DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to communications filed December 29, 2025.
Status of Claims
1. Claims 1-4 and 6-20 are pending and currently under consideration for patentability.
Claim 5 is cancelled as of the December 29, 2025 claim amendment.
Information Disclosure Statement
2. The information disclosure statements (IDS) submitted on December 29, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Response to Amendment
3. Applicant has amended claim 19 to overcome the previously applied 35 U.S.C. 112(b) rejection; accordingly, this rejection is withdrawn.
Response to Arguments
4. Applicant’s arguments with respect to claim(s) 1-4 and 6-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Haber et al. (US 5,647,845) is introduced as the primary reference for rejection herein.
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.
5. Claim(s) 1-4, 6, 7, 10-14 and 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haber et al. (US 5,647,845).
6. With regard to claim 1, Haber discloses a protective housing (generic intravenous infusion system, 1) for a fragile article for containing fluid medicament (any commercially available or proprietary medication/pharmaceutical vial, 100; abstract; Figs. 1, 6, 7), the protective housing (1) comprising: a shroud top (fluid control valve, 2 with cylindrical housing, 4) including an upper collar (“distal end of housing 4 is of solid cross section”) for absorbing one or more forces (col. 3, line 66 – col. 4, line 31); a shroud base (docking receptacle, 20) configured to receive the shroud top (2, 4) and including a lower collar (vial limiting end cap, 22) for absorbing one or more forces (col. 4, line 55 – col. 5, line 21); a spike (hollow vial cannula, 16) configured to pierce the fragile article (100) and coupled to the shroud top (2, 4); and a connector (hollow administration port cannula, 14 and coupling sleeve, 17) located at the shroud top (2, 4; col. 4, lines 32-47), the connector (14, 17) configured to provide the fluid medicament from the fragile article (100) to an injector (administration port, 70 of an IV bag, 80; Fig. 9); and a guide member (two-stage docking port, 5) on the shroud top (2, 4) and a protrusion (locking tab, 42) on the shroud base (20, when attached to 22; Fig. 1), the guide member (5) comprising an inclined guide track (track, 48) and a security alignment recess (detent, 54), wherein the security alignment recess (54) is positioned relative to the protrusion (42) to limit a radial alignment between the shroud top (2, 4) and the shroud base (20, 22) at which a snap fit is attainable between the shroud top (2, 4) and the shroud base (20, 22) and at which the spike (16) is positioned above the fragile article (col. 4, line 55 – col. 5, line 21), and wherein the inclined guide track (48) is configured to guide movement of the shroud top (2, 4) toward the shroud base (20, 22) through rotation of the shroud top (2, 4) with respect to the shroud base (20, 22), the inclined guide track (48) terminating in a lock (flexible lock catch, 58; Figs. 6, 7; col. 5, lines 33-52).
7. With regard to claim 2, Haber discloses that the fragile article (100) comprises a glass bottle, a plastic container, or a cartridge for containing the fluid medicament (any commercially available or proprietary medication/pharmaceutical vial, 100)
8. With regard to claim 3, Haber discloses a first indicium (axial inlet slot, 50) on the shroud top (2, 4); and a second indicium (neck of locking tab, 44) on the shroud base (20, 22), wherein the first indicium aligns with the second indicium when the shroud base receives the shroud top (Figs. 1, 6, 7; col. 4, line 55 – col. 5, line 21).
9. With regard to claim 4, Haber discloses that the spike (16) is movable toward the fragile article (100) through rotation of the shroud top (2, 4) with respect to the shroud base (20, 22; Figs. 6, 7, 8; col. 4, line 33 – col. 5, line 21).
10. With regard to claim 6, Haber discloses that the at least one inclined guide track (48) provides a path for the shroud based (20, 22) to push the spike (16) through a seal in the fragile article (100; Figs. 1, 6, 7; col. 4, line 55 – col. 5, line 21).
11. With regard to claim 7, Haber discloses that the lock (58) is configured to secure the shroud base (20, 22) to the shroud top (2, 4) in a final position after the spike (16) has pierced the fragile article (100; Figs. 1, 6, 7, 8; col. 4, line 55 – col. 5, line 21).
12. With regard to claim 10, Haber discloses a method for manufacturing a protective housing (generic intravenous infusion system ,1; abstract; Figs. 1, 6, 7), the method comprising: providing a sealed vial containing fluid medicament (any commercially available or proprietary medication/pharmaceutical vial, 100) to a shroud base (20) including a lower collar (vial limiting end cap, 22) for absorbing one or more forces on the protective housing (1; col. 4, line 55 – col. 5, line 21); aligning a shroud top (fluid control valve, 2 with cylindrical housing, 4) with the shroud base (20, 22), the shroud top (2, 4) including an upper collar (“distal end of housing 4 is of solid cross section”) for absorbing one or more forces on the protective housing (1; col. 3, line 66 – col. 4, line 31; Figs. 6, 7); the shroud top (2, 4) including a guide member (5) and the shroud base (20, 22) including a protrusion (42), the guide member (5) comprising an inclined guide track (48) and a security alignment recess (54; Fig. 1), the security alignment recess (54) positioned relative to the protrusion (42) to limit a radial alignment between the shroud top (2, 4) and the shroud base (20, 22) at which a snap fit is attainable between the shroud top (2, 4), the inclined guide track (48) configured to guide movement of the shroud top (2, 4) toward the shroud base (20, 22) through rotation of the shroud top (2, 4) with respect to the shroud base (20, 22), the inclined guide track (48) terminating in a lock (58; Fig. 1); and connecting, via the snap fit upon receipt of the protrusion in the security alignment recess, the shroud top and the shroud base to position a spike (16) in a predetermined position above the sealed vial (100), the spike (16) configured to pierce the sealed vial (100; Figs. 6, 7, 8; col. 4, line 55 – col. 5, line 21; col. 5, lines 33-52).
13. With regard to claim 11, Haber discloses coupling a connector (hollow administration port cannula, 14 and coupling sleeve, 17) to the shroud top (2, 4), the connector (14, 17) configured to provide fluid medicament from the sealed vial (100) to an injector (administration port, 70 of an IV bag, 80; Fig. 9).
14. With regard to claim 12, Haber discloses that aligning a shroud top (2, 3) with the shroud base (20, 22) comprises: aligning a first indicium (50) on the shroud top with a second indicium (44) on the shroud base (2, 4; Figs. 1, 6, 7).
15. With regard to claim 13, Haber discloses that the spike (16) is movable toward the sealed vial (100) through rotation of the shroud top (2, 4) with respect to the shroud base (20, 22; Figs. 6, 7).
16. With regard to claim 14, Haber discloses that the lock (58) is configured to secure the shroud base (22, 20) to the shroud top (2, 4) in a final position after the spike (16) has pierced the sealed vial (100; Figs. 1, 6, 7).
17. With regard to claim 16, Haber discloses that connecting the shroud top (2, 4) and the shroud base (20, 22) comprises: applying a force to the shroud top or the shroud base to snap the shroud top and shroud base together (Figs. 1, 6, 7, 8; . 4, line 55 – col. 5, line 21; col. 5, lines 33-52).
18. With regard to claim 17, Haber discloses a method for using a protective housing (generic intravenous infusion system, 1) including a shroud top (2, 4) and a shroud base (20) configured to protect a sealed vial (100) by absorbing one or more forces (abstract; Figs. 1, 6, 7, 8; col. 3, line 66 – col. 4, line 31), the method comprising: removing at least one tamper prevention device (22) from the protective housing (1); removing a protrusion (42) of one of the shroud base (20, 22) from a security alignment recess (54) of a guide member (5) of the shroud top (2, 4; Fig. 1), the security alignment recess (54) positioned relative to the protrusion (42) to limit a radial alignment between the shroud top (2, 4) and the shroud base (20, 22) at which a snap fit is attainable between the shroud top (2, 4) and the shroud base (20, 22) and at which a spike (16) of the protective housing (1) is positioned above the fragile article (100; Fig. 6); rotating the shroud top (2, 3) with respect to the shroud base (20, 22) to pierce, via the spike (16), the sealed vial (100; Figs. 7, 8), the guide member (5) including an inclined guide track (48) configured to guide movement of the shroud top (2, 4) toward the shroud base (20, 22) through rotation of shroud top (2, 4) with respect to the shroud base (20, 22), the inclined guide track (48) terminating in a lock (58; Figs. 6, 7); and connecting an injector (70, 80; Fig. 9) to the protective housing (1) to provide a path for fluid medicament from the sealed vial (100) after the sealed vial has been pierced (Figs. 6, 7; col. 4, line 55 – col. 5, line 21; col. 5, lines 33-52).
19. With regard to claims 18 and 19, Haber discloses coupling a draw-off tube (14) to the injector (70, 80); wherein connecting the injector (70, 80) comprises: coupling the draw-off tube (14) to a connector of the shroud top and the shroud base (20, 22; Figs. 1, 6-13; col. 4, line 55 – col. 5, line 21; col. 5, lines 33-52).
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.
20. Claim(s) 8, 9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Haber in view of Dunki-Jacobs et al. (WO 2016/154413 A1).
21. With regard to claims 8 and 15, while Haber discloses a spike assembly (2, 4, 16, 14; Fig. 1) comprising the spike (16) and a split valve (rotatable valve barrel 6 is of solid cross section except for a series of fluid distribution paths, 72), Haber is silent in regard to coupling a spike assembly to the shroud top and at least one release valve to vent the fragile article. However, within the same field of endeavor, Dunki discloses a protective housing (transfer device, 115; abstract; Figs. 18-19) for a fragile glass bottle for containing fluid medicament (liquid medicament vial, 102; [0079]), and a spike assembly (122 including connector, first and second spike lumen valve, and its means of coupling to 115) coupled to the shroud top (117; Figs. 18-19), the spike assembly comprising the spike (122) and at least one release valve (gas lumen; [0011]; [0066]; [0080]) to vent the fragile article (102; Figs. 18-19).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the shroud top and spike assembly disclosed by Haber to be separate structures coupled together and further including a release valve, similar to that disclosed by Dunki, in order to allow for replaceable and/or cleanable spike assemblies for the system with a reasonable expectation of success, while additionally providing the spike with a gas lumen for venting during use, as suggested by Dunki in paragraph [0066].
22. With regard to claim 9, while Haber discloses that the spike assembly (2, 4, 16, 14) further comprises a tension clip (coupling sleeve, 17) configured to couple the spike assembly to the shroud top (2, 4; Fig. 1), Haber is silent in regard to a cap configured to cover the connector.
However, Dunki discloses that the spike assembly (122) further comprises a cap (116) configured to cover the connector (122; Figs. 18-19; [0079-0080]),
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the connector disclosed by Haber to include a covering cap, similar to that disclosed by Dunki, in order to utilize a well-known and widely-utilized means of covering a spike assembly prior to use or connection to a partnering system, with a reasonable expectation of success, as suggested by Dunki in at least paragraph [0079].
23. Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Haber in view of Howlett et al. (US PGPUB 2009/0062766).
24. With regard to claim 20, Haber is silent in regard to the step of priming the injector to ready fluid medicament to be injected to a subject.
However, Howlett discloses the steps of priming an injector to ready fluid medicament to be injected to a subject ([0018]; [0103]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method disclosed by Haber to include the step of priming the injector, similar to that disclosed by Howlett, in order to ensure that all excess air is removed from the injector prior to use with a subject, as suggested by Howlett in paragraph [0103]. Further, one having ordinary skill in the art would recognize that the step of priming an injector is a well-known method step in the medical injector arts for purposes of patient safety; accordingly, the inclusion of such a method step is obvious.
Conclusion
20. 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.
21. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, 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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/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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