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 1-20 are currently pending.
Election/Restrictions
3. Applicant's election with traverse of Group I, claims 1-16, in the reply filed on December 15, 2025 is acknowledged. The traversal is on the ground(s) that a search of both groups of invention would not be burdensome because both groups are classified in A61K 36/9062. This is not found persuasive because overlapping classification is not evidence that a search and examination would not be burdensome. Composition claims and method of making claims require distinct search strategies and analysis of the prior art. Thus, this argument is not persuasive.
Applicant also argues that both groups should be examined together because “once the preparation method is examined and found to be allowable, the resulting product will necessarily possess substantive differences in composition from the prior art.” However, as discussed in MPEP section 2113, “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process…”. Thus, even if the process claims are found allowable, the product is not necessarily allowable and needs further consideration for prior art and non-prior art issues. Therefore, applicant’s argument is not persuasive.
The requirement is still deemed proper and is therefore made FINAL.
4. Claims 17-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
5. Claims 1-16 are currently pending.
Claim Objections
6. Claim 13 is objected to because of the following informalities: in line 2, “sodium stearoyl lactate” should be “sodium stearoyl lactylate” and “calcium stearoyl lactate” should be “calcium stearoyl lactylate”. Appropriate correction is required.
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 1-16 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.
7. Claims 1, 2, 6 are indefinite because it is unclear what particle sizes are considered to be encompassed by “superfine.”
8. Claim 6 is indefinite because it refers to a solid-liquid ratio of the Alpina officinarium superfine powder to vegetable oil in step S1. However, in step S1, the A. officinarium powder is claimed as a solution rather than the powder itself. It appears that the powder of the A. officinarium would be dissolved in the solution; thus, it is unclear what solid content is used to determine the ratio of solid to liquid as claimed in claim 6.
9. Claim 8 is indefinite because it refers to a preparation method of the acidic mixed solution of the A. officinarium precipitate in step S2. However, the acidic mixed solution precipitate is prepared in step S1 rather than S2. It is unclear if claim 8 is adding an additional precipitation step to the process of claim 1.
10. Claim 15 is indefinite because it refers to a solid to liquid ratio but does not define both components of the ratio.
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.
11. Claim(s) 1-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nogueira (US 2017/0100326) in view of Lin (CN 105054066 A – English translation).
Nogueira teaches a method of making an extract from A. officinarium rhizomes for use in cosmetic compositions. The rhizomes are dried and ground to produce milled particles. The particles are then extracted and mixed with a citric acid solution to produce an extract with a pH of 5. The extract is then mixed with additional ingredients such as lecithin (an emulsifier) and starch (a filler) to produce a product. The reference teaches that the resulting product can be a powder (see paragraphs 40, 54, 55, 69, and 71). An artisan of ordinary skill would reasonably expect that homogenization, drying and grinding would be used to produce a powdered product containing the extract, the lecithin, and the starch. The reference does not teach using vegetable oil to produce an extract from the acidic solution.
However, Lin teaches using vegetable oils such as olive oil to extract active substances from A. officinarium for use in cosmetic compositions. The reference teaches that using vegetable oil as the solvent produces extracts that are superior to extracts made with conventional solvents due to the lower toxicity to the body, lower cost, and lower environmental burden (see pages 2 and 3 of the translation). Thus, given these benefits of vegetable oil extraction, an artisan of ordinary skill would reasonably expect that the process of making the A. officinarium extract taught by Nogueira would be improved if a vegetable oil extraction step was added. This reasonable expectation of success would have motivated the artisan to modify the references to include the addition of the vegetable oil extraction.
The references do not specifically teach using all of the processing parameters, i.e. powder size, solvent concentration, and homogenization speeds and times, 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).” Varying the specific processing parameters within a procedure taught by the prior art is not considered to be inventive unless these procedures are demonstrated as critical. In this particular case, there is no evidence that the claimed processing procedures produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of processing procedures would have been obvious before the effective filing date of applicant’s claimed invention.
12. 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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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655