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 .
Election/Restrictions
Applicant’s election without traverse of YIV-906, liver cancer, anti-PD1, Pembrolizumab and anti-PD1 as the species in the reply filed on 09/24/2025 is acknowledged.
Claims 1-18 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 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).
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 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 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.
Conclusion
Currently no claims are allowed.
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
/TERRY A MCKELVEY/ Supervisory Patent Examiner, Art Unit 1655