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 .
Status of Application, Amendments and Claims
Claims 1-2, 5-6, 8-18 and 26-27 are pending; claims 1, 6, 8 and 10 are amended; and claims 26-27 are newly added.
Response to Arguments
Applicant’s arguments with respect to claims 1-2, 5-6 and 8-18 have been considered but are moot in view of new grounds of rejection to address the amended claims.
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 1-2, 5-6, 8-16, 18 and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Luu et al. (US 2021/0113852) in view of Kaneda et al. (US 2024/0108725).
[Claim 1] Luu discloses a method for phototherapy [abstract], comprising:
implanting an illumination source in a patient (implanting light illumination system, #100, in the brain of a patient) [pars. 0029, 0079];
delivering a photosensitizer to the patient, wherein the photosensitizer accumulates in a target treatment tissue (photosensitizer absorbed by cells) [pars. 0029, 0081, 0092], and wherein the photosensitizer comprises 5-aminolevulinic acid (5-ALA) [par. 0097];
illuminating the target treatment tissue with light from the illumination source, wherein the illumination source is wirelessly powered (the illumination system includes a power receiver element comprising a wireless coil, #101) [pars. 0030-0031, 0038, 0089];
photoactivating the photosensitizer, wherein the photoactivated photosensitizer in combination with oxygen in cells of the target treatment tissue, generate cytotoxic reactive oxygen species (ROS) [pars. 0029, 0040];
discontinuing the illuminating for a first desired period of time (a duty cycle may include one minute of illumination with thirty seconds without illumination) [par. 0089];
administering a new dose of the photosensitizer to the patient and further allowing uptake of the new dose of photosensitizer (a dose includes photosensitizer drug dosage and frequency) [par. 0081];
re-starting the illuminating for a second desired period of time (the duty cycle is repeated) [pars. 0089]; and
causing cells in the target treatment tissue to be destroyed by the cytotoxic reactive oxygen species [pars. 0029, 0040].
Luu does not disclose (1) allowing uptake of the photosensitizer by the patient and expression of protoporphyrin IX (PPIX); (2) photoactivating the PPIX with the light; and (3) administering a new dose thereby expressing additional PPIX.
Kaneda discloses an analogous method for treating cancer comprising administering 5-aminolevulinic acid (5-ALA), wherein the 5-ALA is converted to protoporphyrin IX (PPIX) which selectively accumulated in caner cells and when PPIX is activated by light irradiation, single oxygen is generated and cancer cells are damaged [par. 0049].
It would have been obvious to one of ordinary skill in the art before the effective filing date to allow the 5-ALA administered to the patient as taught by Luu to be converted and expressed as PPIX, photoactivate the PPIX with the illumination source, and administer multiple doses of 5-ALA to allow for further PPIX expression as taught by Kaneda in order to treat cancer multiple times as required by the particular cancer of the patient.
[Claim 2] Kaneda discloses delivering the photosensitizer comprises delivering the photosensitizer orally, intravenously, intraperitoneally, or topically to the patient (a photosensitive substance can be administered to a subject by oral administration or by parenteral administration such as intravenous, transdermal, or rectal administration) [par. 0053].
[Claims 5-6] Luu discloses the treatment tissues comprises a glioblastoma tumor [pars. 0029, 0082].
[Claim 8] Luu discloses repeating the discontinuing of illumination and the re-starting of the illumination repeatedly results in destruction of more cells in the target treatment tissue than a single treatment of photodynamic therapy [pars. 0040, 0089].
[Claim 9] Luu discloses after the bulk of a glioblastoma tumor or other diseased tissue is removed the light source is secured in place such as by glueing the light source to the formed cavity [par. 0082]. It would have been obvious to one of ordinary skill in the art before the effective filing date that gluing the light source to the cavity would result in a distance of no more than 1 cm away from the target treatment tissue.
[Claim 10] Luu discloses implanting the illumination source comprises implanting the illumination source in a brain of the patient [pars. 0029, 0079, 0082].
[Claim 11] Luu discloses after the bulk of a glioblastoma tumor or other diseased tissue is removed the light source is secured in place such as by glueing the light source to the formed cavity [par. 0082]. It would have been obvious to one of ordinary skill in the art before the effective filing date that gluing the light source to the cavity would result in a distance of no more than 6-8 mm away from the target treatment tissue.
[Claim 12] Luu discloses the light has a wavelength in the near infrared region of the spectrum (wavelength range of about 600 nm to 940 nm) [par. 0095]. Kaneda also discloses using a wavelength of 200 to 2500 nm such as 600 to 800 nm [par. 0064].
[Claim 13] Luu in view of Kaneda follows the method and would result in cell destruction in the target treatment tissue following a linear dose response to time and light intensity of the illumination from the illumination source. Where the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on “inherency” under 35 USC § 102, on prima facie obviousness” under 35 USC § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO' s inability to manufacture products or to obtain and compare prior art products.” [In re Best, 562 F2d 1252, 1255, 195 USPQ 430, 433-4 (CCPA 1977); MPEP §2112.01].
[Claim 14] Luu in view of Kaneda follows the method and would result destroying tumor vasculature with the reactive oxygen species. Where the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on “inherency” under 35 USC § 102, on prima facie obviousness” under 35 USC § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO' s inability to manufacture products or to obtain and compare prior art products.” [In re Best, 562 F2d 1252, 1255, 195 USPQ 430, 433-4 (CCPA 1977); MPEP §2112.01].
[Claim 15] Luu in view of Kaneda discloses the reactive oxygen species causes apoptosis and necrosis of the target treatment tissue [Luu: par. 0100; Kaneda par. 0066].
[Claim 16] Luu discloses monitoring the target treatment tissue with magnetic resonance imaging (MRI) [pars. 0081, 0088].
[Claim 18] Luu in view of Kaneda follows the method and would induce an anti-tumor immune response in the patient, and prevent local tumor growth in the target treatment tissue or delay growth of distant untreated disease away from the target treatment tissue, after one or more applications of photodynamic therapy to the patient. Where the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on “inherency” under 35 USC § 102, on prima facie obviousness” under 35 USC § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO' s inability to manufacture products or to obtain and compare prior art products.” [In re Best, 562 F2d 1252, 1255, 195 USPQ 430, 433-4 (CCPA 1977); MPEP §2112.01].
[Claim 26] Luu discloses the target treatment tissue comprises an organ (e.g. the brain).
[Claim 27] Luu discloses the target treatment tissue comprises diseased or damaged tissue (e.g. glioblastoma tumor).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Luu et al. (US 2021/0113852) in view of Kaneda et al. (US 2024/0108725) applied to claim 1 above and further in view of Gallant et al. (US 2010/0312097).
[Claims 16-17] Luu in view Kaneda render obvious using MRI and adjusting dosages of photosensitizer but do not disclose personalizing a treatment regimen for the patient by modifying the delivering of the photosensitizer, or modifying the illuminating of the target treatment tissue, or modifying the photoactivating of the photosensitizer agent, based on the monitoring of the target treatment tissue with magnetic resonance imaging.
Gallant, in the same field of endeavor of photodynamic therapy monitoring, discloses personalizing a treatment regimen for the patient by modifying the delivering of the photosensitizer, or modifying the illuminating of the target treatment tissue, or modifying the photoactivating of the photosensitizer agent, based on the monitoring of the target treatment tissue with magnetic resonance imaging (Typically, the MRI scanner is used to establish diagnostic and follow therapy effectiveness through morphology of tissues. Therapy monitoring in this case is dependent on the tissue structure in the MRI dataset. For example, in cancer, treatments will be monitored by looking at the tumor size, tissue cellular characteristic (necrotic, hemorrhaging, amount of stroma, etc.) and blood perfusion, through functional MRI... For example, in the case of a photodynamic drug, dynamic information about local tissue oxygenation levels is required in order to optimize the photo toxicity treatment program closer to real time, or indicate a critical time-point for switching to ionizing radiation therapy or antiangiogenic therapy. This is a current issue in PDT, currently hindering its wider scale use in the clinical field) [pars. 0025-0026, 0043].
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to include MRI adjusted dosages of photosensitizer and illumination, as taught by Gallant, in order to provide a more accurate dosage of photosensitizer and illumination to treat the specifics of a particular patient’s tumor.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
(1) Teh et al. (US 2023/0045729) discloses an implementation of an implantable light delivery device according to an embodiment in a mice glioblastoma model. As shown in FIG. 8, implantable light delivery device 820 was implanted in the brain 810 of a mouse 800. The implantable light delivery device 820 was implanted close to a tumor 812 through an incision in the skull 814 of the mouse 800. The photosensitizer protoporphyrin (PpIX) was administered and the implantable light delivery device 820 was illuminated with NIR excitation radiation [par. 0062].
(2) Pandey et al. (US 2020/0078459) discloses Porphyrin-based compounds (e. G., Photofrin), 5-aminolevulenic acid (5-ALA), a prodrug for the photosensitizer protoporphyrin-IX have been used in diagnosis of cancer by fluorescence and treatment by PDT [par. 0120].
(3) Jung et al. (US 2019/0240166) discloses amethod for treating skin cancer, said method comprising: adhering a transdermal therapeutic system containing 5-aminolevulinic acid hydrochloride in the form of particles less than 250 μm to skin at a place affected by cancer or precancerous lesions, allowing said 5-aminolevulinic acid hydrochloride to dissolve via sweat from the place on the skin where the transdermal therapeutic system is applied, transdermally absorbing the dissolved 5-aminolevulinic acid hydrochloride and enriching the concentration of 5-aminolevulinic acid hydrochloride in proximity of said cancer or precancerous lesions, allowing said 5-aminolevulinic acid hydrochloride to convert into protoporphyrin IX, irradiating said cancer or precancerous lesions enriched with protoporphyrin IX with light of a wavelength selected from the group consisting of 408 nm, 506 nm, 532 nm, 580 nm and 635 nm, thereby producing reactive oxygen compounds, and allowing said reactive oxygen compounds to induce necrosis in said cancer or precancerous lesions [claim 25].
(4) Babic et al. (US 2018/0133320) discloses a method of treating or repressing a cancer, said method comprising administering in a subject in need thereof a therapeutically effective amount of a pharmaceutical formulation according to the invention and exposing cancer cells to light. Typically, in a method of treatment according to the invention, protoporphyrin IX intracellular accumulation into cancer cells is triggered by the administration of a formulation according to the invention and cancer cells are exposed to a light having a suitable wavelength (e.g. white light, for example light in the wavelength region 300-800 nm, typically light in the wavelength region 380-660 nm) in order to activate protoporphyrin IX and convert it into a cytotoxic form thereof [par. 0263].
(5) Tananka et al. (US 2014/0128799) discloses although 5-aminolevulinic acid (hereinafter also referred to as "ALA") is one natural amino acid contained in a living body, broadly present in animals, plants, and fungi, ALA has no photosensitivity per se; however, protoporphyrin IX (hereinafter also referred to as "PpIX") produced by its metabolic activation by a series of enzymes of the heme biosynthetic pathway in cells is known as a photosensitizing agent showing peaks at 410 nm, 545 nm, 580 nm, 630 nm, and the like, and work is proceeding on 5-aminolevulinic acid-based photodynamic therapy (hereinafter also referred to as "ALA-PDT") which involves accumulating PpIX in cancer cells followed by irradiation with excitation light around 600 to 700 nm to degenerate/necrotize cells of an affected part [par. 0003].
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 NATHAN J JENNESS whose telephone number is (571)270-5055. The examiner can normally be reached M-F 8:00-5:00 EST.
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/NATHAN J JENNESS/Supervisory Patent Examiner, Art Unit 3733 3 June 2026
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