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 .
Claims 1-14 are pending in the instant application. Claims 1, 2 and 11-13 are rejected. Claims 3-10 and 14 are objected.
Information Disclosure Statement
The information disclosure statement filed on February 28, 2024 has been considered and a signed copy of form 1449 is enclosed herewith.
Election/Restrictions
Applicant’s election of the species isobutyrate in the response filed on June 11, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). Upon further search and consideration, however, the election of species requirement has been withdrawn (i.e., the full scope of the subject matter of claims 1-14 has been searched and examined in its entirety).
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.
Claim 2 is 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). In the present instance, the claim recites the broad recitation “Crohn’s disease,” and the claim also recites “especially Crohn’s disease in a state that affect specifically the colon with or without ileitis” which is the narrower statement of the range/limitation. 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.
Also, the phrase "such as" and the word “including” render the claim indefinite because it is unclear whether the limitations following the phrase and word are part of the claimed invention. See MPEP § 2173.05(d).
Finally, the limitations within the parentheses render the claim indefinite because it is unclear whether the limitations are part of the claimed invention.
This rejection can be overcome by amending the claim to read, for example, “The method of claim 1 wherein the patient suffers from intestinal inflammation associated with diseases selected from the group consisting of inflammatory bowel diseases, Crohn’s disease, microscopic colitis, infectious colitis caused by bacteria or by virus, radiation colitis, ischemic colitis, pediatric colitis, undetermined colitis, functional bowel disorders, and other states of digestive microinflammation.”
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, 11, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2009/039101 A1.
WO 2009/039101 A1 discloses a method of preventing or treating a gastrointestinal condition in a subject, said method comprising: administering one or more branched chain fatty acid to the subject under conditions effective to prevent or treat the gastrointestinal condition in the subject (see claim 1), wherein the gastrointestinal condition is inflammatory bowel disease (see claim 9, [27]). It is also disclosed that the composition can be "administered orally, parenterally, subcutaneously, intravenously, intramuscularly, intraperitoneally, by intranasal instillation, by implantation, by intracavitary or intravesical instillation, intraocularly, in traarterially, intralesionally, transdermally, by application to mucous membranes (such as, that of the nose, throat, and bronchial tubes), or by introduction into one or more lymph nodes" (see [33]) or in a food product (see [34]). Therefore, a method of treating intestinal inflammation in a patient in need thereof of the claims is anticipated by the reference.
Claims 1, 2, 11, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2014/0037603 A1.
US 2014/037603 A1 discloses a method for use in improving gut barrier function comprising administering a nutritional composition including an effective amount of branched chain fatty acids to an individual in need thereof (see claim 1), wherein the improved function is related to a condition selected from the group consisting of infection, sepsis, malabsorption, allergy, inflammatory bowel disease, irritable bowel syndrome, diarrhea, and combinations thereof (see claim 2, [87]). Administration occurs through an administration route selected from the group consisting of orally, topically, a tube or catheter, and combinations thereof (see claim 32, [122]). It is also disclosed in the reference that the nutritional compositions can also comprise amino acids, such as isoleucine (see [114]). Therefore, a method of treating intestinal inflammation in a patient in need thereof of the claims is anticipated by the reference.
Claim Objections
Claims 3-10 and 14 are objected to for depending on a previous rejected claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTIN ANN VAJDA whose telephone number is (571)270-5232. The examiner can normally be reached Mon-Fri 6:00-4:00.
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622
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