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 .
DETAIL ACTION
This office action is a response to a 371 application filed -----9/13/2024, which is a national stage application of PCT/JP2023/016215 filed 4/25/2023, which claims foreign priority to JP2022/073291 filed 4/27/2022.
As filed, claims 1-8 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/11/2024; 11/20/2024; 3/11/2026; and 7/23/2026 has been considered by the Examiner.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Specification
The disclosure is objected to because of the following informalities:
The amendment filed 9/13/2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “each of which is incorporated by reference herein in its entirety”.
MPEP 211.02 and MPEP 201.06(c)(IV) state the following in regard to “Incorporation by Reference” and PCT Rule 20.6, Rule 20.7 and Rule 4.18 are directed specifically to International applications:
MPEP 211.02, in-part
For applications filed on or after September 21, 2004, a claim under 35 U.S.C. 119(e) or 120 and 37 CFR 1.78 for benefit of a prior-filed provisional application, nonprovisional application, international application designating the United States, or international design application designating the United States that was present on the filing date of the continuation or divisional application, or the nonprovisional application claiming benefit of a prior-filed provisional application, is considered an incorporation by reference of the prior-filed application as to inadvertently omitted material, subject to the conditions and requirements of 37 CFR 1.57(b). The purpose of 37 CFR 1.57(b) is to provide a safeguard for applicants when all or a portion of the specification and/or drawing(s) is (are) inadvertently omitted from an application. See MPEP § 201.06 and 217. However, applicants are encouraged to provide in the specification an explicit incorporation by reference statement to the prior-filed application(s) for which benefit is claimed under 35 U.S.C. 119(e) or 120 if applicants do not wish the incorporation by reference to be limited to inadvertently omitted material pursuant to 37 CFR 1.57(b). See 37 CFR 1.57(c). See also MPEP §§ 217 and MPEP § 608.01(p).
MPEP 201.06(c)(IV), in-part
201.06(c) 37 CFR 1.53(b) and 37 CFR 1.63(d) Divisional-Continuation Procedure [R-07.2015]
IV. INCORPORATION BY REFERENCE
An applicant may incorporate by reference the prior application by including, in the continuing application-as-filed, an explicit statement that such specifically enumerated prior application or applications are “hereby incorporated by reference.” The statement must appear in the specification. See 37 CFR 1.57(c) and MPEP § 608.01(p). The inclusion of this incorporation by reference statement will permit an applicant to amend the continuing application to include subject matter from the prior application(s), without the need for a petition provided the continuing application is entitled to a filing date notwithstanding the incorporation by reference. For applications filed prior to September 21, 2004, the incorporation by reference statement may appear in the transmittal letter or in the specification. Note that for applications filed prior to September 21, 2004, if applicants used a former version of the transmittal letter form provided by the USPTO, the incorporation by reference statement could only be relied upon to add inadvertently omitted material to the continuation or divisional application.
An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a) ). If an incorporation by reference statement is included in an amendment to the specification to add a benefit claim under 35 U.S.C. 120 after the filing date of the application, the amendment would not be proper. When a benefit claim under 35 U.S.C. 120 is submitted after the filing of an application, the reference to the prior application cannot include an incorporation by reference statement of the prior application. See Dart Indus. v. Banner, 636 F.2d 684, 207 USPQ 273 (C.A.D.C. 1980).
20.6 Confirmation of Incorporation by Reference of Elements and Parts
(a) The applicant may submit to the receiving Office, within the applicable time limit under Rule 20.7, a written notice confirming that an element or part is incorporated by reference in the international application under Rule 4.18, accompanied by:
(i) a sheet or sheets embodying the entire element as contained in the earlier application or embodying the part concerned;
(ii) where the applicant has not already complied with Rule 17.1(a), (b) or (b-bis) in relation to the priority document, a copy of the earlier application as filed;
(iii) where the earlier application is not in the language in which the international application is filed, a translation of the earlier application into that language or, where a translation of the international application is required under Rule 12.3(a) or 12.4(a), a translation of the earlier application into both the language in which the international application is filed and the language of that translation; and
(iv) in the case of a part of the description, claims or drawings, an indication as to where that part is contained in the earlier application and, where applicable, in any translation referred to in item (iii).
(b) Where the receiving Office finds that the requirements of Rule 4.18 and paragraph (a) have been complied with and that the element or part referred to in paragraph (a) is completely contained in the earlier application concerned, that element or part shall be considered to have been contained in the purported international application on the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office.
(c) Where the receiving Office finds that a requirement under Rule 4.18 or paragraph (a) has not been complied with or that the element or part referred to in paragraph (a) is not completely contained in the earlier application concerned, the receiving Office shall proceed as provided for in Rule 20.3(b)(i), 20.5(b) or 20.5(c), as the case may be.
20.7 Time Limit
(a) The applicable time limit referred to in Rules 20.3(a) and (b), 20.4, 20.5(a), (b) and (c), and 20.6(a) shall be:
(i) where an invitation under Rule 20.3(a) or 20.5(a), as applicable, was sent to the applicant, two months from the date of the invitation;
(ii) where no such invitation was sent to the applicant, two months from the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office.
(b) Where neither a correction under Article 11(2) nor a notice under Rule 20.6(a) confirming the incorporation by reference of an element referred to in Article 11(1)(iii)(d) or (e) is received by the receiving Office prior to the expiration of the applicable time limit under paragraph (a), any such correction or notice received by that Office after the expiration of that time limit but before it sends a notification to the applicant under Rule 20.4(i) shall be considered to have been received within that time limit.
4.18 Statement of Incorporation by Reference
Where the international application, on the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office, claims the priority of an earlier application, the request may contain a statement that, where an element of the international application referred to in Article 11(1)(iii)(d) or (e) or a part of the description, claims or drawings referred to in Rule 20.5(a) is not otherwise contained in the international application but is completely contained in the earlier application, that element or part is, subject to confirmation under Rule 20.6, incorporated by reference in the international application for the purposes of Rule 20.6. Such a statement, if not contained in the request on that date, may be added to the request if, and only if, it was otherwise contained in, or submitted with, the international application on that date.
The instant application is a 371 application which has an International filing date of 4/25/2023. See a partial capture of the BIB sheet of the instant application below.
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The incorporation by reference statement is being added by way of a Preliminary Amendment filed 9/13/2024, which is after the instant application's International filing date of 4/25/2023. Therefore, the “incorporation by reference” statement being added to the instant specification by way of the Preliminary Amendment is deemed new matter.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over “Tiagabine Protects Dopaminergic Neurons against Neurotoxins by Inhibiting Microglial Activation”, hereinafter Liu (see IDS filed 10/11/2024); and foreign patent application publication No. WO2022/113778 and its machine-generated English translation, hereinafter Fukushima (see IDS filed 10/11/2024).
Regarding claims 1 and 4:
Determining the scope and contents of the prior art:
Liu, for instance, teaches that tiagabine, which is a GAT-1 inhibitor, attenuated microglial activation and improved motor deficits in a MPTP mouse model of Parkinson’s disease (PD).
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(abstract)
Fukushima, for instance, teaches that N-[(1S)-22,57-tetrafluoro-2,3-dihydro-1H-inden-1-yl]sulfamide or pharmaceutically acceptable salt thereof, which acts as a GAT-1 inhibitor, is used to treat various type of epilepsy, including refractory epilepsy.
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(paragraph 0001 of the machine-generated English translation)
Ascertaining of the difference between the prior art and the claim at issue:
Liu, for instance, did not explicitly teach the use of N-[(1S)-22,57-tetrafluoro-2,3-dihydro-1H-inden-1-yl]sulfamide or pharmaceutically acceptable salt thereof for treating and improving motor deficit of PD.
Fukushima, for instance, did not explicitly teach N-[(1S)-22,57-tetrafluoro-2,3-dihydro-1H-inden-1-yl]sulfamide or pharmaceutically acceptable salt thereof is used to treat and improve motor deficit of PD.
Finding of prima facie obviousness --- rationale and motivation:
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’" KSR, 550 U.S. at 418, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
Based on the teachings of the MPEP and KSR above, by employing the rationale in (B) above, it would have been obvious to one of ordinary skill in the art to substitute tiagabine of Liu with N-[(1S)-22,57-tetrafluoro-2,3-dihydro-1H-inden-1-yl]sulfamide of Fukushima or to substitute epilepsy of Fukushima with PD of Liu in order to arrive at the instantly claimed process because there is a reasonable expectation of success that N-[(1S)-22,57-tetrafluoro-2,3-dihydro-1H-inden-1-yl]sulfamide or tiagabine can be used interchangeably to treat epilepsy or PD when both Liu and Fukushima used the same underlying biological mechanism, which is GAT-1 inhibition, to treat PD or epilepsy, respectively.
Allowable Subject Matter
Claims 2, 3, and 5-8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1 and 4 are rejected.
Claims 2, 3, and 5-8 are objected.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621
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