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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites “said tip comprises a nozzle and a blocker.” However a nozzle was already recited in a tip in claim 1. It is assumed this was intended to refer to the same nozzle.
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) 26-28, 30-31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamalova [US 2022/0047281 A1].
Re. claim 26, Kamalova discloses a method of removal of target tissue [“fluid flow along discharge channel 22 acts to remove material such as thrombi, emboli, tissue or other particulate from a living body that was drawn into chamber 13 through suction opening 15,” Par. 0024] comprising:
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positioning an opening [15] to a housing [2] adjacent to the target tissue [“material outside the catheter in the vicinity of the suction opening [emphasis added] 15 is sucked through this opening 15,” Par. 0019; thus, Kamalova discloses placing the tissue (“material” adjacent the opening], which housing hosts an outlet to a fluid supply [“fluid which is delivered through the pressure channel 25 in a carefully controlled manner along the inside of the suction opening 15,” Par. 0019. See Fig. 2]; and
supplying fluid to said outlet to provide a fluid flow [jet 20] within said housing which fluid flow interacts, through said opening, with said target tissue to erode said target tissue [“material outside the catheter in the vicinity of the suction opening 15 is sucked through this opening 15….Fluid under pressure delivered through the pressure channel 25 is emitted in the form of a jet 20 at a relatively high velocity through the tube 21, thus creating suction at the location of suction opening 15. The removal of material brought into the suction catheter through suction opening 15 via the discharge channel 22 and the discharge tube 24 is supported by means of this suction,” Par. 0019].
Re. claim 27, Kamalova discloses said outlet comprises a nozzle [tube 21], which produces a fluid jet upon said supplying [“Tube 21…functions as a jet nozzle and directs the fluid which is delivered through the pressure channel 25 in a carefully controlled manner along the inside of the suction opening 15,” Par. 0019].
Re. claim 28, Kamalova discloses said fluid jet is at least partially enclosed by said housing [Fig. 2].
Re. claim 30, Kamalova discloses blocking a path of said water jet [Fig. 4 shows wall 38 blocking a path of water jet, shown by redirection arrow 39].
Re. claim 31, Kamalova discloses removing eroded tissue by suctioning eroded tissue and jetted fluid [“fluid flow along discharge channel 22 acts to remove material such as thrombi, emboli, tissue or other particulate from a living body that was drawn into chamber 13 through suction opening 15,” Par. 0024, and “The removal of material brought into the suction catheter through suction opening 15 via the discharge channel 22 and the discharge tube 24 is supported by means of this suction. Together with the fluid delivered through the pressure channel 25 the sucked up material is removed through the discharge tube 24 to a discharge reservoir such as the discharge reservoir 8 of FIG. 3,” Par. 0019].
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.
Claim(s) 1, 2, 5-10, 15-16, 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamalova in view of Oliver et al. [20160066943 A1, hereinafter “Oliver”].
Re. claim 1, Kamalova discloses a device [Figs. 1-2] for selective tissue removal [“fluid flow along discharge channel 22 acts to remove material such as thrombi, emboli, tissue or other particulate from a living body that was drawn into chamber 13 through suction opening 15,” Par. 0024] comprising a tip [Annotated Fig. 2] having:
a housing [body 2, Fig. 1];
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a nozzle [tube 21] positioned to jet fluid supplied to said nozzle as a fluid jet [“Tube 21…functions as a jet nozzle and directs the fluid which is delivered through the pressure channel 25 in a carefully controlled manner along the inside of the suction opening 15,” Par. 0019] disposed within and restricted by a volume defined by said housing [Fig. 2 shows the nozzle being inside housing 2]; and
an opening [15] in said housing to said fluid jet, sized and shaped for said fluid jet to erode tissue adjacent to said volume [“Fluid under pressure delivered through the pressure channel 25 is emitted in the form of a jet 20 at a relatively high velocity through the tube 21, thus creating suction at the location of suction opening 15. The removal of material brought into the suction catheter through suction opening 15 via the discharge channel 22 and the discharge tube 24 is supported by means of this suction. Together with the fluid delivered through the pressure channel 25 the sucked up material is removed through the discharge tube 24 to a discharge reservoir such as the discharge reservoir 8 of FIG. 3,” Par. 0019].
Kamalova fails to disclose the housing sized and shaped to enter a cranial cavity through an aperture 5 mm in diameter. However, Oliver teaches, in a device for selective tissue removal [Par. 0028], the housing is sized and shaped to enter a cranial cavity through an aperture [“treatment of a tumor 400 in a cranial procedure in accordance with aspects of the present disclosure includes forming an access opening in the patient's skull 402 (e.g., a conventional craniotomy),” Par. 0097] 5 mm in diameter [“the outer diameter d.sub.1 of the distal portion 160 is 0.1452″ to 0.1457″,” Par. 0055. This corresponds to a range of about 3.69 to 3.70 mm, which is sized and shaped to fit through a 5mm diameter aperture]. The advantage of forming the housing such that it is sized and shaped to enter a cranial cavity through an aperture 5 mm in diameter is that this allows the device to remove intracranial and spine tumors [Oliver Par. 0097]. Thus, It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Kamalova by configuring the housing to be sized and shaped to enter a cranial cavity through a 5 mm diameter aperture, as taught by Oliver, in order to allow the device to remove brain tumors.
Re. claim 2, Kamalova discloses said opening is sized and shaped to allow said tissue to intrude into said opening [“material outside the catheter in the vicinity of the suction opening 15 is sucked through this opening 15,” Par. 0019.].
Re. claim 5, Kamalova discloses said opening is to a side of said fluid jet [Fig. 2].
Re. claim 6, Kamalova discloses a portion of said fluid jet flows alongside said opening [Fig. 2 and Par. 0019].
Re. claim 7, Kamalova discloses said jet impinges on an inner surface of said housing [39, Fig. 4].
Re. claim 8, Kamalova discloses said fluid jet is in a direction alongside or away from said opening [alongside, Fig. 2], said fluid jet not impinging directly onto tissue outside said housing [see Par. 0019].
Re. claim 9, Kamalova discloses said tip comprises a nozzle [21] and a blocker [directional wall 38]; and said fluid jet is jetted through said nozzle and travel of said fluid jet is restricted by said blocker [Fig. 4, Par. 0024].
Re. claim 10, Kamalova discloses said tip has a proximal and a distal end [see Fig. 4, the proximal end being the direction connected to fluid supply, and the distal end being at 38], the blocker is positioned distal of said nozzle [Fig. 4], and disrupts flow of jetted fluid distal of said blocker [Par. 0024].
Re. claim 15, Kamalova discloses a fluid supply conduit [25] which supplies fluid to said nozzle, wherein said fluid supply conduit extends in a proximal-distal direction [Fig. 2] but in this embodiment fails to teach a turn at the tip. However, in the embodiment of Fig. 5, Kamalova teaches and includes a turn at said tip prior to fluidly connect to said nozzle to supply fluid for said fluid jet [Fig. 5]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Fig. 2 such that the fluid supply conduit includes a turn at the tip as taught in Fig. 5 because this allows water to move in a different direction (towards the return rather than towards the tip).
Re. claim 16, Kamalova discloses The device according to claim 15, wherein said device comprises a suction conduit [22] having suction inlet disposed at said tip for extraction of fluid and eroded tissue [Par. 0019. Because fluid and tissue are removed by the discharge channel, it inherently must have an opening in the housing].
Re. claim 33, Kamalova discloses the method set forth above, and further discloses said eroding is of a portion of said target [target tissue, Par. 0004], but is silent regarding repositioning the opening, wherein the target tissue is within a cranial cavity. However, Oliver teaches, in a method of removing tissue, said method comprises repositioning said opening to continue to erode target tissue [Figs. 14A-B], wherein said target tissue is tissue within a cranial cavity [Par. 0097]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Kamalova by configuring the opening to be repositioned and wherein said target tissue is within a cranial cavity, as taught by Oliver, in order to allow the method to be used to remove brain tumors.
Claim(s) 17, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamalova in view of Oliver, as applied to claim 1, and further in view of Stevens-Wright et al. [US Pat. 5462527, hereinafter “Stevens”].
Re. claim 17, Kamalova discloses The device according to claim 1, wherein said device comprises an arm [annotated fig 1] hosting said tip at a distal portion thereof, wherein said arm is bendable at one or more joints [fig. 2, where the “joint” is the places where 2 is bent]; but fails to teach an actuator.
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However, Stevens teaches, in a steerable catheter device, wherein said device includes one or more actuator [“handle/actuator”] configured to bend said arm at said one or more joints [Col. 2 lines 58-65]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Kamalova by adding an actuator to bend the arm at one or more joints, as taught by Stevens, because this allows the device to be effectively steered, offering improved maneuverability to specific site [Stevens Col. 1 lines 34-37]
Re. claim 20, Kamalova discloses said device comprises a suction conduit [22] having suction inlet disposed at said tip for extraction of fluid and eroded tissue [Par. 0019. Because fluid and tissue are removed by the discharge channel, it inherently must have an opening in the housing]; and said fluid supply conduit and said suction conduit extend through said arm [Figs. 1-2].
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamalova in view of Oliver, as applied to claim 17, and further in view of Uchiyama et al. [US Pat. 4898574, hereinafter “Uchiyama.”]
Re. claim 21, Kamalova as modified above discloses the apparatus set forth above including the fludi supply conduit connected to the suction conduit [”Tube 21 extends from pressure channel 25,” Par. 0018] but fails to teach the fluid supply conduit extending through a lumen of the suction conduit. However, Uchiyama teaches, in a tissue removal device, a fluid supply conduit [11, Fig. 2] extends through a lumen of said suction conduit [7; Col. 23 lines 49-68]. It would have been obvious to modify the apparatus of the modified Kamalova by configuring the fluid supply conduit to extend through a lumen of the suction conduit because this ensures that all the fluid supplied will be removed.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamalova in view of Oliver, as applied to claim 1, and further in view of Andrew et al. [US 2013/0261606 A1, hereinafter “Andrew”].
Re. claim 22, Kamalova as modified above discloses the apparatus set forth above, but teaches only one nozzle. However, Andrew teaches, in a device for selective tissue removal, a second nozzle [two nozzles 43, Fig. 3] positioned to jet fluid supplied to said second nozzle as a second fluid jet disposed within and restricted by said volume defined by said housing [Par. 0024]; and wherein said housing comprises a second opening [two openings 37], sized and shaped for said second fluid jet to erode tissue adjacent to said volume [Par. 0067]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Kamalova by adding a second nozzle and opening as taught by Andrew in order to improve the speed of tissue collection [Par. 0067].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN MCGRATH whose telephone number is (571)270-0674. The examiner can normally be reached M-F 9 am to 5 pm ET.
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771