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 .
Response to Amendment
Applicant's amendment and argument filed 7/20/2026 in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 12-29 are pending of which claims 13, 15 and 17 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/26/2024.
Claims 12, 14, 16 and 18-29 are being examined on the merits.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 12, 14, 16, 19-21, 23 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Jamous et al. (“Jamous”, Evidence-Based Complementary and Alternative Medicine 2018, cited by Applicant in the IDS filed 14 September 2021), Chitturi et al. (“Chitturi”, Hepatology 2002), Alessandra Piras et. al. (From IDS, 09/14/2021, Evaluation of antioxidant and tyrosinase inhibitory activities of the extracts of Sarcopoterium spinosum (L.) Spach fruits, Nat Prod Res. 2017 Dec; 31(24):2900-2904) and Xi Li et. al. (The Flavonoid Quercetin Ameliorates Liver Inflammation and Fibrosis by Regulating Hepatic Macrophages Activation and Polarization in Mice, Frontiers in Pharmacology, 09 February 2018, Vol. 9, Article 72). This is a new rejection based on the amendments filed on 07/20/2026.
Regarding claims 12 and 16, Jamous teaches Sarcopoterium spinosum is a widely distributed chamaephyte of the Rosaceae family growing in the eastern Mediterranean region, and the use of its aqueous root extract by traditional medicinal practitioners for the treatment of diabetes and pain relief is documented in several ethnobotanical surveys (e.g., page 15, right column, last paragraph). Jamous further teaches the bioactive constituents in the extracts of Sarcopoterium spinosum have numerous beneficial effects, including decreasing inflammation (e.g., see Figure 7).
Jamous does not explicitly teach administering the Sarcopoterium spinosum for “preventing or treating inflammation”. However, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to administer the Sarcopoterium spinosum extract for preventing or treating inflammation; thus arriving at the claimed invention. One skilled in the art would be motivated to do so, with a reasonable expectation of success, because Jamous teaches the extract is used to treat pain (often a major symptom of inflammation), and also teaches the beneficial effects of the bioactive constituents of the Sarcopoterium spinosum extract include decreasing inflammation. Therefore, the skilled artisan would find it obvious to administer the Sarcopoterium spinosum extract to prevent or treat inflammation, with a reasonable expectation of success.
Regarding claims 14 and 19, Jamous further teaches the beneficial effects of the bioactive constituents of the Sarcopoterium spinosum extract include decreasing insulin resistance (e.g., Figure 7) as well as preventing atherosclerosis (i.e., conditions with prolonged, or chronic, inflammation; e.g., see page 17, left column, 1st paragraph). Regarding Applicant’s elected species wherein the inflammation is associated with nonalcoholic steatohepatitis (NASH), it is noted that, while Jamous does not specifically teach preventing or treating NASH, Jamous does teach the plant’s glucose lowering agents (bioactive polyphenols such as catechin) target insulin affected tissues such as the liver, and that these catechins also possess antiobesity properties, including decreasing weight gain, decreasing food consumption, and/or reducing or preventing obesity (e.g., page 15, right column, last paragraph; page 17, left column, 1st paragraph). Therefore, the skilled artisan would reasonably expect a decrease in fat buildup in the liver (the cause of NASH), as well as a reduction or prevention of inflammation resulting from said fat buildup. Optionally additionally, Chitturi teaches NASH is often linked obesity, and most patients with NASH also have insulin resistance (e.g., abstract; page 378). Therefore, since Jamous teaches the bioactive constituents of the Sarcopoterium spinosum extract decrease inflammation and insulin resistance, as well as obesity (e.g., Figure 7; page 17), the skilled artisan would find it obvious to administer the Sarcopoterium spinosum extract to prevent or treat inflammation of disorders associated with obesity and insulin resistance, including NASH, with a reasonable expectation of success.
Regarding claims 20 and 21, Jamous teaches the extracts may be comprised in a nutraceutical composition such as a tea or condiment (e.g., page 17, right column 2nd paragraph), and may further comprise pharmaceutically acceptable and/or nutraceutical carriers/vehicles, such as water or ethanolic (e.g., page 5, right column, 6th paragraph (ethanolic extracts); page 15, right column, last paragraph (aqueous extracts)).
Jamous makes obvious the instantly claimed method of treating inflammation by administering a water extract of Sarcopoterium spinosum (SSE), however is silent on the M1 and M2 macrophage polarization effects.
Piras discusses that the aqueous residual water obtained through hydro-distillation brought about certain polyphenols such as quercetin and its derivatives (see 2.3 polyphenol composition).
Li teaches specifically that “quercetin dramatically ameliorated liver inflammation, fibrosis, and inhibited HSCs activation. These results were attributed to the reductive recruitment of macrophages (F4/80+ and CD68+) into the liver in quercetin-treated fibrotic mice confirmed by immunostaining and expression levels of marker molecules. Importantly, quercetin strongly inhibited M1 polarization and M1-related inflammatory cytokines in fibrotic livers when compared with vehicle-treated mice. In vitro, studies further revealed that quercetin efficiently inhibited macrophages activation and M1 polarization, as well as decreased the mRNA expression of M1 macrophage markers such as TNF-α, IL-1β, IL-6, and nitric oxide synthase 2. Mechanistically, the inhibition of M1 macrophages by quercetin was associated with the decreased levels of Notch1 expression on macrophages both in vivo and in vitro. Taken together, our data indicated that quercetin attenuated CCl4 induced liver inflammation and fibrosis in mice through inhibiting macrophages infiltration and modulating M1 macrophages polarization via targeting Notch1 pathway. Hence, quercetin holds promise as potential therapeutic agent for human fibrotic liver disease” (see abstract).
Therefore it would have been obvious to persons having ordinary skill in the art to use an aqueous extract of Sarcopoterium spinosum for the treatment of inflammation and to subjects characterized by M1 macrophage-derived inflammation and to suppress M1 macrophage activity because as Li teaches quercetin is a compound which is known to do so and as Piras teaches water extracts of Sarcopoterium spinosum would contain quercetin. Determining how much of the aqueous extract would be effective to induce phosphorylation of signal transducer and activator of transcription STAT3, STAT6 or both in macrophages of inhibition of NFkB in macrophages would have been obvious given that the components within the extract are known for polarizing macrophages to a non-inflammatory phenotype because that is what the art teaches. These are merely different pathways known to regulate macrophage polarization. STAT3 and NFkB signaling are known drivers for M1 polarization and thus determining the an amount that would inhibit STAT3 phosphorylation and inhibition of NFkB would have been prima facie obvious in light of the relied upon art.
Claim 18 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Jamous et al., Chitturi et al., Alessandra Piras et. al. and Xi Li et. al., as applied to claims 12, 14, 16, 19-21, 23 and 28-29 above, and further in view of Cade et al. (“Cade”, US 2010/0168410). This is a new rejection based on the amendments filed on 07/20/2026.
The inventions of Jamous and Chitturi are delineated above (see paragraph 10, above).
Specifically regarding claims 18 and 22 (and more generally regarding the remaining claims), Jamous does not specifically teach a particular form of administration, such as a capsule.
However, Cade generally teaches capsules are well-known dosage forms that normally consist of a shell filled with one or more specific substances (e.g., paragraph [0002]). Cade additionally teaches an improved hydroxypropyl methylcellulose capsule having high quality, excellent dissolution and mechanical performance, which may be filled with all kinds of suitable liquid or dry ingredients, including plant extracts (e.g., paragraphs [0012], [0032], [0080]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to formulate the Sarcopoterium spinosum extract as a capsule; thus arriving at the claimed invention. One skilled in the art would be motivated to do so, with a reasonable expectation of success, because capsules are already well-known dosage forms, and the capsules of Cade are capable of containing plant extracts and provide the benefits high quality, excellent dissolution and mechanical performance, as taught by Cade.
Claims 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Jamous et al., Chitturi et al., Alessandra Piras et al., and Xi Li et. al. as applied to claims 12, 14, 16, 19-21, 23 and 28-29 above, and further in view of Young Kim and Wansu Park (Anti-Inflammatory Effect of Quercetin on RAW 264.7 Mouse Macrophages Induced with Polyinosinic-Polycytidylic Acid, Molecules, 2016, 21, 450). This is a new rejection based on the amendments filed on 07/20/2026.
Jamous, Piras and Li’s combined teachings make obvious the instantly claimed method of treating inflammation by administering a water extract of Sarcopoterium spinosum (SSE), however is silent on the administration being in an amount that induces/increases M2 macrophage polarization.
Kim teaches that quercetin also has known anti-inflammatory effects on lipopolysaccharide-induced macrophages and at concentrations up to 50 µM significantly inhibited the production of NO, IL-6, MCP-1, IP-10, RANTES, GM-CSF, G-CSF, TNF-α, LIF, LIX, and VEGF (see abstract).
Kim teaches “quercetin significantly increased IL-10 secretions by peritoneal macrophages” (see first line of page 2). Kim also teaches “quercetin significantly inhibited excessive production of NO in the cells at concentrations of 5, 10, 25, and 50 µM (Figure 2)” and and was a dose-dependent effect (Figure 2).
Kim teaches that quercetin significantly increased IL-10 secretion of macrophages and as the applicant recognizes that this indeed is a marker for M2 polarization (see page 5 of instant specifications).
Therefore it would have been obvious to persons having ordinary skill in the art to use an aqueous extract of Sarcopoterium spinosum for the treatment of inflammation and in amounts that were enough to induce M2 polarization and to suppress M1 macrophage activity, because as Kim teaches quercetin is known to increase IL-10 expression which is known to increase M2 polarization.
Response to Arguments
Applicant's arguments filed 07/20/2026 have been fully considered but they are not persuasive. The applicant argues that the claimed water extract of S. spinosum works through different mechanisms than isolated quercetin. The Office is not relying on an argument that teaches using isolated quercetin. The Office articulated that it is known that quercetin is an active compound in S. spinosum and which is known to exert anti-inflammatory effects towards macrophages, and that it is known to ameliorate liver inflammation and fibrosis through inhibition of M1 polarization of macrophages thus it would have been obvious to include water extracts of S. spinosum which contains quercetin as an active component for a method of treating inflammation. The mechanism of action of isolated quercetin and an extract of S. spinosum may be different, however given the prior art the instant invention is prima facie obvious. The applicant argues that the direct activation of STAT3/STAT6 phosphorylation pathways by SSE was not taught in the art. The mechanism of action may not have been described in the art prior to the applicant’s invention; however, "[T]he 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." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).
The applicant argues that there is no articulate reason for a reasonable expectation of success. This is not the case as this was just argued above. The applicant argues that there is no expectation of success in using isolated quercetin for accomplishing the STAT3/STAT6 phosphorylation and M2 polarization. The applicant argues that there would have been no reasonable expectation of success in any skilled artisan in using a water extract of S. spinosum for STAT3/STAT6 phosphorylation and M2 polarization from the relied upon art. If quercetin is contained in water extracts of S. spinosum and its effects are known to polarize macrophages to an anti-inflammatory phenotype then there is a reasonable expectation of success in arriving at the instant invention.
Conclusion
Currently no claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. 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).
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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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