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 .
DETAILED ACTION
Claims 1-15, 18-25, 27 and 28 are pending in the application. Claims 1-15, 18-25, 27 and 28 are rejected.
Priority
This application is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/IB2022/000314, filed on June 2, 2022, which claims benefit of Provisional Application No. 63/331,371, filed on April 15, 2022, which claims benefit of Provisional Application No. 63/196,036, filed on June 2, 2021.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on December 1, 2023 and January 22, 2026 are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached.
Drawings
The drawings are objected to because the text in FIG. 5, FIG. 6, FIG. 7, FIG. 8, FIG. 9 and FIG. 10 are faint and difficult to read. To further improve the clarity and reproducibility of the aforementioned figures, Applicant should submit replacement drawings. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via EFS-Web or three sets of color drawings or color photographs, as appropriate, if not submitted via EFS-Web, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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 5, 8-13 and 24 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.
Claim 5 recites the expression “wherein the composition has a pH of about 2.6 to about 6.74 measured in 1% w/v Aqueous Suspension” and is rejected as indefinite. It is unclear whether Applicant intended the claim to (a) be drawn towards the pharmaceutical composition of parent claim 4 in the form of an aqueous suspension with 1% w/v of a compound of Formula 1 and having the recited pH values or (b) indicate that the pharmaceutical composition of parent claim 4- when dissolved in water at 1% w/v- would form an “Aqueous Suspension” having a measured pH value of about 2.6 to about 6.74. For the purposes of examination, claim 5 is being interpreted as being drawn towards interpretation (b).
Claims 8-13 recite the limitation “pharmaceutical composition” and are rejected as indefinite. There is insufficient antecedent basis for this limitation in each claim as parent claim 1 does not provide for a “pharmaceutical composition.” It is suggested Applicant overcome this issue of indefiniteness by canceling the expression “or pharmaceutical composition” in each of claims 8-13.
Claim 24 recites the limitation “the composition” and is rejected as indefinite. There is insufficient antecedent basis for this limitation in the claim as parent claim 14 does not provide for a “composition.” In addition, claim 24 recites the expression “wherein the composition has a pH of about 2.6 to about 6.74 measured in 1% w/v Aqueous Suspension” and is further rejected as indefinite. Even after assuming it was Applicant’s intent for claim 24 to be drawn instead towards a composition comprising the compound of Formula 1 as recited in parent claim 14, it is still unclear whether claim 24 is (a) drawn towards a composition in the form of an aqueous suspension comprising 1% w/v of the compound of Formula 1 and having the recited pH values or (b) merely indicating that the composition when dissolved in water at 1% w/v- would form an “Aqueous Suspension” having a measured pH value of about 2.6 to about 6.74. However, for the purposes of examination, claim 24 is being interpreted as being drawn towards a composition comprising Formula 1 and interpretation (b).
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.
Claims 1-3, 8-15, 18-23, 25, 27 and 28 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by PCT Publication No. WO 2015/037939 A1 (March 19, 2015).
The prior art teaches 4-(3-(3-((cyclopropylamino)methyl)azetidine-1-carbonyl)-4-fluorobenzyl)phthalazin-1(2H)-one (i.e., “Example 143”) which corresponds to the following chemical structure (see e.g., paragraph [1739]):
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Regarding instant claims 1-3, 8-15, 18-23, 25, 27 and 28, the above prior art compound corresponds to the instantly claimed compound of Formula 1. Note: the expression “for use...” as recited in each of claims 1-3, 8-15, 18-23, 25, 27 and 28 is merely drawn towards the purpose or intended use of the claimed compound of Formula 1 and does not create a structural difference between the claimed compound and the prior art compound (i.e., Example 143). An intended use will not limit the scope of the claim because it merely defines a context in which the invention operates. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). Accordingly, the expression “for use...” as recited in the claims is considered non-limiting.
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.
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.
Claims 4-7 and 24 are rejected under 35 U.S.C. § 103 as being unpatentable over PCT Publication No. WO 2015/037939 A1 (March 19, 2015) as evidenced by BALB/c ("Physiological Data Summary – BALB/cJ" (PDF). jackson.jax.org. Retrieved January 28, 2026).
Determining the scope and contents of the prior art (See MPEP § 2141.01)
The prior art teaches 4-(3-(3-((cyclopropylamino)methyl)azetidine-1-carbonyl)-4-fluorobenzyl)phthalazin-1(2H)-one (i.e., “Example 143”) which corresponds to the following chemical structure (see e.g., paragraph [1739]):
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Regarding instant claim 4, the above prior art structure corresponds to the instantly claimed compound of Formula 1. The prior art further teaches “administering an effective amount of the pharmaceutical composition to the subject.” See e.g., paragraph [386]. The prior art further teaches an excipient (i.e., “a pharmaceutically acceptable inactive ingredient that is commonly used for preparing a pharmaceutical formulation” as disclosed in paragraph [0125] of the instant specification) or “a carrier, for example, water, ethanol polyethylene glycol, propylene glycol, methylcellulose, or a suitable oil, and one or more emulsifying agents and/or suspending agents.” See e.g., paragraph [395].
Note that the recited “for use” expression in each of claims 4, 6 and 7 is merely drawn towards the purpose or intended use of the claimed composition comprising a compound of Formula 1 and does not create a structural difference between the claimed composition and the prior art composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. It is noted that intended use confers no patentable weight to composition claims. In re Hack, 114 USPQ 161. Furthermore, “the patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure.” (Catalina Mktg. Int’l, v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002).
As indicated above, instant claims 5 and 24 are both being interpreted as being drawn towards a pharmaceutical composition dissolved in water at 1% w/v to form an “Aqueous Suspension” measured to have a pH of about 2.6 to about 6.74. Accordingly, the recited pH limitations of instant claims 5 and 24 are considered characteristics that would necessarily be present in the claimed pharmaceutical composition. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. MPEP § 2112.01(II)
Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
Regarding instant claim 4, the prior art does not explicitly teach a composition comprising “about 2 mg to about 300 mg” of the prior art compound (i.e., Example 143) as instantly required. However, the prior art does provide a daily dosage ranging from 0.05 mg to 1000 mg- which encompasses the instantly required dosage range. See e.g., paragraph [417]. In addition, the prior art teaches an oral dose of 30-200 mg/kg of Example 143 being administered to adult female BALB/c mice. See e.g., paragraph [2033]. Based on the attached BALB/c reference, the average weight of a female BALB/c mouse at 15 weeks is 24.7 g. Accordingly, the prior art teaches an oral dosage ranging from 0.741 mg to 4.94 mg which overlaps with the instantly claimed dosage range (i.e., about 2 mg to about 300 mg).
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claim 4, it would therefore have been obvious to a person of ordinary skill in the art to arrive at the instantly claimed dosage requirements based on the teachings of the prior art. At least in the interest of determining an effective therapeutic dosage range for the prior art composition, a person of ordinary skill would have been motivated to arrive at the instant invention through a process of routine optimization. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
No claims are allowed.
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/D.M.S./Examiner, Art Unit 1626
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626