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 .
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 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.
Priority
This application is a Divisional U.S. Application No. 16/343,749, which is the U.S. National Stage application of PCT/JP2017/038079, filed October 20, 2017, which claims priority from Japanese application JP 2016-207027, filed October 21, 2016.
The effective filing date is 10/21/2016.
Current Status of 18/068,406
This Office Action is responsive to the claims of 19 December 2022.
Claims 1-17 are pending and have been examined on the merits.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/19/2022 and 07/13/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Claim(s) 1-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by IRIYAMA (US 8901160 B2, 12/02/2014).
Iriyama teaches a method for suppressing the formation of large wrinkles by inhibiting heparanase activity, comprising administering to a subject in need thereof 1-(2-hydroxyethyl)-2-imidazolidinone or a salt thereof (lines 53-54, col 2; Table 1, col 9; claim 1), thereby anticipating claim 1.
Claims 2-6 are directed to the intended targets and claims 7-17 to the effects achieved by the administration of the instant compound, they are all inherent actions of the compound once the method step in claim 1 is practiced. They are biological activities, and any/all of the actions from the compound can’t be stopped after administration of it.
Therefore, Claims 1-17 are anticipated by Iriyama.
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 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over reference claims 16, 18 and 20 (on 08/04/2026) of copending Application No. 18/706,991.
Reference Application ‘991 discloses a method for promoting proliferation of epidermal stem cells by applying the composition of a heparanase/MMP-9 inhibitor and a seaweed extract (ref. claim 16), wherein the heparanase/MMP-9 inhibitor is 1-(2-hydroxyethyl)-2-imidazolidinone (ref. clam 18) and heparanase/MMP-9 inhibitor is 1-(2-hydroxyethyl)-2-imidazolidinone and seaweed extract is Argelex (ref. claim 20). The fact that 1-(2-hydroxyethyl)-2-imidazolidinone is a duel inhibitor against both extracellular matrix degrading enzymes, heparinase and MMP-9, makes instant claims 1-6 obvious. Note: MMP-9 (matrix metalloproteinase 9) is a member of MMP (matrix metalloproteinases) family.
Claims 7-17 directing to the effects achieved by the administration of the compound, they are all biological activities and inherent actions of the compound and would happy once the compound is administrated.
Claims 1-17 are obvious over reference claims 16, 18 and 20 of ‘991.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are presently allowable as written.
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/B.T./Examiner, Art Unit 1625
/Andrew D Kosar/
Supervisory Patent Examiner, Art Unit 1625
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