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 on 2/2/2026 has been entered. Claims 1-2 and 5-20 remain pending in the application. Claims 21-27 are new.
Applicants amendments to the specification have overcome the drawing objections and specification objections previously set forth in the Non-final Office Action mailed 12/16/2025.
Applicants amendments to the claims have overcome the claim objections previously set forth in the Non-final Office Action mailed 12/16/2025.
Applicants amendments to the claims have failed to overcome all of the rejections under 35 USC 112 previously set forth in the Non-final Office Action mailed 12/16/2025.
Claim Objections
Claim 21 objected to because of the following informalities:
Line 1 recites “of claim 1 wherein”. Examiner suggests adding a comma between “of claim 1" and “wherein”.
Claim 22 objected to because of the following informalities:
Line 1 recites “of claim 1 wherein”. Examiner suggests adding a comma between “of claim 1" and “wherein”.
Claim 24 objected to because of the following informalities:
Line 1 recites “of claim 23 wherein”. Examiner suggests adding a comma between “of claim 23" and “wherein”.
Claim 25 objected to because of the following informalities:
Line 29 recites “the first mating structure”. Line 17-18 introduces a first internal mating structure. Examiner suggests replacing “the first mating structure” in line 29 with “the first internal mating structure” to put the claim in clearer form and clearly refer to the first internal mating structure of line 17-18.
Line 38-39 recites “the second mating structure”. Line 18 introduces a second internal mating structure. Examiner suggests replacing “the second mating structure” in line 38-39 with “the second internal mating structure” to put the claim in clearer form and clearly refer to the second internal mating structure of line 18.
Claim 26 objected to because of the following informalities:
Line 1 recites “of claim 25 wherein”. Examiner suggests adding a comma between “of claim 25" and “wherein”.
Claim 27 objected to because of the following informalities:
Line 1 recites “of claim 26 wherein”. Examiner suggests adding a comma between “of claim 26" and “wherein”.
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 1-2 and 5-27 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.
In regard to claim 1,
Line 12 recites “the first longitudinal end”. A first longitudinal end of the manifold and a first longitudinal end of the BFS module have been introduced in claim 1. It is therefore unclear which first longitudinal end line 12 refers to. For examination purposes Examiner construes the first longitudinal end to be of the manifold. As suggested in the Non-final Office action mailed 12/16/2025, Examiner suggests replacing “the first longitudinal end” in line 12 of claim 1 with “the first longitudinal end of the manifold”.
Line 12-13 recites “the second longitudinal end”. A second longitudinal end of the manifold and a second longitudinal end of the BFS module have been introduced in claim 1. It is therefore unclear which second longitudinal end line 12-13 refers to. For examination purposes Examiner construes the second longitudinal end to be of the manifold. As suggested in the Non-final Office action mailed 12/16/2025, Examiner suggests replacing “the second longitudinal end” in line 12-13 of claim 1 with “the second longitudinal end of the manifold”.
Line 13-14 recites “the first longitudinal end”. A first longitudinal end of the manifold and a first longitudinal end of the BFS module have been introduced in claim 1. It is therefore unclear which first longitudinal end line 13-14 refers to. For examination purposes Examiner construes the first longitudinal end to be of the manifold. As suggested in the Non-final Office action mailed 12/16/2025, Examiner suggests replacing “the first longitudinal end” in line 13-14 of claim 1 with “the first longitudinal end of the manifold”.
Line 25-28 recites “a second orientation corresponding to a fluid delivery state wherein the removable casing is removed from the BFS module and arranged such that at least part of the first and second reservoirs exposed from the manifold is received within the internal actuation chamber”. As the BFS module comprises the first and second reservoirs, it is unclear how the removable casing is both removed from the BFS module and arranged such that at least part of the first and second reservoirs exposed from the manifold is received within the internal actuation chamber. For examination purposes Examiner construes the removable casing to be removed and then reattached to the BFS module such that the removable casing is arranged such that at least part of the first and second reservoirs exposed from the manifold is received within the internal actuation chamber.
Line 32 recites “the first fluid agent”. There is insufficient antecedent basis for the limitation in this claim. Line 4 introduces a first liquid agent. It is unclear if the first fluid agent is the same or different than the first liquid agent. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the first fluid agent” in line 32 of claim 1 with “the first liquid agent”. Examiner notes “the first and second fluid agents” in line 34 of claim 1 should also be replaced with “the first and second liquid agents”.
Line 32 recites “the second fluid agent”. There is insufficient antecedent basis for the limitation in this claim. Line 5 introduces a second liquid agent. It is unclear if the second fluid agent is the same or different than the second liquid agent. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the second fluid agent” in line 32 of claim 1 with “the first liquid agent”. Examiner notes “the first and second fluid agents” in line 34 of claim 1 should also be replaced with “the first and second liquid agents”.
Examiner notes claims 2 and 5-22 are similarly rejected by virtue of their dependency on claim 1.
In regard to claim 5,
Line 2-3 recites “the at least part of the first and second reservoirs exposed from the manifold”. Claim 5 depends on claim 1. Claim 1 introduces at least part of the first and second reservoirs exposed from the manifold in line 27-28 and line 16. It is therefore unclear which at least part of the first and second reservoirs exposed from the manifold claim 5 refers to. For examination purposes Examiner construes at least part of the first and second reservoirs exposed from the manifold in line 27-28 and line 16 to be the same. Examiner suggests replacing “at least part of the first and second reservoirs exposed from the manifold” in line 27-28 of claim 1 with “the at least part of the first and second reservoirs exposed from the manifold”.
In regard to claim 8,
Line 5 recites “the first longitudinal end”. Line 4 of claim 8 introduces a first longitudinal end of the administration casing. Claim 1, which claim 8 depends on, also introduces a first longitudinal end of the manifold and a first longitudinal end of the BFS module. It is therefore unclear which first longitudinal end line 5 refers to. For examination purposes Examiner construes the first longitudinal end to be of the removable casing. As suggested in the Non-final Office action mailed 12/16/2025, Examiner suggests replacing “the first longitudinal end” in line 5 of claim 8 with “the first longitudinal end of the removable casing”.
Line 6-7 recites “an internal actuation chamber of the removable casing”. Claim 8 depends on claim 1. Claim 1 was amended on 2/2/2026 to introduce an internal actuation chamber of the removable casing. It is therefore unclear if line 6-7 of claim 8 is intending to refer to the internal actuation chamber of the removable casing of claim 1 or introduce a second internal actuation chamber of the removable casing. For examination purposes Examiner construes the internal actuation chamber of the removable casing in claim 1 and 8 to be the same. Examiner suggests replacing “an internal actuation chamber of the removable casing” in line 6-7 of claim 8 with “the internal actuation chamber of the removable casing”.
In regard to claim 9,
Line 10-11 recites “each of the first and second necks has a laterally-protruding portion that is received in the first mating feature of each of the first and second bores”. It is unclear if line 10-11 is intending to claim that each laterally-protruding portion is received in both the first mating feature of the first and second bores i.e. the laterally-protruding portion of the first neck is received in the first mating feature of the first and second bores and the laterally-protruding portion of the second neck is received in the first mating feature of the first and second bores. Based on the disclosure, it appears the laterally-protruding portion of the first neck is received in the first mating feature of the first bore and the laterally-protruding portion of the second neck is received in the first mating feature of the second bore. Examiner suggests replacing “each of the first and second necks has a laterally-protruding portion that is received in the first mating feature of each of the first and second bores” in line 10-11 of claim 9 with “each of the first and second necks has a laterally-protruding portion that is received in the first mating feature of each of the first and second bores respectfully”.
Examiner notes claims 10-11 are similarly rejected by virtue of their dependency on claim 9.
In regard to claim 10,
Line 3-4 recites “the laterally-protruding portion of each of the first and necks”. It is unclear what is meant by this. For examination purposes Examiner construes “the laterally-protruding portion of each of the first and necks” to be “the laterally-protruding portion of each of the first and second necks”. Examiner suggests replacing “the laterally-protruding portion of each of the first and necks” in line 3-4 of claim 10 with “the laterally-protruding portion of each of the first and second necks”.
In regard to claim 11,
Line 3-4 recites “the second mating feature”. Line 3 introduces a second mating feature of each of the first and second bores. It is unclear which second mating feature line 3-4 refers to. For examination purposes Examiner construes the second mating feature to be of the first and second bores. Examiner suggests replacing “the second mating feature” in line 3-4 with “the second mating feature of each of the first and second bores”.
Line 3-4 recites “the second mating feature being disposed between the first mating feature of each of the first and second bores and the mixing chamber”. It is unclear if “the second mating feature being disposed between the first mating feature of each of the first and second bores and the mixing chamber” requires the second mating feature of the first bore and the second mating feature of the second bore to each be disposed between the first mating feature of each of the first and second bores and the mixing chamber. Based on the disclosure, the second mating feature of the first bore is disposed between the first mating feature of the first bore and the mixing chamber and the second mating feature of the second bore is disposed between the first mating feature of the second bore and the mixing chamber. Examiner suggests replacing “the second mating feature being disposed between the first mating feature of each of the first and second bores and the mixing chamber” in line 3-4 with “the second mating feature of each of the first and second bores being disposed between the first mating feature of each of the first and second bores and the mixing chamber respectfully.
Line 6-8 recites “the laterally-protruding portion of each of the first and second necks is constructed to laterally deform when longitudinally displaced from the first mating feature of each of the first and second bores to the second mating feature of each of the first and second bores”. It is unclear if line 6-8 requires the laterally-protruding portion of the first neck and the laterally-protruding portion of the second neck to each be constructed to laterally deform when longitudinally displaced from the first mating feature of each of the first and second bores to the second mating feature of each of the first and second bores. Based on the disclosure, the laterally-protruding portion of the first neck is constructed to laterally deform when longitudinally displaced from the first mating feature of the first bore to the second mating feature of the first bore and the laterally-protruding portion of the second neck is constructed to laterally deform when longitudinally displaced from the first mating feature of the second bore to the second mating feature of the second bore. Examiner suggests replacing “the laterally-protruding portion of each of the first and second necks is constructed to laterally deform when longitudinally displaced from the first mating feature of each of the first and second bores to the second mating feature of each of the first and second bores” with “the laterally-protruding portion of each of the first and second necks is constructed to laterally deform when longitudinally displaced from the first mating feature of each of the first and second bores to the second mating feature of each of the first and second bores respectfully”.
Line 9-10 recites “the laterally-protruding portion received in the second mating feature of each of the first and second bores”. Claim 11 depends on claim 9. Claim 9 recites "each of the first and second necks has a laterally-protruding portion" i.e. two laterally-protruding portions are present. It is unclear which laterally-protruding portion line 9 of claim 11 refers to. For examination purposes Examiner construes "the laterally-protruding portion" to be “the laterally-protruding portion of each of the first and second necks”. Examiner suggests replacing "the laterally-protruding portion received in the second mating feature of each of the first and second bores " in line 9-10 of claim 11 with “the laterally-protruding portion of each of the first and second necks are respectfully received in the second mating feature of each of the first and second bores” as the laterally-protruding portion of the first neck is received in the second mating feature of the first bore and the laterally-protruding portion of the second neck is received in the second mating feature of the second bore.
In regard to claim 12,
Line 2 recites “the second longitudinal end”. A second longitudinal end of the manifold and a second longitudinal end of the BFS module have been introduced in claim 1. It is therefore unclear which second longitudinal end line 2 refers to. For examination purposes Examiner construes the second longitudinal end to be of the manifold. As suggested in the Non-final Office action mailed 12/16/2025, “the second longitudinal end” in line 2 of claim 12 should state “the second longitudinal end of the manifold”.
In regard to claim 21,
Line 4 recites “the first and second fluid agents from the first and second reservoirs”. Claim 21 depends on claim 1. Claim 1 requires the first reservoir having a first liquid agent therein, the second reservoir having a second liquid agent therein. It is unclear if line 4 should therefore state “the first and second liquid agents from the first and second reservoirs”. For examination purposes Examiner construes the first and second fluid agents to be the same as the first and second liquid agents. Examiner suggests replacing “the first and second fluid agents from the first and second reservoirs” in line 4 of claim 21 with “the first and second liquid agents from the first and second reservoirs”.
In regard to claim 23,
Line 5-6 recites “first and second sealed ports in fluid communication with the first and second reservoirs”. It is unclear if line 5-6 requires first and second sealed ports that are each in fluid communication with the first and second reservoirs or requires first and second sealed ports that are respectfully in fluid communication with the first and second reservoirs. Based on the disclosure, it appears that the first sealed port is in fluid communication with the first reservoir and the second sealed port is in fluid communication with the second reservoir. Examiner suggests replacing “first and second sealed ports in fluid communication with the first and second reservoirs” in line 5-6 of claim 23 with “a first sealed port in fluid communication with the first reservoir and a second sealed port in fluid communication with the second reservoir”.
Line 18-20 recites “a second orientation corresponding to a fluid delivery state wherein the removable casing is removed from the BFS module and arranged such that the internal actuation chamber at least partially receives the first and second reservoirs of the BFS module”. As the BFS module comprises the first and second reservoirs, it is unclear how the removable casing is both removed from the BFS module and arranged such that the internal actuation chamber at least partially receives the first and second reservoirs of the BFS module. For examination purposes Examiner construes the removable casing to be removed and then reattached to the BFS module such that the removable casing is arranged such that the internal actuation chamber at least partially receives the first and second reservoirs of the BFS module.
Line 22-23 recites “the first and second internal piercing members”. There is insufficient antecedent basis for the limitation in this claim. Line 9 recites “first and second longitudinal piercing elements”. It is unclear if the first and second internal piercing members are the same or different than the “first and second longitudinal piercing elements”. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the first and second internal piercing members” in line 22-23 of claim 23 with “the first and second longitudinal piercing elements”.
Line 25-26 recites “the first and second fluid agents”. There is insufficient antecedent basis for the limitation in this claim. Line 3-4 recites “the first reservoir having a first liquid agent therein, the second reservoir having a second liquid agent therein”. It is unclear if the first and second fluid agents is the same as the first and second liquid agents. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the first and second fluid agents” in line 25-26 with “the first and second liquid agents”. Examiner notes “the first and second fluid agents” in line 27 of claim 23 should also be amended to state “the first and second liquid agents”.
Examiner notes claim 24 is similarly rejected by virtue of its dependency on claim 23.
In regard to claim 25,
Line 18-19 recites “the first internal mating structure”. Line 17-18 introduces a first internal mating structure of each of the first and second axial walls. It is unclear which first internal mating structure line 18-19 refers to. For examination purposes Examiner construes “the first internal mating structure” to be “the first internal mating structure of the first and second axial walls”. Examiner suggests replacing “the first internal mating structure” in line 18-19 with “the first internal mating structure of the first and second axial walls”.
Line 42 recites “the first fluid agent”. There is insufficient antecedent basis for the limitation in this claim. Line 3 recites “a first reservoir containing a first liquid agent”. It is unclear if the first fluid agent is the same or different than the first liquid agent. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the first fluid agent” in line 42 of claim 25 with “the first liquid agent”. Examiner notes “the first and second fluid agents” in line 43 of claim 25 AND line 4 of claim 26 should also be replaced with “the first and second liquid agents”.
Line 42 recites “the second fluid agent”. There is insufficient antecedent basis for the limitation in this claim. Line 5 recites “a second reservoir containing a second liquid agent”. It is unclear if the second fluid agent is the same or different than the second liquid agent. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the second fluid agent” in line 42 of claim 25 with “the second liquid agent”. Examiner notes “the first and second fluid agents” in line 43 of claim 25 AND line 4 of claim 26 should also be replaced with “the first and second liquid agents”.
Examiner notes claims 26-27 are similarly rejected by virtue of their dependency on claim 25.
Allowable Subject Matter
Claims 1-2 and 5-27 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
In regard to claim 1,
The prior art of record does not teach or otherwise render obvious before the effective filing date of the claimed invention in combination with all claim limitations a pre-filled medical delivery assembly as claimed in claim 1 comprising the removable casing being configured to transition between a first orientation corresponding to a transit state wherein the at least part of the first and second reservoirs exposed from the manifold is received within the internal protection chamber, and a second orientation corresponding to a fluid delivery state wherein the removable casing is removed from the BFS module and arranged such that at least part of the first and second reservoirs exposed from the manifold is received within the internal actuation chamber.
Nessel (U.S. PG publication 20140052102) discloses a removable casing (figure 11, item 40). The removable casing however is not configured to transition between a first orientation corresponding to a transit state wherein the at least part of the first and second reservoirs exposed from the manifold is received within the internal protection chamber, and a second orientation corresponding to a fluid delivery state wherein the removable casing is removed from the BFS module and arranged such that at least part of the first and second reservoirs exposed from the manifold is received within the internal actuation chamber. Accordingly, claim 1 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Dependent claims 2 and 5-22 would be allowable by virtue of being dependent upon allowable independent claim 1.
In regard to claim 23,
The prior art of record does not teach or otherwise render obvious before the effective filing date of the claimed invention in combination with all claim limitations a pre-filled medical delivery assembly as claimed in claim 23 comprising the removable casing being configured to transition between a first orientation corresponding to a transit state wherein the internal protection chamber at least partially receives the first and second reservoirs of the BFS module, and a second orientation corresponding to a fluid delivery state wherein the removable casing is removed from the BFS module and arranged such that the internal actuation chamber at least partially receives the first and second reservoirs of the BFS module; and wherein, when in the second orientation, axial movement of the removable casing toward the manifold causes displacement of the BFS module relative to the manifold such that the first and second internal piercing members of the manifold respectively penetrate the first and second sealed ports of the BFS module and the internal actuation chamber of the BFS module compresses the first and second reservoirs of the BFS module, to thereby facilitate distribution of the first and second fluid agents from the first and second reservoirs and into the internal volume of the manifold to cause combining and/or mixing of the first and second fluid agents for distribution through the lumen of the administration member. Claim 23 includes similar limitations as claim 1 and would therefore be allowable for similar reasons as claim 1 if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Dependent claim 24 would be allowable by virtue of being dependent upon allowable independent claim 23.
In regard to claim 25,
The prior art of record does not teach or otherwise render obvious before the effective filing date of the claimed invention in combination with all claim limitations a pre-filled medical delivery assembly as claimed in claim 25 comprising the removable casing being configured to transition between a first orientation corresponding to a transit state wherein the internal protection chamber at least partially receives the first and second reservoirs of the BFS module, and a second orientation corresponding to a fluid delivery state wherein the internal actuation chamber at least partially receives the first and second reservoirs of the BFS module; and wherein, when in the second orientation of the removable casing, axial movement of the removable casing toward the manifold causes the laterally projecting portion of each of the first and second necks of the BFS module to deform to thereby enable the BFS module to move relative to the manifold from the initial longitudinal position to an activated longitudinal position whereby the laterally projecting portion of each of the first and second necks engages the second mating structure of each of the first axial wall and the second axial wall.
Nessel (U.S. PG publication 20140052102) discloses a removable casing (figure 11, item 40). The removable casing however is not configured to transition between a first orientation corresponding to a transit state wherein the internal protection chamber at least partially receives the first and second reservoirs of the BFS module, and a second orientation corresponding to a fluid delivery state wherein the internal actuation chamber at least partially receives the first and second reservoirs of the BFS module; and wherein, when in the second orientation of the removable casing, axial movement of the removable casing toward the manifold causes the laterally projecting portion of each of the first and second necks of the BFS module to deform to thereby enable the BFS module to move relative to the manifold from the initial longitudinal position to an activated longitudinal position whereby the laterally projecting portion of each of the first and second necks engages the second mating structure of each of the first axial wall and the second axial wall. Accordingly, claim 25 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Dependent claims 26-27 would be allowable by virtue of being dependent upon allowable independent claim 25.
Response to Arguments
Applicant's arguments filed 2/2/206 have been fully considered but they are not persuasive. Applicant argues that the claims have been amended in a manner which is believed to overcome the 112 rejections. As detailed above, several 112 rejections were not overcome. Additionally, the claim amendments have necessitated new rejections under 35 U.S.C. 112. No further arguments have been included.
Conclusion
THIS ACTION IS MADE FINAL. 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 ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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/ALEXANDRA LALONDE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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