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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The instant application 18/041151filled on 02/09/23 is a 371 of PCT/KR2021/010910 filed on 08/17/2021 with foreign priority to KR10-2020-0102604 and KR10-2021-0048006, filed on 08/14/2020 and 04/13/2021 respectively. The instant application will be examined with an effective priority date of 08/14/2020.
Status of the Claims
In the claim set filed 3/2/2026, claims 1-36 are indicated as canceled and claim 27 is indicated as amended. It appears that “claims 1-36” is a typographical error and applicant may have intended the claim set to read, “claims 1-26.” Appropriate correction is required.
Thus, in the 3/2/2026 claim set, claims 1-26 are canceled, claims 27, 28, 34 are amended. Claims 27-46 are under consideration.
Withdrawn Objections/Rejections
Claim objection
Regarding the objection to claim 34, wherein the claim recited, “regionwherein,” applicant amended the claim. The objection to claim 34 has been withdrawn.
35 USC 103
Regarding the rejection of claims 27-46 as being obvious over US271, Choi, US520, and Gaspari, the rejection is withdrawn as the claims have been amended to specific SEQ ID NOs:. Further, applicant indicates that Choi teaches body weight reduction, improvement in lipid profiles, improvement in NASH/NAFLD-related indices and balancing risk of hyperglycemia. This is not related to lowering blood pressure effects.
NSDP
Regarding the provisional rejection of claims 27, 28, 32, 34, 35 as being unpatentable over claims 1-6, 8, 9 of copending application 18031940, the rejection is withdrawn as there is no art that teaches a glucagon, GLP-1, GIP receptor agonist that reduces blood pressure.
Regarding the provisional rejection of claims 27, 28, 32, 34, 45 as being unpatentable over claims 1-6, 8, 9 of copending application 18032076, the rejection is withdrawn as there is no art that teaches a glucagon, GLP-1, GIP receptor agonist that reduces blood pressure.
New Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 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.
Claims 27-46 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for
a method of lowering blood pressure comprising SEQ ID NO: 42, does not reasonably provide enablement for
a method of lowering blood pressure comprising SEQ ID NOs: 21-22, 27, 30-32, 34, 36, 37, 42, 43, 50-56, 58, 64-79, 83, 86, 91, 93, 96-102 .
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The specification teaches that triple (glucagon, GLP-1, and GIP receptor) agonists were prepared (specification, example 1) and that SEQ ID NO: 42 was characterized as having a blood pressure lowering effect (specification, example 3). While the specification provides guidance for using SEQ ID NO: 42, it does not provide guidance for using other peptides isolated from example 1 to reduce blood pressure.
At the time of filing, the art teaches that there are a wide range of structural and functional changes caused by single amino acid differences, including changes in enzyme activity, aggregation propensity, structural stability, binding, and dissociation, some in context of large assemblies (Bhattacharya R, Rose PW, Burley SK, Prlić A (2017) Impact of genetic variation on three dimensional structure and function of proteins. PLoS ONE12(3): e0171355. https://doi.org/ 10.1371/journal.pone.0171355, abstract). As this applies to the instant invention, while there is characterization of SEQ ID NO: 42, the specification does not teach that other sequences similar to SEQ ID NO: 42 (e.g. SEQ ID NO: 43, comparison with SEQ ID NO: 42 below) have the same ability to reduce blood pressure. Further, Bhattacharya et al. teach that even single amino acid changes to a sequence can change the property of the original protein that it is unclear if proteins similar in sequence to SEQ ID NO: 42 will also function similar to SEQ ID NO: 42.
YXQGTFTSDYSKYLDEKRAKEFVQWLLDHHPSSGQPPPSC SEQ ID NO: 42
YXQGTFTSDYSKYLDEKRAKEFVQWLLDHHCSSGQPPPS SEQ ID NO: 43
(Differences in amino acid sequences are underlined and bolded.)
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMMANUEL LED YOUTCHOM PENDIE whose telephone number is (571)272-6313. The examiner can normally be reached Mon - Fri: 8AM - 5PM CST.
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/EMMANUEL LED YOUTCHOM PENDIE/ Examiner, Art Unit 1647
/JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647
