CTNF 18/029,470 CTNF 79380 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. Election/Restrictions 08-25-02 Applicant’s election of Group I in the reply filed on 2/23/26 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 § 818.01(a)). Likewise, applicant’s election of the species having the formula: PNG media_image1.png 272 378 media_image1.png Greyscale is acknowledged. This species is seen to be free of the art, as are all of the compounds of claim 24. As such, the search and examination has been expanded as noted below to compounds reading on claims 1, 5, 8, 14, 17-18, and 22-23. Applicants noted that claims 1-6, 8-12, 14, 17-18, 22-24, 55-58, 60, and 71 read on their elected species. As such, claims 25-27, 29-33, 35, 37-39, 41, 44-45, 49-53, and 61-62 are withdrawn as being drawn to a non-elected invention. Claim Objections 07-29-01 AIA Claim 10 is objected to because of the following informalities: there should be an “or” after the semicolon in line 2 . Appropriate correction is required. Claims 1-6, 8-12, 14, 17-18, 22-24, 55-58, 60, and 71 are objected to for containing non-elected subject matter. This objection will be overcome as the claims are further searched and examined upon allowable subject matter being determined. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claims 1-6, 8-12, 14, 17-18, 22-23, 55-58, 60, and 71 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 is indefinite wherein the claim is drawn to a compound having a coupler domain (called C1); a hydrophobic or cationic charge domain (called HD2); a hydrophilic domain (called HD1); and a biodegradable linker (called L1). L1 is linked to HD1 on one end and either HD2 or an optional 1 st linker (called L3) on the other end. This optional linker L3 is linked to C1 on one end and either HD2 or an optional second linker on the other end. As such, if the L1 is linked to HD1 and HD2, it is unclear where the C1 is located. Is the 1 st optional linker required to be present as this is linked to the C1 group, or is the C1 group linked anywhere on the HD1-C1-HD2 compound if the optional linkers are not present? Claim 70 is rejected for the same reason. In applicant’s election of the compound PNG media_image1.png 272 378 media_image1.png Greyscale , applicants stated that this would read on formula I of claim 2 wherein various groups are defined such as HD2 is an indole and L1 is a carbamate. However, HD2 in formula I is linked to L1, not combined with L1, per se. As applicants are stating, if L1 is a carbamate, a carbamate has an -OC(O)N- group such as PNG media_image2.png 177 241 media_image2.png Greyscale , and HD2 is an indole having the structure such as: PNG media_image3.png 54 76 media_image3.png Greyscale , this HD2-L1 group would have a separate N-containing ring and thus the N of the carbamate would then be linked to an indole ring such as a compound like this: PNG media_image4.png 98 174 media_image4.png Greyscale , wherein the N-atom of the carbamate would not be in the indole ring. As such, it is unclear what is embraced by the claims and a skilled artisan would not know the metes and bounds of the claims. Likewise, in applicant’s election L4 is defeined as alkyl – however this portion of the compound is seen to be: PNG media_image5.png 86 116 media_image5.png Greyscale and a skilled artisan would likely not read this as being an alkyl group. Additionally, applicants stated that C1 is phosphoramidite and that which is linked to R 2 in formula I. R 2 is identified by applicants as N,N diisopropylphosphoramidite in their elected compound. It is uncelar how both C1 and R2 can be the same phosphoramidite group if they are depicted as being linked together, as there is only one phosphoramidite group present in the elected compound. If C1 is linked to R 2 , they can be the same singular group on the compound. Claim 23 recites the limitation "the functional or protecting groups for solid state synthesis" in the 2 nd line. There is insufficient antecedent basis for this limitation in the claim as claim 1 does not provide support for and protecting groups. All claims which depend from an indefinite claim are also indefinite. Ex parte Cordova, 10 U.S.P.Q. 2d 1949, 1952 (P.T.O. Bd. App. 1989). Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 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, 5, 8, 14, 17-18, and 22-23 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by WO19/112965 . ‘965 discloses compounds wherein a hydrophilic moiety M is bound to a cleavable linker Z which is bound to a hydrophobic group A and comprises a coupler group T attached to a linked biomolecule or cell delivery agent Y (see page 23, formula (M-Z-A-T)-Y. The compounds are taught to be endosomal disruptor compounds and are further limited to formula II-VII. The hydrophilic group M (defined in [0125]) is linked to a cleavable linker Z such as an acetal or disulfide group (see [0126]) which is linked to the hydrophobic group A. ‘965 also discloses the endosomal disruptors are associated (covalently or non-covalently) with a macromolecule such as polypeptides or polynucleotides for use in methods of delivering he macromolecules to the cytoplasm of the cell (see claims 18-20, paragraphs [0194]-[0203] and [0320]-[0325]) . Allowable Subject Matter 12-151-08 AIA 07-43 12-51-08 Claim 24 is 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. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRAVISS C MCINTOSH III whose telephone number is (571)272-0657. The examiner can normally be reached Monday-Friday 9AM-5:30PM EST. 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, Scarlett Goon can be reached at 571-270-5241. 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. /TRAVISS C MCINTOSH III/Primary Examiner, Art Unit 1693 Application/Control Number: 18/029,470 Page 2 Art Unit: 1693 Application/Control Number: 18/029,470 Page 3 Art Unit: 1693 Application/Control Number: 18/029,470 Page 4 Art Unit: 1693 Application/Control Number: 18/029,470 Page 5 Art Unit: 1693 Application/Control Number: 18/029,470 Page 6 Art Unit: 1693 Application/Control Number: 18/029,470 Page 7 Art Unit: 1693
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