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
Applicant’s election without traverse of claims 11 – 16 and 41 in the reply filed on 08/24/2026, is acknowledged.
Claims 17 – 18, 22 – 25, and 42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/24/2026.
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 14 – 16 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 claims 14 – 16, the phrase "preferably" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "preferably"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
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.
Claims 11 – 12 and 41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meyers et al. (U.S. Patent Application Publication No. 2007/0065848; hereinafter Meyers).
Regarding claims 11 – 12 and 41, Meyers discloses novel human transferase family members, in which SEQ ID NO: 17 has 100% identity to SEQ ID NO: 1 of the instant application (ABSS file data-09/08/2026-Issued_Patents_AA; Result No. 1- US-11-493-347-17; 58764). Meyer further discloses methods to identify modulators of said transferases like small molecules, peptides, antibodies, and others (claims 17 – 19; para. [0017]). Meyer discloses recombinant expression vectors (including 58764), host cells, and genetically engineered cells (starting at para. [0611]) for the invention. Meyer discloses that mutations can be introduced randomly along all or part of a 58764 coding sequence, such as by saturation mutagenesis, and the resultant mutants can be screened for 58764 biological activity to identify mutants that retain activity (para. [0485]). Meyer further discloses that variants of a 58764 protein can be identified by screening combinatorial libraries of mutants, e.g. truncation mutants, for agonist or antagonist activity (para. [0578]). Meyer discloses methods (paras. [0704 – 0706]) for detecting a change in activity of the DIESL polypeptide compared to a control that comprises introducing the candidate agent in a biological sample that comprises the DIESL polypeptide.
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 13 – 16 are rejected under 35 U.S.C. 103 as being unpatentable over Meyers in view of Chang et al. (Molecular identification of transmembrane protein 68 as an endoplasmic reticulum anchored and brain-specific protein, PLoS ONE 12(5) 2017; cited on IDS, hereinafter Chang).
Regarding claims 13 – 14, Meyers teaches all of the elements of the current invention as stated above except explicitly disclosing triacylglycerol activity or accumulation. However, Chang discloses TMEM68, which is a acyltransferase involved in brain glycerolipid metabolism (Abstract). Chang further discloses that the biosynthesis of the major form of dietary lipid in fats and oils, triacylglycerol (TAG), is regulated by TMEM68 (Introduction). TMEM68 is known as DIESL.
Regarding claim 15, Neither Meyers nor Chang explicitly disclose using a cell that does not express a DGAT polypeptide or TMX1, which is a negative regulator of DIESL activity. DGAT1 is an enzyme that catalyzes the final step in triacylglycerol biosynthesis. DGAT2 transfers a fatty acyl group from fatty acyl-CoA to the hydroxyl group of diacylglycerol, forming TAG. DIESL functions independently of the canonical DGAT1 and DGAT2 enzymes.
However, it would be obvious to one of ordinary skill in the art to assay a cell that does not negatively regulate or overexpresses DGAT activity as a control.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the knowledge from Chang about TMEM68 being able to synthesize triacylglycerol and incorporate that knowledge in the method of Meyers for screening DIESL. Doing so would give a person of ordinary skill in the art a control sample and a measurable component to monitor the activity of DIESL/TMEM68 in order to determine if a candidate agent can modulate DIESL activity.
Regarding claim 16, Meyers teaches all of the elements of the current invention as stated above except TMEM68’s ability to modulate diglyceride acyltransferases (DGAT). However, Chang suggests that TMEM68 may be a DGAT-like protein (p. 13, Discussion).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the knowledge from Chang about TMEM68 being a DGAT-like protein to use a DGAT1 or DGAT2 polypeptide as a candidate agent that is a modulator of diglyceride acyltransferase in the screening method of Meyers. Doing so would give a person of ordinary skill in the art a positive control for comparative analysis (expression, pathway, etc.) in respect to modulating TAG.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER JACKSON III whose telephone number is (571)272-0247. The examiner can normally be reached M-F 9:00A - 5:00P.
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/WALTER JACKSON III/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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