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 amendments filed on 10/23/2025 has been entered. Claim 1 has been amended; claims 2, 19 and 22 have been cancelled. Accordingly, claims 1, 3-18 and 20-21 are pending and under consideration.
Response to Arguments
Applicant's arguments filed on 10/23/2025 have been fully considered but they are not persuasive.
Regarding Applicant’s remarks stating that “As a first matter, the art of record relates to mixing of fluids or liquids, not suspension of particles that have settled on the bottom of a vial. These are two different things” on page 7 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. The Abstract section and Par. 14 of Hayashi discuss that the liquid medium produced by mixing liquids comprises fine structures dispersed therein. Furthermore, Hayashi also discusses that the second liquid, which is the liquid inside vial/container 3 comprises one or both of calcium ion and magnesium ion. Therefore, one of ordinary skill in the art would have reasonably deduced that these particles can settle in the bottom of the vial/container 3 via the effect of gravity. Thus settled particles are dispersed in the solution as claimed. See rejection of claims below.
Regarding Applicant’s remarks stating that “the Office Action states that it would have been obvious "to have modified the device of Hayashi to further include an outlet channel as taught by Yagi, in order to allow the mixed rug solution within the device to be injected into a blood vessel of the patient." Such a proposed modification is inapposite as the Hayashi reference describes its mixing method for the preparation of culture media with cross-linked structures permitting attachment by cells distributed therein, not delivery of anything to a patient” on page 7 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. While the disclosure of Hayashi’s PG-PUB does not directly recite any delivery of substance to a patient, Hayashi’s disclosure does discuss the incorporation of method in patent document 1 (Par. 57 of Hayashi), which is also known as Nishino et al. WO 2014/017513 A1 (hereinafter Nishino). The disclosure of Nishino establishes that the cultured media can be transplanted for therapeutic purposed to patients with diseases or disorders (Page 76 in the provided translation). Therefore, the method/apparatus of Hayashi is understood to also be readily available for delivery to a patient. In addition, in regards to Applicant’s remarks stating that “Hayashi does not teach an outlet channel, nor would there be any reason to introduce an outlet channel to the described technology, in view of the described problem to be solved. Hayashi looks to solve the problem of mixing two liquids such that the liquids form a preferable state. To accomplish a preferable state of mixing, a very specific flow rate is necessary. There is no motivation to add an outlet channel for dispersal to the container taught by Hayashi” on page 8-9 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. For the reasons established above that allow the produced composition to be delivered to a patient, one of ordinary skill in the art would have been reasonably motivated to include an outlet for patient delivery, as taught by Yagi.
Regarding Applicant’s remarks stating that “However, the Office has provided no rationale as to why such a combination would result in the inlet channel being positioned near the bottom surface and the outlet channel at the top. Yagi teaches two inlet channels. One inlet channel is expressly in line with, or above the outlet channel, see, for example paragraph [0102]; and the location of the other inlet channel is not expressly taught by the specification. Turning then to the drawings, at best, the drawings disclose the second inlet channel is in line with or above the outlet channel, see for example figures 7, 10, and 14. More strikingly, figures 1, 2, and 3 show that the second inlet channel is perpendicular to the outlet channel and in no way is clearly positioned to the bottom of the surface compared to the outlet channel. Therefore, there is no teaching disclosed in Yagi that would suggest a combination with Hayashi's vial would result in the inlet channel being disposed closer to the bottom and the outlet channel being disposed closer to the upper end” on page 8 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. In the Office Action mailed on 07/24/2025, page 7, second paragraph, Examiner interprets the fluid flow direction A of Yagi to have an inflow at inlet channel 15 and an outflow at outlet channel 16, thus an inlet channel at the bottom of mixing device 1 and an outlet channel at the top of mixing device 1. Hence the modification by Yagi would result in the Hayashi’s channels to have the same position. In response to applicant's argument that the location of the inlet and outlet channel is critical, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Hayashi et al. US 2018/0112013 A1 (previously cited, hereinafter Hayashi) in view of Yagi et al. US 2013/0028841 A1 (previously cited, hereinafter Yagi) and Kress et al. US 2016/0346758 A1 (previously cited, hereinafter Kress).
Regarding claim 1, Hayashi discloses a vial 3 (Fig. 3 – container 3) comprising:
a bottom interior surface IB (see annotated Fig. 3 below) at least a portion of which has an incline angle to a horizontal plane X (see annotated Fig. 3 below – the annotated surface IB is an incline relative to the horizontal plane X) greater than 0 degrees (see annotated Fig. 3 below – the angle of incline is greater than 0) and a cylindrical interior wall IW (see annotated Fig. 3 below) substantially perpendicular to the horizontal plane X (see annotated Fig. 3 below – the annotated wall IW and plane X form a 90 degree angle) and meeting the bottom interior surface (see annotated Fig. 3 below – annotated wall IW meets the horizontal plane X via the interior bottom surface IB), wherein the bottom interior surface IB (see annotated Fig. 3 below) and cylindrical interior wall IW (see annotated Fig. 3 below) form a container 31 (Fig. 3 – body 31) for containing a liquid B (Fig. 3 – second liquid B);
an inlet channel 33 (Fig. 3 – tubular component 33) for fluid flow A1 (Fig. 3 – first liquid A1) into the vial 3 (Fig. 3 – first liquid A1 enters the container 3), the inlet channel 33 (Fig. 3) defining a direction vector of fluid flow A1 (Fig. 3 – first liquid A1 flows in a vertical manner), wherein the direction vector causes a moving fluid vortex (Fig. 3 – the spinning arrows within body 31) to be created in the vial 3 (Fig. 3) such that settled particles in a particle-containing solution B (Fig. 3 – second liquid B, and Par. 25 – “the second liquid is a liquid medium containing one or both of calcium ion and magnesium ion”) placed in the vial 3 (Fig. 3) are dispersed in the solution (Par. 79 – “the first liquid rushes into the second liquid with impact, the structure can be more preferably subdivided and dispersed”) by the fluid vortex (Fig. 3, and Par. 91 – “When the first liquid is injected into a position offset from the center toward the periphery of the container, the first liquid enters deeply into the second liquid, makes a large turn at the bottom of the container, and affords an effect of moving around as one flow in the container, as shown with arrows in the container in FIG. 3”).
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Annotated Fig. 3 of Hayashi
However, Hayashi does not disclose an outlet channel for fluid flow out of the vial through the cylindrical interior wall; an inlet channel through the cylindrical interior wall; the direction vector is oriented at a first predefined angle with respect to the horizontal plane and at a second predefined angle with respect to a line tangent to the cylindrical interior wall such that fluid flowing in through the inlet channel and causes an upwardly moving fluid vortex and exit through the exit channel; wherein the inlet channel is disposed at vertical position closer to the bottom interior surface than the outlet channel.
Yagi, in the same field of endeavor of mixing device and tube for injecting a drug solution (Abstract), teaches an outlet channel 16 (Fig. 7 – outflow opening 16) for fluid flow out A (Fig. 7 – flow direction A; according to the arrow of flow direction A, fluid exits at outflow opening 16) of the vial 1 (Fig. 5 – mixing device 1) through the cylindrical interior wall 18 (Fig. 7 – inner surface 18; the surface is cylindrical); an inlet channel 15 (Fig. 6-8 – inflow opening 15) through the cylindrical interior wall 17 (Fig. 7 – inner surface 17); the direction vector 15 (Fig. 10) is oriented at a second predefined angle (see annotated Fig. 11 below) with respect to a line tangent (see annotated Fig. 11 below) to the cylindrical interior wall 17 (see annotated Fig. 11 below) such that fluid flowing in through the inlet channel 15 (Fig. 11) and causes an upwardly moving fluid vortex G (Fig. 10 – swirling flow G; flow G is a upward swirl towards the outflow opening 16) and exit through the exit channel 16 (Fig. 7 – flow direction A; according to the arrow of flow direction A, fluid exits at outflow opening 16); wherein the inlet channel 15 (Fig. 7) is disposed at vertical position closer B (Fig. 7 – center line B of the mixing device 1 as the vertical orientation) to the bottom interior surface 11B (Fig. 7 – inside end surface 11B) than the outlet channel 16 (Fig. 7).
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Annotated Fig. 11 of Yagi
Kress, in the same field of endeavor of vortex induction mechanism to process fluids (Abstract), teaches the direction vector is oriented at a first predefined angle with respect to the horizontal plane (annotated Fig. 1E below – inlet port 102 forms an angle with the horizontal plane).
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Annotated Fig. 1E of Kress
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inlet channel of Hayashi to be oriented at a second predefined angle as taught by Yagi, in order to generate a swirling flow (Par. 62 of Yagi). It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the position of the inlet channel to so it was near the bottom surface, as taught by Yagi, since this claimed position of the inlet channel does not change its ability to deliver fluid into the vial and form a vortex. Since applicant has not given any criticality to why the position of the inlet channel disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Hayashi to further include an outlet channel as taught by Yagi, in order to allow the mixed drug solution within the device to be injected into a blood vessel of the patient (Par. 46 of Yagi), given that the outlet channel 16 communicates with tube 303 (Fig. 6 of Yagi) and ultimately catheter 103 (Fig. 2 of Yagi). Once the modification is made as discussed, the inlet channel will be positioned near the bottom surface and the outlet channel at the top as taught by Yagi.
Lastly, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Hayashi in view of Yagi to further have the inlet angled with respect to the horizontal plane as taught by Kress, in order to provide beneficial mixing of inflowing reactor fluid in at least the initial flow region of the container (Par. 51 of Kress).
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Hayashi in view of Yagi in view of Kress as applied to claim 1 above, and in view of Chee Mun US 2014/0269160 A1 (previously cited, hereinafter Chee Mun).
Regarding claim 3, Hayashi in view of Yagi in view of Kress discloses the invention of claim 1. The combination of Hayashi, Yagi, and Kress does not currently disclose wherein the cylindrical interior wall includes a ramp portion that extends inwardly from the cylindrical interior wall and further defines an interior surface that pushes the upwardly moving fluid vortex a rotational flow in the vial toward a center of the vial and wherein the ramp portion extends vertically from a position proximate to the bottom interior surface to a first predefined vertical position with respect to the outlet channel.
Chee Mun, in the same field of endeavor of container for mixing substances in preparation for injection (Abstract), teaches wherein the cylindrical interior wall 118 (Fig. 17 – inner wall 118) includes a ramp portion 120 (Fig. 17 – mixing fin 120) that extends inwardly from the cylindrical interior wall 118 (Fig. 17) and further defines an interior surface 121, 122 (Fig. 18 – mixing faces 121, 122) that pushes the moving fluid vortex in the vial toward a center of the vial 110 (Fig. 17, and Par. 11 – “the first mixing element forms at least one vortex which effectuates mixing of a first substance and a second substance contained within the container assembly”, and Par. 61 – “The shape and angles of the two mixing faces, as well as the length of mixing fin 120, are all variables which can be adjusted to provide sufficient mixing”; as an exemplary demonstration, Fig. 6 of Chee Mun depicts a vortex that whirls around towards the center of the vial; thus the mixing fin 120 with such angled seen in Fig. 18 will further push the vortex in the center) and wherein the ramp portion 120 (Fig. 17) extends vertically from a position proximate to the bottom interior surface (Fig. 17 – the mixing fin 120 starts at a vertical height that is a proximate distance away from the bottommost surface of vial 110) to a first predefined vertical position with respect to the outlet channel 112 (Fig. 17 – upper end 112; mixing fin 120 ends at a vertical height that is a proximate distance away from the opening of the vial 110).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to further include a ramp portion as taught by Chee Mun, in order to allow formation of a vortex that effectuates mixing between substances within the vial/container (Par. 12 of Chee Mun).
Regarding claim 4, Hayashi in view of Yagi in view of Kress in view of Chee Mun discloses the invention of claim 3. The combination further discloses the ramp portion 120 (Fig. 17 of Chee Mun).
However, the combination does not explicitly disclose the ramp portion is configured to produce a higher mixing shear in a solution in a first portion of the vial in a region proximate to the inlet and outlet as compared to lower mixing shear in a solution in a second portion of the vial in regions further from the inlet and outlet.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized that the ramp portion of the combination would have the capability to perform the claimed function, as evidenced by Chee Mun in Fig. 17 and Par. 61 – mixing fin 120 extending from the inner wall 118 provides sufficient mixing. Due to the protruding structure of the mixing fin of Chee Mun, the vortex while spinning along its path will be pushed inwardly with a smaller radial distance. Therefore, the vortex formed in the areas without the protrusion of the ramp portion/mixing fin 120 would be less dense than that formed in the areas with the mixing fin 120; thus, various degrees of mixing shear are likely to occur.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hayashi in view of Yagi in view of Kress as applied to claim 1 above, and further in view of Urrutia US 6,099,512 A (previously cited, hereinafter Urrutia).
Regarding claim 5, Hayashi in view of Yagi in view of Kress discloses the invention of claim 1. However, the combination does not explicitly disclose the inlet channel comprises an inner diameter equal to or smaller than an inner diameter of the outlet channel.
Urrutia, considered to be analogous art since the invention employs a fluid delivery system with a cylindrical housing (Abstract and Col. 3, line 7-8), teaches the inlet channel 26 (Fig. 2 – inlet port 26) comprises an inner diameter dinlet (Fig. 2 – inner diameter dinlet) equal to an inner diameter doutlet (Fig. 2 – inner diameter doutlet; and Col. 3, line 12-15 – dinlet = doutlet) of the outlet channel 28 (Fig. 2 – outlet port 28).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner diameter of both inlet and outlet channel of the combination to incorporate the equal channel size as taught by Urrutia, in order to create an entering and exiting flow rate that are substantially equal to reduce entrapment of air bubbles (Col. 4, line 7-13 of Urrutia).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Hayashi in view of Yagi in view of Kress as applied to claim 1 above, and further in view of Denisart et al. US 2007/0144355 A1 (previously cited, hereinafter Denisart), as cited in the IDS.
Regarding claim 6, Hayashi in view of Yagi in view of Kress discloses the invention of claim 1. The combination further discloses the bottom interior surface IB is approximately flat (see annotated Fig. 3 of Hayashi above – the surface IB is flat with no curves).
However, the combination does not explicitly disclose the first predefined angle is in a range from about 10 degrees to 60 degrees with respect to the horizontal plane.
Denisart, considered to be analogous art since the invention employs a mixing capsule using vortex effect (Par. 54), teaches disclose the first predefined angle is in a range from about 20 degrees to 40 degrees with respect to the horizontal plane (Fig. 2, see annotated Fig. 4 below, and Par. 54 – first predefined angle range is derived from the angle β). Examiner notes according to the range of β which is 50 to 70 degrees (Par. 43), an angle calculation within a right triangle reveals that the first predefined angle between the horizontal plane and the injection port 42 (see annotated Fig. 4 below) has to be between 20 and 40 degrees.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the angle of the combination’s inlet channel to further incorporate the degree of slant as taught by Denisart, in order to achieve a general swirling movement which leads to thorough mixing (Par. 53 of Denisart).
Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the angle range of the combination, from between 20 and 40 degrees to between 10 and 60 degrees, as applicant appears to have placed no criticality on the claimed range (see Par. 12 of Applicant’s specification) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, the combination would not operate differently with the claimed range, since the claimed range is still within the working range as taught by Denisart. Therefore, one of ordinary skill in the art would have been motivated to modify the angle to achieve an angled inflow for vortex formation.
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Annotated Fig. 4 of Denisart
Regarding claim 7, Hayashi in view of Yagi in view of Kress in view of Denisart discloses the invention of claim 6. The combination further discloses the second predefined angle (see annotated Fig. 11 of Yagi above) of the direction vector of fluid flow through the inlet 15 (see annotated Fig. 11 of Yagi above) is greater than 0ᵒ with respect to the line tangent to cylindrical wall 17 (see annotated Fig. 11 of Yagi above).
Examiner notes that in the annotated Fig. 11 of Yagi above, the dashed line, i.e. tangent line, forms a second predefined angle that is great than 0ᵒ with the inlet 15; thus, the limitation is met.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hayashi in view of Yagi in view of Kress as applied to claim 1 above, and further in view of Deutschle et al. US 2018/0148222 A1 (previously cited, hereinafter Deutschle).
Regarding claim 8, Hayashi in view of Yagi in view of Kress discloses the invention of claim 1. However, the combination does not disclose the vial has a convex interior bottom surface, and wherein a radius of curvature of the cylindrical interior wall is greater than a radius of curvature of the convex bottom interior surface.
Deutschle, in the same field of endeavor of vials (Title), teaches the vial 1 (Fig. 6b – vial 1) has a convex interior bottom surface 3 (Fig. 6b and Par. 94 – annular convex gap at the bottom 3).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the straight and flat bottom interior surface of the combination that allows the vial to store drug content and form a vortex upon mixing, for the convex interior bottom surface of Deutschle, since these mechanisms perform the same function of storing drug content with vial and create vortex upon mixing. Simply substituting one surface configuration for another would yield the predicable result of allowing pharmaceutical substance to be contained and facilitate vortex formation. See MPEP 2143.
Also, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have made the radius of curvature of the cylindrical wall greater than the radius of curvature of the convex, in order to fit the particular procedure being done since this claimed radius of curvature does not change the vial’s ability to store pharmaceutical content. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see Par. 78 of Applicant’s specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777. Therefore, one of ordinary skill in the art would have been motivated to modify the radius of curvature to adjust the regions where drug can settle at the bottom surface of the vial.
Claims 9, 10, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Hayashi in view of Yagi in view of Kress as applied to claim 1 above, further in view of Sirtex Medical US, “Delivery Box Set Up for SIR-Spheres Y-90 resin microspheres" from Youtube (previously cited, hereinafter Sirtex Medical US).
Regarding claim 9, Hayashi in view of Yagi in view of Kress discloses a vial according to claim 1 (see rejection of Claim 1 above).
However, the combination does not disclose a delivery device comprising: a first syringe in fluid connection to the inlet of the vial according to claim 1, wherein the vial is in fluid connection to a three-way fluid connector through the outlet channel to the vial; a second syringe in fluid connection to the three-way fluid connector; and a patient interface in fluid connection to the three-way fluid connector; wherein, the delivery device is configured for delivery of: (a) a first solution from the first syringe, through the vial, through the three- way fluid connector, and through the patient interface to a patient, and (b) a second solution from the second syringe, through the three-way fluid connector, and through the patient interface to a patient, and wherein the inlet channel is disposed for delivering the first solution to the vial at the first predefined angle such that settled particles in a particle-containing solution in the vial are dispersed in the solution and exit the vial through the outlet channel.
Sirtex Medical US, in the same field of endeavor of delivery system (Title), teaches disclose a delivery device (Title – delivery box set up) comprising:
a first syringe D (@2:23 – syringe D) in fluid connection (@5:11-5:15 – D line needle, which is connected to syringe D, is inserted into the vial) to the vial (@5:15 – syringe D in fluid connection with the vial via tubing D and needle D), wherein the vial is in fluid connection to a three-way fluid connector (@0:50 – three-way stopcock) to the vial (@0:54– three-way stopcock connecting to line C on the right; and @4:32-4:40 in the video – line C is inserted into the vial);
a second syringe B (@2:23– syringe B) in fluid connection to the three-way fluid connector (@2:41 – syringe B is connected to the three-way fluid stopcock, which is placed underneath the letter “A”, via line B); and a patient interface (see annotated Figure @6:06 below – patient interface annotated as the blue connection going into the patient’s body) in fluid connection to the three-way fluid connector (@0:58-1:00 – patient interface is connected to the three-way stopcock via line A), wherein, the delivery device (Title – delivery box set up) is configured for delivery of:
(a) a first solution (@5:50 – water) from the first syringe D (@5:50 – “injecting water… from syringe on line D”), through the vial (@5:55 – injected water stirs up content in the vial), through the three-way fluid connector (@6:01 – swirled up content “passes into line C”, which is connected to the three-way stopcock), and through the patient interface (see annotated Figure @6:06 below) to a patient (@5:50-6:05 – fluid from the three-way stopcock travels “into line A that is connected into the patient”), and
(b) a second solution (@2:21 – purple solution) from the second syringe B (@2:21-2:28 – purple solution from syringe B connected to line B), through the three-way fluid connector (@2:41 – syringe B, line B, and three-way stopcock is fluidly connected), and through the patient interface to a patient (@2:41 – three-way stopcock is fluidly connected to patient interface via line A; see annotated Figure @6:06 and @2:41 below to observe the claimed path of second solution), and
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vial of the combination and further implemented the vial usage in such an environment as taught by Sirtex Medical US, since Sirtex Medical US’s delivery system helps deliver the content of the vial to patient, and the vial of the combination is also required to deliver its mixed solution to a user (Par. 155 of Hayashi). Therefore, one of ordinary skill in the art would have been motivated to apply the known delivery system of Sirtex Medical US, which cooperates with a vial, to the base device that is also a vial from Hayashi in view of Yagi in view of Kress, yielding predictable result of delivering drug content within the vial to a patient’s body.
Also, once the combination is made as discussed in claim 1, the vial of Hayashi in view of Yagi in view of Kress will have an inlet channel near the bottom surface and an outlet channel at the top of the vial as taught by Yagi. Therefore, with the combination of Hayashi, Yagi, Kress, and Sirtex Medical US, any solution entering and exiting the vial will take place via this inlet channel and outlet channel. Therefore, one of ordinary skill in the art would have had the technological capability to recognize that the first syringe, whose fluid going into the vial, has to be fluidly coupled to the inlet channel 15 (Fig. 7 of Yagi) of the combination; likewise, the mixed fluid has to exit through the outlet channel 16 (Fig. 7 of Yagi) of the combination. Thus, the limitations of “a first syringe in fluid connection to the inlet of the vial”, “the vial is in fluid connection to a three-way fluid connector the outlet channel to the vial”, and “wherein the inlet channel is disposed for delivering the first solution to the vial at the first predefined angle such that settled particles in a particle-containing solution in the vial are dispersed in the solution and exit the vial through the outlet channel” are met. See rejection of claim 1 for first predefined angle.
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Annotated Figure @6:06 of Sirtex Medical US
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Annotated Figure @2:41 of Sirtex Medical US, dashed lines indicate second solution pathway
Regarding claim 10, Hayashi in view of Yagi in view of Kress in view of Sirtex Medical US discloses the invention of claim 9. The combination further discloses a selecting-valve integrated with the three-way fluid connector (see annotated Figure @0:54 of Sirtex Medical US below – the selecting-valve is the built-in element controlling the flow direction) for selective delivery of the second solution from the second syringe B through the selecting valve to the patient (@3:37-3:40 of Sirtex Medical US – fluid from second syringe B reaches the three-way stopcock, as well as the selecting valve, and further goes into line A connected to a patient).
Once the combination is made as discussed in claim 9, the three-way connector of the combination will have a selecting valve as shown in annotated Figure @0:54 of Sirtex Medical US below; thus, the limitation is met.
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Annotated Figure @0:54 of Sirtex Medical US, dashed lines indicate the selecting valve of the three-way stopcock, in this instant case, the three-way connector
Regarding claim 11, Hayashi in view of Yagi in view of Kress in view of Sirtex Medical US discloses the invention of claim 10. The combination further discloses the selecting-valve integrated with the three-way fluid connector is configured as a three-way stopcock (@0:42-0:47 of Sirtex Medical US – “… firmly placed the three-way stopcock…”; thus, the combination of the selecting-valve and clear tubing makes up the three-way stopcock).
Once the combination is made as discussed in claim 9, the three-way connector of the combination is in fact a three-way stopcock as taught by Sirtex Medical US; thus, the limitation is met.
Regarding claim 12, Hayashi in view of Yagi in view of Kress in view of Sirtex Medical US discloses the invention of claim 9. The combination further discloses a first one-way valve disposed between the first syringe D (@2:32 of Sirtex Medical US – “… one-way valve fitted to line D…”), and a second one-way valve disposed between the second syringe B and the three-way fluid connector (@2:32 of Sirtex Medical US – “… one-way valve fitted to line B…”), wherein the first one-way valve allows fluid flow from the first syringe D to the vial (@5:11-5:15 of Sirtex Medical US and in rejection of claim 9 – fluid is already flowing from first syringe D to the vial, therefore, Examiner notes that the addition of one-way valve still allows fluid to flow in the claimed manner), and the second one-way valve allows fluid flow from the second syringe B to the three-way fluid-connector (@2:41 of Sirtex Medical US and in rejection of claim 9 – fluid is already flowing from second syringe B to the three-way connector, therefore, Examiner notes that the addition of one-way valve still allows fluid to flow in the claimed manner).
Once the combination is made as discussed in claim 9, the vial of the combination will have an inlet channel and an outlet channel as taught by Yagi. Therefore, with the combination of Hayashi, Yagi, Kress, and Sirtex Medical US, any solution entering and exiting the vial will take place via this inlet channel and outlet channel. Thus, the limitation of “a first one-way valve disposed between the first syringe and the inlet channel” is met, since solution from the first syringe eventually flows into the vial.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Hayashi in view of Yagi in view of Kress in view of Sirtex Medical US as applied to claim 12 above, and further in view of Zannoli US 2018/0339101 A1 (previously cited, hereinafter Zannoli).
Regarding claim 13, Hayashi in view of Yagi in view of Kress in view of Sirtex Medical US discloses the invention of claim 12. However, the combination does not disclose a third one-way valve disposed between the vial outlet and the three-way fluid connector, wherein the third one-way valve allows fluid and particle flow from the vial to the patient interface when a fluid pressure on an inlet of the third one-way valve is at least about 0.2 psi above a pressure on an outlet of the third one-way valve.
Zannoli, considered to be analogous art since the invention employs a delivery device to inject contrast agent from a supply line to a catheter for angiography (Abstract), teaches a fluid pressure on an inlet (Par. 32 – inlet pressure Ps) of the third valve 2 (Par. 32 – pressure regulator 2) is about 0.5 bar above (Par. 32 – inlet pressure Ps > outlet pressure Pa) a pressure on an outlet (Par. 32 – outlet pressure Pa) of the third valve 2 (Par. 32).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have duplicated the one-way valve as taught by Sirtex Medical US to include a third one-way valve that is disposed between the vial outlet and the three-way connector to the combined device, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Furthermore, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In the instant case, the addition of the third one-way valve produces expected result of allowing fluid to flow from the vial to the patient. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144. Therefore, one of ordinary skill in the art would have been motivated to add another one-way valve to the internal circuit of the delivery system of the combination, in order to further restrict and/or permit fluid movement inside the system as desired. Thus, the limitation of “a third one-way valve disposed between the vial outlet and the three-way fluid connector, wherein the third one-way valve allows fluid and particle flow from the vial to the patient interface” is met.
Also, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the third one-way valve of the combination to include the pressure difference between the inlet and outlet as taught by Zannoli, in order to supplying the treatment drug with adequate chemical purity (Par. 32 of Zannoli). It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure difference of the combination from about 0.5 bar to at least 0.2 psi, as applicant appears to have placed no criticality on the claimed range (see Par. 16 and Par. 60 of Applicant’s specification). In the instant case, the combined device would not operate differently with the claimed range, since the claimed range of at least 0.2 psi is still within the working range of the combination, evidenced by the following unit conversion: 0.5 bar is equivalent to 7.25 psi. Therefore, one of ordinary skill in the art would have been motivated to modify the pressure difference range in order to impart an appropriate flow profile to the patient.
Claims 14, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hayashi in view of Yagi in view of Kress in view of Sirtex Medical US, as applied to claim 9 above, and further in view of Nishioka et al. US 2015/0290079 A1 (previously cited, hereinafter Nishioka) and Malhotra et al. US 2013/0251790 A1 (previously cited, hereinafter Malhotra).
Regarding claim 14, Hayashi in view of Yagi in view of Kress in view of Sirtex Medical US discloses the invention of claim 9. The combination further discloses a vial holder (see annotated Figure @3:46 below of Sirtex Medical US) configured as a container (see annotated Figure @3:46 below of Sirtex Medical US – a clear holder/container) having a top opening (see annotated Figure @3:54 below of Sirtex Medical US – a central aperture at the top of the clear holder) and a removable top cover (see annotated Figure @3:46 and @3:54 below of Sirtex Medical US – a removable black plug), and wherein the container is configured to receive the vial therein through the top opening (see annotated Figure @3:54 below of Sirtex Medical US – top opening for receiving the vial in the middle), and the removeable top cover is configured for compressing an seal against an opening at the top of the vial (see annotated Figure @3:46 and 3:54 below of Sirtex Medical US – the shape of the black plug seals the opening at the top of the vial) when the removable top cover is attached to the container (@3:36 of Sirtex Medical US), thereby providing a fluid seal at the top opening of the vial (@3:36 of Sirtex Medical US), the first syringe D using a first tube line D (@2:23 – syringe D connected to line D), the three-way fluid connector using a second tube line C (@1:16 and @4:32-4:40 of Sirtex Medical US – three-way stopcock connected to line C).
However, the combination does not disclose an elastomeric seal, and the inlet channel is provided with fluid connection to the first syringe using a first tube, and the outlet channel is provided with fluid connection to the three-way valve using a second tube, and the vial holder includes an opening for allowing connection of the first tube to the inlet channel, and an opening for allowing connection of the second tube to the outlet channel.
Nishioka, in the same field of endeavor of drug container storage device (Title), teaches an elastomeric seal 13 (Fig. 4 – elastic sealing member 13).
Malhotra, in the same field of endeavor of capsule holder (Par. 136), teaches the vial holder 2 (Fig. 11 – capsule holder 2) includes an opening 18 (Fig. 16 – bottom opening 18) for allowing connection of the first tube to the inlet channel 20 (Fig. 15 and Par. 139 – the intended use for openings 18 is to receive piercing pin in bottom guiding means 20, however, Examiner contends the structure of opening 18 is capable of receiving a first tubing), and an opening 18 (Fig. 16 – top opening 18) for allowing connection of the second tube to the outlet channel 20 (Fig. 15 – top guiding means 20; Examiner contends the structure of opening 18 is capable of receiving a second tubing).
Once the combination is made as discussed in claim 9 and claim 1, the inlet channel of Yagi will be on the vial of Hayashi, and said inlet channel will communicate with the first syringe of using a first tube of Sirtex Medical US. Likewise, the outlet channel of Yagi will be on the vial of Hayashi, and said outlet channel will communicate with three-way connector using second tube of Sirtex Medical US. Thus, the limitation is met.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the removable top cover of the combined device to have an elastomeric seal as taught Nishioka, in order to provide a seal that is elastically deformable to the opening in a radial direction (Par. 95 of Nishioka).
Also, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the holder of the combination to further include two openings as taught by Malhotra, in order to provide a communication portal to reach the inner capsule, in this instant case, the vial (Par. 138 and Par. 139 of Malhotra).
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Annotated Figure from @3:46 below of Sirtex Medical US
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Annotated Figure @3:54 below of Sirtex Medical US
Regarding claim 17, Hayashi in view of Yagi in view of Kress in view of Sirtex Medical US in view of Nishioka in view of Malhotra discloses the invention of claim 14. The combination further discloses a holder (see annotated Figure @1:08 below of Sirtex Medical US – transparent delivery box) for the vial and vial holder (@3:46 of Sirtex Medical US – the frame shows the vial and vial holder being disposed within the holder), wherein the holder (@1:08 of Sirtex Medical US) includes,
a moat channel (see annotated Figure @1:08 below and annotated Figure @3:46 above of Sirtex Medical US – transparent annular moat channel) surrounding the vial channel (see annotated Figure @3:46 above of Sirtex Medical US – moat channel encircling the vial) and configured for containing at least the volume of the interior of the vial (see annotated Figure @3:46 above of Sirtex Medical US – moat channel receiving the vial and the vial’s content),
a transparent lid (@5:38 of Sirtex Medical US – “place the lid onto the delivery box”) for enclosing the vial and three-way fluid connector (@5:38 of Sirtex Medical US – the transparent lid keeping the vial and vial within the delivery box), and
a tray (see annotated Figure @0:43 above of Sirtex Medical US – white bracket) configured for attachment to the holder (@0:45 of Sirtex Medical US – “bracket on the back wall of the delivery box”) and configured for holding the three-way fluid connector (see annotated Figure @0:54 above of Sirtex Medical US) and removably attaching to the vial holder (@5:13 of Sirtex Medical US – bracket joining the vial holder via line C).
However, the combination does not explicitly disclose a removable tray.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tray of the combination to be removable since the Courts have held that making known elements separable is within the skill of a person of ordinary skill in the art. See In re Dulberg, 129 USPQ 348 (CCPA 1961) (see MPEP § 2144.04). Therefore, one of ordinary skill in the art would have been motivated to make the tray removable for ease of assembly and sterilization.
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Annotated Figure @1:08 of Sirtex Medical US
Regarding claim 18, Hayashi in view of Yagi in view of Kress in view of Sirtex Medical US in view of Nishioka in view of Malhotra discloses the invention of claim 17. The combination further discloses the fluid connection from the second syringe B (@2:23 of Sirtex Medical US – syringe B) to the three-way fluid connector (@2:41 of Sirtex Medical US – syringe B is connected to the three-way fluid stopcock) is provide by removable attachment to a third tube line B (@0:25 and @2:23 of Sirtex Medical US – removable line B), the fluid connection from the three-way fluid connector (@0:50 of Sirtex Medical US – three-way stopcock) to the patient interface (see annotated Figure @6:06 below of Sirtex Medical US) is provide by removable attachment to a fourth tube line A (@0:25 and annotated Figure @6:06 above of Sirtex Medical US – removable line A), wherein at least a portion of the first line D, third line B and fourth tubes line A (@0:25 and @1:39 of Sirtex Medical US) are placed in the holder when the device is in operation (@1:39 of Sirtex Medical US – portions of line D, line B, and line A are within the holder and inserted through their respective openings in the delivery box).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Hayashi in view of Yagi in view of Kress in view of Sirtex Medical US in view of Nishioka in view of Malhotra as applied to claim 14 above, and further in view of Klumph US 2018/0357476 A1 (previously cited, hereinafter Klumph) and Chou et al. WO 2019018169 A1 (previously cited, hereinafter Chou).
Regarding claim 15, Hayashi in view of Yagi in view of Kress in view of Sirtex Medical US in view of Nishioka in view of Malhotra discloses the invention of claim 14. The combination further discloses the vial and vial container are transparent (@3:46 of Sirtex Medical US – both the vial holder and vial are see-through).
However, the combination does not disclose a light disposed to illuminate the interior of the vial and wherein the vial and vial container are at least 80% transparent to the light.
Klumph, in the same field of endeavor of drug receiving in a container (Abstract), teaches a light 2702 (Fig. 27 – illumination device 2702) disposed to illuminate the interior of the vial 18 (Fig. 27 – vial 18, and Par. 75 – illumination device 2702 illuminates the vial 18).
Chou, in the same field of endeavor of drug delivery device (Abstract), teaches container 29, 35 (Fig. 1 – housing 29 with window 35) are at least 75% transparent to the light (Par. 33 – portion of visible light filtered out by window 35 may fall in a range between 0-25%, i.e. filtering a maximum of 25% of light and allowing a minimum of 75% of light to traverse).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the delivery device of the combination to further include a light as taught by Klumph, in order to illuminate the vial for visualization and imaging (Par. 75 of Klumph).
Also, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vial and the vial container of the combination to incorporate the transparent housing as taught by Chou, in order to protect drugs that are photosensitive to light but still allow for visual inspection of a user (Par. 33 of Chou). Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the percentage of light allowed through the transparent vial and vial container of the combination from at least 75% to at least 80%, as applicant appears to have placed no criticality on the claimed range (see Par. 17 of Applicant’s specification) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, the combination would not operate differently with the claimed range, since the claimed range is still within the working range as taught by Chou. Therefore, one of ordinary skill in the art would have been motivated to modify the traversable light percentage to protect the pharmaceutical content within the vial.
20. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Hayashi in view of Yagi in view of Kress in view of Sirtex Medical US in view of Nishioka in view of Malhotra as applied to claim 14 above, and further in view of Dugmore US 5,236,101 A (previously cited, hereinafter Dugmore).
Regarding claim 16, Hayashi in view of Yagi in view of Kress in view of Sirtex Medical US in view of Nishioka in view of Malhotra discloses the invention of claim 14. However, the combination does not disclose the container and vial are at least partially opaque to ionizing radiation.
Dugmore, in the same field of endeavor of radiation proof container (Title), teaches the vial 14 (Fig. 1 – canister 14) is opaque (Col. 4, line 41-43 – opaque material) to ionizing radiation (Claim 1 – “… shielding… from ionizing radiation…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vial and the vial holder/container of the combined device to be opaque to ionizing radiation as taught by Dugmore, in order to shield the contents of the container (Abstract of Dugmore). Doing so would provide protection to both the pharmaceutical content and medical operator from potential harmful radiation.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Hayashi in view of Yagi in view of Kress in view of Sirtex Medical US as applied to claim 9 above, and further in view of Sirtex Medical US “Radiology Room Set Up for SIR-Spheres Y-90 resin microspheres” from Youtube (previously cited, hereinafter Sirtex Medical US’).
Regarding claim 20, Hayashi in view of Yagi in view of Kress in view of Sirtex Medical US discloses the device of claim 9 (see rejection of Claim 9 above).
However, the combination does not disclose a method for delivery of radiomicrospheres to a patient in need of radioembolization, the method comprising using the device of claim 9 to deliver radiomicrospheres from the vial to the patient.
Sirtex Medical US’, in the same field of endeavor of radioembolization (Description section of Youtube video), teaches a method for delivery of radiomicrospheres to a patient in need of radioembolization (@1:10 – “microspheres implant procedure”, and Description section of Youtube video – “…Y-90 resin microspheres product is radioactive…”), the method comprising using the device of claim 9 (see annotated Figure @1:21 below – delivery box of claim 9) to deliver radiomicrospheres from the vial to the patient (@1:24 – “… dose of microspheres contained in the v-vial and v-vial holder…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the delivery device of the combination and further implemented the delivery device usage in a method as taught by Sirtex Medical US, since all claimed elements of the method were known in Sirtex Medical US’, including the delivery device and the vial/vial holder. Therefore, one of ordinary skill in the art would have been motivated to apply the known method of Sirtex Medical US’, which cooperates with delivery box and a vial, to the base device that is also a delivery device from the combination of Hayashi, Yagi, Kress, and Sirtex Medical US, yielding predictable result of delivering radiomicrospheres from within the vial to a patient’s body.
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Annotated Figure @1:21 of Sirtex Medical US’ – delivery device of claim 9
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Hayashi in view of Yagi in view of Kress in view of Sirtex Medical US in view of Sirtex Medical US’ as applied to claim 20 above, and evidenced by Zannoli.
Regarding claim 21, Hayashi in view of Yagi in view of Kress in view of Sirtex Medical US in view of Sirtex Medical US’ discloses the invention of claim 20. The combination of further discloses delivering a contrast agent (@1:52 of Sirtex Medical US’ – contrast media) from the second syringe B (@2:00-2:02 of Sirtex Medical US’ – 10ml syringe for the contrast media”; annotated Figure @1:21 above of Sirtex Medical US’ shows the smaller syringe D, i.e. the 10ml syringe D for contrast media) to the patient (see rejection of claim 9 for fluid pathway of second syringe B to a patient interface) and visualizing the artery (@0:10 of Sirtex Medical US’ – “angiography”; the term is known in the art as medical imaging to visualize the blood vessels, including arteries, therefore, the limitation is met).
However, the combination does not explicitly disclose using the delivered contrast agent.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized that to visualize the artery in the combined method, the contrast agent indeed must be used, so that blood vessels can be shown under radiographic imaging, evidenced by Zannoli in Par. 3 – “It is known that an angiographic examination includes injection of a contrast agent into a vascular cavity (artery or vein) and recording of radiological images of the area being examined”. Therefore, without the explicit teaching visualizing the artery using contrast agent of Sirtex Medical US’, one of ordinary skill in the art would still have understood that the contrast agent taught by Sirtex Medical US’ is provided for the step of artery visualization.
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.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781