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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains phrases which can be implied (“The present disclose relates to…”). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
In paragraphs [0057], the phrase “Such transparent portions of the evacuation port device are described in co-pending U.S. application Ser. No. ______, Attorney Docket Number 349240.01001, filed on Jul. 5, 2023 and having a title “TRANSPARENT SURGICAL EVACUATION PORT DEVICE”” should be corrected to include the corresponding US application number.
In paragraphs [0076], the phrase “Such transparent subdural port devices are described in U.S. application Ser. No. ______, Attorney Docket Number 349240.01001, filed Jul. 5, 2023 and having a title “TRANSPARENT SURGICAL EVACUATION PORT DEVICE”” should be corrected to include the corresponding US application number.
Appropriate correction is required.
Claim Objections
Claim 26 is objected to because there is a lack of antecedent basis for “the cause of the blockage” in line 1. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 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.
Claims 1, 5-6, 8, 10-14, 16, 18-19, 21-23, 25, and 27-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipate by Branch, Jr. et al. (US 20170291017).
Regarding claim 1, Branch discloses 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 distal opening (opening 114) at a distal end (Figure 3),
a primary evacuation opening (at end 205) at a proximal end (Figure 3);
a skull engagement region (threaded region at lower opening 114) that at least partially surrounds the distal end of the body, and that is configured to engage with a skull of a patient (“The subdural drainage device 100 includes a housing 110 that has a drainage passageway 112 with a lower opening 114 configured to connect to a subdural space 22 of a skull 20” [0043]; Figure 2); and
a primary lumen (from housing opening 114 through drainage passageway 112 body 204) extending from the distal opening to the primary evacuation opening (“a housing 110 that has a drainage passageway 112 with a lower opening 114 configured to connect to a subdural space 22 of a skull 20, and an upper opening 116…The body 204 is generally hollow and includes apertures 206 for receiving fluid from the housing opening 114. The body 204 further includes an end 205 that is configured to connect the housing drainage passageway 112 to a tube 26 (FIG. 2).” [0043-0044]),
wherein the body is formed from a polymer that is sufficiently rigid (“The devices described herein may be rigid or somewhat flexible, and may be formed of any suitable polymeric, metallic, composite material or combination thereof.” [0052]) to sustain a suction in the lumen to allow withdrawal of subdural fluid from the distal opening through the lumen to a suction device connected to the primary evacuation opening (“the body 204 of the blockage removal unit 200 forms a generally hollow fluid chamber such that the fluid from the subdural space 22 is permitted to flow into the housing 110 from the opening 114 and through the apertures 206 into the body 204 of the unit 200 where it exits the body 204 at the end 205.” [0046]).
Regarding claim 5, Branch discloses the subdural evacuation port device of claim 1, further comprising: a needle access port (drug delivery port 120) defining an access port lumen (conduit 124) in communication with 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]); and a seal (sealing member 122) at a proximal end of the access port lumen (Figure 3) that seals the access port lumen to preserve the suction within the lumen and that is penetrable by a needle (“a drug delivery device or needle 500 is inserted in the drug delivery port 120 via the sealing member 122. The sealing member 122 may be a self-sealing plug formed of an elastomeric material that is configured to reseal after it is punctured with the needle 500.” [0049]).
Regarding claim 6, Branch discloses the subdural evacuation port device of claim 5, wherein the needle access port (drug delivery port 200) is disposed and oriented with respect to the body to allow a needle inserted into the access port lumen to extend into the primary lumen (Figure 8; “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.” [0049]).
Regarding claim 8, Branch discloses the subdural evacuation port device of claim 1, wherein the skull engagement region comprises threads (threaded region at lower opening 114; Figure 2) for cutting threads into the skull of the patient (“a threaded portion thereof is twisted into the skull” [0018]; “a SEPS device 10 is essentially a hollow screw placed in the skull 20 which communicates with the subdural space 22” [0004]; “The housing according to embodiments of the present invention may be configured to attach to existing subdural drainage devices, such as a subdural evacuation port system (or “SEPS”)” [0053]).
Regarding claim 10, Branch discloses 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 distal opening (opening 114),
a primary evacuation opening (at end 205), and
a primary lumen (from housing opening 114 through drainage passageway 112 body 204) extending from the distal opening to the primary evacuation opening “a housing 110 that has a drainage passageway 112 with a lower opening 114 configured to connect to a subdural space 22 of a skull 20, and an upper opening 116…The body 204 is generally hollow and includes apertures 206 for receiving fluid from the housing opening 114. The body 204 further includes an end 205 that is configured to connect the housing drainage passageway 112 to a tube 26 (FIG. 2).” [0043-0044]); and
a needle access port (drug delivery port 120) defining an access port lumen (conduit 124) that is in communication with 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 needle access port is positioned with respect to the body to direct a needle inserted within the access port lumen into the primary lumen (Figure 8; “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.” [0049]).
Regarding claim 11, Branch discloses the subdural evacuation port device of claim 10, wherein the needle access port (drug delivery port 120) includes a stop surface (proximal outer surface of drug delivery port 120) positioned at a first distance away from the distal opening to stop insertion of the needle past a threshold depth of insertion into the access port lumen (Figures 7-8).
Regarding claim 12, Branch discloses the subdural evacuation port device of claim 10, wherein the primary evacuation opening (at end 205) is configured to connect to an evacuation device that is configured to provide suction through the primary lumen (“The body 204 further includes an end 205 that is configured to connect the housing drainage passageway 112 to a tube 26 (FIG. 2).” [0044]; “Drains and reservoirs used to carry out the present invention may be any suitable form, including electromechanical devices that apply a negative pressure, simple tube and bulb devices, etc., and may be connected to the subdural drainage system at any suitable position, such as the housing, the subdural drainage device, catheter, catheter support or subdural drainage port.” [0053]).
Regarding claim 13, Branch discloses the subdural evacuation port device of claim 10, further comprising a seal (sealing member 122) that seals the access port lumen to preserve suction within the primary lumen and that is penetrable by the needle (“a drug delivery device or needle 500 is inserted in the drug delivery port 120 via the sealing member 122. The sealing member 122 may be a self-sealing plug formed of an elastomeric material that is configured to reseal after it is punctured with the needle 500.” [0049]).
Regarding claim 14, Branch discloses the subdural evacuation port device of claim 10, further comprising a second needle access port (“two side delivery ports 120” [0043]; Figure 3) defining a second access port lumen (conduit 124) in communication with 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 second needle access port is configured direct a needle inserted within the second access port lumen into the primary lumen and at a location or an orientation that is different from that of a needle inserted within the access port lumen (Figure 8; “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.” [0049], wherein the two side delivery ports 120 are oriented opposite of each other relative to a longitudinal axis of the subdural evacuation port device).
Regarding claim 16, Branch discloses the subdural evacuation port device of claim 10, wherein the body is formed from a polymer (“The devices described herein may be rigid or somewhat flexible, and may be formed of any suitable polymeric, metallic, composite material or combination thereof.” [0052]).
Regarding claim 18, Branch discloses a kit for evacuating fluid from subdural space of a skull (“a subdural drainage device includes a subdural drainage housing defining a drainage passageway.” [0006]; “a kit comprises the device described above.” [0014]), comprising:
the subdural evacuation port device (subdural drainage device 100) of claim 10; and
a needle (needle 500) configured for insertion into the port lumen for removal of a blockage within the primary lumen (Figures 7-8).
Regarding claim 19, Branch discloses the kit of claim 18, wherein the needle access port of the subdural evacuation port device includes a stop surface (proximal outer surface of drug delivery port 120) positioned at a first distance away from the distal opening to stop insertion of the needle past a threshold depth of insertion into the access port lumen (Figures 7-8).
Regarding claim 21, Branch discloses the kit of claim 18, further comprising an evacuation device that is configured to provide suction through the primary lumen (The body 204 further includes an end 205 that is configured to connect the housing drainage passageway 112 to a tube 26 (FIG. 2).” [0044]; “Drains and reservoirs used to carry out the present invention may be any suitable form, including electromechanical devices that apply a negative pressure, simple tube and bulb devices, etc., and may be connected to the subdural drainage system at any suitable position, such as the housing, the subdural drainage device, catheter, catheter support or subdural drainage port.” [0053]).
Regarding claim 22, Branch discloses the kit of claim 21, wherein the evacuation device is a bulb pump (The body 204 further includes an end 205 that is configured to connect the housing drainage passageway 112 to a tube 26 (FIG. 2).” [0044]; “Drains and reservoirs used to carry out the present invention may be any suitable form, including electromechanical devices that apply a negative pressure, simple tube and bulb devices, etc., and may be connected to the subdural drainage system at any suitable position, such as the housing, the subdural drainage device, catheter, catheter support or subdural drainage port.” [0053]).
Regarding claim 23, Branch discloses the kit of claim 18, wherein the needle is hollow and includes a needle lumen (“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, antibiotic agents, and/or chemotherapy agents.” [0049]; Figures 7-8).
Regarding claim 25, Branch discloses a method of using the subdural evacuation port device of claim 10, comprising the steps of:
drilling a hole through a skull and dura of a patient (“placement of a tangential drainage catheter within the subdural space via a twist-drill craniostomy” [0003]; see Figure 2);
mounting the subdural evacuation port device to the hole via a skull engagement region surrounding a distal end of the body (Figure 2; threaded region at lower opening 114; “a threaded portion thereof is twisted into the skull” [0018]; “a SEPS device 10 is essentially a hollow screw placed in the skull 20 which communicates with the subdural space 22” [0004]; “The housing according to embodiments of the present invention may be configured to attach to existing subdural drainage devices, such as a subdural evacuation port system (or “SEPS”)” [0053]);
applying suction within the primary lumen to withdraw subdural fluid from the dura of the patient through the primary lumen (“The body 204 further includes an end 205 that is configured to connect the housing drainage passageway 112 to a tube 26 (FIG. 2).” [0044]; “the body 204 of the blockage removal unit 200 forms a generally hollow fluid chamber such that the fluid from the subdural space 22 is permitted to flow into the housing 110 from the opening 114 and through the apertures 206 into the body 204 of the unit 200 where it exits the body 204 at the end 205.” [0046]; “Drains and reservoirs used to carry out the present invention may be any suitable form, including electromechanical devices that apply a negative pressure, simple tube and bulb devices, etc., and may be connected to the subdural drainage system at any suitable position, such as the housing, the subdural drainage device, catheter, catheter support or subdural drainage port.” [0053]);
determining whether there is a blockage preventing subdural fluid from flowing through the primary lumen (“catheter obstruction and cessation of flow is often encountered.” [0003]); and
in response to determining that a blockage is preventing subdural fluid from flowing through the primary lumen, removing the blockage (“the deformable member 202 is configured to dislodge, reduce and/or remove blockages that may accumulate adjacent the opening 114 in the subdural space 22 (FIG. 2).” [0045]).
Regarding claim 27, Branch discloses the method of claim 25, further comprising removing the blockage by inserting a hollow needle (needle 500) through the access port lumen (conduit 124) into the primary lumen (“With reference to FIGS. 7-8, 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.” [0049]).
Regarding claim 28, Branch discloses the method of claim 27, further 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]).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Branch, Jr. et al. (US 20170291017) in view of Anzai (US 20180369556).
Regarding claim 2, Branch discloses the subdural evacuation port device of claim 1.
Branch fails to explicitly disclose the polymer has a substantially low thrombogenicity.
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 (“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]).
Claims 3, 7, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Branch, Jr. et al. (US 20170291017) in view of Ghodke et al. (US 20130158578).
Regarding claim 3, Branch discloses the subdural evacuation port device of claim 1.
Branch fails to explicitly disclose the subdural evacuation port device is compatible for use during computerized tomography (CT) scans.
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 Branch to be compatible for use during CT scans based on the teachings of Ghodke to facilitate both navigation and data acquisition during use of the subdural evacuation port device (Ghodke [0057], [0078]).
Regarding claim 7, Branch discloses the subdural evacuation port device of claim 1.
Branch fails to explicitly disclose the polymer is optically transparent.
Ghodke discloses a subdural port device (skull mount 200) made of a polymer (“skull mount 200 can be made primarily of a low-cost, hard plastic.” [0052]) that is optically transparent (“the catheterization portal can be substantially transparent to fluoroscopy or be substantially transparent to fluoroscopy” [0057]).
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 Branch to be made of a polymer that is optically transparent based on the teachings of Ghodke to ensure the subdural evacuation port device is compatible for use with during CT scans to facilitate both navigation and data acquisition during use of the subdural evacuation port device (Ghodke [0057], [0078]).
Regarding claim 15, Branch discloses the subdural evacuation port device of claim 10.
Branch fails to explicitly disclose the subdural evacuation port device is compatible for use during computerized tomography (CT) scans.
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 Branch to be compatible for use during CT scans based on the teachings of Ghodke to facilitate both navigation and data acquisition during use of the subdural evacuation port device (Ghodke [0057], [0078]).
Regarding claim 17, Branch discloses the subdural evacuation port device of claim 10.
Branch fails to explicitly disclose the subdural evacuation port device is formed from an optically transparent material.
Ghodke discloses a subdural port device (skull mount 200) made of a the subdural evacuation port device is formed from an optically transparent material (“skull mount 200 can be made primarily of a low-cost, hard plastic.” [0052]; “the catheterization portal can be substantially transparent to fluoroscopy or be substantially transparent to fluoroscopy” [0057]).
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 Branch to be formed from an optically transparent material based on the teachings of Ghodke to ensure the subdural evacuation port device is compatible for use with during CT scans to facilitate both navigation and data acquisition during use of the subdural evacuation port device (Ghodke [0057], [0078]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Branch, Jr. et al. (US 20170291017) in view of Okiyama et al. (US 20110160679).
Regarding claim 4, Branch discloses the subdural evacuation port device of claim 1.
Branch fails to explicitly disclose the polymer is polyacetal.
Okiyama discloses a medical port device (Figure 2) having a body (cover 2) formed of a polymer that is polyacetal (“polyacetal…are preferable as the material for the cover 2 in view of the chemical resistance, heat resistance, and the like.” [0055]).
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 polyacetal based on the teachings of Okiyama to ensure the subdural evacuation port device has sufficient strength and chemical resistance (Okiyama [0055]).
Claims 9, 26, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Branch, Jr. et al. (US 20170291017) in view of Asfora (USPN 8343138).
Regarding claim 9, Branch discloses the subdural evacuation port device of claim 8, wherein the threads (threaded region at lower opening 114; Figure 2) are fluted (Figure 2, see longitudinal extending fluids at lower opening 114).
Branch fails to explicitly disclose the threads are self-tapping.
Asfora discloses a subdural evacuation port device (subdural evacuating port device 10) comprising a skull engagement region (exterior surface 44) comprising threads (threads 46) that are fluted (via longitudinal groove 48) and self-tapping (“a longitudinal groove 48 may extend through the self-tapping threads 46 to produce thread cutting surfaces on the exterior surface 44.” [Col 7, lines 14-17]).
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 threads of Branch to be fluted and self-tapping to engage the skull and prevent unintentional withdrawal of the device (Branch [Col 8, line 20-24]).
Regarding claim 26, Branch discloses the method of claim 25.
Branch fails to explicitly disclose determining the cause of the blockage by performing a CT scan.
Asfora discloses a method of using a subdural evacuation port device (subdural evacuation portion aspiration system 80 with port aspiration device 80; Figure 8), comprising the steps of mounting the subdural evacuation port device to a drilled hole via a skull engagement region (Figure 7; “An opening 8 is created in the skull 2 of the patient using the drill bit 14 mounted in the drill device 12…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 3-23]); and determining the cause of a blockage by performing a CT scan (“determining the region of the scalp 1 of the patient that is adjacent to the location of the collection of fluid in the subdural space…The location of the greatest dimension of the fluid collection may be determined by performing an imaging study of the head of the patient using, for example, computerized tomography or magnetic resonance imaging to determine the extent of the collection of fluid. Once the greatest dimension of the collection of fluid is determined, the location of the opening to be made through the skull 2 to the subdural cavity is selected on the scalp 1 at a substantially central location corresponding to the greatest dimension of the collection of fluid.” [Col 7, lines 43-59]).
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 Branch to include determining the cause of the blockage by performing a CT scan based on the teachings of Asfora to identify the target area and best method for removing the blockage (Asfora [Col 12, lines 49-55]).
Regarding claim 29, Branch discloses the method of claim 27.
Branch fails to explicitly disclose suctioning the blockage using the needle.
Asfora discloses a method of using a subdural evacuation port device (subdural evacuation portion aspiration system 80 with port aspiration device 80; Figure 8), comprising the steps of mounting the subdural evacuation port device to a drilled hole via a skull engagement region (Figure 7; “An opening 8 is created in the skull 2 of the patient using the drill bit 14 mounted in the drill device 12…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 3-23]); determining there is a blockage preventing subdural fluid from flowing through a primary lumen (“The method may be useful when 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. Such obstructions may also occur in the subdural space just outside the evacuating lumen 42, such as when an agglomeration too large to pass through the evacuating lumen is drawn by the negative pressure toward the port device 10.” [Col 12, lines 49-55]); and inserting a hollow needle through an access port lumen (aspiration channel 84) into the primary lumen and suctioning the blockage using the needle (evacuating lumen 42; “The obstruction may then be removed by aspiration or by dissolution.” [Col 12, lines 56-57]; “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 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 34-44]).
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 Branch to include suctioning the blockage using the needle based on the teachings of Asfora to assist in removing a blockage that is too large to pass through the primary lumen without additional intervention (Asfora [Col 12, lines 49-55]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Branch, Jr. et al. (US 20170291017) in view of Asfora (USPN 7694821).
Regarding claim 20, Branch discloses the kit of claim 18.
Branch fails to explicitly disclose the needle is a lumbar puncture needle.
Asfora discloses a kit (enhanced kit 100) comprising a subdural evacuation port device (subdural evacuating port device 10) and a needle (needle 148) that is a lumbar puncture needle (“the enhanced kit 100 may also include a needle 148 for penetrating the conduit 22, preferably at a location close to the installed subdural evacuating port device 10, to extend into the lumen of the port device 10. This needle, which may be a spinal needle of a size of 18 G.times.3.5 inches (approximately 9 cm), may be useful for passing through the lumen of the port device 10 after it has been installed to dislodge and clear blockages from blood clots that may occur adjacent to or in the lumen of the port device 10 that may block drainage or evacuation of the subdural area of the patient.” [Col 10, lines 13-23]).
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 needle of the kit of Branch to be a lumbar puncture needle based on the teachings of Asfora to clear blockages due to blood clots within the primary lumen that are occluding drainage of the subdural area (Asfora [Col 10, lines 13-23]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Branch, Jr. et al. (US 20170291017) in view of Piferi (US 20150080708).
Regarding claim 24, Branch discloses the kit of claim 23.
Branch 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 modify the kit 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]).
Conclusion
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