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 .
Priority
Acknowledgment is made of applicant’s claim for priority to Application No. (63/343,833) filed on the May 19, 2022.
Election/Restrictions
Applicant's election of Species A in the reply filed on February 04, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The requirement is still deemed proper and is therefore made FINAL.
Claims 9-15 and 18-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Therefore claims 1-8, 16-17, and 20 are the only claims being examined on merit.
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 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-6, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Keller (US 20090127288 A1).
Regarding Claim 1, Keller discloses a valve assembly (Figs. 3A-3B) for a medical device, comprising:
an inlet (Fig. 3A-3B; 24, 25) that is in fluid communication with an enclosure (Fig. 1; 19) of the medical device, wherein the enclosure stores an agent (para. 0029);
an outlet (Fig. 3A-3B; 4) that is in fluid communication with a delivery conduit of the medical device; and
a body (Fig. 3A-3B; 30) having a channel (Fig. 3A-3B; 31, 32) that is in fluid communication with a source of fluid (Examiner notes: in 28 the fluid is gas),
wherein the body is configured to move relative to the inlet and the outlet to selectively fluidly couple the channel with the enclosure and the delivery conduit (Fig. 3A-3B; This limitation is functional however, valve member 27 has plug 30 that turns; para. 0037);
wherein, in a first position of the body, the channel is misaligned with at least one of the inlet or the outlet (Fig. 3A), such that the delivery conduit is not in fluid communication with at least one of the enclosure or the source of fluid; and
wherein, in a second position of the body, the channel is aligned with the inlet and the outlet such that the delivery conduit is in fluid communication with the enclosure and the source of fluid (Fig. 3B; para. 0037-0038; claim 5-6, 16-17).
Regarding Claim 2, Keller discloses the valve assembly of claim 1, wherein, in the first position (Fig. 3A), the channel (Fig. 3A-3B; 31, 32) is positioned in a transverse alignment (32) relative to an axis extending between the inlet (Fig. 3A-3B; 24, 25) and the outlet (Fig. 3A-3B; 4) (Fig. 3A; Examiner notes: the outlet is blocked off causing a transverse alignment).
Regarding Claim 3, Keller discloses the valve assembly of claim 1, wherein, in the second position (Fig. 3B), the channel (Fig. 3A-3B; 31, 32) is positioned in a parallel alignment relative to an axis extending between the inlet (Fig. 3A-3B; 24, 25) and the outlet (Fig. 3A-3B; 4); (Fig. 3B).
Regarding Claim 4, Keller discloses the valve assembly of claim 1, wherein the channel (Fig. 3A-3B; 31, 32) is in fluid communication with the source of fluid (Examiner notes: gas) when the body (Fig. 3A-3B; 30) is in the first position (Fig. 3A) and the second position (Fig. 3B).
Regarding Claim 5, Keller discloses the valve assembly of claim 1, wherein the body (Fig. 3A-3B; 30) is configured to guide the fluid through the channel (Fig. 3A-3B; 31, 32) and into the enclosure via the inlet (Fig. 3A-3B; 24, 25) to agitate the agent within the enclosure (19) when in the first position (Examiner notes: this limitation is functional, the air is configured to be “guided” through the channel).
Regarding Claim 6, Keller discloses the valve assembly of claim 5, wherein the body (Fig. 3A-3B; 30) is configured to guide a mixture of the fluid and the agent from the enclosure into the channel(Fig. 3A-3B; 31, 32) via the inlet (Fig. 3A-3B; 24, 25), and the channel is configured to guide the mixture into the delivery conduit via the outlet(Fig. 3A-3B; 4; Examiner notes: this limitation is functional, the air is configured to be “guided” through the channel to the delivery conduit as shown in Fig. 3B).
Regarding Claim 20, Keller discloses a method for delivering a fluid (gas) from a medical device, the medical device including an enclosure (Fig. 1; 19) for storing an agent,
the method comprising:
moving a channel (Fig. 3A-3B; 31, 32) of a valve body (Fig. 3A-3B; 30) to a first position (Fig. 3B) that is aligned with an inlet (Fig. 3A-3B; 24, 25) and an outlet (Fig. 3A-3B; 4) of the enclosure, thereby permitting delivery of a fluid through the channel and into the enclosure via the inlet to agitate the agent in the enclosure, and permitting delivery of the fluid and the agitated agent through the channel and toward a delivery conduit of the medical device via the outlet (Fig. 3B);
and moving the channel (Fig. 3A-3B; 31, 32) to a second position (Fig. 3A) that is misaligned with the inlet (Fig. 3A-3B; 24, 25) and the outlet (Fig. 3A-3B; 4), thereby inhibiting delivery of the fluid through the channel and into the enclosure via the inlet, and inhibiting delivery of the fluid toward the delivery conduit via the outlet (Fig. 3A).
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 20180193574 A1), in view of Keller.
Regarding Claim 1, Smith discloses a valve assembly (Figs. 1-2) for a medical device, comprising:
an inlet (Fig. 1; 14) that is in fluid communication with an enclosure (Fig. 1; 16) of the medical device, wherein the enclosure stores an agent (Fig. 2; 54; para. 0018);
an outlet (Fig. 1; 36) that is in fluid communication with a delivery conduit of the medical device (Fig. 1; 18; para. 23); and
a body (Fig. 44) having a channel (Fig. 2; 46, 55, 56) that is in fluid communication with a source of fluid (para. 0005, 0012, 0024; Fig. 1-2; 22);
wherein the body configured to move relative to the inlet and outlet (para. 0025).
Smith does not specifically disclose wherein the body is configured to move relative to the inlet and the outlet to selectively fluidly couple the channel with the enclosure and the delivery conduit; wherein, in a first position of the body, the channel is misaligned with at least one of the inlet or the outlet, such that the delivery conduit is not in fluid communication with at least one of the enclosure or the source of fluid; and wherein, in a second position of the body, the channel is aligned with the inlet and the outlet such that the delivery conduit is in fluid communication with the enclosure and the source of fluid.
However, Keller teaches wherein the body is configured to move relative to the inlet and the outlet to selectively fluidly couple the channel with the enclosure and the delivery conduit (Fig. 3A-3B; This limitation is functional however, valve member 27 has plug 30 that turns; para. 0037); wherein, in a first position of the body, the channel is misaligned with at least one of the inlet or the outlet (Fig. 3A), such that the delivery conduit is not in fluid communication with at least one of the enclosure or the source of fluid; and wherein, in a second position of the body, the channel is aligned with the inlet and the outlet such that the delivery conduit is in fluid communication with the enclosure and the source of fluid (Fig. 3B; para. 0037-0038; claim 5-6, 16-17).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Smith to include the body is configured to move relative to the inlet and the outlet to selectively fluidly couple the channel with the enclosure and the delivery conduit; wherein, in a first position of the body, the channel is misaligned with at least one of the inlet or the outlet, such that the delivery conduit is not in fluid communication with at least one of the enclosure or the source of fluid; and wherein, in a second position of the body, the channel is aligned with the inlet and the outlet such that the delivery conduit is in fluid communication with the enclosure and the source of fluid as taught by Keller for the purpose of purpose of controlling the flow of one or more of the pressurized gas, powdered agent, and the fluidized powdered agent and providing a valve assembly for selectively connecting the inlet area of the device with a deviating channel or with an outlet (abstract).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith and Keller, as applied to claim 1, in view of Goodman et al. (US 10507293 B2) hereafter as Goodman.
Regarding Claim 7, Modified Smith discloses the valve assembly of claim 1,
Modified Smith does not disclose wherein the body includes an insert positioned within the channel, the insert including a porous mesh.
However, Goodman teaches an insert (50) positioned within the channel (Fig. 9, 11, 12), the insert including a porous mesh (Col. 10; lines 7-21).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the channel of Modified Smith to include an insert positioned within the channel, the insert including a porous mesh as taught by Goodman for the purpose of selectively allowing gas flow through filter while preventing flow of powder through filter (Col. 10; lines 7-21).
Regarding Claim 8, Modified Smith discloses the valve of claim 7, wherein the insert (50; Goodman) is configured to inhibit the agent from moving through the insert towards the source of fluid, and to permit the fluid to pass through the insert (Col. 10; lines 7-21; Goodman).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Keller.
Regarding Claim 16, Smith discloses a device (Figs. 1-2) for delivering an agent, comprising:
an enclosure (Fig. 1; 16) configured to store the agent (Fig. 2; 54; para. 0018), the enclosure having an inlet (Fig. 2; 34);
a pressurized fluid source (Fig. 1; 14) configured to store a pressurized fluid (para. 0005, 0018, 0024; Fig. 1-2; 22);
a valve assembly (para. 0025), including a body (Fig. 1-2; 44, 38) having a channel (from 32, 34, and 36),
Smith does not specifically disclose or show wherein the body is configured to move between a first position and a second position to selectively fluidly couple the pressurized fluid source to the enclosure via the channel; wherein, in the first position, the valve assembly is configured to misalign the channel from the inlet to inhibit the pressurized fluid from moving through the channel and delivering the agent out of the device; and wherein, in the second position, the valve assembly is configured to align the channel with the inlet to permit the pressurized fluid from moving through the channel and delivering the agent out of the device.
However, Keller teaches a valve assembly (Figs. 3A-3B), including a body (Fig. 3A-3B; 30) having a channel (Fig. 3A-3B; 31, 32), wherein the body is configured to move between a first position (Fig. 3A) and a second position (Fig. 3B) to selectively fluidly couple the fluid source to the enclosure via the channel (para. 0037); wherein, in the first position (Fig. 3A), the valve assembly is configured to misalign the channel (Fig. 3A-3B; 31, 32) from the inlet to inhibit the fluid from moving through the channel and delivering the agent out of the device (Fig. 3A); and wherein, in the second position (Fig. 3B), the valve assembly is configured to align the channel (Fig. 3A-3B; 31, 32) with the inlet (Fig. 1; 3) to permit the fluid from moving through the channel and delivering the agent out of the device (Fig. 3B; Claim 5-6).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system and valve system of Smith to include wherein the body is configured to move between a first position and a second position to selectively fluidly couple the pressurized fluid source to the enclosure via the channel; wherein, in the first position, the valve assembly is configured to misalign the channel from the inlet to inhibit the pressurized fluid from moving through the channel and delivering the agent out of the device; and wherein, in the second position, the valve assembly is configured to align the channel with the inlet to permit the pressurized fluid from moving through the channel and delivering the agent out of the device as taught by Keller for the purpose of controlling the flow of one or more of the pressurized gas, powdered agent, and the fluidized powdered agent and providing a valve assembly for selectively connecting the inlet area of the device with a deviating channel or with an outlet (abstract, para. 0038).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith and Keller, as applied to claim 16, in view of Goodman.
Regarding Claim 17, Modified Smith discloses the device of claim 16,
Modified Smith does not disclose wherein the body includes an insert positioned within the channel that is configured to inhibit the agent from moving through the insert and permit the pressurized fluid to pass through the insert.
However, Goodman teaches wherein the body (10) includes an insert (50) positioned within the channel (20) that is configured to inhibit the agent from moving through the insert and permit the pressurized fluid to pass through the insert (Col. 10; lines 7-21).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the body of Modified Smith to include an insert positioned within the channel that is configured to inhibit the agent from moving through the insert and permit the pressurized fluid to pass through the insert as taught by Goodman for the purpose of selectively allowing gas flow through filter while preventing flow of powder through filter (Col. 10; lines 7-21).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAAP A ELLABIB whose telephone number is (571)272-5879. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KENDRA CARTER can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAAP ELLABIB/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785