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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/17/2023 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: "0,01" should . 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 2 and 15 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.
It is important to recognize that a trademark or trade name is used to identify a source of goods, and is not the name of the goods themselves. Thus a trademark or trade name does not define or describe the goods associated with the trademark or trade name. See definitions of trademark and trade name in MPEP § 608.01(v).If the trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). Trade names such as XAD4 are used to describe the nonionic adsorption resin of claim 2 which renders the claim indefinite because the actual structural limitations of each resin cannot be determined from the trade name alone. See MPEP 2173.05(u).
While claim 15 appears intended to be a product-by-process claim, the language “based on” renders the scope unclear as it is unclear what the term “based on” means. The term “based on” makes it unclear to what extent the product need actually be produced by the process of claim 13. The claim is interpreted as product-by-process for examination purposes. Furthermore, the “can be” step is optional and if interpreted as product-by-process it is unclear whether claim 15 refers to the eluted extract obtained from step (b), or its concentrated product must be powdered. Applicant may overcome the rejection by amending the claim to recite “A product obtained by the process according to claim 13.”
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.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/118027 A1 to Lemke et al (See 12/27/2023 IDS Foreign Patent Document Cite No 8).
Lemke et al. is drawn to extraction of anthocyanins using an adsorption resin and acid. Example 7 is drawn to the use of an HP20 resin and 20% ethanoic acid (~3.5 M). Example 8 is drawn to the use of a Sepac PS/DVB resin and 30% formic acid. The organic solvent used to elute anthocyanins may range from 5% to 99% of the total volume (p. 6, lines 9-13). Examples 1-6 are drawn to various extractions using different columns, solvents and amounts thereof. Example 2 involves a preliminary extraction at 40 C.
Lemke et al. does not teach the 0.1 M to 1 M or 35 to 100 C range of the instant claims or reaching over 50% recovery.
Both concentration and temperature are suggested as result-effective variables given that the extractions are performed at different concentrations. Furthermore, Lemke et al. teaches at p. 6 that the solvent used to elute may range from 5% to 99% of the total volume. That an extraction occurs at elevated temperature suggests it as a result-effective variable for extraction, and resin chromatography is understood to operate under the same principles as a traditional extraction. Furthermore, both parameters are recognized by a PHOSITA as result-effective variables. Accordingly, a PHOSITA would have been motivated to extract anthocyanins with a carboxylic acid as taught by Lemke et al. and it would have been routine to optimize the concentration of acid and temperature. See MPEP 2144.05(II). With respect to over 50% recovery, the preamble is interpreted as intended use. While data in the specification may show unexpected results, said results are not commensurate in scope with the claims which are drawn to a broader range of adsorption resins, acid concentrations, temperatures and monocarboxylic acids than those of the examples. Accordingly, claims 1, 3 and 5-7 are obvious.
With respect to claim 2, neither Example 7 or 8 uses one of the claimed resins. However, others such as Example 1 use an XAD7 resin which a PHOSITA would consider a suitable equivalent for substitution. With respect to claim 4, while neither Example 7 or 8 uses propionic acid, it would have been considered a suitable equivalent to substitute for formic or acetic acid. Other organic acids such as citric acid are taught and organic acids are generically taught as acceptable (p. 2, lines 13-20). Accordingly, propionic acid would be considered an acceptable organic acid to utilize for elution. See MPEP 2144.06(II).
With respect to claim 8, the method taught is a batch mode system. In In re Dilnot, 319 F.2d 188, 138 USPQ 248 (CCPA 1963), the court held the claimed continuous operation would have been obvious in light of the batch process of the prior art. See MPEP 2144.04(V)(E).
With respect to claims 9-10, resin regeneration with a basic solution is a routine practice of resin adsorption chromatography in order to reduce waste. Note also that “can be” language denotes an optional step.
With respect to claims 11-15, the extracts are dried and claims 12 and 14 are drawn to routine methods of drying. The product of claim 15 would naturally flow from the teachings of the prior art. Note also that “can be” language denotes an optional step.
Conclusion
Claims 1-15 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JED A KUCHARCZK/ Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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