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 .
Claim Status
Claims 1-4, 6-8, and 10 are currently pending and under examination.
Any rejection found in the previous Office Action and not presented herein has been withdrawn based upon Applicant’s amendments.
Claim Objections
Claim 10 remains objected to because of the following informalities: "The method of claim 8, the method improve and/or enhance" should read The method of claim 8, wherein the method improves and/or enhances. Applicant has not fully corrected original objection, and has omitted wherein, as indicated. Appropriate correction is required.
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.
Claim(s) 1-4, 6-8, and 10 remain rejected under 35 U.S.C. 103 as being unpatentable over McAllister, S. D., et. al. (US Patent No. 9,084,771 B2; Issued 07/21/2015), in view of Hamad, H. (Cannabidiol Induces Cell Death in Human Lung Cancer Cells and Cancer Stem Cells, Pharmaceuticals, Vol. 14, no. 11 (Nov. 17, 2021), pp. 1-2, further in view of Song, D. Etoposide induced NMI promotes cell apoptosis by activating the ARF-p53 signaling pathway in lung carcinoma, Biochemical and Biophysical Research Communications, Vol. 495, no. 1 (Jan. 1, 2018), pp. 368 – 374).
McAllister teaches a method of treating or preventing cancer (Breast cancer cell lines MDA-MB231, MDA-MB436 (See e.g. col. 37; lines 28-29), and glioblastoma cell lines SF126, U87, and U251 used in cell cultures, (See e.g. col. 40; lines 24-25) comprising: administering to a subject (See e.g. col. 35; lines 55-59): cannabidiol (CBD) (See e.g. col.34; lines 45-53) and paclitaxel (See e.g. col. 34; lines 45-53) or a pharmaceutical composition comprising (See e.g. col. 1; lines 2-4) cannabidiol (CBD) and paclitaxel as active ingredients.
McAllister does not teach a method of treating lung cancer specifically. However, McAllister teaches that breast cancer and glioblastoma proliferate through a known ID-1 protein mechanism (See e.g. col. 5; lines 60-62) through which lung cancer also proliferates (See e.g. col. 7; lines 1-10). McAllister also teaches that cannabidiol (CBD) alone is able to affect the ID-1 protein mechanism and inhibit proliferation of the breast cancer and glioblastoma cells (See e.g. col. 5; lines 60-62).
Hamad further teaches that CBD reduces viability of both lung cancer stem cells and adherent lung cancer cells (See e.g. Introduction; par.4 “Here, we show that CBD reduced viability in both lung cancer stem cells and adherent lung cancer cells”).
Song teaches that etoposide has activity against the A549 cell line used by the applicant (See e.g. Introduction; par. 3 “We found that etoposide treatment suppresses the proliferation and increases the apoptosis of A549 cells”).
The applicant defines a subject in the specification as a human or animal who either has lung cancer or is at risk of developing it. A person having ordinary skill in the art could interpret this limitation as any person or animal, as every person and animal is at risk of developing lung cancer, and would benefit from the claimed method. McAllister defines subject as any human or animal, and therefore teaches the applicants claimed subject.
The applicant has not set forth effective amounts of CBD in the claims. Any amount or
concentration would be presumed to work in the claimed method in the absence of a recitation
of amount effective for treatment. Hamad teaches that CBD has a dose-dependent effect on
A549 lung cancer cell viability, showing a measurable decrease in viability starting from 1.5
micromolar CBD, and therefore teaches the applicants claimed dose.
Obviousness can be established by combining or modifying the teachings of the prior art
to produce the claimed invention where there is some teaching, suggestion, or motivation to do
so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale
underlying the motivation-suggestion-teaching test as a guard against using hindsight in an
obviousness analysis). Axonics, Inc. v. Medtronic, Inc., 73 F.4th 950, 957-58, 2023 USPQ2d 795
(Fed. Cir. 2023) (the court found an erroneous framing of the motivation inquiry led to an
incorrect conclusion of nonobviousness). A "motivation to combine may be found explicitly or
implicitly in market forces; design incentives; the ‘interrelated teachings of multiple patents’;
‘any need or problem known in the field of endeavor at the time of invention and addressed by
the patent’; and the background knowledge, creativity, and common sense of the person of
ordinary skill." Zup v. Nash Mfg., 896 F.3d 1365, 1371, 127 USPQ2d 1423, 1427 (Fed. Cir. 2018)
(quoting Plantronics, Inc. v. Aliph, Inc., 724 F.3d 1343, 1354 [107 USPQ2d 1706] (Fed. Cir. 2013)
(Citing Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1328 [92 USPQ2d 1849] (Fed.
Cir.2009) (quoting KSR, 550 U.S. at 418-21)). See MPEP § 2143 regarding the need to provide a
reasoned explanation even in situations involving common sense or ordinary ingenuity. See
also, MPEP § 2144.05, subsection II, B.
In the instant case, McAllister, Hamad, and Song provide adequate teaching, suggestion, or motivation for one having ordinary skill in the art, before the Applicant’s effective filling date, to use CBD in a method to treat lung cancer comprising administrating to a subject, CBD and etoposide. CBD on its own is known to inhibit proliferation of breast cancer and glioblastoma cell lines through the ID-1 mechanism, and the ID-1 mechanism is known to be responsible for proliferation of lung cancer. Both CBD and etoposide as monotherapies have been shown to inhibit proliferation of lung cancer cells. One skilled in the art would have been motivated and have had reasonable expectation of success to combine the teachings in these references prior to the applicant’s effective filling date. Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to combine these teachings and develop a method to treat lung cancer in a subject comprising administering CBD and etoposide, either alone or in combination, to a subject in need thereof.
Response to Arguments
Applicant’s arguments filed 2/13/2026 have been fully considered, but they are not persuasive.
In regards to the traversal of the 35 U.S.C. 103 rejection of claims 1-4, 6-8, and 10:
Applicant argues that there is synergism between CBD and etoposide, and that by administering CBD at 15 μM, an amount that is lower than its IC50 of 18.6 μM against A549 lung cancer cells, as a monotherapy, should not induce any changes in cell viability.
Applicant further argues that administration of CBD at this concentration of 15 μM concomitantly or subsequentially with etoposide, would result in a greater than expected anti-cancer effect of etoposide.
This is not found persuasive because the Applicant’s claims do not recite amounts of either CBD or etoposide. Synergism is a highly unpredictable phenomenon and requires specific amounts of each compound in relation to each other. At present, the claims are not commensurate in scope with what the Applicant is arguing.
In further detail, while it is acknowledged that McAllister, Hamad, and Song do not specifically disclose a composition comprising the combination of CBD and etoposide, Hamad teaches that CBD causes apoptosis in the Applicant’s A549 lung cancer cell line at a CBD concentration of only 10 μM, a concentration less than what the Applicant claims to be the minimum level for inducing any effect on cell viability (See Page 7; Figure 4).
Moreover, the Applicant’s argument that the identified IC50 is the minimum level at which any effect in cell viability is observed is unsubstantiated, as an IC50 value is not understood in the art to equate to the point of observable change in inhibition. Rather, it is the concentration at which a 50% inhibition rate is observed, as is standard in the art to measure potency of an inhibitor. As can be observed from Applicant’s FIG. 2, there is a range of CBD concentrations starting from where changes in cell viability are seen up to the IC50 value. A CBD concentration at any point in this range would contribute to a decrease in cell viability, either as a monotherapy or when used with etoposide. As the X-axis of the Applicant’s FIG.2 is unlabeled, there is no conclusive way to determine if a CBD concentration of 15 μM is outside of this contributory range.
Therefore, the rejection is maintained for the reasons of record and the reasons set forth above.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 OROD MOTEVALLI whose telephone number is (571)272-6026. The examiner can normally be reached Monday - Friday 10:00AM - 6:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OROD MOTEVALLI/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628