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 and Species A in the reply filed on February 9th 2026 is acknowledged.
Claims 5 and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.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 February 9th 2026.
Claim Objections
Claims 1-3, 6-7, 13, 15, and 17-19 are objected to because of the following informalities:
Regarding claim 1, “the chamber” should be corrected to “the central chamber” for claim language consistency
Regarding claim 2, “comprising housing” should be corrected to “comprising the housing manifold” for claim language consistency.
Regarding claims 3 and 15, “contact all” should be corrected to “contact with all” or similarly for clarity.
Regarding claims 6-7, “the chamber” should be corrected to “the central chamber” for claim language consistency.
Regarding claim 13, “at least one of the syringe ports” should be corrected to “at least one of the plurality of syringe ports” for claim language consistency.
Regarding claim 17, “the housing” should be corrected to “the housing manifold” for claim language consistency. The period should be removed after “16”.
Regarding claim 18, all recitations of “the central chamber” should be corrected to “the cylindrical central chamber”, “the housing” should be corrected to “the housing manifold”, all recitations of “the tube” should be corrected to “the elastomeric tube” for claim language consistency.
Regarding claim 19, “the syringe ports” should be corrected to “the plurality of syringe ports” for claim language consistency.
Appropriate correction is required.
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 3-4 and 14-20 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.
Regarding claims 3 and 15, the limitation of “any of them when fluid is dispensed out of its corresponding runner” renders the claim indefinite and unclear. The term “any of them” and “its” does not create clear connection between corresponding structure. The Examiner recommends amending the claim limitation to read “any of the runner outlets [[them]] when fluid is dispensed out of [[its]] a corresponding one of the plurality of manifold runners” or similarly to clearly define corresponding structure in the claim.
Regarding claim 14, the limitation of “at least one of the respective one-way valves” and “when fluid is dispensed out of its corresponding runner” renders the claim indefinite and unclear. First, there is insufficient antecedent basis for the limitation of “at least one of the respective one-way valves” in the claim. Claim 1 introduces “a one-way valve”, not one-way valves. The Examiner recommends either amending claim 1 or claim 14 to create a clear connection between the valve(s) and clearly define how many valves there are. Secondly, the term “its” does not create clear connection between corresponding structure. The Examiner recommends amending the claim limitation to read “when fluid is dispensed out of [[its]] a corresponding one of the plurality of manifold runners” or similarly to clearly define corresponding structure in the claim.
Regarding claim 18, the limitation of “when fluid is dispensed out of its corresponding runner” renders the claim indefinite and unclear. The term “its” does not create clear connection between corresponding structure. The Examiner recommends amending the claim limitation to read “when fluid is dispensed out of [[its]] a corresponding one of the plurality of manifold runners” or similarly to clearly define corresponding structure in the claim.
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, 6-9, and 14-18 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stone (US 4666429 A).
Regarding claim 1, Stone discloses a multi-port distribution hub for a vascular access device (VAD) (valving apparatus 50 for vascular infusion device including needle 14, Col 3 lines 26-35 and Col 5 lines 17-28 & Fig. 1 and 11-13), comprising: a housing manifold (fluid addition device 52, Col 5 lines 17-38 & Fig. 11-13) defining therein: a central chamber (passageway 58, Col 5 lines 17-38 & Fig. 11-13);
a plurality of manifold runners, respectively having runner outlets on proximal ends thereof, in fluid communication with the central chamber, and respectively having runner inlets on distal ends thereof (one or more secondary inlets 54 comprising secondary fluid passage 56 and restricted fluid passage 57, Col 5 lines 17-38 & Fig. 11-13; passage 57 of each inlet 54, which is being interpreted as a runner outlet, is in fluid communication with passage 58; passage 56 of each inlet 54 is being interpreted as runner inlets, Col 5 lines 39-48); a plurality of syringe ports respectively in fluid communication only with a corresponding runner inlet (“fluid addition device 52 has secondary inlet 54 therein (one or more secondary inlets can be provided in the same manner as described in connection with conduit 16 of embodiment 20 of the valving apparatus”, Col 5 lines 17-22 & Fig. 1-3, 5, and 11-13; “valving apparatus 20 includes a tubular spacer 33… having an outer end 34 adapted to connect with secondary conduit 19 (which can be the nozzle of syringe 18, for example).”, Col 4 lines 18-23 & Fig. 3; each inlet 54 includes outer end 34 configured to connect to a syringe); and
a patient access port in fluid communication with the chamber (connector 25 connected to the valving apparatus is in fluid communication with passage 58 and tubing 12 connected to a patient, Col 3 line 65-Col 4 line 11 and Col 3 lines 26-35 & Fig. 1-3 and 11-13); and a one-way valve corresponding to and interposed between each respective runner outlet and the central chamber, for isolating each runner from fluid backflow (elastomeric member 62 acting as a one-way valve corresponding to and interposed between passage 57 and passage 58 for preventing backflow, Col 5 lines 29-48 & Fig. 11-13).
Regarding claim 2, Stone discloses all the limitations of claim 1. Stone further discloses the distribution hub further comprising housing defining a cylindrical central chamber having a chamber central axis (inner wall 60 of device 52 defines cylindrical passageway 58, Col 5 lines 17-48 & see Fig. 11-13; the cylindrical central portion of passage 58 includes a central axis, see Fig. 3 and 11-13).
Regarding claims 3 and 15, Stone discloses all the limitations of claims 1-2. Stone further discloses the distribution hub further comprising a unitary one-way valve, oriented within the central chamber (elastomeric member 62 acting as a one-way valve and positioned within passage 58, Col 5 lines 29-48 & Fig. 11-13) that is biased into sealing contact all of the runner outlets and deflects out of contact with any of them when fluid is dispensed out of its corresponding runner (“As indicated in FIG. 12, when no secondary fluid is flowing through passages 56 and 57 of secondary inlet 54, flap 65 seals the inlet against flow of fluid from the primary fluid passage 58 into the secondary inlet. As shown in FIG. 13, however, when secondary fluid is caused to flow through secondary inlet passages 56 and 57, flap 65 is displaced inwardly, from its normal position adjacent to the inner wall of the primary fluid passage, to allow the secondary fluid to be inserted into the primary fluid passage.”, Col 5 lines 39-48 & Fig. 11-13).
Regarding claims 4 and 16-17, Stone discloses all the limitations of claims 3 and 15. Stone further discloses the distribution hub the unitary one-way valve further comprising an elastomeric tube in abutting contact with a wall of the housing that defines the central chamber (elastomeric member 62, which may be interpreted as a covered passageway or a hollow recess, a tunnel, or a tube, is in contact with inner wall 60 of device 52, which defines passage 58, Col 5 lines 16-48 & Fig. 11-13), with the chamber central axis oriented coaxially with a central axis of the patient access port (the cylindrical central portion of passage 58 including the central axis is oriented coaxially with a central axis of connector 25, see Fig. 3 and 11-13.
Regarding claims 6-7, Stone discloses all the limitations of claims 1-2. Stone further discloses the distribution hub further comprising the respective distal ends of the plurality of manifold runners radially projecting away from the chamber (passage 56 of each inlet 54, which is being interpreted as runner inlets, define the distal ends of inlets 54, Col 5 lines 39-48 & Fig. 11-13; the distal ends of inlets 54 project radially away from passage 58).
Regarding claim 8, Stone discloses all the limitations of claim 1. Stone further discloses the distribution hub further comprising at least three manifold runners and respective corresponding syringe ports (“fluid addition device 52 has secondary inlet 54 therein (one or more secondary inlets can be provided in the same manner as described in connection with conduit 16 of embodiment 20 of the valving apparatus”, Col 5 lines 17-22 & Fig. 1-3, 5, and 11-13; “fluid addition device 16 (which forms a part of the overall valving structure) is illustrated to allow one or two secondary conduits to be connected with the primary conduit established through device 16 (as indicated in FIG. 2… device 16 could be modified, if desired, to provide additional secondary conduit junctions”, Col 3 line 68-Col 4 line 7 & Fig. 1-3 and 11; the fluid addition device can include three secondary conduit junctions as is explicitly contemplated by Stone, which would each include corresponding outer ends 34, see Fig. 1-3, 5, and 11-13).
Regarding claims 9, Stone discloses all the limitations of claim 1. Stone further discloses the distribution hub, the patient access port comprising a catheter port (connector 25 connecting to tubing 12 connected to needle 14, Col 3 line 65-Col 4 line 11 and Col 3 lines 26-35 & Fig. 1-3 and 11-13; connector 25 capable of connecting to a catheter to infuse a drug; “Infusion devices are well known, and have therefore been shown herein only to the extent necessary to better illustrate the invention.”, Col 3 lines 32-25).
Regarding claim 14, Stone discloses all the limitations of claim 1. Stone further discloses the distribution hub at least one of the respective one-way valves comprising a pliable membrane oriented within the central chamber (elastomeric member 62 acting as a one-way valve and positioned within passage 58, Col 5 lines 29-48 & Fig. 11-13) that is biased into sealing contact with a runner outlet and deflects out of contact therewith when fluid is dispensed out of its corresponding runner (“As indicated in FIG. 12, when no secondary fluid is flowing through passages 56 and 57 of secondary inlet 54, flap 65 seals the inlet against flow of fluid from the primary fluid passage 58 into the secondary inlet. As shown in FIG. 13, however, when secondary fluid is caused to flow through secondary inlet passages 56 and 57, flap 65 is displaced inwardly, from its normal position adjacent to the inner wall of the primary fluid passage, to allow the secondary fluid to be inserted into the primary fluid passage.”, Col 5 lines 39-48 & Fig. 11-1).
Regarding claim 18, Stone discloses a multi-port distribution hub for a vascular access device (valving apparatus 50 for vascular infusion device including needle 14, Col 3 lines 26-35 and Col 5 lines 17-28 & Fig. 1 and 11-13), comprising: a unistructural, homogeneous, mono-block, housing manifold (fluid addition device 52 defines a unistructural, homogeneous, mono-block, housing, Col 5 lines 17-38 & see Fig. 11-13) defining therein:
a cylindrical central chamber (the cylindrical portion of passageway 58, the portion in which fluid flows, defined by inner wall 60 is being interpreted as a cylindrical central chamber, Col 5 lines 17-48 & Fig. 11-13);
a plurality of manifold runners, respectively having runner outlets on proximal ends thereof, in fluid communication with the central chamber, and respectively having runner inlets on distal ends thereof (one or more secondary inlets 54 comprising secondary fluid passage 56 and restricted fluid passage 57, Col 5 lines 17-38 & Fig. 11-13; passage 57 of each inlet 54, which is being interpreted as a runner outlet, is in fluid communication with passage 58; passage 56 of each inlet 54 is being interpreted as runner inlets, Col 5 lines 39-48);
a plurality of syringe ports respectively in fluid communication only with a corresponding runner inlet (“fluid addition device 52 has secondary inlet 54 therein (one or more secondary inlets can be provided in the same manner as described in connection with conduit 16 of embodiment 20 of the valving apparatus”, Col 5 lines 17-22 & Fig. 1-3, 5, and 11-13; “valving apparatus 20 includes a tubular spacer 33… having an outer end 34 adapted to connect with secondary conduit 19 (which can be the nozzle of syringe 18, for example).”, Col 4 lines 18-23 & Fig. 3; each inlet 54 includes outer end 34 configured to connect to a syringe); and a patient access port in fluid communication with the central chamber (connector 25 connected to the valving apparatus is in fluid communication with passage 58 and tubing 12 connected to a patient, Col 3 line 65-Col 4 line 11 and Col 3 lines 26-35 & Fig. 1-3 and 11-13); and
a unitary, elastomeric tube in abutting contact with a wall of the housing that defines the central chamber (elastomeric member 62, which may be interpreted as a covered passageway or a hollow recess, a tunnel, or a tube, is in contact with inner wall 60 of device 52, which defines passage 58, Col 5 lines 16-48 & Fig. 11-13), the tube interposed between each respective runner outlet and the central chamber, for isolating each runner from fluid backflow, the tube functioning as a one-way valve (elastomeric member 62 acting as a one-way valve corresponding to and interposed between passage 57 and passage 58 for preventing backflow, Col 5 lines 29-48 & Fig. 11-13), which deflects out of contact with any of the respective runner outlets when fluid is dispensed out of its corresponding runner (“As indicated in FIG. 12, when no secondary fluid is flowing through passages 56 and 57 of secondary inlet 54, flap 65 seals the inlet against flow of fluid from the primary fluid passage 58 into the secondary inlet. As shown in FIG. 13, however, when secondary fluid is caused to flow through secondary inlet passages 56 and 57, flap 65 is displaced inwardly, from its normal position adjacent to the inner wall of the primary fluid passage, to allow the secondary fluid to be inserted into the primary fluid passage.”, Col 5 lines 38-48 & Fig. 11-13).
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) 10-12 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stone (US 4666429 A) as applied to claims 1 and 18 above, and further in view of Thomsen (US 4908018 A).
Regarding claims 10, Stone discloses all the limitations of claim 1. Stone further discloses the distribution hub the patient access port comprising a port (connector 25 connecting to tubing 12 connected to needle 14, Col 3 line 65-Col 4 line 11 and Col 3 lines 26-35 & Fig. 1-3 and 11-13) but fails to explicitly disclose the patient access port comprising a threaded Luer connector.
However, Thomsen teaches a distribution hub (intravenous assembly 42, Fig. 1) wherein the patient access port comprises a threaded Luer connector (output end 54 comprising male lure tapered bore 60 and threaded nut 102, Col 8 last line-Col 9 lines 1-5 & Fig. 1-3).
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 patient access port of Stone with Thomsen to include a threaded Luer connector since Thomsen teaches a threaded Luer connector to be an art effective coupling for a port of a distribution hub to medical tubing connected to a patient (see Col 7 line 65-Col 8 line 7 & Fig. 1).
Regarding claims 11-12, Stone discloses all the limitations of claim 1. However, Stone fails to explicitly disclose the distribution hub, the plurality of syringe ports comprising threaded Luer connectors.
However, Thomsen teaches a distribution hub (intravenous assembly 42, Fig. 1), the plurality of syringe ports comprising threaded Luer connectors (valve bodies 72 comprising threaded teeth 106 and lure conical tapers 78 for coupling to syringes, see Col 10 lines 29-33 & Fig. 1-3; “Threaded teeth 106 may also be provided on the ends of the valve bodies 72 for coupling with rotatable nuts, similar to those as described above, as are often provided on syringes.”; “The upper interior portion of the body, radially exterior of the riser, has an internal female conical taper 78, again of 6 percent representing the conventional industry standard, for the receipt of the needleless end 82 of a syringe 84. Taper 78 is configured and sized so that an inserted syringe 84 extends therein to an intermediate point along the length of the taper.”, Col 9 lines 30-37).
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 plurality of syringe ports of Stone with Thomsen to include threaded Luer connectors since Thomsen teaches threaded Luer connectors to be art effective coupling means for ports of a distribution hub to syringes (see Col 9 third paragraph and Col 10 second paragraph).
Regarding claim 19, Stone discloses all the limitations of claim 18. However, Stone fails to explicitly disclose the distribution hub, the syringe ports and/or the patient access port further comprising a threaded Luer connector.
However, Thomsen teaches a distribution hub (intravenous assembly 42, Fig. 1), the plurality of syringe ports comprising threaded Luer connectors (valve bodies 72 comprising threaded teeth 106 and lure conical tapers 78 for coupling to syringes, see Col 10 lines 29-33 & Fig. 1-3; “Threaded teeth 106 may also be provided on the ends of the valve bodies 72 for coupling with rotatable nuts, similar to those as described above, as are often provided on syringes.”; “The upper interior portion of the body, radially exterior of the riser, has an internal female conical taper 78, again of 6 percent representing the conventional industry standard, for the receipt of the needleless end 82 of a syringe 84. Taper 78 is configured and sized so that an inserted syringe 84 extends therein to an intermediate point along the length of the taper.”, Col 9 lines 30-37) and/or the patient access port further comprising a threaded Luer connector (output end 54 comprising male lure tapered bore 60 and threaded nut 102, Col 8 last line-Col 9 lines 1-5 & Fig. 1-3).
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 plurality of syringe ports and the patient access port of Stone with Thomsen to include threaded Luer connectors since Thomsen teaches threaded Luer connectors to be art effective coupling means for ports of a distribution hub to syringes and medical tubing connected to a patient (see Col 9 third paragraph, Col 10 second paragraph, and Col 7 line 65-Col 8 line 7 & Fig. 1).
Regarding claim 20, Stone, as modified, discloses all the limitations of claim 19. Stone further discloses the distribution hub further comprising at least three manifold runners (“fluid addition device 52 has secondary inlet 54 therein (one or more secondary inlets can be provided in the same manner as described in connection with conduit 16 of embodiment 20 of the valving apparatus”, Col 5 lines 17-22 & Fig. 1-3, 5, and 11-13; “fluid addition device 16 (which forms a part of the overall valving structure) is illustrated to allow one or two secondary conduits to be connected with the primary conduit established through device 16 (as indicated in FIG. 2… device 16 could be modified, if desired, to provide additional secondary conduit junctions”, Col 3 line 68-Col 4 line 7 & Fig. 1-3 and 11; the fluid addition device can include three secondary conduit junctions as is explicitly contemplated by Stone), each with a corresponding threaded Luer connector-type, syringe access port (as modified in claim 19, each outer end 34 of inlets 54 would include corresponding threaded teeth 106 and Luer connector taper 78 of Thomsen, see Fig. 1 and 3 of Stone and Fig. 2-3 of Thomsen).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stone (US 4666429 A) as applied to claims 1 above, and further in view of Grant (US 20210146114 A1).
Regarding claim 13, Stone discloses all the limitations of claim 1. However, Stone fails to explicitly disclose the distribution hub, further comprising at least one peel tab covering at least one of the syringe ports and/or the patient access port. However, Grant teaches at least one peel tab covering at least one of the syringe ports (Y-site vascular access port 3/ 72 capable of attaching to a syringe, [0049] and [0063] & Fig. 1 and 6A-6B, including a cap 70 that is configured to be pulled off using pull tab 80, [0063]-[0067] & Fig. 6C).
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 device of Stone with Grant to include at least one peel tab covering at least one of the syringe ports since such a modification would provide structure to cover and protect the access port prior to use ([0017] and [0023] of Grant). As modified, cap 70 would be included on at least one of inlets 54 of Stone.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Wahlberg (US-6003553-A) and Nelson (US-10369349-B2).
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.
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, 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 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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