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 .
Status of the Claims
Claim 2 has been cancelled. Claims 4-15 have been withdrawn. Therefore, claims 1 and 3 are pending and currently under examination (claim set filed 09/19/2025).
Withdrawal of Rejections
The response and amendments filed on 09/19/2025 are acknowledged. Any previously applied minor objections and/or minor rejections (i.e., formal matters), not explicitly restated here for brevity, have been withdrawn necessitated by Applicant’s formality corrections and/or amendments. For the purposes of the clarity of the record, the reasons for the Examiner’s withdrawal, and/or maintaining, if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner’s Response to Arguments section.
Briefly, the previous drawing objections have been withdrawn necessitated by Applicant’s submission of new drawings.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presenting being applied to the instant application.
Maintained Rejections
Claim Rejections - 35 USC § 112(a), Written Description
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 3 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claim 1 recites “wherein said bacterial strain and said mesalamine are present in an amount sufficient to synergistically treat an inflammatory gastrointestinal disease.” Applicant is broadly claiming amounts of Faecalibacterium prausnitzii CNCM I-4573 and mesalamine that result in synergy to treat inflammatory gastrointestinal disease; however, the instant Specification does not describe these amounts in enough specificity such that the Applicant has shown possession of a representative number of species for Faecalibacterium prausnitzii CNCM I-4573 and mesalamine that induce synergy.
Regarding the amount of mesalamine, the instant Specification teaches “The amount of mesalamine, or its derivatives, used in an association or composition of the present invention can be in the range from about 100 to about 8000 mg, and in particular from about 100 to about 500 mg. In a particular embodiment, a composition of the invention comprises 400 mg, 600 mg, or 800 mg of mesalamine or a derivative thereof” (see, e.g., instant Specification, pg. 9, lines 19-23). Regarding the amount of Faecalibacterium prausnitzii CNCM I-4573, the instant Specification teaches “In particular, a composition of the invention is suitable for the administration of a daily dose of the bacterial strain of the species Faecalibacterium prausnitzii CNCM I-4573 representing from 103 to 1012 bacteria as a medicament, in particular a daily dose representing from 104 to 1012 bacteria as a medicament, more particularly a daily dose 106 to 1012 bacteria as a medicament, preferably in the form of a daily dose equivalent to 1010 bacteria” (see, e.g., instant Specification, pg. 11, lines 18-23). These amounts taught in the instant Specification pertain to individual amounts of mesalamine and Faecalibacterium prausnitzii CNCM I-4573 that can be administered, but do not pertain to amounts that result in synergy.
The written description requirement can be met by providing a representative number of species for each claimed genus. To satisfy written description, the Applicant must have possession of a representative number of species which are adequately described and are representative of the entire genus at the time the invention was filed (see, e.g., MPEP 2163(II)(A)(2)(ii)). The instant Specification teaches one example (see, e.g., instant Specification, pg. 13, lines 9-12) of amounts of Faecalibacterium prausnitzii CNCM I-4573 and mesalamine that result in synergism in mice when measuring disease activity, presence of occult blood, and weight/colon length (see, e.g., instant Specification, Figures 1-3). More specifically, the instant Specification teaches Faecalibacterium prausnitzii CNCM I-4573 at an amount of 1x109 CFU and 2.88 g of Pentasa (i.e., mesalamine) for treatment of inflammatory gastrointestinal disease in mice. Therefore, the instant Specification does not provide a representative number of species that are representative of the entire genus (i.e., amounts of Faecalibacterium prausnitzii CNCM I-4573 and mesalamine that result in synergism). Moreover, the instant Specification only provides amounts of Faecalibacterium prausnitzii CNCM I-4573 and mesalamine that result in synergism in mice; however, independent claim 1 is broadly claiming amounts of Faecalibacterium prausnitzii CNCM I-4573 and mesalamine that result in synergism, which can be in any organism. Therefore, a skilled artisan would not know from the guidance provided in the instant Specification what amounts of Faecalibacterium prausnitzii CNCM I-4573 and mesalamine result in synergism to treat inflammatory gastrointestinal disease, especially in different organisms that suffer from inflammatory gastrointestinal disease, such as humans.
With regard to the state of the art, the prior art does not teach specific amounts of Faecalibacterium prausnitzii CNCM I-4573 and mesalamine that result in synergism. Langella teaches the administration of Faecalibacterium prausnitzii CNCM I-4573 at an amount of “1x107 to 1x1011 colony-forming units (CFU) as a drug, preferably a daily dose equivalent to 1x109 CFU” for the treatment of inflammatory gastrointestinal disease (see, e.g., Langella, English Translation, pg. 3). Criscuoli teaches the administration of mesalamine at a dose of at least 2 g/day for the treatment of mild-to-moderate ulcerative colitis (see, e.g., Criscuoli, Section 2, pg. 1670). Therefore, the prior art teaches the individual amounts of Faecalibacterium prausnitzii CNCM I-4573 and mesalamine that can be administered to treat inflammatory gastrointestinal disease; however, the prior art does not teach amounts of Faecalibacterium prausnitzii CNCM I-4573 and mesalamine that synergistically treat inflammatory gastrointestinal disease.
Accordingly, claim 1 does not meet the written description requirement. Claim 3 depends on rejected claim 1 and fails to rectify the noted deficiencies.
Examiner’s Response to Arguments
Applicant’s arguments pertaining to the 35 U.S.C. 112(a), written description filed on 09/19/2025 have been fully considered but they are not persuasive and deemed insufficient to overcome the rejection.
Regarding Applicant’s argument pertaining to the written description not demanding that every possible combination of amounts be exemplified for synergism (remarks, pages 4-5), this argument is not persuasive. Applicant provides one example for the concentration of Faecalibacterium prausnitzii CNCM I-4573 at an amount of 1x109 CFU and 2.88 g of Pentasa (i.e., mesalamine) for treatment of inflammatory gastrointestinal disease in mice, wherein F. prausnitzii and Pentasa exhibit synergism at these specific concentrations (see, e.g., instant Specification, Figures 1-3). Moreover, the instant Specification teaches “In particular, a composition of the invention is suitable for the administration of a daily dose of the bacterial strain of the species Faecalibacterium prausnitzii CNCM I-4573 representing from 103 to 1012 bacteria as a medicament, in particular a daily dose representing from 104 to 1012 bacteria as a medicament, more particularly a daily dose 106 to 1012 bacteria as a medicament, preferably in the form of a daily dose equivalent to 1010 bacteria” (see, e.g., instant Specification, pg. 11, lines 18-23). Additionally, the instant Specification teaches “The amount of mesalamine, or its derivatives, used in an association or composition of the present invention can be in the range from about 100 to about 8000 mg, and in particular from about 100 to about 500 mg. In a particular embodiment, a composition of the invention comprises 400 mg, 600 mg, or 800 mg of mesalamine or a derivative thereof” (see, e.g., instant Specification, pg. 9, lines 19-23). MPEP 2163.05(1)(B) states “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).” Based on Applicant’s written description provided in the instant Specification, Faecalibacterium prausnitzii CNCM I-4573 can range from 103 to 1012 bacteria, and Pentasa can range from about 100 to about 8000 mg; therefore, providing one example of Faecalibacterium prausnitzii CNCM I-4573 at an amount of 1x109 CFU and 2.88 g of Pentasa is not sufficient to reflect the variation within the genus, and does not provide adequate written description.
Maintained Rejections
Claim Rejections - 35 USC § 103, Obviousness
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Langella (FR3046934; Date of Publication: July 28, 2017 – previously cited) in view of Criscuoli (Mesalazine for the Treatment of Inflammatory Bowel Disease; 2013 – previously cited).
Langella’s general disclosure relates to “a bacterial strain of the species Faecalibacterium prausnitzii deposited with the CNCM under the accession number CNCM I-4573, for its use in the treatment and/or prevention of an inflammatory gastrointestinal disease in a patient” (see, e.g., Langella, English translation, abstract, pg. 1). Additionally, Langella teaches that Faecalibacterium prausnitzii CNCM I-4573 has the unexpected ability to reduce in vitro and in vivo inflammation within the gastrointestinal tract by reducing the production of pro-inflammatory molecules, such as interleukin-8, interleukin-2, interleukin-4, interleukin-6, and gamma interferon, as well as increase the production of anti-inflammatory molecules, such as interleukin-10 (see, e.g., Langella, English translation, pg. 2).
Regarding claim 1 pertaining to the bacterial strain, Langella teaches “a bacterial strain of the species Faecalibacterium prausnitzii deposited with the CNCM under the accession number CNCM I-4573” (see, e.g., Langella, English translation, abstract, pg. 1).
Regarding claim 3 pertaining to a pharmaceutically acceptable medium, Langella teaches a “physiologically acceptable medium”, which “may be, for example, a non-toxic solvent such as water” (see, e.g., Langella, English translation, “Field of the Invention”, pg. 2).
Regarding claim 1 pertaining to the amount of Faecalibacterium prausnitzii CNCM I-4573 to treat an inflammatory gastrointestinal disease, Langella teaches “1x107 to 1x1011 colony-forming units (CFU) as a drug, preferably a daily dose equivalent to 1x109 CFU” for the treatment of inflammatory gastrointestinal disease (see, e.g., Langella, English Translation, pg. 3). Moreover, the instant Specification teaches administration of Faecalibacterium prausnitzii CNCM I-4573 at a dose of Faecalibacterium prausnitzii CNCM I-4573 ranging from 103 CFU to 1012 CFU (see, e.g., instant Specification, pg. 11, lines 18-23), with 1x109 CFU being used for the treatment of bowel inflammation and modulation of immune responses (see, e.g., instant Specification, pg. 13, lines 7-9). Therefore, Langella teaches the same doses of Faecalibacterium prausnitzii CNCM I-4573 as what is taught in the instant Specification. Furthermore, Langella teaches that Faecalibacterium prausnitzii CNCM I-4573 at a dose of 1x109 CFU is sufficient for exhibiting anti-inflammatory properties within the gastrointestinal tract (see, e.g., Langella, English Translation, Examples, pgs. 5-6)
However, Langella does not teach: mesalamine (claim 1); or the amount of mesalamine sufficient to synergistically treat an inflammatory gastrointestinal disease (claim 1).
Criscuoli’s general disclosure relates to the role of mesalazine in the management and treatment of inflammatory bowel disease (see, e.g., Criscuoli, abstract, pg. 1669). Additionally, Criscuoli discloses that mesalazine has a well-established role in the management of ulcerative colitis (UC), but no clear role in the prevention of colon cancer and management of Crohn’s disease (CD) (see, e.g., Criscuoli, abstract, pg. 1669). Moreover, Criscuoli teaches that mesalamine exhibits multiple anti-inflammatory effects, including “inhibition of cyclooxygenase, lipoxygenase, B-cells and several key inflammatory cytokines” (see, e.g., Criscuoli, Introduction, pg. 1670). Additionally, Criscuoli teaches that mesalamine “has been shown to activate selective peroxisome proliferators-activated receptor ligand-g (PPAR-γ), a nuclear receptor that controls cell proliferation and apoptosis. PPAR-γ is a transcription factor that modulates the inflammatory response of monocytes and macrophages by inhibiting the production of nitric oxide (iNOS) and macrophage-derived cytokines, such as TNF-a, IL-1 and IL-6” (see, e.g., Criscuoli, Introduction, pg. 1670).
Regarding claim 1 pertaining to mesalamine, Criscuoli teaches the role of mesalamine in the treatment of inflammatory diseases, such as UC and CD (see, e.g., Criscuoli, Introduction, pg. 1670).
Regarding claim 1 pertaining to the amount of mesalamine, Criscuoli teaches the administration of mesalamine at a dose of at least 2 g/day for the treatment of mild-to-moderate ulcerative colitis (see, e.g., Criscuoli, Section 2, pg. 1670). Moreover, the instant Specification teaches that the composition should contain 100 mg to 8000 mg of mesalamine (see, e.g., instant Specification, pg. 9, lines 19-23), with 2.88 g of mesalamine being used for the treatment of bowel inflammation and modulation of immune responses (see, e.g., instant Specification, lines 9-12). Therefore, Criscuoli teaches the same doses of mesalamine as what is taught in the instant Specification. Moreover, Criscuoli teaches that mesalamine at a dose of at least 2 g/day is sufficient for treating mild-to-moderate UC (see, e.g., Criscuoli, Section 2, pg. 1670-1671).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a composition for treating inflammatory gastrointestinal disease by combining Faecalibacterium prausnitzii CNCM I-4573, as taught by Langella, with mesalamine, as taught by Criscuoli. One would have been motivated to do so because Criscuoli teaches that mesalamine has a well-established role in the management of ulcerative colitis and inflammatory bowel disease, both of which are inflammatory gastrointestinal disorders. Additionally, Criscuoli teaches that mesalamine exhibits multiple anti-inflammatory effects, including “inhibition of cyclooxygenase, lipoxygenase, B-cells and several key inflammatory cytokines” (see, e.g., Criscuoli, Introduction, pg. 1670). Additionally, Criscuoli teaches that mesalamine “has been shown to activate selective peroxisome proliferators-activated receptor ligand-g (PPAR-γ), a nuclear receptor that controls cell proliferation and apoptosis. PPAR-γ is a transcription factor that modulates the inflammatory response of monocytes and macrophages by inhibiting the production of nitric oxide (iNOS) and macrophage-derived cytokines, such as TNF-a, IL-1 and IL-6” (see, e.g., Criscuoli, Introduction, pg. 1670). Furthermore, it would have been obvious to combine mesalamine with Faecalibacterium prausnitzii CNCM I-4573 because Langella teaches that Faecalibacterium prausnitzii CNCM I-4573 has been used to treat inflammatory gastrointestinal diseases in patients (see, e.g., Langella, abstract). Moreover, Langella teaches that Faecalibacterium prausnitzii CNCM I-4573 has the unexpected ability to reduce in vitro and in vivo inflammation within the gastrointestinal tract by reducing the production of pro-inflammatory molecules, such as interleukin-8, interleukin-2, interleukin-4, interleukin-6, and gamma interferon, as well as increase the production of anti-inflammatory molecules, such as interleukin-10 (see, e.g., Langella, English translation, pg. 2). Therefore, based on the teachings of Langella and Criscuoli, it would have been obvious to combine Faecalibacterium prausnitzii CNCM I-4573 and mesalamine in a composition to treat inflammatory gastrointestinal diseases because both are already used as treatments for inflammatory gastrointestinal diseases, and both exhibit anti-inflammatory properties. Moreover, since Faecalibacterium prausnitzii CNCM I-4573 and mesalamine exhibit similar properties, one of ordinary skill in the art would expect Faecalibacterium prausnitzii CNCM I-4573 and mesalamine to produce additive effects when used to treat inflammatory gastrointestinal disease. One would have expected success because Langella and Criscuoli both teach the treatment of inflammatory gastrointestinal diseases through administration of compounds that exhibit anti-inflammatory properties.
Regarding claim 1’s concentration limitations, MPEP 2144.05 states that “Generally, differences in concentrations or temperatures will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where 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.” Those working in the biological and/or pharmaceutical arts would understand that the adjustments of particular conventional working conditions (e.g., concentration or amount of a compound) is deemed a matter of judicious selection and routine optimization, which is within the purview of the skilled artisan. For example, Langella teaches Faecalibacterium prausnitzii CNCM I-4573 concentrations of “1x107 to 1x1011 colony-forming units (CFU) as a drug, preferably a daily dose equivalent to 1x109 CFU” for the treatment of inflammatory gastrointestinal disease (see, e.g., Langella, English Translation, pg. 3). Additionally, Criscuoli teaches at least 2 g/day for the treatment of mild-to-moderate ulcerative colitis (see, e.g., Criscuoli, Section 2, pg. 1670). Criscuoli also teaches that “patients with moderate disease may benefit from an higher initial dose (4.8 g/day)”, in regards to mesalamine treatment. Therefore, one of ordinary skill in the art would readily understand that the amounts/concentrations of Faecalibacterium prausnitzii CNCM I-4573 and mesalamine influences the outcome of gastrointestinal disease. This is motivation for someone of ordinary skill in the art to practice or test the parameter widely, based on the concentrations taught by Langella and Criscuoli, to find those that are functional, optimal, and/or synergistic, which then would be inclusive or cover the steps as instantly claimed. Absent any teaching of criticality by the Applicant concerning concentration, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are result effective variables which can be met as a matter of routine optimization.
Examiner’s Response to Arguments
Applicant’s amendments and arguments filed on 09/19/2025 have been fully considered but they are not persuasive and deemed insufficient to overcome the prior arts of record.
Regarding Applicant’s argument pertaining to unexpected results (remarks, pages 6-7), this argument is not persuasive for multiple reasons:
First, Faecalibacterium prausnitzii CNCM I-4573 and mesalamine are both used to treat inflammatory gastrointestinal diseases and exhibit anti-inflammatory properties; therefore, since both exhibit the same properties, one of ordinary skill in the art would at least expect an additive effect when combining Faecalibacterium prausnitzii CNCM I-4573 and mesalamine.
Secondly, the instant Specification teaches Faecalibacterium prausnitzii CNCM I-4573 at an amount of 1x109 CFU and 2.88 g of Pentasa (i.e., mesalamine) for treatment of inflammatory gastrointestinal disease in mice, and further shows that these amounts of Faecalibacterium prausnitzii CNCM I-4573 and mesalamine exhibit a synergistic effect when measuring disease activity, presence of occult blood, and weight/colon length (see, e.g., instant Specification, Figures 1-3). Langella teaches the administration of Faecalibacterium prausnitzii CNCM I-4573 at an amount of “1x107 to 1x1011 colony-forming units (CFU) as a drug, preferably a daily dose equivalent to 1x109 CFU” for the treatment of inflammatory gastrointestinal disease (see, e.g., Langella, English Translation, pg. 3). Criscuoli teaches the administration of mesalamine at a dose of at least 2 g/day for the treatment of mild-to-moderate ulcerative colitis (see, e.g., Criscuoli, Section 2, pg. 1670). Therefore, Langella and Criscuoli both teach the same amounts that are used in the instant Specification to evaluate synergy between Faecalibacterium prausnitzii CNCM I-4573 and mesalamine. One of ordinary skill in the art would have been motivated to use the amounts of Faecalibacterium prausnitzii CNCM I-4573 and mesalamine, as taught by Langella and Criscuoli, as starting points when identifying and testing for synergy.
Thirdly, as previously discussed, Faecalibacterium prausnitzii CNCM I-4573 and mesalamine both exhibit properties for treating and/or preventing inflammatory gastrointestinal diseases, one of ordinary skill in the art would have been motivated to combine the two in order to produce a composition with enhanced and/or additive effects. Langella teaches that Faecalibacterium prausnitzii CNCM I-4573 has the unexpected ability to reduce in vitro and in vivo inflammation within the gastrointestinal tract by reducing the production of pro-inflammatory molecules, such as interleukin-8, interleukin-2, interleukin-4, interleukin-6, and gamma interferon, as well as increase the production of anti-inflammatory molecules, such as interleukin-10 (see, e.g., Langella, English translation, pg. 2). Criscuoli teaches that mesalamine exhibits multiple anti-inflammatory effects, including “inhibition of cyclooxygenase, lipoxygenase, B-cells and several key inflammatory cytokines” (see, e.g., Criscuoli, Introduction, pg. 1670). Additionally, Criscuoli teaches that mesalamine “has been shown to activate selective peroxisome proliferators-activated receptor ligand-g (PPAR-γ), a nuclear receptor that controls cell proliferation and apoptosis. PPAR-γ is a transcription factor that modulates the inflammatory response of monocytes and macrophages by inhibiting the production of nitric oxide (iNOS) and macrophage-derived cytokines, such as TNF-a, IL-1 and IL-6” (see, e.g., Criscuoli, Introduction, pg. 1670). Therefore, the teachings of Langella and Criscuoli show that Faecalibacterium prausnitzii CNCM I-4573 and mesalamine exhibit anti-inflammatory properties with the ability to treat and/or prevent inflammatory gastrointestinal disease. Based on the similar anti-inflammatory properties exhibited by Faecalibacterium prausnitzii CNCM I-4573 and mesalamine, one of ordinary skill in the art would have been motivated to combine Faecalibacterium prausnitzii CNCM I-4573 and mesalamine in a composition to treat inflammatory gastrointestinal diseases. Moreover, based on the similar properties exhibited by Faecalibacterium prausnitzii CNCM I-4573 and mesalamine, one of ordinary skill in the art would have expected an additive, or even synergistic effect, when combining Faecalibacterium prausnitzii CNCM I-4573 and mesalamine into a single composition.
Fourthly, as discussed above, it would be a matter of routine optimization to find the concentrations of Faecalibacterium prausnitzii CNCM I-4573 and mesalamine that result in synergy (see, e.g., MPEP 2144.05), especially when one of ordinary skill in the art has the amounts of Faecalibacterium prausnitzii CNCM I-4573 and mesalamine, as taught by Langella and Criscuoli, as starting points. Arguments of unexpected synergy must be supported by evidence when the art clearly teaches both Faecalibacterium prausnitzii CNCM I-4573 and mesalamine useful for the same purpose (see, e.g., MPEP 716.02(a)).
Fifthly, the Broadest Reasonable Interpretation (BRI) of independent claim 1 is a composition comprising Faecalibacterium prausnitzii CNCM I-4573 and mesalamine. Assuming arguendo that there is unexpectedness in regards to the synergy, the data are not commensurate in scope with the claimed invention (see, e.g., MPEP 716.02(d)). Applicant is relying on a specific concentration of Faecalibacterium prausnitzii CNCM I-4573 (i.e., 1x109 CFU) and a specific amount of Pentasa (i.e., 2.88g), both of which are not part of the claimed invention based on the BRI of independent claim 1.
Conclusion
Claims 1 and 3 are rejected.
No claims are allowed.
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.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE IANNUZO whose telephone number is (703)756-5559. The examiner can normally be reached Mon - Fri: 8:30-6:00 EST.
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/NATALIE IANNUZO/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653