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 .
Receipt is acknowledged of IDS filed on 07/10/2023 and 05/17/2025.
Claims 31-34, 37 and 39-53 are pending.
Claims 47-50 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 05/18/2026 is acknowledged.
Claim Rejections - 35 USC § 102
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 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.
Claims 31-33, 37, 39-42 and 51-52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by BRIGHT (WO 2019/178564).
Regarding claim 31, BRIGHT teaches a method of deactivating a sensory nerve tissue (page 31, paragraph 0121 and page 1, paragraph 0002), which can use for cancer (page 91, paragraph 0319). The method comprising:
locally administered a composition to the sensory nerve, specifically the peripheral locus of the nerve (page 6, paragraph 0020 and page 8, paragraph 0024 and page 1, paragraph 0002), which reads on locally administering to a peripheral locus of the sensory nerve cell a conjugate.
The conjugate comprising a hydrogel comprising:
i) wheat germ agglutin (WGA) (page 92, paragraph 0325), which is a retrograde transport agent; and
ii) a drug can be added to the composition that triggers apoptosis to the nerve cell and is used as a neurotoxic agent (page 78, paragraph 0289), which reads on a cell-deactivating agent. The drug can be externally activated and released via ultrasound or electrical stimulation (page 36, paragraph 0132), which reads on having an inactive state and adapted to be activated and to be activated and to become cytotoxic or ablative upon application of external activation energy thereto,
The WGA allows for rapid axonal transport of the composition to the desired location (page 92, paragraph 0325), which reads on wherein the retrograde transport agent is adapted to cause the conjugate to undergo endocytosis by an axon of the sensory nerve cell at the peripheral locus, and to effect retrograde axonal transport of the conjugate, through the sensory nerve cell, to a soma of the sensory nerve cell, the soma being remote from the peripheral locus and being included in a ganglion;
b) the composition can be injected and allowed to transport to the desired location, such as the ganglia to trigger apoptosis or neuronal cell death (page 78, paragraph 0289), which reads on allowing a time period to lapse, thereby allowing the conjugate to reach the ganglion including the soma of the sensory nerve cell; and
c) The drug can be externally activated and released via the application of ultrasound or electrical stimulation (page 36, paragraph 0132), the energy can be selectively applied at the ganglion, such as the dorsal root ganglion (page 30, paragraph 0113, page 31, paragraph 00122, and page 76, paragraph 0285), which reads on selectively applying the external activation energy to the ganglion including the soma of the nerve cell, thereby applying the external activation energy to the cell-deactivating agent and causing the cell-deactivating agent to become cytotoxic or ablative and to effect silencing or ablation of the sensory nerve cell, while avoiding damage to the adjacent nerve cells.
Note, additionally, since the same components are used, WGA, and same steps performed, application of energy, it would be inherent that the retrograde transport agent has the ability to cause the conjugate to undergo endocytosis by an axon of the sensory nerve cell at the peripheral locus, and to; effect retrograde axonal transport of the conjugate, through the sensory nerve cell, to a soma of the sensory nerve cell, the soma being remote from the peripheral locus and being included in a ganglion.
Regarding claim 32, BRIGHT teaches the composition can be injected and allowed to transport to the desired location, such as the ganglia to trigger apoptosis or neuronal cell death (page 78, paragraph 0289), which reads on allows an estimated time period to lapse. A dye can be administered to confirm target delivery/composition location (page 5, paragraph 0017).
Regarding claim 33, BRIGHT teaches radiation can be used in place of ultrasound (page 32, paragraph 0123). The energy can be selectively applied at the ganglion, such as the dorsal root ganglion (page 30, paragraph 0113, page 31, paragraph 00122, and page 76, paragraph 0285), which reads on minimally invasive.
Regarding claim 37 and 52, BRIGHT teaches the drug can be externally activated and released via the application of ultrasound or electrical stimulation (page 36, paragraph 0132), the energy can be selectively applied at the ganglion, such as the dorsal root ganglion (page 30, paragraph 0113, page 31, paragraph 00122, and page 76, paragraph 0285). The composition can be transported retrogradely to the target area (page 78, paragraph 0289 and page 92, paragraph 0325). A dye can be administered to confirm target delivery/composition location (page 5, paragraph 0017).
Regarding claim 39, BRIGHT teaches the drug can be externally activated and released via the application of ultrasound or electrical stimulation (page 36, paragraph 0132).
Regarding claims 40 and 41, BRIGHT teaches that wheat germ agglutin (WGA) can be added to the composition (page 92, paragraph 0325).
Regarding claim 42, BRIGHT teaches the composition can be delivered within a gold nanoparticle (page 68, paragraph 0250).
Regarding claim 51, a local anesthetic can be applied to the region and prior to the injection of therapy and efficacy, safety and pain relief are confirmed (page 57, paragraph 0198. Page 103, paragraph 0353, page 16, paragraph 0064 and page 17, paragraph 0067). Furthermore, “validating” appears to be a mental step.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 31-34, 37, 39-42, 45 and 51-53 are rejected under 35 U.S.C. 103 as being unpatentable over BRIGHT (WO 2019/178564) in view of SALMAN (Riboflavin Arrests Cisplatin-Induced Neurotoxicity by Ameliorating Cellular Damage in Dorsal Root Ganglion Cells. BioMed Research International. 2015.).
BRIGHT teaches Applicant’s invention as discussed above.
BRIGHT does teach applying radiation to a photosensitizer that produces free radicals.
Regarding claims 34, 45 and 53, SALMAN teaches a method of inducing apoptosis of cancer cells in the dorsal root ganglia (DRG) (abstract). The method comparing administering Riboflavin and exposing the patient to radiation (page 2, paragraph 4). The radiation makes Riboflavin act as a photosensitizer and it in turn releases free radicals (page 1, paragraph 3). This method induced apoptosis in the target cells up to a significant extent and can improve clinical outcomes for cancer treatment (abstract).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate applying radiation to a photosensitizer to produce free radicals. The person of ordinary skill in the art would have been motivated to make those modifications, because it induces apoptosis in target cells to a significant extent and can improve clinical outcomes for cancer treatment, and reasonably would have expected success because the references are in the same field of endeavor, such as administering a composition that reacts to an external energy source to achieve apoptosis in cells near the DRG.
Claims 31-34, 37, 39-45 and 51-53 are rejected under 35 U.S.C. 103 as being unpatentable over BRIGHT (WO 2019/178564) and SALMAN (Riboflavin Arrests Cisplatin-Induced Neurotoxicity by Ameliorating Cellular Damage in Dorsal Root Ganglion Cells. BioMed Research International. 2015.) in view of KIM (In-Vivo Ultrasound and Photoacoustic Image-Guided Photothermal Cancer Therapy Using Silica-Coated Gold Nanorods. IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control. 2014.).
BRIGHT and SALMAN teach Applicant’s invention as discussed above. BRIGHT teaches the nanoparticles, such as nanospheres (page 67, paragraph 0247) are heated by an external energy to ablate the nerves (page 31, paragraph 0119).
BRIGHT and SALMAN do not specifically teach applying the ultrasound to the gold nanoparticles, or using gold nanorods.
Regarding claims 43-44, KIM teaches a method of applying ultrasound to gold nanorods (abstract). This method allowed for photothermal therapy, which is utilizing applying energy on the gold nanorods to produce heat energy that results in cancer cell death, also known as thermal ablation (page 1, paragraph 2), and imaging, which can effectively guide photothermal therapy to achieve the desired thermal treatment (abstract). Nanorods were used because of their enhanced thermal stability and photoacoustic signal response (page 892, paragraph 4), when compared to nanospheres (page 894, paragraph 1).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate applying ultrasound to gold nanorods. The person of ordinary skill in the art would have been motivated to make those modifications, because nanorods are better than nanospheres due to their enhanced thermal stability and photoacoustic signal response. Furthermore, when ultrasound is applied to gold nanorods, they can have a therapeutic effect is causing ablation to target cells and can be used for imaging to guide therapy. One reasonably would have expected success because the references are in the same field of endeavor, such as gold nanoparticles that are have a therapeutic effect when exposed to energy, used for destroying target cells.
Claims 31-34, 37, 39-46 and 51-53 are rejected under 35 U.S.C. 103 as being unpatentable over BRIGHT (WO 2019/178564), SALMAN (Riboflavin Arrests Cisplatin-Induced Neurotoxicity by Ameliorating Cellular Damage in Dorsal Root Ganglion Cells. BioMed Research International. 2015.) and KIM (In-Vivo Ultrasound and Photoacoustic Image-Guided Photothermal Cancer Therapy Using Silica-Coated Gold Nanorods. IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control. 2014.) in view of SINGH (Multi-dye theranostic nanoparticle platform for bioimaging and cancer therapy. International Journal of Nanomedicine. 2012.).
BRIGHT, SALMAN and KIM teach Applicant’s invention as discussed above. BRIGHT teaches a contrast agent can be bound to or incorporated into the composition to confirm target delivery and prevention of off-target spread (page 5, paragraph 0017).
BRIGHT, SALMAN and KIM do not teach incorporating a fluorescent dye.
Regarding claim 46, SINGH teaches a composition that comprises a fluorescent and photothermal agent and is delivered in the form of nanoparticles (abstract). The fluorescent agent allowed for clear visualization of the targeted cells (abstract).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a fluorescent dye. The person of ordinary skill in the art would have been motivated to make those modifications, because it allows for clear visualization of the targeted cells, and reasonably would have expected success because the references are in the same field of endeavor, such as compositions for cell photoablation that comprise nanoparticles.
Conclusion
No claims are allowable.
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/S.L.M./Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618
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