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 .
Claims 1,2,4,15,29,31,35,38,40,44,53,57,61,73,87,89,93,96,98,111,130,131,134,135,140, and 145 remain pending and all claims are examined on the merits, following rejoinder of the previously withdrawn claims.
Applicant’s arguments have overcome the rejection of record, that the prior art combination applied does not reasonably teach or suggest the genus and/or species within the structure of claim 1 and dependencies thereto. As the elected species has been found allowable, the rejection thereon traversed, the remaining species and claims thereto have thus been rejoined in full. Notwithstanding, a rejection was overlooked on initial pass that must be addressed on the record, as such the present Office action is sent non-final. The examiner remains open to interview to advance prosecution on the merits.
Allowable Subject Matter
The updated structure search (STN, 5/5/26) of the claim 1 structure (and associated species thereof within the dependent claims) was not found to reasonably teach or suggested the instantly claimed structures. The previous prior art combination remains deemed the closest art of record: WO 2015/184256 (hereafter ‘256; Shire, 12/3/2015) in view of WO 2017/049209 (hereafter ‘209; Univ. Utah Res. Found.; 3/23/2017) and DONG-LIN LIU ET AL: "Reduction- and thermo-sensitive star polypeptide micelles and hydrogels for on-demand drug delivery", CHEMICAL COMMUNICATIONS, vol. 49, no. 12, 1 January 2013 (2013-01-01), page 1229, XP0055670468, UK ISSN: 13859-7345, DOI: 10.1039/c2cc38343h (hereafter Dong-Lin).
Election/Restriction-Species, Withdrawn
Applicant’s election without traverse of the following species:
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188
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; in the reply filed on 4/30/25 is acknowledged.
The remaining claims 38,40,44,53,57,61,73,87,89,93,96,98 and 111 which were previously withdrawn as not drawn to the elected species, have been rejoined.
Claim Rejections - 35 USC § 112-Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1,2,4,15,29,31,35,38,40,44,53,57,61,73,87,89,93,96,98,111,130,131,134,135,140, and 145 – in view of claim 130 directed to Compounds 1-552 – are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. There is insufficient guidance as to which of Compounds 1-552 fall within the possession of the scope of the claim 1 formula. Further, there is insufficient guidance as to whether some of the Compounds have already been claimed (duplicatively) as the species structures claimed are not claimed by Compound #. As such, taking claim 130 in the context of claim 1 to which is depends and across the full scope of the claims, possession cannot be reasonably determined as to overlap in scope, as the volume of Compounds 1-552 (presumably all within the specification, as not claimed expressly) does not lend itself to review within the limited time for review, search, and examination by every examiner per case. NOTE: Applicant may wish to consider independent claiming Compounds 1-552 to remove such from uncertainty as to falling within the scope of the claim 1 formula and/or other 35 USC 112 issues (e.g. (b), antecedent basis).
Claim Rejections - 35 USC § 112(b)-Indefiniteness, Antecedent Basis
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.
Claims 131 and 140 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.
Claims 131 and 140 recites the limitation "mRNA" yet the latter expands the scope to include peptides, beyond the proteins of claim 131. There is insufficient antecedent basis for this limitation in the latter claim and the latter should be put into the former and the latter limited to one or the other (peptide or protein) in order to further limit the former.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAURY A AUDET/Primary Examiner, Art Unit 1654
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