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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Species B, claims 1-4 and 8-15 in the reply filed on November 13th 2025 is acknowledged.
Claims 5-7 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 13th 2025.
Specification
The disclosure is objected to because of the following informalities: “one or more assembled constraint members 405”, in line 1 of [0301], should be corrected to “one or more assembled constraint members 1705”. Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: reference numerals 2702a, 2712, and 2723 are not in the written description. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the constraint profile being substantially asymmetric, subject matter of claim 9, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 11 is objected to because of the following informalities: Regarding claim 11, all instances of “the apparatus” should be corrected to “the modular constrain assembly”, all instances “the constraint” should be corrected “the constraint member”, “a medication administration temperature” should be corrected to “the medication administration temperature”, and “the flow rate” should be corrected to “the calibrated flow rate” for claim language consistency.
Appropriate correction is required.
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.
Claim(s) 1-4 and 8-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hu (US 4685654 A).
Regarding claims 1-2, Hu discloses a modular constraint assembly (a flow regulator, abstract and Col 2 lines 30-33 & Fig. 1-5C) connectable to a tubing set for use in medication delivery (projections 11 and 12 configured for connection with an upstream and downstream hose for drip infusion, see abstract, claim 1, and Col 2 lines 30-33 & Fig. 1 and 6) comprising: a constraint member (main body 1 and ridge e’, Col 2 lines 30-51 & Fig. 1-2 and 4A-4C) comprising a constraint profile (groove 14 having a V-shaped section, which is being interpreted as a constraint profile, Col 2 lines 36-40 & Fig. 1 and 5A-5C; the profile of Fig. 5B, with the V-shaped orifice partially occupied by ridge e’, is an exemplary constraint profile, see Col 3 lines 46-50), a distal aperture, and a proximal aperture defining a lumen having a first diameter (hole 122 and hole 112 having a diameter which is being interpreted as the first diameter, Col 2 lines 36-40 & Fig. 4A-4C),
where the constraint profile defines a restricted lumen having a second diameter (the V-shaped section defined by groove 14 defines a restricted lumen having a second, smaller diameter, as seen in Fig. 4A-4C and 5A-5C & Col 2 lines 49-53 and Col 3 lines 46-50); a distal connector in fluid communication with the distal aperture; and a proximal connector in fluid communication with the proximal aperture (projections 11 and 12 in fluid communication with holes 122 and 112 through canals 121 and 111, Col 2 lines 33-41 & Fig. 1 and 4A-4C), wherein the first diameter is greater than the second diameter (the diameter of hole 112 is seen as greater than the diameter of groove 14 in the partially occupied position, see Fig. 4A-4c and 5B and Col 3 lines 44-50),
and wherein the constraint profile is configured with a predetermined shape to achieve a calibrated flow rate for a fluid medication at a specific concentration and at a medication administration temperature. (“When the knob is turned in a forward direction, the flexible disc (2) is pressed by plunger (d') and deformed, and the V-shaped orifice is partially occupied by the deformed ridge (e'), and the flow rate is reduced. (See FIG. 4B and FIG. 5B).”, Col 3 lines 45-50 & Fig. 5B; “When the disc (2) is pressed, part of the ridge (e') is pushed into the groove (14) to partially or totally block the groove (14), thus the dripping rate can be controlled. From experimental data, it can be seen that the V-shaped cross section is by far the best shape to give a constant flow rate, and the omega-shaped meander can further enhance the stability of the flow. As stated hereinbefore, an ideal control can be achieved when the ridge is perpendicular to the flow path which is to be squeezed by the ridge. Accordingly, a constant, steady, and finely adjustable dripping can be achieved using the present invention.”, Col 2 lines 49-60; the shape of groove 14 would necessarily yield a flow rate for a given substance at a given temperature).
Regarding claim 3, Hu discloses all the limitations of claim 1. Hu further discloses the modular constraint assembly wherein the distal and proximal connectors are integral to the constraint member (“that the main body (1) is a hollow, rigid cylinder with two diametrically opposite projections (11 and 12) for connecting with the upstream hose and downstream hose.”, Col 2 lines 30-34 & Fig. 4A-4C; projections 11 and 12 are integrally formed to main body 1).
Regarding claim 4, Hu discloses all the limitations of claim 1. Hu further discloses the modular constraint assembly wherein the distal and proximal connectors are each connected to flexible tubing connected to the constraint member (“…two diametrically opposite projections (11 and 12) for connecting with the upstream hose and downstream hose.”, Col 2 lines 30-34 & Fig. 4A-4C and 6).
Regarding claim 8, Hu discloses all the limitations of claim 1. Hu further discloses the modular constraint assembly wherein the constraint profile is substantially symmetric (V-shaped section defined by groove 14 is seen being substantially symmetric, see Fig. 4A-4C and 5A-5C).
Regarding claim 9, Hu discloses all the limitations of claim 1. Hu further discloses the modular constraint assembly wherein the constraint profile is substantially asymmetric (V-shaped section defined by groove 14 is seen being substantially asymmetric with respect to its horizontal axis, see Fig. 5A-5C).
Claim Rejections - 35 USC § 103
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.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hu (US 4685654 A) as applied to claim 4 above, and further in view of Wilson (US 5916201 A).
Regarding claim 10, Hu discloses all the limitations of claim 4. However, Hu fails to explicitly disclose the modular constraint assembly further comprising a clamping feature slidable between two positions, where the clamping feature is configured to either fully stop fluid flow in a first position or allow fluid flow in a second position.
However, Wilson teaches a modular constraint assembly (slide clamp 24 and roll-type clamp 25 can be interpreted as a modular constraint assembly of solution set 10, Col 3 second paragraph & Fig. 1) further comprising a clamping feature slidable between two positions, where the clamping feature is configured to fully stop fluid flow in a first position (slide clamp 24 capable of sliding into a pinch position in which flow is fully stopped, Col 3 second paragraph).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the assembly of Hu with Wilson to include a clamping feature slidable between two positions, where the clamping feature is configured to fully stop fluid flow in a first position, since such a modification would allow a user to completely shut off flow (Col 3 lines 36-41) in case of assembly failure or other device operational error.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hu (US 4685654 A) as applied to claim 1 above, and further in view of Abal (US 20120179142 A1).
Regarding claims 11-13, Hu discloses all the limitations of claim 1. However, Hu fails to explicitly disclose the modular constraint assembly wherein an outside surface of the constraint member or an outer housing containing the constraint member is provided with one or more indicia related to use or manufacture of the apparatus, wherein the one or more indicia comprises one or more of: a tubing set outer diameter, a tubing set material, a tubing set material lot code, a constraint material lot code, one or more internal batch control numbers, a number of fluid lumens disposed within the tubing set, a tubing set medication lumen diameters, a tubing set medication lumen arrangement within the tubing set cross section, a number of electrical conductors disposed within the tubing set, a number of optical conductors disposed within the tubing set, a name of the medication name, a medication dose, the medication concentration, a medication lot number, a medication expiration date, a numeric medication flow rate corresponding to the constraint, an ordinal identifier of the flow rate corresponding to the constraint, a medication administration temperature corresponding to the flow rate, a presence or absence of a clamping device in the apparatus, a tubing set apparatus lot code, a tubing set apparatus serial number or unique device identifier, a tubing set apparatus Global Trade Item Number (GTIN), or a tubing set apparatus expiration date,
wherein the one or more indicia further comprises a machine-readable encoding or a human readable encoding or a scannable QR code, and
wherein the one or more indicia further comprises a near-field communication or radiofrequency identification chip.
However, Abal teaches a modular constraint assembly (infusion tubing fitment 150, [0019] & Fig. 2) wherein an outside surface of the constraint member is provided with one or more indicia related to use of the apparatus, wherein the one or more indicia comprises a tubing set apparatus unique device identifier (identification mechanism 710A, tag 710B, bar code 710C, are all example of indicia provided on an outer surface of fitment 150, “It is appreciated that one or more or these or other identification mechanisms 710 may be employed independently or in combination.”, [0037] & Fig. 6-7B; “In one embodiment, such a unique identifier of an identification mechanism 710 can be used for auditing stock, or otherwise keeping track of IV infusion tubing fitment(s) 150 or IV infusion set(s) 100 in which IV infusion tubing fitment 150 is included.”, [0037] and see [0038]), wherein the one or more indicia further comprises a machine-readable encoding (bar code 710C, [0037] & Fig. 7B), and wherein the one or more indicia further comprises a radiofrequency identification chip (RFID tag 710b, [0037] & Fig. 7B).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the assembly of Hu with Abal to include an outside surface of the constraint member provided with one or more indicia related to use of the apparatus, wherein the one or more indicia comprises a tubing set apparatus unique device identifier, wherein the one or more indicia further comprises a machine-readable encoding, and wherein the one or more indicia further comprises a radiofrequency identification chip,
since such a modification would allow a user to keep track of the modular constraint assembly and/or the infusion set to be used with it and distinguish between modular constraint assemblies used for specific treatment, as well as provide means for identification between multiple modular constraint assemblies (see [0037]-[0038] of Abal).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hu (US 4685654 A) as applied to claim 1 above, and further in view of Bae (KR 20170041393 A).
Regarding claim 14, Hu discloses all the limitations of claim 1. However, Hu fails to explicitly disclose the modular constraint assembly wherein an outside surface of the constraint member or an outer housing containing the constraint member further comprises a plurality of shapes, where the plurality of shapes corresponds to a different dose or type of medication.
However, Bae teaches a modular constrain assembly (flow-controlled drug dose controller 10, [0028] & Fig. 1) wherein an outside surface of the constraint member further comprises a plurality of shapes (display portion 19 comprising a numerical portion 19a and a hue portion 19b, both defining two separate shapes as seen in Fig. 3, also see [0047]), where the plurality of shapes corresponds to a different dose (“The display portion 19 may include a numerical portion 19a indicating a dose and a hue portion 19b corresponding to the numerical portion 19a. Where the numerical portion 19a corresponding to the dose can correspond to the diameter of the through hole 16a of the orifice 16”, [0047] & Fig. 3).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the assembly of Hu with Bae to include an outside surface of the constraint member further comprises a plurality of shapes, where the plurality of shapes corresponds to a different dose, since such a modification would provide a display to indicate to a user the size of the constraint profile ([0047]-[0048] of Bae)
Regarding claim 15, Hu discloses all the limitations of claim 1. However, Hu fails to explicitly disclose the modular constraint assembly wherein an outside surface of the constraint member or an outer housing containing the constraint member further comprises a plurality of colors, where the plurality of colors corresponds to a different dose or type of medication.
However, Bae teaches a modular constrain assembly (flow-controlled drug dose controller 10, [0028] & Fig. 1) wherein an outside surface of the constraint member further comprises a plurality of colors, where the plurality of colors corresponds to a different dose (display unit 19 in the form of a sticker, as seen in Fig. 6, containing multiple colors corresponding to a drug dose, [0049] & Fig. 6). Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the assembly of Hu with Bae to include an outside surface of the constraint member further comprises a plurality of colors, where the plurality of colors corresponds to a different dose since such a modification would provide a display to indicate to a user the size of the constraint profile ([0047]-[0048] of Bae)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Isaacson (US 20200316292 A1) teaches “fluid flow rate may be determined based on a temperature difference between the upstream point and the downstream point.” ([0046]);
Dia (CN 112587757 A) teaches a transfusion device (Fig. 1) including a flow rate controller 3 including a flow speed controller/tube 31 having a set structure to control infusion stability and speed (page 3 paragraphs 1-2 & Fig. 1-2). The capillary tube 31 is made of quartz glass cylinder 32 which has heat preservation characteristics (page 3 paragraph 3 & Fig. 2); and
Woodson (US-3685786-A).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783