Prosecution Insights
Last updated: October 25, 2026
Application No. 19/238,030

POLYGLYCEROL-CONJUGATED LIPIDS AND LIPID NANOPARTICLE COMPOSITIONS COMPRISING THE SAME

Final Rejection §112
Filed
Jun 13, 2025
Priority
Dec 01, 2022 — provisional 63/429,226 +8 more
Examiner
CABRAL, ROBERT S
Art Unit
1614
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Generation Bio Co.
OA Round
2 (Final)
63%
Grant Probability
Moderate
3-4
OA Rounds
4y 2m
Est. Remaining
95%
With Interview

Examiner Intelligence

Grants 63% of resolved cases
63%
Career Allowance Rate
546 granted / 870 resolved
+2.8% vs TC avg
Strong +32% interview lift
Without
With
+32.3%
Interview Lift
resolved cases with interview
Typical timeline
5y 6m
Avg Prosecution
33 currently pending
Career history
911
Total Applications
across all art units

Statute-Specific Performance

§101
1.9%
-38.1% vs TC avg
§103
44.9%
+4.9% vs TC avg
§102
16.7%
-23.3% vs TC avg
§112
23.6%
-16.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 870 resolved cases

Office Action

§112
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 . Applicant’s reply and amendment filed 4/14/2026, are acknowledged. Claims 1, 3, 6-13, 15-20, 29-34, 39, 40 and 194-198 are pending. Response to Arguments Applicant’s arguments and amendment in response to the rejection of the claims under 35 U.S.C. §112 as it concerned the use of the term “derivative” are persuasive. However, the Applicant’s argument to the rejection as it concerns the use of the term “linker” is not persuasive. In this regard, Applicant refers to the specification for a definition of linker. See Reply at pages 8-9. However, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Claim Rejections - 35 USC § 112 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 1, 3, 6-13, 15-20, 29-34, 39, 40 and 194-196 are 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. The recitation of “linker” renders the claim 1 indefinite. The term “linker” may imply both functional or structure. Notwithstanding the permissible instances, the use of functional language in a claim may fail “to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite.” In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. Further, without reciting the particular structure, materials or steps that accomplish the function or achieve the result, all means or methods of resolving the problem may be encompassed by the claim. Ariad Pharmaceuticals., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353, 94 USPQ2d 1161, 1173 (Fed. Cir. 2010) (en banc). Here, there are no structural limits inherent or implied by the term “linker”. The limitation is unlimited and extends to all means or methods of linking, which are not adequately supported by the written description, generic examples in the specification notwithstanding. Claims 2, 3, 6-9, 11-13, 15-18, 29-34, 39, 40 and 194-196 are indefinite because they depend on claim 1 and do not resolve the indefiniteness of claim 1’s use of “linker.” Allowable Subject Matter The following is a statement of reasons for the indication of allowable subject matter: Claims 197 and 198 appear to be free of the prior art. Conclusion THIS ACTION IS MADE FINAL. 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 ROBERT S CABRAL whose telephone number is (571)270-3769. The examiner can normally be reached M-F 8 am - 5 pm. 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, Ali Soroush can be reached at 571-272-9925. 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. /ROBERT S CABRAL/ Primary Examiner, Art Unit 1614
Read full office action

Prosecution Timeline

Jun 13, 2025
Application Filed
Jan 14, 2026
Non-Final Rejection mailed — §112
Apr 14, 2026
Response Filed
May 12, 2026
Final Rejection mailed — §112 (current)

Precedent Cases

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

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Prosecution Projections

3-4
Expected OA Rounds
63%
Grant Probability
95%
With Interview (+32.3%)
5y 6m (~4y 2m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 870 resolved cases by this examiner. Grant probability derived from career allowance rate.

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