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 .
Status of Claims
Receipt of Remarks/Amendments filed on 02/13/2026 is acknowledged. Claim 7 is amended. Claims 1-11 are currently pending and are examined on the merits herein.
Priority
The instant application filed 09/27/2023, is a 371 filing of PCT/FR2022/050559, filed 03/25/2022, which claims foreign priority to FR2103424, filed 04/02/2021.
Withdrawn Rejections
Claim 7 was rejected under 35 U.S.C. 112(b). Applicant’s amendment to claim 7 has overcome the rejection and the rejection is withdrawn.
Claims 1-11 were rejected under 35 U.S.C. 101. Upon further consideration and in view of Applicant’s arguments, the rejection is withdrawn.
The following rejections are maintained:
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 10-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for methods of non-therapeutic cosmetic care with white birch sap in combination with beech bud oily macerate or beech buds aqueous extract, does not reasonably provide enablement for providing non-therapeutic cosmetic care using any birch sap extract or any aqueous or oily beech bud extract. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized in In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation'" (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all of these factors are considered, a sufficient amount for a prima facie case are discussed below.
Applicants claim a composition with a combination of at least one birch sap extract and at least one extract chosen form an aqueous extract of beech bud and an oily extract of beech bud. Applicant has not demonstrated, and it is highly questionable that any other extracts of birch sap or beech bud besides the ones specifically disclosed as having a positive effect (Table 1) would provide for the method and intended use of the claimed invention. Furthermore, none of the claims specify the chemical identity of the extracts.
The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one species, what other species will work. (MPEP § 2164.04)
The state of the art is unpredictable with regard to plant extracts. It is well known in the art that polarity of solvents plays a key role in determining the final product obtained by an extraction. However, because many phytochemicals remain undiscovered, the skilled artisan has to make his best educated guess as to what types of phytochemicals will be successfully extracted with a solvent of a particular polarity. Often times, unless the constituents in a particular plant extract have been well evaluated and documented in the literature, the skilled artisan must adhere to trial and error protocols in order to quantitatively determine phytochemical constituents present in samples obtained from respective extraction procedures. These procedures are common when, for example, a plant or part thereof has been documented in the literature as possessing some medicinal quality. The skilled artisan will attempt numerous extraction protocols in attempt to isolate the particular ingredient which has this medicinal quality. Typically, beginning with the first crude extraction, it is a guess as to whether or not the extract will possess certain phytochemical constituents.
Applicant’s specification has disclosed the effects of the compounds beech bud oil macerate, beech bud aqueous extract, white birch sap and the combinations of “beech bud oil macerate + white birch sap” and “beech bud aqueous extract + white birch sap” (Ex. 1). However, instant claim 1 does not specify the species of birch tree nor the method of obtaining the active ingredient of the extract. Unless a crude extract has been elucidated for a particular active ingredient or group of ingredients, it cannot be ‘standardized’ by means known in the art. Therefore, the method for making the extract is deemed crucial to the medicinal efficacy of the extract because the method for making including the type of solvent used as well as part of the plant which was extracted is the only means of ensuring a reproducible product. The method for making the extract is a crucial aspect in that it defines the nature of the extract such as the concentration of the active component, wherein the active component is only defined by the extract itself.
Additionally, undue experimentation involved with elucidating an active ingredient of plant material is well established, as explained by H.B. MacPhillamy (1963):
When activity is found, it is then the chemist's task to isolate the chemical individual responsible for this particular effect. This is highly desirable for a number of reasons. The use of medicinal plants in their natural state, or as crude extracts, presents several difficulties. The actual content of the drug may vary with both the locality and the season in which the plant is gathered. As the active principles of many plants are powerful poisons when taken in excess, the dangers of prescribing drugs of uncertain origin are obvious. Equally, the patient may suffer if the drug is of lower activity than usual. Then too, the plant may contain variable amounts of other substances which have only harmful effects. These difficulties can, of course, be overcome by means of suitable biological control tests, but they have the disadvantage that they are rarely capable of high accuracy and are usually time-consuming and expensive. (see page 6) emphasis added.
While Applicant may argue that MacPhillamy was published long ago, and that more sophisticated means of isolating active ingredients from plants are presently used, it remains, to this day, an arduous task to isolate active ingredients of plants. Raskin et al. (2004) list the primary difficulties of natural drug discovery as:
1. Incompatibility of a high throughput format with complex botanical extracts.
2. Reproducibility
3. Price
4. Difficulty in isolating an active ingredient: “Today’s high throughput NCE discovery format requires that active ingredients are characterized rapidly and that the activities associated with previously characterized compounds are ignored. This is often difficult to achieve in the time frame of the screen. Since the extract’s activity may be the result of potentiating effects of several compounds, it may be lost or reduced during the isolation process”.
5. Long resupply time
6. Geopolitical reasons (see entire reference, especially pages 3419-3421).
Raskin et al. clearly establish the grave difficulty in elucidating active ingredients from plant sources:
Multi-component botanical therapeutics also present unique challenges in identifying their active ingredients and in validating their clinical effects. Activity-guided fractionation and reconstitution experiments currently used to characterize compound interferences within a mixture are cumbersome and time consuming…..While chromatographic analysis is often employed to produce biochemical fingerprints used for product comparison…..in the absence of information about the identity of active ingredients, such analysis is hardly reliable, since chromatography provides an incomplete picture of the qualitative and quantitative comparison of a complex extract (p. 3426, col. 2 – p. 3427, col. 1) emphasis added.
Due to the unpredictable nature of plant extracts, it is deemed that the skilled artisan would need to perform undue experimentation in order to ascertain what other extracts of birch sap and beech bud would provide for the method and intended use as instantly claimed. Unpredictability with regard to plant extracts due to their highly complex nature has been well documented in the art. Revilla et al. for example (1998) showed that the slightest variations in polarity of solvent and reaction time upon grape extraction provided respective products with unique characteristic properties (See Tables 1, 2, 4, 5, 6 and 7). In turn, each product would possess varying pharmacological properties based upon their respective methods of extraction.
It is the opinion of the Examiner, in light of the grave unpredictability in the art with regard to plant extracts, coupled with the unpredictability as set forth in the instant specification itself, that Applicant is not enabled for a method of non-therapeutic cosmetic care using any birch sap extract or aqueous or oily beech bud extract as claimed in instant claim 1 and its dependent claims. Each product obtained from an extraction is unpredictable in nature. Even the most skilled of artisans would need to quantify each product for constituents as well as medicinal efficacy. Considering this evidence, the skilled artisan, lacking guidance with regard to any specific solvents and active compounds within the extract which will provide for the intended cosmetic use and skin improvements of the claims, would necessarily need to perform tedious trial and error protocols without expectation of success in order to ascertain what other extracts would provide for the specific therapeutic uses as described in the specification.
Claims 1-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant claims a composition comprising a combination of at least one birch sap extract with at least one extract chosen from an aqueous extract or an oily extract of beech bud. However, Applicant has not disclosed in the instant disclosure the specific extraction methods used or chemical compounds isolated. As discussed above in the enablement rejection, the state of the art is unpredictable with regards to plant extracts and undue experimentation is involved with elucidating an active ingredient of a plant. As such, Applicant has not provided a description that explicitly conveys that the Applicant was in possession of all birch sap extracts and aqueous/oily extracts of beech bud, as claimed, nor how such extracts were obtained.
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.
1. Claims 1-2, 4-5, and 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Croda Inc. (2015), Body energizing and beautifying mist with HYDRONESIS® and BIRCH SAP PH, Development Formulation (on record), hereinafter Croda, in view of Nakayama, Y., et al. (WO 9831338 A1, 07/23/1998, IDS dated 09/27/2023, translation provided used), hereinafter Nakayama as evidenced by Gattefosse (2019), GATULINE RC BIO Technical Data Sheet (on record), hereinafter Gattefosse.
Croda discloses a body energizing and beautifying mist with HYDRONESIS® and BIRCH SAP PH TM (title). The mist is an aqueous alcoholic mist containing Hydronesis and Bitch Sap PH, a natural skin toning and moisturizing ingredient. The mist may be used at any time during the day and provides optimal hydration and revitalizes the skin, leaving it soft and silky. The clear gentle skin toner is sprayable thanks to Crovol™ A70 that also provides additional skin moisturization. Tween™ 20 used as a mildness additive helps counteract irritation. In addition, Phytessence™ Peach Flower provides detoxifying and protective properties. The enlivening body mist hydrates and softens the skin for a global beauty enhancement (p. 1, description). The formulation comprises Birch Sap PH (Betula Alba Juice (and) Glycerin) at 3.0 % w/w based on the weight of the composition (Table 1).
The teachings of Croda differ from the instantly claimed invention in that Croda does not teach that the cosmetic composition additionally comprises a beech bud extract.
Nakayama discloses compositions containing as the active ingredient an extract of buds, in particular, young buds of plants of the genus Fagus of the family Fagaceae (i.e., beech tree). These compositions promote the production of collagen which is one of the constituents of the extracellular matrix and thus activate the extracellular matrix and normalize the skin tissue on the basis of the above effect, thus exerting an excellent aging-resisting effect (abstract; [0016]). For the extraction, solvents usually used at the time of production of a cosmetic material such as water, ethanol, methanol, propanol, butanol, 1,3-butylene glycol are used alone or in mixtures thereof ([0011]). As an extract from a shoot of the tree belonging to the Fagus genus, GATULINE (trademarked) RC and GATULINE (trademarked) R may be mentioned ([0013]). GATULINE RC is an example of an aqueous extract of Beech tree buds as evidenced by Gattefosse. The amount blended is preferably 0.001 to 10.0% by weight, based upon the total amount of the collagen production promoter composition ([0015]).
It would have been obvious to combine the compositions of Croda and Nakayama before the effective filing date of the claimed invention by adding the beech bud extract of Nakayama to the composition of Croda to yield the instantly claimed invention. One of ordinary skill in the art would have been motivated to incorporate the beech bud extract of Nakayama, specifically GATULINE RC, into the composition of Croda since such a beech bud extract promotes collagen production thereby activating the extracellular matrix and normalizing the skin tissue for increased anti-aging effects. As recognized by someone of ordinary skill in the art, these properties would have been desirable in the cosmetic composition of Croda which is a cosmetic mist that is applied to the skin to hydrate and revitalize the skin. Furthermore, it is considered prima facie obvious to combine prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have had a reasonable expectation of success in adding the beech extract of Nakayama to the composition of Croda since both Nakayama and Croda teach cosmetic compositions applied to skin for its improvement.
Thus, the combined composition of Croda and Nakayama comprises at least one birch sap extract (i.e., Birch Sap PH as taught by Croda) and at least one extract chosen from an aqueous extract of beech bud (i.e., GATULINE RC as taught by Nakayama), and at least one cosmetically acceptable vehicle (i.e., a mist as taught by Croda), as recited in instant claim 1. As currently written, instant claim 1 only requires one of the beech bud extracts (i.e., aqueous or oily). As such, the oily extract of beech bud is being treated as optional in the rejection of claim 1. The combined composition of Croda and Nakayama further reads on claim 2. Birch Sap PH comprises Betula Alba Juice (and) Glycerin, as taught by Croda above, thereby reading on the glycerin extract of birch sap of claim 4. Croda teaches 3.0% w/w of Birch Sap PH which falls within the range of instant claim 7. Nakayama teaches incorporating 0.001 to 10.0% by weight of the beech bud extract. It would have been obvious when combining the compositions of Croda and Nakayama to incorporate the aqueous beech bud extract at such an amount since this is a known and effective amount of the extract to include in order to promote collagen production. Although 0.001 to 10.0% does not fall within the instantly claimed range of claim 5, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. The combined composition of Croda and Nakayama is in the form of a sprayable mist, as disclosed by Croda, thereby reading on the solution of claim 8 and the spray of claim 9.
Regarding the method of claims 10-11, Croda does not explicitly recite “applying” the mist to the skin, however, Croda discloses that the mist is used at any time during the day to provide hydration and revitalize the skin, and that the mist is sprayable. Thus, it would have been obvious to use the combined composition of Croda and Nakayama in a method of spraying the composition onto the skin, as reasonably suggested by Croda, since the combined composition of Croda and Nakayama is useful for improving skin condition and it is in the form of a sprayable mist. Regarding the improvement of hydration, nutrition, oxygenation and stimulation of the protective barrier function of the skin, these would be considered inherent properties of the combined composition of Croda and Nakayama. Since the composition made obvious by the prior art is identical to the composition of claim 1, the composition must necessarily have the characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Croda and Nakayama as applied to claims 1-2, 4-5, and 7-11 above, and further in view of Devilard, E., et al. (FR 3009195 A1, 02/06/2015, IDS dated 09/27/2023, translation provided used), hereinafter Devilard.
The combined teaching of Croda and Nakayama are discussed above.
The combined teaching of Croda and Nakayama differ from that of the instantly claimed invention in that Croda nor Nakayama explicitly teach that the cosmetic composition additionally comprises an oily extract of beech bud as defined in claims 3 and 6.
Devilard teaches a cosmetic composition comprising a pine bud extract and a raspberry bud extract and/or an extract of blackcurrant buds and/or an extract of beech buds (abstract). "The beech bud extract" may be a fat-soluble extract, a water-soluble extract or a mixture thereof ([0008]). The term "fat-soluble extract" means an extract rich in fatty acid and/or fat and/or a non-water-soluble extract, for example, an oily extract. It may be, for example, be an extract obtained by oily extraction by microwave, by supercritical extraction, by maceration in an oily solvent, by oily extraction assisted by ultra sounds or by distillation ([0003]). The beech bud extract may be present at a concentration of 0.1 to 3% in weight relative to the total weight of said composition ([0009]). Whatever the extract or mixtures of extracts used, the cosmetic or dermatological composition may further comprise at least one additional active agent chosen, for example from an anti-aging agent, a moisturizing agent, a soothing agent, an agent acting on microcirculation, a firming agent, a tightening agent or a mixture of these agents ([0010]). Furthermore, the cosmetic or dermatological composition can be in any form known to those skilled in the art in the fields of cosmetics and dermatology, examples include an ointment, a cream, an oil, a milk, an ointment, a powder, a stick, an impregnated buffer, a transdermal patch, a solution, a gel, a spray, a lotion or a suspension. It may be for example a cream, a milk, a gel, an ointment, a transdermal patch. The cosmetic composition may be, for example a composition for the care of the face, of the body, for example compositions for the face and/or the body ([0010]). Devilard also teaches a cosmetic treatment method comprising the application on the skin of a cosmetic composition comprising at least one pine bud extract, at least one raspberry bud extract, at least one extract of buds of blackcurrant and at least one extract of beech buds. According to the invention, the cosmetic treatment may be an anti-aging treatment, a firming treatment, a protective treatment ([0012]).
It would have been prima facie obvious to modify the combined composition of Croda and Nakayama with the teachings of Devilard, before the effective filing date of the claimed invention, by adding a fat-soluble extract of beech bud to the combined composition since fat-soluble extracts of beech bud are known and routine in the art. It would have been obvious to incorporate the fat-soluble extract of beech bud of Devilard into the combined composition of Croda and Nakayama since it entails no more than the combination of prior art elements according to known methods to yield predictable results. The combined composition of Croda and Nakayama already comprises an aqueous beech bud extract and Devilard teaches the incorporation of a fat-soluble beech bud extract, a water-soluble beech bud extract or a mixture thereof. Additionally, Devilard teaches that its composition which comprises the fat-soluble and/or water-soluble beech bud extracts may be incorporated into cosmetic or dermatological compositions such as sprays for treating the skin thereby giving one of ordinary skill in the art a reasonable expectation of success. It would have been further obvious to incorporate the fat-soluble beech bud extract of Devilard into the combined composition at an amount of 0.1 to 3% by weight since this is a known and effective amount at which to incorporate the extract as taught by Devilard. While 0.1 to 3% does not fall exactly within the range of claim 6, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
Response to Arguments
Applicant's arguments filed 02/13/2026 have been fully considered but they are not persuasive:
(1) Applicant argues that the instantly claimed combination of “beech bud oil macerate + white birch sap” and/or “beech bud aqueous extract + white birch sap” produces synergistic effects exceeding the additive effects of the individual components. Applicant points to pages 14-17, Tables 7-9 of the instant specification, concluding that the demonstrated synergy represents “significant and unexpected results” (p. 5-6 of Remarks).
In response to Applicant’s assertion of unexpected results, Examiner has carefully reviewed the evidence presented on pages 14-17 of the instant specification. The relevant tables for observing each extracts’ individual gene control versus their combined control are tables 7-8. As alleged on page 17 of the specification, the combination of white birch sap + beech bud oily macerate induced an increase in gene expression for KRT19, FLG, and HMOX1 genes. The combination of white birch sap + aqueous beech bud extract induced an increase in gene expression for KRT19, KLK7, FLG, HMOX1, and TGM1 genes. Based on Examiners calculations for these genes, the additive effects of the individual extracts as compared to the actual effects of a combined composition are as follows:
Beech bud oily macerate + White birch sap
Genes
Additive effect (% control)
Actual effect of combined composition (% control)
Increase in % control (Actual – Additive)
KRT19
259
354
+95
FLG
210
213
+3
HMOX1
264
281
+17
Beach bud aqueous extract + White birch sap
Genes
Additive effect (% control)
Actual effect of combined composition (% control)
Increase in % control (Actual – Additive)
KRT19
276
301
+25
KLK7
239
212
-27
FLG
238
311
+73
HMOX1
263
273
+10
TGM1
212
229
+17
MPEP 716.02 discusses the requirements for establishing unexpected results. First, the evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). It is noted that “% control” is provided as an HK average, with no discussion of standard deviation or p-value. Based on the results of Tables 7-8, the Examiner has no way of determining if the actual effect of the combined composition constitutes significantly more than the expected additive effect. Additionally, there appears to be no consistency or trend among the data. For instance, KLK7 gene control in the “Beach bud aqueous extract + White birch sap” example actually shows a decrease from the additive effect. The increase from additive to actual effect in several of the examples is only between a 3 and 30% increase, which does not appear to be outwardly significant.
Secondly, the unexpected results must be commensurate in scope with the claimed invention. See MPEP 716.02(d). The data of Tables 7-8 define combined compositions containing 0.1% beech bud oil macerate and 1% white birch sap or 0.3% beech bud aqueous extract and 1% white birch sap. Instant claim 1 is drawn to a composition comprising any amount of the extracts at any ratio. The data provided in the instant specification provides results for very specific concentrations of each extract at very specific ratios, which cannot be considered representative of every amount or ratio of the instantly claimed extracts. Thus, the data is not commensurate with the full scope of claim 1. Additionally, instant claim 1 encompasses and claim 3 further defines a composition comprising a birch sap extract with both an aqueous and an oily beech bud extract. No example in the instant specification provides data for such a tertiary mixture. Lastly, while claims 5-7 define weight percents for each extract, relative to the total weight of the composition, the claimed ranges encompass a broader scope than evidence is provided for. Would such results be observed if the ratio was altered while keeping the amounts within the instantly claimed ranges? As such, the data provided in the instant specification is not enough to demonstrate unexpected synergy across the entire scope of the instant claims, and the prima facie case is not overcome.
(2) Applicant further argues that the Examiners motivation to combine the claimed extracts rests solely on the general proposition that one might add anti-aging ingredients together, which improperly relies on hindsight reconstruction using Applicant’s disclosure (p. 7 of Remarks).
In response to Applicant's argument that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). It was known prior to the effective filing date of the claimed invention that all of the instantly claimed extracts had beneficial skin care properties and were known and routine skincare ingredients. The fact that the above rejections rely on combining anti-aging ingredients is not evidence of hindsight, but a distinct rationale to combine. Specifically, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…[T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Additionally, the ability of beech bud extract to promote collagen production, as taught by Nakayama, is a distinct teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference, a skin revitalizing mist, to arrive at the claimed invention. See MPEP 2143.
(3) Applicant argues that the cosmetic art is notoriously unpredictable, particularly with botanical extracts. Applicant asserts that the Office acknowledges this unpredictability and that such unpredictability “undermines any assertion that combining these specific extracts would produce predictable results” (p. 7 of Remarks).
It is noted that the unpredictability acknowledged by the Examiner were in reference to obtaining the extracts of the instant invention, particularly as it relates to extraction methods and characterizing active compounds. Given that the prior art teaches well defined and routine extracts used in the cosmetic art, the act of combining said extracts would not be unpredictable as asserted by the Applicant.
(4) Applicant argues that the claimed ranges of claims 5-7 represent critical ranges producing optimal synergy which the overlapping ranges of the prior art fail to account for (p. 7 of Remarks).
As discussed in relation to the synergy data above, the data provided in the instant specification provides results for very specific concentrations of each extract at very specific ratios, which cannot be considered representative of every amount or ratio of the instantly claimed compositions. While claims 5-7 define weight percents for each extract, relative to the total weight of the composition, the claimed ranges encompass a broader scope than evidence is provided for. Would such results be observed if the ratio was altered while keeping the amounts within the instantly claimed ranges? As such, the data provided in the instant specification is not enough to demonstrate unexpected synergy across the entire scope of the instant claims, and the prima facie case is not overcome.
(5) Applicant argues that the determination of the active ingredients is not necessary based on the language of the claims, and that the specification provides detailed experimental results demonstrating that the claimed composition produces measurable effects on human epidermal keratinocytes. Applicant asserts that the specification need not enable every conceivable variation, only provide sufficient guidance for an artisan of ordinary skill to practice the invention without undue experimentation. The working examples provide clear direction on extraction methods, solvent systems, and measurable outcomes, according to the Applicant (p. 13 of Remarks).
Examiner respectfully disagrees, specifically in the fact that the specification provides clear direction on extraction methods. The specification provides no clear guidance on extraction methods nor any quantification of the active components in the so called “aqueous” and “oily” extracts. As such, a person of ordinary skill in the art would have no way of reproducibly generating extracts with the same effects on human keratinocytes as instantly disclosed. One would have to perform trial and error extraction and gene expression testing in order to isolate extracts suitable for the intended use and outcome of the instantly claimed method. Such a process would result in undue experimentation as set out in the rejection above.
(6) Applicant argues that the only requirement to meet the written description requirement is that the inventors had possession of the “claimed” invention, not elements which are not recited in the claims (p. 14 of Remarks).
Examiner agrees in part with the Applicant’s above statement, however, as discussed in the enablement rejection, there exist various extracts depending on the various factors laid out (i.e., extraction method, plant part, etc.). Thus, the fact that the claims do not recite such elements is the very reason that the claims do not possess adequate written description. Examiner cannot assume that Applicant was in possession of every birch sap extract and every aqueous and oily beech bud extract, since the art of botanical extracts is vast.
Conclusion
No claims allowed.
THIS ACTION IS MADE FINAL. 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 SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 7:30-5 (Flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616
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