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 04/06/2026 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 Any previous rejection or objection not mentioned herein is withdrawn.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 1-18 are pending and being examined on the merits.
Claim Rejections - 35 USC § 102/ - 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 1-18 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Yung-Chi Cheng and Lieping Chen (From IDS, WO2017205389A1). This rejection is maintained with slight modifications due to the amendments file on 04/06/2026.
Cheng teaches a “method of treating cancer in a subject, the method comprising administering to the subject in need thereof a therapeutically effective amount of at least one herbal composition selected from the group consisting of: (a) an herbal extract of Scutellaria baicalensis (S), a fraction thereof or any active chemical present in the herbal extract or fraction thereof; (b) the herbal extract PHY906, which comprises herbal extracts of Scutellaria baicalensis (S), Glycyrrhiza uralensis (G), Paeonia lactiflora (P), and Ziziphus jujuba (Z), a fraction thereof or any active chemical present in the herbal extract or fraction thereof; (c) an herbal extract comprising an extract of S, a fraction thereof or any active chemical present in the herbal extract or fraction thereof; and (d) an herbal extract comprising a combination of S, G, P and Z, a fraction thereof or any active chemical present in the herbal extract or fraction thereof; wherein the subject is further administered one or more immune checkpoint inhibitors, wherein the cancer is at least one selected from the group consisting of melanoma, non-small cell lung cancer, renal cell carcinoma, liver cancer, colon cancer, urothelial bladder cancer and pancreatic cancer” (see claim 6).
Cheng also discloses the S, G, P and Z, a fraction thereof or any active chemical present in the herbal extract or fraction thereof, wherein the herbs S, G, P and Z are in a ratio of about 3 : 2 : 2 : 2 (see page 9, lines 29-30, page 11- lines 27-33).
Cheng further discloses “As used herein, the term "prevent," "prevention," or "preventing" refers to any method to partially or completely prevent or delay the onset of one or more symptoms or features of a disease, disorder, and/or condition, for example, cancer. Prevention is causing the clinical symptoms of the disease state not to develop, i.e., inhibiting the onset of disease, in a subject that may be exposed to or predisposed to the disease state, but does not yet experience or display symptoms of the disease state. Prevention may be administered to a subject who does not exhibit signs of a disease, disorder, and/or condition” (see page 9 at bottom).
“In certain embodiments, the present invention is directed to a packaged
pharmaceutical composition comprising a container holding a therapeutically effective amount of a compound of the invention, alone or in combination with a second pharmaceutical agent; and instructions for using the compound to treat, prevent, or reduce one or more symptoms of a disease or disorder contemplated in the invention” (see page 16, lines 17-21). This would thus describe the same invention because it would be the same administration of the same components (an herbal extract YIV-906) and for the same purpose preventing cancer.
Regarding claim 15, wherein the herbal composition is administered for about 30 mins before administering a chemotherapy or radiation therapy is common practice in treatment of cancer patients as many treatments may assist with nausea, anxiety, or can assist with the chemo/radiation therapy itself.
Regarding claims 2-3, Cheng describes wherein the tumors are Hepa 1-6 hepatic adenocarcinomas and CMT-167 non-small cell lung cancer (see example 7 and 8, page 27) which are known solid tumors and liver cancers.
Regarding claims 4 and 6, Cheng discloses wherein the immune checkpoint is anti-PD 1, an anti-PD-LI and an anti-CTLA4 (see claim 3, page 28).
Regarding claims 5, Cheng discloses wherein the immune checkpoint is Ipilimumab, Pembrolizumab, Nivolumab, Durvalumab and Atezolizumab (see claim 4, page 28).
Regarding claim 7, Cheng discloses wherein the herbal extract PHY906 is shown to enhance the therapeutic index of the chemotherapy agent of the PDL-PD1 pathway (see page 2, lines 3-5).
Regarding claims 8 and 18, Cheng discloses to the subject orally (see page 3, lines 11) and teaches wherein the subject is a mammal and human (see page 3, lines 24-25).
Regarding claim 10, Cheng discloses the forms being administered as a pill, tablet, capsule, soup, tea, concentrate, dragees, liquids, drops, and gelcaps (see page 3, lines 11-14).
Regarding claim 11, Cheng teaches the therapeutically effective amount is about 20 mg/day to about 2 g/day (see page 3, lines 15-16).
Regarding claim 12, Cheng discloses the therapeutically effective amount of the herbal composition is about 1,600 mg/day (see page 3, lines 16-17).
Regarding claim 13, Cheng discloses the herbal composition is administered twice daily (see page 3, line 18).
Regarding claim 14, Cheng discloses the herbal composition is administered twice daily for about one about two weeks, followed by a suspension of treatment for at least one week (see page 3, lines 19-20).
Regarding claim 16, Cheng discloses administering being continued for four days (see at least figures 8A, 7E, 7D, 7C, 7B etc).
Regarding claim 17, Cheng discloses the herbal composition is administered at a time selected from prior to, simultaneously with and after administration of the one or more immune checkpoint inhibitors to the subject (see page 3, lines 21-23).
Regarding claim 9, pertaining to wherein the administering the herbal composition promotes stimulator of interferon genes (STING) agonist action, the same administration of the same components to the same patient population would inherently have the same effect unless shown some evidence to the contrary by the applicant.
Therefore it would have been obvious before the effective filing date to persons having skill in the art to administer the herbal composition 30 minutes before chemo or radiation therapy because such administration before chemo is common practice. Cheng already discloses administering the composition prior to a checkpoint inhibitor and so administering the herbal composition 30 mins prior to other cancer treatments would have also been obvious. Additionally, determining administration times is well within the purview of any skilled artisan. Also, if for some reason the applicant believes that the patient population is not anticipated by the above art it would have been prima facie obvious to administer the same composition for preventing recurrence of a cancer in a mammal because Cheng already discloses using the method to prevent cancer and so preventing the cancer from recurring would have been prima facie obvious.
Response to Arguments
Applicant's arguments filed 04/20/2026 have been fully considered but they are not persuasive. The applicant argues that Cheng does not anticipate the claims because Cheng does not teach that the Scutellaria baicalensis (S), Glycyrrhiza uralensis (G), Paeonia lactiflora (P), and Ziziphus jujuba (Z) are in amounts from 3:2:2:2, however Cheng does teach this limitation as can be appreciated from the claims above. The applicant argues that Cheng does not specifically teach that the administration is for the recurrence of a cancer. Cheng teaches the administration of the same exact components, in the same ratios for preventing and treating cancer and with the broadest reasonable interpretation with the definitions given by Cheng, the administration of the same components would prevent the recurrence of cancer. There is no patentable difference from that of Cheng’s invention and the instant application. The applicant also shows treatment of cancer without recurrence but only at 21 days with no other treatment as argued in their response (see page 7). The same treatment would warrant the same effects.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. US20250177467A1 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application is to a method of enhancing Nuclear Factor of Activated T-cells (NFAT) through the administration of the same composition at the same therapeutically effective amounts. The patient populations would be obvious as the copending application also claims that the method is used for cancer chemoprevention (see claim 13). Determining which components are in the same extracts would have prima facie been obvious and a purview of any skilled artisan (pertaining to copending claims 3-4). Co-administration with other immunotherapeutic agents is also obvious for increasing chances of treatment of disease. The method of increasing the effectiveness of a vaccine is not obvious however the same administration of the same components would inherently have the same activity unless shown evidence that this is not the case. Determining the ratio of components to be the same as the instant invention would also have been prima facie obvious given the entire application and the knowledge of those skilled in the art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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.
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JACOB A BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655
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