Prosecution Insights
Last updated: July 17, 2026
Application No. 18/263,795

LIPIDS SUITABLE FOR NUCLEIC ACID DELIVERY

Non-Final OA §103
Filed
Aug 01, 2023
Priority
Feb 02, 2021 — provisional 63/144,500 +1 more
Examiner
SAWYER, JENNIFER C
Art Unit
1691
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Ramot At Tel-aviv University Ltd.
OA Round
1 (Non-Final)
69%
Grant Probability
Favorable
1-2
OA Rounds
0m
Est. Remaining
60%
With Interview

Examiner Intelligence

Grants 69% — above average
69%
Career Allowance Rate
384 granted / 559 resolved
+8.7% vs TC avg
Minimal -9% lift
Without
With
+-9.1%
Interview Lift
resolved cases with interview
Typical timeline
2y 9m
Avg Prosecution
49 currently pending
Career history
601
Total Applications
across all art units

Statute-Specific Performance

§101
0.3%
-39.7% vs TC avg
§103
68.9%
+28.9% vs TC avg
§102
8.4%
-31.6% vs TC avg
§112
8.9%
-31.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 559 resolved cases

Office Action

§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 . Detailed Action This office action is in response to applicant’s communication filed on 3/20/26. Claims 55-63 and 71-78 are pending in this application. Applicant’s election without traverse of Group I, claims 55-63 in the reply filed on 3/20/2026 is acknowledged. Thus Claims 71-74 are withdrawn from further consideration being drawn to the nonelected invention. Applicant’s election of the following compound is acknowledged herewith: PNG media_image1.png 116 610 media_image1.png Greyscale Claims 55-58, 60-63 and 75-78 read on applicant’s elected species. However, applicant’s elected species has been found allowable. Thus the new species to be examined is the following: PNG media_image2.png 472 818 media_image2.png Greyscale Thus, additionally, claims are hereby withdrawn from consideration being non-readable on the new and elected species. The search has not been extended to determine the patentability of the other species encompassed by the claims. As a result, claims 55-57, 61-63 and 77-78 are being examined in this Office Action. Claims 58-60 and 71-76 are withdrawn. Priority The applicant claims benefit as follows: PNG media_image3.png 84 440 media_image3.png Greyscale Objections Claims 63 and 77-78 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. 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 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 of this title, 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 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. 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. Claims 55-57 and 61-62 are rejected under 35 U.S.C. 103 as being unpatentable over Toray (JP 59137508, pub date 8/7/1984) (also see the English Translation). The instant claims are drawn to the following compound of Formula (II): PNG media_image4.png 160 570 media_image4.png Greyscale The following species below reads on applicant’s compound of Formula (II), when: R1 = -CH2-CH2-OH R13 = -OH R12 = R14 = C13 alkyl La = Lb = -CH2-CH2- Xa = -O2C-C4 alkyl-CO2- PNG media_image2.png 472 818 media_image2.png Greyscale Determination of the Scope and Content of the Prior Art (MPEP §2141.01) Toray exemplifies the following nonionic surfactant agent, a stearyl alcohol adduct. (JP Patent: pg 42, second column, second to the last paragraph; pg 43, second column, last paragraph, compound 9; pg 44, first column, last paragraph) (English translation: claims and examples): PNG media_image5.png 466 822 media_image5.png Greyscale This compound reads on applicant’s compound of Formula (II), when: R1 = -CH2-CH2-OH R13 = -OH R12 = R14 = C13 alkyl La = Lb = -CH2-CH2- Xa = -O2C-C7 alkyl-CO2- Furthermore, Toray teaches a range for the methylene chain, - (CH2)n-, of 1 to 10 methylene groups, (n = 1 – 10). (JP Patent: page 38, column 1, second paragraph; page 41, second column, first paragraph) Ascertainment of the Difference Between Scope the Prior Art and the Claims (MPEP §2141.012) Toray is deficient in the sense that it does not exemplify a methylene chain of 4, but instead exemplifies a methylene chain of 7. Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-2143) Therefore, it would be prima facie obvious to one of ordinary skill in the art at the time of the invention, to substitute a methylene chain of 4 for Toray’s methylene chain of 7, since it is an adjacent homolog and homologs are prima facie obvious. See Ex parte Bluestone, 135 USPQ 199 (Bd. Pat. App. & Int. 1961). Additionally, Toray teaches the interchangeability of methylene chains between 1-10. Thus with regard to applicant' s particular compound, it is the position of the examiner that one of ordinary skill in the art, at the time of the invention, would through routine and normal experimentation determine the appropriate number of methylene groups in the compound, since Toray teaches a structural homolog of applicant's compound. The applicant does not show any unusual and/or unexpected results for the limitations stated. The close structural similarity between four methylene groups and seven methylene groups, as shown in the art, suggests the compounds have similar properties and utilities (see MPEP § 2144.09). Applicant's compound with four methylene groups is a structurally similar isomer to that known in the art. Furthermore, Toray teaches the equivalency for a range of the methylene chain, - (CH2)n-, of 1 to 10 methylene groups Thus, at the time of instant invention, a person of ordinary skill in the art would have been motivated to substitute 7 methylene groups with 4 4 methylene groups with a reasonable expectation of success. Note that an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). Furthermore, “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homolog because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.” (see In re Deuel 34 USPQ2d 1210, 1214 and MPEP § 2144.08c). In addition, homologs are generally so structurally similar that “without more” such structural similarity could give rise to prima facie obviousness (see In re Wilder, 563 F.2d 457, 195 USPQ 426). Additionally, it has long been established that this type of difference --- varying the size of a chain --- constitutes a form of homology, and is a fact of very close structural similarity, rendering the homolog obvious. 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.” See specifically In re Shetty, 195 USPQ 753; In re Wilder, 195 USPQ 426 and Ex Parte Greshem, 121 USPQ 422, all of which feature a compound with a C2 link rejected over a compound with a C1 link. Similarly, In re Chupp, 2 USPQ2d 1437 and In re Coes, 81 USPQ 369 have a compound with a C1 link unpatentable over prior art showing C2 link. Note also In re Schaub, 190 USPQ 324, 326, where compounds with C5 and C6 chains were called “adjacent homologs in the classic sense”. Ex parte Ruddy, 121 USPQ 427 has a C3 link unpatentable over a C1 link. Ex parte Nathan, 121 USPQ 349 found the insertion of a C2H4 link obvious. In all of these cases, the variation was found to be obvious on the basis of close structural similarity; no secondary teaching was employed. As was stated directly in THE GENERAL TIRE & RUBBER COMPANY v. JEFFERSON CHEMICAL COMPANY, INC., 182 USPQ 70 (1974): “If any structural change is obvious to one skilled in the art, a substitution of the next higher homolog would seem to be.” Note also In re Jones, 21 USPQ2d 1942, which states at 1943 “Particular types or categories of structural similarity without more, have, in past cases, given rise to prima facie obviousness”; one of those listed is “adjacent homologues and structural isomers”. Similar is In re Schechter and LaForge, 98 USPQ 144, 150, which states “a novel useful chemical compound which is homologous or isomeric with compounds of the prior art is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compounds.” Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer Cho Sawyer whose telephone number is (571) 270 1690. The examiner can normally be reached on Monday-Friday 9 AM - 6 PM PST. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Renee Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-274-1690. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. Jennifer Cho Sawyer Patent Examiner Art Unit: 1691 /RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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Prosecution Timeline

Aug 01, 2023
Application Filed
Jun 04, 2026
Non-Final Rejection mailed — §103 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
69%
Grant Probability
60%
With Interview (-9.1%)
2y 9m (~0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 559 resolved cases by this examiner. Grant probability derived from career allowance rate.

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