DETAILED ACTION
Election/Restrictions
Applicant’s election of Group I, claims 21-33, in the reply filed on 11/24/25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 34-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Specification
The use of the term Promitor, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112-Deposit Requirement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 22, 28 and 31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification lacks complete deposit information for the deposit of strain Lactobacillus mucosae DPC6426. Because it is not clear that the properties of the strain are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the best mode disclosed by the specification requires the use of the plasmids, a suitable deposit for patent purposes is required.
If the deposit has been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of the deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of the deposit and the complete name and full street address of the depository is required.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR §1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring:
(a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request;
(b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application;
© the deposits will be maintained in a public depository for a period of at least thirty years from the date of the deposit or for the enforceable life of the patent or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and
(d) the deposits will be replaced if they should become non-viable or non-replicable.
In addition, a deposit of the biological material that is capable of self-replication either directly or indirectly must be viable at the time of the deposit and during the term of deposit. Viability may be tested by the depository. The test must conclude only that the deposited material is capable of reproduction. A viability statement for each deposit of a biological material not made under the Budapest Treaty must be filed in the application and must contain:
1)The name and address of the depository;
2)The name and address of the depositor;
3)The date of deposit;
4)The identity of the deposit and the accession number given by the depository;
5)The date of the viability test;
6)The procedures used to obtain a sample if the test is not done by the depository; and
7)A statement that the deposit is capable of reproduction.
If the deposit was made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by Applicants, assignees or a statement by an attorney of record over his or her signature and registration number stating that deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and that the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when a deposit is made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of the deposit and the complete name and address of the depository is required.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If the deposit was made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the cell line described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing of a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant's possession at the time the application was filed.
Applicant's attention is directed to In re Lundak, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 21-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by London et al (International Dairy J., GB, Vol. 40. Pp. 33-38, 8/21/24; 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.
Claim(s) 21-24 and 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by David et al (US 2019/224254 A1, 7/25/19; provided by Applicant).
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.
Claim(s) 21-24 and 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stanton et al (US 2015/329923; provided by Applicants).
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) in the amount recited in claim 24, or its exopolysaccharides, in the treatment or prevention of cardiovascular disease. Agar is a soluble dietary fiber. The exopolysaccharide 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. 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.
Claim(s) 21-24 and 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhao et al (US 2020/069746 A1, 3/5/2020; provided by Applicant).
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.
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) 25-32 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)
The teachings of London et al, David et al, Zhao et al and Stanton et al are set forth above. However, they do not particularly recite the use of soluble dietary fiber as recited in the 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.
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 anticipation of the claims under 35 USC 102 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.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Daniel E. Kolker, can be reached on (571) 272-3181.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-0500.
/JENNIFER E GRASER/ Primary Examiner, Art Unit 1645 2/13/26