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 -----3/20/2023, which is a national stage application of PCT/US2021/050841 filed 9/17/2021, which claims domestic priority to 63/080,985 filed 9/21/2020.
As filed, claims 19-27 are pending, wherein claim 19 is an independent claim; and claims 1-18 are cancelled.
Election/Restrictions
Applicant’s election without traverse of Group I – Claims 19-23 in the reply filed on 10/28/2025 is acknowledged.
Claim 24-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/28/2025.
Priority
The instant application is a 371 application filed -----3/20/2023, which is a national stage application of PCT/US2021/050841 filed 9/17/2021, which claims the benefit under 35 USC 119 (e) from US Provisional Applications 63/080,985 filed 9/21/2020.
With respect to the claim for the benefit of an effective U.S. filing date, it is noted that “the written description and drawing(s) (if any) of the provisional application must adequately support and enable the subject matter claimed in the nonprovisional application that claims the benefit of the provisional application. In New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co., 298 F.3d 1290, 1294, 63 USPQ2d 1843, 1846 (Fed. Cir. 2002), the court held that for a nonprovisional application to be afforded the priority date of the provisional application, 'the specification of the provisional must contain a written description of the invention and the manner and process of making and using it, in such full, clear, concise, and exact terms' to enable an ordinarily skilled artisan to practice the invention claimed in the nonprovisional application" [MPEP 201.11A - emphasis in original].
It is noted that the requirement for support is evaluated for each claim individually such that different claims may be examined with different effective filing dates. In the instant case, the ‘985 provisional application provided support for instant claims 19-23. Accordingly, claims 19-23 are examined with an effective filing date of 9/21/2020, which is the filing date of the ‘985 provisional application (i.e. earliest filing date).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/5/2023 and 10/29/2025 has been considered by the Examiner.
Claim Interpretation
With regards to the preamble phrase, such as “A pharmaceutical composition”, in claim 23, wherein the term, “pharmaceutical” has not been accorded patentable weight for prior art purpose because such term recites intended use and fails to limit the structure of the instant amorphous form of OAD2 dihydrochloride salt.
The Examiner finds that any prior art composition teaches the instant amorphous form of OAD2 dihydrochloride salt with a pharmaceutically acceptable carrier would be capable of performing the intended use, according to the guidance in MPEP 2111.02(II)
Regarding the phrase, “substantially the same”, in claim 19-21, one of ordinary skill in the art, in the context of the figures depicted in the abovementioned claims, would know what is meant by “substantially the same” according to the guidance in MPEP 2173.05(b)(III)(D).
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)(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 19-23 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent Application Publication No. 2023/0348412, hereinafter Hu .
Regarding claims 19-23, Hu, for instance, teaches a process of converting compound II to compound I, wherein compound II is “OAD2” mono-hydrochloride salt and compound I is “OAD2” dihydrochloride salt.
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(pg. 7-8, compounds II and I)
A sample of “OAD2” dihydrochloride salt (II) is prepared by first dissolving the mono-hydrochloride salt (I) in aqueous THF and adding 4M HCl to precipitate a solid. The term “crystalize” is used, however no other information is provided to identify the actual form of the solid isolated in the procedure, such as melting point, etc. The term, as it is used in the reference, does not imply that an actual crystalline material is obtained - but rather identifies the type of procedure that was used to obtain the solid substance. The reference is otherwise silent as to the physical form of the substance obtained in the preparation and does not use XRPD, TGA, DSC or IR to characterize the substance.
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(pg. 11, paragraph 0063, example 6)
See MPEP 2112.01 in this regard. Highlighting added:
“"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
“Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.”
Thus, in order to determine as to whether the present claims recite a different substance than that disclosed in the reference, the Examiner has reviewed the instant specification. Of particular relevance, as indicated by MPEP 2112.01, is a comparison of the processes used to make the claimed and prior art substances. See the specification at page 7, lines 15-27, (see also example 4 on page 16) where an embodiment is described wherein the amorphous material is isolated using nearly the same process as disclosed in the Hu reference (underlining added):
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The reference process is substantially similar to the embodiment described by Applicant, wherein aqueous THF/HCl is used to convert the monohydrochloride salt to the amorphous dihydrochloride salt. Therefore, the Examiner asserts that there is a reasonable basis to conclude that the reference material is necessarily identical to that claimed. Note also that the procedure of example 4 of the examined specification produces amorphous OAD2 dihydrochloride salt using THF and 4M HCl after “crystallization for 2 hours”: Applicant also the uses the term “crystallization” to generically describe the procedure used and not the substance obtained.
Regarding the XRPD, TGA, DSC and IR properties recited in present claim 19, these limitations are necessary features of the claimed substance and must be present in a substance which is identical to that claimed: “if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present”.
The Examiner has set forth reasoning to establish that the prior art (i.e. compound I of Hu) and instantly claimed product (i.e. amorphous form of OAD2 dihydrochloride salt) are the same.
In addition, the Examiner finds that a composition containing compound I of Hu was inherently made when compound I of Hu was crystallize in presence of water (i.e. a pharmaceutically acceptable carrier) and 4M HCl solution prior to filtration and drying in the abovementioned sample preparation.
All of which meet all the limitations of these claims.
Conclusion
Claims 19-23 are rejected.
Claims 24-27 are withdrawn.
Claims 1-18 are cancelled.
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