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 .
DETAILED ACTION
Election/Restrictions
The applicant has elected Group IA (claims 1-3 and 5) without indicating traverse, and no argument has been submitted. Applicant’s election in the reply 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 § 818.03(a)).
This restriction is made FINAL. See previous action for the reasons of applying restriction.
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.
Claim(s) 1-3 and 5 (is)are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding X of claim 1, the phrase " an alternative terminating atom" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. Claims 2-3 and 5 depend upon claim 1 and fail to rectify the issue in claim 1. See MPEP § 2173.05(d).
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 of this title, 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) 1-3 and 5 is (are) rejected under 35 U.S.C. 103(a) as being unpatentable over Sung et al. (Biol. Pham. Bull. 26(4) 492-500 (2203) listed on IDS) in view of Wang et al. (CN 104419004 A) and evidenced by Char et al. (KR 20100131391 A).
As to claims, Sung (abs., Table 1, Fig. 2-5, Experimental) discloses a polyethylene glycol grafted conjugate of a branched polyethyleneimine (25kDa) for gene delivery systems by forming complexes with DNA that decreases in the transfection activity of the DNA complexes:
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118
303
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338
452
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270
1043
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499
496
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Sung is silent on the claimed linear polyethyleneimine that yields the claimed formulae III and IIIa.
Solving the same problem and in the same area of endeavor of modifying polyethyleneimine as a transfection reagent for gene delivery systems, Wang discloses (abs., claims, examples, 1-3, 25, 34, 28, 45, 78-83) linear and branched polyethyleneimines are functionally equivalent polyethyleneimines having better transfection effect and low immunogenic properties. Linear polyethyleneimine having 25KDa is known to one of ordinary skill in the art, as evidenced by Char (Ex.3-4). Linear polyethyleneimine having methyl and hydroxyl terminals (CAS 9002-98-6) is known to one of ordinary skill in the art:
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161
332
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85
365
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.
Therefore, 1-3 and 5, it would have been obvious to one of ordinary skill in the art to have replaced Sung’s branched polyethyleneimine with Wang’s linear polyethyleneimine because of their equivalent functionality as transfection reagents for gene delivery systems with better transfection effect and low immunogenic properties. These conditions appear to equally apply to both productions using similar polyethyleneimines. This adaptation would have obviously yielded instantly claimed formulae III and IIIa of instant claims 1-2 and the claimed units and substitution percentage of polyethyleneimine and polyethylene glycol of instant claims 3 and 5 (See Sung’s tables), because Sung, Wang, and Char obviously satisfy all of the material and chemical limitations of the instant invention-see MPEP 2112.01. The claimed terminals of formulae III and IIIa are also met in view of the above 112b rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANE FANG whose telephone number is (571)270-7378. The examiner can normally be reached on Mon-Thurs. 8am-6pm. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Randy Gulakowski can be reached on 571.572.1302. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHANE FANG/Primary Examiner, Art Unit 1766
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