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
The amendment filed June 15, 2026 has been entered. Claims 1-5, 7, 10, 12-18, 21, 23-43 remain pending in the application. Claims 6, 8-9, 11, 19-20, and 22 have been cancelled. Applicant’s amendments to the abstract, specification, and claims have overcome the objections previously set forth in the Non-Final Office Action mailed January 14, 2026.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1, 4, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Asfora (USPN 8343138) in view of Edelman et al. (US 20100063452).
Regarding claim 1, Asfora discloses a subdural evacuation port device (subdural evacuating port device 10), comprising:
a body (Figure 5) that includes:
a distal end (proximal end 36) defining a distal opening (Figure 5, from lumen 42),
a proximal end (distal end 38) defining a primary evacuation opening (Figure 5, into lumen 42) and disposed opposite the distal end (Figure 5),
a skull engagement region (self-tapping threads 46) extending proximally from and at least partially surrounding the distal end of the body (Figure 5) and configured to engage with a skull of a patient such that upon engagement the distal end is in fluid communication with a cranial cavity defined within the skull (Figure 7), and
a primary lumen (lumen 42) extending from the distal opening to the primary evacuation opening (Figure 5) and defining a first unobstructed path between the distal opening and the primary evacuation opening (Figure 5); and
wherein the body is formed from a material that is sufficiently rigid (“The subdural evacuation portion includes a rigid tubular portion” [Abstract]) to withstand a suction within the primary lumen to allow withdrawal of subdural fluid from the distal opening through the primary lumen to a suction device (negative pressure device 20) connected to the primary evacuation opening (via conduit 22; “The conduit 22 may be provided for fluidly connecting the subdural evacuating port device 10 with the negative pressure source 20” [Col 6, lines 58-60]; “A substantially uniform negative pressure condition is created in the subdural space. This negative pressure condition can be created through the lumen 42 of the subdural evacuating port device 10 of the disclosure…The negative pressure condition created in the lumen 42 of the port device 10 tends to draw fluid collected in the subdural space through the lumen 42 and into the conduit 22 and into the interior of the bulb 20.” See all of [Col8, lines 15-60]).
Asfora fails to explicitly disclose the body is formed from a polymer.
Edelman teaches a surgical port device (port device 300) comprising a body (suture plate 370) formed from a rigid polymer (“The suture plate 370 can be made substantially rigid when formed from a metal, polyoxymethylene such as Delrin, polycarbonate, polyurethane, poly(acrylonitrile-butadiene-styrene) which is commonly referred to as ABS, etc…When substantially rigid, the suture plate 370 will not bend or stretch much when held down with sutures.” [0040]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the sufficiently rigid material of the body of Asfora to be a polymer based on the teachings of Edelman to ensure that the subdural evacuation port device is not damaged during normal use (Edelman [0040]).
Regarding claim 4, modified Asfora discloses the subdural evacuation port device of claim 1.
Modified Asfora fails to explicitly disclose the polymer comprises at least one of polyacetal, acrylonitrile butadiene styrene (ABS), polycarbonate, or acetate.
Edelman teaches a surgical port device (port device 300) comprising a body (suture plate 370) formed from polymer comprising at least one of polyacetal, acrylonitrile butadiene styrene (ABS), polycarbonate, or acetate (“The suture plate 370 can be made substantially rigid when formed from a metal, polyoxymethylene such as Delrin, polycarbonate, polyurethane, poly(acrylonitrile-butadiene-styrene) which is commonly referred to as ABS, etc…When substantially rigid, the suture plate 370 will not bend or stretch much when held down with sutures.” [0040]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the sufficiently rigid material of the body of Asfora to be a polymer comprising at least one of polyacetal, acrylonitrile butadiene styrene (ABS), polycarbonate, or acetate based on the teachings of Edelman to ensure that the subdural evacuation port device is not damaged during normal use (Edelman [0040]).
Regarding claim 30, modified Asfora discloses the subdural evacuation port device of claim 1, wherein the first unobstructed path is substantially linear between the distal opening and primary evacuation opening (Figure 5).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Asfora (USPN 8343138) in view of Edelman et al. (US 20100063452) as applied in claim 1, in further view of Anzai (US 20180369556).
Regarding claim 2, Asfora discloses the subdural evacuation port device of claim 1.
Asfora fails to explicitly disclose the polymer has a substantially low thrombogenicity to resist a thrombus forming within the primary lumen.
Anzai discloses a medical port device (medical instrument 100) having a body (body 110 having coating layer 160; Figure 1B) formed of a polymer having a substantially low thrombogenicity to resist a thrombus forming within a primary lumen (“The coating layer 160 is formed of a biocompatible material that is an antithrombotic material, so that it is possible to suitably prevent the thrombus from being formed on the inner peripheral surface 110b of the first tube body 110 and the inner peripheral surface 120b of the second tube body 120.” [0063]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the body of the subdural evacuation port device of Branch to be formed from a polymer having a substantially low thrombogenicity based on the teachings of Anzai to limit the formation of clots at the subdural evacuation port device (Anzai [0063]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Asfora (USPN 8343138) in view of Edelman et al. (US 20100063452) as applied in claim 1, in further view of Ghodke et al. (US 20130158578).
Regarding claim 3, Asfora discloses the subdural evacuation port device of claim 1.
Asfora fails to explicitly disclose the subdural evacuation port device is compatible for use during at least one of computerized tomography (CT) scans, magnetic resonance imaging (MRI), or ultrasound imaging.
Ghodke discloses a subdural port device (skull mount 200) compatible for use during CT scans (“the catheterization portal can be substantially transparent to fluoroscopy or be substantially transparent to fluoroscopy except for one or more radiopaque markers to facilitate navigation” [0057]; “Data acquisition including fluoroscopy or ultrasonography can be used to navigate the cannula or catheter along a catheterization path as well as to monitor surrounding tissue. Several embodiments of the present technology include data acquisition that accounts for shifts of the brain and surrounding structures in real time. Other data acquisition can be real time or delayed. Fluoroscopy used in several embodiments of the present technology can include any type of fluoroscopy known in the art, including CT fluoroscopy, flat-panel CT fluoroscopy, and 3D-biplane fluoroscopy.” [0078]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the subdural evacuation port device of Asfora to be compatible for use during at least one of computerized tomography (CT) scans, magnetic resonance imaging (MRI), or ultrasound imaging based on the teachings of Ghodke to facilitate both navigation and data acquisition during use of the subdural evacuation port device (Ghodke [0057], [0078]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Asfora (USPN 8343138) in view of Edelman et al. (US 20100063452) as applied in claim 1, in further view of Branch, Jr et al. (US 20170291017).
Regarding claim 5, modified Asfora discloses the subdural evacuation port device of claim 1.
Modified Asfora fails to explicitly disclose a plurality of needle access ports, each defining an access port lumen in fluid communication with the primary lumen and configured to receive a needle inserted therein, and wherein each needle access port is disposed and oriented in relation to the body to allow the needle inserted within the access port lumen to extend into the primary lumen.
Branch teaches a subdural evacuation port device (subdural drainage device 100), comprising a body (housing 110 and blockage removal unit 200 having body 204) that includes: a primary lumen (from housing opening 114 through drainage passageway 112 body 204); further comprising: a plurality of needle access ports (two side delivery ports 120), each defining an access port lumen (conduit 124) in fluid communication with the primary lumen and configured to receive a needle (needle 500) inserted therein, and wherein each needle access port is disposed and oriented in relation to the body to allow the needle inserted within the access port lumen to extend into the primary lumen (Figure 8; “The needle 500 extends at least a portion of the way down the conduit 124 to dispense a therapeutic agent to the passageway 112 and into the subdural space 22” [0049] wherein the conduits 124 are configured such that a needle 500 could extend out of the distal end of the conduit 124 into the primary lumen as shown in Figure 8).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the subdural evacuation port device of Asfora to include a plurality of needle access ports each defining an access port lumen based on the teachings of Branch to provide a means for delivering a therapeutic agent to the subdural space (Branch [0049]).
Claims 7 and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Asfora (USPN 8343138) in view of Edelman et al. (US 20100063452) as applied in claim 1, in further view of Stiner et al. (US 20140206941).
Regarding claims 7 and 32-33, modified Asfora discloses the subdural evacuation port device of claim 1.
Modified Asfora fails to explicitly disclose the polymer is optically transparent, and configured to allow a user to optically see into the evacuation lumen, as required by claim 7; wherein the polymer allows at least 60% of visible light to pass through, as required by claim 32; and wherein the polymer allows at least 90% of visible light to pass through, as required by claim 33.
Stiner teaches a port device (surgical access assembly 100) comprising a body (cannula component 102) formed from a polymer that is optically transparent, and configured to allow a user to optically see into the evacuation lumen (“surgical access assembly may be formed of a lightweight plastic material for ease of manipulation and/or the material may be transparent to allow direct visualization of underlying brain tissue thorough the instrument assembly portions. cannula component 102 is preferably formed with clear polycarbonate.” [0037]), wherein the polymer allows at least 90% of visible light to pass through (“cannula component 102 is preferably formed with clear polycarbonate” [0037], wherein a clear material is able to let all visible light through).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the material of the body of Asfora to be a polymer that is optically transparent, wherein the polymer allows at least 90% of visible light to pass through based on the teachings of Stiner to allow directly visualization cranial cavity and the primary lumen (Stiner [0037]).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Asfora (USPN 8343138) in view of Edelman et al. (US 20100063452) as applied in claim 1, in further view of Werp et al. (USPN 6152933).
Regarding claim 31, modified Asfora discloses the subdural evacuation port device of claim 1.
Modified Asfora fails to explicitly disclose the polymer is radiolucent to minimize interference with X-rays.
Werp teaches a subdural evacuation port device (intracranial bolt 20) comprising a body (body 22) formed from a polymer that is radiolucent to minimize interference with X-rays (“The body 22 is preferably made of a plastic material such as polycarbonate, that is not affected by magnetic fields, and is transparent to x-ray and magnetic imaging techniques.” [Col 3, lines 2-5]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the material of the body of Asfora to be a polymer that is radiolucent based on the teachings of Werp to allow the port device to be utilized for imaging guided access to the cranial cavity without causing interference to the imaging (Asfora [Col 3, lines 2-5] and [Col 4, lines 13-22]).
Claim 10, 12-14, 18, 21, 23, 25-29, and 35-41 are rejected under 35 U.S.C. 103 as being unpatentable over Asfora (USPN 8343138) in view of Branch, Jr et al. (US 20170291017).
Regarding claim 10, Asfora discloses a subdural evacuation port device (subdural evacuating port device 10), comprising:
a body (Figure 5) that includes:
a distal end (proximal end 36) defining a distal opening (Figure 5, from lumen 42),
a proximal end (distal end 38) defining a primary evacuation opening (Figure 5, into lumen 42) and disposed opposite the distal end (Figure 5),
a primary lumen (lumen 42) extending from the distal opening to the primary evacuation opening (Figure 5) and defining a first unobstructed path between the distal opening and the primary evacuation opening (Figure 5); and
a needle access port (evacuation port aspiration device 82) defining an access port lumen (aspiration channel 84) in fluid communication with the primary lumen (Figure 12; “The port aspiration device 82 defines an aspiration channel 84 (see FIGS. 11 and 12), and may be configured to create fluid communication between the aspiration channel 84 and the evacuation port lumen 42 when the port aspiration device 82 is mounted on the evacuation port device 10” [Col 9, lines 16-21]) and configured to receive a needle therein and wherein the needle access port is disposed and oriented in relation to the body to allow the needle inserted within the access port lumen to extend into the primary lumen (Figure 12; “An instrument, such as a hypodermic needle, may be positioned in the aspiration channel 84 of the port aspiration device 82…The needle may continue through the evacuation lumen 42 of the evacuating port device 10. Once the end of the needle has reached the evacuating lumen 42, it may be used to remove an obstruction in the lumen 42 or in the subdural space, as well as to deliver medicine or other fluids to the subdural space.” [Col 13, lines 35-46]).
Asfora fails to explicitly disclose a plurality of needle access ports, each defining an access port lumen in fluid communication with the primary lumen and configured to receive a needle inserted therein, and wherein each needle access port is disposed and oriented in relation to the body to allow the needle inserted within the access port lumen to extend into the primary lumen.
Branch teaches a subdural evacuation port device (subdural drainage device 100), comprising a body (housing 110 and blockage removal unit 200 having body 204) that includes: a primary lumen (from housing opening 114 through drainage passageway 112 body 204); further comprising: a plurality of needle access ports (two side delivery ports 120), each defining an access port lumen (conduit 124) in fluid communication with the primary lumen and configured to receive a needle (needle 500) inserted therein, and wherein each needle access port is disposed and oriented in relation to the body to allow the needle inserted within the access port lumen to extend into the primary lumen (Figure 8; “The needle 500 extends at least a portion of the way down the conduit 124 to dispense a therapeutic agent to the passageway 112 and into the subdural space 22” [0049], wherein the conduits 124 are configured such that a needle 500 could extend out of the distal end of the conduit 124 into the primary lumen as shown in Figure 8).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the subdural evacuation port device of Asfora to include a plurality of needle access ports each defining an access port lumen based on the teachings of Branch to provide a means for delivering a therapeutic agent to the subdural space (Branch [0049]).
Regarding claim 12, modified Asfora discloses the subdural evacuation port device of claim 10, wherein the primary evacuation opening is configured to be connected to an evacuation device (negative pressure device 20) that is configured to provide suction at the distal opening through the primary lumen (via conduit 22; “The conduit 22 may be provided for fluidly connecting the subdural evacuating port device 10 with the negative pressure source 20” [Col 6, lines 58-60]; “A substantially uniform negative pressure condition is created in the subdural space. This negative pressure condition can be created through the lumen 42 of the subdural evacuating port device 10 of the disclosure…The negative pressure condition created in the lumen 42 of the port device 10 tends to draw fluid collected in the subdural space through the lumen 42 and into the conduit 22 and into the interior of the bulb 20.” See all of [Col8, lines 15-60]).
Regarding claim 13, modified Asfora discloses the subdural evacuation port device of claim 10, wherein the each needle access port includes a seal (closing structure 108) disposed at a proximal end of the access port lumen that seals the access port lumen to preserve a suction within the primary lumen and that is penetrable by the needle (“A closing structure 108 may be provided on the aspiration portion 100 of the device 82 for closing the second portion 102 of the aspiration channel 84 (see FIG. 11). The closing structure 108 may close the aspiration channel 84 in an air tight and fluid tight manner…The closing structure 108 may be puncturable or be otherwise penetrated by a needle or other instrument.” [Col 10, lines 10-20]).
Regarding claim 14, modified Asfora discloses the subdural evacuation port device of claim 10, wherein the access port lumen (aspiration channel 84) intersects the primary lumen at a location (Figure 12).
Modified Asfora fails to explicitly disclose wherein each of the access port lumens intersects the primary lumen at a location and/or a different orientation.
Branch teaches a subdural evacuation port device (subdural drainage device 100), comprising a body (housing 110 and blockage removal unit 200 having body 204) that includes: a primary lumen (from housing opening 114 through drainage passageway 112 body 204); further comprising: a plurality of needle access ports (two side delivery ports 120), each defining an access port lumen (conduit 124), wherein each of the access port lumens intersects the primary lumen at a location and/or a different orientation (Figures 5 and 7).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the subdural evacuation port device of Asfora to include that each access port lumen intersects the primary lumen at a location and/or a different orientation based on the teachings of Branch to provide a means for delivering a therapeutic agent to the subdural space (Branch [0049]).
Regarding claim 18, modified Asfora discloses a kit for evacuating fluid from subdural space of a skull (“a kit for evacuating a collection of fluid from a subdural space of a patient having a scalp.” [Col 3, lines 4-5]), comprising:
the subdural evacuation port device (subdural evacuating port device 10; “The kit may include a subdural evacuating port device having a proximal end and a distal end.” [Col 3, lines 6-7]) of claim 10; and
a needle configured to be inserted into the access port lumen to assist with clearing a blockage within the primary lumen (“An instrument, such as a hypodermic needle, may be positioned in the aspiration channel 84 of the port aspiration device 82…The needle may continue through the evacuation lumen 42 of the evacuating port device 10. Once the end of the needle has reached the evacuating lumen 42, it may be used to remove an obstruction in the lumen 42 or in the subdural space, as well as to deliver medicine or other fluids to the subdural space.” [Col 13, lines 35-46]).
Regarding claim 21, modified Asfora discloses the kit of claim 18, further comprising an evacuation device (negative pressure device 20) that is configured to provide suction through the primary lumen (via conduit 22; “The conduit 22 may be provided for fluidly connecting the subdural evacuating port device 10 with the negative pressure source 20” [Col 6, lines 58-60]; “A substantially uniform negative pressure condition is created in the subdural space. This negative pressure condition can be created through the lumen 42 of the subdural evacuating port device 10 of the disclosure…The negative pressure condition created in the lumen 42 of the port device 10 tends to draw fluid collected in the subdural space through the lumen 42 and into the conduit 22 and into the interior of the bulb 20.” See all [Col8, lines 15-60]).
Regarding claim 23, modified Asfora discloses the kit of claim 18, wherein the needle is hollow and includes a needle lumen (Figure 12; “An instrument, such as a hypodermic needle, may be positioned in the aspiration channel 84 of the port aspiration device 82…The needle may continue through the evacuation lumen 42 of the evacuating port device 10. Once the end of the needle has reached the evacuating lumen 42, it may be used to remove an obstruction in the lumen 42 or in the subdural space, as well as to deliver medicine or other fluids to the subdural space.” [Col 13, lines 35-46]).
Regarding claim 25, modified Asfora discloses a method of using the subdural evacuation port device of claim 10, comprising:
drilling a hole through a skull and dura of a patient to access a subdural region (“An opening 8 is created in the skull 2 of the patient using the drill bit 14 mounted in the drill device 12…The size of the drill bit 14 is such that it will create a suitable size opening in the skull. The dura 3 may then be penetrated by incising the dura of the patient using, for example, a unipolar cautery device. The underlying membranes may be transected with the unipolar cautery device.” [Col 8, lines 3-14]);
mounting the subdural evacuation port device to the hole via a skull engagement region (self-tapping threads 46) that extends proximally from and at least partially surrounds a distal end of the body (“The proximal end 36 of the subdural evacuating port device 10 is introduced into the opening 8 in the skull 2. The port device 10 is rotated in the opening 8 such that the self-tapping threads 46 engage the sides of the opening 8 and pull the proximal end 36 into the opening 8 and secure the port device 10 against unintentional withdrawal of the device 10 from the opening 8.” [Col 8, lines 18-24]; Figure 7);
applying suction within the primary lumen to withdraw subdural fluid from the subdural region of the patient through the primary lumen (“The negative pressure condition created in the lumen 42 of the port device 10 tends to draw fluid collected in the subdural space through the lumen 42 and into the conduit 22 and into the interior of the bulb 20.” [Col 8, lines 47-50]);
determining whether there is a blockage preventing subdural fluid from flowing through the primary lumen (“a blood clot or other accumulation of matter has become lodged in, or is otherwise obstructing, the evacuating lumen 42 of the port device 10.” [Col 12, lines 49-52]); and
in response to determining that a blockage is preventing subdural fluid from flowing through the primary lumen, clearing the blockage (“An instrument, such as a hypodermic needle, may be positioned in the aspiration channel 84 of the port aspiration device 82...The needle may continue through the evacuation lumen 42 of the evacuating port device 10. Once the end of the needle has reached the evacuating lumen 42, it may be used to remove an obstruction in the lumen 42 or in the subdural space, as well as to deliver medicine or other fluids to the subdural space.” [Col 13, lines 35-46]).
Regarding claim 27, modified Asfora discloses the method of claim 25, further comprising removing the blockage by inserting a hollow needle through the access port lumen (aspiration channel 84) into the primary lumen (“An instrument, such as a hypodermic needle, may be positioned in the aspiration channel 84 of the port aspiration device 82….The needle may continue through the evacuation lumen 42 of the evacuating port device 10. Once the end of the needle has reached the evacuating lumen 42, it may be used to remove an obstruction in the lumen 42 or in the subdural space, as well as to deliver medicine or other fluids to the subdural space.” [Col 13, lines 35-46]).
Regarding claim 28, modified Asfora discloses the method of claim 27.
Modified Asfora fails to explicitly disclose injecting a thrombolytic agent via a hollow needle lumen of the needle.
Branch teaches a method of using a subdural evacuation port device (subdural drainage device) comprising injecting a thrombolytic agent via a hollow needle lumen of the needle (“a drug delivery device or needle 500 is inserted in the drug delivery port 120 via the sealing member 122…The needle 500 extends at least a portion of the way down the conduit 124 to dispense a therapeutic agent to the passageway 112 and into the subdural space 22. Any suitable drug or therapeutic agent may be used, including thrombolytic agents” [0049]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the method of Asfora to include injecting a thrombolytic agent via a hollow needle lumen of the needle based on the teachings of Branch to dissolve clots directly within the primary lumen (Branch [0049]).
Regarding claim 29, modified Asfora discloses the method of claim 27, further comprising suctioning the blockage using the needle (“An instrument, such as a hypodermic needle, may be positioned in the aspiration channel 84 of the port aspiration device 82...The needle may continue through the evacuation lumen 42 of the evacuating port device 10. Once the end of the needle has reached the evacuating lumen 42, it may be used to remove an obstruction in the lumen 42 or in the subdural space, as well as to deliver medicine or other fluids to the subdural space.” [Col 13, lines 35-46]).
Regarding claim 34, modified Asfora discloses the subdural evacuation port device of claim 10, wherein each needle access port (aspiration channel 34) is disposed and oriented in relation to the body to allow the needle inserted within the access port lumen to extend through the primary lumen and beyond the distal opening (Figure 12 showing tip of needle extending distally of the distal opening; “An instrument, such as a hypodermic needle, may be positioned in the aspiration channel 84 of the port aspiration device 82. The needle may be inserted into the aspiration channel 84 through the aspiration portion 100 of the aspiration device. The needle may be inserted through the closing structure 108 in the aspiration channel 84 of the port aspiration device 82. The needle may continue through the evacuation lumen 42 of the evacuating port device 10. Once the end of the needle has reached the evacuating lumen 42, it may be used to remove an obstruction in the lumen 42 or in the subdural space, as well as to deliver medicine or other fluids to the subdural space.” [Col 13, lines 35-46]; “The degree of penetration is dependent upon the effective length of the aspiration device 82 and the length of the needle.” [Col 13, lines 25-26]).
Regarding claim 35, modified Asfora discloses the subdural evacuation port device of claim 10, wherein the first unobstructed path is substantially linear between the distal opening and primary evacuation opening (Figure 5).
Regarding claim 36, modified Asfora discloses the subdural evacuation port device of claim 10, further comprising a second unobstructed path defined between at least one of the access port lumens (aspiration channel 84) and the distal opening (Figure 12).
Regarding claim 37, modified Asfora discloses the subdural evacuation port device of claim 36, wherein the second unobstructed path intersects the first unobstructed path (Figure 12).
Regarding claim 38, modified Asfora discloses the subdural evacuation port device of claim 10, further comprising a needle received within one of the access port lumens and extending into the primary lumen (Figure 12; “An instrument, such as a hypodermic needle, may be positioned in the aspiration channel 84 of the port aspiration device 82. The needle may be inserted into the aspiration channel 84 through the aspiration portion 100 of the aspiration device. The needle may be inserted through the closing structure 108 in the aspiration channel 84 of the port aspiration device 82. The needle may continue through the evacuation lumen 42 of the evacuating port device 10. Once the end of the needle has reached the evacuating lumen 42, it may be used to remove an obstruction in the lumen 42 or in the subdural space, as well as to deliver medicine or other fluids to the subdural space.” [Col 13, lines 35-46]).
Regarding claim 39, modified Asfora discloses the subdural evacuation port device of claim 38, wherein at least a portion of the needle follows a path when the needle is received within the access port lumen and extends into the primary lumen (Figure 12).
Modified Asfora fails to explicitly disclose at least a portion of the needle follows a nonlinear path.
Branch teaches a subdural evacuation port device (subdural drainage device 100), comprising a body (housing 110 and blockage removal unit 200 having body 204) that includes: a primary lumen (from housing opening 114 through drainage passageway 112 body 204); further comprising: a plurality of needle access ports (two side delivery ports 120), each defining an access port lumen (conduit 124) in fluid communication with the primary lumen; and a needle (needle 500) that follows a nonlinear path when the needle is received within the access port lumen and extends into the primary lumen (Figure 8; “The needle 500 extends at least a portion of the way down the conduit 124 to dispense a therapeutic agent to the passageway 112 and into the subdural space 22” [0049], wherein the conduits 124 are configured such that a needle 500 could extend out of the distal end of the conduit 124 into the primary lumen as shown in Figure 8, and the full path through the access port lumen to the distal end is nonlinear).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the subdural evacuation port device of Asfora to include at least a portion of the needle follows a nonlinear path based on the teachings of Branch to provide a means for delivering a therapeutic agent to the subdural space (Branch [0049]).
Regarding claim 40, modified Asfora discloses the subdural evacuation port device of claim 38, wherein a tip of the needle is positioned adjacent the distal opening when the needle is received within the access port lumen (Figure 12 showing tip of needle adjacent to distal opening; “An instrument, such as a hypodermic needle, may be positioned in the aspiration channel 84 of the port aspiration device 82. The needle may be inserted into the aspiration channel 84 through the aspiration portion 100 of the aspiration device. The needle may be inserted through the closing structure 108 in the aspiration channel 84 of the port aspiration device 82. The needle may continue through the evacuation lumen 42 of the evacuating port device 10. Once the end of the needle has reached the evacuating lumen 42, it may be used to remove an obstruction in the lumen 42 or in the subdural space, as well as to deliver medicine or other fluids to the subdural space.” [Col 13, lines 35-46]; “The degree of penetration is dependent upon the effective length of the aspiration device 82 and the length of the needle.” [Col 13, lines 25-26]).
Regarding claim 41, modified Asfora discloses the subdural evacuation port device of claim 38, wherein a tip of the needle extends beyond the distal opening when the needle is received within the access port lumen (Figure 12 showing tip of needle extending distally of the distal opening; “An instrument, such as a hypodermic needle, may be positioned in the aspiration channel 84 of the port aspiration device 82. The needle may be inserted into the aspiration channel 84 through the aspiration portion 100 of the aspiration device. The needle may be inserted through the closing structure 108 in the aspiration channel 84 of the port aspiration device 82. The needle may continue through the evacuation lumen 42 of the evacuating port device 10. Once the end of the needle has reached the evacuating lumen 42, it may be used to remove an obstruction in the lumen 42 or in the subdural space, as well as to deliver medicine or other fluids to the subdural space.” [Col 13, lines 35-46]; “The degree of penetration is dependent upon the effective length of the aspiration device 82 and the length of the needle.” [Col 13, lines 25-26]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Asfora (USPN 8343138) in view of Branch, Jr et al. (US 20170291017) as applied in claim 10 above, in further view of Ghodke et al. (US 20130158578).
Regarding claim 15, modified Asfora discloses the subdural evacuation port device of claim 10.
Modified Asfora fails to explicitly disclose the subdural evacuation port device is compatible for use during at least one of computerized tomography (CT) scans, magnetic resonance imaging (MRI), or ultrasound imaging.
Ghodke discloses a subdural port device (skull mount 200) compatible for use during CT scans (“the catheterization portal can be substantially transparent to fluoroscopy or be substantially transparent to fluoroscopy except for one or more radiopaque markers to facilitate navigation” [0057]; “Data acquisition including fluoroscopy or ultrasonography can be used to navigate the cannula or catheter along a catheterization path as well as to monitor surrounding tissue. Several embodiments of the present technology include data acquisition that accounts for shifts of the brain and surrounding structures in real time. Other data acquisition can be real time or delayed. Fluoroscopy used in several embodiments of the present technology can include any type of fluoroscopy known in the art, including CT fluoroscopy, flat-panel CT fluoroscopy, and 3D-biplane fluoroscopy.” [0078]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the subdural evacuation port device of Asfora to be compatible for use during at least one of computerized tomography (CT) scans, magnetic resonance imaging (MRI), or ultrasound imaging based on the teachings of Ghodke to facilitate both navigation and data acquisition during use of the subdural evacuation port device (Ghodke [0057], [0078]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Asfora (USPN 8343138) in view of Branch, Jr et al. (US 20170291017) as applied in claim 10 above, in further view of Edelman et al. (US 20100063452).
Regarding claim 16, modified Asfora discloses the subdural evacuation port device of claim 10, wherein the body is formed from a material that is sufficiently rigid (“The subdural evacuation portion includes a rigid tubular portion” [Abstract]) to withstand a suction within the primary lumen to allow withdrawal of subdural fluid from the distal opening through the primary lumen to a suction device (negative pressure device 20) connected to the primary evacuation opening (via conduit 22; “The conduit 22 may be provided for fluidly connecting the subdural evacuating port device 10 with the negative pressure source 20” [Col 6, lines 58-60]; “A substantially uniform negative pressure condition is created in the subdural space. This negative pressure condition can be created through the lumen 42 of the subdural evacuating port device 10 of the disclosure…The negative pressure condition created in the lumen 42 of the port device 10 tends to draw fluid collected in the subdural space through the lumen 42 and into the conduit 22 and into the interior of the bulb 20.” See all of [Col8, lines 15-60]).
Modified Asfora fails to explicitly disclose the body is formed from a polymer.
Edelman teaches a surgical port device (port device 300) comprising a body (suture plate 370) formed from a rigid polymer (“The suture plate 370 can be made substantially rigid when formed from a metal, polyoxymethylene such as Delrin, polycarbonate, polyurethane, poly(acrylonitrile-butadiene-styrene) which is commonly referred to as ABS, etc…When substantially rigid, the suture plate 370 will not bend or stretch much when held down with sutures.” [0040]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the sufficiently rigid material of the body of Asfora to be a polymer based on the teachings of Edelman to ensure that the subdural evacuation port device is not damaged during normal use (Edelman [0040]).
Claims 17 and 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Asfora (USPN 8343138) in view of in view of Branch, Jr et al. (US 20170291017) as applied in claim 10 above, in further view of Stiner et al. (US 20140206941).
Regarding claims 17 and 42-43, modified Asfora discloses the subdural evacuation port device of claim 10.
Modified Asfora fails to explicitly disclose the subdural evacuation port device is formed from an optically transparent material to allow a user to optically see into the evacuation lumen to view an obstruction therein, as required by claim 17; wherein the optically transparent material allows greater than 60% of visible light to pass through, as required by claim 42; and wherein the optically transparent material allows greater than 90% of visible light to pass through, as required by claim 43.
Stiner teaches a port device (surgical access assembly 100) comprising a body (cannula component 102) formed from an optically transparent material to allow a user to optically see into the evacuation lumen to view an obstruction therein (“surgical access assembly may be formed of a lightweight plastic material for ease of manipulation and/or the material may be transparent to allow direct visualization of underlying brain tissue thorough the instrument assembly portions. cannula component 102 is preferably formed with clear polycarbonate.” [0037]), wherein the optically transparent material allows greater than 90% of visible light to pass through (“cannula component 102 is preferably formed with clear polycarbonate” [0037], wherein a clear material is able to let all visible light through).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the material of the body of Asfora to be optically transparent, wherein the optically transparent material allows greater than 90% of visible light to pass through based on the teachings of Stiner to allow directly visualization cranial cavity and the primary lumen (Stiner [0037]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Asfora (USPN 8343138) in view of in view of Branch, Jr et al. (US 20170291017) as applied in claim 23 above, and further in view of Piferi (US 20150080708).
Regarding claim 24, modified Asfora discloses the kit of claim 23.
Modified Asfora fails to explicitly disclose a stylet configured to removably extend through the needle lumen to puncture a seal that seals the access port lumen of the subdural evacuation port device while preserving suction within the primary lumen.
Piferi discloses a subdural port device (fluid transfer assembly 300) comprising a needle (guide cannula 100) and a stylet (stylet 110) configured to removably extend through the needle lumen (Figures 7A-7B and 10A; “inserting a stylet with a sharp distal tip into the guide cannula lumen and attaching the stylet to the guide cannula so that the distal tip extends a distance outside the guide cannula distal end…then slidably withdrawing the stylet from the guide cannula and out of the subject, while leaving the guide cannula in position” [0028]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the kit of Asfora in view of Branch to include a stylet configured to removably extend through the needle lumen to puncture a seal that seals the access port lumen of the subdural evacuation port device while preserving suction within the primary lumen based on the teachings of Piferi to guide the needle into the subdural evacuation port device without undue trauma to the tissues of the target anatomy (Piferi [0082]).
Response to Arguments
Applicant’s arguments with respect to claims 1-5, 7, 10, 12-18, 21, and 23-43 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
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