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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/31/2024 and 01/24/2025 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 § 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.
Claim 11 is 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 11 further limits the method of treating a central nervous system disorder of claim 1 to “wherein the central nervous system disorder is selected comprises at least disorder1 selected from the group consisting of. . .”. The term “at least disorder” is ambiguous because a person of ordinary skill in the art would not understand how many disorders from the Markush group must be simultaneously applicable to the invention (e.g., one disorder selected from the Markush group, two disorders, etc.).
For purpose of examination, claim 11 will be interpreted as requiring that the central nervous system to be treated comprises at least one disorder selected from the Markush group of disorders disclosed therein.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 10 seeks to further limit claim 9, itself further limiting the method of treatment of claim 1 to wherein the patient to be treated is human, such that claim 10 seeks to further limit the patient population to wherein “the human is an infant, child, adolescent, or adult.” However, given that claim 10 encompasses every possible age of a human between the moments of birth and death, claim 10 does not actually further limit the patient population as claimed in its parent claim 9.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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.
Claims 1, 5-21, 24, 26, 28-32, 34-37 and 40-41 are anticipated by Kovacs.
Claims 1, 5-21, 24, 26, 28-32, 34-37 and 40-41 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kovacs (U.S. PG Pub 2009/0318520 A1)2.
Claim 1 is drawn to a method for treating a central nervous system disorder in a subject in need thereof, the method comprising administering to said subject in need thereof a therapeutically
effective amount of a compound of any of a Markush group of genera, designated by structural formulae as being of Formula I, II, or III, or a stereoisomer thereof, or a pharmaceutically acceptable salt thereof. Kovacs discloses methods for the treatment of a neurobehavioral disorder and/or treatment or prevention of symptoms of a neurobehavioral disorder by administering “suitable Isoindole derivatives” alone or in combination with other agents (Abstract). Kovacs discloses that the invention disclosed therein comprises “methods for the treatment or prevention of neurobehavioral disorders using the compounds of formula (I), or pharmaceutical compositions
containing one or more of the compounds of formula (I), or pharmaceutical compositions containing one or more prodrugs of the compounds of formula (I)” (paragraph [0016]), wherein specific examples of the genus of compounds disclosed as “formula (I)” are provided, including mazindol3 (paragraph [0050]) shown below:
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274
254
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(mazindol).
Kovacs also discloses an exemplary member of the disclosed “formula (I)” that anticipates the instant formula (I): mazindol’s 5-methoxy analogue4 (paragraph [0064]), shown in the table below:
Claim Number(s) of Instant Application
Instant Application
Kovacs
1
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382
396
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wherein:
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256
232
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Thus, claim 1 is anticipated by the disclosure of Kovacs.
Claim 5 further limits claim 1 to wherein the central nervous system disorder to be treated is selected from a Markush group that includes attention deficit hyperactivity disorder (ADHD).
Claim 6 further limits claim 1 to wherein the central nervous system disorder to be treated is ADHD.
Kovacs discloses that the invention disclosed therein, regarding treatment of neurobehavioral disorders, defines “neurobehavioral disorder” as a Markush group of disorders that includes “Attention Deficit Hyperactivity Disorder” (paragraph [0027]) and Kovacs claims a method for treating a neurobehavioral disorder selected from a Markush group that includes attention deficit hyperactivity disorder, the method comprising administering a compound from Kovacs’ formula I, which includes the compound shown in the table above (Kovacs’ claim 6).
Claim 7 further limits claim 1 to wherein the administration route of the active agent is selected from a Markush group of routes that includes oral administration.
Claim 8 further limits claim 1 to wherein the administration route of the active agent is oral administration.
Kovacs discloses that a compound of formula I disclosed therein can be administered orally at a daily dosage in the range of 0.01 to 2000 mg for an average adult human (paragraph [0069]) and further discloses oral administration dosage forms (paragraph [0070]).
Claim 9 further limits claim 1 to wherein the subject as human. Kovacs discloses that, for the invention disclosed therein, “patient” refers to a mammal, including specifically a human (paragraph [0029]).
Claim 10 depends from claim 9 and requires that the human to be treated must be an infant, child, adolescent, or adult. As discussed above, Kovacs discloses a dosage range for an average adult human (paragraph [0069]). Kovacs further discloses “Example 4”, wherein a 14 year old male (i.e., an adolescent) is treated for ADHD with mazindol, a compound of Kovacs’ formula I.
Claim 11 further limits claim 1 to wherein the CNS disorder is selected from a Markush group that includes ADHD. As discussed above, Kovacs treats ADHD.
Claims 12-15, 17, 19, 21, 24, 26, 28-32, 34, 36-37 and 40 each claim particular expected result(s) of the method of treatment of claim 1 but do not further limit the structure of the method in regard to the patient population and step(s) to be performed, and are therefore not further limiting to claim 1 and are met by the disclosure of Kovacs.
Claim 16 further limits claim 15, regarding expected result(s) of the method of claim 1, to wherein the subject to be treated has symptoms caused by and/or associated with a disease or disorder selected from a group that includes ADHD. As discussed above, Kovacs treats ADHD.
Claims 18 and 20 further limit claims 17 and 19, respectively, each parent claim regarding expected result(s) of the method of claim 1, to wherein the subject has a disease or disorder selected from a group that includes Binge Eating Disorder. Kovacs discloses that the invention disclosed therein includes treatment of “Obsessive-Compulsive Spectrum Disorder” (paragraph [0027]), which includes eating disorders (paragraph [0028]).
Claim 35 further limits claim 26, itself regarding expected result(s) of the method of claim 1, to wherein the subject has a disease or condition selected from a Markush group that includes cancer. Kovacs discloses that the invention disclosed therein includes treatment of “Somatization Disorder” (paragraph [0027]), which includes “various cancers” (paragraph [0042]).
Claim 41 further limits claim 40, itself regarding expected result(s) of the method of claim 1, to wherein the administration treats chronic fatigue syndrome. Kovacs discloses that the invention disclosed therein includes treatment of “Somatization Disorder” (paragraph [0027]), which includes chronic fatigue (paragraph [0042]).
Thus, claims 5-21, 24, 26, 28-32, 34-37 and 40-41 are anticipated by the disclosure of Kovacs.
Double Patenting - Statutory
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 1 is provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 34 of copending Application No. 18/784,106. This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Double Patenting – Non-Statutory
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 1-2 and 5-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 12,454,535 B2 (hereafter referred to as “Olson”). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 3 of Olson claims all 22 of the same compounds as claimed in the method of instant claim 2, which in turn anticipate the genus of compounds of “Formula (I)” claimed in the method of instant claim 1 and its dependent claims 5-42.
Claims 1-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of copending Application No. 18/784,106 (hereafter referred to as “Supernus”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Supernus anticipate the instant claims.
Claim 1 of Supernus claims the same genus of compounds designated as “Formula (I)” in instant claim 1. Claims 3, 5-6, 8, 10, 12 and 14 of Supernus further limit the genus of compounds of claim 1, each to a narrower genus that continues to anticipate the genus of “Formula (I)” of instant claim 1. Claims 2, 4, 7, 9, 11, 13 and 15-16 of Supernus claim specific compounds that are claimed in instant claim 2 and anticipate the genus of “Formula (I)” of instant claim 1 and its dependent claims 5-42. Claim 17 of Supernus claims the same genus of compounds as “Formula (II)” of instant claim 1. Claims 18, 20-21, 23 and 25-26 of Supernus further limit the genus of compounds of claim 17, each to a narrower genus that continues to anticipate the genus of “Formula (II)” of instant claim 1. Claims 19, 22, 24, and 27-28 of Supernus claim specific compounds that are claimed in instant claim 3 and anticipate the genus of “Formula (II)” of instant claim 1. Claim 29 claims the same genus of compounds as “Formula (III)” of instant claim 1. Claim 30 of Supernus further limits the genus of compounds of claim 17 to a narrower genus that continues to anticipate the genus of “Formula (III)” of instant claim 1. Claims 31-32 of Supernus each claim the same specific compound that is claimed in instant claim 4 and anticipates the genus of “Formula (III)” of instant claim 1.
This is a provisional nonstatutory double patenting rejection.
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 Text italicized by Examiner for emphasis.
2 Cited in Applicant’s Information Disclosure Statement dated 12/31/2024.
3 3H-Imidazo[2,1-a]isoindol-5-ol, 5-(p-chlorophenyl)-2,5-dihydro
4 5-(4-chlorophenyl)-5-methoxy-5H-imidazo[2,1-a]isoindole
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