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 .
Applicant’s response (amendments, arguments, submission of jumbo IDS’s) is acknowledged.
Claims 2, 8, 18, 28-29, 49, 54-57, and 61 are now pending after amendments and examined on the merits.
Claim Observation: In claim 2, line 3 (and all other claims therewith), the term “product” may be deleted as superfluous.
After further review, the scope of what falls inside and outside of an agonist with “affinity” to the claimed receptors v. the peptides compared thereto within the specification (e.g. semaglutide, etc.) requires further amendment and/or evidence to adequately claim the scope of that which falls inside v. outside of the intended invention.
The examiner invites applicant to schedule an interview to advance prosecution on the merits of the instant application.
Election/Restrictions - Maintained
Applicant’s election without traverse of the peptide species of SEQ ID NO: 1 (His Aib Gln Gly Thr Phe Thr Ser Asp Tyr Ser Lys Tyr Leu Asp Glu Lys Ala Ala Lys Glu Phe Ile Gln Trp Leu Leu Gln Thr) in the reply filed on 12/4/21 is acknowledged. Per standard species election practice should the species be found allowable the search and examination will proceed to the next species(s).
All of the pending claims read on the elected species and are examined on the merits.
Claim Rejections - 35 USC § 112(a)(i)/(pre-AIA ) – Written Description
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
Claims 2, 8, 18, 28-29, 49, 54-57, and 61 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
To provide 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.
In this case, the claims are drawn to any agonist peptide with “affinity” to the receptors claimed. After further review, the scope (possession) of what falls inside and outside of an agonist with “affinity” to the claimed receptors v. the peptides compared thereto within the specification (e.g. semaglutide, etc.) requires further amendment and/or evidence to adequately claim the scope of that which falls inside v. outside of the intended invention. The specification describes that such should have “balanced” or equal affinity thereto, rather than unbalanced, but such is not claimed and leaves open the door for ‘any’ affinity however loose, which raises questions as to possession of what falls inside v. outside beyond the representative examples of peptide SEQ ID NOS: 1-10 and 12-27.
See e.g. instant PGPUB U.S. 20210290732 A1 (emphasis by examiner):
[0058] The peptides of SEQ ID NOS: 1-10 or 12-27 can be collectively referred to herein as the “dual agonist peptides” (or individually as “dual agonist peptide”) as each is an agonist for the glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR). In some embodiments, the peptide is a dual agonist of GLP-1R and GCGR as can be determined by a cellular assay such as that described in Example 2 herein. Briefly, in some embodiments, cellular assays can be carried out by measuring cAMP stimulation or arrestin activation in CHO cells into which human GLP-IR or GCGR are expressed ((LeadHunter assays (DiscoveRx)). Preferably, such assays are carried out in the presence of 0.1% ovalbumin as compared to 0.1% bovine serum albumin (BSA) as may be typical, since the dual agonist peptides of SEQ ID NOS: 1-10 or 12-27 can bind very tightly to serum albumin (>99%) and distort the results (see, e.g., Example 2 herein). In some embodiments, as determined using such assays, the dual agonist peptide can have affinity for both GLP-1R and GCGR, and in preferred embodiments about equal affinity for GLP-1R and GCGR. “About equal affinity” means that the dual agonist peptide has no more than about two to three times, preferably not more than two times, the affinity for GLP-1R or GCGR as for the other, as can be determined by such a cellular assay. For instance, as shown in the Examples herein, the dual agonist peptide SEQ ID NO: 1 (EU-A1873) has been surprisingly found to be a dual agonist peptide with about equal affinity for GLP-1R and GCGR (e.g., an EC50 of about 39 pm (115% intrinsic activity) for GLP-1R and 44 pm (115% intrinsic activity) for GCGR). This is unlike the GLP-1 “specific” compounds including semaglutide and Exendin-4, that present affinity strongly biased toward, or only for, GLP-1R; or the strongly GCGR-biased hormone glucagon, which do not show high, or about equal, affinity for both of GLP-1R and GCGR. The native hormone oxyntomodulin has agonistic action at both GLP-1 and glucagon receptors, but this activity is not potent and is not balanced. Those of ordinary skill in the art will understand that affinity to GLP-1R and GCGR can be determined by methods and/or assays other than those described herein and that such methods and/or assays for determining affinity are contemplated herein (e.g., a determination of about equal affinity can be made by such other methods and/or assays).
In the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
The skilled artisan cannot envision the detailed chemical structure of the encompassed agonist peptides “with affinity” for the two receptors claimed, without more structure + function being claimed. Conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
Therefore, the full breadth of the claims are not presently deemed to have been in Applicant’s ‘possession’ and found to meet the written description provision of 35 U.S.C. §112.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAURY A AUDET/Primary Examiner, Art Unit 1654
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