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 .
Status of Claims
Claims 1-7 are pending and examined on the merits.
Claims 1 and 6 are currently amended.
Claims 8-13 are withdrawn for being drawn to non-elected inventions.
Response to Amendment
Applicant’s amendments filed 08/07/2025 have been fully considered.
Claim Objections:
Applicant amended claim 6 to correct a minor informality. Accordingly, the objection to claim 6 is withdrawn.
Response to Arguments
Applicant provided amendments to the independent claims which necessitates a new ground of rejection. Accordingly, Schweiss (U.S. Pre Grant Pub. No. 2017/0020784 A1) and Nelson (U.S. Pre Grant Pub. No. 2004/0265179 A1) are reintroduced as primary and secondary references in the present rejection for disclosing and rendering obvious the limitations presented in the amendments.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-4, and 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schweiss (U.S. Pre Grant Pub. No. 2017/0020784 A1).
Regarding claim 1, Schweiss teaches: A module for use in a combinatorial drug device (see at least Abstract and medical container unit 12 in Fig. 4), the module formed to accommodate a drug vial (see containers 14a-c in Fig. 5) sealed by a septum (see stopper 44 at least in Fig. 4), the module comprising:
a vial spike (see spike 48 in Fig. 2) formed to pierce the septum of the drug vial accommodated by the module (see at least para. [0058]), wherein the vial spike includes an inlet path and a separate outlet path (see first spike channel 62a and second spike channel 66a in para. [0073] and Fig. 6);
a first sealing port (see one of fluid collection assemblies 104 at least in Fig. 10 and para. [0084]; as taught in para. [0084], fluid connection assembly 104 includes a first fluid valve 108 which can be closed to prevent fluid flow via connector 114);
a first fluid line connecting the inlet path with the first sealing port (as shown in Fig. 10, inlet port 18 forms a first fluid line connecting inlet path 62);
a first branch line (see outlet port 26b in Fig. 4) extending from, and in communication with, the first fluid line (at least inherent since the device is a closed system and the tubes/connectors/ports have to necessarily be in communication with one another for the device to function as intended), the first branch line including an exposed tube portion (as shown in Fig. 4, and as broadly claimed, outlet port 26b comprises an exposed tube portion);
a second sealing port (see one of fluid collection assemblies 104 at least in Fig. 10 and para. [0084]);
a third sealing port (see filter 118 in Fig. 10; as broadly claimed, the filter will cause at least some to total restriction of fluid flow);
a second fluid line connecting the second sealing port with the third sealing port (as shown in Fig. 10, for example, the filter 118 is fluidly connected to fluid collection assembly 104), wherein the first branch line extends to, and is in communication with, the second fluid line (at least inherent since the device is a closed system and the tubes/connectors/ports have to necessarily be in communication with one another for the device to function as intended);
a fourth sealing port (see air connection assembly 106 in Fig. 10);
a third fluid line connecting the outlet path with the fourth sealing port (as shown in Fig. 10, for example, the filter 118 is fluidly connected to the air connection assembly 106); and,
a male pin (see numeral 16a in Fig. 4) formed to pressingly engage against the exposed tube portion in pinching closed the first branch line (as described in para. [0090], when the first and second pooling devices 74a, 74b are linked, the air vent paths of the connected pooling devices are closed or blocked) of a similarly- formed module connected directly to the module (see at least para. [0072]).
Regarding claim 3, Schweiss teaches the invention as discussed above in claim 1. Additionally, Schweiss teaches:
a plurality of modules (see Fig. 5) formed in accordance with claim 1 (see above) serially connected to form a combination of the modules with a first of the modules defining a terminus thereof (see Fig. 5).
Additionally, Schweiss generally discloses a pump module (see at least para. [0054]), such as a peristaltic pump (Id.). Therefore, the peristaltic pump of Schweiss is:
a pump module (see at least para. [0054]) connected to the first module (see para. [0065]), the pump module including a first inlet sealing port interfacing with the fourth sealing port of the first module (as described in para. [0074], outlet port 26a is connected to the pumping system; therefore, the pumping system also comprises a port to connect to outlet port 26a), a second inlet sealing port interfacing with the third sealing port of the first module (this limitation is met at least because a peristaltic pump requires two connections in order to function as intended; for example, the tube that the peristaltic pump acts on has two ends that are connected to the outlet port 26a), a first outlet port (inherent), and a pump (see para. [0054]), wherein, an outlet passageway is defined between the first inlet sealing port and the first outlet port (inherent), with the pump being configured to draw liquid drug into the outlet passageway and to urge the drawn liquid drug from the first outlet port (see para. [0054]).
Regarding claim 4, Schweiss teaches the invention as discussed above in claim 1. Additionally, Schweiss teaches wherein the pump module includes a vented passageway in communication with the second inlet sealing port (see para [0016]; since the device is a closed system, the vented passageway is in communication with the second inlet sealing port).
Regarding claim 6, Schweiss teaches: A module for use in a combinatorial drug device (see at least Abstract and medical container unit 12 in Fig. 4), the module formed to accommodate a drug vial (see containers 14a-c in Fig. 5) sealed by a septum (see stopper 44 at least in Fig. 4), the module comprising:
a vial spike (see spike 48 in Fig. 2) formed to pierce the septum of the drug vial accommodated by the module (see at least para. [0058]), wherein the vial spike includes an inlet path and a separate outlet path (see first spike channel 62a and second spike channel 66a in para. [0073] and Fig. 6);
a first sealing port (see one of fluid collection assemblies 104 at least in Fig. 10 and para. [0084]);
a first fluid line connecting the inlet path with the first sealing port (as shown in Fig. 10, inlet port 18 forms a first fluid line connecting inlet path 62), the first fluid line including a first exposed tube portion (as shown in Fig. 4, and as broadly claimed, outlet port 26b comprises a first exposed tube portion);
a first fluid line connecting the inlet path with the first sealing port (as shown in Fig. 10, inlet port 18 forms a first fluid line connecting inlet path 62), the first fluid line including a first exposed tube portion (inherent);
a second sealing port (see one of fluid collection assemblies 104 at least in Fig. 10 and para. [0084]);
a first branch line (see outlet port 26b in Fig. 4) extending from, and in communication with, the first fluid line (at least inherent since the device is a closed system and the tubes/connectors/ports have to necessarily be in communication with one another for the device to function as intended), the first branch line including a second exposed tube portion (as shown in Fig. 4, and as broadly claimed, outlet port 26b comprises a second exposed tube portion);
a third sealing port (see filter 118 in Fig. 10; as broadly claimed, the filter will cause at least some to total restriction of fluid flow);
a second fluid line connecting the outlet path with the third sealing port (as shown in Fig. 10, for example, the filter 118 is fluidly connected to fluid collection assembly 104);
a fourth sealing port (see air connection assembly 106 in Fig. 10);
a second branch line extending from, and in communication with, the second fluid line (as shown in Fig. 10, a second branch line extends between filter 118 and air connection assembly 106 and is in communication with the second fluid line at least since the system is a closed system), the second branch line extending to the fourth sealing port (see Fig. 10); and
a male pin (see numeral 16a in Fig. 4) formed to pressingly engage against the exposed tube portion in shutting off the first branch line (as described in para. [0090], when the first and second pooling devices 74a, 74b are linked, the air vent paths of the connected pooling devices are closed or blocked) of a similarly- formed module connected directly to the module (see at least para. [0072]).
Regarding claim 7, Schweiss teaches the invention as discussed above in claim 6. Additionally, Schweiss teaches a base tray (see numerals 74a and 74b in Fig. 4) including a second male pin formed to pressingly engage against the first exposed tube portion with the module connected directly to the base tray ( as broadly claimed, and as shown in Fig. 4, two pins are located at numerals 26b and 16a).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Schweiss (U.S. Pre Grant Pub. No. 2017/0020784 A1) in view of Nelson (U.S. Pre Grant Pub. No. 2004/0265179 A1).
Regarding claims 2 and 5, Schweiss teaches the invention as discussed above in claims 1 and 3, respectively. However, Schweiss fails to explicitly teach at least one collapsible gas chamber in communication with or more of the first, the second fluid line, and the third fluid line, as required by the claim.
Nelson teaches an analogous pumping system comprising a fluid flow against a deflectable gas transport bladder (see Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Schweiss to incorporate the teachings of Nelson by including at least one collapsible gas chamber in communication with or more of the first, the second fluid line, and the third fluid line at least because Nelson teaches that it is known that the use of commercially available pumps lead to unacceptably high gas losses and that having a collapsible gas bladder minimizes such losses (see para. [0003]).
Conclusion
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 JIHAD DAKKAK whose telephone number is (571)272-0567. The examiner can normally be reached Mon-Fri: 9AM - 5PM ET.
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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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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/SARAH AL HASHIMI/ Supervisory Patent Examiner, Art Unit 3781
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