CTFR 18/011,071 CTFR 79041 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. Acknowledgment of Papers Received: Amendment/Response dated 2/11/26. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim (s) 1-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Cedrowska et al (Functionalized TiO 2 nanoparticle labelled with 225 Ac for targeted alpha radionuclide therapy, J Nanopart Res (2018) 20: 83 hereafter Cedrowska) in view of Sgouros et al (WO 01/97859 A1 hereafter Sgouros) and Bilodeau et al (CA 2 896 571 hereafter Bilodeau) . Cedrowska discloses a method of inhibiting cancer cell growth contacting cancer wells with a nanoparticle comprising an anticancer agent where the anticancer is an alpha particle emitting radiopharmaceutical agent [abstract]. The anticancer agent is 225 Ac [pg. 3]. The surface of the nanoparticle comprises cationic polymers [pg. 5]. The nanoparticles, comprising the 225Ac are contacted with cancer cells and shown to be toxic against those cells after incubation [pg. 7]. While the reference discloses the use of radiopharmaceutical agents for the treatment of cancer, the reference is silent the additional use of chemotherapy agents for cancer treatment in addition to the radio metals. Such combinations are disclosed in the prior art as seen in the Sgouros patent. Sgouros discloses a method for treating cancer comprising Actinium-225 encapsulated into nanoparticles [abstract, pg. 6]. The nanoparticles is coated with an antibody conjugated to the surface and a polyethylene glycol coating [pg. 6, 9]. The method is useful in treating breast cancer [pg. 8, 9]. It would have been obvious to combine the radiotherapeutic agent into the method of Cedrowska as they solve the same problem. The combination discloses a method for directly treating cancer by contacting tumors with a 1st and 2nd compounds comprising a nanoparticle, anticancer agent and an antibody conjugated to the nanoparticle. The combination is however silent to the specific coating comprising the cationic polymers of the instant claims. PEG and cationic polymers are known in the art as seen in Cedrowska, and the specific combination of the instant claims is well known as seen in the Bilodeau patent. Bilodeau discloses a method for treating cancer comprising the delivery of targeted nanoparticles to tumors in the body [abstract]. The nanoparticles comprise a drug core and an antibody conjugated to the surface of the nanoparticle where the surface further comprises a coating comprising PEG conjugated to cationic polymers such as dimethyl ammonium propane [pg. 48, 5-10; pg. 52, lin. 15- 25]. The nanoparticles comprise chemotherapeutic agents like paclitaxel [pg. 29, lin. 20-35; pg. 33, lin. 20-30]. The antibody conjugated to the nanoparticle surface include VEGF [pg. 43, lin. 1-5]. The nanoparticles are used in a method for treating various cancers including pancreatic cancers [pg. 8, lin. 1-5]. It would have been obvious to include the conjugated polymer to the nanoparticle of the combination as they solve the same problem. With these aspects in mind it would have been obvious to combine the prior art with an expected result of a stable means of directly treating cancerous tumors. It would have been obvious to include the radiotherapy agent of Sgouros into the method of Cedrowska in order to track the uptake of the nanoparticle in the tumor. It would have been obvious to combine the specific coating of Bilodeau into the method of Cedrowska as it suggests the inclusion of cationic polymers and they solve the same problems. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a stable means of directly treating tumors . Response to Arguments 07-38-02 AIA Applicant’s arguments, see Amendments , filed 2/11/26 , with respect to the rejection(s) of claim(s) 1-21 under 35 USC 103(a) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the above recited rejection . Conclusion 07-40 AIA Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL . See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm. 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, Michael Hartley can be reached at 5712720616. 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. /MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618 Application/Control Number: 18/011,071 Page 2 Art Unit: 1618 Application/Control Number: 18/011,071 Page 3 Art Unit: 1618 Application/Control Number: 18/011,071 Page 4 Art Unit: 1618 Application/Control Number: 18/011,071 Page 5 Art Unit: 1618
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