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 .
Election/Restrictions
Applicant's election with traverse of claims 1-19 in the reply filed on 22 December 2025 is acknowledged. The traversal is on the grounds that the examination of all claims would not present a serious burden due to the relatedness of Groups I. and II. This is not found persuasive because Group I is drawn to a composition comprising cell components and supernatant from a Faecalibacterium prausnitzii culture. Group II is drawn to the method of making the composition. These two groups would require significantly different searches since the search for Group II would require searching bacterial growth, collection and preservation methods while the composition of Group I will not require searching these methods.
The requirement is still deemed proper and is therefore made FINAL.
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claims 1-3, 6, 10, 11, 15 and 17 are objected to because of the following informalities: Claims 1-3, 6, 10, 11 and 15: Faecalibacterium prausnitzii should be italicized Claim 10, line 2: there should be a space between “Faecalibacterium” and “prausnitzii” Claim 17, lines 4-5: the list of human bacterial pathogens should be italicized
Claim 17, line 4: write out E. coli the first time it is used.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 4, 6 and 10 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 4 recites the phrase “a poultry feed optimized to meet the nutritional requirements of poultry”. It is unclear what the contents of a poultry feed must be in order to be considered optimized to meet the nutritional requirements of poultry. What ingredients or quantities would be required? For the purpose of examination, claim 4 will be interpreted as requiring a poultry feed comprising cereal grains, oilseed meal, animal by-product meal, fats, and vitamin and mineral premixes.
Claim 6 recites the phrase “hydrogel spray”. It is unclear if certain ingredients are required in order for a gel to be considered a hydrogel. For the purpose of examination, a hydrogel will be interpreted as requiring one or more gelling agents (e.g., selected from carboxymethylcellulose, hydroxypropylmethyl cellulose, methyl cellulose, alginate, pectin, carrageenan, gellan, gelatin, agar, modified starch, xanthan gum, locust bean gum, and combinations thereof) as indicated in the specification, (page 15. 1.12).
Claim 10 recites the limitation "the product" in line 3 of the claims. There is insufficient antecedent basis for this limitation in the claim. It is unclear if “the product” to be dried refers to the supernatant portion after centrifuging, the sediment portion after centrifuging or the combination of the sediment and the supernatant. The specification indicates that the composition can comprise optionally dried cell components and supernatant [0015]. For the purpose of examination, "the product" will be interpreted as either the supernatant portion after centrifuging, the sediment portion after centrifuging or the combination of the sediment and the supernatant.
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).
Regarding claim 1, 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 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.
As to the claim language “which is a poultry food composition or composition adapted for delivery to poultry,” this claim language is deemed to be an intended use in so far as the structure of the product is concerned. In article claims, a claimed intended use must result in structural 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 probiotic composition of Bicalho in view of Sokol is identical to that of the presently claimed in terms of structure and composition, it meets the intended use of the claimed article. Additionally, Bicalho discloses the composition can be administered to an animal and the animal may be poultry [0006], which meets the claim limitation of a poultry food composition or composition adapted for delivery to poultry.
Regarding claim 2, Bicalho discloses the bacteria can be freeze dried cells [0055].
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 food supplement.
Regarding the claim 10 limitation “obtained by culturing a strain of Faecalibacterium prausnitzii, centrifuging the Faecalibacterium culture to separate it into a supernatant portion and a sediment portion, drying the product, and combining it 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 teaches the composition of claim 1 as discussed above, 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 fed to the poultry 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 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.
Additionally, Bicalho discloses the method of using the Faecalibacterium prausnitzii improves weight gain, improves feed efficiency of the animal and provides prophylaxis against diarrhea [0042] which meets the claim limitations of reducing morbidity and./or mortality in the poultry from gastrointestinal disease, and enhancing the feed conversion ratio of the poultry.
Regarding claims 12 and 15, Bicalho in view of Sokol 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 language "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 language 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 Sokol 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 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 limitations:
“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 all 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 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.
Additionally, Bicalho discloses the composition comprises one or more Faecalibacterium spp. in an amount effective to improve weight gain, provide phophylaxis against diarrhea, and/or improve feed efficiency in the animal [0006].
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 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 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 also 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 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 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 discloses meat and bone meal is appropriate for poultry feed and provides a source of calcium, phosphorus and lysine.
Double Patenting
Claim 1-19 of this application is patentably indistinct from claims 1-19 of Application No. 17/652,274. 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.
Claim 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 17/652,274 (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 1 recites a composition which is a poultry feed composition or a composition adapted for delivery to poultry comprising cell components and supernatant from a killed Faecalibaterium prausnitzii culture. The instant claims do not specify if the Faecalibaterium prausnitzii culture is alive or has been killed.
Regarding instant claims 2-19 of the instant application are substantially identical to claims 2-19 of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 7, 8, 10 and 11 of this application is patentably indistinct from claims 1, 6, 8, 9, 15 and 20 of Application No. 18/616,617. 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, 8, 10 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, 9, 15 and 20 of copending Application No. 18/616,617 (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. 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 claims 7 and 8 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. Additionally, reference claims 1 and 20 recite the Faecalibacterium prausnitzii culture may be mixed with food or mixed with liquid.
Regarding instant claim 10, reference claim 9 discloses the same method steps of making the composition of the instant claim 10 and reference claim 20 discloses mixing the composition with liquid or food.
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.
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