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 .
Status of the Claims
Claims 1-8, 11, 17-18, 22-24, 26-27, and 31 are pending. Claims 11, 17-18, 22-24, 26-27, and 31 are withdrawn. Claims 1-8 are rejected.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 11/17/2022 was considered by the Examiner.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-8) and the species of JAG021:
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, in the reply filed on 11/5/2025 is acknowledged.
Claims 1-8 embrace the elected species and are under examination. The elected species is not allowable.
Claims 11, 17-18, 22-24, 26-27, and 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 4 is objected to because of the following informalities: before the list of structures should read “selected from the group consisting of” and there should be an “and” between the last two compounds. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 2 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 2 depends from claim 1 and recites definitions of both “m” and “n” which are identical to claim 1. Because this fails to limit claim 1, Examiner recommends deleting the “m” and “n” definitions from instant claim 2. 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 § 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over McLeod et al. (WO2017112678).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
McLeod discloses JAG021 in Figure 15 which is drawn to the following structure:
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, which is embraced by a compound of instant Formula (I), wherein R1= H; R2 = C1-alkyl (methyl); m = 0; n = 1; R3 = C1 haloalkoxy (trifluoromethoxy). (JAG021 is also identical to the first compound listed in instant claim 4). JAG21 (JAG021) is taught as a lead compound and found to be anti-apicomplexan, potent against Toxoplasma gondii (see p. 84, lines 12-17).
McLeod additionally discloses compounds tested were prepared in 0.5% (w/v) hydroxyethyl cellulose (hydrophobic material) and 0.2% (0.5% HECT, v/v) Tween-80 (surfactant) in distilled water (an aqueous carrier fluid) (p. 91, lines 17-18).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art does not show a single embodiment of JAG021 in the solvents listed supra. Additional dependent limitations will be addressed below.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 1-4, it would have been obvious to a skilled artisan to arrive at a formulation of a dispersion of particles within an aqueous carrier fluid with JAG021 (a compound of instant formula (I)) having successful anti-apicomplexan properties. A PHOSITA would have been motivated to explore various compositions with JAG021 as anti-apicomplexan with a reasonable expectation of success in effectively treating parasitic infections.
**Regarding the limitation, “nanoparticle formulation”, which is in the preamble, such limitation is not limiting and does not further affect the claims. “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)”. See MPEP 2111.02(II). The instant claims are drawn to a “dispersion of particles within the aqueous carrier fluid”, wherein the particle dispersion would be inherent for a soluble compound in an aqueous carrier fluid. There is no limitation in the body of the claims regarding size of particles.
Regarding instant claims 5-6, the prior art teaches 0.5% (w/v) hydroxyethyl cellulose, which is the equivalent of 0.5 mg/ml (using a density of ~1 mg/ml). “[A] prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.” See MPEP 2144.05(I). A skilled artisan would have been motivated to explore various amounts of hydrophobic material in an effort to achieve maximum formulation effectiveness.
Regarding instant claims 7-8, the prior art teaches 0.2% (0.5% HECT, v/v) Tween-80 in distilled water, wherein polyethylene glycol sorbitan monooleate is another name for Tween-80. Additionally, the percentage range of the prior art is equivalent to 0.5 mg/ml (using a density of ~1 mg/ml). “[A] prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.” See MPEP 2144.05(I). A skilled artisan would have been motivated to explore various amounts of surfactant in an effort to achieve maximum formulation effectiveness.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGHAN C HEASLEY whose telephone number is (571)270-0785. The examiner can normally be reached Monday - Friday 8:30-4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph McKane can be reached at 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGHAN C HEASLEY/Examiner, Art Unit 1626 /KAMAL A SAEED/Primary Examiner, Art Unit 1626