DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 26, 2026 has been entered.
Claim Amendment
3. The amendment filed May 26, 2026 has been entered. Claim 20 has been amended. Claims 25-26 and 35-36 were cancelled. Claims 30-34 and 37-39 are withdrawn from consideration. Claims 20-24 and 27-29 are under consideration in this Office Action.
Withdrawn Claim Rejections - 35 USC § 112
4. The scope of enablement rejection of claims 20-24 and 27-29 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in view of applicants amendment.
Maintained Grounds of Rejection
Claim Rejections - 35 USC § 103
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 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.
5. Claims 20-24 and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Panigrahi et al., (WO2014178007 published Nov 2014; priority to May 2013) in view of Chandel et al., (J Med Microbiol. 2011 Apr; 60(Pt 4): 500–507).
The claims are drawn to a method of reducing colonization by an Extended-Spectrum Beta-Lactamases (ESBL) producing bacteria in a human infant in need thereof, the method comprising administering to the infant a therapeutically effective amount of a probiotic and an effective amount of a prebiotic, wherein the administering is daily for one week once a month for two months or longer, wherein the probiotic comprises Lactobacillus plantarum strain ATCC 202195 and the prebiotic comprises a fructo-oligosaccharide.
Panigrahi et al., teach a method of treatment of infections such as neonatal sepsis and pneumonia in neonates and infants [para 9]. Specific strains of genera Lactobacilli and Bifidobacteria have been found to be able to colonize the intestinal mucosa, to reduce the capability of pathogenic bacteria to adhere to the intestinal epithelium, to have immunomodulatory effects and to assist in the maintenance of well-being. Such bacteria are called probiotics [para 3]. It is an advantage of the present invention to provide a pharmaceutical composition comprising a combination of a prebiotic and probiotic that promotes maturation of the immune system and contributes to support of natural defences to enhance gut comfort and reduces crying time, cramps and/or colics in neonates and infants [para 94]. The synbiotic composition significantly reduced the incidence of clinical sepsis and culture positive sepsis in neonates and infants and also significantly reduced LRTI/pneumonia. Apart from blocking bacterial translocation, the composition seems to have other immunomodulatory effects as well [para 90]. Thus teaching reduced colonization.
The method of treatment of infections selected from a group comprising neonatal sepsis and/or pneumonia comprising administering an effective amount of a pharmaceutical composition comprising a probiotic and a prebiotic to neonates and infants in need thereof [para 14]. The combination of a prebiotic and a probiotic that promotes gut maturation and enhances gut health and protection later in life in neonates and infants [para10]. It is yet another object of the present invention to provide a pharmaceutical composition comprising a combination of a prebiotic and probiotic that promotes maturation of the immune system and contributes to support of natural defenses to enhance gut comfort and reduces crying time, cramps and/or colics in neonates and infants [para 11]. Panigrahi et al., teach a pharmaceutical synbiotic composition comprising a probiotic and a pre-biotic for alleviating symptoms associated with infections such as neonatal sepsis and pneumonia in neonates and infants [para 26]. Panigrahi et al., teach a method of treatment of infections selected from a group comprising neonatal sepsis and/or pneumonia comprising administering an effective amount of a pharmaceutical composition comprising a probiotic and a pre-biotic to neonates and infants in need thereof [para 27]. Panigrahi et al., teach infections caused by Klebsiella and Escherichia coli.
The term "neonatal sepsis" as used herein specifically refers to the presence in a new born baby (neonate) of a bacterial blood stream infection (BSI) (such as meningitis, pneumonia, pyelonephritis or gastroenteritis) in a setting of fever. A number of different bacteria, including Escherichia coli (E.coli), may cause neonatal sepsis [para 40]. Table 19 illustrates highly significant effect in sepsis, pneumonia, diarrhea, and other infections. Thus teaching treating an infection caused by an Extended-Spectrum Beta-Lactamases (ESBL) producing organism in a human infant in need thereof. The administered pharmaceutical composition comprises a combination of a prebiotic and a probiotic that promotes gut maturation and enhances gut health and protection later in life in neonates and infants [para 10]. In a preferred embodiment, a probiotic comprises Lactobacillus plantarum. More preferably, a probiotic comprises Lactobacillus plantarum strain ATCC 202195 [para 16]. Thus teaching claim 20. The preferred prebiotic comprises a fructo-oligosaccharide [para 18]. Thus teaching instant claim 20.
The pharmaceutical composition of the present invention can be suitable for oral or parenteral administration [para 19]. Thus teaching claims 21-22. The pharmaceutical composition of the present invention can include 1-10 billion counts of cells of a probiotic and 150-250 mg of prebiotic [para 20]; thus teaching claim 24. The pharmaceutical compositions and methods of the present invention include one or more prebiotics in combination with one or more probiotics. Thereby teaching claim 23. The composition was given once a day for 7 days. Active follow-up occurred over a 28 day period either in the hospital or at home. Infants who left the hospital after receiving 4 or more doses of the study composition but before all 7 doses were administered received the remaining doses at home [para 55]. Panigrahi et al., provide fecal testing that would illuminate to the ordinary artisan the need for additional administration of the composition with the same administration schedule because 54% to 98% of infants were colonized with L. plantarum during the 3-28 day period (Table 9). Thus teaching claims 27-29.
Therefore, Panigrahi et al., teach a method of reducing colonization by an ESBL producing bacteria, such as Klebsiella and Escherichia coli, in a human infant in need thereof, the method comprising administering to the infant a therapeutically effective amount of a probiotic and an effective amount of a prebiotic, wherein the administering is effected daily for one week once a month for two months or longer, wherein the probiotic comprises Lactobacillus plantarum strain ATCC 202195 and fructo-oligosaccharide; however Panigrahi et al., does not state neonatal sepsis, is caused by an Extended-Spectrum Beta-Lactamases (ESBL) producing organism such as Klebsiella and Escherichia coli.
Chandel et al., teach Extended-spectrum β-lactamase-producing Gram-negative bacteria causing neonatal sepsis. The present study included identification and genotyping, by PFGE, of ESBL-positive Klebsiella species and Escherichia coli isolates from confirmed neonatal sepsis in hospital- and community-acquired infections from different participating centres. The results demonstrated that Klebsiella species and E. coli are the most common GNB causes of neonatal sepsis in India, and over one-third are ESBL producers in both community and hospital settings.
Therefore, it would have been prima facie obvious at the time of applicants’ invention to apply Panigrahi et al., L plantarum ATCC 202195 and method of preventing or treating a neonatal sepsis infection caused by an Extended-Spectrum Beta-Lactamases (ESBL) producing organism comprising administering to the subject a therapeutically effective amount of a probiotic, L plantarum ATCC 202195 and the prebiotic fructo-oligosaccharide, as taught by Panigrahi et al., in order to not only treat neonatal sepsis, but to also promote gut maturation, gut nervous system, and maturation of the immune system. One of ordinary skill in the art would have a reasonable expectation of success by administering L plantarum ATCC 202195, and fructo-oligosaccharide as taught by Panigrahi et al., to contribute to the support of natural defenses, to support growth, and reducing crying time, cramps and/or colics in neonates and infants.
It is noted, that while Panigrahi et al., recite administration for one week, it does not specifically recite repeating the dosing schedule for up to one year. Regarding the specific dosing regimen recited in the instant claims, MPEP 2144.05 states, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)."
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "The combination of familiar element according to known methods is likely to be obvious when it does no more than yield predictable results". It is well known to take a method of the method of treating a neonatal sepsis infection caused by an Extended- Spectrum Beta-Lactamases (ESBL) producing organism comprising administering the L. plantarum and fructo-oligosaccharide where there is no change in the respective function of L plantarum ATCC 202195 and the fructo-oligosaccharide; thus the combination would have yielded a reasonable expectation or success along with predictable results to one of ordinary skill in the art at the time of the invention. Therefore, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Response to Arguments
6. Applicant's arguments filed May 26, 2026 have been fully considered but they are not persuasive. Applicants urge that while Panigrahi discloses using L. plantarum ATCC 202195 and a prebiotic (including FOS) for alleviating symptoms of neonatal sepsis and pneumonia generally, but does not disclose or suggest use against infections specifically caused by ESBL-producing organisms, or drug-resistant pathogens. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case,
Panigrahi et al., teach a method of reducing colonization by an ESBL producing bacteria in a human infant having neonatal sepsis, the method comprising administering to the infant a therapeutically effective amount of a probiotic and an effective amount of a prebiotic, wherein the administering is effected daily for one week once a month for two months or longer, wherein the probiotic comprises Lactobacillus plantarum strain ATCC 202195 and fructo-oligosaccharide. Panigrahi et al., do not teach that neonatal sepsis, is caused by an Extended-Spectrum Beta-Lactamases (ESBL) producing organism, such as Klebsiella and/or E. coli. However, Chandel et al., clearly teach Extended-spectrum β-lactamase-producing Gram-negative bacteria such as Klebsiella species and Escherichia coli, causing neonatal sepsis. These are the same bacterial species, specifically named by Panigrahi et al., as causing neonatal sepsis.
Next, Applicants argue that Chandel does not disclose administration of any probiotic, prebiotic, or synbiotic. In response to applicant's arguments against the Chandel reference individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Panigrahi et al., teach administration of the probiotic ATCC 202195, prebiotic, and/or symbiotic to reduce colonization of Klebsiella and/or E coli. Therefore this argument is not persuasive.
Applicants argue that there is no teaching in either reference that would have motivated a skilled artisan to arrive at the specific claimed method with a reasonable expectation of success against ESBL-producing organisms. Contrary to Applicants arguments, it would have been prima facie obvious at the time of applicants’ invention to apply Panigrahi et al., L plantarum ATCC 202195 and method of reducing colonization of Extended-Spectrum Beta-Lactamases (ESBL) producing E coli and/or Klebsiella comprising administering to the subject a therapeutically effective amount of L plantarum ATCC 202195 and the prebiotic fructo-oligosaccharide, as taught by Panigrahi et al., in order to not only treat neonatal sepsis, but to also promote gut maturation, gut nervous system, and maturation of the immune system. One of ordinary skill in the art would have a reasonable expectation of success by administering L plantarum ATCC 202195, and fructo-oligosaccharide as taught by Panigrahi et al., in order to contribute to the support of natural defenses, to support growth, and reducing crying time, cramps and/or colic in neonates and infants and reduce colonization. Furthermore, administration of the ATCC202195 and prebiotic will inherently reduce colonization of E coli and/or Klebsiella. Therefore, the argument is not found persuasive.
Applicants assert that the claimed method unexpectedly provides effective prevention or treatment of ESBL infections in human infants using this precise regimen by reduction of ESBL colonization, as supported by the specification. However, contrary to Applicants assertion, the reduction of Klebsiella and E coli inherently occurs when the probiotic and prebiotic are administered. Thus none of Applicants arguments were found persuasive and the rejection is maintained.
Claim Rejections - 35 USC § 103
7. Claims 20-24 and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Panigrahi et al., (J Pediatr Gastroenterol Nutr. 2008 Jul;47(1):45-53) as evidenced by Cotton et al., (S Afr Med J. 2001 Feb;91(2):133-5.) in view of Chow et al., (US Patent 9539269 published Jan 10, 2017; priority to Dec 2011).
The claims are drawn to a method of preventing or treating an infection caused by an Extended-Spectrum Beta-Lactamases (ESBL) producing organism in a human infant in need thereof.
Panigrahi et al., 2008 teach long-term colonization of a Lactobacillus plantarum Synbiotic Preparation in the Neonatal Gut. Panigrahi et al., 2008 teach Probiotic, prebiotic, and synbiotic (a combination of pro- and prebiotic) supplements increasingly are being used to prevent and treat a variety of health conditions [Background]. Neonatal diseases in which probiotics may be useful include necrotizing enterocolitis (NEC), sepsis, and urinary tract infection [Background]; teaching claim 20. Prebiotics are nondigestible food ingredients/sugars present in breast milk and are found in fruits and vegetables [Introduction]. The probiotics stimulate the growth or activity of anaerobic/microaerophilic flora in the colon and improve gastrointestinal health [Introduction]. Probiotics given during infancy also may play a role in the prevention of diseases that manifest later in childhood, such as neonatal diseases in which probiotics may be useful include necrotizing enterocolitis, sepsis, and urinary tract infection [Conclusion]. Thus, a combination of probiotics and prebiotics (called synbiotics) has been proposed for more efficient colonization of the probiotic bacteria in the host intestine [Introduction]. Panigrahi et al., 2008, human infants received an oral synbiotic preparation Lactobacillus plantarum and fructooligosaccharides [Patients and Methods] teaching claim 20. Infants received either the synbiotic preparation containing 109 L plantarum (ATCC 202195) cells and 150 mg of fructooligosaccharides [Study Sites, Population, and Design]; teaching claims 20 and 24. Nineteen infants received the active study supplement for 7 days. Of the infants, 100%, 94%, 88%, 56%, and 32% remained colonized at months 2, 3, 4, 5, and 6, respectively [Results]. Although Panigrahi et al., 2008 provides testing that would illuminate to the ordinary artisan the need for additional administration of the composition with the same administration schedule because 54% to 98% of infants were colonized with L. plantarum during the 3-28 day period. Thus teaching claims 27-29. Panigrahi et al., teach critical changes in the overall microbial milieu of the newborn intestine; such as inducing species diversity and resulting bacterial translocation and induction of proinflammatory responses.
Thus Panigrahi et al., 2008 teach a method of preventing or treating an infection in a human infant in need thereof, the method comprising administering to the infant a therapeutically effective amount of a probiotic and an effective amount of a prebiotic, wherein the administering is effected daily for one week once a month for two months or longer, wherein the probiotic comprises Lactobacillus plantarum strain ATCC 202195 and fructooligosaccharide; however Panigrahi et al., 2008 do not mention the administration treats an infection caused by an Extended- Spectrum Beta-Lactamases (ESBL) producing bacteria.
Cotton et al., teach Necrotising enterocolitis (NEC) is a severe gastro-intestinal disorder, predominantly seen in hospitalized low-birth-weight newborn infants. It is associated with significant morbidity and mortality. Cotton et al., documented an outbreak of invasive disease due to extended-spectrum beta-lactamase-producing Klebsiella pneumoniae (ESKP). The aims of this study included investigating the relationship between ESKP, and NEC in a cross-sectional study [page 133]. NEC probably has a multifactorial aetiology [page 134]. Risk factors include prematurity, immunological immaturity, immature intestinal epithelial barrier, aggressive enteral feeding, formula feeding and hypoxia-ischaemia.10 Infectious agents probably act as co-factors. It was documented that K. pneumoniae may be entero-invasive, thus providing another mechanism for causing NEC [page 134].
Therefore, Panigrahi et al., 2008 as evidenced by Cotton et al., teach infant necrotising enterocolitis is an infection caused by an Extended-Spectrum Beta-Lactamases (ESBL) producing organism.
Chow et al., teach a method of reducing the incidence of necrotizing enterocolitis in an infant, toddler, or child, the method comprising administering to an infant, toddler, or child in need thereof, a nutritional composition comprising human milk oligosaccharides selected from the group consisting of 2′-fucosyllactose, lacto-N-neotetraose, and combinations thereof further comprising probiotic [para 8]. Specifically, the synbiotic combination includes a probiotic, at least one of a galactooligosaccharide and a fructooligosaccharide (such as a short chain fructooligosaccharide) and at least one HMO [para 15]. Non-limiting examples of probiotic strains for use in the nutritional compositions herein include the genus Lactobacillus including L. plantarum [para 99]. The nutritional compositions of the present disclosure may be formulated and administered in any known or otherwise suitable oral or enteral product form [para 68]. Thus teaching claims 21-22. Probiotics has been found to prevent and treat gastrointestinal diseases and/or disorders, pathogen-induced diarrhea and toxin-producing bacteria, urogenital infections, and atopic diseases [para 97]. Specifically, the compositions can stimulate enteric nerve cells in the gastrointestinal tract of an individual to improve intestinal/gut barrier integrity; improve feeding tolerance (e.g., reduced diarrhea, loose stools, gas, and bloating); reduce colic in infants; protect against necrotizing enterocolitis and other disorders of prematurity; address gastrointestinal diseases and disorders associated with the enteric nervous system; address gastrointestinal diseases and disorders of gut contractility and inflammation; correct effects of gut dysbiosis; and affect long-term modulation of allergic tolerance [para 145]. The prebiotics such as 6′-Sialyllactose (6′SL); 2′-Fucosyllactose (2′FL); Lacto-N-neotetraose (LNnT), are markers for epithelial barrier function, wherein a higher resistance is associated with a higher barrier function. Epithelial cell resistance or barrier function is a measure of differentiated epithelial cell function. Specifically, as the cells mature, tighter junctions between the cells are formed resulting in a stronger epithelial cell barrier. This barrier prevents the movement of large molecules, bacteria, or viruses from one side of the barrier to the other, which could improve resistance to infection, sepsis, and NEC [para 187].
Therefore, it would have been prima facie obvious at the time of applicants’ invention to apply Panigrahi et al., 2008 L plantarum ATCC 202195 in the method of preventing or treating a NEC infection caused by an Extended- Spectrum Beta-Lactamases (ESBL) producing organism as taught by Cotton et al.,
in an infant, the method comprising administering to the subject a therapeutically effective amount of a probiotic, L plantarum ATCC 202195 and an effective amount of fructooligosaccharide, as taught by Panigrahi et al., 2008 and Chow et al., in order to treat a variety of NEC, neonatal sepsis and other diseases caused by an Extended- Spectrum Beta-Lactamases (ESBL) producing organism. One of ordinary skill in the art would have a reasonable expectation of success by incorporating L plantarum ATCC 202195 and fructooligosaccharide, to treat neonatal diseases in which Lactobacillus plantarum is in treating necrotizing enterocolitis, sepsis, and urinary tract infection and inducing proinflammatory responses.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "The combination of familiar element according to known methods is likely to be obvious when it does no more than yield predictable results". It is well known to take a method of treating an infection caused by an Extended- Spectrum Beta-Lactamases (ESBL) producing organism in an infant, and there is no change in the respective function of the prebiotic or probiotic, thus the combination would have yielded a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Therefore, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Response to Arguments
8. Applicant's arguments filed April 16, 2025 have been fully considered but they are not persuasive. The rejection of claims 20-24 and 27-29 under 35 U.S.C. 103 as being unpatentable over Panigrahi et al., (J Pediatr Gastroenterol Nutr. 2008 Jul;47(1):45-53) as evidenced by Cotton et al., in view of Chow et al., is maintained for reasons of record.
Applicants urge that there is no reasonable expectation of success to combine these references. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, one of ordinary skill in the art would have a reasonable expectation of success by incorporating L plantarum ATCC 202195 and fructooligosaccharide, to treat neonatal diseases in which Lactobacillus plantarum is in treating necrotizing enterocolitis, sepsis, and urinary tract infection and inducing proinflammatory responses.
Applicants assert that the Office did not supply a reason to connect the reasons. The Office sets forth that it would have been prima facie obvious at the time of applicants’ invention to apply Panigrahi et al., 2008 L plantarum ATCC 202195 in the method of reducing the bacterial colonization caused by an Extended-Spectrum Beta-Lactamases (ESBL) producing organism as taught by Cotton et al., in an infant, the method comprising administering to the subject a therapeutically effective amount of a probiotic, L plantarum ATCC 202195 and an effective amount of fructooligosaccharide, as taught by Panigrahi et al., 2008 and Chow et al., in order to treat a variety of NEC, neonatal sepsis and other diseases caused by an Extended- Spectrum Beta-Lactamases (ESBL) producing organism. Furthermore, Panigrahi et al., 2008 as evidenced by Cotton et al., teach infant necrotising enterocolitis is an infection caused by an Extended-Spectrum Beta-Lactamases (ESBL) producing organism. Chow et al., teach a method of reducing the incidence of necrotizing enterocolitis. Applicant is reminded that Cotton and Panigrahi et al., 2008 both teach necrotizing enterocolitis. Panigrahi et al., 2008 teach the method comprising administering to an infant, toddler, or child in need thereof, a nutritional composition comprising human milk oligosaccharides and further comprising probiotic; just like the probiotic as taught by Panigrahi et al. 2008.
In this case, Panigrahi et al., 2008 teach a method reducing colonization , where colonization caused infant necrotising enterocolitis in a human infant in need thereof, the method comprising administering to the infant a therapeutically effective amount of a probiotic and an effective amount of a prebiotic, wherein the administering is daily for one week once a month for two months or longer, wherein the probiotic comprises Lactobacillus plantarum strain ATCC 202195 and the prebiotic comprises a fructo-oligosaccharide; while Cotton et al., provides evidences that infant necrotising enterocolitis is an infection caused by an Extended-Spectrum Beta-Lactamases (ESBL) producing organism. Additionally, Chow et al., teach a method of reducing the incidence of necrotizing enterocolitis in an infant, toddler, or child, the method comprising administering to an infant, toddler, or child in need thereof, a nutritional composition comprising human milk oligosaccharides. Specifically, the synbiotic combination includes a probiotic, at least one of a galactooligosaccharide and a fructooligosaccharide. Therefore, Applicants amendments do not overcome the instant rejection.
Pertinent Art
9. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Panigrahi et al., (US Patent 6,132,710 published Oct. 2010; priority to March 1997) the Lactobacilli strains prevent neonatal necrotizing enterocolitis tissue injury and necrotizing enterocolitis in preterm infants [abstract]. Preterm infants, full-term infants, and children may be given the Lactobacilli strains. The strain is Lactobacillus plantarum strain ATCC 202195 [abstract].
Delerue et al., (25 Jul 2017, 6(F1000 Faculty Rev):1217) teach extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-PE) in neonatal population. The spread of extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-PE) in the hospital and also the community is worrisome. Neonates particularly are exposed to the risk of ESBL-PE acquisition and, owing to the immaturity of their immune system, to a higher secondary risk of ESBL-PE-related infection [Abstract]. ESBL colonization rates in pediatric intensive care units (PICUs) range up to 12% for Escherichia coli and 39% for Klebsiella spp. ESBL rates as high as 60% for Klebsiella spp. and 75% for E. coli have been reported from blood cultures from infected infants in some NICUs [Introduction]. Rates of E. coli early-onset sepsis have increased along with infection in infants with very low birth weight, the spread of ESBL-PE presents major challenges in managing neonatal sepsis [Introduction].
Simonsen et al., (ASM Journals. Clinical Microbiology Reviews. Vol. 27, No. 1 January 2014). Simonsen et al., teach there has, however, been an increased prevalence of community extended-spectrum beta-lactamase (ESBL) producers as etiologic agents of neonatal sepsis. ESBLs, found mostly in nosocomial E. coli and Klebsiella pneumoniae infections. In addition, most ESBL producers demonstrate resistance to aminoglycosides as well. An increasing prevalence in community-acquired ESBLs has also been observed across the globe, including Europe, Asia, and South America, and there are reports of neonatal sepsis secondary to community-acquired ESBL producers in India. A recent report showed an increase in the prevalence of ESBL producers in the United States, with 36% of all E. coli infections in that study being caused by community-acquired ESBL produces. There is, however, a paucity of neonatal community-acquired ESBL epidemiologic data in the United States in the setting of early onset sepsis (EOS). The ongoing emergence of ESBL-producing organisms in the community calls for vigilance in monitoring local patterns of susceptibility to gentamicin, as this may eventually render this aminoglycoside less useful in the setting of empirical therapy for EOS.
Conclusion
10. No claims allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JA-NA A HINES whose telephone number is (571)272-0859. The examiner can normally be reached Monday thru Thursday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Peter Paras, can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANA A HINES/Primary Examiner, Art Unit 1645
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