DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 22, 2026 has been entered.
Response to Arguments
Applicant's arguments filed March 5, 2026 have been fully considered but they are not persuasive. Regarding Applicant’s arguments that Pic fails to teach claim 21 as amended, the Examiner respectfully disagrees. Pic teaches that gas is flown into the chamber continuously, but that the perforations may be selectively aligned to allow the mixture to flow out of the medical device and out to the endoscope (a number of embodiments describe continuous flow; see also ¶ [0080] which describes a baseline flow of mixed powder through the device continuously which may be selectively increased via changing the alignment of the perforations). Furthermore, the limitation setting forth the pressurized fluid source as being configured to continuously deliver a pressurized fluid is a function recitation of intended use. The prior art device need only be capable of continuously flowing gas into the device. It is also noted that some mixing of the agent and the gas will occur within the outlet catheter before it gets to the endoscope as the gas and agent are still flowing in the catheter lumen after mixing in the chamber. For these reasons, the rejection is considered to meet the claim limitations as currently amended and as maintained below.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 21 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,918,780 in view of Pic et al. (US 2019/0232030). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent discloses a medical system, comprising: an medical device including a shaft (e.g., forming lumen; Col. 10, line16); a pressurized fluid source in fluid communication with the device (Col. 10, line 16), the pressurized fluid source is configured to continuously deliver a pressurized fluid towards the medical device (through the lumen; the fluid source is considered fully capable of continuously flowing the pressurized fluid source toward the endoscope); and a second medical device in fluid communication with the medical device (body of enclosure, Col. 10, line 15), the medical device including an enclosure storing an agent (Col. 10, line 15) and a barrier having a passage extending therethrough (Col. 10, lines 17-19), the barrier is configured to selectively deliver the agent out of the enclosure out of the medical device and towards the medical device (Col. 10, lines 17-19); the patent fails to explicitly disclose an endoscope as the device and wherein the medical system is configured such that the pressurized fluid from the pressurized fluid source and the agent from the medical device are mixed with one another outside of the medical device prior to entering the endoscope, and the medical device is configured to receive and deliver a mixture of the pressurized fluid and the agent through the shaft.
Pic et al. (henceforth Pic) teaches an endoscope (¶ [0021]) device comprising an enclosure (16) and barrier (shaft 92 comprises closed portions for retaining the agent in the enclosure; ¶¶ [0048]-[0049]) for providing an agent into a pressurized fluid source (from gas line 116 in Figure 10) for delivery through the endoscope during a procedure, and wherein the agent is mixed before being delivered (¶¶ [0020] and [0026]). Pic further teaches (¶ [0080]) that the pressurized fluid source is continuously flowed into the chamber and can be selectively increased which teaches the continuous flow explicitly even if it’s a functional limitation. Finally, Pic further teaches that at least a portion of the pressurized fluid from the pressurized fluid source and the agent from the medical device are mixed outside of the medical device prior to entering the endoscope (at least some of the pressurized fluid and agent will continue mixing in the outlet catheter leading to the endoscope which is downstream of the medical device as claimed).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of the patent to utilize an endoscope as the medical device and to mix the agent before administration as taught by Pic so as to allow for utilizing the agent and pressurized gas for mixing before being delivered during an endoscope procedure as taught by Pic.
Regarding claim 22, Pic further teaches a tube (e.g., catheter 18) connected to a port of the endoscope and extending through a working channel of the shaft via the port (¶ [0021] discloses the catheter shaft as extending through a channel in the endoscope; the proximal receiving opening on the endoscope for receiving the catheter of Pic is considered a port).
Regarding claim 23, the patent fails to explicitly teach the source as coupled to the endoscope. However, Pic further teaches wherein the pressurized fluid source and the medical device are fluidly coupled to the endoscope via the tube (¶ [0021]; the shaft of 18 extends through a port and passage in the endoscope to locate it adjacent the treatment site).
Regarding claim 24, the patent further teaches wherein the barrier is configured to move (rotate) relative to the enclosure to selectively release the agent from the enclosure (claim 5, Col. 10, lines 39-40).
Regarding claim 25, the subject matter of rotating the barrier relative to the enclosure is known from claim 1 of the patent (Col. 10, lines 17-23 disclose the passage for receiving the agent before passing through the lumen).
Regarding claim 26, the subject matter is known from claim 1 of the patent (Col. 10, lines 17-23). However, the patent fails to explicitly disclose rotating the barrier about a longitudinal axis of the enclosure. Pic teaches (in the embodiment of Figure 19A; which is equally applicable to the device of claims 21-25), a barrier member (body of passage 232) rotatable about the longitudinal axis of the enclosure (190; Figure 19A; ¶ [0076]) for establishing fluid communication between a cavity of the enclosure and a lumen of the tube (182) via the passage (¶¶ [0076]-[0080]). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the patent device to utilize the dispensing chamber configuration of Pic to provide a means of selectively providing powdered agent to an endoscope device during a procedure as taught by Pic.
Regarding claim 27, the subject matter is known from claim 1 of the patent (Col. 10, lines 17-27).
Regarding claim 28, the subject matter is known from claim 7 of the patent (Col. 10, lines 44-45).
Regarding claims 29 and 30, Pic further teaches wherein the pressurized fluid source (or medical device as per claim 30) is selectively actuated to initiate delivery of the pressurized fluid to the endoscope independent of the agent from the medical device (e.g., ¶ [0026] discloses the pressurized fluid and agent being released separately).
Regarding claim 31, the subject matter is known from claim 1 of the patent (Col. 10, line 16; the medical device comprises a pressurized gas source which will be from a canister or tank as claimed).
Regarding claim 32, the patent discloses wherein the barrier includes a plurality of openings positioned between the enclosure and the tube, the plurality of Openings are each configured to transfer the agent stored in the enclosure to the tube in response to the barrier moving relative to the enclosure (Col. 10, lines 17-27 disclose a plurality of openings for allowing the agent to move into the passage).
Regarding claim 33, the patent discloses a medical system, comprising: a medical device including a shaft (Col. 10, lines 14-27); a pressurized fluid source positioned external to and in fluid communication with the medical device (Col. 10, line 16). The patent fails to explicitly disclose an endoscope as the device and wherein the medical system is configured such that the pressurized fluid from an external source, is selectively actuated to continuously release an agent via a passage extending through a barrier of the medical device (Col. 10, lines 17-19; the pressurized fluid source is fully capable of continuously delivering a fluid as claimed); and the agent from the medical device are mixed with one another prior to entering the medical device, and the medical device is configured to receive and deliver a mixture of the pressurized fluid and the agent through the shaft.
Pic et al. (henceforth Pic) teaches a device for use with an endoscope (¶ [0021]) device comprising an enclosure (16), external to an endoscope (the shaft of the device of Pic is fed through the endoscope), and barrier (shaft 92 comprises closed portions for retaining the agent in the enclosure; ¶¶ [0048]-[0049]) for providing an agent into a pressurized fluid source (from gas line 116 in Figure 10) for delivery through the endoscope during a procedure, and wherein the agent is mixed before being delivered (¶¶ [0020] and [0026]; see also ¶ [0080] which discloses the continuous flow of pressurized fluid through the device and the selective increased flow as desired). Pic further teaches wherein the pressurized fluid source (or medical device as per claim 30) is selectively actuated to continuously deliver the pressurized fluid to the endoscope independent of the agent from the medical device (e.g., ¶ [0080] discloses the pressurized fluid and agent being released continuously at a base rate as claimed); and wherein the pressurized fluid and agent mix outside of the medical device prior to entering the endoscope (some amount of pressurized fluid and agent will mix in the outlet catheter downstream of the medical device before entering the endoscope as claimed).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of the patent to utilize an endoscope as the medical device and to mix the agent before administration as taught by Pic so as to allow for utilizing the agent and pressurized gas for mixing before being delivered during an endoscope procedure as taught by Pic.
Regarding claim 34, Pic further teaches a tube (e.g., catheter 18) connected to a port of the endoscope and extending through a working channel of the shaft via the port (¶ [0021] discloses the catheter shaft as extending through a channel in the endoscope; the proximal receiving opening on the endoscope for receiving the catheter of Pic is considered a port).
Regarding claim 35, the subject matter is known from claim 1 of the patent (Col. 10, lines 15-23).
Regarding claim 36, the subject matter is known from claim 5 of the patent.
Regarding claim 37, the subject matter is known from claim 5 of the patent (Col. 10, lines 15-27 and 39-40).
Regarding claim 38, the patent (claim 10) teaches method of administering an agent via a medical system that includes a pressurized fluid source, and a medical device, the method comprising: coupling the pressurized fluid source with a tube (Col. 10, line 67); separate from the step of coupling the pressurized fluid source with the tube, coupling the medical device with the tube(Col. 11, lines 1-4; the lumen being the tube); coupling the tube with the medical device to establish fluid communication between (1) the pressurized fluid source and the medical device, with (2) the medical device, via the tube: actuating the pressurized fluid source to deliver a pressurized fluid through the tube (Col. 10, line 67, the step of providing the gas is considered actuation): separate from the step of actuating the pressurized fluid source, actuating the medical device to deliver an agent through a barrier member that includes a passage extending therethrough towards the tube (Col. 10, lines 17-19; Col. 11, lines 1-4), wherein the medical system is configured such that the pressurized fluid from the pressurized fluid source and the agent from the medical device are mixed with one another within the tube prior to entering the endoscope; and receiving a mixture of the pressurized fluid and the agent at the medical device and delivering the mixture through a shaft of the endoscope (claim 10 sets forth the step of providing the pressurized fluid along with the step of rotating the barrier member to provide the agent into the lumen comprising the pressurized fluid; it will be mixed after such steps before exiting the lumen). The patent fails to explicitly teach the medical device as used with an endoscope, the continuous flow of pressurized fluid, and the mixing of the agent and pressurized fluid outside of the medical device.
Pic et al. (henceforth Pic) teaches a device for use with an endoscope (¶ [0021]) device comprising an enclosure (16), external to an endoscope (the shaft of the device of Pic is fed through the endoscope), and barrier (shaft 92 comprises closed portions for retaining the agent in the enclosure; ¶¶ [0048]-[0049]) for providing an agent into a continuously flowing pressurized fluid source (from gas line 116 in Figure 10; see ¶ [0080] which discloses that the pressurized fluid is continuously flowed into the medical device to provide a baseline mixed agent delivery as claimed) for delivery through the endoscope during a procedure, and wherein the agent is mixed before being delivered (¶¶ [0020] and [0026]). Pic further teaches wherein the pressurized fluid source (or medical device as per claim 30) is selectively actuated to initiate delivery of the pressurized fluid to the endoscope independent of the agent from the medical device (e.g., ¶ [0026] discloses the pressurized fluid and agent being released separately); and wherein the agent and pressurized fluid are mixed outside of the medical device prior to entering the endoscope (some mixing of the agent and pressurized fluid will occur in the catheter outside the device while moving toward the endoscope).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of the patent to utilize an endoscope as the medical device and to mix the agent before administration as taught by Pic so as to allow for utilizing the agent and pressurized gas for mixing before being delivered during an endoscope procedure as taught by Pic.
Regarding claim 39, the subject matter is known from claim 10 of the patent (Col. 11, lines 1-4).
Regarding claim 40, Pic further teaches a tube (e.g., catheter 18) connected to a port of the endoscope and extending through a working channel of the shaft via the port (¶ [0021] discloses the catheter shaft as extending through a channel in the endoscope to the treatment site).
Claim Rejections - 35 USC § 102
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.
Claim(s) 21-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pic (US 2019/0232030).
Regarding claim 21, Pic discloses (Figures 19A-19B) a medical system, comprising: an endoscope including a shaft (¶ [0021]; the device is used to deliver an agent through an endoscope during use); a pressurized fluid source in fluid communication with the endoscope (the catheter 18 of the device of Pic is intended to extend within a channel in the endoscope to deliver the pressurized agent to the target site), the pressurized fluid source is configured to continuously deliver a pressurized fluid towards the endoscope (see ¶ [0080] which discloses a constant flow of pressurized fluid through the device which can be selectively increased if desired; also, the limitation is functional and the device if Pic is fully capable of continuously flowing gas); and a medical device (170) in fluid communication with the endoscope, the medical device including an enclosure (190) storing an agent (54) and a barrier (rotatable passage 232) configured to selectively deliver the agent out of the enclosure and towards the endoscope (¶ [0074]); wherein the medical system is configured such that the pressurized fluid is continuously received from the pressurized fluid source (¶ [0080]) separate from the medical device (the pressurized fluid source is upstream of the medical device and generates the pressurized fluid separately) and at least a portion of the pressurized fluid from the pressurized fluid source and the agent from the medical device are mixed with one another outside of the medical device prior to entering the endoscope (some mixing of the pressurized fluid and agent will occur in the catheter downstream from the medical device before entering the endoscope as claimed), and the endoscope is configured to receive and deliver a mixture of the pressurized fluid and the agent through the shaft (¶ [0066] discloses the mixing chamber and movement of the agent into the passage for engaging with the pressurized fluid; ¶ [0074] discloses that the embodiment of Figures 19A-19B is used with the same features of the embodiment of Figure 15 disclosed to use pressurized fluid in ¶ [0066]).
Regarding claim 22, Pic further discloses a tube (182 through 180 into catheter 18) that is coupled to a port of the endoscope and extends through a working channel of the shaft via the port (¶ [0021] discloses the catheter 18 as extending through the endoscope to the target site; ¶ [0080]).
Regarding claim 23, Pic further discloses wherein the pressurized fluid source and the medical device are fluidly coupled to the endoscope via the tube (¶ [0021]; all embodiments of the enclosure and barrier are applicable to the same end use of delivering a powdered agent through the catheter in the endoscope).
Regarding claim 24, Pic further discloses wherein the barrier (shaft of 232) is configured to move relative to the enclosure to selectively release the agent from the enclosure (¶ [0076] discloses that the passage and outer sleeve 240 may rotate relative to one another via actuator 248 to align openings 236/244 with each other to allow passage of agent 54 through the channel of barrier member 232 and out tubing 182).
Regarding claim 25, Pic further discloses wherein the barrier (shaft of 232) includes a passage (the inside of 232 is disclosed as a passage for agent 54 to pass therethrough; ¶ [0076]) that is positioned between the enclosure (190) and the tube (182).
Regarding claim 26, Pic further discloses wherein rotation of the barrier relative to the enclosure and the tube established fluid communication between a cavity of the enclosure (190) and a lumen of the tube via the passage (channel of 232; ¶¶ [0078] and [0080] disclose powder passing through barrier member 232 from enclosure 190 and out through tubing 182 to port 180).
Regarding claim 27, Pic further discloses wherein the barrier (232) is configured to align the passage (inside of 232) with each of the enclosure (190) and the tube (182) to selectively deliver the agent (54) from the cavity to the lumen in response to rotating the passage (rotation of barrier 232 aligns holes 236 and 244 to allow passage of the agent from the enclosure through the barrier member and out the tube 182; ¶¶ [0077]-[0080]).
Regarding claim 28, Pic further discloses wherein the enclosure (190) is configured to feed the agent into the passage (182) via gravity (¶ [0079], the openings allow the powder to pass into the channel of 232, and as it sits above the channel 182, it will fall down into said channel), and the passage is configured to feed the agent into the lumen (¶ [0079]) via gravity (the agent falls into the passage before mixing with the pressurized mixing fluid; gravity will provide some downward force on the powder even if the pressurized fluid is forced into the enclosure to move the agent through the openings).
Regarding claim 29, Pic further discloses wherein the pressurized fluid source (116) is selectively actuated to initiate delivery of the pressurized fluid to the endoscope independent of the agent from the medical device (¶ [0051] discloses that dosed agent may enter mixing chamber to mix with the pressurized fluid before exiting the mixing chamber; therefore, the gas and the agent are considered to be selectively released for mixing; this is applicable to all embodiments).
Regarding claim 30, Pic further discloses wherein the medical device is selectively actuated to initiate delivery of the agent to the endoscope independent of the pressurized fluid from the pressurized fluid source (the device of Figure 19A provides openings which, when aligned, allow movement of a powdered agent from the enclosure into the channel of member 232; this can happen even without pressurized fluid being forced through passage 176 since the openings are in a vertical tube and can therefore enter the channel if the openings are aligned even in the absence of pressurized fluid).
Regarding claim 31, Pic further discloses wherein the pressurized fluid source (116) includes a gas canister or tank positioned within a medical facility and adjacent to the endoscope and the medical device (¶ [0022] discloses the gas supply as a hospital wall access or canister as claimed).
Regarding claim 32, Pic further discloses wherein the barrier includes a plurality of openings (perforations or voids 236; ¶ [0074]) positioned between the enclosure and the tube (Figure 19A; they’re formed in the barrier and form an opening for fluidly connecting the barrier 190 to tube 182), the plurality of openings are each configured to transfer the agent stored in the enclosure to the tube in response to the barrier moving relative to the enclosure (¶ [0077] discloses aligning the openings to transfer the agent into the tube).
Regarding claim 33, Pic discloses (Figures 19A-19B) a medical system, comprising: an endoscope including a shaft (¶ [0021] discloses that the device is used with an endoscope); a pressurized fluid source (116) positioned external to and in fluid communication with the endoscope (depicted in Figure 10; ¶ [0021]), the pressurized fluid source is selectively actuated to release a pressurized fluid continuously towards the endoscope upon actuation (¶ [0051] discloses that dosed agent may enter mixing chamber 94 to mix with the pressurized fluid before exiting the mixing chamber; this feature is used with all embodiments and would enter through pressurized fluid tube 176; therefore, the gas and the agent are considered to be selectively released for mixing; see also ¶ [0080] which discloses the continuous flowing of pressurized fluid into the agent chamber which can be selectively increased); and a medical device (114) positioned external to and in fluid communication with the endoscope, the medical device is selectively actuated to release an agent via a passage extending through a barrier of the medical device (agent 54 is passed through openings 236 in barrier 232 and into the shaft of 232 before passing into tube 182; ¶¶ [0077]-[0079] discloses that the barrier 232 is rotated to selectively release agent into tube 182): wherein each of the pressurized fluid source and the medical device are selectively actuated independent of one another (¶ [0076] discloses that dosed agent may enter the channel of barrier 232 via rotation of actuator 248 which aligns the openings 236, 244); wherein the pressurized fluid is continuously received from the pressurized fluid source at the endoscope separately from the medical device (¶ [0080]) at the endoscope separately from the medical device (this is broad enough to only require the pressurized fluid to arrive at the endoscope separately from the medical device, which it does, since the medical device with the agent chamber is upstream from the endoscope; the claim does not require the pressurized fluid line to have a direct fluid connection to the endoscope without the gas passing through the medical device as depicted in instant application Figure 4A), at least a portion of the pressurized fluid is configured to mix with the agent released from the medical device outside of the medical device prior to entering the endoscope (e.g., in the catheter before reaching the endoscope, some mixing of the gas and agent will still be happening within the catheter lumen), and a continuous flow of the pressurized fluid from the pressurized fluid source is configured to urge a mixture of the pressurized fluid and the agent into the endoscope and through the shaft (¶ [0066] discloses the passage 176 (present in the embodiment of Figure 19A) for passing pressurized fluid into the enclosure for moving through the barrier member 232; see also ¶ [0080]).
Regarding claim 34, Pic further discloses a tube (catheter 18) that is coupled to a port of the endoscope and extends through a working channel of the shaft via the port (¶ [0021] discloses the catheter 18 as extending through the endoscope to the target site); wherein the pressurized fluid source and the medical device are fluidly coupled to the endoscope via the tube (¶ [0021]).
Regarding claim 35, Pic further discloses an enclosure (190) configured to store the agent (54) and a barrier (232) configured to release the agent from the enclosure in response to the barrier rotating relative to the enclosure (¶¶ [0076]-[0077]).
Regarding claim 36, Pic further discloses wherein the barrier (232) is configured to release the agent towards the endoscope in response to the barrier rotating relative to the enclosure (¶¶ [0077]-[0079]).
Regarding claim 37, Pic further discloses wherein the barrier (232) includes one or more openings (236) defining a passage that is positioned between the enclosure and the tube (¶ [0079]), the one or more openings are configured to transfer the agent stored in the enclosure to the tube in response to the barrier rotating relative to the enclosure (¶ [0077]).
Regarding claim 38, Pic discloses (Figures 19A-19B) a method of administering an agent via a medical system that includes an endoscope (¶ [0021] discloses the device passing through a shaft of an endoscope), a pressurized fluid source (116), and a medical device (114), the method comprising: coupling the pressurized fluid source with a tube (the source is coupled via 116 to gas line 118); separate from the step of coupling the pressurized fluid source with the tube, coupling the medical device with the tube (Figure 10); coupling the tube with the endoscope to establish fluid communication between (1) the pressurized fluid source and the medical device (Figure 10; ¶¶ [0021] and [0050]; the tube 182 is coupled to catheter 18 of the endoscope which passes through a channel in the endoscope which is analogous to instant Figure 1A of the application), with (2) the endoscope, via the tube: actuating the pressurized fluid source to continuously deliver a pressurized fluid through the tube (¶¶ [0049]-[0051]; ¶ [0080] discloses a constant flow of pressurized fluid through the medical device which can be selectively increased to deliver more agent through the endoscope as claimed): separate from the step of actuating the pressurized fluid source, actuating the medical device to deliver an agent through a barrier (232) that includes a passage (inside 232) extending therethrough towards the tube (54; the agent is release separately from the gas source via rotation of actuator 248; ¶ [0080] discloses that the pressurized fluid may allow some of the powder to exit the openings in 232 and that 248 can be actuated to allow additional agent flow if desired; it therefore performs this function separate from the gas initialization), wherein the medical system is configured such that the pressurized fluid is continuously received from the pressurized fluid source (¶ [0080]) away from the medical device (the pressurized fluid source is upstream of the agent chamber and is therefore separate), wherein at least a portion of the pressurized fluid and the agent released from the medical device are mixed with one another within the tube and outside of the medical device prior to entering the endoscope (they’re mixed in chamber 190 before exiting the device to the endoscope as per ¶¶ [0051] and [0080]; also, there will be some mixing of the pressurized fluid and the agent in the outlet catheter lumen which leads to the endoscope as the mixture flows downstream toward the endoscope); and receiving a mixture of the pressurized fluid and the agent at the endoscope and delivering the mixture through a shaft of the endoscope (¶¶ [0049]-[0051] disclose separate release of the agent into the mixing chamber for mixing with the pressurized gas before exiting the medical device into the endoscope shaft via tube 182 and port 180 which lead into the catheter passing through the endoscope).
Regarding claim 39, Pic further discloses wherein actuating the medical device to deliver the agent through the tube comprises: rotating a barrier (232; ¶ [0077]) of the medical device to selectively align a passage (inside of 232) of the barrier with each of an enclosure of the medical device that stores the agent and a lumen of the tube that receives the agent (54) from the enclosure via the passage (¶ [0077]-[0079]; the barrier is rotated to align the holes with those in shaft 240 to allow the agent from the enclosure to exit through the channel of the barrier member and into tube 182).
Regarding claim 40, Pic further discloses wherein coupling the tube with the endoscope comprises: extending the tube into a port of the endoscope (¶ [0021] discloses extending the catheter 18 through a shaft of the endoscope to the target site) and through a shaft of the endoscope that terminates at a target treatment site, such that the mixture of the pressurized fluid and the agent are delivered through the shaft and to the target treatment site (¶¶ [0021] and [0049]-[0051] teach the means of mixing the agent with the pressurized fluid source and expelling it from the device to catheter 18 which has an exit at the treatment site as claimed; this function is equally applicable to the embodiment of Figure 19A).
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 JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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