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 .
Claims status
The amendments filed 05/21/2026 are entered. Claims 1, 3, 4, 6-12 are rejected.
Priority
Acknowledgment is made of applicant's claim for foreign priority and the English translated foreign priority document filed 05/21/2026 is entered. Therefore, the effective filing date of this application is the filing date of the foreign priority application, 07/15/2021.
Response to Amendments
Withdrawn Objections/Rejections
Objections to the claims
The previous objections to claims 7 and 9 are withdrawn in response to the Applicant’s amendments fixing the informalities.
Rejections under 35 U.S.C. § 112(b)
The previous rejection under 35 U.S.C. § 112(b) to claim 1-12 is withdrawn in response to Applicant’s amendments for the reasons that follow.
The previous rejection to claim 5 regarding the recitations of “mixture” is withdrawn in response to Applicant’s deletion of claim 5.
The previous rejections to claims 6 and 7 are withdrawn in response to Applicant’s amendment of the dependency to claim 1 and the replacement of the recitation of “mixture” with “composition”, removing the indefiniteness from the term “mixture” as previously explained.
The previous rejections to claims 10 and 12 are withdrawn in response to Applicant’s amendments to their parent claims, so that claims 10 and 12 no longer depend on indefinite claims.
The previous rejections to claim 5 regarding the trademark/trade name “DG®” is withdrawn in response to Applicant’s amendments deleting claim 5.
The previous rejections to claims 2-4 and 7-12 due to their dependency on previously indefinite claims 1, 5, and 6 are withdrawn in response to Applicant’s amendments to claims 1, 5, and 6 removing the indefiniteness.
The previous rejection to claim 7 regarding the recitations of “such as” is withdrawn in response to Applicant’s deletion of "such as” and replacing it with “selected from the group consisting of”, replacing the indefinite exemplary language with definite language.
Rejections under 35 U.S.C. § 112(d)
The previous rejection under 35 U.S.C. § 112(d) to claim 2, 5-7, 10, and 12 is withdrawn in response to Applicant’s amendments for the reasons that follow.
The previous rejection to claims 2 and 5 are withdrawn in response to the Applicant’s amendments canceling claims 2 and 5.
The previous rejection to claims 6, 7, 10, and 12, are withdrawn in response to the Applicant’s amendments changing the claims’ dependency to claim 1 (or claim 7 for claim 10), wherein claim 1 recites the composition “comprises”, enabling the dependent claims to add further components to the composition, thereby eliminating the issue of the dependent claim broadening the scope of its parent claims.
Rejections under 35 U.S.C. § 103
The previous rejection to claims 2 and 5 are withdrawn in response to the Applicant’s amendments deleting claims 2 and 5.
New Objections/Rejections
Claim Objection
Applicant’s amendments to claim 12 makes it a duplicate of claim 11.
Applicant is advised that should claim 11 be found allowable, claim 12 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Maintained Objections/Rejections
Applicant’s arguments and amendments, filed 05/21/2026, with respect to the rejection(s) of claim(s) 1, 3, 4, 6-12 under 35 U.S.C. § 103 and Double Patenting; and rejection(s) of claim(s) 1 and 6 under 112(b) have been fully considered. However, the arguments are not persuasive. Updated rejections are made in view of the Applicant’s amendments.
Rejections under 35 U.S.C. § 112(b)
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 and 6 contain the trademark/trade name DG. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the Lactobacillus paracasei strain and, accordingly, the identification/description is indefinite.
The examiner suggests that Lactobacillus paracasei with deposit number CNCM I-1572 alone, without the trademarked DG®, would be sufficiently definite towards describing the strain. Furthermore, for all the deposited bacteria strains, the Examiner suggests claim language that recites the “[bacteria name] strain, deposited in [name of repository] as [deposit accession number]” or the like.
Rejections under 35 U.S.C. § 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 4, 7, 9, 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Vlieger et al (Vlieger, A., et al, Tolerance and safety of Lactobacillus paracasei ssp. paracasei in combination with Bifidobacterium animalis ssp. lactis in a prebiotic-containing infant formula: a randomised controlled trial, British Journal of Nutrition, 102, 869–875; published 03/31/2009) in view of Cremon et al (Cremon, C., et al, Effect of Lactobacillus paracasei CNCM I-1572 on symptoms, gut microbiota, short chain fatty acids, and immune activation in patients with irritable bowel syndrome: A pilot randomized clinical trial ; published 05/2018) and further in view of Navarro-Tapia et al (Navarro-Tapia, E., et al, Probiotic Supplementation during the Perinatal and Infant Period: Effects on gut Dysbiosis and Disease, Nutrients 2020, 12, 2243, published 07/27/2020), as evidenced by Ragan (Ragan et al, Next-Generation Probiotic Therapy to Protect the Intestines From Injury, published 2022).
The instant specification defines a “method of treating” to include “the elimination, reduction/decrease or prevention of a pathology or disease and related symptoms or disorders” (page 10, line 6-9).
Vlieger et al teaches a method of treating and/or preventing gastrointestinal related disorders of an inflammatory and/or functional nature in a subject in need thereof by administering a therapeutically effective amount of a composition comprising of bacteria strains (Abstract). Vlieger et al further teaches the method further comprises at least one food grade or pharmaceutical grade additive and/or excipient, as they teach the strain was added to an infant formula mix that contains such additives, called Friso 1 (section Study formulas). Vlieger et al teach that the strain of bacteria is a Lactobacillus paracasei strain (Abstract). Vlieger et al teaches that the effect of this treatment was softer stool and increased defecation frequency in the subject, which is a reduction of a related symptom of the claimed disorders, such as intestinal colic, IBS with alternating bowel (also known as IBS-M/Mixed) and IBS with prevalent constipation or constipated bowel (also known as IBS-C/with Constipation) (section Discussion). Vlieger et al teaches the method in newborns starting from at most 7 days of age until 3 months of age (section Subjects and section Trial Design).
Vlieger et al does not explicitly teach the specific Lactobacillus paracasei strain instantly claimed.
Vlieger et al does not explicitly teach the specific disorder.
However, Cremon et al teaches Lactobacillus paracasei DG® CNCM I-1572 has effects on the reduction/decrease or prevention of a pathology or disease and related symptoms or disorders in adult subjects with IBS. Cremon et al teaches that subjects treated with Lactobacillus paracasei DG® CNCM I-1572 showed reduced presence of a bacteria genus associated with IBS (page 609), and reduced pro-inflammatory cytokine IL-15 levels which is taught to play a primary role in the development of several inflammatory diseases, such as IBS (page 611), arriving at some of the limitations of claim 1.
Vlieger et al in view of Cremon et al does not explicitly teach the motivation to treat newborn subjects in the first four weeks of life or 1 month to 12 months.
However, Navarro-Tapia et al teaches the importance of the perinatal period, which starts at the 20th week of gestation and ends 4 weeks after birth, in establishing lifelong gut microbiota; and that use of probiotics and paraprobiotics as therapeutic tools is attracting great interest, especially in the perinatal period (Abstract), providing motivation for focusing on the specific timeframe in claim 1, arriving at all the limitations of claim 1.
Furthermore, as evidenced by Ragan, the state of probiotic studies is that studies conducted in adults are required prior to studies in newborns (p. 6, col. 2, para. 2).
It would have been obvious to one skilled in the art, before the effective filing date of the instant application, to substitute the Lactobacillus paracasei strain taught by Vlieger et al with the Lactobacillus paracasei strain taught by Cremon et al in light of the finding that this strain can reduce bacteria and cytokines associated with IBS and gastrointestinal inflammatory diseases. It would have been obvious to one skilled in the art, before the effective filing date of the instant application, to specifically focus on administration during the four weeks after birth during the perinatal phase, taught by Navarro-Tapia et al as critical to the lifelong health of the infant.
Vlieger et al teaches a study that comprised of healthy newborn subjects. In contrast, Cremon et al teaches a study that comprised of adult patients diagnosed with IBS. One skilled in the art, before the effective filing date of the instant application, would be motivated to harness the advantages of the Lactobacillus paracasei strain taught by Cremon et al for newborns with IBS or other related pathologies. One skilled in the art, before the effective filing date of the instant application, would be motivated to administer these beneficial probiotics during a defined period that is critical to the lifelong health of the infant.
One skilled in the art, before the effective filing date of the instant application, would have reasonable expectation of success due to the findings of no treatment-related adverse effects for the Lactobacillus paracasei strain and its beneficial mechanisms of action taught by Cremon et al. One skilled in the art, before the effective filing date of the instant application, would have reasonable expectation of success due to the examples supporting probiotic supplementation during the perinatal period taught by Navarro-Tapia et al (reviewed throughout Table 6). Furthermore, as evidenced by Ragan, for probiotic studies in the past and currently, success in adults enables testing in newborns, implying that there is some likelihood of success in newborns that was not present without the success in adults, despite the differences in adult and neonatal microbiota structures cited by the Applicant. Clearly, success in adults provides some reasonable expectation of success translated to newborns.
KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, (2007), discloses that a simple substitution of one known element for another to obtain predictable results is obvious. The prior art contained a method that differed from the instant application by the substitution of the Lactobacillus paracasei strain with another Lactobacillus paracasei strain taught in a different prior art. Therefore, the substituted components and their functions were known in the art to serve similar purposes in treating and/or preventing gastro-intestinal disorders of an inflammatory and/or functional nature. The state of the art at the time and currently establishes probiotic studies results in adults as an indicator that the probiotic candidate can be tested in newborns, indicated a likelihood of success. One of ordinary skill in the art, before the effective filing date, could have substituted on known element for another, and the results of the substitution would have bene reasonably predictable in light of the human-subject trials presented in the prior art. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, (2007), also discloses that if some teaching, suggestion, or motivation in the prior art would lead one skilled in the art before the effective filing date to combine prior art references, then the modification is obvious. The direct teaching by Navarro-Tapia et al regarding the motivation to administer probiotics during the first four weeks of life provides an obvious motivation for focusing on this timeframe.
Claims 3, 4, 7, 9, 11, and 12 depend on claim 1. The teachings of the references for claim 1 are described above and incorporated in its entirety for the dependent claims and further described below.
Regarding claim 3, Vlieger et al (section Study formulas) and Cremon et al (section Study design) further teaches the method using viable strains of bacteria. Navarro-Tapia et al further teaches that derivatives of strains of bacteria, such as inactivated strains (also called paraprobiotics) could be useful for infants and vulnerable populations (page 38, paragraph 2).
Regarding claim 4, Cremon et al further teach the method wherein the disorder is IBS (Abstract).
Regarding claim 7, Vlieger et al further teaches the strain was added to an infant formula mix, called Friso 1, which contains, for example, GOS (galacto-oligosaccharide), zinc, and Vitamins B and D (section Study formulas).
Regarding claim 11, Vlieger et al further teaches the method wherein said disorders are selected from the group consisting of: neonatal colic, intestinal colic, chronic enterocolitis or chronic enterocolitis in preterm newborns and necrotizing enterocolitis, as evidenced by the increase in defecation frequency and softer stools (page 873, paragraph 2).
Regarding claim 12, Vlieger et al further teaches the limitations of claim 5 and Vlieger et al further teaches the method wherein said disorders are selected from the group consisting of: neonatal colic, intestinal colic, chronic enterocolitis or chronic enterocolitis in preterm newborns and necrotizing enterocolitis, as described for claim 1, as evidenced by the increase in defecation frequency and softer stools (page 873, paragraph 2).
Claim 9 depends on claim 3, which depends on claim 1. The teachings of the references for claims 1 and 3 are described above and incorporated in its entirety for claim 9, and further described below.
Regarding claim 9, Navarro-Tapia et al further teaches tyndallized probiotics for infants and vulnerable population (page 38, paragraph 2).
It would have been obvious to one skilled in the art, before the effective filing date of the instant application, to combine components from each of the prior art references in light of the advantages taught. Regarding claims 3 and 9, it would be obvious to one skilled in the art, before the effective filing date of the instant application, that viable bacteria strains can be used in newborns, but the option to use derivatives of the bacteria strains may be considered for highly vulnerable populations. Regarding claims 4 and 11-12, it would be obvious to one skilled in the art, before the effective filing date of the instant application, that the bacteria strains taught by the prior art would be reasonable probiotic candidates for the gastro-intestinal disorders claimed, as the prior art teaches them for use in treating and/or preventing these gastrointestinal disorders. Regarding claim 7, it would be obvious that these bacterial strains could be formulated with the additives claimed, and would benefit from coformulation with additional components, such as prebiotics, in light of the art teaching the synergy of prebiotic oligosaccharides and beneficial bacteria (Navarro-Tapia et al, page 16).
One skilled in the art, before the effective filing date of the instant application, would be motivated to combine these beneficial elements in known disease models to reduce the risk of adverse effects and treat gastrointestinal disorders in newborns.
One skilled in the art, before the effective filing date of the instant application, would have reasonable expectation of success with inactivated bacteria and the additional components in the formulation since these techniques and components are not specifically beneficial to the particular bacteria strains but rather for probiotics in general.
KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, (2007), discloses that combining prior art elements according to known methods to yield predictable results is obvious. The prior art includes each element claimed although not necessarily in a single reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements in a single prior art reference. The use of the particular strain from Cremon et al likely does not preclude the addition of the additives, the use in the claimed disease models, the use of its derivatives, and the use in certain populations, as is relevant to these claims and taught by Vlieger et al and Navarro-Tapia et al. Therefore, one of ordinary skill in the art, before the effective filing date, could have combined the elements and each element would be expected to perform, at least, the same function as it does separately.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Vlieger et al in view of Cremon et al and further in view of Navarro-Tapia et al, as evidenced by Ragan (Ragan et al, Next-Generation Probiotic Therapy to Protect the Intestines From Injury, published 2022), as applied to claim 1 above, and further in view of Biffi WO‘458 (Biffi, A., WO2022208458A1, Inactivated strains of bacteria, such as viable but non-culturable bacteria, compositions and use thereof; Effectively filed 04/01/2021 by priority application IT102021000008300).
Claim 6 depends on claim 1. The teachings of the references for claim 1 are discussed above and incorporated in its entirety for claim 6 and further discussed below.
Vlieger et al teaches the method comprising of a mixture of Lactobacillus paracasei and Bifidobacterium animalis ssp. Lactis in an infant formula (Abstract).
Vlieger et al in view of Cremon et al and further in view of Navarro-Tapia et al do not explicitly teach the instantly claimed strain of Bifidobacterium animalis ssp. Lactis.
However, Biffi WO‘458 teaches the instantly claimed strain Bifidobacterium animalis subsp. Lactis BlIBS01 DSM 33233 in a method of treating intestinal dysbiosis, inflammatory or functional gastrointestinal diseases and diseases caused by pathogenic microorganisms (Abstract and page 9).
It would have been obvious to one skilled in the art, before the effective filing date of the instant application, that combining two bacteria species, Lactobacillus paracasei ssp. paracasei and Bifidobacterium animalis ssp. lactis is possible and beneficial, in light of Vlieger et at teaching this combination and the art especially recognizing the benefits of mixtures of Lactobacillus and Bifidobacterium (Navarro-Tapia et al, Abstract). It would have been obvious to one skilled in the art, before the effective filing date of the instant application, to choose from the strain provided by Biffi WO’458 as this strain was already disclosed to treat gastrointestinal diseases.
One skilled in the art, before the effective filing date of the instant application, would be motivated to use the combination of two bacteria species known in the art and choose specific strains for the particular desired purpose based on teachings of the prior art about these strains, as both bacteria have different beneficial but compatible effects. One skilled in the art, before the effective filing date of the instant application, would have reasonable expectation of success in the method to treat gastrointestinal diseases as this strain was already disclosed to treat gastrointestinal diseases.
KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, (2007), discloses that use of a known technique to improve similar methods or products in the same way is obvious. The combination of bacteria species to improve on formulations with single bacteria species are known techniques used to improve probiotic formulations that can be applied to the relevant probiotic strains taught in the art, to arrive at the claimed invention. Although the prior art teaches the specific bacteria strains in different references, the bacteria strains and its uses are comparable and therefore, could benefit from the same improvement when combined with other probiotic bacteria, and the results would still be reasonably predictable.
Claim 6 is also rejected under 35 U.S.C. 103 as being unpatentable over Vlieger et al in view of Cremon et al and further in view of Navarro-Tapia et al, as evidenced by Ragan (Ragan et al, Next-Generation Probiotic Therapy to Protect the Intestines From Injury, published 2022), as applied to claim 1 above, and further in view of Biffi WO’636 (Biffi, A., et al, WO2021053636A1, Bacterial strains, their compositions and their use for the treatment of gastrointestinal disorders; published 03/25/2021).
Claim 6 depends on claim 1. The teachings of the references for claim 1 are discussed above and incorporated in its entirety for claim 6 and further discussed below.
Vlieger et al teaches the method comprising of a mixture of Lactobacillus paracasei and Bifidobacterium animalis ssp. Lactis in an infant formula (Abstract).
Vlieger et al in view of Cremon et al and further in view of Navarro-Tapia et al do not explicitly teach the instantly claimed strain of Bifidobacterium animalis ssp. Lactis.
However, Biffi WO‘636 teaches the instantly claimed strain Bifidobacterium breve DSM 33231, Bifidobacterium breve DSM 33232, Bifidobacterium animalis subsp. Lactis DSM 33233, Lactobacillus plantarum DSM 33234, and Bifidobacterium bifidum BbfIBS0l DSM 32708 in methods for the preventive and/or curative treatment of gastrointestinal diseases, disorders or symptoms (page 1, paragraphs 1-3).
It would have been obvious to one skilled in the art, before the effective filing date of the instant application, that combining two bacteria species of the Lactobacillus and/or Bifidobacterium, is possible and beneficial, in light of Vlieger et at teaching this combination and the art especially recognizing the benefits of mixtures of Lactobacillus and Bifidobacterium species (Navarro-Tapia et al, Abstract). It would have been obvious to one skilled in the art, before the effective filing date of the instant application, to choose from the list of strains provided by Biffi WO’636 as these strains were already disclosed to treat gastrointestinal diseases.
One skilled in the art, before the effective filing date of the instant application, would be motivated to use the combination of two bacteria species known in the art and choose specific strains for the particular desired purpose based on teachings of the prior art about these strains, as both bacteria have different beneficial but compatible effects. One skilled in the art, before the effective filing date of the instant application, would have reasonable expectation of success in the method to treat gastrointestinal diseases as these strains were already disclosed to treat gastrointestinal diseases.
KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, (2007), discloses that use of a known technique to improve similar methods or products in the same way is obvious. The combination of bacteria species to improve on formulations with single bacteria species are known techniques used to improve probiotic formulations that can be applied to the relevant probiotic strains taught in the art, to arrive at the claimed invention. Although the prior art teaches the specific bacteria strains in different references, the bacteria strains and its uses are comparable and therefore, could benefit from the same improvement when combined with other probiotic bacteria, and the results would still be reasonably predictable.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Vlieger et al in view of Cremon et al and further in view of Navarro-Tapia et al, as evidenced by Ragan (Ragan et al, Next-Generation Probiotic Therapy to Protect the Intestines From Injury, published 2022), as applied to claim 3 above, and further in view of Malfa et al (Malfa, P., et al, IT201900000801A1, Composition including non-viable probiotic bacteria and its use in therapy; published 07/18/2020).
Claim 8 depends on claim 3, which depends on claim 1.
Navarro-Tapia et al further teaches that derivatives of strains of bacteria, such as inactivated strains (also called paraprobiotics) could be useful for infants and vulnerable populations.
Vlieger et al in view of Cremon et al and further in view of Navarro-Tapia et al do not explicitly teach the bacterial strain is gamma irradiated.
However, Malfa et al teaches the bacterial strain is gamma irradiated.
Malfa et al teaches the disadvantages of other methods of bacteria inactivation (section State of the Art) and contrast it to inactivation by gamma rays, which maintain integrity of the bacteria cell wall, which allow it to maintain adhesive properties, which is helpful for remaining at the target site (Description of the invention). Malfa et al teaches this method can be applied to Lactobacillus paracasei (Description of the invention).
It would have been obvious to one skilled in the art, before the effective filing date of the instant application, that gamma irradiated bacteria strains could be advantageous for probiotic functions over other methods of bacteria inactivation, according to the teachings of Malfa et al, and that although Malfa et al teaches their method with topical administration of the bacteria, the benefits are applicable to the gastrointestinal environment.
One skilled in the art, before the effective filing date of the instant application, would be motivated to utilize gamma irradiation to inactivate probiotic bacteria in light of the potential drawbacks taught for other common methods of bacteria inactivation.
One skilled in the art, before the effective filing date of the instant application, would have reasonable expectation of success because this combination of bacteria species is already taught in the art to provide a multi-pronged approach to treatment. One skilled in the art, before the effective filing date of the instant application, would have reasonable expectation of success with gamma irradiated bacteria as it has been taught to be a suitable and perhaps better substitute for heat-inactivated probiotic bacteria or other common methods of inactivation, as it helps retain the ability for the bacteria to adhere to the intestinal wall, where it needs to work, but reduces potential undesired reactions against a live probiotic that may be especially salient in newborn subjects.
KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, (2007), discloses that use of a known technique to improve similar methods or products in the same way is obvious. The use of gamma irradiation to improve on probiotics inactivated by other methods are known techniques used to improve probiotic formulations that can be applied to the relevant probiotic strains taught in the art, to arrive at the claimed invention.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Vlieger et al in view of Cremon et al and further in view of Navarro-Tapia et al, as evidenced by Ragan (Ragan et al, Next-Generation Probiotic Therapy to Protect the Intestines From Injury, published 2022), as applied to claim 7 above, and further in view of Dilli et al (Dilli, D., et al, The ProPre-Save Study: Effects of Probiotics and Prebiotics Alone or Combined on Necrotizing Enterocolitis in Very Low Birth Weight Infants, J Pediatr 2015;166:545-51; published 03/2015).
Claim 10 depends on claim 7, which depends on claim 1.
Vlieger et al further teaches the strain was added to an infant formula mix, called Friso 1, which contains Vitamins B and D (section Study formula). Vlieger et al further explicitly teaches a prebiotic-containing formula was chosen (section Study formula).
Vlieger et al does not explicitly teach at least one prebiotic is inulin.
However, Dilli et al teaches a synbiotic comprising of inulin and Bifidobacterium lactis (also known as Bifidobacterium animalis subsp. Lactis) for infants to prevent necrotizing enterocolitis (NEC). Dilli et al further teaches inulin as a prebiotic sugar that stimulate the growth and metabolic activity of beneficial bacteria. Dilli et al provides a list of exemplary prebiotic sugars including inulin and galacto-oligosaccharide (Abstract) and therefore they can be understood by one skilled in the art, before the effective filing date, that these prebiotic sugars may be suitable alternatives to choose from depending on its utility to specific bacteria probiotic. Dilli et al further teaches that both normal flora Bifidobacterium and Lactobacillus spp. colonization is delayed in premature infants (Discussion paragraph 1). As such, one would be motivated to also use inulin with Lactobacillus species, arriving at the claimed invention.
In summary, Vlieger et al teaches probiotics Lactobacillus paracasei and Bifidobacterium animalis subsp. Lactis with prebiotic galacto-oligosaccharide while Dilli et al teaches Bifidobacterium animalis subsp. Lactis with prebiotic inulin but teaches inulin and galacto-oligosaccharide as prebiotics (Abstract). It would have been obvious to one skilled in the art, before the effective filing date of the instant application, that the galacto-oligosaccharide could be substituted with inulin as the prebiotic for formulations comprising of Lactobacillus paracasei as both sugars are used to stimulate probiotic growth.
One skilled in the art, before the effective filing date of the instant application, would be motivated to try the inulin as a prebiotic for Lactobacillus paracasei, as Dilli et al teaches that Lactobacillus and Bifidobacterium are two normal bacterial flora (Discussion, paragraph 1), and therefore, are often probiotic candidates administered together, as taught by Vlieger et al. As such, since inulin is shown to work for Bifidobacterium, it would be useful to try this with Lactobacillus to see if inulin can be used for both probiotics, which could be especially useful in probiotic combinations.
One skilled in the art, before the effective filing date of the instant application, would have reasonable expectation of success since these common prebiotics are chosen for their ability to be metabolized by many bacterial species.
KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, (2007), discloses that choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success is obvious. Dilli et al teaches a finite number of identified predictable potential solutions (i.e. prebiotics) that could be useful with the probiotic bacteria. One skilled in the art, before the effective filing date of the instant application, could have pursued the known potential prebiotics with reasonable expectation of success with the two common species of probiotics.
Nonstatutory double patenting
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). The applicant should amend or cancel claims such that the reference and the instant application no longer contain claims directed to the same invention.
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.
U.S. Patent No. US11752179B2:
Claims 1, 3, 4, 7, 9, 11-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. US11752179B2 (hereafter referred to as Biffi ‘179) in view of Vlieger et al (Vlieger, A., et al, Tolerance and safety of Lactobacillus paracasei ssp. paracasei in combination with Bifidobacterium animalis ssp. lactis in a prebiotic-containing infant formula: a randomised controlled trial, British Journal of Nutrition, 102, 869–875; published 03/31/2009) and further in view of Cremon et al (Cremon, C., et al, Effect of Lactobacillus paracasei CNCM I-1572 on symptoms, gut microbiota, short chain fatty acids, and immune activation in patients with irritable bowel syndrome: A pilot randomized clinical trial ; published 05/2018) and further in view of Navarro-Tapia et al (Navarro-Tapia, E., et al, Probiotic Supplementation during the Perinatal and Infant Period: Effects on gut Dysbiosis and Disease, Nutrients 2020, 12, 2243, published 07/27/2020), as evidenced by Ragan (Ragan et al, Next-Generation Probiotic Therapy to Protect the Intestines From Injury, published 2022).
The previous double patenting rejections are maintained and updated in response to the Applicant’s amendments. The teachings and obviousness rationales used in the previous double patenting rejections are updated with the updated obviousness rationales used in the updated 35 U.S.C. 103 rejections presented above.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. US11752179B2 (hereafter referred to as Biffi ‘179) in view of Vlieger et al and further in view of Cremon et al and further in view of Navarro-Tapia et al, as evidenced by Ragan (Ragan et al, Next-Generation Probiotic Therapy to Protect the Intestines From Injury, published 2022), as applied to claim 1 above, and further in view of Biffi WO‘458 (Biffi, A., WO2022208458A1, Inactivated strains of bacteria, such as viable but non-culturable bacteria, compositions and use thereof; Effectively filed 04/01/2021 by priority application IT102021000008300).
The previous double patenting rejections are maintained and updated in response to the Applicant’s amendments. The teachings and obviousness rationales used in the previous double patenting rejections are updated with the updated obviousness rationales used in the updated 35 U.S.C. 103 rejections presented above.
Claim 6 is also rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. US11752179B2 (hereafter referred to as Biffi ‘179) in view of Vlieger et al and further in view of Cremon et al and further in view of Navarro-Tapia et al, as evidenced by Ragan (Ragan et al, Next-Generation Probiotic Therapy to Protect the Intestines From Injury, published 2022), as applied to claim 1 above, and further in view of Biffi WO’636 (Biffi, A., et al, WO2021053636A1, Bacterial strains, their compositions and their use for the treatment of gastrointestinal disorders; published 03/25/2021).
The previous double patenting rejections are maintained and updated in response to the Applicant’s amendments. The teachings and obviousness rationales used in the previous double patenting rejections are updated with the updated obviousness rationales used in the updated 35 U.S.C. 103 rejections presented above.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. US11752179B2 (hereafter referred to as Biffi ‘179) in view of Vlieger et al and further in view of Cremon et al and further in view of Navarro-Tapia et al, as evidenced by Ragan (Ragan et al, Next-Generation Probiotic Therapy to Protect the Intestines From Injury, published 2022), as applied to claim 3 above, and further in view of Malfa et al (Malfa, P., et al, IT201900000801A1, Composition including non-viable probiotic bacteria and its use in therapy; published 07/18/2020).
The previous double patenting rejections are maintained and updated in response to the Applicant’s amendments. The teachings and obviousness rationales used in the previous double patenting rejections are updated with the updated obviousness rationales used in the updated 35 U.S.C. 103 rejections presented above.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable claims 1-16 of U.S. Patent No. US11752179B2 (hereafter referred to as Biffi ‘179) in view of Vlieger et al and further in view of Cremon et al and further in view of Navarro-Tapia et al, as evidenced by Ragan (Ragan et al, Next-Generation Probiotic Therapy to Protect the Intestines From Injury, published 2022), as applied to claim 7 above, and further in view of Dilli et al (Dilli, D., et al, The ProPre-Save Study: Effects of Probiotics and Prebiotics Alone or Combined on Necrotizing Enterocolitis in Very Low Birth Weight Infants, J Pediatr 2015;166:545-51; published 03/2015).
The previous double patenting rejections are maintained and updated in response to the Applicant’s amendments. The teachings and obviousness rationales used in the previous double patenting rejections are updated with the updated obviousness rationales used in the updated 35 U.S.C. 103 rejections presented above.
U.S. Patent No. US12447183B2
Claims 1, 3, 4, 7, 9, 11-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. US12447183B2 (hereafter referred to as Biffi ‘183) in view of Vlieger et al (Vlieger, A., et al, Tolerance and safety of Lactobacillus paracasei ssp. paracasei in combination with Bifidobacterium animalis ssp. lactis in a prebiotic-containing infant formula: a randomised controlled trial, British Journal of Nutrition, 102, 869–875; published 03/31/2009) and further in view of Cremon et al (Cremon, C., et al, Effect of Lactobacillus paracasei CNCM I-1572 on symptoms, gut microbiota, short chain fatty acids, and immune activation in patients with irritable bowel syndrome: A pilot randomized clinical trial ; published 05/2018) and further in view of Navarro-Tapia et al (Navarro-Tapia, E., et al, Probiotic Supplementation during the Perinatal and Infant Period: Effects on gut Dysbiosis and Disease, Nutrients 2020, 12, 2243, published 07/27/2020), as evidenced by Ragan (Ragan et al, Next-Generation Probiotic Therapy to Protect the Intestines From Injury, published 2022).
The previous double patenting rejections are maintained and updated in response to the Applicant’s amendments. The teachings and obviousness rationales used in the previous double patenting rejections are updated with the updated obviousness rationales used in the updated 35 U.S.C. 103 rejections presented above.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. US12447183B2 (hereafter referred to as Biffi ‘183) in view of Vlieger et al and further in view of Cremon et al and further in view of Navarro-Tapia et al, as evidenced by Ragan (Ragan et al, Next-Generation Probiotic Therapy to Protect the Intestines From Injury, published 2022), as applied to claim 1 above, and further in view of Biffi WO‘458 (Biffi, A., WO2022208458A1, Inactivated strains of bacteria, such as viable but non-culturable bacteria, compositions and use thereof; Effectively filed 04/01/2021 by priority application IT102021000008300).
The previous double patenting rejections are maintained and updated in response to the Applicant’s amendments. The teachings and obviousness rationales used in the previous double patenting rejections are updated with the updated obviousness rationales used in the updated 35 U.S.C. 103 rejections presented above.
Claim 6 is also rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. US12447183B2 (hereafter referred to as Biffi ‘183) in view of Vlieger et al and further in view of Cremon et al and further in view of Navarro-Tapia et al, as evidenced by Ragan (Ragan et al, Next-Generation Probiotic Therapy to Protect the Intestines From Injury, published 2022), as applied to claim 1 above, and further in view of Biffi WO’636 (Biffi, A., et al, WO2021053636A1, Bacterial strains, their compositions and their use for the treatment of gastrointestinal disorders; published 03/25/2021).
The previous double patenting rejections are maintained and updated in response to the Applicant’s amendments. The teachings and obviousness rationales used in the previous double patenting rejections are updated with the updated obviousness rationales used in the updated 35 U.S.C. 103 rejections presented above.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. US12447183B2 (hereafter referred to as Biffi ‘183) in view of Vlieger et al and further in view of Cremon et al and further in view of Navarro-Tapia et al, as evidenced by Ragan (Ragan et al, Next-Generation Probiotic Therapy to Protect the Intestines From Injury, published 2022), as applied to claim 3 above, and further in view of Malfa et al (Malfa, P., et al, IT201900000801A1, Composition including non-viable probiotic bacteria and its use in therapy; published 07/18/2020).
The previous double patenting rejections are maintained and updated in response to the Applicant’s amendments. The teachings and obviousness rationales used in the previous double patenting rejections are updated with the updated obviousness rationales used in the updated 35 U.S.C. 103 rejections presented above.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. US12447183B2 (hereafter referred to as Biffi ‘183) in view of Vlieger et al and further in view of Cremon et al and further in view of Navarro-Tapia et al, as evidenced by Ragan (Ragan et al, Next-Generation Probiotic Therapy to Protect the Intestines From Injury, published 2022), as applied to claim 7 above, and further in view of Dilli et al (Dilli, D., et al, The ProPre-Save Study: Effects of Probiotics and Prebiotics Alone or Combined on Necrotizing Enterocolitis in Very Low Birth Weight Infants, J Pediatr 2015;166:545-51; published 03/2015).
The previous double patenting rejections are maintained and updated in response to the Applicant’s amendments. The teachings and obviousness rationales used in the previous double patenting rejections are updated with the updated obviousness rationales used in the updated 35 U.S.C. 103 rejections presented above.
Application No. 18865784
Claims 1, 3, 4, 7, 9, 11-12 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3 and 5-16 of copending Application No. 18865784 (hereafter referred to as Biffi ‘784) in view of Vlieger et al (Vlieger, A., et al, Tolerance and safety of Lactobacillus paracasei ssp. paracasei in combination with Bifidobacterium animalis ssp. lactis in a prebiotic-containing infant formula: a randomised controlled trial, British Journal of Nutrition, 102, 869–875; published 03/31/2009) in view of Cremon et al (Cremon, C., et al, Effect of Lactobacillus paracasei CNCM I-1572 on symptoms, gut microbiota, short chain fatty acids, and immune activation in patients with irritable bowel syndrome: A pilot randomized clinical trial ; published 05/2018) and further in view of Navarro-Tapia et al (Navarro-Tapia, E., et al, Probiotic Supplementation during the Perinatal and Infant Period: Effects on gut Dysbiosis and Disease, Nutrients 2020, 12, 2243, published 07/27/2020), as evidenced by Ragan (Ragan et al, Next-Generation Probiotic Therapy to Protect the Intestines From Injury, published 2022).
The previous double patenting rejections are maintained and updated in response to the Applicant’s amendments. The teachings and obviousness rationales used in the previous double patenting rejections are updated with the updated obviousness rationales used in the updated 35 U.S.C. 103 rejections presented above.
Claim 6 is also provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3 and 5-16 of copending Application No. 18865784 (hereafter referred to as Biffi ‘784) in view of Vlieger et al, and further in view of Cremon et al, and further in view of Navarro-Tapia et al, as evidenced by Ragan (Ragan et al, Next-Generation Probiotic Therapy to Protect the Intestines From Injury, published 2022), as applied to claim 1 above, and further in view of Biffi WO‘458 (Biffi, A., WO2022208458A1, Inactivated strains of bacteria, such as viable but non-culturable bacteria, compositions and use thereof; Effectively filed 04/01/2021 by priority application IT102021000008300). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The previous double patenting rejections are maintained and updated in response to the Applicant’s amendments. The teachings and obviousness rationales used in the previous double patenting rejections are updated with the updated obviousness rationales used in the updated 35 U.S.C. 103 rejections presented above.
Claim 6 is also provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3 and 5-16 of copending Application No. 18865784 (hereafter referred to as Biffi ‘784) in view of Vlieger et al, and further in view of Cremon et al, and further in view of Navarro-Tapia et al, as evidenced by Ragan (Ragan et al, Next-Generation Probiotic Therapy to Protect the Intestines From Injury, published 2022), as applied to claim 1 above, and further in view of Biffi WO’636 (Biffi, A., et al, WO2021053636A1, Bacterial strains, their compositions and their use for the treatment of gastrointestinal disorders; published 03/25/2021). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The previous double patenting rejections are maintained and updated in response to the Applicant’s amendments. The teachings and obviousness rationales used in the previous double patenting rejections are updated with the updated obviousness rationales used in the updated 35 U.S.C. 103 rejections presented above.
Claim 8 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3 and 5-16 of copending Application No. 18865784 (hereafter referred to as Biffi ‘784) in view of Vlieger et al, and further in view of Cremon et al, and further in view of Navarro-Tapia et al, as evidenced by Ragan (Ragan et al, Next-Generation Probiotic Therapy to Protect the Intestines From Injury, published 2022), as applied to claims 3 above, and further in view of Malfa et al (Malfa, P., et al, IT201900000801A1, Composition including non-viable probiotic bacteria and its use in therapy; published 07/18/2020). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The previous double patenting rejections are maintained and updated in response to the Applicant’s amendments. The teachings and obviousness rationales used in the previous double patenting rejections are updated with the updated obviousness rationales used in the updated 35 U.S.C. 103 rejections presented above.
Claim 10 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3 and 5-16 of copending Application No. 18865784 (hereafter referred to as Biffi ‘784) in view of Vlieger et al, and further in view of Cremon et al, and further in view of Navarro-Tapia et al, as evidenced by Ragan (Ragan et al, Next-Generation Probiotic Therapy to Protect the Intestines From Injury, published 2022), as applied to claim 7 above, and further in view of Dilli et al (Dilli, D., et al, The ProPre-Save Study: Effects of Probiotics and Prebiotics Alone or Combined on Necrotizing Enterocolitis in Very Low Birth Weight Infants, J Pediatr 2015;166:545-51; published 03/2015). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The previous double patenting rejections are maintained and updated in response to the Applicant’s amendments. The teachings and obviousness rationales used in the previous double patenting rejections are updated with the updated obviousness rationales used in the updated 35 U.S.C. 103 rejections presented above.
Response to Arguments
Applicant’s arguments, filed 05/21/2026, with respect to claims 1, 3, 4, 6-12 have been fully considered. However, these arguments are not found persuasive for the following reasons.
Applicant argues the combination of the cited references fails to teach or suggest the claimed invention. Applicant further argues that Vlieger does not describe the specific claimed Lactobacillus paracasei DG CNCM I-1572 strain, nor does it describe the treatment of the claimed pathological conditions. These arguments are not found persuasive for the following reasons.
In response to applicant's argument that Vlieger is silent with regards to the specific claimed bacteria strain, the Examiner acknowledges this. However, 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). The rejection is a combination of references. While Vlieger teaches that the bacteria is a Lactobacillus paracasei strain (Abstract) Vlieger does not teach the specific strain as claimed; however, this is remedied by Cremon et al. Cremon teaches Lactobacillus paracasei DG having deposit number CNCM I-1572 used for the same purpose as Vlieger and the instant claim. Additionally, Navarro-Tapia provides the motivation for using this strain to treat newborns. For this reason, the claims are rejected over Vlieger in view of Cremon, where Cremon teaches the specific Lactobacillus paracasei strain.
In response to applicant's argument that Vlieger fails to show certain features of the invention, (i.e. Vlieger does not teach “treating serious inflammatory or functional gastrointestinal disorders in neonates”) it is noted that:
The features upon which applicant relies (“treating”) is explicitly defined by the instant specification to include the scope of the reference teachings as previously discussed. The instant specification defines a “method of treating” to include “the elimination, reduction/decrease or prevention of a pathology or disease and related symptoms or disorders” (page 10, line 6-9). The obviousness rejection explains how the symptoms in the references are symptoms of the claimed disorders, and therefore fall within the scope of what the instant application considers “treatment”.
The features upon which applicant relies are recited in the alternative in the rejected claim(s). The claims recite a method of “treating and/or preventing” gastrointestinal disorders of an inflammatory and/or functional nature. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). However, definitions from the specification define the scope of the words used in the claims. Therefore, the Applicant’s argument that the reference teachings are fundamentally different from the claimed therapeutic use for treating serious inflammatory or functional gastrointestinal disorder does not accurately depict the full scope of the claims and incorrectly compares the references’ teachings to only one possible embodiment of the claims. The combination of references’ teachings do read on the scope of the claims.
Applicant argues that Cremons does not provide any suggestion that results observed in adults would translate to newborns with a reasonable expectation of success.
Applicant further argues that probiotic efficacy is highly strain-specific and not readily predictable; and that because Navarro-Tapia teaches that there are few existing studies, heterogeneity in these studies, that the properties of one strain cannot be extrapolated to others, making it difficult to establish recommendations for probiotic use for the prevention of food allergies during infancy, and that further studies are necessary to verify specific benefits of individual strains, these teachings contradicts a simple substitution rationale; i.e. that because of the argued unpredictability of probiotics efficacy at a strain level there is no possible motivation to substitute a probiotic strain known to work in neonates with another probiotic strain of the same species known to treat symptoms of IBS in adults to help treat symptoms of gastrointestinal disorders of an inflammatory and/or functional nature in neonates.
Applicant further argues that the even if there was motivation to combine the references to arrive at the claimed invention, there is no reasonable expectation of success from adult to neonates due to the unique physiological characteristics of neonates compared to adults Applicant cites references Endo et al reciting the changes in intestinal microbiota during the neonatal stage until a more stable configuration around 12 months and Jena et al reciting the structural development of the intestine during the first year of life. In relation to this, Applicant further argues that a person skilled in the art understands that a probiotic strain must survive, colonize or interact with the microbiota, and modulate host physiology, which are all dependent on the host environment, microbiota, and immune system. Applicant argues that because of the differences between adult and neonatal intestinal differences, there is no reasonable expectation of success; i.e. that there is no reasonable expectation of success in using the claimed strain even though another strain was successful in treating symptoms of gastrointestinal disorders of an inflammatory and/or functional nature in neonates under 3 months old and the exact strain was successful in treating symptoms of gastrointestinal disorders of an inflammatory and/or functional nature in adults.
These arguments are not found persuasive for the following reasons.
In response to Applicant’s argument the combination of the cited references fails to establish any reasonable expectation of success, MPEP 2143.02 teaches that obviousness does not require absolute predictability, but only a reasonable expectation of success is required. Reasonable expectation of success is explained in the obviousness rejection above and summarized below.
Cremons teaches the exact claimed strain of bacteria, Lactobacillus paracasei DG® CNCM I-1572, has effects on the reduces or prevents pathology or disease and related symptoms or disorders in adult subjects with IBS, as previously presented in the obviousness rejections above. As evidenced by Ragan, success in adults enables testing in newborns, implying that there is some likelihood of success in newborns that was not present without the success in adults, despite the differences in adult and neonatal microbiota structures cited by the Applicant. Clearly, success in adults provides some reasonable expectation of success translated to newborns. The mere fact that further testing in newborns is needed to enable clinical recommendations of use in newborns and the fact that there is a chance there is a difference between effects in adults and newborns does not itself mean that the results in adults confers no reasonable expectation of success in newborns. The standard for arriving at clinical recommendations to newborns is closer to absolute predictability with direct evidence that gives a specific risk and/or likelihood of response while the standard for obviousness is that the probiotic can reasonably be successful in newborns and does not require absolute predictability.
Secondly, Vlieger teaches probiotics of the same species as the instant in infants. Although it is not the same strain as the instantly claimed bacteria, one skilled in the art would reasonably expect that the instant strain, being in the same species as in the art and already showing success in adults, would more likely than other strains to have success therapeutic effects in neonates. Taking these teachings together, i.e. that another strain in the same species is safe and effective in infants and that this particular strain has already been safe and effective in adults, there is reasonable expectation of success in applying the instantly claimed strain to neonates.
Applicant further argues that Cremon and Navarro-Tapia fails to provide a motivation to apply the probiotic strain to neonates and therefore, the Examiner’s rationale for the motivation to do so relies on impermissible hindsight reconstruction of the present invention. These arguments are not found persuasive for the following reasons.
In response to applicant's argument that Cremons and Navarro-Tapia fails to provide the stated motivation:
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.
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, the motivation to is provided by the combination of teachings by Navarro-Tapia teaching the lifelong impact of the perinatal microbiota development on the gut microbiota and that use of probiotics and paraprobiotics as therapeutic tools is attracting great interest, especially in the perinatal period (Abstract); with the teachings of the probiotics by Vlieger and Cremon, as previously described, which establish the specific probiotic as a candidate with reasonable expectation of success in perinatal neonates.
Further, MPEP 2144 teaches that the references do not have to explicitly suggest to combine the teachings. Rather, establishing a prima facie case of obviousness requires a clear articulation of a rationale for combining the teachings of the references, and such rationale has been provided in the rejection above.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon the instant disclosure. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The information regarding the safety and effectiveness of the instant species and specific strain, as previously presented, was known in the art at the time of the invention, and the motivation to develop probiotics for the perinatal and neonatal stages were also known in the art at the time of the invention. Therefore, the motivation does not rely on hindsight reconstruction simply from the instant disclosure.
Conclusion
All claims are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIRATH CHHAY whose telephone number is (571)272-0682. The examiner can normally be reached Mon-Thu 8AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached at (571) 272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BONIRATH CHHAY/ Examiner, Art Unit 1645 Wednesday, July 14, 2026
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 July 14, 2026
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