DETAILED ACTION
Notice of AIA Status
The instant application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ).
If the status of the application as subject to AIA or pre-AIA is incorrect, any correction of the statutory basis (e.g., changing from AIA to pre-AIA ) for a rejection under 35 U.S.C. §§ 102 and/or 103 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.
Status of the Claims
The listing of claims filed 24 November 2023 has been examined.
Claims 1, 2, 5, 10, 12, 14, 17, 19, 21, 23, 24, 26–28, 33, 36, 38, 41, 51, and 61 are pending.
Claims 36 and 51 are amended. Claims 1, 5, 10, 12, 14, 17, 19, 21, 23, 24, 27, 28, 33, 36, 38, 41, 51, and 61 were previously amended in a listing of claims filed 6 July 2023.
Claims 3, 4, 6–9, 11, 13, 15, 16, 18, 20, 22, 25, 29–32, 34, 35, 37, 39, 40, 42–50, and 52–60 are canceled.
Benefit of Earlier Filing Date
The instant application was filed 6 July 2026; is a national stage application of PCT/CA2022/050014, filed 7 January 2022, and claims the benefit of U.S. Prov. Pat. App. Serial No. 63/134,739, filed 7 January 2021. Applicant’s claim is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 16 October 2023 and 10 December 2025 are acknowledged and have been considered.
Objections to the Specification
The abstract of the disclosure is objected to because it recites phrases that can be implied (“The present application relates to”) and legal phraseology (“comprising”).
Appropriate correction is required.
For guidelines for the preparation of patent abstracts, see MPEP § 608.01(b) (Explaining: The abstract should be in narrative form and avoid legal phraseology (e.g., means, said), terms referring to purported merits of the invention (e.g., new, novel), and phrases that can be implied (e.g., The disclosure concerns, The disclosure defined by this invention). The language should be clear and concise, and not repeat information given in the title. It should not compare the invention with the prior art. The abstract is generally limited to a single paragraph within the range of 50 to 150 words in length.).
Claim Rejections - 35 U.S.C. § 112
The following is a quotation 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 36 and 51 are rejected under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. The claims contain subject matter that was not described in the Specification in such a way as to reasonably convey to one of ordinary skill in the art that Applicant, at the time the application was filed, had possession of the claimed invention.
In Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc), the Federal Circuit stated “the hallmark of written description is disclosure.” A specification adequately describes an invention when it “reasonably conveys to those skilled in the art the inventor had possession of the claimed subject matter as of the filing date.” (Id.). “A ‘mere wish or plan’ for obtaining the claimed invention is not adequate written description.” Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1348 (Fed. Cir. 2011).
What is required to meet the written description requirement “varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). In Ariad, the Federal Circuit explained what is required to meet the written description requirement:
This inquiry, as we have long held, is a question of fact. Ralston Purina, 772 F.2d at 575. Thus, we have recognized that determining whether a patent complies with the written description requirement will necessarily vary depending on the context. Capon v. Eshhar, 418 F.3d 1349, 1357–58 (Fed. Cir. 2005). Specifically, the level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. Id. For generic claims, we have set forth a number of factors for evaluating the adequacy of the disclosure, including “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue.” Id. at 1359.
(Ariad, at 1351).
The written description of a genus, such as a chemical genus, “requires a precise structure, formula, [or] chemical name” of the claimed subject matter sufficient to distinguish it from other materials. Regents of the Univ. of Cal. v. Eli Lilly & Co., 199 F.3d 1559, 1568 (Fed. Cir. 1997). The Federal Circuit commented on that case in the Ariad decision:
We held that a sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. at 1568-69. We explained that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials. Id. at 1568 (quoting Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993)). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001)). But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
(Ariad, at 1350).
The factors outlined in the above Federal Circuit cases are analyzed with respect to the claimed invention in turn below.
(A) The nature and scope of the claim invention in view of the specification: the invention relates generally to the chemical and pharmaceutical arts and more specifically to treating a condition treatable by inhibiting or blocking NUAK kinase. (Spec., ¶¶2, 145).
The Specification states that cancer and fibrosis are conditions treatable by inhibiting or blocking NUAK kinase. (Id., ¶¶2–9, 35–42). The Specification includes in vitro assays evidencing the activity of certain compounds. (Id., ¶¶2–9, 378–389).
The scope of diseases disclosed with particular detail in the specification includes cancer and fibrosis.
Claim 36 is directed to “treating a disease, disorder or condition that is treatable by inhibiting NUAK2 and/or NUAK1.” One of ordinary skill in the art would not be able to determine the scope of diseases encompassed by claim 36 because that determination would require testing for every disease, disorder, or condition to identify those which are treatable by inhibiting NUAK2 and/or NUAK1. Claim 51 is directed to “treating a disease, disorder or condition by inhibiting localization of YAP/TAZ to the nucleus of a cell.” The scope of claim 51 encompasses any disease, disorder, or condition. The intended result of inhibiting localization of YAP/TAZ to the nucleus of a cell is not given much patentable weight because the body of the claim sets forth the steps (limitations) of the claimed method. (MPEP § 2111.02(II)).
(B) The extent and content of the prior art: Relevant prior art appears to support the use of structurally related compounds for the treatment of cancer and fibrosis. See, e.g., Faisal et al., J. Med. Chem. (2021), 64, 2–25 (“Faisal”) [IDS]. See also WO 2005/118544 [IDS] and WO 2008/077885 [IDS].
(C) The maturity of the science or technology: Examiner is not aware of any NUAK inhibitors that are approved as medicine. In Faisal, the authors explain, “only a limited number of NUAKs substrates and upstream regulators are well investigated, whereas a more in-depth understanding of NUAKs network is lacking. Therefore, further investigation is demanded to explain the functions and regulatory mechanisms of NUAK isoforms.” (Faisal, p. 17). Faisal states: “However, to date, no genetically modified mouse or genetically engineered mouse model (GEMM) has been utilized to elucidate the biological operations of NUAKs in the late and early phases of tumor progression.” (Id.). Based on the lack of approved NUAK inhibitors or an established model, the technology is considered to be in its infancy.
(D) The predictability of the aspect at issue: the pharmaceutical art is generally recognized as unpredictable. In re Fisher, 427 F.2d 833, 839 (CCPA 1970). The art requires each potential drug candidate to be assessed for physiological activity. Id. The more unpredictable an area is the more specific disclosure is necessary to satisfy the statutory requirement. In this case, there is no evidence suggesting the claimed invention is more predictable than the pharmaceutical art is generally.
The question of written description
When the factors and evidence discussed above are considered as a whole, one of ordinary skill in the art would conclude the specification does not adequately describe a representative number of species (i.e., diseases) to support the claimed methods of administering the claimed compounds to a subject to treat undisclosed diseases (i.e., diseases other than cancer and fibrosis). In contrast to the claims, the specification discusses cancer and fibrosis and provides in vitro assays evidencing the activity of certain compounds in the context of cancer and fibrosis. Further, the technology is considered to be in its infancy and unpredictable, and the relevant prior art extends to the treatment of cancer and fibrosis. Accordingly, the specification would not reasonably convey to those skilled in the art the inventor had possession of the claimed genus as of the filing date.
Claim Rejections - 35 U.S.C. § 103
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.
Graham v. John Deere Co., 383 U.S. 1, 17 (1966); MPEP § 2141(II).
Claim 61 is rejected under 35 U.S.C. § 103 as being unpatentable over WO2005/118544 (“Rigel”) [IDS].
The Graham factors are addressed in turn below.
Determining the scope and contents of the prior art
Rigel discloses a method of preparing a compound of formula (I) (Rigel, compounds: pp. 21–40; synthesis: pp. 41–49). In particular, Rigel discloses the reaction of compound 4 at the C4 halide followed by the reaction of compound 8 at the C2 halide to obtain compound 12:
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(Id., p.41).
The above steps are identical to the instantly claimed steps, in both substance and order.
Ascertaining the differences between the prior art and the claims at issue
The compounds in Rigel do not include the combination of the R3 variable that is fluoroalkyl or fluoroalkoxy and the Z variable that includes an amino group.
Resolving the level of ordinary skill in the pertinent art
The level of one of ordinary skill may be found by inquiring into: (i) the type of problems encountered in the art; (ii) prior art solutions to those problems; (iii) the rapidity with which innovations are made; (iv) the sophistication of the technology; and (v) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of the factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983). Based on the typically high education level of workers in the pharmaceutical art and the high degree of sophistication required to solve problems encountered in the art, Examiner finds a person having ordinary skill in the art would have at least a college degree in chemistry and several years of experience in chemical synthesis.
Considering objective evidence present in the application indicating obviousness or nonobviousness
The instant application does not include any evidence applicable to the claimed method.
The question of obviousness
Based on the above factors, it would have been prima facie obvious for a person having ordinary skill in the art, prior to the filing of the instant application, to arrive at the claimed method based on the disclosures in Rigel because the same two reactions are applied to compounds having essentially the same structure as those claimed. While the compounds in Rigel do not include the combination of the R3 variable (fluoroalkyl or fluoroalkoxy) and the Z variable (comprising an amino group), those substituents are peripheral on the structure and are not involved in the reactions. Accordingly, one of ordinary skill in the art would have had a reasonable expectation of success at modifying the peripheral substituents in Rigel to obtain the claimed method, particularly since there is a high level of skill for one of ordinary skill in the art.
Allowable Subject Matter
Claims 1, 2, 5, 10, 12, 14, 17, 19, 21, 23, 24, 26–28, and 33 are allowable. The claims are directed to novel compounds comprising the A ring that is cycloalkyl or thiophene, the R3 variable that is fluoroalkyl or fluoroalkoxy, and the Z variable that includes an amino group. The closest prior art includes US 2006/0270694 [IDS], which discloses structurally related compounds (e.g., compound 2, p.13) that are identical to the claimed compound but for one of the features noted above (e.g., R3).
Claims 38 and 41 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
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/JASON M. NOLAN/Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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