Prosecution Insights
Last updated: October 25, 2026
Application No. 19/266,317

ENCAPSULATED SYSTEM FOR PRESSURIZED FLUID PROCESSES

Non-Final OA §103§112
Filed
Jul 11, 2025
Priority
Aug 14, 2020 — continuation of 11/384,848 +2 more
Examiner
BARRY, DAPHNE MARIE
Art Unit
3753
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Repligen Corporation
OA Round
2 (Non-Final)
76%
Grant Probability
Favorable
2-3
OA Rounds
1y 2m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 76% — above average
76%
Career Allowance Rate
568 granted / 747 resolved
+6.0% vs TC avg
Strong +28% interview lift
Without
With
+28.3%
Interview Lift
resolved cases with interview
Typical timeline
2y 6m
Avg Prosecution
17 currently pending
Career history
771
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
42.3%
+2.3% vs TC avg
§102
32.0%
-8.0% vs TC avg
§112
23.0%
-17.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 747 resolved cases

Office Action

§103 §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 . Response to Arguments Applicant’s arguments filed on 8/27/2026 have been considered but are moot because the arguments are drawn to newly added claim limitation of the angle of the actuator with respect to the conduit being less than 90 degrees. Claim Rejections - 35 USC § 112 Amendment to the Claims filed on 8/27/2026 obviates the necessity of the 112b or 112 second paragraph rejection raised in the office action mailed on 7/28/2026. Claim Rejections - 35 USC § 103 The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. Claims 21-32 are rejected under 35 U.S.C. 103 as being unpatentable over Welch et al. (US PG PUB 20060048818, hereinafter “Welch”) in view of Fleming (US 2931387, hereinafter “Fleming”). Regarding Claim 21, Welch discloses a fluid management system (fig. figs. 2, 5, 6, and 11) comprising: a two-part valve (32, figs. 2, 5, 6, and 11) including a first half (1) and a second half (2) configured to mate with each other to define a passageway (passageway for conduit 12) for receiving and encapsulating a straight portion of conduit (12, tubing element 12, para 0043) therein, wherein the two part valve (32) includes: an actuator (4) positioned relative to the passageway (passageway for conduit 12) such that an end portion (contact point of compression bar 7, see fig. 2) of the actuator (4) is engageable with the conduit (12) to modulate flow within the conduit (12); a first flange (9) at one end of the valve, the flange dimensioned to receive a second flange (11) disposed at one end of the conduit (12) (see figs. 11 and 12; and para 0066, “The parent valve of the present invention can also be designed without the integral flange bodies such that the flexible element 12 is manufactured with specialized backup cups 8, i.e. flanges, on the ends. FIGS. 12 and 13 illustrate this alternative embodiment of the valve casings of the present invention. Parent valve casing 104 that has a slightly shorter valve casing body than the valve casing 102 in FIGS. 1 and 2. Referring to FIG. 12, the element 12 has specialized backup cups 8 that are tolerance fitted onto the molded ends 20 of the tubing element 12 and which lock into the upper and lower halves 1, 2 of the valve body 104 via grooves 9 on the valve casing 104 and a protruding lip 11 on each backup cup 8. The backup cups 8 prevent movement of the element 12 within the valve during operation, which increases the life of the element 12. FIG. 14 illustrates a cross-section of element 12 with the backup cups 8.”); wherein the actuator is oriented at a fixed angle (fig. 2 illustrates actuator 7 perpendicular to passageway for conduit 12) relative to the passageway (passageway for conduit 12) (para 0043, “A piston is located in both actuator types 100, 101 in the valve, as shown in FIGS. 1 through 4 that pushes a compression bar 7. The compression bar 7 has a smooth radius to prevent cutting of the tubing element 12 when engaged and is operably connected to both pneumatic and manual actuator styles 100, 101, as shown on FIGS. 1 and 2 respectively, for closing the parent valve. Referring to FIG. 2, preferably the manual version of the valve prevents the flexible tubing element 12 from being over-compressed by having the topworks 4 bottom out on the manual stem 6 when the actuator 101 is fully engaged or closed.”). PNG media_image1.png 247 373 media_image1.png Greyscale PNG media_image2.png 345 406 media_image2.png Greyscale WELCH – FIGURES 11 and 12 Welch discloses the claimed invention, except the actuator is oriented at a fixed angle relative to the valve passageway such that the end portion of the actuator is engageable with the straight portion of the conduit at the fixed angle, the fixed angle being greater than zero degrees and less than ninety-degrees. Fleming teaches an actuator (66, 65) is oriented at a fixed angle (ann. fig. 2) relative to a valve passageway (53) such that the end portion (ann. fig. 2, distal end of threaded actuator 65) of the actuator is engageable with the straight portion of a conduit (18) at the fixed angle (ann. fig. 2), the fixed angle being greater than zero degrees and less than ninety-degrees. PNG media_image3.png 283 535 media_image3.png Greyscale FLEMING – ANNOTATED FIGURE 2 It would have been obvious to a person having ordinary skill in the art at a time prior to the effective filing date to have modified the angle of the actuator (7), as disclosed by Welch, to use an actuator with an angle less than 90 degrees and greater than 0 degrees, as taught by Fleming, for the purpose of creating an adjustable actuator to compress a conduit to control a flow of fluid therethrough (col. 2 line 66- col. 3 line 11). Regarding Claims 22 and 28, Welch discloses the first half (1) and the second half (2) of the two-part pinch valve (32) are connected via a hinge (18). Regarding Claims 23 and 29, Welch discloses the first half (1) and the second half (2) of the two-part pinch valve (32) are secured to each other via a threaded latch (17) and a knob (13). Regarding Claims 24 and 30, Welch discloses the two-part pinch valve (32) includes a manually operated bonnet (4) arranged and configured to move the actuator (7). Regarding Claim 25 and 31, Welch discloses the actuator (7) contacts and pinches the conduit (12) to adjust the flow therethrough. Regarding Claim 26 and 32, Welch discloses the actuator(4) is configured to adjust a flow of fluid through the conduit (12) by adjusting the effective diameter or cross-sectional area of the lumen in the conduit (12) (para 0043, “A piston is located in both actuator types 100, 101 in the valve, as shown in FIGS. 1 through 4 that pushes a compression bar 7. The compression bar 7 has a smooth radius to prevent cutting of the tubing element 12 when engaged and is operably connected to both pneumatic and manual actuator styles 100, 101, as shown on FIGS. 1 and 2 respectively, for closing the parent valve. Referring to FIG. 2, preferably the manual version of the valve prevents the flexible tubing element 12 from being over-compressed by having the topworks 4 bottom out on the manual stem 6 when the actuator 101 is fully engaged or closed. “). Regarding Claim 27, Welch discloses a fluid management system (fig. figs. 2, 5, 6, and 11), comprising: a conduit (12); and a two-part valve including a two-part valve (32, figs. 2, 5, 6, and 11) including a first half (1) and a second half (2) defining a passageway (passageway for conduit 12) for receiving and encapsulating a straight portion of the conduit (12, tubing element 12, para 0043) therein, wherein the two part valve (32) includes: an actuator (4) positioned relative to the passageway (passageway for conduit 12) such that an end portion (contact point of compression bar 7, see fig. 2) of the actuator (4) is engageable with the conduit (12) to modulate flow within the conduit (12);and a first flange (9) at one end og the two-part valve, the first flange dimensioned to receive a second flange (11) disposed at one end of the conduit (12) (see figs. 11 and 12; and para 0066, “The parent valve of the present invention can also be designed without the integral flange bodies such that the flexible element 12 is manufactured with specialized backup cups 8, i.e. flanges, on the ends. FIGS. 12 and 13 illustrate this alternative embodiment of the valve casings of the present invention. Parent valve casing 104 that has a slightly shorter valve casing body than the valve casing 102 in FIGS. 1 and 2. Referring to FIG. 12, the element 12 has specialized backup cups 8 that are tolerance fitted onto the molded ends 20 of the tubing element 12 and which lock into the upper and lower halves 1, 2 of the valve body 104 via grooves 9 on the valve casing 104 and a protruding lip 11 on each backup cup 8. The backup cups 8 prevent movement of the element 12 within the valve during operation, which increases the life of the element 12. FIG. 14 illustrates a cross-section of element 12 with the backup cups 8.”); wherein the actuator is oriented at a fixed angled (fig. 2 illustrates actuator 7 perpendicular to passageway for conduit 12) relative to the passageway (passageway for conduit 12) (para 0043, “A piston is located in both actuator types 100, 101 in the valve, as shown in FIGS. 1 through 4 that pushes a compression bar 7. The compression bar 7 has a smooth radius to prevent cutting of the tubing element 12 when engaged and is operably connected to both pneumatic and manual actuator styles 100, 101, as shown on FIGS. 1 and 2 respectively, for closing the parent valve. Referring to FIG. 2, preferably the manual version of the valve prevents the flexible tubing element 12 from being over-compressed by having the topworks 4 bottom out on the manual stem 6 when the actuator 101 is fully engaged or closed.”). Welch discloses the claimed invention, except the actuator is oriented at a fixed angle relative to the valve passageway such that the end portion of the actuator is engageable with the straight portion of the conduit at the fixed angle, the fixed angle being greater than zero degrees and less than ninety-degrees. Fleming teaches an actuator (66, 65) is oriented at a fixed angle (ann. fig. 2) relative to a valve passageway (53) such that the end portion (ann. fig. 2, distal end of threaded actuator 65) of the actuator is engageable with the straight portion of a conduit (18) at the fixed angle (ann. fig. 2), the fixed angle being greater than zero degrees and less than ninety-degrees. It would have been obvious to a person having ordinary skill in the art at a time prior to the effective filing date to have modified the angle of the actuator (7), as disclosed by Welch, to use an actuator with an angle less than 90 degrees and greater than 0 degrees, as taught by Fleming, for the purpose of creating an adjustable actuator to compress a conduit to control a flow of fluid therethrough (col. 2 line 66- col. 3 line 11). Claims 33-38 are rejected under 35 U.S.C. 103 as being unpatentable over Bertelo et al. (US PG PUB 20120024412, hereinafter “Bertelo”) in view of Welch et al. (US PG PUB 20060048818, hereinafter “Welch”), in further view of Fleming (US 2931387, hereinafter “Fleming”). Regarding Claim 33, Bertelo discloses a fluid management system (figs. 3A, 3B), comprising: an unreinforced polymer conduit (12, can be either unreinforced or it may have reinforcing, “provided the conduit remains sufficiently flexible to permit the pipeline to be deployed in the field”, para 0033); a two-part jacket (60) including a first half (66) and a second half (68)fluid management system, comprising: an unreinforced polymer conduit (12). Bertelo discloses the claimed invention, except a two-part valve including first and second halves that together define a passageway for receiving and encapsulating the unreinforced polymer conduit therein, wherein the two- part valve includes: an actuator positioned relative to the passageway such that an end portion of the actuator is engageable with the unreinforced polymer conduit to modulate flow within the conduit, and a first flange at one end thereof, the flange dimensioned to receive a second flange disposed at one end of the unreinforced polymer conduit; and wherein the actuator is angled relative to the valve passageway to minimize a hold-up volume within the two-part valve. Welch teaches a two-part valve including a two-part valve (32, figs. 2, 5, 6, and 11) including a first half (1) and a second half (2) defining a passageway (passageway for conduit 12) for receiving and encapsulating the conduit (12, tubing element 12, para 0043) therein, wherein the two part valve (32) includes: an actuator (4) positioned relative to the passageway (passageway for conduit 12) such that an end portion (contact point of compression bar 7, see fig. 2) of the actuator (4) is engageable with the conduit (12) to modulate flow within the conduit (12);and a first flange (9) at one end thereof, the flange dimensioned to receive a second flange (11) disposed at one end of the conduit (12) (see figs. 11 and 12; and para 0066, “The parent valve of the present invention can also be designed without the integral flange bodies such that the flexible element 12 is manufactured with specialized backup cups 8, i.e. flanges, on the ends. FIGS. 12 and 13 illustrate this alternative embodiment of the valve casings of the present invention. Parent valve casing 104 that has a slightly shorter valve casing body than the valve casing 102 in FIGS. 1 and 2. Referring to FIG. 12, the element 12 has specialized backup cups 8 that are tolerance fitted onto the molded ends 20 of the tubing element 12 and which lock into the upper and lower halves 1, 2 of the valve body 104 via grooves 9 on the valve casing 104 and a protruding lip 11 on each backup cup 8. The backup cups 8 prevent movement of the element 12 within the valve during operation, which increases the life of the element 12. FIG. 14 illustrates a cross-section of element 12 with the backup cups 8.”); wherein the actuator is angled (fig. 2 illustrates actuator 7 perpendicular to passageway for conduit 12) relative to the valve passageway (passageway for conduit 12) to minimize a hold-up volume within the two-part valve (para 0043, “A piston is located in both actuator types 100, 101 in the valve, as shown in FIGS. 1 through 4 that pushes a compression bar 7. The compression bar 7 has a smooth radius to prevent cutting of the tubing element 12 when engaged and is operably connected to both pneumatic and manual actuator styles 100, 101, as shown on FIGS. 1 and 2 respectively, for closing the parent valve. Referring to FIG. 2, preferably the manual version of the valve prevents the flexible tubing element 12 from being over-compressed by having the topworks 4 bottom out on the manual stem 6 when the actuator 101 is fully engaged or closed.”). It would have been obvious to one having ordinary skill in the art at a time prior to the effective filing date to have substituted one of the plurality of two part jackets, as disclosed by Bertelo, with a two-part pinch valve, as taught by Welch, for the purpose of using a positive shutoff-type flow valve, “More specifically, the invention pertains to pinch-type valves that incorporate a flexible, compressible and gasket-less tubing element to create smooth, non-contaminating fluid flow and to create easy and inexpensive removal, disposal and replacement of all wetted surfaces (ie, surfaces making contact with fluid product)”, para 0001. Bertelo as amended above discloses the claimed invention, except the actuator is oriented at a fixed angle relative to the valve passageway such that the end portion of the actuator is engageable with the straight portion of the conduit at the fixed angle, the fixed angle being greater than zero degrees and less than ninety-degrees. Fleming teaches an actuator (66, 65) is oriented at a fixed angle (ann. fig. 2) relative to a valve passageway (53) such that the end portion (ann. fig. 2, distal end of threaded actuator 65) of the actuator is engageable with the straight portion of a conduit (18) at the fixed angle (ann. fig. 2), the fixed angle being greater than zero degrees and less than ninety-degrees. It would have been obvious to a person having ordinary skill in the art at a time prior to the effective filing date to have modified the angle of the actuator (7), as disclosed by Bertelo, to use an actuator with an angle less than 90 degrees and greater than 0 degrees, as taught by Fleming, for the purpose of creating an adjustable actuator to compress a conduit to control a flow of fluid therethrough (col. 2 line 66- col. 3 line 11). Regarding Claim 34, Welch teaches the first half (1) and the second half (2) of the two-part pinch valve (32) are connected via a hinge (18). Regarding Claim 35, Welch teaches the first half (1) and the second half (2) of the two-part pinch valve (32) are secured to each other via a threaded latch (17) and a knob (13). Regarding Claim 36, Welch teaches the two-part pinch valve (32) includes a manually operated bonnet (4) arranged and configured to move the actuator (7). Regarding Claim 37, Welch teaches the actuator (7) contacts and pinches the conduit (12) to adjust the flow therethrough. Regarding Claim 38, Fleming teaches discloses the actuator (65, 66) is configured to adjust a flow of fluid through the conduit (18) by adjusting the effective diameter or cross-sectional area of the lumen in the conduit (18). 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 Daphne Barry whose telephone number is (571)272-9966 and fax number is (571) 273-9966. The examiner can normally be reached on Monday through Friday 9 AM-6 PM (eastern). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor either Kenneth Rinehart can be reached at (571) 272-4881 or Craig Schneider can be reached at (571) 272-3607. 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 Patent Center and the Private Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from Patent Center or Private PAIR. Status information for unpublished applications is available through Patent Center and Private PAIR to authorized users only. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form. /DAPHNE BARRY/Primary Examiner, Art Unit 3753
Read full office action

Prosecution Timeline

Jul 11, 2025
Application Filed
Sep 17, 2025
Response after Non-Final Action
Jul 28, 2026
Non-Final Rejection mailed — §103, §112
Aug 27, 2026
Response Filed
Oct 06, 2026
Final Rejection mailed — §103, §112
Oct 07, 2026
Response after Non-Final Action

Precedent Cases

Applications granted by this same examiner with similar technology

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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
76%
Grant Probability
99%
With Interview (+28.3%)
2y 6m (~1y 2m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 747 resolved cases by this examiner. Grant probability derived from career allowance rate.

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