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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/16/2026 has been entered.
Response to Arguments
Applicant's arguments, filed 01/16/2026, with respect to the rejections under 35 U.S.C. §103 have been fully considered but they are not persuasive. Additionally, since the amendments to independent claim 1 change the scope of claims 1, 3-6, 9-10, 13-16, 32, 34, 43-44, and 47-48, and do not merely incorporate limitations from previous dependent claims, where the claims were amended to clarify that an ultrasound signal is applied to an already photoexcited mechanoluminescent particle, a new grounds of rejection is made in view of previously applied references as well as new reference Zhang et al. (U.S. Pub. No. 2020/0024513 A1) as explained in further detail below.
Applicant contends that it would not have been obvious to modify Bourke with the teachings of Schneider, where the teachings of Schneider would have been irrelevant to Bourke because of fundamentally distinct purposes and modes of operation between the two references. Applicant further contends that Bourke and Schneider employ fundamentally distinct mechanisms for performing the desired biological functions, where Schneider directly stimulates the genetically modified cells with light themselves and Bourke stimulates control cells, which then only indirectly affect the target cells to kill cancer cells ex vivo with hydrogen peroxide and then transmitting the corresponding cell signals into the patient to cause cancer cells in vivo to die. Examiner respectfully disagrees.
Examiner takes the position that Bourke does in fact teach directly applying stimulus to the cells at the target site, where Bourke teaches photoexciting a mechanoluminescent particle and thereby producing a photoexcited mechanoluminescent particle and causing the mechanoluminescent particle to emit light that contacts the tissue (¶[0259], where “ultrasonic waves concentrated on a particular region of the organ could induce mechanical stresses (e.g., compression and/or elongation of the cell membranes) changing the transport of nutrients across the membrane, thereby stressing those cells to induce biophoton emission,” ¶[0384], where “Mechano-luminescent materials convert ultrasonic or mechanical energy (such as vibrations naturally existing on an article such as motor or vibrations from driven by transducers) into visible light. Here, for example, the mechano-luminescent materials would be placed in a vicinity of a diseased site or at a site or sites to be treated with internally generated light,” ¶[0389], where “composites made of a piezoelectric material and an electroluminescent material, hereinafter ‘composite mechano-luminescent emitters,’ provides a structure that, upon stimulation with … ultrasonic transducer, emit light to a diseased site or at a site or sites to be treated with internally generated light”). Since the mechanoluminescent particles are photoexcited with ultrasound while within a diseased site, and the mechanoluminescent particles emit internally generated light to treat the diseased area, light is applied in vivo to directly stimulate the cells with light themselves. Therefore, Bourke directly stimulates in vivo to cause cancer cells in vivo to die.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 3-6, 13-16, 32, 34, 43, and 47-48 are rejected under 35 U.S.C. 103 as being unpatentable over Bourke, Jr. et al. (hereinafter “Bourke”) (U.S. Pub. No. 2010/0016783 A1) in view of Kislev (WO 2008/065652 A2), Zhang et al. (hereinafter “Zhang ‘513”) (U.S. Pub. No. 2020/0024513 A1), and Schneider et al. (hereinafter “Schneider”) (U.S. Pub. No. 2008/0085265 A1).
Regarding claim 1, Bourke teaches a method of contacting a tissue of a subject with light (¶[0384], where “the mechano-luminescent materials would be placed in a vicinity of a diseased site or at a site or sites to be treated with internally generated light”), comprising:
photoexciting a mechanoluminescent particle and thereby producing a photoexcited mechanoluminescent particle (¶[0259], where “a number of sources of stress can be used to introduce at least one of chemical and physical stresses on the selected portion of cells in the organ. For example, ultrasonic waves concentrated on a particular region of the organ could induce mechanical stresses (e.g., compression and/or elongation of the cell membranes) changing the transport of nutrients across the membrane, thereby stressing those cells to induce biophoton emission,” ¶[0384], where “Mechano-luminescent materials convert ultrasonic or mechanical energy (such as vibrations naturally existing on an article such as motor or vibrations from driven by transducers) into visible light. Here, for example, the mechano-luminescent materials would be placed in a vicinity of a diseased site or at a site or sites to be treated with internally generated light,” ¶[0389], where “composites made of a piezoelectric material and an electroluminescent material, hereinafter ‘composite mechano-luminescent emitters,’ provides a structure that, upon stimulation with … ultrasonic transducer, emit light to a diseased site or at a site or sites to be treated with internally generated light”); and
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 (¶[0384], where “Mechano-luminescent materials convert ultrasonic or mechanical energy (such as vibrations naturally existing on an article such as motor or vibrations from driven by transducers) into visible light. Here, for example, the mechano-luminescent materials would be placed in a vicinity of a diseased site or at a site or sites to be treated with internally generated light,” ¶[0389], where “composites made of a piezoelectric material and an electroluminescent material, hereinafter ‘composite mechano-luminescent emitters,’ provides a structure that, upon stimulation with … ultrasonic transducer, emit light to a diseased site or at a site or sites to be treated with internally generated light”).
Although Bourke 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, Bourke does not teach applying an ultrasound signal to the photoexcited mechanoluminescent particle, nor that the tissue comprises a neuron that comprises a photosensitive protein and the emitted light modulates the photosensitive protein.
Kislev teaches electromagnetic radiation and ultrasound application to a nanoparticle to generate reactive oxygen species (ROS) (Abstract) for biological treatment (Page 15, lines 30-33), and further teaches applying an ultrasound signal to the photoexcited particle (Page 5, lines 7-9 and 11-12, where “The present invention is of electromagnetic radiation absorbing nanoparticles operable for generating excited species when exposed to electromagnetic radiation … generating microbubbles near the nanoparticles by interaction of the excited species induced nucleation with ultrasound”).
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 Kislev, which teaches applying an ultrasound signal to the photoexcited particle, into the invention of Bourke in order to effectively generate ROS through the application of suitable electromagnetic radiation (Kislev Page 14, lines 1-3).
Although Bourke 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 and Kislev teaches applying an ultrasound signal to a photoexcited particle, where Bourke teaches applying an ultrasound signal to a mechanoluminescent particle and Kislev teaches applying an ultrasound signal to a photoexcited particle, respectively, neither Bourke nor Kislev teaches applying energy to the photoexcited mechanoluminescent particle, such that an already photoexcited mechanoluminescent has energy applied to it to re-excite the particle. Furthermore, neither Bourke nor Kislev teach that the tissue comprises a neuron that comprises a photosensitive protein and the emitted light modulates the photosensitive protein.
Zhang ‘513 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 ‘513, which teaches applying energy to the photoexcited mechanoluminescent particle, into the modified invention of Bourke 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 ‘513 ¶[0071]).
None of Bourke, Kislev, nor Zhang ‘513 teaches that the tissue comprises a neuron that comprises a photosensitive protein and the emitted light modulates the photosensitive protein.
Schneider teaches stimulation of target cells using light in vivo (Abstract), and further teaches that the tissue comprises a neuron that comprises a photosensitive protein (¶[0034], where “the target cells are neurons located in the brain of a mammal. The target cells are genetically modified to express photosensitive bio-molecular arrangement, for example, ChR2 ion channels”) and the emitted light modulates the photosensitive protein (¶[0034], where “Light can then be used to stimulate the neurons”).
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 Schneider, which teaches that the tissue comprises a neuron that comprises a photosensitive protein and the emitted light modulates the photosensitive protein, into the modified invention of Bourke in order to stimulate the targeted cells without stimulating other cells that are in proximity to the targeted cells (Schneider ¶[0037]).
Regarding claim 3, Bourke in combination with Kislev, Zhang ‘513, and Schneider teaches all limitations of claim 1 as described in the rejection above.
Schneider teaches that the modulation results in hyperpolarization of the neuron (¶[0005], where “light activated proteins can be used to control the flow of ions through cell membranes. By facilitating or inhibiting the flow of positive or negative ions through cell membranes, the cell can be briefly … hyperpolarized … as to hyperpolarize neuronal membrane”).
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 Schneider, which teaches hyperpolarization of the neuron, into the modified invention of Bourke in order to make the neuronal membrane resistant to firing (Schneider ¶[0005]) and resist action potential generation (Schneider ¶[0036]).
Regarding claim 4, Bourke in combination with Kislev, Zhang ‘513, and Schneider teaches all limitations of claim 1 as described in the rejection above.
Schneider teaches that the modulation results in depolarization of the neuron (¶[0005], where “light activated proteins can be used to control the flow of ions through cell membranes. By facilitating or inhibiting the flow of positive or negative ions through cell membranes, the cell can be briefly depolarized … Neurons are an example of a type of cell that uses the electrical currents created by depolarization to generate communication signals”).
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 Schneider, which teaches depolarization of the neuron, into the modified invention of Bourke in order to transmit signals throughout the body and for various purposes, such as motor control (e.g., muscle contractions), sensory responses (e.g., touch, hearing, and other senses) and computational functions (e.g., brain functions) for psychological therapy, muscle control, and sensory functions (Schneider ¶[0005]).
Regarding claim 5, Bourke in combination with Kislev, Zhang ‘513, and Schneider teaches all limitations of claim 1 as described in the rejection above.
Schneider teaches genetically modifying the neuron to express the photosensitive protein (¶[0034], where “the target cells are neurons located in the brain of a mammal. The target cells are genetically modified to express photosensitive bio-molecular arrangement, for example, ChR2 ion channels”).
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 Schneider, which teaches genetically modifying the neuron to express the photosensitive protein, into the modified invention of Bourke in order to use light to stimulate the neuron (Schneider ¶[0034]) and to stimulate the targeted cells without stimulating other cells that are in proximity to the targeted cells (Schneider ¶[0037]).
Regarding claim 6, Bourke in combination with Kislev, Zhang ‘513, and Schneider teaches all limitations of claim 1 as described in the rejection above.
Schneider teaches that the photosensitive protein is a channelrhodopsin-2 (ChR2) (¶[0034], where “the target cells are neurons located in the brain of a mammal. The target cells are genetically modified to express photosensitive bio-molecular arrangement, for example, ChR2 ion channels”), a Volvox carteri light-activated protein (VChR1), a iC++, a ChRmine, or a halorhodopsin (HPHR).
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 Schneider, which teaches that the photosensitive protein is a channelrhodopsin-2 (ChR2), into the modified invention of Bourke in order to use light to stimulate the neuron (Schneider ¶[0034]) and to stimulate the targeted cells without stimulating other cells that are in proximity to the targeted cells (Schneider ¶[0037]).
Regarding claim 13, Bourke in combination with Kislev, Zhang ‘513, and Schneider teaches all limitations of claim 1 as described in the rejection above.
Kislev teaches that the tissue comprises a photosensitizer that is contacted by the emitted light, thereby generating a reactive oxygen species (Page 4, lines 8-10, where “Controlled generation of ROS in vivo may be conducted using nanoparticles loaded with photosensitizers which generate ROS following exposure to light including IR radiation,” Page 6, lines 13-14, where “a plurality of nanoparticles spread on a surface of a tissue whose size is measured in a few microns”).
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 Kislev, which teaches that the tissue comprises a photosensitizer that is contacted by the emitted light, thereby generating a reactive oxygen species, into the modified invention of Bourke in order to promote collagen destruction and fibroblast stimulation (Kislev Page 30, lines 7-8).
Regarding claim 14, Bourke in combination with Kislev, Zhang ‘513, and Schneider teaches all limitations of claim 13 as described in the rejection above.
Bourke teaches that 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 (¶[0487], where “Lesions have been treated with target light-sensitive molecules called photosensitizers (PSs). When irradiated with light, PSs generate reactive oxygen species (ROS) which very rapidly react with any nearby biomolecule and can eventually kill cells through apoptosis or necrosis. The technique, called chromophore-assisted light inactivation (CALI), has been used for the treatment of precancerous lesions and superficial tumors”).
Regarding claim 15, Bourke in combination with Kislev, Zhang ‘513, and Schneider teaches all limitations of claim 14 as described in the rejection above.
Bourke teaches that the disease is an infection by a microorganism (¶[0351], where “the phrase ‘a disease or condition’ refers to a condition, disorder or disease that may include, but are not limited to, cancer, soft and bone tissue injury, chronic pain, wound healing, nerve regeneration, viral and bacterial infections).
Regarding claim 16, Bourke in combination with Kislev, Zhang ‘513, and Schneider teaches all limitations of claim 14 as described in the rejection above.
Bourke teaches that the disease is cancer (¶[0351], where “the phrase ‘a disease or condition’ refers to a condition, disorder or disease that may include, but are not limited to, cancer, soft and bone tissue injury, chronic pain, wound healing, nerve regeneration, viral and bacterial infections) and the tissue comprises cancer cells (¶[0277], where “a target cell to be treated is analyzed first to ascertain its biophoton emission characteristics. If the target cell is a known cancer strain, representative cancer lines could be analyzed).
Regarding claim 32, Bourke in combination with Kislev, Zhang ‘513, and Schneider teaches all limitations of claim 1 as described in the rejection above.
Bourke teaches that the photoexcited mechanoluminescent particle comprises an inorganic material (¶[0317], where “a downconverting energy modulation agent (e.g., a down converting phosphor) can comprise inorganic particulates … the downconverting material can comprise at least one of … ZnS” , ¶[0386], where “Various mechano-luminescent materials suitable for the present invention include … ZnS”).
Regarding claim 34, Bourke in combination with Kislev, Zhang ‘513, and Schneider teaches all limitations of claim 32 as described in the rejection above.
Bourke teaches that the mechanoluminescent particle comprises zinc sulfide (ZnS) (¶[0386], where “Various mechano-luminescent materials suitable for the present invention include … ZnS”); tridymite (X'A1204 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); BaSi2O2N2; SrSi2O2N2; CaZr (PO4)2; or a combination thereof.
Regarding claim 43, Bourke in combination with Kislev, Zhang ‘513, and Schneider teaches all limitations of claim 1 as described in the rejection above.
Bourke teaches that the mechanoluminescent particle comprises an organic material (¶[0288], where “The present invention can use any desired energy converter, including, but not limited to, organic fluorescent molecules.” Examiner takes the position that since organic fluorescent molecules can be utilized, that they can be applied to the mechanoluminescent particle previously taught.).
Regarding claim 47, Bourke in combination with Kislev, Zhang ‘513, and Schneider teaches all limitations of claim 1 as described in the rejection above.
Kislev teaches that the ultrasound signal is a focused ultrasound signal (FUS) (Page 25, lines 18-23, where “the ultrasound energy used for treating a subject according to the present invention may optionally and preferably be introduced to the targeted tissue (generally, superficial tissue) region by positioning external ultrasound source. However, deep tissue treatment may require focusing the ultrasonic energy so that it is preferentially directed within a focal zone. Examples for such sources are HIFU sources composed of an array of ultrasound sub sources.” Examiner takes the position that HIFU (high intensity focused ultrasound) is equivalent to FUS, being another name for the same procedure.).
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 Kislev, which teaches that the ultrasound signal is a focused ultrasound signal (FUS), into the modified invention of Bourke in order to direct the energy within a focal zone (Kislev Page 25, line 22).
Regarding claim 48, Bourke in combination with Kislev, Zhang ‘513, and Schneider teaches all limitations of claim 1 as described in the rejection above.
Kislev teaches that the ultrasound signal has a frequency ranging from 150 kHz to 15 MHz (Page 25, lines 3-4, where “Preferably, the ultrasound energy frequency for evolving a microbubble from a nucleation site varies between about 20 kHz and 10 MHz”).
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 Kislev, which teaches that the ultrasound signal has a frequency ranging from 150 kHz to 15 MHz, into the modified invention of Bourke in order to evolve the nucleation sites (Kislev Page 25, lines 3-4). Additionally, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Bourke in view of Kislev, Zhang ‘513, and Schneider as applied to claim 1 above, and further in view of Zhang et al. (hereinafter “Zhang”) (WO 2019/005884 A1).
Regarding claim 9, Bourke in combination with Kislev, Zhang ‘513, and Schneider teaches all limitations of claim 1 as described in the rejection above.
Neither Bourke nor Kislev teach that the tissue comprises a group of compounds that causes genetic modification to the tissue after absorbing the emitted light.
Zhang 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 (¶[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, 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 Bourke 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, Bourke in combination with Kislev, Zhang ‘513, Schneider, and Zhang teaches all limitations of claim 9 as described in the rejection above.
Zhang 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, 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]).
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Bourke in view of Kislev, Zhang ‘513, and Schneider as applied to claim 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: 10.3389/fchem.2019.00387).
Regarding claim 44, Bourke in combination with Kislev, Zhang ‘513, and Schneider teaches all limitations of claim 43 as described in the rejection above.
Neither Bourke nor Kislev 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, ¶ 2, 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, ¶ 2).
Conclusion
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/SEFRA D. MANOS/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792