DETAILED ACTION
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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55, and are found in parent U.S. application 18/791 967.
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 – 6 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 does not provide clear evidence that the claimed biological material is known and readily available to the public; reproducible; and deposited per the deposit rules under 37 C.F.R 1.801 - 1.809.
Every patent must contain a written description of the invention sufficient to enable a person skilled in the art to which the invention pertains to make and use the invention. Where the invention involves a biological material and words alone cannot sufficiently describe how to make and use the invention in a reproducible manner, access to the biological material may be necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112. Courts have recognized the necessity and desirability of permitting an applicant for a patent to supplement the written disclosure in an application with a deposit of biological material which is essential to meet some requirement of the statute with respect to the claimed invention. See, e.g., Ajinomoto Co. v. Archer-Daniels-Midland Co., 228 F.3d 1338, 1345-46, 56 USPQ2d 1332, 1337-38 (Fed. Cir. 2000), cert. denied, 121 S.Ct. 1957 (2001) (explaining how deposit may help satisfy enablement requirement); Merck and Co., Inc. v. Chase Chemical Co., 273 F. Supp. 68, 155 USPQ 139 (D. N.J. 1967); In re Argoudelis, 434 F.2d 666, 168 USPQ 99 (CCPA 1970). To facilitate the recognition of deposited biological material in patent applications throughout the world, the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure was established in 1977, and became operational in 1981. The Treaty requires signatory countries, like the United States, to recognize a deposit with any depository which has been approved by the World Intellectual Property Organization (WIPO).
The deposit rules (37 CFR 1.801 - 1.809) set forth examining procedures and conditions of deposit which must be satisfied in the event a deposit is required. The rules do not address the substantive issue of whether a deposit is required under any particular set of facts. (MPEP 2402).
Since the microorganism, Lactobacillus fermentum GM-090, CCTCC M 204055 is recited in the claims, it is essential to the invention recited in those claims. It must therefore be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the microorganism is not so obtainable or available, a deposit of the microorganism may satisfy the requirements of 35 U.S.C. § 112. The specification does not disclose a repeatable process to obtain the microorganism and it is not apparent if the microorganism is readily available to the public. Moreover, because no taxonomic information appears in the specification, it is not clear what the microorganism actually is.
However, since a deposit has been made under the terms of the Budapest Treaty, then an affidavit or declaration by Applicants, someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his/her signature and registration number, stating that the specific strain has been deposited under the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 C.F.R. § 1.808.
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 – 6 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 and its dependents are drawn to a method of administering a composition, however are rendered indefinite for reciting “an effective amount” without a clear preamble of what the method requires. For example, it is unclear if the claims are treating, preventing, or ameliorating allergy and inflammation, which may require different “effective amounts.” Moreover, the claims are indefinite for not reciting what the method actually requires to be achieved. Clarification is required.
Claims 4 and 6 recite that the composition “may” further comprise additional components, rendering it unclear if the components that follow are required or optional. Clarification is required. For purposes of examination, the components are interpreted as optional.
In claim 6, the following phrases render the claim indefinite as neither the claim language nor the specification adequately define the phrases: “edible material comprising water,” “a sports beverage,” and “a Chinese medicinal herb.”
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.
(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.
Claims 1 – 6 are rejected under 35 U.S.C. 102a1 and 102a2 as being anticipated by Ching-Hsiang et al. (US 2006/0083723).
Regarding claims 1 – 2, Ching-Hsiang teaches a method of treating allergy and stimulating IFN-γ secretion by administering Lactobacillus fermentum GM-090 (abstract). Since the method is achieving the claimed results as applicant, e.g., treat allergy and inflammation (abstract, 0004, 0041, examples, claims) the methods are administering “an effective amount” as claimed.
Regarding the claimed nucleotide fragments, the claimed sequences are disclosed as from the deposited strain, Lactobacillus fermentum GM-090 CCTCC M 204055 (page 2 - 3 of the instant specification). As such, by administering the same bacteria as applicant, one is also administering its various nucleotides and fragments thereof.
Regarding claim 2, although the reference does not indicate the effects are achieved by also stimulating IL-10 and IL-12, the method steps are the same. Moreover, the prior art is administering the same bacteria to the same treating population for the same effects (e.g., treating allergy, inflammation and stimulating IFN-γ). Therefore, when practicing the methods of the prior art, one is inherently achieving the claimed intended function of administering the composition.
Regarding claims 3 – 4 and 6, the compositions are included in a pharmaceutical composition, dietary supplement, food, healthy food, medical food (0045), indicating a pharmaceutically acceptable vehicle is included (examples 7, 8).
Regarding claims 5 – 6, the compositions may be lyophilized (powder), a coagulated or fermented milk or infant food (solution, suspension, emulsion) (0043, 0045, example 7, 8, claim 5, 16).
Therefore, the reference anticipates the claimed subject matter.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUTH A DAVIS/Primary Examiner, Art Unit 1699
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