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 .
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.
Current Status of 18/247,943
This Office Action is responsive to the amended claims of 11 May 2026.
Claims 1-3 and 5-30 have been examined on the merits. Claims 1-3 and 5-29 are currently amended. Claim 30 is new.
Priority
The effective filing date is 27 October 2020.
Response to Arguments
The Examiner acknowledges receipt of and has reviewed Applicants’ claim amendments and Reply of 11 May 2026.
Applicants revised the dependent claims into proper form hence rendering moot the claim objections of record.
Applicants’ claim 1 amendments render moot the 35 USC 102 rejection of record.
Examiner has decided to withdraw both obviousness rejections in light of the following persuasive points from Applicants’ 11 May 2026 traversals:
In AMATERASU, the synergy of using combination of non-ionic surfactant and gel strength enhancer in gel formation is established.
In AMATERASU, the Examples show that neither PLGA nor PLA were considered result-effective variables because they were not recognized as achieving any recognized result.
Only Example 4 in AMATERASU is directed to donepezil injectable compositions. Example 4 does not disclose or suggest an injectable composition comprising donepezil and other release retarding agents, including PLGA and PLA, or combinations thereof.
AMATERASU fails to teach or suggest any composition that includes PLGA with a molar ratio of 65-85% lactic acid to 35-15% glycolic acid.
The claimed compositions can surprisingly achieve extended, controlled release of donepezil, even in absence of ingredients, such as surfactant and gel strength enhancer, which was previously believed to be important for controlling release of an active ingredient over time.
As shown in the Specification’s Examples 2.8-2.10, 3.6-3.8, and 4.1-4.12, tested liquid injectable compositions comprising PLGA, PLA, or combination thereof achieve extended, controlled release of donepezil over a period of at least 30 days during the in-vitro release testing as shown in Figures 1-5.
New Objections
Claim Objections
Claim 19 is objected to for the word “comprising” immediately preceding “selected from poly(lactic-co-glycolic acid)” (see line 2 of claim 19). This is objected to because it does not make sense: “comprising selected from…”. Please delete “comprising”. Note: if the claim is amended to “selected from the group comprising” then it will be rejected as indefinite because Markush limitations cannot be “open-ended”. See MPEP 2173.05(h).
New Rejection
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 22 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 22 recites the limitation "the liquid injectable composition" in penultimate line. There is insufficient antecedent basis for this limitation in the claim.
As drafted, “the liquid injectable composition” renders the metes and bounds of claim 22 undefined (hence rendering claim 22 indefinite under 35 USC 112(b)). The artisan does not know where antecedent basis is first found for the limitation “the liquid injectable composition” within independent claim 22.
Conclusion
Claim 19 is objected to for awkward wording (see “Claim Objections”, above).
Claim 22 is not presently allowable as written.
Claims 1-3, 5-18, 20-21, and 23-30 are presently allowable as written.
There is no known prior art reference that either teaches or anticipates the instant claims 1, 12, 19-23, and 30.
The references AMATERASU, ANSEL, BERGE; and ZADBUKE used to be considered obviousness prior art references.
However, given Applicants’ claim amendments and persuasive traversal, these references are no longer considered prior art. The Examiner notes Applicants’ persuasive traversal of 11 May 2026 indicating surprising and unexpected results, per, above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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, Andrew D Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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