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 .
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.
Request for Telephone Interview
It is noted the Examiner called the Attorney of Record, Mark Swanson, on 09/05/2025 to set up a telephone interview as requested by Mark Swanson in the response filed on 07/23/2025. During the call on 09/05/2025, Mark Swanson indicated he did not wish to set up an interview at this time, but would wait for the next Action to be mailed instead.
Amendment and Claim Status
In the reply filed on 07/23/2025, Applicant amended claim 1, canceled claims 3, 7, 12 and 14 and added new claims 22-23.
Newly submitted claims 22-23 are directed to an invention that lacks unity with the invention originally claimed for the following reasons: Claims 22-23 lack unity of invention with the originally claimed invention because even though they share the same technical feature of a combination of strains, including Lactobacillus plantarum deposited with the DSMZ under deposit number DSM 33580 and Lactobacillus casei deposited with the DSMZ under deposit number DSM 33579, these strains do not make a contribution over the prior art in view of Anonymous (CN 108486007 A, 09/04/2018; hereinafter CN ‘007) (IDS Reference; Translation Provided) and Cui et al. (CN 110055199 B, 07/07/2020) (IDS Reference, Translation Provided). CN ‘007 discloses a probiotic composition for reducing blood uric acid containing multiple strains of Lactobacillus, including Lactobacterium casei strain ZM15, Lactobacillus rhamnosus strain ZM15, Lactobacillus strain ZM122 and Lactobacillus fermenti strain ZM05 (Claim 3). CN ‘007 does not disclose wherein a strain is Lactobacillus plantarum deposited with DSMZ under deposit number DSM 33580 and a Lactobacillus casei strain deposited with the DSMZ under deposit number DSM 33579. However, the claimed L. casei strain as claimed is not patentably distinct from the L. casei strain taught by CN ‘007. Additionally, Cui et al. disclose Lactobacillus plantarum UA149 for preparing a product with uric acid lowering function (Claim 6). The claimed L. plantarum strain as claimed is not patentably distinct from the L. plantarum strain taught by Cui et al. The strain being deposited with a specific deposit number is nothing more than an identifier, the strain simply being deposited does not distinguish it from other known strains.
“It is prima facie 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. As such, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the L. plantarum strain in the composition of CN ‘007 as both strains are taught to be useful for reducing uric acid levels are it amounts to combining two compositions useful for the same purpose.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 22-23 are withdrawn from consideration as being directed to a nonelected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 1-2, 4-6, 8-11 and 15-23 are pending.
Claims 22-23 are withdrawn as being directed to a nonelected invention.
Claims 1-2, 4-6, 8-11 and 15-21 are under examination.
Withdrawn Rejections
The 35 USC § 112(a) rejection over claims 7, 12, 15, 16, 20 and 21 is withdrawn due to the statement by the Attorney of Record stating that the biological materials have been deposited under the Budapest Treaty and that the biological materials will be irrevocably and without restriction or condition be released to the public upon the issuance of a patent. It is further noted claims 7 and 12 are no longer pending as they were canceled by Applicant in the reply filed on 07/23/2025.
The 35 USC § 112(b) rejection over claim 3 is withdrawn as it was rendered moot due to Applicant canceling the claim in the reply filed on 07/23/2025.
The 35 USC § 102/103 rejection over claim 12 is withdrawn due to Applicant canceling claim 12 in the reply filed on 07/23/2025.
Maintained Rejections (including modifications due to claim amendment)
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, 8-10 and 15-21 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.
Claims 1-2, 4-6, 8-10 and 15-21 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. This judicial exception is not integrated into a practical application because only an isolated strain of Lactobacillus casei strain deposited with the DSMZ under deposit number DSM 33579, a Lactobacillus plantarum strain deposited with the DSMZ under deposit number DSM 33580 and Lactobacillus plantarum strain deposited with the DSMZ under deposit number DSM 33581 are claimed. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because only an isolated strain of Lactobacillus casei strain deposited with the DSMZ under deposit number DSM 33579, a Lactobacillus plantarum strain deposited with the DSMZ under deposit number DSM 33580 and Lactobacillus plantarum strain deposited with the DSMZ under deposit number DSM 33581 are claimed.
With regard to Step 1, the composition and strains as claimed in claims 1-2, 4-6, 8-10 and 15-21 is a composition of matter.
With regard to Step 2A, prong one, claims 1, 15, 16, 20 and 21 encompass 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. Thus, claims 1, 15, 16, 20 and 21 are generally directed to a microorganism. 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 strain deposited with the DSMZ under deposit number DSM 33579, a Lactobacillus plantarum strain deposited with the DSMZ under deposit number DSM 33580 and Lactobacillus plantarum strain deposited with the DSMZ under deposit number DSM 33581 are natural strains that have been isolated. As such, the microorganisms of claims 1, 15, 16, 20 and 21, which only includes Lactobacillus casei strain deposited with the DSMZ under deposit number DSM 33579, a Lactobacillus plantarum strain deposited with the DSMZ under deposit number DSM 33580 and Lactobacillus plantarum strain deposited with the DSMZ under deposit number DSM 33581, are deemed to be a natural product.
With regard to Step 2A, prong two, claims 1, 15, 16, 20 and 21 do not recite any elements in addition to Lactobacillus casei strain deposited with the DSMZ under deposit number DSM 33579, a Lactobacillus plantarum strain deposited with the DSMZ under deposit number DSM 33580 and Lactobacillus plantarum strain deposited with the DSMZ under deposit number DSM 33581. As such, there is no additional element in claims 1, 15, 16, 20 and 21 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 strain deposited with the DSMZ under deposit number DSM 33579, a Lactobacillus plantarum strain deposited with the DSMZ under deposit number DSM 33580 and Lactobacillus plantarum strain 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, 15, 16, 20 and 21 do not recite any elements in addition to Lactobacillus casei strain deposited with the DSMZ under deposit number DSM 33579, a Lactobacillus plantarum strain deposited with the DSMZ under deposit number DSM 33580 and Lactobacillus plantarum strain 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 8, 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. 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-glucan, which beta-glucans are abundantly found in nature, does not render the composition non-natural. Regarding claim 19, indicating the 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.
35 USC § 101 – Response to Arguments
In the reply filed on 07/23/2025, Applicant argued the strains were not merely isolated from nature, but were obtained through experimentation involving applying selection pressure and directed evolution which led to enhanced functional traits.
Applicants arguments have been fully considered, but are not persuasive. The claims are not directed to a culture environment, but to the microorganisms themselves. There is no evidence presented within the disclosure that the genetic or phenotypic properties of the microorganisms were changed upon challenging the microorganisms to any particular culture environment. Thus, it appears that the ‘enhanced functional traits’ are 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.
In the reply filed on 07/23/2025, Applicant further argued the composition has markedly different characteristics from any naturally occurring counterpart due to an unexpected synergistic effect in lowering serum urate levels.
Applicants arguments have been fully considered, but are not persuasive. The Instant specification provides no evidence of synergism. Synergism is an unpredictable phenomenon, highly dependent upon specific proportions and/or amounts of particular ingredients. The examples presented in the Specification are anecdotal, non-quantitative and do not provide evidence of synergy; i.e., A alone, B alone and A+B together which would provide for an unexpected result. It is the Examiner’s position that the data is not significant and does not show a synergistic effect. The combination of strains is within the standard deviation of a single strain alone. One would expect at least an additive effect, but that is not shown.
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, 8, 10, 11 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ranganathan (US 20130330299 A1, 12/12/2013) (IDS Reference), Chen et al. (US 20170216376 A1, 08/03/2017) and Handayani et al. (International Food Research Journal, 08/2018) and further in view of Cui et al. (CN 110055199 B, 07/07/2020) and Anonymous (CN 108486007 A, 09/04/2018; hereinafter CN ‘007).
Regarding claim 1, Ranganathan discloses a method for reducing uric acid levels in the blood comprising administering an effective amount of a composition comprising a Lactobacillus bacterium, Bifidobacterium bacterium, and xylooligosaccharide to a subject in need of treatment thereby reducing the subject’s uric acid levels (Claim 1). Further, a prebiotic component of the present invention refers to a non-digestive food that beneficially affects the host by selectively stimulating the growth and/or activity of one or more non-pathogenic bacteria in the colon.
Ranganathan does not disclose wherein the plurality of bacterial strains comprises at least one bacterial strain with xanthine oxidase inhibitory activity and at least one bacterial strain with uricase activity. It is noted the instant Specification states urate is in most mammals further metabolized to allantoin by the enzyme uricase (Specification, Page 1, Line 15). As such, uricase activity is being interpretated as having the ability to convert uric acid, or urate, into allantoin and if uricase in present, the ability is there.
However, Chen et al. disclose a composition for reducing uric acid levels in a subject, the composition comprising a metabolite of Lactobacillus rhamnosus, wherein the metabolite is an inhibitor of xanthine oxidase activity (Claim 1).
Additionally, Handayani et al. disclose multiple Lactobacillus strains that can produce uricase (Abstract).
Exemplary rationales that may support a conclusion of obviousness include combining prior art elements according to known methods to yield predictable results. See MPEP 2143(I)(A). Ranganathan discloses a composition comprising Lactobacillus for reducing uric acid levels, Chen et al. disclose a Lactobacillus strain that produces a metabolite that inhibits xanthine oxidase activity and Handayani et al. disclose multiple Lactobacillus strains that can produce uricase. Chen et al. further disclose xanthine oxidase is a key enzyme in the synthesis of uric acid. As a result, inhibition of xanthine oxidase activity can reduce the production of uric acid. Indeed, the xanthine oxidase inhibitor, uricase, is effective for lowering the concentration of uric acid in the blood. Uricase is an enzyme not found in humans (Paragraph [0007]). It would have been obvious to utilize a Lactobacillus strain that can produce uricase in the combined method of Ranganathan and Chen et al. as the method is directed to reducing uric acid levels with Lactobacillus and uricase is a known and effective xanthine oxidase inhibitor as taught by Chen et al. and there are multiple Lactobacillus strains capable of producing uricase as taught by Handayani et al. Therefore, one of ordinary skill in the art would be able to predict the combination would produce a composition comprising Lactobacillus that would be beneficial for treating elevated serum urate via inhibition of xanthine oxidase and uricase activity as uricase is a xanthine oxidase inhibitor and the Lactobacillus strain used additionally produces a metabolite that inhibits xanthine oxidase activity. As such, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a Lactobacillus strain that produces uricase in the method of combined Ranganathan and Chen et al. as it amounts to combining prior art elements.
Regarding the new limitations to instant claim 1, the limitations of prior claim 7, neither Ranganathan, Chen et al. nor Handayani et al. disclose the plurality of strains being Lactobacillus casei strain under the deposit number DSM 33579 and at least one of a Lactobacillus plantarum strain deposited with the DSMZ under deposit number DSM 33580 and a Lactobacillus plantarum strain deposited with the DSMZ under deposit number DSM 33581.
However, as explained above, the strains as claimed are not patentably distinct from the strains disclosed by Cui et al. and CN ‘007 as Cui et al. disclose a L. plantarum strain and CN ‘007 discloses a L. casei strain both of which are for reducing uric acid.
Regarding claim 2, Ranganathan discloses a method for preventing or treating hyperuricemia or gout comprising administering an effective amount of a composition comprising a Lactobacillus bacterium, Bifidobacterium bacterium, and xylooligosaccharide to a subject in need of treatment (Claim 2).
Regarding claim 4, Chen et al. disclose a composition for reducing uric acid levels in a subject, the composition comprising a metabolite of Lactobacillus rhamnosus, wherein the metabolite is an inhibitor of xanthine oxidase activity (Claim 1).
Regarding claim 5, Ranganathan does not disclose wherein the plurality of bacterial strains has a synergistic effect in lowering serum urate levels. However, as the composition of combined Ranganathan, Chen et al. and Handayani et al. disclose the instant composition, it would necessarily have the same functional characteristics and provide the same results, including having a synergistic effect in lowering serum urate levels. It is noted, as indicated in the response to arguments pertaining to the 101 and 103 rejections herein, there is no evidence which substantiates any synergistic effect and that it would be expected, if the strains of the prior art were put under the same external culture conditions, they would display the same activities as the instantly-claimed/instantly-disclosed strains.
Regarding claims 6 and 19, Ranganathan discloses a method for reducing uric acid levels in the blood comprising administering an effective amount of a composition comprising a Lactobacillus bacterium, Bifidobacterium bacterium, and xylooligosaccharide to a subject in need of treatment thereby reducing the subject’s uric acid levels (Claim 1). Further, wherein the Lactobacillus species (e.g., bulgaricus, acidophilus, lactic, helveticus, casei, plantarum, reuteri, delbrueckii, chamnosus, johnsonii, paracasei) (Paragraph [0012]).
Regarding claim 8, Ranganathan discloses a pharmaceutical product comprising a Lactobacillus and a Bifidobacterium (Paragraph [0048]).
Regarding claim 10, Ranganathan discloses a pharmaceutical product for persons suffering from gout or hyperuricemia can be prepared by aseptically freeze-drying a Lactobacillus and a Bifidobacterium, combining the processed bulk microorganisms with the prebiotic component, and preparing the synbiotic product as enterically coated capsules (Paragraph [0048]). The synbiotic product reads on a further agent.
Regarding claim 11, Ranganathan does not disclose wherein the pharmaceutical composition is administered in combination with a xanthine oxidase inhibitor wherein that agent is allopurinol.
However, Chen et al. disclose allopurinol is a xanthine oxidase inhibitor that is administered to lower serum uric acid levels (Paragraph [0008]).. “It is prima facie 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. As such, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized allopurinol in the method of Ranganathan as it is a known and effective xanthine oxidase inhibitor that lowers serum uric acid levels as taught by Chen et al. It would be obvious to add allopurinol to a probiotic composition that is also directed to inhibiting xanthine oxidase activity and lowering uric acid levels as it amounts to combining two compositions useful for the same purpose.
Regarding claim 15, neither Ranganathan, Chen et al. nor Handayani et al. disclose the plurality of strains being Lactobacillus casei strain under the deposit number DSM 33579 or a Lactobacillus plantarum strain deposited with the DSMZ under deposit number DSM 33580.
However, as explained above, the strains as claimed are not patentably distinct from the strains disclosed by Cui et al. and CN ‘007 as Cui et al. disclose a L. plantarum strain and CN ‘007 discloses a L. casei strain both of which are for reducing uric acid.
Regarding claim 16, neither Ranganathan, Chen et al. nor Handayani et al. disclose a strain of the species Lactobacillus plantarum deposited with the DSMZ under deposit number DSM 33581.
However, as explained above, the L. plantarum strains as claimed are not patentably distinct from the L. plantarum strains as taught by Cui et al.
Regarding claim 17, neither Ranganathan, Chen et al. nor Handayani et al. specifically disclose the plurality of bacterial strains having a synergistic effect in lowering serum urate levels. However, as the composition of combined Ranganathan, Chen et al. and Handayani et al. disclose the instant composition, it would necessarily have the same functional characteristics and provide the same results, including having a synergistic effect in lowering serum urate levels.
Regarding claim 18, neither Ranganathan, Chen et al. nor Handayani et al. disclose the composition further comprising allopurinol.
However, Chen et al. disclose allopurinol is a xanthine oxidase inhibitor that is administered to lower serum uric acid levels (Paragraph [0008]). Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As such, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized allopurinol in the composition of Ranganathan, Chen et al. and Handayani et al. as it is a known and effective xanthine oxidase inhibitor that lowers serum uric acid levels as taught by Chen et al.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ranganathan (US 20130330299 A1, 12/12/2013) (IDS Reference), Chen et al. (US 20170216376 A1, 08/03/2017), Handayani et al. (International Food Research Journal, 08/2018), Cui et al. (CN 110055199 B, 07/07/2020) and Anonymous (CN 108486007 A, 09/04/2018; hereinafter CN ‘007) as applied to claims 1-2, 4-6, 8, 10, 11 and 15-19 above, and further in view of Ritter et al. (US 20100215738 A1, 08/26/2010).
Regarding claim 9, Ranganathan discloses the present invention combines the properties of probiotic and prebiotic components into a synbiotic product (Paragraph [0011]).
Ranganathan does not disclose wherein the prebiotic is beta-glucan.
However, Ritter et al. disclose a prebiotic composition comprising one or more of the following including beta-glucan (Paragraph [0044]). Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As such, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have used beta-glucan as the prebiotic in the combined method of Ranganathan, Chen et al., Handayani et al., Cui et al. and CN ‘007 since the method does not require a specific prebiotic and beta-glucan is a known and effective prebiotic as taught by Ritter et al.
Claims 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Anonymous (CN 108486007 A, 09/04/2018; hereinafter CN ‘007) (IDS Reference; Translation Provided) and Cui et al. (CN 110055199 B, 07/07/2020) (IDS Reference, Translation Provided).
Regarding claim 20, CN ‘007 discloses a probiotic composition for reducing blood uric acid containing multiple strains of Lactobacillus, including Lactobacterium casei strain ZM15, Lactobacillus rhamnosus strain ZM15, Lactobacillus strain ZM122 and Lactobacillus fermenti strain ZM05 (Claim 3).
CN ‘007 does not disclose wherein a strain is Lactobacillus plantarum deposited with DSMZ under deposit number DSM 33580 and a Lactobacillus casei strain deposited with the DSMZ under deposit number DSM 33579. As explained above, the claimed L. casei strain as claimed is not patentably distinct from the L. casei strain taught by CN ‘007.
Additionally, Cui et al. disclose Lactobacillus plantarum UA149 for preparing a product with uric acid lowering function (Claim 6). As explained above, the claimed L. plantarum strain as claimed is not patentably distinct from the L. plantarum strain taught by Cui et al.
Regarding claim 21, CN ‘007 does not disclose a strain of L. plantarum deposited with the DSMZ under deposit number DSM 33581.
However, as explained above, the claimed L. plantarum strain as claimed is not patentably distinct from the L. plantarum strains as taught by Cui et al. Additionally, the use of an additional L. plantarum strain amounts to simple substitution of one known element for another to obtain predictable results as CN ‘007 discloses a composition with multiple Lactobacillus strains for lowering uric acid and the instant L. plantarum strain deposited with the DSMZ under deposit number DSM 33581 is also for reducing uric acid. The claimed strain would have been obvious as it is also an L. plantarum strain and would therefore be expected to have similar properties to L. plantarum strains disclosed in the prior art, including being usable for reducing uric acid levels.
The Supreme court acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable varition..103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions…
…the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) emphasis added.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton.").
The Examiner is therefore of the opinion that from the combined teachings of the references cited above, that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art especially in the absence of unexpected results.
35 USC § 103 – Response to Arguments
In the reply filed on 07/23/2025, Applicant argued claims 1-6, 8, 9, 10, 11, 14 and 19 are believed to be moot due to the amendment to claim 1.
Applicants arguments have been fully considered, but are not persuasive. It is noted Applicant simply moved the limitations from previous claim 7 into claim 1. The rejection has been modified to address the limitations moved into instant claim 1.
In the reply filed on 07/23/2025, Applicant further argued CN 110055199 and CN 108486007 disclose natural strains without any manipulation.
Applicants arguments have been fully considered, and are persuasive. However, the instantly disclosed strains are also strains without any manipulations. Placing a strain into an environment with higher and higher uric acid concentration does not materially change the strain. If a strain has higher uricase activity after such treatment, it would appear, absent evidence to the contrary, that was an inherent characteristic of such strain.
In the reply filed on 07/23/2025, Applicant argued there was a synergistic effect in reducing serum uric acid levels and that the combination of strains leads to a significantly greater reduction in serum urate levels than each strain in isolation.
Applicants arguments have been fully considered, but are not persuasive. As discussed above, a synergistic effect is not seen with the combination of strains. The combination of strains did not even have an additive effect, as would be expected, therefore, there is no synergistic effect seen with the combination of strains.
Conclusion
Claims 1-2, 4-6, 8-11 and 15-21 are rejected.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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