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 .
Claim Rejections - 35 USC § 112
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, 3 and 5-9 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Claim 1, for instance, recites the broad recitation “A legume composition...”, and the claim also recites “…preferably [emphasis added] containing more than 90% by weight…” which is the narrower statement of the range/limitation. Analysis of the other instances of “preferably” and “preferentially” clauses in the remaining claims is similar.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 2 and 4 are also 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.
Claims 2 and 4 depend, or ultimately depend, upon an indefinite claim yet do not relieve the indefiniteness. Dependent claims 2 and 4 are also, therefore, indefinite.
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.
Claims 1, 2, 4, 5, 7 and 8 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by WO 2020/239619 A1, cited in the IDS.
The reference teaches a therapeutic composition (i.e. a pharmaceutical composition) comprising a soluble fiber such as inulin (a plant polysaccharide) and pea, or pulse, protein for the treatment of, for instance, sarcopenia i.e. the age-related loss of skeletal muscle in humans (abstract; page 6, line 10; page 19, line 20; page 20, lines 6 and 22). The pulse may be faba beans (page 20, line 14). The legume protein is preferably non-hydrolyzed with a degree of hydrolysis of 5% or lower, preferably 4%, 3%, 2%, or 1% or lower (page 22, line 9, line 16). That is, the reference teaches a legume protein composition, the degree of hydrolysis of which is less than 10%, for use in the prevention and/or treatment of a disease susceptible to treatment by activation of the synthesis of FGF19 in a subject wherein said disease is sarcopenia.
The examiner notes, with respect to independent claim 7, that the preamble of the claim “…capable of overexpressing the synthesis of FGF19…” can be given no patentable weight because claim language that merely states a problem to be solved or a result obtained, without setting forth well-defined boundaries of the claimed scope (i.e. by not specifying any way to achieve the desired results), is unclear. Typically no patentable distinction (no limit on the claim scope) is made by a recitation of an intended use or result unless some structural difference is imposed by the use or result on the structure or material recited in the claim, or some manipulative difference is imposed by the use or result on the action recited in the claim. Note the discussion at MPEP 2173.05(g). That being the case, claim 7 distills simply to a claim to a pharmaceutical composition comprising legume proteins the degree of hydrolysis of which is less than 10% (since the remaining limitations recited in the claim are merely optional or preferable limitations).
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/239619 A1, cited in the IDS.
Inventor teaches a legume protein composition, the degree of hydrolysis of which is between 6-8%, for use in the prevention and/or treatment of a disease susceptible to treatment by activation of the synthesis of FGF19 in a subject where said disease is sarcopenia.
WO 2020/239619 A1 has been outlined above (102 rejection).
Inventor principally distinguishes over the cited art in that the degree of hydrolysis is just above the preferred range of the cited art. Note, however, that it is well established that consideration of a reference is not limited to the preferred embodiments or working examples, but extends to the entire disclosure for what it fairly teaches to a person of ordinary skill in the art. (Note the discussion at MPEP 2141.02, VI.) One of ordinary skill, before the effective filing date of the instant invention, would have found it obvious, and with a reasonable expectation of success, to optimize a results-effective variable, such as the degree of legume protein hydrolysis. One of ordinary skill would have been motivated to do so in order to optimize desirable characteristics of the composition in the near vicinity of the preferred degree of legume protein hydrolysis range of the cited art.
Allowable Subject Matter
The subject matter of claims 6 and 9 would be allowable once the rejections outlined above have been overcome. The following is a statement of reasons for the indication of allowable subject matter:
The key to the instant invention is the combination of the legume composition with a FXR agonist. The closest representative prior art appears to be WO 2020/239619 cited and outlined above. The reference does not teach, show, suggest or make obvious the instant legume protein composition and FXR agonist combination.
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.
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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 8/11/2026
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