Prosecution Insights
Last updated: July 17, 2026
Application No. 18/725,289

IONIZABLE LIPIDS FOR MULTIPLE ORGAN TARGETING

Non-Final OA §102§103
Filed
Jun 28, 2024
Priority
Jan 04, 2022 — provisional 63/296,291 +1 more
Examiner
ARNOLD, ERNST V
Art Unit
1613
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Massachusetts Institute of Technology
OA Round
1 (Non-Final)
48%
Grant Probability
Moderate
1-2
OA Rounds
1y 1m
Est. Remaining
61%
With Interview

Examiner Intelligence

Grants 48% of resolved cases
48%
Career Allowance Rate
660 granted / 1376 resolved
-12.0% vs TC avg
Moderate +13% lift
Without
With
+13.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
69 currently pending
Career history
1446
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
57.3%
+17.3% vs TC avg
§102
5.3%
-34.7% vs TC avg
§112
2.9%
-37.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1376 resolved cases

Office Action

§102 §103
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 . Election/Restrictions Applicant’s election of Group I, claims 1, 2, 5, 10, 12, 21, 23, 24, 26, 32, 58, 75, 77, 78, 83, 97, 100 and 106 and the species: PNG media_image1.png 242 876 media_image1.png Greyscale PNG media_image2.png 38 416 media_image2.png Greyscale in the reply filed on 5/11/2026 is acknowledged. Applicant submits that claims 1, 2, 5, 10, 12, 21, 23, 26, 77, 78, 83, 97, 100 and 106 encompass the elected species. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 24, 32, 58, 75, 132 and 134 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups and species claims, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/11/26. A search for the elected species found it free of the art. The Examiner has expanded the search to include species encompassed by claim 1. Priority PNG media_image3.png 136 968 media_image3.png Greyscale Information Disclosure Statement The information disclosure statements (IDSs) submitted on 1/21/2025, 1/30/26 and 5/11/26 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. Claim Rejections - 35 USC § 102 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, 12, 23, 78 and 83 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Solleder et al. (Polym Chem. 2015;6:3201-3203, 8 pages; of record). Solleder et al. disclose, for example, CAS number 1801987-91-6 N-[1-[[(1,1-Dimethylethyl)amino]carbonyl]-10-undecen-1-yl]-N-propyloctadecanamide: PNG media_image4.png 468 706 media_image4.png Greyscale In the structure above: R is a C4 substituted alkyl; R1 is an C3 unsubstituted alkyl; X1 is a C10 aliphatic; and X2 is a C17 aliphatic, which meet Applicant’s definitions of alkyl and aliphatic and the claimed limitations (Specification [0019 and 0021]). Thus, Solleder et al. disclose a compound within the genus of Formula (I) (Page 3202, Figure 1 and attached SCIFINDER substances). See MPEP 2131.03: A SPECIFIC EXAMPLE IN THE PRIOR ART WHICH IS WITHIN A CLAIMED RANGE ANTICIPATES THE RANGE. 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. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Solleder et al. (Polym Chem. 2015;6:3201-3203, 8 pages; of record). This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103. Applicant claims: PNG media_image5.png 318 960 media_image5.png Greyscale Level of Ordinary Skill in the Art (MPEP 2141.03) MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a pharmaceutical organic chemist research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from synthetic organic chemistry— without being told to do so. In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)). Determination of the scope and content of the prior art (MPEP 2141.01) It is well settled that “a disclosure that anticipates under § 102 also renders the claim invalid under §103, for anticipation is the epitome of obviousness. See MPEP 1207.03(a)(II) states: “"lack of novelty is the epitome of obviousness." May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))”. Accordingly, the claims rejected under §102 above are also invalid under §103. Solleder et al. is discussed in detail above and that discussion is incorporated by reference. Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143) The difference between the instant application and Solleder et al. is that Solleder et al. do not expressly teach X2 as being C15. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the compound of Solleder et al. where X2 is C15, and produce the instant invention. One of ordinary skill in the art would have been motivated to do this because compounds that are 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. (MPEP 2144.09(II)). As noted above, Solleder et al. teach X2 is C17. Consequently, the ordinary artisan would have a reasonable expectation of success in modifying the compound of Solleder et al. where X2 is C15 as a homolog with the same or similar properties. In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the reference, especially in the absence of evidence to the contrary. Allowable Subject Matter Claims 2, 5, 10, 24, 26, 32, 58, 75, 77, 97, 100 and 106 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. Conclusion Claims 2, 5, 10, 24, 26, 32, 58, 75, 77, 97, 100 and 106 are objected. Claims 1, 12, 21, 23, 78 and 83 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30. 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, Brian Y Kwon can be reached at 571-272-0581. 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. /ERNST V ARNOLD/Primary Examiner, Art Unit 1613
Read full office action

Prosecution Timeline

Jun 28, 2024
Application Filed
Jul 02, 2026
Non-Final Rejection mailed — §102, §103 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12678455
INHIBITION OF CRYSTALLIZATION AND/OR BIOFILM FORMATION ON AN INDWELLING URINARY CATHETER
2y 8m to grant Granted Jul 14, 2026
Patent 12661477
NITRIC OXIDE THERAPIES
2y 5m to grant Granted Jun 23, 2026
Patent 12642871
Lyophilized Formulations of AAV Drug Products
3y 2m to grant Granted Jun 02, 2026
Patent 12629388
INTRADIALYTIC USE OF SODIUM NITRITE
2y 0m to grant Granted May 19, 2026
Patent 12616775
METHOD FOR MANUFACTURING BONE-REGENERATION MATERIAL COMPRISING BIODEGRADABLE FIBERS BY USING ELECTROSPINNING METHOD
2y 0m to grant Granted May 05, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

Strategy Recommendation AI-generated — please review before filing

Get a prosecution strategy drawn from examiner precedents, rejection analysis, and claim mapping.
Typically takes 5-10 seconds — AI-generated, attorney review required before filing

Prosecution Projections

1-2
Expected OA Rounds
48%
Grant Probability
61%
With Interview (+13.0%)
3y 2m (~1y 1m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1376 resolved cases by this examiner. Grant probability derived from career allowance rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month