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
The amendment filed 07/29/2026 has been entered. Claims 1 has been amended. Claims 2 and 4 are cancelled. Claims 20-21 are new. Claims 1, 3, 5-21 remain pending in this application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on Tsai in view of Schriver for any teaching or matter specifically challenged in the argument. A new grounds of rejection is made over Tsai in view of Sadiow. Sadiow teaches the features of amended claim 1.
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.
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.
Claims 1, 3, 5-7, 10-12, 16 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Tsai et al. (WO 2021/253264 A1, Pub. No.: US 2023/0240939 A1 cited herein) in view of Sadiow (Pub. No.: US 2003/0083640 A1).
Regarding claim 1, Tsai discloses (fig. 1, 5, 7, annotated fig. 7) a medical fluid container adapter assembly, comprising:
A first connector part (hub 20) connectable to a medical fluid container (drug liquid container, ¶ 0083), comprising:
A first body (lancet 26) comprising a first base distal surface (annotated fig. 7) and a perforator extension extending distally from said base distal surface (annotated fig. 7), the perforator extension having a first liquid passage (first pathway 262) and a first air passage (second pathway 264) (¶ 0070), and
A container perforator (tip 261) disposed on a distal end of the perforator extension (¶ 0070, fig. 7),
A multi-use assembly (closed system transfer device 10) detachably connected to said first body (¶ 0064), wherein said multi-use assembly comprises:
A medical conduit interface (barrel 12); and
A second connector part (connecting port 16) comprising a second liquid passage (first channel 122) and a second air passage (second channel 124), wherein said first liquid passage and said first air passage are fluidly connected with said second liquid passage and said second air passage, respectively (fig. 7).
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Tsai annotated fig. 7
Tsai fails to disclose wherein the distal end of the perforator extension is incapable of perforating a septum of a medical fluid container, such that the first connector part without the container perforator cannot be used to spike the medical fluid container, wherein the container perforator comprises a proximal end section provided with retention sections spaced from the first base distal surface by a proximal section of the perforator extension; and wherein the container perforator is interconnected with said perforator extension by a breakage area such that the container perforator will separate from said first body before said first body will separate from the medical fluid container when the medical container fluid container adapter assembly is in an installed configuration.
Sadiow teaches (fig. 8-10) a medical fluid container adapter assembly (abstract) and thus in the same field of endeavor, comprising: a first connector part connectable to a medical fluid container (bag 10), comprising: a first body comprising a first base distal surface and a perforator extension (hollow tube 42), and a container perforator (removable cap 60) disposed on a distal end of the perforator extension (fig. 8, ¶ 0036), wherein the distal end of the perforator extension is incapable of perforating a septum of a medical fluid container, such that the first connector part without the container perforator cannot be used to spike the medical fluid container (fig. 8, cannula tube is blunt), wherein the container perforator comprises a proximal end section provided with retention sections (internal ledge 66) spaced from the first base distal surface by a proximal section of the perforator extension (¶ 0036, fig. 8a); and wherein the container perforator is interconnected with said perforator extension by a breakage area such that the container perforator will separate from said first body before said first body will separate from the medical fluid container when the medical container fluid container adapter assembly is in an installed configuration (¶ 0036, fig. 9-10), wherein the separable container perforator is configured to prevent coring (¶ 0001).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical fluid container adapter assembly of Tsai such that the distal end of the perforator extension is incapable of perforating a septum of a medical fluid container, such that the first connector part without the container perforator cannot be used to spike the medical fluid container, wherein the container perforator comprises a proximal end section provided with retention sections spaced from the first base distal surface by a proximal section of the perforator extension; and wherein the container perforator is interconnected with said perforator extension by a breakage area such that the container perforator will separate from said first body before said first body will separate from the medical fluid container when the medical container fluid container adapter assembly is in an installed configuration, as taught by Sadiow, in order to prevent coring (Sadiow ¶ 0001).
Regarding claim 3, Tsai discloses (fig. 10) wherein the second connector part comprises clips or clamps (hooking members 167a, 167b) that are movably integrated with a second body of the second connector part and that are configured to detachably engage the first connector part (¶ 0069, fig. 10).
Regarding claim 5, Tsai discloses wherein said second connector part comprises a second base distal surface (annotated fig. 7), a perforator for said second liquid passage (first protruding column 121a, fig. 6), and a perforator for said second air passage (second protruding column 121b, fig. 6),
Wherein said perforator for said second liquid passage protrudes distally from said second base distal surface (annotated fig. 7), is fluidly connected with said second liquid passage, and is fluidly connected with said first liquid passage of said first connector part (fig. 7, ¶ 0050), and
Wherein said perforator for said second air passage protrudes distally from said second base distal surface (annotated fig. 7), is fluidly connected with said second air passage, and is fluidly connected withs aid first air passage of said first connector part (fig. 7, ¶ 0050).
Regarding claim 6, Tsai discloses wherein said first body comprises a liquid chamber fluidly connected with said first liquid passage and an air chamber fluidly connected with said first air passage (see liquid and air chamber formed by first end portion 22), wherein said second liquid passage of said second connector part is fluidly connected with said liquid chamber and said second air passage of said second connector part is fluidly connected with said air chamber, wherein said perforator for said second liquid passage extends into said liquid chamber, and wherein said perforator for said second air passageway extends into said air chamber (fig. 7, ¶ 0064).
Regarding claim 7, Tsai discloses wherein said second connector further comprises a plurality of upper wall segments (annular wall 163, fig. 5), that are spaced from one another that protrude distally from said second base distal surface of said second connector part (fig. 5), said perforator for said second liquid passage and said perforator for said second air passage are located inwardly of an outer perimeter collectively defined by said plurality of upper wall segments (fig. 7), and a distal end of each of said perforator for said second liquid passage and said perforator for said second air passage are disposed closer to said second base distal surface than a distal end of each of said plurality of upper wall segments (fig. 7).
Regarding claim 10, Tsai disclose (fig. 10) wherein said first body comprises first and second catches (hook members 22a, 22b) that are spaced from one another (fig. 10), wherein the second connector part comprises a second body and first and second clips (hooking members 167a, 167b) that are movable relative to said second body (¶ 0069) and that detachably engage said first and second catches, respectively, to detachably connect said first connector part and said second connector part (fig. 10, ¶ 0069), wherein said first and second catches are disposed on an outer perimeter of said first body (fig. 10).
Regarding claim 11, Tsai discloses wherein said first body comprises first and second channels disposed on said outer perimeter of said first body, and wherein said first and second catches are disposed within said first and second channels, respectively (fig. 18).
Regarding claim 12¸ Tsai discloses wherein said first and second channels are configured to only accommodate a single relative orientation between said first connector part and said second connector part when detachably connected (¶ 0068).
Regarding claim 16, Tsai in view of Sadiow disclose wherein the retention sections form an entire circumference of the proximal end section of the container perforator (¶ 0036, fig. 8a).
Regarding claim 20, Tsai in view of Sadiow disclose wherein the distal end of the perforator extension is blunt (Sadiow, upper surface 43, fig. 8-8a).
Regarding claim 21, Tsai discloses wherein the container perforator is integrally formed with the first body as a single piece (fig. 7).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Tsai in view of Sadiow, as applied to claim 5 above, and further in view of Veneroni et al. (Pub. No.: US 2012/0302967 A1)
Regarding claim 8, Tsai discloses wherein said first body comprises a proximal end spaced from said first base distal surface of said first body (annotated fig. 7), said first connector part comprises a first interface disposed on said proximal end of said first body that interfaces with said second connector part (¶ 0064, fig. 7), said interface comprises a first perforable section (pin hole 166a) in a flow path of said first liquid passage (fig. 7) and a second perforable section (pin hole 166b) in a flow path to said first air passage (fig. 7), said perforator for said second liquid passage extends through said first perforable section and into said liquid chamber (fig. 7), and said perforator for said second air passage extends through said second perforable section and into said air chamber (fig.7).
Tsai in view of Sadiow fail to disclose said first interface is of a first hardness and said first body is of a second hardness that is greater than said first hardness.
Veneroni teaches (fig. 5) a medical fluid container adapter assembly (abstract) and thus in the same field of endeavor, comprising: a first connector part (insert 20) comprising a first body (piercing spike 26) comprising a first base distal surface (flange 263), said first connector part comprises a first interface (resilient element 24) disposed on a proximal end (fig. 5), said first interface is of a first hardness (¶ 0036) and said first body is of second hardness (¶ 0033) that is greater than said first hardness (first interface is elastic ¶ 0036 and first body is rigid ¶ 0033).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first interface and first body of Tsai in view of Sadiow such that said first interface is of a first hardness and said first body is of a second hardness that is greater than said first hardness, as taught by Veneroni, in order to allow the first body to be suitable for perforating (Veneroni ¶ 0031) and the first interface to interface with said second connector part.
Claim(s) 9, 13-15, 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsai in view of Sadiow, as applied to claim 1 above, and further in view of Schriver et al. (Pub. No.: US 2016/0074580 A1).
Regarding claim 9, Tsai in view of Sadiow disclose wherein said container perforator extends along a first reference axis, wherein the retention sections extend away from said first reference axis proceeding in a direction of said first base distal surface of said first connector part, and have a free end that is spaced from said first base distal surface of said first connector part,
Wherein an open space is adjacent to and radially inward of each said retention section, and
Wherein a proximal section of each retention section curves away from said first reference axis proceeding to a corresponding free end.
Schriver teaches (fig. 1, 10-15) a medical fluid container adapter assembly (abstract) and thus in the same field of endeavor, comprising:
A first connector part (attachment device 100i) connectable to a medical fluid container (medical container 102, ¶ 0048), comprising:
A first body comprising a first base distal surface (tab 122i) and a perforator extension body (body 110i) extending distally from said first base distal surface (fig. 10), and a container perforator (one or more removable elements 140i) disposed on a distal end of the perforator extension (¶ 0075, fig. 10), wherein the container perforator comprises a proximal end section provided with retention sections (see locking mechanism 144i, fig. 12) spaced from the first base distal surface by a proximal second of the perforator extension (¶ 0076);
Wherein said container perforator extends along a first reference axis, wherein the retention sections extend away from said first reference axis proceeding in a direction of said first base distal surface of said first connector part, and have a free end that is spaced from said first base distal surface of said first connector part (fig. 11-12),
Wherein an open space is adjacent to and radially inward of each said retention section (fig. 12), and
Wherein a proximal section of each retention section curves away from said first reference axis proceeding to a corresponding free end (see barb 146i),
Wherein the retention sections are configured allow for engagement and disengagement of the container perforator (¶ 0010).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container perforator of Tsai in view of Sadiow such that it extends along a first reference axis, wherein the retention sections extend away from said first reference axis proceeding in a direction of said first base distal surface of said first connector part, and have a free end that is spaced from said first base distal surface of said first connector part, wherein an open space is adjacent to and radially inward of each said retention section, and wherein a proximal section of each retention section curves away from said first reference axis proceeding to a corresponding free end, as taught by Schriver, in order to allow for engagement and disengagement of the container perforator (Schriver ¶ 0010).
Regarding claim 13, Tsai in view of Sadiow fail to disclose wherein said container perforator comprises a distal tip, a frusto-conical section and a transition section, said frusto-conical section is disposed between said distal tip and said transition section, said transition section is located between said frusto-conical section and said proximal end section, and said transition section is a concave surface on an exterior of said container perforator proceeding proximally relative to said frusto-conical section.
Schriver teaches (fig. 1, annotated fig. 12) a medical fluid container adapter assembly (abstract) and thus in the same field of endeavor, comprising:
A first connector part (attachment device 100i) connectable to a medical fluid container (medical container 102, ¶ 0048), comprising:
A container perforator (one or more removable elements 140i);
Wherein said container perforator comprises a distal tip (Schriver pointed tip 152i), a frusto-conical section (Schriver see barb 146i) and a transition section (Schriver annotated fig. 12), said frusto-conical section is disposed between said distal tip and said transition section (Shriver fig. 12), said transition section is located between said frusto-conical section and said proximal end section (Schriver fig. 12), and, and said transition section is concave surface (Schriver see groove 148i) on said exterior of said container perforator proceeding proximally relative to said frusto-conical section (Schriver annotated fig. 12),
Wherein such container perforator is configured for engagement and disengagement of the container perforator (¶ 0010).
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Schriver annotated fig. 12’
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container perforator of Tsai in view of Sadiow such that it comprises a distal tip, a frusto-conical section and a transition section, said frusto-conical section is disposed between said distal tip and said transition section, said transition section is located between said frusto-conical section and said proximal end section, and said transition section is a concave surface on an exterior of said container perforator proceeding proximally relative to said frusto-conical section, as taught by Schriver, in order to configure the container perforator for engagement and disengagement (Schriver ¶ 0010).
Regarding claim 14, Tsai in view of Sadiow fail to disclose wherein said container perforator further comprises a distal tip, a body between the distal tip and the proximal end section, and a plurality of elongate liquid inlet channels spaced from one another that are formed on an exterior surface of said body of the container perforator and that are concave, and wherein each of said elongate liquid channel is fluidly connected withs aid first liquid passage.
Schriver teaches (fig. 1, 12) a medical fluid container adapter assembly (abstract) and thus in the same field of endeavor, comprising:
A first connector part (attachment device 100i) connectable to a medical fluid container (medical container 102, ¶ 0048), comprising:
A container perforator (one or more removable elements 140i);
Wherein the container perforator further comprises a distal tip (Schriver pointed tip 152i) and a body between the distal tip and the proximal end section (Schriver fig. 12), and a plurality of elongate liquid inlet channels (Schriver see fluid channel 117i) that are spaced from one another that are formed on an exterior surface of said body of the container perforator and that are concave (Schriver see fig. 12), and wherein each said elongate liquid inlet channel is fluidly connected with said first liquid passage (Schriver fig. 12), in order to provide multiple elongate liquid channels to improve sterility (¶ 0007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container perforator of Tsai in view of Sadiow such that it comprises a distal tip, a body between the distal tip and the proximal end section, and a plurality of elongate liquid inlet channels spaced from one another that are formed on an exterior surface of said body of the container perforator and that are concave, and wherein each of said elongate liquid channel is fluidly connected withs aid first liquid passage, as taught by Schriver, in order to provide multiple elongate liquid channels to improve sterility (Schriver ¶ 0007).
Regarding claim 15, Tsai in view of Sadiow fail to disclose wherein said container perforator further comprises a distal tip, a body between the distal tip and the proximal end section, and a plurality of elongate liquid inlet channels spaced from one another that are formed on an exterior surface of said body of the container perforator and that are concave, wherein a width of each elongate channel of said plurality of elongate channels progressively increases proceeding distally toward said distal tip of said container perforator.
Schriver teaches (fig. 1, 12) a medical fluid container adapter assembly (abstract) and thus in the same field of endeavor, comprising:
A first connector part (attachment device 100i) connectable to a medical fluid container (medical container 102, ¶ 0048), comprising:
A container perforator (one or more removable elements 140i);
Wherein the container perforator further comprises a distal tip (Schriver pointed tip 152i) and a body between the distal tip and the proximal end section (Schriver fig. 12), and a plurality of elongate liquid inlet channels (Schriver see fluid channel 117i) that are spaced from one another that are formed on an exterior surface of said body of the container perforator and that are concave (Schriver see fig. 12), wherein a width of each elongate channel of said plurality of elongate channels progressively increases proceeding distally toward said distal tip of said container perforator (Schriver fig. 12, elongate channel at the distal tip is a beveled edge), in order to provide multiple elongate liquid channels to improve sterility (¶ 0007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container perforator of Tsai in view of Sadiow such that it comprises a distal tip, a body between the distal tip and the proximal end section, and a plurality of elongate liquid inlet channels spaced from one another that are formed on an exterior surface of said body of the container perforator and that are concave, wherein a width of each elongate channel of said plurality of elongate channels progressively increases proceeding distally toward said distal tip of said container perforator, as taught by Schriver, in order to provide multiple elongate liquid channels to improve sterility (Schriver ¶ 0007).
Regarding claim 17, Tsai in view Sadiow fail to disclose wherein the retention sections have a frusto-conical shape.
Schriver teaches (fig. 1, 12) a medical fluid container adapter assembly (abstract) and thus in the same field of endeavor, comprising:
A first connector part (attachment device 100i) connectable to a medical fluid container (medical container 102, ¶ 0048), comprising:
A container perforator (one or more removable elements 140i);
Wherein the container perforator comprises a proximal end section provided with retention sections (see locking mechanism 144i, fig. 12);
Wherein the retention sections have a frusto-conical shape (Schriver fig. 11-12);
Wherein such container perforator is configured for engagement and disengagement of the container perforator (¶ 0010).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the retention sections of Tsai in view Sadiow such that they have a frusto-conical shape, as taught by Schriver, in order to configure the container perforator for engagement and disengagement (Schriver, ¶ 0010).
Regarding claim 18, Tsai in view of Sadiow fail to disclose wherein the retention sections are tabs formed by slits extending from a free end of the container perforator.
Schriver teaches (fig. 1, 12) a medical fluid container adapter assembly (abstract) and thus in the same field of endeavor, comprising:
A first connector part (attachment device 100i) connectable to a medical fluid container (medical container 102, ¶ 0048), comprising:
A container perforator (one or more removable elements 140i);
Wherein the container perforator comprises a proximal end section provided with retention sections (see locking mechanism 144i, fig. 12);
Wherein the retention sections are tabs formed by slits extending from a free end of the container perforator (Schriver fig. 11-12);
Wherein such container perforator is configured for engagement and disengagement of the container perforator (¶ 0010).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the retention sections of Tsai in view Sadiow such that are tabs formed by slits extending from a free end of the container perforator, as taught by Schriver, in order to configure the container perforator for engagement and disengagement (Schriver, ¶ 0010).
Regarding claim 19, Tsai in view of Sadiow fail to disclose wherein the proximal end section of the container perforator is provided with at least 3 retention sections that are spaced from one another.
Schriver teaches (fig. 1, 12) a medical fluid container adapter assembly (abstract) and thus in the same field of endeavor, comprising:
A first connector part (attachment device 100i) connectable to a medical fluid container (medical container 102, ¶ 0048), comprising:
A container perforator (one or more removable elements 140i);
Wherein the container perforator comprises a proximal end section provided with retention sections (see locking mechanism 144i, fig. 12);
Wherein the proximal end section is provided with four retention sections that are spaced from one another (Schriver, fig. 15) which falls within the claimed range of at least 3;
Wherein such container perforator is configured for engagement and disengagement of the container perforator (¶ 0010).
In this case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art”, a prima facie case of obviousness exists (MPEP §2144.05 I.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the retention sections of Tsai in view Sadiow such that there are at least 3 retention sections that are spaced from one another, as taught by Schriver, in order to configure the container perforator for engagement and disengagement (Schriver, ¶ 0010).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Smith et al. (Pub. No.: US 2010/0160889 A1) discloses a perforator extension.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEAGAN NGO whose telephone number is (571)270-1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
