DETAILED ACTION
The receipt is acknowledged of applicant’s request for continued examination (RCE) and amendment filed 03/11/2026.
Claims 1-6 are pending and subject of this office 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/11/1016 has been entered.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Marchant et al. (US 2008/0311358, of record), Changoer et al. (US 2016/0235661, of record), the article by Yeager et al. (“What’s new in photoprotection: A review of new concept and controversies” of record), Bertaina et al. (US 2020/0060959, of record), optionally, combined with Weller et al. (US 2020/0330543, of record), and further combined with the article by Caliskan et al. (“Essential oils as skin permeation boosters and their predicted effect mechanisms”, currently provided), the article by Nielsen et al. (“Natural oils affect the human skin integrity and the percutaneous penetration of benzoic acid dose-dependency”, currently provided), and Shibuya et al. (US 2019/0008747, currently cited on PTO 892).
Applicant Claims
Claim 1 is directed to a composition for transdermal delivery of therapeutic agent, comprising:
an aqueous gel comprising:
a cross-linked sodium hyaluronate polymer aqueous gel therapeutically effective amounts of:
carnosine in a concentration of 0.1%-0.2%;
aloe vera gel;
alpha-tocopherol in an amount 0f 400-500 IU;
eucalyptus oil in an amount of 0.5%-1.5% by weight;
an extract of the Silybum marianum plant; and
peppermint oil in an amount of 2%-4% by weight;
wherein the cross-linked sodium hyaluronate polymer enhances absorption across cell membranes through endocytosis, and wherein the eucalyptus oil and the peppermint oil act synergistically to enhance transdermal penetration.
Claim 4 is directed to a method of treating wrinkles and loss of skin firmness using transdermal delivery of therapeutic agents, comprising the step of:
applying a cross-linked sodium hyaluronate polymer aqueous gel to a human’s skin from a dispenser, the aqueous gel comprising:
carnosine in a concentration of 0.1-0.2%;
aloe vera gel;
alpha-tocopherol in an amount 0f 400-500 IU;
eucalyptus oil in an amount of 0.5%-1.5% by weight;
an extract of the Silybum marianum plant; and
peppermint oil in an amount of 2%-4% by weight;
wherein the cross-linked sodium hyaluronate polymer enhances absorption across cell membranes through endocytosis, and wherein the eucalyptus oil and the peppermint oil act synergistically to enhance transdermal penetration.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Marchant teaches hydrogel composition useful for transdermal delivery of active ingredients in personal care, health care and medicine application. The composition is useful for skin firming, restructuring and as skin antioxidant (abstract; ¶ 0001). Hydrogel is gel that absorb water, i.e. aqueous gel, dispensed from a device (¶¶ 0001, 0005-0006, 0028, 0075, 0125-0126). The composition comprises the following active agents: antiaging agents called Ameliox™ that is a mixture of carnosine, vitamin E and Silybum marianum extract. The composition comprises additional agents including moisturizing skin firming agent including aloe vera in any form; antioxidants including carnosine, α-tocopherol; micro-organism ferment lysate for DNA repair; and product of milk fermentation with Lactobacillus and Lactobacillus extract as collagen synthetic stimulating substance (¶¶ 0138, 0140-0142, 0145, 0156, 0164, 0187-0191, 0196, 0200, 0203, 0207, 0224; claims). The composition further comprises essential oils including peppermint oil and eucalyptus oil (¶¶ 0247-0248).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Marchant carnosine, aloe vera extract, vitamin E and Silybum marianum extract, in a composition and method of treating, however, the reference does not teach single embodiment including all the claimed ingredients.
While Marchant teaches aqueous gel, the reference however does not teach crosslinked sodium hyaluronate aqueous gel as claimed by claims 1 and 4.
Marchant does not teach the claimed amount of carnosine of 0.1-0.2%, and amount of alpha tocopherol in the composition as claimed by claims 1 and 4.
While Marchant teaches essential oil in the cosmetic composition including peppermint oil and eucalyptus oil, the reference does not teach their use a permeation enhancer and their amounts as claimed by claims 1 and 4.
Changoer teaches cosmetic and topical formulations for skin firming and soothing and UV ray protection properties (abstract). The topical composition is formulated to be anti-aging cream and nourishing agent (¶¶ 0021, 0033, 0080). The topical composition comprises tocopherol and tocopherol derivatives (vitamin E) as anti-inflammatory, skin conditioning and antioxidant, Silybum marianum fruit extract or silymarin as antioxidant, aloe vera extract as antimicrobial agent, and carnosine as skin conditioning agent. Skin conditioning agents are present in amount between 0.01-30% of the composition (¶¶ 0049-0053, 0058, claims).
Yeager teaches combination of photolyases including and carnosine as antioxidants in topical composition provides the greatest reduction of free radical-induced UV ray damage of dermal proteins when compared by sunscreens using either ingredient alone. Topical antioxidants include tocopherol, aloe vera, and Silybum marianum or Silymarin milk thistle (see the entire document, and in particular the abstract; page 150, right column; Table 4).
Bertaina teaches an aqueous crosslinked hyaluronic acid gel useful in tissue repair reconstruction, and filling wrinkles (abstract; ¶ 0012).
Weller teaches α-tocopherol used as preservative in topical formulation, and has useful antioxidant effect at dose 250-1400 IU (¶ 0107).
Caliskan teaches essential oils used to increase cutaneous penetration of active agent, both lipophilic and hydrophilic. Essential oils are administered to the skin and easily discharged from the body without accumulation in the body. Essential oils are natural and do not damage the skin, less toxic and less allergenic, and cause temporary reduction in the barrier function of the stratum cornum. Essential oils used in much less concentrations than chemical penetration enhancers. Synergistic effects of essential oils will be observed in formulations chosen according to the biological activities of essential oils. The multi components structure of the essential oils creates synergistic effect. Examples of essential oils include peppermint oil and eucalyptus oil (see the entire document).
Nielsen teaches exposure of skin to low concentration of peppermint oil reduced percutaneous penetration and acts protective against percutaneous penetration of some drugs, while higher concentration may decrease the integrity of the dermal barrier. The reference teaches percutaneous flux is decreased at the lowest concentration of oils including peppermint and eucalyptus oil, followed by slow increase in skin flux along with increasing concentrations of the oils. Figure 2 shows concentrations of essential oils including peppermint and eucalyptus ranging 1-5 % (see the entire document).
Shibuya teaches antiaging external dermal composition to improve skin wrinkles and barrier function of the skin. The composition comprises essential oils in an amount of 0.1-10% including eucalyptus oil and peppermint oil (abstract; ¶¶ 0081-0082).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide aqueous gel composition for treating skin conditions, skin firming, skin restructuring and providing antioxidant skin effect, wherein the composition comprises carnosine, aloe vera gel, α-tocopherol, essential oils, and extract of Silybum marianum as taught by Marchant, and surely and confidently use combination of tocopherol, Silybum marianum fruit extract and aloe vera as taught by Changoer, and further combine carnosine taught by Yeager. One would have been motivated to do so because Changoer teaches combination of tocopherol, Silybum marianum fruit extract and aloe vera provides anti-aging, nourishing, cleansing and conditioning skin effect, and Yeager teaches combination of carnosine with antioxidants including tocopherol, aloe vera, and Silybum marianum in topical composition provides the greatest reduction of free radical-induced UV ray damage of dermal proteins when compared by sunscreens using either ingredient alone. One would reasonably expect formulating topical aqueous gel composition comprising carnosine, aloe vera gel, tocopherol, essential oils, and extract of Silybum marianum that successfully treats skin aging, moisturizes, conditions the skin while having great antioxidant effect.
Further one having ordinary skill in the art would have replaced the aqueous gel taught by the combination of Marchant, Changoer, and Yeager with crosslinked aqueous gel of crosslinked hyaluronic acid taught by Bertaina because Bertaina teaches aqueous crosslinked hyaluronic acid gel is useful in tissue repair reconstruction, and filling wrinkles.
Optionally, furthermore, one having ordinary skill in the art would have used α-tocopherol in a dose of 250-1400 IU as taught by Weller because Weller teaches the antioxidant effect of such dose. In any event, one having ordinary skill in the art would have determined the amount desired amount of α-tocopherol IU based on the used formulation and the desired effect.
Furthermore, one having ordinary skill in the art would have used essential oils comprising peppermint oil and eucalyptus oil in the cosmetic composition because both oils are taught by Marchant in the composition, and because Caliskan teaches essential oils comprising peppermint oil and eucalyptus oil increase cutaneous penetration of active agent administered to the skin, both lipophilic and hydrophilic, and do not damage the skin because they cause temporary reduction in the barrier function of the stratum cornum, and further teaches that the multi components structure of the essential oils creates synergistic effect. One would have used peppermint oil and eucalyptus oil taught by Nielsen in a concentration 1-5% because Nielsen teaches percutaneous flux is decreased at the lowest concentration of oils including peppermint and eucalyptus oil, followed by slow increase in skin flux along with increasing concentrations of the oils and teaches 1-5%.
One having ordinary skill in the art would have used peppermint and eucalyptus oils as skin permeation enhancer in small concentration between 1-5 as taught by Nielsen and as further taught by Shibuya that teaches concentration of 0.1-10% in cosmetic antiwrinkle composition. 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 [R-5]. Applicants failed to show unexpected results obtained from the claimed concentration. One having ordinary skill in the art would have determined the concentration of essential oils from the concentration taught by the references based on desired penetration to the skin.
Regarding the concertation of carnosine as claimed by claims 1 and 4 of 0.1-0.2%, Changoer teaches 0.01-30% that embraces the claimed dose. 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 [R-5]. Applicants failed to show unexpected results obtained from the claimed concentration. One having ordinary skill in the art would have determined the concentration of carnosine from the concentration taught by the reference based on specific intended use.
Regarding synergistic effect claimed by claims 1 and 4, Caliskan teaches essential oils comprising peppermint oil and eucalyptus oil increase cutaneous penetration of active agent administered to the skin, and further teaches that the multi components structure of the essential oils creates synergistic effect. In any event, “There is no single, appropriate test for determining whether synergism has been demonstrated for chemical combination; rather, facts shown in each case must be analyzed to determine whether chosen method has clearly and convincingly demonstrated existence of synergism or unobvious result”. “Assuming arguendo that the differences in values presented are statistically significant, there is no evidence that they represent a true, practical advantage. In re Freeman, 474 F.2d 1318, 177 USPQ 139 (CCPA 1973); In re Klosak , 455 F.2d 1077, 173 USPQ 14 (CCPA 1972); In re D'Ancicco, 439 F.2d 1244, 169 USPQ 303 (CCPA 1971). Also, prescinding from the Colby formula test, which as we have already indicated is at best controversial and in our view probably invalid, there is no evidence that the differences are unexpected. In re Merck, 800 F.2d 1091, 231 USPQ 375 (Fed.Cir. 1986); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed.Cir. 1985); In re Freeman, supra” .
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, e.g. peppermint oil and eucalyptus oil, in order to form a third composition that is to be used for the very same purpose; the idea of combining them flows logically from their having been individually taught in the prior art. In re Kerkhoven, 205 USPQ 1069.
Regarding the limitation of applying from dispenser as claimed by claims 4, Marchant teaches a device to deliver the hydrogel.
Regarding the property of crosslinked sodium hyaluronate to enhance absorption across cell membrane through endocytosis as claimed by claims 1 and 4, this is a property of the crosslinked sodium hyaluronate of the prior art that is inseparable from the crosslinked hyaluronate since same compounds cannot have mutually exclusive characteristics.
Regarding silymarin claimed by claims 2 and 5, Marchant, Changoer and Yeager teach silymarin milk.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Claims 3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Marchant, Changoer, Yeager, Bertaina, optionally Weller, Caliskan, Nielsen and Shibuya as applied to claims 1-2 and 4-5 above, and further in view of Lundqvist et al. (US 2023/0241134, of record).
Applicant Claims
Claims 3 and 6 recite the composition and method of claims 1 and 4 further comprises Lactobacillus ferment lysate.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The combined teachings of Marchant, Changoer, Yeager, Bertaina, optionally Weller, Caliskan, Nielsen and Shibuya are previously discussed in this office action.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Marchant teaches the topical composition comprises micro-organism ferment and lysate as DNA repair agents, and teaches product of milk fermentation with Lactobacillus and Lactobacillus extract as collagen synthetic stimulating substance, the reference however does not explicitly teach Lactobacillus ferment lysate as claimed by claims 3 and 6.
Lundqvist teaches topical cosmetic composition comprising probiotic bacteria that shows improved storage and stability while being beneficial for the user for cosmetic purpose. The composition comprises bacterial lysate and ferment including Lactobacillus to avoid instability of live bacteria (abstract; ¶¶ 0001, 0010, 0057, 0076).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide composition comprising carnosine, aloe vera gel, vitamin E and extract of Silybum marianum that may comprise bacterial lysate and Lactobacillus ferment as taught by the combination of Marchant, Changoer, Yeager, Bertaina, optionally Weller, Caliskan, Nielsen and Shibuya and include both Lactobacillus ferment and lysate taught by Lundqvist in the topical composition. One would have been motivated to do so because Lundqvist teaches topical cosmetic composition comprising probiotic bacteria, e.g. Lactobacillus ferment and lysate, shows improved storage and stability while being beneficial for the user for cosmetic purpose, unlike instable live bacteria. One would reasonably expect formulating topical composition comprising carnosine, aloe vera gel, vitamin E, extract of Silybum marianum and Lactobacillus ferment and lysate that has beneficial cosmetic effect while being stable at storage.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Response to Arguments
Applicant's arguments filed 03/11/2026 have been fully considered but they are not persuasive.
Rejection under 35 U.S.C. §103(a)
Applicants argue that amended Claim 1 now requires two specific penetration enhancers, eucalyptus oil and peppermint oil (essential oils), present at defined concentrations and acting synergistically to enhance transdermal penetration. These limitations introduce a specific penetration enhancement subsystem into the claimed formulation that was not previously recited and that is absent from the Examiner's prior analysis. None of cited references teaches or suggests the new limitation.
In response to this argument, it is argued that the instantly added new limitation of the claimed penetration enhancers are taught by combination of the cited references including the newly cited references, as set forth in this office action. The newly cited references show that peppermint oil and eucalyptus oil are known permeation enhancers, and suggest the claimed amount. Synergy is expected from the teachings of the cited references, as set forth supra.
Regarding synergistic effect, it is suggested by the cited reference. In any event, the Federal Circuit and USPTO have set a high bar for an inventor to overcome a finding of obviousness in a patent application by using evidence of unexpected synergistic results. Synergy by itself is not enough to overcome an examiner' s prima facie case for obviousness; instead, the synergy must be unexpected or surprising and the applicant must show that it could not have been predicted based upon the cited references. Broad disclosures of synergy in the prior art weigh toward a finding of obviousness. Additionally, evidence of synergy over a broad range of compositions or components in the prior art, or in the application at issue, weighs toward a finding of obviousness. To show unexpected results, an applicant must provide a side-by-side comparison of the claimed invention with the closest prior art and explain why the results would have been unexpected by one of ordinary skill in the art.
Applicants argue that the Examiner's obviousness rationale is directed primarily to antioxidant activity and skin conditioning benefits. However, the amended claims are directed to a formulation that includes a penetration enhancement subsystem designed to increase transdermal delivery of therapeutic agents. The cited references do not address this technological objective and provide no teaching or suggestion that would have led a skilled artisan to incorporate eucalyptus oil and peppermint oil in the claimed concentrations to achieve synergistic enhancement of transdermal penetration.
In response to this argument, applicant’s attention is directed to the scope of the present claims that are directed to composition (claim 1) and method of its use in treating wrinkles and firming the skin (claim 4), and all the elements of the claimed composition and method are taught by combination of the cited references. The use of both claimed peppermint and eucalyptus oils as permeation enhancers in topical composition in the claimed amount are known in the art and taught by combination of the cited references as taught by the newly cited references: Caliskan, Nielsen and Shibuya as set forth supra. Argument regarding synergy above is hereby reiterated.
Applicants argue that the specification expressly describes that eucalyptus oil and peppermint oil operate synergistically as penetration enhancers, increasing transdermal penetration by a factor of approximately 10 to 20 times. None of the cited references suggests this combination or its synergistic effect.
In response to this argument, it is argued that instantly claimed essential oils were know before he effective filing date of the present invention, and were known to be included in cosmetic composition for skin firming as taught by Marchant. While Marchant does not teach peppermint oil and eucalyptus oil with sufficient specificity, the newly cited references teaches using these oils in overlapping amount and teaches they have synergistic effect. Caliskan teaches essential oils comprising peppermint oil and eucalyptus oil increase cutaneous penetration of active agent administered to the skin, and further teaches that the multi components structure of the essential oils creates synergistic effect. MPEP 716.02(a) states, “Evidence of a greater than expected result may also be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately (i.e., demonstrating "synergism"). Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). However, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991)”. “There is no single, appropriate test for determining whether synergism has been demonstrated for chemical combination; rather, facts shown in each case must be analyzed to determine whether chosen method has clearly and convincingly demonstrated existence of synergism or unobvious result”. “Assuming arguendo that the differences in values presented are statistically significant, there is no evidence that they represent a true, practical advantage. In re Freeman, 474 F.2d 1318, 177 USPQ 139 (CCPA 1973); In re Klosak , 455 F.2d 1077, 173 USPQ 14 (CCPA 1972); In re D'Ancicco, 439 F.2d 1244, 169 USPQ 303 (CCPA 1971). Also, prescinding from the Colby formula test, which as we have already indicated is at best controversial and in our view probably invalid, there is no evidence that the differences are unexpected. In re Merck, 800 F.2d 1091, 231 USPQ 375 (Fed.Cir. 1986); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed.Cir. 1985); In re Freeman, supra” .
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, e.g. peppermint oil and eucalyptus oil that are known as skin permeation enhancers, in order to form a third composition that is to be used for the very same purpose; the idea of combining them flows logically from their having been individually taught in the prior art. In re Kerkhoven, 205 USPQ 1069.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., increasing transdermal penetration by a factor of approximately 10 to 20 times) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicants disagree with the Examiner that the claimed carnosine concentration of 0.1%-0.2% is rendered obvious by Changoer's disclosure of skin conditioning agents at concentrations of 0.01%-30%. This argument is not persuasive. Changoer's disclosed range is extremely broad and provides no specific guidance toward the narrow 0.1%-0.2% subrange claimed. A disclosure of such breadth does not direct a skilled artisan toward any particular subrange within it, and the Examiner has not identified any specific example, working embodiment, or teaching within Changoer that points toward concentrations in the 0.1%-0.2% range. The mere mathematical overlap between a claimed range and an exceptionally broad prior art range does not, by itself, establish obviousness where the prior art provides no meaningful direction toward the claimed subrange. See MPEP $2144.05, which explains that a prima facie case based on overlapping ranges depends on evidence that the prior art would have led a skilled artisan to select the claimed range.
In response to this argument, it is argued that “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05. There is no evidence of record as to the criticality of the claimed ranges. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant's invention.
Further, It had been decided by Courts that the indiscriminate selection of "some" from among "many" is considered prima facie obvious. In re Lemin, 141 USPQ 814 (1964); National Distillers and Chem. Corp. V. Brenner, 156 USPQ 163. This is applicable on selecting narrow amount among broader amount of the prior art.
Applicants argue that the claimed concentration range is not an isolated parameter. Rather, it operates within a coordinated formulation system that includes eucalyptus oil and peppermint oil acting synergistically to enhance transdermal penetration. The cited references provide no teaching or suggestion that would have directed a skilled artisan to select this specific concentration range within such a penetration-enhancing formulation.
In response to this argument, it is argued that all the elements of the claimed composition and method are known before the effective filing date of the present invention as suitable for skin care/cosmetic composition, and it is obvious to combine them, similarly, it is obvious to combine the taught elements in the claimed amounts because they are taught by combination of the cited references. One having ordinary skill in the art would have determined amount based on the condition to be treated, method and site of application.
Applicants argue that the claimed alpha-tocopherol amount of 400-500 IU is not rendered obvious by Weller's disclosure of alpha-tocopherol at 250-1400 IU in topical formulations. While Weller's range is narrower than Changoer's, it nonetheless spans nearly a six-fold difference in dosage, and the claimed 400-500 IU window represents only approximately 8% of that continuum. The breadth of Weller's disclosed range is therefore still insufficient, standing alone, to direct a skilled artisan toward the specific subrange now claimed.
In response to this argument, it is argued that, it was known before the effective fining date of the present invention to use dose overlapping with the claimed of alpha-tocopherol dose in cosmetic formulation. It has been held that 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). It has been further held that a prima facie case of obviousness exists where the claimed ranges and the prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Meals Corp. of America v. Banner, 778 F2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Applicants argue that Weller discloses alpha-tocopherol in the context of its use as a preservative and antioxidant additive in topical formulations. A skilled artisan selecting a functional additive concentration from a broad range for preservation purposes has not been directed toward a specific therapeutic dose of the same compound for use as an active ingredient in a penetration- enhanced transdermal delivery system. The claimed 400-500 IU parameter reflects a deliberate therapeutic dosage decision within a formulation context that Weller does not address. The Examiner has not identified any example, preferred embodiment, or other teaching within Weller that would have directed a skilled artisan to select this particular range for this purpose, and in the absence of such guidance the mathematical overlap between the claimed range and Weller's disclosure does not establish obviousness. See MPEP $2144.05.
In response to this argument, it is argued that even if Weller teaches alpha-tocopherol as antioxidant agent, the intended use does not impart patentability to composition claim 1. Further the use of antioxidant of claim 4 in cosmetic antidrinking composition is known and obvious, absent evidence to the contrary. One having ordinary skill in the art would have used dose of alpha tocopherol that is suitable to be included in the cosmetic composition. Even if the reference does not teach example with the claimed amount, it is suggested by the broader disclosure of the reference. Disclosed examples and preferred embodiments do not constitute a teaching away from broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). Furthermore, “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
Applicants argue that the specification discloses the 400-500 IU amount as a deliberate formulation parameter within the claimed topical gel system. Paragraph [0192] describes alpha- tocopherol in this range in connection with the disclosed formulations designed to improve skin firmness and reduce wrinkles. As with the carnosine concentration, this parameter does not operate in isolation but as part of a coordinated formulation that includes eucalyptus oil and peppermint oil acting synergistically to enhance transdermal penetration - a system that Weller does not address at all.
In response to this argument, it is argued that all the elements in overlapping amounts with the claims are taught by combination of the cited references. MPEP 716.02(a) states, “Evidence of a greater than expected result may also be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately (i.e., demonstrating "synergism"). Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). However, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991)”.
In addition, regarding applicant's arguments of unexpected superior results in the instant specification, it is the examiner's position that the data in the specification regarding firming the skin are not unexpected results because other ingredients in the composition work to firm the skin, therefore cannot rebut prima facie obviousness. The examiner directs applicant's attention to MPEP 716.02 (a). "A greater than expected result is an evidentiary factor pertinent to the legal conclusion of obviousness...of the claims at issue." In re Corkhill, 711 F.2d 1496, 266 USPQ 1006 (Fed.Cir. 1985). In Corkhill, the claimed combination showed an additive result when a diminished result would have been expected. Furthermore, the MPEP states, "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).
Applicants disagree with the Examiner argues that the endocytosis-mediated absorption property recited in the wherein clause of amended Claim 1 is inherent in the cross-linked sodium hyaluronate taught by Bertaina. This argument is not supported by the cited references. Inherency requires that the prior art necessarily and inevitably result in the claimed functional characteristic, not merely that the characteristic could occur under certain circumstances. See In re Oelrich, 666 F.2d 578 (CCPA 1981). Bertaina discloses cross-linked hyaluronic acid gels in the context of tissue repair, reconstruction, and wrinkle filling, but contains no disclosure relating to transdermal delivery mechanisms or cellular uptake processes such as endocytosis-mediated absorption of therapeutic agents. The Examiner has not established that the cross-linked hyaluronic acid gel of Bertaina would necessarily exhibit endocytosis-mediated absorption when formulated together with other ingredients in the specific aqueous gel formulation now claimed. The wherein clause therefore does not merely describe a newly discovered property of a prior art material. Rather, it defines a functional characteristic of the claimed formulation as a whole operating within the specific transdermal delivery system recited in the claims. The cited references provide no evidence that this functional result inevitably arises from the prior art compositions.
In response to this argument, it is argued that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). Further compounds and their properties are inseparable and cannot have mutually exclusive characteristics, absent evidence to the contrary. Applicants did not show combination of the claimed elements would change the endocytosis-mediated absorption property.
Where a valid case of prima facie obviousness has been established, the burden is shifted to applicant to demonstrate that a claimed functional property is applicable to the claim in its broad scope: In re Greenfield, 197 USPQ 227, 229 (CCPA 1978). (Holding that despite the fact that the rejection was one of obviousness and not anticipation, the burden was nevertheless on applicant to provide factual verification of the alleged functional property). Thus, even assuming arguendo that applicant has shown that a specific combination of components might exhibit unexpected property, this has not been shown for the broad genus of all ranges of combination currently claimed.
Applicants argue that the Examiner argues that motivation to combine the cited references exists even if the motivation differs from that described by Applicant. However, the Examiner must still identify some teaching, suggestion, or rationale that would have led a skilled artisan to arrive at the specific combination now claimed. No such teaching, suggestion, or rationale has been identified with respect to the eucalyptus oil and peppermint oil limitations.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, motivation to combine the cited references was suggested by the cited references as set forth in this office action. It should be noted that the motivation to combine references can be different from the ones set forth by Applicant. That is, as long as motivation exists to combine the elements, the problem to be solved does not have to involve the same reason.
In determining obviousness, neither the particular motivation to make the claimed invention nor the problem the inventor is solving controls. The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts. See 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a). Factors other than the disclosures of the cited prior art may provide a basis for concluding that it would have been obvious to one of ordinary skill in the art to bridge the gap. See MPEP 2141, section III.
The discovery of a new action underlying a known process does not make it patentable. MEHL/Biophile, 192 F.3d at 1365, 52 U.S.P.Q.2d at 1303. Also, it is irrelevant that the prior art observers did not recognize the property or function of the disputed claim; if the prior art inherently possessed that characteristic, it anticipates. See Verdeegal Brothers, lnc. v. Union Oil Co. of Cal., 814 F.2d 628, 633, 2 U.S.P.Q.2d 1051, 1054 (Fed. Cir. 1987). This is believed to be applicable here because anticipation is the epitome of obviousness.
The obviousness does not require absolute predictability of success all that is required is a reasonable expectation of success. See In re Kubin, 561 F.3d at 1360. The Court has held that "the test of obviousness is not express suggestion of the claimed invention in any or all of the references but rather what the references taken collectively would suggest to those of ordinary skill in the art presumed to be familiar with them." See In re Rosselet, 146 USPQ 183, 186 (CCPA 1965). "There is no requirement (under 35 USC 103(a)) that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art." Motorola, Inc. v. Interdigital Tech. Corp., 43 USPQ2d 1481, 1489 (Fed. Cir.1997). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR Int'l Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) ("The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.").
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./
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