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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-6, 9-10, 13-16, 32, 34, 43-44, 47-48 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.
Applicant’s arguments, see Remarks, filed 6/3/26, with respect to the rejection(s) of claim(s) 1, 3-6, 9-10, 13-16, 32, 34, 43-44, 47-48 under Bourke in view of Kislev in view of Shang and Schneider have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Wang et al. (U.S. Pub. 2016/0199852).
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) 1, 3-6, 13-14, 32, 34 and 47-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (U.S. Pub. 2016/0199852 hereinafter “Wang”) in view of Zhang et al. (U.S. Pub. 2020/0024513 A1 hereinafter “Zhang”).
Regarding claim 1, Wang discloses a method of contacting a brain tissue of a subject with light (e.g. ¶4), comprising: a photoexcited mechanoluminescent particles (e.g. ¶¶9, 13); and wherein the mechanoluminescent particle is within a blood vessel during the photoexciting (e.g. ¶16), wherein the blood vessel is 20 mm or less below a head or neck skin surface of the subject (e.g. ¶13; 2-5.5mm), wherein the photoexciting comprises directing photoexcitation onto the head or neck skin surface such that the photoexcitation light enters the blood vessel and photoexcites the mechanoluminescent particle therein (e.g. ¶13); and applying an ultrasound signal to the photoexcited mechanoluminescent particle while the photoexcited mechanoluminescent particle is in a blood vessel in a head region of the subject and also in proximity to the brain tissue of the subject (e.g. ¶16), thereby causing the photoexcited mechanoluminescent particle to emit light that contacts the brain tissue (e.g. ¶16; (“Referring to FIG. 2, an ultrasound source 60 can provide ultrasound waves 65 to the target (e.g., a mammal brain 40). Light-emitting particles 35 can be provided to the target and can emit light (e.g., visible light) upon stimulation caused by the ultrasound waves 65.)”), wherein the brain tissue comprises a neuron that comprises a photosensitive protein and the emitted light modulates the photosensitive protein (e.g. ¶¶10-11).
Although Wang teaches applying an ultrasound signal to a mechanoluminescent particle while the mechanoluminescent particle is in proximity to the tissue of the subject, thereby causing the mechanoluminescent particle to emit light that contacts the tissue. Wang fails to teach applying energy to the photoexcited mechanoluminescent particle, such that an already photoexcited mechanoluminescent has energy applied to it to re-excite the particle. Zhang teaches a luminescent material and a preparation method thereof (Abstract), where the luminescent material is capable of emitting mechanoluminescence under mechanical stimulation, and an intensity of the mechanoluminescence is directly proportional to an intensity of applied stress (¶[0012]), and further teaches applying energy to the photoexcited mechanoluminescent particle (¶[0050], where "the mechanoluminescence has light irradiation reproducibility, that is, the mechanoluminescence reappears after light irradiation and decays over time," (¶[0071], where "The mechanoluminescence intensity decreases as the times of stress applications increase. This is because the energy captured by the trap is emptied gradually. The trap can be recharged by the effective excitation of light irradiation, so as to realize the recoverability of the mechanoluminescence characteristic, which is similar to the recoverability of the long-lasting luminescence." Examiner interprets that a rechargeable mechanoluminescent particle, that is recharged with light, teaches applying energy to the photoexcited mechanoluminescent particle.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Zhang, which teaches applying energy to the photoexcited mechanoluminescent particle, into the modified invention of Wang in order to recharge the mechanoluminescent particle and to realize the recoverability of the mechanoluminescence characteristic since the mechanoluminescence intensity decreases as the times of stress applications increase (Zhang ¶[0071]).
Regarding claim 3, meeting the limitations of claim 1 above, Wang further discloses wherein the modulation results in hyperpolarization of the neuron (e.g. ¶11).
Regarding claim 4, meeting the limitations of claim 1 above, Wang further discloses wherein the modulation results in depolarization of the neuron (e.g. ¶11).
Regarding claim 5, meeting the limitations of claim 1 above, Wang further discloses genetically modifying the neuron to express the photosensitive protein (e.g. ¶¶ 10, 28).
Regarding claim 6, meeting the limitations of claim 1 above, Wang further discloses wherein the photosensitive protein is a channelrhodopsin-2 (ChR2), a Volvox carteri light-activated protein (VChR1), a iC++, a ChRmine, or a halorhodopsin (HPHR) (e.g. ¶10; [ChR2]).
Regarding claim 13, meeting the limitations of claim 1 above, Wang further discloses wherein the tissue comprises a photosensitizer that is contacted by the emitted light, thereby generating a reactive oxygen species (e.g. ¶17).
Regarding claim 14, meeting the limitations of claims 1 and 13 above, Wang further discloses wherein the subject has a disease and the method is a method of treating the subject for the disease by generating the reactive oxygen species in the tissue (e.g. ¶¶2, 3, 35; [Parkinsons]).
Regarding claim 32, meeting the limitations of claim 1 above, Wang further discloses wherein the mechanoluminescent particle comprises an inorganic material (e.g. ¶4).
Regarding claim 34, meeting the limitations of claims 1 and 32 above, Wang further discloses wherein the mechanoluminescent particle comprises zinc sulfide (ZnS); tridymite (X1A1204 wherein X1 is Sr, Ca, Ba, or a combination thereof); melilite (X22ESi2O7 wherein X2 is Ca, Sr, Ba, or a combination thereof, E is Mg); SrMg2(PO4)2; perovskite (Ba1.xCaxTiO3 wherein 0.25 < x < 0.8); BaSi202N2; SrSi202N2; CaZr(P04)2; or a combination thereof (e.g. ¶4; [light emitting nanosphophors]).
Regarding claim 47, meeting the limitations of claim 1 above, Wang further discloses wherein the ultrasound signal is a focused ultrasound signal (FUS) (e.g. ¶16; [focused ultrasound]).
Regarding claim 48, meeting the limitations of claim 1 above, Wang further discloses wherein the ultrasound signal has a frequency ranging from 150kHz to 15MHz (e.g. ¶37; [1Mhz]).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Zhang and further in view of Zhang et al. (WO 2019/005884 A1 hereinafter "Zhang ‘884" – Previously Cited).
Regarding claim 9, Wang in combination with Zhang teaches all limitations of claim 1 as described in the rejection above. Neither Wang nor Zhang teach that the tissue comprises a group of compounds that causes genetic modification to the tissue after absorbing the emitted light. Zhang ‘884 teaches systems, methods, and compositions for targeting and editing nucleic acids, in particular, non-naturally occurring or engineered RNA-targeting systems comprising a RNA-targeting Cas13 protein (Abstract), and further teaches that the tissue comprises a group of compounds that causes genetic modification to the tissue after absorbing the emitted light (e.g. ¶[0520], where "Transient receptor potential (TRP) ion channel based system TRP family proteins respond to different stimuli, including light and heat the ion channel will open and allow the entering of ions such as calcium into the plasma membrane This influx of ions will bind to intracellular ion interacting partners linked to a polypeptide including the guide and the other components of the Casl3 CRISPR-Cas complex or system, and the binding will induce the change of sub-cellular localization of the polypeptide, leading to the entire polypeptide entering the nucleus of cells Once inside the nucleus, the Casl3 CRISPR-Cas complex will be active and modulating target gene expression in cells").
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Zhang ‘884, which teaches that the tissue comprises a group of compounds that causes genetic modification to the tissue after absorbing the emitted light, into the modified invention of Wang in view of Zhang in order to modulate target gene expression in cells (Zhang ¶[0520]) or to induce the cleavage of a genomic locus of interest in a cell (Zhang ¶[0521]).
Regarding claim 10, Wang in combination with Zhang, Schneider, and Zhang ‘884 teaches all limitations of claim 9 as described in the rejection above. Zhang ‘884 teaches that the group of compounds comprises a CRISPR compound and a Cas9 compound (¶[0593], where "In certain embodiments, CRISPR-Cas protein may comprise one or more modifications resulting in enhanced activity and/or specificity, such as including mutating residues that stabilize the targeted or non-targeted strand (e.g. eCas9)").
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Zhang ‘884, which teaches that the group of compounds comprises a CRISPR compound and a Cas9 compound, into the modified invention of Bourke in order to enhance activity and/or specificity, such as including mutating residues that stabilize the targeted or non-targeted strand (Zhang ¶[0593]).
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Zhang and further in view of Bourke, Jr. et al. (U.S. Pub. 2010/0016783 A1 hereinafter "Bourke" – Previously Cited).
Regarding claims 15-16, Wang in view of Zhang teach the claimed invention but fails to explicitly state that the disease is an infection of a microorganism or cancer. However, Bourke teaches a similar method using a photosensitizer as set forth in Paragraphs 351 and 487 to provide treatment for microorganisms and cancer. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system, as taught by Wang in view of Zhang, with treatment for microorganisms and cancer as taught by Bourke, since such a modification would provide the predictable results of using known methods of providing photosensitizers to tissue to treat known diseases caused by microorganisms and/or cancer (Bourke, ¶¶351, 487).
Claims 43 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Zhang as applied to claims 43 above, and further in view of Tan et al. (hereinafter "Tan") (Tan H., Wang T., Shao Y., Yu C. and Hu L. (2019) Crucial Breakthrough of Functional Persistent Luminescence Materials for Biomedical and Information Technological Applications. Front. Chem. 7:387. doi: 0.3389/fchem.2019.00387 – Previously Cited).
Regarding claims 43-44, Wang in combination with Zhang teaches all limitations of claim 43 as described in the rejection above. Neither Wang nor Zhang teach an organic material comprising a N-(4-trifluoromethylphenyl)phthalimide group. Tan teaches persistent luminescence materials (Abstract), and further teaches an organic material comprising a N-(4-trifluoromethylphenyl)phthalimide group (Page 5, Col. 1, 12, where "a purely organic aggregation-induced emission (AIE) for the first time that exhibited transient, persistent photoluminescence, and persistent mechanoluminescence (ML) at room temperature (Li et al., 2018). As a key functional unit, N-(4-trifluoromethylphenyl)phthalimide was introduced").
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Tan, which teaches an organic material comprising a N-(4-trifluoromethylphenyl)phthalimide group, into the modified invention of Bourke since it is favorable to form crystals and to prevent non-radiative transitions by immobilizing the molecular conformations (Tan Page 5, Col. 1, 1 2).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kislev (WO2008/065652) – discloses electromagnetic radiation and ultrasound application to nanoparticles to provide biological treatment (Page. 15, lines 30-33 and Page 5, lines 7-12).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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/REX R HOLMES/Primary Examiner, Art Unit 3796
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