DETAILED ACTION
Claim Rejections - 35 USC § 112-Deposit
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 1-18 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 Bifidobacterium animalis CCFM1230 deposited as GDMCC No. 62248. 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 § 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 1-7 and 10, 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter because the claims are drawn to a bacterium which exists in nature. The claimed bacterium is not markedly different from what naturally exists in nature. Even though isolation structurally changes a bacterium from its natural state, the resultant difference is no enough to render the isolated bacteria markedly different because the genetic structure has not been altered. It is unclear that the ‘zinc enrichment’ changes the properties of the bacterium as no conditions of the culture are recited in the instant claims. No specific conditions are recited in the claims. See Myriad, 133 S.Ct. at 2166-18.
Claim Rejections - 35 USC § 112-2nd paragraph
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 1-11, 17 and 18 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 1-11, 17 and 18 are vague and indefinite due to the language “zinc enrichment culture” as the culture conditions are unclear and the metes and bounds of this language is not readily understood. While the specification can be used to provide definitive support, the claims are not read in a vacuum. Rather, the claim must be definite and complete in and of itself. Limitations from the specification will not be read into the claims. The claims as they stand are incomplete and fail to provide adequate structural properties to allow for one to identify what is being claimed. Appropriate clarification and/or correction is required.
Claim 1 is vague and indefinite due to the phrase “or a product thereof” because the metes and bounds of this term is not readily understood. This term encompasses proteins or DNA, etc.? A protein would not be expected to be affected by the zinc enrichment culture and would be the same as a protein expressed from a cell not grown in zinc enrichment. A review of the specification does not recite products other than cell lysates (as recited in instant claim 2), supernatants, etc. so it is unclear how the term ‘product thereof’ is to be interpreted. While the specification can be used to provide definitive support, the claims are not read in a vacuum. Rather, the claim must be definite and complete in and of itself. Limitations from the specification will not be read into the claims. The claims as they stand are incomplete and fail to provide adequate structural properties to allow for one to identify what is being claimed. Appropriate clarification and/or correction is required.
Claim 7 is vague and indefinite because it is unclear what the 200-700 mg/L is in reference to and what is the 200-700mg? Is this zinc? And what is the liter? Appropriate clarification and/or correction is required.
Claims 17 and 18 are vague and indefinite for the recitation of “Application of the” does not set forth any steps involved in the method/process, it is unclear what method/process, e.g., “application,” applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Appropriate clarification and/or correction is required.
Claim Rejections - 35 USC § 102 or 103
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)(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.
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) 1-18 is/are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Bendetti et al (US 20100203018 A1).
Bendetti et al teach a zinc-enriched biomass comprising living or subsequently killed micro-organisms, selected from the group consisting of Streptococcus thermophilus and Bifidobacterium animalis subsp. lactis and combinations thereof, a method for the manufacture of said zinc-enriched biomass, as well as food preparations, nutraceutical products, functional foods, cosmetic and cosmeceutical products, and food supplements, comprising the said biomass. See abstract. Paragraph [0010] teaches that Bendetti et al have found that certain bacterial species belonging to the Bifidobacterium and Streptococcus genera, especially the Bifidobacterium animalis species, when grown on a culture medium containing inorganic zinc, display the unexpected and advantageous ability to accumulate extremely high quantities of zinc within the cell, without such high amounts of intracellular zinc which is deleterious for the survival of the biomass itself. Such a capacity to accumulate zinc intracellularly makes the aforesaid bacterial species particularly suitable for use as a zinc delivery means within the human or animal body, particularly useful for the manufacture of probiotic products that, by definition, must contain a living biomass. The zinc-enriched biomass of the invention may also be used in cosmetic applications, especially for the manufacture of cosmetic or cosmeceutical products. For the manufacture of cosmetic products, the biomass needs to be made up of dead micro-organisms, whereas for the manufacture of cosmeceuticals. Bifidobacterium animalis subsp. lactis BB 1 BM and have been deposited at the DSMZ (Deutsche Sammlung fur Mikroorganismen and Zellkulturen, Braunschweig, Germany), under the Budapest Treaty, as Streptococcus thermophilus ST 16 BM deposited on Jul. 13, 2007, under the accession number DSM 19526, and Bifidobacterium animalis subsp. lactis BB 1 BM deposited on Dec. 23, 2005, under the accession number DSM 17850, respectively, are exemplified.
The DSM 17850 shows the concentration of zinc is very low when grown on a zinc-free MRS culture medium, and after 10mM zinc sulfate is added into the MRS culture medium to induce an increase in the concentration of zinc in the cells, the concentration of zinc in the B. animalis increased to 53.32 mg/g. It is taught that the bacterium is suitable as zinc delivery means in a human or animal, for example, manufacturing a product containing a live biomass. A culture method of the bacterium comprises culture in a liquid nutrient medium containing zinc sulfate, wherein the culture medium preferably contains a carbon source, such as glucose, lactose, a nitrogen source such as peptone, a casein hydrolysate, and a yeast extract; an inorganic salt, a trace element in a vitamin. Paragraph [0016] The concentration of the zinc salt in the culture medium is preferably between 5 and 50 mM, even more preferably between 10 and 40 mM. Example 9, paragraph [0056] teaches 90 ml of minimal basal medium (in grams per litre) were formulated as follows: Casamino acids (Difco Laboratories, Sparks, Md.), 15; yeast nitrogen base (Difco Laboratories), 6.7; ascorbic acid, 10; sodium acetate, 10; (NH.sub.4).sub.2SO.sub.4, 5; urea, 2; MgSO.sub.4.7H.sub.2O, 0.2; Fe--SO.sub.4.7H.sub.2O, 0.01; MnSO.sub.4.7H.sub.2O, 0.007; NaCl, 0.01; Tween 80, 1; cysteine, 0.5 (pH adjusted to 7.0 and autoclaved for 30 minutes at 110.degree. C.). One of the following carbohydrates (glucose, fructo-oligosaccharides, inulin, raffinose, lactose, galacto-oligosaccharides, fructose, galactose or xylo-oligosaccharides) was autoclaved separately and added to the basal medium in order to achieve a 10 g/l concentration. 10 mM Zn sulphate was further added. Accordingly, the method comprises wherein the zinc-rich medium comprises: 20-30 g/L of glucose, 15-25 g/L of nitrogen source, 2 g/L of anhydrous sodium acetate, 2 g/L of diammonium citrate, 4.3H 2O 2.6 g/L of K2 HPO4, 0.1 g/L of MgSO4. 7H2 O, 0.05 g/L of MnSO4 · H2 O, Tween -80 1 g/L, 0.5 g/L of cysteine, and zinc sulfate. Fermentation is performed at 25-48 Degrees Celsius for 6-40 hours. A biomass is obtained by centrifugation or microfiltration after fermentation and freeze drying, drying, microencapsulation and/or freezing, and the bacterial load of a freeze-dried or dried product in a composition having beneficial bacterial activity is at least 1010-1011 CFU g/product. For products such as cosmetics or backed food in which a biomass must die, dead cell can be obtained by means of methods such as drying (see paragraphs 10-45, Examples 6-12 and Figure 1).
Although Bendetti et al does not particularly recite that the B. animalis strain is B. animalis CCFM1230 with a preservation number of GDMCC No.: 62248. Applicants claim a B. animalis strain with similar properties. The disclosed strains of the prior art reference appear to be identical to Applicants' claimed strain given the identity of the source, and the identical functional/culture abilities. If the claimed B. animalis strain and the B. animalis strains of Bendetti are not the same, they appear to be obvious or analogous variants of the claimed strains because they appear to possess the same or similar functional characteristics (i.e., same Genus/species with the same zinc-enrichment abilities). Since the Patent Office does not have the facilities for examining and comparing Applicant's strain with the strain of the prior art, the burden of proof is upon applicants to show an unobvious distinction between the material structural and functional characteristics of the claimed CCFM1230, GDMCC No. 62248 and the B. animalis strains of Bendetti et al. See In re Best, 195 USPQ 430, 433 (CCPA 19&&).
Prior art not presently relied upon:
KR 101509530 B1
Date Published
2015-04-06
The present invention is directed to a biochemical composition comprising zinc enriched biomass comprising live or later killed microorganisms selected from the group consisting of Streptococcus thermophilus and Bifidobacterium aniarris subtilis and combinations thereof, A food product containing the biomass, a food medicinal product, a functional food, a cosmetic product, a medicinal cosmetic product, and a food supplement. In addition, the present invention describes novel microbial strains which are capable of concentrating zinc in cells in a very large amount, and are thus particularly suitable for use in the method of the present invention.
For example, U.S. patent application 20070009502 A includes probiotic agents (e.g., yeast and / or bacteria, such as Bifidobacterium , Enterococcus , or Lactobacillus ) ), Pre-biotic agonists, glutamine or analogs thereof, glucose, glycine, electrolytes, vitamins and minerals such as minerals zinc (100-200 mg / kg) Nutritional Composition for Animal Feeds Designed for Improvement or Maintenance of Animal Feeds.
The patent application WO 2006/112998 discloses a method for the treatment of breastfeeding suffering from growth retardation, comprising a plurality of components, in particular probiotic (e.g., lactobacillus and / or bifidobacterium) and minerals, Described are liquid nutritional supplements that are intended to be used in combination with human breast milk to facilitate the growth of an infant.
The patent application CA 2525342 A contains additional auxiliary components, binders and vitality components, for example, Lactobacillus plantarum , Lactobacillus fermentum ), Lactobacillus casei sbp . Lactobacillus casei sbp . pseudoplantarum), Lactobacillus even know Phil Ruth (Lactobacillus a wide range of probiotic food preparations useful for food supplements, including, for example, to improve the immune response to disease, including certain bacterial strains of Lactobacillus casei and Lactobacillus casei have been described.
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 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 3/3/26