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 .
Response to Amendment
Applicant's amendment and argument filed 11/11/2025 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 Any previous rejection or objection not mentioned herein is withdrawn.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 10 and 15-16 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 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. (see file wrapper, CN102174009B). This rejection is maintained with modifications due to the amendments filed on 11/21/2025.
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 11/21/2025 have been fully considered but they are not persuasive. The applicant argues the applicant has found an unexpected discovery that Istaidis folium when compared to Isatidis radix has better nitric oxide increasing capabilities. The google patent document from Jiao and the patent document from Jainping shows that Isatidis folium contains active components which are known to treat inflammation of the bowel and its symptoms. Although the art may be silent on this activity, its effects would be inherent to the administration of the same 70% ethanolic extract of the Isatidis folium to the same patient population. Additionally, this increase in nitric oxide activity is not a claimed limitation.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655