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
Applicant amended claims 1 and 11. Claims 1-20 are currently pending.
Response to Arguments
Applicant’s arguments, see page 5 of Applicant’s Remarks, filed 07/23/26, with respect to the rejection of claims 2-10 under 35 U.S.C. 112(b) have been fully considered and are not persuasive. Applicant argues that the amendments cure the rejections under 35 U.S.C. 112(b). However, amended claim 1 as written recites a method, and dependent claims 2-10 still recite “the method and device …”. Therefore, from amended claim 1 as written, it is not clear what device is being referred to in dependent claims 2-10. Applicant similarly deleted the term “device” from independent claim 11, and therefore it is similarly unclear what device is being referred to by dependent claims 12-20 from the claims as written.
Applicant’s arguments, see pages 5-7 of Applicant’s Remarks, with respect to the rejections of claims 1-3 and 11-13 under 35 U.S.C. 102(a)(1) as being anticipated by Waziri have been fully considered and are not persuasive.
Applicant argues that Waziri discloses an external ventricular drain (EVD), while the claimed invention is a method comprising a procedure that places a non-penetrating subdural drain electrode in a location where it rests on the cortical surface within the subdural space, between the brain and the inner table of the skull. However, claim 1 as written recites a method comprising the steps of placing a subdural electrode strip and drain tube having a distal tip between the brain and skull on the cortex of the patient. Claim 11 as written recites a method of placing a subdural assembly comprising a drainage tube and an electrode strip is placed between the brain and skull of a patient. The claims as written do not require the electrode strip and drainage tube to be non-penetrating, and therefore do not exclude the device of Waziri from their scope. Furthermore, the device of Waziri is placed within the skull of the patient and in contact with the cortex of the patient, and therefore comprises a portion between the brain and skull and on the cortex as required by the claims as written. Waziri further discloses that that one or more of the electrodes may be positioned to record data from the subdural space (¶0048), and because the device of Waziri necessarily passes through the subdural space, it comprises a portion within the subdural space.
Applicant further argues, see page 7, that the claimed drain is a flexible strip designed to conform to the cortical surface, and that this is in contrast to the structurally rigid device of Waziri. However, the claims as written make no mention of whether or not the device should be rigid or flexible and conforming. Applicant further argues that the claimed device has perforations along its entire length, in contrast to the device of Waziri having drainage openings clustered at the distal tip. However, the claims as written do not recite that a device comprising perforations along its entire length, and claims 5 and 15 in fact recite perforations along the distal portion of the tip.
Applicant’s arguments, see pages 7-9, with respect to the rejections of claims 4-5 and 14-15 under 35 U.S.C. 103 as being unpatentable over Waziri in view of Sklar have been fully considered and are not persuasive.
With respect to claims 4 and 14, applicant argues that a skilled artisan would have had no motivation to trim the distal tip of an external ventricular drain (EVD) like the one disclosed by Waziri because the insertion depth of an EVD is set by using depth markings on the catheter and would remove distal drainage holes and defeat the device’s purpose. However, Sklar teaches a device (Figs. 1 and 11, feat. 10; ¶0029) which may drain small volumes of CSF from the ventricle (Fig. 11, feat. V; ¶0034-0037) and which may have a tube which is cuttable or trimmable in order to adjust its length to fit the patient’s anatomy (¶0047).
With respect to claims 5 and 15, applicant argues that the distal tip perforations of Waziri function to drain CSF from the ventricles of the brain, while the distal tip perforations of the claimed invention function to drain blood and fluid from the subdural space along the surface of the cortex. However, the claims as written only require the presence of perforations that function as drainage holes, and therefore the perforations of Waziri fall within the scope of the claimed invention.
Applicant’s arguments, see pages 9-10, with respect to the rejections of claims 6-10 and 16-20 under 35 U.S.C. 103 as unpatentable over Waziri in view of Sklar and in further view of Folzenlogen have been fully considered and are not persuasive. Because the combination of Waziri in view of Sklar suggests methods and devices which fall within the scope of claims 5 and 15, because Folzenlogen teaches or renders obvious the subject matter of claims 6-8 and 16-18, the combination of Waziri, Sklar, and Folzenlogen suggests the methods and devices of claims 6-10 and 16-20.
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 2-10 and 12-20 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.
Claims 2-10 are directly or indirectly dependent on claim 1, and each recite “The method and device …”. Similarly, claims 12-20 are directly or indirectly dependent on claim 11, and each recite “The method and device …”. Claims 1 and 11 each recite methods, but it is unclear what the devices of claims 1 and 11 are intended to be from the claims as written. Based on ¶00011 and 00015-00018 of the present specification, the claimed devices appear to be intended to be the assembly comprising the subdural electrode strip and drain tube. Therefore, for the purpose of interpretation, claims 1 and 11 were interpreted as though it also recited a device comprising a subdural electrode strip and drain tube.
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 1-3 and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Waziri et al. (US 2010/0168532 A1).
Regarding claim 1, Waziri discloses a method for monitoring patients undergoing cSDH evacuation for spreading depolarization (¶0019-0020, 0080-0097, and Table 1: the disclosed method is for monitoring the electrical activity of the cortex of a patient and may be used with patients having hematomas drained) comprising the steps of: placing a subdural electrode strip (Fig. 1, feat. 5; ¶0045) and drain tube (2; ¶0019-0020 and 0045) having a distal tip (4; ¶0045) between the brain and skull on the cortex of the patient (¶0019-0020 and 0045). Regarding claim 2, Waziri further discloses that the electrode strip (5) includes a plurality of electrodes located inside said distal tip of said drain tube (¶0049: the electrodes may be placed along the entire length of the device, including the distal end). Regarding claim 3, Waziri further discloses that said electrode strip (5) includes six platinum electrodes (¶0049 and 0053).
Regarding claim 11, Waziri discloses a method (¶0019-0020) wherein, at the time of surgery, a subdural assembly (Fig. 1, feat. 1; ¶0045) comprising a drainage tube (2; ¶0045) and an electrode strip (5; ¶0045) is placed between the brain and skull (¶0019-0020 and 0045) of a patient undergoing cSDH evacuation (¶0019-0020, 0080-0097 and Table 1). Regarding claim 12, Waziri further discloses that the electrode strip (5) includes a plurality of electrodes located inside said distal tip of said drain tube (¶0049: the electrodes may be placed along the entire length of the device, including the distal end). Regarding claim 13, Waziri further discloses that said electrode strip (5) includes six platinum electrodes (¶0049 and 0053).
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 4-5 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Waziri in view of Sklar (US 2021/0244922 A1).
Regarding claim 4, Waziri discloses the method and device of claim 2, but is silent with respect to the drain tube including a trimmable distal tip.
Sklar teaches a CSF drainage device (Figs. 1 and 11, feat. 10; ¶0029) comprising a drainage catheter tube (30) with a distal end (34). Sklar teaches that the drainage catheter tube may be cuttable or trimmable in order to adjust its length to fit the patient’s anatomy (¶0047). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method and device disclosed by Waziri so that the drain tube includes a trimmable distal tip in order to allow its length to be adjusted to fit the patient’s anatomy as taught by Sklar.
Regarding claim 5, Waziri in view of Sklar suggests the method and device of claim 4, and Waziri further discloses that said drain tube (Fig. 1, feat. 2) includes perforations that function as drainage holes (14) along the distal portion (13) of said tip (4; ¶0045).
Regarding claim 14, Waziri discloses the method and device of claim 12, but is silent with respect to the drain tube including a trimmable distal tip.
Sklar teaches a CSF drainage device (Figs. 1 and 11, feat. 10; ¶0029) comprising a drainage catheter tube (30) with a distal end (34). Sklar teaches that the drainage catheter tube may be cuttable or trimmable in order to adjust its length to fit the patient’s anatomy (¶0047). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method and device disclosed by Waziri so that the drain tube includes a trimmable distal tip in order to allow its length to be adjusted to fit the patient’s anatomy as taught by Sklar.
Regarding claim 15, Waziri in view of Sklar suggests the method and device of claim 14, and Waziri further discloses that said drain tube (Fig. 1, feat. 2) includes perforations that function as drainage holes (14) along the distal portion (13) of said tip (4; ¶0045).
Claims 6-10 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Waziri in view of Sklar and in further view of Folzenlogen et al. (US 2020/0170748 A1).
Regarding claims 6-7, Waziri in view of Sklar suggests the method and device of claim 5, but does not disclose that one or more bolt channels configured to angularly direct said electrode strip and said drain tube, with respect to claim 6, or that one or more bolt channels configured to angularly direct said electrode strip and said drain tube at an angle of 90°, with respect to claim 7.
Folzenlogen teaches an intracranial guide system for evacuating a subdural hematoma (¶0002 and 0010) comprising a port (Figs. 1A-E and 24, feat. 4; ¶0068-0071) with a threaded stem (8), like a bolt, and a lumen (10) extending through the stem. In use, the port is anchored in a burr hole in the patient’s skull (Fig. 24, feat. 80) such that the distal end of the stem extends no more than 8 mm beyond the interior surface of the skull (¶0100). The system further includes a cannula (Figs. 11-12, feat. 160; ¶0103-0111) with a shaft (162) for insertion through the port’s lumen and into the patient’s skull no more than 8 mm beyond the interior surface of the skull (¶0104). The cannula shaft (Figs. 11A-F, feat. 162) comprises at least one channel (180A-B) with an exit port (182A-B) oriented angularly with about an angle of 90° to guide and direct a drainage catheter during evacuation of the subdural hematoma (¶0107-0108). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method and device suggested by Waziri in view of Sklar so that it includes one or more bolt channels configured to angularly direct said electrode strip and said drain tube, with respect to claim 6, or one or more bolt channels configured to angularly direct said electrode strip and said drain tube at an angle of 90°, with respect to claim 7, in order to guide and direct the drainage tube during evacuation of the subdural hematoma as taught by Folzenlogen.
Regarding claim 8, Waziri in view of Sklar and in further view of Folzenlogen suggested the method and device of claim 7. As discussed above, Folzenlogen teaches that, in use, the port and cannula, which comprise the claimed bolt channels, should extend no more than 8 mm beyond the interior surface of the skull, or a maximum of an 8 mm inset, in order to reduce the risk of injuring the patient’s brain as it expands as the subdural hematoma is drained (¶0100 and 0104). This prior art range of an inset less than 8 mm overlaps the claimed inset of 2 mm or less, and therefore a prima facie case exists for the claimed inset range. Please see MPEP §2144.05(I). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method and device suggested by Waziri in view of Sklar and in further view of Folzenlogen so that the bolt channels are fully inserted with a 2 mm inset into the subdural space in order to reduce the risk of injuring the patient’s brain as it expands as the subdural hematoma is drained.
Regarding claims 9-10, Waziri in view of Sklar and in further view of Folzenlogen suggests the method and device of claim 8, and Waziri further discloses that the method and device may further include an ICP sensor (¶0075), with respect to claim 9, and that the method and device may further include an ICP sensor located at said tip (¶0075: ICP sensor may be mounted at the tip of a catheter and the drain tube of Waziri is a catheter), with respect to claim 10.
Regarding claims 16-17, Waziri in view of Sklar suggests the method and device of claim 15, but does not disclose that one or more bolt channels configured to angularly direct said electrode strip and said drain tube, with respect to claim 16, or that one or more bolt channels configured to angularly direct said electrode strip and said drain tube at an angle of 90°, with respect to claim 17.
Folzenlogen teaches an intracranial guide system for evacuating a subdural hematoma (¶0002 and 0010) comprising a port (Figs. 1A-E and 24, feat. 4; ¶0068-0071) with a threaded stem (8), like a bolt, and a lumen (10) extending through the stem. In use, the port is anchored in a burr hole in the patient’s skull (Fig. 24, feat. 80) such that the distal end of the stem extends no more than 8 mm beyond the interior surface of the skull (¶0100). The system further includes a cannula (Figs. 11-12, feat. 160; ¶0103-0111) with a shaft (162) for insertion through the port’s lumen and into the patient’s skull no more than 8 mm beyond the interior surface of the skull (¶0104). The cannula shaft (Figs. 11A-F, feat. 162) comprises at least one channel (180A-B) with an exit port (182A-B) oriented angularly with about an angle of 90° to guide and direct a drainage catheter during evacuation of the subdural hematoma (¶0107-0108). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method and device suggested by Waziri in view of Sklar so that it includes one or more bolt channels configured to angularly direct said electrode strip and said drain tube, with respect to claim 16, or one or more bolt channels configured to angularly direct said electrode strip and said drain tube at an angle of 90°, with respect to claim 17, in order to guide and direct the drainage tube during evacuation of the subdural hematoma as taught by Folzenlogen.
Regarding claim 18, Waziri in view of Sklar and in further view of Folzenlogen suggested the method and device of claim 17. As discussed above, Folzenlogen teaches that, in use, the port and cannula, which comprise the claimed bolt channels, should extend no more than 8 mm beyond the interior surface of the skull, or a maximum of an 8 mm inset, in order to reduce the risk of injuring the patient’s brain as it expands as the subdural hematoma is drained (¶0100 and 0104). This prior art range of an inset less than 8 mm overlaps the claimed inset of 2 mm or less, and therefore a prima facie case exists for the claimed inset range. Please see MPEP §2144.05(I). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method and device suggested by Waziri in view of Sklar and in further view of Folzenlogen so that the bolt channels are fully inserted with a 2 mm inset into the subdural space in order to reduce the risk of injuring the patient’s brain as it expands as the subdural hematoma is drained.
Regarding claims 19-20, Waziri in view of Sklar and in further view of Folzenlogen suggests the method and device of claim 18, and Waziri further discloses that the method and device may further include an ICP sensor (¶0075), with respect to claim 19, and that the method and device may further include an ICP sensor located at said tip (¶0075: ICP sensor may be mounted at the tip of a catheter and the drain tube of Waziri is a catheter), with respect to claim 20.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Rosengart et al. (WO 2018/038930 A1) discloses an intracranial drainage catheter with electrodes for monitoring cortical activity, with or without combined brain fluid drainage.
Lieberman (US 2005/0043673 A1) discloses a method and apparatus for irrigation and drainage of the subdural space.
Papanastassiou (US 2020/0353134 A1) discloses systems and methods for evacuating subdural hematomas.
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 ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 5712727159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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