DETAILED ACTION
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 .
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.
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.
Claims 18, 20, and 49 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 18 recites the broad recitation C1-C6 alkyl, and the claim also recites C1-C3 alkyl which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 20 recites the broad recitation C8-C20 alkyl, and the claim also recites C14-C18 alkyl, which is the narrower statement of the range/limitation. The examiner would like to point out that C8-C20 alkyl is actually recited twice in the claim.
Claim 49 refers to compounds of Table 1; however, a claim should be complete in and of itself if at all possible and should not refer to the specification to establish the metes and bounds of the claim.
Claim Rejections - 35 USC § 102
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 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 –
(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.
Claim(s) 1, 8, 17, 18, and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Benenato et al. (WO 2018/170306).
Benenato et al. disclose lipid compounds for the intracellular delivery of therapeutic agents. The compounds disclosed in paragraphs 00240, 00260, and 00350, anticipate the instant claims.
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, 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) 25-29, 31, 37, 38, 40, and 47-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benenato et al.
The instant claims are drawn to a composition comprising a compound of claim 1 and at least one additional lipid, wherein the additional lipid is a neutral lipid or a cationic/ionizable lipid, and to a method for delivering a bioactive agent to the spleen and/or lung tissue in a subject by admixing the bioactive agent with a composition of the present invention and administering the formed complex to a subject.
The reference does not expressly disclose an example wherein a compound of instant claim 1 is in a composition with another lipid as required by the instant claims. However, as stated in the rejection under 35 U.S.C. 102, the reference discloses compounds that anticipate the compounds in the rejected claims. The reference teaches that such compounds may be combined with other lipids, e.g., PEG lipids, phospholipids, etc., to be used in compositions for delivering a therapeutic and/or prophylactic to a mammalian cell or organ. The therapeutic agents include inter alia, proteins, polynucleotides, or nucleic acids, e.g., DNA, RNA, including mRNA (00274-00284).
The instant claims are therefore rendered obvious by Benenato et al. since the reference teaches compounds within the scope of the compound of the present invention that may be combined in compositions with additional lipids such as PEG lipids, phospholipids, etc., to be used in compositions for delivering a therapeutic and/or prophylactic to a mammalian cell or organ.
Claims 3 and 10 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIKARL A WITHERSPOON whose telephone number is (571)272-0649. The examiner can normally be reached M-F 9am-9pm IFP.
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.
/SIKARL A WITHERSPOON/Primary Examiner, Art Unit 1692
Prosecution Insights