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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application on 12/07/2023.
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 01/08/2026 is acknowledged.
Claims 1-7 and 11-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 01/08/2026.
Claims 8-9 are being examined on the merits.
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 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Bin Xian et. al. (Comprehensive review of two groups of flavonoids in Carthamus tinctorius L., Biomedicine & Pharmacotherapy 153, pages 1-26, August, 2022, 113462), Yunin Ji et al (Extraction and determination of flavonoids in Carthamus tinctorius, Open Chem., 2018; 16: 1129-1133) and Xin Xue-lei et. al. (CN105920071B).
Xian teaches “Safflower (Carthamus tinctorius L.) is cultivated in various countries for the flavonoid compounds it contains. These flavonoids have been used in many industries as drugs”, and “the mechanism of two groups of flavonoids in treatment of cardiovascular and cerebrovascular diseases was described in detail, and pharmacological mechanisms of protecting liver, lung and bone, and anti-cancer and anti-inflammatory were also summarized” (see abstract).
Xian teaches flavonoids which are ethanol soluble and from leaves (see page 4, table 1).
Xian teaches “flavonoids in safflower belong to common group exists in many species, also possess a variety of activities, which are represented by kaempferol, hyperoside, naringenin, quercetin, and luteolin (see page 2, 2nd para.),
Xian teaches “flavonoids are considered the active ingredients of safflower that promote cardiovascular and cerebrovascular health. 67 flavonoid derivatives have been summarized in this article. The flavonoids of safflower can be divided into two groups, the special one, which represented by quinochalcones (24 compounds), and the common one (43 compounds), which including flavonoids, flavonols, and dihydroflavonoids. Quinochalcones in safflower including HSYA, hydroxysafflor yellow B, and cartormin, which mostly belong to C-glycosylated. The common groups of flavanoids are represented by kaempferol, hyperoside, and naringenin, and the flavonoid glycosylation products belong to O-glycosides (Fig. 2)” (see page 3, 3. Phytochemistry, 2nd para.).
Xian teaches “the pigments contained in safflower are also flavonoids and can be divided into yellow and red pigments. The main compounds contained in yellow pigment are HSYA, anhydrosafflor yellow B, safflomin C, isosafflomin C, safflor yellow A, safflor yellow B,” (see page 3, 2.2 Natural dye).
“Regarding the protective effects on the liver, HSYA has been the subject of more research than other flavonoids. Inflammation-induced liver injury can activate hepatic stellate cells (HSCs), leading to liver fibrosis and cirrhosis. Restraining activation and inducing apoptosis by decreasing the level of inflammation is one way to block HSC activation. HYSA can block HSC activation by inhibiting TGF-β1 and myocyte enhancer factor 2 [145–147]. Furthermore, HSYA can induce HSC apoptosis by suppressing the activation of ERK1/2 and its regulated gene expression [148]. In addition, the hepatoprotective effects of HSYA and hydroxy saffron yellow C (HSYC) are better than those of acetylcysteine, which is more robust than aspirin. HSYA and HSYC can enhance blood circulation and reduce liver toxicity [149]. HSYA has been shown to protect against ischaemic liver in mice by attenuating inflammation and necrosis, reducing serum transaminase levels, inflammatory cytokine expression, and macrophage recruitment [150]. Kaempferol can inhibit hepatocyte apoptosis, and hyperoside has anti-inflammatory and anti-oxidative effects, which contribute to alleviation of acute liver injury [151,152]” (see page 12 last para. -13 first para.).
“The therapeutic effect of safflower is related to certain flavonoids that belong to phytoestrogens, which worth further research. In case of relevance to the occurrence of diabetes, obesity, and liver inflammation, safflower might synergistically may enhance the effect of single compounds” (see page 21, 3rd para.).
Xian also teaches that the while 80% of the safflower consists of seed residue, leaf and stem, these parts also contain beneficial compounds, mainly flavonoid-type phenolic compounds (see page 20 last para. to page 21 first para.).
Xian does not specifically teach that the extraction is through reflux extraction as described in the instant claims.
Ji’s general disclosure is to extraction of flavonoids from Carthamus tinctorius (see abstract).
Ji teaches that reflux extraction method has a high extraction efficiency and shortens extraction time for extraction of safflower total flavone and flavonoids, but the method shouldn’t be applied to thermally unstable components (see page 1129, 1.3).
Xue-lei teaches “heating and refluxing extraction, macroreticular resin isolate and purify acquisition safflower extract” (see page 7, Summary of the invention, 1st para.) and teaches medicinal material extract: after safflower is crushed, the 20-40 times distilled water is added for refluxing extraction 1-3 times at 40-100 minutes each and combining the extract, then eluting with 10% ethanol, concentrating and drying the extract (see top page 8, part 1, 3 and 4).
Although Xue-lei teaches using water during extraction, persons having ordinary skill in the art would recognize from Xian’s disclosure that many flavonoids are alcohol (ethanol) soluble and therefore use ethanol as a solvent for extracting flavonoids from Carthamus tinctorius.
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to create a method of treating acute and chronic liver injury by extracting flavonoids from Carthamus tinctorius L. leaves or whole plant because Xian teaches that flavonoids are known as pharmacological mechanisms for protecting liver and teaches that many flavonoids are found not only in the flowers but in also in the leaves, stems and seed oils residues of safflower plants.
It would have also been obvious to use reflux extraction for the process in extracting flavonoids from Carthamus tinctorius because Li teaches that this is the more efficient way to scale up production. One would look to Xue-lei to show how to reflux extract from the safflower plant which is by adding anywhere from 20-40 amount of medicinal material to solvent, concentrate and filter using microporous resin, eluting with 10% ethanol and concentrating and drying. Although Xue-lei does not particularly describe freeze drying, this is common and conventionally done in the art to preserve the final product and thus would have been prima facie obvious.
Given the prior art there would have been a reasonable expectation of success in arriving at the instant invention given the prior art.
Conclusion
No claims are allowed.
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JACOB A BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655