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 .
Status of the Claims
Claim(s) 15-17 are currently pending and examined here.
The following Office Action is in response to Applicant's communication dated 04/27/2026.
Rejection(s) and/or objection(s) not reiterated from previous office actions are hereby withdrawn. The following rejection(s) and/or objection(s) are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Please note that the new examiner of record is Khai Q Pham.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 15 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Munke et al. (Proc Natl Acad Sci U S A. 2017;114(25):6444-6449).
Regarding claim 15, Munke discloses A method for identifying one or more antibodies which bind preferentially to a protein in aggregate form compared with a monomeric form, the method comprising: (a) performing one or more negative screens of an antibody library against a monomeric form of the protein, (b) performing one or more positive screens of the antibody library against aggregate forms of the protein, and (c) repeating steps (a) and (b), whereby one or more antibodies are identified that bind to the protein in aggregate form with high affinity and bind to monomers of the same protein with low affinity, wherein the protein is amyloid beta (e.g. The reference discloses strategy for generating fibril-specific antibodies that selectively suppress fibrils/aggregates form of Aβ (Aβ42). The strategy includes 1) perform negative selection against monomeric forms to remove scFvs that bind monomeric Aβ42. 2) the remaining unbound phages then subjected to positive selection against fibrils/aggregates forms to capture scFvs that bind to the Aβ42 fibrils/aggregates. Munke repeats the monomer binding removal, then fibril binding capture procedure multiple times, thereby selectively enriching candidates that preferentially bind Aβ42 fibrils/aggregates with high affinity relative to Aβ42
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Munke et al. and Martins et al.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Munke et al. (Proc Natl Acad Sci U S A. 2017;114(25):6444-6449) in view of Martins et al. (Haematologica. 2018;103(12)).
Regarding claims 16 Munke does not disclose the protein is glucagon or liraglutide. However, as of the application’ s effective filing date, it would have been prima facie obvious to a person of ordinary skill in the art to use the screening method to identifying one or more antibodies which bind preferentially to glucagon or liraglutide amyloid fibrils because liraglutide is known to form extensive localized amyloid deposition after repeated injections, taught by Martins. The reference’s LC-MS analysis confirmed the diagnosis of amyloidosis was the result of subcutaneously injected liraglutide. The reference further teaches diabetes patients with liraglutide amyloid can be misdiagnose because liraglutide-induced amyloidosis and systemic immunoglobulin-derived light chain amyloidosis have overlap symptoms, both causing renal disease and peripheral neuropathy and clinical/laboratory state of the art are not sufficient to establish the nature of amyloid deposition [both pages of case report]. Hence, a skilled artisan would have been motivated with reasonable expectation of success to obtain binders capable of selectively detect liraglutide amyloid for accurate diagnostic of the diseases. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 — 97 (2007) (MPEP § 2143).
Munke et al. and Lee et al.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Munke et al. (Proc Natl Acad Sci U S A. 2017;114(25):6444-6449) in view of Lee et al. (J. Biol. Chem. 291.6 (2016): 2858-2873.)
Regarding claims 17, Munke discloses phage display instead of yeast display as claimed.
Lee discloses a method for selecting antibody candidates that show significant preference for recognizing Aβ fibrils relative to Aβ monomers using yeast surface display method.[experimental and results section, especially table 1])
As of the application’ s effective filing date, it would have been prima facie obvious to a person of ordinary skill in the art to substitute Lee’s yeast display in place of phage display used by Munke because both references directed to identifying antibody/antibody fragments having conformational specificity for amyloid aggregate/fibril. Munke teaches the claimed screening strategy including negative screens of an antibody library against a monomeric form followed by positive screens of the antibody library against aggregate forms using phage display. Lee teaches both yeast and phage are known in the art as powerful approaches that has proven useful for in vitro display because both yeast and phage display systems enable more control over antigen presentation and have been used primarily to identify antibody fragments (rather than full length antibodies) specific for oligomers and fibrils of several amyloid-forming polypeptides [Lee’s Introduction]. Lee further demonstrates yeast surface display of engineered anti-amyloid VH domains. Accordingly, a person of ordinary skill in the art would have been motivated to substitute yeast display for phage display because Lee teaches both as recognized in vitro display methods for generating amyloid specific antibody binders. The substitution represents use of a known alternative display format to perform Munke’s same monomer-depletion and fibril-enrichment strategy. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 — 97 (2007) (MPEP § 2143, B).
Conclusion
No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Khai Quynh Tien Pham whose telephone number is (571)272-6998. The examiner can normally be reached M-T, 9-4 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached at (571) 272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KHAI QUYNH TIEN PHAM/ Examiner, Art Unit 1684
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684
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