DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Response to Arguments
3. Applicant’s arguments with respect to claim(s) 1-3, 6-9, and 12 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.
Claim Rejections - 35 USC § 103
4. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
5. Claims 1-3, 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Njemanze U.S. 2005/0177212 (herein referred to as “Njemanze”), and in view of Vase U.S. 2020/0046953 (herein referred to as “Vase ‘953”), Khanna U.S. 2019/0083303 (herein referred to as “Khanna”), Klee U.S. 2012/0123270 (herein referred to as “Klee”), and Non-Patent Literature Three-dimensional computational modeling of subject-specific cerebrospinal fluid flow in the subarachnoid space by Gupta (herein referred to as “Gupta”).
6. Regarding Claim 1, Njemanze teaches a method of preventing brain death and ischemic injury by the rapid and safe cooling of the brain (para 0073, Fig. 1) accessible through a basal cisterna and sub-arachnoid space in an one-man field or hospital operation (para 0073) comprising:
a. inserting a specially design needle/cannula into the basal cisterna and sub-arachnoid space (Figs. 8, 15, and 17; para 0073, 0093);
c. providing a computer-controlled motorized system that pumps cooled solution into the needle/cannula placed in the cisterna magna (para 0085; 0095, “cooling solution is drawn from a refrigerated 137 or ice 138 cooled reservoir 139… could be computer controlled”);
d. circulating cooled solution through the basal cisterna and sub-arachnoid space to cool the subarachnoid vessels and brain cortex (para 0041, 0073, 0075);
e. monitoring brain parenchymal temperature and pressure through convexity burrholes that drain perfusate from the convexity sub-arachnoid space (para 0093, “burr hole 114… providing means of drainage of excess cerebrospinal fluid to maintain the desired intracranial pressure…”; para 0096, “monitored… for measurement of cerebral prefusion pressure 148, brain temperature 149”; para 0097) ; and
f. maintaining a predetermined parenchymal temperature and pressure (para 0097, “the normative data are used to set threshold values 158…”; Fig. 19).
Njemanze fails to teach the cannula is inserted under ultrasound control in the one-man field or hospital operation and that the cooled solution is artificial cerebrospinal fluid (aCSF) and generating a 3D ultrasound image of the basal cisterna and sub-arachnoid space in front of the tip of the needle/cannula by a phase array of ultrasound elements disposed in the tip of the needle/cannula.
Vase ‘953 teaches a method of analogous art (Fig. 1, para 0124) that circulates cooled artificial cerebrospinal fluid (para 0161, “cooling treatment module 42 may cool fluid passing there through…the added pre-cooled fluid may be a cooled saline, a cooled artificial CSF”). By circulating aCSF, this produces the same expected result of maintaining a desired pressure of the brain by the volume of the fluid. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Njemanze to have the cooled solution be an artificial CSF, as this produces the same expected result of circulating said solution in order to maintain a pressure in the brain.
Khanna teaches a method of analogous art (Figs. 1, 20, and 21; para 0062, 0065), comprising a placement guidance mechanism (para 0067), such that the guidance is under ultrasound control (para 0067, “placement of the catheter 1 intracranially… can be further facilitated by… ultrasound”). This aids the surgeon with visually placing the cannula at the proper target site (para 0067). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Njemanze to include ultrasound control to improve the method of placing the cannula in the correct location.
Klee teaches a method of analogous art (para 0003), wherein the method comprises generating ultrasound images of a target area in front of a tip of the needle/cannula by a phased array of ultrasound elements disposed in the tip of the needle/cannula (Fig. 1, ref num 120 = phased array of ultrasound elements disposed on the tip of the needle, ref num 100; para 0024, “a larger number of MUT arrays as linear arrays or 2D arrays may be realized. The arrays mounted on a catheter or on a needle can be used during minimally invasive surgery procedures e.g. neurosurgery procedures to realize along forward or sideward looking ultrasound images to support positioning of the needle or catheter”). This information can be used to guide the needle within the brain and prevent damage to the surrounding areas (para 0024). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Njemanze to generated ultrasound images of the target space in front of the tip of the needle in order to guide the needle to the target spot while avoiding damage to untargeted areas.
While Njemanze as modified by Klee fails to explicitly teach that the ultrasound images generated are 3D, as well as fails to explicitly teach the imaged areas by the basal cisterna and sub-arachnoid space, Gupta teaches a method in which a 3D ultrasound image is produced of the basal cisterna and sub-arachnoid space (Conclusion --, “anatomically accurate three-dimensional, transient computational model for the investigation of CSF dynamics in the inferior cranial and the superior spinal subarachnoid space”). This type of imaging produces subject specific modeling of CSF flow in the intracranial cavities, providing better insight for various CSF related disorders, and ultimately improving the treatment to these areas (Conclusion). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Njemanze to utilize a 3D ultrasound image model to the specific target areas, as this would improve the overall treatment to the target areas.
7. Regarding Claim 2, Njemanze as modified teaches the method of Claim 1, but fails to teach collection of the exiting aCSF in a sterile container below the patient without recycling.
Vase ‘953 teaches a method of analogous art (Fig. 4), wherein the method comprises a collection of exiting aCSF in a sterile container below the patient without recycling (Fig 4. Ref nums 40 and 50; para 0157, “may receive waste fluid via the fluid line 48…control a rate at which waste CSF passed along a waste outlet pathway to a collection apparatus 50 for disposal”). A waste management mechanism is utilized in order to provide inflammation management, such as controlling the pressure of the brain (para 0140, 0142, 0157). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Njemanze to include a collection of exiting aCSF in order to control the pressure on the brain, as well as provide inflammation management via a waste management mechanism.
8. Regarding Claim 3, Njemanze as modified teaches the method of claim 1, as well as recycling exiting aCSF through a closed filtering and cooling system with the aCSF recycled by the computer-controlled motorized system into the cisterna magna (para 0095, “the repeated cycling of the fluid provides cooling of the CSF…could be computer controlled”; Fig. 17).
9. Regarding Claim 6, Njemanze as modified teaches the method of claim 1, as well as performing procedures in neurological surgery, radiation therapy, stereotactic surgery, vascular surgery, ultrasound intervention, high energy proton-beam therapy, or other invasive or non-invasive therapy (para 0008).
10. Regarding Claim 7, Njemanze as modified teaches the method of claim 1, but fails to teach inserting sensors in a sub-arachnoid space of the brain and monitoring brain chemistry using the sensors inserting in the sub-arachnoid space.
11. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Njemanze, Vase ‘953, Khanna, Klee, and Gupta, and further in view of Mantle U.S. 2006/0161107 (herein referred to as “Mantle”).
12. Regarding Claim 8, Njemanze as modified teaches the method of claim 1, as well as positioning aCSF drainage burrholes toward the forehead of the skull to facilitate aCSF flow through the subarachnoid space by establishing convection cooling with the patient supine, facing upward to cause a differential between cooler fluid in the occipital area brain closer to the cisterna magna and the warmer fluid rising toward the forehead, resulting in a more efficient and rapid flow of aCSF out of the skull and a more rapid cooling effect.
Mantle teaches a method of analogous art (Fig. 1; para 0061-0062), such that the method comprises positioning aCSF drainage burrholes toward the forehead of the skull (Fig. 3C, ref num 31) to facilitated aCSF flow through the subarachnoid space by establishing convection cooling with the patient supine, facing upward (para 0061) to cause a differential between cooler fluid in the occipital area brain closer to the cisterna magna and the warmer fluid rising toward the forehead, resulting in a more efficient and rapid flow of aCSF out of the skull and a more rapid cooling effect (para 0022, 0061-0062). This improves distribution of the recirculated liquid to the targeted areas (para 0022, 0028). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Njemanze to position drainage burrholes towards the forehead in order to establish convection cooling, as this is a more efficient result of flow through the skull and liquid distribution to the target areas.
13. Claim 9 rejected under 35 U.S.C. 103 as being unpatentable over Klee and in view of Vase U.S. 2020/0188646 (herein referred to as “Vase ‘646”).
14. Regarding Claim 9, Klee teaches an apparatus (Fig. 1) comprising:
a. a needle having a tip for puncture through a patient’s skin (Fig. 1, ref num 160); and
b. a phase array of ultrasound elements (Fig. 1, ref num 120; para 0039, “an array of ultrasound transducers 120”) for generating an ultrasound image (para 0046-0047; Fig. 2a, ref num 124), the phase array being disposed in the tip of the needle, or being disposed externally to the tip of the needle (see Fig. 1).
d. wherein the phased array of ultrasound elements is configured to generate one or multiple planes of spatial viewing (see Fig. 1, para 0024, 0059).
Klee fails to teach a closed filtering and cooling system coupled to the needle.
Vase ‘646 teaches an apparatus of analogous art (Fig. 28), wherein the apparatus comprises a needle configured to puncture through a patient’s skin (Fig. 28, ref num 130) and a closed filtering and cooling system coupled to the needle (Fig. 28, ref nums 112 and 110; para 0179, “CSF being withdrawn from a cerebral ventricle using a first plurality of ports 132 of a catheter 130 and filtered by a filter 112 in a treatment unit 106, with the filtered CSF being returned to the cerebral ventricle using a second plurality of ports 134 of the catheter 130… provides cooling of a treatment site 102 using a temperature control unit 110 for cooling a heat transfer fluid that flows within the catheter 130 to change the temperature of the treatment site 102”). The filtering system is used in order to filter contaminants and cytokines out of the CSF, as this cleans the CSF that is then returned to the target site (para 0073). The cooling system cools fluid in order to cool the biologic fluid at the target site (para 0072). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Klee to include a closed filtering and cooling system coupled to the needle in order to properly treat the target area, such as filtering out contaminants and cooling the CSF.
15. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Klee and Vase ‘646, and further in view of Goyal U.S. 2022/0273322 (herein referred to as “Goyal”) and Chiang U.S. 2022/0304661 (herein referred to as “Chiang”).
16. Regarding Claim 12, Klee teaches the apparatus is to simplify rapid insertion by a single person that further comprises:
b. an ultrasound imaging system (Fig. 7, ref num 500) with audio capabilities communicated to the phased array in the tip of the needle to generate an image of all tissues from a skin surface down to a target tissue (para 0046-0047, 0062); and
c. a servo-controlled motorized inserter controlled by ultrasound imaging system to guide the needle into the cisterna magna using the ultrasound image data (para 0062; Fig. 7, ref num 220, 240).
Klee fails to teach the apparatus comprises (a) a semi-autonomous unit with a micro-controller with artificial intelligence; (b) the ultrasound imaging system is in a lightweight hand-held monitor.
Goyal teaches an apparatus of analogous art (para 0240), wherein the apparatus comprises a semi-autonomous unit with a microcontroller with artificial intelligence (para 0244, “the fluid cooling module includes a fluid pump and controller for pumping a calculated volume of cooling liquid through the cooling catheter”; para 0250, “aspiration pumps… using data through machine learning and artificial intelligences based algorithms to improve the pressure pulse and using the information gained from the first pressure pulse to improve the next pressure pulse based on the AI algorithms developed from the continuously growing database”; para 0248). Utilizing a controller with artificial intelligence improves control of the pressure during the procedure (para 0248, 0250). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing of the claimed invention to have modified Klee to include this microcontroller in order to improve control over the system.
Chiang teaches an apparatus of analogous art (para 0345, “helps the rapid delivery of cold perfusate into... hypothermic preservation of the brain”), such that the apparatus comprises an ultrasound imaging system (Fig. 29), such that the system includes a lightweight hand-held monitor (Fig. 29, ref num 2912; para 0333, “the wireless viewer 2912 residing on a handheld side”). By having the hand-held monitor, this lower costs with the apparatus (para 0383). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Klee to have the ultrasound imaging system include a handheld monitor in order to lower the costs of the apparatus.
Conclusion
17. 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.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
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