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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/02/2026 has been entered.
Response to Amendment
Applicant's amendment and argument filed 06/02/2026 in response to the
final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1, 3, 6-7, 9-13, and 20 are pending of which claims 11-13 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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, 3, 6-7, 9-10 and 20 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 therefore, subject to the conditions and requirements of this title.
This rejection is maintained due to the amendments filed on 06/02/2026. Claims 1, 3, 6-7, 9-10 and 20 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 06/02/2026 have been fully considered but they are not persuasive. The applicant argues that the naturally occurring counterpart which is supposed to be analyzed is the whole plant material in its unprocessed state. This is not what is the closest naturally counterpart to what the applicant is claiming because the applicant does not claim a whole plant material. The applicant claims a hydroalcoholic extract of aerial parts of a plant and it is those extracted compounds which are the closest naturally existing counterparts. Those compounds being the six molecules claimed in claim 1 and any other molecule extracted from the living plant. Comparing an aqueous extract of the plant to a 50% ethanol extract does not compare those judicial exceptions to their natural counterparts. It compares two different solutions which are able to extract out varying components from the plant. The applicant claims that the specific activity is not inherent to the plant species and rather uniquely conferred by the 50:50 hydroalcoholic extraction process. This extraction process does not give the molecules extracted from the plant any specific activity as the applicant has argued. The applicant then argues that the six molecules extracted and claimed are distinct from their natural state and cannot be obtained by any other extraction process. The applicant makes this statement without showing that these molecules are indeed distinct from their natural counterparts and that there is no other way to extract them. Determining a solvent to extract a molecule from a plant does not make the molecule distinct from how it is found in the plant. The applicant argues that the six active molecules, taken individually, have an effect that is opposite to that of the overall extract on the CNFN, FLG2, LCE3D and SPRR1A markers and points to table 3 at page 16 of the instant specifications. The data shows indeed that there is an increase of mRNA transcripts for CNFN, LCE3D and SPRR1A when a 0.1 mg/mL of the hydroalcoholic extract is used on human epidermal keratinocytes as compared to any of the six molecules oenothein B, quercetin, ellagic acid, hyperoside, isoquercitrin and luteoline-7-0-glucuronide alone do, however it is not known that these six molecules are indeed the molecules of the extract which confer the noted increase in activity. The extract indeed would be expected to comprise of many other compounds and molecules which may exert the activity on increasing the mRNA expression of the CNFN, LCE3D and SPRR1A genes. It is unclear why the applicant has decided that the best test of comparison is to these six molecules or why they have determined that these six are critical to the extract or even how they determined that these are part of the hydroalcoholic extract. The applicant seems to have arbitrarily assigned these six molecules an expected activity and then compared them to an extract which is expected to comprise of many other components and tested if they can increase mRNA expression of specific genes. The six molecules appear to have a modest influence on these 4 gene transcripts. The hydroalcoholic extract appears to have a much greater influence on those same genes because the extract comprises of many other molecules that are not disclosed. If it is the applicant’s intent to determine synergy of these six molecules then a proper test would be testing their combined activity and not a comparison to a whole extract as what was done in the instant application. Again, this would be like comparing two different extracts for the same activity which are known to comprise different (and different amounts) of molecules.
The applicant argues that the aqueous extract of the same plant does not convey the same activity (mRNA increase of the CNFN, LCE3D and SPRR1A genes). This is not a proper comparison because the 101 analyses does not compare one extract solution to another.
The applicant argues that the claimed mixture or components do not exist in nature. Then where does the applicant think that those components came from? The claimed components indeed exist together in nature as they were extracted from a single source. Human intervention needing to extract those components from the plant is not a persuasive argument for reciting that they do not naturally occur.
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 rejection is maintained with slight modifications due to the amendments filed on 06/02/2026.
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 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 to 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 same 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 06/02/2026 have been fully considered but they are not persuasive. The applicant argues that the Schwaller teaches away from the present invention because Schwaller teaches an alcoholic extract is not used because the alcoholic extract does not contain the active fraction and describes wherein the use of water/alcohol mixtures can be used to precipitate the active compounds from previously obtained aqueous extract. The applicant argues that precipitation is a form of purification step after an extraction has been done and that is distinctly different than an extraction step by maceration. A person having ordinary skill in the art (PHOSITA) would not merely copy the invention taught by Schwaller but would appreciate that the active components in the extract are the polar substances which protect the skin barrier. A PHOSITA would not be taught away from using a hydroalcoholic extract given the prior art. A PHOSITA would use combinations of polar solvents to determine which has the greatest activity much like the instant applicant has done and which is common practice and conventional to the art. As Schwaller explains one cannot use an alcoholic extract presumably an absolute alcoholic extract or else the active components precipitate out of solution. Schwaller explains the solvent used for maceration is thus water or an organic solvent with a close polarity to water. Here Schwaller is teaching to use other solvents with close polarities to water. A hydroalcoholic extract is such a solvent! This is common knowledge to a PHOSITA and one which would be obvious. Schwaller then describes that 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. Thus, one would not want to use absolute alcohol in the maceration/extraction step because the active ingredients would precipitate out of solution. One would be guided to use solvents that have similar polarities to water such as alcohols that are diluted in water. This would help to extract out the more water-soluble components. Determining to use a different solvent which has similar properties as the original solvent being used and expecting the properties to remain the same or be slightly changed is prima facie obvious, especially given the art and the knowledge of a PHOSITA. Schwaller teaches using solvents which have similar polarities as water. Even if Schwaller teaches away from using an absolute alcoholic solvent during maceration because the active components may precipitate out of solution, Schwaller still teaches that water is not the only solvent which can be used, thus PHOSITA’s would be encouraged to use solvents with similar polarities, of which 50% ethanol 50%/50% water is extremely close in polarity. There would not have been much experimentation needed to determine this as Schwaller already teaches in using alternatives which have similar polarities. Schwaller’s invention is directed at an aqueous extract of aerial parts of the evening primrose which pulls out active components known for strengthening the barrier of skin. Schwaller teaches using other solvents with similar polarities as water. Ethanol indeed has a similar polarity as water and diluting it with 50% water brings the polarity even closer to that of water. This is what the instant invention is too without any changes made thus the invention is prima facie obvious.
The applicant argues that maceration and precipitation are different processes, however the instant application and examination it directed to an extract and not a process of extraction. The applicant argues that Schwaller’s invention is directed to active components that are extracted out with aqueous solvents. This is what the applicant is using. Half of the solvent is made of water, thus constituting a partial aqueous component able to extract out similar polar compounds in the solution. Using water in the solvent for extraction is what is taught and optimizing it with 50% ethanol would have been obvious given Schwaller’s teachings.
Conclusion
No claims are allowed.
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JACOB A BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655
