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 .
The preliminary amendment is received.
Claims 1, 3, 13-17 and 19 are canceled by Applicant.
The new claims 25 and 26 are added.
Claims 2, 4-12, 18 and 20-26 are pending and are being examined.
Objection(s):
Claims 2, 8, 11, 12 and 18 are objected to because of the following informalities:
In claim 2, line 2, replace “Leuconostoc mesenteroides” with --Leuconostoc mesenteroides--.
In claim 8, lines 2-4, replace “Escherichia sp., Staphylococcus sp., Salmonella sp., Shigella sp., Klebsiella sp., Enterobacteriaceae sp.,Pseudomonas sp., Moraxella sp., Helicobacter sp., Stenotrophomonas sp., Listeria sp., and Vibrio sp.” with --Escherichia sp., Staphylococcus sp., Salmonella sp., Shigella sp., Klebsiella sp., Enterobacteriaceae sp., Pseudomonas sp., Moraxella sp., Helicobacter sp., Stenotrophomonas sp., Listeria sp., and Vibrio sp.--.
In claim 11, lines 2-3, replace “Leuconostoc mesenteroides” with --Leuconostoc mesenteroides--.
In claim 12, lines 2-3, replace “Leuconostoc mesenteroides” with --Leuconostoc mesenteroides--.
In claim 18, line 3, replace “Leuconostoc mesenteroides” with --Leuconostoc mesenteroides--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 2, 4-12, 18 and 20-26 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The invention appears to employ a specific strain: Leuconostoc mesenteroides CJLM119.
It is not clear if the written description is sufficiently repeatable to avoid the need for a deposit.
Further it is unclear if the starting materials were readily available to the public at the time of invention.
It appears that a deposit was made in this application as filed as noted in applicant’s specification (p. 5 last paragraph). However, it is not clear if the deposit meets all of the criteria set forth in 37 CFR 1.801-1.809. Applicant or applicant's representative may provide assurance of compliance with the requirements of 35 U.S.C § 112, first paragraph, in the following manner.
SUGGESTION FOR DEPOSIT OF BIOLOGICAL MATERIAL
A declaration by applicant, assignee, or applicant's agent identifying a deposit of biological material and averring the following may be sufficient to overcome an objection and rejection based on a lack of availability of biological material.
1. Identifies declarant.
2. States that a deposit of the material has been made in a depository affording permanence of the deposit and ready accessibility thereto by the public if a patent is granted. The depository is to be identified by name and address.
3. States that the deposited material has been accorded a specific (recited) accession number.
4. States that all restriction on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
5. States that the material has been deposited under conditions that access to the material will be available during the pendency of the patent application to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C § 122.
6. States that the deposited material will be maintained with all the care necessary to keep it viable and uncontaminated for a period of at least five years after the most recent request for the furnishing of a sample of the deposited microorganism, and in any case, for a period of at least thirty (30) years after the date of deposit for the enforceable life of the patent, whichever period is longer.
7. That he/she declares further that all statements made therein of his/her own knowledge are true and that all statements made on information and belief are believed to be true, and further that these statements were made with knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the instant patent application or any patent issuing thereon.
Alternatively, it may be averred that deposited material has been accepted for deposit under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purpose of Patent Procedure (e.g. see 961 OG 21, 1977) and that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
Additionally, the deposit must be referred to in the body of the specification and be identified by deposit (accession) number, date of deposit, name and address of the depository and the complete taxonomic description.
Copy of deposit receipt is/are required.
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 6 and 7 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.
In claim 6, the recitation “effective amount” is indefinite because it is not exactly clear what amount applicant is trying to encompass by this recitation. In addition, there is no special definition in the specification for the effective amount. As such the scope of the claim is not clearly set forth.
Suggestion to obviate the rejection: delete the phrase.
In claim 7, the recitation “effective amount” is indefinite because it is not exactly clear what amount applicant is trying to encompass by this recitation. In addition, there is no special definition in the specification for the effective amount. As such the scope of the claim is not clearly set forth.
Suggestion to obviate the rejection: delete the phrase.
Claim Rejections - 35 USC § 102/103
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)(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.
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.
Claims 2, 4, 6-8, 10-12, 18, 20, 21 and 23-26 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative under 35 U.S.C. 103 as obvious over Park et al. (J Med Food. 2014, Vol. 17, No. 1, p. 6-20).
Regarding claim 2, Park et al. disclose a fermented composition comprising a fermentation product fermented with a Leuconostoc mesenteroides strain or a culture thereof (fermented cabbage kimchi by Leuconostoc mesenteroides) (See for example, p. 7 right-hand column 1st paragraph, and p. 11 right-hand column 1st paragraph).
Regarding claim 4, Park et al. disclose the fermentation product is a product in which a composition comprising any one or more selected from the group consisting of garlic, red pepper powder, and a nitrogen source is fermented (kimchi contains ingredients including garlic, red pepper powder, salt-fermented fish, etc.) (See for example, p. 7 left-hand column 3rd paragraph).
Regarding claim 6, Park et al. disclose a method of increasing expression of TNF-a or IL-6 in a subject, the method comprising administering an effective amount of the fermented composition of claim 2 to the subject (treatment with kimchi enhanced immune function both in vitro and in vivo and modulated production of IL-6, etc.) (See for example, 12 left-hand column 5th paragraph).
Regarding claim 7, Park et al. disclose a method of reducing growth of harmful bacteria in a subject, the method comprising administering an effective amount of the fermented composition of claim 2 to the subject (kimchi antimicrobial activities against B. subtilis, etc., and kimchi reduced H. pylori infections) (See for example, p. 15 right-hand column “Antimicrobial activities of kimchi LAB”, and p. 16 left-hand column 1st paragraph).
Regarding claim 8, Park et al. disclose the harmful bacteria are any one or more selected from the group consisting of Escherichia sp., Staphylococcus sp., Salmonella sp., Shigella sp., Klebsiella sp., Enterobacteriaceae sp., Pseudomonas sp., Moraxella sp., Helicobacter sp., Stenotrophomonas sp., Listeria sp., and Vibrio sp. (kimchi antimicrobial activities against B. subtilis, etc. , and kimchi reduced H. pylori infections) (See for example, p. 15 left-hand column “Antimicrobial activities of kimchi LAB”, and p. 16 left-hand column 1st paragraph).
Regarding claim 10, Park et al. disclose the fermentation product is a product in which a composition further comprising any one or more selected from a carbon source or salt is fermented (e.g., kimchi ingredient … salt-fermented fish) (See for example, p. 7 right-hand column 3rd paragraph).
Regarding claim 11, Park et al. disclose the fermentation product comprises any one or more selected from a culture of Leuconostoc mesenteroides strain, a lysate thereof, an extract thereof, or a component derived therefrom (kimchi fermented with starter culture of Leuconostoc mesenteroides) (See for example, p. 8 right-hand column last line -Continued on left-hand column).
Regarding claim 12, Park et al. disclose the fermentation product comprises a fermentation product fermented with a Leuconostoc mesenteroides strain or a culture thereof; or a fermentation product in which the fermentation product is further fermented (kimchi fermented with starter culture of Leuconostoc mesenteroides) (See for example, p. 8 right-hand column last line -Continued on left-hand column).
Regarding claim 18, Park et al. disclose a method for preparing the fermented composition of claim 2, the method comprising fermenting a composition with the Leuconostoc mesenteroides strain or the culture thereof (kimchi fermented with starter culture of Leuconostoc mesenteroides) (See for example, p. 8 left-hand column last line -Continued on right-hand column).
Regarding claim 20, Park et al. disclose the fermented composition further comprises any one or more selected from the group consisting of garlic, red pepper powder, and a nitrogen source (kimchi contains ingredients including garlic, red pepper powder, salt-fermented fish, etc.) (See for example, p. 7 left-hand column 3rd paragraph).
Regarding claim 21, Park et al. disclose the fermented composition is a food composition (kimchi) (See for example, p. 8 right-hand column 2nd paragraph and Figure 1.).
Regarding claim 23, Park et al. disclose the fermented composition increases expression of TNF-a or IL-6 (treatment with kimchi enhanced immune function both in vitro and in vivo and modulated production of IL-6, etc.) (See for example, 12 left-hand column 5th paragraph).
Regarding claim 24, Park et al. disclose the fermented composition inhibits growth of harmful bacteria (kimchi antimicrobial activities against B. subtilis, etc. , and kimchi reduced H. pylori infections) (See for example, p. 15 left-hand column “Antimicrobial activities of kimchi LAB”, and p. 16 left-hand column 1st paragraph).
Regarding claim 25, Park et al. disclose the method increases an immune enhancing effect of the composition (treatment with kimchi enhanced immune function both in vitro and in vivo and modulated production of IL-6, etc.) (See for example, 12 left-hand column 5th paragraph).
Regarding claim 26, Park et al. disclose the method increases a gut health improving effect of the composition (consumption of kimchi containing LAB significantly increased levels of Lactobacillus sp. and Leuconostoc sp.) (See for example, p. 16 left-hand column 3rd paragraph).
In this case, although the strain of Leuconostoc mesenteroides disclosed by Park et al. does not have the claimed designation numbers of, CJLM119, but it appears to be the same as the claimed Leuconostoc mesenteroides strain. It should be noted that a single strain can be deposited under different deposit numbers.
Therefore Park et al. anticipates the subject matter of claims 2, 4, 6-8, 10-12, 18, 20, 21 and 23-26.
In alternative,
Regarding claim 2, Park et al. teach a fermented composition comprising a fermentation product fermented with a Leuconostoc mesenteroides strain or a culture thereof (fermented cabbage kimchi by Leuconostoc mesenteroides) (See for example, p. 7 right-hand column 1st paragraph, and p. 11 right-hand column 1st paragraph).
Regarding claim 4, Park et al. teach the fermentation product is a product in which a composition comprising any one or more selected from the group consisting of garlic, red pepper powder, and a nitrogen source is fermented (kimchi contains ingredients including garlic, red pepper powder, salt-fermented fish, etc.) (See for example, p. 7 left-hand column 3rd paragraph).
Regarding claim 6, Park et al. teach a method of increasing expression of TNF-a or IL-6 in a subject, the method comprising administering an effective amount of the fermented composition of claim 2 to the subject (treatment with kimchi enhanced immune function both in vitro and in vivo and modulated production of IL-6, etc.) (See for example, 12 left-hand column 5th paragraph).
Regarding claim 7, Park et al. teach a method of reducing growth of harmful bacteria in a subject, the method comprising administering an effective amount of the fermented composition of claim 2 to the subject (kimchi antimicrobial activities against B. subtilis, etc., and kimchi reduced H. pylori infections) (See for example, p. 15 right-hand column “Antimicrobial activities of kimchi LAB”, and p. 16 left-hand column 1st paragraph).
Regarding claim 8, Park et al. teach the harmful bacteria are any one or more selected from the group consisting of Escherichia sp., Staphylococcus sp., Salmonella sp., Shigella sp., Klebsiella sp., Enterobacteriaceae sp., Pseudomonas sp., Moraxella sp., Helicobacter sp., Stenotrophomonas sp., Listeria sp., and Vibrio sp. (kimchi antimicrobial activities against B. subtilis, etc. , and kimchi reduced H. pylori infections) (See for example, p. 15 left-hand column “Antimicrobial activities of kimchi LAB”, and p. 16 left-hand column 1st paragraph).
Regarding claim 10, Park et al. teach the fermentation product is a product in which a composition further comprising any one or more selected from a carbon source or salt is fermented (e.g., kimchi ingredient … salt-fermented fish) (See for example, p. 7 right-hand column 3rd paragraph).
Regarding claim 11, Park et al. teach the fermentation product comprises any one or more selected from a culture of Leuconostoc mesenteroides strain, a lysate thereof, an extract thereof, or a component derived therefrom (kimchi fermented with starter culture of Leuconostoc mesenteroides) (See for example, p. 8 right-hand column last line -Continued on left-hand column).
Regarding claim 12, Park et al. teach the fermentation product comprises a fermentation product fermented with a Leuconostoc mesenteroides strain or a culture thereof; or a fermentation product in which the fermentation product is further fermented (kimchi fermented with starter culture of Leuconostoc mesenteroides) (See for example, p. 8 right-hand column last line -Continued on left-hand column).
Regarding claim 18, Park et al. teach a method for preparing the fermented composition of claim 2, the method comprising fermenting a composition with the Leuconostoc mesenteroides strain or the culture thereof (kimchi fermented with starter culture of Leuconostoc mesenteroides) (See for example, p. 8 left-hand column last line -Continued on right-hand column).
Regarding claim 20, Park et al. teach the fermented composition further comprises any one or more selected from the group consisting of garlic, red pepper powder, and a nitrogen source (kimchi contains ingredients including garlic, red pepper powder, salt-fermented fish, etc.) (See for example, p. 7 left-hand column 3rd paragraph).
Regarding claim 21, Park et al. teach the fermented composition is a food composition (kimchi) (See for example, p. 8 right-hand column 2nd paragraph and Figure 1.).
Regarding claim 23, Park et al. teach the fermented composition increases expression of TNF-a or IL-6 (treatment with kimchi enhanced immune function both in vitro and in vivo and modulated production of IL-6, etc.) (See for example, 12 left-hand column 5th paragraph).
Regarding claim 24, Park et al. teach the fermented composition inhibits growth of harmful bacteria (kimchi antimicrobial activities against B. subtilis, etc., and kimchi reduced H. pylori infections) (See for example, p. 15 left-hand column “Antimicrobial activities of kimchi LAB”, and p. 16 left-hand column 1st paragraph).
Regarding claim 25, Park et al. teach the method increases an immune enhancing effect of the composition (treatment with kimchi enhanced immune function both in vitro and in vivo and modulated production of IL-6, etc.) (See for example, 12 left-hand column 5th paragraph).
Regarding claim 26, Park et al. teach the method increases a gut health improving effect of the composition (consumption of kimchi containing LAB significantly increased levels of Lactobacillus sp. and Leuconostoc sp.) (See for example, p. 16 left-hand column 3rd paragraph).
In this case, although the strain of Leuconostoc mesenteroides taught by Park et al. does not have the claimed designation numbers of, CJLM119, however it appears to be the same as the claimed Leuconostoc mesenteroides strain. It should be noted that a single strain can be deposited under different deposit numbers.
Moreover, a person of ordinary skill in the art before the effective filing date of the invention knowing the health benefits of fermented product fermented by Leuconostoc mesenteroides, would have been motivated to isolate a Leuconostoc mesenteroides by known and available techniques taught by the prior art and obtain a deposit number and further use it in the method according to the teachings of Park et al. with a reasonable expectation or success in providing the claimed fermented composition(s), and the claimed method of increasing expression of TNF-a or IL-6, the method of reducing growth of harmful bacteria in a subject, and the method for preparing the fermented composition.
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 2, 4-12, 18 and 20-26 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (J Med Food. 2014, Vol. 17, No. 1, p. 6-20) as applied to claims 2, 4, 6-8, 10-12, 18, 20, 21 and 23-26 above, and further in view of Jung et al. (Prev Nutr Food Sci. 2012 Sep;17(3):217-22) and Park et al. (Bioscience, 2018, Vol. 23, p. 100-106).
The teachings of Park et al. with respect to the limitations of claims 2, 4, 6-8, 10-12, 18, 20, 21 and 23-26.
Park et al. (2014) do not teach the fermented composition comprises garlic at 5% to 9% by weight with respect to a total weight of the composition (claims 5 and 22), and the fermentation product is a product fermented at 32°C to 42°C for 10 to 30 hours (claim 9).
Regarding claims 5 and 9, although, Park et al. (2014) do not teach the fermented composition comprises garlic at 5% to 9% by weight with respect to a total weight of the composition, however, Park et al. (2014) the fermentation product is a product in which a composition comprising garlic at 1.4% by weight with respect to a total weight of the composition is fermented (1.4% garlic) (See for example, p. 7 right-hand column 3rd paragraph).
In addition, before the effective filing date of the invention, Jung et al. teach a fermented composition comprising a fermentation product fermented with a Leuconostoc mesenteroides strain or a culture thereof kimchi wherein the fermentation product is a product in which a composition comprising garlic at 5% to 9% by weight with respect to a total weight of the composition is fermented (see for example, p. 217 Materials and Methods table 1. 3rd ingredients per starter culture).
Therefore, the amount of garlic would have been optimized by a person of ordinary skill in the art before the effective filing date of the invention based on the teachings of Park et al. and Jung et al.
Regarding claim 9, the fermentation product is a product fermented at 32°C to 42°C for 10 to 30 hours, Park et al. (2014) teach optimizing the fermentation conditions to improve functionalities (See for example, p. 7 left-hand column 4th paragraph).
Moreover, before the effective filing date of the invention, Park et al. (2018) teach commercially produced kimchi is usually fermented for 1-2 days (or 24 to 48 hours) at 20°C (See for example, p. 105 right-hand column last paragraph). and further teach optimizing the fermentation conditions (See for example, p. 106 left-hand column 1st paragraph).
Therefore, the temperature and duration of the fermentation would have been optimized by a person of ordinary skill in the art before the effective filing date of the invention based on the teachings of Park et al. and Park et al.
Conclusion(s):
No claims(s) is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KADE ARIANI whose telephone number is (571)272-6083. The examiner can normally be reached IFP, Monday - Friday, 8:00 AM -4:00 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L. Gordon can be reached at (571)272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KADE ARIANI/Primary Examiner, Art Unit 1651