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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/27/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The spacing of the lines of the specification is such as to make reading difficult. New application papers with lines 1 1/2 or double spaced (see 37 CFR 1.52(b)(2)) on good quality paper are required.
The disclosure is objected to because of the following informalities:
In paragraph [0046], the specification states “…including a portion of the disc 12…” Based on other reference numbers used in the same paragraph, the examiner interprets “disc 12” to mean disc 120. Appropriate correction is required.
In paragraph [0047], the specification states “…a first portion of the fluid flow path 19 is coupled to an inlet 102a of the chamber body 102, and a second portion of the fluid flow path 19 is coupled to an outlet 102b of a chamber body 102.” Identifying inlet 102a and outlet 102b of chamber bodies 102 leads to confusion as previously, 102a and 102b were disclosed as the first end and second end, respectively, of an adjacent chamber body. Furthermore, the terms inlet and outlet are used to describe reference numbers 103 and 104, respectively, as the inlet 103 and outlet 104 of channel 106. The applicant should correct the use of the terms inlet and outlet to described 102a and 102b to be first end and second end, as had been previously disclosed, to resume continuity. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“the drive mechanism adapted to” in claims 1 and 14. However, paragraph [0039] of the specification provides corresponding structure for “drive mechanism” that includes “any number of components and/or sub-components to drive, urge, and/or exert a force on the plunger 34 to cause the drug or medicament 38 stored therein to be dispensed therefrom and to operate the needle assembly 70”. These components may be compressed CO2 gas, a hydro-pneumatic actuation system, or springs.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 6 and 19 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.
Claim 6 recites the limitation "the at least one chamber body" in the second and fifth lines of the claim. There is insufficient antecedent basis for this limitation in the claim. Therefore, for purposes of examination, the examiner interprets that claim 6 depends from claim 2 to provide proper antecedent basis for “the at least one chamber body”.
Claim 19 recites the limitation "the at least one chamber body" in the second line of the claim. There is insufficient antecedent basis for this limitation in the claim. Therefore, for purposes of examination, the examiner interprets that claim 19 depends from claim 15 to provide proper antecedent basis for “the at least one chamber body”.
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, 6-8, 14, 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gibson et al. (United States Patent Application Publication No. US 2016/0354555 A1; herein, Gibson), and further in view of Tsien (United States Patent No. US 4,087,862 A).
Regarding claim 1, Gibson discloses a drug delivery device (FIG. 9, drug delivery system 300) comprising:
a housing defining an inner volume (FIG. 9, housing 302 defining interior space 314);
a container at least partially disposed within the housing (FIG. 9, reservoir 340), the container containing a medicament ([0050] “the reservoir 340 may correspond to the reservoir 102”, [0036] “The reservoir 102 is adapted to contain a drug.”);
a drive mechanism (a drive mechanism is interpreted under 112f - see above - to include components and sub-components that exert force on a plunger) at least partially disposed within the housing (FIG. 9, drive 342), the drive mechanism adapted to exert a force to urge the medicament out the container ([0051], plunger 366 forces “drug out of the reservoir 340” and “the movement of the plunger 366 may be caused by the operation of the drive 342”);
a needle assembly having a needle and/or a cannula to deliver the medicament (FIG. 9, [0056], needle 344);
a fluid flow path fluidically connecting the container and the needle assembly (FIG. 9 shows a tube-like structure which connects from the reservoir 340, through the lock 454, to the needle 344, [0037] “a fluid flow path (e.g., tubing) that connects the reservoir 102 to the drug delivery device 104”, [0050] “the reservoir 340 may correspond to the reservoir 102, while the drive 342, needle 344, and the injector 346 may correspond to the drug delivery device 104”).
Gibson does not disclose a vortex flow adapter disposed within or defining at least a portion of the fluid flow path, the vortex flow adapter adapted to urge the medicament to flow in a vortex pattern. However, Tsien teaches a vortex flow adapter disposed within or defining at least a portion of the fluid flow path (Fig. 12, mixer system as a whole), the vortex flow adapter adapted to urge the medicament to flow in a vortex pattern (col. 8 lines 30-49, helical vortex created in the inlet chamber). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid flow path disclosed by Gibson to incorporate a vortex flow adapter as taught by Tsien in order to homogenize a plurality of streams in a bladeless manner, while also reducing operational maintenance costs (col. 8 lines 57-64). Further, the vortex flow adapter taught by Tsien can modify the flow velocity by controlling the stream direction (col. 8 lines 30-50).
Regarding claim 6, in the modified device of Gibson, Gibson does not disclose an adjacent chamber body operably coupled with the at least one chamber body, the adjacent chamber body adapted to urge the medicament to flow in a vortex pattern having an opposite rotational flow direction than a rotational flow direction of the at least one chamber body.
However, Tsien teaches an adjacent chamber body operably coupled with the at least one chamber body (Fig. 12, mixing stages 18a and 18b are interconnected), the adjacent chamber body adapted to urge the medicament to flow in a vortex pattern having an opposite rotational flow direction than a rotational flow direction of the at least one chamber body (Fig. 2, col. 8 lines 30-50, at some point the direction of flow will be opposite in one section of a mixing stage from another section in an adjacent mixing stage). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid flow path disclosed by Gibson to incorporate an adjacent chamber body with an at least one chamber body as taught by Tsien in order to keep continuous flow of the fluid while thoroughly mixing the streams as they move (Fig. 2, col. 8 lines 44-50).
Regarding claim 7, in the modified device of Gibson, Gibson does not disclose the vortex flow adapter is adapted to generate a minor head loss to the medicament flowing within the fluid flow path.
However, Tsien teaches the vortex flow adapter is adapted to generate a minor head loss to the medicament flowing within the fluid flow path (col. 1 line 66 - col. 2 line 16 and col. 2 lines 45-54, a mixing system that continuously divides streams of fluid and recombines them will inherently have conversion of energy and a pressure drop, which is synonymous with what occurs during minor head loss). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid flow path disclosed by Gibson to include a vortex flow adapter adapted to generate a minor head loss to the medicament flowing within the fluid flow path as taught by Tsien in order to regulate the fluid flow rate and balance pressure across all mixing stages (col. 8 lines 16-22). The orifice features and movement from the inlet cavity through the orifice to the outlet cavity taught by Tsien enable the actions of a minor head loss as a result of the turbulence.
Regarding claim 8, in the modified device of Gibson, Gibson discloses the fluid flow path comprises a generally tubular member defining an interior channel (FIG. 9 shows a tube-like structure which connects from reservoir 340, through lock 454, to needle 344, [0037] “a fluid flow path (e.g., tubing) that connects the reservoir 102 to the drug delivery device 104”, [0050] “the reservoir 340 may correspond to the reservoir 102, while the drive 342, needle 344, and the injector 346 may correspond to the drug delivery device 104”).
Regarding claim 14, Gibson discloses a drug delivery device (FIG. 9, drug delivery system 300) comprising:
a housing defining an inner volume (FIG. 9, housing 302 defining interior space 314);
a container at least partially disposed within the housing (FIG. 9, reservoir 340), the container containing a medicament ([0050] “the reservoir 340 may correspond to the reservoir 102”, [0036] “The reservoir 102 is adapted to contain a drug.”);
a drive mechanism at least partially disposed within the housing (FIG. 9, drive 342), the drive mechanism adapted to exert a force to urge the medicament out the container ([0051], plunger 366 forces “drug out of the reservoir 340” and “the movement of the plunger 366 may be caused by the operation of the drive 342”);
a needle assembly having a needle and/or a cannula to deliver the medicament (FIG. 9, [0056], needle 344);
a fluid flow path fluidically connecting the container and the needle assembly (FIG. 9 shows a tube-like structure which connects from the reservoir 340, through the lock 454, to the needle 344, [0037] “a fluid flow path (e.g., tubing) that connects the reservoir 102 to the drug delivery device 104”, [0050] “the reservoir 340 may correspond to the reservoir 102, while the drive 342, needle 344, and the injector 346 may correspond to the drug delivery device 104”).
Gibson does not disclose a vortex flow adapter disposed within or defining at least a portion of the fluid flow path, the vortex flow adapter adapted to generate a minor head loss to the medicament flowing within the fluid flow path. However, Tsien teaches a vortex flow adapter disposed within or defining at least a portion of the fluid flow path (Fig. 12, mixer system as a whole), the vortex flow adapter adapted to generate a minor head loss to the medicament flowing within the fluid flow path (col. 1 line 66 - col. 2 line 16 and col. 2 lines 45-54, a mixing system that continuously divides streams of fluid and recombines them will inherently have conversion of energy and a pressure drop, which is synonymous with what occurs during minor head loss). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid flow path disclosed by Gibson to incorporate a vortex flow adapter as taught by Tsien in order to homogenize a plurality of streams in a bladeless manner, while also reducing operational maintenance costs (col. 8 lines 57-64). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid flow path disclosed by Gibson to incorporate a vortex flow adapter to generate a minor head loss to the medicament flowing within the fluid flow path as taught by Tsien in order to regulate the fluid flow rate and balance pressure across all mixing stages (col. 8 lines 16-22). The orifice features and movement from the inlet cavity through the orifice to the outlet cavity taught by Tsien enable the actions of a minor head loss as a result of the turbulence.
Regarding claim 19, in the modified device of Gibson, Gibson does not disclose the at least one chamber body further comprises a first coupling portion at the first end and a second coupling portion at the second end, wherein the first and the second coupling portions are adapted to couple with an additional chamber body.
However Tsien teaches the at least one chamber body further comprises a first coupling portion at the first end and a second coupling portion at the second end (Figs. 1 and 12, bores 40 extend through each of the mixing stages 18 to receive bolt 22), wherein the first and the second coupling portions are adapted to couple with an additional chamber body (Fig. 12, col. 4 lines 34-39, bolts 22 secure the mixing stages 18 together by fastening hex nuts 24 at the ends of the bolts 22). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid flow path disclosed by Gibson to include a chamber body with first and second coupling ends adapted to couple to additional bodies using bolts and hex nuts as taught by Tsien in order to prevent leakages (col. 5 lines 62-68).
Regarding claim 20, in the modified device of Gibson, Gibson discloses the fluid flow path comprises a generally tubular member defining an interior channel (FIG. 9 shows a tube-like structure which connects from reservoir 340, through lock 454, to needle 344, [0037] “a fluid flow path (e.g., tubing) that connects the reservoir 102 to the drug delivery device 104”, [0050] “the reservoir 340 may correspond to the reservoir 102, while the drive 342, needle 344, and the injector 346 may correspond to the drug delivery device 104”).
Claims 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Tsien, and further in view of Lake (United States Patent No. US 6,062,722 A).
Regarding claim 9, Tsien discloses a modular vortex flow adapter (Fig. 12, mixer system as a whole) for use in a drug delivery device, the modular vortex flow adapter comprising:
at least one chamber body (Fig. 3, mixing stage 18) including a first end having an inlet (Fig. 3, inlet 32), a second end having an outlet (Fig. 3, outlet 46), and a longitudinal length extending therebetween (Fig. 12), the at least one chamber body defining a channel extending between the inlet and the outlet (Figs. 1 and 12, tubular transfer members 38 within passageway 34),
the device is adapted to urge the medicament flowing through the channel in a vortex pattern (col. 8 lines 30-55, fluid flowing into the inlet cavity 26 from tubular transfer members 38 create helical vortex).
Tsien does not disclose at least one disc adapted to be disposed within the channel, the at least one disc including a disc body extending along a longitudinal length, the disc body including an outer surface and at least one groove extending along the outer surface in a first direction; and specifically the at least one groove of the disc body adapted to urge the medicament flowing through the channel in a vortex pattern.
However, Lake teaches at least one disc adapted to be disposed within the channel (Fig. 1, helix 33), the at least one disc including a disc body extending along a longitudinal length (Fig. 1, helix 33 within mixing passageway 16), the disc body including an outer surface and at least one groove extending along the outer surface in a first direction (annotated on Fig. 1 below); and specifically the at least one groove of the disc body (annotated on Fig. 1 below) is adapted to urge the medicament flowing through the channel in a vortex pattern (shape of the helixes 31-34 would naturally cause the fluid to mix in a spiraling flow manner similar to that of a vortex).
PNG
media_image1.png
334
863
media_image1.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the passageways and tubular transfer members as disclosed by Tsien to include a grooved disc as taught by Lake in order to fully mix the fluids as each fluid passes over one of the helixes (col. 3 lines 49-56) by changing the flow direction due to the groove design (col. 4 lines 7-13). Although the mixer system as disclosed by Tsien is built in a way that creates a helical vortex, the addition of the grooved disc as taught by Lake within the passageway would support the intended outcome of flow shape by preemptively forming the fluid in a spiral manner.
Regarding claim 10, Tsien discloses the at least one chamber body further includes at least one vortex chamber formed by the channel (Fig. 12, inlet cavity 26).
Regarding claim 11, Tsien discloses the at least one vortex chamber comprises a tapered region having a varying cross-sectional area along the longitudinal length of the chamber body (Fig. 3, tapering of inlet cavity 26).
Regarding claim 12, Tsien discloses the at least one chamber body further comprises a second vortex chamber formed by the channel (Fig. 12, outlet cavity 42).
Regarding claim 13, Tsien discloses the at least one chamber body further comprises a first coupling portion at the first end and a second coupling portion at the second end (Figs. 1 and 12, bores 40 extend through each of the mixing stages 18 to receive bolt 22), wherein the first and the second coupling portions are adapted to couple with an additional chamber body (Fig. 12, col. 4 lines 34-39, bolts 22 secure the mixing stages 18 together by fastening hex nuts 24 at the ends of the bolts 22).
Claims 2-5 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Gibson in view of Tsien as applied to claims 1 and 14 above, and further in view of Lake.
Regarding claim 2, in the modified device of Gibson, Gibson does not disclose the vortex flow adapter comprises: at least one chamber body including a first end having an inlet, a second end having an outlet, and a longitudinal length extending therebetween, the at least one chamber body defining a channel extending between the inlet and the outlet; and at least one disc adapted to be disposed within the channel, the at least one disc including a disc body extending along a longitudinal length, the disc body including an outer surface and at least one groove extending along the outer surface in a first direction; wherein the at least one groove of the disc body is adapted to urge the medicament flowing through the channel in the vortex pattern.
However, Tsien teaches the vortex flow adapter (Fig. 12, mixer system as a whole) comprises:
at least one chamber body (Fig. 3, mixing stage 18) including a first end having an inlet (Fig. 3, inlet 32), a second end having an outlet (Fig. 3, outlet 46), and a longitudinal length extending therebetween (Fig. 12), the at least one chamber body defining a channel extending between the inlet and the outlet (Figs. 1 and 12, tubular transfer members 38 within passageway 34);
the device is adapted to urge the medicament flowing through the channel in the vortex pattern (col. 8 lines 30-55, fluid flowing into the inlet cavity 26 from tubular transfer members 38 create helical vortex).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid flow path disclosed by Gibson to incorporate chamber bodies and passageways between the bodies as taught by Tsien in order to homogenize a plurality of streams in a bladeless manner, while also supporting continuous flow of the fluid while thoroughly mixing the streams as they move (Fig. 2, col. 8 lines 44-50, 57-64). Further, the vortex flow adapter taught by Tsien can modify the flow velocity by controlling the stream direction (col. 8 lines 30-50).
Gibson in view of Tsien still does not disclose the at least one disc including a disc body extending along a longitudinal length, the disc body including an outer surface and at least one groove extending along the outer surface in a first direction; wherein the at least one groove of the disc body is adapted to urge the medicament flowing through the channel in the vortex pattern.
However, Lake teaches at least one disc adapted to be disposed within the channel (Fig. 1, helix 33), the at least one disc including a disc body extending along a longitudinal length (Fig. 1, helix 33 within mixing passageway 16), the disc body including an outer surface and at least one groove extending along the outer surface in a first direction (annotated on Fig. 1 below); wherein the at least one groove of the disc body (annotated on Fig. 1 below) is adapted to urge the medicament flowing through the channel in the vortex pattern (shape of the helixes 31-34 would naturally cause the fluid to mix in a spiraling flow manner similar to that of a vortex).
PNG
media_image1.png
334
863
media_image1.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the passageways and tubular transfer members as disclosed by Tsien to include a grooved disc as taught by Lake in order to fully mix the fluids as each fluid passes over one of the helixes (col. 3 lines 49-56) by changing the flow direction due to the groove design (col. 4 lines 7-13). Although the mixer system as disclosed by Tsien is built in a way that creates a helical vortex, the addition of the grooved disc as taught by Lake within the passageway would support the intended outcome of flow shape by preemptively forming the fluid in a spiral manner.
Regarding claim 3, in the modified device of Gibson, Gibson does not disclose the at least one chamber body further includes at least one vortex chamber formed by the channel. However, Tsien teaches the at least one chamber body further includes at least one vortex chamber formed by the channel (Fig. 12, inlet cavity 26). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid flow path disclosed by Gibson to include the at least one chamber body with at least one vortex chamber formed by the channel as taught by Tsien in order to create helical vortex flow (col. 8 lines 30-50).
Regarding claim 4, in the modified device of Gibson, Gibson does not disclose the at least one vortex chamber comprises a tapered region having a varying cross-sectional area along the longitudinal length of the chamber body. However, Tsien teaches the at least one vortex chamber comprises a tapered region having a varying cross-sectional area along the longitudinal length of the chamber body (Fig. 3, tapering of inlet cavity 26). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid flow path disclosed by Gibson to include a tapered inlet cavity within the chamber body as taught by Tsien in order to create helical vortex flow (col. 8 lines 30-50).
Regarding claim 5, in the modified device of Gibson, Gibson does not disclose the at least one chamber body further comprises a second vortex chamber formed by the channel. However, Tsien teaches the at least one chamber body further comprises a second vortex chamber formed by the channel (Fig. 12, outlet cavity 42). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid flow path disclosed by Gibson to include an outlet cavity in addition to the inlet cavity within the chamber body as taught by Tsien in order to create a helical vortex flow that changes direction from one cavity to the next (col. 8 lines 30-50). The change in direction decreases the velocity at which the fluid moves, allowing the device better regulation over the fluid flow.
Regarding claim 15, in the modified device of Gibson, Gibson does not disclose the vortex flow adapter comprises: at least one chamber body including a first end having an inlet, a second end having an outlet, and a longitudinal length extending therebetween, the at least one chamber body defining a channel extending between the inlet and the outlet; and at least one disc adapted to be disposed within the channel, the at least one disc including a disc body extending along a longitudinal length, the disc body including an outer surface and at least one groove extending along the outer surface in a first direction; wherein the at least one groove of the disc body is adapted to urge the medicament flowing through the channel in the vortex pattern.
However, Tsien teaches the vortex flow adapter (Fig. 12, mixer system as a whole) comprises:
at least one chamber body (Fig. 3, mixing stage 18) including a first end having an inlet (Fig. 3, inlet 32), a second end having an outlet (Fig. 3, outlet 46), and a longitudinal length extending therebetween (Fig. 12), the at least one chamber body defining a channel extending between the inlet and the outlet (Figs. 1 and 12, tubular transfer members 38 within passageway 34);
the device is adapted to urge the medicament flowing through the channel in the vortex pattern (col. 8 lines 30-55, fluid flowing into the inlet cavity 26 from tubular transfer members 38 create helical vortex).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid flow path disclosed by Gibson to incorporate chamber bodies and passageways between the stages as taught by Tsien in order to homogenize a plurality of streams in a bladeless manner, while also supporting continuous flow of the fluid while thoroughly mixing the streams as they move (Fig. 2, col. 8 lines 44-50, 57-64). Further, the vortex flow adapter taught by Tsien can modify the flow velocity by controlling the stream direction (col. 8 lines 30-50).
Gibson in view of Tsien still does not disclose the at least one disc including a disc body extending along a longitudinal length, the disc body including an outer surface and at least one groove extending along the outer surface in a first direction; wherein the at least one groove of the disc body is adapted to urge the medicament flowing through the channel in the vortex pattern.
However, Lake teaches at least one disc adapted to be disposed within the channel (Fig. 1, helix 33), the at least one disc including a disc body extending along a longitudinal length (Fig. 1, helix 33 within mixing passageway 16), the disc body including an outer surface and at least one groove extending along the outer surface in a first direction (annotated on Fig. 1 below); wherein the at least one groove of the disc body (annotated on Fig. 1 below) is adapted to urge the medicament flowing through the channel in the vortex pattern (shape of the helixes 31-34 would naturally cause the fluid to mix in a spiraling flow manner similar to that of a vortex).
PNG
media_image1.png
334
863
media_image1.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the passageways and tubular transfer members as disclosed by Tsien to include a grooved disc as taught by Lake in order to fully mix the fluids as each fluid passes over one of the helixes (col. 3 lines 49-56) by changing the flow direction due to the groove design (col. 4 lines 7-13). Although the mixer system as disclosed by Tsien is built in a way that creates a helical vortex, the addition of the grooved disc as taught by Lake within the passageway would support the intended outcome of flow shape by preemptively forming the fluid in a spiral manner.
Regarding claim 16, in the modified device of Gibson, Gibson does not disclose the at least one chamber body further includes at least one vortex chamber formed by the channel. However, Tsien teaches the at least one chamber body further includes at least one vortex chamber formed by the channel (Fig. 12, inlet cavity 26). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid flow path disclosed by Gibson to include an inlet cavity within the chamber body as taught by Tsien in order to create a helical vortex flow (col. 8 lines 30-50).
Regarding claim 17, in the modified device of Gibson, Gibson does not disclose the at least one vortex chamber comprises a tapered region having a varying cross-sectional area along the longitudinal length of the chamber body. However, Tsien teaches the at least one vortex chamber comprises a tapered region having a varying cross-sectional area along the longitudinal length of the chamber body (Fig. 3, tapering of inlet cavity 26). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid flow path disclosed by Gibson to include a tapered inlet cavity within the chamber body as taught by Tsien in order to create a helical vortex flow (col. 8 lines 30-50).
Regarding claim 18, in the modified device of Gibson, Gibson does not disclose the at least one chamber body further comprises a second vortex chamber formed by the channel. However, Tsien teaches the at least one chamber body further comprises a second vortex chamber formed by the channel (Fig. 12, outlet cavity 42). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid flow path disclosed by Gibson to include an outlet cavity in addition to the inlet cavity within the chamber body as taught by Tsien in order to create a helical vortex flow that changes direction from one cavity to the next (col. 8 lines 30-50). The change in direction decreases the velocity at which the fluid moves, allowing the device better regulation over the fluid flow.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fukano (United States Patent No. US 6,830,368 B2) is considered relevant prior art in regards to helical member similar to disc with grooves for passing a fluid supply.
Gordon et al. (United States Patent Application Publication No. US 2014/0363855 A1) is considered relevant prior art in regards to a system for moving fluids, where the fluids must pass from one side to the other going through a small port.
Davies et al. (United States Patent No. US 9,352,092 B2) is considered relevant prior art in regards to using grooves to create turbulent, helical flow.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evelyn A Thoman whose telephone number is (571)272-8496. The examiner can normally be reached Monday-Friday 8:00 a.m-4:30 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights