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 .
Receipt and entry of the response dated 3/6/2026 is acknowledged.
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) 7, 8, 10, 38-46, 48, 49, 53-57, 59, 61, 62, 77-79, 81, 84-89, 94, 95, 99, 102-110 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Brito et al (WO2015/095340, of record), reference is made to the corresponding US 2016/0311759, also of record. This rejection is maintained for reasons made of record in the Office Actions dated 12/26/2024, 4/24/2025, 10/2/2025 and for reasons set forth below.
The claims have been amended to incorporate limitations from canceled or amended claims, limitations that have already been addressed, or to rephrase what an “N/P” ratio is. The term “N/P” ratio will continue to be used for the purposes of referring to this limitation. Claims 39, 41, 43, and 45 have been amended to recite an unspecified “target mol-%” as related to an unclaimed and undescribed “LNP batch”. What exactly these amendments modify with respect to parent claim 7 cannot be determined, as at first glance they do not alter the mol-% of the recited lipids in the parent claim. In the interests of compact prosecution, these claims have been treated as non-limiting to the parent claims for purposes of prior art interpretation and are appropriately objected to below.
Response to Arguments
Applicant's arguments filed 3/6/2026 have been fully considered but they are not persuasive. Applicants essentially assert that Brito et al do not teach the claimed lipids, in the claimed amounts, with the recited N/P ratios of 5-7 or 6.
Such is not convincing for reasons set forth above and of record. The embodiments taught by Brito et al are not as limited as applicants assert: see the analysis of various N/P ratios obtainable by the disclosure of Brito et al by varying components necessary to the instant compositions. Brito et al teach much more than the single Example referred to by applicants regarding the relative amounts of the recited lipids, also as set forth above. Each and every limitation of the instant claims has is taught by Brito et al, and referenced by ¶ number. Further, Brito et al do provide guidance on the optimization of N/P ratios and lipid content in contrast to applicants assertions: Brito et al provide starting points with specific ratios and lipid mol-percentages, and teach that N/P ratios are variable given the molar amount of amine lipid and nucleic acid size or composition. All of the evidence indicates that the skilled artisan could predictably optimize or find workable ranges of the N/P ratio for a desired LNP according to the instant claims given no more than the teachings of Brito et al. Further, applicants have provided no evidence of an unpredictable result that is attributable to the claimed N/P ratios or the relative % amounts of the recited lipids.
Claim Objections
Applicant is advised that should claim 7 be found allowable, claims 39, 41, 43, and 45 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 39, 41, 43, and 45 recite an unspecified “target mol-%” as related to an unclaimed and undescribed “LNP batch”. What exactly these amendments modify with respect to parent claim 7 cannot be determined, as at first glance they do not alter the mol-% of the recited lipids in the parent claim, only attempt to compare them to an unknowable value. Therefore, they have been treated as duplicates of the parent claim.
Conclusion
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 Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638
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