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
This office action is responsive to the amendment filed on 07/15/2026. As directed by the amendment: claims 11 and 19-21 have been amended, claims 1-10 have been cancelled and claims 23-26 have been added. Thus, claims 11-26 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pages 6-9, filed 07/15/2026, with respect to the rejection(s) of claim(s) 11 under 35 U.S.C. 103 as being unpatentable over Mantri in view of Molnar and Ciulla as applied to claim 11 above, and further in view of Yurek (US 11116530 B2), herein referenced to as “Yurek” have been fully considered and are persuasive.
The applicant has amended claim 11 to further recite “with an outlet positioned within the aspiration lumen”. The applicant argues that the combination of Mantri, Molnar, and Ciulla does not explicitly teach the amended claim language.
The examiner agrees, that Mantri, Molnar, and Ciulla does not teach the outlet of the supply lumen is positioned within the aspiration lumen.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Mantri, Molnar, Ciulla, and Yurek.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 15 recites “wherein the supply lumen is positioned at least partially in the aspiration lumen”. Claim 11, which claim 15 is dependent on now recites “the supply lumen comprising a first portion and a second portion with an outlet positioned within the aspiration lumen”, hence already limiting claim 11 to have at least part (the second portion with an outlet) positioned in the aspiration lumen. As such claim 15 fails to further limit from claim 11.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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) 11-20, 23, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mantri (US 20200360100 A1), herein referenced to as “Mantri” in view of Molnar (US 20160262603 A1), herein referenced to as “Molnar”, Ciulla et al (US 20160166320 A1), herein referenced to as “Ciulla”, and Yurek (US 11116530 B2), herein referenced to as “Yurek”.
Claim 11
Mantri discloses: A system 2600 (see Figs. 26-27, [0240]) for use in a removal procedure of a biological object (see [0010], tissue resection) from an anatomical structure, the system 2600 comprising: an access sheath 2620 (see Figs. 26-27, [0240]) comprising an irrigation lumen 2622 (see Fig. 27, [0241]), the access sheath 2620 being configured to be inserted into the anatomical structure (see [0245] and [0241], sheath is sized and shaped for insertion into the patient) and to transport a first liquid saline (see [0241], irrigation fluid such as saline) from a first liquid source a source of irrigation fluid (see [0241]) to the anatomical structure through the irrigation lumen 2622 (see [0241]); an endoscope 2650 (see Fig. 27, [0241]) configured to be inserted into the anatomical structure (see [0241], treatment site) the access sheath 2620 (see Fig. 27).
Mantri does not explicitly disclose: and a seal positioned at a proximal end of the irrigation lumen; the endoscope through the seal of the access sheath; the endoscope comprising a working channel extending between a proximal end of the endoscope and a distal end of the endoscope; an aspiration lumen positioned at least partially through the working channel the aspiration lumen being in fluid communication with one or more openings configured to receive the biological object, and the aspiration lumen being configured to aspirate and transport at least the biological object from the one or more openings toward a proximal end of the aspiration lumen; and a supply lumen configured to transport a second liquid from a second liquid source to the distal end of the working channel, the supply lumen comprising a first portion and a second portion configured to eject the second liquid outside the supply lumen, the second portion being positioned at the distal end of the working channel and configured to redirect the second liquid at least partially toward the proximal end of the working channel, wherein ejecting the second liquid from an outlet of the supply lumen creates a vacuum to attract the biological object toward the one or more openings.
However, Molnar in a similar field of invention teaches a medical system 10 (see Figs. 4A-5B) for use of visualizing an anatomical structure (see Figs. 4A-5B) with an access sheath 12 (see Figs. 4A-5B) with a lumen the lumen of 12 (see Figs. 4A-5B) and an endoscope 18 + 20 (see Figs. 4A-5B). Molnar further teaches: and a seal 68 + 76 (see Figs. 4A-5B, [0100], 68 + 76 is a seal as it keeps 10 sterile) positioned at a proximal end the proximal end of 12 at 68 + 76 of the lumen the lumen of 12; the endoscope 20 + 18 through the seal (see Figs. 4A-5B, 20 + 18 extends through 68 + 76) of the access sheath 12.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the irrigation lumen of the access sheath of Mantri to incorporate the teachings of Molnar and teach a system for use in a removal procedure of a biological object from an anatomical structure with a seal positioned at a proximal end of the irrigation lumen; the endoscope through the seal of the access sheath. Motivation for such can be found in Molnar as this ensures sterility of the rest of the device outside of the lumen and free of contamination (see [0100]).
The combination of Mantri and Molnar does not explicitly teach: the endoscope comprising a working channel extending between a proximal end of the endoscope and a distal end of the endoscope; an aspiration lumen positioned at least partially through the working channel the aspiration lumen being in fluid communication with one or more openings configured to receive the biological object, and the aspiration lumen being configured to aspirate and transport at least the biological object from the one or more openings toward a proximal end of the aspiration lumen; and a supply lumen configured to transport a second liquid from a second liquid source to the distal end of the aspiration lumen, the supply lumen comprising a first portion and a second portion positioned within the aspiration lumen, the outlet configured to eject the second liquid outside the supply lumen into the aspiration lumen, the second portion being positioned at the distal end of the working channel and configured to redirect the second liquid at least partially toward the proximal end of the working channel, wherein ejecting the second liquid from an outlet of the supply lumen creates a vacuum to attract the biological object toward the one or more openings.
However, Ciulla in a similar field of invention teaches a system 100 (see Figs. 1-3) for use in a removal procedure of a biological object (see [0002]-[0003], removal of urinary calculi) from an anatomical structure (see [0002]-[0003], kidney) with an endoscope 102 (see Figs. 1-3). Ciulla further teaches: the endoscope 102 comprising a working channel 112 + 114 (see Figs. 1-3, [0020]) extending between a proximal end 106 (see Fig. 1, [0020]) of the endoscope 102 and a distal end 104 (see Figs. 1-3, [0020]) of the endoscope 102; an aspiration lumen 114 (see Figs. 1-3, [0020], suction) positioned at least partially through the working channel 112 + 114 (see Fig. 2) the aspiration lumen 114 being in fluid communication (see Fig. 2, [0033]) with one or more openings 128 (see Fig. 2, [0030] and [0033]) configured to receive the biological object stone fragments (see [0033]), and the aspiration lumen 114 being configured to aspirate (see [0033]) and transport at least the biological object from the one or more openings 128 toward a proximal end the proximal end of 114 connected to a 150 (see Fig. 1, [0035]) of the aspiration lumen 114; and a supply lumen 112 (see Figs. 1-3, [0022]) configured to transport a second liquid irrigation fluid (see [0020]) from a second liquid source 140 (see Fig. 1, [0020]-[0021]) to the distal end 104 of the working channel 112 + 114, the supply lumen 112 comprising a first portion proximal portion of 112 (see Figs. 1-2) and a second portion distal portion of 112 adjacent to 122 (see Fig. 2) configured to eject the second liquid irrigation fluid outside the supply lumen 112, the second portion distal portion of 112 adjacent to 122 being positioned at the distal end the distal end of 112 + 114 (see Fig. 2) of the working channel 112 + 114 and configured to redirect the second liquid irrigation fluid (see [0033], pushing the fluid to direct stones to enter into 128, which then enters into 114 to the proximal end attached to 150) at least partially toward the proximal end the proximal end of 112 + 114 attached to 140 and 150 (see Figs. 1-2, [0020]) of the working channel 112 + 114, wherein ejecting the second liquid irrigation fluid from an outlet 122 (see Fig. 2, [0033]) of the supply lumen creates a vacuum (see [0033], assist in pushing stone fragments/dust toward the vacuum) to attract the biological object toward the one or more openings 128.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mantri to incorporate the teachings of Ciulla and teach a system for use in a removal procedure of a biological object from an anatomical structure with the endoscope comprising a working channel extending between a proximal end of the endoscope and a distal end of the endoscope; an aspiration lumen positioned at least partially through the working channel the aspiration lumen being in fluid communication with one or more openings configured to receive the biological object, and the aspiration lumen being configured to aspirate and transport at least the biological object from the one or more openings toward a proximal end of the aspiration lumen; and a supply lumen configured to transport a second liquid from a second liquid source to the distal end of the working channel, the supply lumen comprising a first portion and a second portion configured to eject the second liquid outside the supply lumen, the second portion being positioned at the distal end of the working channel and configured to redirect the second liquid at least partially toward the proximal end of the working channel, wherein ejecting the second liquid from an outlet of the supply lumen creates a vacuum to attract the biological object toward the one or more openings. Motivation for such can be found in Ciulla as this allows for suction of stone fragments and assistance of an additional irrigation fluid source to push stone fragments/dust towards the vacuum (see [0033]).
The combination of Mantri, Molnar, and Ciulla does not explicitly disclose: the supply lumen configured to transport to a distal end of the aspiration lumen, an outlet positioned within the aspiration lumen, the outlet configured to eject the second liquid outside the supply lumen into the aspiration lumen, and configured to redirect the second liquid at least partially toward the proximal end of the aspiration lumen.
However, Yurek in a similar field of invention teaches system (see Fig. 13S) for use in a removal procedure of a biological object (col. 7, lines 27-44, kidney stones) from an anatomical structure with an endoscope 102 (see Fig. 13S) with a supply lumen 134 (see Fig. 13S) with a second portion 136 + 150 (see Fig. 13S, col. 33, lines 25-34) with a second liquid irrigation stream (see col. 33, lines 32-34) and an aspiration lumen 114 (see Fig. 13S). Yurek further teaches: the supply lumen 134 configured to transport to a distal end the distal end of 114 (see Fig. 13S) of the aspiration lumen 114, an outlet the outlet of 134 that leads into 114 (see Fig. 13S) positioned within the aspiration lumen 114, the outlet the outlet of 134 that leads into 114 configured to eject the second liquid irrigation stream (see col. 33, lines 32-34) outside the supply lumen 134 into the aspiration lumen 114 (see Fig. 13S, col. 33, lines 25-34), and configured to redirect the second liquid at least partially toward the proximal end of the aspiration lumen.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined endoscope of Mantri and Ciulla to incorporate the teachings of Yurek and teach a system for use in a removal procedure of a biological object from an anatomical structure with the supply lumen configured to transport to a distal end of the aspiration lumen, an outlet positioned within the aspiration lumen, the outlet configured to eject the second liquid outside the supply lumen into the aspiration lumen. Motivation for such can be found in Yurek as this allows the alternation of the shape and/or direction of the irrigation stream (see col. 33, lines 25-34) which can produce a vortex effect which can better aspirate kidney stones (see col. 4, lines 41-64).
The language, " configured to redirect the second liquid at least partially toward the proximal end of the aspiration lumen," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Mantri, Ciulla, and Yurek meets the structural limitations of the claim, and is capable of ejecting the second liquid such that it is aspirated by the suction of the aspiration lumen toward the proximal end of the aspiration lumen, as the sloping of the nozzle redirects the fluid from travelling parallel with the aspiration lumen to intersecting into the line of suction, thus causing the fluid to be aspirated and to travel towards the proximal end of the aspiration lumen.
Claim 12
The combination of Mantri, Molnar, Ciulla, and Yurek teaches: The system of claim 11, see 103 rejection above. The combination of Mantri, Molnar, and Ciulla does not explicitly teach: wherein the second portion is configured to eject the second liquid along a helical path within the aspiration lumen.
However, Yurek in a similar field of invention teaches system (see Fig. 13S) for use in a removal procedure of a biological object (col. 7, lines 27-44, kidney stones) from an anatomical structure with an endoscope 102 (see Fig. 13S) with a supply lumen 134 (see Fig. 13S) with a second portion 136 + 150 (see Fig. 13S, col. 33, lines 25-34) with a second liquid irrigation stream (see col. 33, lines 32-34) and an aspiration lumen 114 (see Fig. 13S). Yurek further teaches: wherein the second portion 136 + 150 is configured to eject the second liquid irrigation stream (see Fig. 13S, col 33, lines 25-34) within the aspiration lumen 114 (see Fig. 13S).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined endoscope of Mantri and Ciulla to incorporate the teachings of Yurek and teach a system for use in a removal procedure of a biological object from an anatomical structure with the second portion is configured to eject the second liquid within the aspiration lumen. Motivation for such can be found in Yurek as this allows the alternation of the shape and/or direction of the irrigation stream (see col. 33, lines 25-34) which can produce a vortex effect which can better aspirate kidney stones (see col. 4, lines 41-64).
The language, "configured to eject the second liquid along a helical path," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Mantri, Ciulla, and Yurek meets the structural limitations of the claim, and is capable of ejecting the second liquid a helical path, as firstly, Yurek states that the structure the nozzle forms can alternate the shape and/or direction of the irrigation stream (see col. 33, lines 25-34) which can produce vortex effect which is a spiraling/helical flow pattern. Secondly, the narrowing of the second portion due to the nozzle of 150 causes a flow of higher velocity with lower pressure that when combined with flowing in the suction lumen creates a turbulent flow in the form of a vortex.
Claim 13
The combination of Mantri, Molnar, Ciulla, and Yurek teaches: The system of claim 11, see 103 rejection above. Ciulla further teaches: further comprising a plurality of vent port openings 122 (see Fig. 2, [0033], the outlet comprises a plurality of vent port openings) formed in the working channel 112 + 114 and fluidly connected (see [0033], by pushing liquid towards 128/114, 122 is fluidly connected to 114 via the vacuum) to the aspiration lumen 114.
Claim 14
The combination of Mantri, Molnar, Ciulla, and Yurek teaches: The system of claim 13, see 103 rejection above. Ciulla further teaches: wherein the plurality of vent port openings 122 is configured to resupply into the anatomical structure (see [0031], provide fluid to desired site, such as the kidney) at least some of the second liquid irrigation fluid ejected from the supply lumen 112.
Claim 15
The combination of Mantri, Molnar, Ciulla, and Yurek teaches: The system of claim 11, see 103 rejection above. Yurek further teaches: wherein the supply lumen 134 is positioned at least partially in the aspiration lumen 114 (see Fig. 13S, 134 is placed within 114).
Claim 16
The combination of Mantri, Molnar, Ciulla, and Yurek teaches: The system of claim 11, see 103 rejection above. Ciulla further teaches: wherein the aspiration lumen 114 is configured to receive an energy device 120 (see Fig. 2, [0020], [0022], and [0039]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mantri to incorporate the teachings of Ciulla and teach a system for use in a removal procedure of a biological object from an anatomical structure with the aspiration lumen is configured to receive an energy device. Motivation for such can be found in Ciulla as this allows particulates/stone fragments to be broken up as they are drawn into the aspiration lumen (see [0039]).
Claim 17
The combination of Mantri, Molnar, Ciulla, and Yurek teaches: The system of claim 11, see 103 rejection above. Ciulla further teaches: further comprising a flow regulator pressure sensor (see [0031], 114 is in fluid communication with 112, hence the pressure sensor in fluid communication with 112 is also in fluid communication with 112) configured to be in fluid communication with the proximal end the proximal end of 114 of the aspiration lumen 114.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mantri to incorporate the teachings of Ciulla and teach a system for use in a removal procedure of a biological object from an anatomical structure with a flow regulator configured to be in fluid communication with the proximal end of the aspiration lumen. Motivation for such can be found in Ciulla as this for a matched flow rate to prevent the kidney from collapsing due to no fluid in the system (see [0048]).
Claim 18
The combination of Mantri, Molnar, Ciulla, and Yurek teaches: The system of claim 11, see 103 rejection above. Ciulla further teaches: further comprising a flow controller pressure sensor + processor (see [0031], [0047], and [0048], 114 is in fluid communication with 112, hence the pressure sensor in fluid communication with 112 is also in fluid communication with 112) configured to regulate a fluid flow (see [0047]-[0048], sensing mechanism, to control flow rate, which regulates how much is also supplied to be vacuumed through the aspiration lumen 112) through the aspiration lumen 112.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mantri to incorporate the teachings of Ciulla and teach a system for use in a removal procedure of a biological object from an anatomical structure with a flow controller configured to regulate a fluid flow through the aspiration lumen. Motivation for such can be found in Ciulla as this for a matched flow rate to prevent the kidney from collapsing due to no fluid in the system (see [0048]).
Claim 19
The combination of Mantri, Molnar, Ciulla, and Yurek teaches: The system of claim 11, see 103 rejection above. Ciulla further teaches: further comprising at least one sensor pressure sensor/temperature sensor (see [0031], 114 is in fluid communication with 112, hence the pressure sensor in fluid communication with 112 is also in fluid communication with 112) configured to monitor one or more of a pressure a pressure sensor (see [0031]), a temperature a temperture sensor (see [0031]), or a flow rate (see [0047]-[0048], monitoring of flow rate/maintaining flow equilibrium).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mantri to incorporate the teachings of Ciulla and teach a system for use in a removal procedure of a biological object from an anatomical structure with at least one sensor configured to monitor one or more of a pressure, a temperature, and a flow rate. Motivation for such can be found in Ciulla as this for a matched flow rate to prevent the kidney from collapsing due to no fluid in the system (see [0048]).
Claim 20
The combination of Mantri, Molnar, Ciulla, and Yurek teaches: The system of claim 11, see 103 rejection above. Mantri further discloses: wherein the first liquid source saline is configured to be raised at a height relative to the irrigation lumen 2622 to provide an irrigation flow of the first liquid in the irrigation lumen 2622.
The language, " wherein the first liquid source is configured to be raised at a height relative to the irrigation lumen to provide an irrigation flow of the first liquid in the irrigation lumen," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Mantri meets the structural limitations of the claim, and is capable of providing an irrigation flow by filling the irrigation lumen with a height of fluid of the first liquid to allow flow out of the lumen as the source fills the lumen of the tube, allowing for irrigation.
Furthermore, wherein in product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01 I.
Claim 23
The combination of Mantri, Molnar, Ciulla, and Yurek teaches: The system of claim 11, see 103 rejection above. Yurek further teaches: wherein the second portion (see annotated Fig. 13S below) of the supply lumen 134 extends along an axis oriented at an angle relative to an axis orthogonal (see annotated Fig. 13S below) to a longitudinal axis (see annotated Fig. 13S below) of the aspiration lumen 114.
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Claim 26
The combination of Mantri, Molnar, Ciulla, and Yurek teaches: The system of claim 11, see 103 rejection above. Ciulla further teaches: wherein the plurality of vent port openings is configured to resupply (see [0039], maintain pressure equilibrium through introduction of fluid) at least a portion of the fluid aspirated from the anatomical structure into the anatomical structure (see [0031] and [0033], provide fluid to desired site, such as the kidney).
Yurek further teaches: wherein ejecting the second liquid from the outlet the outlet of 114 that leads into 114 of the supply lumen 134 (see col. 33, lines 25-34) creates the vacuum to attract fluid located within the anatomical structure toward the one or more openings (see col. 4, lines 41-64, produce a vortex effect which can better aspirate kidney stones).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mantri in view of Molnar, Ciulla, and Yurek as applied to claim 11 above, and further in view of Sun et al (US 12465424 B1), herein referenced to as “Sun”.
Claim 21
The combination of Mantri, Molnar, Ciulla, and Yurek teaches: The system of claim 11, see 103 rejection above. Ciulla further teaches: an ablation instrument 120 (see Fig. 2, [0020], [0022], and [0039]) positioned within the aspiration lumen 114.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mantri to incorporate the teachings of Ciulla and teach a system for use in a removal procedure of a biological object from an anatomical structure with an ablation instrument positioned within the aspiration lumen. Motivation for such can be found in Ciulla as this allows particulates/stone fragments to be broken up as they are drawn into the aspiration lumen (see [0039]).
The combination of Mantri, Molnar, Ciulla, and Yurek does not explicitly teach: further comprising a reciprocator comprising a body portion and a pinion gear, wherein rotation of the pinion gear axially moves a portion of the body portion, and wherein a movement of the reciprocator axially moves the ablation instrument positioned within the aspiration lumen.
However, Sun in a similar field of invention teaches a catheter protective sleeve (see Fig. 8, 802 within the protective sleeve, col. 11, lines 14-20) with an ablation instrument distal end of 802 (see Figs. 3, 8-9A, and 33-34 col. 1, lines 36-42). Sun further teaches: comprising a reciprocator 3302 (see Figs. 33-34, col. 27, lines 16-26) comprising a body portion 3404 which attaches to 3306 (see Figs. 33-34, col. 27, lines 29-39, 3306 is operable with the rest of the disclosure, including 3404 which connects to 802, col. 27, lines 48-59) and a pinion gear 3304 (see Figs. 33-34, col. 27, lines 29-39), wherein rotation of the pinion gear 3304 axially moves a portion 3404 (see Figs. 33-34, col. 27, lines 29-39 and lines 48-59, 3404 can be driven by rotation of 3304 to push 3306 which 3404 is connected to drive 802) of the body portion 3404 + 3306, and wherein a movement of the portion of the body portion 3404 axially moves the ablation instrument 802 (see col. 27, lines 29-39 and lines 48-59).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined endoscope and ablation instrument within the aspiration lumen of Mantri and Ciulla to incorporate the teachings of Sun and teach a system for use in a removal procedure of a biological object from an anatomical structure with a reciprocator comprising a body portion and a pinion gear, wherein rotation of the pinion gear axially moves a portion of the body portion, and wherein a movement of the reciprocator axially moves the ablation instrument positioned within the aspiration lumen. Motivation for such can be found in Sun as this allows pushing of the ablation instrument without permitting it to buckle (see col. 27, lines 48-59).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mantri in view of Molnar, Ciulla, and Yurek as applied to claim 11 above, and further in view of Altshuler et al (US 20230248434 A1), herein referenced to as “Altshuler”.
Claim 22
The combination of Mantri, Molnar, Ciulla, and Yurek teaches: The system of claim 11, see 103 rejection above. Ciulla further teaches: an ablation instrument 120 (see Fig. 2, [0020], [0022], and [0039]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mantri to incorporate the teachings of Ciulla and teach a system for use in a removal procedure of a biological object from an anatomical structure with an ablation instrument. Motivation for such can be found in Ciulla as this allows particulates/stone fragments to be broken up as they are drawn into the aspiration lumen (see [0039]).
The combination of Mantri, Molnar, Ciulla, and Yurek does not explicitly teach: wherein a portion of the distal end of the endoscope is transparent at wavelengths corresponding to visible light and wavelengths corresponding to laser energy emitted by the ablation instrument.
However, Altshuler in a similar field of invention teaches an endoscope 30 (see Figs. 1-2A) with a distal end 100 with an ablation instrument 112 + 114 (see Figs. 1-2A). Altshuler further teaches: wherein a portion the transparent cap 100 (see [0077]) of the distal end 100 of the endoscope 30 is transparent (see [0077]) at wavelengths corresponding to visible light and wavelengths corresponding to laser energy (see [0077], The transparent cap portion 100 is fabricated from a material appropriate for transmitting visible light and may include a low absorptivity and high damage threshold at the operating wavelengths of the ablation laser system 46, low absorptivity indicates that 100 allows wavelengths of the ablation laser to pass through while having a high damage threshold such that 100 is not damage by the wavelengths of the ablation laser) emitted by the ablation instrument 112 + 114.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined endoscope of Mantri and Ciulla to incorporate the teachings of Altshuler and teach a system for use in a removal procedure of a biological object from an anatomical structure with a portion of the distal end of the endoscope is transparent at wavelengths corresponding to visible light and wavelengths corresponding to laser energy emitted by the ablation instrument. Motivation for such can be found in Altshuler as this allows visible light to pass through for a camera to operate and allows the ablation wavelengths to pass through without receiving damage (see [0077] and [0085]).
Claim(s) 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mantri in view of Molnar, Ciulla, and Yurek as applied to claim 11 above, and further in view of Arepally et al (US 20200108239 A1A1), herein referenced to as “Arepally”.
Claim 24
The combination of Mantri, Molnar, Ciulla, and Yurek teaches: The system of claim 11, see 103 rejection above. The combination of Mantri, Molnar, Ciulla, and Yurek does not explicitly teach: wherein the first liquid is provided at a first velocity and the second liquid is provided at a second velocity greater than the first velocity.
However, Arepally in a similar field of invention teaches a catheter system 10 (see Figs. 1-3) with an irrigation lumen 18 (see Figs. 1-3) with a first liquid (see [0049], therapy for extended periods of time, see also claim 37, the therapeutic agents are liquids) and a supply lumen 20 (see Figs. 1-3) with a second liquid (see [0049], a bolus of therapy) with a second liquid source syringe (see [0049]). Arepally further teaches: wherein the first liquid (see [0049], therapy for extended periods of time) is provided at a first velocity (see [0049], 20 ml/hour) and the second liquid (see [0049], a bolus of therapy) is provided at a second velocity (see [0049], 360 to 3600 ml/hour) greater than the first velocity (see [0049], 360 ml/hour is greater than 20 ml/hour).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Mantri and Ciulla to incorporate the teachings of Arepally and teach a system for use in a removal procedure of a biological object with the first liquid is provided at a first velocity and the second liquid is provided at a second velocity greater than the first velocity. Motivation for such can be found in Arepally as this allows for rate of infusion to be varied to administer therapy over time or to inject a rapid bolus of therapy as needed (see [0049]).
Claim 25
The combination of Mantri, Molnar, Ciulla, Yurek, and Arepally teaches: The system of claim 24, see 103 rejection above. Arepally further teaches: further comprising a pump syringe (see [0049], a syringe meets the definition of a pump per the online Merriam-Webster dictionary as “a device that raises, transfers, delivers, or compresses fluids or that attenuates gases especially by suction or pressure or both”, in this case the syringe is a device that deliver and compresses a fluid via pressure) configured to supply the second liquid (see [0049]) from the second liquid source syringe to the supply lumen 20 at the second velocity (see [0049], 360 ml/hour is greater than 20 ml/hour).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Muller et al (US 20180021494 A1), teaches a system with a circular fluid pathway, with changing rate of fluid flow
Komiya et al (US 20170100028 A1) teaches a system with first and second supply sections with differing rates of fluid flow rate
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.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
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