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 .
This is the first action on the merits.
Election/Restrictions
Applicant notes that the Examiner's characterization of claims 11 to 14 (Group III) is inaccurate. Claim 11 is directed to a "method of preventing chronic pain in a cancer patient, the method comprising administering an effective amount of an agent to the cancer patient, wherein said agent is a NAAA inhibitor, FAAH inhibitor, PPARa agonist, PEA, acetyl- L-carnitine, a-lipoic acid, or olesoxime" (emphasis added). Claim 11 does not specify that the agent is administered perioperatively. The Examiner agrees with Applicant regarding Group (III).
Applicant's election without traverse of Group (II) in the reply filed on May 29, 2026 is acknowledged. Group (II), drawn to a method of preventing chronic pain comprising administering perioperatively an NAAA inhibitor, embraced by claims 1-7 and 9-11 was elected by Applicant. Applicant has not pointed to any errors in the Examiner’s analysis of the different inventions. The requirement is still deemed proper and is therefore made FINAL.
Applicant elected, without traverse, the following species: an NAAA inhibitor, specifically ARN19702. The structure for ARN19702 is provided below:
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Applicant indicated claims 10 and 37-39 read on said species.
Newly submitted claims 40 and 41 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: said claims are drawn to FAAH and PPARα inhibitors.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 40 and 41 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 1, 2, 4, 8-13, 16, 19, 20, 22, 26, 27 and 37-41 are pending and claims 10 and 37-39 are under examination. Claims 1, 2, 4, 8, 9, 11-13, 16, 19, 20, 22, 26, 27 and 40-41are withdrawn based on the species election and restriction requirement.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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.
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) 10 and 37-39 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Piomelli et al. (WO 2017201103).
The Piomelli reference teaches ARN19702, see the top of page 3 and below, as a potent and selective NAAA inhibitor, see page 7, paragraph [0033], and produce therapeutic effects in treating a pathological state, e.g. chronic pain and allodynia, see page 8, paragraph [0035] and page 28, paragraph [0106] caused by injury, ischemia, cancer or diabetes, among the many others, see page 28, paragraph [0106]. The term “treatment” and the phrase “effective amount” are defined on pages 23-25, paragraphs [0091] and [0093].
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Assuming, arguendo, that the claims are not anticipated, then the claims would be obvious based on the definition of “treatment” and the phrase “effective amount” which embrace prevention and perioperatively.
Thus, said claims are anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Piomelli et al.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 10 and 37-39 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10556892. Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims in the ‘892 patent are drawn to a genus of compounds of formula (I), but specifically excludes compound ARN19702, see column 118. The exclusion does not remove compounds which are obvious variants of ARN19702, for example homologues and positional isomers. The MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Moreover, the same utility is claimed and both the ‘892 patent and the present application. Thus, the claims are rendered obvious.
Claim(s) 10 and 37-39 provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-7 21-24, 27-29 and 81 of copending Application No. 19067308 in view of Haze, J.J. (The Journal of Craniomandibular & Sleep Practice, 1991, 9(4), abstract), Ko et al. (The Clinical of Pain, 2010, 26(2), abstract), and Gabrielsson et al. (British Journal of Clinical Phamacology, 2016, 82, 932-942). Although the conflicting claims are not identical, they are not patentably distinct from each other because the present application is drawn to a method of preventing chronic pain in a subject, the method comprising administering perioperatively an effective amount of an agent to the subject, wherein said agent is a NAAA inhibitor, i.e. ARN19702.
The claims in the ‘308 application are drawn to a method of preventing chronic pain after a traumatic pain event in a subject with diabetes; or preventing peripheral neuropathic pain in a subject previously treated with an anti-cancer agent comprising administering a composition comprising at least one purified free amino acid, at least one purified fatty acid, e.g. 3-omega fatty acid and purified fatty acid amide, e.g. PEA. Claims 29 and 81 require an additional component, e.g. an NAAA inhibitor, such as ARN19702. PEA, 3-omega fatty acids and tryptophan are known to treat pain, see the references.
It has been held that combinations of two or more compositions each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is to be used for the very same purpose. In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77, 126 USPQ 186, 188 (1960). Thus, combining them flows logically from having been individually taught in prior art.
Moreover, oleic acid is known excipient, see claim 4, found in many different compositions.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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