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 08/04/2023 is a National Stage entry of PCT/KR2021/019974, International Filing Date: 12/27/2021. PCT/KR2021/019974 claims foreign priority to 10-2020-0184007, filed 12/25/2020. A certified copy of the foreign priority application is of record. It is noted however that the foreign priority application copy is not in English, and an English translation has not been provided. Therefore, the effective filing and priority date of the claims is currently 12/27/2021.
Status of Claims
Claims 1-8 are currently pending as of the claim set filed on 8/4/23.
Claims 1-8 were examined. Claims 1-7 are rejected. Claim 8 is objected to.
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.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park et. al., WO 2020262996 A1, publ. 12/30/2020, international filing date 6/25/2020.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Park et. al., WO 2020262996 A1, publ. 12/30/2020, international filing date 6/25/2020. Park was not published in English. An English translation is provided for discussion.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Park discloses compounds that are functional derivatives of alanine and proline, having a biphenyl group, wherein the compounds exhibit excellent antifungal activity; and pharmaceutical compositions comprising these compounds (see abstract; para [1], [3]). The compounds are disclosed to have the following structural formula (para [10]-[16]):
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. In particular, Park discloses the following compounds (Tables 1, 2, & 3; paras [617]-[619]):
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. The compounds of Table 1 are included within the instant claims, having n=0; R3=methyl, ethyl, or n-propyl; R1 and R2 are each hydrogen or methyl; m=1 or 2; and X=chloro or trifluoromethoxy. The compounds of Table 2 are included within the instant claims, having n=1; R3= ethyl or n-propyl; R1 and R2 are each hydrogen or methyl; m=1 or 2; and X=chloro, trifluoromethyl, or trifluoromethoxy. The compounds of Table 3 are included within the instant claims, having n=2; R3= methyl, ethyl, or n-propyl; R1 and R2 are each hydrogen or methyl; m=1 or 2; and X=chloro, fluoro, trifluoromethyl, or trifluoromethoxy. Park discloses administering a pharmaceutical composition comprising a compound as described above as an active ingredient for treating or preventing fungal infection diseases (para [114]-[119], [123]). Park further discloses the compounds to have anti-inflammatory activity, and for treating an inflammatory disease (para [644-645]; p. 54, claim 21).
Regarding instant claim 1, “A pharmaceutical composition for preventing or treating inflammatory diseases”, this is interpreted as a statement of intended use of the claimed product. If statements of intended use don’t impart structural limitations to the claims, then the statement of intended use doesn’t further distinguish the composition. See MPEP 2111.02: "where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81. As the statement of intended use doesn’t impart structural limitations to the claimed composition, it doesn’t distinguish the claimed composition from the composition disclosed by Park.
Regarding instant claim 2, “wherein the inflammatory disease is selected from…”, see above. As the statement of intended use of the claimed composition for treating an inflammatory disease doesn’t further limit the claim structurally, it doesn’t distinguish the claimed composition from the composition disclosed by Park.
Regarding instant claim 3, “A pharmaceutical composition for preventing or treating fibrosis disease…”, see above. As the statement of intended use of the claimed composition for preventing or treating a fibrosis disease doesn’t further limit the claim structurally, it doesn’t distinguish the claimed composition from the composition disclosed by Park.
Regarding instant claim 4, “wherein the fibrosis is one or more selected from…”, see above. As the statement of intended use of the claimed composition for preventing or treating a fibrosis disease doesn’t further limit the claim structurally, it doesn’t distinguish the claimed composition from the composition disclosed by Park.
Regarding instant claim 5, “The pharmaceutical composition of claim 1, which inhibits TSLP signaling”, see above. As the statement of intended use of the claimed composition for doesn’t further limit the claim structurally, it doesn’t distinguish the claimed composition from the composition disclosed by Park.
Regarding instant claim 6, “The pharmaceutical composition of claim 1, which inhibits TSLP signaling”, see above. As the statement of intended use of the claimed composition for doesn’t further limit the claim structurally, it doesn’t distinguish the claimed composition from the composition disclosed by Park.
Park therefore anticipates the claims.
Claim Rejections-Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12172945 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims encompass compounds that substantially overlap structurally. For instance, the claims of US ‘945 are drawn to compounds having the following structural formula, and pharmaceutical compositions containing these compounds:
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. The above shown compounds overlap with those of the instant claims, having n=2; R3=alkyl; X=chloro; and R1 and R2 are hydrogen or alkyl. Furthermore, claim 11 of US ‘945 recites the compound for treating an inflammatory disease, which would therefore render prima facie obvious the method of instant claim 7. The instant and patented claims are as such not patentably distinct.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 12129220 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims encompass compounds that substantially overlap structurally. For instance, the claims of US ‘220 recite the following compounds, and a pharmaceutical composition comprising the compound:
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. These compounds are included within the instant claims, with compound 1) having n=0; m=2, X=chloro; R3=methyl; R1, R2=both hydrogen; and compound 2) having n=0; m=2, X=chloro; R3=ethyl; R1, R2=both hydrogen. The instant and patented claims are as such not patentably distinct.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 11479526 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims encompass compounds that substantially overlap structurally. For instance, the claims of US ‘526 recite the following compounds, and a pharmaceutical composition comprising the compound:
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These compounds are included within the instant claims, with the first compound having n=0; m=2, X=chloro; R3=methyl; R1, R2=both hydrogen; and the second compound having n=0; m=2, X=chloro; R3=ethyl; R1, R2=both hydrogen. Furthermore, claim 10 of US ‘526 recites the compound for treating an inflammatory disease, which would therefore render prima facie obvious the method of instant claim 7. The instant and patented claims are as such not patentably distinct.
Claim Objection
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627