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 .
Applicants' arguments, filed 05/26/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mahato et al (WO 022174 A1).
Mahato et al discloses lipopolymer complexes of positively charged cationic lipids with negatively charged nucleic acids and other bioactive agents with a charge ratio of 5/1 to 1/1, which can also include cholesterol (pg 6 lines 5-15). The particle sizes will range from about 80 to about 200 nm, depending on the components (pg 14, lines 8-10). The ideal ratio of anion to cation appears to be having average molecular weights of 1:1 to 1:20 (pg 4 lines 24-31).
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 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 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Mahato et al (WO 022174 A1).
Mahato et al is discussed above and appears to be anticipatory. But in the event that the weight ratio does not directly apply from PEI to cholesterol, it would have been obvious to the skilled artisan to follow the charge ratio, which will result in overlapping weights of actives, depending on the specific active selected. A prima facie case of obviousness can be established when the claimed ranges overlap or lie inside the ranges made obvious by the prior art. See MPEP 2144.05.
Allowable Subject Matter
Claims 1-4, 6, 7 and 10-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As Applicants point out in their response, the prior art references that discuss fungicides and pesticides with complexes are directed to complexes of polyallylamine or chitosan do not directly complex to negatively charged fungicide or pesticides. But as claim 1 is directed to bioactive agents generally, the rejections above apply to the broader scope of the composition claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri 9:30am-6:30pm + mid-day flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612
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