitzii in a composition for controlling infections in poultry.
Regarding claim 7, Bicalho discloses the composition can be administered to poultry [0006] and the composition may be added to the diet of a domestic animal [0010]. Therefore the composition of Bicalho comprising Faecalibacterium prausnitzii when added to the diet of a poultry animal is considered to meet the claim limitation of a poultry feed supplement.
Regarding the claim 10 limitation “obtained by culturing a strain of Faecalibacterium prausnitzii, killing the Faecalibacterium prausnitzii, centrifuging the Faecalibacterium culture to separate it into a supernatant portion and a sediment portion, removing water from the supernatant portion, combining the supernatant portion with the sediment portion, drying the combined product thus obtained, and combining the dried product with poultry feed or a delivery vehicle selected from water, gel and feed supplement”, it is noted the claims are to the composition and these are product by process claim limitations, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. MPEP 2113 I. Since the claims are to the composition itself and Bicalho in view of Sokol as evidenced by Bircher teaches the composition of claim 1 as discussed above and Bicalho discloses the Faecalibacterium prausnitzii can be added as part of the diet of poultry [0006] and [0010], the process of making the composition is not considered to provide a patentable distinction.
Regarding claim 11, regarding the claim language “wherein the cell components and supernatant from a Faecalibacterium prausnitzii culture are present in a concentration effective when administered to poultry to (i) enhance the feed conversion ratio of the poultry, measured with respect to weight gain, meat production, or egg production; (ii) reduce the morbidity and/or mortality in the poultry from gastrointestinal disease; (iii) reduce the pathogen contamination of meat or eggs from the poultry; (iv) improve of the meat quality of the poultry; and/or (v) to alter the poultry gut microbiota to facilitate beneficial health effects in the poultry”; given the prior art teaches all of the components of the composition of claim 1 and there are no amounts of enhancement, reduction, improvement or alteration claimed in points (i)-(v) above, any amount of the composition of claim 1 in the composition is considered to be an effective concentration.
It is noted the claims are drawn to the composition and points (i)-(v) of claim 11 are merely the intended results of using the claimed composition and do not further define the scope of the invention. Since the prior art discloses the composition of the instant claims, the composition of the prior art is considered to provide the intended results.
Additionally it is noted Bicalho discloses the composition of the invention improves weight gain, provides prophylaxis against diarrhea and/or improves feed efficiency in an animal [0005] which meets the claim limitation of reducing the morbidity and/or mortality in the poultry from gastrointestinal disease.
Regarding claims 12 and 15, Bicalho in view of Sokol as evidenced by Bircher discloses the composition of claim 1 as detailed above. Bicalho further discloses the composition of the invention may be administered in an effective amount to poultry [0006] via oral delivery [0008]. Bicalho’s oral administration of the composition to poultry meets the claim 15 limitation of “by feeding the poultry.”
As to the claim 12 language “for improving feed efficiency in poultry”, this is the preamble of the claim and only states the purpose or intended use for the invention and is therefore not a claim limitation. MPEP 2111.02 II. Given the fact that the prior art teaches all of the components of the method of the instant claims, it is considered to provide the same effects as the instantly claimed method.
As to the claim 12 language “an effective amount of the composition”, given the prior art teaches all of the components of the composition of claim 1, the method step of administering it to poultry and there is no amount of effectiveness claimed, any amount of the composition of claim 1 fed to the poultry is considered to be an effective amount.
Regarding claim 13, as discussed above, Bicalho discloses orally administering the composition to poultry. Bicalho discloses the animal may be neonatal, newborn or young, between one day and one month of age [0067], which meets the claim limitation of administration only during the first 30 days of life.
Regarding the claim language “but the improvement in feed efficiency is sustained throughout the bird's life”, this is merely the intended results of using the claimed method and does not further define the scope of the invention. Since the prior art discloses all of the method steps of the claimed method, the composition of the prior art is considered to provide the intended results.
Regarding claim 14, it is noted the claims are drawn to the method of administering a composition. As to the claim limitation "wherein the improved feed efficiency is measured by feed conversion ratio (FCR) with respect to weight gain and/or meat production or with respect to egg production, wherein the poultry exhibit an improvement in feed conversion ratio of at least 0.5%, relative to control poultry, which do not receive the composition”, this limitation is deemed to further limit an intended use so far as the process is concerned. In process claims, a claimed intended use must result in a manipulative difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. MPEP 2111.02. Given that the method of Bicalho in view of Skol as evidenced by Bircher is identical to that of the presently claimed in terms of process, it meets the intended use of the claimed method.
Regarding claims 16-19, Bicalho in view of Sokol as evidenced by Bircher discloses the composition of claim 1 as detailed above. Bicalho further discloses the composition of the invention may be administered in an effective amount to poultry [0006] via oral delivery [0008].
As to the claim language:
“for reducing morbidity and/or mortality in poultry from gastrointestinal disease” (claim 16, line 1)
“for reducing pathogen load in poultry and/or reducing pathogen contamination of meat or eggs from poultry” (claim 17, lines 1-2) and “wherein the pathogen is a human bacterial pathogen selected from Campylobacter spp., pathogenic E. coli strains, Enterobacteriaceae spp. and Salmonella spp (claim 17, lines 3-4)
“for improvement of meat quality in poultry” (claim 18, line 1)
“for alteration of poultry gut microbiota to facilitate beneficial health effects, in comparison to untreated poultry” (claims 19, lines 1-2).
This claim language is deemed intended use so far as the process is concerned. In process claims, a claimed intended use must result in a manipulative difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. MPEP 2111.02. Given that the method of Bicalho in view of Sokol as evidenced by Bircher is identical to that of the presently claimed in terms of process, it meets the intended use of the claimed method.
As to the claim 16-19 language “an effective amount of the composition of claim 1”, given the prior art teaches all of the components of the composition of claim 1, the method step of administering it to poultry and there is no amount of effectiveness claimed, any amount of the composition of claim 1 fed to the poultry is considered to be an effective amount.
Claims 3, 5-6 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Bicalho in view of Sokol as evidenced by Bircher as applied to claim 1 above, and further in view of Embree (US 2018/0333443 A1, MICROBIAL COMPOSITIONS AND METHODS OF USE FOR IMPROVING FOWL PRODUCTION).
Regarding claim 3, Bicalho discloses the composition may be formulated as capsules [0059].
Bicalho does not disclose the size of the capsules.
Embree, in the field of microorganisms for poultry, discloses a composition comprising one or more isolated microbes [0011]. Embree also discloses the microbes may be bacteria with a 16S nucleic acid sequence, and/or a fungi with an ITS nucleic acid sequence, which is at least about 97% identical to a nucleic acid sequence selected from the group consisting of: SEQ ID NOs: 1-387 [0038] where Table 1 (page 6) lists strain designations of the bacteria of the invention [0043]. The bacteria can include Faecalibacterium prausnitzii (Table 1. #10, #20 and #38; sequence ID Nos: 7, 16 and 28, respectively). Embree further discloses the composition can be a fowl supplement [0019]. Embree also discloses the microorganisms may be used in their crude form and not isolated from the growth media [0284], which is considered to meet the claim limitation of comprising cell components and supernatant. Embree further discloses the microbial culture may be dried [0177]. Embree discloses the microbial composition may be encapsulated [0244] and the encapsulating shell may be up to 100 µm [0245].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected the dried microbial culture to have an average diameter of less than 100 microns in order for the dried particles to fit inside the encapsulating shell.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combined the capsuled composition of Bicalho with the dimensions of the encapsulated particles of Embree since both are disclosed as appropriate for administering to poultry.
Regarding claim 5, Bicalho discloses the composition may be a spray or gel [0059].
Bicalho does not disclose the spray is a gel.
Embree discloses the microbial composition may be sprayed directly on the animal, wherein the animal ingests the composition having been sprayed on the animal [0255]. Embree further discloses the composition may be a consumable spray additive, a consumable gel or combinations thereof [0019] and the composition can be administered to poultry on day 1 post-hatching [0256], which is considered to meet the claim limitation of chicks.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combined the spray of Bicalho with the consumable sprayed gel of Embree since both are disclosed as appropriate for administering nutritional compositions to chicks.
Regarding claim 6, Bicalho in view of Sokol as evidenced by Bircher discloses the cell components and supernatant from a Faecalibacterium prausnitzii culture as discussed in the claim 1 rejection above. Bicalho discloses the composition may be a spray or gel [0059].
Bicalho does not disclose the spray is a hydrogel spray.
Embree discloses the composition can comprise thickening agents such as locust bean gum, methylcelluloses, alginates and anti-settling agents such as xanthan gum [0198], which is considered to meet the claim limitation of a hydrogel. Embree discloses the microbial composition may be sprayed directly on the animal, wherein the animal ingests the composition having been sprayed on the animal [0255]. Embree further discloses the composition may be a consumable spray additive, a consumable gel or combinations thereof [0019]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combined the spray of Bicalho with the consumable sprayed hydrogel gel of Embree since both are disclosed as appropriate for administering nutritional microorganism based compositions to chicks.
Regarding claim 8, Bicalho discloses the composition may take the form of a reconstitutable powder [0059] and that for oral administration the composition may be presented as a dry product for reconstitution with water [0062], which is considered to meet the claim limitation of a powder for admixture with drinking water. Bicalho discloses the composition may be an aqueous or oily suspension or an aqueous or oily solution [0059].
Regarding claim 9, Bicalho in view of Sokol as evidenced by Bircher discloses the composition of claim 1 as discussed above.
Regarding the claim limitation “for injection into eggs,” the claims are drawn to the composition and this limitation only states the purpose or intended use for the invention and is therefore does not further limit the composition. MPEP 2111.02 II. Given the fact that the prior art teaches all of the components of the composition of the instant claims, it is considered to provide the intended use as recited in the claim.
Additionally, Bicalho discloses the composition may be administered in vials, as an aqueous or oily solution [0059].
Bicalho does not disclose the composition is for injection into eggs.
Embree discloses the microbial composition are administered into the egg (e.g. injection) [0256].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combined the composition of Bicalho with the administration by injection of Embree since both are drawn to administering nutritional microorganism based compositions to poultry.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bicalho in view of Sokol as evidenced by Bircher as applied to claim 1 above, and further in view of Connerton (US 2019/0320683 A1) and Miles (Miles and Jacob, Using Meat and Bone Meal in Poultry Diets, 2008, https://en.engormix.com/poultry-industry/articles/using-meat-bone-meal-t34074.htm).
Regarding claim 4, Bicalho disclose the composition can be administered to poultry, the composition can be added to food product or food [0005], [0057].
Bicalho does not disclose the ingredients of the poultry food.
Connerton, in the field of poultry supplements, discloses a composition for the nutrition of chickens comprising one or more probiotic where the probiotic can be Faecalibacterium prausnitzii (Abstract). Connerton discloses the composition of the invention may be combined with a poultry feed mixture which includes wheat (grain), soya meal (oilseed meal), soybean oil (fat) and TM-Blank mixture for Broiler Formulation (vitamin and mineral premix) [0132] and Tables 1 and 2 on p7.
Miles, in the field of poultry diets, discloses the use of meat and bone meal in poultry diets as a source of calcium, phosphorus and lysine (page 3, Inclusion Levels).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the composition of Bicalho added to a poultry food with the poultry feed of Connerton and the meat and bone meal of Miles since Connerton discloses the diet is appropriate for a combining with Faecalibacterium prausnitzii and Miles disclose meat and bone meal is appropriate for poultry feed and provides a source of calcium, phosphorus and lysine.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Bicalho in view of Sokol as evidenced by Bircher and Embree (US 2018/0333443 A1, MICROBIAL COMPOSITIONS AND METHODS OF USE FOR IMPROVING FOWL PRODUCTION).
Regarding claim 20,Bicalho in view of Sokol as evidenced by Bircher discloses the composition of claim 1 as detailed above. Bicalho discloses the composition can be administered to an animal and the animal may be poultry [0006]. Bicalho discloses freeze drying the composition [0055]. Bichalo discloses the composition can be a powder, gel, or aqueous solution [0059] or the composition can be mixed with the diet of the animal [0010].
Bicalho discloses the bacteria can be freeze dried cells [0055]. As evidenced by Bircher, when Faecalibacterium prausnitzii is lyophilized in anaerobic conditions the number of intact cells in the sample goes from about 85% for the Fresh, un-lyophilized cells, down to 27% for the lyophilized cells (Figure 2 (F), p725, RH column p725 and pp729-730 “Cryopreservation , lyophilization and storage” section). The non-intact cells of Faecalibacterium prausnitzii will be non-viable, or killed in the freeze drying process. Therefore the freeze dried Faecalibacterium prausnitzii of Bicalho will also comprise Faecalibacterium prausnitzii which have been killed during the freeze drying process.
Bicalho does not disclose the method steps of culturing the strain, centrifuging the culture and separating.
Embree discloses culturing the microbes [0173]. Embree further discloses isolating the microbial cells by centrifugal separation [0177]. Embree discloses the culture may be dried using a freeze dryer [0177]. Embree further discloses the microbial supplement for fowl can be administered as a feed additive, a consumable gel [0019] or a water additive [0019].
As to the claim language “to separate it into a supernatant potion and a sediment portion”, this is merely describing the purpose of centrifuging the culture. Since Embree teaches centrifugal separation of the culture, this is considered to meet the claim limitation of “to separate it into a supernatant potion and a sediment portion.”
As to the claim language “removing water from the supernatant portion, combining the supernatant portion with the sediment portion, drying the combined product thus obtained,” Embree discloses drying the microbial culture. Embree does not disclose removing excess water from the supernatant before recombining the supernatant with the sediment and then drying the resulting product. However, the drying of Embree’s microbial culture combines the claimed steps of removing the excess water from the supernatant and drying the final product.
Additionally the killing of the Faecalibacterium prausnitzii cells by freeze drying may not occur in the same order as the claimed method steps.
However, the selection of any order of performing process steps, with regards to Bicalho and Embree is prima facie obvious in the absence of new or unexpected results and the selection of any order of mixing ingredients is prima facie obvious. MPEP 2144.04 IV C.
Double Patenting
Claims 1, 2, 7 and 11 of this application are patentably indistinct from claim 8 of Application No. 18/161,617. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 7 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of copending Application No. 18/161,617 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant claim 1, reference claim 8 and instant claim 1 are both drawn to a composition comprising cell components and supernatant from a Faecalibacterium prausnitzii culture. Both claims do not require the presence of additional bacterial species. Regarding the instant claim 1 claim limitation regarding the composition is a poultry food composition or a composition adapted for delivery to poultry, this is the preamble of the claim and only states the purpose or intended use for the invention and is therefore not a claim limitation. MPEP 2111.02 II. Given the fact that the reference application teaches all of the components of the composition of the instant claim, it is considered to provide the same intended use as the instantly claimed composition.
Regarding instant claim 2, reference claim 8 recites the composition can be dried.
Regarding instant claim 7 recitation that the composition is a poultry food supplement, this only states the purpose or intended use for the invention and is therefore not a claim limitation. MPEP 2111.02 II. Given the fact that the reference application teaches all of the components of the composition of the instant claim, it is considered to provide the same intended use as the instantly claimed composition.
Regarding instant claim 11, regarding the claim language “wherein the cell components and supernatant from a Faecalibacterium prausnitzii culture are present in a concentration effective when administered to poultry to (i) enhance the feed conversion ratio of the poultry, measured with respect to weight gain, meat production, or egg production; (ii) reduce the morbidity and/or mortality in the poultry from gastrointestinal disease; (iii) reduce the pathogen contamination of meat or eggs from the poultry; (iv) improve of the meat quality of the poultry; and/or (v) to alter the poultry gut microbiota to facilitate beneficial health effects in the poultry”; given the reference application claim 8 teaches all of the components of the composition of claim 1 and there are no amounts of enhancement, reduction, improvement or alteration claimed in points (i)-(v) above, any amount of the composition of claim 1 in a composition is considered to be an effective concentration.
It is noted the claims are drawn to the composition and points (i)-(v) of claim 11 are merely the intended results of using the claimed method and do not further define the scope of the invention. Since the reference application claim 8 discloses the composition of the instant claim, the composition of the reference application is considered to provide the intended results.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20 of this application are patentably indistinct from claims 1-20 of Application No. 18/175,244. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/175,244 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 1-20 of the instant application are substantially identical to claims 1-20 of the reference application. Claim 1 of the instant application requires the Faecalibacterium prausnitzii culture be substantially free of other bacterial species. The reference application does not require the presence of other bacterial species and therefore meets the claim limitation of the instant claim 1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Declaration Under 37 CFR 1.132
The declaration under 37 CFR 1.132 filed 09 January 2026 is insufficient to overcome the rejection of claims 1-20 based upon Bicalho (US 2015/0044172 A1) in view of Sokol (US 2018/0092949 A1) as evidenced by Bircher (Effect of cryopreservation and lyophilization on viability and growth of strict anaerobic human gut microbes, Lea Bircher, et al. Microbial Biotechnology (2018) 11(4), 721–733) under 35 U.S.C. 103 (claims 1-2, 7 and 10-19); Bicalho in view of Sokol as evidenced by Bircher and further in view of Embree (US 2018/0333443 A1, MICROBIAL COMPOSITIONS AND METHODS OF USE FOR IMPROVING FOWL PRODUCTION) under 35 U.S.C. 103 (claims 3, 5-6 and 8-9); Bicalho in view of Sokol as evidenced by Bircher further in view of Connerton (US 2019/0320683 A1) and Miles (Miles and Jacob, Using Meat and Bone Meal in Poultry Diets, 2008, https://en.engormix.com/poultry-industry/articles/using-meat-bone-meal-t34074.htm) under 35 U.S.C. 103 (claim 4) and Bicalho in view of Sokol as evidenced by Bircher and Embree (US 2018/0333443 A1, MICROBIAL COMPOSITIONS AND METHODS OF USE FOR IMPROVING FOWL PRODUCTION) under 35 U.S.C. 103 (claim 20) as set forth in the last Office action because:
The declaration argues that the lyophilization of the Faecalibacterium prausnitzii culture by Bicalho does not kill the Faecalibacterium prausnitzii culture rather it is the exposure to oxygen that kills the Faecalibacterium prausnitzii culture. The declaration argues the Faecalibacterium prausnitzii culture stays viable after lyophilization and loses its viability upon exposure to oxygen after lyophilization. Declaration pp2-3.
This argument is not persuasive. The data provided by application demonstrates that when the Faecalibacterium prausnitzii culture is lyophilized there remains viable Faecalibacterium prausnitzii cells in the sample which can be grown and when the sample is exposed to oxygen there is no growth of the Faecalibacterium prausnitzii culture after lyophilization as seen in the photo on p3. However, the claims are drawn to a composition comprising cell components and supernatant from a killed Faecalibacterium prausnitzii culture. As the claim is currently written the composition can also comprise other ingredients, including living Faecalibacterium prausnitzii. So the question at hand is whether or not the lyophilization of Bicalho would have killed some of the Faecalibacterium prausnitzii culture, not necessarily all of the culture.
As evidenced by Bircher, when Faecalibacterium prausnitzii is lyophilized in anaerobic conditions the number of intact cells in the sample goes from about 85% for the Fresh, un-lyophilized cells, down to 27% for the lyophilized cells (Figure 2 (F), p725, RH column p725 and pp729-730 “Cryopreservation, lyophilization and storage” section). The non-intact cells of Faecalibacterium prausnitzii will be non-viable, or killed, in the freeze drying process. Therefore the freeze dried Faecalibacterium prausnitzii of Bicalho will also comprise Faecalibacterium prausnitzii which have been killed during the freeze drying process.
Response to Arguments
Applicant's arguments filed 09 January 2026 have been fully considered. To the extent they apply to the above rejections they are not persuasive.
Applicant argues Bicalho is drawn to the probiotic properties of Faecalibacterium prausnitzii and one of ordinary skill would understand that Bicalho desired live Faecalibacterium prausnitzii as opposed to dead cells. Applicant argues that Bicalho discloses the freeze-drying process results in Faecalibacterium prausnitzii which can be stored for several years and remain viable. Therefore Bicalho teaches away from the use of killed Faecalibacterium prausnitzii. Remarks pp1-2.
This argument is not persuasive. As evidenced by Bircher, as discussed in the response to the declaration above, when Faecalibacterium prausnitzii is lyophilized in anaerobic conditions the number of intact cells in the sample goes from about 85% for the Fresh, un-lyophilized cells, down to 27% for the lyophilized cells (Figure 2 (F), p725, RH column p725 and pp729-730 “Cryopreservation, lyophilization and storage” section). While viable Faecalibacterium prausnitzii cells remain after lyophilization, there is also a large quantity of non-intact, dead, cells.
The claims are drawn to a composition comprising cell components and supernatant from a killed Faecalibacterium prausnitzii culture. As the claim is currently written the composition can also comprise other ingredients, including living Faecalibacterium prausnitzii. The freeze drying of Bicalho will result in non-intact cells of Faecalibacterium prausnitzii which are non-viable, or killed, in the freeze drying process. Therefore the freeze dried Faecalibacterium prausnitzii of Bicalho comprises Faecalibacterium prausnitzii which have been killed during the freeze drying process.
Applicant argues the exposure to ambient air is what is detrimental to the Faecalibacterium prausnitzii cells as opposed to the freeze drying process. Applicant argues neither Bicalho nor Kahn discloses the killed bacteria are effective. Applicant points to the data in the declaration, which has been addressed above. Remarks p2.
This argument is not persuasive. In response to applicant's argument that neither Bicalho of Kahn (no longer relied upon) do not disclose the killed Faecalibacterium prausnitzii are effective, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
As to the argument with respect to the exposure to air versus lyophilization killing the Faecalibacterium prausnitzii cells, refer to the discussion above in response to the declaration. As evidenced by Bircher, the lyophilization process will destroy a number of Faecalibacterium prausnitzii cells even when the samples are kept in anaerobic conditions.
Applicant argues Sokol does not describe the use of or efficacy of killed Faecalibacterium prausnitzii cells. Remarks pp2-3.
This argument is not persuasive. Bicalho is relied upon to disclose the lyophilization and therefore killing of a portion of the Faecalibacterium prausnitzii cells. Sokol does disclose the use of a bacterium or extract thereof, including Faecalibacterium prausnitzii cells where a cell extract refers to any fraction obtained from the bacterial cell, including cell debris, a cell wall or a component thereof, which would include non-intact Faecalibacterium prausnitzii cells [0026] and [0041].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARRIE GLIMM whose telephone number is (571)272-2839. The examiner can normally be reached Monday-Thursday 10:30-6:30 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at 571-272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Michele L Jacobson/Primary Examiner, Art Unit 1793
/C.L.G./Examiner, Art Unit 1793