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
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9 December 2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. See attached copy of PTO-1449.
Status of Application
2. Receipt of the Request for Continued Examination (RCE) under 37 C.F.R. 1.114, the Amendment and Applicants’ Arguments/Remarks, all filed 11 May 2026 are acknowledged.
Claims 1, 3-13, 17, and 20 are currently pending. Claims 2, 14-16, and 18-19 have been cancelled. Claim 1 has been amended. Claims 1, 3-13, 17, and 20 are examined on the merits within.
Continued Examination Under 37 C.F.R. 1.114
3. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 2026 has been entered.
Withdrawn Rejections
4. Applicant’s arguments, filed 11 May 2026, with respect to the 35 U.S.C. 112(a) Rejections have been fully considered and are persuasive. The 35 U.S.C. 112(a) Rejections of claims 1, 3-13, 17 and 20 have been withdrawn.
New Rejections
Claim Rejections – 35 U.S.C. 112(a) New Matter
5. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
6. Claims 1, 3-13, 17, and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
7. Claim 1 has been amended to recite “reduce or mitigate development of the one or more deleterious effects of mixed field radiation in the heart and/or lungs of the subject.” Figures 2-3 and Example 1 are directed to heart and lung tissue testing when exposed to LET proton radiation. There is no mention of effect regarding heart and lungs with other types of radiation. The claims have been amended to recite that the radiation is neutron, alpha, beta, and photon radiation. Thus there is no explicit support for correlating the effects on the heart and lungs when exposed to neutron, alpha, beta and photon radiation. The claims lack sufficient written description for this amendment.
Claim Rejections – 35 U.S.C. 112(b)
8. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
9. Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
10. Claim 20 recites that the mixed field radiation comprises 32% neutron radiation and 68% gamma radiation. However, this depends from claim 1 which recites neutron, alpha, beta and photon radiation. Although gamma radiation is a type of photon radiation, it is unclear how alpha and beta radiation can be present when the mixed field radiation of neutron and gamma equates to 100%. Does this mean that the total amount of radiation is over 100%? Or should the mixed radiation only include neutron and gamma, thus not further limiting claim 1. Clarification is requested.
Claim Rejection – 35 U.S.C. 103
11. 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.
12. Claim(s) 1, 3-13, 17, and 20 is/are again rejected under 35 U.S.C. 103 as being unpatentable over Elder, Jr. et al. (U.S. Patent No. 8,551,530) as evidenced by Atomic Archive and The Cleveland Clinic.
Regarding instant claims 1, 4, and 6, Elder, Jr. et al. teach formulations of nanoparticulate genistein. See abstract. Elder, Jr. et al. teach a method of treating acute radiation syndrome comprising identifying a subject that has experienced exposure to radiation of at least 0.3 Gray or 30 rads and administering a therapeutically effective amount of a genistein formulation comprising nanoparticulate genistein, one or more pharmaceutically acceptable excipients including polyvinylpyrrolidone, wherein the nanoparticulate genistein exhibits a D(0.50) of 0.5µm or less, wherein genistein is administered in an amount between 250 and 500 mg/ml. See claim 1. Elder, Jr et al. also teach genistein administered prior to, during and/or after exposure to radiation, may be used to eliminate or reduce the severity of the deleterious cellular effects caused by exposure to ionizing radiation resulting from nuclear explosion, a spill of radioactive material, close proximity to radioactive material, cancer radiation therapy, diagnostic tests that utilize radiation, and the like. See column 12, lines 39-55. Nuclear explosions comprise mixed radiation such as gamma, neutron, and ionizing as evidenced by Atomic Archive. Example 5 shows a twice daily administration of genistein for 6 days prior to irradiation. Example 5 also shows a positive control of genistein administered 24 hours prior to irradiation. Example 6 administers a single dose of 200 mg/kg. Example 8 uses a dose level of 50 mg/kg to 200 mg/kg. Example 9 administers a dose of 20 mg/kg. The subject is a human. See column 4, lines 44-47. Elder et al. teach that genistein displays antitumor, antimetastatic, and antiangiogenic properties (suppression of blood-vessel growth). See column 10, lines 7-30. Elder et al. teach that genistein has been used in treating cystic fibrosis, wherein the symptoms include chronic obstructive lung disease. See column 11, lines 9-33. Chronic obstructive lung disease includes inflammation and scarring (fibrosis) as evidenced by the Cleveland Clinic. The term "radioprotective agent" refers to agents that protect cells or living organisms from the deleterious cellular effects that result from exposure to ionizing radiation. These deleterious cellular effects include damage to cellular DNA, such as DNA strand break, disruption in cellular function, cell death and/or carcinogenesis. See column 4, lines 20-43.
Regarding instant claim 5, Example 8 comprises nanoparticulate genistein with a d(0.5) of 0.136 µm which is less than 0.3µm.
Regarding instant claims 7-8, the composition additionally comprises a diluent and preservative. See claim 2 and column 9, lines 46-59.
Regarding instant claim 9, the composition additionally comprises a nonionic surfactant. See claim 2.
Regarding instant claim 11, genistein is present in an amount ranging from 40 to 75%. See claim 8.
Regarding instant claim 12, genistein may be present at a concentration of 275 mg/ml to 325 mg/ml. See claim 1.
Regarding instant claim 13, the composition is formulated as a capsule for oral delivery. See column 9, lines 46-59.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to administer genistein once daily, 24-36 hours prior to exposure of mixed field radiation, because Elder, Jr specifically exemplify administration at 24 hours prior for Gy 60Co radiation but also teach the use against nuclear explosions. It is noted that the instant specification states “MF radiation can include various combinations of proton radiation, neutron radiation, alpha and/or beta radiation, and photon radiation. For example, in the event of an unshielded nuclear fission event (e.g., an attack or a reactor meltdown), individuals would likely be exposed to a miasma of photons, neutrons, alpha, and beta particles.” See paragraph [0023]. Since nuclear explosions are mixed field radiation, it would have been obvious to try a similar dosing time table for mixed field radiation. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the dosing regimen, including amounts of genistein and frequency, to achieve the optimal desired effect because Elder, Jr teach various frequencies including one or twice daily and various effective amounts ranging from 20 to 200 mg/kg. Since Elder, Jr et al. teach administering genistein to humans prior to or after nuclear explosions, it would have been well within the purview of the skilled artisan to administer genistein to first responders or members of the military since they are humans likely to be called upon to help in a nuclear disaster. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to administer genistein to a subject exposed to 32% neutron radiation and 68% gamma radiation because genistein is known to be effective against radiation, including nuclear radiation which includes both gamma and neutron radiation. Since Elder, Jr teaches administering the same active ingredient, to the same population being exposed to the same conditions, in the same amounts at the same time periods, the treatment should have the same effect, i.e., mitigate development of the one or more deleterious effects of mixed field radiation in the heart or lungs.
13. Claim(s) 1, 3, 6-7, 10-13, 17, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP2004538242, hereinafter JP’242.
JP’242 teaches prophylactic and therapeutic treatment of humans from radiation injury comprising administering genistein. See abstract. The composition may be administered orally. See paragraph [0007]. The composition is administered in 1 mg/kg to 20 mg/kg/day. See paragraph [0008]. The composition is administered 10 minutes to 96 hours before radiation exposure as a single dose or multiple doses. The radiation is selected from ionizing radiation, alpha, beta, gamma, neutron, microwave, and electromagnetic radiation. See paragraph [0009]. Genistein is a protein tyrosine kinase inhibitor shown to prevent radiation induced cell death. See paragraph [0016]. In addition, the present invention has been practiced in clinics, nuclear power plants, food radiation facilities, and in radioactive waste disposal sites and accidents. See paragraph [0025]. Solubilizing agents include polyvinyl pyrrolidone. See paragraph [0031]. The composition includes diluents. See paragraph [0006]. The composition may comprise between 0.1 and 2000 mg of the isoflavonoid. See paragraph [0008]. The composition can be formulated as a tablet or capsule. See paragraph [0031].
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to administer genistein once daily, 24-36 hours prior to exposure of mixed field radiation, because JP’242 specifically exemplify administration up to 96 hours prior to radiation, including radiation from alpha, beta, gamma, and neutron sources, including nuclear power plants. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the dosing regimen, including amounts of genistein and frequency, to achieve the optimal desired effect because JP’242 teach various frequencies including one or twice daily and various effective amounts that fall within the claimed range. Since JP’242 teach administering genistein to humans prior to nuclear explosions, it would have been well within the purview of the skilled artisan to administer genistein to first responders or members of the military since they are humans likely to be called upon to help in a nuclear disaster. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to administer genistein to a subject exposed to 32% neutron radiation and 68% gamma radiation because genistein is known to be effective against radiation, including nuclear radiation which includes both gamma and neutron radiation. One would have been motivated, with a reasonable expectation of success, to administer the genistein to reduce the deleterious effects of radiation exposure, including cell death, as taught by JP’242. Since JP’242 teaches administering the same active ingredient, to the same population being exposed to the same conditions, in the same amounts at the same time periods, the treatment should have the same effect, i.e., mitigate development of the one or more deleterious effects of mixed field radiation in the heart or lungs.
Response to Arguments
Applicants’ arguments filed 11 May 2026 have been fully considered but they are not persuasive.
14. Applicants argued, “Elder does not teach once daily oral administration at a dose of 10 mg/kg to 100 mg/kg starting between 24 to 36 hours before exposure to mixed field radiation wherein the deleterious effects are cell death, tissue fibrosis or inflammation and the mixed field radiation includes neutron, alpha, beta, and photon radiation. The etiology of inflammation and tissue fibrosis caused by cystic fibrosis is different from the etiology of inflammation and tissue fibrosis caused by mixed field radiation. The patient population, dosing requirements and type of radiation are not the same as Elder.”
In response to applicants’ arguments, Elder et al. teach that genistein displays antitumor, antimetastatic, and antiangiogenic properties (suppression of blood-vessel growth). See column 10, lines 7-30. Elder et al. teach that genistein has been used in treating cystic fibrosis, wherein the symptoms include chronic obstructive lung disease. See column 11, lines 9-33. Chronic obstructive lung disease includes inflammation and scarring (fibrosis) as evidenced by the Cleveland Clinic. Elder specifically says that a subject at risk for or suffering from cystic fibrosis is identified and a therapeutically effective amount of genistein formulation selected from any of those described herein is administered to the subject. See column 11, lines 34-53. Thus Elder teach a prophylactic effect of genistein due to administering to a subject at risk, i.e., a subject not currently displaying symptoms. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to administer genistein to a subject exposed to mixed field radiation because genistein is known to be effective against radiation, including nuclear radiation which includes both gamma and neutron radiation. It is noted that the instant specification states “MF radiation can include various combinations of proton radiation, neutron radiation, alpha and/or beta radiation, and photon radiation. For example, in the event of an unshielded nuclear fission event (e.g., an attack or a reactor meltdown), individuals would likely be exposed to a miasma of photons, neutrons, alpha, and beta particles.” See paragraph [0023]. Elder specifically recites “Genistein administered prior to, during, and/or after exposure to radiation, may be used to eliminate or reduce the severity of deleterious cellular effects caused by exposure to ionizing radiation resulting from, for example, from a nuclear explosion, a spill of radioactive material, close proximity to radioactive material, cancer radiation therapy, diagnostic tests that utilize radiation, and the like.” One would have been motivated to administer the genistein to reduce the deleterious effects of radiation exposure, including cardiovascular, tissue fibrosis, and inflammation, because Elder et al. teach the antiangiogenic properties of genistein and effective use for treatment of cystic fibrosis which includes inflammation and tissue fibrosis. Even if the etiology of inflammation and tissue fibrosis is different, there would be a reasonable expectation of success because Elder is directed to administering the same composition, to the same patient population, with the same dosing requirements, wherein the patient population is subjected to the same type of radiation. Elder teaches that genistein is administered orally, teaches doses of 20 mg/kg which falls within the claimed range, and teaches administration 24 hours prior to radiation (see Example 5). Elder also teaches The term "radioprotective agent" refers to agents that protect cells or living organisms from the deleterious cellular effects that result from exposure to ionizing radiation. These deleterious cellular effects include damage to cellular DNA, such as DNA strand break, disruption in cellular function, cell death and/or carcinogenesis. See column 4, lines 20-43. Thus it is unclear how Elder does not teach the same patient population, dosing requirements and radiation to achieve the same effect.
Thus this rejection is maintained.
Correspondence
15. No claims are allowed at this time.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
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