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 .
Receipt is acknowledged of Applicant’s Restriction Response and Amendment filed on 01/09/2026; and IDS filed on 08/26/2025.
Claims 20-22 have been added.
Claims 19, 21-22 are drawn to non-elected species
Claims 1-22 are pending in the instant application.
Claims 19, 21-22 are withdrawn from further consideration.
Election/Restrictions
Applicant’s election of “wherein the levodopa lag time is 3 to 7 hours after the oral administration and the DOPA decarboxylase inhibitor lag time is 3 to 6 hours” (claim 15) and “morning akinesia” (claim 18) in the reply filed on 01/09/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Note, claims 19, 21-22 are drawn to non-elected species.
Claim Rejections - 35 USC § 112, 2nd paragraph
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 1-18, 20 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.
Claim 1 recites “wherein the pharmaceutical composition does not include an amount of controlled release levodopa”; however, claim 1 recites “released from the pharmaceutical composition in one pulsatile release, after a levodopa lag time of at least 3 hours after the oral administration” which is controlling the release of the drug. Especially, when Applicant states at [0032]) that the release is “well controlled”.
Claim 1 further recites “wherein the pharmaceutical composition does not include an amount of immediate-release levodopa”; however, claim 1 recites “pulsatile release”, wherein a pulsatile release can only be done by an immediate release.
Dependent claims 2-18 and 20 do not rectify these issues.
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.
Claim(s) 1-17, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NANGIA US 2010/0316712).
Regarding claim 1, NANGIA teaches a method of treating Parkinson's disease (see title), such as symptoms of movement disorder (see [00291), such as tremors (see [0385]) and akinesia (see [0445]), which reads on motor symptom, comprised of: oral administration (see [0089]) one PM dose before sleeping (see [0318]) a carbidopa and levodopa in delayed formulation (see [0318]), wherein the delayed release coating coated is delayed by a predetermined period of time, such as 4 hours, 6 hours, or more (see [0015]) and the delayed release coating is coated onto an immediate release (IR) portion (see [0112]), which reads on “the amount of levodopa sufficient for treating the motor symptom is released from the pharmaceutical composition in one pulsatile release, after a levodopa lag time of at least 3 hours after the oral administration; the amount of the DOPA decarboxylase inhibitor is released from the pharmaceutical composition in one pulsatile release after a DOPA decarboxylase inhibitor lag time of at least 3 hours after the oral administration, wherein the pharmaceutical composition does not include an amount of controlled release levodopa and wherein the pharmaceutical composition does not include an amount of immediate-release levodopa”.
NANGIA’s immediate release portion would result in a pulsatile release after the delayed release (see Applicant’s specification at [0026]) at “A) standard immediate release”; and Fig 1). Note, Applicant’s invention is simply a delayed-releasing coating over an immediate-release dosage (see Applicant’s specification at [014] and [0043]).
NANGIA further teaches “another aspect of the invention provides a therapeutic composition as described above, except that the dosage form is coated by a layer of delayed-release coating, such that the first IR portion will not start to be released until after a pre-determined period of time, such as the normal 6-10 hours of sleep time. According to this embodiment, a dose taken by the patient at night, for example, just before sleep, would start to be released and thus become effective just before or around the time the patient wakes up in the morning. This would allow the patient to have an effective plasma concentration of levodopa or precursor thereof upon waking in the morning, and the patient can immediately participate in normal daily activities without delay (see [0112]). An additional advantage of the subject formulation relates to tolerance. Specifically, with enteral infusion, patients generally develop tolerance after prolonged period of treatment. However, the subject formulation has the added benefit of having a "break" during the night, so tolerance is generally not developed (see [0113]).
Regarding claim 2-3, NANGIA teaches levodopa can be 150 mg (see [0331]).
Regarding claims 4-5, NANGIA teaches decarboxylase enzyme inhibitor can be 50 mg (see [0196]).
Regarding claims 6-7, NANGIA teaches carbidopa (see abstract).
Regarding claim 8-9, NANGIA teaches a dose taken by the patient at night, for example, just before sleep, which reads on 0 to 1 hours prior to bedtime.
Regarding claims 10-12, as discussed above, NANGIA teaches the delayed release coating coated is delayed by a predetermined period of time, such as 4 hours, 6 hours, which reads on a lag time of about 4 hours or 6 hours.
Regarding claim 12-13, NANGIA’s immediate release portion would result in a pulsatile release with the release profile of 100% released within 2 hours (see Applicant’s specification at [0026]) at “A) standard immediate release”; and Fig 1), unless proven otherwise.
Regarding claims 14-16, NANGIA teaches carbidopa may be released before levodopa thereby more effectively inhibiting peripheral decarboxylase activity and maximizing the efficacy of the levodopa (see [0456]), which reads on the levodopa lag time is longer than the DOPA decarboxylase inhibitor lag time. As discussed above, NANGIA teaches the lag time can be 4 hours or 6 hours.
Regarding claim 17, NANGIA teaches Parkinson’s disease (see title).
Regarding claim 20, the limitation of “wherein the motor symptom returns when the levodopa plasma concentration decreases” does not appear to be an active step, but rather when inherent occurrence when the levodopa plasma concentration decreases, because of the body naturally eliminating the drug from the blood (if needed, see Applicant’s specification at [0004]).
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.
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.
Claim(s) 1-18, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over NANGIA US 2010/0316712) in view of NAVON et al (WO 2012/059815).
As discussed above, NANGIA teaches Applicant’ invention.
Regarding claim 18, NANGIA teaches treating Parkinson’s disease movement disorders, such as tremors (see [0385]) and akinesia (see [0445]).
NANGIA does not specifically teach treating morning akinesia.
NAVON teaches the prior art had known that Parkinson’s disease symptoms (see title), such as morning akinesia can be treated with levodopa give at bedtime (see claim 23-24).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate treating morning akinesia. The person of ordinary skill in the art would have been motivated to make those modifications, because it could treat another symptom of Parkinson’s disease, and reasonably would have expected success because both references teach treating Parkinson’s disease using levodopa at bedtime.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at (571) 272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAKE M VU/Primary Examiner, Art Unit 1618
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