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 .
Claim Status
Claims 1-14 are pending.
Application Data Sheet
The title as filed in the Application Data Sheet is in Spanish. Appropriate translation to English and correction are required with a supplemental Application Data Sheet.
Specification
The abstract of the disclosure is objected to because it exceeds 150 words and contains legal phraseology when stating, “said formulation.” A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claim 7 is 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.
Regarding claim 7, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, Applicant’s claims recite a combination of asiaticoside, verbascoside, hesperidin, and punicalagin. The claims further specify that the chemical compounds can be derived from various plant extracts. Asiaticoside, verbascoside, hesperidin, and punicalagin are all naturally occurring compounds, and the plants they are derived from are also naturally occurring. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception….” To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties….”
In this case, each of the asiaticoside, verbascoside, hesperidin, and punicalagin are naturally occurring compounds. Further, the plants and extracts that these compounds are inherently part of are also naturally occurring. A formulation comprising these compounds derived from the plant extracts wherein there is a carrier (i.e. water as stated in the instant specification) would also be naturally occurring, as the extracts are found in nature and the compounds are inherently part of these compositions, and water is also a naturally occurring element. There is no indication that mixing the specified compounds together as commensurate in scope with the stated claims changes the structure, function, or other properties of the compounds in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for each compound is the compound itself. Each compound appears to maintain its naturally occurring structure and properties and is merely present in the combination. Mixing specific compounds does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field.
In addition, extraction of plants only concentrates and portions the naturally occurring compounds in the plants which are soluble or insoluble in the particular solvent. General extraction does not necessarily result in a markedly distinct change in the naturally occurring compounds from the plant. Thus, while a solvent extract itself may not be found in nature, the compounds which are present in the plant and soluble in the selected solvent are found in nature. The creation of a solvent extract only partitions and concentrates the molecules that are naturally in the plant. There is no evidence or reason to expect that any new compounds are formed. The extract itself is a mixture of the naturally occurring compounds that are simply soluble in a particular solvent. Thus, while extraction of the compounds with the selected solvent would separate a portion of the plant matter away from the naturally-occurring ingredients, the result of extraction is still a mixture of ingredients which are naturally found in the plant material; i.e. the compound is not inventive of “man-made.” Thus, each of the extracts in turn is a mixture of the naturally occurring compounds found in the particular plants. Combining the extracts from the individual plants leads to a combination of the naturally occurring compounds from each of the plants. Thus, the claims are drawn to mixtures of naturally occurring products.
There is no indication that mixing the specified extracts together as commensurate in scope with the stated claims changes the structure, function, or other properties of the extracts in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for each extract is a mixture of the naturally occurring compounds that are present in the extract. Because, as discussed above, each plant extract is only a mixture of the naturally occurring compounds found in the plant. Each extract composition appears to maintain its naturally occurring structure and properties and is merely present in the combination. Mixing specific compounds does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field. In addition, there is nothing to show that mixing the ingredients in the particular concentrations produces any sort of marked distinction. Thus, the claimed mixture as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, Applicant’s claims are directed to a composition with an intended use of treating the effects of ageing on the skin. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, Applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if the claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the additional element in the claims is the combination of extracts. However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. Thus, mixing the ingredients together does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field.
In addition, Applicant’s intended use of treating the effects of ageing on the skin is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 103
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.
Claims 1-6 and 8-14 are rejected under 35 U.S.C. 103 as being unpatentable over Santhanam (US Patent No. 10,076,479B1, published 9/18/2018).
Santhanam teaches a treatment for skin with at least two alternating treatment modalities to improve the health and/or diminish signs of aging (abstract). Santhanam further teaches that some embodiments will comprise a biological extract from plant, yeast, fungus, etc. and that the extracts include ground or pulverized plant materials, as well as ferments, lysates, and isolates (col. 20 lines 52-61). Santhanam continues to state various plants that are useful in treating skin, which includes centella asiatica, cistanche tubulosa, citrus aurantium dulcis (sweet orange), and pomegranate (col. 21-22) (cf. claims 2, 4, 6, 8, 10). Santhanam teaches that actives may be applied to a subject individually or combined (col. 37 lines 19-20) where the actives applied together in a single treatment are shown by “the combination of active ingredients A+B” which suggests combining actives. Santhanam also teaches that other actives may be included, such as melanin inhibitors (col. 24 line 46) which will necessarily block melanin production for skin exposed to solar radiation (cf. claim 12). Santhanam also teaches that the composition may be administered orally or topically (col. 2 lines 35-38) along with a vehicle for delivery of the actives, wherein the vehicle may comprise water (col. 5 lines 45-46) (cf. claims 13-14).
As Santhanam teaches the usefulness of extracts from the previously mentioned plants, their combination together would be motivated by a reasonable expectation that a combined composition of extracts would impart the same benefits as each ingredient alone. As asiaticoside, verbascoside, hesperidin, and punicalagin are necessarily present in these extracts from their respective plants, they would be necessarily combined together when the extracts themselves are combined. The individual compounds are necessarily present in their respective plant extracts, and are therefore necessarily present in the final combined composition of extracts.
Based on the disclosure by this reference that these substances are used in skincare compositions, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating a single skincare composition. Therefore, an artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
Regarding claims 1, 3, 5, 9, and 11, Santhanam does not specifically teach adding the ingredients together in the amounts claimed by applicant. However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” The reference teaches the use of each of the ingredients in a skincare composition. Varying the concentration of ingredients within a composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of Applicant’s claimed invention. Therefore, these claims are rejected.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Santhanam (US Patent No. 10,076,479B1, published 9/18/2018) in view of Funes et al. (Food Chemistry (2009), vol. 117, p. 589-598).
The teachings of Santhanam are discussed above.
However, Santhanam does not teach the inclusion of Lippia citriodora, Budeja sp., Rehmania glutinosa, or Plantago spp.
This deficiency is made up for by the teachings of Funes.
Funes teaches that L. citriodora extract with 25% verbascoside is a highly effective antioxidant composition (p. 589). Antioxidant capability is a desirable trait in skincare compositions. Funes teaches that this composition can be oral, and as Santhanam also teaches application of actives via oral administration, it follows that inclusion of L. citriodora extract alongside the extract containing verbascoside would impart the greater antioxidant benefit.
Therefore, it would have been prima facie obvious to an artisan of ordinary skill in the art before the effective filing date of the claimed invention to additionally include L. citriodora extract in the composition of Santhanam comprising centella asiatica, cistanche tubulosa, citrus aurantium dulcis (sweet orange), and pomegranate extracts to impart greater the antioxidant capabilities in conjunction with the verbascocide component of the composition since Santhanam teaches the importance of antioxidant capability in their formulation by teaching its inclusion in the overall composition (col. 10 line 16 and 55). As a result, claim 7 is rejected.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The pertinent prior art includes the following references:
Sun B., Wu L., Wu Y., Zhang C., Qin L., Hayashi M., Kudo M., Gao M., Liu T. Therapeutic Potential of Centella Asiatica and Its Triterpenes: A Review. Front. Pharmacol. 2020;11:568032. doi: 10.3389/fphar.2020.568032.
Kim Y.J., Cha H.J., Nam K.H., Yoon Y., Lee H., An S. Centella Asiatica Extracts Modulate Hydrogen Peroxide-Induced Senescence in Human Dermal Fibroblasts. Exp. Dermatol. 2011;20:998–1003. doi: 10.1111/j.1600-0625.2011.01388.x.
Eghbali S., Askari S.F., Avan R., Sahebkar A. Therapeutic Effects of Punica Granatum (Pomegranate): An Updated Review of Clinical Trials. J. Nutr. Metab. 2021;2021:5297162. doi: 10.1155/2021/5297162
Pacheco-Palencia L.A., Noratto G., Hingorani L., Talcott S.T., Mertens-Talcott S.U. Protective Effects of Standardized Pomegranate (Punica granatum L.) Polyphenolic Extract in Ultraviolet-Irradiated Human Skin Fibroblasts. J. Agric. Food Chem. 2008;56:8434–8441. doi: 10.1021/jf8005307.
Wang N., Ji S., Zhang H., Mei S., Qiao L., Jin X. Herba Cistanches: Anti-Aging. Aging Dis. 2017;8:740. doi: 10.14336/AD.2017.0720.
Garg A., Garg S., Zaneveld L.J., Singla A.K. Chemistry and Pharmacology of the Citrus Bioflavonoid Hesperidin. Phytother. Res. PTR. 2001;15:655–669. doi: 10.1002/ptr.1074.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW RYAN BURKE whose telephone number is (571)272-8949. The examiner can normally be reached Mon-Fri. 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached at 5712720827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW RYAN BURKE/Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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