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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/23/2026 has been entered.
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 10, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Peng Jiao et. al. (CN112618587A) and google patent document of Liang Jianping et. al. (CN102174009B). This rejection is maintained with modifications due to the arguments filed on 04/23/2026.
Jiao discloses administering a composition comprising of Isatidis root granules for treating chronic inflammatory bowel disease (see page 3, fig 1, detailed description, at bottom) and discloses wherein the Isatidis is folium isatidis (see bottom of page 2). Jiao discloses wherein the root granules contain indoside, isatin, indigo, indirubin, tryptanthrin, adenosine, cytidine, uridine and guanosine. With the broadest reasonable interpretation, granules can be considered an extract because they are essentially dried, concentrated extracts that are produced by decocting herbs and then removing the liquid, resulting in a powdered form.
Regarding claim 15, Jiao discloses wherein the colons of the mice which were administered the composition of Isatidis granules were shortened (see page 7, figures 4-5).
Jiao does not specifically teach that the Isatidis is extracted with 70% ethanol.
Regarding claims 10, Jianping teaches “a method for preparing indigo and indirubin from Folium Folium, its main feature is to include the following steps: drying Folium Folium, pulverizing, sieving, and extracting with ethanol solution containing sodium hydroxide under reflux” (see abstract). Jianping teaches wherein 60wt%-90wt% ethanol solution is to be used for extraction (see claim 1).
Regarding claims 16, wherein the subject requires an inhibiting in the increase in weight or length of the spleen appears to be an intended effect (inhibiting of the weight or length of the spleen) of the compositions administration of the composition which in this case the activity would have been inherent to the administration of the same ethanolic extract of the Isatidis folium to the same patient population unless shown some evidence that this indeed is not the case.
Therefore, it would have been obvious to persons having skill in the art and before the effective filing date to use a 70% ethanol extract because Jianping teaches ethanol extraction with 60wt%-90wt%, which encompasses 70% for extracting indirubin folium isatidis. Indirubin is an active component of Jiao’s method of treating chronic inflammatory bowel disease and so persons having skill could look to Jianping to realize that indirubin can be extracted out with ethanolic extracts wherein the percent is between 60-90% ethanol. 70% ethanol falls within the already known range for solvents used for extracting out the active components for treating inflammatory bowel disease. Using 70% ethanol as an extracting solvent is therefore prima facie obvious. The applicant believes there is no nexus for connecting the two pieces of art because persons would not look to Jianping and decide to use 70% ethanol which is taught on the radix of the isatidis and predict that it could be useful on the folium of isatidis taught by Jiao. Jianping also teaches the folium and it is also obvious because indirubin is taught to be extracted out with 60-90% ethanol and is also taught as one of the active components for treating IBS. Therefore using 70% ethanol would have been obvious.
Response to Arguments
Applicant's arguments filed 04/23/2026 have been fully considered but they are not persuasive. The applicant argues that Office failed to consider submitted DAI experimental evidence. As previously discussed in the Advisory Action filed on 23 of April, 2026, “When any claim of an application or a patent under reexamination is rejected or objected to, any evidence submitted to traverse the rejection or objection on a basis not otherwise provided for must be by way of an oath or declaration under this section as discussed in MPEP 37 CFR 1.132. All data supplied in the application was considered. The applicant believes that the data provides support that the instant invention is superior to the prior art however the evidence provides data showing comparative testing of 70% ETOH Isatidis folium to 70% ETOH Isatidis radix, which is not a comparison to the closest prior art as the art already teaches that Isatidis folium is used when treating IBD. The applicant should properly submit any evidence in a declaration or affidavit that was not included in the original application as filed to be considered. The data is currently objected to as new matter not originally disclosed”.
The applicant argues that they are not required to recite the mechanism of action in their claims. The applicant does not need to recite a mechanism of action however their claims are not so limited and thus the prior art’s teachings are made obvious in lack of such further limitations because the claims merely recite a broad treatment method of IBD by administering a composition of 70% ethanol of Isatidis Folium extract. These limitations have been met and are therefore rejected.
The applicant argues that there is lack of motivation to combine Jiao and Jianping based on indirubin. The applicant believes that since Jiao does not disclose that indirubin itself confers a therapeutic effect for IBD that persons having ordinary skill in the art would not be motivated to substitute an ethanol extract from Jianping in the extract taught by Jiao. Just as the applicant has argued that they are not required to recite a mechanism of action in their claim set, neither do artisans of the prior art. Jiao claims that the health drug for IBD of radix Isatidis granule comprises of indioside, isatin, indigo, indirubin, tryptanthrin, adenosine, cytidine, uridine and guanosine (see claims 2 and 7). Therefore, persons having ordinary skill in the art would recognize that this is an active alkaloid component that is effective in treating IBD because Jiao claims it in their composition for such treatment. Jiao does not need to describe its mechanism of action. It would be obvious to use 70% ethanol because Jianping teaches this percentage of ethanol can indeed be used to extract this component from Folium.
Examiner’s note: The applicant, Miss. Mih Suhn Koh had requested an interview to discuss the case on 06/23/2026. The Office sent an email requesting an agenda and any proposed amendments and topics for discussion prior to the interview; however, the applicant did not respond to the email and did not call in for their time that was requested for interview.
Conclusion
Currently no claims are allowed.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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