DETAILED ACTION
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 .
Claims 1-23 have been canceled.
Claims 24-42 have been added and are examined on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 24-42 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 25-26 and 40 are vague and indefinite in the recitation of “activities” on a GLP-1 receptor, a glucagon receptor and GIP receptor as opposed to an “activity” It is unclear if “activities” is meant to encompass multiple activities at a single receptor, such as receptor endocytosis (Authier and Desbuquois, Cellular and Molecular Life Sciences, 2008, Vol. 65, pp. 1880-1899), activation of the phospholipase C inositol phosphate pathway and mobilization of intracellular ca+2 (Authier and Desbuquois , 1885, second column, last four lines) in addition to elevation of intracellular cAMP (Authier and Desbuquois, page 1884 lines 1-4 under the heading “Signal Transduction pathways …”).
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 39-41 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 treating a metabolic syndrome in a patient in need therefor comprising the administration of the peptide of claim 24, does not reasonably provide enablement for method of preventing a metabolic syndrome in a patient in need therefor comprising the administration of the peptide of claim 24. 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 factors considered when determining if the disclosure satisfies the enablement requirement and whether any necessary experimentation is undue include, but are not limited to: 1) nature of the invention, 2) state of the prior art, 3) relative skill of those in the art, 4) level of predictability in the art, 5) existence of working examples, 6) breadth of claims, 7) amount of direction or guidance by the inventor, and 8) quantity of experimentation needed to make or use the invention. In re wands, 858 F.2d 731, 737.8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
When given the broadest reasonable interpretation, a patient in need thereof encompasses humans and non-experimental animals. The specification defines preventing as the inhibition or delay of onset of metabolic syndrome by administration of the peptide, conjugate, or composition (page 47, paragraph [366]). In order to inhibit the onset, or delay the onset of a metabolic syndrome in a human or non-experimental animal it is necessary that the composition comprising the peptide of claim24 be present prior to the onset of the metabolic syndrome. It is noted that even a long-acting conjugate comprising a peptide of SEQ ID NO: 1-12 would have a finite lifetime in circulation. The specification fails to teach how to identify patients who will develop metabolic syndrome, before the metabolic syndrome manifests in said patients. Therefore, one of skill in the art would not be able to provide a composition comprising a peptide of SEQ ID NO: 1-12 such that the amount present in the patient will have therapeutic efficacy against the metabolic syndrome, thus preventing or delaying occurrences. One of skill in the art would be subject to undue experimentation without reasonable expectation of success in order to carry out the broadly claimed method.
Claims 24-41 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 24-41 are reliant, in part, on the identity of the peptides of SEQ ID NO: 1-11. The sequence listing indicates that the peptides of SEQ ID NO:1-11 comprise a ring structure either between the Glu at position 12 and the Lys at position 16 or the Glu at position 16 and the Lys at position 20. The specification fails to describe the isopeptide bonds resulting in the structure of the ring cyclized by joining the Glu to Lys at the indicated positions. The specification states that in an embodiment, the cyclized peptides comprising a lactam ring. The specification fails to define the cyclized peptides as comprising a lactam ring. The art teaches various methods for intramolecular peptide cyclization relying on amino acid side chains such as the traceless Staudinger ligation-Mediated Peptide cyclization (Chow et al, Chemical Review, 2019, Vol. 119, pp. 9971-10001, see page 9985) as well as other biorthogonal reactions Cu-catalyzed azide-alkyne cyclo-addition,(Chow et al, page 9976, first column, lines 3-5 under Figure 8 and Legre et al Advanced Therapeutics, 2018, Vol. 1, article 1800052, 22 pages, see Figure 5B) and strain promoted azide alkyne cycloaddition, SPAAC (Legre et al , see Figure 5C) in addition to the lactam ring formation (Lundquist and Pelletier, Organic Letters, 2002, Vol. 4, pp. 3219-3221, abstract, Scheme 3, and page 3221, second column, lines 1-6). All of these methods result in different structures connecting the side chains of the glutamic acid and lysine. Thus, the claims are drawn to a genus of cyclic peptides which differ by the intramolecular linkage between the glutamic acid and lysine. Claim 24 requires that the peptides have activities on a glucagon receptor, a GLP-1 receptor and a GIP receptor. It would be expected that the additional structures encompassed within the cyclic peptides would interact differently with the glucagon receptor, a GLP-1 receptor and/or a GIP receptor. Claims 25-31 specify particular levels of activity on the glucagon receptor, a GLP-1 receptor and/or GIP receptor. One of skill in the art could not envisage the cyclic peptides having the required activities outside of the embodiment taught by the specification that the cyclized peptides comprising a lactam ring as one could do with a well-described genus. One of skill in the art would reasonably conclude that applicant was not in possession of the genus of cyclic peptides of SEQ ID NO:1-11 having “activities” on a glucagon receptor, a GLP-1 receptor and a GIP receptor.
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/ Primary Examiner, Art Unit 1643
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