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 .
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.
Claim 88 and all dependents there of are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 88 recites “the steady-streaming fluid velocities” in line 1. However, a steady-streaming fluid velocity has not been introduced. Thus it appears the claim should recite –a steady-streaming fluid velocities--.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 67-70, 74-77, 79-82, 86, 89, 92-94 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anand et al. (US 2019/0143037 A1).
With regard to claim 67, Anand discloses A fluid delivery system (Fig. 1, 2 and 3) comprising: a pump device including a first syringe (one of 34 or 42) configured to contain a therapeutic bolus (syringe would be capable of containing a bolus), a second syringe (other of 34 or 42) configured to contain a flush fluid (syringe would be capable of containing a flush fluid), and one or more drivers (58/62) configured to cause the therapeutic bolus and the flush fluid to be expelled from the first and second syringes ([0035]), respectively; a fluid delivery device (catheters 26 connected to the syringes, shown in Fig. 1) fluidly coupled to the plurality of syringes; and a controller (82) configured to: control operation of the pump device to expel the therapeutic bolus from the first syringe and deliver the therapeutic bolus to the fluid delivery device for a first infusion into an intrathecal space of a patient in a first location ([0054], [0033]), ; and subsequently control operation of the pump device to expel the flush fluid from the second syringe and deliver flush fluid to the fluid delivery device at one or more flush flow rates for a second infusion into the intrathecal space of the patient in a second location ([0073], both syringe barrels 42 may be used to infuse a fluid into the location 14. A second fluid is infused into the target location from a second syringe 34, the delivery of the second fluid is sequential and follows the delivery of the first fluid. The first and second location are not indicated to be the same or different and therefore can be considered the same) , the one or more flush flow rates based on at least one of patient anatomy or physiology ([0033], flowrate is entered based on what is necessary for the patient and therefore must be determined by some type of anatomy or physiology).
With regard to claim 68, Anand discloses wherein the first location is within a lumbar region (see Fig. 1, showing lumbar region 14) up to a cistern magna region of the patient for infusion of the therapeutic bolus; and the second location is within a lumbar region up to a cisterna magna region of the patient for infusion of the flush fluid (second location is also at 14 considered a lumbar region).
With regard to claim 69, Anand discloses wherein the first location is within a thoracic region up to the cervical region (claims only recite that the device is configured to deliver within the thoracic region up to the cervical region and therefore must only be capable of doing so, because the catheters and device are designed to be used in the spine it would be capable of delivering to these specific regions); and the second location is within the lumbar region up to a cervical region (location 14).
With regard to claim 70, Anand discloses wherein the fluid delivery device comprises a catheter (26), the catheter including: a first lumen with a first fluid port, the first lumen sized to position the first fluid port at the first location (see Fig. 1); and a second lumen (other of 26) with a second fluid port, the second lumen sized to position the second fluid port at the second location (there are two catheters 26 that are attached to each of the first and second syringes, respectively, and therefore would be sized and positioned to delivery to the first and second locations).
With regard to claim 74, Anand discloses wherein the catheter comprises an atraumatic tip (catheters 26 are inherently flexible and would be considered to have a tip that is atraumatic without further distinction of the structure of the tip).
With regard to claim 75, Anand discloses wherein the second location is spaced caudally from the first location (claims only recite that the device is configured to deliver a first and second location and therefore must only be capable of doing so, because the catheters and device are designed to be used in the spine it would be capable of delivering to these specific regions. Further significance or placement limitations would be needed to overcome the current rejection).
With regard to claim 76, Anand discloses wherein the first location and the second location are in a same region of the intrathecal space (at 14).
With regard to claim 77, Anand discloses wherein the fluid delivery device comprises a lumbar puncture needle ([0063], [0003]) fluidly coupled to the plurality of syringes, the lumbar puncture needle comprising a lumen with a fluid port (needle would inherently have a port); and wherein the controller is configured to: control operation of the pump device to expel the therapeutic bolus from the first syringe and deliver the therapeutic bolus to the lumbar puncture needle for the first infusion through the fluid port of the lumbar puncture needle into the intrathecal space of the patient in the first location ([0054], [0033]); and subsequently control operation of the pump device to expel the flush fluid from the second syringe and deliver flush fluid to the lumbar puncture needle at the one or more flush flow rates for the second infusion through the fluid port of the lumbar puncture needle into the intrathecal space of the patient in the second location ([0073], both syringe barrels 42 may be used to infuse a fluid into the location 14. A second fluid is infused into the target location from a second syringe 34, the delivery of the second fluid is sequential and follows the delivery of the first fluid. The first and second location are not indicated to be the same or different and therefore can be considered the same).
With regard to claim 79, Anand discloses wherein the controller is internal to the pump device (see Fig. 3, showing controller inside pump housing 30).
With regard to claim 80, Anand discloses further comprising a pressure sensor (94) configured to measure cerebrospinal fluid (CSF) pressure of the patient ([0007], [0059] sensor monitors patient pressure); and wherein the controller is in communication with the pressure sensor and configured to at least one of: stop the first infusion or the second infusion in response to determining that the CSF pressure exceeds a predetermined threshold ([0076]); reduce the one or more flush flow rates in response to determining that the CSF pressure exceeds a predetermined threshold; or begin the second infusion in response to determining that the CSF pressure indicates an ascending or descending phase of a waveform.
With regard to claim 81, Anand discloses wherein the pressure sensor is in line (96, [0076]) or coupled to the catheter along the length thereof to be positioned within the intrathecal space of the patient.
With regard to claim 82, Anand discloses further comprising a display (38) configured to provide a user interface.
With regard to claim 86, Anand discloses wherein the at least one of patient anatomy or physiology data comprises data obtained from patient imaging and tests, and computations performed on the patient imaging and tests ([0073], imaging agent used to confirm placement can be considered gathering physiological data).
With regard to claim 89, Anand discloses wherein the target area is the spine (see Fig. 1, location 14).
With regard to claim 92, Anand discloses further comprising the therapeutic bolus and the flush fluid, at least one of the therapeutic bolus or the flush fluid comprising a contrast agent ([0049]).
With regard to claim 93, Anand discloses further comprising the therapeutic bolus, wherein the therapeutic bolus comprises a nucleic acid, a protein therapeutic, a cell therapy, a small molecule therapeutic, a viral vector encoding a therapeutic protein, or a combination thereof ([0041]).
With regard to claim 94, Anand discloses wherein therapeutic bolus comprises the nucleic acid selected from the group consisting of an antisense oligonucleotide, a ribozyme, an miRNA, an siRNA, and shRNA, or a nucleic acid encoding a clustered regularly interspaced short palindromic repeats (CRISPR) associated protein (Cas) system, or a combination thereof ([0041]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 71, 72, 73, 78 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anand et al. (US 2019/0143037 A1) in view of Heruth (US 5,713,858).
With regard to claim 71, Anand discloses the first and second lumen but not where the first lumen is received by the second lumen.
Heruth teaches concentric lumens (Fig. 3, first lumen 24 received within lumen 16) at the end of a catheter.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anand with the first lumen received within the second lumen as taught by Heruth for the purpose of consolidating the separate catheters of Anand into a single instrument for insertion (Col 5, line 66 to Col 6, line 20).
With regard to claim 72, Anand disclose the claimed invention except for a valve.
Heruth teaches further comprising a valve (fig. 3, element 25) configured to allow a length of the first lumen to be adjusted relative to the second lumen while maintaining a fluid seal of the second lumen (see Fig. 3).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anand with the valve as taught by Heruth for the purpose of preventing bodily fluids from entering into the guiding catheter (Col 6, lines 28-36).
With regard to claim 73, Anand discloses wherein the controller is configured to: control operation of the pump device to expel the therapeutic bolus from the first syringe and deliver the therapeutic bolus to the catheter for the first infusion through the fluid port of the catheter into the intrathecal space of the patient in the first location ([0033], [0054]); and subsequently control operation of the pump device to expel the flush fluid from the second syringe and deliver flush fluid to the introducer needle at the one or more flush flow rates for the second infusion through the fluid port of the introducer needle into the intrathecal space of the patient in the second location ([0073], both syringe barrels 42 may be used to infuse a fluid into the location 14. A second fluid is infused into the target location from a second syringe 34, the delivery of the second fluid is sequential and follows the delivery of the first fluid. The first and second location are not indicated to be the same or different and therefore can be considered the same).
However, Anand does not disclose the needle having a lumen with the catheter capable of being threaded.
Heruth teaches wherein the fluid delivery device comprises: an introducer needle (22, Fig. 1) fluidly coupled to the plurality of syringes, the introducer needle comprising a lumen with a fluid port (lumen within 22, and port at a distal end to receive element 24); and a catheter (24) fluidly coupled to the plurality of syringes and configured to be threaded through the lumen of the introducer needle (configured to language is functional and the catheter must only be capable of being threaded. Thus the catheter of 24 could be rotated or threaded while being placed through the needle 22), the catheter comprising a lumen with a fluid port (catheter inherently has a port at its ends).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anand with the catheter capable of being threaded through an introducer needle as taught by Heruth for the purpose of accessing the patient body through an access port (Col 4, lines 24-36).
With regard to claim 78, Anand discloses the claimed invention including the controller is configured to at least one of: control operation of the pump device to expel the therapeutic bolus from the first syringe and deliver the therapeutic bolus to the needle for the first infusion through the one or more fluid outlets of the plug-in port into the intrathecal space of the patient in the first location ([0054], [0033]); or control operation of the pump device to expel the flush fluid from the second syringe and deliver flush fluid to the needle at the one or more flush flow rates for the second infusion through the one or more fluid outlets of the plug-in port into the intrathecal space of the patient in the second location ([0073], both syringe barrels 42 may be used to infuse a fluid into the location 14. A second fluid is infused into the target location from a second syringe 34, the delivery of the second fluid is sequential and follows the delivery of the first fluid. The first and second location are not indicated to be the same or different and therefore can be considered the same).
However, Anand does not disclose the plug-in ports.
Heruth teaches further comprising one or more plug-in ports (Fig. 1 element 17), each having a septum (20) and one or more fluid outlets (at 18), the plug-in ports configured to be implanted in the patient (As shown in Fig. 1); and wherein the drug delivery member comprises a needle (22) configured to pierce the septum of one of the plug-in ports to deliver fluid thereto (as shown in Fig. 1).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anand with the plug-in ports as taught by Heruth to provide an easy access location for multiple uses of drug delivery to the same location (Col 4, lines 24-36).
Claim(s) 83 and 84 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anand et al. (US 2019/0143037 A1) in view of Martinez et al. (US 2019/0290481 A1).
With regard to claim 83 and 84, Anand discloses the claimed invention except for the specification calculation of the flow rate.
Claim 83: Martinez teaches a catheter for delivery into an intrathecal space ([0008]). Martinez further teaches wherein the one or more flow rates are calculated using: estimated or measured steady-streaming fluid velocities of cerebrospinal fluid ([0067]-[0070]) within the intrathecal space of the patient between the first location and the target area divided into one or more axial sections; and estimated or measured axial cross-sectional areas of the one or more axial sections ([0067]-[0070] drained CSF volumes can be used to indicate size of the intrathecal space).
Claim 84, Martinez teaches wherein the one or more flush flow rates are based on averages of the steady-streaming fluid velocities or maximum values of the steady-streaming fluid velocities in the one or more axial sections ([0067]-[0070]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anand with the calculation of flow rate as taught by Martinez for the purpose of modulating the flow rate to create the desired flow ([0070]).
Claim(s) 87, 90 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anand et al. (US 2019/0143037 A1) in view of Heruth et al. (US 2005/0137578 A1) (hereinafter referred to as Heruth II).
With regard to claim 87, Anand discloses the claimed invention except for the specific type of patient anatomy.
Heruth II teaches wherein the at least one of patient anatomy or physiology data comprises one or more of: patient age, patient sex, patient size, patient CSF volume, patient CSF dynamics (as described in claim 36, flow rates are based on pressure which can be considered part of CSF dynamics, [0016], [0030]), patient respiration data, patient sleep data, patient anatomical geography, heart rate, or disease.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anand with the specific patient anatomy as taught by Heruth II for the purpose of generating flow dynamics that are specific to patient needs ([0016], [0030]).
With regard to claim 90, Anand discloses the claimed invention except for CSF.
Heruth II teaches further comprising the flush fluid, the flush fluid comprising an artificial cerebrospinal fluid or anti-inflammatory fluid ([0180]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anand with the CSF as the delivered agent as taught by Heruth II because the substitution of one known agent for another is well-known in the art and does not alter the overall function of the device ([0180]).
Claim(s) 88, 91 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anand et al. (US 2019/0143037 A1) in view of Bodner (US 2021/0077016 A1).
With regard to claim 88, Anand discloses the claimed invention except for using a computational or in vitro model.
Bodner teaches wherein the steady-streaming fluid velocities are estimated by a central nervous system computational or in vitro model for the patient using the at least one of patient anatomy or physiology data as input ([0033]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Anand with the computational model as taught by Bodner for the purpose of simulating real life situations ([0033]).
With regard to claim 91, Anand discloses the claimed invention except for changing the temperature of the therapeutic fluid.
Bodner teaches a buffer being colder than a temperature of the CSF ([0039]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Anand with the cooled bufer as taught by Bodner for the purpose of an additional aid in surveying the fluid flow within the cerebrospinal fluid of the patient ([0039]).
Claim(s) 95 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anand et al. (US 2019/0143037 A1) in view of DePasqua et al. (US 2021/0023293 A1).
With regard to claim 95, Anand discloses the claimed invention except for the specific agent being delivered.
DePasqua teaches wherein therapeutic bolus comprises the nucleic acid selected from the group consisting of an antisense oligonucleotide, a ribozyme, an miRNA ([0076]), an siRNA, and shRNA, or a nucleic acid ([0087]) encoding a clustered regularly interspaced short palindromic repeats (CRISPR) associated protein (Cas) system, or a combination thereof.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Anand with the nucleic acid or RNA as taught by DePasqua because the substitute of one agent for another is well-known in the art and does not alter the overall function of the claims ([0087]).
Claim(s) 96 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anand et al. (US 2019/0143037 A1) in view of Singh et al. (US 2015/0038949 A1).
With regard to claim 96, Heruth discloses the claimed invention except for the specific type of bolus.
Singh teaches wherein the therapeutic bolus comprises adeno-associated virus (AAV) vector DNA sequences ([0102]), recombinant AAV particles, or combinations thereof.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Anand with the specific bolus agent as taught by Singh because the substitute of one agent for another is well-known in the art and does not alter the overall function of the claims ([0102]).
Claim(s) 97, 98 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anand et al. (US 2019/0143037 A1) in view of Deverman et al. (US 2017/0204144 A1).
With regard to claim 97, Anand teaches the claimed invention except for the AAV vector.
Deverman teaches wherein the AAV vector RNA sequences encode miRNA sponge sequences that interfere with miRNA106a and Xist on the silent X- chromosome thereby slightly unfolding the chromosome and allowing re-expression of the silent healthy gene ([0134]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Anand with the specific bolus agent as taught by Deverman for the purpose of treating specific disease such as Parkinson’s, muscular atrophy etc. ([0134]).
With regard to claim 98, Anand disclose the claimed invention except for the specific therapy platform.
Deverman teaches conventional gene replacement ([0134]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Anand with the specific therapy platform as taught by Deverman for the purpose of treating specific disease such as Parkinson’s, muscular atrophy etc. ([0134]).
Allowable Subject Matter
Claim 85 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/Lauren P Farrar/Primary Examiner, Art Unit 3783