Prosecution Insights
Last updated: October 25, 2026
Application No. 18/284,740

PEGYLATED LIPID, LIPOSOME MODIFIED BY THE LIPID, PHARMACEUTICAL COMPOSITION CONTAINING THE LIPOSOME, FORMULATION AND APPLICATION THEREOF

Non-Final OA §112
Filed
Sep 28, 2023
Priority
Apr 08, 2021 — CN 202110379685.5 +3 more
Examiner
SHOMER, ISAAC
Art Unit
1612
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Xiamen Sinopeg Biotech Co. Ltd.
OA Round
2 (Non-Final)
63%
Grant Probability
Moderate
2-3
OA Rounds
0m
Est. Remaining
94%
With Interview

Examiner Intelligence

Grants 63% of resolved cases
63%
Career Allowance Rate
756 granted / 1198 resolved
+3.1% vs TC avg
Strong +30% interview lift
Without
With
+30.5%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
62 currently pending
Career history
1260
Total Applications
across all art units

Statute-Specific Performance

§101
1.0%
-39.0% vs TC avg
§103
45.8%
+5.8% vs TC avg
§102
11.5%
-28.5% vs TC avg
§112
25.9%
-14.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1198 resolved cases

Office Action

§112
DETAILED ACTION Applicants’ arguments, filed 8 September 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Office Action is NON-FINAL This office action has been made NON-FINAL because it includes a rejection under 35 U.S.C. 112(b) that was not necessitated by amendment. In the prior office action, the examiner made an error by failing to reject claims 4 and 33-36 under 35 U.S.C. 112(b). As such, the examiner has rejected these claims under 35 U.S.C. 112(b), and this rejection was not necessitated by amendment. This error has been corrected herein, and as a consequence, this office action has been made NON-FINAL. Claim Rejections - 35 USC § 112(b) – Indefiniteness 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. Claims 4, 33-36 and 42 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. Claim 42 recites the following: PNG media_image1.png 106 630 media_image1.png Greyscale The variable “t”, representing the number of repeat units of (CH2), is recited in claim 42 but does not appear to have been defined by claim 42. As such, it is unclear how the variable “t” further modifies the claim scope. Claim 42 also recites the following, wherein relevant text is reproduced below with annotation by the examiner: PNG media_image2.png 104 624 media_image2.png Greyscale Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made. See MPEP 2173.05(d), also see MPEP 2173.05(c). In this case, the phrase “more specifically” renders the claim unclear as to whether R1 and R2 are drawn to the broader limitation of a C1-30 linear alkyl group or a C1-30 branched alkyl group, or to the specific alkyl groups recited later in the claim. For example, it is unclear if a tert-butyl group or a neopentyl group is included in the claim scope because these are branched C1-30 alkyl group but are not one of the groups recited following the phrase “more specifically.” This rejection also applies to claims 4 and 33-36, as these claims also recite the text “more specifically” and the same indefiniteness issues apply. For the purposes of examination under prior art, the examiner will examine the claim with the understanding that “t” is any non-zero positive integer and that R1 and R2 are drawn to the broader limitation of a C1-30 linear alkyl group or a C1-30 branched alkyl group. Regarding claims 4 and 33-36, these claims will be examined with the understanding that the broader limitation is further limiting. Claim 45 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. Claim 45 recites the following. PNG media_image3.png 52 628 media_image3.png Greyscale This claim requirement appears to lack antecedent basis earlier in the claim as the terms “alkyl group”, “alkylene group” and “alkoxy group” are not recited earlier in the claim. The examiner notes that claim 45 does recite that R1 and R2 are each independently selected from the group consisting of a heptadecyl group, an octadecyl group, a nonadecyl group, and an eicosyl group. These are types of alkyl groups. However, it is unclear if the above-indicated claim limitations limiting the alkyl, alkylene, or alkoxy group further limit the above-indicated groups. For the purposes of examination under prior art, the examiner will examine the claim with the understanding that the above-reproduced text further limiting the scope of the alkyl group, alkylene group, and alkoxy group does not actually further limit the claim scope. Claim Rejections - 35 USC § 112(d) – Failure to Limit Parent Claim The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 44 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 44 recites multiple chemical structures, including the following. PNG media_image4.png 116 310 media_image4.png Greyscale Claim 44 depends upon claim 1, which requires that L7 is a carbonyl and L8 is a linking bond. The above-reproduced structures do not include a carbonyl and are therefore outside the scope of claim 1 upon which they depend. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. The examiner notes that if applicant were to amend the dependency of claim 44 to depend from claim 40 instead of claim 1, this would create a new issue under 35 U.S.C. 112(d). Specifically, claim 44 recites the following structure, which is reproduced below with annotation by the examiner. PNG media_image5.png 138 298 media_image5.png Greyscale The above-indicated carbonyl group appears to be outside the scope of L7 and/or L8 for claim 40, which appears to exclude a carbonyl at the indicated position. For the purposes of examination under prior art, the examiner will examine claim 44 as if it has the same scope as claim 1 upon which it depends. Withdrawn Rejections The examiner previously rejected the instant claims as obvious over Cartwright (GB 2230022 A) in view of Guo et al. (Journal of Colloid and Interface Science, Vol. 298, 2006, pages 441-450). The examiner also previously rejected the instant claims as obvious over Uemura (KR 101476656 B1). These rejections have been withdrawn. The examiner presents the following rationale for withdrawing these rejections. Cartwright is drawn to a detergent comprising a surfactant, as of Cartwright, title and abstract. Cartwright teaches the following as of page 9, relevant text reproduced below. PNG media_image6.png 436 802 media_image6.png Greyscale With respect to independent claims 1 and 45, the examiner notes that Cartwright teaches 10 repeat units of CH2CH2O (i.e. ethylene oxide). In contrast, instant claim 1 requires 40-60 repeat units of ethylene oxide. It is the examiner’s position that modification of Cartwright to include 40 repeat units of ethylene oxide would not have been routine optimization. This determination is made in view of applicant’s arguments in applicant’s response on 8 September 2026. One relevant argument is made as of applicant’s response on 8 September 2026, pages 23-24, relevant text reproduced below. PNG media_image7.png 176 622 media_image7.png Greyscale PNG media_image8.png 290 628 media_image8.png Greyscale As such, the skilled artisan would have expected that, had the ethylene oxide chain length of Cartwright been modified to have been lengthened from 10 repeat units, as taught by Cartwright, to 40-60 repeat units, as required by the instant claims, the skilled artisan would have expected that the resultant compound would have been unsuitable for the purposes desired by Cartwright. This is because the skilled artisan would have expected that, due to the increased hydrophilicity caused by a longer ethylene oxide chain, such a compound would have been too hydrophilic to have successfully remained on clay. The proposed modification cannot render the prior art unsatisfactory for its intended purpose, and there would have been a reasonable expectation that lengthening the ethylene oxide chain of Cartwright to have been in the claimed range would have rendered the resultant compound unsuitable for the purpose desired by Cartwright. See MPEP 2143.01(V). Additionally, with respect to instant claim 1, the longest functional group of R1 and R2 recited by the instant claims are hexadecyl groups. In contrast, the groups taught by Cartwright that would correspond to R1 and R2 have 18 and 17 carbon atoms respectively, which is longer than what is recited by the instant claims. Regarding instant independent claim 40, the examiner notes that the claim requires the following: PNG media_image9.png 210 622 media_image9.png Greyscale This list of functional groups excludes the case wherein L7 and/or L8 is –(C=O). In contrast, in the structure of Cartwright, one of L7 and L8 would be –(C=O)- and the other would be a linking group. This does not appear to be within the scope of claim 40. Regarding the previously applied rejection over Uemura, the examiner notes that Uemura teaches the following structures on page 6 of the translation, reproduced in part below. PNG media_image10.png 415 840 media_image10.png Greyscale Structures D1-D4 and D10-D12 have only a single ethylene oxide containing group attached to the nitrogen atom, as in the instant claims. However, in structures D1-D4 of Uemura, the structure is such that both claimed variables L7 and L8 would have been a linking bond. In structures of D10-D12 of Uemura, the structures are such that both claimed variables L7 and L8 would have been a carbonyl group. This is outside the scope of claims 1 and 45 because these claims require that L7 be a carbonyl group and L8 be a linking bond. This degree of asymmetry required by instant claims 1 and 45 does not appear to have been found in Uemura. This is also outside the scope of claim 40 because (a) claim 40 excludes L7 and L8 from being carbonyl groups, and (b) excludes the case wherein both L7 and L8 are linking bonds. The examiner further notes that in the applied translation of Uemura from Google Translate, claim 1 is translated in the following manner, as of page 1 of the translation: PNG media_image11.png 152 702 media_image11.png Greyscale A case wherein both R1 and R2 are hydrogen, alkyl group, alkenyl group, cycloalkyl group, aryl group, aralkyl group, or polyoxyethylene chain would, if interpreted under its normal definition, not appear to include a case where there is a carbonyl bond between the nitrogen atom and the carbon chain. This is because the resulting group would be an acyl group rather than an alkyl group, and an acyl group is not one of the alternatives taught by Uemura. Therefore, such a teaching by Uemura would not appear to read on the requirement of claims 1 and 45 that L7 be a carbonyl bond. Such a teaching of Uemura would also appear to fail to read on the requirement of claim 40 that, although one of L7 and L8 may be a linking group, the other must be selected from the recited group and must not be a linking group. Response to Arguments Applicant has presented arguments in applicant’s response on 8 September 2026. These arguments have not been addressed substantively as they relate to grounds of rejections which have been withdrawn. Terminal Disclaimer The terminal disclaimer filed on 8 September 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US application serial numbers 18/700,022 18/269,728 (now US Patent 12,648,908) 18/839,059; and 18/284,762 has been reviewed and is accepted. The terminal disclaimer has been recorded. Allowable Subject Matter Claims 1, 5-7, 13, 18, 25-32, 37, 40-41, and 43 are allowed. The examiner notes that these claims are not rejected over prior art because the previously applied prior art rejections have been withdrawn. See the above section entitled “Withdrawn Rejections.” Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday. 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, Sahana Kaup can be reached at (571)272-6897. 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. ISAAC . SHOMER Primary Examiner Art Unit 1612 /ISAAC SHOMER/ Primary Examiner, Art Unit 1612
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Prosecution Timeline

Sep 28, 2023
Application Filed
Jan 07, 2026
Response after Non-Final Action
May 07, 2026
Non-Final Rejection mailed — §112
Jul 29, 2026
Applicant Interview (Telephonic)
Jul 29, 2026
Examiner Interview Summary
Sep 08, 2026
Response Filed
Sep 21, 2026
Non-Final Rejection mailed — §112 (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

2-3
Expected OA Rounds
63%
Grant Probability
94%
With Interview (+30.5%)
2y 11m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 1198 resolved cases by this examiner. Grant probability derived from career allowance rate.

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