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 is acknowledged of Applicant’s Restriction Requirement Response filed on 05/18/2026; and IDS filed on 05/18/2026, 11/25/2024 and 09/15/2023.
Claims 2, 10, 19-24, 26-29, 32-36, 40-41 are drawn to non-elected species.
Claims 1-43, 138-141 are pending in the instant application.
Claims 2, 10, 19-24, 26-29, 32-36, 40-41, 43, 138-141 are withdrawn from consideration.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-42) and specie election of “Lipid 15 in Table 1” in the reply filed on 05/18/2026 is acknowledged.
Note, claims 2, 10, 19-24, 26-29, 32-36, 40-41 are drawn to non-elected species.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1,3-9,11-18,25,30-31,37-39 and 42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 19/284,535 and 18/979,339 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-applications recites cationic Lipid 15 (see 19/284,535 at claim 22) and compound formula I (see 18/979,339 at claim 1).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112, 2nd paragraph
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.
Claim 39 is 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.
Regarding claim 39, claims 39 recites “the compound is selected from Table 1”. However, the court has stated "Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table 'is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.' Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993)" (MPEP 2173.05(s)). Applicants should copy the table contents into the claim itself. There is no limit to the length of a claim. If the subject matter can be listed in the specification, that list can be copied and pasted into a claim.
Claim Rejections - 35 USC § 102/103
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, 3-7, 12-18, 25, 30-31, 37-38 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 MADDEN et al (WO 2019/089828).
MADDEN teaches lipid nanoparticles (see title) made from cationic lipids (see pg. 3, line 17) similar to Applicant’s compound in several structural features, such cationic lipid compounds include compound II-9 (see pg. 71), compounds II-10 to II-13 (see pg. 72), compound II-17 to II-21 (see pg. 73), compound II-22 (see pg. 75), compounds II-35, II-36, II-38, II-39 (see pg. 76), and compounds II-41 to II-43 (see pg. 114) and compound VIII-7 (see pg. 130), wherein compound II-36 is provided below.
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156
356
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MADDEN further teaches the hydrocarbon chain can have varying lengths and double bonds (see pg. 65-69, and 108; Formula (IIC) on pg. 65 as shown below).
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145
423
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, wherein R7 can be (see pg. 68-69):
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223
564
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303
562
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MADDEN’s examples have R1 and R2 to be at least 5 carbons, such as Compound II-36 has R1 and R2 to be 9 carbons. However, MADDEN teaches the carbon length can be from 2 to 12 (see pg. 52, line 8), wherein 2-3 carbons would read on Applicant’s R1 and R2 is C1-3 alkylene.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1,3-9,11-18, 25, 30-31, 37-39 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over MADDEN et al (WO 2019/089828).
As discussed above, MADDEN teaches Applicant’s invention. Especially, R1 and R2 can have 2 carbon length.
MADDEN does not teach R1 and R2 are methyl (1 carbon length).
The difference between the instant claims and MADEN is that the substituents at R1 and R2 differ by one -CH2 moiety. Compounds that differ only by the presence or absence of an extra methyl group or two are homologues. Homologues are of such close structural similarity that the disclosure of a compound renders prima facie obvious its homologue. As was stated in In re Grose, 201 USPQ 57, 63, “The known structural relationship between adjacent homologues, for example, supplies a chemical theory upon which a prima facie case of obviousness of a compound may rest.” The homologue is expected to be preparable by the same method and to have generally the same properties. This expectation is then deemed the motivation for preparing homologues. Of course, these presumptions are rebuttable by the showing of unexpected effects, but initially, the homologues are obvious even in the absence of a specific teaching to add or remove methyl groups. See In re Wood, 199 USPQ 137; In re Hoke, 195 USPQ 148; In re Lohr, 137 USPQ 548; In re Magerlein, 202 USPQ 473; In re Wiechert, 152 USPQ 247; Ex parte Henkel, 130 USPQ 474; In re Jones, 74 USPQ 152, 154; In re Herr, 134 USPQ 176; Ex parte Dibella, 157 USPQ 59; In re Zickendraht, 138 USPQ 22; Ex Parte Fischer, 96 USPQ 345; In re Fauque, 121 USPQ 425; In re Druey, 138 USPQ 39; In re Bowers and Orr, 149 USPQ 570; Redox Technologies Inc. v. Pourreau, 73 USPQ2d 1435, 1451; In re Henze, 85 USPQ 261; In re Basell Poliolefine Italia S.P.A., 89 USPQ2d1030 (“As homologs are presumptively obvious over known compounds…..”). In all of these cases, the close structural similarity between two compounds differing by one or two methyl groups was itself sufficient show obviousness.
It would have been obvious to one of ordinary skill in the art to expect similar beneficial results with compounds having only additional -CH2- groups. Case laws holds that homologs (compounds differing regularly by the successive addition of the same chemical group, e.g,. by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). Thus, it would be presumed that the addition of a single or two -CH2- group would possess similar properties.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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, Michael Hartley can be reached at (571) 272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAKE M VU/Primary Examiner, Art Unit 1618
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