DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-8 are currently pending.
Claims 1-8 are being examined in this application.
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 1-8 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 pre-AIA the applicant regards as the invention.
Claim 1, line 8-14, the recitation of “wherein the gastrointestinal disorder is gastric disorder caused by alcohol, and the gastrointestinal disorder is an elevated IL6/IL10 ratio; and wherein the gastrointestinal disorder is one or more selected from the group consisting of gastritis, gastric ulcer, esophagitis, esophageal ulcer, duodenitis, and duodenal ulcer” is indefinite as it is unclear whether the gastrointestinal disorder is gastric disorder caused by alcohol or the gastrointestinal disorder is gastric ulcer, esophagitis, esophageal ulcer, duodenitis, or duodenal ulcer, because alcohol does not directly cause gastric ulcer and duodenal ulcer. In addition, esophagitis, esophageal ulcer, and duodenitis are not a gastric disorder, and although duodenal ulcer is closely related to gastric disorders, it falls under peptic ulcer disease.
Claim 4, line 3-6, the recitation of “the lysed product, … is 1x103 CFU to 1x1013 CFU of the APsulloc 331261 (accession number: KCCM11179P) strain of Lactobacillus plantarum” is indefinite because the lysed product normally contains broken-down components of cells.
Claims 1 (line 5), 4 (line 2-3 & 5-6), 5 (line 3 & 8), 6 (line 3), and 7 (line 3) recite “(accession number: KCCM11179P)”. It is unclear what the parenthetical information is conveying. Further, parenthesis is reserved for reference characters and information within parenthesis has no effect on the scope of the claims. See MPEP 608.01(m).
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 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 of this title, 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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kwack et al (US 2014/0106435 A1; 4/17/2014. Cited on IDS) in view of ACG (MedicalXpress. 2011;1-2. Cited on IDS) and Liu et al (Environmental Toxicology and Pharmacology. 2012;34:280-287. Cited on IDS).
The instant claims recite a method for improving or treating a gastrointestinal disorder in a subject in need thereof, comprising administering an effective amount of one or more selected from the group consisting of the APsulloc 331261 (accession number: KCCM11179P) strain of Lactobacillus plantarum, a lysed product thereof, a culture thereof, and an extract thereof to the subject, wherein the gastrointestinal disorder is gastric disorder caused by alcohol, and the gastrointestinal disorder is an elevated IL6/IL10 ratio; and wherein the gastrointestinal disorder is one or more selected from the group consisting of gastritis, gastric ulcer, esophagitis, esophageal ulcer, duodenitis, and duodenal ulcer.
Kwack teaches a pharmaceutical composition containing Lactobacillus plantarum APsulloc 331261 under accession number: KCCM11179P (para 0028, 0031-0033), wherein the pharmaceutical composition may be used for treating intestinal disorder (a subset of a gastrointestinal disorder) (para 0028). Active ingredient of the pharmaceutical composition may be varied with the age, sex and body weight of a subject to be treated, pathological condition be treated, severity of the pathological condition, administration route and the judgement of a prescriber. Determination of the dose considering these factors is within the level of those skilled in the art, e.g., the daily dose may be 0.1 mg/kg/day to 5000 mg/kg/day, but not limited thereto (para 0030). The pharmaceutical composition may be administered orally, and formulations for oral administration include powder and solution (para 0029).
Kwack does not teach the gastrointestinal disorder is a gastric disorder caused by alcohol, and the gastrointestinal disorder is an elevated IL6/IL10 ratio (claim 1), wherein the alcohol is ethanol (claim 2), and wherein the elevated ratio of IL6/IL10 level is a higher ratio of IL6/IL10 expression level in tissues of the stomach or duodenum of the subject than that of a normal person (claim 3).
However, Kwack does teach the pharmaceutical composition containing Lactobacillus plantarum APsulloc 331261 under accession number: KCCM11179P may be used for treating intestinal disorder such as constipation and diarrhea (para 0028). ACG teaches alcohol led to small intestinal bacterial overgrowth and subsequently cause gastrointestinal symptoms like constipation and diarrhea (p.1 para 1). In addition, Liu teaches administration of ethanol significantly elevated the levels of IL-6 when compared with normal control, and the level of IL-10 is moderately reduced when compared with normal control (p.284 col left – para 4), an elevated IL-6/IL-10 ratio is observed in ethanol-induced gastric ulcer (p.286 col left – para 2).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to administer Lactobacillus plantarum APsulloc 331261 under accession number: KCCM11179P to a subject to improve or treat a gastric disorder caused by ethanol (alcohol) and a gastrointestinal disorder that has an elevated IL6/IL10 ratio, since it was well-known in the art that alcohol cause gastrointestinal symptoms like constipation and diarrhea, and that IL-6/IL-10 ratio is elevated in ethanol-induced gastric ulcer, as evidenced by ACG and Liu, respectively. In addition, Kwack discloses that Lactobacillus plantarum APsulloc 331261 under accession number: KCCM11179P may be used to treat intestinal disorders such as constipation and diarrhea. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited references to administer Lactobacillus plantarum APsulloc 331261 under accession number: KCCM11179P to a subject to improve or treat a gastric disorder caused by ethanol (alcohol) and a gastrointestinal disorder that has an elevated IL6/IL10 ratio with a reasonable expectation of success.
References cited above do not teach the claimed daily dosage (claim 4) as well as the claimed percentage by weight (claim 5).
However, Kwack does teach a pharmaceutical composition contains Lactobacillus plantarum APsulloc 331261 under accession number: KCCM11179P as an active ingredient, and active ingredient of the pharmaceutical composition may be varied with the age, sex and body weight of a subject to be treated, pathological condition be treated, severity of the pathological condition, administration route and the judgement of a prescriber, and determination of the dose considering these factors is within the level of those skilled in the art.
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to optimize daily dosage of Lactobacillus plantarum APsulloc 331261 under accession number: KCCM11179P as well as the percentage by weight of Lactobacillus plantarum APsulloc 331261 under accession number: KCCM11179P in a composition to achieve a desired medical outcome, as evidenced by Kwack. Generally, differences in concentration will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. (MPEP 2144.05 II) Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to optimize daily dosage of Lactobacillus plantarum APsulloc 331261 under accession number: KCCM11179P as well as the percentage by weight of Lactobacillus plantarum APsulloc 331261 under accession number: KCCM11179P in a composition, with a reasonable expectation for successfully obtaining a pharmaceutical composition.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759
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