DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendment filed on 6/24/2025 has been entered. Claims 1-19 remain pending in the application. Claim 21 is new.
Applicants arguments regarding the specification have overcome the specification objections previously set forth in the Non-final Office Action mailed 3/27/2025.
Applicants amendments to the claims have overcome all of the rejections under 35 USC 112 previously set forth in the Non-final Office Action mailed 3/27/2025.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 7/29/2026, 11/11/2025, and 7/7/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 17-19 objected to because of the following informalities:
Line 1 of claims 17-19 recite “The delivery system according to claim 16”. It appears a typo has been made as claim 16 is drawn to a device, not a delivery system. Examiner suggests replacing “The delivery system according to claim 16” in claims 17-19 with “The device according to claim 16”.
Claim 21 objected to because of the following informalities:
Line 1 recites “A device for delivering a pressurized fluid, comprising”. Examiner suggests replacing “A device for delivering a pressurized fluid, comprising” with “A device for delivering a pressurized fluid, the device comprising” to put the claim in clearer form that the components listed are of the device.
Line 8-9 recites “an external atmosphere external, thereby”. This is grammatically incorrect. Examiner suggests replacing “an external atmosphere external” in line 8-9 of claim 21 with “an external atmosphere”.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 6-7, 11, 15-16, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haar (U.S. PG publication 20030114789).
In regard to claim 1,
Haar discloses a device (see all of figure 1-2B) configured to deliver a pressurized fluid (paragraph [0089]; Examiner notes “configured to deliver a pressurized fluid” is a functional limitation. The device is fully capable of delivering a pressurized fluid to dispense medication due to its structure as supported by paragraph [0089]), the device comprising:
a body (figure 1-3B, item 20 and 28) having an input opening (see figure 1) for receiving the pressurized fluid (see figure 1) and an output opening (see figure 1) for delivering the pressurized fluid (see figure 1);
a handle (figure 1, item 41; Examiner notes item 41 is construed as a handle as it is capable of being grasped by a user) defining a lumen (see figure 1), wherein the lumen is configured to receive a container (figure 2B, item 23) containing the pressurized fluid (paragraph [0089]; Examiner notes “configured to receive a container containing the pressurized fluid” is a functional limitation. The container containing the pressurized fluid is not positively required by the claim); and
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at least one aperture (Examiner notes the at least one aperture is being construed as the opening formed in item 41 labeled above, figure 1, item 44, and figure 3B, item 51; see paragraph [0110] OR the at least one aperture is being construed as the opening formed in item 41 labeled above only OR the at least one aperture is being construed as figure 1, item 44 only) fluidly connecting the lumen to an atmosphere external of the device (see figure 1) such that the at least one aperture is configured to vent the pressurized fluid released into the lumen from the container to the atmosphere external of the device (paragraph [0107]-[0108], and [0110]; Examiner notes “such that the at least one aperture is configured to vent the pressurized fluid released into the lumen from the container to the atmosphere external of the device” is a functional limitation. The at least one aperture is fully capable of the recited function as supported by paragraph [0107]-[0108], and [0110]).
In regard to claim 2,
Haar discloses the device according to claim 1, wherein the at least one aperture (the at least one aperture is being construed as the opening formed in item 41 labeled above only) is defined by a wall of the handle (see figure 1).
In regard to claim 3,
Haar discloses the device according to claim 1, wherein the at least one aperture includes a plurality of apertures (the at least one aperture is being construed as the opening formed in item 41 labeled above, figure 1, item 44, and figure 3B, item 51), and wherein the plurality of apertures are arranged in an asymmetrical pattern on the handle (see figure 1 wherein the plurality of apertures are arranged in an asymmetrical pattern and are on the handle as item 28 is on the handle).
In regard to claim 6,
Haar discloses the device according to claim 1, wherein the at least one aperture (the at least one aperture is being construed as the opening formed in item 41 labeled above only) is a single aperture disposed at a proximalmost end of the handle (See figure 1), and wherein the single aperture faces a proximal direction (see figure 1).
In regard to claim 7,
Haar discloses the device according to claim 6, wherein the device includes a plurality of crenellations (see threads of item 41 in figure 1) and a plurality of openings defined between adjacent crenellations (see figure 1), and wherein the openings are fluidly connected to the single aperture (see figure 1).
In regard to claim 11,
Haar discloses the device according to claim 1, wherein the at least one aperture (the at least one aperture is being construed as figure 1, item 44 only) is configured to release the pressurized gas in a time equal to or less than 0.5 seconds (Examiner notes “configured to release the pressurized gas in a time equal to or less than 0.5 seconds” is a functional limitation. Item 44 is fully capable of the recited function due to its structure once item 23 ruptures).
In regard to claim 15,
Haar discloses the device according to claim 1, wherein the pressurized fluid has a pressure of approximately 14 pounds per square inch (Examiner notes the pressurized fluid is not positively required by the claim. A pressurized fluid having a pressure of approximately 14 pounds per square inch is fully capable of being used due to the structure of the device).
In regard to claim 16,
Haar discloses a device (see all of figure 1-2B) configured to deliver a pressurized fluid (paragraph [0089]; Examiner notes “configured to deliver a pressurized fluid” is a functional limitation. The device is fully capable of delivering a pressurized fluid to dispense medication due to its structure as supported by paragraph [0089]), the device comprising:
a body (figure 1-3B, item 20 and 28) having an input opening (see figure 1) for receiving the pressurized fluid (see figure 1) and an output opening (see figure 1) for delivering the pressurized fluid (see figure 1);
a handle (figure 1, item 41; Examiner notes item 41 is construed as a handle as it is capable of being grasped by a user) defining a lumen (see figure 1), wherein the lumen is configured to receive a container (figure 2B, item 23) containing the pressurized fluid (paragraph [0089]; Examiner notes “configured to receive a container containing the pressurized fluid” is a functional limitation. The container containing the pressurized fluid is not positively required by the claim); and
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plurality of apertures (figure 1, item 44, and figure 3B, item 51; see paragraph [0110] OR the plurality of apertures are construed as item 44 and the opening formed in item 41 labeled above) fluidly connecting the lumen and an outer surface of the device (See figure 1) such that each of the plurality of apertures is configured to vent the pressurized fluid released into the lumen from the container to the outer surface external of the device (paragraph [0107]-[0108], and [0110]; Examiner notes “such that each of the plurality of apertures is configured to vent the pressurized fluid released into the lumen from the container to the outer surface external of the device” is a functional limitation. The plurality of apertures is fully capable of the recited function as supported by paragraph [0107]-[0108], and [0110]).
In regard to claim 21,
Harr discloses a device (see all of figure 1-2B) for delivering a pressurized fluid (paragraph [0089]; Examiner notes “for delivering a pressurized fluid” is a functional limitation. The device is fully capable of delivering a pressurized fluid due to its structure as supported by paragraph [0089]; The pressurized fluid is not positively required by the claim), comprising:
a body (figure 1, item 23 and 28) configured to deliver the pressurized fluid to a target treatment site (Examiner notes “configured to deliver the pressurized fluid to a target treatment site” is a functional limitation. The body is fully capable of the recited function as supported by paragraph [0089] as the body causes delivery of fluid 12 which is pressurized);
a handle (figure 1, item 20, 21, 41 and 15) fluidly couped to the body (see figure 1; paragraph [0089]; Examiner notes item 23 and 28 are fluidly coupled to at least item 20 of the handle), the handle including a lumen (lumen formed by the opening in item 21 and 15) configured to receive a container (figure 1, item 14) storing the pressurized fluid (see figure 1), the handle is configured to guide the pressurized fluid from the container towards the body (see figure 1; Examiner notes “configured to guide the pressurized fluid from the container towards the body” is a functional limitation. The handle is fully capable of the recited function as the pressurized fluid is guided from the container towards the distal end of item 28 of the body) and the lumen is configured to receive a portion of the pressurized fluid released from the container (see figure 1); and
an aperture (figure 1, item 17) in fluid communication with the lumen (see figure 1), the aperture is configured to release the portion of the pressurized fluid received in the lumen to an external atmosphere external (paragraph [0086]), thereby venting the pressurized fluid out of the handle and into the external atmosphere (paragraph [0086]).
Claim Rejections - 35 USC § 103
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.
Claims 4-5, 8-10, 12-13, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Haar (U.S. PG publication 20030114789).
In regard to claim 4,
Haar discloses device according to claim 1, wherein a distal end of the handle is configured to be connected to the body via screw threads (see figure 1 wherein item 41 and 28 are connected via screw threads; Examiner notes “configured to be connected to the body via screw threads” is a functional limitation. The screw threads are not positively required by the claim), and wherein the at least one aperture (the at least one aperture is being construed as figure 1, item 44 only) extends next to a portion of the screw threads (see figure 1).
Haar is silent as to wherein the at least one aperture extends through a portion of the screw threads.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Haar to include wherein the at least one aperture extends through a portion of the screw threads since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Further, it would have been an obvious matter of design choice to modify Haar to include wherein the at least one aperture extends through a portion of the screw threads since applicant has not disclosed that having wherein the at least one aperture extends through a portion of the screw threads solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein the at least one aperture extends through a portion of the screw threads, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
In regard to claim 5,
Haar teaches the device according to claim 4, wherein the handle includes one or more screw threads (see figure 1), wherein the body includes one or more screw threads (see figure 1), wherein one or more apertures are configured to be formed through the one or more screw threads of each of the handle and the body (Examiner notes “wherein one or more apertures are configured to be formed through the one or more screw threads of each of the handle and the body” is a functional limitation. The one or more apertures are not positively required by the claim. One or more apertures are fully capable of being formed through the one or more screw threads of each of the handle and the body due to the structure of the screw threads), and wherein the one or more apertures on the handle and the one or more apertures on the body (As noted above “the one or more apertures on the handle and the one or more apertures on the body” are not positively required by the claim) are configured to align when the handle is attached to the body (Examiner notes ‘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” is a functional limitation. The one or more apertures on the handle and the one or more apertures on the body as fully capable of the recited function due to the structure of the screws as shown in figure 1).
In regard to claim 8,
Haar discloses the device according to claim 7.
Haar is silent as to wherein the plurality of crenellations are configured to contact a proximalmost end of the container when the container is attached to the device.
A second embodiment of Haar teaches wherein the plurality of crenellations (figure 12, item 58) are configured to contact a proximalmost end of the container (figure 10C and 12, item 23, and 29) when the container is attached to the device (see figure 12).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Haar to include wherein the plurality of crenellations are configured to contact a proximalmost end of the container when the container is attached to the device, as taught by the second embodiment of Haar, for the purpose of forming a secure snap connection (paragraph [0125] of Haar).
In regard to claim 9,
Haar discloses the device according to claim 7.
Haar is silent as to wherein 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.
It would have been an obvious matter of design choice to modify Haar to include wherein 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 since applicant has not disclosed that having wherein 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 solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein 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, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
In regard to claim 10,
Haar discloses the device according to claim 1.
Haar is silent as to 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.
It would have been an obvious matter of design choice to modify Haar to include 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 since applicant has not disclosed that having 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 solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of 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, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). It is noted that the container is not positively required by the claim. A container in which 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 is fully capable of use with the device.
In regard to claim 12,
Examiner notes the at least one aperture is construed as the opening formed in item 41 labeled above.
Haar discloses the device according to claim 1, wherein the body is configured to form a hole in the container (Examiner notes “configured to form a hole in the container” is a functional limitation. The hole is not positively required by the claim. See figure 1 where item 44 of the body or item 54 of the body forms a hole in the container), wherein the pressurized fluid is configured to pass from the container via the hole (Examiner notes “wherein the pressurized fluid is configured to pass from the container via the hole” is a functional limitation. The pressurized fluid is fully capable of passing from the container via the hole as supported by paragraph [0110] and [0107]).
Haar is silent as to wherein a diameter of the hole is less than or equal to 0.060 inches.
It would have been an obvious matter of design choice to modify Haar to include wherein a diameter of the hole is less than or equal to 0.060 inches since the only difference between the prior art and what is claimed is 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. As noted above, the hole is not positively required by the claim. A hole with a diameter less than or equal to 0.060 inches is fully capable of being used with the device of Haar.
In regard to claim 13,
Haar discloses the device according to claim 1.
Haar is silent as to wherein 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.
It would have been an obvious matter of design choice to modify Haar to include wherein 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 since the only difference between the prior art and what is claimed is 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. Paragraph [0049] of the instant disclosure further supports the cross-sectional area can be modified.
In regard to claim 17,
Examiner notes the plurality of apertures are being construed as figure 1, item 44, and figure 3B, item 51; OR the plurality of apertures are construed as item 44 and the opening formed in item 41 labeled above.
Haar discloses the delivery system according to claim 16, wherein the plurality of apertures is arranged in an asymmetrical shape on the handle (see figure 1 wherein the plurality of apertures are arranged in an asymmetrical pattern and are on the handle as item 28 is on the handle); and
wherein the pressurized fluid is configured to be released from the lumen in approximately 0.5 seconds or less (Examiner notes “the pressurized fluid is configured to be released from the lumen in approximately 0.5 seconds or less” is a functional limitation. The pressurized fluid is fully capable of being released from the lumen in approximately 0.5 seconds or less due to the structure of the device. It is noted that claim 17 does not require the pressurized fluid to be released from the plurality of apertures in approximately 0.5 seconds or less.
Haar is silent as to 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.
It would have been an obvious matter of design choice to modify Haar to include 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 since the only difference between the prior art and what is claimed is 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. Paragraph [0049] of the instant disclosure further supports the cross-sectional area can be modified.
In regard to claim 18,
Examiner notes the plurality of apertures are being construed as figure 1, item 44, and figure 3B, item 51.
Haar discloses the delivery system according to claim 16, wherein the handle is connected to the body via a threaded connection (see figure 1 wherein the handle is connected to the body via a threaded connection).
Haar is silent as to wherein the plurality of apertures pass through the threaded connection.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Haar to include wherein the plurality of apertures pass through the threaded connection since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Further, it would have been an obvious matter of design choice to modify Haar to include wherein the plurality of apertures pass through the threaded connection since applicant has not disclosed that having wherein the plurality of apertures pass through the threaded connection solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein the plurality of apertures pass through the threaded connection, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Claims 14 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Haar (U.S. PG publication 20030114789) further in view of Perry (U.S. Patent no 5957119).
In regard to claim 14,
Examiner notes the at least one aperture is being construed as the opening formed in item 41 labeled above only OR the at least one aperture is being construed as figure 1, item 44 only.
Haar discloses the device according to claim 1, further comprising:
the container (see figure 1, item 23).
Haar is silent as to a membrane covering 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.
Perry teaches a membrane (figure 1, item 71) covering the at least one aperture (see figure 1), wherein the membrane is configured to rupture when a pressure of the pressurized fluid within the lumen exceeds a threshold (column 9, line 27-45).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one aperture of Haar to include a membrane covering 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 Perry, for the purpose of enabling precise venting when pressure exceeds a set pressure (column 9, line 27-45 of Perry).
In regard to claim 19,
Examiner notes the plurality of apertures are being construed as figure 1, item 44, and figure 3B, item 51; OR the plurality of apertures are construed as item 44 and the opening formed in item 41 labeled above.
Haar discloses the delivery system according to claim 16.
Haar is silent as to a membrane covering each aperture of the plurality of apertures, 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.
Perry teaches a membrane (figure 1, item 71) covering each aperture of the plurality of apertures (see figure 1), 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 (column 9, line 27-45).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify each aperture of the plurality of apertures of Haar to include a membrane covering each aperture of the plurality of apertures, 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, as taught by Perry, for the purpose of enabling precise venting when pressure exceeds a set pressure (column 9, line 27-45 of Perry).
Response to Arguments
Applicant’s arguments with respect to the rejection of the claims under 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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/ALEXANDRA LALONDE/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
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