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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The earliest effective filing date to which the instant application is entitled is 12/18/2020.
Information Disclosure Statement
Receipt of an information disclosure statement on 03/25/2024 is acknowledged. The signed and initialed PTO-1449 has been mailed with this action.
Drawings
The drawings are objected to because:
With regard to Figures 4 and 6, the grayscale data labels are not all easily distinguishable from each other both in the graphs and in the keys of said graphs. It would be remedial to modify the data labels such that it is clear which data points correspond with which species or time point.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see page 15, line 14; page 40, line 1; page 40, line 19). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 33, 39, and 40 are objected to because of the following informalities:
With regard to claim 33, which recites “the compound of claim 1 that is selected from…,” while this recitation is not strictly grammatically improper, it is nonetheless structured differently from the preambles of the rest of the instant claim set. For purposes of internal consistency, it would be remedial to amend claim 33 such that the preamble is consistent with other preambles in the instant claim set, for example “the compound of claim 1, wherein the compound is selected from…”. This is merely an example set forth by the Examiner and is not intended to be limiting.
With regard to claims 39 and 40, which both recite the preamble “the lipid particle of claim 38,” the Examiner notes that claim 38 is drawn to a lipid nanoparticle (bolded emphasis added). For purposes of internal consistency and clarity, it would be remedial to amend claims 38 and 40 such that the preamble recites “the lipid nanoparticle of claim 38” (bolded emphasis added).
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-3, 9, 19, 33-40, 43-46, and 49-52 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.
With regard to claims 1-3, 9, 19, 33-40, 43-46, and 49-52, the term “about” in claim 1 (and claim 19) is a relative term which renders the claims indefinite. Given that all claims in the instant claim set directly or indirectly depend from claim 1 and do not clarify the scope of protection sought by the term “about,” all of the claims in the instant claim set inherit the rejection of claim 1. Claim 19 also recites the relative term “about” and is therefore rejected for the same reasons. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In the absence of a clear definition of “about,” the bounds of the claimed compound are not clearly defined such that one of ordinary skill in the art would be reasonably apprised of the metes and bounds of protection sought by the instant claim language. It would be remedial to clarify and clearly define the metes and bounds of protection sought by the instant claim language.
Allowable Subject Matter
Claim 1, from which all other claims in the instant claim set directly or indirectly depend, would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Additionally, claim 19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
A thorough search of both the patent and non-patent literature did not return any art disclosing the instantly claimed compounds that was either effectively filed or publicly available prior to the effective filing date of the instant invention. While similar compounds have been disclosed in art such as WO 2015/199952 A1 (i.e. pegylated lipid 42-6), none of the instantly claimed compounds have been disclosed in entirety. Therefore, it is considered that the instantly claimed compounds are free of the prior art and the claims drawn to them would be allowable if rewritten or amended to overcome the rejections under 35 U.S.C. 112(b) that are set forth above.
Conclusion
No claims are allowed.
Claims 33, 39, and 40 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sarah E Allen whose telephone number is (571)272-0408. The examiner can normally be reached M-Th 8-5, F 8-12.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at 571-272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH E ALLEN/ Examiner, Art Unit 1637
/J. E. ANGELL/ Primary Examiner, Art Unit 1637