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 .
DETAILED ACTION
Claims 29-43 are pending in the application. Claims 29-39 are rejected. Claim 39 is objected to. Claims 40-43 are withdrawn.
Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 29-39, drawn to compounds of Formula (II-3) and composition thereof, classified in C07D487/14, C07D471/14, C07D471/20, C07D487/04, C07D491/20, C07D498/14 and C07D513/14.
II. Claims 40-43, drawn to methods for treating neurodegeneration disease, classified in A61P3/00, A61P3/06, A61P3/10, A61P5/18, A61P9/10, A61P11/00, A61P17/02, A61P17/06, A61P19/02, A61P19/08, A61P25/00, A61P25/14, A61P25/16, A61P25/28, A61P27/02, A61P29/00, A61P35/00, A61P43/00 and A61K31/519.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the process for using the product as claimed can be practiced with another materially different product. For instance, Salat et al. (J Parkinsons Dis. 2013, 3(3):255-269) teach oral levodopa to treat Parkinson’s disease (i.e., a neurodegeneration disease). See e.g., page 255.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have acquired a separate status in the art in view of their different classification.
The inventions have acquired a separate status in the art due to their recognized divergent subject matter.
The inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Election of Species
This application contains claims directed to the following patentably distinct species: a species of a compound of Formula (II-3). The species are independent or patentably distinct because as disclosed the different species have mutually exclusive characteristics for each identified species. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. § 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, claims 29-35 and 39-43 are generic.
There is a search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
The species or groupings of patentably indistinct species have acquired a separate status in the art in view of their different classification.
The species or groupings of patentably indistinct species have acquired a separate status in the art due to their recognized divergent subject matter.
The species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
During a telephone conversation with HAO YIN on April 22, 2026 a provisional election was made with without traverse to prosecute the invention of Group I, claims 29-39, and further elect the species (shown below) as recited in claims 37 and 38:
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.
Affirmation of this election must be made by Applicant in replying to this Office Action. Claims 29-39 read on the elected species. Claims 40-43 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. § 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. § 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
As per MPEP § 803.02(III), the examiner will determine whether the entire scope of the claims is patentable. Applicant’s elected species appears to be free of the prior art. Therefore, according to MPEP § 803.02(III): should the elected species be found allowable over the prior art, the examination of the Markush claim will be extended. Consequently, the prior art search was extended to include the full scope of instant claim 29 but did not result in any prior art being found.
Priority
This application is a continuation of U.S. Application No. 16/524,238, filed on July 29, 2019, which is a continuation of U.S. Application No. 16/143,788, filed on September 27, 2018, which is a continuation of U.S. Application No. 15/327,706, filed on January 20, 2017, which is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/CN2015/084606, filed on July 21, 2015, which claims priority to International Application No. PCT/CN2014/000695, filed on July 22, 2014.
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. § 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on April 25, 2024 is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 88, line 19. 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 Objections
Claim 39 is objected to because of the following informalities:
Claim 39 should be amended to replace “a compound” with -the compound- in the first line of the claim for sake of consistency and clarity.
Appropriate correction is required.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
The analysis employed for an obviousness-type double patenting rejection parallels the analysis for a determination of obviousness under 35 U.S.C. § 103. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. § 103 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 29-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9,783,546 (‘546 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘546 patent are drawn towards the following compound- and compositions thereof- which anticipates the instantly claimed compound of Formula (II-3).
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The above compound of the ‘546 patent is encompassed by variable definitions of the instantly claimed compound of Formula (II-3), wherein, R1 and R2 together with the nitrogen and carbon to which they are attached form a 5-membered saturated heterocyclic ring; R3 is H; R4 is H; X is -O-; n is 1; A is
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, further wherein R5 and R9 are independently H; Z and Z’ are CF; V is CR7; R7 is -Q-(CH2)m-W, wherein Q is O; m is 0; and W is pyridinyl substituted with C1 haloalkyl. In addition, claims 12-16 of the ‘546 patent are drawn towards methods of treating neurodegeneration disease in a subject in need comprising administering the instantly claimed compound of Formula (II-3).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID SHIM whose telephone number is (571)270-1205. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RENEE CLAYTOR can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.M.S./Examiner, Art Unit 1626
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626
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