DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-25 are currently pending.
Election/Restrictions
3. Applicant's election with traverse of Group I, claims 2-9 with claim 1 as a linking claim in the reply filed on January 26, 2026 is acknowledged. The traversal is on the ground(s) that it would not be burdensome to examine all of the groups of invention. This is not found persuasive because each group requires a separate search and raises distinct prior art and non-prior art issues. Thus, the search and examination of all groups is considered burdensome.
The requirement is still deemed proper and is therefore made FINAL.
4. Claims 10-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
5. Claims 1-9 are examined on the merits.
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 3-9 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.
6. Claim 3 at step (b) is indefinite because it is unclear how the “raffinate” differs from the “extract solution.” The definition of “raffinate” is “a liquid product resulting from extraction of a liquid with a solvent” (see https://www.merriam-webster.com/dictionary/raffinate). Thus, “raffinate” since appears to be synonymous with “extract solution,” it unclear what procedure must be performed on the extract solution in order to produce the raffinate.
Furthermore, it is unclear if the “raffinate” is considered to be the extract. Lines 1 and 2 of the claim state that the Adenostemma lavenia extract is obtained by the claimed method; however, the method results in a “raffinate” rather than an “extract.” Thus, this inconsistency between the beginning of the claim and the resulting product is confusing.
7. Claim 7 is indefinite at step (f) because it states that “collecting and combining at least one fraction…” can occur. However, it is unclear what the fraction is combined with.
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.
8. Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hsu (US 6,383,525).
This reference teaches a method for treating atopic dermatitis by administering a composition comprising Taiwan Adenostemma (Adenostemma lavenia). The plant material is mixed with a liquid solution which would produce an extract of the Adenostemma lavenia (see abstract; Table 2; and Example 1).
Claim Rejections - 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.
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.
9. Claim(s) 2-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hsu (US 6,383,525) in view of Liu (CN 102391106 – English translation).
The teachings of Hsu are discussed above. The reference teaches that the whole plant should be used in the composition (see column 8, lines 52-56). The reference does not specifically teach using an ethanolic extract from the Adenostemma lavenia. However, applicant’s specification defines edema as a symptom of dermatitis (see paragraph 31).
Liu teaches an ethanolic extract from Adenostemma lavenia that is used to inhibit swelling (edema) and carbuncles (boils on the skin) (see page 2 of the translation). Liu teaches that ethanol is added to the plant material and heating extraction is performed for 2-4 hours followed by filtration to separate the solid material from the liquid. This procedure is performed twice and the extracts are merged and dried. Next an ethanolic solution is used to create a liquid eluate. This would dissolve the dry extract in the ethanol. Next the dissolved extract is purified by chromatography using hexane and ethyl acetate to collect the active fraction (see page 2 of the translation). The reference does not specifically teach that this fraction inhibits IL-4. However, since the reference teaches extracting the same plant material using the same solvents, it is reasonable to conclude that the reference fraction would also exhibit the ability to inhibit IL-4.
An artisan of ordinary skill would reasonably expect that the extract taught by Liu would function successfully in the method of treating atopic dermatitis taught by Hsu because the extract is able to treat edema and other skin inflammations. This reasonable expectation of success would have motivated the artisan to modify Hsu to include the use of the Adenostemma lavenia extract taught by Liu.
Liu does not specifically performing the extraction at all of the temperatures claimed by applicant. In addition, the reference teaches using countercurrent chromatography rather than column chromatography as claimed by applicant. However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” Liu teaches performing the extractions under heating condition. Varying the temperature of a heating extraction is not considered to be inventive unless the temperature is demonstrated as critical. In this particular case, there is no evidence that the claimed temperature of the ingredients produces an unexpected result. In addition, both column chromatography and countercurrent chromatography are known chromatography techniques that an artisan would expect could be substituted for each other. Thus, absent some demonstration of unexpected results from the claimed temperature or use of column chromatography, this optimization of the extraction procedure would have been obvious before the effective filing date of applicant’s claimed invention.
10. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655