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 .
Claims 1-12 are pending and are under examination.
Information Disclosure Statement
Information disclosure statement filed 4/12/24 has been considered and an initialed copy is enclosed.
Drawings
The drawings are objected to because the font is not legible. See figures 1-3, 5-6 and 8.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Abstract
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The disclosure is objected to because of the following informalities: the specification contains implied language such as “the present invention relates to” and “the present invention”.
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 1-12 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 Propionibacterium freudenreichii (KCCM12272P). Because it is not clear that the bacteria is known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the claims require the bacteria, a suitable deposit for patent purposes is required. Exact replication of the bacteria is an unpredictable event.
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 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 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 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 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;
(c) the deposits will be maintained in a public depository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of 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 nonviable or non-replicable.
In addition, a deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of 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.
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.
Applicant's attention is directed to In re Lundack, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
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 1-12 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.
Claim 1 is drawn to a pharmaceutical for treating rheumatoid arthritis comprising Propionibacterium freudenreichii MJ2(KCCM12272P), a culture solution thereof, live cells thereof, dead cells thereof or mixture there as an active ingredient.
Claim 10 is drawn to a food composition for alleviating rheumatoid arthritis comprising Propionibacterium freudenreichii MJ2(KCCM12272P), a culture solution thereof, live cells thereof, dead cells thereof or mixture there as an active ingredient.
The metes and bounds of the claims are not clear because the claims the composition comprises Propionibacterium freudenreichii MJ2(KCCM12272P), live cells thereof or dead cells thereof or a mixture. What is “live cells thereof” of Propionibacterium freudenreichii MJ2(KCCM12272P)? Is Propionibacterium freudenreichii MJ2(KCCM12272P) as listed in the claim different from the live cells of Propionibacterium freudenreichii MJ2(KCCM12272P)?
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 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
Claim 1 is drawn to a pharmaceutical for treating rheumatoid arthritis comprising Propionibacterium freudenreichii MJ2 (KCCM12272P), a culture solution thereof, live cells thereof, dead cells thereof or mixture there as an active ingredient.
STEP 1: THE CLAIMS ARE DRAWN TO A COMPOSITION OF MATTER
STEP 2A PRONG ONE – THE CLAIM RECITES A JUDICIAL EXCEPTION -SEE MPEP 2106.4
The specification disclose that the MJ2 strain was selected as a candidate strain through a process of purifying single colonies 3 times from raw milk procured from a farm in Gimpo, Gyeonggi-do.
Absent other evidence to the contrary the MJ2 strain is a product of nature.
Thus, the bacteria and substances derived from the bacteria are products of nature.
There is no evidence that the culturing and isolation process from milk changes any characteristics of the bacteria. Thus, the MJ2 strain and live cells thereof are product of nature.
Regarding dead cells, these are also products of nature as the bacteria has a life span.
The food of claims 10-11 is recited at a high level of generality and encompasses a food such as milk, for example. This combination exists in nature as the specification disclose the bacteria was isolated from raw milk procured from a farm in Gimpo, Gyeonggi-do. There is no evidence that the combination of grains or an edible plant results in markedly different characteristic of any of the component. This each component is a product of nature.
STEP 2A PRONG TWO – THE CLAIM DOES NOT RECITE ADDITIONAL ELEMENTS THAT INTEGRATE THE JUDICIAL EXCEPTION INTO A PRACTICAL APPLICATION. SEE MPEP 2106.4
Next, the claim as a whole is analyzed to determine whether any additional element or combination of elements that integrates the judicial exception into a practical application is recited. The claims do not recite additional elements that integrate the judicial exception into a practical application such a particular treatment or prophylaxis for a disease or medical condition i.e. affirmatively reciting an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of said action is a step of administering the intestinal bacteria to a subject and not the recitation of the intended use of the composition for treating rheumatoid arthritis. See MPEP 2106.04(d)(2).
STEP 2B – THE CLAIMS DO NOT AMOUNT TO SIGNIFICANTLY MORE. SEE MPEP 2106.05.
Next, the claims as a whole is analyzed to determine whether any additional element, or combinations of elements, is sufficient to ensure that the claim amounts to significantly more than the exceptions. Integration requires an additional element in the claim to apply, rely on, or use the judicial exception in a manner than imposes a meaningful limit on the judicial exception. The claims does not recite any additional elements that is sufficient that the claim amounts to significantly more than the exception.
These claims do not recite any meaningful additional limitations, modification(s) or transformation(s) of the products of nature.
The culturing of the bacteria and centrifuging does not modify or transform the bacteria. Heating the cultured strain kills the bacteria but heating as generally recited does not sufficiently modify the bacteria so that it is significantly more than the same bacteria that has naturally expired.
Thus, the claims as a whole does not amount to significantly more than the “product of nature” by itself. Thus, the claims do not qualify as eligible subject matter under 35 USC 101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lim et al. KR 20200000957A 1-06-2020 cited in IDS.
Claim interpretation: The recitation of the intended uses of the claimed composition in the claims 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 1: Lee et al disclose a pharmaceutical composition for treating rheumatoid arthritis comprising Propionibacterium freudenreichii MJ2 (KCCM12272P), a culture solution thereof, live cells thereof, dead cells thereof, or a mixture thereof as an active ingredient. See abstract.
Claim 2: The pharmaceutical composition of claim 1, wherein the live cells are obtained by culturing the MJ2 strain activated in a culture medium for 30 to 50 hours under anaerobic conditions at 20 to 40°C and centrifuging the cultured strain solution.
In the present invention, the Propionibacterium freudenreichii may be characterized as Propionibacterium freudenreichii MJ2 ( Propionibacterium freudenreichii KCCM12272P) (Korea Microorganism Conservation Center).
In the present invention, the Propionibacterium freudenreichii may be characterized by being a microorganism of Propionibacterium freudenreichii MJ2 ( Propionibacterium freudenreichii KCCM12272P) (Korea Microorganism Conservation Center).
In the present invention, the microbial cells can be prepared by heat treatment of the corresponding live cells or by treatment with formalin or other fungicides, and the microbial cells can be used even if they are substantially dead. In addition, the microorganism used in the present invention may be prepared by the following method, but is not limited thereto.
In the present invention, Propionibacterium freudenreichii KCCM12272P (Propionibacterium freudenreichii KCCM12272P) (Korea Microorganisms Preservation Center) microorganisms, Propionibacterium freudenreichii in anaerobic conditions and a temperature range of 20 ~ 40 ? After incubation for 30 to 50 hours, it may be characterized in that it is obtained through a heat treatment.
The type of the medium that can be used in the culture in the present invention is not particularly limited, for example, RCM (Reinforced Clostridial Medium) medium can be used.
In addition, the culture may be further incubated for 1 to 5 hours by adding fresh medium to 10 to 100 times the volume of the medium inoculated with the strain.
In the present invention, the culture broth obtained by the culture as described above can be centrifuged to obtain a strain, diluted, and then treated with bacteria through heat treatment.
Claim 3: Lee et al disclose the pharmaceutical composition of claim 1, wherein the dead cells are obtained by culturing the MJ2 strain activated in a culture medium for 30 to 50 hours under anaerobic conditions at 20 to 40°C and heat-treating the cultured strain.
Claim 4: Lee et al disclose the pharmaceutical composition of claim 1, wherein the composition is for oral administration e.g. capsules, tablets etc.
Claim 5: Lee et al disclose the same MJ2 strain and thus the composition will also inhibit inflammatory reactions by increasing expression of IL-10.
Claim 6: Lee et al disclose the same MJ2 strain and thus the composition will also inhibit osteoclast differentiation.
Claim 7: Lee et al disclose the same MJ2 strain and thus the composition will also composition decreases production of IgG, IgG1, and IgG2a.
Claim 8: Lee et al disclose the same MJ2 strain and thus the composition will also inhibit apoptosis and restores autophagy to a normal level.
Claim 9: Lee et al discloses the pharmaceutical composition of claim 1, wherein the composition includes the live cells or dead cells at a concentration of 1 x 109 CFU/mL. See example 1. Lee et al also disclose concentration of live or dead cells at a concentration of 1 x 106 to 1 x 108 CFU/mL. See examples 2-3.
Claim 10: Lee et al discloses a food composition for alleviating rheumatoid arthritis comprising Propionibacterium freudenreichii MJ2 (KCCM12272P), a culture solution thereof, live cells thereof, dead cells thereof, or a mixture thereof as an active ingredient.
Claim 11: Lee et al disclose The food composition of claim 10, wherein the food is a health functional food, and the composition includes the live cells or dead cells at a concentration of 1 x 109 CFU/mL. See example 1. Lee et al also disclose concentration of live or dead cells at a concentration of 1 x 106 to 1 x 108 CFU/mL. See examples 2-3.
See entirety of Lee et al.
Status of Claims
Claims 1-12 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLUWATOSIN A OGUNBIYI whose telephone number is (571)272-9939. The examiner can normally be reached IFP.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645