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 .
The amendment filed 12/8/25 has been entered into the record.
Claims 2-4, 7,9, 18-19, 22-23, 26, 29 and 34-42 have been cancelled.
Claims 1, 6, 8, 10-12, 17, 21, 25, 27, 28, 30, 32 and 43 have been amended.
Claims 1, 5-6, , 8, 10-13, 17, 20-21, 24-25, 27-28, 30-33 and 43 are pending and are under examination.
Information disclosure statement filed 12/8/25 has been considered and an initialed copy is enclosed.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
The sequence listing filed 12/8/25 is defective. Please see attached reviewer’s comment which can also be found in the application filed and is dated 1/20/26.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The implied phrase in the abstract is “this invention relates to” and the abstract should be amended to remove the implied phrase.
Claim Objections/Rejections Withdrawn
The objection to claim 17 and 28 are withdrawn in view of the amendments to the claims.
The rejection of claims 1, 5-6, 8, 10-13, 17, 20-21, 24-25, 27-28, 30-33 and 43 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of the amendments to the claims.
The rejection of claims 1, 5-6, 8, 10-13, 17, 20-21, 24-25, 27-28, 30-33 and 43 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph is withdrawn. Applicants argument is found persuasive.
The rejection of claims 1, 5, 8, 10-13, 17, 20-21, 24-25, 27-28, 30-33 and 43 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 27-28 and 30-32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wickens et al. WO 2018/115985 6/28/2018 cited in IDS is withdrawn in view of the amendment to the claims.
The rejection of claim 27 on the ground of nonstatutory double patenting as being unpatentable over claim 31 of U.S. Patent No. 8062687 (‘687) is withdrawn in view of the amendment to the claims.
The rejection of claim 27-28 and 30-32 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8, 13-15, 18-19, 23, 28-33, 36, and 39 of copending Application No. 18/543,604 (‘604) is withdrawn in view of the amendment to the claims.
Claim Rejections Maintained
The rejection of claims 6 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 is maintained.
As stated in the prior action “for example” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
New Claim Rejections Based on Amendment
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.
Claims 6, 8, 10, 12, 21,24, 25, 28 and 32 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.
The metes and bounds of the claims definite because these claims recite L. rhamnosus and it is not clear which L. rhamnosus is being referred to because claim 1 recites Lacticaseibacillus rhamnosus i.e. L. rhamnosus with deposit number NM97/09514 and also recites the derivative of the strain which is a killed L. rhamnosus. These are both L. rhamnosus.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 27, 30, and 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aguilar-Uscanga et al. Journal of Microbiology, Biotechnology and Food Sciences 2013: 2(6) 2462-2468, cited in IDS.
Aguilar-Uscanga et al disclose a ruminant feed comprising L. rhamnosus HN001 and sugar cane molasses (YPM broth). Aguilar-Uscanga et al disclose a ruminant feed comprising bacteriocin produced from L. rhamnosus HN001, a cell suspension of HN001 and culture supernatant of the strain and further comprising sugar cane molasses w (YPM broth). See under culture media, kinetic production of bacteriocin, biomass production, and preparation of culture supernatant. See figure 1-3 and table 1-4.
Claim 30: the culture of HN001 further comprises said bacteriocin of HN001 which inherently is a natural inhibitor of methanogenesis or methanogen inhibitor as evidenced by the instant specification at p. 19 under bacteriocins to page 20.
Claim(s) 1, 5, 6, 8, 11, 12, 13, 17, 25, 27, 30-31, 33 and 43 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berger et al. EP 2245943 cited in IDS.
Claims 27, 30 and 31: Berger et al disclose a ruminant feed composition comprising dead (inactivated) L. rhamnosus and other probiotics such as P. jensenii P63, L. paracasei, L. farciminis and L. plantarum Lp15 and grains or corn.
Claims 1, 5, 6, 8, 11, 12, 13, 17, 25, 33, and 43: Furthermore, Berger et al also administers the feed composition to ruminant (polygastric) animal in an amount of:
Typically, the quantity of microbial feed supplement given to a polygastric herbivore per kg of weight of the animal per day, is comprised between 2x10^3 and 2x10^10 CFU/kg of animal body weight/day, preferably between 2x10.sup.5 and 2x10.sup.9 CFU/kg of animal body weight/day, more preferably 2x10.sup.6 to 2x10.sup.8 CFU/kg of animal body weight/day, even more preferably around 2x10.sup.7 CFU/kg of animal body weight/day.
Typically, the quantity of microbial feed supplement per g of feedlot is comprised between 50 and 10.sup.10 CFU/kg of feedlot, preferably between 5x10.sup.3 and 10.sup.9 CFU/kg of feedlot, more preferably 5x10.sup.4 to 10.sup.8 CFU/kg of feedlot, even more preferably around 10.sup.6 CFU/kg of feedlot.
Berger et al disclose the animals are cows, sheep, ewes, goats, dears, camels and giraffes.
Regarding the method claims, since Berger et al disclose administering the same killed L. rhamnosus, the method will necessarily result in inhibiting the growth of methane-producing bacteria and/or archaea in the forestomach of ruminant animals; b. reducing ruminal methane production by a ruminant animal; c. increasing feed efficiency in a ruminant animal; or d. reducing the ability of the rumen microbiome to produce methane, inhibit the growth of hydrogenotrophic methanogens in the forestomach of the animal, e. increasing the yield of milk and/or milk components produced from a ruminant animal ;f. improving the body weight and/or body composition of a ruminant animal; or g. reducing the ability of the rumen microbiome to produce methane in a ruminant animal the inhibition of the growth of methane- producing bacteria and/or archaea in the forestomach of the ruminant animals, the reduction of methane production by the ruminant animal, and/or the increased feed efficiency in the ruminant animal persists for at least 2 days, 3 days, 5 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months 8 months, 9 months, 10 months, 11 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, or 7 years after the last administration of the L. rhamnosus or for the life of the ruminant animal.
Claim interpretation: regarding the composition claims, the functional limitations are drawn to the intended uses of the composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
See whole document especially claims and the following highlighted portions”
“ feed lot diet" is defined as a high grain diet useful for fattening up animals. Non limiting examples are grains, green corn, green apples, carbohydrates (starches, cereal concentrates...), beet pulp, fast fermentable feedstuff or fast fermentable sugars.
Typically, the microbial feed supplement as defined above is combined to a feedlot diet.
Although the microbial feed supplement according to the invention can comprise activated bacteria (that is to say live bacteria, whose reproductive and enzymatic activities are not affected), typically some or all of the bacteria are inactivated.
Other techniques exist and can be used to inactivate microorganisms, such as ionization or light inactivation. Microorganisms can also, for example, be inactivated by storing them for long periods of time at temperatures or with humidity levels which are not compatible with their viability.
According to a particular embodiment, all of the objects of the present invention are designed for polygastric herbivores (non limiting examples being bovinae, cervidae, antilocapridae and camelidae). Even more particularly, the polygastric herbivores are polygastric ruminants such as, but not limited to, cows, sheep, ewes, goats, dears, camels, giraffes.
Claim(s) 27, 28, 30, 31 and 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Putaala et al. CN 109715181 5/3/2019.
Claim interpretation: regarding the composition claims, the functional limitations are drawn to the intended uses of the composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Putaala et al disclose a ruminant feed composition comprising L. rhamnosus HN001 corresponding to the strain deposited under NM09/09514 and soybean or fiber such as and one or more prebiotics such as inulin, galacto-oligosaccharides etc.
Putaala et al disclose the ruminant feed composition may further be used as an ingredient for fermentation to make fermented products such as yoghurt, cheese, fermented cream.
Putaala et al disclose the composition further comprises other probiotic species such as L. acidophilus etc.
Putaala et al disclose the culture supernatant can be used in the composition in lieu of the strain.
See whole of Putaala which some highlighted portions cited below:
In one embodiment, the probiotic composition of the invention further comprises one or more compounds selected from the following strains: lactobacillus acidophilus (Lactobacillus acidophilus) NCFM; lactic acid bifidobacterium (bifidobacterium lactis) Lactobacillus BL-04, Lactobacillus casei (Lactobacillus paracasei LPC37, B. animalis lactis (Bifidobacterium lactis) HN019, HN001 of the rhamnose lactobacillus (Lactobacillus rhamnosus), lactobacillus acidophilus La-14 and/or Bifidobacterium lactic Bi-07.
Probiotic compositions of the invention may additionally contain one or more prebiotics. The term used herein "prebiotics components" refers to for support or enhanced probiotic health effect or assist the probiotic growth and/or activity of any compound, nutrient or other microorganism. Typically, prebiotics are carbohydrates (e.g., oligosaccharides), but the definition does not exclude non-carbohydrate. the most common form of prebiotics on the nutrient are classified as soluble fiber. to a certain extent, many forms of dietary fiber exhibits a prebiotic function of a certain level.
Examples of dietary source of prebiotics comprises soybean, inulin, sources (e.g., Jerusalem artichoke (Jerusalemartichoke), Phakopsora pachyrhizi) and chickory root, oat (raw oat), barley unprocessed wheat, unprocessed and saussurea involucrata mashed fruit. a suitable prebiotic examples include alginates, xanthan gum, pectin, locust bean gum (LBG), inulin, guar gum, galacto-oligosaccharides (GOS), fructo-oligosaccharide (FOS), polydextrose lactitol, lactosucrose, soybean oligosaccharide, isomaltulose (PalatinoseTM), isomalt, glucose oligosaccharide, wood oligosaccharide, manna oligosaccharide, β-glucose, cellobiose, raffinose, cellobiose, gentiobiose, melibiose, cellobiose, cyclodextrin, maltose, fucose, stachyose, panose, aureobasidium pullulans polysaccharide, hair bead flower sugar, resistant starch, galactomannan and all form. particularly preferred example of prebiotics is polydextrose.
The probiotic composition may further be used as ingredient of the following food products such as American cheese sauce, cheese antiblocking agent for grinding and cutting, dessert plate, cream cheese, dry mixing the free fatty acid cream. freeze/thaw dairy fresh cream, freeze/thaw stable beating cream, low-fat and light natural cheddar cheese, low fat Swiss style yoghurt, aerated frozen desserts, hard ice cream, label friendly with improved economic and large capacity hard ice cream, low fat ice cream: the soft ice cream, barbecue sauce, cheese dip sauce, cottage cheese dressing, dry mix poly (Alfredo) sauce, mix cheese sauce, dry mix tomato sauce and so on.
The term "dairy" herein used in a milk medium containing animal and/or plant origin. As milk of animal origin, can be mentioned milk of cow, sheep, goat or buffalo. As milk of plant origin can be fermented substance can be any plant origin can be used according to the invention, in particular derived from soybean, rice or corn fermentation substance.
According to one specific aspect, use according to the invention of the food product is a fermented milk or humanized milk.
For certain aspects, the present invention can be used in dairy product to fermentation and non-dairy products, such as yoghurt product of fermented yoghurt drink, yoghurt, drinking yoghurt, cheese, fermented cream, milk-based desserts. Suitably, the composition can further be used as one or more of cheese, meat applications, or protective cultures in the application component.
In one embodiment, the probiotic composition of the invention further comprises one or more compounds selected from the following strains: lactobacillus acidophilus (Lactobacillus acidophilus) NCFM; lactic acid bifidobacterium (bifidobacterium lactis) Lactobacillus BL-04, Lactobacillus casei (Lactobacillus paracasei LPC37, B. animalis lactis (Bifidobacterium lactis) HN019, HN001 of the rhamnose lactobacillus (Lactobacillus rhamnosus), lactobacillus acidophilus La-14 and/or Bifidobacterium lactic Bi-07.
In one embodiment, the probiotic composition of the invention further comprises one or more kinds of bacterium such as lactobacillus acidophilus NCFM, rhamnose lactobacillus HN001, B. animalis lactis HN019, Bifidobacterium breve Bb-03, B. animalis lactis Bi-07, lactic acid bifidobacterium BI-04, bifidobacterium longum BI-05, lactobacillus acidophilus La-14, Lactobacillus Lb-64 bulgaricus, Lactobacillus brevis Lbr-35, Lactobacillus casei Lc-11. Lactococcus lactis LI-23, Lactobacillus plantarum Lp-115, Lactobacillus paracasei Lpc-37, rhamnose lactobacillus Lr-32 lactobacillus, saliva lactobacillus Ls-33, streptococcus thermophilus St-21, rhamnose lactobacillus GG. B. animalis lactis Bb-12, rhamnose lactobacillus GR-1, Lactobacillus reuteri RC-14, rhamnose lactobacillus Rosell-11, Lactobacillus helveticus Rosell-52, Lactobacillus helveticus LAFTI L10, Lactobacillus casei HA-108, rhamnose lactobacillus HA-111, Lactobacillus brevis HA-112, Lactobacillus plantarum HA-119, Lactobacillus fermentum HA-179, Lactobacillus reuteri HA-188.
For better understanding, the supernatant can be directly used in the formulations of the present invention, or before use can separate one or more metabolites from the supernatant by any suitable method.
Claim(s) 1, 5, 6, 11-13, 17, 25, 27, 30, 31, 33 and 43 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berger et al. WO 2012/147044 11/1/2012, cited in IDS.
Claim interpretation: regarding the composition claims, the functional limitations are drawn to the intended uses of the composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Berger et al disclose a method for:
a. Inhibiting the growth of methane producing bacteria and/or archaea in the forestomach of ruminant animals,
b. reducing ruminal methane production by a ruminant animal;
c. increasing feed efficiency in a ruminant animal; or
d. improves the body weight of the ruminant animal;
e. increases the yield of milk and/or milk components produced from the ruminant animal;
f. enhances the growth or productivity of the ruminant animal; and
g. increases the yield of milk fat, milk protein or milk solids in milk produced from the animal; h. reducing the ability of the rumen microbiome to produce methane in a ruminant animal.
wherein the method comprises administering to the animal an effective amount of a Lacticaseibacillus rhamnosus strain(L. rhamnosus) wherein the L. rhamnosus has been killed (inactivated).
See page 1 under statements of the invention, page 2, p. 3, p.8 3rd paragraph
Berger et al disclose the same method step of administering and will also inhibit the growth of hydrogenotrophic methanogens in the forestomach of the animal, wherein the methanogen is from the genus Methanobrevibacter.
Berger et al disclose the killed L. rhamnosus is administered in
a composition that is a food, drink, food additive, drink additive, animal feed, animal feed additive, animal feed supplement, dietary supplement, carrier, nutritional product, supplement, pharmaceutical wherein the feed is grain, hay, silage, grass or corn some of which are also fiber; and drinking water(see p. 8-10).
Berger et al disclose the composition administered to the ruminant comprising the killed L. rhamnosus further comprises Propionibacterium species and other species of Lactobacillus. See p. 2-3.
Berger et al disclose the L. rhamnosus is administered simultaneously with other probiotics such as Propionibacterium species and other species of Lactobacillus and also prebiotic such as raffinose which is also dietary fiber. See p. 2-3 and p. 9.
Berger et al disclose the ruminant animal is a bovine (cattle), goat, cattle, sheep, Illama, yak, water buffalo, bison, alpaca, nilgai, wildebeest, and members of the Antilcapridae. See p. 3 and p. 5.
Berger et al disclose the same method step of administering killed L. rhamnosus to a ruminant animal, therefore the method will result in the inhibition of the growth of methane- producing bacteria and/or archaea in the forestomach of the ruminant animals, the reduction of methane production by the ruminant animal, and/or the increased feed efficiency in the ruminant animal persists for at least 2 days, 3 days, 5 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months 8 months, 9 months, 10 months, 11 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, or 7 years after the last administration of the killed L. rhamnosus or for the life of the ruminant animal.
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.
Claim(s) 1 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berger et al. WO 2012/147044 11/1/2012, cited in IDS.
Berger et al disclose a method for:
a. Inhibiting the growth of methane producing bacteria and/or archaea in the forestomach of ruminant animals,
b. reducing ruminal methane production by a ruminant animal;
c. increasing feed efficiency in a ruminant animal; or
d. reducing the ability of the rumen microbiome to produce methane in a ruminant animal; wherein the method comprises administering to the animal an effective amount of a Lacticaseibacillus rhamnosus strain(L. rhamnosus) wherein the L. rhamnosus has been killed (inactivated).
See page 1 under statements of the invention, page 2, p. 3 and p.8 3rd paragraph.
Berger et al disclose the effective amount of the at least one strain of bacteria is 10^5 -10^13 CFU, 10^7 -10^112 CFU, 10^8 -10^11 CFU or 10^10 CFU.
Berger et al does not disclose that the killed L. rhamnosus is administered in an amount of a. from 104 to 1013 colony forming units per kilogram of dry weight carrier feed, from 104to 1010 colony forming units per kilogram of body weight of the animal per day, or from 104 to 1013 colony forming units per day; or from 108 to 1012 colony forming units per kilogram of dry weight carrier feed, from 105 to 108 colony forming units per kilogram of body weight of the animal per day, or from 106 to 1013 colony forming units per day.
Double Patenting
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 27-28 and 30-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-12, 14-16, 19-23, 25 and 36-37 of copending Application No. 18,259,014 (‘014). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘014 claims disclose:
Claim 27: a feed composition comprising Lacticaseibacillus rhamnosus strain HN001 or a derivative thereof, wherein the derivative is a cell lysate of the strain, a cell suspension of the strain, a bacteriocin extract of the strain, a culture supernatant of the strain, or killed L. rhamnosus, and wherein the ruminant feed composition: comprises corn, soybean, forage, graindistiller's grain, sprouted grain, legumes, fiber, fodder, grass, hay, straw, silage, kernel, leaves, meal, mash feed, lick block, or molasses; and/or b. further comprises a vaccine that inhibits methanogens or methanogenesis, and/or a natural or chemically-synthesized inhibitor of methanogenesis and/or methanogen inhibitor.
Claim 28: a feed composition is in the fermented yoghurt-style formed through a process of growing the HN001 strains using a milk-based carrier.
Claim 30: Claim 11 of the ‘014 claims disclose the composition further comprises a at least one additional microorganism of a different species or strain, a vaccine that inhibits methanogens or methanogenesis, and/or a natural or chemically-synthesized inhibitor of methanogenesis and/or methanogen inhibitor, such as bromoform.
Claim 31: Claim 12 of the “014 claims disclose the composition further comprises
one or more agents selected from one or more prebiotics, one or more
probiotics, one or more postbiotics, one or more sources of dietary fiber, one or more galactooligosaccharides, one or more short chain galactooligosaccharides, one or more long chain galactooligosaccharides, one or more fructooligosaccharides, inulin, one or more galactans, one or more fructans, lactulose, or any mixture of any two or more thereof.
Claim 32: Claim 10 of the “014 claims disclose the derivative of
L. rhamnosus HN001 is a culture supernatant of the strain.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicants disagrees with the Office Action’s assertion and request the rejection be held in abeyance until allowable subject matter is indicated. This has been carefully considered but is not persuasive. Applicants provide any statements regarding the disagreement with the rejection. Thus, the rejection will continue to be maintained.
Status of Claims
Claims 1, 5-6, 8, 10-13, 17, 21, 24-25, 27-28, 30-33 and 43 are rejected.
Claim 20 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645