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 .
Response to Amendment
Applicant's amendment and argument filed 09/19/2025 in response to the non-
final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-23 are pending of which claims 11-13 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/28/2024.
Claims 1-10 and 14-23 are being examined on the merits.
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.
This rejection is maintained with slight modifications due to the amendments filed on 03/04/2025. Claims 1-10 and 14-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claims recite a hydro-alcoholic plant extract from above ground parts of Oenothera biennis. The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since the claim is directed to a composition comprising plant components the claim is a composition of matter. Step 2A prong one of the analyses evaluates whether the claim is a judicial exception (see MPEP 2106.04). Because the claim states the nature-based products, recite a hydro-alcoholic plant extract from above ground parts of Oenothera biennis, the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart.
The claim recites the naturally occurring components found within plants. Plant extracts are made by partitioning the starting plant material into separate compositions based upon some property such as solubility in a solvent, with the soluble compounds being in one composition and the insoluble being in another composition, which compositions are then generally separated into the solvent extract of that plant versus the insoluble material composition that is generally discarded. Each composition has a different subset of the compounds originally present in the plant material. Plant extracts are purified by removing unwanted plant material from the remaining solvents. The closest naturally occurring counterparts of extracts are the same compounds found within the extract that are found in the plant in an unseparated form, even when purified, which is chemically identical to the extracted compounds. All of these are naturally occurring in nature and are not markedly different from its naturally occurring counterpart in its natural state. The properties of the nature-based product as claimed are not markedly different than the properties of these naturally occurring counterparts found in nature as these activities would inherently be found within the plants they come from. The components which would give the activities claimed in the instant invention would inherently do the same in nature as there has been nothing done in the instant invention that would make them act in any different way.
Step 2A prong two evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a) identifying whether there are any additional recited elements in the claim beyond the judicial exception and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. This judicial exception is not integrated into a practical application because the only other limitations of the claims are directed to how the extract itself is obtained.
The claims do not integrate the judicial exceptions into a practical application because in this context, such integration for a claimed product would be a physical form of the specific practical application instead of a more general composition that is not so limited.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these components and their activity are already found naturally occurring in nature and the addition of an intended use (from the specifications) does not impart any added benefit to the compounds or integrate the composition into a practical application.
Step 2 B evaluates whether the claim as a whole, amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP § 2106.05(b)). The only other limitations to consider are the solvents used in extracting out those judicial exceptions or to the specific judicial exceptions that should be found in the extract. None of those limitations amount to significantly more than the judicial exceptions being claimed.
Please also note, the mere modifying the concentration and proportions of the product/composition is not sufficient to remove the claimed composition from a judicial exception.
Response to Arguments
Applicant's arguments filed 09/19/2025 have been fully considered but they are not persuasive. The applicant argues that the hydro-alcoholic extract comprises of at least two molecules selected from among oenothein B, quercetin, ellagic acid, hyperoside, isoquercitrin and luteoline-7-0-glucuronide. The applicant argues that none of these molecules are found existing together. This however is not true. These molecules are found together existing in the species of Oenothera biennis plant. The applicant is simply making an argument to the solvent being used to extract those molecules out from the plant. The applicant argues that there are no existing extracts of Oenothera biennis plant. The components extracted from the plant are those judicial exceptions and are what is being claimed without anything being done to them. It is not the entirety of the extract itself but the components that exist within the extract, because the extract is made up of the judicial exceptions. The applicant argues that the hydroalcoholic extract has different properties from two different aqueous extracts which should show that there is some markedly different characteristics. This is not a proper testing of markedly different characteristics from the judicial exceptions. An aqueous extract would comprise of different components or amounts of those components when compared to a hydroalcoholic extract and thus would be expected to have different or different strength properties.
The applicant argues that a sweetener comprised of extracts from a mushroom and Texas mint is considered eligible because the components are not found existing together in nature. This is quite different than what the applicant is claiming. The sweetener also is shown to have enhanced organoleptic properties. This is not comparable to the applicant’s invention because there is no showing of different properties from the “naturally existing counterparts” which are the molecules and components of the extract being claimed. The applicant is not comparing the molecules to their counterparts. They are comparing many molecules comprised together to other many molecules which may be different from the claimed ones. This comparison is improper.
The applicant argues that human intervention was required to obtain the products. This argument does not mean that what the applicant is claiming is still just the judicial exceptions. Any extract requires human intervention to assist with removing the judicial exceptions and collecting them. This does not mean that a human created those judicial exceptions.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-10 and 14-23 are rejected under 35 U.S.C. 103 as being unpatentable over Schwaller (from IDS, WO2009010587A1) and Magdalena Timoszuk (Evening Primrose (Oenothera biennis) Biological Activity Dependent on Chemical Composition, Antioxidants, 7(8), 108, 14-Aug-2018). This is a new rejection maintained with slight modifications due to the amendments filed on 09/19/2025.
Schwaller teaches extracts of aerial parts of the Willowweed and / or Evening Primrose for the preparation of a composition intended to restore the barrier function of keratinized tissues such as skin, hair, and nails, or mucous membranes, or to prevent and / or treat alterations in the barrier function of said keratinized tissues or said mucous membranes (see claim 1).
Regarding claims 1-4, 7 and 14-17, Schwaller teaches wherein “Advantageously according to the present invention, the active fraction of the extract according to the present invention is selectively precipitated in water / alcohol mixtures (such as ethanol), so as to obtain an extract rich in active fraction.
By the term "active fraction of the extract" is meant in the sense of the present invention the fraction of the aqueous extract which is insoluble when said aqueous extract is precipitated in 70 to 99% of alcohol (such as ethanol). Said aqueous extract is prepared beforehand by macerating the aerial parts of Epilobe and / or Evening primrose, advantageously milled, in hot water, typically at a temperature below 80 ° C., of the order of 50 to 70 ° C.” (see 8, para. 9-10). In this context it would be the same as a hydro-alcoholic extract of above-ground parts of Oenothera biennis and extracting the above-ground parts in a mixture of water and at least one alcohol, because with the broadest reasonable interpretation a 70% alcohol (such as ethanol) solution contains 30% water and this is a mixture of water and alcohol, which would be within the instantly claimed amounts for water and alcohol percentages.
Additionally, Schwaller teaches “grinding the aerial parts of the willowberry or evening primrose maceration of the ground aerated parts in at least one polar solvent such as water” (see claim 11).
Furthermore, Schwaller already teaches specifically “that extracts of aerial parts of plants from the family of onagraceae showed an intense and immediate action of restoration of the barrier functions of the skin and had a positive action for pharmaceutical applications, dermatological, cosmetic, or food. The two main plants which are the subject of the invention are the pilchard (Epilobium angustifolium) and the evening primrose (Onagra biennis), and more particularly the aqueous extracts, obtained by maceration of the aboveground parts of these crushed plants in hot water or other solvents of similar polarity, followed by filtration” (see page 7, para. 4).
Schwaller teaches filtering (see page 10, example 1) and partly or total evaporation of the solvent (see claim 3).
Regarding claim 3, Schwaller teaches “for the purposes of the present invention, the term "aerial parts" is intended to mean those parts of plants that grow out of the ground, with the exception of seeds. These include, in particular, leaves, fruits, flowers, petals, twigs, stems, and mixtures thereof” (see page 3, para. 3).
Regarding claim 8, pertaining to wherein the extract comprises of the instantly claimed components; the extracts of taught by Schwaller are extracted in the same manner as being claimed and would thus inherently contain the same active components listed unless shown some evidence to the contrary.
Regarding claim 9, Schwaller teaches the extract as a dry extract (see page8, para. 6).
Regarding claim 10, Schwaller teaches “advantageously according to the present invention, the composition is a pharmaceutical, dermatological, cosmetic, nutraceutical or food composition, and may comprise any suitable vehicle or excipient, which is acceptable from the pharmaceutical, dermatological, cosmetic or nutraceutical point of view, as well as conventional additives, known to those skilled in the art” (see page 3, para. 6).
Regarding claims 5-6 and 18-20, pertaining to the limitations wherein the mixture of water and at least one alcohol is comprising 50 volume % of water and 50 volume % alcohol relative to the volume of the mixture, wherein the extract is obtained from above-ground parts previously ground and extracted with a hydro-alcoholic mixture would have been obvious to persons skilled in the art before the effective filing date because the water and alcohol percentages are right outside the prior arts teaching amounts and extracting components from the same already extracted components is prima facie obvious given the prior art. The art teaches the same extraction and techniques of the same species and for the same purpose (skin barrier function). It would be expected that not every active component would have been extracted out through the first run, thus extracting the previously ground and extracted aerial parts would allow for additional active components to be extracted.
Even though Schwaller states “An alcoholic extract according to the present invention is not used because the alcoholic extracts of the aerial parts of the Willow heron or Evening primrose do not contain the active fraction of the plants which makes it possible to obtain an action on the barrier function of the plants keratinized tissues” (see page 8, para. 5), Schwaller teaches the use of a hydro-alcoholic extracts (polar) of the aerial parts of primrose and thus it would be appreciated that Schwaller must mean an absolute alcohol extract when referring to “an alcohol extract”, since Schwaller specifically states “Advantageously according to the present invention, the active fraction of the extract according to the present invention is selectively precipitated in water / alcohol mixtures (such as ethanol), so as to obtain an extract rich in active fraction” (see page 8).
Regarding claims 21-23, pertaining to the specific amount of water and alcohol being used and wherein the alcohol is ethanol as part of the extracting solvent, Schwaller teaches that the active components would precipitate out of solution if an alcoholic extract is used (see p. 8, para. 5), and teaches the extracting solvent to be used is water or an organic solvent of polarity close to water (see p. 8, para. 6).
Schwaller does not specifically teach the compounds oenothein B, quercetin, ellagic acid, hyperoside, isoquercitrin and luteoline-7-0-glucuronide are contained in the extract.
Timoszuk teaches that both ellagic acid and oenothein are phenolic acids found within the aerial parts of alcoholic extracts of Oenothera biennis (see page 4, Chemical composition of Evening Primrose.
It would have been obvious to persons skilled in the art and before the filing date to use a hydro-alcoholic extract as suggested by Schwaller, because Schwaller teaches “advantageously according to the present invention, the active fraction of the extract according to the present invention is selectively precipitated in water / alcohol mixtures (such as ethanol), so as to obtain an extract rich in active fraction”. It can be appreciated that the active components would be precipitated out if an absolute alcohol solvent was used. It can also be appreciated that the active components are polar substances that can be extracted out with water and/or an organic solvent having a similar polarity as water (such as ethanol). Furthermore, if the active components are precipitated out from an aqueous extract with the use of ethanol and water mixtures, it shows that the active components would have the same polarity as an ethanol/water mixture. Thus, optimizing the solvents alcohol percentage to be that of the instantly claimed would have been prima facie obvious, because it would be appreciated from Schwaller’s disclosure that use of an absolute alcoholic extract would allow the active components to precipitate out of solution. Water and solvents having similar polarities to water also extract out those components. Ethanol has a similar polarity as water and depending on how high the proof (percentage) is, it would share an even more similar polarity. If the active components are polar, which they indeed appear to be, and ethanol is useful in precipitating those components from solution, then using a non-absolute ethanol extract which has water would be expected to extract out the active ingredients. The active components being claimed are known to be extracts of polar solutions of the aerial parts of the plant and would be found in the prior arts teaching as described by Timoszuk.
There would have been a reasonable expectation of success in arriving at the instant invention given the prior art because the prior art teaches the active ingredients which are known for the same purpose (to restore skin barrier function) are indeed polar compounds and Schwaller teaches using solvents with similar polarities as water. Ethanol, methanol and water mixtures are known to precipitate out the active components which means those components have polarities similar to ethanol/water and using this as a solvent is prima facie obvious given the prior art.
Response to Arguments
Applicant's arguments filed 09/19/2025 have been fully considered but they are not persuasive. The applicant argues that as pointed out in their prior response that Schwaller’s teachings of using alcohol/water solution to precipitate the active components cannot be used to motivate someone to use an alcohol/water solution to macerate the active components because maceration and precipitation have conflicting or contradictory objectives. The applicant argues that persons having skill in the art would know that components used for precipitation would not be selected for maceration. This argument is made without any evidence that this would indeed lead to difference in extraction. The term for maceration literally means: (especially with reference to food) soften or become softened by soaking in a liquid (see Oxford Languages). It is a commonly known term and one which may or may not be used during extraction because it is so general in describing any specific technique that merely describes soaking a plant in the extraction solvent. To further show that these claimed components are extracted out with polar solvents as claimed, the Office also included art from Timoszuk who teaches that both ellagic acid and oenothein are phenolic acids found within the aerial parts of alcoholic extracts of Oenothera biennis. Furthermore, Schwaller already teaches specifically “that extracts of aerial parts of plants from the family of onagraceae showed an intense and immediate action of restoration of the barrier functions of the skin and had a positive action for pharmaceutical applications, dermatological, cosmetic, or food. The two main plants which are the subject of the invention are the pilchard (Epilobium angustifolium) and the evening primrose (Onagra biennis), and more particularly the aqueous extracts, obtained by maceration of the aboveground parts of these crushed plants in hot water or other solvents of similar polarity, followed by filtration” (see above).
The applicant fails to appreciate the direct teachings of Schwalller and the knowledge of those skilled in the art. The applicant recites that the molecules limited to Schwaller’s teachings are only to aqueous extracts however as just pointed out this is not the case. Solvents such as methanol and/or ethanol (which is known to be safer than methanol) are known to have similar polarities as water and will extract out similar compounds. The applicant argues that solutions during extraction are not recognized as an effect with different variability. This is not the cases as can just be appreciated from the statement made by Schwaller. Schwaller recognizes that the active compounds may be extracted to a different distinction by the selection of solutions which have similar polarities. Additionally, it is common and conventional practice to optimize solvents during extraction. This is routine practice in the art.
The art already teaches that the Oenothera biennis aerial parts extracted with similarly polar extracts have the same hydrating skin and barrier function protecting effects. The applicant’s invention would have been obvious given the prior art. Schwaller makes obvious the invention because Schwaller teaches that the active components can be extracted via maceration and with water and similarly polar solvents. Timoszuk teaches that both ellagic acid and oenothein are phenolic acids found within the aerial parts of alcoholic extracts of Oenothera biennis and this shows that indeed these components being claimed are polar and can be similarly extracted with other polar solvents.
Conclusion
Currently no claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655