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 .
Application Status
The preliminary amendment filed on 4/11/2023 is acknowledged. Claims 1-24 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statements filed on 10/05/2023, 1/05/2024 and 10/29/2024 have been considered except where lined through.
The listing of references in the PCT international search report is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, “the list ... must be submitted on a separate paper.” Therefore, the references cited in the international search report have not been considered. Applicant is advised that the date of submission of any item of information in the international search report will be the date of submission of the IDS for purposes of determining compliance with the requirements for the IDS with 37 CFR 1.97, including all timing statement requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Specification
The specification is objected to because it contains an embedded hyperlink and/or other form of browser executable code (see for example, paragraphs 0020 and 0021). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser executable code. See MPEP 608.01.
Claim Interpretation
Claims 19-21 recite the limitation “…informing the patient or medical care worker that co-administration of Compound A, or a pharmaceutically acceptable salt thereof, with a strong inducer of CYP3A4 results in no significant changes to the pharmacokinetics of Compound A.”. The instant scenario is similar to MPEP 2102.01 (III) which states that:
The court has extended the rationale in the printed matter cases, in which, for example, written instructions are added to a known product, to method claims in which "an instruction limitation" (i.e., a limitation "informing" someone about the existence of an inherent property of that method) is added to a method known in the art. King Pharmaceuticals, Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1279, 95 USPQ2d 1833, 1842 (2010). Similar to the inquiry for products with printed matter thereon, for such method cases the relevant inquiry is whether a new and nonobvious functional relationship with the known method exists. In King Pharma, the court found that the relevant determination is whether the "instruction limitation" has a "new and unobvious functional relationship" with the known method of administering the drug with food. Id. The court held that the relationship was non-functional because "[i]nforming a patient about the benefits of a drug in no way transforms the process of taking the drug with food." Id. That is, the actual method of taking a drug with food is the same regardless of whether the patient is informed of the benefits. Id. "In other words, the ‘informing’ limitation ‘in no way depends on the method, and the method does not depend on the ‘informing’ limitation.’" Id. (citing In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004)); see also In re Kao, 639 F.3d 1057, 1072-73, 98 USPQ2d 1799, 1811-12 (Fed. Cir. 2011). Since the actual method of treating epilepsy comprising administering a combination of Compound A and a strong inducer of CYP3A4 is the same regardless of whether the patient is informed of the benefits, the examiner is interpreting the limitation as non-functional or non-limiting.
Claim Objections
Claim 20 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 19. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
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 3 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 3 recites the limitation “… subsequently determining that the patient is to begin treatment with a strong inducer of cytochrome P450 3A4 (CYP3A4)….”. However, it is unclear what steps are involved in the determining step and what threshold should be used to determine whether a patient should begin treatment or not begin treatment. Moreover, there does not appear to be an active step of actually administering a strong inducer of cytochrome P450 3A4 (CYP3A4) once the determination has been made. Accordingly, for prior art purposes, the claim is interpreting that the only agent being administered is compound A.
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 11 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 11, which depends from claim 10, recites the limitation wherein the disease or condition is selection from a variety of different diseases/conditions including, but not limited to, Rett syndrome, multiple sclerosis, Alzheimer’s disease, autism, ataxia, hypotonia and paroxysmal dyskinesia. However, claim 10 has already limited the disease or condition to epilepsy. According, claim 11 appears to broaden the diseases or conditions encompassed by the method. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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) 3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xenon Pharmaceuticals (WO2017/201468A1, 2017-11-23, IDS) referred to herein as Xenon.
Xenon teaches benzenesulfonamide compounds, pharmaceutical composition comprising said compounds and methods of using the compounds and pharmaceutical compositions for the treatment of diseases or conditions associated with the activity of the voltage-gated sodium channels, particularly, Nav1.6 activity, such as epilepsy and/or epileptic seizure disorder (page 7, lines 2-6). Specifically, Xenon teaches that preferred compounds include, but are not limited to, (S)-4-((1-benzylpyrrolidin-3-yl)(methyl)amino)-2-fluoro-5-methyl-N-(thiazol-4-yl)benzenesulfonamide (page 46, lines 26-27). Moreover, Xenon teaches that the total dose required for each treatment is administered by multiple doses or in a single dose over the course of the day (page 68, lines 12-13).
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.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 11,299,490 to Andrez et al. (2022-04-12). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims overlap in scope. For example, US Patent No. 11,299,490 claims a method of treating a disease or a condition associated with aberrant Nav1.6 activity in a patient, wherein the disease or disorder is epilepsy or epileptic seizure disorder comprising administering to the patient a therapeutically effective amount of a compound of the following formula:
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(claim 1). The US Patent further claims wherein the compound of claim 1 is (S)-4-((1-benzylpyrrolidin-3-yl)(methyl)amino)-2-fluoro-5-methyl-N-(thiazol-4-yl)benzenesulfonamide (claim 7).
Claim 3 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 24 of copending Application No. 18248661 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the two application overlap in scope in that they both claim a method of treating a disease or condition associated with Nav1.6 activity in a patient in need thereof, the method comprising administering to the patient in need thereof a therapeutically effective amount of (S)-4-((1-benzylpyrrolidin-3-yl)(methyl)amino)-2-fluoro-5-methyl-N-(thiazol-4-yl)benzenesulfonamide.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-2 and 4-24 appear to be free of the prior art. The closest prior art is Xenon Pharmaceuticals (WO2017/201468A1, 2017-11-23, IDS) as set forth above and incorporated herein. Xenon further teaches that the compounds can be combined with a laundry list of additional agents including, but not limited to, phenytoin which is a strong CYP450 3A4 inducer. Accordingly, there is a selection that would need to be made to select the claimed compound A and phenytoin. However, the selection of a strong CYP450 3A4 inducer seems unreasonable since it was known in the art that compound A primary metabolism is by CYP450 3A4. For example, Bialer et al. (Epilepsia 2018;59:1811-1841) teach XEN901 (compound A) is metabolized by CYP3A4, CYP2D6 and to a lesser extent CYP2C9 (page 1836, 2nd column, 2nd full paragraph). Accordingly, there does not appear to be a teaching or suggestion to select a strong CYP3A4 inducer to use in combination with compound A since co administration would result in more metabolism of compound A.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph McKane can be reached at 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626