DETAILED ACTION
This office action is in response to the Applicant’s filing dated March 19th, 2026.
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 .
Priority
This application is a CON of PCT/IL2022/050357 filed on April 5th, 2022; and has a PRO of 63/287,149 filed on December 8th, 2021, 63/234,340 filed on August 18th, 2021 and 63/170,604 filed on April 5th, 2021.
Status of Claims
Claims 1, 3, 5 and 11-28 are pending in the instant application. Acknowledgement is made of the applicant’s remarks and amendments filed on March 19th, 2026. Acknowledgement is made of Applicant’s amendment of claims 3 and 18; cancelation of claims 2, 4 and 6-10; and addition of new claims 21-28.
Election/Restrictions
Applicant’s election of Group II, and species election of F7 and ovarian cancer, in the reply filed on March 19th, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 15-16, 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 19th, 2026.
A prior art search was conducted on the elected species. In light of the prior art, and in order to accelerate prosecution, examination has been expanded to include the full scope of the claims, therefore claims 15-16 and 19-20 are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on January 20th, 2026 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 1, 3, 5 and 11-28 will be examined herein.
Claim Objections
Claim 26 is objected to because of the following informalities: in the recitation of concentration ratios, the claim recites “… 0.2-0.5 CBC : 0.01-0.04 CBDV, 0.005-0.025 CDBVA…”. The use of the quoted comma renders the claim unclear as to whether the subsequent values are a part of the same ratio, or the beginning of a newly recited ratio. Appropriate correction is required.
Claim 28 is objected to because of the following informalities: the claim recites “The methof of claim 1”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 5 and 11-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating ovarian cancer in vivo with F7 in combination with niraparib and avastin in Example 17 on pages 75-77, and treating glioblastoma, does not reasonably provide enablement for treating all cancers. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. This is a scope of enablement rejection.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the quantity of experimentation necessary,
2- the amount of direction or guidance provided,
3- the presence or absence of working examples,
4- the nature of the invention,
5- the state of the prior art,
6- the relative skill of those in the art,
7- the predictability of the art, and
8- the breadth of the claims
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention and breadth of the claims
The invention relates to a method of treating a subject having or susceptible to cancer.
Claims 1, 3, 5 and 11-28 are directed to a method of treating a subject having or susceptible to cancer comprising administering a composition comprising phytocannabinoids. Thus, the claims are extremely broad with regards to the diseases to be treated as well as the possible compounds that can be utilized.
2. The state and predictability of the art, and relative skill of those in the art
The relative skill of those in the art is high, generally that of an M.D. or Ph.D. The artisan using Applicant’s invention would generally be a physician with a M.D. degree and several years of experience.
The factor is outweighed, however, by the unpredictable nature of the art. It is well established that “the scope of enablement varies with the degree of unpredictability of the factors involved” and physiological activity is considered to be an unpredictable factor. See In re Fisher, 166 USPQ 18, at 24 (In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved); Nationwide Chemical Corporation, et. al. v. Wright, et. al., 192 USPQ 95 (one skilled in chemical and biological arts cannot always reasonably predict how different chemical compounds and elements might behave under varying circumstances); Ex parte Sudilovsky 21 USPQ2d 1702 (Applicant’s invention concerns pharmaceutical activity. Because there is no evidence of record of analogous activity for similar compounds, the art is relatively unpredictable); In re Wright 27 USPQ2d 1510 (the physiological activity of RNA viruses was sufficiently unpredictable that success in developing specific avian vaccine was uncertain).
As illustrative of the state of the art, the examiner cites Gura et al (Science, New Series, (1997), 278(5340), 1041-1042), cited for evidentiary purposes, teaches that researchers face the problem of sifting through potential anticancer agents to find ones promising enough to justify human clinical trials. The reference further teaches that, since formal screening began in 1955, many thousands of drugs have shown activity in cell or animal models, but only 39 have actually been useful for chemotherapy (page 1041, first and second paragraphs). With regard to unpredictability, Johnson et al (British Journal of Cancer, (2001), 84(10), 1424-1431), also cited for evidentiary purposes, teaches that the in vivo activity of 39 different agents in a particular histology in a tumor model did not correlate with activity in the same human cancer (page 1426, Results). Parolaro et al (US 2015/0086653 A1), also cited for evidentiary purposes, teaches a method of treating a patient with a glioma, comprising administering a therapeutically effective amount of a combination of phytocannabinoids together with a chemotherapeutic agent which is not a cannabinoid, to the patient (page 22, right column, Embodiment 92). Parolaro further discloses the use of phytocannabinoid compositions comprising THC and CBD exhibiting anticancer activity against U87 glioma cells both alone and in combination with an anticancer agent (page 18, right column, Example 12, paragraphs [0222-0225]).
“The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability of the art” In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970).
Accordingly, the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statutory requirements. Furthermore, the mechanism of action of anticancer agents is often unknown or highly unpredictable, and the administration of such agents is frequently accompanied by undesirable side effects.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides data for treating ovarian cancer in vivo with F7 in combination with niraparib and avastin in Example 17 on pages 75-77, is not sufficient to provide support for the full scope of phytocannabinoid compositions encompassed by the claims, particularly alone, or for the full scope of conditions or disorders associated with all cancer.
The specification provides no particular direction or guidance for determining the particular administration regimens (e.g. timing, administration routes, etc) necessary to treat all cancer encompassed by the claims with any claimed phytocannabinoid composition, particularly in humans. At best, an "effective amount" is exemplified as a dosage sufficient to provide treatment for cancer. While in vivo experimentation is presented for treatment of ovarian cancer in mice with niraparib, avastin and F7, there is no experimentation or mechanism or action presented or discussed in the specification regarding all cancers with any of the claimed phytocannabinoid compositions.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art (as discussed supra) and in the absence of experimental evidence commensurate in scope with the claims, the skilled artisan would not accept that any claimed phytocannabinoid composition could be predictably used as treatment for all conditions or disorders associated with cancer.
Genentech Inc. vs. Nova Nordisk states, "[A] patent is not a hunting license. It is not a reward for a search but a compensation for its successful conclusion and 'patent protection' is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable" (42 USPQ 2d 1001, Fed. Circuit 1997). A review of the state of the art fails to reveal the mechanism of action or experimental data regarding the use of any phytocannabinoid composition in the specification to treat any cancer related disease or disorder. Determining if any particular claimed compound would treat a conditions or disorders associated with all cancer would require synthesis of the compound, formulation into a suitable dosage form, and subjecting it to clinical trials or to testing in an assay known to correlate to clinical efficacy of such treatment. As noted in supra, even in vitro and in vivo assays do not always correlate to efficacy in humans and are not generally predictive of clinical efficacy. This is undue experimentation given the limited guidance and direction provided by Applicants.
Accordingly, the inventions of claims 1, 3, 5 and 11-28 do not comply with the scope of enablement requirement of 35 U.S.C 112, first paragraph, since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation with no assurance of success.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 21, in line 2 the claim recites “composition (iii) comprises at least two.”, but it is unclear as to what two things are required by the claim to be included in composition (iii); thus rendering the metes and bounds of the claim unclear.
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, 3, 5, 11, 13-16, 19-20 and 22-28 are rejected under 35 U.S.C. 103 as being unpatentable over Parolaro et al (US 2015/0086653 A1); as evidenced by Formolo et al (Journal of Proteome Research, (2011), 10(7), 3149-3159), cited for evidentiary purposes only.
Regarding claims 1, 5, 11 and 13-16, Parolaro teaches a method of treating a patient with a glioma comprising administering a therapeutically effective amount of a combination of phytocannabinoids together with a chemotherapeutic agent which is not a cannabinoid, to the patient (page 22, right column, Embodiment 92). Although the presence of a chemotherapeutic agent which is not a cannabinoid is noted, given the comprising language of instant claim 1, the examiner notes that other ingredients are not precluded. Parolaro further exemplifies a Botanical Drug Substance (BDS, page 9, left column, paragraph [0130]) composition comprising 86.65% THC and 2.34% CBG, which reads on composition (ii) of instant claim 1 (page 10, left column, Table 2.2.2). Parolaro further discloses the use of phytocannabinoid compositions comprising THC and CBD exhibiting anticancer activity against U87 glioma cells both alone and in combination with an anticancer agent (page 18, right column, Example 12, paragraphs [0222-0225]). U87 cells are a human glioblastoma cell line commonly used in the art as an in vitro model for glioblastoma multiforme as evidenced by Formolo et al (page 2, Introduction; pages 7-8, Discussion, paragraphs 1-3), cited for evidentiary purposes only. The disclosed data shows activity when the phytocannabinoid composition is administered alone, but more importantly a synergistic effect when the phytocannabinoid composition is combined with the anticancer agent; the combination therapy exhibiting a significantly more pronounced effect against U87 cell viability than the phytocannabinoid composition or anticancer agent alone (page 18, right column, Example 12, Table 12.2).
Parolaro does not explicitly teach the administration of the BDS of Table 2.2.2.
It would have been prima facie obvious to a person of ordinary skill in the art to administer the BDS of Table 2.2.2 in combination with a chemotherapeutic agent which is not a cannabinoid to treat cancer because Parolaro teaches that phytocannabinoids possess anticancer activity and may be administered in combination with non-cannabinoid chemotherapeutic agents for treatment of glioma. A person of ordinary skill in the art would have been motivated to select the BDS composition of Table 2.2.2 from the finite number of specifically disclosed phytocannabinoid compositions taught by Parolaro because Parolaro teaches that such phytocannabinoid compositions exhibit anticancer activity against U87 glioma cells and may be administered alone or in combination with non-cannabinoid chemotherapeutic agents for the treatment of glioma. The use of the phytocannabinoid composition from Table 2.2.2 of Parolaro to treat glioblastoma multiforme therefore represents the predictable use of prior art elements according to their established functions.
“[T]he rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395.
Regarding claims 3, 19-20 and 22-28, Parolaro renders obvious claims 1, 5, 11 and 13-16 as discussed in the above rejection.
It would have been prima facie obvious to one of ordinary skill in the art to utilize the amounts of phytocannabinoids taught by Parolaro in Table 2.2.2 as a starting point for optimizing the amount of phytocannabinoids comprising the phytocannabinoid composition utilized to treat cancer since Parolaro teaches phytocannabinoid compositions are useful for treating cancer (page 21, right column, Embodiment 79), and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable phytocannabinoid amounts would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage ranges, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Taken together, all of this would result in the methods of instant claims 1, 3, 5, 11, 13-16, 19-20 and 22-28 with a reasonable expectation of success.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Parolaro et al (US 2015/0086653 A1); in view of Ncbi.nlm.nih.gov (https://www.ncbi.nlm.nih.gov/books/NBK548160/).
Regarding claim 12, Parolaro renders obvious claims 1, 3, 5, 11, 13-16, 19-20 and 22-28 as discussed in the above rejection.
Parolaro further teaches that when treating cancer, phytocannabinoids may be combined with a non-cannabinoid chemotherapeutic agent, and that the non-cannabinoid chemotherapeutic agent can be an alkylating agent (page 2, right column, paragraph [0031]).
Parolaro does not explicitly disclose the use of cisplatin as the non-cannabinoid chemotherapeutic agent.
Ncbi.nlm.nih.gov teaches that cisplatin is the prototype platinum coordination complex, classified as an alkylating agent and used intravenously in the treatment of several forms of cancer (page 1, Introduction).
It would have been prima facie obvious to a person of ordinary skill in the art to combine the phytocannabinoid composition of Table 2.2.2 of Parolaro with cisplatin, because Parolaro teaches that phytocannabinoid compositions possess anticancer activity and may be administered in combination with non-cannabinoid chemotherapeutic agents, including alkylating agents, for the treatment of cancer; and because cisplatin is a well-known alkylating agent used in the treatment of several forms of cancer. A person of ordinary skill in the art would have recognized cisplatin is a known chemotherapeutic agent suitable for such combination therapy and would have had a reasonable expectation of success because the combination merely involves the predictable use of prior art elements according to their established functions.
“[T]he rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395.
Taken together, all of this would result in the method of instant claim 12 with a reasonable expectation of success.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Parolaro et al (US 2015/0086653 A1); in view of Barrie et al (Gynecologic Oncology Reports, (2019), 29, 10-12).
Regarding claims 17-18, Parolaro renders obvious claims 1, 3, 5, 11, 13-16, 19-20 and 22-28 as discussed in the above rejections.
Parolaro does not teach a method of treating ovarian cancer comprising administering a phytocannabinoid composition.
Barrie teaches that ovarian cancer cell lines express GPR55, a target that is inhibited indirectly by CBD and that plays a role in ovarian cancer cell proliferation; disclosing that mouse model studies have demonstrated cannabinoids inhibit many types of tumor cell growth and induce apoptosis (page 12, left column, first paragraph). Barrie further teaches that basic scientific studies have identified cannabinoid receptors in ovarian cancer as potential therapeutic targets for cannabinoid use in treating malignancy (page 12, left column, last paragraph).
It would have been prima facie obvious to a person of ordinary skill in the art to administer the phytocannabinoid composition from Table 2.2.2 of Parolaro for treatment of ovarian cancer because Parolaro teaches that phytocannabinoid compositions possess anti-cancer activity, while Barrie teaches that cannabinoid related signaling pathways and receptors, including GPR55, are implicated in ovarian cancer proliferation, and represent potential therapeutic targets for cannabinoid-based therapies. A person of ordinary skill in the art would have been motivated to apply the known anticancer phytocannabinoid compositions of Parolaro to ovarian cancer with a reasonable expectation of success in view of the recognized role of cannabinoids in inhibiting tumor growth and inducing apoptosis across several cancer types, particularly in view of Barrie’s teaching that cannabinoid receptors are potential therapeutic targets in ovarian cancer. The claimed method therefore represents the predictable use of prior art elements according to their established functions.
“[T]he rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395.
Taken together, all of this would result in the methods of instant claims 17-18 with a reasonable expectation of success.
Conclusion
Claims 1, 3, 5 and 11-28 are rejected.
Claims 26 and 28 are objected to.
No claim is allowed.
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/C.L.J./Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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