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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 42 – 54, and species SEQ ID NO: 1 in the reply filed on October 13, 2025 is acknowledged.
Claims 42 – 61 are pending; claims 55 – 61 are withdrawn as being drawn to non-elected subject matter; claims 42 – 54 have been considered insofar as they read on the elected species, SEQ ID NO:1.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 14, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 42 – 54 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 42 recites “functional variants thereof” in line 4. This claim and those depending therefrom are considered genus claims that encompass a wide array of variants. The specification fails to set forth a representative number of examples in order to reasonably verify possession of such a potentially enormous number of functional variants.
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that the claims are broad generics, with respect to all variants that might result from mutations, deletions, additions or fragments in the claimed sequences. The instant disclosure fails to identify a single variant of a single sequence. The possible variations of mutations are limitless with potentially millions of types of variations.
The purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by them. A patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention. Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations" and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." The specification lacks sufficient variety of species of functional mutations to reflect this variance in the genus since the specification does not provide any examples of such a genus of functional variants. Accordingly, the specification fails to provide adequate written description for the genus of “functional variants” and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed had possession of the entire scope of the claimed invention Moreover, the specification neither describes the complete structure of a representative number of species, nor describes a representative number of species in terms of partial structure and relevant identifying characteristics. Absent of such teachings and guidance as to the structure and function of these mutations and variations, the specification does not describe the claimed in such full, clear, concise and exact terms so as to indicate that Applicant had possession of these functional variants at the time of filing of the present application. Thus, the written description requirement has not been satisfied.
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 46 and 53 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 46 is drawn to a method of reducing uptake of fructose and/or glucose in a subject, however are rendered indefinite because the claim appears to broaden the claim on which it depends. Specifically, the claim requires that the inulosucrase has 70% identity to SEQ ID NO:1 or 5 while the claim on which it depends requires the polypeptide to be these sequences. Clarification is required.
Claim 53 is rendered indefinite as it is unclear whether the claim intends to further limit or change the food composition or foodstuff. Applicant may overcome this rejection by inserting “further” before the recitation of “comprises.”
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 42 – 54 are rejected under 35 U.S.C. 102a1 and 102a2 as being anticipated by Kralj et la. (US 2017/0267981) as supported by Result 3.
Regarding claims 42 and 44, Kralj teaches a method comprising administering to a subject an isolated inulosucrase (0010 – 0011, claims) which is interpreted as a functional variant of SEQ ID NO:1. Krali teaches variants of the inulosucrase include those recited in Table 2, reciting SEQ ID NO:11, which is a 100% match to applicant’s claimed SEQ ID NO:1 (see Result 3). Although the reference does not teach the method is effective to reduce uptake and/or formation of fructose and/or glucose in the subject and produce inulin in the subject, the reference teaches the claimed step of administering the same inulosucrase and that the inulosucrase metabolizes sucrose into oligosaccharides (0013). Moreover, in practicing the method of Kralj, one is inherently practicing the method as claimed.
Regarding claim 43, since all inulosucrase are classified as EC 2.4.1.9, the inulosucrase of Kralj must also have the same EC classification.
Regarding claims 45 – 47, Kralj teaches the instantly claimed SEQ ID NO:1 (SEQ ID NO:11, Table 2) can also be used in the methods, which meets at least 70% homology, homology at the claimed positions, and alanine at A182 (See Result 3).
Regarding claim 48, Kralj does not teach the method wherein the inulosucrase has the claimed GRAVY score. However, since the sequences are 100% matched, it appears that the enzyme of Kralj would also intrinsically have the same score as that of the prior art.
Regarding claims 49 – 50, the inulosucrase may be obtained from Bacillus subtilis, B. agaradhaerens, Lactobacillus gasseri, L. jonsonii, L. reuteri, Leuconostoc citreum (0007, Table 2).
Regarding claims 51 and 54, the inulosucrase can be comprised in food-grade, feed-grade, industrial-grade, or pharmacologically acceptable carrier, diluent, or excipient (0011, 0076) which implies the composition is orally administered.
Regarding claims 52 – 53, the inulosucrase can be combined with a food containing sucrose (or a carbohydrate such as juice or yogurt (contains fat) (0072).
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).
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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