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 .
Status of the Claims
Claims 1-17 are pending in the instant application and subject to examination herein.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. PCT/KR2023/000277, filed on 01/06/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/10/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
Claim 1 is drawn to a method for the prevention or treatment of inflammatory diseases, comprising administering to a subject a compound of a genus of 1-alkyl-5-arylidene-2-selenoxoimidazolidin-4-one compounds, identified as instant formula 1, or a pharmaceutically acceptable salt thereof, “as an active ingredient”. The term “ingredient” is commonly understood to mean “a component part of any combination or mixture”1. The instant disclosure states that the compound of formula 1 can be used in a food composition, with other foods or food ingredients (page 40) and separately provides for a pharmaceutical composition comprising the compound “as an active ingredient” (pages 3-4, bridging paragraph). Thus, a person of ordinary skill in the art would understand that claim 1 does not include within its scope the administration of the neat compound of formula 1, or a pharmaceutically acceptable salt thereof, to a subject.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is drawn to a method for the prevention or treatment of inflammatory diseases, comprising administering to a subject a compound of a genus of 1-alkyl-5-arylidene-2-selenoxoimidazolidin-4-one compounds, identified as instant formula 1, or a pharmaceutically acceptable salt thereof, as an active ingredient. The claim is indefinite because a person of ordinary skill in the art would not be able to determine the patient population to whom the compound of formula 1 should be administered, as the claim does not require that the subject has any inflammatory disease(s), and a person of ordinary skill in the art would not be able to identify a subject who, despite not having any inflammatory disease(s), would be in need of the prevention of inflammatory disease. The instant Specification includes the term “prevention” 18 times (pages 1, 3-5, 32, 40 and 140), and the term “preventing” once (page 39), and in none of these instances is any population of patients identified by the attribute of being in need of the prevention of inflammatory disease.
Claims 2-18 depend from claim 1 and none of these claims resolve the indefiniteness of claim 1 in regard to the indefinite patient population of patient(s) to whom a compound of formula 1, or a pharmaceutically acceptable salt thereof, should be administered, “as an active ingredient”.
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 10-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10 and 12-16 of U.S. Patent No. 12,552,779 B2 (hereafter referred to as “Lee”. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Lee anticipate the instant claims.
The limitations of instant claim 1 are discussed in the rejection above and hereby incorporated into the instant rejection.
Instant claim 10 further limits independent claim 1 to wherein the compound of formula 1 is selected from a Markush group of 122 specific compounds. Claim 10 of Lee claims all 122 of the compounds of instant claim 10, listed in exactly the same order. Instant claim 11 further limits the method of treatment of instant claim 1 to wherein the compound of instant formula 1 must be synthesized in a specific manner. A person of ordinary skill in the art would at once recognize that the compound to be administered is not dependent on the method by which said compound is synthesized, and therefore the method of prevention or treatment of inflammatory disease(s) is not meaningfully limited by specifying the means of chemical synthesis of the compound to be administered. Additionally, claim 12 of Lee details precisely the exact synthesis process of instant claim 11. Instant claims 12-15 further limit the method of synthesis of a compound of instant formula 1 and are precisely mirrored in Lee’s claims 13-16.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to W. JUSTIN YOUNGBLOOD whose telephone number is (703)756-5979. The examiner can normally be reached on Monday-Thursday from 8am to 5pm. The examiner can also be reached on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren, can be reached at telephone number (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center to authorized users only. Should you have questions about access to the USPTO patent electronic filing system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via a variety of formats. See MPEP § 713.01. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/InterviewPractice.
/W.J.Y./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 See for example, Merriam-Webster dictionary: https://www.merriam-webster.com/dictionary/ingredient
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