DETAILED ACTION
Acknowledgment and entry of the Amendment submitted on 8/20/26 is made.
Claims 21-41 are currently pending.
Claims 34-41 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claims 21-33 are currently under examination.
The Deposit Requirements have been satisfied.
The former 102 rejections have been rendered moot due to the amendment to the claims.
The new grounds of rejection necessitated by the amendments are set forth below:
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.
Claim(s) 21-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over London et al (International Dairy J., GB, Vol. 40. Pp. 33-38, 8/21/24; provided by Applicants), David et al (US 2019/224254 A1, 7/25/19; provided by Applicant), Zhao et al (US 2020/069746 A1, 3/5/2020; provided by Applicant) and Stanton et al (US 2015/329923; provided by Applicants) in view Costabile et al (Frontiers in Immunol. Vol. 8. 12/12/17, pages 1-13; provided by Applicants).
London et al discloses the use of Lactobacillus mucosae DPC 6426 in the preparation of yogurt. In paragraph 2.1. It is stated that Lactobacillus mucosae DPC 6426 was activated and propagated three times in MRS medium. This medium contains agar, which is a soluble dietary fiber. The exopolysaccharide described in claim 23 is an inherent property of L. mucosae and London et al teaches the same strain used in the instant application so would be expected to express the same polysaccharides. Page 34, column 2, section 2.2 Yoghurt manufacture, teaches the L. mucosae within the range recited in claim 24. The term “composition” is an intended use only. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
David et al discloses (claims 2-52, par.47-50) a method for facilitating maturation of the mammalian immune system by creating a healthy microbiome, comprising administering a bacterial composition, e.g. Lactobacillus mucosae, in the range recited in claim 24, and a food composition containing mammalian milk oligosaccharides, which will comprise soluble dietary fiber. The exopolysaccharide described in claim 23 is an inherent property of L. mucosae.
Zhao et al discloses (claims 1-24, par.38) the use of Lactobacillus mucosae combined with Bifidobacterium pseudocatenulatum for prevention and treatment of overweight, obesity, hyperglycemia, diabetes, fatty liver, dyslipidemia, metabolic syndrome, infections. In par.96-100 it is stated that the composition is advantageously combined with a prebiotic composition, comprising soluble dietary fiber. Paragraph [0045]-[0047] recite the CFU amounts of Lactobacillus in the range recited in claim 24. Paragraphs [0095]-[099] teach the different fibers, including fiber beverages.
However, London, David and Zhao do not explicitly recite the amount of dextrose oligomers and dextrose in the soluble dietary fiber, or the fiber as recited in claims 25-32.
Costabile investigated the effects of a probiotic Lactobacillus rhamnosus GG and pilus-deficient L. rhamnosus GG-PB12 combined with Promitor™ Soluble Corn Fiber (SCF, a candidate prebiotic) on fecal microbiota, metabolism, immunity, and blood lipids in healthy elderly persons. In the “Introduction”, Costabile recites that evidence exists on immune-stimulating effects of certain probiotics and the potential to use prebiotics to increase the levels of such bacteria, the latter being a selectively metabolized microbial substrate. Furthermore, by providing a probiotic at the same time as a prebiotic, conditions for survival of the live addition should be enhanced. Promitor™ Soluble Corn Fiber (SCF) is a well-known maize-derived source of dietary fiber with potential selective fermentation properties. Costabile et al conclude that the synbiotic combination of L. rhamnosus GG with Promitor™ Soluble Corn Fiber (SCF) showed a tendency to promote innate immunity by increasing NK cell activity in elderly women and in 70 to 80-year-old volunteers and decreased TC and LDL-c in hypercholesterolemic patients. In addition, L. rhamnosus GG-PB12 combined with SCF demonstrated an increase in NK cell activity compared to SCF alone in older volunteers. They also found significant positive effects on the immune response, evidenced by a decrease of the pro-inflammatory cytokine IL-6. Therefore, dietary intervention with L. rhamnosus GG combined with SCF could be of importance in elderly as an attractive option for enhancement of both the microbial and immune systems.
Accordingly, although Costabile examined the effects of SCF with Lactobacillus rhamnosus instead of Lactobacillus mucosae, both Lactobacillus strains are well-known in the prior art as prominent probiotics. Additionally, as shown in the prior art references, it was well known in the prior art to combine probiotic Lactobacillus mucosae strains with prebiotics that are soluble fiber. The primary reference Zhao teaches the composition is advantageously combined with a prebiotic composition, comprising soluble dietary fiber. Paragraph [0045]-[0047] recite the CFU amounts of Lactobacillus in the range recited in claim 24. Paragraphs [0095]-[099] teach the different fibers, including fiber beverages. David et al teaches administering a bacterial composition, e.g. Lactobacillus mucosae, and a food composition containing mammalian milk oligosaccharides, which will comprise soluble dietary fiber. London et al discloses the use of Lactobacillus mucosae DPC 6426 in the preparation of yogurt. Stanton et al discloses (claims 16-21, par.30, 85, 95, 96, Fig. 1-43) the use of Lactobacillus mucosae DPC 6426 (cultivated on agar) or its exopolysaccharides, in the treatment or prevention of cardiovascular disease. Accordingly, the prior art teaches the use of Lactobacillus mucosae, and more particularly of Lactobacillus mucosae DPC 6426, as a well-known probiotic and in combination with prebiotics comprising soluble dietary fiber. Costabile further teaches the advantages of a specific dietary soluble fiber in combination with Lactobacillus probiotics. The molecular weight of the soluble dietary fiber in claim 25 and the fiber content of at least 70% in claims 27, 31 and 32 would be inherent in the soluble fiber taught in the cited prior art references. If such is not found to be the case, they would have been obvious since well known soluble fiber products such as psyllium husk and Metamucil type products (70-85%), polydextrose (90%), inulin, i.e., chicory root fiber (85-90%), soluble corn fiber (wheat or corn based resistant dextrin 85-90%), PHGG (80-85%) are very common soluble dietary products used in probiotic solutions. The claims are broad enough to include the use of any of these. Claim 30 is a product-by-process claim. “The patentability of a product does not depend upon its method of production. If the product in [a] product-by-process claim is the same as or obvious from a product of the prior art, [then] the claim is unpatentable even though the prior [art] product was made by a different process.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). Further, the use of the term “comprising” in the claims allows for additional ingredients. Therefore, the fiber products appear to be structurally the same. Although the prior art references do not specifically teach that the fiber content is at least 60% or 70% fiber the soluble fiber amount is a ‘results effective variable”. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicants have not shown the amount for any particular purpose or solve any stated problem and the prior art teaches that the amount of type of soluble dietary fiber often vary accordingly and they appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the amount to by normal optimization procedures known in the immunological art.
Lastly, Promitor™ Soluble Corn Fiber (SCF) is the same soluble dietary fiber used in the Examples in the instant specification so would inherently comprise the linkage pattern recited in the instant claims. Given the advantages and success shown in the studies of Costabile it would have been obvious to substitute Promitor™ in any of the compositions of L. mucosae.
Response to Applicants’ arguments that pertain to the 103 rejection:
Applicants argue, in summary:
The general idea of combining probiotics with prebiotics is well-established. However, one of ordinary skill in the art will appreciate that the synergies that arise between different species of probiotics and different prebiotic compositions can be unpredictable. Thus, the benefits that arise from combining a particular prebiotic (here, Promitorᵀ with Lactobacillus rhamnosus would not be expected to also impart the same benefits when used together with a different species, such as Lactobacillus mucosae. Accordingly, one of ordinary skill in the art seeking to modify the disclosures of any one of London, David, Zhao, or Stanton to arrive at the amended claims would have had no reason to seek teachings from Costible, which relates to a different species of bacteria.
The present inventors advantageously found that the combination of lactobacillus mucosae with PROMITOR® led to unexpected improvements when treating pig models suffering from various metabolic syndromes. For example, while PROMITOR fiber alone had no significant effect on weight loss, the combination of PROMITOR® with Lactobacillus mucosae did. [See Figs 1A and 1B and para. [163]].
The present inventor have also found that the combination of PROMITOR® and Lactobacillus mucosae improve various markers for metabolic syndrome compared the use of PROMITOR alone. For example, left ventricle and left atrium thicknesses were lowered. See, e.g., Specification as filed, [163] and Figs. 2E and 2F. Amounts of tumor necrosis factor alpha (TNF-alpha), cluster of differentiation 163 (CD163), and alpha smooth muscle actin (aSMA) were reduced. See, e.g., Specification as filed, [170] and Figs. 2G, 3A, and 3B. And amounts of fibroblast growth factor 9 (FGF19) were increased. See, e.g., Specification as filed, [164] and Fig. 3D. Applicant submits that there is nothing in the references cited above that suggest the unexpected improvements in treating metabolic syndromes that arise from the combination of PROMITOR and Lactobacillus mucosae.
For at least these additional reasons, Applicant submits that the amended claims demonstrate patentability. Furthermore, claims 26, 28, and 29 recite linkage patterns for the soluble dietary fiber. And as noted by the Office: Lastly, Promitorᵀ Soluble Corn Fiber (SCF) is the same soluble dietary fiber used in the Examples in the instant specification so would inherently comprise the linkage pattern recited in the instant claims. Given the advantages and success shown in the studies of Costabile it would have been obvious to substitute Promitor™ in any of the compositions of L. mucosae. Non-Final Office Action, p. 12. As such, Applicant submits that claims 26, 28, and 29 in particular are commensurate in scope with the unexpected synergistic effects described above for PROMITOR and Lactobacillus mucosae.
These arguments have been fully and carefully considered but are not deemed persuasive because they are not commensurate in scope with the claimed invention. No claims are presently allowed. The scope of claim 1 is broad in the sense that the combination of any Lactobacillus mucosae and any soluble dietary fiber is claimed, whereas in all the examples on file only Lactobacillus mucosae DPC 6426 combined with PROMITOR® 70 was used (par. 196). The specification teaches unexpected results with Lactobacillus mucosae DPC 6426 combined with PROMITOR® 70 and the strain should be limited accordingly in order to overcome the rejection of record. NOTE: trademarks are not allowed in claims, and the actual ingredients of the trademark must be recited. As Applicants have recited, the actual strain (not just species) of bacteria matters as well as the actual soluble fiber. The deposited strain should also be recited in claim 21, e.g., Lactobacillus mucosae deposited as DPC6426.
Status of Claims
No claims are presently allowed.
The scope of claim 1 is broad in the sense that the combination of any Lactobacillus mucosae and any soluble dietary fiber is claimed, whereas in all the examples on file only Lactobacillus mucosae DPC 6426 combined with PROMITOR® 70 was used (par. 196). This broad scope causes rejection of the claims above. The soluble dietary fiber used in the present examples, PROMITOR®, the inventors showed could be used to help controlling blood glucose levels, (WO 2021/081305 A1; 4/29/21; provided by Applicants: same assignee, inventor’s work), claims 12-19 and par.63, 64, 134 and known as a prebiotic and symbiotic.
The Anonymous references (see below) cited in the PCT 371 Written Description PCT/US2022/061319 with priority to 5/27/21, were not publicly available one year before the effective filing date of the instant application, and have a common inventor and the same assignee.
Anonymous: "Promitor Soluble Fibre and Synbiotics", 1 January 2021 (2021-01-01), XP55846166, Retrieved from the Internet: URL:https://www.tateandlyle.com/sites/default/files/2021-01./ tlsynbioticsleavebehindfinal.pdf [retrieved on 2021-09-30]
Anonymous: "Tate & Lyle announces the publication of a gut health claim for PROMITOR Soluble Fibre by FSANZ I Tate & Lyle", , 31 March 2020 (2020-03-31), XP55846172, Retrieved from the Internet: URLhttps://www.tateandlyle.com/news/tate-lyle-announces-publication-gut health-claim-promitor-soluble-fibre-fsanz [retrieved on 2021-09-30]
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Prior art, not presently relied upon:
Kim et al (JOURNAL OF MICROBIOLOGY AND BIOTECHNOLOGY, vol. 30, no. 4, 28 April 2020; provided by Applicants); and
Kim et al (FRONTIERS IN IMMUNOLOGY, vol. 11, 1 January 2020 (2020-01-01), page 27300273; provided by Applicants), teach various medical uses of Lactobacillus mucosae.
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.
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Friday from 8:00 AM-4 PM.
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/JENNIFER E GRASER/Primary Examiner, Art Unit 1645 9/21/26
