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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/26/2026 has been entered.
Priority
This application claims benefit of priority to Swiss Confederation Application No. CH00923/20 filed on 07/24/2020 and is also a 371 of PCT/EP2021/070685 filed on 07/23/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The Drawings filed on 01/20/2023 are accepted by the Examiner.
Amendment and Claim Status
In the reply filed 01/22/2026, Applicant amended claims 1 and 9-11 and canceled claims 3, 7-8, 12-14 and 20-23.
The elections of species from the reply filed 04/04/2025 of hyperuricemia, beta-glucan and allopurinol are reiterated.
Claims 1-2, 4-6, 9-11 and 15-19 are currently pending and under examination.
Claim Rejections - 35 USC § 112
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 2, 4, 6, 9, 11 and 15-19 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.
Claims 2, 6, 9, 11 and 19 recite “is selected from” and proceed to recite a group of options. It is unclear if Applicant is attempting to use Markush language by reciting “is selected from” before reciting a group of alternatives. A Markush group is a closed group of alternatives. Therefore, if Applicant is attempting to use Markush language, claims 2, 6, 9, 11 and 19 should be amended to recite “is selected from the group consisting of” instead of just “is selected from” so that it is clear whether the groups of alternatives listed in the claims are open or closed groups. See MPEP 2173.05(h).
Regarding claim 4, the claim recites “wherein the metabolite is preferably a flavonoid” in line 3. The term "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The preamble of claim 15 recites “the composition for use according to claim 14.” The preamble of claims 16-18 recite “the composition for use according to claim 15.” All of claims 15-18 ultimately depend upon claim 14, however, claim 14 has been canceled. Thus, the dependency of claims 15-18 is unclear, leaving it unclear what the limitations present within claims 15-18 are intended to limit.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2, 4-6, 9-10 and 15-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to a product of nature as explained below.
Claims 1-2, 4-6, 9-10 and 15-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The claims recite a microorganism comprising Lactobacillus casei strain deposited with the DSMZ under deposit number DSM 33579, a microorganism comprising a Lactobacillus plantarum strain deposited with the DSMZ under deposit number DSM 33580 and a microorganism comprising Lactobacillus plantarum strain deposited with the DSMZ under deposit number DSM 33581. The judicial exceptions are not integrated into a practical application because only isolated strains are claimed, specifically Lactobacillus casei deposited with the DSMZ under deposit number DSM 33579, Lactobacillus plantarum deposited with the DSMZ under deposit number DSM 33580 and Lactobacillus plantarum deposited with the DSMZ under deposit number DSM 33581. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because only isolated strains are claimed, being Lactobacillus casei deposited with the DSMZ under deposit number DSM 33579, Lactobacillus plantarum deposited with the DSMZ under deposit number DSM 33580 and Lactobacillus plantarum deposited with the DSMZ under deposit number DSM 33581. Additionally, the composition being in the form of a pharmaceutical or nutraceutical does not change the structure of the bacterial strains nor does the amount of the bacteria present change the structure of the bacterial strains.
With regard to Step 1, the composition as claimed in claims 1-2, 4-6, 9-10 and 15-19 is a composition of matter.
With regard to Step 2A, prong one, claims 1 and 15-16 encompass a microorganism comprising Lactobacillus casei deposited with the DSMZ under deposit number DSM 33579, a microorganism comprising Lactobacillus plantarum deposited with the DSMZ under deposit number DSM 33580 and a microorganism comprising Lactobacillus plantarum deposited with the DSMZ under deposit number DSM 33581. Thus, claims 1 and 15-16 are generally directed to microorganisms. It is indicated in the Specification that the bacterial strains are isolated from food (Specification, Page 12, Line 15). Thus, it appears that Lactobacillus casei deposited with the DSMZ under deposit number DSM 33579, Lactobacillus plantarum deposited with the DSMZ under deposit number DSM 33580 and Lactobacillus plantarum deposited with the DSMZ under deposit number DSM 33581 are natural strains that have been isolated. As such, the microorganisms of claims 1 and 15-16, which only include Lactobacillus casei deposited with the DSMZ under deposit number DSM 33579, Lactobacillus plantarum deposited with the DSMZ under deposit number DSM 33580 and Lactobacillus plantarum deposited with the DSMZ under deposit number DSM 33581, are deemed to be a natural product. Additionally, the composition being in the form of a pharmaceutical or nutraceutical does not change the structure of the bacterial strains nor does the amount the strains are present in change the structure of the bacterial strains, thus, neither the specific form nor the amount of bacteria renders the composition non-natural.
With regard to Step 2A, prong two, claims 1 and 15-16 do not recite any elements in addition to the Lactobacillus casei deposited with the DSMZ under deposit number DSM 33579, the Lactobacillus plantarum deposited with the DSMZ under deposit number DSM 33580 and the Lactobacillus plantarum deposited with the DSMZ under deposit number DSM 33581. As such, there are no additional elements in claims 1 and 15-16 that apply to or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to the natural microorganisms Lactobacillus casei deposited with the DSMZ under deposit number DSM 33579, Lactobacillus plantarum deposited with the DSMZ under deposit number DSM 33580 and Lactobacillus plantarum deposited with the DSMZ under deposit number DSM 33581, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
With regard to Step 2B, claims 1 and 15-16 do not recite any elements in addition to Lactobacillus casei deposited with the DSMZ under deposit number DSM 33579, Lactobacillus plantarum deposited with the DSMZ under deposit number DSM 33580 and Lactobacillus plantarum deposited with the DSMZ under deposit number DSM 33581. As such, the claims do not recite additional elements that alone or together amount to significantly more than the judicial exception itself.
It is noted that all other claims simply recite elements that further characterize the natural product, or further natural components that can be included with the composition. Regarding claim 2, delineating conditions that may be treated with the composition is a further characterization of the natural product and does not render the composition non-natural. Regarding claim 4, stating a property of the bacterial strain including expressing a metabolite that inhibits xanthine oxidase is a further characterization of the natural product and does not render the composition non-natural. Regarding claim 5, the bacterial strains having a synergistic effect is a further characterization of the natural product and does not render the composition non-natural. With regard to claim 6, indicating the genus of the bacteria is a further characterization of the natural product and does not render the composition non-natural. Regarding claim 9, the composition being co-formulated and/or co-administered with beta-glucans, which beta-glucans are abundantly found in nature, is another natural component and does not render the composition non-natural. With regard to claim 10, being administered in combination with a further agent, which could include a natural component like beta-glucans, does not render the composition non-natural. With regard to claim 17, the plurality of bacterial strains having a synergistic effect in lowering serum urate levels is a further characterization of the natural product and does not render the composition non-natural. With regard to claim 18, further comprising beta-glucans, which beta-glucans are abundantly found in nature, does not render the composition non-natural. Regarding claim 19, indicating the specific genus and species of the bacteria is a further characterization of the natural product and does not render the composition non-natural.
For the forgoing reasons, the microorganisms as claimed are not deemed to encompass patent eligible subject matter under 35 USC § 101.
USC § 101 – Response to Arguments
Applicant's arguments filed 01/22/2026 have been fully considered but they are not persuasive.
Applicant argued amended claim 1 recites a pharmaceutical or nutraceutical composition with bacterial strains in a concentration of at least 1 x 109 which is a highly concentrated composition not found in nature.
The Examiner respectfully disagrees. As stated above, the composition being in the form of a pharmaceutical or nutraceutical composition does not change the structure of the bacterial strains and therefore does not render the composition non-natural. Similarly, the bacteria being present in a specific amount does not change the structure of the bacterial strains and does not render the composition non-natural.
Applicant reiterated the strains are different from those that occur naturally because the bacteria have been “trained” to enhance the therapeutic effect of the bacteria.
It remains the Examiner’s position that there is no evidence presented within the disclosure that the genetic or phenotypic properties of the microorganisms have been changed via ‘training’ the bacteria. Thus, it appears that the ‘enhanced therapeutic effect’ is directly attributed to the microorganisms being placed in a specific environment and any results achieved by carrying out such a culture of the microorganisms were achieved by the innate capabilities of the microorganisms themselves, as they exist in nature.
Applicant further argued the composition is markedly different from strains occurring in nature due the evolutionary pressure applied over 20 generations and points to the experiment discussed on Pages 6-7.
It remains the Examiner’s position that the composition is not markedly different from the strains as they occur in nature even in view of the experiment. First, it is not clear what strains are being referred to as ‘trained’ and ‘untrained.’ It is not clear if all three of the claimed strains are present in the ‘trained’ group or just one strain or two strains. Second, it is unclear what the ‘untrained’ group refers to, it is unclear if the ‘untrained’ group comprises random Lactobacillus strains or a specific strain/s. Third, both the ‘trained’ and ‘untrained’ groups show the same amount of uric acid degradation. Thus, the composition is not markedly different.
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.
Claims 1-2, 4-6, 10-11 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Anonymous (CN 108486007 A, 09/04/2018; hereinafter CN ‘007) (Of Record, New Translation Provided) and Cui et al. (CN 110055199 B, 07/07/2020) (Of Record) as evidenced by Handayani et al. (International Food Research Journal, 2018) (Of Record).
Regarding claims 1 and 15-16, ‘007 discloses a Lactobacillus casei strain and a probiotic composition for reducing blood uric acid (See entire document, Abstract). The specific L. casei strain completely degrades adenylate, guanylic acid, adenosine and guanosine, leaving the catabolite free of uric acid and allantoin (Abstract). ‘007 further teaches a composition comprising multiple stains of Lactobacillus which is better at reducing blood uric acid compared to the individual stains alone (Abstract). Hyperuricemia is a clinical syndrome wherein the content of uric acid in the blood is higher than the normal level (Page 2, Line 6). Since the human body lacks urate oxidase, urate oxidase reads on uricase, many purine skeleton-containing derivatives undergo a series of metabolic changes in the human body to eventually form uric acid, thus, the amount of purine components taken directly affects the uric acid level in the blood (Page 2, Lines 13-15). Currently, allopurinol, which is a xanthine oxidase inhibitor, is a drug utilized for treating hyperuricemia (Page 2, Lines 17-19). ‘007 discloses a medicine for preventing and treating hyperuricemia comprising the probiotic composition (Page 5, Lines 45-48), reading on being in the form of a pharmaceutical. Auxiliary materials of the medicine comprise maltodextrin, erythritol and fructo-oligosaccharides (Page 5, Lines 47-79). The viable count of L. casei in the probiotic composition is 1.0 x 1010 – 3.0 x 1011 CFU/g (Claim 1 of ‘007). ‘007 further discloses a specific strain of Lactobacillus plantarum that was cultured and the degradation rate of adenylic acid, guanylic acid, adenosine and guanosine was detected by liquid chromatography (Page 5, Example 1 and Figure 1).
Regarding the uricase activity, ‘007 does not explicitly state the Lactobacillus strains possess uricase activity. However, absent evidence to the contrary, it would be expected the Lactobacillus strains of ‘007 would necessarily have uricase activity as it is well known that Lactobacillus species produce uricase as evidenced by Handayani et al. (See entire document, Abstract).
’007 does not disclose an L. casei strain with deposit number DSM 33579, an L. plantarum strain with deposit number DSM 33580 or an L. plantarum strain with deposit number DSM 33581.
While ‘007 does not disclose the specific deposit numbers, it is noted deposit numbers are simply identifiers, deposit numbers themselves do not distinguish a bacterial strain from another bacterial strain. The bacterial strains disclosed by the prior art are the same genus and species as instantly-claimed and provide the same function and effect as the instantly-claimed strains. Thus, while the prior art does not specifically disclose the claimed deposit numbers, the strains recited in the instant claims, which are also for reducing uric acid, are not patentably distinct from the strains of the prior art absent evidence to the contrary.
Cui et al. disclose a Lactobacillus plantarum strain that can reduce uric acid and/or resist gout (See entire document, Abstract). The L. plantarum strain can participate in the digestion and absorption of food, enhance immunity and eliminate harmful substances from the body (Page 2, Lines 13-14). The L. plantarum strain is mainly used for treating gout by reducing the activity level of xanthine oxidase in serum which reduces uric acid levels (Page 2, Lines, 14-15), reading on a strain with xanthine oxidase inhibitory activity. Therefore, the L. plantarum strain can treat hyperuricemia and gout (Page 2, Line 16).
Thus, it would have been obvious to include the L. plantarum strain disclosed by ‘007 in the probiotic composition of ‘007 because it was a known and effective strain with the ability to degrade adenylic acid, guanylic acid, adenosine and guanosine as taught by ‘007. It would have been obvious to utilize the L. plantarum strain because it was known to be able to effectively degrade purine substances and therefore reduce uric acid in the blood and the probiotic composition of ‘007 is directed to a composition for reducing uric acid.
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the L. plantarum strain of Cui et al. in the probiotic composition of ‘007 because it was a known and effective L. plantarum strain for treating hyperuricemia and ‘007 is directed to a probiotic composition for treating hyperuricemia. It would have been obvious to include the L. plantarum strain of Cui et al. in the probiotic composition of ‘007 because they are both useful for treating hyperuricemia and it is obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose. See MPEP 2144.06.
Regarding claim 2, as discussed above, ‘007 discloses a medicine for preventing and treating hyperuricemia comprising the probiotic composition (Page 5, Lines 45-48).
Regarding claim 4, ‘007 does not explicitly state the bacterial strain with xanthine oxidase inhibitory activity expresses a metabolite that inhibits xanthine oxidase. However, as ‘007 teaches the strain and the xanthine oxidase activity, it appears, absent evidence to the contrary, this is an inherent property of the strain and therefore the Lactobacillus strain taught by ‘007 would necessarily have this property.
Regarding claims 5 and 17, as discussed above, ‘007 teaches a composition comprising multiple stains of Lactobacillus which is better at reducing blood uric acid compared to the individual strains alone (Abstract). The combination more effectively reducing blood uric acid levels compared to the individual strains reads on a synergistic effect. Additionally, as the combination of the strains is taught by the prior art, the combination would necessarily have the same functional characteristics and provide the same results, including having a synergistic effect in lowering serum urate levels.
Regarding claims 6 and 19, ‘007 discloses a probiotic composition comprising L. casei, L. rhamnosus, L. reuteri and L. fermentum (Page 4, Lines 26-30).
Regarding claims 10-11 and 18, ‘007 do not disclose the pharmaceutical composition is co-formulated or co-administered with another agent nor do they disclose the pharmaceutical composition being administered in combination with allopurinol.
However, as discussed above, ‘007 disclose allopurinol, which is a xanthine oxidase inhibitor, is a drug currently utilized for treating hyperuricemia (Page 2, Lines 17-19).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have co-administered another agent, specifically allopurinol, with the composition of ‘007 because it was a known and effective xanthine oxidase inhibitor for treating hyperuricemia and ‘007 is directed to treating hyperuricemia. It would have been obvious to combine the probiotic composition of ‘007 and allopurinol because they are both useful for treating hyperuricemia and it is obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose. See MPEP 2144.06.
Claims 1-2, 4-6, 9-11 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Anonymous (CN 108486007 A, 09/04/2018; hereinafter CN ‘007) (Of Record, New Translation Provided) and Cui et al. (CN 110055199 B, 07/07/2020) (Of Record) and further in view of Russo et al. (International Journal of Molecular Sciences, 2012).
The teachings of ‘007 and Cui et al. are discussed above.
Regarding claim 9, as discussed above, ‘007 disclose the composition comprises fructo-oligosaccharides (Page 5, Lines 47-79). Fructo-oligosaccharides are prebiotics.
‘007 does not disclose the composition comprises beta-glucans.
However, Russo et al. disclose beta-glucans improve the growth, viability and colonization of probiotic microorganisms (See entire document, Title). Probiotics, prebiotics and synbiotics are frequently-used components for the elaboration of functional food (Abstract). Most of the commercialized probiotics are limited to a few strains of the genera Bifidobacteria, Lactobacillus and Streptococcus, most of which produce exopolysaccharides (Abstract). Russo et al. further disclose a specific beta-glucan that has a prebiotic effect on probiotic strains and potentiates in vitro adhesion of L. plantarum to human intestinal cells (Abstract). Russo et al. found the beta-glucan had a positive effect on the growth of the investigated strains, being L. plantarum, and the use of beta-glucan as a prebiotic positively modulates the growth of probiotic organisms (Page 6031, Last Paragraph).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized a beta-glucan as the prebiotic in the composition of ‘007 because it was a known and effective prebiotic useful with Lactobacillus strains as taught by Russo et al. Therefore it would have been obvious to utilize a beta-glucan in the probiotic composition comprising Lactobacillus of ‘007 instead of a fructo-oligosaccharide motivated by the desire to provide the provide the probiotic organisms nourishment from the beta-glucan and promote growth of the probiotic organisms because Russo et al. teach beta-glucan is an effective prebiotic for Lactobacillus as it amounts to simple substitution of one known element for another to obtain predictable results. See MPEP 2143(I)(B).
35 USC § 103 - Response to Arguments
Applicant's arguments filed 01/22/2026 have been fully considered but they are not persuasive.
Applicant argued the claimed strains provide a surprising result and point to Example 9 and Figure 7 of the instant disclosure.
The Examiner respectfully disagrees. It is the Examiner’s position that an additional 16% reduction compared to the reduction seen in the individual strains is not an unexpected or surprising result. A significant result would be if the combination of the strains provided a reduction more than double what the individual strains provide. A 16% increase compared to an individual strain is not significant.
Applicant further argued there is no disclosure or motivation in the prior art to combine the specifically claimed strains because the strains are novel and not provided by a prior art reference.
As discussed above, there is no evidence the strains are novel. A deposit number is simply an identifier, it is not an indicator of novelty. There are no defining characteristics of the instantly claimed strains that differentiate them from the strains of the prior art as the strains of the prior art are also Lactobacillus stains of the same species that provide the same effects.
Conclusion
Claims 1-2, 4-6, 9-11 and 15-19 are rejected.
No claims are allowed.
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/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
