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 .
Claims 1-12 are presented for examination 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 and 10-12 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.
Claim 3 is rendered vague and indefinite by the phrase “essentially consists of”. It is unclear how this is meant to differ from the more customary phrase “consists essentially of”, which is not as limiting as the phrase “consists of”. However, in the context of the instant claim, which contains the phrase “for the remainder of the extraction solvent”, the phrase “consists of” would seem to be more appropriate. Appropriate clarification is required.
Claim 10 is rendered vague and indefinite by the phrase “an extract obtainable by the method according to claim 1”. The phrase is unclear because the term “obtainable” merely means that the extract can be obtained by the method of claim 1, not necessarily that it is actually obtained by the method of claim 1. Thus, it is unclear how this phrase is meant to limit the claimed extract. Appropriate clarification is required.
Claim 10 recites the limitation "the alkane diol" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 provides for the use of, but, since the claims do not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under U.S.C. 112, second paragraph, for the reasons set forth above.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 12 is rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
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.
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.
Claim(s) 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Gewel-Beben et al. (2020) and Viera et al. (2020).
Gewel-Beben et al. beneficially disclose that plant extracts contain various beneficial bioactive phytochemicals beneficial for cosmetic skincare purposes. The most promising active ingredients of these type of cosmetic products are plant extracts, rich in polyphenolic compounds displaying multiple protecting functions. Particularly interesting for this type of application are extracts obtained from plants native to the Mediterranean region. Due to the constant exposure to stressful environmental conditions, including water deficiency, high temperature, and intensive solar radiation these plants contain broad spectrum of polyphenolic compounds protecting them from the negative consequences of the photo-oxidative stress. Polyphenolic compounds, especially flavonoids, are known for their ability to scavenge reactive oxygen species (ROS), chelate transition metal ions, and reduce lipid peroxidation. These compounds were also shown to possess skin calming, UV-protecting, lightening and skin cancer preventing properties. Cistus sp. are rich in flavonoids, particularly from the group of flavonols (quercetin, kaempferol, and myricetin) and flavan-3-ols (catechins, gallocatechins, proanthocyanidins). Extracts and active compounds isolated from C. incanus and C. ladanifer were shown to possess several properties valuable for skin protecting applications. C. ladanifer extracts showed antimicrobial activity against several Gram-positive and Gram-negative bacteria strains, pathogenic yeast, and fungi. Aqueous extracts from this plant possess also anti-inflammatory and anti-nociceptive activities in vivo. Several biological properties of Cistus extracts was correlated with the high content of polyphenolic compounds.
The cited reference does not disclose the extraction of Cistus plants with an extraction solvent containing propylene diol.
Viera et al. beneficially discloses glycerol and alkanediols are being studied as alternative solvents to extract phytochemicals from plant material, often as hydrogen bond donors in deep eutectic solvents (DESs). The reference discloses glycerol and a series of alkanediols (1,2-ethanediol, 1,2-propanediol, 1,3-propanediol,
1,3-butanediol, 1,2-pentanediol, 1,5-pentanediol, and 1,2-hexanediol) were studied for the extraction of phenolic compounds from Juglans regia L. leaves, a rich source of this class of bioactive compounds. The extraction yield was quantified, and the bioactivity of both extracts and pure solvents was evaluated by measuring the anti-inflammatory and cytotoxic activities. The solvents showing the best combined results were 1,2 and 1,3-propanediol, as their extracts presented a high amount of phenolic compounds, close to the results of ethanol, and similar cytotoxicity against cervical carcinoma cells, with no impact on non-tumor porcine liver cells in the studied concentration range. Further disclosed is that in the case of systems containing glycerol, higher total phenolic contents were obtained, using small amounts of glycerol in water, from Olea europaea leaves (9.3%, w/v) [28], Hypericum perforatum dried aerial parts (10%, w/v) [26], and Oryza sativa bran (20%, v/v) [30]. On the other hand, an increasing
concentration of glycerol (10–90%, w/v) leads to extracts of two Artemisia species with higher total phenolic content. Regarding the use of propylene glycol, in some cases, higher extraction yields were obtained than by using water and/or ethanol in a number of different botanical materials, such as extracts obtained from Stevia rebaudiana leaves, Terminalia chebula fruits, Malus sylvestris wild fruit, and Pandanus amaryllifolius leaves.
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the instant Application to employ beneficial polyphenols from Cistus sp. for skincare and cosmetics as taught by Gewel-Beben et al. and to extract them employing extraction solvent that includes alkane diols, to maximize extraction as taught by Viera et al.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton."). In KSR, the Supreme Court indicated that the obviousness analysis should consider the “background knowledge possessed by a person having ordinary skill in the art.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007). Under KSR, information deemed within PHOSITA’s general knowledge is more powerful than that found buried in a prior art reference because we assume that PHOSITA would consider using their general knowledge in combination with the prior art — even absent any express motivation to do so. Under 35 U.S.C. § 103, the obviousness inquiry turns not only on the prior art, but whether “the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious . . . to a person having ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C. § 103. Regardless of the tribunal, the inquiry into whether any “differences” between the invention and the prior art would have rendered the invention obvious to a skilled artisan necessarily depends on such artisan’s knowledge.
The claims essentially employ a known method of extraction of bioactive components from plant material and use it for the specific plant type of Cistus ladanifer, which is known to possess beneficial bioactives. The adjustment of particular conventional working conditions (e.g. determining optimal percentage of alkane diol in extraction solvent, duration of extraction, etc. as well as employing common separation techniques and commonly-employed adjuvants/excipients, etc.) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Accordingly, the instant claims, where no unexpected results are observed, would have been obvious to one of ordinary skill having the above cited references before him/her.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
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/RUSSELL G FIEBIG/Examiner, Art Unit 1655