DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/04/2026 has been entered.
Withdrawal of Rejections
The response and amendments filed on 02/03/2026 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minor objections and/or minor rejections (i.e., formal matters), not explicitly restated here for brevity, have been withdrawn necessitated by Applicant’s formality correction and/or amendments. For the purposes of 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Briefly, the previous claim rejections under 35 U.S.C. 103 for obviousness have been withdrawn necessitated by Applicant’s amendments; however, new grounds of rejection are set forth below.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
New Grounds of Rejection Necessitated by Amendments
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, 8-9, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Schneider (WO 2017/218680; Date of Publication: December 21, 2017 – previously cited) in view of Biffi (WO 2019/053604; Date of Publication: March 21, 2019 – newly cited) and Kawaguchi (WO 2020/075637; Date of Publication: April 16, 2020 – previously cited).
Schneider’s general disclosure relates to compositions of purified bacterial strains for the
treatment of pathogenic infections, such as Clostridium difficile infections (see, e.g., Schneider, “Field of Invention”, pg. 1, lines 9-11).
Regarding claims 1 and 9 pertaining to the composition, Schneider teaches a
composition comprising cells of Clostridium scindens and Blautia producta for treatment or
prevention of C. difficile infections (see, e.g., Schneider, “Summary of Invention”, pg. 3, lines 7-
8, 11, 14). Moreover, Schneider teaches that the composition can be a pharmaceutical
composition (see, e.g., Schneider, pg. 18, line 5), or a food composition (see, e.g., Schneider, pg.
18, lines 7-9). Additionally, Schneider teaches that the bacterial cells can be lyophilized (see,
e.g., Schneider, pg. 16, lines 23-24).
Regarding claims 1 and 9 pertaining to the Clostridium scindens KBL987 strain, it cannot be ascertained if the prior art of Schneider and the instantly claimed strain, Clostridium scindens KBL987, are the same. However, it is the Examiner’s position that they are identical, or substantially similar since they share similar properties/functions:
Claimed Clostridium scindens KBL987 strain
Genus, Species: Clostridium scindens
Growth: Anaerobic fermentation techniques (see, e.g., instant spec, pg. 10)
Intended use: Clostridium difficile growth inhibition (see, e.g., instant spec, pg. 2)
Dosage forms: Oral, rectal, or intravenous delivery (see, e.g., instant spec, pg. 11)
Treatment results: Inhibits the growth and/or survival of C. difficile (see, e.g., instant spec, pg. 29)
Prior Art Strain (Schneider’s Clostridium scindens)
Genus, Species: Clostridium scindens
Growth: Anaerobic fermentation techniques (see, e.g., Schneider, pg. 95, lines 31- 34)
Intended use: Clostridium difficile growth inhibition (see, e.g., Schneider, pg. 25, lines 14-18)
Dosage forms: Oral or rectal delivery (see, e.g., Schneider, pg. 18, lines 32-34)
Treatment results: Inhibits the growth and/or survival of C. difficile (see, e.g., Schneider, pg. 25, lines 22-23)
Therefore, the cited reference discloses Clostridium scindens (see, e.g., Schneider, “Summary of Invention”, pg. 3, lines 7-8, 11, 14) which appears to be identical to the presently
claimed strain since it is suitable for inhibiting Clostridium difficile growth and is the same bacterial species as the claimed microorganism. Furthermore, it appears that the Clostridium
scindens strain, such as taught by Schneider, is structurally the same to that as instantly claimed;
therefore, it would also perform the intended use of treating/preventing Clostridium difficile
infection.
Regarding claims 1 and 9 pertaining to Blautia producta KBL988, Blautia producta KBL990, or Blautia producta KBL991, it cannot be ascertained if the prior art strain of Schneider and the instantly claimed Blautia producta KBL988, Blautia producta KBL990, and Blautia producta KBL991 strains are the same. However, it is the Examiner’s position that they are identical, or substantially similar since they share similar properties/functions:
Claimed Blautia producta KBL988, Blautia producta KBL990, and
Blautia producta KBL991 strains
Genus, Species: Blautia producta
Growth: Anaerobic fermentation techniques (see, e.g., instant spec, pg. 10)
Intended use: Clostridium difficile growth inhibition (see, e.g., instant spec, pg. 2)
Dosage forms: Oral, rectal, or intravenous delivery (see, e.g., instant spec, pg. 11)
Treatment results: Inhibits the growth and/or survival of C. difficile (see, e.g., instant spec, pg. 29)
Prior Art Strain (Schneider’s Blautia producta)
Genus, Species: Blautia producta
Growth: Anaerobic fermentation techniques (see, e.g., Schneider, pg. 95, lines 31- 34)
Intended use: Clostridium difficile growth inhibition (see, e.g., Schneider, pg. 25, lines 14-18)
Dosage forms: Oral or rectal delivery (see, e.g., Schneider, pg. 18, lines 32-34)
Treatment results: Inhibits the growth and/or survival of C. difficile (see, e.g., Schneider, pg. 25, lines 22-23)
Therefore, the cited reference discloses Blautia producta (see, e.g., Schneider, “Summary
of Invention”, pg. 3, lines 7-8, 11, 14) which appears to be identical to the presently claimed
strain since it is suitable for inhibiting Clostridium difficile growth and is the same bacterial
species as claimed microorganisms. Furthermore, it appears that the Blautia producta strain,
such as taught by Schneider, is structurally the same to the instantly claimed Blautia producta
strains; therefore, it would also perform the intended use of treating/preventing Clostridium
difficile infection.
Regarding claims 8 and 12 pertaining to the concentration, Schneider teaches that the
composition can contain about 108 CFU of bacteria per dosage amount (see, e.g., Schneider, pg.
100, lines 13-16). The skilled artisan would readily understand that the dosage amount can be 1 mL.
Regarding claims 13-14 pertaining to administering the pharmaceutical composition,
Schneider teaches administration of a bacterial composition comprising Clostridium scindens
and Blautia producta for treatment or prevention of C. difficile infections (see, e.g., Schneider,
“Summary of Invention”, pg. 3, lines 7-8, 11, 14 & pg. 18, lines 9-11). Moreover, Schneider
teaches that the composition can be a pharmaceutical composition (see, e.g., Schneider, pg. 18,
line 5), or a food composition (see, e.g., Schneider, pg. 18, lines 7-9). Additionally, Schneider
teaches that the bacterial cells can be lyophilized (see, e.g., Schneider, pg. 16, lines 23-24). Furthermore, Schneider teaches that the composition can comprise Blautia faecis (see, e.g.,
Schneider, pg. 3, lines 25-26).
However, Schneider does not teach: wherein the composition comprises Enterococcus
faecium and wherein the Enterococcus faecium is Enterococcus faecium KBL986 strain (claims 1, 9, and 13).
Biffi’s general disclosure relates “use of specific strains of Lactobacillus paracasei or of a composition comprising said strains for the prevention and/or treatment of a physiopathological condition related to/associated with Clostridium difficile infection, preferably intestinal infections, or so-called CD-associated disease (CDAD) or CD infection (CDI)” (see, e.g., Biffi, abstract).
Regarding claims 1, 9, and 13 pertaining to the Enterococcus faecium KBL986 strain, Biffi teaches a prophylactic and/or therapeutic treatment for Clostridium difficile infection comprising administration of compositions comprising Enterococcus faecium (see, e.g., Biffi, pg. 10). However, it cannot be ascertained if the prior art Enterococcus faecium strain of Biffi and the instant claimed strain Enterococcus faecium KBL986 are the same. However, it is the Examiner’s position that they are substantially similar since they share similar properties/function:
Claimed Enterococcus faecium KBL986 strain
Genus, Species: Enterococcus faecium
Intended use: Clostridium difficile growth inhibition (see, e.g., instant spec, pg. 2)
Dosage forms: Oral, rectal, or intravenous delivery (see, e.g., instant spec, pg. 11)
Treatment results: Inhibits the growth and/or survival of C. difficile (see, e.g., instant spec, pg. 29)
Prior Art Strain (Biffi’s Enterococcus faecium)
Genus, Species: Enterococcus faecium
Intended use: Prophylactic and/or therapeutic agent for treatment of C. difficile infection (see, e.g., Biffi, pgs. 6-7 & 10)
Dosage forms: Oral delivery (see, e.g., Biffi, pg. 11)
Treatment results: Treats and prevents C. difficile infection (see, e.g., Biffi, pgs. 17-21)
Therefore, the cited reference discloses Enterococcus faecium (see, e.g., Biffi, pg. 10) which appears to be identical to the presently claimed strain since it is suitable for inhibiting Clostridium difficile and is the same bacterial species as the claimed microorganism. Furthermore, it appears that the Enterococcus faecium strain, such as taught by Biffi, is structurally the same to that as instantly claimed; therefore, it would also perform the intended use of treating/preventing Clostridium difficile infection.
Kawaguchi’s general disclosure relates to bacteria belonging to Enterococcus for the treatment or prevention of Clostridium difficile infection (see, e.g., Kawaguchi, English Translation, abstract).
Regarding claims 1, 9, and 13 pertaining to Enterococcus faecium, Kawaguchi teaches that bacteria belonging to the genus Enterococcus can be used as a prophylactic and/or therapeutic agent for C. difficile infection, wherein the bacteria belonging to the genus Enterococcus are often lactic acid bacteria, such as Enterococcus faecium (see, e.g., Kawaguchi, English Translation, “Description”, pg. 3). Kawaguchi teaches that “Bacteria belonging to the genus Enterococcus can be administered by various routes such as oral, nasal, rectal, transdermal, subcutaneous, intravenous, and intramuscular” (see, e.g., Kawaguchi, English Translation, “Description”, pg. 3). Moreover, Kawaguchi teaches “The dose of the bacteria belonging to the genus Enterococcus may be a pharmaceutically effective amount, that is, an amount capable of confirming the preventive and /or therapeutic effect of Clostridium difficile infection, and the dosage type, administration route, patient age, etc” (see, e.g., Kawaguchi, English Translation, “Description”, pg. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to product Schneider’s composition comprising Clostridium
scindens and Blautia producta, wherein the composition also comprises Enterococcus faecium,
as taught by Biffi and Kawaguchi. One would have been motivated to do so because Biffi and Kawaguchi teaches that Enterococcus faecium is effective in preventing invention by Clostridium difficile (see, e.g., Biffi, pg. 11 & Kawaguchi, Discussion, pg. 18). Moreover, Schneider teaches a composition comprising cells of Clostridium scindens and Blautia producta for treatment or prevention of C. difficile infections (see, e.g., Schneider, “Summary of Invention”, pg. 3, lines 7- 8, 11, 14). Therefore, based on the teachings of Schneider, Biffi, and Kawaguchi, it would have been obvious to produce a composition comprising Clostridium scindens, Blautia producta, and Enterococcus faecium for the treatment or prevention of Clostridium difficile infection. One would have expected success because Schneider, Biffi, and Kawaguchi all teach the treatment and/or prevention of Clostridium difficile infection through administration of bacterial compositions.
Regarding the concentration limitations, as recited in claims 8 and 12, those working in
the biological and/or pharmaceutical arts would understand that the adjustments of particular
working conditions (e.g., concentrations or amounts of a compound) is deemed a matter of judicious selection and routine optimization, which is within the purview of the skilled artisan
(see, e.g., MPEP 2144.05). For example, Schneider states “The compositions comprising
bacterial strains are formulated into pharmaceutically acceptable dosage forms by conventional
methods known to those of skill in the art. Dosage regimens are adjusted to provide the optimum
desired response (e.g., the prophylactic or therapeutic effect)” (see, e.g., Schneider, pg. 99, lines
8-11). Additionally, Schneider states “Dosages of the active ingredients in the pharmaceutical
compositions of the present invention can be varied so as to obtain an amount of the active
ingredient which is effective to achieve the desired pharmaceutical response for a particular
subject, composition, and mode of administration, without being toxic or having adverse effect
on the subject” (see, e.g., Schneider, pg. 99, lines 21-24). This is motivation for someone of
ordinary skill in the art to practice or test the parameter widely to find those that are functional or
optimal which then would be inclusive or cover the steps as instantly claimed. Absent any
teaching of criticality by the Applicant concerning the concentration, it would be prima facie
obvious that one of ordinary skill in the art would recognize these limitations are result effective
variable would can be met as a matter of routine optimization.
Regarding claims 1 and 9 pertaining to the preamble recitation of “for preventing or treating Clostridium difficile infection”, this is intended use and does not impart a structural limitation (see, e.g., MPEP 2111.02(II)). The combined prior art of Schneider, Biffi, and Kawaguchi teaches the instantly claimed invention, which is a composition comprising lyophilized Clostridium scindens, Blautia producta, and Enterococcus faecium; therefore, this composition would be capable of performing the intended use of preventing or treating Clostridium difficile infection.
Examiner’s Response to Arguments
Applicant’s arguments filed on 02/03/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s statement that a POSITA would not have been able to derive the strain combination of the present application from Schneider and Kawaguchi (remarks, pg. 4), this argument is not persuasive because the prior art of Schneider and Kawaguchi teaches that Clostridium scindens, Blautia producta, and Enterococcus faecium all inhibit growth and survival of Clostridium difficile (see, e.g., Schneider, pg. 25, lines 14-18 & Schneider, pg. 25, lines 22-23 & Kawaguchi, English Translation, “Discussion”, pg. 18). Therefore, since Clostridium scindens, Blautia producta, and Enterococcus faecium all exhibit the same properties of inhibiting growth and survival of Clostridium difficile, one of ordinary skill in the art would at least expect an additive, or even synergistic effect, when combining Clostridium scindens, Blautia producta, and Enterococcus faecium. Furthermore, Biffi was added as new art to further teach that Enterococcus faecium is added to compositions for treatment of Clostridium difficile infections (see, e.g., Biffi, pgs. 6-7 & 10).
Regarding Applicant’s arguments that Schneider discloses CDI treatment efficacy data with compositions that do not include Clostridium scindens as a component (remarks, pg. 4), this argument is not persuasive because Schneider teaches Compositions C and D, which includes Clostridium scindens as a component (see, e.g., Schneider, Figure 1).
Regarding Applicant’s arguments pertaining to Kawaguchi teaching Enterococcus faecalis, not Enterococcus faecium (remarks, pg. 5), this argument is not persuasive because Kawaguchi teaches bacteria belonging to Enterococcus, in general, for the treatment or prevention of Clostridium difficile infection (see, e.g., Kawaguchi, English Translation, abstract). Moreover, Kawaguchi teaches that the Enterococcus bacteria can be Enterococcus faecalis, Enterococcus faecium, Enterococcus avium, Enterococcus avium, or Enterococcus gallrum (see, e.g., Kawaguchi, English Translation, “Description”, pg. 3). Furthermore, Biffi was cited to provide additional support that Enterococcus faecium is used in compositions for the treatment of C. difficile infections (see, e.g., Biffi, pgs. 6-7 & 10).
Regarding Applicant’s arguments pertaining to the teachings of Henn and Sai, these arguments are moot because they depend on cancelled claims. Moreover, Henn and Sai were not relied upon in the rejection above because claim 2 was cancelled by Applicant.
Regarding Applicant’s arguments pertaining to the effects of the bacteria being strain specific (remarks, pg. 6), this argument is not persuasive because Applicant has not provided any evidence that the instantly claimed strains are different than the strains taught by Schneider, Biffi, and Kawaguchi. Applicant is merely providing arguments that the claimed strains and the prior art strains are different without providing any evidence or comparison to the prior art that these strains are different. More specifically, Applicant has not provided concrete evidence, such as, for example, comparison of sequences between the instantly claimed strains and the strains taught by Schneider, Biffi, and Kawaguchi. Moreover, Applicant has not provided evidence comparing phenotype characteristics of the claimed and prior art strains to show similarities and differences. MPEP 716.01(C)(II) states that “Arguments presented by the applicant cannot take the place of objective evidence of the record”; therefore, Applicant’s arguments are not sufficient to overcome the prior arts of record because the Applicant has not provided objective evidence. Furthermore, the instantly claimed invention pertains to cells, cultures, lysates, and extracts of the bacteria; therefore, even if the instantly claimed strains are not the same as the strains taught by Schneider, Biffi, and Kawaguchi, an extract, for example, derived from the instantly claimed strains would most likely be the same as extracts derived from the strains taught by Schneider, Biffi, and Kawaguchi. Therefore, even if the bacterial strains are obvious variants, the cultures, lysates, and extracts derived from these strains would most likely be the same because the claimed strains are the same genus and species, and exhibit the same therapeutic properties, as the bacterial strains taught by Schneider, Biffi, and Kawaguchi.
Regarding Applicant’s arguments pertaining to their experimental data showing that the combination of Blautia producta, Enterococcus faecium, and Clostridium scindens exhibits superior preventative or therapeutic effects against Clostridium difficile, and synergistic effects in Example 4 (remarks, pg. 6), this argument is not persuasive for multiple reasons:
First, the prior art of Schneider, Biffi, and Kawaguchi teach that Clostridium scindens, Blautia producta, and Enterococcus faecium all inhibit the growth and survival of Clostridium difficile (see, e.g., Schneider, pg. 25, lines 14-18 & Schneider, pg. 25, lines 22-23 & Kawaguchi, English Translation, “Discussion”, pg. 18 & Biffi, pgs. 6-7, 10). Therefore, since Clostridium scindens, Blautia producta, and Enterococcus faecium all exhibit the same properties of inhibiting the growth and survival of Clostridium difficile, one of ordinary skill in the art would at least expect an additive, or even synergistic effect, when combining Clostridium scindens, Blautia producta, and Enterococcus faecium (see, e.g., MPEP 716.02(a)(I)).
Secondly, Applicant states that Example 4 within the instant specification demonstrates synergism between Clostridium scindens, Blautia producta, and Enterococcus faecium; however, Applicant’s results are not commensurate in scope with the claimed invention (see, e.g., MPEP 716.02(d)). Applicant is relying on a specific concentration of bacteria (i.e., 1x109 CFU/ml), which is not part of the claimed invention.
Thirdly, Applicant states in their remarks and in their instant specification that Example 4 and figures 7A to 7C demonstrate that when Clostridium scindens, Blautia producta, and Enterococcus faecium are excluded from the combination, that Clostridium difficile inhibitory activity was significantly reduced and that these strains contribute to a synergistic Clostridium difficile inhibitory effect (see, e.g., instant specification, pgs. 26-27); however, Figures 7A to 7C, which show the results of Example 4, merely show the body weights of the animals administered Clostridium scindens, Blautia producta, and Enterococcus faecium. There is no data in this example and in these figures showing the actual CFU counts of Clostridium difficile in these animals after treatment with Clostridium scindens, Blautia producta, and Enterococcus faecium in order to show that these bacteria actually exhibit a synergistic effect against Clostridium difficile. Merely showing body weights of the animals administered Clostridium scindens, Blautia producta, and Enterococcus faecium is not the same as showing an actual synergistic effect of the bacteria by, for example, log change reductions in Clostridium difficile CFUs within the animals.
Conclusion
Claims 1, 8-9, and 12-14 are rejected.
No claims are allowed.
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
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