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 .
DETAILED ACTION
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.
Claims 1, 3-4, 8-14 and 17-25 are rejected under 35 U.S.C. 103 as being unpatentable over Bonutti et al. (US 2017/0209717), in view of Pusic (US 2015/0216899 (provided in the IDS)), further in view of John et al. (US 2008/0140149).
Addressing claim 1, Bonutti discloses a method of delivering drug into a patient’s brain comprising:
targeting a region of the patient’s brain with light from a light emitter at a non-thermal and nondestructive intensity ([0132]; Bonutti does not disclose light is used for heating; treatment region is the brain is implicitly taught as Bonutti discloses drug penetration through blood brain barrier);
using the light to irradiate the region of the patient’s brain to facilitate selective delivery of the drug to the region of the patient’s, sufficient to increase local perfusion of the region, without opening the BBB and without relying on microbubbles (see [0132]; light is used for penetration-enhancement modalities to help deliver drug; the light is sufficient to increase local perfusion of the region, without opening the BBB and without relying on microbubbles; Bonutti does not disclose using light to open BBB and no disclosure of microbubbles; sufficient to increase local perfusion of the region is a result of light treatment);
using low intensity and diffuse ultrasound/(sonic transducer) to the region of the patient’s brain (see [0057], [0104] and [0131-0132]; 3 W/cm2 and less is low intensity ultrasound which does not generate heat; Bonutti does not disclose ultrasound open BBB; Bonutti discloses make cell wall/membrane more porous but does not disclose make BBB more porous; as see in [0105], cell wall/membrane more porous so drug can pass into cell).
Bonutti does not disclose administering the exosome to the patient’s blood stream, wherein the exosome selectively traverses the BBB at the targeted region. Pusic discloses administering the exosome to the patient’s blood stream, wherein the exosome selectively traverses the BBB at the targeted region (see [0071]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bonutti to administering the exosome to the patient’s blood stream, wherein the exosome selectively traverses the BBB at the targeted region as taught by Pusic because exosome provide therapeutics against neurodegenerative disorder (see abstract).
Bonutti also does not disclose wherein the region is targeted using MRI neuronavigation specific to the patient. In the same field of endeavor, John discloses wherein the region is targeted using MRI neuronavigation specific to the patient (see [0072-0073] and [0102]; using MRI images of the patient to place stimulation probe at the target site is targeted using MRI neuronavigation specific to the patient). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bonutti to have wherein the region is targeted using MRI neuronavigation specific to the patient as taught by John because this provides accurate treatment, use for evaluation and adjust post stimulation (see [0073]). Bonutti discloses use ultrasound in combination of light to enhance drug/agent penetration; John discloses using MRI neuronavigation to target treatment therefore Bonutti in view of John would use MRI neuronavigation images specific to the patient to help deliver light and ultrasound energy to the targeted brain region.
4. Addressing claims 3-4, 19 and 21, Pusic discloses:
addressing claim 3, wherein the disease condition is associated with a disease selected from the group consisting of 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 dementing conditions, Parkinson’s disease, multiple sclerosis, cancer, schizophrenia, depression, anxiety disorder, developmental disorder, substance abuse, and traumatic brain injury (see [0011]).
addressing claim 4, 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, and a point of injury (see [0012], [0114-0115] and [0192]; treat lesion in brain and treat hippocampus brain region).
addressing claim 19, wherein the region of the patient’s brain is of therapeutic interest (see [0071-0072] and abstract; exosome carry drug for therapeutic treatment of brain for neurogenerative disorder).
addressing claim 21, wherein the step of administering the exosome occurs after increasing local perfusion at the targeted region (see [0071]; Pusic discloses administer the exosome; Bonutti discloses using light to enhance drug deliver; increasing local perfusion at the targeted region is a result of light treatment).
Addressing claims 8-12, 17-18, 20 and 22-25, Bonutti discloses:
addressing claim 8, wherein the first light emitter comprises a laser (see [0145]).
addressing claim 9, wherein the first light emitter comprises a light emitting diode (LED) (see [0093]).
addressing claim 10, wherein the light used to irradiate the patient's brain includes radiation in a red-to-near-infrared range (using electromagnetic in any spectrum is only require routine skill in the art).
addressing claim 11, wherein the light used to irradiate the patient's brain includes ultraviolet radiation (see [0145]).
addressing claim 12, wherein the light used to irradiate the patient's brain includes x-ray, gamma ray, radar, or radio wave radiation (see [0145]; radio to gamma cover all the spectrum in between such as infrared, near-infrared, red, ultraviolet etc.).
addressing claim 17, using continuous emission from the first light emitter to irradiate the patient (using pulse or continuous emission is a choice that only require routine skill in the art; the claim basically claim only two possible choices; can only pulse or continuous emission).
addressing claim 18, using pulsed emission from the first light emitter to irradiate the patient (using pulse or continuous emission is a choice that only require routine skill in the art; the claim basically claim only two possible choices; can only pulse or continuous emission).
addressing claim 20, wherein selective delivery of the exosome to the region of the patient’s brain is facilitated by increasing local perfusion at the targeted region (see [0132], light is used to treat the target that result in local perfusion to improve drug delivery; Pusic discloses delivery of the exosome to the region of the patient’s brain (see [0071])).
addressing claim 22, wherein increasing local perfusion is temporary (see [0132]).
addressing claim 23, administering a medication to the patient (see [0132]).
addressing claims 24-25, ultrasound concurrently or sequentially with light to facilitate the selective delivery of the exosome to the region of the patient’s brain (see [0104] and [0131-0132]; only two ways of combination use concurrently and sequentially; Bonutti using either or both ways; Bonutti use combination of ultrasound and light to facilitate the selective delivery of agent to the region of the patient’s brain; Pusic discloses exosome).
Addressing claims 13-14, John discloses:
addressing claim 13, wherein the light used to irradiate the patient's brain includes multiple wavelengths (see [0099]).
addressing claim 14, applying energy from a second light emitter to constructive light interfere at the targeted region (see [0113]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Bonutti et al. (US 2017/0209717), in view of Pusic (US 2015/0216899 (provided in the IDS)), further in view of John et al. (US 2008/0140149) and Wagner et al. (US 2018/0280444).
Addressing claim 5, Bonutti does not disclose wherein the exosome is derived from a full term placental tissue. Wagner discloses wherein the exosome is derived from a full term placental tissue (see [0007], [0009], [0011], [0030], [0041] and claim 18; nanoparticle/microparticle/nanovesicle/nanovesicle generated naturally from full term placental endothelial cells is exosomes). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bonutti to have wherein the exosome is derived from a full term placental tissue as taught by Wagner because this enhance body immunity and help body fight against disease (see [0002]; fight against tumor).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Bonutti et al. (US 2017/0209717), in view of Pusic (US 2015/0216899 (provided in the IDS)), further in view of John et al. (US 2008/0140149), and Zhang (US 2012/0315324 (provide in the IDS)).
Addressing claim 6, Bonutti does not disclose delivering more than one exosome, of more than one type or derivation. Zhang discloses delivering more than one exosome, of more than one type or derivation (see [0032] and [0144]; exosome derive from different types of cells are exosome of different types). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bonutti to deliver more than one exosome, of more than one type or derivation as taught by Zhang because this provides advantage as different exosome from different cells provide different level of activation to direct exosome to a specific cells and tissue (see [0065]).
Claims 2, 7 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Bonutti et al. (US 2017/0209717), in view of Pusic (US 2015/0216899 (provided in the IDS)), further in view of John et al. (US 2008/0140149) and Huang (US 2018/0185667).
Addressing claims 2, 7 and 15-16, Bonutti does not disclose wherein intensity of the light is no more than 15 J/cm2, light intensity of no more than 75 J/cm2, irradiating the light into the patient for a duration of 4-10 minutes and using light to irradiate the region comprises alternating application of the light among at least two sites targeting the region. In the same field of endeavor, which light treatment/therapy, Huang discloses wherein intensity of the light is no more than 15 J/cm2, irradiating the light into the patient for a duration of 4-10 minutes and using light to irradiate the region comprises alternating application of the light among at least two sites targeting the region (see [0032-0033]; light intensity of 13.75 J/cm2 per cycle; Huang discloses prevent heating of the target site that is non-thermal use of light treatment; Bonutti does not disclose light treatment heat the target site; Bonutti in view of Huang explicitly disclose prevent heating the target site (non-thermal light treatment)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bonutti to have wherein intensity of the light is no more than 15 J/cm2, irradiating the light into the patient for a duration of 4-10 minutes, use light to irradiate the region comprises alternating application of the light among at least two sites targeting the region as taught by Huang because the prevent over heating of the target region (see [0032]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-25 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2018/0177728 (see [0524]; provided in the IDS; use light to enhance drug delivery) and US 2004/0193236 (see [0122]; light intensity less than 75 J/cm2).
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.
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3797
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