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 .
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.
Claims 1-5, 11-18, and 20, are rejected under 35 U.S.C. 103 as being obvious over Akerele et al (WO 2019/222713 A1) in view of Bahrami et al. (US 20100330589 A1).
The applied reference has a common assignee and inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claim 1, Akerele discloses a particulate material delivery assembly, comprising:
a console 510 including a vial containment region 518;
a vial assembly 580 comprising a particulate material [ 00169, 00158, 00285];
a vial engagement mechanism 520 extending from the console within the vial containment region 518, wherein the vial engagement mechanism is configured to engage the vial assembly and move the vial assembly to a locked position; and
a multi-port needle (proximal and bottom distal ports, not shown) configured to puncture a septum of the vial assembly when the vial assembly is in the locked position (figs 26a-26b);
the top distal port and at least the bottom proximal port configured to inject a fluid into the vial assembly to mix with the particulate material upon actuation of the vial engagement mechanism in a first direction and to receive a resulting mixed fluid from the vial assembly upon actuation of the vial engagement mechanism in a second direction opposite the first direction;
wherein the top distal port is further configured to be at a distance above and spaced away from the particulate material in the vial assembly when in the locked position.
However, Akerele fails to disclose the multi-port needle comprises the top distal port of a first diameter and the at least a bottom proximal port of a second diameter that is smaller than the first diameter, and wherein each of the top distal port and the at least the bottom proximal port is formed in a lateral surface of the multi-port needle.
Bahrami teaches a needle array comprising a multi-port needle (fig 2B) comprises the top distal port of a first diameter and the at least a bottom proximal port of a second diameter that is smaller than the first diameter, and wherein each of the top distal port and the at least the bottom proximal port is formed in a lateral surface of the multi-port needle. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Akerele’s multi-port needle with Bahrami’s port shape since such modification would have speed up the delivery/removal of saline solution into/from the vial after mixing both saline and the particulate material.
Regarding claim 2, Akerele discloses the particulate material delivery assembly comprises a radioembolization delivery device [500,540 figures 13-29], the particulate material comprises a plurality of radioembolization beads [00158], the fluid comprises a contrast-saline solution (saline bag [00160], not shown), the resulting mixed fluid comprises a radioembolization beads-contrast-saline solution, and the multi-port needle is configured to deliver the radioembolization beads-contrast-saline solution through the radioembolization delivery device.
Regarding claim 3, Akerele discloses the top distal port and the at least the bottom proximal port is configured to inject the fluid into the vial assembly to mix with the particulate material upon actuation of the vial engagement mechanism 520 in the first direction comprising a negative pressure inducing direction and to receive the resulting mixed fluid from the vial assembly upon actuation of the vial engagement mechanism in the second direction comprising a positive pressure inducing direction opposite the negative pressure inducing direction (figures 27 and 29).
Regarding claim 4, Akerele discloses actuation of the vial engagement mechanism in the negative pressure inducing direction comprises an upward movement of a lever 528 of the vial engagement mechanism 520 with the vial assembly in the locked position, and actuation of the vial engagement mechanism in the positive pressure inducing direction comprises a downward movement of the lever of the vial engagement mechanism with the vial assembly in the locked position (figs 27 and 29).
Regarding claim 5, Akerele discloses the particulate material delivery assembly comprises a radioembolization delivery device 500,540, the particulate material comprises a plurality of radioembolization beads [00158], the fluid comprises a saline solution [00160], the resulting mixed fluid comprises a radioembolization beads-saline solution, and the multi-port needle 559 is configured to deliver the radioembolization beads-saline solution through the radioembolization delivery device upon actuation of the vial engagement mechanism in the positive pressure direction (figs 27 and 29).
Regarding claim 11, Akerele/Bahrami discloses the invention substantially as claimed. Bahrami teaches in figures 2b, 2c the at least the bottom proximal port of the multi-port needle comprises a plurality of proximal ports on the multi- port needle.
Regarding claim 12, Akerele/Bahrami discloses the invention substantially as claimed. Bahrami teaches in figures 2b,2c the multi-port needle comprises a horizontal plane and a longitudinal axis, the horizontal plane perpendicular to the longitudinal axis, and the plurality of proximal ports are evenly and concentrically spaced around the multi-port needle such that the plurality of proximal ports are intersected by the horizontal plane of the multi-port needle.
Regarding claim 13, Akerele/Bahrami discloses the invention substantially as claimed. Bahrami teaches in figures 2b,2c the multi-port needle comprises a horizontal plane and a longitudinal axis, the horizontal plane perpendicular to the longitudinal axis, and the plurality of proximal ports are concentrically spaced around the multi-port needle such that at least two proximal ports are staggered in spacing with respect to the horizontal plane of the multi-port needle.
Regarding claim 14, Akerele/Bahrami discloses the invention substantially as claimed. Bahrami teaches in figure 2b the plurality of proximal ports comprises eight proximal ports, and each proximal port is spaced at a range of from about twenty degrees to about ninety degrees from another proximal port.
Regarding claim 15, Akerele/Bahrami discloses the invention substantially as claimed. Bahrami teaches in figure 2c the plurality of proximal ports comprises four proximal ports, and each proximal port is spaced at a range of from about twenty degrees to about ninety degrees from another proximal port.
Regarding claim 16, Akerele (see claim 1 above for similar elements) discloses a method of use of a particulate material delivery assembly to deliver particulate, comprising:
engaging a vial engagement mechanism extending from a console within a vial
containment region of the console with a vial assembly comprising a particulate material;
moving the vial assembly engaged with the vial engagement mechanism to a locked position;
puncturing a septum of the vial assembly with a multi-port needle 559 when the vial assembly is in the locked position,
wherein the multi-port needle comprises a top distal port and at least a bottom proximal port, and the top distal port is further configured to be at a distance above and spaced away from the particulate material in the vial assembly when in the locked position;
injecting through the top distal port and the at least the bottom proximal port a fluid into the vial assembly to mix with the particulate material to generate a resulting mixed fluid in the vial assembly upon actuation of the vial engagement mechanism in a first direction; and
receiving through top distal port and the at least the bottom proximal port the resulting mixed fluid from the vial assembly into the multi-port needle upon actuation of the vial engagement mechanism in a second direction opposite the first direction.
Akerele fails to disclose the multi-port needle comprises the top distal port of a first diameter and the at least a bottom proximal port of a second diameter that is smaller than the first diameter, and wherein each of the top distal port and the at least the bottom proximal port is formed in a lateral surface of the multi-port needle.
Bahrami teaches a needle array comprising a multi-port needle (fig 2B) comprises the top distal port of a first diameter and the at least a bottom proximal port of a second diameter that is smaller than the first diameter, and wherein each of the top distal port and the at least the bottom proximal port is formed in a lateral surface of the multi-port needle. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Akerele’s multi-port needle with Bahrami’s port shape since such modification would have speed up the delivery/removal of saline solution into/from the vial after mixing both saline and the particulate material.
Regarding claim 17, Akerele further comprising delivering the resulting mixed fluid from the multi-port needle through a radioembolization delivery device of the particulate material delivery assembly, wherein the particulate material comprises a plurality of radioembolization beads, the fluid comprises a saline solution, and the resulting mixed fluid comprises a radioembolization beads-saline solution (figure 33, step 728).
Regarding claim 18, Akerele further comprising injecting through the top distal port and the at least the bottom proximal port the fluid into the vial assembly to mix with the particulate material upon actuation of the vial engagement mechanism in the first direction comprising a negative pressure inducing direction; and receiving through top distal port and the at least the bottom proximal port the resulting mixed fluid from the vial assembly into the multi-port needle upon actuation of the vial engagement mechanism in the second direction comprising a positive pressure inducing direction opposite the negative pressure inducing direction (figure 33, step 728).
Regarding claim 20, Akerele/Bahrami discloses the invention substantially as claimed. Bahrami teaches in figure 2b at least the bottom proximal port of the multi-port needle comprises a plurality of proximal ports on the multi-port needle.
Allowable Subject Matter
Claims 6-10, and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 12/16/2025 have been fully considered.
In regards to the rejection under 112, enablement, the examiner agrees with the remarks, therefore the rejection under 112a enablement is withdrawn.
In regards to remarks over the 103 rejection, Akerele in view of Sweeney, have been considered but are moot because of the new grounds of rejection of applied reference Bahrami et al. (US 20100330589 A1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892 form.
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 Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783