CTNF 18/463,711 CTNF 85770 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Objections 07-29-01 AIA Claim 1 is objected to because of the following informalities: the last two lines have parenthesis around them, which could indicate that this is optional. Please remove the parenthesis . Appropriate correction is required. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15-aia AIA Claim(s) 1-3, 5-6 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Kataoka (US 2015/0051347) . Kataoka teaches an example of MeO-PEG-PLys(TEA): PNG media_image1.png 220 226 media_image1.png Greyscale where the polylysine has a polymerization degree of 40 (¶ 97-100). This meets claimed formula (II) PNG media_image2.png 170 574 media_image2.png Greyscale when R1 is a hydrogen atom, A is a hydrophilic polymer chain (PEG), L1b is a linking group, p is 4, L2 is a single bond, B is a C1 haloalkyl group (-CF3), x is 100% of z, y, w, z-x-y-w are 0, z is 40 and R2 is H . 07-15-aia AIA Claim(s) 1-2, 4-6 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Guillermain, Macromol. Chem. Phys. 2002, 203, 1346-1356 . Guillermain teaches homopolymers and copolymers of trifluoroacetyl-L-lysine (abstract) where polymerization is carried out with hexylamine (pg. 1348): PNG media_image3.png 120 552 media_image3.png Greyscale where R is a -C(O)-CF3 group (pg. 1354, Scheme 4). This meets claimed formula (II) when R1 is a hydrogen atom, A is a single bond, L1b is a linking group, p is 4, L2 is a single bond, B is a C1 haloalkyl group (-CF3), x is 100% of z, y, w, z-x-y-w are 0, and R2 is H. Guillermain teaches the molecular weight of the homopolymer includes 39253 (Table 1) which, as trifluoroacetyl lysine has a molecular weight of 242.2, corresponds to about 162 repeat units which meets the claimed range of z . Allowable Subject Matter 12-151-08 AIA 07-43 12-51-08 Claim s 7-9 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. Claim 7 recites a polymer-drug complex comprising a polymer according to claim 1 and a drug where the polymer and the drug form a complex. Claims 8-9 depend from claim 7 and contain the same allowable subject matter. Relevant prior art includes Kataoka (US 2015/0051347), Guillermain, Macromol. Chem. Phys. 2002, 203, 1346-1356, Thoma (US 6,677,164), and Xiong (US 2009/0232762). Kataoka teaches a block copolymer that includes a polyamino acid segment which acts as a carrier for a drug (abstract). Kataoka teaches a trifluoroacetyl polylysine block as described above. However, Kataoka teaches the trifluoroacetyl group is a protecting group which is removed after polymerization and before any drug interaction (¶87, 99). Thus, Kataoka fails to teach a polymer-drug complex with a halogen containing polymer. Guillermain teaches the trifluoroacetyl polylysine formed are used for liquid crystalline properties (pg. 1352) and fails to teach use with drugs or medicine. Thoma teaches reacting polylysine with chloroacetic acid (col. 22) which give monomeric units that meet the formula of claim 1. Thoma then teaches these halogen containing polypeptides are reacted with thiol containing reactants (col. 26-30) and that these products are used with drugs (col. 44). Xiong teaches trifluoroacetyl (TFA) groups on polylysine (¶ 171). Xiong teaches the TFApolylysine forms a coating on a polyplex particle (¶ 76) which is further deprotected by removal of the TFA group (¶ 131, 195). Thus, the fluorinated polylysine is not used with a drug or complexed with a drug. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT C BOYLE whose telephone number is (571)270-7347. The examiner can normally be reached Monday-Thursday, 10am-4pm. 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, Arrie (Lanee) Reuther can be reached at (571)270-7026. 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. /ROBERT C BOYLE/Primary Examiner, Art Unit 1764 Application/Control Number: 18/463,711 Page 2 Art Unit: 1764 Application/Control Number: 18/463,711 Page 3 Art Unit: 1764 Application/Control Number: 18/463,711 Page 4 Art Unit: 1764 Application/Control Number: 18/463,711 Page 5 Art Unit: 1764 Application/Control Number: 18/463,711 Page 6 Art Unit: 1764