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 .
Information Disclosure Statement
The submitted information disclosure statement (IDS) were filed on 02/05/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Restriction
Applicants' election without traverse of Group I (claims 1-8) in the reply filed on 06/17/2026 is acknowledged. The requirement is therefore made FINAL. For examining purpose, Claims 1-8 of Group I are examined in this office action.
Claim Objections
Claim 1 is objected to because of the following informalities: “an area under curve (AUC)”. It should be an area under a curve (AUC). Appropriate correction is required.
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.
Claim 4 is 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.
Claim 4 is indefinite because it recites: “…those with a theoretical drug loading amount of 32% to 40% and those with a theoretical drug loading amount of 28 to 32%”, by which the two microspheres have the same drug concentrations at 32%, contradicting their claims of different drug loading amounts. For examining purposes, examiner will assume that claim 4: “…those with a theoretical drug loading amount of 32% to 40% and those with a theoretical drug loading amount of 28 to less than 32%”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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) 1-3, 5 and 7, is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lee et al. (US 20240358694Al).
Claims 1-2,
Lee et al. teach a sustained-release injectable preparation comprising biodegradable polymer microspheres containing donepezil as an active ingredient, and a method for producing the same, and a sustained-release preparation of donepezil sustained-release microspheres having a high content of donepezil and a method for producing the same. It is possible to maximize the therapeutic effect by decreasing gastrointestinal side effects frequently encountered in conventional oral administration agents and increasing patients' compliance of medicines. (Abs).
A Formulation Prepared by Mixing Two Kinds of Microsphere Suspensions and Hardening the Same. (Example 7) and two different drug loading amounts: 0.38g Donezepil/1.13 g Resomer R202H, ratio 0.34 versus 1.05 g Donezepil/2.45 g Resomer R205S, ratio 0.43. (0080).
% release
Days
min
max
0
0
0
1
0
8
14
5
65
21
20
75
56
80
100
In one specific embodiment, when the sustained release microparticles are administered to the muscle of the SD rat, the donepezil in the microsphere release may be 0% to 8% in 24 hours, 20% to 75% in 21 days, 80% to 100% in 56 days, and the donepezil release in any two weeks from administration to 56 days after administration is 5% to 65%, preferably 5% to 60%. (0080).[Chart]
28 days is the first half of a dosing 56 days cycle, that has the average % release in between the max % release and the min % release in the graph above, which are in the range of 30-80%. This range cover the range of 40-60% of Donezepil release.
With regard to claim 3,
Lee et al. teach, the dosing cycle overlapping the dosing cycle 10-28days, (0080).
With regard to claim 5,
Lee et al. teach Donezepil loading 25% and 30%, which are below 32%, (0080).
With regard to claim 7,
Lee et al. teach the drug is Donezepil and
RESOMER® R 202H is an acid-terminated, bioabsorbable poly(D,L-lactide)
RESOMER® R 205S is a solvent-purified, ester-terminated poly(D,L-lactide) (PDLLA), (0080).
Claim Rejections - 35 USC § 102/§ 103
Claim Rejections - 35 USC § 102
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 Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claim(s) 1 and 4, 6 and 8 is/are rejected under 35 U.S.C. 103 as being obvious over Lee et al. (US 20240358694Al).
The teachings of Lee et al. are described in claim 1 above.
Lee et al. do not teach exact the Donezepil loading range 1. 28-32% and 2. to 32-40%.
Claims 4, 6 and 8,
Lee et al. teach the drug loading of series 1, 25%, which is close to the range 28-32% and 2, 30%, which is close to 32-40%.
a weight ratio of microspheres with a theoretical drug loading amount of 32% to 40% to microspheres with a theoretical drug loading amount of 28% to 32%, (0080).
Donezepil
polymer
DCM
Ratio
Loading
Weight ratio
g
g
g
drug/polymer
%
Microsphere
0.38
R202H
1.13
2.8
0.34
25.17
2.32
1.05
R205S
2.45
12.25
0.43
30.00
(1.05+2.45)/(0.38+1.13)=2.32
And based on the loading percentages of 25 and 30%, which mean 100 mg of microspheres have 25 to 30mg of Donezepil, which are obviously close to 25-32 mg per 100 mg microspheres.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NGOC-ANH THI NGUYEN whose telephone number is (571)270-0867. The examiner can normally be reached Monday - Friday 8:00 am.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NGOC-ANH THI NGUYEN/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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