CTNF 18/734,176 CTNF 74599 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Rejections - 35 USC § 112(a) 07-30-01 AIA 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. 07-31-03 AIA Claim s 80-87 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 a method of treating a STING-mediated disease or disorder where such treatment does not encompass prophylactic treatment , does not reasonably provide enablement for such a method which does encompass prophylactic treatment . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. With regard to rejections under 35 USC 112(a) or 35 USC 112, first paragraph, the following factors are considered (MPEP 2164.01(a)): a) Breadth of claims; b) Nature of invention; c) State of the prior art; d) Level of ordinary skill in the art; e) Level of predictability in the art; f) Amount of direction and guidance provided by the inventor; g) Working examples and; h) Level of experimentation needed to make or use the invention based on the content of the disclosure. a) The claims are extraordinarily broad: “A method of treatment of a STING-mediated disease or disorder…comprising administering…a compound of Formula I…and…a therapeutic agent that inhibits PD-1” (independent claim 80). Dependent claim 81 further defines the term treatment . Dependent claim 82 further defines the disease (cancer). Dependent claims 83 and 84 further define the PD-1 inhibitor. Dependent claims 85-87 define the timing, dosage and method of administration. The examiner notes that the specification explicitly teaches that the instant method of treatment encompasses prophylactic treatment (page 37, [0194]) and that STING-mediated diseases encompass inter alia cancer, particularly metastatic solid tumors and lymphomas, and autoimmune diseases (page 1, [002]) . b,c) The nature of the invention is determined in part by the state of the prior art. As even a cursory perusal of the medicinal arts reveals, they have not advanced to the point where complex diseases with a significant genetic component, such as cancers and autoimmune diseases, can be said to be treatable prophylactically i.e. prevented . d) The level of skill in the art is considered to be relatively high. e) The level of predictability in the art is considered to be relatively low. The basis of all modern medicine and biology is, of course, chemistry. Yet even under the best of circumstances, and more than two hundred years after Lavoisier laid the foundations of its modern practice, chemistry remains an experimental science. Neither the medicinal/biological arts nor the chemical arts upon which they are based have advanced to the point where certainty has replaced the need for clinical and/or laboratory experimentation. Cancer, for instance, is neither a simple disease, nor a single disease. While some cancers can be treated in some hosts using specific methods, the effective treatment - let alone prevention - of various forms of cancer remains highly unpredictable in the art. Note that 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 in the art (MPEP 2164.03). f,g) The amount of direction provided by the inventor is considered to be determined by the specification and the working examples. Inventor’s data do not demonstrate that the instant method prevents , for instance, cancers or autoimmune diseases. h) It would clearly require an extraordinary - and thus undue - amount of experimentation (myriad clinical trials, etc.) in order to determine if, in fact, the instant method is actually efficacious in the prevention of, for instance, cancers or autoimmune diseases. Claim Rejections - 35 USC § 112(d) 07-36 AIA 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. Claim 85 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth 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. In the present instance, the claim fails to further limit the subject matter of the claim upon which it depends (claim 80). Claim 85 merely explicitly lists the only logical possibilities there are in administering the two compounds: simultaneously, sequentially or intermittently. However, claim 80, the independent claim, already implicitly encompasses all these possibilities (because it is silent with respect to any order or sequence of administration). 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. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15-03-aia AIA Claim s 80-88 are rejected under 35 U.S.C. 102(a)(2) as being clearly anticipated by WO 2017/075477 A1, cited in the IDS (and whose priority application dates are 10/28/2015 and 8/25/2016) . The reference teaches stereoisomers encompassed by instant Formula I as highly active cyclic-di-nucleotide (CDN) immune stimulators utilized in a method that activates the STING pathway (page 213, compounds 16, 16a, 20 and 20a; abstract) in order to treat STING-mediated diseases such as cancer (page 85, [00168]). The CDNs may be in the form of pharmaceutically acceptable salts or prodrugs (an example of which could be an ester thereof) (page 79, [00154]). The CDNs may be administered with a PD-1 antagonist, and the CDN and the PD-1 antagonist may be administered as a single administration or as separate administrations (page 111, [00235]; page 98, [00202]). Nivolumab, pembrolizumab and pidilizumab are explicitly taught as PD-1 antagonists (page 84, [00157], 3 rd line from the bottom of the paragraph). Oral or injected administration, for instance, is explicitly taught (page 197, [00393]; page 199, [00400]). Dosage is typically about 0.1-100 mg/kg – but will depend upon many factors and one of ordinary skill (i.e. a highly skilled individual such as a clinical physician) is explicitly presumed to able to formulate an effective dosage (page 199, [00401]). The reference teaches that in response to binding CDNs, STING pathway signaling is activated which induces expression of IFN-β and other coregulated genes (i.e. the method induces transcription of host defense genes) (page 95, [00198]). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /BRIAN J DAVIS/Primary Examiner, Art Unit 1614 3/18/2026 Application/Control Number: 18/734,176 Page 2 Art Unit: 1614 Application/Control Number: 18/734,176 Page 3 Art Unit: 1614 Application/Control Number: 18/734,176 Page 4 Art Unit: 1614 Application/Control Number: 18/734,176 Page 5 Art Unit: 1614 Application/Control Number: 18/734,176 Page 6 Art Unit: 1614 Application/Control Number: 18/734,176 Page 7 Art Unit: 1614 Application/Control Number: 18/734,176 Page 8 Art Unit: 1614
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