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 III, Figures 52-59 in the reply filed on June 4, 2026 is acknowledged.
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 23-77 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 23, 34, 48, and 58, the limitation “fluid traveling between any of the inlet, the outlet the filling port will” renders the claim indefinite as it is unclear what the connection between “the inlet, the outlet the filling port” is due to the lack of connecting word between this parts. For instance, did applicant intend “the inlet, the outlet, and the filling port?”
Claims 24-33 are rejected as dependents of claim 23; claims 35-47 are rejected as dependents of claim 34; claims 49-57 are rejected as dependents of claim 48; and claims 59-77 are rejected as dependents of claim 58.
Claim 28 recites the limitation "the stopper" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 45 recites the limitation "the stopper" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 55 recites the limitation "the stopper" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 75 recites the limitation "the stopper" in line 2. There is insufficient antecedent basis for this limitation 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.
Claim(s) 23-25, 27-32, 34-40, 42, 44-50, 52, 54-58, 60-70, 72, 74, and 76-77 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wyss (US 2010/0228196).
Regarding claim 23, Wyss discloses a reservoir assembly (see Fig. 6B) comprising: a reservoir 10, 11 (see Figs. 1A-1C; 6B, top flexible sheets 10, 11; par. 37, 56); and a port connector 2 mating to the reservoir (see Fig. 6B) comprising: a reservoir access channel (see annotated drawing below); an inlet 221 in fluid communication with the reservoir access channel, the inlet defining an inlet axis (see annotated drawing below); an outlet 24 and/or 232 wherein fluid contained in the interior volume of the reservoir exits the reservoir (see par. 53, septum 24 allows for transferring medicament out of flexible container through outlet); a filling port (see Fig. 6B, port connected to outer conduit system 41) configured wherein the reservoir may be filled with a fluid (see par. 60), the filling port defining a filling axis (see annotated drawing below); and a common chamber in fluid communication with the inlet, the outlet and the filling port (see annotated drawing below)whereby fluid traveling between any of the inlet, the outlet the filling port will pass through the common chamber (see Fib. 6B), and whereby the inlet axis and the filling axis are in the same plane (see Fig. 1A, 6B, showing centered shape of adapter 23).
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Regarding claim 24, Wyss discloses the outlet defines an outlet axis, and the outlet axis is perpendicular to the inlet axis (see Fig. 6B, annotated above showing outlet axis and inlet axis generally).
Regarding claim 25, Wyss discloses the reservoir is at least partially constructed of a flexible material (see Figs. 1A-1C; 6B, top flexible sheets 10, 11; par. 37, 56).
Regarding claim 27, Wyss discloses at least a section of the port connector is substantially perpendicular to a top and a bottom side formed by the reservoir (see Fig. 6B, annotated drawing below).
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Regarding claim 28, Wyss discloses the port connector is configured to accept a fill nozzle (see par. 60, nozzle of syringe or infusion pump device) at a first time and the stopper at a second time (see par. 60, septum).
Regarding claim 29, Wyss discloses the inlet defines a trough open on one side (see Fig. 6B, curvature of inlet 221 creates trough).
Regarding claim 30, Wyss discloses a cover plate 24 sealing over the trough (see Fig. 6B).
Regarding claim 31, Wyss discloses the port connector defines a branch member 21, the inlet defined as a channel in the branch member (see Fig. 6B).
Regarding claim 32, Wyss discloses the branch member defines a coupling surface and the reservoir is adhered to the coupling surface (see Fig. 6B, portion of branch member coupled to portion of sheet 10, which is part of reservoir).
Regarding claim 34, Wyss discloses a reservoir assembly (see Fig. 6B) comprising: a reservoir 10, 11 (see Figs. 1A-1C; 6B, top flexible sheets 10, 11; par. 37, 56); and a port connector 2 mating to the reservoir (see Fig. 6B) comprising: a reservoir access channel (see annotated Fig. 6B below); an inlet 221 in fluid communication with the reservoir access channel, the inlet defining an inlet axis; an outlet 24 and/or 232 wherein fluid contained in the interior volume of the reservoir exits the reservoir; a filling port (see Fig. 6B, port connected to outer conduit system 41) configured wherein the reservoir may be filled with a fluid (see par. 60), the filling port defining a filling axis; and a common chamber (see annotated Fig. 6B below) in fluid communication with the inlet, the outlet and the filling port whereby fluid traveling between any of the inlet, the outlet the filling port will pass through the common chamber, and whereby the inlet axis and the filling axis are parallel (see Fig. 6B below).
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Regarding claim 35, Wyss discloses the outlet defines an outlet axis, and the outlet axis is perpendicular to the inlet axis (see annotated Fig. 6B above).
Regarding claim 36, Wyss discloses the inlet axis, the outlet axis and the filling axis are all in the same plane (see Fig. 1A, 6B, showing centered shape of adapter 23).
Regarding claim 37, Wyss discloses the port connector is symmetrical about the plane (see Fig. 1A, 6B, showing centered shape of adapter 23).
Regarding claim 38, Wyss discloses a portion of the common chamber is disposed within the plane (see Fig. 1A, 6B, showing centered shape of adapter 23).
Regarding claim 39, Wyss discloses the port connector defines a branch member 21, the inlet defined as a channel in the branch member (see Fig. 6B).
Regarding claim 40, Wyss discloses the branch member defines a coupling surface and the reservoir is adhered to the coupling surface (see Fig. 6B, portion of branch member coupled to portion of sheet 10, which is part of reservoir).
Regarding claim 42, Wyss discloses the reservoir is at least partially constructed of a flexible material (see Figs. 1A-1C; 6B, top flexible sheets 10, 11; par. 37, 56).
Regarding claim 44, Wyss discloses at least a section of the port connector is substantially perpendicular to a top and a bottom side formed by the reservoir (see Fig. 6B, annotated drawing below).
Regarding claim 45, Wyss discloses the port connector is configured to accept a fill nozzle (see par. 60, nozzle of syringe or infusion pump device) at a first time and the stopper at a second time (see par. 60, septum).
Regarding claim 46, Wyss discloses the inlet defines a trough open on one side (see Fig. 6B, curvature of inlet 221 creates trough).
Regarding claim 47, Wyss discloses a cover plate 24 sealing over the trough (see Fig. 6B).
Regarding claim 48, Wyss discloses a reservoir assembly (see Fig. 6B) comprising: a reservoir 10, 11 (see Figs. 1A-1C; 6B, top flexible sheets 10, 11; par. 37, 56); and a port connector 2 mating to the reservoir (see Fig. 6B) comprising: a reservoir access channel (see annotated drawing below); an inlet 221 in fluid communication with the reservoir access channel, the inlet defining an inlet axis (see annotated drawing below); an outlet 24 and/or 232 wherein fluid contained in the interior volume of the reservoir exits the reservoir (see par. 53, septum 24 allows for transferring medicament out of flexible container through outlet), the outlet defining an outlet axis (see annotated drawing below); a filling port (see Fig. 6B, port connected to outer conduit system 41) configured wherein the reservoir may be filled with a fluid (see par. 60), the filling port defining a filling axis (see annotated drawing below); and a common chamber in fluid communication with the inlet, the outlet and the filling port (see annotated drawing below) whereby fluid traveling between any of the inlet, the outlet the filling port will pass through the common chamber, and whereby the outlet axis is perpendicular to both the filling axis and the inlet axis (see annotated figure below).
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Regarding claim 49, Wyss discloses the port connector defines a branch member 21, the inlet defined as a channel in the branch member (see Fig. 6B).
Regarding claim 50, Wyss discloses the branch member defines a coupling surface and the reservoir is adhered to the coupling surface (see Fig. 6B, portion of branch member coupled to portion of sheet 10, which is part of reservoir).
Regarding claim 52, Wyss discloses the reservoir is at least partially constructed of a flexible material (see Figs. 1A-1C; 6B, top flexible sheets 10, 11; par. 37, 56).
Regarding claim 54, Wyss discloses at least a section of the port connector is substantially perpendicular to a top and a bottom side formed by the reservoir (see Fig. 6B, annotated drawing below).
Regarding claim 55, Wyss discloses the port connector is configured to accept a fill nozzle (see par. 60, nozzle of syringe or infusion pump device) at a first time and the stopper at a second time (see par. 60, septum).
Regarding claim 56, Wyss discloses the inlet defines a trough open on one side (see Fig. 6B, curvature of inlet 221 creates trough).
Regarding claim 57, Wyss discloses a cover plate 24 sealing over the trough (see Fig. 6B).
Regarding claim 58, Wyss discloses a reservoir assembly (see Fig. 6B) comprising: a reservoir 10, 11 (see Figs. 1A-1C; 6B, top flexible sheets 10, 11; par. 37, 56); and a port connector 2 mating to the reservoir (see Fig. 6B), the port connector comprising; a port connector body comprising a reservoir access channel (see annotated drawing below), an inlet 221 in fluid communication with the reservoir access channel, an outlet 232 wherein fluid contained in the interior volume of the reservoir exits the reservoir (see par. 53, septum 24 allows for transferring medicament out of flexible container through outlet), a filling port (see Fig. 6B, port connected to outer conduit system 41) configured wherein the reservoir may be filled with a fluid (see par. 60); and a common chamber in fluid communication with the inlet, the outlet and the filling port (see annotated drawing below) whereby fluid traveling between any of the inlet, the outlet the filling port will pass through the common chamber (see annotated drawing below); and a cover plate 24 coupled to the port connector body to seal the inlet, the common chamber and the reservoir access channel from the environment (see Fig. 6B).
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Regarding claim 60, Wyss discloses the reservoir defines a pass through and the reservoir access channel aligns with a reservoir axis defined by the pass through (see Figs. 4A-4B showing how reservoir expands and is emptied for filling, with pass through/reservoir axis being in center below port and aligning with reservoir access channel).
Regarding claim 61, Wyss discloses the port connector body defines an outlet wall that extends parallel to the outlet axis (see Fig. 6B, portion of outlet wall containing plate 24).
Regarding claim 62, Wyss discloses the outlet wall is annular (see Fig. 6B and 1A).
Regarding claim 63, Wyss discloses wherein the outlet wall includes a head portion 21 of greater thickness opposite the outlet (see Fig. 6B, outlet wall could be considered annular wall surrounding outlet downward and parallel to outlet axis).
Regarding claim 64, Wyss discloses wherein the outlet wall includes a head portion 21 of greater thickness opposite the outlet (see Fig. 6B, outlet wall could be considered annular wall surrounding outlet downward and parallel to outlet axis).
Regarding claim 65 and 66, Wyss discloses the port connector body defines a fill wall projecting from the outlet wall, the fill wall defining a portion of the filling port (see Fig. 6B annotated below, with common chamber interpretation changed as indicated below).
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Regarding claim 67, Wyss discloses the port connector body defines a recess to receive the cover plate (see Fig. 6B, par. 53, 55, 61).
Regarding claim 68, Wyss discloses the cover plate defines a thickness and the recess is the same depth as the cover plate thickness (see Fig. 6B).
Regarding claim 69, Wyss discloses the port connector body defines a branch member 21, the inlet defined as a channel in the branch member (see Fig. 6B).
Regarding claim 70, Wyss discloses the branch member defines a coupling surface and the reservoir is adhered to the coupling surface (see Fig. 6B, portion of branch member coupled to portion of sheet 10, which is part of reservoir).
Regarding claim 72, Wyss discloses the reservoir is at least partially constructed of a flexible material (see Figs. 1A-1C; 6B, top flexible sheets 10, 11; par. 37, 56).
Regarding claim 74, Wyss discloses at least a section of the port connector is substantially perpendicular to a top and a bottom side formed by the reservoir (see Fig. 6B, annotated drawing below).
Regarding claim 76, Wyss discloses the inlet defines a trough open on one side (see Fig. 6B, curvature of inlet 221 creates trough).
Regarding claim 77, Wyss discloses the port connector body defines a recess to receive the cover plate over the trough (see Fig. 6B, par. 53, 55, 61).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 26, 43, 53, and 73 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wyss in view of Wyss et al. (US 2013/0253439), hereinafter Wyss 2.
Regarding claim 26, Wyss discloses limitations of claim 23 and discloses the reservoir is at least partially constructed of a flexible material (see Figs. 1A-1C; 6B, top flexible sheets 10, 11; par. 37, 56) but does not disclose the reservoir is at least partially constructed of a rigid material.
Wyss 2 discloses a reservoir at least partially constructed of a flexible material 3 and a rigid material 2 (see Figs. 1a-1b, par. 66) as an alternative to having two flexible wall sheets together (see par. 51). Consequently, 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 reservoir comprised of both rigid and flexible material as disclosed Wyss 2, this being a well known alternative to the two flexible sheets disclosed by Wyss and predictably resulting in a reservoir that can connect to the port connector and contain material as well as be emptied.
Regarding claim 43, Wyss discloses limitations of claim 34 and discloses the reservoir is at least partially constructed of a flexible material (see Figs. 1A-1C; 6B, top flexible sheets 10, 11; par. 37, 56) but does not disclose the reservoir is at least partially constructed of a rigid material.
Wyss 2 discloses a reservoir at least partially constructed of a flexible material 3 and a rigid material 2 (see Figs. 1a-1b, par. 66) as an alternative to having two flexible wall sheets together (see par. 51). Consequently, 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 reservoir comprised of both rigid and flexible material as disclosed Wyss 2, this being a well-known alternative to the two flexible sheets disclosed by Wyss and predictably resulting in a reservoir that can connect to the port connector and contain material as well as be emptied.
Regarding claim 53, Wyss discloses limitations of claim 48 and discloses the reservoir is at least partially constructed of a flexible material (see Figs. 1A-1C; 6B, top flexible sheets 10, 11; par. 37, 56) but does not disclose the reservoir is at least partially constructed of a rigid material.
Wyss 2 discloses a reservoir at least partially constructed of a flexible material 3 and a rigid material 2 (see Figs. 1a-1b, par. 66) as an alternative to having two flexible wall sheets together (see par. 51). Consequently, 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 reservoir comprised of both rigid and flexible material as disclosed Wyss 2, this being a well-known alternative to the two flexible sheets disclosed by Wyss and predictably resulting in a reservoir that can connect to the port connector and contain material as well as be emptied.
Regarding claim 73, Wyss discloses limitations of claim 58 and discloses the reservoir is at least partially constructed of a flexible material (see Figs. 1A-1C; 6B, top flexible sheets 10, 11; par. 37, 56) but does not disclose the reservoir is at least partially constructed of a rigid material.
Wyss 2 discloses a reservoir at least partially constructed of a flexible material 3 and a rigid material 2 (see Figs. 1a-1b, par. 66) as an alternative to having two flexible wall sheets together (see par. 51). Consequently, 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 reservoir comprised of both rigid and flexible material as disclosed Wyss 2, this being a well-known alternative to the two flexible sheets disclosed by Wyss and predictably resulting in a reservoir that can connect to the port connector and contain material as well as be emptied.
Claim(s) 33, 41, 51, and 71 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wyss.
Regarding claim 33, Wyss discloses the limitations of claim 32 but does not specifically disclose the coupling surface is planar.
Wyss discloses an alternative shaped coupling surface of a branch member that is planar (see Fig. 5b, coupling surface 111 and Fig. 5A, coupling surface 111) in addition to a coupling surface 222 that is slanted. 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 single slanted coupling surface structure in Fig. 6B with the multiple coupling surface structures of slanted and planar as disclosed in Figs. 5A and 5B, as this substitution would have yielded predictable results, namely, a coupling of the reservoir with the port connector.
Regarding claim 41, Wyss discloses the limitations of claim 40 but does not specifically disclose the coupling surface is planar.
Wyss discloses an alternative shaped coupling surface of a branch member that is planar (see Fig. 5b, coupling surface 111 and Fig. 5A, coupling surface 111) in addition to a coupling surface 222 that is slanted. 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 single slanted coupling surface structure in Fig. 6B with the multiple coupling surface structures of slanted and planar as disclosed in Figs. 5A and 5B, as this substitution would have yielded predictable results, namely, a coupling of the reservoir with the port connector.
Regarding claim 51, Wyss discloses the limitations of claim 50 but does not specifically disclose the coupling surface is planar.
Wyss discloses an alternative shaped coupling surface of a branch member that is planar (see Fig. 5b, coupling surface 111 and Fig. 5A, coupling surface 111) in addition to a coupling surface 222 that is slanted. 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 single slanted coupling surface structure in Fig. 6B with the multiple coupling surface structures of slanted and planar as disclosed in Figs. 5A and 5B, as this substitution would have yielded predictable results, namely, a coupling of the reservoir with the port connector.
Regarding claim 71, Wyss discloses the limitations of claim 70 but does not specifically disclose the coupling surface is planar.
Wyss discloses an alternative shaped coupling surface of a branch member that is planar (see Fig. 5b, coupling surface 111 and Fig. 5A, coupling surface 111) in addition to a coupling surface 222 that is slanted. 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 single slanted coupling surface structure in Fig. 6B with the multiple coupling surface structures of slanted and planar as disclosed in Figs. 5A and 5B, as this substitution would have yielded predictable results, namely, a coupling of the reservoir with the port connector.
Claim(s) 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wyss in view of Balteau et al. (US 2009/0105684).
Regarding claim 59, Wyss discloses the limitations of claim 58 but does not disclose the cover plate is welded to the port connector body.
Balteau discloses a septum joined to a housing of a septum via welding (see par. 36, cl. 2, 22). As the septum of Wyss is interpreted as the plate, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to bond the septum/plate to the port connector body, interpreted as a housing, Balteau disclosing such welding and it resulting in a secure coupling between the septum/plate and the port connector body.
Claim(s) 75 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wyss in view of Houwaert et al. (US 2003/0233083).
Regarding claim 75, Wyss discloses the limitations of claim 58 and further discloses the port connector is configured to accept a fill nozzle at a first time (see par. 60, nozzle of syringe or infusion pump device) but does not disclose the port connector is configured to accept the stopper at a second time.
Houwaert discloses a cover plate 9 on a port connector body to seal a septum 4 from the environment (see par. 67). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to further include a cover plate on a port connector body sealing septum 24 to protect the septum, and therefore the associated parts within the port connector body, from the environment as disclosed by Houwaert. Consequently, the cover plate would then be coupled to the port connector body to seal the inlet, the common chamber and the reservoir access channel from the environment and the septum 24 (see Wyss, Fig. 6B), and therefore Wyss and Houwaert further disclose the port connector configured to accept the septum at a second time (see par. 60, septum).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Barnes et al. (US 11,660,389), disclosing how a reservoir having one flexible sheet and one semi-rigid sheet would allow flexible sheet to fully press against semi-rigid sheet and empty contents of reservoir.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, REBECCA E EISENBERG can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARIANA ZIMBOUSKI/ Primary Examiner, Art Unit 3781
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