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 .
This office action is in response to the amendment filed on December 29, 2025. Claims 2, 10, 12, and 15-33 have been cancelled. Claims 1, 3-9, 11, 13, and 14 are currently pending and are under examination.
Withdrawal of Rejections
The rejection of claims 20, 21, and 31 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn based on the cancellation of the claims.
The rejection of claims 1-9 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn based on the amendment to claim 1 to refer to the lipokine as 12,13-diHOME and the cancellation of claim 2.
The rejection of claims 11-14, 20, and 21 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn based on the amendment to claim 11 to refer to the Ephx polypeptide, the cardiovascular diseases and description of the lipokine as 12,13-diHOME; The rejection is also withdrawn for the cancelled claims 12, 20, and 21.
The rejection of claims 22 and 31-33 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn based on the cancellation of the claims.
The rejection of claims 1-10 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, scope of enablement for increasing any lipokine level with any epoxide hydrolase is withdrawn based on the amendment to the claims.
The rejection of claims 11-14, and 20 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, scope of enablement to practice the claimed method of treating any cardiovascular disease by administering any genus of epoxide hydrolases is withdrawn based on the amendment to the claims.
The rejection of claims 22 and 31 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, scope of enablement to practice the claimed method of treating any inflammatory disease by administering any genus of epoxide hydrolases is withdrawn based on the amendment to the claims.
The rejection of claim(s) 21, 22, 32, and 33 under 35 U.S.C. 103 as being unpatentable over Joslin Diabetes Center, Inc (WO 2018/142379 A1) in view of NCBI Reference Sequence NP_001365357.1/ UniProt P07099 is withdrawn based on the amendment to the claims.
Pending Objection(s) and Rejection(s)
Claim Objections
Claim 1 is objected to because of the following informalities: the chemical name of the abbreviation of 12,13-diHOME should be recited at its first occurrence in the claim. Appropriate correction is required.
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 4, 11, and 14 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.
The term “low” in claim 11 is a relative term which renders the claim indefinite. The phrase “level of a lipokine” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what a low level of a lipokine is claiming. Clarification is requested.
Claims 4 and 14 claim “at least about” a percentage identical to a SEQ ID NO:, but the phrasing “at least” and “about” make the minimum percentage unclear. Suggest, at least 80% percent to define the lower boundary.
Claims dependent on a rejected claim are rejected for failing to cure the indefiniteness.
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.
Claims 3 and 13 are 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.
Claims 1 and 11 refer to the alternative of Ephx1 polypeptide or Ephx2 polypeptide, but dependent claims 3 and 13 refer to the combination of Ephx 1 and Ephx2. These are improper dependent claims, because they broaden the scope of the claim from which they depend.
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
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.
Claim(s) 1, 3, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Joslin Diabetes Center, Inc (WO 2018/142379 A1; previously cited) in view of NCBI Reference Sequence NP_001365357.1/ UniProt P07099; previously cited.
Joslin Diabetes Center, Inc disclose a method of treating a human subject having a metabolic disorder, said method comprising administering an effective amount of 12,13-dihydroxy-9Z-octadecenoic acid (12,13-diHOME). The human subject can have a disorder selected from diabetes, atherosclerosis, and heart disease (see claims 1-4).
Joslin Diabetes Center, Inc does not disclose the administration of epoxide hydrolase. It was known in the art that soluble epoxide hydrolase (sEH) metabolize 12,13-epoxyoctadecnoic acid (12,13-EpOME) to 12,13-dihydroxyoctadecenoic acid (12,13-DiHOME; Isoleukotoxin Diol) as evidenced by Hildreth et al. (see figure 1) and see also Joslin Diabetes Center (WO 2018/142379 A1) page 12, lines 2-7 and Figure 5C. Joslin Diabetes Center defines “cardiovascular disease” or “heart disease” to include cardiomyopathy, which would overlap with wall thickness and chamber dilation. NCBI Reference Sequence NP_001365357.1/ UniProt P07099 is the amino acid sequence of the epoxide hydrolase.
Therefore it would have been obvious to the person having ordinary skill in the art to administer the known soluble epoxide hydrolas polypeptide to thereby produce 12,13-DiHOME to treat diabetes and heart disease as disclosed by Joslin Diabetes Center, Inc.
Claim(s) 1, 4-8, 11, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Joslin Diabetes Center, Inc (WO 2018/142379 A1) in view of NCBI Reference Sequence NM_010145.3 (June 30, 2020, mRNA transcript sequence submission) and Clement and Grieger (Molecular Therapy – Methods & Clinical Development (2016) 3, 16002).
Joslin Diabetes Center, Inc disclose a method of treating a human subject having a metabolic disorder, said method comprising administering an effective amount of 12,13-dihydroxy-9Z-octadecenoic acid (12,13-diHOME). The human subject can have a disorder selected from diabetes, atherosclerosis, and heart disease (see claims 1-4).
Joslin Diabetes Center, Inc does not disclose the administration of epoxide hydrolase. It was known in the art that soluble epoxide hydrolase (sEH) metabolize 12,13-epoxyoctadecnoic acid (12,13-EpOME) to 12,13-dihydroxyoctadecenoic acid (12,13-DiHOME; Isoleukotoxin Diol) (see Joslin Diabetes Center (WO 2018/142379 A1) page 12, lines 2-7 and Figure 5C). Joslin Diabetes Center defines “cardiovascular disease” or “heart disease” to include cardiomyopathy, which would overlap with wall thickness and chamber dilation. NCBI Reference Sequence NM_010145.3 is the mRNA nucleotide sequence of the epoxide hydrolase. Clement and Grieger disclose the use of recombinant adeno-associated virus vectors for transfer of genes into subjects for gene therapy (see entire document, also Abstract).
Therefore it would have been obvious to the person having ordinary skill in the art to administer the known mRNA polynucleotide as disclosed by NM_010145.3 in a adeno-associated viral vector as disclosed by Clement and Grieger to express epoxide hydrolase polypeptide to thereby produce 12,13-DiHOME to treat diabetes and heart disease as disclosed by Joslin Diabetes Center, Inc.
Claim(s) 1, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Joslin Diabetes Center, Inc (WO 2018/142379 A1) in view of NCBI Reference Sequence NM_010145.3 (June 30, 2020, mRNA transcript sequence submission) and Derosa et al. (WO 2014/089486 A1).
Joslin Diabetes Center, Inc disclose a method of treating a human subject having a metabolic disorder, said method comprising administering an effective amount of 12,13-dihydroxy-9Z-octadecenoic acid (12,13-diHOME). The human subject can have a disorder selected from diabetes, atherosclerosis, and heart disease (see claims 1-4).
Joslin Diabetes Center, Inc does not disclose the administration of epoxide hydrolase. It was known in the art that soluble epoxide hydrolase (sEH) metabolize 12,13-epoxyoctadecnoic acid (12,13-EpOME) to 12,13-dihydroxyoctadecenoic acid (12,13-DiHOME; Isoleukotoxin Diol) (see Joslin Diabetes Center (WO 2018/142379 A1) page 12, lines 2-7 and Figure 5C). Joslin Diabetes Center defines “cardiovascular disease” or “heart disease” to include cardiomyopathy, which would overlap with wall thickness and chamber dilation. NCBI Reference Sequence NM_010145.3 is the mRNA nucleotide sequence of the epoxide hydrolase. Derosa et al. disclose a composition comprising a mRNA that encodes a polypeptide that can be delivered by a lipid nanoparticle (see entire document, also Abstract).
Therefore it would have been obvious to the person having ordinary skill in the art to administer the known mRNA polynucleotide as disclosed by NM_010145.3 in a lipid nanoparticle as disclosed by Derosa et al. to express epoxide hydrolase polypeptide to thereby produce 12,13-DiHOME to treat diabetes and heart disease as disclosed by Joslin Diabetes Center, Inc.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANAND U DESAI whose telephone number is (571)272-0947. The examiner can normally be reached 9:00-5:30 EST.
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/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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