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 Amendment
Amended claims filed July 23, 2026 are acknowledged.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: tabs 137 on page 7, line 10 of the filed specification. 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. 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 detachable tab and a puncturable membrane attached to the IV connector distal of the IV port, content of claim 35, 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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the first channel having a constant width from the IV port to the partition where the bifurcated junction body joins the IV connector, content of claim 24, needs proper antecedent basis provided in the specification and an interior diameter of the first channel does not exceed a diameter of an exterior of the patient IV line, content of claim 34, needs proper antecedent basis provided in the specification.
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 44-45 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 claim 44, it is unclear whether the “a first channel” and “a second channel” are the same or different than those of claim 24, from which claim 44 depends. Furthermore, the phrase “enclosing” is indefinite as there is no figure or description within the current application that could be found that shows the first channel disposed as an enclosed closed tubular volume within an enclosed tubular volume of a second channel or description of the specification that applies under the typical meaning of “enclosed,” being interpreted under the meaning of surrounded or closed in. Additional, such language in reference to this limitation does not appear within the specification, making the meaning further unclear.
Regarding claim 45, the limitation “below” renders the claim indefinite as the description of the flange between the bifurcated junction portion and the bag spike, along with the drawings, suggest above the bifurcated junction, like in Figures 4-6, not “below,” as it does not seem in Figure 5 that the flange could be below the bifurcated junction and also between the bifurcated junction portion and the bag spike.
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 34, 37, and 44 are 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.
Regarding claim 34, the originally filed claims and specification of August 10, 2024 do not disclose “an interior diameter of the first channel does not exceed a diameter of an exterior of the patient IV line,” as nowhere does the disclosure state such limitations, nor does the disclosure show the entirety of a patient IV line along with the diameter of the first channel.
Regarding claim 37, the originally filed claims and specification of August 10, 2024 do not disclose “the IV port is configured to engage the patient IV line via a slidable engagement,” as nowhere does the disclosure state such or show such limitations.
Regarding the limitation 44, the originally filed claims and specification of August 10, 2024 do not disclose “a first channel disposed as an enclosed closed tubular volume within an enclosed tubular volume of a second channel,” as nowhere does the disclosure state such limitations or show such limitations. The closest is in Figure 11B, but it is not clear from that drawing whether the first channel 210 actually encloses second channel 220 as claimed, as this is not actually described and there is only a side view shown, which could be interpreted as two channels merely side by side in the upper half and not the first channel enclosed within an enclosed tubular volume of the second channel.
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.
Claim(s) 24-34, 36-40, 42, and 45-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallen (US 2003/0191445), submitted in the IDS of February 11, 2025, in view of Lev (US 2016/0166824), submitted in the IDS of February 11, 2025,.
Regarding claim 24, Wallen discloses an intravenous (IV) inline dispensing device (see Fig. 2a, 3-4), comprising: an IV connector having a bifurcated junction body extending therefrom (see Fig. 4), the bifurcated junction body extending to a receptacle 102 configured for receiving a medicinal container 124, 125 (see Fig. 4); the IV connector extending from a bag spike 114 at one end to an IV port 103, alternatively membrane 118, at an opposing end (see Figs. 2a, 4), the IV port configured for receiving a patient IV line 214, 215 (see Fig. 4); and the bag spike having a first orifice and a second orifice and configured for insertion into a fluid reservoir defined by an IV bag 120 for fluid communication with the first and second orifices (see Figs. 3,4, with Fig. 2a annotated below and par. 42); a first channel extending in direct and continuous fluid communication from the first orifice to the IV port (see Figs. 2a-4 with Fig. 2a, annotated below); a second channel extending in direct and continuous fluid communication from the second orifice to the receptacle (see Figs. 2a-4 with Fig.2a annotated below), a partition extending within the IV connector in parallel between the first channel and the second channel for providing fluidic separation when the first channel and the second channel run parallel (see Fig. 3, annotated below); and a transfer channel defined by the bifurcated junction body where a portion of the second channel forms an angled branch to the receptacle (see Fig. 2a, annotated below).
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Wallen does not teach the medicinal container being a medicinal vial; the receptacle having a vial spike extending from the second channel and configured for piercing insertion into the medicinal vial.
Lev discloses an intravenous (IV) inline dispensing device (see Figs. 5A-5B) having a barrel configured to fluidly connect to an infusion line (see Fig. 5B, barrel that holds and attaches to IV port 43); a vial adapter 102 in communication with a vial adapter lumen (see Fig. 5B) and having a vial spike 106 (see Fig. 5B), the vial spike being configured to puncture a stopper of a vial containing a medicament (see par. 32), and the vial adapter being configured to receive the vial (see par. 32); and an intravenous (IV) spike 22 configured to be sealingly inserted into an IV administration port of a container of an infusion liquid (see Fig. 5B; par. 31-33). In Lev, the vial adapter allows for injection of a second fluid for mixing with a medicament (see par. 33) and an alternative to the vial adapter could be a syringe 17 with connector 16 (see Fig. 7, par. 36). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute the receptacle and associated medical container 124, 125 of Wallen with vial configuration of Lev, including vial adapter with spike, disclosed by Lev as the substitution of one known element for another would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the connector and vial configuration disclosed by Lev would have yielded predictable results, namely, the ability to attach a different medical container in the form of a vial for the injection of a second fluid for mixing with the medicament within the IV bag for infusion via an IV line to a patient.
Wallen and Lev as disclosed above do not specifically teach the first channel having a constant width from the IV port to the partition where the bifurcated junction body joins the IV connector.
Lev discloses an administration port 43 with membrane 46 for an IV line spike (see Figs. 5A-5B, par. 30), allowing for a 5 mm to 6mm diameter IV spike to be sealingly received (see par. 30). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute the IV port of Wallen with the IV port disclosed by Lev as the substitution of one known element for another would have been obvious to one of ordinary skill in the art since the substitution of the IV port of Wallen with the IV port of Lev would have yielded predictable results, namely, the ability to attach an IV port to the IV inline dispensing device. Additionally, a 5 mm to 6 mm diameter IV spike, known in the art, could be sealingly received.
While Lev does not disclose a constant width from the IV port to the partition, Lev discloses a nearly constant diameter to a partition, though there is a slight variation in diameter (see Fig. 5B). Lev discloses the IV port 43 is a conventional IV port similar to the IV port 11 made in an infusion liquid bag (see par. 25, 30). Wallen discloses an IV port of a liquid bag being a constant diameter (see Figs. 4, 6). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the IV port be constant, as Wallen discloses it is well known to have an IV port that is constant on a liquid bag, Lev discloses having an IV port similar to that on an infusion liquid bag, and such a substitution would have yielded predictable results, mainly the ability to attach an IV spike of an IV line to the IV port.
Regarding claim 25, Wallen and Lev disclose the limitations of claim 24 and Wallen further discloses the first channel and the second channel each have a respective constant width between the first and second orifices and the angled branch (see Figs. 2a, 3-4).
Regarding claim 26, Wallen and Lev disclose the limitations of claim 24, and combined further disclose the first channel has a second constant width between the IV port and the angled branch (see Wallen, Figures 2B, 4), wherein a width of the first channel transitions between the constant width (see Lev, Figs. 5A-5B) and the second constant width where the bifurcated junction body joins the IV connector (see rejection of claim 24 above, for teachings of Lev combined with that of Wallen), as one of ordinary skill would have expected such a transition due to the required constant widths and angled branch.
Regarding claim 27, Wallen and Lev disclose the limitations of claim 24, and Wallen further discloses the first channel defines direct, continuous, unvalved fluid communication between the first orifice and the IV port (see Figs. 3-4 of Wallen which have been modified in light of teachings of Fig. 5A-5B of Lev).
Regarding claim 28, Wallen and Lev disclose the limitations of claim 24, and Wallen further discloses the IV port defines an engagement to a patient TV line for fluid communication and medicinal delivery therewith (see Fig. 4).
Regarding claim 29, Wallen and Lev disclose the limitations of claim 24, and further disclose the first channel defines an absence of a fluidic separation or valved control between the first orifice and the IV port (see Figs. 3-4 of Wallen which have been modified in light of teachings of Fig. 5A-5B of Lev).
Regarding claim 30, Wallen and Lev disclose the limitations of claim 24, and further disclose the IV connector defines a direct and continuous, fixed distance fluid communication between the first orifice and the IV port (see Figs. 3-4 of Wallen which have been modified in light of teachings of Fig. 5A-5B and par. 30 of Lev).
Regarding claim 31, Wallen and Lev disclose the limitations of claim 24, and an exterior width of the part of the IV connector in which the spike of the patient IV line is placed inside is based on the outside diameter of the patient IV line as the spike of the patient IV line must be inside the part of the IV connector (see Fig. 4 of Wallen).
Regarding claim 32, Wallen and Lev disclose the limitations of claim 24 and Wallen further discloses the first channel has an interior width smaller or equal to an outside diameter of the patient IV line (see Fig. 4, interior width of channel near first orifice).
Regarding claim 33, Wallen and Lev disclose the limitations of claim 24 and Wallen and Lev, together, further disclose an interior diameter of the first channel is sized to accommodate a fitting of a patient IV line (see Figs. 3-4 of Wallen which have been modified in light of teachings of Fig. 5A-5B and par. 30 of Lev, all disclosing spike of patient IV line fitting within IV port).
Regarding claim 34, Wallen and Lev disclose the limitations of claim 24 and Wallen further discloses wherein an interior diameter of the first channel does not exceed a diameter of an exterior of the patient IV line (see Fig. 4, an interior of the first channel within the spike does not exceed a diameter of an exterior of the patient IV line shown in the figure).
Regarding claim 36, Wallen and Lev disclose the limitations of claim 24 and Wallen and Lev, together, disclose the first channel is defined by an unobstructed lumen from the first orifice to the TV port (see Fig. 3 of Wallen with membrane 118 interpreted as port and Fig. 5B of Lev with membrane 46 interpreted as port).
Regarding claim 37, Wallen and Lev disclose the limitations of claim 24 and Wallen further discloses the IV port is configured to engage the patient IV line via a slidable engagement (see Figs. 2a and 4, the IV line is slid into the IV port).
Regarding claim 38, Wallen and Lev disclose the limitations of claim 24 and Wallen further discloses the IV port is defined by a fixed, continuous, unmovable engagement with the bag spike (see (see Figs. 3-4 of Wallen which have been modified in light of teachings of Fig. 5A-5B and par. 30 of Lev).
Regarding claim 39, Wallen and Lev disclose the limitations of claim 24 and Wallen further discloses the IV port is in a fixed communication with the IV connector (see Fig. 4).
Regarding claim 40, Wallen and Lev disclose the limitations of claim 24 and further disclose the IV port, bag spike and receptacle are defined by a continuous structure including the first channel and the second channel (see Figs. 3-4 of Wallen which have been modified in light of teachings of Fig. 5A-5B and par. 30 of Lev, structure all connected and allowing for flow throughout).
Regarding claim 42, Wallen and Lev disclose the limitations of claim 24 but do not disclose in the embodiment described above having the transfer channel include a valve for selectively opening and closing the transfer channel for interrupting fluid communication between the second channel and the medicinal vial.
Lev discloses it is well known to use a connector in the form of an additive port 29 (see Fig. 7) that can be connected to either a syringe or a vial adapter with spike (see Fig. 7, par. 36). The additive port includes a valve 32 for selectively opening and closing the transfer channel for interrupting fluid communication between the second channel and the medicinal vial (see Figs. 2A-3B, par. 28-29). Consequently, it would have been obvious to use a connector with vial adapter as disclosed by Lev as the use of a syringe in controlled manner into the additive port can be used with the connector in addition to the vial adapter, allowing for the benefits of both syringes and vials to be used as desired. Consequently, the valve included in the connector would allow for the required functional language of the valve.
Regarding claim 45, Wallen discloses an intravenous (IV) dispensing device (see Figs. 2a, 3-4), comprising: an IV connector having a bag spike 114 at a first end region (see Fig.4), an IV port 103 at a second opposing end region (see Fig. 4), and a bifurcated junction portion that forms a receptacle 102 configured for receiving a medicinal container 124, 125 (see Fig. 4), the IV port being configured for receiving a patient IV line 214, 215 (see Fig. 4), the bag spike including a first orifice and a second orifice (see Figs. 3,4, with Fig. 2a annotated below and par. 42), the bag spike being configured for insertion into a fluid reservoir defined by an IV bag 120 (see Fig. 4); a first channel extending from the first orifice to a distal end of the IV port and for providing direct and continuous fluid communication between the IV bag and the patient IV line (see Figs. 2a-4 with Fig. 2a, annotated below), the first channel being unobstructed so as to provide for an unobstructed flow of fluid between the IV bag and the patient IV line (see Fig. 4); a second channel extending from the second orifice to the bifurcated junction portion and for providing direct and continuous fluid communication (see Figs. 2a-4 with Fig.2a annotated below), a partition extending between the first channel and the second channel for providing fluidic separation between the first channel and the second channel (see Figs. 2a-4 with Fig.2a annotated below); and a transfer channel extending within the bifurcated junction portion to the receptacle, the transfer channel being in fluid communication with the second channel and being at an angle relative to the second channel (see Fig. 2a, annotated below).
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Wallen does not teach the medicinal container being a medicinal vial.
Lev discloses an intravenous (IV) inline dispensing device (see Figs. 5A-5B) having a barrel configured to fluidly connect to an infusion line (see Fig. 5B, barrel that holds and attaches to IV port 43); a vial adapter 102 in communication with a vial adapter lumen (see Fig. 5B) and having a vial spike 106 (see Fig. 5B), the vial spike being configured to puncture a stopper of a vial containing a medicament (see par. 32), and the vial adapter being configured to receive the vial (see par. 32); and an intravenous (IV) spike 22 configured to be sealingly inserted into an IV administration port of a container of an infusion liquid (see Fig. 5B; par. 31-33). In Lev, the vial adapter allows for injection of a second fluid for mixing with a medicament (see par. 33) and an alternative to the vial adapter could be a syringe 17 with connector 16 (see Fig. 7, par. 36). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute the receptacle and associated medical container 124, 125 of Wallen with vial configuration of Lev, including vial adapter with spike, disclosed by Lev as the substitution of one known element for another would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the vial configuration disclosed by Lev would have yielded predictable results, namely, the ability to attach a different medical containers such as a vial for the injection of a second fluid for mixing with the medicament within the IV bag for infusion via an IV line to a patient.
Regarding claim 46, Wallen and Lev disclose claim 45 but as described above do not disclose the device further comprising an outwardly extending flange located on the IV connector adjacent to bifurcated junction portion, the outwardly extending flange being wider than the bag spike and the IV port.
Lev discloses an outwardly extending flange located on an IV connector adjacent to a bifurcated junction portion, the outwardly extending flange being wider than a bag spike and an IV port (see Figs. 2A, 4-5B, flange at bottom of spike), and also explains that such a flange is for restricting insertion into an IV port of an infusion liquid bag (see par. 27). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include such an outwardly extending flange as disclosed by Lev in the device of Wallen in Lev in order to restrict insertion into an IV port, as disclosed by Lev.
Regarding claim 47, Wallen and Lev disclose claim 46 and consequently, a portion of the flange would be located directly above the bifurcated junction portion such that the portion of the flange would be between the bifurcated junction portion and the bag spike (see rejection of claim 46 above and Lev, Figs. 2A, 4-5B and par. 27 requiring positioning to be at bottom of the spike to help with restricting insertion).
Regarding claim 48, Wallen and Lev disclose the limitations of claim 45 and Wallen further discloses the first channel has a constant width along the partition from the first orifice to the bifurcated junction portion (see Fig. 4).
Regarding claim 49, Wallen and Lev disclose the limitations of claim 45 and Wallen further discloses the second orifice is located nearer to a distal end of the bag spike within the first end region than the first orifice (see Figs. 2a, 4).
Regarding claim 50, Wallen and Lev disclose the limitations of claim 45 but do not disclose in the embodiment described above having the transfer channel include a valve for selectively opening and closing the transfer channel for interrupting fluid communication between the second channel and the medicinal vial.
Lev discloses it is well known to use a connector in the form of an additive port 29 (see Fig. 7) that can be connected to either a syringe or a vial adapter with spike (see Fig. 7, par. 36). The additive port includes a valve 32 for selectively opening and closing the transfer channel for interrupting fluid communication between the second channel and the medicinal vial (see Figs. 2A-3B, par. 28-29). Consequently, it would have been obvious to use a connector with vial adapter as disclosed by Lev as the use of a syringe in controlled manner into the additive port can be used with the connector in addition to the vial adapter, allowing for the benefits of both syringes and vials to be used as desired. Consequently, the valve included in the connector would allow for the required functional language of the valve.
Regarding claim 51, Wallen and Lev disclose the limitations of claim 45 and Wallen further discloses the first channel has a first width along the partition from the first orifice to the bifurcated junction portion (see Figs. 2a-4, Fig. 2a annotated above with the portion of the first channel along the spike having a first width) and a second width within the IV port, the second width being larger than the first width (see Figs. 2a, 4 for IV port second width that is larger than the first width).
Regarding claim 52, Wallen and Lev disclose claim 49 but as described above do not disclose the device further comprising an outwardly extending flange located on the IV connector adjacent to an expansion from the first width to the second width within the first channel, the outwardly extending flange being wider than the bag spike and the IV port.
Lev discloses an outwardly extending flange located on an IV connector adjacent an expansion of width of the first channel below at the bifurcation, the outwardly extending flange being wider than a bag spike and an IV port (see Figs. 2A, 4-5B, flange at bottom of spike), and also explains that such a flange is for restricting insertion into an IV port of an infusion liquid bag (see par. 27). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include such an outwardly extending flange as disclosed by Lev in the device of Wallen in Lev in order to restrict insertion into an IV port, as disclosed by Lev.
Lev discloses the port for receiving an about 5 mm to 6 mm diameter IV spike (see par. 30). Furthermore, it would have been obvious to include such an expansion of width as disclosed by Lev with respect to the flange in order to accommodate for such a well-known diameter of an IV spike, which would predictably result in connection to the infusion line.
Regarding claim 53, Wallen discloses an intravenous (IV) dispensing device (see Figs. 2a, 3-4), comprising: an IV connector having a bag spike 114 at a first end region (see Fig. 4), an IV port 103 at a second opposing end region (see Fig. 4), and a bifurcated junction portion that forms a receptacle configured for receiving a medicinal container 124, 125 containing medicine (see Fig. 4), the IV port being configured for receiving a patient IV line 214, 215, the bag spike including a first orifice and a second orifice (see annotated drawing below), the bag spike being configured for insertion into a fluid reservoir defined by an IV bag 120 having fluid therein (see Fig. 4); a first channel extending from the first orifice to a distal end of the IV port and for providing fluid communication between the IV bag and the patient IV line (see Fig. 2a, annotated below and Fig. 4); a second channel extending from the second orifice to the bifurcated junction portion and for providing fluid communication (see Figure 2a annotated below), a partition extending between the first channel and the second channel for providing fluidic separation between the first channel and the second channel (see Fig. 2a annotated below); a transfer channel extending within the bifurcated junction portion to the receptacle, the transfer channel being in fluid communication with the second channel and being at an angle relative to the second channel (see Fig. 2a annotated below), and wherein (i) the fluid IV bag first travels between the IV bag and the medicinal vial along the second channel and the transfer channel so as to allow the fluid to mix with the medicine to form a medicated fluid within the IV bag, and thereafter (ii) the medicated fluid flows from the IV bag to the patient IV line via the first channel in a direct and continuous manner without obstructions within the first channel (see par. 16, 28).
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Wallen does not teach the medicinal container being a medicinal vial.
Lev discloses an intravenous (IV) inline dispensing device (see Figs. 5A-5B) having a barrel configured to fluidly connect to an infusion line (see Fig. 5B, barrel that holds and attaches to IV port 43); a vial adapter 102 in communication with a vial adapter lumen (see Fig. 5B) and having a vial spike 106 (see Fig. 5B), the vial spike being configured to puncture a stopper of a vial containing a medicament (see par. 32), and the vial adapter being configured to receive the vial (see par. 32); and an intravenous (IV) spike 22 configured to be sealingly inserted into an IV administration port of a container of an infusion liquid (see Fig. 5B; par. 31-33). In Lev, the vial adapter allows for injection of a second fluid for mixing with a medicament (see par. 33) and an alternative to the vial adapter could be a syringe 17 with connector 16 (see Fig. 7, par. 36). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute the receptacle and associated medical container 124, 125 of Wallen with vial configuration of Lev, including vial adapter with spike, disclosed by Lev as the substitution of one known element for another would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the vial configuration disclosed by Lev would have yielded predictable results, namely, the ability to attach a different medical containers such as a vial for the injection of a second fluid for mixing with the medicament within the IV bag for infusion via an IV line to a patient.
Claim(s) 35 and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallen in view of Lev as applied to claim 24 above, and further in view of Lev et al. (WO 2018/104932), hereinafter Lev 2 and disclosed by applicant in an IDS filed July 23, 2026.
Regarding claim 35, Wallen and Lev disclose the limitations of claim 24, but does not specifically state that at least one of a detachable tab and a puncturable membrane attached to the IV connector distal of the IV port.
Lev 2 discloses tabs 66B, 66A, one of the tabs, 66B, below an IV port 76, the tab being detachable (see Fig. 2A), in order to allow puncturing by the infusion set’s IV spike (see Figs. 2A-2B; page 7, lines 3-8). Such a tab and membrane configuration also appears in Lev (see Figs. 5A-5B). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include such tabs as disclosed by Lev and Lev 2, one of the tabs being detachable, in order to protect the puncturable membrane before use and then, once detached, allow puncturing, as disclosed by Lev 2.
Regarding claim 41, Wallen and Lev disclose the limitations of claim 24, but does not specifically state the device further comprising a detachable tab distal from the IV port secured in a fixed position relative to the bag spike.
Lev 2 discloses tabs 66B, 66A, one of the tabs, 66B, below an IV port 76, the tab being secured in a fixed position relative to a bag spike (see Fig. 2B) and detachable (see Fig. 2A), in order to allow puncturing by the infusion set’s IV spike (see Figs. 2A-2B; page 7, lines 3-8). Such a tab and membrane configuration also appears in Lev (see Figs. 5A-5B). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include such tabs as disclosed by Lev and Lev 2, one of the tabs being detachable, in order to protect the puncturable membrane before use and then, once detached, allow puncturing, as disclosed by Lev 2.
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 24-30, 36, 38-40, 45, 48-49, 51, and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 11,497,684, hereinafter ‘684. Although the claims at issue are not identical, they are not patentably distinct from each other because the following claims of ‘684 match the identified claims of the current application under a 35 USC 112(f) interpretation of “a flow control element for ensuing a controlled flow path through the connector” in ‘684:
Current claims
24
25
26
27
28
29
30
‘684 claims
1
1
1
1
1
1
1
Current claims
36
38
39
40
45
48
49
‘684 claims
1
1
1
7
1
1
7
Current claims
51
53
‘684 claims
1
1
Claims 31-34, 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of ‘684 in view of Wallen.
Regarding claims 31-34, 37, claim 1 of ‘684 discloses limitations of claim 24 but does not disclose the additional details required by claims 31-34.
Wallen discloses an exterior width of the part of the IV connector in which the spike of the patient IV line is placed inside is based on the outside diameter of the patient IV line as the spike of the patient IV line must be inside the part of the IV connector (see Fig. 4 of Wallen). Wallen further discloses the first channel has an interior width smaller or equal to an outside diameter of the patient IV line (see Fig. 4, interior width of channel near first orifice). Wallen further disclose an interior diameter of the first channel is sized to accommodate a fitting of a patient IV line (see Figs. 3-4, all disclosing spike of patient IV line fitting within IV port). Wallen further discloses wherein an interior diameter of the first channel does not exceed a diameter of an exterior of the patient IV line (see Fig. 4, an interior of the first channel within the spike does not exceed a diameter of an exterior of the patient IV line shown in the figure). Wallen further discloses the IV port is configured to engage the patient IV line via a slidable engagement (see Figs. 2a and 4, the IV line is slid into the IV port).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings of Wallen regarding the patient IV line and IV connector sizes/interactions as these would allow for a connection with the IV line to allow for confusion via the device.
Claims 35 and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of ‘684 in view of Lev 2.
Regarding claim 35, claim 1 of ‘684 does not disclose at least one of a detachable tab and a puncturable membrane attached to the IV connector distal of the IV port.
Lev 2 discloses tabs 66B, 66A, one of the tabs, 66B, below an IV port 76, the tab being detachable (see Fig. 2A), in order to allow puncturing by the infusion set’s IV spike (see Figs. 2A-2B; page 7, lines 3-8). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include such tabs as disclosed by Lev 2, one of the tabs being detachable, in order to protect the puncturable membrane before use and then, once detached, allow puncturing, as disclosed by Lev 2.
Regarding claim 41, claim 1 of ‘684 does not disclose a detachable tab distal from the IV port secured in a fixed position relative to the bag spike.
Lev 2 discloses tabs 66B, 66A, one of the tabs, 66B, below an IV port 76, the tab being detachable (see Fig. 2A), distal from the IV port secured in a fixed position relative to the bag spike, the tab detachable in order to allow puncturing by the infusion set’s IV spike (see Figs. 2A-2B; page 7, lines 3-8). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include such tabs as disclosed by Lev 2, one of the tabs being detachable, in order to protect the puncturable membrane before use and then, once detached, allow puncturing, as disclosed by Lev 2.
Claims 42, 46, 47, 50, and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of ‘684 in view of Lev.
Regarding claim 42, claim 1 of ‘684 does not disclose in the embodiment described above having the transfer channel include a valve for selectively opening and closing the transfer channel for interrupting fluid communication between the second channel and the medicinal vial.
Lev discloses it is well known to use a connector in the form of an additive port 29 (see Fig. 7) that can be connected to either a syringe or a vial adapter with spike (see Fig. 7, par. 36). The additive port includes a valve 32 for selectively opening and closing the transfer channel for interrupting fluid communication between the second channel and the medicinal vial (see Figs. 2A-3B, par. 28-29). Consequently, it would have been obvious to use a connector with vial adapter as disclosed by Lev as the use of a syringe in controlled manner into the additive port can be used with the connector in addition to the vial adapter, allowing for the benefits of both syringes and vials to be used as desired. Consequently, the valve included in the connector would allow for the required functional language.
Regarding claim 50, claim 1 of ‘684 does not disclose in the embodiment described above having the transfer channel include a valve for selectively opening and closing the transfer channel for interrupting fluid communication between the second channel and the medicinal vial.
Lev discloses it is well known to use a connector in the form of an additive port 29 (see Fig. 7) that can be connected to either a syringe or a vial adapter with spike (see Fig. 7, par. 36). The additive port includes a valve 32 for selectively opening and closing the transfer channel for interrupting fluid communication between the second channel and the medicinal vial (see Figs. 2A-3B, par. 28-29). Consequently, it would have been obvious to use a connector with vial adapter as disclosed by Lev as the use of a syringe in controlled manner into the additive port can be used with the connector in addition to the vial adapter, allowing for the benefits of both syringes and vials to be used as desired. Consequently, the valve included in the connector would allow for the required functional language of the valve.
Regarding claim 46, claim 1 of ‘684 does not disclose the device further comprising an outwardly extending flange located on the IV connector adjacent to bifurcated junction portion, the outwardly extending flange being wider than the bag spike and the IV port.
Lev discloses an outwardly extending flange located on an IV connector adjacent to a bifurcated junction portion, the outwardly extending flange being wider than a bag spike and an IV port (see Figs. 2A, 4-5B, flange at bottom of spike), and also explains that such a flange is for restricting insertion into an IV port of an infusion liquid bag (see par. 27). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include such an outwardly extending flange as disclosed by Lev in the device of Wallen in Lev in order to restrict insertion into an IV port, as disclosed by Lev.
Regarding claim 47, claim 1 of ‘684 and Lev disclose claim 46 and consequently, a portion of the flange would be located directly above the bifurcated junction portion such that the portion of the flange would be between the bifurcated junction portion and the bag spike (see rejection of claim 46 above and Lev, Figs. 2A, 4-5B and par. 27 requiring positioning to be at bottom of the spike to help with restricting insertion).
Regarding claim 52, claim 1 of ‘684 and Lev disclose claim 49 but as described above do not disclose the device further comprising an outwardly extending flange located on the IV connector adjacent to an expansion from the first width to the second width within the first channel, the outwardly extending flange being wider than the bag spike and the IV port.
Lev discloses an outwardly extending flange located on an IV connector adjacent an expansion of width of the first channel below at the bifurcation, the outwardly extending flange being wider than a bag spike and an IV port (see Figs. 2A, 4-5B, flange at bottom of spike), and also explains that such a flange is for restricting insertion into an IV port of an infusion liquid bag (see par. 27). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include such an outwardly extending flange as disclosed by Lev in order to restrict insertion into an IV port, as disclosed by Lev.
Lev discloses the port for receiving an about 5 mm to 6 mm diameter IV spike (see par. 30). Furthermore, it would have been obvious to include such an expansion of width as disclosed by Lev with respect to the flange in order to accommodate for such a well-known diameter of an IV spike, which would predictably result in connection to the infusion line.
Allowable Subject Matter
Claim 43 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art found is Wallen and Lev, which do not disclose the valve further comprising “an intermediate segment having a bore, the bore adapted for rotational engagement for selective alignment with the transfer channel; and an axial shaft extending to an exterior of the transfer channel for rotation from a handle, the axial shaft rotating perpendicular to an axis through the bore for controlling flow. Proksch et al. (US 2011/0004184) discloses a valve that further comprises an intermediate segment having a bore, the bore adapted for rotational engagement for selective alignment with a fluid channel of device for introducing medicine into an infusion container (see Fig. 5), but Proksch does not disclose an axial shaft extending to an exterior of the of the transfer channel for rotation from a handle, the axial shaft rotating perpendicular to an axis through the bore for controlling flow. No art could be found to address such deficiencies.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA ZIMBOUSKI whose telephone number is (303)297-4665. The examiner can normally be reached 8:30 - 5:00 PST M-F.
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/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
