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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 24 August 2026 has been entered.
Claims Status
Applicant’s claim amendments and arguments in the response filed 24 August 2026 are acknowledged.
Claims 1 & 5-20 are pending
Claims 2-4 are cancelled.
Claims 1, 17 & 19 are amended.
Claims 7 & 12-16 are withdrawn.
Claims 1, 5, 6, 8-11 & 17-20 are under current examination.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
New & Maintained Rejections
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1, line 3, is not written in parallel to claim 1, line 2. Claim 1, line 2, recites “at least one sunscreen active agent…” which encompasses multiple sunscreen active agents (emphasis added). However, claim 1, line 3, recites “the sunscreen active agent…” (emphasis added).
Applicant may wish to consider whether an amendment to claim 1, line 3, to recite “at least one sunscreen active agent…” would obviate the objection.
Appropriate correction is required.
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, 5, 6, 8-11 and 17-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature, or natural phenomenon (Step 2A, Prong One). In the instant application, the claims recite the following limitations:
A cosmetic composition comprising: a cosmetic formulation comprising at least one sunscreen active agent; and benthic pennate diatom frustules in an amount of from 0.05 % wt to 0.3% wt. Claim 5 recites the amount of sunscreen active. Claims 6 & 17 recites the type of the inorganic sunscreen active (e.g. titanium dioxide). Claim 18 recites the cosmetic composition comprises a preservative. Claim 19 recites the biomass of the benthic pennate frustules has been removed and claim 20 recites the frustules are whole.
The claims are directed to a judicial exception such as a natural phenomenon (e.g., product of nature) as the only compositional requirement set forth in the instant claims is that the composition comprises a combination of naturally occurring ingredients of a preservative, titanium dioxide and benthic pennate diatom frustules. The ordinary artisan before the effective filing date knew that sodium chloride is naturally occurring and is a preservative. Anderson (previously cited) teaches titanium dioxide is formed naturally in the environment (pg. 2).
Allert (WO2017211892; previously cited) teaches benthic pennate diatoms may grow on stones in the bottom sediment or on other surfaces that are covered with water (pg. 5, ll. 4-10). Lavaud (previously cited) teaches diatoms are unicellular microalgae organisms (see definition). There are two groups of diatoms, centris and pennate (see diversity and evolution section). Pennate diatoms are benthic and dominate biofilm forming communities that colonize intertidal and well-lit subtidal sediments (introduction, diversity and evolution sections). The silicified cell wall of diatoms is a frustule ( see siliceous cell wall). Accordingly, sodium chloride, titanium dioxide and benthic pennate diatom frustules are found in nature. Claim 9 recites that the carrier is water which does not add an element beyond the judicial expectation as water is naturally occurring. The fact that the water can be removed to render the frustules in powdered form (i.e. a dry product) does not add an element beyond the judicial exception because removal of water by removing from sediment in water does not change the structure of diatom frustules as the dry product is still composed of naturally occurring benthic pennate diatom frustules.
MPEP 2106.04(c) states that the markedly different characteristics analysis is part of Step 2A Prong One: “Where the claim is to a nature-based product produced by combining multiple components (e.g., a claim to "a probiotic composition comprising a mixture of Lactobacillus and milk"), the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. For instance, for the probiotic composition example, the mixture of Lactobacillus and milk should be analyzed for markedly different characteristics, rather than the Lactobacillus separately and the milk separately. See subsection II, below, for further guidance on the markedly different characteristic analysis.”
Further, from MPEP 2106.04(c): “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, and are evaluated based on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception.”
The guidelines for performing the markedly different characteristics analysis, include (a) selecting the appropriate naturally occurring counterpart(s) to the nature-based product limitation, (b) identifying appropriate characteristics for analysis, and (c) evaluating characteristics to determine whether they are "markedly different".
Regarding (a), MPEP 2106.04(c) recites: “When the nature-based product is a combination produced from multiple components, the closest counterpart may be the individual nature-based components of the combination. For example, assume that applicant claims an inoculant comprising a mixture of bacteria from different species, e.g., some bacteria of species E and some bacteria of species F. Because there is no counterpart mixture in nature, the closest counterparts to the claimed mixture are the individual components of the mixture, i.e., each naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281 (comparing claimed mixture of bacterial species to each species as it occurs in nature); Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 (although claimed as a pair, individual primer molecules were compared to corresponding segments of naturally occurring gene sequence); In re Bhagat, 726 Fed. Appx. 772, 778-79 (Fed. Cir. 2018) (non-precedential) (comparing claimed mixture of lipids with particular lipid profile to "naturally occurring lipid profiles of walnut oil and olive oil").”
In the instant case, the closest counterparts to the claimed mixture are the individual components of the mixture: a preservative (sodium chloride), a sunscreen active (titanium dioxide) and benthic pennate diatom frustules in an amount of 0.05 % wt. to 0.3 % wt.
Regarding (b), MPEP 2106.04(c) recites: “Appropriate characteristics must be possessed by the claimed product, because it is the claim that must define the invention to be patented. Cf. Roslin, 750 F.3d at 1338, 110 USPQ2d at 1673 (unclaimed characteristics could not contribute to eligibility). Examiners can identify the characteristics possessed by the claimed product by looking at what is recited in the claim language and encompassed within the broadest reasonable interpretation of the nature-based product. In some claims, a characteristic may be explicitly recited.”
In the instant case, the appropriate characteristic for the preservative, sunscreen active and benthic pennate diatom frustules for its intended use as a cosmetic.
Regarding (c), MPEP 2106.04(c)recites: “The final step in the markedly different characteristics analysis is to compare the characteristics of the claimed nature-based product to its naturally occurring counterpart in its natural state, in order to determine whether the characteristics of the claimed product are markedly different. The courts have emphasized that to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, the inventor must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart.
If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception. If there is a change in at least one characteristic as compared to the counterpart, and the change came about or was produced by the inventor’s efforts or influences, then the change will generally be considered a markedly different characteristic such that the claimed product is not a product of nature exception.”
Here, the specification does not indicate what the preservative does. However, preservatives preserve by definition. The ordinary skilled artisan knew of natural preservatives, including sodium chloride, preserve. The specification indicates that the frustules claimed boosts SPF. Kuehnle teaches that biomineralized products boost SPF and/or UVA-PF protection provided in sunscreens with silica in frustules being combined with titanium dioxide having the advantages of scattering UV radiation ([0131] & [0220]). Thus Kuehnle suggests that diatom frustules with a sunscreen active (titanium dioxide) boost SPF properties. Antoine teaches “frustules or their mixtures have advantageous properties against UV radiation” (see Antoine’s Statement of Invention-pg. 3). As discussed above, benthic pennate diatoms and titanium dioxide are both found in nature.
Consequently, the claimed composition lacks markedly different characteristics and is a product of nature exception (Step 2A, Prong 1: YES)
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2).
This judicial exception is not integrated into a practical application because there are no additional elements recited in the claims beyond the judicial exception. From MPEP 2106.04(d): “Because a judicial exception alone is not eligible subject matter, if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application.” (Step 2A, Prong 2: NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B).
As noted above, there are no additional elements recited in the claims beyond the judicial exception, and a judicial exception alone is not eligible subject matter (Step 2B: NO). The claims do not recite anything else, compositionally or structurally, which provides an inventive concept that departs from merely reciting a composition containing all naturally occurring components. The amounts recited in the dependent claims not appear to add significantly more. Furthermore, the claimed amounts for the titanium dioxide sunscreen active and benthic pennate diatoms are known for use in cosmetic products. Corinaldesi teaches that inorganic UV filters including titanium dioxide are often used in sunscreen due to their broad UV protection and limited penetration into skin (abstract and entire document). The maximum concentration for sunscreen products in the U.S. includes 12% (section 2.2). Antoine teaches cosmetic compositions which comprise diatom frustules. The cosmetic composition is used for the protection against UV radiation (claims 1 & 8).The diatom frustules can be present from 0.1-10% weight. The fact that the natural product is cultured does not add anything more beyond the judicial exception. The fact that the frustules are whole and have had the biomass removed (which would occur through the natural process of decay) does not add anything more beyond the judicial exception.
Therefore, simply combining the naturally occurring ingredients for cosmetic use would not provide significantly more than the judicial exception.
Therefore, the claims are not patent eligible subject matter under 35 USC § 101.
Response to Arguments
Applicant argues claim 1 now requires a specific range of 0.05% to 0.3% benthic pennate diatom frustules (pg. 6). Applicant argues “Table 8 on page 13 of the application… compositions comprising 0.1 % and 0.3% frustules increased the SPF of the composition. However, at 0.3% of frustules, the improve-ment was reduced as compared to 0.1 %. The presently amended limitation of from 0.05% to 0.3% thus relates to a specific range of frustules that exhibits the improvement in SPF” (reply, pg. 5). Applicant argues the recited amount of frustules “has shown a markedly improved effect on SPF. Applicant respectfully submits that the markedly different characteristics analysis results in the claim no longer specifying a naturally occurring phenomenon. The upper limit of 0.3% is specifically selected because at levels above this amount, the markedly improved properties are not present and therefore the combination changes the function of the frustules which results in the improved SPF characteristics (reply, pg. 6).
This is not persuasive. Applicant has not shown the specific amount of frustules results in a “markedly improved effect on SPF”. In particular, titanium dioxide is a known UV absorbing/scattering/-reflecting agent. Antoine teaches inclusion of diatom frustules in an amount of 0.1-10% in cosmetic composition used for the protection against UV radiation. Antoine teaches “frustules or their mixtures have advantageous properties against UV radiation” (see Antoine’s Statement of Invention-pg. 3). Applicant has not evaluated frustules on their own to determine their effect of SPF (See Table 8-pg. 12). As such, Applicant has not shown the combination of the frustules in the claimed range with at least one sunscreen active agent provide “markedly improved effect on SPF”. Further, Applicant has not evaluated the SPF of the combination with frustules that fall at the lower limit (i.e. 0.05 wt%) and beyond the upper limit (i.e. greater than 0.3 % wt). As such, not enough data are present to determine whether a trend is really present for a “markedly improved effect on SPF” at low concentrations of frustules because a decrease in the mean SPF over multiple higher concentrations of benthic pennate diatom frustules has not been evaluated as only a maximum of 0.3% frustules has been used. Also, the Examiner notes that the standard deviations for the mean SPF between 0.1 % frustules and 0% frustules overlap; the standard deviations for the mean SPF between 0.3% frustules and 0% frustules overlap; and the standard deviations for the mean SPF between 0.3% frustules and 0.1% frustules overlap. No statistical tests, such as a Mann-Whitney U test, have been performed to determine whether the differences in mean SPF between amounts is significant (i.e. ““markedly improved”).
Applicant reiterates the guidelines for performing the markedly different characteristics analysis (reply, pg. 6). Applicant argues Kuehnle does not describe a natural counterpart because Kuehnle relates to a process for biomineralizing the diatom frustules via the addition of Ti and Si. See Kuehnle at paragraph [0305], Example 10 (reply, pg. 6). Applicant argues Kuehnle does not describe a naturally occurring frustule, nor does it describe any SPF boosting effects of naturally occurring frustules (reply, pg. 7). Applicant further argues “Kuehnle relates to the combination of crushed frustules with titanium dioxide performs similar to titanium dioxide. There is no improved effect shown” (reply, pg. 7).
This is not persuasive. Antoine recognizes frustules as an individual reagent in a cosmetic formulation which “have advantageous properties against UV radiation” (pg. 7). Allert teaches the benthic pennate diatoms can be provided as a dry powder mixed with titanium dioxide (pg. 14, ll. 29-31; pg. 16, ll. 12-16). The ordinary skilled artisan, before the effective filing date, knew that titanium dioxide scatters/reflects UV. Kuehnle also recognizes “Amorphous silica in frustules is transparent to visible light but combined with TiO2 or zinc oxide (ZnO) gains the ability to scatter light including UV radiation, contribute to iridescence, and whiten substances (opacity) as an additive” (i.e. emphasis added; [0220]). With regard to Applicant’s arguments about an “improved effect”, Applicant has not shown an improved effect as discussed immediately above. In brief, not enough concentrations of frustules were evaluated to demonstrate a trend and the SPF of frustules alone was not measure to establish a greater than additive effect.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 20 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This new matter.
Claim 20 requires the frustules be whole frustules. The reply filed 24 August 2026 states support is found at least on page 5, ll. 8-11 which states in part “The frustules may be extracted via a chemical extraction process whereby the organic biomass of the diatom is removed via a chemical agent leaving the frustules”. Applicant points the harvesting and extraction process described in the referenced PCT publication WO 2017/211892 on page 5, lines 8 to 10 to allege the process results in whole frustules (reply, pg. 8). Applicant argues while the term “whole” is not used literally, the application as a whole, and in particular the above cited parts of the application, relate implicitly yet specifically to whole frustules (reply, pg. 8). Applicant further argues if the process does not yield whole or structurally intact frustules, it would fail to achieve the inventions stated purpose (reply, pg. 8).
This is not persuasive. WO 2017/211892, page 5, ll. 8-10 is directed to the length of the benthic pennate diatoms and that these benthic pennate diatoms are cultured. No teachings of the diatom being “whole” is used in the specification of the WO 2017/211892 application. With regard to the instant application under examination, no teachings of the diatom being “whole” is used in the instant specification. Applicant’s claiming and arguing the concept of “whole” frustule indicates that Applicant considers whole frustules as essential to their invention because Applicant’s representative clearly states “the application explicitly attributes the novel SPF boosting effect to the “specific structure and form of the benthic pennate diatom frustules”. A process that did not yield “whole” or structurally intact frustules would fail to achieve the invention’s stated purpose and function.” (reply, pg. 8). MPEP 608.01 (p). I.A. is clear on how “essential material” is to be conveyed to the ordinary artisan in U.S. patent applications. ““Essential material” is defined in 37 CFR 1.57(d) as that which is necessary to (1) provide a written description of the claimed invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and set forth the best mode contemplated by the inventor of carrying out the invention as required by 35 U.S.C. 112(a); (2) describe the claimed invention in terms that particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b); or (3) describe the structure, material, or acts that correspond to a claimed means or step for performing a specified function as required by 35 U.S.C. 112(f). In any application that is to issue as a U.S. patent, essential material may only be incorporated by reference to a U.S. patent or patent application publication.” Applicant’s representative has failed to provide written description of the claimed invention being a whole frustule and failed to convey using whole frustules in both the instant and WO 2017/211892 applications. Applicant’s representative has failed to concisely indicate, point out, and “describe the structure” of whole frustule in the instant and WO 2017/211892 applications. Nonetheless, Applicant cannot point to the WO 2017/211892 application for support for a process which yields a whole frustule because MPEP 608.01 (p). I.A. requires “an application for a patent when filed may incorporate “essential material” by reference to (1) a U.S. patent, or (2) a U.S. patent application publication, which patent or patent application publication does not itself incorporate such essential material by reference. See 37 CFR 1.57(d)” (emphasis added; See MPEP 608.01 (p). I.A.). To put it plainly, WO 2017/211892 is not a US document. The specification of instant application also fails properly incorporate by reference any document because it fails to meet “the bright line”. MPEP states “Mere reference to another application, patent, or publication is not an incorporation of anything therein into the application containing such reference for the purpose of the disclosure required by 35 U.S.C. 112. In re de Seversky, 474 F.2d 671, 177 USPQ 144 (CCPA 1973). 37 CFR 1.57(c)(1) limits a proper incorporation by reference (except as provided in 37 CFR 1.57(b)) to instances only where the perfecting words “incorporated by reference” or the root of the words “incorporate” (e.g., incorporating, incorporated) and “reference” (e.g., referencing) appear. The requirement for specific root words will bring greater clarity to the record and provide a bright line test as to where something is being referred to is an incorporation by reference. The Office intends to treat references to documents that do not meet this “bright line” test as noncompliant incorporations by reference and may require correction pursuant to 37 CFR 1.57(h)”. The specification of the instant application fails to use “the perfecting words “incorporated by reference” or the root of the words “incorporate” (e.g., incorporating, incorporated) and “reference” (e.g., referencing)”.
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.
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, 6, 8-11 & 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Antoine (FR3054128; previously cited) in view of Allert (WO2017211892; previously cited) and Kuehnle (United States Patent 2020/0232003; previously cited).
*All references refer to the English language translation.
With regard to claim 1, Antoine teaches cosmetic compositions which comprise diatom frustules (abstract; pg. 2-5 & 7-10). With regard to claim 1, the cosmetic composition is used for the protection against UV radiation (abstract; pg. 2-4 & 5-8 and claims 1 & 8). With regard to claims 1 & 11, the diatom frustules can be present from 0.1-10% weight in the purified state, it would have been obvious to provide the diatom frustules within this amount in the native state for a cosmetic composition. With regard to claim 11, Antoine teaches the diatoms are cultured and harvested; the frustules are purified (pg. 9). With claims 8, 9 & 18, Antoine teaches a basic cream (i.e. acceptable cosmetic carrier medium which comprises water and oil) which comprises phenoxy ethanol (i.e. a preservative; pg. 9).
Antoine does not expressly teach the presence of an inorganic sunscreen active or that the diatom frustules comprise benthic pennate diatom frustules in a dry powder state.
With regard to claim 1, Allert teaches frustules extracted from benthic pennate diatoms that are provided as a powder or liquid solution (abstract: pg. 2, ll. 10-28: pg. 3, ll. 10-20; pg. 9, ll. 8-33). The frustules traps energy of ultraviolet range light. Benthic pennate diatoms may have thicker frustules than other diatoms which makes them more durable than frustules from other diatoms. In other words, the benthic pennate diatoms are more heavily silicified than other diatoms (pg. 4, ll. 21-32). Compared to centric diatoms, pennate diatoms are also easier to cultivate industrially in larger scale (pg. 4, ll. 23-25). With regard to claims 1 & 10, the benthic pennate diatoms can be provided as a dry powder mixed with titanium dioxide (pg. 14, ll. 29-31; pg. 16, ll. 12-16). With regard to claim 1, the frustules can absorb ultraviolet energy (pg. 17, ll. 1-4). With regard to claim 19, Allert teaches the frustules are separated from organic biomass comprised in said benthic pennate diatoms (abstract). With regard to claim 20, Figure 1b shows the frustules are whole.
With regard to claims 1, 6, & 17, Kuehnle teach that for sunscreens, frustules which contain silica when combined with titanium dioxide scatters light including UV radiation and contributes to the opacity of the formulation [0220]. “ Amorphous silica in frustules is transparent to visible light but combined with TiO2 or zinc oxide (ZnO) gains the ability to scatter light including UV radiation, contribute to iridescence, and whiten substances (opacity) as an additive” [0220]. The sunscreen powders can further comprise inorganic UV blocking compound ([0110] & [0305]).
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Here, at least rationale (B) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified Antione’s composition by substituting Antione’s diatom frustules with Allert’s benthic pennate diatom frustules in powder form which are whole and separated from the organic biomass of benthic pennate diatoms because Antione and Allert are both directed to frustules and their impact on UV radiation. One of ordinary skill in the art would have been motivated to do so, with an expectation of success, because Allert teaches that these diatoms are more durable than other diatoms and easier to cultivate.
With regard to at least one sunscreen active agent, here at least rationale (A) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified Antione’s composition by adding a sunscreen active of titanium dioxide as taught by Allert and Kuehnle because the frustules of benthic pennate diatoms contain silica and when combined with titanium dioxide scatters UV light as taught by Kuehnle. The ordinary skilled artisan would have had been motivated to do so, with an expectation of success because the benthic pennate diatoms are taught in Allert to be more silicified than other diatoms and per the teachings of Kuehnle, sunscreens comprising frustules with silica work advantageously with titanium dioxide to scatter light. Furthermore, both Antoine and Kuehnle teach formulations which protect against UV radiation with Antione teaching the use of diatom frustules and Allert suggests that diatoms including benthic pennate diatom frustules absorb ultraviolet energy.
Regarding claim 11 in that the frustules are extracted from cultured and harvested benthic pennate diatoms, the patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985; citations omitted). Here, the modified Antione arrives at the claimed benthic pennate diatom frustules and thus meets the claim. Further, Antoine teaches the diatoms are cultured and harvested; the frustules are purified (pg. 9).
With regard to the recited amount of benthic pennate diatom frustules, the combined teachings of Antoine, Allert, and Kuehnle suggest this parameter with values which overlap with the claimed range. 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).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Antoine in view of Allert and Kuehnle as applied to claims 1, 6, 8-11 & 17-20 above, and further in view of Corinaldesi (Impact of inorganic UV filters contained in sunscreen products on tropical stony corals (Acropora spp.; previously cited)).
The teachings of Antione, Allert, and Kuehnle are discussed above. Titanium dioxide is taught to be combined with frustules having silica to hep scatter light in sunscreen products.
However, neither Antione, Allert, nor Kuehnle teach titanium dioxide is present in amounts from 0.1-75% by weight.
Corinaldesi teach that inorganic UV filters including titanium dioxide are often used in sunscreen due to their broad UV protection and limited penetration into skin (abstract & introduction). The maximum concentration for sunscreen products in the U.S. includes 12% (Section 2.2). A modified titanium dioxide Optisol® offers the same advantages as untreated titanium dioxide without bleaching of the coral reefs (abstracts, section 2.1, results and discussion).
Here, at least rationale (G) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified the composition suggested by the combined teachings of Antione, Allert, and Kuehnle substituting the unmodified titanium dioxide with Corinaldesi’s modified titanium dioxide, Optisol®, by adjusting the amount of modified titanium dioxide to an amount of up to 12% by weight as taught by Corinaldesi because both Kuehnle and Corinaldesi teach the use of titanium dioxide in sunscreens, with Corinaldesi suggesting that Optisol® titanium dioxide offers superior ecological advantages over unmodified zinc oxide. Furthermore, Corinaldesi teaches that the amount of titanium dioxide that can be utilized in sunscreens can be up to 12% by weight based upon U.S. standards. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to protect against UV radiation which is the purpose of Antione’s cosmetic formulations.
With regard to the recited amount of at least one sunscreen active agent/titanium dioxide, the combined teachings of Antoine, Allert, Kuehnle, and Corinaldesi suggest this parameter with values which overlap with the claimed range. 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).
Response to Arguments
Applicant summarizes the teachings of Antoine, Allert and Kuehnle (reply, pg. 9-10). Applicant argues neither Antoine nor Allert teach the amount of diatom frustules (reply, pg. 9). Applicant argues Kuehnle does not teach that frustules at a specific upper bounded range have a UV scattering effect and provides no information on the amounts of frustule powder beyond reference Example 10 “which equals 0.00625%” (reply, pg. 9). Applicant further argues Kuehnle’s frustules and titanium dioxide are not “separately and in addition to the sunscreen active agent” (reply, pg. 10). Applicant argues a person of ordinary skill in the art would have no found no reasonable expectation of success that the addition of a specific and upper-bounded amount of benthic pennate frustules, separate to the sunscreen active agent would improve the SPF of a composition comprising titanium dioxide based upon Kuehnle (reply, pg. 10).
This is not persuasive. Applicant is arguing the references individually, In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, Antoine teaches a cosmetic compositions to protect against UV radiation which comprises frustules. Allert teaches benthic pennate diatoms are more heavily silicified than other diatoms (i.e. they contain silica; pg. 4, ll. 21-32). Allert teaches the benthic pennate diatoms can be provided as a dry powder mixed with titanium dioxide and that the frustules can absorb ultraviolet energy (i.e. the at least one sunscreen active agent and frustules are separate and in addition to the at least one sunscreen active agent; pg. 14, ll. 29-31; pg. 16, ll. 12-16; pg. 17, ll. 1-4). Kuehnle also teaches that for sunscreens, frustules which contain silica when combined with titanium dioxide scatters light including UV radiation and contributes to the opacity of the formulation [0220]. There is an expectation of success in adding titanium dioxide to scatter UV based upon Kuehnle’s teachings and the known fact that titanium dioxide scatters UV light (See instant specification pg. 5 and MPEP 2114.03).
With regard to Applicant’s allegation that the combination of references do not recognize that benthic pennate diatoms scatter UV light, the property of scattering UV effect is inherent to the benthic pennate diatoms. Applicant’s own specification at pg. 4, ll. 5-10 admits “the inventors contend that the specific structure and form of the benthic pennate diatom frustules has both a UV absorbing, UV refracting, and UV conversion effect”. Further, Kuehnle teaches silica containing frustules when combined with titanium dioxide scatters light including UV radiation [0220]. “Amorphous silica in frustules is transparent to visible light but combined with TiO2 or zinc oxide (ZnO) gains the ability to scatter light including UV radiation, contribute to iridescence, and whiten substances (opacity) as an additive” [0220]. 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).
With regard to the recited amount of frustules, Antoine is relied upon not Kuehnle. Antoine teaches inclusion of diatom frustules in an amount of 0.1-10% in cosmetic composition used for the protection against UV radiation. This overlaps with the claimed range. 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). With regard to Applicant’s argument pertaining to an “specific upper bounded range have a UV scattering effect”, Table 1 on page 8 of the specification evaluated a maximum amount of benthic pennate diatom frustules of 0.3%. No higher amounts of frustules were evaluated. As such, not enough data are present to determine whether a trend is really present for the alleged synergism at low concentrations of frustules because a decrease in the mean SPF over multiple higher concentrations of benthic pennate diatom frustules has not been demonstrated because only a maximum of 0.3% frustules has been evaluated. Also, the Examiner notes that the standard deviations for the mean SPF between 0.1 % frustules and 0% frustules overlap; the standard deviations for the mean SPF between 0.3% frustules and 0% frustules overlap; and the standard deviations for the mean SPF between 0.3% frustules and 0.1% frustules overlap. No statistical tests, such as a non-parametric test, have been performed to determine whether the differences in mean SPF between amounts is significant. 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). To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960) (see MPEP 716.02).
Applicant argues synergism is present; frustules act as a distinct booster for a primary active ingredient while Kuehnle relates to a single, integrated ingredient (reply, pg. 9-10).
This is not persuasive. Synergism is a statistical term in which the interaction of two or more substances produce a combined effect greater than the sum of their separate effects. While Applicant has shown the effect of inorganic sunscreen comprising zinc oxide, titanium dioxide, and silica alone at a concentration of 12% (see instant specification-Table 1, pg. 8), Applicant has not shown the effect of benthic pennate diatom frustules alone. As such, it cannot be determined whether synergism is present. Further claim 1 is generic to the amount of sunscreen active agent, whether it is organic or inorganic, and its amount. Claim 1 also requires the lower limit for the amount of benthic pennate diatom frustules be 0.05% by weight, however this lower limit was not evaluated. In other words, the data are not commensurate with the scope of the claims. "[O]bjective 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 Applicant’s arguments pertaining to Kuehnle relating to a single, integrated ingredient, the examiner reiterates that Kuehnle is used to teach that silica-containing frustules have the property of scattering UV radiation when combined with titanium dioxide [0220].” Amorphous silica in frustules is transparent to visible light but combined with TiO2 or zinc oxide (ZnO) gains the ability to scatter light including UV radiation, contribute to iridescence, and whiten substances (opacity) as an additive” [0220]. Further, Antoine teaches the concept of frustules as an individual reagent in a cosmetic formulation to protect against UV radiation and Allert teaches the benthic pennate diatoms can be provided as a dry powder mixed with titanium dioxide (pg. 14, ll. 29-31; pg. 16, ll. 12-16).
In the traverse of the rejection of claim 5, Applicant argues Corinaldesi does not remedy the deficiencies of Antoine, Allert, and Kuehnle (reply, pg. 10).
This is not persuasive. Discussion as to how Antoine, Allert, and Kuehnle render the instant claims obvious is presented in the 35 USC 103 rejection and Response to Arguments above.
Conclusion
No claims are allowed.
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/LORI K MATTISON/ Examiner, Art Unit 1619
/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
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