DETAILED ACTION
This office action is in response to applicant’s filing dated December 2, 2025.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Claims 1-5, 7, 8, and 10-24 are pending in the instant application. Acknowledgement is made of Applicant's remarks and amendments filed December 2, 2025. Acknowledgement is made of Applicant’s addition of new claims 23 and 24. Claims 6 and 9 were previously canceled.
Applicants elected without traverse 1,3-propanediol as the elected species and a formulation species with no other additional species required and a non-therapeutic cosmetic treatment process for caring for keratin material as the process species in the reply filed on February 18, 2021. The requirement is still deemed proper. Claim 14 remains withdrawn.
New claims 23 and 24 are related to the elected invention. Thus, new claims 23 and 24 are presently under examination.
Claims 1-5, 7, 8, 10-13, and 15-24 are presently under examination as they relate to the elected species (i) 1,3-propanediol and a non-therapeutic cosmetic treatment process for caring for keratin material.
Priority
The present application is divisional application of US Application No. 14/00,520 filed November 5, 2013, which is a national stage entry of PCT/EP12/55657 filed on March 29, 2012 which claims benefit of US Provisional Application No. 61/499,708 filed on June 22, 2011. The present application also claims benefit of foreign priority to France 1152787 filed on April 1, 2011. The effective filing date of the instant application is June 22, 2011.
Objections and/or Rejections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Objections and/or Rejections) or newly applied (New Objections and/or Rejections, Necessitated by Amendment or New Objections and/or Rejections not Necessitated by Amendment. They constitute the complete set presently being applied to the instant application.
Withdrawn Objections and/or Rejections
Double Patenting
The terminal disclaimer filed on December 2, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,458,077 B2 has been reviewed and is accepted. The terminal disclaimer has been recorded. Therefore, the rejection of claims 1-5,8,10-13 and 15-22 on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8, 10-14, and 21 of U.S. Patent No. 11,458,077 B2 has been withdrawn.
Modified Objections and/or Rejections
Modifications Necessitated by Claim Amendment
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 1-5, 7-13, and 15-24 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.
Claims 1-5, 7, 8, 10-13, and 15-24 are directed to a non-therapeutic cosmetic treatment process for caring for, making up, and/or cleansing keratin materials. It is unclear what processes are encompassed by the instant claims. In particular, it is unclear what is excluded by the instant claims. In a review of the specification, a disclosure of a definition non-therapeutic cosmetic treatment or what is encompassed by said treatment was not identified. The Examiner notes that Applicant argues that the claim recitation concerning of "non-therapeutic" excludes the presence of components and/or their relative amounts that would result in the process being a therapeutic treatment. However, in a review of the specification, disclosure of what components were excluded by the limitation “non-therapeutic” was not identified. Thus, the metes and bounds of the instant claims are not clear.
Response to Arguments
Applicant argues:
This rejection is not tenable since persons of ordinary skill in the art would readily appreciate the difference between non-therapeutic cosmetic treatment processes and non- therapeutic cosmetic compositions and therapeutic cosmetic treatment processes and therapeutic cosmetic compositions. Persons of ordinary skill in the cosmetic art are keenly aware of the fact that non- therapeutic cosmetic treatment processes and non-therapeutic cosmetic compositions significantly differ from therapeutic cosmetic treatment processes and therapeutic cosmetic compositions.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
As set forth above, it is unclear what processes are encompassed by the instant claims. In particular, it is unclear what is excluded by the instant claims. In a review of the specification, disclosure of what components were excluded by the limitation “non-therapeutic” was not identified. Thus, the metes and bounds of the instant claims are not clear.
Modified Objections and/or Rejections
Modifications Necessitated by Claim Amendment
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-5, 7, 8, 10, 13, and 15-21, 23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Weidner (US 2002/0051800 A1, cited in the IDS filed May 14, 2020) in view of Berlin et al (J Gen Chem of USSR, 1949; 19:1-10, cited in the IDS filed May 14, 2020) and Sakuta (US 7,713,520 B2).
While the examination has not been expanded beyond the elected species: 1,3-propanediol (as the organic solvent species), the following rejection is made to further prosecution with regards to the claims which read on the elected species with regard to the broader genus of "organic solvents with solubility parameters in the Hansen solubility space such that 14.5< δa<30 and 15< δd<22."
The Examiner notes that with regard to the transitional phrase "consisting essentially of", the phrase "consisting essentially of" has been construed as equivalent to "comprising". The transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (emphasis in original). For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355. See MPEP 2111.03.
In the instant case, Applicant has not demonstrated that the addition of other components such as adjuvants common in cosmetics or dermatology would materially change the characteristics of the instant invention. The specification teaches the compositions according to the invention may also contain adjuvants that are common in cosmetics or dermatology, such as gelling agents, film-forming polymers, preserving agents, fragrances, UV-screening agents, bactericides, odour absorbers, dyestuffs, plant extracts, cosmetic and dermatological active agents (page 7, lines 26-32). In view of the instant disclosure, it is unclear how the inclusion of other adjuvants common in cosmetics or dermatology would materially change the characteristics of applicant's invention.
Regarding claims 1-3, 8, 10, and 13, Weidner teaches a cosmetic use of a mixture comprising zingiber officinale components and a cosmetically acceptable vehicle (claim 19); and a cosmetic composition comprising zingerone and a cosmetically acceptable vehicle (claims 1 and 2). Weidner teaches vehicles include propane-1,2-diol and propylene glycol [104-106]. Propylene glycol reads on an organic solvent with solubility parameters in the Hansen solubility space such that 14.5 < δa < 30 and 15 < δd < 22 as evidenced by instant claim 2, which depends from and thus further limits claim 1, and lists 1,2-propylene glycol as an organic solvent. Weidner teaches the cosmetic composition may be administered as a cream [0113]. Weidner does not teach a composition comprising the claimed compound or that the composition is formulated as a facial care cream.
Berlin teaches derivatives of zingerone (title); and teaches 4-hydroxy-3-ethoxyphenyl ethyl methyl ketone (I) is a homologue of zingerone (page 1, 2nd and 3rd paragraphs):
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The structure for Zingerone is
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, while this is not identical to the claimed compound
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, it is noted that these compounds are homologs of each other and the only difference is a CH2 group. Therefore, while the compounds are not identical, they are sufficiently close in structure that one of skill in the art would expect such compounds to possess similar properties, thus it would be obvious to make and use the claimed compounds in a cosmetic composition with a reasonable expectation of success, absent factual evidence to the contrary.
MPEP 2144.09: A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. “An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.” In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1991) as is stated in MPEP 2144.09.
Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious).
The motivation to make a composition with the instantly claimed compounds derives from the expectation that structurally similar compounds such as positional isomers would possess similar activity (i.e. they would be useful in a cosmetic use). There would be a reasonable expectation of success in producing and using the instantly claimed compounds and compositions in view of the compounds and compositions taught by Weidner and Berlin and their use in a cosmetic composition. Motivation to produce a single isomer by utilizing a method well-known in the art flows logically from the desirability of producing a compound and cosmetic composition that will produce a cosmetic effect, taken together with the fact that a method of producing the claimed compound is taught in the prior art. Please reference In re Anthony, 162 USPQ 594, and In re Adamson, 125 USPQ 233.
With regard to the limitation directed to wherein the composition is in the form of a facial care cream, the combination of Weidner and Berlin suggest a cosmetic cream composition comprising the claimed compound and propylene glycol. The cited references do not explicitly teach the cosmetic cream composition is formulated as a facial cream. However, Sakuta teaches a cosmetic composition comprising components commonly used in cosmetics including a moisture retention agent and skin beautifying components (col 15, lines 58-66); a moisture retention agent includes propylene glycol (col 16, lines 17-18) and a beautifying agent includes zingerone (col 16, lines 42-48). Moreover, Sakuta teaches cosmetics include skincare cosmetics such as milky lotions, cream, cleansing, facial pack formulas, oil liquid, massage cream, essence lotion, facial washes, deodorants, hand cream, and lip cream; makeup products such as makeup base, makeup powder, liquid foundation, oily foundation, cheek colors, eye shadow, eyeliner, eyebrow, and lipsticks; hair care products such as shampoos, rinses, treatment and hair-setting agents; antiperspirants; UV-ray protective cosmetics such as sun screen lotions and sunscreen cream (col 8, lines 7-13). It would have been prima facie obvious to one of ordinary skill in the art to formulate the cosmetic cream composition comprising the claimed compound and propylene glycol suggested by Weidner and Berlin as a facial cream, sun cream or shower gel with a reasonable expectation of success since the prior art teaches the structurally similar compound zingerone is suitable in cosmetic compositions for the face, for cleansing, and sun screen creams.
With regard to the amount of 4-3(ethoxy-4-hydroxyphenyl)-2-butanone of claims 1, 5, 16, 17, and 21, Weidner teaches the weight percentage (w/w) of Zingiber officinale Roscoe or parts thereof of ran extract or component thereof in the composition (includes zingerone) is typically at least at least 0.1 %, such as at least, 0.2%, e.g. at least 0.3%, at least 0.5%, at least 0.75%, at least 1.0%, at least 1.5%, such as at least 2.0%, e.g. at least 2.5%, at least 3.0%, at least 4.0%, at least 5.0%, at least 10.0%, such as at least 20.0%, e.g. at least 30.0% [0084], and teaches a composition comprising 2.5% of an extract of Zingiber officinale Roscoe [0118].
With regard to the claimed amounts of organic solvent of claims 1, 2, 4, 15, and 21, Weidner teaches glyceryl monostearate and propane-1,2-diol are alternatively useful vehicles that can be included in the composition and teaches a cosmetic composition comprising an extract of Zingiber Officinale Roscoe and glyceryl monostearate, wherein glyceryl monostearate is in the amount of 2.0% [0118]. It would have been obvious to one of ordinary skill in the art to utilize the amounts of zingerone taught by Weidner as a starting point to optimize the amount of 4-3(ethoxy-4-hydroxyphenyl)-2-butanone in formulating a composition comprising 4-3(ethoxy-4-hydroxyphenyl)-2-butanone. Moreover, it would be obvious to one of ordinary skill in the art to utilize the amount of glyceryl monostearate as a starting point for optimizing the amount of propane-1,2 diol (1,2-propylene glycol), based on the fact that the prior art establishes that glyceryl monostearate and propane-1,2 diol are alternatively useful as an emollient vehicle in compositions comprising zingerone, a known homologue of Compound I.
Regarding the mass ratio of instant claims 1, 18-21, and 23, the cited art does not explicitly teach the organic solvent and Compound I are in a solvent/compound I mass ratio of less than or equal to 10. However, as set forth above, it would be obvious to utilize the amounts of glyceryl monostearate (e.g. 2.0%) as a starting point for optimizing the amount of propane-1,2-diol which is equivalent to 1,2-propylene glycol and to utilize the amount of Zingiber officinale Roscoe or parts and component thereof such as zingerone as a starting point for optimizing the amount of Compound I (e.g. 2.5%). An amount of 2.0% of 1,2 propylene glycol and an amount of 2.5% of Compound I would give a composition with a solvent/Compound ratio of 0.8 which is less than or equal to 10. It would be obvious to one of ordinary skill in the art to utilize the ratio of solvent/ Zingiber officinale Roscoe or parts and component thereof such as zingerone as a starting point to optimize the ratio of solvent/Compound I, based on the fact that the prior art establishes that Compound I is a known homologue of zingerone and compounds which are homologs are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.
MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
Taken together, all this would result in the practice of the method of claims 1-5, 8, 10, 13, 15-21, and 23 with a reasonable expectation of success.
Regarding claim 7, Weidner teaches the compositions can be formulated in the form of emulsions [0113]. Weidner does not explicitly teach a composition in the form of a water-in-oil or oil-in-water emulsion; however, all emulsions are either water-in-oil or oil-in-water. It would have been obvious to one of ordinary skill in the art to formulate the composition comprising Compound I and propylene glycol rendered obvious by the cited in the form of an emulsion as suggested by Weidner, since the prior art establishes that Compound I is a known homologue of zingerone and compounds which are homologs are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties and thus could be formulated in similar compositions formulations such as emulsions, resulting in the method of claim 7 with a reasonable expectation of success.
Claims 11, 12, and 24 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Weidner (US 2002/0051800 A1, cited in the IDS filed May 14, 2020) in view of Berlin et al (J Gen Chem of USSR, 1949; 19:1-10, cited in the IDS filed May 14, 2020) and Sakuta (US 7,713,520 B2) as applied to claims 1-5, 7, 8, 10, 13, 15-21, and 23 further in view of Belcher et al (Cosmetics & Toiletries, 2010; 125(5):81-86, published May 2010, cited in the IDS filed May 14, 2020).
The combination of Weidner, Berlin, and Sakuta suggest all the limitations of claims 11, 12, and 24 (see 103 rejection above), except the cited art does not teach the organic solvent is the elected species, 1,3-propanediol.
However, Belcher et al teaches propylene glycol (PG) is a substance structurally similar to 1,3-propanediol (PDO) (1st page, left, 1st paragraph); propylene glycol has widespread use and distribution in personal care products-but it also has a history of some dermal irritation and to a lesser extent, sensitization (page 81, left, 1st paragraph). Belcher et al teaches PG and PDO are different molecules that have similar structures and physicochemical properties; human repeat-insult patch test (RIPT) dermal studies suggest that PG may be more likely to cause skin reactions than PDO; factors that may influence this difference in response include chemical structure and the extent and nature of exposure; it has been hypothesized that dipole moment may influence skin irritation responses, which could provide one explanation for this difference since PDO and PG have different dipole moments—the PDO molecule having greater flexibility (3rd page, 3rd column).
At the time of the invention it would have been prima facie obvious for a person of ordinary skill in the art to substitute 1,3-propanediol for propylene glycol as the aqueous solvent in the cosmetic composition comprising Compound I rendered obvious by Berlin and Weidner with an expectation of success, since the 1,3-propanediol is taught to be less likely to cause skin irritation responses compared to propylene glycol, thus resulting in the method of the claims 11 and 12, with a reasonable expectation of success.
Claim 22 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Weidner (US 2002/0051800 A1, cited in the IDS filed May 14, 2020) in view of Berlin et al (J Gen Chem of USSR, 1949; 19:1-10, cited in the IDS filed May 14, 2020) and Sakuta (US 7,713,520 B2) as applied to claims 1-5, 7, 8, 10, 13, 15-21, and 23, and further in view of Zhang et al (WO 2010/045415, published May 2010.
The combination of Weidner, Berlin, and Sakuta suggest a cosmetic facial cream composition comprising the claimed compound and propylene glycol and that the compositions can be formulated in the form of emulsions and emulsifier and emollient/oil are added to water, which would result in an oil-in-water or water-in-oil emulsion. The cited art does not teach the emulsifier is in the amount of 0.5% to 20% by weight relative to the total weight of the emulsifier or that the oil phase of the emulsion is 5% to 50%.
However, Zhang et al teach a topical pharmacological composition comprising at least one sensate agent (claim 1) wherein the sensate agent includes zingerone (claim 5); zingerone is equivalent to 4,(4-hydroxy-3-methoxyphenyl)butan-2-one. Zhang teaches the topically administrable vehicle comprises an emulsion gel (claim 25); and an emulsion gel system comprising the aqueous gel to which are added an emulsifier, and an emollient or oil (page 17, lines 8-10), wherein the emulsifiers include propylene glycol (page 22, lines 26-27). Thus, Zhang further supports that it was known in the art that propylene glycol was useful in formulating emulsion compositions comprising the structurally similar compound zingerone.
Moreover, Zhang teaches compositions comprising 5-75% of one or more nonaqueous solvents; 2-30 wt% of emollients; 1-10% of an emulsifier (page 28, lines 16-19). It would be obvious to one of ordinary skill in the art to utilize the amount of emulsifier and emollient taught by Zhang as a starting point for optimizing the amount of emollient and emulsifier (propylene glycol) utilized to produce a composition comprising Compound I and propylene glycol with a reasonable expectation of success, since the prior art teaches these excipients as suitable excipients for producing a composition comprising a structurally similar compound and because amounts are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable amounts would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed amounts, the determination of the optimum or workable amounts given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Taken together, all this would result in the composition of claims 22 with a reasonable expectation of success.
Response to Arguments
Applicant argues:
Weidner is concerned with mixtures comprising at least one of the fatty acids eicosapentaenoic acid (20:5n3) and docosahexaenoic acid (22:6n3) and the plant Zingiber officinale Roscoe or parts thereof or an extract or a component thereof as novel pharmaceuticals, dietary supplements or cosmetic compositions containing such mixtures, and to their use for preparing a medicament or a dietary supplement for the suppression of hypersensitivity and/or inflammatory reaction. Weidner discloses that Zingiber officinale Roscoe contains several phenolic compounds, most of which have a characteristic hydroxy-methoxy-phenyl moiety and that they are responsible for the pungency of ginger. Accordingly, persons of ordinary skill in the art would not be led or motivated to deviate from the Zingiber officinale Roscoe or the specifically disclosed possible extracts or components thereof and reasonably expect that such would inhibit the generation of eicosanoids through a direct inhibition of cyclooxygenase and 5-lipoxygenase. Accordingly, persons of ordinary skill in the art would not be led or motivated to deviate from the Zingiber officinale Roscoe or the specifically disclosed possible extracts or components thereof and reasonably expect that such would inhibit the generation of eicosanoids through a direct inhibition of cyclooxygenase and 5-lipoxygenase.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
As set forth above, Weidner teaches a composition comprising zingerone and a cosmetically acceptable vehicle, and a vehicle includes propane-1,2-diol and propylene glycol. Thus, Weidner is directed to cosmetic compositions comprising zingerone. Weidner teaches Zingiber officinale Roscoe contains a number of phenolic compounds, most of which have a characteristic hydroxy-methoxy-phenyl moiety; these compounds are responsible for the pungency of ginger [0016]. However, Weidner does not teach that the pungency is required for the disclosed compositions. As set forth above, since Berlin teaches Compound I is a known compound and a homologue of zingerone, and since Weidner teaches that propylene glycol is a suitable vehicle for compositions comprising zingerone, at the time of the invention it would have been prima facie obvious for a person of ordinary skill in the art to utilize the vehicles taught as suitable for compositions comprising zingerone as a vehicle for compositions comprising Compound I with an expectation of success, since the prior art establishes that Compound I is a known homologue of zingerone and compounds which are homologs are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.
Applicant argues:
The present invention further patentably distinguishes over the cited art and especially over Weidner since the present invention relates to a non-therapeutic cosmetic treatment process as contrasted to a therapeutic cosmetic treatment process. On the other hand, Weidner is concerned with therapeutic compositions and therapeutic uses. Weidner is especially concerned with the therapeutic effect of the plant Zingiber officinale Roscoe or parts thereof or an extract or a component thereof, which is discussed throughout the disclosure of Weidner. Accordingly, persons of ordinary skill in the art would readily appreciate that the reference to cosmetic compositions in Weidner is indeed to therapeutic cosmetic compositions as distinguished from non-therapeutic cosmetic compositions. Thus, persons of ordinary skill in the art concerned with problems addressed by the present invention would not even look to or be motivated by Weidner to find a solution to such problems. Moreover, the claim recitation concerning of "non-therapeutic" excludes the presence of components and/or their relative amounts that would result in the process being a therapeutic treatment. On the other hand, to modify Weidner so that the compositions, regardless of the use, no longer function as a therapeutic would render Weidner unsatisfactory or inoperative for its intended purposes and therefore is non-obvious. The composition, as now specified in independent claim 1, is a non-therapeutic cosmetic composition consisting essentially of the recited components. The recitation of "consisting essentially of', excludes ingredients and/or their relative amounts that would defeat the basic relationship of the claimed ingredients such as rendering the process a therapeutic process.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
As noted in the decision by the Patent Trial and Appeal Board dated January 29, 2025, “In general, a preamble limits the invention if it recites essential structure or steps, or if it is necessary to give life, meaning, and vitality to the claim.” Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (citations omitted). “Conversely, a preamble is not limiting where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.” Id. (citations omitted). “[T]he rule against giving invention defining effect to intended-use preamble language reflects . . . the “well settled” fundamental principle ‘that the recitation of a new intended use for an old product does not make a claim to that old product patentable.” Arctic Cat Inc. v. GEP Power Prods., Inc., 919 F.3d 1320, 1328 (Fed. Cir. 2019) (quoting In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997)). Here, the body of claim 1 recites a single step, i.e., applying (at least) the recited composition to keratin materials. The body of the claim, therefore, defines a complete invention. The preamble here states only a purpose or intended use. Thus, the board concluded that the preamble does not limit the scope of the claims, and was not given patentable weight.
Moreover, Applicant’s attention is directed to the Board’s decision in copending US Application No. 14/007,549 in which the Board addressed similar arguments. The copending claims are directed to a non-therapeutic cosmetic composition comprising the instantly claimed compound and an excipient. The Board similarly concluded that the preamble was not limiting the scope of the claims and was not given patentable weight. The Board further noted that even assuming the term “non-therapeutic” was a limitation, it did not serve to distinguish the claims from Weidner’s composition because it wasn’t clear what components of Weidner’s composition would be excluded. For this reason and for those set forth above, this argument is not found persuasive.
Regarding the arguments directed to the claim amendment to include the transitional phrase “consisting essentially of, “ the Examiner notes that with regard to the transitional phrase "consisting essentially of", the phrase "consisting essentially of" has been construed as equivalent to "comprising". The transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (emphasis in original). For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355. See MPEP 2111.03.
In the instant case, Applicant has not demonstrated that the addition of other components such as adjuvants common in cosmetics or dermatology would materially change the characteristics of the instant invention. The specification teaches the compositions according to the invention may also contain adjuvants that are common in cosmetics or dermatology, such as gelling agents, film-forming polymers, preserving agents, fragrances, UV-screening agents, bactericides, odour absorbers, dyestuffs, plant extracts, cosmetic and dermatological active agents (page 7, lines 26-32). In view of the instant disclosure, it is unclear how the inclusion of other adjuvants common in cosmetics or dermatology would materially change the characteristics of applicant's invention.
Applicant argues:
The present inventors have surprisingly and unexpectedly found that these organic solvents employed according to the present invention enable the 4-(3-ethoxy-4-hydroxyphenyl)-2-butanone to be incorporated in the compositions in a long-lasting solubilized form. Without the solvents according to the present invention and using only water and/or glycerol, the 4-(3-ethoxy-4-hydroxyphenyl)-2-butanone would not be present in the compositions in a long-lasting solubilized form, as achieved by the present invention. As disclosed in the specification, 4-(3-ethoxy-4-hydroxyphenyl)-2-butanone is only very sparingly soluble in water or glycerol. Nothing at all in Weidner would have led or motivated a person of ordinary skill in the art to have selected the claimed solvents from all the possible solvents to address the solubility problem, which is an objective of the present invention. According to understanding by those of ordinary skill in the art, no predicable connection exists between the chemical structure of a compound and its properties, especially its biological activity (“Pesaro”). Applicant also cites evidence, including declarations from Veronique Chevalier and Sylvie Cuperferman and articles by Winter, Galal, and Berlin, and a patent to Heuser, relating to differences in properties of zingerone and ethyl zingerone and the alleged unexpected solubility of ethyl zingerone in the claimed solvents.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
As noted in the arguments the Declarations were filed with the parent application US Application No. 14/007,520 which were addressed in the Examiner’s Answer and the rejections were affirmed by the Board’s decision dated March 28, 2025.
“Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof.” In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967). See MPEP 716.02(c).II. In the instant case, the prior art teaches a compound structurally similar to the claimed compound and discloses the claimed solvents as preferred solvents for use in formulating a composition. One of ordinary skill in the art would expect that the claimed compound which is structurally similar to the compound disclosed in the prior art would be soluble in solvents that are suitable for dissolving a structurally similar compound.
MPEP 716.02(d) states:
Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980).
With regard to the data provided in the first declaration which shows data for mixtures of 4-(3-ethoxy-4-hydroxyphenyl)-2-butanone in 3 solvents, ethanol, 1,3-propanediol, and 1,2-propylene glycol, the data provided simply demonstrates that Compound I is soluble in ethanol, 1,3-propanediol, and 1,2-propylene glycol, but does not provide a comparison of the solubility of zingerone. Thus, the Examiner is unable to ascertain from the data provided if the solubility of Compound I is in fact unexpected and unobvious and of both statistical and practical significance.
MPEP 716.02(b).I. states:
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) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992) (Applicant alleged unexpected results with regard to the claimed soybean plant, however there was no basis for judging the practical significance of data with regard to maturity date, flowering date, flower color, or height of the plant.). See also In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) and In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) as discussed in MPEP § 716.02(c).
With regard to the 2nd declaration, which shows the solubility of 4-(3-ethoxy-4-hydroxyphenyl)-2-butanone and gingerone in glycerol, the Examiner acknowledges that it appears that zingerone and Compound I have different solubilities in glycerol. Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (differences in sedative and anticholinergic effects between prior art and claimed antidepressants were not unexpected). In the instant case, while differences in solubility in certain solvents would not be unexpected, one of ordinary skill in the art would reasonably expect that structurally similar compounds would possess similar solubilities in many solvents. As set forth above, Compound I is a known homolog of zingerone and Weidner discloses aqueous solvents that are within the parameters of the instant claims including propylene glycol as a solvent for a compound that is structurally similar to the claimed compound, differing only in a single -CH2- group. As set forth above, one of ordinary skill in the art would have been motivated to utilize solvents that are taught as suitable solvents for zingerone to produce compositions with the structural homolog of the instant claims.
With regard to the citation of Pesaro, Applicant’s attention is directed to the Board’s decision in copending US Application No. 14/007,549 in which the Board addressed similar arguments. The Board also concluded that the argument was not persuasive in view of Pesaro. Pesaro does not address homologous series, which is expected to have gradual variance in properties among its members. The Board concluded that the obviousness rejection was not rebutted.
For this reason and for those set forth above, this argument is not found persuasive.
Applicant argues:
The Examiner relied upon Sakuta as a teaching that cosmetics include skincare cosmetics such as milky lotions, cream, cleansing, facial pack formulas, oil liquid, massage cream, essence lotion, facial washes, deodorants, hand cream, and lip cream; makeup products such as makeup base, makeup powder, liquid foundation, oily foundation, cheek colors, eye shadow, eyeliner, eyebrow, and lipsticks; hair care products such as shampoos, rinses, treatment and hair-setting agents; antiperspirants; UV-ray protective cosmetics such as sun screen lotions and sunscreen cream. The Examiner then concluded that it would have been obvious to formulate the cosmetic cream composition comprising the claimed compound and propylene glycol suggested by Weidner and Berlin as a facial cream, sun cream or shower gel with a reasonable expectation of success. However, Sakuta does not overcome the above discussed deficiencies of Weidner and Berlin with respect to rendering unpatentable the present invention. Sakuta is completely silent with respect to the solubility of 4-(3-ethoxy-4-hydroxyphenyl)-2-butanone in the claimed compounds. Sakuta merely includes a passing reference to zingerone. Reference to zingerone as a blood circulation improver also has nothing whatsoever to do with the therapeutic effects concerning the plant Zingiber officinale Roscoe to which Weidner is directed. With respect to this distinction, it is important to keep in mind that it is well known in the art, that various ingredients function in vastly different ways in different compositions depending upon the other ingredients present therein. The cited art lacks the necessary direction or incentive to those or ordinary skill in the art to render a rejection under 35 USC 103 sustainable. The cited art fails to provide the degree of predictability of success of achieving the properties attainable by the present invention needed to sustain a rejection under 35 USC 103.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
As set forth above, the combination of Weidner and Berlin suggest a cosmetic cream composition comprising the claimed compound and propylene glycol. The cited references do not explicitly teach the cosmetic cream composition is formulated as a facial cream. However, Sakuta teaches a cosmetic composition comprising components commonly used in cosmetics including a moisture retention agent and skin beautifying components; a moisture retention agent includes propylene glycol and a beautifying agent includes zingerone and that such cosmetics include skincare cosmetics such as milky lotions, cream, cleansing, facial pack formulas, and facial washes. Thus, Sakuta establishes that zingerone was known to be formulated in a facial cream cosmetic composition. As set forth above, it would have been prima facie obvious to one of ordinary skill in the art to formulate the cosmetic cream composition comprising the claimed compound and propylene glycol suggested by Weidner and Berlin as a facial cream, sun cream or shower gel with a reasonable expectation of success since the prior art teaches the structurally similar compound zingerone is suitable in cosmetic compositions for the face, for cleansing, and sun screen creams.
Applicant argues:
It would not have been obvious to utilize the amounts of glyceryl monostearate (e.g. 2.0%) as a starting point for optimizing the amount of propane-1,2-diol which is equivalent to 1,2-propylene glycol. The cited art does not recognize that this claimed ratio is a result-effective variable. The cited art would need to disclose that the variable was recognized to be a result-effective variable for the purpose of the claimed invention. Reliance on glyceryl monostearate is misplaced since such is described by Weidner as an emollient; whereas 1,2-propylene glycol is one of the solvents that can be used according to the present invention.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
In the Board’s decision dated March 28, 2025, the Board concluded that a person of ordinary skill in the art would have arrived at the claimed solvent/ethyl zingerone mass ratio based on the teachings, a person of ordinary skill in the art would have used 2.0% as a starting point for the amount of propane-1,2-diol and 2.5% as a starting point for an amount of a Zingiber officinale Roscoe extract, such as zingerone or ethyl zingerone, and a person of ordinary skill in the art would have used 2.0% propane-1,2-diol and 2.5% ethyl zingerone, providing a mass ratio of 0.8. Moreover, the Board concluded that Weidner’s example provides a useful starting point, and thus a person of ordinary skill in the art would have been motivated to make a composition that meets the mass ratio as claimed. Thus, the claimed ratio would have been obvious.
Applicant argues:
Belcher was relied upon for a teaching that propylene glycol is a substance structurally similar to 1,3-propain diol. However, Belcher does not overcome the above discussed deficiencies of Weidner, Berlin and Sakuta with respect to rendering unpatentable the present invention. Accordingly, claims 11 and 12 are patentable for at least those reasons to why claim 1 is patentable.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
Applicant has not independently argued the merits of this rejection. Arguments regarding Weidner, Berlin and Sakuta have been addressed above. Therefore, the rejection is maintained for the reasons set forth on the record and for those set forth in the response to the arguments above.
Conclusion
Claims 1-5, 7, 8, 10-13, and 15-24 are rejected.
No claim is 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 RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628
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