DETAILED ACTION
This office action is in response to applicant’s filing dated April 27, 2026.
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 Claims
Claims 1-11 are pending in the instant application. Acknowledgement is made of Applicant's remarks filed April 27, 2026.
Election/Restrictions
Applicant’s election without traverse of KIT-020 (2-((hydroxy((R)-2-(5Z,8Z,11Z,14Z)-icosa-5,8,11,14-tetraenoyl)oxy)-3-(((E)-octadec-2-en-1-yl)oxy)propoxy)phosphoryl)oxy)ethane-1-ammonium 2,2,2-trifluoroacetate):
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as the elected compound of Formula (I) species and depression as the elected cranial nerve inflammatory disease species in the reply filed on April 27, 2026 is acknowledged.
KIT-020 is construed as a trifluoroacetate salt of a compound of formula (I) wherein X is oxygen atom; R1 is unsaturated aliphatic hydrocarbon group having 17 carbons; R2 is an unsaturated hydrocarbon group having 19 carbons; and R3 is ethanolamine.
In view of the cited art, examination has been expanded to encompass 1-O-1'-(Z)-hexadecenyl-2-arachidonoyl-sn-glycero-3-phosphoethanolamine, hereinafter referred to as Compound A:
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Compound A is a compound of formula (I) wherein X is oxygen atom; R1 is unsaturated aliphatic hydrocarbon group having 15 carbons; R2 is an unsaturated hydrocarbon group having 19 carbons; and R3 is ethanolamine.
Claims 1-11 are presently under examination as they relate to the elected species:
Depression and KIT-020:
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and expanded species Compound A:
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Priority
The present application is a 371 of PCT/JP2022/031555 filed on August 22, 2022, which claims benefit of foreign priority to JAPAN 2021-135911 filed on August 23 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 21, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner, except where marked with a strikethrough.
Drawings
Acknowledgement is made of the drawings received on February 21, 2024.
The drawings are objected to because the claims are pixelated and difficult to decipher and read.
Fig 1: It is difficult to decipher what is in the boxes labeled IL-1 beta and Gapdh.
Fig 2: It is difficult to read the labels of the graphs and the gel box.
Fig 3: It is difficult to read the labels of the graphs and the gel box.
Fig 6-8: The legend are unreadable.
Fig 9-11: It is difficult to see what is in the boxes and the boxes are labeled LysoPrime Green and LysoTracer Red, but there is no color in the images.
Fig 13 and 15: It is difficult to see what is in the boxes and what the arrows are pointing to.
Fig 17: It is difficult to see what is in the boxes and the text is blurry.
Fig 18: The text above the bar graphs and the text of the y-axis label are blurry and difficult to read.
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.
Claim Rejections - 35 USC § 112
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 1-11 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 1 recites a compound of formula (I):
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The Formula contains three dots with no definition of the dots. It is unclear what is meant by the dots. It is unclear if the three dots are meant to be an ellipsis, which generally represent the omission of words. It is unclear if variables are being omitted or what the three dots represent.
Claims 2-11, which depend from claim 1, do not clarify the ambiguity of claim 1. Thus, the rejection also applies to claims 2-11.
Claim Rejections - 35 USC § 102
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.
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 1-4 and 6-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harats et al (US 2010/0048515 A1).
Regarding claims 1, 2 6, and 11, Harats teaches a pharmaceutical composition comprising, as an active ingredient, an oxidized lipid having the general formula (I) and a pharmaceutically acceptable carrier (claim 46), and an oxidized lipid of formula (I) is 1-O-1'-(Z)-hexadecenyl-2-arachidonoyl-sn-glycero-3-phosphoethanolamine (Compound A) (claims 1, 3, and 24):
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Compound A is a compound of formula (I) wherein X is oxygen atom; R1 is unsaturated aliphatic hydrocarbon group having 16 carbons; R2 is an unsaturated hydrocarbon group having 19 carbons; and R3 is ethanolamine.
Regarding claims 3 and 4, R1 of Compound A contains one double bond.
Regarding claims 7-10, the wherein limitations of these claims are directed to an intended use of the composition, for use in inducing an anti-inflammatory effect (instant claim 7), preventing or ameliorating cranial nerve inflammatory diseases, including depression and Rett syndrome (instant claims 8-10). Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. In the instant case, the intended use as an anti-inflammatory for preventing or ameliorating cranial nerve inflammatory diseases, including depression and Rett syndrome.
Thus, Harats anticipates the composition of claims 1-4 and 6-11.
Claim Rejections - 35 USC § 103
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.
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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Harats et al (US 2010/0048515 A1).
As set forth above (see above 102), Harats teaches a pharmaceutical composition comprising Compound A and a pharmaceutical carrier. Moreover, Harats teaches the disclosed compositions are useful for treating inflammation associated with an endogenous oxidized lipid (claim 1) wherein said inflammation is associated with disease wherein the disease is an inflammatory neurological disease (claim 25).
Harats does not explicitly teach the elected compound KIT-020 or that the double bond of R1 is present between the carbon at position 1 and the carbon at position 2, when carbon bonded to the carbon bonded to X is defined as the carbon at position 1. Compound A differs from the instantly claimed compound in that it contains the double bond of R1 is between the carbon bonded to X and the carbon at position 1 and R1 is hydrocarbon with 15 carbons, while the instantly claimed compound the double bond of R1 is present between the carbon at position 1 and the carbon at position 2, when carbon bonded to the carbon bonded to X is defined as the carbon at position 1 and R1 is hydrocarbon with 17 carbons.
MPEP 2144.09 states: A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) (discussed below and in MPEP § 2144) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. See also MPEP § 2144.08, subsection II.A.4.(c). Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). In the instant case, it would have been prima facie obvious to select Compound A as a compound to modify as Harats teaches Compound A is useful for treating inflammation associated with neurological disease; to produce a positional isomer and homolog wherein the R1 comprises a hydrocarbon with 17 carbons (homolog) and the double bond of R1 is between position 1 and 2 (positional isomer) to arrive at the elected compound with a reasonable expectation of success. The motivation to make the instantly elected compound derives from the expectation that structurally similar compounds such as positional isomers and homologs would possess similar activity. There would be a reasonable expectation of success in producing and using the instantly claimed compounds and compositions in view of the compounds and compositions taught by Harats.
Taken together, all this would result in the composition of claims 1-11 with a reasonable expectation of success.
Conclusion
Claims 1-11 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628
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