DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-9, 11 and 15-19 in the reply filed on 12/5/25 is acknowledged.
Claims 10 and 12-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claim Rejections - 35 USC § 112-2nd paragraph
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9, 11 and 15-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping in claim 11 of:
Species A: A pharmaceutical composition according to claim 1 (An anti-inflammatory extract of soil microorganisms or a fraction thereof, wherein the microorganisms comprise one or more selected from Chlorophyta, Xanthophyceae or Cyanobacteria, optionally together with a suitable carrier substance and/or excipient).
Species B: A composition comprising two or more of Lyso-DGTS, p-Coumaric acid (ester-linked), oleamide, theophylline or DGTS as an active ingredient, optionally together with a suitable carrier substance and/or excipient.
Species B belongs in Group II with claim 10.
The grouping with Species A is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: they comprise different active ingredients. The bacteria extract from claim 1 is not the same as the chemical composition in Species B.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim 11 is vague and indefinite because it does not appear the “or a composition comprising two or more of Lyso-DGTS, p-Coumaric acid (ester-linked), oleamide, theophylline or DGTS as an active ingredient is intended to also comprise the anti-inflammatory extract of soil microorganisms or a fraction thereof, wherein the microorganisms comprise one or more selected from Chlorophyta, Xanthophyceae or Cyanobacteria. The wording of the claim makes this vague and confusing. It is being treated as a Markush group with the composition of Species A being examined. See above Markush rejection. It is suggested it be removed from the claim and be placed in Group II as its own claim. Appropriate clarification and/or correction is required.
Claim 1 is vague and indefinite because the product being claimed is unclear. The mere recitation of a name, i.e., anti-inflammatory extract or fraction thereof, to describe the invention is not sufficient to satisfy the Statute's requirement of adequately describing and setting forth the inventive concept. The claim should provide any structural properties of the extract or a distinct method of obtaining the extract, which would allow for one to identify the claimed compound without ambiguity. The mere recitation of a name does not adequately define the claimed compound. Claims 1 and 2 comprise a large list of different microorganisms and it is unclear what extracts would contain this extract with special anti-inflammatory properties, much less any fraction thereof. The terms "Chlorophyta", "Xanthophyceae" and "Cyanobacteria" refer to huge classes of thousands of microorganisms and the claim does not make clear what structure/extract would function as an anti-inflammatory. Appropriate clarification and/or correction is required.
Claim 3 is vague and indefinite due to the phrase “part of the soil microorganisms” because it is unclear what “part” is necessary and what it comprises which contains the specific anti-inflammatory properties. Claim 3 is also vague and indefinite for use of the term “obtainable by.” This is not an active step. The word “obtainable” should be changed to “obtained” for the method steps to be part of the claim. The use of the term “optionally” in claim 3 is vague and indefinite as it makes it unclear if this step is part of the claim. See MPEP 2173.05(h). Appropriate clarification and/or correction is required.
Claim 5 is vague and indefinite due to the term “stress conditions.” It is unclear what type of specific conditions are considered “stress conditions” and such conditions appear to be critical to the formation of the extract. While the specification can be used to provide definitive support, the claims are not read in a vacuum. Rather, the claim must be definite and complete in and of itself. Limitations from the specification will not be read into the claims. The claims as they stand are incomplete and fail to provide adequate structural properties to allow for one to identify what is being claimed. Appropriate clarification and/or correction is required.
Claim 6 recites generic types of stress but the actual conditions are vague and unclear, specifically since such a large and diverse group of microorganisms are included in the scope of the claim. While the specification can be used to provide definitive support, the claims are not read in a vacuum. Rather, the claim must be definite and complete in and of itself. Limitations from the specification will not be read into the claims. The claims as they stand are incomplete and fail to provide adequate structural properties to allow for one to identify what is being claimed. Appropriate clarification and/or correction is required.
Claims 7 and 11 are unclear if the microbial extract is intended to contain the one or more of Lyso-DGTS, p-Coumaric acid (ester-linked), oleamide, theophylline or DGTS or if these compounds are added separately to the composition comprising the extract. The way the claim is written it recites that the extracts will contain these themselves. If it is the former, then any of the extracts recited in the prior art below would inherently comprise these compounds. Appropriate clarification and/or correction is required.
Claim 15 is vague and confusing as it recites a “non-pharmaceutical composition” yet the composition comprises and anti-inflammatory extract or fraction thereof which is a medical/therapeutic/pharmaceutical activity. Appropriate clarification and/or correction is required.
Claim Rejections - 35 USC § 112-Written Description
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.
Claims 1-9, 11 and 15-19 are 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.
The claims recite, for example:
Claim 1. An anti-inflammatory extract of soil microorganisms or a fraction thereof, wherein the microorganisms comprise one or more selected from Chlorophyta, Xanthophyceae or Cyanobacteria.
Claim 2. The extract or fraction thereof according to claim 1, wherein the soil microorganisms comprise one or more selected from Xanthophyceae, Nostoc sp., Pseudochlorella sp., CoccoTyxa sp., Neocystis brevis; Chromochloris sp., Chlorella saccharophila, Bracteacoccus sp., Dictyococcus varians, Muriella sp., or Coelastrella sp.,
The terms "Chlorophyta", "Xanthophyceae" and "Cyanobacteria" refer to huge classes of thousands of microorganisms, as do the numerous species recited in claim 2. However, the instant specification does not provide sufficient technical guidance or written description as to which compounds are suitable to fulfil the desired function or activity ("anti-inflammatory"). Further, there is no simple (in vivo or in vitro) tests (such as e.g. screening methods, etc) are available to determine/verify whether or not a particular compound fulfils the desired function (e.g. "inhibition of release of pro- inflammatory cytokines", "inhibition of the IKK complex" etc.). Thus, the present functional definition "anti-inflammatory/inhibition of release of pro-inflammatory cytokines/IKK complex" can only be seen as a mere invitation to the skilled person to perform a full research program in order to find the suitable variants (species, extracts, fractions, ingredients). Under these circumstances, the claimed invention does not have adequate written description.
With the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus. See Ariad, 598 F.3d at 1353 (The written description requirement guards against claims that "merely recite a description of the problem to be solved while claiming all solutions to it and . . . cover any compound later actually invented and determined to fall within the claim's functional boundaries."). Abbvie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 U.S.P.Q.2d 1780, 1790, 2014 BL 183329, 12 (Fed. Cir. 2014).
To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. Applicants have not described the genus of anti-inflammatory extracts or fractions thereof such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the claimed invention at the time the application was filed.
The purpose of the "written description" requirement is broader than tomerely explain how to "make and use"; the applicant must convey with reasonableclarity to those skilled in the art that, as of the filing date sought, he or she was inpossession of the invention. The invention is, for purposes of the "writtendescription" inquiry, whatever is now claimed. See Vas-Cath, Inc. v. Mahurkar,935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991).Furthermore, the written description provision of 35 USC § 112 is severable fromits enablement provision; and adequate written description requires more than amere statement that it is part of the invention and reference to a potential methodfor isolating it. The nucleic acid [product] itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was "ready for patenting" by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus'" (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus.
It is noted that MPEP 2111.01 states that "[d]uring examination, the claims must be interpreted as broadly as their terms reasonably allow." The Court of Appeals for the Federal Circuit has recently held that a "written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." University of California v. Eli Lilly and Co., 1997 U.S. App. LEXIS 18221, at *23, quoting Fires v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993). To fully describe a genus of genetic material, which is a chemical compound, applicants must (1) fully describe at least one species of the claimed genus sufficient to represent said genus whereby a skilled artisan, in view of the prior art, could predict the structure of other species encompassed by the claimed genus and (2) identify the common characteristics of the claimed molecules, e.g., structure, physical and/or chemical characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or a combination of these (paraphrased from Enzo Biochemical).University of Rochester v. G.D. Searle & Co. (69 USPQ2d 1886 (2004)) specifically points to the applicability of both Lilly and Enzo Biochemical to methods of using products, wherein said products lack adequate written description. While in University of Rochester v. G.D. Searle & Co. the methods were held to lack written description because not a single example of the product used in the claimed methods was described, the same analysis applies wherein the product, used in the claimed methods, must have adequate written description (see Enzo paraphrased above).
In the instant case, there is no structure associated with function with regard to the members of a genus. Extracts, as well as any fractions thereof, from thousands of different microorganisms, are claimed. There is no information or characterization of the actual biological material which possess this function. The claimed genera of extracts and fractions thereof have widely variable structures and a specific structure has not been correlated to function. One skilled in the art cannot reasonably conclude that applicant had possession of the claimed invention at the time the instant application was filed. Furthermore, "Possession may not be shown by merely describing how to obtain possession of members of the claimed ,genus or how to identify their common structural features" (See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895). A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the .gene does (function), rather what it is (structure), see University of California v. Eli Lilly & Co., 43 USPQ2d 1938, thus above claims lack adequate written description.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 8, 9, 11, 15 and 17-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kuniyoshi et al (JP 2014 055128 A, March 2014; provided by Applicants).
Kuniyoshi teaches compositions used for treating and preventing an inflammatory disease like acne or arthritis, comprising an extract of Chlorophyta strain A07, Chlorella strain A03, Chlamydomonas strain A13 and Chlamydomonas strain A14. Claims 5-6 are product-by-process claims. “The patentability of a product does not depend upon its method of production. If the product in [a] product-by-process claim is the same as or obvious from a product of the prior art, [then] the claim is unpatentable even though the prior [art] product was made by a different process.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). Further, the use of the term “comprises” in the claims allows for additional ingredients. Given the extracts of Kuniyoshi are structurally the same as those instantly claimed, e.g., an extract or fraction thereof from at least one or more of the microorganisms recited in the claims, they would inherently possess the same functional properties, e.g., anti-inflammatory, inhibits the IKK complex and/or the processes downstream of the NF-kB pathway and/or inhibits the release of pro-inflammatory cytokines. Atlas Powder Co. V IRECA, 51 USPQ2d 1943, (FED Cir. 1999) states Artisans of ordinary skill may not recognize the inherent characteristics or functioning of the prior art. However, the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer. The Court further held that this same reasoning holds true when it is not a property but an ingredient which is inherently contained in the prior art. Additionally, a “cosmetic” or food or drink supplement” are intended uses only. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. A “physiologically acceptable carrier” reads on water and therefore would be inherent in the preparation of the extracts.
Claim(s) 1-6, 8, 9 and 15-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xiaoqun et al (CN 107 582 574 A, January 16, 2018; provided by Applicants).
Xiaoqun et al describe the use of Nostoc commune ethanol extract in preparing medicine or health products for treating inflammatory bowel disease. Claims 5-6 are product-by-process claims. “The patentability of a product does not depend upon its method of production. If the product in [a] product-by-process claim is the same as or obvious from a product of the prior art, [then] the claim is unpatentable even though the prior [art] product was made by a different process.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). Further, the use of the term “comprises” in the claims allows for additional ingredients. Given the extracts of Xiaoqun are structurally the same as those instantly claimed, e.g., an extract or fraction thereof from at least one or more of the microorganisms recited in the claims, they would inherently possess the same functional properties, e.g., anti-inflammatory, inhibits the IKK complex and/or the processes downstream of the NF-kB pathway and/or inhibits the release of pro-inflammatory cytokines. Atlas Powder Co. V IRECA, 51 USPQ2d 1943, (FED Cir. 1999) states Artisans of ordinary skill may not recognize the inherent characteristics or functioning of the prior art. However, the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer. The Court further held that this same reasoning holds true when it is not a property but an ingredient which is inherently contained in the prior art. Additionally, a “cosmetic” or food or drink supplement” are intended uses only. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. A “physiologically acceptable carrier” reads on water and therefore would be inherent in the preparation of the extracts.
Claim(s) 1-6, 8, 9, 11, 15 and 17-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cho Chung Won et al (KR 2004 0084376 A, October 6, 2004; provided by Applicants).
Cho Chung Won et al teaches compositions comprising the extract of Chlorella (, obtained by using water, ethanol, methanol, butanol or their mixture as extracting solvent,) for the prevention and treatment of inflammatory diseases, where the extract inhibits inflammation by inhibiting anion generation of nitrogen oxide and superoxide and the activity of NF-kB in macrophage. Claims 5-6 are product-by-process claims. “The patentability of a product does not depend upon its method of production. If the product in [a] product-by-process claim is the same as or obvious from a product of the prior art, [then] the claim is unpatentable even though the prior [art] product was made by a different process.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). Further, the use of the term “comprises” in the claims allows for additional ingredients. Given the extracts of Cho Chung Won are structurally the same as those instantly claimed, e.g., an extract or fraction thereof from at least one or more of the microorganisms recited in the claims, they would inherently possess the same functional properties, e.g., anti-inflammatory, inhibits the IKK complex and/or the processes downstream of the NF-kB pathway and/or inhibits the release of pro-inflammatory cytokines. Atlas Powder Co. V IRECA, 51 USPQ2d 1943, (FED Cir. 1999) states Artisans of ordinary skill may not recognize the inherent characteristics or functioning of the prior art. However, the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer. The Court further held that this same reasoning holds true when it is not a property but an ingredient which is inherently contained in the prior art. Additionally, a “cosmetic” or food or drink supplement” are intended uses only. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. A “physiologically acceptable carrier” reads on water and therefore would be inherent in the preparation of the extracts.
Claim(s) 1-6, 8, 9, 11, 15 and 17-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cho Chung Won et al (KR 2004 0084377 A, October 6, 2004; provided by Applicants).
Cho Chung Won describes cosmetic compositions comprising the extract of Chlorella (obtained by using water, ethanol, methanol, butanol or their mixture as extracting solvent,) for the prevention and treatment of inflammatory skin damage and diseases, where the extract inhibits inflammation by inhibiting anion generation of nitrogen oxide and superoxide and the activity of NF-kB in macrophage. Claims 5-6 are product-by-process claims. “The patentability of a product does not depend upon its method of production. If the product in [a] product-by-process claim is the same as or obvious from a product of the prior art, [then] the claim is unpatentable even though the prior [art] product was made by a different process.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). Further, the use of the term “comprises” in the claims allows for additional ingredients. Given the extracts of Cho Chung Won are structurally the same as those instantly claimed, e.g., an extract or fraction thereof from at least one or more of the microorganisms recited in the claims, they would inherently possess the same functional properties, e.g., anti-inflammatory, inhibits the IKK complex and/or the processes downstream of the NF-kB pathway and/or inhibits the release of pro-inflammatory cytokines. Atlas Powder Co. V IRECA, 51 USPQ2d 1943, (FED Cir. 1999) states Artisans of ordinary skill may not recognize the inherent characteristics or functioning of the prior art. However, the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer. The Court further held that this same reasoning holds true when it is not a property but an ingredient which is inherently contained in the prior art. Additionally, a “cosmetic” or food or drink supplement” are intended uses only. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. A “physiologically acceptable carrier” reads on water and therefore would be inherent in the preparation of the extracts.
Claim(s) 1-6, 8, 9, 11, 15-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fengfei et al (CN 110 974 775 A, April 10, 2020; provided by Applicants).
Fengfei teaches compositions containing water algae extract from Nostoc sphaeroides (and Chinese herbal complex extract) useful for e.g. repairing skin barrier, reducing inflammation, relieving allergy and itching, improving skin elasticity etc. Claims 5-6 are product-by-process claims. “The patentability of a product does not depend upon its method of production. If the product in [a] product-by-process claim is the same as or obvious from a product of the prior art, [then] the claim is unpatentable even though the prior [art] product was made by a different process.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). Further, the use of the term “comprises” in the claims allows for additional ingredients. Given the extracts of Fengfei are structurally the same as those instantly claimed, e.g., an extract or fraction thereof from at least one or more of the microorganisms recited in the claims, they would inherently possess the same functional properties, e.g., anti-inflammatory, inhibits the IKK complex and/or the processes downstream of the NF-kB pathway and/or inhibits the release of pro-inflammatory cytokines. Atlas Powder Co. V IRECA, 51 USPQ2d 1943, (FED Cir. 1999) states Artisans of ordinary skill may not recognize the inherent characteristics or functioning of the prior art. However, the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer. The Court further held that this same reasoning holds true when it is not a property but an ingredient which is inherently contained in the prior art. Additionally, a “cosmetic” or food or drink supplement” are intended uses only. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. A “physiologically acceptable carrier” reads on water and therefore would be inherent in the preparation of the extracts.
Claim(s) 1-6, 8, 9, 11, 15 and 17-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KIM JU-HYOUNG ET AL: "Anti-inflammatory Effects of Polyphenol Extracts from Ulva linza(Ulvophyceae, Chlorophyta)", TOXICOLOGY AND ENVIRONMENTAL HEALTH SCIENCES, BASEL : BIRKHÄUSER, SPRINGER, vol. 10, no. 3, 17 October 2018; pages 212-219; provided by Applicants).
Ju-Hyoung et al teaches the anti-inflammatory effects of polyphenol extracts (obtained from ethanol extract, CHCI₃, EtOAc, and water fractions) from Ulva linza (Ulvophyceae, Chlorophyta). Claims 5-6 are product-by-process claims. “The patentability of a product does not depend upon its method of production. If the product in [a] product-by-process claim is the same as or obvious from a product of the prior art, [then] the claim is unpatentable even though the prior [art] product was made by a different process.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). Further, the use of the term “comprises” in the claims allows for additional ingredients. Given the extracts of Ju-Hyoung are structurally the same as those instantly claimed, e.g., an extract or fraction thereof from at least one or more of the microorganisms recited in the claims, they would inherently possess the same functional properties, e.g., anti-inflammatory, inhibits the IKK complex and/or the processes downstream of the NF-kB pathway and/or inhibits the release of pro-inflammatory cytokines. Atlas Powder Co. V IRECA, 51 USPQ2d 1943, (FED Cir. 1999) states Artisans of ordinary skill may not recognize the inherent characteristics or functioning of the prior art. However, the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer. The Court further held that this same reasoning holds true when it is not a property but an ingredient which is inherently contained in the prior art. Additionally, a “cosmetic” or food or drink supplement” are intended uses only. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. A “physiologically acceptable carrier” reads on water and therefore would be inherent in the preparation of the extracts.
Claim(s) 1-6, 8, 9, 11, 15 and 17-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DA COSTA ELISABETE ET AL ("Screening for polar lipids, antioxidant, and anti-inflammatory activities ofsp. lipid extracts pursuing new phytochemicals from cyanobacteria", JOURNAL OF APPLIED PHYCOLOGY, KLUWER, DORDRECHT, NL, vol. 32, no. 5, 26 June 2020 (2020-06-26), pages 3015-3030; provided by Applicants)
Da Costa et al reports on polar lipid Extracts from Gloeothece (Cyanobacterium) which showed anti-inflammatory activity (by the inhibition of the conversion of arachidonic acid to prostaglandin H2 (PGH2) via inhibition of COX-2). Claims 5-6 are product-by-process claims. “The patentability of a product does not depend upon its method of production. If the product in [a] product-by-process claim is the same as or obvious from a product of the prior art, [then] the claim is unpatentable even though the prior [art] product was made by a different process.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). Further, the use of the term “comprises” in the claims allows for additional ingredients. Given the extracts of Da Costa are structurally the same as those instantly claimed, e.g., an extract or fraction thereof from at least one or more of the microorganisms recited in the claims, they would inherently possess the same functional properties, e.g., anti-inflammatory, inhibits the IKK complex and/or the processes downstream of the NF-kB pathway and/or inhibits the release of pro-inflammatory cytokines. Atlas Powder Co. V IRECA, 51 USPQ2d 1943, (FED Cir. 1999) states Artisans of ordinary skill may not recognize the inherent characteristics or functioning of the prior art. However, the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer. The Court further held that this same reasoning holds true when it is not a property but an ingredient which is inherently contained in the prior art. Additionally, a “cosmetic” or food or drink supplement” are intended uses only. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. A “physiologically acceptable carrier” reads on water and therefore would be inherent in the preparation of the extracts.
Claim(s) 1-9, 11, 15 and 17-19 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Winget et al (US Patent No. 5,767,095 A, June 16, 1998; provided by Applicants).
Winget teaches topical dermal anti-inflammatory compositions (A) comprising 0.1-10 % by weight (wt.%) anti-inflammatory microalgal (e.g. Chlorella minutissima) lipid preparation (I) and a vehicle (V1). (I) comprises 35-100 wt.% monogalactosyl dieicosapentaenoyl glycerol of formula (la) and 0-65 wt.% of at least one contaminant. V1 is an ointment, cream, lotion, emollient or bioadhesive delivery system. The contaminant is a diacylglyceryl-N,N,N-trimethylhomoserine, chlorophyll, carotenoid or phospholipid. Claims 5-6 are product-by-process claims. “The patentability of a product does not depend upon its method of production. If the product in [a] product-by-process claim is the same as or obvious from a product of the prior art, [then] the claim is unpatentable even though the prior [art] product was made by a different process.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). Further, the use of the term “comprises” in the claims allows for additional ingredients. Given the extracts of Winget are structurally the same as those instantly claimed, e.g., an extract or fraction thereof from at least one or more of the microorganisms recited in the claims, they would inherently possess the same functional properties, e.g., anti-inflammatory, inhibits the IKK complex and/or the processes downstream of the NF-kB pathway and/or inhibits the release of pro-inflammatory cytokines. Atlas Powder Co. V IRECA, 51 USPQ2d 1943, (FED Cir. 1999) states Artisans of ordinary skill may not recognize the inherent characteristics or functioning of the prior art. However, the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer. The Court further held that this same reasoning holds true when it is not a property but an ingredient which is inherently contained in the prior art. Additionally, a “cosmetic” or food or drink supplement” are intended uses only. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. A “physiologically acceptable carrier” reads on water and therefore would be inherent in the preparation of the extracts.
Claim(s) 1-9, 11, 15 and 17-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by MOON ET AL ("Oleamide suppresses inflammatory responses in LPS-induced RAW264.7 murine macrophages and alleviates paw edema in a carrageenan-induced inflammatory rat model", INTERNATIONAL IMMUNOPHARMACOLOGY 20180301 ELSEVIER B.V. NLD, vol. 56, 1 March 2018 (2018-03-01), pages 179-185; provided by Applicants).
Moon teaches oleamide obtained from an extract from Codium fragile (Chlorophyta) can be used as a single ingredient treatment for inflammatory diseases: It suppresses inflammatory responses and alleviates paw edema in a carrageenan- induced inflammatory rat model. Claims 5-6 are product-by-process claims. “The patentability of a product does not depend upon its method of production. If the product in [a] product-by-process claim is the same as or obvious from a product of the prior art, [then] the claim is unpatentable even though the prior [art] product was made by a different process.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). Further, the use of the term “comprises” in the claims allows for additional ingredients. Given the extracts of Moon are structurally the same as those instantly claimed, e.g., an extract or fraction thereof from at least one or more of the microorganisms recited in the claims, they would inherently possess the same functional properties, e.g., anti-inflammatory, inhibits the IKK complex and/or the processes downstream of the NF-kB pathway and/or inhibits the release of pro-inflammatory cytokines. Atlas Powder Co. V IRECA, 51 USPQ2d 1943, (FED Cir. 1999) states Artisans of ordinary skill may not recognize the inherent characteristics or functioning of the prior art. However, the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer. The Court further held that this same reasoning holds true when it is not a property but an ingredient which is inherently contained in the prior art. Additionally, a “cosmetic” or food or drink supplement” are intended uses only. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. A “physiologically acceptable carrier” reads on water and therefore would be inherent in the preparation of the extracts.
Claim(s) 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pragasam et al ("Dietary component p-coumaric acid suppresses monosodium urate crystal-induced inflammation in rats.", INFLAMMATION RESEARCH : OFFICIAL JOURNAL OF THE EUROPEAN HISTAMINE RESEARCH SOCIETY [ET AL.] MAY 2013, vol. 62, no. 5, May 2013 (2013-05), pages 489-498; provided by Applicants).
Pragasm et al teaches dietary component p-coumaric acid which suppresses monosodium urate crystalinduced inflammation in rats. Claim 7 is a product-by-process claims. “The patentability of a product does not depend upon its method of production. If the product in [a] product-by-process claim is the same as or obvious from a product of the prior art, [then] the claim is unpatentable even though the prior [art] product was made by a different process.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
Claim(s) 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boner et al ("Theophylline inhibition of BCG-induced pulmonary inflammatory responses", Ann Allergy, 1990 Jun;64(6):530-535; cited by Applicant; abstract only).
Boner et al describes theophylline which may have anti-inflammatory effects that may contribute to recurrent infections in asthmatic patients. Claim 7 is a product-by-process claims. “The patentability of a product does not depend upon its method of production. If the product in [a] product-by-process claim is the same as or obvious from a product of the prior art, [then] the claim is unpatentable even though the prior [art] product was made by a different process.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
Prior art not presently relied upon:
Kuca Kamil (Archives of toxicology, (2016 Aug) Vol. 90, No. 8, pp. 1817-40
. Here, we discuss the antioxidant, immunomodulatory,
and anti-inflammatory activities of the cyanobacteria, Spirulina in both animals and
humans, along with the underlying mechanisms. In addition, its commercial
and regulatory status in different countries is discussed as well.
Spirulina activates cellular antioxidant enzymes, inhibits lipid
peroxidation and DNA damage, scavenges free radicals, and increases the
activity of superoxide dismutase and catalase. Notably, there appears to
be a threshold level above which Spirulina will taper off the antioxidant
activity. Clinical trials show that Spirulina prevents skeletal muscle
damage under conditions of exercise-induced oxidative stress and can
stimulate the production of antibodies and up- or downregulate the
expression of cytokine-encoding genes to induce immunomodulatory and
anti-inflammatory responses.
Olafsdottier et al (Phytomedicine : international journal of phytotherapy and phytopharmacology, (2014 Sep 25) Vol. 21, No. 11, pp.1451-1457)
A heteroglycan from the cyanobacterium Nostoc commune modulates LPS-induced inflammatory cytokine secretion by THP-1 monocytes through phosphorylation of ERK1/2 and Nostoc sp. are common in cyanolichen symbiosis and lichen
polysaccharides are known to have immunomodulating effects. Nc-5-s is a
heteroglycan isolated from free-living colonies of Nostoc commune and
its structure has been characterized in detail. The aim of this study was
to determine the effects of Nc-5-s on the inflammatory response of
lipopolysaccharide (LPS)-stimulated human THP-1 monocytes and how the
effects are mediated. THP-1 monocytes primed with interferon-γ and
stimulated with LPS in the presence of Nc-5-s secreted less of the
pro-inflammatory cytokine interleukin (IL)-6 and more of the
anti-inflammatory cytokine IL-10 than THP-1 monocytes stimulated
Gao et al (Algal Research-Biomass Biofuels and Bioproducts, (APR 2021) Vol. 54, pp. Article No.: 102180.
Cyanobacteria can use solar energy and
carbon dioxide to produce organic molecules bypassing the need for
carbohydrate feedstock. This valuable trait has spearheaded its use in
the field of bioproduction and ultimately metabolic engineering. As a
natural phenolic compound, p-Coumaric acid is widely present in
plants. Like other secondary metabolites, they are mainly produced to
protect the plants against stress. p-Coumaric acid has many
antioxidant and anti-inflammatory properties which are of importance
to the pharmaceutical, food, cosmetic, and agricultural industries as
precursors of active ingredients.In this study, we report the heterologous
expression of the phenylalanine ammonia-lyase (PAL) and the cinnamic acid
4-hydroxylase (C4H) exogenous genes under the Pcpc560 promoter in the
cyanobacteria Synechocystis sp. PCC6803. After 7 days of
photoautotrophic growth, 0.8 mM of p-Coumaric acid was produced. To
further increase production titer, we knocked out the Synechocystis sp.
PCC6803 gene encoding the arogenate dehydrogenase which led to the
production of 1.2 mM p-Coumaric acid after 7 days of
photoautotrophic growth.
without Nc-5-s.
Kang et al (Marine Drugs (2020), 18(6), 300)
AB Scytonemin is a yellow-green UV sunscreen pigment present in different
genera of aquatic and terrestrial blue-green algae, including marine
cyanobacteria. In the present study, the anti-inflammatory
activities of scytonemin were evaluated in vitro and in vivo. Topical
application of scytonemin inhibited 12-O-tetradecanoylphorbol-13-acetate
(TPA)-induced ear swelling in BALB/c mice. The expression of tumor
necrosis factor-α (TNF-α) and inducible nitric oxide synthase
(iNOS) was also suppressed by scytonemin treatment in the TPA-treated ear
of BALB/c mice. In addn., scytonemin inhibited lipopolysaccharide
(LPS)-induced prodn. of TNF-α and nitric oxide (NO) in RAW264.7
cells, a murine macrophage-like cell line, and the mRNA expressions of
TNF-α and iNOS were also suppressed by scytonemin in LPS-stimulated
RAW 264.7 cells. Our results also showed that the degrdn. of
IκBα and nuclear translocation of the p65 subunit were
blocked by scytonemin in LPS-stimulated RAW264.7 cells. Collectively,
these results suggest that scytonemin inhibits skin inflammation by
blocking the expression of inflammatory mediators, and the
anti-inflammatory effect of scytonemin is mediated, at least in part,
by down-regulation of NF-κB activity. Our results also suggest that
scytonemin might be used as a multi-function skin care ingredient for UV
protection and anti-inflammation.
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/JENNIFER E GRASER/Primary Examiner, Art Unit 1645 3/3/26