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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/12/2025 has been entered.
Status of Claims
Claim 10 is pending.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Republic of Korea on 02/16/2022.
Response to Arguments/Amendments
Applicant's arguments filed 8/12/2025 have been fully considered but they are not persuasive.
In the final dated 03/10/2025, claim 10 was rejected under 35 U.S.C. 102(a)(1)/(2). In response, Applicant cancelled claims 1-9 and amended claim 10.
In the response filed 8/12/2025, the applicant amended claim 10 to:
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This amendment does not overcome the 102 rejection, because the structure of Formula I, as well as its use in treating sebum secretion, is anticipated by Garin-Shkolnik.
With respect to the Applicant’s argument that Garin-Shkolnik does not meet the requirements of the claim for the “improvement of skin condition of smudged makeup, glossiness, or skin trouble from sebum secretion,” where the subject has “no hyperproliferative keratinocytes or inflammatory skin disease.” The Examiner maintains that Garin-Shkolnik does meet this requirement. Although Garin-Shklonik teaches where the patient population may be towards methods of treating pathologies characterized by hyperproliferative keratinocytes or inflammatory skin diseases, Garin-Shklonik anticipates the structure of the compound, where the structure has the same mechanism as the instant application of being a FABP4 inhibitor, and it is also used for treating disorders caused by sebum secretion. Not all claims recited by Garin-Shkolnik require the subject to explicitly be treated for hyperproliferative keratinocytes or inflammatory skin diseases (Claims 1, 4, 5, and 8). Furthermore, although Garin-Shkolnik does teach the patient population, if the patient population differed slightly, because the prior art teaches the structure with the same mechanism as the instant claims it would be considered to have similar properties.
“In fact, similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have ‘very close’ structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Lintner, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972).” See MPEP § 2144.08.
Therefore, the limitation is met based on the teachings in the art. See maintained rejections below.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
In product claims, the preamble is interpreted as intended use and given no weight. Further, to satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. 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).
With respect to Claim 10, the preamble terminology “composition”, “pharmaceutical composition,” or “cosmetic composition” are interpreted as intended use for “inhibiting” or “improving” diseases/conditions caused by sebum secretion.
The FDA FD&C Act provides evidence that the difference between a pharmaceutical and a cosmetic lies within its intended use. A product can be both a drug and a cosmetic if it has more than one intended use. Please see 21 U.S.C §321(g) and (i) for definitions. A separate webpage document sourced from the FDA has been provided to the applicant to help easily summarize the interpretation from the FD&C Act.
Therefore, Garin-Shkolnik (see rejection below) would be capable of the intended use.
Maintained Rejections
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.
Claim10 is rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Garin-Shkolnik (WO 2018/078624 A1) as evidenced by the FDA FD&C Act (2018).
Garin-Shkolnik teaches a pharmaceutical composition comprising at least one FABP4 inhibitor for use in treating or preventing a skin disease (Claim 1). The FABP4 inhibitor can be BMS309403 (Specs, see picture below) which is the same structure claimed in instant claim 10.
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Garin-Shkolnik teaches the skin diseases in which the pharmaceutical composition containing the FABP4 inhibitor can be used includes seborrheic dermatitis, acne, and rosacea (Claim 35 and Spec, Page 23, p.5). Since these diseases are known to be caused by sebum secretion, instant claim 10 is anticipated. Thus, Garin-Shkolnik teaches a link to sebum secretion as well. Therefore, along the line of the description in the Claim Interpretation section, instant claim 10 is anticipated.
Conclusion
Claims 1-9 are cancelled. Claim 10 is rejected.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621