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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/16/2026 has been entered. Claims 1, 6, 10 and 27 have been amended. Claims 2-4, 7, 9, 14-16, 18-19, 22-23, 26, 29, and 34-42 have been canceled. Claims 1, 5-6, 8, 10-13, 17, 20-21, 24-25, 27-33 and 43 are pending and are under examination.
Claim Rejections Withdrawn
The rejection of claims 6 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment to the claims.
The rejection of claims 6, 8, 10, 12, 21,24, 25, 28 and 32 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 27, 30, and 32 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 Journal of Microbiology, Biotechnology and Food Sciences 2013: 2(6) 2462-2468, cited in IDS is withdrawn upon further consideration and in view of the definition of “feed” as material(s) that are consumed by animals and contribute energy and/or nutrients to an animal’s dies on page 20 of the instant specification lines 26-28.
The rejection of 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 EP 2245943 cited in IDS is withdrawn in view of the amendment to the claims to remove the limitation “killed L. rhamnosus”.
The rejection of claim(s) 1, 5, 6, 11-13, 17, 25, 27, 30, 31, 33 and 43 under 35 U.S.C. 102(a)(1) as being anticipated by Berger et al. WO 2012/147044 11/1/2012, cited in IDS is withdrawn in view of the amendment to the claims to remove the limitation drawn to “killed L. rhamnosus”.
The rejection of claim(s) 1 and 8 under 35 U.S.C. 103 as being unpatentable over Berger et al. WO 2012/147044 11/1/2012, cited in IDS is withdrawn in view of the amendment to the claims to remove the limitation “killed L. rhamnosus”.
The rejection of claims 27-28 and 30-32 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) is withdrawn. The terminal disclaimer filed on 04/16/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 18/259014 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claimed Rejections Maintained
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 (Jerusalem artichoke), 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.
Response to Applicant’s Argument
Applicants argues that Putaala relates to a new bacterium that is useful for preventing and/or treating urogenital disorders (abstract) wherein the new bacterium is Lactobacillus helveticus LH0138 and that Putaala does not teach or suggest the use of L. rhamnosus strain HN001 wherein a representative sample of the strain has been deposited under deposit number NM97/09514 dated 18 August 1997, or derivative thereof, in a ruminant fee composition as claimed.
Applicant’s argument has been considered but is not found persuasive. Putaala et al discloses the L. rhamnosus strain HN001. According to the instant specification, strain HN001 was deposited in 1997 under deposit number NM97/09514. Putaala discloses a probiotic composition comprising the HN001 strain.
Putaala et al disclose 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.
The recitation of “ruminant” does not imply any structure to the claimed ruminant feed composition. The definition of “feed” as material(s) that are consumed by animals and contribute energy and/or nutrients to an animal’s diet on page 20 of the instant specification lines 26-28.
Putaala et al disclose many examples of a feed that comprises the probiotic composition. Putaala et al disclose the probiotic compositions of the invention may additionally contain one or more prebiotics. Putaala et al disclose 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. Putaala provides several examples of said prebiotic which are material(s) that are consumed by animals and contribute energy and/or nutrients to an animal’s diet. Putaala et al disclose that the probiotic composition can be used as ingredients in food products which meets the definition of feed including cheese and yoghurt, diary of animal or plant origin as set forth above in the rejection.
Putaala et al specifically discloses that the probiotic composition of the present invention can be used as, or can be used for preparing food products. Here, the term "food" used in general, and human food and animal food (i.e., feed). In one aspect, the food is for human consumption.
Applicants argument that Putaala does not disclose ruminant feed composition and is not concerned with such and does not mention ruminants.
Applicants argument is considered but is not found persuasive Putaala et al does not disclose administering the feed composition comprising HN001 to ruminants. However, the instant claims are not drawn to feeding a ruminant. The instant claims are composition claims and the recitation of ruminant does not impose any structure to the claimed composition. The composition disclosed by Putaala et al would be suitable for administration to a ruminant but the claims are not drawn to feeding a ruminant the ruminant feed composition.
Applicants argue that Putaala also does not unambiguously disclose a composition comprising soybean or fiber that comprises HN001 and that HN001 is listed in a laundry list of bacterial species and strains and soybean and fiber are merely listed as some possible components of the composition disclosed.
Applicants argument has been considered but is not found persuasive. The teachings of Putaala et al anticipates the claimed ruminant feed composition. HN001 is not disclosed in a laundry list of bacterial species. HN001 is listed as part of one or more strains that can be in the probiotic composition. In this embodiment, the list of bacteria is 6 strains:
“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.”
Therefore, Applicants argument that there is no teaching or guidance in Putaala et al that would lead a skilled artisan to select HN001 from the laundry list of bacterial species and strains and then produce a ruminant feed composition comprising soybean or fiber is not persuasive. This is because Putaala et al anticipates the claimed animal feed composition and there is no picking or choosing to arrive at a particular combination which would be a relevant consideration in a rejection under 35 USC 103 (obviousness). Applicants argument about picking out two references and combining the references to arrive at the claimed invention is not persuasive because this argument is relevant to an obviousness rejection under 35 USC 103. Only Putaala is cited in the anticipation rejection and there is no combining of two refences. Putaala et al clearly directs one of skill in the art to use HN001 in the probiotic composition. In addition, the instant claimed composition allows for other microorganisms in the composition.
Regarding soybean and fiber, Putaala et al specifically discloses as cited above in the rejection that the probiotic composition contains one or more prebiotics such as soybean and fiber sources such as soluble fiber, inulin sources (e.g., Jerusalem artichoke (Jerusalem artichoke), Phakopsora pachyrhizi and chicory root), oat (raw oat), barley unprocessed wheat, unprocessed and saussurea involucrata mashed fruit.
Applicant argues that the Examiner must show that each and every limitation of the claim is taught or suggested by the combination of references or would have been obvious based on the knowledge of those skilled in the art.
Applicants argument has been carefully considered but is not found persuasive. The disclosure of Putaala et al anticipates the claimed ruminant feed composition. Therefore, Applicant argument about combination of references and obviousness is moot.
For these reasons, the rejection is maintained.
New Claim Rejections - 35 USC § 102
Claim(s) 27, 30 and 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mercado et al. AU 2016100865 07-14-2016.
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.
Claim 27 and 31 : Mercado et al disclose a ruminant feed composition comprising Lacticaseibacillus rhamnosus strain aka HN001 strain deposited under deposit number NM97/09514 (according to the instant specification) wherein the composition further comprises one or more fiber e.g. fiber 9 FOS or MOS, inulins, oligofructose, frutosaccharides etc. See paragraph 33.
Mercado et al disclose the animal is cattle (see paragraph 27).
See paragraph 13, 17-19, 22, 23, 25, 27, 32, 49. See p. 14 table 5 and p. 27.
Claim 30: Mercado et al disclose that the composition further comprises 7 other probiotics species.
Claim(s) 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mercado et al. AU 2016100865 07-14-2016.
Mercado et al disclose a method that comprises administering to an animal Lacticaseibacillus rhamnosus strain aka HN001 strain deposited under deposit number NM97/09514 (according to the instant specification).
Mercado et al disclose the L. rhamnosus is administered in a dosage unit form (paragraph 31) and the composition further comprises vitamins or one or more prebiotics such as fiber e.g. fiber 9 FOS or MOS, inulins, oligofructose, frutosaccharides etc. See paragraph 33.
Mercado et al disclose the animal is cattle (see paragraph 27).
See paragraph 13, 17-19, 22, 23, 25, 27, 32, 49. See p. 14 table 5 and p. 27.
Mercado et al disclose the same method step of administering of the strain to an animal and thus will also result in inhibiting the growth of methane-producing bacteria and/or archaea in the forestomach of ruminant animals; reducing ruminal methane production by a ruminant animal; increasing feed efficiency in a ruminant animal; or
Enhancing the growth and/or productivity in a ruminant animal, increasing the yield of milk and or milk components produced from a ruminant animal; improving the body weight and/or body composition of a ruminant animal, and reducing the ability of the rumen microbiome to produce methane in a ruminant animal.
The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds, as well as a method of using them for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the inventors had merely found a new property of the compound and such a discovery did not constitute a new use. See MPEP 2112.02 II.
This rejection can be overcome by reciting similarly in claim 1 that the method comprises administering “effective amounts”. The term "effective amount" as defined on p. 10 of the specification refers to a quantity of Lacticaseibacillus rhamnosus strain HN001 sufficient to allow a desired effect, i.e., inhibition of the growth of methane- producing bacteria and/or archaea in the forestomach of the animal, a reduction in methane production or emission by the animal, or an increase in feed efficiency in the animal, in comparison with a reference.
The recitation of “effective amount” would be effective to overcome the instant rejection regarding limitations inhibition of the growth of methane- producing bacteria and/or archaea in the forestomach of the animal, a reduction in methane production or emission by the animal, or an increase in feed efficiency in the animal i.e. claim 27 parts a-c and g but would not overcome the rejection regarding claim 27 part d. enhancing the growth and/or productivity in a ruminant animal; part f. increasing the yield of milk and or milk components produced from a ruminant animal; and part f, improving the body weight and/or body composition of a ruminant animal.
The definition of “effective amount” does not cover enhancing the growth and/or productivity in a ruminant animal; increasing the yield of milk and or milk components produced from a ruminant animal; improving the body weight and/or body composition of a ruminant animal.
Status of Claims
Claims 27-28 and 30-33 are rejected. Claims 1, 5-6, 8, 10-13, 17, 20-21, 24-25 and 43 are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLUWATOSIN A OGUNBIYI whose telephone number is (571)272-9939. The examiner can normally be reached IFP.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645
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