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 .
DETAILED ACTION
The amendment filed 10/09/2025 has been entered. Claims 1, 2, 7, 8, 10, 11, 14-16, 18, 19, 26, 28, and 29 are cancelled.
Claims 3-6, 9, 12, 13, 17, 20-22, 24, 25, 27, and 30-33 are pending.
Response to Arguments
Applicant’s arguments filed 10/09/2025 have been fully considered but they are not persuasive. With regard to the rejection of claims 3-6, 9, 12, 13, 17, 20-22, 24, 25, 27, and 30-33 under 35 USC 112(b), Applicant argues that it is well understood by a POSITA that an increase in vigour and decrease in fatigue, or a decrease in vigour and an increase in fatigue, are different features that do not always change in the same rejection.
Applicant repeats arguments presented in the Response filed on 02/28/2025. As stated, Applicant points to Figure 1 of the specification and argues that said figure provides direct evidence that “increased vigour” is different from “decreased fatigue”. However, this figure only shows differences in POMS scores between “less successful” and “successful” oarsmen. There is no direct evidence to support that “increased vigour” is different from “decreased fatigue”.
Applicant argues that Mogna teaches an improvement in fatigue with no significant effect on energy/activity, i.e., vigour. However, Mogna teaches that taking composition C shows significant changes in mood, which is more positive and inclined to optimism, and teaches that there was significant improvement in the general emotional state of individuals. Optimism is canonically defined as “hopefulness and confidence about the future or the successful outcome or something”. Therefore, it is interpreted that positive mood and increased optimism are synonymous with increased mental energy, enthusiasm or determination (i.e., vigour as defined by the instant specification).
Again, Applicant’s arguments support the position of the Office, as page 3 of Applicant arguments states that Terry et al., 2003 states that vigour would show an inverse relationship with fatigue.
With respect to the rejection of claims 3-6, 9, 12, 13, 17, 20-22, 24, 25, 27, and 30-33 under 35 USC 103, Applicant argues that Mogna does not teach L. plantarum DSM 9843, however, Hoppe, which is now relied on for the rejection of independent claim 3, does teach L. plantarum DSM 9843. Applicant again argues that the Examiner’s reasoning is contradicted by the disclosure of Mogna. The Examiner respectfully disagrees, see arguments regarding Mogna which have also been presented in the Non-Final rejection mailed 07/10/2025.
In response to Applicant's arguments against the secondary 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 motivation to combine said references with Mogna are presented in the instant rejection and in the Non-Final rejection mailed 07/10/2025. One of ordinary skill in the art would have a reasonable expectation of success because all references are in the same field of endeavor of L. plantarum probiotic development.
Claim Rejections - 35 USC § 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 3-6, 9, 12, 13, 17, 20-22, 24, 25, 27, and 30-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites: a method of increasing vigour in a human…comprising administering to the human at least one strain of Lactobacillus plantarum...wherein the treatment does not result in the human experiencing an improvement in fatigue. Vigour is defined in the specification as increased mental energy, enthusiasm, and determination (page 1, lines 8-9). The specification also states: “it will be appreciated that a person in need of increased vigour may be suffering from decreased vigour. For example, they may suffer from lethargy. By ‘lethargy’, we include the meaning of a pathological state of sleepiness and/or unresponsiveness and inactivity. Hence the term is intended to cover physical and/or mental inertness’ and a lack of energy and enthusiasm.” Therefore, it is interpreted that decreased vigour, i.e., lethargy, is synonymous with fatigue, based on the instant disclosure and the established definitions of the “vigour” and “fatigue”. Therefore, the language of claim 3 is contradictory and is therefore indefinite. It is unclear how an increase in vigour differs from a decrease in fatigue, or how an increase in vigour would not result in a decrease in fatigue. To obviate the rejection, Applicant may consider deleting the phrase: and wherein the treatment does not result in the human experiencing an improvement in fatigue. Furthermore, the latter portion of the preamble, compared to vigour without treatment as assessed by a Profile of Mood States (POMS) psychological rating scale, is confusing. It is uncertain whether this phrase limits the human or not, and does not fit with the first portion of the sentence, a method of increasing vigour in a human.
Claims 4-6, 9, 12, 13, 17, 20-22, 24, 25, 27, and 30-33 are also rejected as they depend from claim 3.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 3-6, 9, 12, 13, 17, 20-22, 24, 25, 27, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Mogna et al. (U.S. Patent No. 11,298,384), previously cited, in view of Hoppe et al., 2017 (Freeze-dried Lactobacillus plantarum 299v increases iron absorption in young females-Double isotope sequential single-blind studies in menstruating women), previously cited, as evidenced by Holst et al., 2019 (Molecular Switch Controlling Expression of the Mannose-Specific Adhesin, Msa, in Lactobacillus plantarum).
Regarding claim 3, Mogna teaches compositions for use in the treatment and/or improvement of the mood state (Abstract). Mogna teaches the administration of composition C, which contains Lactobacillus plantarum (Column 10, line 63; Column 11, line 1). Mogna teaches that the subjects were healthy males (i.e., humans) (Column 11, line 11). Mogna teaches that composition C, which comprises Lactobacillus plantarum, was administered daily for 6 weeks (Column 11, lines 55-65), i.e., at least once a week for at least four weeks. Mogna teaches that the subjects were evaluated using the Profile of Mood State questionnaire (Column 11, line 44). Although Mogna does not explicitly mention increased vigour, Mogna teaches that taking composition C shows significant changes in mood, which is more positive and inclined to optimism, and teaches that there was significant improvement in the general emotional state of individuals. Optimism is canonically defined as “hopefulness and confidence about the future or the successful outcome or something”. Therefore, it is interpreted that positive mood and increased optimism are synonymous with increased mental energy, enthusiasm or determination (i.e., vigour as defined by the instant specification).
Mogna does not teach the administration of L. plantarum DSM 9843.
Hoppe teaches the administration of L. plantarum DSM 9843 (Page 1, Objective).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to substitute L. plantarum DSM 9843 as taught by Hoppe for L. plantarum LP01 or LP02 as taught by Mogna (col. 6, lines 25-30). One of ordinary skill in the art would have had a reasonable expectation of success as Mogna and Hoppe are in the same field of endeavor of L. plantarum therapeutic development.
Regarding claim 4, Mogna teaches that composition C, which comprises L. plantarum, may be used to treat and/or improve mood disorders and/or for use in the treatment and/or improvement of the mood state (both in healthy and pathological individuals (patients) who have been diagnosed with a disorder) (Column 9, lines 4-8). Therefore, it would have been obvious to one of ordinary skill in the art that individuals in need of increased vigour (i.e., increased mental energy or enthusiasm) may be treated using the invention of modified Mogna.
Regarding claim 5, Hoppe teaches a method of administering Lactobacillus plantarum to increase iron absorption (Pages 1 and 2, Background-Conclusion). Hoppe also teaches that iron deficiency is the most common nutrient deficiency in the world, and is primarily present in women of reproductive age (Page 2, Introduction, Paragraph 1). Hoppe teaches that Lactobacillus plantarum was administered to women of reproductive age (Page 3, General protocol/design). Therefore, it would have been obvious to one of ordinary skill in the art that L. plantarum may be administered to a human with iron deficiency. One of ordinary skill in the art would have been motivated to do so because Hoppe teaches that administration of L. plantarum increases iron absorption (Page 2, Conclusion), and teaches that iron deficiency results in fatigue and altered cognitive functions (Page 2, Introduction, Paragraph 1).
Regarding claim 6, Hoppe teaches that L. plantarum was administered to females of reproductive age, i.e., a premenopausal female.
Regarding claim 9, Mogna teaches that composition C was administered daily, and teaches that composition C contains Lactobacillus plantarum in a concentration of 1x109 CFU (Column 10, lines 61-64; Column 11, lines 1-3).
Regarding claim 12, Mogna teaches that composition C was administered daily. Mogna also teaches that the composition may be a capsule (Column 9, line 60). Therefore, one of ordinary skill in the art would be reasonably expected to understand that a single capsule comprising the daily dose of L. plantarum may be administered.
Regarding claim 13, Mogna teaches that composition C, which comprises Lactobacillus plantarum, was administered daily for 6 weeks (Column 11, lines 55-65), i.e., the strain of L. plantarum was administered every day for at least 4 weeks.
Regarding claim 17, Hoppe teaches that L. plantarum Lp299v (i.e., L. plantarum DSM 9843) has been shown to possess the ability to survive the passage through the GI tract and to colonize human intestinal mucosa (Page 2, Introduction, Paragraph 2). Moreover, L. plantarum 299v comprises a mannose-specific adhesin, as evidenced by Holst et al., (Title; Abstract).
Regarding claim 20, Mogna teaches the administration of L. plantarum in the form of a composition (Claim 1), and teaches that the composition further comprises an additive, a pharmaceutical excipient, or a food grade excipient (Column 13, lines 18-21).
Regarding claim 21, Hoppe teaches that L. plantarum is able to increase iron absorption when present live in fermented oat gruel and in fruit drinks (i.e., a food carrier material).
Regarding claim 22, Mogna teaches that the bacterial strains in composition C may be present in powder form (Column 10, line 2). As stated, Mogna teaches that the composition comprising L. plantarum may be a capsule (Column 9, line 60).
Regarding claims 24 and 25, Hoppe teaches that L. plantarum is administered with iron as well as FeCl3 (ferric chloride), which is an iron salt. It would have been obvious to one of ordinary skill to administer iron and ferric chloride in combination with L. plantarum because the method of Hoppe of administering L. plantarum is to increase iron absorption (p. 2, Introduction, para. 2).
Regarding claim 27, Hoppe teaches the administration of iron at approximately 4 mgs (Hoppe Page 4) and L. plantarum at. Although the concentrations taught by Hoppe differ from the concentration of the instant claim, MPEP § 2144.05 II states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.")”
The selection of specific iron concentrations would have been a routine matter of optimization on the part of the artisan of ordinary skill, said artisan recognizing that iron absorption in the presence of L. plantarum may be affected by iron concentration.
Regarding claim 31, Mogna teaches that the composition comprising L. plantarum is administered daily (i.e. 7 days a week) for 6 weeks (Column 11, lines 56-65).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Mogna et al. (U.S. Patent No. 11,298,384) and Hoppe et al., 2017 (Freeze-dried Lactobacillus plantarum 299v increases iron absorption in young females-Double isotope sequential single-blind studies in menstruating women) as applied to claims 20 and 27 above, and further in view of Sandberg et al., 2017 (Iron Supplements Containing Lactobacillus plantarum 299v Increase Ferric Iron and Up-regulate the Ferric Reductase DCYTB in Human Caco-2/HT29 MTX Co-Cultures), previously cited.
See discussion of Mogna and Hoppe above, which is incorporated into this rejection as well. Mogna and Hoppe do not teach the administration of ferrous fumarate.
Sandberg teaches the administration of ferrous fumarate in combination with L. plantarum (Page 3, Table 1, superscript “b”).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have administered L. plantarum, as taught by the combination of Mogna and Hoppe, with ferrous fumarate, as taught by Sandberg. One of ordinary skill in the art would have been motivated to do so because Sandberg teaches that ferrous fumarate added to oat or mango drinks in combination with L. plantarum (Table 1, superscript “b”) increases ferric iron in simulated gastrointestinal-digested oat drinks (Page 5, Results). One of ordinary skill in the art would have had a reasonable expectation of success because Mogna, Hoppe, and Sandberg are in the same field of endeavor of L. plantarum probiotic development.
Claims 32 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Mogna et al. (U.S. Patent No. 11,298,384) and Hoppe et al., 2017 (Freeze-dried Lactobacillus plantarum 299v increases iron absorption in young females-Double isotope sequential single-blind studies in menstruating women), as applied to claim 31 above, and further in view of Hirose et al., 2013 (Oral intake of heat-killed Lactobacillus plantarum L-137 decreases the incidence of upper respiratory tract infection in healthy subjects with high levels of psychological stress), previously cited.
See discussion of Mogna and Hoppe above, which is incorporated into this rejection as well. Mogna and Hoppe do not teach administration of L. plantarum for 12 weeks.
Regarding claims 32 and 33, Hirose teaches the administration of a tablet containing heat-killed L. plantarum daily (i.e., at least once a week) for 12 weeks (Abstract).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have administered L. plantarum DSM 9843, as taught by Hoppe, once a day for 12 weeks, as taught by Hirose, to increase vigour, as taught by Mogna. One of ordinary skill in the art would have been motivated to do so because Hirose teaches that administration of L. plantarum daily for 12 weeks decreases the incidence of upper respiratory tract infections in subjects with high levels of stress (Title). One of ordinary skill in the art would have had a reasonable expectation of success as Mogna, Hoppe, and Hirose are in the same field of endeavor of probiotic development.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL EMILY MARTIN whose telephone number is (703)756-1416. The examiner can normally be reached M-Th 8:30-16:00, F 8:30-10:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at (571) 272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/RACHEL EMILY MARTIN/Examiner, Art Unit 1657