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 § 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) 1, 3-4, 6-18, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jordan (US 2020/0108241).
Jordan shows a method of facilitating delivery of a structure to a patient’s brain across the blood-brain barrier (BBB) (abstract), comprising: targeting a region of the patient’s brain with a pressure device (transducer; [0013]); using the pressure device to induce a pressure wave in the region of the patient’s brain and facilitate selective delivery of the structure to the region of the patient’s brain ([0013]); and administering the structure to the patient’s blood stream, or spinal fluid space, or proximal to the BBB, wherein the structure traverses the BBB at the targeted region ([0013]); wherein the structure is one of a microvesicle or a stem cell ([0016]).
Jordan also shows wherein the microvesicle is one of a liposome, an exosome, or a nanoparticle ([0013], [0015]); wherein the region of the patient’s brain is targeted via imaging data based on an MRI or a CT scan navigation (functional/structural imaging; [0030]); wherein no microbubble is administered to the patient, the BBB at the targeted region is not torn during performance of the method, or the BBB is not disrupted at the targeted region ([0026]-[0027]); administering a plurality of microvesicles or stem cells, and wherein at least 50% of the plurality of microvesicles or stem cells traverse the BBB at the targeted region ([0026]); wherein the region of the patient’s brain is associated with a health, physical, or mental condition sought to be altered ([0014]); wherein the condition is associated with one of the following: a disease, dementia, a learning disorder, an anxiety disorder, a motor disorder, a consciousness disorder, a movement disorder, an attention disorder, a stroke, a vascular disease, Alzheimer’s disease or other progressive potentially degenerative conditions, Parkinson’s disease, multiple sclerosis, cancer, schizophrenia, depression, anxiety disorder, developmental disorder, substance abuse, and traumatic brain injury ([0014]); wherein the region of the patient’s brain is selected from the group consisting of frontal lobe, parietal lobe, occipital lobe, temporal lobe, hippocampus, hypothalamus, brain stem, cerebellum amygdala, corticospinal tract, thalamus, substantia nigra, basal ganglia, a tumor, a lesion, necrotic tissue, Heschl’s gyrus, Brodmann area 25, spinal cord, and a point of injury ([0014]); wherein the structure is derived from a natural cell culture, an expanded cell culture, a full term placental tissue, or an umbilical tissue ([0015]); wherein the pressure device is one of electrohydraulic, electromagnetic, or piezoelectric ([0016]); wherein the pressure wave is induced for at least 10 minutes ([0016]); wherein the step of administering the structure occurs after inducing the pressure wave ([0016]); wherein selective delivery of the structure to the region of the patient’s brain is facilitated for between 10 minutes and 1 hour ([0016]); selective delivery of the structure to the region of the patient’s brain does not harm or degrade the BBB ([0026]-[0027]); wherein one of the nanoparticle or liposome is synthetic ([0015]); wherein the structure is selected to alter the condition ([0014]); wherein the pressure device is a first pressure device and a pressure wave is a first pressure wave, further comprising using a second pressure device to induce a second pressure wave in a region of the patient’s brain ([0025]-[0026]).
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) 2 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jordan (US 2020/0108241) in view of Koyfman et al. (US 8684970; hereinafter Koyfman).
Jordan shows the invention substantially as described in the 102 rejection above.
Jordan fails to show wherein the pressure wave is a shockwave administered in a repetitive fashion; wherein the shockwave does not tear or disrupt the BBB at the targeted region.
Koyfman discloses stereotactic shockwave surgery and drug delivery apparatus. Koyfman teaches wherein the pressure wave is a shockwave administered in a repetitive fashion (weaken brain/blood barrier; column 3, lines 40-60); wherein the shockwave does not tear or disrupt the BBB at the targeted region (weaken brain/blood barrier; column 3, lines 40-60).
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 the invention of Jordan to utilize additional types of known waves as a substitute or in addition to the ultrasound, such as shockwaves as taught by Koyfman, as each type of known wave has unique characteristics and benefits which may be selected by one of ordinary skill in the art without undue experimentation, where for example shockwaves may allow for the wave to be delivered to a deeper target location.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jordan (US 2020/0108241) in view of Wallace (US 2016/0270806).
Jordan shows the invention substantially as described in the 102 rejection above.
Jordan fails to show wherein delivery of the structure is selectively facilitated by transcytosis.
Wallace discloses methods and devices for endovascular therapy. Wallace teaches wherein delivery of the structure is selectively facilitated by transcytosis ([0048]).
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 the invention of Jordan to deliver the exosome through various known type of effects on the barrier, such as through transcytosis as taught by Wallace, as a variety of effects will be created by the application of the wave to the barrier as described by Wallace including transcytosis ([0048]), where the particular mechanism for delivery through the barrier may be selected by one of ordinary skill in the art without undue experimentation to achieve the desired application while avoiding tissue damage.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Friedman (US 2006/0142746) discloses the use of laser based shockwaves to disrupt the blood brain barrier ([0067]);
Kimmel (US 2013/0046213) discloses the use of shockwaves ([0058]) for penetration of a drug through the blood brain barrier ([0104]);
Li (US 2016/0324989) discloses techniques for enhancing blood brain barrier permeability (abstract) including use of stem cells ([0072]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN CWERN whose telephone number is (571)270-1560. The examiner can normally be reached Monday - Friday, 8:00 am - 5:00 pm.
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/JONATHAN CWERN/ Primary Examiner, Art Unit 3797
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