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 .
The preliminary amendment are received.
Claims 1-11 are canceled by Applicant.
New claims 12-21 are added.
Claims 12-21 are pending in this application and are being examined.
Objection(s):
Claim 13 is objected to because of the following informalities:
In claim 13, beginning of line 6, before fermentation, insert –a--.
Appropriate correction is required.
Claim Rejection - 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 14 is ejected 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.
In claim 14, line 2, the phrase “yeast” is indefinite because there is no specific definition in the specification for it. In this case, a genus claim that could be interpreted in such a way that it is not clear which species are covered would be indefinite (e.g., because there is more than one reasonable interpretation of what species are included in the claim). In addition, no species claim is presented.
Suggestion to obviated the rejection: delete the phrase.
Claim Rejection - 35 USC § 102
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.
Examiner Note:
The filing date of the priority document is not perfected unless applicant has filed a certified priority document in the application, and an English language translation, if the document is not in English.
Claims 12-19 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by KR 20210128938 A (Machine/English translation, which is also cited in IDS filed on 01/12/2025).
Regarding claim 12, KR 20210128938 A disclose a method for ameliorating or treating a respiratory disease, the method comprising administering a composition comprising fermented Centella asiatica extract as effective component to a subject in need thereof (improving or treating allergy, allergy is asthma, with a administering a composition fermented Centella asiatica extract as effective component to a subject in need thereof) (See for example, p. 2 “description”, p. 4 13th paragraph, and p. 6 4th paragraph).
Regarding claim 13, KR 20210128938 A disclose the fermented Centella asiatica extract is produced by: adding water to Centella asiatica powder; sterilizing the Centella asiatica powder in the water; cooling the sterilized Centella asiatica powder to room temperature and adding fermentation strain followed by fermentation at 25 to 40°C to prepare a fermented product of Centella asiatica; and adding an extraction solvent to the fermented product of Centella asiatica to produce the fermented Centella asiatica extract (See for example, p. 4 paragraphs 2nd-8th).
Regarding claim 14, KR 20210128938 A disclose wherein the fermentation strain is lactic acid bacteria or yeast (fermented bacteria added are preferably lactic acid bacteria) (See for example, p. 4 9th paragraph).
Regarding claim 15, KR 20210128938 A disclose wherein the fermentation strain is lactic acid bacteria selected from the group consisting of Enterococcus faecium, Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus plantarum, Leuconostoc kimchii, Leuconostoc citreum, Leuconostoc mesenteroides, and Lactobacillus sakei (the lactic acid bacteria are Enterococcus faecium, Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus plantarum, Leuconostoc kimchii, Leuconostoc citreum, Leuconostoc mesenteroides, and Lactobacillus sakei) (See for example, p. 4 9th paragraph).
Regarding claim 16, KR 20210128938 A disclose wherein the extraction solvent comprises water, C1-C4 lower alcohol, or a mixture thereof (solvent extraction by C1 to C4 lower alcohols) (See for example, p. 4 10th paragraph).
Regarding claim 17: The method of claim 12, wherein the respiratory disease is one or more selected from the group consisting of asthma, chronic obstructive pulmonary disease, bronchitis, pharyngitis, tonsillitis, and laryngitis (asthma) (See for example, p. 4 14th paragraph).
Regarding claim 18, KR 20210128938 A disclose wherein the composition is prepared in any one formulation selected from powder, granule, pill, tablet, capsule, candy, syrup, and beverage (See for example, p. 4 15th paragraph).
Regarding claim 19, KR 20210128938 A disclose wherein the composition is a pharmaceutical composition further comprising a pharmaceutically acceptable carrier, excipient, and/or diluent (see for example, p. 6 4th paragraph).
KR 20210128938 A therefore anticipate the claimed method.
Claim Rejection - 35 USC § 103
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.
A)
Claims 12-21 are rejected under 35 U.S.C. 103 as being unpatentable over KR 20210128938 A as applied to claims 12-19 above, and further in view of Reinero et al. (Environ Res. 2009 Jul;109(5):634-640).
The teachings of KR 20210128938 A with respect to the limitations of claims 12-19 were discussed above in details.
KR 20210128938 A do not explicitly teach, wherein the subject is a human (claim 20), and wherein the subject is an animal (claim 21).
However, before the effective filing dated of the invention Reinero et al. teach asthma occurs in both human and an animal (asthma cases in both human and domestic cats, feline asthma and human asthma, etc.) (See for example, Introduction).
Therefore, s person of ordinary skill in the art before the effective filing dated of the invention would have been motivated to apply the method taught by KR 20210128938 A to a human subject and an animal subject based on the teachings of Reinero et al.
B)
Claims 12, 17, 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Affrin et al. ( J Sci Food Agric. 2011; 91(15), p. 2731-2739) in view of Reinero et al. (Environ Res. 2009 Jul;109(5):634-640).
Regarding claims 12 and 17, Affrin et al. teach Centella asiatica is a famous medicine for treatment of a respiratory disease, i.e., asthma (See for example, p. 2731 “Introduction” left-hand column last paragraph) and further teach fermenting Centella asiatica and further extracting to obtain a fermented Centella asiatica extract with optimum antioxidant activity (See for example, p. 2732 right-hand column last paragraph – Continued on p. 2733 left-hand column 1st-5th paragraphs).
Therefore, a person of ordinary skill in the art before the effective filing date of the invention would have been motivated to apply the teaching of Affrin et al. and administering a composition comprising a fermented Centella asiatica extract with improved antioxidant activity to a subject in need of treating a respiratory disease, with a reasonable expectation of success in providing the claimed method for ameliorating or treating a respiratory disease, the method comprising administering a composition comprising fermented Centella asiatica extract as effective component to a subject in need thereof. The motivation is because Affrin et al. teach Centella asiatica is a famous medicine for treatment of a respiratory disease, i.e., asthma, and further teach fermenting Centella asiatica and further extracting to obtain a fermented Centella asiatica extract optimizes/improves its antioxidant activities.
Regarding claims 20 and 21, before the effective filing date of the invention Reinero et al. teach asthma occurs in both human and an animal (asthma cases in both human and domestic cats, feline asthma and human asthma, etc.) (See for example, Introduction). Therefore, s person of ordinary skill in the art before the effective filing dated of the invention would have been motivated to administer the fermented Centella asiatica extra taught by Affrin et al. to human and to an animal subjects based on the teachings of Reinero et al.
Conclusion(s):
No claim(s) is allowed at this time.
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/KADE ARIANI/Primary Examiner, Art Unit 1651