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
This application filed 05/02/2024 is a National Stage entry of PCT/KR2022/016032 , International Filing Date: 10/20/2022, claims foreign priority to 10-2021-0149854, filed 11/03/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/02/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
(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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102 (a)(1) and 35 U.S.C. 102 (a)(2) as being anticipated by Takuya Uematsu et al., hereinafter Uematsu (Takuya Uematsu et al., European Journal of Pharmacology 668 (2011) 163–168) evidenced by Ewan St. John Smith (J Neurol (2018) 265:231–238).
Regarding claim 1, Uematsu teaches GR82334 (see Abstract) that is identical to the claimed composition. Examiner interprets “for preventing….pain’ as intended use. As the teachings in Uematsu of the compound, is 100 % identical to the claimed composition, it would be capable of the same intended use. 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)). As previously noted, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). (See MPEP § 2112.01 (I)).
Regarding claim 2, Uematsu teaches intra-articular administration (see Abstract).
Regarding claim 3, Uematsu teaches persistent pain (i.e. chronic) (see Abstract).
Regarding claim 4, Uematsu teaches sensitization of nociceptors in join inflammation (see introduction, 2nd paragraph) (i.e. neuropathic pain) as evidenced by Ewan St. John Smith.
Regarding claim 5, Uematsu teaches nociceptors are peripherally sensitized (see introduction, 2nd paragraph) (i.e. peripheral nerve damage).
Regarding claim 6, Uematsu teaches joint pain (see Introduction, 2nd paragraph).
Regarding claim 7, the claim limitation ‘wherein the....pathway’ is interpreted by the Examiner as unappreciated property. Applicant is reminded that “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art' s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). 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).
Regarding claim 8, the claim limitation ‘wherein the....cytokine’ is interpreted by the Examiner as unappreciated property. The reasoning is set forth above.
Regarding claim 9, the claim limitation ‘wherein the....IL-6’ is interpreted by the Examiner as unappreciated property. The reasoning is set forth above in the rejection under claim 7.
Regarding claim 10, embodiments of the specification disclose treatment to encompass alleviating pain (see page 29, [129]). Uematsu teaches intra-articular administration (see Abstract) and effect of GR82334 on hyperalgesia (see section 3.3, page 165).
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 5712707430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARCHANA VARADARAJ/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658