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.
Response to Amendment
This office action is responsive to the amendment filed as July 01, 2025. As directed by the amendment: claims 1, 5, 16, and 20 have been amended, no claims have been canceled, and no claims have been added. Thus, claims 1-8, 16-17, 20 are presently pending in the application.
Response to Arguments
Applicant argues on page 8-10 of the remarks that the 102/103 rejections should be withdrawn. However, Applicant amended the claim to add new limitation from claim 1“the channel is misaligned with the enclosure, such that the delivery conduit is not in fluid communication with the enclosure; and wherein, in a second position of the body, the channel is aligned with the enclosure, the inlet., and the outlet such that the delivery conduit is in fluid communication with the enclosure and the source of fluid,” that was not previously considered. Applicant has amended the claims and a new 103 rejection stated below addresses the new limitation of the claim.
Applicant’s arguments with respect to claim(s) dependent from the independent claim have been considered but are not persuasive.
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) 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Willeford (US 20050229934 A1).
Regarding Claim 1, Willeford discloses a valve assembly for a medical device, comprising: an inlet ( Fig. 3A-5A; 47) that is in fluid communication with an enclosure (tube 20 ; fluids; para. 0045, 0052) of the medical device, wherein the enclosure stores an agent (the tube holds the fluids being delivered); an outlet ( Fig. 3A-5A; 24) that is in fluid communication with a delivery conduit of the medical device (para. 0041 connected to tip 24); and a body (Fig. 2, 3A,3C, 4A, 4C; 18) having a channel (50, 51, 52) that is in fluid communication with a source of fluid (can be in communication with 12; para. 0036, 0039), 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 (Figs. 3A-5C; para. 0036, 0040-0041; Examiner notes: this limitation is functional however stopcock 18 is able to move); wherein, in a first position of the body (18), the channel is misaligned with the enclosure (shown best in Fig. 4B, and 4D) such that the delivery conduit (24)is not in fluid communication with enclosure; and wherein, in a second position of the body, the channel is aligned with the enclosure (20), the inlet (47), and the outlet such that the delivery conduit (24) is in fluid communication with the enclosure and the source of fluid (Best shown in in Figs. 3B, 3D or 5A).
Regarding Claim 2, Willeford discloses the valve assembly of claim 1, wherein, in the first position (Fig. 4B, 4D), the channel (50, 52) is positioned in a transverse alignment relative to an axis extending between the inlet (47) and the outlet (24).
Regarding Claim 3, Willeford discloses the valve assembly of claim 1, wherein, in the second position (Figs. 3B, 3D or 5A), the channel (50, 52) is positioned in a parallel alignment relative to an axis extending between the inlet (47) and the outlet (24).
Regarding Claim 4, Willeford discloses the valve assembly of claim 1, wherein the channel (Fig. 3A-5A; 50, 51) is in fluid communication with the source of fluid (12; para. 0036, 0039) when the body (Fig. 3A-5A; 18) is in the first position and the second position (shown in Fig. 4b, 4D AND 5A).
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, 5-6, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keller (US 20090127288 A1), in view of William (US 2162242 A).
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);
Keller does not disclose specifically wherein, in a first position of the body, the channel is misaligned with the enclosure, such that the delivery conduit is not in fluid communication with enclosure; and wherein, in a second position of the body, the channel is aligned with the enclosure, the inlet, and the outlet such that the delivery conduit is in fluid communication with the enclosure and the source of fluid.
However, William teaches valve assembly (Fig. 1, 5-8; 36) wherein, in a first position of the body (Fig. 5-8; 68), the channel (“T” within 68 in Figs. 5-8) is misaligned with the enclosure (38), such that the delivery conduit (45) is not in fluid communication with enclosure (41); and wherein, in a second position of the body, the channel is aligned with the enclosure (Fig. 5 or 6 one of the passageways are misaligned), the inlet, and the outlet such that the delivery conduit (Fig. 8 all the passages are connected) is in fluid communication with the enclosure and the source of fluid (Fig. 5-8; Col. 4 lines 1-38, Col. 5 lines 3-24).
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 valve system in Keller to include the in a first position of the body, the channel is misaligned with the enclosure, such that the delivery conduit is not in fluid communication with enclosure; and wherein, in a second position of the body, the channel is aligned with the enclosure, 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 William for the purpose of which can be moved into register with the valve ports to connect any combination of the conduits 41, 45 and 55 (Col. 5 lines 3-24).
Regarding Claim 5, Modified Keller discloses the valve assembly of claim 1, wherein the body (Fig. 1, 5-8; 36; Williams) is configured to guide the fluid through the channel (Fig. Fig. 5-8; Williams) and into the enclosure via the inlet (Fig. 3A-3B; 24, 25: Keller) to agitate the agent within the enclosure (19; Keller) when in the first position (Examiner notes: this limitation is functional, the air is configured to be “guided” through the channel; Keller).
Regarding Claim 6, Modified Keller discloses the valve assembly of claim 5, wherein the body (Fig. 1, 5-8; 36; Williams) is configured to guide a mixture of the fluid and the agent from the enclosure into the channel(Fig. 1, 5-8; 36, “T” within 68; Williams) via the inlet (Fig. 3A-3B; 24, 25; Keller), 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; Keller).
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);
Keller does not disclose specifically moving the channel to a second position that is misaligned with the inlets the outlet, and the enclosure, 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.
However, William teaches moving the channel (“T” within 68 in Figs. 5-8) to a second position that is misaligned with the inlet(s the outlet, and the enclosure, (Shown best in Fig. 7) 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. 7).
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 valve system in Keller to include the moving the channel to a second position that is misaligned with the inlets the outlet, and the enclosure, 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 as taught by William for the purpose of which can be moved into register with the valve ports to connect any combination of the conduits and to cut off supply of gas to the patient and at the same time prevents escape of the insufflated gases from the lungs (Col. 5 lines 3-24, 50-73).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Willeford, as applied to claim 1, in view of Goodman et al. (US 10507293 B2) hereafter as Goodman.
Regarding Claim 7, Modified Willeford discloses the valve assembly of claim 1,
Modified Willeford 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 Willeford 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 Anderson et al. (US 20140124087 A1) in view of William.
Regarding Claim 16, Anderson discloses a device for delivering an agent, comprising: an enclosure (Fig. 2B; 70) configured to store the agent (Fig. 2B; 86; Examiner notes: this limitations is functional the holds the fluids being delivered), the enclosure having an inlet (Fig. 2B; 120); a pressurized fluid source configured to store a pressurized fluid (para. 0039); a valve assembly (Fig. 2B; 18), including a body (108) having a channel (Fig. 2B; 60), wherein the body is configured to move between a first position and a second position (shown in 2B-2C) to selectively fluidly couple the pressurized fluid source (30) to the enclosure (70) via the channel (120, 130);
Anderson does not disclose wherein, in the first position, the valve assembly is configured to misalign the channel from the enclosure 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 enclosure to permit the pressurized fluid from moving through the channel and delivering the agent out of the device.
However, William teaches valve assembly (Fig. 1, 5-8; 36) wherein, is configured to misalign the channel (“T” within 68 in Figs. 5-8) from the enclosure (38) to inhibit the pressurized fluid from moving through the channel and delivering the agent out of the device (This limitation is functional); wherein, in the second position, the valve assembly is configured to align the channel with the enclosure to permit the pressurized fluid from moving through the channel and delivering the agent out of the device (Fig. 5-8; Col. 4 lines 1-38, Col. 5 lines 3-24).
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 valve system in Anderson to include the wherein, in the first position, the valve assembly is configured to misalign the channel from the enclosure 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 enclosure to permit the pressurized fluid from moving through the channel and delivering the agent out of the device as taught by William for the purpose of which can be moved into register with the valve ports to connect any combination of the conduits (Col. 5 lines 3-24).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson and William, as applied to claim 16, in view of Goodman.
Regarding Claim 17, Modified Anderson discloses the device of claim 16,
Modified Anderson 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 Anderson 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
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 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
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