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 . 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.
Priority
The instant application is a 371 of PCT/EP2022/053678 filed on 02/15/2022 and claims domestic benefit to US provisional application no. 63/149,812 filed on 02/16/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/11/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of the Claims
The preliminary claim amendments filed on 08/11/2023 is acknowledged. Claims 1-3, 6-7, 9, 11, 19, 21, 23, 27-28, 30, and 34-35 are amended. Claims 4-5, 8, 10 ,12-18, 20, 24-26, 29, 31-33, and 36 are cancelled.
Accordingly, claims 1-3, 6-7, 9, 11, 19, 21-23, 27-28, 30, and 34-35 are pending and being examined on the merits herein.
Claim Objections
Claims 19 and 28 are objected to because of the following informalities:
Claims 19 and 28 recite “method of …”, which does not begin with a capital letter and is suggested to start with “A”. MPEP 608.01(m) states that “Each claim begins with a capital letter and ends with a period.”
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.
Claims 1-3, 6-7, 9, 11, 19, 21-23, 27-28, 30, and 34-35 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.
Claims 1, 19, 28, and 35 recite “… wherein said synthetic oligosaccharide preparation comprises at least n fractions of oligosaccharides each having a distinct degree of polymerization selected from 1 to n (DP1 to DPn fractions), wherein n is an integer greater than or equal to 2 … “
Claims 1, 19, 28, and 35 are indefinite because these claims recite two “n” variables and therefore it is unclear if the “n is an integer greater than or equal to 2” is referring to the “at least n fractions of oligosaccharides” or the “distinct degree of polymerization selected from 1 to n (DP1 to DPn fractions)”.
Claims 2-3, 6-7, 9, and 11 depend from claim 1, claims 21-23 and 27 depend from claim 19, and claims 30 and 34 depend from claim 28 but do not overcome the described indefinite issue.
For purposes of examination, both “n” variables are being interpreted as independently being an integer greater than or equal to 2.
Claims 1, 19, 28, and 35 recite “… wherein each fraction comprises from at least about 0.5% to about 90% (e.g. from 1% to 90%; or e.g. from about 0.5% to about 15%) …”
A broad range together with a narrow range that falls within the broad range (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 1, 19, 28, and 35 recite the broad recitation “from at least about 0.5% to about 90%”, and the claim also recites “(e.g. from 1% to 90%; or e.g. from about 0.5% to about 15%)” which is the narrower statement of the range. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. The phrase “e.g.” is exemplary language, and it is not clear if the narrower limitation that follows is exemplary or a limitation. See MPEP 2173.05(d).
Claims 2-3, 6-7, 9, and 11 depend from claim 1, claims 21-23 and 27 depend from claim 19, and claims 30 and 34 depend from claim 28 but do not overcome the described indefinite issue.
Claims 9, 27, and 34 recite “wherein the concentration of said synthetic oligosaccharide preparation is … at least 50 ppm (e.g. at least 50, 70, 100, 150, 200, 300, 400, 500 ppm) of the feed …”
A broad range together with a narrow range that falls within the broad range (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 1, 19, 28, and 35 recites the broad recitation “at least 50 ppm”, and the claim also recites “(e.g. at least 50, 70, 100, 150, 200, 300, 400, 500 ppm)” which is the narrower statement of the range. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. The phrase “e.g.” is exemplary language, and it is not clear if the narrower limitation that follows is exemplary or a limitation. See MPEP 2173.05(d).
Claim 19 recites “A method of reducing the population of E. coli … , wherein the systemic inflammation and/or local inflammation of the animal … “.
There is insufficient antecedent basis for the limitation “the systemic inflammation and/or local inflammation” in the claim because there is no prior recitation of a “systemic inflammation and/or local inflammation”.
Claims 1, 19, 28, and 35 recites “said feed additives”.
There is insufficient antecedent basis for the limitation “said feed additives” in the claim because there is no prior recitation of “feed additives”.
Claims 9, 27, and 34 recite “the feed”
There is insufficient antecedent basis for the limitation “the feed” in the claim because there is no prior recitation of a “feed”.
Claims 23 and 30 recite “the fecal sample”.
There is insufficient antecedent basis for the limitation “the fecal sample” in the claim because there is no prior recitation of a “fecal sample”.
The recitation “Use of” in claim 35 is suggestive of a method, however the claim recites a use without setting forth any steps involved in the use. See MPEP 2173.05(q).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 35 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because it is unclear if the claim is directed toward a product (synthetic oligosaccharide preparation) or a method (the recited a), b), and/or c) limitations). See MPEP 2173.05(q).
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.
Claim(s) 1-3, 6-7, 9, 11, 19, 21-23, 27-28, 30, and 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Murphy et al. (WO2017083520A1 in PTO-892) in view of Geremia et al. (WO2016007778A1 in IDS filed 08/11/2023), Goodman et al. (US20170209504A1 in PTO-892), Shoaf et al. (Infection and Immunity, 2006 in PTO-892), Ding et al. (Plos One, 2019 in PTO-892), and Murphy et al. (WO2017083520A1 in PTO-892).
Murphy discloses animal feed compositions comprising oligosaccharides for administration to animals suitable for improving animal health, including, for example, to treat diseases or disorders or to enhance animal growth (see Abstract and paragraph 0001). Murphy discloses their compositions are formulated to target certain regions of the GI tract in animals and modulate at least a portion of gut microbiome to improve animal health (see paragraph 0004). Murphy discloses that one or more beneficial bacterial taxa may be increased in the gastrointestinal tract, or one or more pathogenic bacterial taxa may be decreased in the gastrointestinal tract, or any combinations of the foregoing may be achieved, by administering their oligosaccharide compositions (paragraph 0175).
Murphy discloses that their oligosaccharide compositions are produced by combing a feed sugar with a catalyst to form a reaction mixture (paragraph 0007), and further discloses that their oligosaccharides may include galacto-oligosaccharides, fructo-oligosaccharides and among others (paragraph 0041). Murphy discloses their compositions can be provided to an animal at an inclusion rate of between 50 ppm and 500 ppm (paragraph 0193). Murphy discloses that various types of animals can be administered including chicken, duck, turkey, and among others (paragraph 0033). Murphy discloses their compositions can be combined with various other ingredients including probiotics (paragraphs 0130 and 0136-0140).
The difference between Murphy and the claimed invention is that Murphy does not disclose administering the recited synthetic oligosaccharide preparation. Furthermore, even though Murphy discloses administering oligosaccharide compositions to decrease pathogenic bacteria in the GI tract, Murphy does not disclose reducing LEE/non-LEE genes of EHEC, EPEC, APEC in the GI tract as well as reducing these E. coli strains and inflammation caused by these E. coli strains.
Geremia discloses the production of oligosaccharides, including functionalized oligosaccharides, from one or more sugars, such as one or more monosaccharides, using polymeric and solid- supported catalysts containing acidic and ionic groups (see Abstract). Geremia discloses that the condensation of sugars to soluble oligosaccharides is of great economic, nutritional, and therapeutic relevance (paragraph 0003). Geremia discloses that oligosaccharides can be added into animal feeds and interact favorably with the ecosystem of human and animal gut micro biota, stimulating the growth of advantageous gut bacteria, inhibiting the growth of undesirable gut bacteria, and inhibiting the ability of pathogenic bacteria to colonize the gut (paragraphs 0003 and 0005).
Geremia demonstrates the DP distribution of several oligosaccharide reaction mixtures produced using their method in Table 1A (paragraph 0299). Here, the entries meet the limitation of at least n fractions of oligosaccharides each having a distinct degree of polymerization selected from 1 to n, wherein n is an integer greater than or equal to 2. Geremia also discloses that the reaction method results in sugar degradation products of less than 10% of any one or combination of 1,6-anhydroglucose and others (see 71 on page 148), which meets the limitation of a DP1 fraction having between 0.5%-90% anhydro-subunit containing sugar. Furthermore, Example 80 of Geremia (paragraph 0414) demonstrates the conversion of monomeric glucose and galactose into galacto-oligosaccharides, and Example 81 of Geremia (paragraph 0415) demonstrates the conversion of monomeric fructose to fructo-oligosaccharides. Here, the conversion to fructo- oligosaccharides yielded DP2 oligosaccharides and di-anhydro disaccharides at 37% mol/mol, which meets the limitation of a DP2 fraction having between 0.5%-90% anhydro-subunit containing oligosaccharide.
Goodman teaches probiotic formulations comprising a biocompatible microsphere, a biofilm-generating probiotic bacterium, a prebiotic, and/or a prebiofilmic (see Abstract).
Goodman teaches that probiotics are live microbes that have the capacity to enhance immune system activity with few probiotic microbes also having anti-inflammatory effects (paragraph 0009-0010). Goodman discloses that Lactobacillus reuteri (L. reuteri) is a commonly used probiotic that has been shown to regulate mammalian and avian intestinal immune system (paragraph 0010). Goodman further teaches that L. reuteri can down-regulate both cytokine and chemokine production by colonic epithelial cells stimulated with a pathogenic Citrobacter rodentium (C. rodentium) as well as reduce colonic inflammation in both juvenile and adult animals (paragraph 0010-0012). Goodman teaches that L. reuteri also attenuates the exacerbating effects of stress on C. rodentium-induced colitis as marked by reductions in colonic cytokines and chemokines, inflammatory cell infiltration, colonic epithelial cell defects, and pathogen translocation from the colon to the spleen (paragraph 0012).
Goodman teaches that C. rodentium is a closely related pathogen to human enteropathogenic E. coli (EPEC) and enterohemorrhagic E. coli (EHEC) infection and is widely used as a model to these pathogens (paragraph 0005). Goodman teaches that C. rodentium results in colonic pathology that is nearly indistinguishable from that produced by EPEC and EHEC in humans, and that C. rodentium possesses a homologue of the locus of enterocyte effacement (LEE) pathogenicity island carried by EPEC and EHEC that encodes for the effector proteins necessary for the development of attaching and effacing (A/E) lesions (paragraph 0005).
Goodman teaches that their probiotic formulations comprise the probiotic bacterium Lactobacillus reuteri (L. reuteri) (claim 8). Goodman discloses that the probiotic bacterium provides one or more of supporting anti-bacterial immunity, enhancing or supporting the gastrointestinal barrier, treating dysbiosis, treating or preventing gut pathogenesis, supporting gastrointestinal health, a chronic and/or a recurrent disease that is caused by pathogenic bacteria displacing healthy bacteria or antagonizing disease-related bacterial infections (claim 9). Goodman discloses that the probiotic bacterium also prevents pathogen colonization and/or limits excessive inflammatory responses by down-regulating cytokine and chemokine production (claim 10). Goodman teaches that the subject for treatment can be non-human animals such as livestock (paragraph 0060).
Goodman teaches that their probiotic formulations also comprise a prebiotic which comprises water-soluble carbohydrates such as inulin, oligofructose, fructo-oligosaccharide, galacto-oligosaccharide, glucose, maltose, maltodextrins, polydextrose, sucrose, fructose, lactose, isomaltulose, polyols, glycerol, and combination thereof (claim 5). Goodman teaches that the prebiotic is a nutritional supplement for the probiotic bacterium and helps stimulates the growth of beneficial bacteria while also inhibiting the grow of pathogenic bacteria (paragraph 0041). Goodman discloses that inulin, fructo-oligosaccharides, and galacto-oligosaccharides support lactobacilli growth (paragraph 0129).
Goodman demonstrates in Example 2 (paragraphs 0106-0107) that colony-forming unites reduced for C. rodentium in an vitro model when in the presence of their L. reuteri formulations (see Table 1 paragraph 0107). Goodman also demonstrates in Example 3 that there was a 10-fold reduction in C. rodentium penetration to the spleen in an in vivo mouse model when treated with L. reuteri biofilm (paragraph 0108 and FIG. 4). Goodman discloses in Example 4.1 (paragraphs 0110-0112) that in their in vivo experiments, each mouse is assessed by counting total lactobacilli levels in fecal samples daily for 12 days (paragraph 0111). Goodman discloses in addition, real-time PCR method is used to assess 16S rRNA gene sequence copy numbers for the Lactobacillus genus, and that the gene copy numbers are determined in the feces daily for 12 days, as well as in the colon, cecum, small intestine using real-time PCR on specified days (paragraph 0112).
Shoaf discloses prebiotic galacto-oligosaccharides that reduce adherence of enteropathogenic E. coli to tissue culture cells (see Abstract). Shoaf discloses that prebiotic oligosaccharides may confer health benefits via their antiadhesive activity by directly inhibiting infections by enteric pathogens due to their ability to act as structural mimics of the pathogen binding sites that coat the surface of gastrointestinal epithelial cells (see Abstract). Shoaf demonstrates the adherence of EPEC strain E2348/69 on HEp-2 and Caco-2 cells, in the presence of fructooligosaccharides, inulin, galactooligosaccharides (GOS), lactulose, and raffinose was determined by cultural enumeration and microscopy (see Abstract and Fig. 1). Shoaf discloses that galacto-oligosaccharides exhibited the greatest adherence inhibition on both HEp-2 and Caco-2 cells, reducing the adherence of EPEC by 65 and 70%, respectively (see Abstract and Fig. 2). Shoaf concludes that some prebiotic oligosaccharides may have antiadhesive activity and directly inhibit the adherence of pathogens to the host epithelial cell surface (see Abstract).
Ding discloses the effects of Lactobacillus plantarum 15-1 and fructo-oligosaccharides on the response of chicken broilers to pathogenic E. coli O78 (APEC) challenge (see Abstract). Ding discloses that one-day-old broiler chicken were randomly allocated to five treatment groups: basal diet and orally administered sterile saline (negative control, n-control); basal diet challenged with E. coli O78 (positive control, p-control); basal diet supplemented with 1×108 CFU/kg L. plantarum 15–1 and challenged with E. coli O78 (LP); basal diet supplemented with 5 g/kg fructo-oligosaccharides (FOS) and challenged with E. coli O78 (FOS); and basal diet supplemented with both L. plantarum 15–1 and FOS and challenged with E. coli O78 (LP+FOS) (see Abstract). Ding demonstrates in Fig. 1-4 (pages 7-9) that broilers in the LP, FOS, and LP+FOS groups displayed a decrease of crypt depth at day 14 compared with the control groups. Furthermore, at days 14 and 21, the broilers in the LP group exhibited reduced serum levels of diamine oxidase (DAO) compared with the p-control group (p<0.05), and the broilers in the LP+FOS group showed increased serum concentrations of IgA and IgG relative to both control groups and decreased DAO levels compared with the p-control group (p<0.05). Moreover, the LP group displayed higher levels of acetic acid and total short-chain fatty acids (SCFAs) compared with the p-control group at day 14 (p<0.05), and the FOS group showed higher levels of valeric acid and total SCFAs at day 21 (p<0.05). The LP+FOS group also displayed a higher level of butyric acid at day 14 (p<0.05) (see Abstract). Ding concludes that dietary supplementation with L. plantarum 15–1 and FOS may ameliorate the negative effects of E. coli O78 (see last paragraph page 11), as the supplementation improved intestinal health by increasing the levels of SCFAs and mitigating the damage caused by E. coli O78, thus preventing intestinal damage and enhancing the immune response (see Abstract)
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the oligosaccharides in the animal feed compositions disclosed in Murphy with the oligosaccharide preparations disclosed in Geremia at 50-500 ppm concentration as disclosed in Murphy, and further select the galacto-oligosaccharide and fructo-oligosaccharide preparations of Geremia to inhibit the growth of pathogenic bacteria and reduce inflammation caused by pathogenic bacteria such as EPEC or EHEC in the GI tract of an animal as suggested in Goodman and disclosed by Shoaf as well as ameliorate the negative effects of E.coli O78 (APEC) as disclosed in Ding to arrive at the claimed invention One of ordinary skill in the art would have made the substitution of the oligosaccharides at 50-500 ppm concentration with a reasonable expectation of success because both Murphy and Geremia disclose the use of oligosaccharides for stimulating growth of healthy bacteria in the gut while inhibiting pathogenic bacteria in animals, and Murphy provides further guidance that a ppm amount between 50 – 500 ppm of oligosaccharides is effective for modulating the gut microbiome to improve animal health . Furthermore, one of ordinary skill in the art would have been motivated to select galacto-oligosaccharide and fructo-oligosaccharide preparations to inhibit the growth of pathogenic bacteria and reduce inflammation caused by pathogenic bacteria such as EPEC or EHEC in the GI tract of an animal as well as ameliorate the negative effects of E.coli O78 (APEC) because Goodman suggests that oligosaccharides can help promote beneficial bacteria while inhibiting pathogenic bacteria including EPEC and EHEC in animals, Shoaf provides guidance that galacto-oligosaccharides exhibited the greatest adherence inhibition of enteropathogenic E. coli to tissue culture cells, and Ding provides guidance that fructo-oligosaccharide supplementation in broiler chickens improved intestinal health by increasing the levels of SCFAs and mitigating the damage caused by E. coli O78, thus preventing intestinal damage and enhancing the immune response. One of ordinary skill in the art would have a reasonable expectation of success because Murphy discloses including oligosaccharides such as galacto-oligosaccharides and fructo-oligosaccharides in their animal feed compositions and further suggests that these oligosaccharides can help promote beneficial bacteria while inhibiting pathogenic bacteria.
Lastly, the combined references do not teach a method of reducing LEE and non-LEE gene from EPEC, EHEC, and APEC wherein a 10% reduction of LEE and non-LEE gene populations occurs as recited in instant claims 1-3 and 35. Furthermore, the combined references also do not teach a method of reducing these E. coli strains and inflammation caused by these E. coli strains, wherein a 10% inflammation reduction occurs as recited in instant claims 19, 22-23, 28, 30, and 35. However, these limitations would flow naturally from the combined references described above because the combined references teach treating an animal to reduce pathogenic EPEC, EHEC, and APEC comprising feeding the animal a recited oligosaccharide feed composition at 50-500 ppm, and as evidenced in paragraph 0127 of the instant specification, a 500 ppm test material comprising the recited oligosaccharide preparation was used which resulted in the recited method limitations (also see paragraphs 0150-0151 of the instant specification).
MPEP 2145 II recites “The fact that appellant 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." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
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 1-3, 6-7, 9, 11, 19, 21-23, 27-28, 30, and 34-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-8 of U.S. Patent No. 11,911,405 in view of Murphy et al. (WO2017083520A1 in PTO-892), Goodman et al. (US20170209504A1 in PTO-892), Shoaf et al. (Infection and Immunity, 2006 in PTO-892), and Ding et al. (Plos One, 2019 in PTO-892).
Claim 5 of US’405 recites a method of increasing the feed efficacy of an animal, the method comprising: administering a nutritional composition comprising a base nutritional composition and a synthetic oligosaccharide preparation to an animal, wherein said synthetic oligosaccharide preparation comprises at least n fractions of oligosaccharides each having a distinct degree of polymerization selected from 1 to n (DP1 to DPn fractions), wherein n is an integer greater than 3; and wherein each of a DP1 and DP2 fraction independently comprises from about 0.5% to about 15% of anhydro-subunit containing oligosaccharides by relative abundance as determined by mass spectrometry. Claim 8 of US’405 recites wherein said nutritional composition comprises at least 100 ppm, 200 ppm, 300 ppm, 400 ppm, 500 ppm, 600 ppm, 700 ppm, 800 ppm, 900 ppm, 1000 ppm, 1500 ppm, or 2000 ppm oligosaccharide preparation.
The difference between the reference application and the claimed invention is that the reference application does teach a method for treating the pathogen E. coli as recited in the instant claims.
The independent teachings of Murphy, Goodman, Shoaf and Ding are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have administered the composition recited in the reference application in the 50-500 ppm amounts disclosed in Murphy to stimulate the growth of beneficial bacteria while also inhibiting the grow of pathogenic bacteria and reduce inflammation caused by pathogenic bacteria such as EPEC or EHEC in the GI tract of an animal as suggested in Goodman and disclosed by Shoaf as well as ameliorate the negative effects of E.coli O78 (APEC) as disclosed in Ding to arrive at the claimed invention. One of ordinary skill in the art would have made the modification of the ppm amounts with a reasonable expectation of success because Murphy provides guidance of animal feed compositions comprising oligosaccharides and also discloses that a ppm amount between 50 – 500 ppm of oligosaccharides is effective for modulating the gut microbiome to improve animal health. Furthermore, one of ordinary skill in the art would have been motivated to administer the composition recited in the reference application for inhibiting EPEC,EHEC, or APEC in the gut as well as reducing inflammation caused by these pathogenic bacteria because Shoaf provides guidance that galacto-oligosaccharides exhibited the greatest adherence inhibition of enteropathogenic E. coli to tissue culture cells, and Ding provides guidance that fructo-oligosaccharide supplementation in broiler chickens improved intestinal health by increasing the levels of SCFAs and mitigating the damage caused by E. coli O78, thus preventing intestinal damage and enhancing the immune response. One of ordinary skill in the art would have a reasonable expectation of success because Goodman suggests the use of oligosaccharides for stimulating growth of healthy bacteria in the gut while inhibiting pathogenic bacteria including EPEC and EHEC in animals including chickens.
The combination of the reference application and prior art references described above do not teach a method of reducing LEE and non-LEE gene wherein a 10% reduction of LEE and non-LEE gene populations occurs as recited in instant claims 1-3 and 35. Furthermore, the reference application also does not teach a method of reducing E. coli or reducing inflammation caused by E.coli infection in the GI tract of an animal wherein a 10% inflammation reduction occurs as recited in instant claims 19, 22-23, 28, 30, and 35. However, these limitations would flow naturally from the combination of the reference application and prior art references described above because the combination recites treating an animal with pathogenic EPEC, EHEC, and APEC comprising feeding the animal an oligosaccharide containing feed composition at 50-500 ppm, and as evidenced in paragraph 0127 of the instant specification, a 500 ppm test material comprising the recited oligosaccharide preparation was used which resulted in the recited method limitations (also see paragraphs 0150-0151 of the instant specification).
MPEP 2145 II recites “The fact that appellant 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." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
Claims 1-3, 6-7, 9, 11, 19, 21-23, 27-28, 30, and 34-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18/839, 554 (‘554) in view of Murphy et al. (WO2017083520A1 in PTO-892), Goodman et al. (US20170209504A1 in PTO-892), Shoaf et al. (Infection and Immunity, 2006 in PTO-892), and Ding et al. (Plos One, 2019 in PTO-892).
Claim 1 of ‘554 recites a method for modulating the level of at least one secondary metabolite (e.g. neutrotransmitter) in the body of an animal (e.g. increasing the level of gamma-aminobutyric acid (GABA) in the gastrointestinal tract of the animal; and/or increasing the ratio of kynurenine: tryptophan in the body of the animal; and/or increasing the ratio of peripheral serotonin: tryptophan in the digestive system of the animal; and/or increasing the ratio of melatonin: tryptophan in the digestive system of the animal; and/or decreasing the ratio of tryptamine: tryptophan in the digestive system of the animal), the method comprising one or more of the following steps: administering an oligosaccharide preparation to the animal, wherein the oligosaccharide preparation comprises at least n fractions of oligosaccharides each having a distinct degree of polymerization selected from 1 to n (DP1 to DPn fractions), wherein n is an integer greater than or equal to 2; wherein each fraction comprises from at least about 0.5% to about 90% (e.g. from 1% to 90%; or e.g. from about 0.5% to about 15%) of anhydro-subunit containing oligosaccharides by relative abundance as determined by mass spectrometry. Claim 7 of ‘554 recites the method according to claim 1, wherein the oligosaccharide preparation is comprised in a nutritional composition administered to an animal at an inclusion rate of at least 50 ppm (e.g. at least 50, 70, 100, 150, 200, 300, 400, 500 ppm).
The difference between the reference application and the claimed invention is that the reference application does teach a method for treating the pathogenic E. coli as recited in the instant claims.
The independent teachings of Murphy, Goodman, Shoaf and Ding are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have administered the composition recited in the reference application in the 50-500 ppm amounts disclosed in Murphy to stimulate the growth of beneficial bacteria while also inhibiting the grow of pathogenic bacteria and reduce inflammation caused by pathogenic bacteria such as EPEC or EHEC in the GI tract of an animal as suggested in Goodman and disclosed by Shoaf as well as ameliorate the negative effects of E.coli O78 (APEC) as disclosed in Ding to arrive at the claimed invention. One of ordinary skill in the art would have made the modification of the ppm amounts with a reasonable expectation of success because Murphy provides guidance of animal feed compositions comprising oligosaccharides and also discloses that a ppm amount between 50 – 500 ppm of oligosaccharides is effective for modulating the gut microbiome to improve animal health. Furthermore, one of ordinary skill in the art would have been motivated to administer the composition recited in the reference application for inhibiting EPEC,EHEC, or APEC in the gut as well as reducing inflammation caused by these pathogenic bacteria because Shoaf provides guidance that galacto-oligosaccharides exhibited the greatest adherence inhibition of enteropathogenic E. coli to tissue culture cells, and Ding provides guidance that fructo-oligosaccharide supplementation in broiler chickens improved intestinal health by increasing the levels of SCFAs and mitigating the damage caused by E. coli O78, thus preventing intestinal damage and enhancing the immune response. One of ordinary skill in the art would have a reasonable expectation of success because Goodman suggests the use of oligosaccharides for stimulating growth of healthy bacteria in the gut while inhibiting pathogenic bacteria including EPEC and EHEC in animals including chickens.
The combination of the reference application and prior art references described above do not teach a method of reducing LEE and non-LEE gene wherein a 10% reduction of LEE and non-LEE gene populations occurs as recited in instant claims 1-3 and 35. Furthermore, the reference application also does not teach a method of reducing E. coli or reducing inflammation caused by E.coli infection in the GI tract of an animal wherein a 10% inflammation reduction occurs as recited in instant claims 19, 22-23, 28, 30, and 35. However, these limitations would flow naturally from the combination of the reference application and prior art references described above because the combination recites treating an animal with pathogenic EPEC, EHEC, and APEC comprising feeding the animal an oligosaccharide containing feed composition at 50-500 ppm, and as evidenced in paragraph 0127 of the instant specification, a 500 ppm test material comprising the recited oligosaccharide preparation was used which resulted in the recited method limitations (also see paragraphs 0150-0151 of the instant specification).
MPEP 2145 II recites “The fact that appellant 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." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 6-7, 9, 11, 19, 21-23, 27-28, 30, and 34-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 19/060,625 (‘625) in view of Murphy et al. (WO2017083520A1 in PTO-892), Goodman et al. (US20170209504A1 in PTO-892), Shoaf et al. (Infection and Immunity, 2006 in PTO-892), and Ding et al. (Plos One, 2019 in PTO-892).
Claim 1 of ‘625 recites a method of reducing gas emission from a ruminant, the method comprising: administering a nutritional composition comprising a base nutritional composition and a synthetic oligosaccharide preparation to a ruminant, wherein said synthetic oligosaccharide preparation comprises at least n fractions of oligosaccharides each having a distinct degree of polymerization selected from 1 to n (DP1 to DPn fractions), wherein n is an integer greater than 3; and wherein each of a DP1 and DP2 fraction independently comprises from about 0.5% to about 15% of anhydro-subunit containing oligosaccharides by relative abundance as determined by mass spectrometry; wherein said synthetic oligosaccharide preparation is administered in a dose sufficient to decrease emission of at least one gas from said animal, as compared to a comparable control ruminant administered a comparable nutritional composition lacking said synthetic oligosaccharide preparation. Claim 6 of ‘625 recites wherein the composition is an animal feed composition. Claim 20 of ‘625 recites wherein said nutritional composition comprises from about 300 ppm-600 ppm said synthetic oligosaccharide preparation.
The difference between the reference application and the claimed invention is that the reference application does teach a method for treating the pathogen E. coli as recited in the instant claims.
The independent teachings of Murphy, Goodman, Shoaf and Ding are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have administered the composition recited in the reference application in the 50-500 ppm amounts disclosed in Murphy to stimulate the growth of beneficial bacteria while also inhibiting the grow of pathogenic bacteria and reduce inflammation caused by pathogenic bacteria such as EPEC or EHEC in the GI tract of an animal as suggested in Goodman and disclosed by Shoaf as well as ameliorate the negative effects of E.coli O78 (APEC) as disclosed in Ding to arrive at the claimed invention. One of ordinary skill in the art would have made the modification of the ppm amounts with a reasonable expectation of success because Murphy provides guidance of animal feed compositions comprising oligosaccharides and also discloses that a ppm amount between 50 – 500 ppm of oligosaccharides is effective for modulating the gut microbiome to improve animal health. Furthermore, one of ordinary skill in the art would have been motivated to administer the composition recited in the reference application for inhibiting EPEC,EHEC, or APEC in the gut as well as reducing inflammation caused by these pathogenic bacteria because Shoaf provides guidance that galacto-oligosaccharides exhibited the greatest adherence inhibition of enteropathogenic E. coli to tissue culture cells, and Ding provides guidance that fructo-oligosaccharide supplementation in broiler chickens improved intestinal health by increasing the levels of SCFAs and mitigating the damage caused by E. coli O78, thus preventing intestinal damage and enhancing the immune response. One of ordinary skill in the art would have a reasonable expectation of success because Goodman suggests the use of oligosaccharides for stimulating growth of healthy bacteria in the gut while inhibiting pathogenic bacteria including EPEC and EHEC in animals including chickens.
The combination of the reference application and prior art references described above do not teach a method of reducing LEE and non-LEE gene wherein a 10% reduction of LEE and non-LEE gene populations occurs as recited in instant claims 1-3 and 35. Furthermore, the reference application also does not teach a method of reducing E. coli or reducing inflammation caused by E.coli infection in the GI tract of an animal wherein a 10% inflammation reduction occurs as recited in instant claims 19, 22-23, 28, 30, and 35. However, these limitations would flow naturally from the combination of the reference application and prior art references described above because the combination recites treating an animal with pathogenic EPEC, EHEC, and APEC comprising feeding the animal an oligosaccharide containing feed composition at 50-500 ppm, and as evidenced in paragraph 0127 of the instant specification, a 500 ppm test material comprising the recited oligosaccharide preparation was used which resulted in the recited method limitations (also see paragraphs 0150-0151 of the instant specification).
MPEP 2145 II recites “The fact that appellant 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." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 6-7, 9, 11, 19, 21-23, 27-28, 30, and 34-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 19/060,614 (‘614) in view of Murphy et al. (WO2017083520A1 in PTO-892), Goodman et al. (US20170209504A1 in PTO-892), Shoaf et al. (Infection and Immunity, 2006 in PTO-892), and Ding et al. (Plos One, 2019 in PTO-892).
Claim 1 of ‘614 recites a method of improving fat marbling of animal meat comprising administering to an animal a nutritional composition comprising a base nutritional composition and a synthetic oligosaccharide preparation, wherein said synthetic oligosaccharide preparation comprises at least n fractions of oligosaccharides each having a distinct degree of polymerization selected from 1 to n (DP1 to DPn fractions), wherein n is an integer greater than 3; and wherein each of a DP1 and DP2 fraction independently comprises from about 0.5% to about 15% of anhydro-subunit containing oligosaccharides by relative abundance as determined by mass spectrometry; wherein said synthetic oligosaccharide preparation is administered in a dose sufficient to improve fat marbling of meat from the animal. Claim 5 of ‘614 recites wherein the composition is an animal feed composition. Claim 20 of ‘614 recites wherein said nutritional composition comprises from about 300 ppm-600 ppm said synthetic oligosaccharide preparation.
The difference between the reference application and the claimed invention is that the reference application does teach a method for treating the pathogen E. coli as recited in the instant claims.
The independent teachings of Murphy, Goodman, Shoaf and Ding are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have administered the composition recited in the reference application in the 50-500 ppm amounts disclosed in Murphy to stimulate the growth of beneficial bacteria while also inhibiting the grow of pathogenic bacteria and reduce inflammation caused by pathogenic bacteria such as EPEC or EHEC in the GI tract of an animal as suggested in Goodman and disclosed by Shoaf as well as ameliorate the negative effects of E.coli O78 (APEC) as disclosed in Ding to arrive at the claimed invention. One of ordinary skill in the art would have made the modification of the ppm amounts with a reasonable expectation of success because Murphy provides guidance of animal feed compositions comprising oligosaccharides and also discloses that a ppm amount between 50 – 500 ppm of oligosaccharides is effective for modulating the gut microbiome to improve animal health. Furthermore, one of ordinary skill in the art would have been motivated to administer the composition recited in the reference application for inhibiting EPEC,EHEC, or APEC in the gut as well as reducing inflammation caused by these pathogenic bacteria because Shoaf provides guidance that galacto-oligosaccharides exhibited the greatest adherence inhibition of enteropathogenic E. coli to tissue culture cells, and Ding provides guidance that fructo-oligosaccharide supplementation in broiler chickens improved intestinal health by increasing the levels of SCFAs and mitigating the damage caused by E. coli O78, thus preventing intestinal damage and enhancing the immune response. One of ordinary skill in the art would have a reasonable expectation of success because Goodman suggests the use of oligosaccharides for stimulating growth of healthy bacteria in the gut while inhibiting pathogenic bacteria including EPEC and EHEC in animals including chickens.
The combination of the reference application and prior art references described above do not teach a method of reducing LEE and non-LEE gene wherein a 10% reduction of LEE and non-LEE gene populations occurs as recited in instant claims 1-3 and 35. Furthermore, the reference application also does not teach a method of reducing E. coli or reducing inflammation caused by E.coli infection in the GI tract of an animal wherein a 10% inflammation reduction occurs as recited in instant claims 19, 22-23, 28, 30, and 35. However, these limitations would flow naturally from the combination of the reference application and prior art references described above because the combination recites treating an animal with pathogenic EPEC, EHEC, and APEC comprising feeding the animal an oligosaccharide containing feed composition at 50-500 ppm, and as evidenced in paragraph 0127 of the instant specification, a 500 ppm test material comprising the recited oligosaccharide preparation was used which resulted in the recited method limitations (also see paragraphs 0150-0151 of the instant specification).
MPEP 2145 II recites “The fact that appellant 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." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 6-7, 9, 11, 19, 21-23, 27-28, 30, and 34-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 19/059,233 (‘233) in view of Murphy et al. (WO2017083520A1 in PTO-892), Goodman et al. (US20170209504A1 in PTO-892), Shoaf et al. (Infection and Immunity, 2006 in PTO-892), and Ding et al. (Plos One, 2019 in PTO-892).
Claim 1 of ‘233 recites a method of preventing or decreasing the severity of footpad disease in an animal, the method comprising: administering a nutritional composition comprising a base nutritional composition and a synthetic oligosaccharide preparation to the animal, wherein said synthetic oligosaccharide preparation comprises at least n fractions of oligosaccharides each having a distinct degree of polymerization selected from 1 to n (DP1 to DPn fractions), wherein n is an integer greater than 3; and wherein each of a DP1 and DP2 fraction independently comprises from about 0.5% to about 15% of anhydro-subunit containing oligosaccharides by relative abundance as determined by mass spectrometry. Claim 9 of ‘233 recites wherein the nutritional composition is an animal feed composition. Claim 20 ‘223 recites wherein said nutritional composition comprises from about 300 ppm-600 ppm said synthetic oligosaccharide preparation.
The difference between the reference application and the claimed invention is that the reference application does teach a method for treating the pathogen E. coli as recited in the instant claims.
The independent teachings of Murphy, Goodman, Shoaf and Ding are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have administered the composition recited in the reference application in the 50-500 ppm amounts disclosed in Murphy to stimulate the growth of beneficial bacteria while also inhibiting the grow of pathogenic bacteria and reduce inflammation caused by pathogenic bacteria such as EPEC or EHEC in the GI tract of an animal as suggested in Goodman and disclosed by Shoaf as well as ameliorate the negative effects of E.coli O78 (APEC) as disclosed in Ding to arrive at the claimed invention. One of ordinary skill in the art would have made the modification of the ppm amounts with a reasonable expectation of success because Murphy provides guidance of animal feed compositions comprising oligosaccharides and also discloses that a ppm amount between 50 – 500 ppm of oligosaccharides is effective for modulating the gut microbiome to improve animal health. Furthermore, one of ordinary skill in the art would have been motivated to administer the composition recited in the reference application for inhibiting EPEC,EHEC, or APEC in the gut as well as reducing inflammation caused by these pathogenic bacteria because Shoaf provides guidance that galacto-oligosaccharides exhibited the greatest adherence inhibition of enteropathogenic E. coli to tissue culture cells, and Ding provides guidance that fructo-oligosaccharide supplementation in broiler chickens improved intestinal health by increasing the levels of SCFAs and mitigating the damage caused by E. coli O78, thus preventing intestinal damage and enhancing the immune response. One of ordinary skill in the art would have a reasonable expectation of success because Goodman suggests the use of oligosaccharides for stimulating growth of healthy bacteria in the gut while inhibiting pathogenic bacteria including EPEC and EHEC in animals including chickens.
The combination of the reference application and prior art references described above do not teach a method of reducing LEE and non-LEE gene wherein a 10% reduction of LEE and non-LEE gene populations occurs as recited in instant claims 1-3 and 35. Furthermore, the reference application also does not teach a method of reducing E. coli or reducing inflammation caused by E.coli infection in the GI tract of an animal wherein a 10% inflammation reduction occurs as recited in instant claims 19, 22-23, 28, 30, and 35. However, these limitations would flow naturally from the combination of the reference application and prior art references described above because the combination recites treating an animal with pathogenic EPEC, EHEC, and APEC comprising feeding the animal an oligosaccharide containing feed composition at 50-500 ppm, and as evidenced in paragraph 0127 of the instant specification, a 500 ppm test material comprising the recited oligosaccharide preparation was used which resulted in the recited method limitations (also see paragraphs 0150-0151 of the instant specification).
MPEP 2145 II recites “The fact that appellant 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." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 6-7, 9, 11, 19, 21-23, 27-28, 30, and 34-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 19/059,037 (‘037) in view of Murphy et al. (WO2017083520A1 in PTO-892), Goodman et al. (US20170209504A1 in PTO-892), Shoaf et al. (Infection and Immunity, 2006 in PTO-892), and Ding et al. (Plos One, 2019 in PTO-892).
Claim 1 of ‘037 recites a method of improving feces quality of an animal, the method comprising: administering a nutritional composition comprising a base nutritional composition and a synthetic oligosaccharide preparation to the animal, wherein said synthetic oligosaccharide preparation comprises at least n fractions of oligosaccharides each having a distinct degree of polymerization selected from 1 to n (DP1 to DPn fractions), wherein n is an integer greater than 3; and wherein each of a DP1 and DP2 fraction independently comprises from about 0.5% to about 15% of anhydro-subunit containing oligosaccharides by relative abundance as determined by mass spectrometry. Claim 12 of ‘037 recites wherein the nutritional composition is an animal feed composition. Claim 20 of ‘037 recites wherein said nutritional composition comprises from about 300 ppm-600 ppm said synthetic oligosaccharide preparation.
The difference between the reference application and the claimed invention is that the reference application does teach a method for treating the pathogen E. coli as recited in the instant claims.
The independent teachings of Murphy, Goodman, Shoaf and Ding are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have administered the composition recited in the reference application in the 50-500 ppm amounts disclosed in Murphy to stimulate the growth of beneficial bacteria while also inhibiting the grow of pathogenic bacteria and reduce inflammation caused by pathogenic bacteria such as EPEC or EHEC in the GI tract of an animal as suggested in Goodman and disclosed by Shoaf as well as ameliorate the negative effects of E.coli O78 (APEC) as disclosed in Ding to arrive at the claimed invention. One of ordinary skill in the art would have made the modification of the ppm amounts with a reasonable expectation of success because Murphy provides guidance of animal feed compositions comprising oligosaccharides and also discloses that a ppm amount between 50 – 500 ppm of oligosaccharides is effective for modulating the gut microbiome to improve animal health. Furthermore, one of ordinary skill in the art would have been motivated to administer the composition recited in the reference application for inhibiting EPEC,EHEC, or APEC in the gut as well as reducing inflammation caused by these pathogenic bacteria because Shoaf provides guidance that galacto-oligosaccharides exhibited the greatest adherence inhibition of enteropathogenic E. coli to tissue culture cells, and Ding provides guidance that fructo-oligosaccharide supplementation in broiler chickens improved intestinal health by increasing the levels of SCFAs and mitigating the damage caused by E. coli O78, thus preventing intestinal damage and enhancing the immune response. One of ordinary skill in the art would have a reasonable expectation of success because Goodman suggests the use of oligosaccharides for stimulating growth of healthy bacteria in the gut while inhibiting pathogenic bacteria including EPEC and EHEC in animals including chickens.
The combination of the reference application and prior art references described above do not teach a method of reducing LEE and non-LEE gene wherein a 10% reduction of LEE and non-LEE gene populations occurs as recited in instant claims 1-3 and 35. Furthermore, the reference application also does not teach a method of reducing E. coli or reducing inflammation caused by E.coli infection in the GI tract of an animal wherein a 10% inflammation reduction occurs as recited in instant claims 19, 22-23, 28, 30, and 35. However, these limitations would flow naturally from the combination of the reference application and prior art references described above because the combination recites treating an animal with pathogenic EPEC, EHEC, and APEC comprising feeding the animal an oligosaccharide containing feed composition at 50-500 ppm, and as evidenced in paragraph 0127 of the instant specification, a 500 ppm test material comprising the recited oligosaccharide preparation was used which resulted in the recited method limitations (also see paragraphs 0150-0151 of the instant specification).
MPEP 2145 II recites “The fact that appellant 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." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 6-7, 9, 11, 19, 21-23, 27-28, 30, and 34-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 19/060,559 (‘559) in view of Murphy et al. (WO2017083520A1 in PTO-892), Goodman et al. (US20170209504A1 in PTO-892), Shoaf et al. (Infection and Immunity, 2006 in PTO-892), and Ding et al. (Plos One, 2019 in PTO-892).
Claim 1 of ‘559 recites a method for increasing milk production or improving milk compositional characteristics in a ruminant, the method comprising: administering a nutritional composition comprising a base nutritional composition and a synthetic oligosaccharide preparation to a ruminant, wherein said synthetic oligosaccharide preparation comprises at least n fractions of oligosaccharides each having a distinct degree of polymerization selected from 1 to n (DP1 to DPn fractions), wherein n is an integer greater than 3; and wherein each of a DP1 and DP2 fraction independently comprises from about 0.5% to about 15% of anhydro-subunit containing oligosaccharides by relative abundance as determined by mass spectrometry. Claim 9 of ‘559 recites wherein the nutritional composition is an animal feed composition. Claim 19 of ‘559 recites wherein said nutritional composition comprises from about 300 ppm-600 ppm said synthetic oligosaccharide preparation.
The difference between the reference application and the claimed invention is that the reference application does teach a method for treating the pathogen E. coli as recited in the instant claims.
The independent teachings of Murphy, Goodman, Shoaf and Ding are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have administered the composition recited in the reference application in the 50-500 ppm amounts disclosed in Murphy to stimulate the growth of beneficial bacteria while also inhibiting the grow of pathogenic bacteria and reduce inflammation caused by pathogenic bacteria such as EPEC or EHEC in the GI tract of an animal as suggested in Goodman and disclosed by Shoaf as well as ameliorate the negative effects of E.coli O78 (APEC) as disclosed in Ding to arrive at the claimed invention. One of ordinary skill in the art would have made the modification of the ppm amounts with a reasonable expectation of success because Murphy provides guidance of animal feed compositions comprising oligosaccharides and also discloses that a ppm amount between 50 – 500 ppm of oligosaccharides is effective for modulating the gut microbiome to improve animal health. Furthermore, one of ordinary skill in the art would have been motivated to administer the composition recited in the reference application for inhibiting EPEC,EHEC, or APEC in the gut as well as reducing inflammation caused by these pathogenic bacteria because Shoaf provides guidance that galacto-oligosaccharides exhibited the greatest adherence inhibition of enteropathogenic E. coli to tissue culture cells, and Ding provides guidance that fructo-oligosaccharide supplementation in broiler chickens improved intestinal health by increasing the levels of SCFAs and mitigating the damage caused by E. coli O78, thus preventing intestinal damage and enhancing the immune response. One of ordinary skill in the art would have a reasonable expectation of success because Goodman suggests the use of oligosaccharides for stimulating growth of healthy bacteria in the gut while inhibiting pathogenic bacteria including EPEC and EHEC in animals including chickens.
The combination of the reference application and prior art references described above do not teach a method of reducing LEE and non-LEE gene wherein a 10% reduction of LEE and non-LEE gene populations occurs as recited in instant claims 1-3 and 35. Furthermore, the reference application also does not teach a method of reducing E. coli or reducing inflammation caused by E.coli infection in the GI tract of an animal wherein a 10% inflammation reduction occurs as recited in instant claims 19, 22-23, 28, 30, and 35. However, these limitations would flow naturally from the combination of the reference application and prior art references described above because the combination recites treating an animal with pathogenic EPEC, EHEC, and APEC comprising feeding the animal an oligosaccharide containing feed composition at 50-500 ppm, and as evidenced in paragraph 0127 of the instant specification, a 500 ppm test material comprising the recited oligosaccharide preparation was used which resulted in the recited method limitations (also see paragraphs 0150-0151 of the instant specification).
MPEP 2145 II recites “The fact that appellant 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." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is found allowable.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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