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 .
Drawings
Figure 1 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g).
Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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.
Claim Rejections - 35 USC § 112(a)
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 and 5 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 claims contain 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 methods of claims 2 and 5 utilize a particular strain of Lactobacillus fermentum: GB-102. As noted in the specification and in claims 2 and 5, this strain has the accession number: KCTC 14105BP.
As per CFR 1.802, biological material need not be deposited if it is known and readily available to the public, or can be made or isolated without undue experimentation. In the instant application, neither of these criteria appear to be satisfied. With respect to public availability, it is noted that the deposit receipt (of record on 12/13/2023) indicates that the deposit was not made under the Budapest Treaty, but was requested that a conversion to such a deposit be made. Note CFR 1.803 for the terms of an acceptable deposit and its conditions and the depository’s obligations. (The examiner notes for clarity of the record that CFR 1.802 – 1.808 outline the making of deposits of biological materials.) With respect to whether the biological material can be made or isolated without undue experimentation, it is noted that the instant specification outlines a complex isolation and identification procedure beginning from an (apparently) random human-derived sample up to and including sequencing of the strain. That is, clearly the instant strain cannot be made or isolated without undue experimentation.
Applicant is required to comply with the deposit requirements as outlined in CRF 1.802 – 1.808 in order for the claims to be properly enabled.
Allowable Subject Matter
Claims 1, 4 and 6 are allowed. The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art appears to be CN 108130297 A, whose English language machine translation has been relied upon for purposes of this Office Action. The reference teaches a composite probiotic agent, inter alia Lactobacillus fementi, matched with a CAR T cell treatment (i.e. chimeric natural killer/cytotoxic cells) in a method for relieving undesired side effects of the CAR T cancer treatment (abstract; description page 1, Background technique and Summary of the Invention). The reference does not teach, show, suggest or make obvious the instant methods of weight gain suppression, or the prevention or treatment of a metabolic disease. The patient populations of the prior art and those of the instant application are separate and distinct and one of ordinary skill would have no motivation to extrapolate the prior art method of treating cancer to encompass the instant methods.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
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, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 11/1/2025