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/Status of Claims
Receipt of Arguments/Remarks filed on 04/14/2026 is acknowledged. Claim 25 was amended. Claims 25,50-55 and 60-67 are pending and under examination.
Rejections Necessitated by 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 25,50-55 and 60-67 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. Claim 25 recites " A method of treating cancer in a subject in need thereof, the method comprising administering to the subject having a cancer with a pathogen-associated molecular pattern (PAMP)-containing nucleic acid molecule for activating retinoic acid-inducible gene I (RIG-I), thereby inducing RIG-I binding partner, TRIM16, that mediates apoptosis in the cancer cell wherein the PAMP-containing nucleic acid molecule comprises: a 5'-arm region comprising a terminal triphosphate, a poly-uracil core comprising at least 8 contiguous uracil residues, and a 3'-arm region comprising at least 8 nucleic acid residues, wherein the 5'-most nucleic acid residue of the 3'-arm region is not an uracil and wherein the 3'-arm region is at least 30% uracil residues”. The omitted steps are that the claim does not recite what is being administered to the subject having a cancer and therefore does not complete the administering method step. The recitation of “with” after “cancer” causes the claim to not recite what is being administered to the subject, as the claim now reads that the subject has a cancer with a PAMP-containing nucleic acid molecule for performing the recited functions rather than what is being administered to the subject having a cancer is a pathogen-associated PAMP-containing nucleic acid molecule.
Claims 50-55 and 60-67 are included in the rejection because they depend on claim 25 and do not correct the issue.
New Matter Rejection
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 25,50-55 and 60-67 introduce new matter as the claims recite the limitation: " A method of treating cancer in a subject in need thereof, the method comprising administering to the subject having a cancer with a pathogen-associated molecular pattern (PAMP)-containing nucleic acid molecule for activating retinoic acid-inducible gene I (RIG-I), thereby inducing RIG-I binding partner, TRIM16, that mediates apoptosis in the cancer cell…”. There is no support in the specification for this limitation of “the method comprising administering to the subject having a cancer with a pathogen-associated molecular pattern (PAMP)-containing nucleic acid molecule”. By adding “with” after “cancer” and before “a pathogen-associated molecular pattern (PAMP)-containing nucleic acid molecule”, the claim now reads that the subject has a cancer with a pathogen-associated molecular pattern (PAMP)-containing nucleic acid molecule”, rather than the pathogen-associated molecular pattern (PAMP)-containing nucleic acid molecule being what is administered. The instant wording of the claim does not complete the administering step and recite what is being administered to the subject. The specification does not describe that the subject has a cancer with a pathogen-associated molecular pattern (PAMP)-containing nucleic acid molecule and person skilled in the art would not recognize in the applicant' s disclosure a description of the invention as presently claimed. Applicant directed the Examiner to page 10, lines 11-16, FIGs 1A, 2A-1, 6A, 7A and 7B-the support in the specification for the amendments. Page 10, lines 11-16 state that RNA-PAMP induced cell death through RIG-I and caspase-dependent signaling that was enhanced by IFN treatment, and that using a proteomics-based screen, a novel RIG-I binding partner, TRIM16, was identified that is essential for PAMP-RNA and RIG-I induced cell death, and TRIM16 was shown to bind to RIG-I CARDs to direct cell-death signaling in response to PAMP-RNA. Similarly, the figures pointed out for support of the amendments do not show support that the subject has a cancer with a PAMP-containing nucleic acid molecule. There is support for the amendment that PAMP-RNA activates RIG-1 which induces RIG-1 binding partner, TRIM16, that mediates cell death in the cancer cells (Huh7 cells). Therefore, it is the Examiner' s position that the disclosure does not reasonably convey that the inventor had possession of the subject matter of the amendment at the time of filing of the instant application.
Written Description Rejection
Claims 25,50-55 and 60-67 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim Interpretation: In the interest of compact prosecution with regards to the written description rejection, the examiner is interpreting claim 25 as the PAMP-containing nucleic acid molecule is what is being administered to the subject having a cancer, rather than administering to the subject having a cancer with a PAMP-containing molecule which does not recite what is being administered to the subject.
Claims 25,50-55 and 60-66 encompass a method of treating a large genus of cancers in a subject in need thereof, comprising administering to the subject having a genus of cancers, a genus of pathogen-associated molecular pattern (PAMP)-containing nucleic acid molecules for activating retinoic acid-inducible gene I (RIG-I), thereby inducing RIG-I binding partner, TRIM16, that mediates apoptosis in a genus of cancer cells, and recites the PAMP-containing nucleic acid molecule comprises a 5’ arm region comprising a terminal triphosphate, a poly-uracil core comprising at least 8 contiguous uracil residues, and a 3’-arm region comprising at least 8 nucleic acid residues, wherein the 5’-most nucleic acid residue of the 3’-arm region is not a uracil and wherein the 3’-arm region is at least 30% uracil residues. Claims 65-66 specify the PAMP-containing nucleic acid molecule comprises or consists of SEQ ID NO:2, and therefor recites a specific species of PAMP-containing nucleic acid molecules, but still encompasses treating a genus of cancers with this specific PAMP-containing nucleic acid molecule. Claim 62 recites the cancer is a hematological cancer and claim 67 recites a specific species of cancer, hepatocellular cancer, however both claims encompass administering a genus of PAMP-containing nucleic acid molecules.
The state of the art is silent as to treating cancer in a subject by administering a PAMP-containing nucleic acid molecule for activating RIG-I, thereby inducing RIG-I binding partner, TRIM 16 that mediates apoptosis in the cancer cell.
Gale et al. (US 20150017207, Published 15 January 2015), cited on an IDS dated 07/31/2020, teach a PAMP molecule comprising a 5’-arm region, a poly-uracil core, and a 3’arm region (page 1, paragraph [0008]), the 5’-arm region comprising a terminal triphosphate and the 5’-arm region further comprises one or more nucleic acid residues disposed between the terminal triphosphate and the poly-uracil core (page 1, paragraph [0009]), the poly-uracil core comprises at least 8 contiguous uracil residues and consists of between 8 and 30 uracil residues (page 1, paragraph [0010]) and the 3’-arm region is not a uracil and is at least 30% uracil residues (page 1, paragraph [0011].
Gale et al. teach the nucleic acid PAMP is capable of inducing RIG-I-like receptor activation [0013], and teaches a method of treating a viral, bacterial, protozoal, fungal or helminth infection in a subject and a method of inducing an innate immune response in a subject by administering an effective amount of a pharmaceutical composition comprising the synthetic nucleic acid PAMP (paragraphs [0017] and [0018]). Gale et al. does not teach that the PAMP-nucleic acid is capable of treating cancer or that it induces TRIM16 mediated apoptotic activity in a genus of cancer cells in a subject.
Zips et al. (In vivo 19:1-8 (2005), Review: “New Anticancer Agents: In Vitro and In Vivo Evaluation), teach that not all tumor cell lines show the same magnitude of response to anticancer agents (right column, page 2). Zips et al. teach that cells in culture are an artificial and simplified system, however tumors are complex consisting of interacting malignant and non-malignant cells, and vascularization, perfusion and drug access to the tumor cells are not evenly distributed which consists of an important source of heterogeneity in tumor response to drugs that do not exist in vitro (Right column, page 3). Zips et al. teach that prediction of drug effects solely on in vitro data is not reliable and further evaluation in animal antitumor systems is essential (Right column, page 3). Zips et al. advocate in vitro and in vivo experiments with at least two or three different tumor cell lines, applying functional non-clonogenic and if applicable clonogenic assays for evaluation of new anticancer agents (Right column, page 6).
Kim et al. (Apoptosis, Published 13 Feb 2013, 18: 639-651), cited on an IDS, teach TRIM16 induces apoptosis in breast and lung cancer cells, by unknown mechanisms, and that overexpression of TRIM16 induces apoptosis in human breast cancer and neuroblastoma cells, by directly modulating caspase-2 activity (Abstract). Kim et al. teach enforced overexpression of TRIM16 induces apoptosis in MB-MDA-231 breast and SK-MES-1 lung cancer cells, however, the exact mechanisms of TRIM16 involvement in the regulation of apoptosis remains unclear (page 640, left column). Therefore, while Kim et al. teach that TRIM16 can induce apoptosis in certain types of cancer cells (breast, lung, neuroblastoma cancer cells), the mechanisms by which it does so are not clear, and Kim et al. do not describe the relationship of TRIM16 with RIG-I or PAMP-containing nucleic acids.
Post-filing art Zhang et al. (Journal for Immunotherapy of Cancer, 2023) teach retinoic acid-inducible gene-I (RIG-I) is a crucial component in innate antiviral immunity, but its role in antitumor immunity remains unclear (Abstract). Zhang et al. teach silencing RIG-I decreased resistance to tumor cells killed by T cells and attenuated colon tumor growth in mice, while overexpressing RIG-I promoted tumor progression, and that RIG-I influenced PD-L1 expression to promote colon cancer immune evasion (Abstract). Zhang et al. teach their previous study also has shown that RIG-I can serve as a binding protein to regulate the PTMs of other proteins, confers resistance to IFN-α-induced apoptosis in melanoma (page 1, right column). Therefore, even post-filing, the state of the art teaches that the role of RIG-I in antitumor immunity is not clear, and RIG-I has been shown to promote colon cancer progression and immune evasion, and resistance to apoptosis in melanoma.
When claims 25,50-55 and 60-67 are analyzed in light of the specification, the instant invention encompasses treating hepatocellular carcinoma cells in vitro comprising administering 50ng, 100ng and 200ng of PAMP-containing nucleic acid molecules as described in PMID: 18548002. The description of Figures 1A-1D on page 5 describes that Figure 1A shows a western blot showing dose-dependent activation of innate immune signaling in human hepatocellular carcinoma cells at all doses of HCV PAMP RNA and dose-dependent induction of apoptosis, and Figure 1D illustrates cell death analysis that shows a dose-dependent increase in cell death induction up to a threshold of 200ng. The description of Figures 7A and 7B on page 7 and page 28 shows that PAMP RNA treatment includes oncolytic destruction of HepG2 and Huh7 hepatocellular carcinoma cells but not normal, noncancerous cells, and shows the amounts 50ng, 100ng and 200ng as the amounts of PAMP administered to the cells (Fig 7A and 7B) but does not show the complete structure of the PAMP-containing nucleic acid molecule. Additionally, these figures only show the results in HepG2 and Huh7 hepatocellular carcinoma cells, and not in any other type of cancer cell. Page 28 contemplates that TRIM16 but not TRIM25 is involved in RIG-I mediated apoptosis, and that PAMP-RNA specifically signals RIG-I mediated apoptosis cell death through the novel RIG-I binding partner TRIM16.
Additionally, the examples starting on page 30 disclose human Huh7 hepatocellular carcinoma cells as treated with a PAMP-containing nucleic acid molecule, but do not show the method being carried out in a subject in vivo, or for any other types of cancers other than in hepatocellular carcinoma cells. Page 32 of the examples describes transfecting cells with a PAMP-containing nucleic acid and refers to PMID:18548002 which is a PubMed identification number for a research article that specifically disclosed instant SEQ ID NO: 2 and experimental results thereof (See Saito T. et al. Nature, 2008). However this article by Saito et al. does not reference cancer at all, much less that the recited genus of PAMP-containing nucleic acids are capable of carrying out the recited function of treating a genus of cancers. The working examples on pages 30-34 do not disclose that TRIM16 mediated apoptotic activity or RIG-I mediated apoptosis in cancer cells occurred as a result of administering the PAMP-containing nucleic acid molecule.
In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their complete structure. In the instant case, while the specification discloses transfecting HepG2 and Huh7 hepatocellular carcinoma cells with a PAMP-containing nucleic acid according to PMID:18548002, the specification does not disclose any other complete structures of the PAMP-containing nucleic acid molecules with the recited function of activating RIG-1, thereby inducing RIG-I binding partner, TRIM16 that mediates apoptosis in a genus of cancer cells and which results in treating a genus of cancers in a subject. The specification discloses 50ng, 100ng and 200ng as the amounts of a PAMP-containing nucleic acid molecule administered to Huh7 cells (Fig 7A and 7B), but that 100ng/mL is the minimal concentration of PAMP-RNA-induced cell death and that 200ng/mL induced the highest level of cell death in Huh7 cells. In addition, the specification only discloses carrying out the method in vitro in hepatocellular carcinoma cells cancer cells and not in vivo in a subject with cancer, as well as the method only being carried out in Huh7 hepatocellular carcinoma cells but not in other types of cancer cells. As evidenced by Zips et al., prediction of drug effects solely on in vitro data is not reliable, and further evaluation in animal antitumor systems is essential (Right column, page 3), and the specification does not show that the recited method can be extrapolated to occurring in vivo in a subject and in any type of cancer cell. The specification only provides written support for the in vitro treatment of Huh7 hepatocellular carcinoma cells with the PAMP-containing nucleic acid of instant SEQ ID NO: 2 at a minimal concentration of 100ng/mL and 200ng/mL of as the concentration inducing the highest level of Huh7 cell death.
Applicant’s attention is directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, first paragraph, "Written Description" Requirement (MPEP2163).
In conclusion, Applicant’s disclosure of the in vitro treatment of Huh7 hepatocellular carcinoma cells with 100ng and 200ng of a PAMP-containing nucleic acid molecule of instant SEQ ID NO: 2 is not deemed sufficient to reasonably convey to one skilled in the art that the instant disclosure was in possession of the claimed broad genus at the time the application was filed. Thus, it is concluded that the written description requirement is not satisfied for the claimed genus.
Response to Arguments
Applicant's arguments filed 04/14/2026 have been fully considered but they are not persuasive.
Applicant states on page 6 of response that to advance prosecution, claim 25 has been amended to recite " A method of treating cancer in a subject in need thereof, the method comprising administering to the subject having a cancer with a pathogen-associated molecular pattern (PAMP)-containing nucleic acid molecule for activating retinoic acid-inducible gene I (RIG-I), thereby inducing RIG-I binding partner, TRIM16, that mediates apoptosis in the cancer cell…”. Applicant cites Rochester, 358 F.3d on page 6 and that in contrast where the genus of compounds for use in not the point of novelty, a lower level of compositional disclosure is needed to satisfy written description as one of skill in the art is readily aware of representative species within the genus, and cites In re Herschler on page 7, and that the instant applicant meets the written description requirement in a manner that can be correlated with Herschler (page 7), and that the instant application provides support for use of known PAMP-containing nucleic acid molecules in a manner auxiliary to the invention, RIG-I agonists induce TRIM16-mediated apoptosis in cancer cells that would lead one of ordinary skill in the art to the PAMP containing nucleic acid molecules as described in Claim 25.
This is not found persuasive. The amendment to claim 25 does not address the written description rejection regarding treating a genus of cancers, or the issues of in vitro to in vivo correlation, or the structure of the genus of PAMP-containing nucleic acid molecules with the recited functions, as explained in the written description rejection. Regarding Applicants arguments pertaining to Rochester and that the instant applicant meets the written description requirement in a manner that can be correlated with Herschler (page 7), this is not found persuasive. Applicant cites that the CCPA reasoned that the physiologically active steroidal agents were known to those of ordinary skill in the art, and “were this application drawn to novel ‘steroidal agents’, a different question would be posed”. This is not the case with the instant application, because while PAMP-containing nucleic acids were known in the art for inducing RIG-I-like receptor activation and treating a viral, bacterial, protozoal, fungal or helminth infection in a subject and inducing an innate immune response, the state of the art does not recognize that the PAMP-containing nucleic acid molecules were known to induce TRIM16 mediated apoptotic activity in cancer cells, or activate RIG-I to induce RIG-I mediated apoptosis in a cancer cell which results in treating cancer. Therefore, it cannot be said that the instant PAMP-containing nucleic acid molecules are well known.
Instant claims 25,50-55,60-64 and 67 only require that the PAMP-containing nucleic acid molecule comprise a 5’ arm region comprising a terminal triphosphate, a poly-uracil core comprising at least 8 contiguous uracil residues, and a 3’ arm region comprising at least 8 nucleic acid residues, wherein the 5’-most nucleic acid residue of the 3’-arm region is not a uracil and wherein the 3’-arm region is at least 30% uracil residues and also requires that administering to a subject having a genus of cancers this PAMP-containing nucleic acid has the recited function of activating RIG-I, thereby inducing RIG-I binding partner, TRIM16 that mediates apoptosis in the cancer cell resulting in treating a genus of cancers in the subject. There is no structure-function correlation described in the prior art or the instant specification. Gale et al. (US 20150017207) may disclose PAMP-containing nucleic acid structures and their use for inducing RIG-I-like receptor activation and treating a viral, bacterial, protozoal, fungal or helminth infection in a subject and inducing an innate immune response, however, Gale et al. does not pertain to treating cancer or to inducing TRIM16 mediated apoptotic activity or RIG-I mediated apoptosis in cancer cells. Therefore, Gale et al. cannot be relied on for the required structure necessary for having the recited functions of the instant claims (activating RIG-I, thereby inducing RIG-I binding partner, TRIM16 that mediates apoptosis in a cancer cell, and resulting in treating cancer in a subject). While page 14 of the instant specification discloses that non-limiting examples of nucleic acid sequences of PAMPs encompassed by the disclosed PAMP-containing nucleic acids are disclosed in US 2015/0017207 and US 2018/0104325 which are incorporated herein by reference and set forth herein as SEQ ID NOs: 2-92, there is no support that the effect described in the instant examples is produced by the sequences disclosed above or SEQ ID NO: 2 as recited in claims 65-66, or that these sequences would have the recited function in a genus of cancers in vivo.
Applicant argues on page 8, that results are summarized in FIGs 1A, 2A-1, 6A,7A and 7B and that FIG. 1A shows that HCV PAMP RNA induces apoptosis in cancer cells in a dose-dependent manner, FIG. 2A-1 shows knocking out RIG-I rescues the induction of apoptosis by HCV PAMP RNA; FIG. 7A,7B show PAMP RNA treatment induces selective destruction of cancer cells with no effect on healthy cells, and therefore shows for the first time that RIG-I activation results in induction of TRIM-16 that selectively mediates apoptosis in cancer cells, and therefore RIG-I antagonists (e.g., PAMPs of SEQ ID NOs: 2-92 can be used for treating cancer.
This is not found persuasive. Applicant is pointing to Figures and providing support that only shows in vitro results in only two types of cancer cells (Huh7 and HepG2 cells), and additionally Applicant even states RIG-I antagonists (e.g., PAMPs of SEQ ID NOs: 2-92) can be used for treating cancer. Instant claim 25 does not recite a PAMP of SEQ ID NOs: 2-92, and does not recite that the method occurs in vitro, or in the specific types of cells that Applicant has support for. To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention", and the examiner maintains that the patent specification does not describe the claimed invention in sufficient detail such that one skilled in the art could conclude that the inventor had possession of the claimed invention. See Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
Applicant argues on page 8, that the Office cites Gale and acknowledges that the claimed PAMP sequences are capable of activating RIG-1, and cites Kim et al. and acknowledges that TRIM16 induces apoptosis in cancer cells (e.g., breast and lung cancer). Applicant argues on page 10 that the Office citing Zhang does not rebut the clear showing that Applicant was in possession of the claimed invention at the time of filing, and that Zhang does not address/undermine RIG-I induced TRIM16-mediated apoptosis in cancer cells as disclosed and experimentally demonstrated in the instant application.
This is not found persuasive. Even if Gale et al. shows that the PAMP-containing nucleic acid molecules induce RIG-I-like receptor activation and induce an innate immune response, and Kim et al. shows that TRIM16 induces apoptosis in specific cancer cells (breast and lung), this data does not show that this response is sufficient to induce apoptosis and to treat all types of cancer as required by the claims or in vivo in a subject. Applicant fails to respond to the examiner’s argument regarding claims 25,50-55 and 60-67 reciting treating a genus of cancers and the in vitro vs in vivo correlation, when the examples only pertain to hepatocellular carcinoma cells in vitro. Additionally as Zhang et al. taught overexpressing RIG-I promoted tumor progression, and that RIG-I influenced PD-L1 expression to promote colon cancer immune evasion, it shows that at the time of filing, that overexpressing or activating RIG-I may not have the same effect in all types of cancer.
In conclusion, the examiner is maintaining the written description rejection based on the reasons and responses set forth above, regarding the lack of structure-function correlation of the recited PAMP-containing nucleic acid molecule that has the function of activating RIG-I, thereby inducing RIG-I binding partner, TRIM16, that mediates apoptosis in a genus of cancer cells, thereby treating a genus of cancer in a subject.
Conclusion
Claims 25,50-55 and 60-67 are rejected.
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 STEPHANIE L SULLIVAN whose telephone number is (703)756-4671. The examiner can normally be reached Monday-Friday, 7:30-3:30 EST.
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/STEPHANIE L SULLIVAN/ Examiner, Art Unit 1635
/ABIGAIL VANHORN/Primary Examiner, Art Unit 1636
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