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 42 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 42 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) 34, 36, 41, 43, 46-47, 57, 61 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heruth et al. (US 2005/0137578 A1).
With regard to claim 34, Heruth discloses A method for fluid delivery to a target area in a central nervous system of a patient ([0195]), the method comprising: infusing a therapeutic bolus into an intrathecal space of a patient in a first location ([0193], delivery into a first and second spinal region, [0088], spinal region can refer to intrathecal space. [0189]); subsequently infusing a flush fluid into the intrathecal space of the patient in a second location ([0193], a second spinal location) at one or more flush flow rates (inherently a delivered fluid would be at a specific flow rates); wherein a volume of the flush fluid corresponds to a volume of cerebrospinal fluid (CSF) between the first location and the target area ([0180], volume delivered is balanced based on its location within the CSF ([0100] thus the volume delivered corresponds to a volume of CSF between the first location and the target area. Further term “corresponds” is broad and can be interpreted to simply mean that it relates in some way to the CSF, thus any volume delivery into the CSF would necessarily be considered to “correspond” or relate to the CSF); and the second location is spaced caudally from the first location (In one embodiment show in Fig. 6, a first delivery location at 327a can also have a second delivery location at 327b which is caudally from the first location), such that infusion of the flush fluid moves the therapeutic bolus rostrally to the target area (fluid delivered out of 327b in Fig. 6 would necessarily move rostrally because the location of the catheter in the spine as shown in Fig. 1b facing in a rostral direction (facing upwards)).
With regard to claim 36, Heruth discloses wherein the one or more flush flow rates are based on at least one of patient anatomy or physiology data ([0161], controller can adjust the pump assembly to a desired flow rate based on a preset program. Further [0016], [0030], teaches using specified flow rates based on pressure which is considered “physiology data”).
With regard to claim 41, Heruth discloses 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.
With regard to claim 43, Heruth discloses wherein the target area is the brain, the spine or combinations thereof (Fig. 1a and 1b, the target area is the spine or brain).
With regard to claim 46, Heruth discloses wherein the second location (Fig. 6, element 327b) is spaced caudally from the first location (Fig. 6, element 327a).
With regard to claim 47, Heruth discloses wherein the first location and the second location are in a same region of the intrathecal space ([0189], the catheter first and second location are located on a single catheter and thus would be considered to be in the same region of the intrathecal space).
With regard to claim 57, Heruth discloses wherein infusing the flush fluid comprises infusing an artificial cerebrospinal fluid or anti-inflammatory ([0194], anti-inflammatory) fluid into the intrathecal space of a patient in the second location at the one or more flush flow rates ([0194]).
With regard to claim 61, Heruth discloses wherein the therapeutic bolus comprises a nucleic acid, a protein therapeutic ([0005]), a cell therapy, a small molecule therapeutic, a viral vector encoding a therapeutic protein, or a combination thereof.
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) 35, 40, 42, 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heruth et al. (US 2005/0137578 A1) in view of Bodner (US 2021/0077016 A1).
With regard to claim 35, Heruth discloses the claimed invention except for imaging.
Bodner teaches a device for delivery into an intrathecal space (Fig. 1), and further teaches further comprising imaging the patient to determine the volume of the cerebrospinal fluid between the first location and the target area ([0005], [0009], [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 Heruth with imaging as taught by Bodner for the purpose of an additional aid in surveying the fluid flow within the cerebrospinal fluid of the patient ([0039]).
With regard to claim 40, Heruth discloses the claimed invention except for imaging.
Bodner teaches wherein the at least one of patient anatomy or physiology data comprises data obtained from patient imaging and tests ([0005], [0009], [0039]), and computations performed on the patient imaging and tests ([0005], [0009], [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 Heruth with imaging as taught by Bodner for the purpose of an additional aid in surveying the fluid flow within the cerebrospinal fluid of the patient ([0039]).
With regard to claim 42, Heruth 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 Heruth with the computational model as taught by Bodner for the purpose of simulating real life situations ([0033]).
With regard to claim 60, Heruth discloses claimed invention except for a contrast.
Bodner teaches wherein at least one of the therapeutic bolus or the flush fluid comprises a contrast agent ([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 Heruth with the contrast agent 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) 37-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heruth et al. (US 2005/0137578 A1) in view of Martinez et al. (US 2019/0290481 A1).
With regard to claim 37 and 38, Heruth discloses the claimed invention except for the specification calculation of the flow rate.
Claim 37: 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 38, 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 method of Heruth 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) 44-45, 62-63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heruth et al. (US 2005/0137578 A1) in view of DePasqua et al. (US 2021/0023293 A1).
With regard to claim 44 and 45, Heruth discloses the claimed invention except or a pressure sensor.
Claim 44: DePasqua teaches a similar device of delivery into the CSF and further teaches further comprising: measuring CSF pressure of the patient with a pressure sensor ([0240]; and stopping the infusion of the flush fluid or reducing the one or more flush flow rates in response to determining that the CSF pressure exceeds a predetermined threshold or drops below a predetermined threshold ([0240]).
Claim 45: DePasqua teaches further comprising: measuring CSF pressure of the patient with a pressure sensor ([0240]); and beginning the infusion of the flush fluid in response to determining that the CSF pressure indicates an ascending or descending phase of a waveform ([0240]).
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 Heruth with the pressure sensor as taught by DePasqua for the purpose of providing a safety measure to ensure only proper flow rates are being used ([0240]).
With regard to claim 62, Heruth 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 Heruth 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]).
With regard to claim 63, Heruth discloses the specific delivered agent.
DePasqua teaches wherein the therapeutic bolus comprises an antisense oligonucleotide ([0076] that targets mRNA encoding Huntington protein (HTT) or an antisense oligonucleotide that targets mRNA encoding survival motor neuron-2 (SMN2) ([0076]).
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 Heruth with the antisense oligonucleotides 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) 48-55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heruth et al. (US 2005/0137578 A1) in view of Pyles (US 2011/0319824 A1).
With regard to claim 48, Heruth discloses the claimed invention except for the method of inserting a catheter.
Pyles teaches a similar intrathecal catheter and further teaches further comprising: creating an access opening (Fig 4 at element 19) into the intrathecal space of the patient in a lumbar region (see Fig. 4) thereof; and inserting a catheter through the access opening and threading the catheter rostrally within the intrathecal space ([0024]), wherein infusion of the therapeutic bolus and the flush fluid is performed through the catheter ([0024]).
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 Heruth with the method of inserting the catheter as taught by Pyles for the purpose of allowing for easier insertion into the desired target area ([0024]).
With regard to claim 49, Heruth wherein the catheter (Fig. 7) comprises a first lumen (426a) with a first fluid port (at 427a) and a second lumen (426b) with a second fluid port (at 427b), the second fluid port spaced proximally of the first fluid port (see Fig. 7).
However, Heruth does not teach threading the catheter rostrally.
Pyles teaches threading the catheter rostrally within the intrathecal space positions the first fluid port at the first location within a lumbar region up to a cisterna magna region for infusion of the therapeutic bolus ([0024]) and positions the second fluid port at the second location within the lumbar region up to the cisterna magna for infusion of the flush fluid ([0024]).
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 Heruth with the method of inserting the catheter as taught by Pyles for the purpose of allowing for easier insertion into the desired target area ([0024]).
With regard to claim 50, Heruth discloses the claimed invention except for threading the catheter rostrally.
Pyles teaches wherein threading the catheter rostrally within the intrathecal space positions the first fluid port at the first location within a thoracic region up to the cervical region of the intrathecal space for infusion of the therapeutic bolus and positions the second fluid port at the second location within the lumbar region up to the cervical region of the intrathecal space for infusion of the flush fluid ([0024]).
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 Heruth with the method of inserting the catheter as taught by Pyles for the purpose of allowing for easier insertion into the desired target area ([0024]).
With regard to claim 51, Heruth discloses wherein threading the catheter rostrally within the intrathecal spaced comprises moving the first lumen relative to the second lumen within the intrathecal space (see Fig. 14, an alternative configuration having a first lumen 920a and a second lumen 920b that can moved relative the first lumen).
With regard to claim 52, Heruth discloses wherein the catheter comprises a single lumen (Fig. 6) with a distal fluid port (327a), and threading the catheter rostrally within the intrathecal space comprises: positioning the distal fluid port at the first location within a lumbar region up to a cisterna magna region for infusion of the therapeutic bolus; and withdrawing the catheter to position the distal fluid port at the second location within the lumbar region up to the cisterna magna for infusion of the flush fluid ([0153], catheter can be steered and thus can be moved distally and proximally in order to place the catheter in the correct location).
With regard to claim 53, Heruth discloses wherein threading the catheter rostrally within the intrathecal space comprises ([0153]): positioning the distal fluid port at the first location within a thoracic region up to a cervical region for infusion of the therapeutic bolus ([0153], [00154], catheter is steerable to the target location); and withdrawing the catheter to position the distal fluid port at the second location within the lumbar region for infusion of the flush fluid ([0153], catheter can be steered and thus can be moved distally and proximally in order to place the catheter in the correct location).
With regard to claim 54, Heruth discloses the claimed invention except for the method of inserting a catheter.
Pyles teaches a similar intrathecal catheter and further teaches further comprising: creating an access opening (Fig 4 at element 19) into the intrathecal space of the patient in a lumbar region (see Fig. 4) thereof; and inserting a catheter through the access opening and threading the catheter rostrally within the intrathecal space ([0024]), wherein infusion of the therapeutic bolus and the flush fluid is performed through the catheter ([0024]).
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 Heruth with the method of inserting the catheter as taught by Pyles for the purpose of allowing for easier insertion into the desired target area ([0024]).
With regard to claim 55, Heruth discloses the clamed invention except the opening and threading the catheter rostrally.
Pyles teaches further comprising creating an access opening (Fig 4 at element 19) into the intrathecal space of the patient in a lumbar region (Fig. 4) thereof with a lumbar puncture needle ([0024]), wherein infusion of the therapeutic bolus and the flush fluid is performed through the lumbar puncture needle in the lumbar region ([0024]).
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 Heruth with the method of inserting the catheter as taught by Pyles for the purpose of allowing for easier insertion into the desired target area ([0024]).
Claim(s) 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heruth et al. (US 2005/0137578 A1) in view of Finch JR (US 2016/036159 A1).
With regard to claim 56, Heruth discloses threaded the catheter through a port ([00153]).
However Heruth does not disclose a septum of a plug in port
Finch teaches access to the body for a catheter via plug-in port ([0005], [0010]) and further comprising a septum ([0010]) and a needle ([0010]).
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 Heruth with the septum and plug-in port as taught by Finch for the purpose of easier access to the target region ([0010]).
Claim(s) 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heruth et al. (US 2005/0137578 A1) in view of Frost (US 2017/0151381 A1).
With regard to claim 58, Heruth discloses the claimed invention except for a specific head position.
Frost teaches drug delivery further comprising positioning the patient in a head up tilt orientation prior to infusing the therapeutic bolus and infusing the flush fluid ([0081]).
. 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 Heruth with the head tilt position as taught by Frost for the purpose of creating an advantage to increase blood pressure redistribution ([0081]).
Claim(s) 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heruth et al. (US 2005/0137578 A1) in view of Frost (US 2017/0151381 A1) and Bodner (US 2021/0077016 A1).
With regard to claim 59, Heruth discloses a buffer ([0093]).
However, Heruth does not disclose the claimed invention except for a specific head position.
Frost teaches drug delivery further comprising positioning the patient in a head down tilt orientation prior to infusing the therapeutic bolus and infusing the flush fluid ([0081]).
. 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 Heruth with the head tilt position as taught by Frost for the purpose of creating an advantage to increase blood pressure redistribution ([0081]).
However, Heruth/Frost do not teach a colder in temperature buffer.
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 Heruth 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) 64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heruth et al. (US 2005/0137578 A1) in view of Singh et al. (US 2015/0038949 A1).
With regard to claim 64, 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 Heruth 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) 65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heruth et al. (US 2005/0137578 A1) in view of Singh et al. (US 2015/0038949 A1) and in further view of Deverman et al. (US 2017/0204144 A1).
With regard to claim 65, Heruth/Singh 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 Heruth/Frost with the specific bolus agent as taught by Deverman for the purpose of treating specific disease such as Parkinson’s, muscular atrophy etc. ([0134]).
Claim(s) 66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heruth et al. (US 2005/0137578 A1) in view of Deverman et al. (US 2017/0204144 A1).
With regard to claim 66, Heruth 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 Heruth 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 39 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783