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 .
Status of Claims
Amendment to the Claims was filed on 9/17/2025.
Claims 1-20 were canceled. Claims 21-38 were newly added.
Claims 21-38 are currently pending.
Information Disclosure Statement
The information disclosure statements filed on 9/16/2025 is acknowledged by the examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 12372156. Although the claims at issue are not identical, they are not patentably distinct from each other because US Patent No. 12372156 is narrower because it contains further limiting claim limitations.
The claims at issue:
US Patent No. 12372156 Application
1, 12, 20 21, 27, 33
4, 14 22, 28, 34
5, 14 23, 29, 35
6, 15 24, 30, 36
7 25, 31, 37
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 21-38 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.
Claim 21 line 9-10, Claim 27 lines 9-10, and Claim 33 lines 11-12 recite “actuator is angled relative to the valve passageway to minimize a hold-up volume within the two-part valve. It is unclear what is meant by the phrase “to minimize a hold-up volume”. “[H]old-up volume” is not disclosed in the Specification.
Claim 21 line 7, Claim 27 line 7, and Claim 33 line 9 recite “a first flange at one end thereof”, It is unclear which at one end “thereof” refers to.
Claims 22-26 are rejected based on their dependency on Claim 21.
Claims 28-32 are rejected based on their dependency on Claim 27.
Claims 34-38 are rejected based on their dependency on Claim 33.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 21-38 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Welch et al. (US PG PUB 20060048818, hereinafter “Welch”).
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 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 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.”).
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WELCH – FIGURES 11 and 12
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 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.”).
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 (i.e., changing from AIA to pre-AIA ) 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, 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 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”).
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.
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, teaches 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. “).
Conclusion
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.
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/DAPHNE BARRY/Primary Examiner, Art Unit 3753
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