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 .
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 5 and 9 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.
The term substantially in claim 5 (“…substantially round…”) and claim 9 (“…substantially square or rectangular…”) is a relative term which renders the claims indefinite. The term is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 16 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.
The term prolonged (“…prolonged period of time…”) is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 6-8 are also 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.
The claims all depend, or ultimately depend, from an indefinite claim yet do no relieve the indefiniteness. Dependent claims 6-8 are also, therefore, indefinite.
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.
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 nonobviousness.
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.
Claims 1-14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Clinical Diabetes/Therapeutics (2018), 2279, Vol. 67, issue supplement 1, cited in the IDS, and further in view of Drug Delivery (2017), 24(1), pp. 1513-1525.
Inventor teaches a glucose-sensitive insulin-loaded microparticle comprising (a) a pH-sensitive, biocompatible, biodegradable polymeric porous matrix, (b) encapsulated insulin granules within this matrix, and (c) a blood glucose sensor attached to a surface of the microparticle (claim 1). Dependent claim 2 teaches that the polymer is PLGA, PEG, hyaluronic acid, etc. Dependent claim 3 teaches that the sensor is attached to an outer surface of the matrix. Dependent claim 4 teaches that the sensor is glucose oxidase or phenylboronic acid. Dependent claim 5 teaches that the microparticle is a microplate having a polygonal or substantially round base. Dependent claims 6-8 teach the dimensions of the microplate. Dependent claim 9 teaches that the microplate has a substantially square or rectangular base. Dependent claim 10 teaches that the encapsulated insulin granules have a diameter of from 100-500 nm. Dependent claim 11 teaches that the encapsulated insulin granules have a diameter of from 100-200 nm. Dependent claim 12 teaches a sustained drug delivery system comprising a plurality of the insulin-loaded microparticles. Dependent claim 13 teaches a method of controlling glucose levels in a diabetic subject comprising releasing insulin from the drug delivery system. Dependent clam 14 teaches that the diabetes is Type 1 or Type 2. Dependent claim 16 teaches that the drug delivery system releases insulin over a prolonged period.
Clinical Diabetes/Therapeutics (2018), 2279, Vol. 67, issue supplement 1, teaches a drug delivery system for the treatment of diabetes by the controlled release of insulin from PLGA microparticles. Insulin granules are incapsulated within the porous matrix of PLGA to yield 20x5 µm square insulin-loaded PLGA microparticles. The encapsulated insulin granules are spherical nanoparticles having a diameter of 209.9±15.8 nm. Significantly, the reference does not teach a blood glucose sensor attached to a surface of the microparticle.
Drug Delivery (2017), 24(1), pp. 1513-1525 teaches insulin-loaded porous PLGA microparticles with a glucose sensor attached to the surface to provide glucose-responsive insulin release for the treatment of diabetes (abstract; page 1516, column 2, Preparation of p(AAPBA-co-NVCL and porous PLGA microspheres). The glucose sensor is novel boronic acid-containing copolymer (abstract).
It would have been obvious to one of ordinary skill, before the effective filing date of the instant invention, to attach the glucose sensor of the insulin-loaded PLGA microparticle of Drug Delivery (2017), 24(1), pp. 1513-1525 on the insulin-loaded PLGA microparticle of Clinical Diabetes/Therapeutics (2018), 2279, Vol. 67, issue supplement 1. One of ordinary skill, a highly skilled individual, would have been motivated to do so, and with a reasonable expectation of success (since the particles of both references are insulin-loaded PLGA microparticles), in order to take advantage of the thus provided glucose-responsive release of the insulin in the treatment of diabetes.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 12/17/2025