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
Claim Status
Claims 1, 5-9 and 14 are pending. Claims 1, 5-9 and 14 are under examination in their entirety. Claims 1, 5-9 and 14 are rejected. No claims allowed.
Filing Receipt
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Election/Restrictions
Election of Group I claims 1-9 and 14 was made without traverse in the reply filed on 01/28/2026.
Specie Election
Applicant elected the below specie without traverse in the reply filed on
01/28/2026.
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Priority
Effective Filing Date of the Claims
Applicant claims foreign priority to an application CN202011424798.4 filed 12/09/2020. However, the claims as filed have an effective filling date of 11/19/2021. The claims are not effectively filed on 12/09/2020 due to the foreign priority not being perfected.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome the immediately below 102 rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
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.
Claim(s) 1, 5-9 and 14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jun et al. (CN112472697, Published 03-2021. Cited in the IDS filed 06/05/2023. English translation attached).
The applied reference has a common assignee and inventor with the instant application. However, inventor XIE FEIFEI in CN112472697 is not a current inventor. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Concerning current claim 1, Jun et al. disclose the following in claims 1-3.
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Concerning claim 5, Jun et al. disclose a 1:1 ratio in claim 8. 0.8 to 1.2 is clearly envisaged when operating within a 1:1 ratio. MPEP 2131.03 II.
Moreover, to achieve the identical polymorph (see X-ray data Figures of the invention and prior art), the ordinary artisan practicing the invention of Jun et al. would have had to operate within identical ranges of reagents.
Concerning current claims 6-9, Jun et al. disclose the following in claim 8-9 and paragraph 17.
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See X-ray data in the Figures of the invention and prior art. ±0.2 is self-evident due to the spectrum being identical.
Concerning claim 14, the disclosed salt by Jun et al. in claim 1 is interpreted to be the composition due to a salt not being covalently linked. A salt is therefore made up of at least to distinct elements. A salt is not interpreted to be a single compound. Identical salts are therefore identical pharmaceutical compositions. Moreover, the salt consists of L-proline, Li and isobutyrate. These are not covalently linked as to form a single compound.
This anticipates the claims.
Conclusion
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/B.G.D/Examiner, Art Unit 1692 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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