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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 02/09/20226 is acknowledged.
Claims 19-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/09/2026.
Claims 1-18 are being examined on the merits.
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 1-6 and 8-17 are rejected under 35 U.S.C. 101 because the claimed composition is directed to a product of nature without significantly more. The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since the claim is directed to a composition comprising plant components the claim is a composition of matter. Step 2A prong one of the analyses evaluates whether the claim is a judicial exception (see MPEP 2106.04). Because the claim states the nature-based products a processed plant product of a seed, such as extracts and fractions from Brassica rapa that include protein and processed plant products from Raphamus sativus and Helianthus annuus seeds, the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart.
The claim recites the naturally occurring components found within plants. Plant extracts are made by partitioning the starting plant material into separate compositions based upon some property such as solubility in a solvent, with the soluble compounds being in one composition and the insoluble being in another composition, which compositions are then generally separated into the solvent extract of that plant versus the insoluble material composition that is generally discarded. Each composition has a different subset of the compounds originally present in the plant material. Plant extracts are purified by removing unwanted plant material from the remaining solvents. The closest naturally occurring counterparts of extracts are the same compounds found within the extract that are found in the plant in an unseparated form, even when purified, which is chemically identical to the extracted compounds. All of these are naturally occurring in nature and are not markedly different from its naturally occurring counterpart in its natural state. The properties of the nature-based product as claimed are not markedly different than the properties of these naturally occurring counterparts found in nature as these activities would inherently be found within the plants they come from. The components which would give the activities claimed in the instant invention would inherently do the same in nature as there has been nothing done in the instant invention that would make them act in any different way.
Step 2A prong two evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a) identifying whether there are any additional recited elements in the claim beyond the judicial exception and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. This judicial exception is not integrated into a practical application because the applicant is merely claiming judicial exceptions or multiple judicial exceptions without any modifications of those judicial exceptions. Merely claiming a fraction of the plant extract or a certain sized protein is still only laying claim to particular judicial exceptions of a certain size or quality.
Doing so would be implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b).
The claims do not integrate the judicial exceptions into a practical application because in this context, such integration for a claimed product would be a physical form of the specific practical application instead of a more general composition that is not so limited.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these components and their activity are already found naturally occurring in nature and the addition of an intended use does not impart any added benefit to the compounds or integrate the composition into a practical application.
Step 2 B evaluates whether the claim as a whole, amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP § 2106.05(b)).
Since the naturally-occurring components as-claimed are not found together in nature, admixing the ingredients into a single formulation is considered an ‘additional element’ which must be analyzed for eligibility. Admixing naturally-occurring plant extracts is well-understood, routine practice in the art and has been conducted for centuries. Admixing plant extracts for modulating an immune response is also well-understood, routine, ordinary practice in the field as evidenced by at least the following documents: US 6030622 A, US 20010018077 A1, US 20010022981 A1, US 20020122833 A1 and US 6464982 B1.
Please also note, the mere modifying the concentration and proportions of the product/composition is not sufficient to remove the claimed composition from a judicial exception.
Therefore, admixing the claimed naturally-occurring ingredients at such a high degree of generality merely involves applying the natural principal and appears to be no more than a drafting effort to claim the judicial exception itself; a mixture of naturally-occurring components that is not markedly different from its’ closest-occurring natural counterpart and which does not offer significantly more than the judicial exception.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Serguei Fetissov et. al. (US11319352B2) and Andrew W. Taylor and Darren J. Lee (The Alpha-Melanocyte Stimulating Hormone Induces Conversion of Effector T Cells into Treg Cells, Journal of Transplantation, Volume July. 2011).
Regading claims 1-6, Fetissov teaches the use of Brassicaseae protein extracts for treating inflammation and weight loss (see abstract), and teaches the Brassicaseae species can be Brassica napus (see claim 3), and teaches the protein as ClpB (see claim 1), and wherein the Brassicaseae protein extract can come from the seeds (see column 11, lines 47-52). Here Fetissov teaches Brassica napus proteins from seeds and with the broadest reasonable interpretation the ClpB would indeed be a fraction of the extract as this is one component (the protein) that would exist in the extract. Additionally, Fetissov teaches of fragments of the ~95 kDa protein (see figure 2, column 3, lines 20-22, column 5, lines 9-24).
Fetissov teaches “" Fragment” refers to a part or a region of a protein, e.g., of the ClpB protein, comprising fewer amino acid residues than an intact or complete protein, e.g., the ClpB protein. The term “ fragment " further refers to , for example , an at least about 5 , 10 , 20 , 30 , 40 , 50 , 75 , 100 , 150 , 200 , 250 , 300 , 400 , 500 , 600 , 700 , 800 or more amino acid portion of an amino acid sequence , e.g. , of amino acid sequence SEQ ID NO : 1 , which portion is cleaved from a naturally occurring amino acid sequence by proteolytic cleavage by at least one pro tease , or is a portion of the naturally occurring amino acid sequence synthesized by chemical methods or using recombinant DNA technology ( e.g. , expressed from a portion of the nucleotide sequence encoding the naturally occurring amino acid sequence ) known to one of skill in the art . “Fragment " may also refer to a portion, for example, of about 5 %, about 10 %, about 20 %, about 30 %, about 40 %, about 50 %, about 60 %, about 70 %, about 80 % about 90 % about 95 % or about 99 % of a particular amino acid sequence, e.g., of amino acid sequence SEQ ID NO: 1” (see column 4, last para.).
Fetissov teaches that “a search for non-brain penetrating α-MSH-like drugs acting on peripheral MCR may represent an alternative strategy for body weight management. In fact, MC4R are expressed in both the peripheral nervous system and in the intestinal enteroendocrine cells. Although MC4R-mediated α-MSH anorexigenic effects have been mainly ascribed to its central sites of actions (Mul et al., 2013. Eur. J. Pharmacol. 719(1-3):192-20), a recent study showed that activation of the MC4R in the gut enteroendocrine cells stimulates release of satiety hormones glucagon-like peptide-1 (GLP-1) and peptide YY (PYY) (Panaro et al., 2014. Cell Metab. 20(6):1018-1029). Thus, α-MSH-like molecules may act as a peripheral satiety signal upstream to the brain anorexigenic pathways.
The hormone α-MSH is also known to have potent anti-inflammatory effects and protective effects on cells of the immune system and on peripheral nonimmune cell types expressing melanocortin receptors, such as MC1R and MC3R (Brzoska et al., 2008. Endrocr. Rev. 29(5):581-602). Moreover, recent studies show that α-MSH is an interesting target for treating psoriasis, allergic rhinitis, osteoarthritis and neuroinflammatory diseases (Auriemma et al, 2012. J. Invest. Dermatol. 132(7):1814-24; Kleiner et al., Clin. Exp. Allergy. 46(8):1066-74; Böhm et al., 2016. Biochem. Pharmacol. 116:89-99; Mykicki et al., 2016. Sci. Transl. Med. 8(362):362ra146).
The inventors have surprisingly identified Brassicaceae proteins having sequence homology with α-MSH. Therefore, the present invention relates to a Brassicaceae protein extract and uses thereof” (see last para. colum 1 and first two para. column 2).
Regarding claims 7, Fetissov teaches capsules (see column 6, line 60 and column 21, lines 24-28.
Fetissov does not specifically teach that the protein can elicit a cell-mediated immune response in a mammal.
Taylor teaches that alpha-melanocyte stimulating hormone (α-MSH) induces conversion of effector T Cells into Treg cells. Such α-MSH-treated T cells have immune regulatory activity and suppress hypersensitivity, autoimmune diseases, and graft rejection. Previous characterizations of the α-MSH-induced Treg cells showed that the cells are CD4+ T cells expressing the same levels of CD25 as effector T cells (see abstract).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to create the instant invention using Fetissov’s relied upon art. Fetissov teaches of ClpB proteins and protein fragments from Brassica napus seeds for treating inflammation and obesity. Fetissov teaches that ClpB can act as a mimetic to α-MSH and is also known to have potent anti-inflammatory effects and protective effects on cells of the immune system and on peripheral nonimmune cell types. Fetissov teaches that smaller fragments, for example of 5-800 amino acids of the ClpB can be used and this would create molecular weights between that of what is being claimed. Furthermore, Fetissov teaches that ClpB mimics α-MSH activities through varying immune functions and Taylor teaches wherein those specific immune functions are cell-mediated. It would have also been obvious to make the capsule plant-based as this would appeal to persons having solely plant-based diets.
Claims 8-13 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Serguei Fetissov et. al. (US11319352B2), Andrew W. Taylor and Darren J. Lee (The Alpha-Melanocyte Stimulating Hormone Induces Conversion of Effector T Cells into Treg Cells, Journal of Transplantation, Volume July. 2011) and Dilip M Shah et. al. (From IDS, US20190194268A1).
Regarding claims 8, 10-11, 13 and 15-16, Shah teaches of “multimeric defensin proteins (MD) containing at least two defensin peptides joined by a spacer peptide that is resistant to endoproteinase cleavage are disclosed along with compositions comprising the MD proteins and transgenic or genetically edited plants or microorganisms that express the MD to inhibit growth of pathogenic fungi. Such MD proteins, compositions, plants, and microorganisms can provide for improved inhibition of fungal growth when compared to a protein containing only one of the defensin peptides found in the MD” (see abstract). Shah teaches “the antifungal polypeptides can be applied directly to a plant, human, or animal” (see 0003). With the broadest reasonable interpretation, a defensin protein as described can be extracted from the plant parts and is thus also an extract and a fraction of an extract when so broadly claimed.
Regarding claim 9, Shah teaches creating transgenic plant seeds comprising the defensin nucleic acid molecules (see 0265-269).
Regarding claim 12, Shah teaches a RsAFP2 defensin from that of Raphanus sativum (see table 1).
Regarding claim 17, Shah teaches the defensin protein from the same plant species and those would be expected to act in the same manner as claimed.
Regarding claim 18, Shah teaches encapsulating the multimeric defensins (see 0135).
Shah does not specifically teach that the composition can induce a cell-mediated immune response.
Fetissov teaches the use of Brassicaseae protein extracts for treating inflammation and weight loss (see abstract), and teaches the Brassicaseae species can be Brassica napus (see claim 3), and teaches the protein as ClpB (see claim 1), and wherein the Brassicaseae protein extract can come from the seeds (see column 11, lines 47-52). Here Fetissov teaches Brassica napus proteins from seeds and with the broadest reasonable interpretation the ClpB would indeed be a fraction of the extract as this is one component (the protein) that would exist in the extract.
Fetissov teaches that “a search for non-brain penetrating α-MSH-like drugs acting on peripheral MCR may represent an alternative strategy for body weight management. In fact, MC4R are expressed in both the peripheral nervous system and in the intestinal enteroendocrine cells. Although MC4R-mediated α-MSH anorexigenic effects have been mainly ascribed to its central sites of actions (Mul et al., 2013. Eur. J. Pharmacol. 719(1-3):192-20), a recent study showed that activation of the MC4R in the gut enteroendocrine cells stimulates release of satiety hormones glucagon-like peptide-1 (GLP-1) and peptide YY (PYY) (Panaro et al., 2014. Cell Metab. 20(6):1018-1029). Thus, α-MSH-like molecules may act as a peripheral satiety signal upstream to the brain anorexigenic pathways.
The hormone α-MSH is also known to have potent anti-inflammatory effects and protective effects on cells of the immune system and on peripheral nonimmune cell types expressing melanocortin receptors, such as MC1R and MC3R (Brzoska et al., 2008. Endrocr. Rev. 29(5):581-602). Moreover, recent studies show that α-MSH is an interesting target for treating psoriasis, allergic rhinitis, osteoarthritis and neuroinflammatory diseases (Auriemma et al, 2012. J. Invest. Dermatol. 132(7):1814-24; Kleiner et al., Clin. Exp. Allergy. 46(8):1066-74; Böhm et al., 2016. Biochem. Pharmacol. 116:89-99; Mykicki et al., 2016. Sci. Transl. Med. 8(362):362ra146).
The inventors have surprisingly identified Brassicaceae proteins having sequence homology with α-MSH. Therefore, the present invention relates to a Brassicaceae protein extract and uses thereof” (see last para. colum 1 and first two para. column 2).
Taylor teaches that alpha-melanocyte stimulating hormone induces conversion of effector T Cells into Treg cells. Such α-MSH-treated T cells have immune regulatory activity and suppress hypersensitivity, autoimmune diseases, and graft rejection. Previous characterizations of the α-MSH-induced Treg cells showed that the cells are CD4+ T cells expressing the same levels of CD25 as effector T cells (see abstract).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to incorporate defensins from Brassica napus and Raphamus sativus for use in a composition for supporting a cell-mediated immune response in a human because Shah teaches of creating genetically altered or transgenic edited plants with the defensin proteins and seeds from those plants to contain such genetic modifications. Using these plants and or seeds to create compositions which contain defensin would have been prima facie obvious as they are known to support antifungal activity in humans. Combing the prior art from Fetissov and Taylor which describes proteins from Brassica napus can modulate an adaptive immune response along with that of Shah’s teaching of creating defensins from Brassica napus and creating a composition comprising both of those beneficial components for supporting immune health would have been prima facie obvious. It would have also been obvious to make the capsule plant-based as this would appeal to persons having solely plant-based diets.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Serguei Fetissov et. al. (US11319352B2), Andrew W. Taylor and Darren J. Lee (The Alpha-Melanocyte Stimulating Hormone Induces Conversion of Effector T Cells into Treg Cells, Journal of Transplantation, Volume July. 2011) and Dilip M Shah et. al. (From IDS, US20190194268A1) as applied to claims 8-13 and 15-18 above, and further in view of Bartholomew Saanu Adeleke et. al. (Oilseed crop sunflower (helianthus annuus) as a source of food: Nutritional and health benefits, Food Sci. Nutr.;8:4666-4684, 30 June 2020).
Fetissov, Taylor and Shah teach a composition for supporting immune health in a mammal comprising a plant product that includes defensin which elicits a cell-mediated immune response by a mammal, however is silent on the composition comprising Helianthus annuus seeds.
Adeleke teaches “Sunflower is an important oilseed crop native to South America and currently cultivated throughout the world. Generally, the sunflower is considered important based on its nutritional and medicinal value. Due to its beneficial health effects, sunflower has been recognized as functional foods or nutraceutical, although not yet fully harnessed. Sunflower contains mineral elements and phytochemicals such as dietary fiber, manganese, vitamins, tocopherols, phytosterols, triterpene glycosides, α-tocopherol, glutathione reductase, flavonoids, phenolic acids, carotenoids, peptides, chlorogenic acid, caffeic acid, alkaloids, tannins, and saponins; and these compounds contribute to their functional and nutraceutical development. The extract from sunflower is known to be a potential source of antimicrobial, anti-inflammatory, antitumor, and antioxidants agents that protect human cells against harmful reactive oxygen molecules and pathogenic microorganisms. Also, the pharmacological survey on sunflower had revealed its curative power to different kinds of diseases. The health benefits of sunflower include blood pressure and diabetic control, skin protection, and lowering cholesterol and other functions” (see abstract).
“Sunflower seeds contain high amounts of vitamins like vitamin E, B, folate, and niacin and minerals like calcium, copper, iron, magnesium, manganese, selenium, phosphorous, potassium, sodium, and zinc. By and large, the therapeutic potential of sunflower seeds has been proven medically curative for colds and coughs, as a substitute for quinine, exhibiting anti-malaria efficacy and as a diuretic and expectorant (Islam et al., 2016)” (see page 4672, fist para.).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to incorporate processed products of Helianthus annuus seed into the composition for supporting immune health in a mammal because Adeleke teaches that sunflower seeds have many health benefits that would ultimately support the immune system. Combining extracts of Helianthus annuus seed into the composition taught by Fetissov, Taylor and Shah would have been prima facie obvious for creating a nutraceutical composition for supporting human health.
Conclusion
Currently no claims are allowed.
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JACOB A BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655