Prosecution Insights
Last updated: October 04, 2026
Application No. 18/957,555

TISSUE EXPANSION DEVICES, SYSTEMS AND METHODS

Final Rejection §112
Filed
Nov 22, 2024
Priority
Apr 19, 2012 — provisional 61/635,810 +3 more
Examiner
IGBOKO, CHIMA U
Art Unit
3771
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Fractyl Health Inc.
OA Round
2 (Final)
79%
Grant Probability
Favorable
3-4
OA Rounds
1y 7m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 79% — above average
79%
Career Allowance Rate
337 granted / 429 resolved
+8.6% vs TC avg
Strong +40% interview lift
Without
With
+39.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
37 currently pending
Career history
468
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
49.0%
+9.0% vs TC avg
§102
22.4%
-17.6% vs TC avg
§112
25.2%
-14.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 429 resolved cases

Office Action

§112
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application is being examined under the pre-AIA first to invent provisions. Response to Amendment The Amendment filed 6/15/26 has been entered. Claims 13 and 15-17 have been amended, and new claims 29-32 have been entered. Claims 13-32 are addressed in the following office action. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 13-32 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Concerning claim 13, applicant’s original disclosure fails to divulge “a recess defined in a wall of the fluid delivery tube… each hollow fluid delivery needle being in fluid communication with the lumen of a respective fluid delivery tube of the at least two fluid delivery tubes and slidably receivable in the recess of the respective fluid delivery tube”. In paragraph 0134 of the original specification applicant details “The distal end of fluid delivery tube 121 is fluidly and mechanically attached to the proximal end of needle 141, such as via a sealed bond and/or frictionally engaging interface (e.g. the interface between a proximal outer diameter portion of needle 141 and a distal inner diameter portion of tube 121). This attachment provides a fluid seal yet allows fluid to pass through fluid delivery tube 121 into needle 141. Needle 141 is constructed and arranged to be advanced into a recess in support arm 133, opening 131, such as to the advanced position shown”. More specifically, each support arm (not detailed in the claim) of the expandable support comprises a recess defined in a wall of the arm, and each hollow fluid delivery needle is slidably receivable in the recess of the respective support arm. Also, each hollow fluid delivery needle is fluidly and mechanically attached to a respective fluid delivery tube such that they slide together and not relative to each other. Hence, the limitations are considered new matter. Claims 14-28 are rejected for the same reasons as claim 13 by virtue of dependency on claim 13. Concerning claim 29, applicant’s original disclosure fails to divulge “each hollow fluid delivery needle of the at least two hollow fluid delivery needles being slidably disposed within the lumen of the respective fluid delivery tube and configured to be advanced from the lumen”. In paragraph 0134 of the original specification applicant details “The distal end of fluid delivery tube 121 is fluidly and mechanically attached to the proximal end of needle 141, such as via a sealed bond and/or frictionally engaging interface (e.g. the interface between a proximal outer diameter portion of needle 141 and a distal inner diameter portion of tube 121). This attachment provides a fluid seal yet allows fluid to pass through fluid delivery tube 121 into needle 141. Needle 141 is constructed and arranged to be advanced into a recess in support arm 133, opening 131, such as to the advanced position shown”. More specifically, each support arm (not detailed in the claim) of the expandable support comprises a recess defined in a wall of the arm, and each hollow fluid delivery needle is slidably receivable in the recess of the respective support arm. Also, each hollow fluid delivery needle is fluidly and mechanically attached to a respective fluid delivery tube such that they slide together and not relative to each other. Hence, the limitations are considered new matter. Claims 30-32 are rejected for the same reasons as claim 29 by virtue of dependency on claim 29. NO PRIOR ART REJECTION Response to Arguments Applicant’s arguments, see pages 7-10, filed 06/15/26, with respect to claims 13-28 have been fully considered and are persuasive. The 35 USC § 102 rejection of claims 13-28 have been withdrawn. Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 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. /C.U.I/ Examiner, Art Unit 3771 /KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
Read full office action

Prosecution Timeline

Nov 22, 2024
Application Filed
Feb 13, 2026
Non-Final Rejection mailed — §112
Jun 15, 2026
Response Filed
Aug 19, 2026
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

3-4
Expected OA Rounds
79%
Grant Probability
99%
With Interview (+39.8%)
3y 5m (~1y 7m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 429 resolved cases by this examiner. Grant probability derived from career allowance rate.

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