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 .
Clams Status
Claims 1-2, 4, 10-11, 13,16,17, and 19-22 are under current examination.
Applicants' arguments and amendments filed on 12/18/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. They constitute the complete set presently being applied to the instant application.
Information Disclosure Statements
Information Disclosure Statement (IDS) filed on 08/13/2025 has been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
New Rejections necessitated by addition of new claims
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 21 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.
Claim 21 recites one or more active substances selected from the group consisting of, and the claim also recites cosmetically or pharmaceutically acceptable excipients selected from as part of the Markush for the active agents in lines 2-3 at page 4 of claim 21. The claim further recites other conventional components of a cosmetic composition. Here, it is unclear what agents the selection for the active encompasses since there is a second selection of excipients embedded in the Markush and other agents. Thus, it is unclear which agents are part of the Markush clam or not for the recitation of one or more active substances selected from the group consisting of.
Claim 21 is indefinite for the recitation of “(metal)” chelating agents because it is unclear whether the metal is required by the claim or not since the metal is in parenthesis.
Claim 21 recites “ waxes or other conventional components of a cosmetic composition such as alcohols, polyols, polymers, foam stabilizers, electrolytes, organic solvents or silicone derivatives and thereof”. 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). It is unclear which other conventional components of a cosmetic composition are required by the claim.
Accordingly, claim 21 is indefinite.
Rejections maintained and slightly modified in view of new claims 21-22
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, 2, 4-5, 10-11, 13, 16-17, 19-20 and new claim 21 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:
Claims 4-5, 10-11, 13, 16-17, and 19-20 require a composition that comprises a) 4-hydroxyacetophenone and at least one avenanthramide (encompassing the elected avenanthramide L).
Claims 4 recites that the avenanthramide comes from an oat of Avena sativa or Avena nuda.
Claim 5 recites an amount of the 4-hydroxyacetophenone and an amount of the avenanthramide (elected species to avenanthramide L).
Claims 10-11 and 19-20 recite that the composition is a cosmetic.
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. As evidenced by Miyagawa et al. (Induction of Avenanthramides in Oat Laves Inoculated with Crown Rust Fungus, Puccinia coronata f. sp. avenae) avenanthramide L is naturally found in oats. As evidenced by Chemical Book, 4-hydroxyacetophenone is a natural compound found naturally in plants like Artemisia and Radix Adenophorae.
Thus both avenanthramide L and 4-hydroxyacetophenone are natural compounds found in oats or plants.
New claim 21 recites a genus of components which encompass naturally occurring components including moisturizing agents. Skin moisturizing substances include jojoba which is a natural product processed from seeds, see pages 1-4 of HobaCare.
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 natural extract of oats and a natural extract of Artemisia or Radix Adenophor plant.
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 natural components from the instant specification is improved solubility although this characteristic is not claimed.
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 instant specification combines 4-hydroxyacetophenone with avenanthramide L with the characteristic to improve solubility (paragraph 001).
Schmaus et al. (United States Patent 20150374599) teach cosmetic compositions which comprise at least one acetophenone derivative, see claim 16 and paragraphs [0048]-[0049]. In one preferred embodiment there is one acetophenone which comprises 4-hdyroxyacetophenone, see paragraph [0048], [0306], and claim 18 and Tables 1-7. The composition can comprise anti-inflammatory active agents including avenanthramides, see paragraphs [0192]-[0193]. The cosmetic composition can comprise 0.05-5% acetophenone derivative including 4-hydroxyacetophenone plus 0-25 active principles, see paragraph [0311]. The acetophenone derivatives stabilize emulsions through improved solubility of lipophilic compound. Thus increasing solubility with acetophenones including 4-hyroxyacetopenone was known prior to the instant invention which combines lipophilic substances with 4-hydroxyacetophenone to improve solubility.
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 claims and ratios do not appear to add significantly more as the combination with lipophilic substances with acetophenones is taught to improve solubility.
Therefore, simply combining the two natural products claimed would not provide significantly more than the judicial exception.
Therefore, the claims are not patent eligible subject matter under 35 USC § 101.
Response to remarks-101
Applicants argue that though avenanthramide L can be obtained by extraction from oats, the formulations of the instant specification were prepared from steps using human intervention and there is no indication that avenanthramides and 4-hydroxyacetaphenone are found in nature together.
Examiner respectfully submits that there is no evidence that the combination has any markedly different characteristics with the instantly claimed ratio and amounts. There is no indication that the claimed ingredients has any characteristics (structure, functional or otherwise) that are different from the naturally occurring ingredients. The test is not whether the ingredients all occur naturally together in nature as the compounds are evaluated for their individual counterparts. At present is no indication that the claimed ingredients has any characteristics (structure, functional or otherwise) that are different from the naturally occurring ingredients in the amounts and ratios claimed. Furthermore, there is no evidence that extracting the avenanthramide natural compound from oat via the processes described alters the compound structurally or functionally from its individual counterpart that is found in nature (i.e. oats).
Applicants argue that the claims offer markedly different characteristics as there is a need for improved solubility. Applicants point to tables 4a and 4b to show the combination provides improved solubility.
Examiner respectfully submits that the claims at present do not commensurate in scope with the examples providing improved solubility. For example, Table 4a has Avenanthramide L in a concentration of 0.01% by weight. Table 4b has aventnathramide L 0.015% by weight. The ratio of the avenanthramide analog in table 4b to 4-hydroxyacetophenone is 0.03. Furthermore, there are no example demonstrating up to 50 times more of 4-hydroxyacetaphenone to avenanthramide to satisfy the ratio of 1:50 or avenanthramide analogue to 4-hydroxyacetophenone of 1:30. Thus, the claims do not commensurate in scope with the alleged unexpected results to improved solubility such that the breadth of claim 1 results in markedly different characteristics. Furthermore, 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. Here, it appears from the teachings of Schmaus et al that the acetophenone derivatives which include 4-hydroxyacetophenone stabilize emulsions through improved solubility of lipophilic compound. Thus, increasing solubility with acetophenones including addition of the natural compound of 4-hyroxyacetopenone was known prior to the instant invention which combines lipophilic substances with 4-hydroxyacetophenone to have the characteristic of improved solubility.
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, 2, 4, 10-11, 13, 16-17, 19-20, and new claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Schmaus et al. (United States Patent 20150374599-See IDS filed 12/2/2022) in view of Redmond et al. (United States Patent Publication 20140066510), Meydani (United States Patent Publication 2007/0254055) and Miyagawa et al. (Induction of Avenanthramides in Oat Laves Inoculated with Crown Rust Fungus, Puccinia coronata f. sp. avenae).
The instant claims are being examined to the extent of the elected specie of: composition comprising avenanthramide L and 4-hydroxyacetophenone, a cosmetic composition, and emulsion form.
Schmaus et al. teach cosmetic compositions which comprise at least one acetophenone derivative, see claim 16 and paragraphs [0048]-[0049]. In one preferred embodiment there is one acetophenone which comprises 4-hdyroxyacetophenone, see paragraph [0048], [0306], and claim 18 and Tables 1-7. The composition can comprise anti-inflammatory active agents including avenanthramides, see paragraphs [0192]-[0193]. The cosmetic composition can comprise 0.05-5% acetophenone derivative including 4-hydroxyacetophenone plus 0-25 active principles, see paragraph [0311]. The amount of the 4-hydroxyacetophenone overlaps and renders obvious the claimed mount of from 0.005-2% by weight. From MPEP 2144.05, 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). The acetophenone derivatives stabilize emulsions through improved solubility of lipophilic compound, see paragraph [0021]. The cosmetic composition can take the form of an emulsion, see paragraph [0182] and [0218]. The avenanthramides can be extracts from an oat source, see paragraph [0193]. Schmaus suggests that the active principles are present from 0-25% by weight and that the 4-hydroxyacetopheneone can be present from 0.05-5% by weight. Schmaus et al. teach that the composition can comprise skin moisturizing agents including 1-2-hexanediol, see paragraphs [0052] and [0187].
Schmaus does not expressly teach that the avenanthramide is avenanthramide L in an amount present from 0.0001-5% by weight with Avena sativa or Avena nuda oat source.
However, Redmond et al. teach stable oat extract compositions for cosmetics, see paragraph [0060]. The avenanthramide can comprise formula I in which R1=OH, R2=H and R3=H wherein n is repeating units.
PNG
media_image1.png
386
825
media_image1.png
Greyscale
The avenanthramide composition treats inflammation and disorders of skin, and can be present at 1-1500ppm (0.0001- 0.15% weight) see paragraph [0159] and disclosure of invention section and claims 6 and 12.
Schmaus at Formula I is suggestive of repeat units n. however does not expressly teach avenanthramide L where the n=2.
Meydani teaches extracts from Avena Sativa oats which comprise formula of:
PNG
media_image2.png
321
690
media_image2.png
Greyscale
Where n is less than 3 and the side chains R1-R4 are each selected from the group H, OH, or OCH3. The phenolic composition which is taken from oats can reduce inflammation.
Miyagawa et al. teach that avenanthramides which can be taken from Avena sativa oats include Compound 6 (see structure below) which is avenanthramide L, see pages 2-3. Avenanthramide L is a structure where n is equal to 2, R1=OH, R2=H and R3=H.
PNG
media_image3.png
243
300
media_image3.png
Greyscale
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the anti-inflammatory avenanthramides taught in Schmaus for Avenanthramide L. One of ordinary skill in the art would have been motivated to do so because avenanthramide L is an extract from Avena sativa oats and per the teachings of Redmond and Meydani avenanthramides are suggested to treat inflammation. There would have been a reasonable expectation of success because Schmaus teaches the use of avenanthramides as anti-inflammatory active agents and the substitution of Schmaus anti-inflammatory avenanthramides for avenanthramide L would per the teachings of Meydani and Redmond provide for anti-inflammatory properties to a cosmetic topical formulation.
Regarding the amount of 4-hydroxyacetophenone, Schmaus cosmetic composition can comprise 0.05-5% acetophenone and per Redmond, the avenanthramide composition treats inflammation and disorders of skin, and can be present at 1-1500ppm (0.0001- 0.15% weight). Together, these amounts overlap and therefore render obvious the amount of avenanthramide and 4-hydroxyacetophenone claimed and ratio claimed (e.g. 1:1). Together the total amount encompass 0.0501-5.15%. 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 remarks-103
Applicant argue that while Schmaus describes that avenanthramides can be used as ani-inflammatory additive, Schmaus does not provide motivation to select an avenanthramide from the dozens of anti-inflammatory agents. Applicants argue that Schmaus does not provide motivation to select a combination of avenanthramide with 4-hydroxyacetophenone from among all combinations of acetophenone derivatives. Applicants argue that Schamus does not disclose the amount and ratio of the claimed avenanthramide and 4-hydroxyacetophenone.
Examiner respectfully submits that the Schamus expressly teaches avenanthramide as preferable anti-inflammatory at paragraph [0193]. The antioxidant is preferably selected from the group consisting of alpha-bisabolol, natural avenanthramides, non-natural avenanthramides, preferably dihydroavenanthramide D (as described in WO 2004 047833 A1), boswellic acid, phytosterols, glycyrrhizin, and licochalcone A. Thus, the avenanthramides are clearly a suitable option for use as the anti-inflammatory agent in Schmaus. Regarding the motivation to combine avenanthramide and 4-hydroxyacetophenone, Schmaus expressly teaches in a preferred embodiment there is an acetophenone of formula 1 and the formulation can further contain anti-inflammatory agents, see paragraphs [0051]-[0052]. 4-hydroxyacetophenone is the preferred acetophenone derivative of formula 1 per paragraph [0030] and examples 1-6. Thus, the 4-hydroxyacetophonone is clearly the preferred acetophenone and the formulations of Schamus contain anti-inflammatory agents. From the teachings of Redmond, avenanthramide treats inflammation and disorders of skin, and can be present at 1-1500ppm (0.0001- 0.15% weight) see paragraph [0159] and disclosure of invention section and claims 6 and 12. Regarding Applicants argument that Schmaus does not disclose amounts or ratios, the 4-hydroxyaceophenone of Schmaus is present from 0.05-5% by weight, and Redmond teaches 0.0001-0.15% by weight of the avenanthramides provides anti-inflammatory properties. These amounts overlap and render obvious the instantly claimed ratios (e.g. 1:1 ratios). 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)
Applicants argue that Redmond or Myedani or Miyagawa do not disclose or suggest a particular combination of avenanthramide with 4-hydroxyacetaphenone. However, Examiner notes that Schmaus does suggest a combination of acetophenone with 4-hydroxyacetopheneone being preferred with anti-inflammatory agents including avenanthramide. Redmond further teaches avenanthramides in amounts from 0.0001-.15% by weight are effective for imparting anti-inflammatory properties. The combination of the amount of avenanthramide and the 4-hydroxyacetaphenone is disclosed in Schmaus et al. in view of Redmond et al., Meydani, and Miyagawa et al. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicants argue that the present invention describes benefits to avenanthramide or analogue in combination with 4-hydroxyacetophenone in amounts and ratio disclosed. Tables 3-8 indicates improved solubility. In particular, Tables 4a and 4b.
From MPEP 716.02(d) the objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). The nonobviousness of a broader claimed range can be supported by evidence based on unexpected results from testing a narrower range if one of ordinary skill in the art would be able to determine a trend in the exemplified data which would allow the artisan to reasonably extend the probative value thereof. In re Kollman, 595 F.2d 48, 201 USPQ 193 (CCPA 1979). Examiner respectfully submits that the claims at present do not commensurate in scope with the examples providing improved solubility. For example, Table 4a has Avenanthramide L in a concentration of 0.01% by weight. Table 4b has aventnathramide L 0.015% by weight. None of tables 4-8 demonstrate avenanthramide at 0.0001% by weight. The ratio of the analog in table 4b to 4-hydroxyacetophenone is 0.03. Furthermore, there are no example demonstrating up to 50 times more of 4-hydroxyacetaphenone to avenanthramide to satisfy the ratio of 1:50 or avenanthramide analogue to 4-hydroxyacetophenone of 1:30. Thus, the claims do not commensurate in scope with the alleged unexpected results to improved solubility such that the breadth of claim 1 results in markedly different characteristics. Furthermore, improved solubility is already disclosed by the teachings of Schmaus in which the acetophenone derivatives stabilize emulsions through improved solubility of lipophilic compounds, see paragraph [0021]. Thus, the formulation of Schmaus is taught to impart improved solubility. 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). Here, the prior art makes it known that 4-hydroxyaceophenone provides the property of improved solubility when combined with lipophilic compounds.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 4, 10-11, 13, 16-17, and 19-20 and new claims 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7,9,15-17 and 19 of copending Application No. 17/909,342 (hereafter ‘342) in view of Schmaus et al. (United States Patent 20150374599) and Miyagawa et al. (Induction of Avenanthramides in Oat Laves Inoculated with Crown Rust Fungus, Puccinia coronata f. sp. avenae).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Both the instant claims and the claims of Application ‘342 are directed a composition comprising at least one avenanthramide or an analogue thereof. Both the instant claims and that of Application ‘342 recite the presence of 4-hydroxyacetophenone with the avenanthramide. Both applications recite that the at least one avenanthramide is selected from the group of avenanthramides A, B, C, G, H, K, L, and R, mixtures thereof (elected species to L). The composition which comprises avenanthramide can be present in a range inclusive of 0.0001-10% by weight and the avenanthramide of ‘342 is present from 0.001-5% by weight, such amounts overlap the instantly claimed ranges.
The claims of ‘342 do not have an amount of the 4-hydroxyacetophenone present or which oat source the avenanthramide is obtained from or the inclusion of skin moisturizing agents such as 1-2 hexanediol.
Schmaus et al. teach cosmetic compositions which comprise at least one acetophenone derivative, see claim 16 and paragraphs [0048]-[0049]. In one preferred embodiment there is one acetophenone which comprises 4-hdyroxyacetophenone, see paragraph [0048], [0306], and claim 18 and Tables 1-7. The composition can comprise anti-inflammatory active agents including avenanthramides, see paragraphs [0192]-[0193]. The cosmetic composition can comprise 0.05-5% acetophenone derivative including 4-hydroxyacetophenone plus 0-25 active principles, see paragraph [0311]. The amount of the 4-hydroxyacetophenone overlaps and renders obvious the claimed mount of from 0.005-2% by weight. The acetophenone derivatives stabilize emulsions through improved solubility of lipophilic compound, see paragraph [0021]. The cosmetic composition can take the form of an emulsion, see paragraph [0182] and [0218]. The avenanthramides can be extracts from an oat source, see paragraph [0193]. Schmaus suggests that the active principles are present from 0-25% by weight and that the 4-hydroxyacetopheneone can be present from 0.05-5% by weight. Schmaus et al. teach that the composition can comprise skin moisturizing agents including 1-2-hexanediol, see paragraphs [0052] and [0187].
Miyagawa et al. teach that Avenanthramides which can be taken from Avena sativa oats include Compound 6 (see structure below) which is avenanthramide L, see pages 2-3. Avenanthramide L is a structure where n is equal to 2, R1=OH, R2=H and R3=H.
PNG
media_image3.png
243
300
media_image3.png
Greyscale
It would have been obvious to provide the 4-hydroxyacetophenone in amount of 0.05-5% by weight and the avenanthramide L from an Avena sativa oat source as the composition of Schmaus comprising 4-hydroxyacetophenone forms stable emulsions with improved solubility and can comprise avenanthramides. This amount of 4-hydroxyacetophenone and the amount of avenanthramide of Application ‘342 overlap the instantly claimed ratios. It would have additionally been obvious to provide 1-2 hexanediol with the composition of Application ‘342 to impart skin moisturizing properties.
Claims 1, 2, 4-5, 10-11, 13, 16-17, and 19-20 are directed to an invention not patentably distinct from claims 1, 7,9,15-17 and 19 of commonly assigned copending Application No. 17/909,342.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411 ). Commonly assigned copending Application No. 17/909,342 discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 1, 2, 4, 10-11, 13, 16-17, and 19-20 and new claims 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2,4,12, and 17 of copending Application No. 17/909,340 (hereafter ‘340) in view of Schmaus et al. (United States Patent 20150374599).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Both the instant claims and the claims of Application ‘340 are directed a composition comprising at least one avenanthramide or an analogue thereof. The composition which comprises avenanthramide can be present in a range inclusive of 0.0001-10% by weight and the avenanthramide of ‘340 is present from 0.0001-5% by weight, such amounts overlap the instantly claimed ranges. The source of the avenanthramide is Avena sativa or Avena nuda oats. Both the instant claims and that of Application ‘340 contain agents including 1-2-hexanediol (see claim 18 of Application ‘340).
The claims of ‘340 do not recite the presence of 4-hydroxyacetophenone in the claimed amount or ratio.
Schmaus et al. teach cosmetic compositions which comprise at least one acetophenone derivative, see claim 16 and paragraphs [0048]-[0049]. In one preferred embodiment there is one acetophenone which comprises 4-hdyroxyacetophenone, see paragraph [0048], [0306], and claim 18 and Tables 1-7. The composition can comprise anti-inflammatory active agents including avenanthramides, see paragraphs [0192]-[0193]. The cosmetic composition can comprise 0.05-5% acetophenone derivative including 4-hydroxyacetophenone plus 0-25 active principles, see paragraph [0311]. The amount of the 4-hydroxyacetophenone overlaps and renders obvious the claimed mount of from 0.005-2% by weight. From MPEP 2144.05, 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). The acetophenone derivatives stabilize emulsions through improved solubility of lipophilic compound, see paragraph [0021]. The cosmetic composition can take the form of an emulsion, see paragraph [0182] and [0218]. The avenanthramides can be extracts from an oat source, see paragraph [0193]. Schmaus suggests that the active principles are present from 0-25% by weight and that the 4-hydroxyacetopheneone can be present from 0.05-5% by weight.
It would have been obvious to provide the 4-hydroxyacetophenone in amount of 0.05-5% by weight as Schmaus’s composition comprising 4-hydroxyacetophenone forms stable emulsions with improved solubility and can comprise avenanthramides. The weight of the 4-hydroxyacetophenone taught by Schmaus with the avenanthramide of Application ‘340 overlaps the instantly claimed weigh ratio. The ratio of the hydroxy acetophenone being from 0.05-5% and the avenanthramide being from 0.001-10% overlap and render obvious the instantly claimed ratio which includes 1:1 ratios.
Claims 1, 2, 4-5, 10-11, 13, 16-17, and 19-20 are directed to an invention not patentably distinct from claims 1-2,4,12, and 17 of commonly assigned copending Application No. 17/909,340. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411 ). Commonly assigned copending Application No. 17/909,340 discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Response to remarks-Double Patenting
Applicants argue that Even if 4-hydroxyacetophenone is considered to be an avenanthramide stabilizer, the present claims do not disclose or suggest a combination of at least two avenanthramide stabilizers comprising a chelating agent and organic carboxylic acid or a chelating agent and an antioxidant or an organic carboxylic acid and antioxidant. Applicants argue that the claims of ‘342 do not recite the amounts and ratios claimed.
Examiner respectfully submits that the instant claims require the combination of avenanthramide and 4-hdyroxyacetophenone. Although, Application ‘342 contains antioxidant, chelating agent and other ingredients, the instant claims would not necessarily exclude their inclusion in view of the comprising language. Nevertheless, the claims of Application ‘342 expressly teach a combination of 4-hydroxyacetaphoneon and avenanthramide in overlapping amounts, see claim 9. The amounts recited in claim 9 are inclusive of the instantly claimed ratios (e.g. 1:1).
Regarding the ‘340 Application, the avenanthramide is present from 0.0001-5% by weight, such amounts overlap the instantly claimed ranges. The source of the avenanthramide is Avena sativa or Avena nuda oats. In view of Schmaus, it would have been obvious to provide the 4-hydroxyacetophenone in amount of 0.05-5% by weight as Schmaus’s composition comprising 4-hydroxyacetophenone forms stable emulsions with improved solubility and can comprise avenanthramides. Thes amounts overlap and render obvious weight ratios instantly claimed (e.g. 1:1).
Conclusion
Applicant’s arguments/remarks are considered unpersuasive and furthermore the additions of new claims necessitated a new grounds of rejection. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Currently, no claims are allowed and all claims are rejected.
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached at 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH ALAWADI/Primary Examiner, Art Unit 1619
Prosecution Insights