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 .
Response to Amendment
The amendment filed 11/12/2025 has been entered.
Any previous rejection not reiterated herein has been withdrawn.
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.
Claim(s) 1, 4, 6-7, 10-13, 15-17, 19-21, 27, 42, 44 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell WO 2011/112597 in view of Smyth-Templeton US 7001614 B2.
Regarding claims 1, 27 and 45 Campbell discloses liposomes comprising lipid mixtures including DOTAP and cholesterol see claims 12 and 13 and [0050], [0055], and RNA, see at least claim 41 and page 10, wherein the core contains iron oxide particles, which include PIONs, claims 48 and 75 and [0072 and 0138]. The iron oxide nanoparticles are in the size range of 30-250 nm, which clearly overlaps with the claimed range, see at least 0009 and claim 10. The liposome compositions are formulated for in vivo use, see at least abstract and examples.
Regarding claims 4, 6-7, 10, 13, 15-17, 19, 20 Campbell teaches that parameters concerning concentration, etc. should be optimized [0045] and teaches a wide range of overlapping ranges of lipids, imaging/therapeutic agents, etc. see pages 8-11. Doses or RNA are taught see [0076].
Regarding claim 11, the liposomes have a size range of 262.67-156 nm which is directly within the scope of claim 11.
Regarding claim 12, the liposomes may have a net surface charge including 43.79 mV which is directly within the scope of instant claim 12 and [0089-0090].
Regarding claim 21, the liposomes comprise siRNA which is an antisense molecule see at least [0012] and page 10 and claim 42.
Regarding claims 42 and 44, cells comprising liposome are taught, see at least [0021] and [0022].
Campbell fails to exemplify liposomes having all the same exact size ranges, weight percents, lipid ratios, etc.; however, such are known parameters to be optimized as taught by Campbell. Campbell does not specifically disclose the 3:1 ratio of DOTAP:cholesterol set forth in claim 10.
Smyth-Templeton discloses liposomes formulated for drug delivery including nucleic acids, including RNA (e.g., col. 5) and teaches, DOTAP to cholesterol in the range of 3:1 see column 7, as well as optimizing molar ratios, concentrations of lipids (col. 3) amounts of nucleic acid, etc. (col. 4).
It 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 to prepare the liposome compositions as instantly claimed because Campbell discloses and claims liposomes which may have the same components in overlapping ranges with the instant claims and teaches that the amounts, ratios etc. can be optimized to achieve the desired result, such as, dose of RNA delivered, functionality of the liposome in vivo, etc. Further, Smyth-Templeton teaches liposomes having the same ratio of 3:1 DOTAP/Cholesterol as well as optimizing the amount/concentration of lipids, nucleic acid (e.g., RNA) in the same filed of endeavor of therapeutic liposomes for nucleic acid delivery.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
No claims are allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael G Hartley whose telephone number is (571)272-0616. The examiner can normally be reached 10-6:30.
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, Jennifer Michener can be reached at 5712721424. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618