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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 15/861,239, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Examiner’s review of the priority application failed to identify disclosure of azelaic acid acting as an agonist of olfactory receptor OR2K2, or any disclosure of OR2K2, including the step of confirming an activation of an olfactory receptor OR2K2 expressed in an adipose tissue of an adipocyte of the subject. Thus, the effective filing date of the instant application is the filing date of this application, 4/7/2022.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-2, in the reply filed on 6/24/2025 is acknowledged.
Applicant’s election without traverse of:
(i-a) azelaic acid; and
(ii-b) a method of treating obesity,
in the reply filed on 6/24/2025 is acknowledged.
Claims 3-6 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 6/24/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Examiner’s review of the specification failed to identify new step (b) confirming an activation of an olfactory receptor OR2K2 expressed in an adipose tissue or an adipocyte of the subject. Accordingly, this language introduces New Matter.
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.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2018/0207120 A1; 2018; cited in a prior Office action), in view of Su Yeon Yun (“Identification of human azelaic acid receptor”; Master of Science Thesis, Graduate School of Korea University; February, 2022; DOI: 10.23186/korea.000000257442.11009.0001253).
Lee teaches a method of, inter alia, Applicant elected treating obesity, comprising administering azelaic acid (claim 1). Wherein the azelaic acid increases triglyceride hydrolysis in adipose tissue (claim 2).
While the amendment to claim 1 requires a new step (b), confirming an activation of an olfactory receptor OR2K2 expressed in an adipose tissue or an adipocyte of the subject, to the best understanding of the arguments presented, this step requires conducting an assay to demonstrate expression of OR2K2, similar to that shown in Figure 2A for Olfr544 for adipose tissue. It is noted that expression of Olfr544 is taught for mouse adipose tissue (see Figure 2A of Lee; [0014]).
While Lee teaches the target molecule of azelaic acid, Olfr544, Lee does not teach the human equivalent, OR2K2.
Yun teaches it was previously reported that azelaic acid (AzA) is a ligand for olfactory receptor 544 (Olfr544) in mouse and has an antiobesogenic activity, to induce lipolysis and fatty acie oxidation in human white adipocytes and hepatocytes, a specific receptor as Olfr544 orthologue has not been defined. In this study, we aimed to deorphanize human OR for AzA and identify its function in human. 6 human ORs were significantly expressed in human adipocytes and hepatocytes. Additional experiments were conducted to demonstrate the activities of the receptors to induce hepatic fatty acid oxidation and adipocyte lipolysis. Collectively, these experiments verified that OR2K2 is a functional receptor for azelaic acid. (Abstract).
Yun establishes that the human olfactory receptor that is targeted by AzA is OR2K2.
Thus, in carrying out the method to treat obesity, it would have been obvious to treat the human subject by administering azelic acid. It would further have been obvious to confirm the teachings of Yun, by verifying expression of OR2K2. The motivation would have been to verify this activation via the agoinism of OR2K2
Regarding the functional language of the wherein clause of claim 1 and the language of claim 2, the Lee reference teaches the same physical step (a) of the method; thus, the functional language is construed to be characteristic of the same method.
It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
Activation of OR2K2 is clearly taught by Yun and is thus reasonably expected to confirm activation of this OR. Figure 9 (p. 42) suggests the OR2K2 expressed in a membrane of an adipose as the target of AzA.
Therefore, the method of claims 1-2 is obvious over Lee and Yun.
Conclusion
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 TIMOTHY P THOMAS whose telephone number is (571)272-8994. The examiner can normally be reached M-Th 6:30-5:00.
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, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
TIMOTHY P. THOMAS
Primary Examiner
Art Unit 1614
/TIMOTHY P THOMAS/Primary Examiner, Art Unit 1614