DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to filed provisions of the AIA .
2. Claims 34, 36, 38 and 98-118 are pending upon entry of amendment filed on 4/29/26.
IN light of Applicant’s amendment to the claims filed on 4/29/26, the restriction requirement mailed on 12/31/25 has been withdrawn.
Claim 34, 36, 38 and 98-118 are under consideration in the instant application.
3. Applicant’s IDS filed on 10/26/23 and 4/29/26 have been acknowledged.
4. The oath filed on 4/13/23 has been acknowledged.
5. 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.
6. Claims 102 and 113 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 pre-AIA the applicant regards as the invention.
The use of the term “optionally” in claims 102 and 113 renders the claim indefinite because it is unclear whether the limitations following such terms or phrases are part of the claimed invention. See MPEP 2173.05 (h).
7. 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 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.
8 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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
9. Claims 34, 36, 38 and 98-118 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pat. 8,906,367 (IDS reference) in view of U.S. 2002/0002136 (IDS reference), U.S. 2005/0276823 (IDS reference) and U.S. 2013/0344088 (IDS reference).
The ‘367 patent teaches methods of treating Alzheimer’s diseases comprising administering pharmaceutical compositions comprising Aβ antibodies set forth in the SEQ ID NO:7-10 (see SEQ ID NO 39, 41, Tables 2-3, col. 65-67, col. 19-24) in pharmaceutically acceptable carriers including buffer, polysorbate and/or antioxidants.
Given that the prior art SEQ ID NO:39 and 41 are full length heavy and light chain antibodies and encompass the claimed SEQ ID NO:1-10 as well as the CDR’s set forth in the claimed SEQ ID NO:1-6 and the variable heavy and light chains set forth in the SEQ ID NO:7-8. It meets the limitations of claims with the SEQ ID NO:1-10.
The disclosure of the ‘367 patent differs from the instant claimed invention in that it does not teach the use of arginine as in claim 1, GSSH as in claim 39, methionine/polysorbate 80 and or sucrose upto 3% as in claims 34, 35 and 98-118 of the instant application, respectively.
The ‘136 publication teaches GSSH as well as cysteine is a strong reducing agent and protects cells from oxidation ([0012]) and the nervous system is vulnerable to GSH depletion ([0015]).
Glutathione works as a carrier for nitric oxide and increase in the blood level is beneficial for treatment or prevention of Parkinson’s or Alzheimer Disease ([0023]). It also improves stability of proteinaceous biomolecules ([0009]).
The ‘823 publication teaches addition of histidine buffer with methionine upto 200mM, mannitol upto 200mM, 0.001-0.01% polysobate 80 at pH, upto 200mM of methionine (Table 5, Examples) with any proteins or antibodies (claims 1-33) upto 500mg/ml.
Such compositions stabilize proteins of interest by reducing degradation of proteins caused by oxidation.
Further, the ‘088 publication teaches addition of sucrose/trehalose/mannitol between 80-300mM, arginine-HCl upto 200mM, 20mM histidine, acetate, or succinate for about 165mg/ml of antibody at pH 5.5-6.5 (claims 1-33). These excipients in antibody formulation extends stability without forming aggregates.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize various excipients including GSSH, arginine, sucrose, polysorbate and/or methionine as taught by the ‘136, 823 and 088 publications into the Aβ antibody compositions taught by the ‘367 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of excipients including GSSH, arginine, sucrose, polysorbate and/or methionine helps to improve stability as well as therapeutic efficacy. Given that the addition of specific concentrations of histidine and methionine generally work for any antibody as disclosed by the ‘823 publication and there are reasonable expectation of success in combining these excipients for Aβ antibody compositions. The ‘367 patent allows addition of pharmaceutically acceptable excipients for Aβ antibody compositions. Note the optimization of ranges within the prior art condition is routine experimentations and claims reciting specific excipients are included in this rejection.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
10. No claims are allowable.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
June 17, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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