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 .
Status of the Claims
Claims 17, 18, and 20-27 are pending. Acknowledgment is made of the cancellation of claims 1-16 and 19, the amendment of claims 17, 18, 20, 21, and 24, and the addition of new claims 25-27, in the reply filed 03/30/2026.
Withdrawn Objections/Rejections
Applicant’s amendments to the drawings and specification, filed 03/30/2026, overcomes the objection to the drawings and the specification for minor informalities. The objection to the drawings and the specification has been withdrawn.
Applicant’s amendments to the claims, filed 03/30/2026, overcomes the objection to claims 17, 19, and 21 for minor informalities. The objection to claims 17, 19, and 21 has been withdrawn.
Applicant’s amendments to the claims, filed 03/30/2026, overcomes the rejection of claims 17-20 under 35 U.S.C. 101 for being an improper process claim. The rejection of claims 17-20 has been withdrawn.
Applicant’s amendments to the claims, filed 03/30/2026, overcomes the rejection of claims 17 and 19-24 on the basis of containing an improper Markush grouping. The rejection of claims 17 and 19-24 has been withdrawn.
Applicant’s amendments to the claims, filed 03/30/2026, overcomes the rejection of claims 17 and 19-24 under 35 U.S.C. 112(a) for scope of enablement. The rejection of claims 17 and 19-24 has been withdrawn.
Applicant’s amendments to the claims, filed 03/30/2026, overcomes the rejection of claims 17-24 under 35 U.S.C. 112(b) for indefiniteness. The rejection of claims 17-24 has been withdrawn.
Modified Rejections
Claim Rejections - 35 USC § 112
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.
Claims 21-24 and 26 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 inhibiting a binding interaction between MYC and TRRAP comprising administering a compound from Table 5, does not reasonably provide enablement for the treatment any MYC-associated cancer comprising administering any compound in Table 5. 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.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: (a) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor or joint inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. {See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986); and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988)}.
The above factors, regarding the present invention, are summarized as follows:
Breadth of the claims
The breadth of the claim includes a method of treating any MYC-associated cancer in a patient, comprising administering any compound in Table 5.
Nature of the invention
The nature of the invention is performance of a method of treating any MYC-associated cancer in a patient, comprising administering any compound in Table 5.
State of the prior art
No single drug has been discovered that is effective in treating the myriad of cancers, including, but not limited to, “adenocarcinoma in glandular tissue, blastoma in embryonic tissue of organs, carcinoma in epithelial tissue, leukemia in tissues that form blood cells, lymphoma in lymphatic tissue, myeloma in bone marrow, sarcoma in connective or supportive tissue, adrenal cancer, AIDS-related lymphoma, Kaposi's sarcoma, bladder cancer, bone cancer, brain cancer, breast cancer, carcinoid tumors, cervical cancer, chemotherapy-resistant cancer, colon cancer, endometrial cancer, esophageal cancer, gastric cancer, head cancer, neck cancer, hepatobiliary cancer, kidney cancer, leukemia, liver cancer, lung cancer, lymphoma, Hodgkin's disease, non-Hodgkin's lymphoma, metastatic cancer, nervous system tumors, oral cancer, ovarian cancer, pancreatic cancer, prostate cancer, rectal cancer, skin cancer, stomach cancer, testicular cancer, thyroid cancer, urethral cancer, cancer of bone marrow, multiple myeloma, tumors that metastasize to the bone, tumors infiltrating the nerve and hollow viscus, and tumors near neural structures” (paragraph [46]). See In re Hokum, 226 USPQ 353 (ComrPats 1985).
Level of one of ordinary skill in the art
The artisans performing the inventor’s or joint inventor’s method of treating any MYC-associated cancer in a patient, comprising administering any compound in Table 5, would be a collaborative team of synthetic chemists and/or health practitioners, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience.
Level of predictability in the art
Synthetic organic chemistry is quite unpredictable. See In re Marzocchi and Horton 169 USPQ at 367 ¶3. Similarly, it is well established that “[T]he scope of enablement varies inversely with the degree of unpredictability of the factors involved, and physiological activity is generally considered to be an unpredictable factor”. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). 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).
The nature of the invention and predictability in the art, with specific reference to cancer, Ex parte Kranz, 19 USPQ2d 1216, 1219 notes the “general unpredictability of the field [of] ...anti-cancer treatment.” In re Application of Hozumi et al., 226 USPQ 353 notes the “fact that the art of cancer chemotherapy is highly unpredictable”. More generally, the invention is directed toward medicine and is therefore physiological in nature. Itis well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
This plainly demonstrates that the art of developing and testing anticancer drugs is extremely unpredictable, particularly in the case of a single compound or genus of compounds being used to treat any and all cancers.
Amount of direction provided by the inventor
The invention lacks direction with respect to making and/or using (performing) a method of treating any MYC-associated cancer in a patient, comprising administering any compound in Table 5.
Existence of working examples
The specification provides no data proving the anti-cancer effects of compounds in Table 5. The data only provides enzymatic activity of compounds and their inhibition of the MYC: TRRAP interaction.
The specification provides no particular direction or guidance for determining the particular administration regimens (e.g., timing, administration routes, etc.) necessary to treat all of the various cancers encompassed by the claims, particularly in humans. At best, an “effective amount” is exemplified as “an amount effective, at dosages/amounts and for periods of time necessary, to achieve a desired result, such as a therapeutic or prophylactic result alone or in combination with other active agents” (paragraph [100]). No exemplary amounts needed to treat any specific cancer are provided.
Similarly, according to the specification, compounds in Table 5, are capable of treating a variety of cancers, including, but not limited to, “adenocarcinoma in glandular tissue, blastoma in embryonic tissue of organs, carcinoma in epithelial tissue, leukemia in tissues that form blood cells, lymphoma in lymphatic tissue, myeloma in bone marrow, sarcoma in connective or supportive tissue, adrenal cancer, AIDS-related lymphoma, Kaposi's sarcoma, bladder cancer, bone cancer, brain cancer, breast cancer, carcinoid tumors, cervical cancer, chemotherapy-resistant cancer, colon cancer, endometrial cancer, esophageal cancer, gastric cancer, head cancer, neck cancer, hepatobiliary cancer, kidney cancer, leukemia, liver cancer, lung cancer, lymphoma, Hodgkin's disease, non-Hodgkin's lymphoma, metastatic cancer, nervous system tumors, oral cancer, ovarian cancer, pancreatic cancer, prostate cancer, rectal cancer, skin cancer, stomach cancer, testicular cancer, thyroid cancer, urethral cancer, cancer of bone marrow, multiple myeloma, tumors that metastasize to the bone, tumors infiltrating the nerve and hollow viscus, and tumors near neural structures” (paragraph [46]).
There is insufficient disclosure to reasonably conclude that the method of treating any MYC-associated cancer in a patient, comprising administering a compound from Table 5, as recited, would contribute to treatment of any the aforementioned diseases. The inventor or joint inventor has neither provided convincing data for any patient population, nor indicated any art recognized correlation between the disclosed data and the breadth of the claim.
Quantity of experimentation needed
Because of the known unpredictability of the art and in the absence of experimental evidence commensurate in scope with the claims, the skilled artisan would not accept that any compound in Table 5, could be predictably used as treatment for all MYC-associated cancers.
One skilled in the art, such as a medical doctor, would be required to perform thousands of clinical trials and in vivo or in vitro assays in order to determine which of the compounds in Table 5, would be capable of treating which cancers. Even in vitro and in vivo assays do not always correlate to efficacy in humans and are not generally predictive of clinical efficacy.
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).
Accordingly, the instant claims do not comply with the enablement requirement of 35 U.S.C. 112(a), 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.
Applicant Argues:
Applicant states, in the remarks filed 03/30/2026, that “the compounds in Table 5 are all predicted to inhibit MYC and be useful in cancer therapies.”
Examiner Responds:
As noted in the above rejection, the inhibition of MYC would not be expected to treat any and every MYC-associated cancer. There is insufficient disclosure to reasonably conclude that the method of treating any MYC-associated cancer in a patient, comprising administering a compound from Table 5, as recited, would contribute to treatment of any MYC-associated cancer. The inventor or joint inventor has neither provided convincing data for any patient population, nor indicated any art recognized correlation between the disclosed data and the breadth of the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 20 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dhaka et al. (Heterocyclic Systems Containing a Bridgehead Nitrogen Atom: Part XXIV - Reaction of 5H-2,3-Dihydro[1,2,4]triazino[5,6-b]indol-3-thione with α-Haloketones, Chloroacetic Acid, Alkyl Halides and 2,3-Dichloroquinoxaline, Indian Journal of Chemistry, 1976, Vol. 14B, pg. 541-544).
Dhaka et al. teaches, in Chart 3, the compound XIII a, prepared in a solution, which is the same as the lead compound from Table 5 and reads on instant claims 20 and 25.
Applicant Argues:
Applicant states that the amended claims are now directed to a method of inhibiting the binding interaction between MYC and TRRAP, and therefore, the prior art compound no longer reads on the instant claims.
Examiner Responds:
Claim 20 is directed to compounds of Table 5, and it is not directed to a method of using said compounds. Newly added claim 25 is also directed solely to compounds, which the prior art reads on.
Claims 17, 20-23, 25, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meleddu et al. ((3Z)-3-(2-[4-(aryl)-1,3-thiazol-2-yl]hydrazin-1-ylidene)-2,3-dihydro-1H-indol-2-one derivatives as dual inhibitors of HIV-1 reverse transcriptase, European Journal of Medicinal Chemistry, 2015, Vol. 93, pages 452-460).
Meleddu et al. teaches, in Table 1 on page 455, the compound EMAC2081, which is the same as the lead compound of Table 5 and reads on claims 20 and 25. The compound is taught to be a dual inhibitor of both RNase H and DP HIV-1 RT-associated function.
Regarding claims 21-23 and 26, the compound is taught, in the abstract, to be used for the treatment of AIDS in a subject. The prior art is silent regarding using the composition to treat “AIDS-related lymphoma”, which is a “MYC-associated cancer”. However: treating “AIDS-related lymphoma” will inevitably flow from the teachings of the prior art, since the same composition (a pharmaceutical composition comprising EMAC 2074) is being administered to the same subjects (a subject suffering from AIDS-related lymphoma). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. See MPEP 2112.
Regarding claim 17, the inhibition of the binding interaction between MYC and TRRAP is an inherent property of the compound taught by the prior art. Therefore, the administration of the prior art compound for the treatment of AIDS would inherently inhibit the binding interaction between MYC and TRRAP. See MPEP 2112.
Applicant Argues:
Applicant states that the claims have been amended to delete the treatment of “AIDS-related lymphoma” and are now directed to a method of inhibiting the interaction between MYC and TRRAP.
Examiner Responds:
In the modified rejection above, it can be seen that the prior art still reads on the instant claims, since the inhibition of the interaction between MYC an TRRAP would be an inherent property of the prior art compounds.
Claims 17 and 20-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eldehna et al. (Synthesis and biological evaluation of certain hydrazonoindolin-2-one derivatives as new potent anti-proliferative agents, Journal of Enzyme Inhibition and Medicinal Chemistry, 2018, Vol. 33(1), pages 867-878).
Eldehna et al. teaches, in Scheme 2, compound 10a, which is the same as the lead compound in Table 5, and reads on claims 20 and 25. The antiproliferative activity of compound 10a was tested towards human cancer cell lines (A-549, ZR-75, HT-29), normal cell lines, and a multidrug-resistant lung cancer NCI-H69AR cell line (page 871 and Tables 1 and 2), as in instant claims 21-24 and 26. The compound was taught, on page 877, to be a “prosperous approach” in developing compounds to treat human cancer cell lines.
Regarding claim 17, the inhibition of the binding interaction between MYC and TRRAP is an inherent property of the compound taught by the prior art. Therefore, the administration of the prior art compound for the treatment of cancers, including MYC-associated cancers such as lung cancer, would inherently inhibit the binding interaction between MYC and TRRAP. See MPEP 2112.
Applicant Argues:
Applicant states that the claims have been amended to be directed to a method of inhibiting the interaction between MYC and TRRAP.
Examiner Responds:
In the modified rejection above, it can be seen that the prior art still reads on the instant claims, since the inhibition of the interaction between MYC an TRRAP would be an inherent property of the prior art compounds.
New Objections
Necessitated by Claim Amendment
Claims 17, 20, and 21 are objected to because of the following informalities:
MPEP 2173.05(s) states: “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993)”.
Claims 17, 20, and 21 incorporate compounds by reference to a Table, and should instead include the compounds themselves within the claim.
Claim 17 reads “…a chemical compound listed Table 5”, and should read “…a chemical compound listed in Table 5”.
Appropriate correction is required.
New Rejections
Necessitated by Claim Amendment
Claim Rejections - 35 USC § 112
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.
Claims 20, 25, and 26 are 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.
Claims 20 and 25 recite a “derivative chemical compound” listed in Table 5. It is unclear whether the compound is meant to be a compound listed in Table 5, or rather a derivative of a compound listed in Table 5. Therefore, claims 20 and 25, and dependent claim 26, are indefinite. For the sake of compact prosecution, the claims will be interpreted as a “chemical compound” listed in Table 5.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 18 and 27 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 18 and 27 teach the compound shown below.
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215
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However, claims 17 and 21, from which claims 18 and 27 are dependent upon, respectively, teach that the compound is selected from Table 5. The above compound is not listed in Table 5, and therefore, claims 18 and 27 fail to include all the limitations of the claims upon which they depend.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
Claims 17, 18, and 20-27 are rejected.
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.
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/R.M.S./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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