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 .
This action is in responses to Applicant’s amendment filed on 12/13/2024
Claims 1-19 are being examined in this office action.
Election/Restrictions
Applicant’s election without traverse of claim 1-19 (corresponding to group I) in the reply filed on 12/13/2024 is acknowledged. Claim 20 is withdrawn.
Specification
The disclosure is objected to because of the following informalities: the description of delivery system 10 is ambiguous due to the unclear relationship between the “application device 20” and the “delivery system 10” itself, the vague use of “e.g.,” without specifying the broader category, and the lack of a clear reference point for the “proximal end” of the handle 30.
Appropriate correction is required.
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 14 are 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.
The description of the aperture in Claim 6 is unclear due to the contradictory statement “one or more aperture is a single aperture”.
Claim 14 mentions “a membrane covering each aperture of the at least one aperture” conflict with the wording of claim 1 of “at least one aperture fluidly connecting the lumen and an outer surface of the device”. The claim limitation of claim 14 is broader than the limitation of claim 1.
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.
Claim(s) 1-3, 6,16, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ducharme (US Patent No. 9101744 B2) in view of Denzer ( US Pub. No. 2015/0045729 A1).
Regarding claim 1, Ducharme discloses a device configured to deliver a pressurized fluid, the device comprising: a body (“housing 22”, Column 3, line 21, Figure 1 as shown below) having an input opening for receiving the pressurized fluid (“ opening 36 through which fluid from the pressure source 68 is directed”, Column 3, line 41-42 ) and an output opening for delivering the pressurized fluid (“the fluid and the therapeutic agent 38 within the reservoir 33 may be directed through the outlet tube 50, through the outlet port 62, and towards a target site” Column 4, line 23-26) ; a handle defining a lumen (“upright section 24 that may be grasped by a user” Column 2, line 25; Note on Figure 2 the upright section 24 includes a lumen where the pressure source lies) , wherein the lumen is configured to receive a container containing the pressurized fluid (“ The system 20 further comprises a housing 22, which is suitable for securely holding, engaging and/or covering the container 30, pressure source 68” Column 3 ,line 21-23).
Ducharme doesn’t expressly disclose at least one aperture fluidly connecting the lumen to an atmosphere external of the device.
Denzer teaches at least one aperture (“ aperture 210A”, [Para 0057] ) fluidly connecting the lumen to an atmosphere external of the device.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Ducharme delivery device to include at least one aperture fluidly connecting the lumen to an atmosphere external of the device as taught by Denzer. A person in ordinary skill in the art would have been motivated to make this change in order to advantageously vent the device and prevent pressure buildup or vacuum formation within the lumen.
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Annotated Figure 1 of Ducharme
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Annotated Figure 2 of Ducharme
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Annotated Figure 4D of Denzer
Regarding claim 2, Ducharme in view of Denzer teaches the device according to claim 1.
Ducharme doesn’t expressly disclose wherein the at least one aperture is defined by a wall of the handle.
Denzer teaches (“ the tab disposed within an aperture defined in a wall of the housing” [Para 0032] ) Note the upright section 24 (shown above in annotated Figure 1 of Ducharme) is where the delivery device is configured to be held and it is connected by a single continuous piece.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Ducharme delivery device to include at least one aperture defined by a wall of the handle taught by Denzer. A person in ordinary skill in the art would have been motivated to make this change in order to advantageously (- Denzer“ prevent removal” [Para 0032] ) of a device.
Regarding claim 3, Ducharme doesn’t expressly disclose wherein the at least one aperture includes a plurality of apertures, and wherein the plurality of apertures are arranged in an asymmetrical pattern on the handle.
Denzer teaches (“The cassette receiving section 306 of the casing 302 may comprise windows 310A, 310B on opposing sides thereof that align with the windows 212 (FIG. 2B) of the cassette 200 when the cassette door 308 is closed with the cassette 200 correctly installed therein.” [Para 0099]). Note that the examiner interprets window as an aperture. While window 310A and 310B, positioned on opposing sides, exhibit symmetry with respect to one another, they are asymmetrical relative to window 212 due to difference in shape.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Ducharme delivery device to include at least one aperture includes a plurality of apertures, and wherein the plurality of apertures are arranged in an asymmetrical pattern on the handle taught by Denzer. A person in ordinary skill in the art would have been motivated to make this change in order to advantageously have a view of the inside of the lumen, (-Denzer “The windows 212 in the side walls 211 of the outer housing 210 in combination with the transparent inner sleeve 220, allow viewing of the syringe 260 housed within the inner sleeve”, Column 4, [Para 0083] ).
Regarding claim 6, Ducharme doesn’t expressly disclose the one or more apertures is a single aperture disposed at a proximal most end of the handle and wherein the single aperture faces a proximal direction.
Denzer teaches (“ The outer housing 210 of the cassette 200 may comprise an elongated opening or window 212 in each side wall 211 thereof. The windows 212 may be disposed opposite to and aligned with one another. Column 4, [Para 0083] ); Note that the examiner interprets window as an aperture and the proximal direction is shown below.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Ducharme delivery device to include the single aperture disposed at a proximal most end of the handle, and wherein the single aperture faces a proximal direction. A person in ordinary skill in the art would have been motivated to make this change in order to advantageously have a view of the inside of the lumen.
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Annotated Figure 2C of Denzer
Regarding claim 10, Ducharme teaches wherein only proximally facing surfaces of an outermost surface of the container contacts an innermost surface of the handle when the container is connected to the device (“ the cap 60 may comprise one or more flanges 63 that permit a secure, removable engagement with a complementary internal region of the section 25 of the housing 22. For example, by rotating the container 30, the flange 63 of the cap 60 may lock in place within the section 25.” Column 4, line 36-41)).
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Annotated Figure 1 and 2 of Ducharme
Regarding claim 11, Ducharme teaches wherein the at least one aperture is configured to release the pressurized gas in a time equal to or less than 0.5 seconds (“ variably permit fluid flow into and/or out of the container 30 at a desired time interval” Column 6, line 48-49).
Regarding claim 15, Ducharme teaches wherein the pressurized fluid has a pressure of approximately 14 pounds per square inch (“although any suitable pressure may be provided” Column 5, line 29-30).
Regarding claim 16, Ducharme teaches a body (“housing 22”, Column 3, line 21) having an input opening for receiving the pressurized fluid (“ opening 36 through which fluid from the pressure source 68 is directed”, Column 3, line 41-42 ) and an output opening for delivering the pressurized fluid (“the fluid and the therapeutic agent 38 within the reservoir 33 may be directed through the outlet tube 50, through the outlet port 62, and towards a target site” Column 4, line 23-26); a handle defining a lumen (“upright section 24 that may be grasped by a user” Column 2, line 25; Note on Figure 2 the upright section 24 includes a lumen where the pressure source lies), wherein the lumen is configured to receive a container containing the pressurized fluid (“ The system 20 further comprises a housing 22, which is suitable for securely holding, engaging and/or covering the container 30, pressure source 68” Column 3 ,line 21-23) and wherein the pressurized fluid is configured to be releases from the lumen in approximately 0.5 seconds or less (“ variably permit fluid flow into and/or out of the container 30 at a desired time interval” Column 6, line 48-49).
Ducharme doesn’t expressly disclose a plurality of apertures fluidly connecting the lumen and an outer surface of the device, wherein a cross-sectional area of a sum of each of the plurality of apertures is equal to or greater than approximately 0.25 square inches.
Denzer teaches a plurality of apertures fluidly connecting the lumen and an outer surface of the device (“ aperture 210A”, Column 3 [Para 0057] ); wherein a cross-sectional area of a sum of each of the plurality of apertures is equal to or greater than approximately 0.25 square inches (“ may include an aperture 308A that is sized and shaped” Column 7, [Para 0101] ).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Ducharme delivery device to include a plurality of apertures fluidly connecting the lumen and an outer surface of the device and a cross-sectional area of a sum of each of the plurality of apertures is equal to or greater than approximately 0.25 square inches as taught by Denzer. A person in ordinary skill in the art would have been motivated to make this change in order to advantageously provide the inside of the device with an external environment providing ventilation and fit any variety of shape and sizes.
Regarding claim 17, Ducharme doesn’t expressly disclose the plurality of apertures is arranged in an asymmetrical shape on the handle.
Denzer teaches (“ The outer housing 210 of the cassette 200 may comprise an elongated opening or window 212 in each side wall 211 thereof. The windows 212 may be disposed opposite to and aligned with one another. Column 4, [Para 0083] ); Note that the examiner interprets window as an aperture.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Ducharme delivery device to include at least one aperture includes a plurality of apertures, and wherein the plurality of apertures are arranged in an asymmetrical pattern on the handle taught by Denzer. A person in ordinary skill in the art would have been motivated to make this change in order to advantageously have a view of the inside of the lumen, (“ The windows 212 in the side walls 211 of the outer housing 210 in combination with the transparent inner sleeve 220, allow viewing of the syringe 260 housed within the inner sleeve”, Column 4, [Para 0083] ).
Claim(s) 4-5, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ducharme (US Patent No. 9101744 B2) in view of Denzer (US Pub. No. 2015/0045729 A1), and Wyrick ( US Pub. No. 2007/0017533 A1).
Regarding claim 4, Ducharme teaches wherein a distal end of the handle is configured to be connected to the body via screw threads ( “ a user may rotate the actuator 26, which translates into linear motion via a threaded engagement 29 between the actuator 26 and the housing 22” Column 5 , line 32-34).
Ducharme doesn’t expressly discloses wherein the at least one aperture extends through a portion of the screw threads.
Wyrick teaches (“The aperture 34 of the nose cap 45 is attached to the barrel by means of inter fitting threads 46” [Para 0101] ).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Ducharme delivery device to include at least one aperture extends through a portion of the screw threads. A person in ordinary skill in the art would have been motivated to make this change in order to advantageously provide stability and the connection of a handle with a body.
Regarding claim 5, Ducharme doesn’t expressly disclose the handle includes one or more screw threads, wherein the body includes one or more screw threads, wherein the one or more apertures are configured to be formed through the one or more screw threads of each of the handle and the body, and wherein the one or more apertures on the handle and the one or more apertures on the body are configured to align when the handle is attached to the body.
Wyrick teaches (“The aperture 34 of the nose cap 45 is attached to the barrel by means of inter fitting threads 46” [Para 0101] ); Note that this device clearly demonstrates the concept of a hand-held device where the body itself serves as the gripping portion.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Ducharme delivery device to include a handles which includes one or more screw threads, wherein the body includes one or more screw threads, wherein the one or more apertures are configured to be formed through the one or more screw threads of each of the handle and the body, and wherein the one or more apertures on the handle and the one or more apertures on the body are configured to align when the handle is attached to the body. A person in ordinary skill in the art would have been motivated to make this change in order to advantageously provide stability and the connection of a handle with a body.
Regarding claim 18, Ducharme doesn’t expressly disclose the handle is connected to the body via a threaded connection, and wherein the plurality of apertures pass through the threaded connection.
Wyrick teaches (“The aperture 34 of the nose cap 45 is attached to the barrel by means of inter fitting threads 46” [Para 0101] ); Note that this device clearly demonstrates the concept of a hand-held device where the body itself serves as the gripping portion.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Ducharme delivery device so that the handle is connected to the body via a threaded connection, and wherein the plurality of apertures pass through the threaded connection as taught by Wyrick. A person in ordinary skill in the art would have been motivated to make this change in order to advantageously provide stability and the connection of a handle with a body.
Claim 7-8 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ducharme (US Patent No. 9101744 B2) in view of Denzer ( US Pub. No. 2015/0045729 A1) and further in view of Kendall (US 2008/0262417 A1) and Beaven (US 2019/0274726 A1).
Regarding claim 7, Ducharme in view of Denzer and further in view of Kendall doesn’t expressly disclose a plurality of crenellations and a plurality of openings defined between adjacent crenellations, and wherein the openings are fluidly connected to the single aperture.
Beaven teaches a plurality of crenellations ( “The spaced apart crenellations” Column 3, [Para 0026] ) and a plurality of openings defined between adjacent crenellations (“create a plurality of conduits or channels 72 within the flow passage 52” Column 3, [Para 0026] ), and wherein the openings are fluidly connected to the single aperture( “to provide uniform longitudinal distribution of the medication down the length of the sleeve” Column 3, [Para 0026]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Ducharme delivery device in view of Denzer and Kendall to include a plurality of crenellations, and a plurality of openings defined between adjacent crenellations, and wherein the openings are fluidly connected to the single aperture as taught by Beaven. A person in ordinary skill in the art would have been motivated to make this change in order to advantageously provide improved fluid delivery, increase surface area for drug release, enhanced structural integrity, or a combination thereof.
Regarding claim 8, Ducharme in view of Denzer and further in view of Kendall doesn’t expressly disclose the plurality of crenellations are configured to contact a proximal most end of the container when the container is attached to the device.
Beaven teaches (“ a crenellated or otherwise contoured pattern in the form of multiple, regular, rectangular spaces. The spaced apart crenellations form the side walls 73, 75 and top wall 77 of each channel 72, such that upon placement within the flow passage 52 the plurality of crenellations outline the plurality of channels 72 down the length of the flow passage 52” Column 4, [Para 0032].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Ducharme delivery device in view of Denzer and Kendall to include a plurality of crenellations, and a plurality of openings defined between adjacent crenellations, and wherein the openings are fluidly connected to the single aperture as taught by Beaven. A person in ordinary skill in the art would have been motivated to make this change in order to advantageously provide improved fluid delivery, increase surface area for drug release, enhanced structural integrity, or a combination thereof.
Claim(s) 9, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ducharme (US Patent No. 9101744 B2) in view of Denzer ( US Pub. No. 2015/0045729 A1), and Hendrik ( US 20200146739 A1)
Regarding claim 9, Ducharme teaches a single aperture (“The openings 97 may comprise slits” Column 8, line 49-50).
Ducharme in view of Denzer doesn’t expressly disclose wherein a sum of a cross-sectional area of each of the plurality of openings is equal to a cross-sectional area.
Hendrik teaches a sum of a cross-sectional area of each of the plurality of openings is equal to a cross-sectional area (“ The term “cross-sectional opening area” as used herein refers to the minimum cross-sectional area of an aperture or of a conduit, normal to the main flow through said aperture or conduit.” [Para 0052]) in corroboration with (“The requirement that the constricted section has a cross-sectional opening area that is at least 150% larger than the cross-sectional opening area of the liquid inlet means that if the liquid inlet has a cross-sectional opening area of 0.12 mm.sup.2, the constricted section has to have a cross-sectional opening area of at least 0.3 mm.sup.2.” [Para 0056] ).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Ducharme delivery device to include a sum of a cross-sectional area of each of the plurality of openings is equal to a cross-sectional area of the single aperture. A person in ordinary skill in the art would have been motivated to make this change in order to advantageously control fluid flow and pressure withing the device.
Regarding claim 13, Ducharme teaches a single aperture (“The openings 97 may comprise slits” Column 8, line 49-50).
Ducharme in view of Denzer doesn’t expressly disclose a cross-sectional area of a sum of each of the at least one aperture is equal to or greater than approximately 0.25 square inches.
Hendrik teaches a sum of a cross-sectional area of each of the plurality of openings is equal to a cross-sectional area (“ The term “cross-sectional opening area” as used herein refers to the minimum cross-sectional area of an aperture or of a conduit, normal to the main flow through said aperture or conduit.” [Para 0052]) in corroboration with (“The requirement that the constricted section has a cross-sectional opening area that is at least 150% larger than the cross-sectional opening area of the liquid inlet means that if the liquid inlet has a cross-sectional opening area of 0.12 mm.sup.2, the constricted section has to have a cross-sectional opening area of at least 0.3 mm.sup.2.” [Para 0056] ).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Ducharme delivery device to include a sum of a cross-sectional area of each of the plurality of openings is equal to a cross-sectional area of the single aperture. A person in ordinary skill in the art would have been motivated to make this change in order to advantageously control fluid flow and pressure withing the device.
Claim 12, 14, and 19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ducharme (US Patent No. 9101744 B2) in view of Denzer ( US Pub. No. 2015/0045729 A1) and further in view of Kendall (US 2008/0262417 A1).
Regarding claim 12, Ducharme in view of Denzer discloses wherein the body is configured to form a hole in the container, wherein the pressurized fluid is configured to pass from the container via the hole ( “the regulator valve 70 may pierce through a seal of the pressure cartridge to release the high pressure fluid. After the regulator valve 70 reduces the pressure, the fluid may flow from the pressure outlet 72 to an actuation valve 80 via tubing 75.” Column 5, line 36-40).
Ducharme in view of Denzer doesn’t expressly disclose a diameter of the hole is less than or equal to 0.060 inches.
Kendall teaches a diameter of the hole is less than or equal to 0.060 inches (“the bleed hole 56 has a diameter of 0.4 mm”, Column 4, [0080] ).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Ducharme delivery device in view of Denzer to include the diameter of a hole as taught by Kendall. A person in ordinary skill in the art would have been motivated to make this change in order to advantageously provide a more precise and controlled delivery of material, preventing over-dispensing or leakage, and ensuring consistent and accurate delivery of the substance.
Regarding claim 14, Ducharme in view of Denzer discloses a container (“at least one pressure source 68” Column 3, line 16).
Ducharme in view of Denzer doesn’t expressly disclose a membrane covering each aperture of the at least one aperture, wherein the membrane is configured to rupture when a pressure of the pressurized fluid within the lumen exceeds a threshold.
Kendall teaches (“the transfer duct consists of a small aperture 134 in the upstream closure means 131. Thus, when a gaseous pressure is exposed to the upstream closure means 131, some gas 133 is routed through the small aperture 134 which acts as a transfer duct prior to membrane rupture”, Column 7, [Para 0119] ).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Ducharme delivery device in view of Denzer to include a membrane covering each aperture of the at least one aperture, wherein the membrane is configured to rupture when a pressure of the pressurized fluid within the lumen exceeds a threshold as taught by Kendall. A person in ordinary skill in the art would have been motivated to make this change in order to advantageously provide a controlled and timed release of the pressurized fluid, preventing unintended delivery while ensuring that the fluid is expelled when desired.
Regarding claim 19, Ducharme in view of Denzer doesn’t expressly disclose a membrane covering each aperture of the at least one aperture, wherein the membrane is configured to rupture when a pressure of the pressurized fluid within the lumen is equal to or greater than a threshold.
Kendall teaches (“the transfer duct consists of a small aperture 134 in the upstream closure means 131. Thus, when a gaseous pressure is exposed to the upstream closure means 131, some gas 133 is routed through the small aperture 134 which acts as a transfer duct prior to membrane rupture”, Column 7, [Para 0119] ).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Ducharme delivery device in view of Denzer to include a membrane covering each aperture of the at least one aperture, wherein the membrane is configured to rupture when a pressure of the pressurized fluid within the lumen exceeds a threshold as taught by Kendall. A person in ordinary skill in the art would have been motivated to make this change in order to advantageously provide a controlled and timed release of the pressurized fluid, preventing unintended delivery while ensuring that the fluid is expelled when desired.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW MIRANDA NEGRON whose telephone number is (703)756-1573. The examiner can normally be reached M-F 0830-1700.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW MIRANDA NEGRON/Examiner, Art Unit 3783
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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