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 .
Priority
This application is a national stage entry of PCT/CN2020/073405 filed on 01/21/2020.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in CHINA (201910819220) on 09/04/2019 and (201910083149.3) on 01/31/2019.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 11, 2026 has been entered.
Response to Amendment
By Applicant’s amendment filed on February 11, 2026, claims 9 and 14-19 have been cancelled and new claims 21-27 have been added. Claims 1-8, 10-13 and 20 were previously canceled. Claims 21-27 are currently pending.
Response to Arguments
Applicant's declaration under 37 CFR 1.132 filed February 11, 2026 with respect to the rejection under 35 USC 103 has been fully considered and is sufficient to overcome the rejection under 35 USC 103 over Mehlmann et al.
Specifically, the current claims are drawn to one compound having the following structure
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and Mehlmann et al. teaches the following structure
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and thus the only difference is the substitution of a thiazole ring for the pyrazole ring. The declaration demonstrates that the claimed compound has binding affinity to sting protein nearly 3 times more than the compound of Mehlmann and is nearly 2 times more potent than the Mehlmann compound in the activation IFN-b and IP10 activity. The declaration further demonstrates that the claimed compound is less toxic than the compound of Mehlmann and has significantly better safety profile than the compound of Mehlmann. Thus Applicant’s data is sufficient to overcome the rejection under 35 USC 103 and thus the previous rejection under 35 USC 103 over Mehlmann et al. is hereby withdrawn.
Claims 21 and 22 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 23-27, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, 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 July 16, 2024 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.
Claim 23 is also allowable as claim 21 is drawn to a novel compound as detailed above and the specification provides sufficient data to demonstrate that the claimed compound binds to and activates STING.
New rejections of claims 24-27 are detailed below. This action is non-final
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.
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 24-26 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The specification does not provide sufficient information to demonstrate that activation of STING by the claimed compounds will result in the treatment of any of the claimed disorders.
The instant specification fails to provide information that would allow the skilled artisan to practice the instant invention without undue experimentation. Enablement is considered in view of the Wands factors (MPEP 2164.01(A)). These include: nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art, predictability of the art, the relative skill of those in the art, and the amount of experimentation necessary. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the Invention: Claims 24-26 are drawn to a method for the treatment of any disease related to STING activity including any inflammatory, autoimmune, and infectious disease; any cancer and precancerous syndrome; related to STING activity or not related to STING activity comprising the administration of the following compound:
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.
Breadth of the claims: The complex nature of the subject matter of this invention is greatly exacerbated by the breadth of the claims. The rejected claims are extremely broad. Applicant claims that the claimed compound can be used to treat hundreds or even thousands of diseases including any type of cancer, any type of inflammatory disease, any type of autoimmune disease, any infectious disease and even any type of precancerous syndrome, related to or unrelated to STING activity. Thus Applicant claims that the claimed compound is a broad-spectrum antimicrobial agent, a broad-spectrum anticancer agent, a broad-spectrum anti-inflammatory agent, as well as a broad-spectrum autoimmune disease inhibitor.
Guidance of the Specification/Working Examples: In the instant specification, Applicant has demonstrated that the claimed compound has binding affinity to sting protein (Table 6 pages 102-103). Applicant further demonstrates agonistic Sting activity by demonstrating stimulation of IFN-b and IP10 activity (Table 7 pages 104-105). Applicant further demonstrates that the claimed compound was able to reduce the size of tumors grown from CT26 murine colon carcinoma cells implanted in mice (Figure 1 Example 4 pages 106-107). Applicant further demonstrates in example 6 that after treatment with the claimed compound, further inoculation of mice with CT26 cells did not result in regrowth of the tumor (Figure 2). No other data was presented in the instant specification. Furthermore, the claims of the instant application are drawn to the treatment of any subject in need thereof, and with the exception of a murine subject, no data was presented administering the claimed compound to any other subject. Thus Applicant has not provided any data which teaches or suggest that any subject other than a murine subject can be treated with the claimed compound for anything other than murine colorectal cancer. There is no data in the instant specification administering the claimed compound to any subject other than a murine subject for the treatment of any disorder other than murine colorectal cancer. Applicant does not provide any other data which demonstrates that these preliminary studies will lead to the treatment of any disorder as claimed in the current claims. No examples of treatment of an inflammatory disease, an autoimmune disease, an infectious disease, cancer or a precancerous disease in a human subject exists in the instant specification.
Thus, the specification fails to provide sufficient evidence in support of the broad use of the claimed compound for the treatment of any disease/disorder as recited in the instant claims.
State of the Art: Prior to the effect filing date of the claimed invention similar STING activator compounds were known in the art. Mehlmann et al. U.S. Publication No. 2018/0105514 A1 (Provided on IDS) teaches the following compound
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as well as a composition comprising said compound (claims 26 and 33 on pages 254-255). Mehlmann et al. teaches that the compounds disclosed therein modulate the activity of STING, and accordingly, may provide a beneficial therapeutic impact in treatment of diseases, disorders and/or conditions in which modulation of STING (Stimulator of Interferon Genes) is beneficial, for example for inflammation, allergic and autoimmune diseases, infectious diseases, cancer, pre-cancerous syndromes and as vaccine adjuvants [0016]. However, Mehlmann et al. does not provide any experimental data demonstrating that the activation of STING leads to the treatment of any disease or disorder. Thus while the teachings of Mehlmann et al. implicates STING activators in a variety of diseases, no evidence exists to actually demonstrate the treatment of any disorder.
Thus the state of the art prior to the effective filing date of the claimed invention does not support the use of the claimed compound in the treatment of any disease or disorder as claimed in the instant application.
Predictability/Unpredictability in the Art: It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. In the instant case, the instant claimed invention is highly unpredictable since one skilled in the art would recognize that the recitation encompasses treating any type of cancer, any type of inflammatory disease, any type of autoimmune disease, any infectious disease and even any type of precancerous syndrome, related to or unrelated to STING activity, which include a great number of diseases with different etiologies, comprising the administration the claimed compound. Thus, the skilled artisan would view that the treatment of all disorders/diseases encompassed by the claims, by administering the compound encompassed by the claims, is highly unpredictable.
Moreover, one of skill in the art would recognize that it is highly unpredictable in regard to therapeutic effects, side effects and toxicity generated by administering the claimed compound for treating all disorders/diseases encompassed by the claims.
The Quantitation of Experimentation Required: In order to practice Applicant’s invention, it would be necessary for one to design and conduct an exhaustive amount of complex experiments to demonstrate that the claimed compound can treat all diseases/disorders encompassed by the claims. One would need to perform complex pharmacokinetic and pharmacological experiments to determine efficacy, potency, etc. for the compound in treating the desired disease/disorder. Therefore, in order to practice the claimed invention, the amount of experimentation required would be considered undue and burdensome.
In conclusion, Genetech, 108 F.3d at 1366 states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague limitations of general ideas that may or may not be workable.” A method for the treatment of any disease related to STING activity including any inflammatory, autoimmune, and infectious disease; any cancer and precancerous syndrome; related to STING activity or not related to STING activity comprising the administration of the following compound:
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is not enabled by the instant specification.
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 24-25 and 27 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.
The term “related to” in claims 24-25 is a relative term which renders the claim indefinite. The term “related to” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Paragraph [0025] of the instant specification states “The diseases related to STING activity defined in the present invention are diseases in which STING plays an important role in the pathogenesis of the disease.” However, the specification does not further define what is meant by an “important role” and how involved must STING be in order to be considered STING related. Furthermore, Applicant does not define how one would determine if STING is involved in a particular disease or disorder. Thus an ordinary skilled artisan cannot ascertain the metes and bounds of the claims.
Claim 27 is 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. The omitted steps are: the steps required to manufacture the immune adjuvant. The claims do not recite how to prepare the immune adjuvant using the compound of claim 21. Thus claim 27 amounts to the use of a compound without any active, positive steps delimiting how this use is actually practiced. Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
Thus claim 27 is rejected as being indefinite.
Conclusion
Claims 24-27 are rejected. Claims 1-20 are canceled. Claims 21-23 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA R. MCMILLIAN whose telephone number is (571)270-5236. The examiner can normally be reached Tuesday-Friday 12:00 PM-6:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached on (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM