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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/19/25 has been entered.
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 1-4, 8-14 and 16-25 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 5,814,008 (provided in the IDS)), in view of Pusic (US 2015/0216899 (provided in the IDS)), further in view of John et al. (US 2008/0140149) and Bonutti et al. (US 2017/0209717).
Addressing claim 1, Chen discloses a method of delivering drug into a patient’s comprising:
targeting a region of the patient’s with light from a light emitter (see claim 2 and col. 2, lines 35-67; first or second light emitter could be exchange; this only require routine skill in the art; any first or second light source could be use as heating element; In reJapikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice); obvious matter of designer choice to arrange light heating element as first or second light emitter);
using the light to irradiate the region of the patient’s brain to facilitate selective delivery of the exosome 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 claim 2 and col. 2, lines 35-67; light is used to heat the target to create local perfusion to improve drug delivery).
Chen does not explicitly disclose the treatment region is the brain, 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 Chen to perform treatment in the brain region, 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 this allows for delivery of drug other region such as the brain. Any region could be target for drug delivery. This is obvious to one of ordinary skill in the art and only require routine skill in the art.
Chen 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 Chen 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]).
Chen further does not disclose using low intensity, diffuse ultrasound/(sonic transducer) to open BBB (target brain). In the same field of endeavor, which is drug/agent delivery through BBB, Bonutti discloses using low intensity, diffuse ultrasound/(sonic transducer) to open BBB (target brain) (see [0057], [0104] and [0131-0132]; 3 W/cm2 and less is low intensity ultrasound; ultrasound use to open barrier for drug/agent delivery is diffuse ultrasound; Bonutti discloses use ultrasound in combination of light to enhance drug/agent penetration; John disclose using MRI neuronavigation to target 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 Chen to use low intensity, diffuse ultrasound/(sonic transducer) to open BBB (target brain) in combination of light because this further enhance drug/agent penetration (see [0132]).
4. Addressing claims 2-4, 19 and 21, Pusic discloses:
addressing claim 2, wherein the region of the patient’s brain is associated with a disease condition (see [0011]).
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 Chen’s abstract; Chen disclose target tumor and Pusic discloses target brain and demyelinated lesions (see [0114-0115])).
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 opening the BBB or increasing local perfusion at the targeted region (see [0071]; Pusic discloses administer the exosome; Chen discloses delivered drug after elevated temperature to cause increase of perfusion (see col. 2, lines 35-67)).
Addressing claims 8-13, 16-18, 20 and 22-23, Chen discloses:
addressing claim 8, wherein the first light emitter comprises a laser (see col. 1, lines 34-40).
addressing claim 9, wherein the first light emitter comprises a light emitting diode (LED) (see abstract).
addressing claim 10, wherein the light used to irradiate the patient's brain includes radiation in a red-to-near-infrared range (see col. 5, lines 1-14; Pusic disclose treating the brain; using electromagnetic in any spectrum is only require routine skill in the art; the claim basically claim all part of the spectrum).
addressing claim 11, wherein the light used to irradiate the patient's brain includes ultraviolet radiation (see col. 5, lines 1-14; Pusic discloses treating the brain; using electromagnetic in any spectrum is only require routine skill in the art; the claim basically claim all part of the spectrum).
addressing claim 12, wherein the light used to irradiate the patient's brain includes x-ray, gamma ray, radar, or radio wave radiation (see col. 5, lines 1-14; Pusic disclose treating the brain; radio to gamma cover all the spectrum in between such as infrared, near-infrared, red, ultraviolet etc.).
addressing claim 13, wherein the light used to irradiate the patient's brain includes multiple wavelengths (see col. 2, lines 55-67; different waveband).
addressing claim 16, irradiating the light into the patient for a duration of 4-10 minutes (see col. 6, lines 35-58; heat source is light source; light use for heating 20-60 minutes; examiner interpreted according to applicant’s specification paragraph [0017]; irradiation can last at least 1 minutes and could last longer than 45 minutes).
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 (4) forming an opening in the BBB at the targeted region, or (ii) increasing local perfusion at the targeted region (see claim 2 and col. 2, lines 35-67; light is used to heat the target to create 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 the opening in the BBB or increasing local perfusion is temporary (see col. 2, lines 35-67; the elevated temperature by light source to increase perfusion therefore it is only temporary).
addressing claim 23, administering a medication to the patient (see col. 2, lines 35-67).
Addressing claim 14, John discloses:
addressing claim 14, applying energy from a second light emitter to constructive light interfere at the targeted region (see [0113]).
Addressing claims 24-25, Bonutti discloses:
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).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 5,814,008 (provided in the IDS)), in view of Pusic (US 2015/0216899 (provided in the IDS)), further in view of John et al. (US 2008/0140149), Bonutti et al. (US 2017/0209717) and Wagner et al. (US 2018/0280444).
Addressing claim 5, Chen 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 Chen 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 Chen et al. (US 5,814,008 (provided in the IDS)), in view of Pusic (US 2015/0216899 (provided in the IDS)), further in view of John et al. (US 2008/0140149), Bonutti et al. (US 2017/0209717) and Zhang (US 2012/0315324 (provide in the IDS)).
Addressing claim 6, Chen 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 Chen 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]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 5,814,008 (provided in the IDS)), in view of Pusic (US 2015/0216899 (provided in the IDS)), further in view of John et al. (US 2008/0140149), Bonutti et al. (US 2017/0209717) and Huang (US 2018/0185667).
Addressing claim 7, Chen does not disclose 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 using light to irradiate the region comprises alternating application of the light among at least two sites targeting the region (see [0032]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chen to 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]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 5,814,008 (provided in the IDS)), in view of Pusic (US 2015/0216899 (provided in the IDS)), further in view of John et al. (US 2008/0140149), Bonutti et al. (US 2017/0209717) and Altshuler et al. (US 2004/0193236).
Addressing claim 15, Chen does not disclose light intensity of no more than 75 J/cm2. The intensity is a designer choice that allow for improvement of drug delivery. Altshuler discloses range of light intensity within this range (see [0108]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chen to have light intensity of no more than 75 J/cm2 as taught by Altshuler because this range provide biostimulation to increase permeability for drug delivery (see [0084] and [0108]).
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).
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3793