Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Status of Application, Amendments, and/or Claims
Applicant's amendment filed on 11/26/2025 has been entered. Claims 21-40 are pending. Claim 21 is currently under consideration. Claims 22-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Withdrawn Objections and/or Rejections
The rejection of claim 21 under 35 U.S.C. 112 (b) is withdrawn in view of amended claim.
The rejection of claim 21 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 1 of US Patent No. 11,673,938 B2 is withdrawn in view of the terminal disclaimer filed on 11/26/2025.
Claim Rejections under 35 USC § 112 (a)
(i). The following is a quotation of the first paragraph of 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
(ii). Claim 21 is rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
Claim 21 is drawn to a mutant β-adrenergic receptor which, when compared to the corresponding wild-type adrenergic receptor, has increased conformational thermostability, and has a different amino acid at a position which corresponds to any one or more of the following positions according to the numbering of the turkey β-adrenergic receptor as defined by SEQ ID NO: 1: I155A, G67A, R68S, R68L, V89L, M90V, M90NA, G9BA, 1129V, 1129A, 1129G, S151E, $151Q, $151R, S151T, V160A, Q194A, Q194A, G197A, L221V, L221], Y227A, R229Q, R229A, V230A, A234L, A234V, A2341, A282L, A282V, A282Q, D322L, D332A, D332P, F327A, F327L, F327V, F327G, F327M, A334L, A334S, A334l, F338M, F338A, F338l, F338L, F338V.
Except for the recited mutations, claim does not require that the rest part of the mutant β-adrenergic receptor possess any particular structural feature. Thus, the claim encompasses a large genus of mutant β-adrenergic receptors without a defined amino acid sequence.
The specification discloses mutations that increase the stability of the turkey β-adrenergic receptor (see, e.g., Example 1). The mutations are listed in Tables 1-2 (pages 63-65), which include G67A, G98A, V230A, D322A, Y227A, A234L, A282L, A334L. Each turkey β-adrenergic receptor mutant comprises a combination of particular point mutations (Tables 1-2). The turkey β-adrenergic receptors used for the study are βAR-m23 and βAR34-424 (Example 1). Such a disclosure is insufficient to support the broad genus of mutant β-adrenergic receptors.
Accordingly, due to the breadth of the genus of mutant β-adrenergic receptors, and lack of the definitive structural features of the genus, one skilled in the art would not recognize from the disclosure that Applicant was in possession of the claimed genus of mutant β-adrenergic receptors.
Applicant argues that the subject matter of the claims is aligned with the disclosure of the description. This is not persuasive for the reasons set forth in the rejection above.
Conclusion
No claims are allowed.
Advisory Information
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/Primary Examiner, Art Unit 1646 December 10, 2025