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 .
Claim Status
Claims 1–20 are pending. Claims 1-10, 12 and 14-20 are rejected. Claims 11 and 13 are objected to.
Claim Rejections - 35 USC § 112(b)
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 2, 8, 12, 14-16 and 20 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.
Regarding claim 2, 8, 12, 14-15 and 20, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Further, regarding claim 15, the phrase "for example" or “e.g.” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 16 is rejected because it refers to Table C1 of the instant specification. A claim should particularly point out and distinctly claim the subject matter which the applicant regards as his invention and, under modern claim practice, stand alone to define the invention. 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)
Claim Rejections - 35 USC § 112(d)
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 16 is 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.
Claim 16 is directed to compounds of Table C1 which contains compounds that exist beyond the scope of Formula (I), for example compound 283 on page 75 of the specification contains a heteroaryl ring where W of instant claim 1 only provides for non-aromatic heterocyclyl and heterocycloalkylene:
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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
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.
(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.
Claim(s) 1-3, 6 and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gao et al., "Discovery of dual death-associated protein related apoptosis inducing protein kinase 1 and 2 inhibitors by a scaffold hopping approach," Journal of Medicinal Chemistry, September 11, 2014, 57(18):7624-7643. cited in the IDS filed 12/08/2023.
(Figure 2, page B):
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The prior art compound reads on claims 1-3, 6, and 9-10 and is embraced by formula (I) where Q2 is hydrogen, LA is absent (a1 is 0), Q1 is unsubstituted heteroarylene with an S heteroatom, Y1 and Y2 are CR1 where R1 is hydrogen, Y3 and X2 are N, X1 is S, R6 is hydrogen, and W is unsubstituted monocyclic C6 cycloalkyl.
Claim(s) 1, 3, 6-8 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 507462-72-8, which entered Registry on April 30th, 2003.
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The prior art compound reads on claims 1, 3, 6, and 8, and is embraced by formula (I) where Q2 is hydrogen, LA is absent (a1 is 0), Q1 is C6 arylene substituted with 2 Rc which are each C1 alkoxy, Y1 and Y2 are CR1 where R1 is hydrogen, Y3 is N, X1 is NR2 where R2 is hydrogen, X2 is CR5 where R5 is hydrogen, R6 is hydrogen, and W is unsubstituted C3 alkyl.
Regarding instant claim 17, which is drawn to a pharmaceutical composition comprising the compound and a pharmaceutically acceptable excipient, the CAS Registry entry includes predicted properties including mass and molar solubilities at varying pH values. MPEP 2131.02 states:
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015)
In this situation, a person having ordinary skill in the art in viewing the properties of the Registry entry would envisage a composition with the compound and water, which is a pharmaceutically acceptable excipient.
Claim(s) 1-6, 8, and 17 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US 2009/0203690 A1 by Akritopoulou-Zanze et al.
The prior art discloses N-[5-(1-benzyl-1H-1,2,3-triazol-4-yl)-1H-indazol3-yl]-2-methoxyacetamide which is represented by the structure below (paragraph [0147]):
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The prior art compound reads on claims 1-6, 8, and 17 and is embraced by formula (I) where Q2 is Rg which is unsubstituted C6 aryl, LA is unsubstituted C1 alkylene (a1 is 1), Q1 is unsubstituted heteroarylene with three N heteroatoms, each of Y1, Y2, and Y3 are CR1 where R1 is hydrogen, X1 is NR2 where R2 is hydrogen, X2 is N, R6 is hydrogen, and W is C1 alkyl substituted by 1 Ra2 which is C1 alkoxy.
Regarding instant claim 17, the prior art teaches pharmaceutical compositions comprising the prior art compound and a pharmaceutically acceptable carrier (paragraph [0049]).
Claim Rejections - 35 USC § 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.
Claims 1-6, 8, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0203690 A1 by Akritopoulou-Zanze et al.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art teaches (title) “5-substituted indazoles and kinase inhibitors” and discloses N-[5-(1-benzyl-1H-1,2,3-triazol-4-yl)-1H-indazol3-yl]-2-methoxyacetamide which is represented by the structure below (paragraph [0147]):
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The prior art compound reads on claims 1-6, 8, and 17 and is embraced by formula (I) where Q2 is Rg which is unsubstituted C6 aryl, LA is unsubstituted C1 alkylene (a1 is 1), Q1 is unsubstituted heteroarylene with three N heteroatoms, each of Y1, Y2, and Y3 are CR1 where R1 is hydrogen, X1 is NR2 where R2 is hydrogen, X2 is N, R6 is hydrogen, and W is C1 alkyl substituted by 1 Ra2 which is C1 alkoxy.
Regarding instant claim 17, the prior art teaches pharmaceutical compositions comprising the prior art compound and a pharmaceutically acceptable carrier (paragraph [0049]).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art compound reads on instant claims 1-6, 8, and 17. Akritopoulou-Zanze et al. teach methods of treating comprising administering the compound above but the reference is silent to STING inhibition.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 18 and 19, Akritopoulou-Zanze et al. teach administering the prior art compound for treating diseases such as lupus which a person of ordinary skill would recognize as embracing a method of inducing an immune response in a subject (paragraph [0016]). Instant claim 18 recites a method “for inhibiting STING activity” wherein this phrase is merely an intended use. Regarding intended uses, MPEP 2112.02(II) states:
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)
Accordingly, the instant claim wherein contacting STING with a compound of formula (I) is the only active step is obvious over the prior art method of administering the compound to treat lupus. Contacting STING would be a natural consequence of administering the compound as STING is present in cells within the body. Regarding the intended inhibition of STING, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0203690 A1 by Akritopoulou-Zanze et al. as applied to claims 1-6, 8, and 17-19 above, and further in view of Zhou R, Xie X, Li X, et al. The triggers of the cGAS-STING pathway and the connection with inflammatory and autoimmune diseases. Infect Genet Evol. 2020; 77:104094.
Akritopoulou-Zanze et al. disclose a method of treating diseases such a lupus by administering the prior art compound but do not teach that the diseases are associated with STING.
Zhou et al. teach (title) “[t]he triggers of the cGAS-STING pathway and the connection with inflammatory and autoimmune diseases” and disclose that Systemic lupus erythematosus is associated with the STING pathway (page 3, Table 1). Accordingly, a person of ordinary performing the prior art method of treating lupus by administering the compound of Akritopoulou-Zanze et al. would embrace the method of claim 20 which involves treating a disease associated with STING.
Allowable Subject Matter
Claims 11 and 13 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLI A CHICKS whose telephone number is (571)270-0582. The examiner can normally be reached M-Th 7 a.m.- 5 p.m..
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/A.A.C./Examiner, Art Unit 1626
/JOSEPH K MCKANE/Supervisory Patent Examiner, Art Unit 1626
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