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 .
Claims Status
Claims 83-84 are new.
Claims 1-3, 5-11, 13-21, 23-27, 32-42, 44, 46-48, 50-65, 69, 73 and 76 have been cancelled.
Claims 4, 12, 22, 28-31, 43, 45, 49, 66-68 and 70-72, 74, 75 and 77-84 are pending and under examination. Applicant’s amendment has necessitated new grounds of rejection. Accordingly, this Action is FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/14/25 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn rejections
Applicant's amendments and arguments filed 11/14/25 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn. Claim(s) 4, 12, 66, 67, 70, 71, 74, 77 and 82 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ning et al. (Can Res. 2012;72(10):2600-2608) as evidenced by Oronsky et al. (EXPERT OPINION ON INVESTIGATIONAL DRUGS, 2017 (online December 21, 2016); VOL. 26 (1): 109–119; reference A9 on the IDS filed 10/27/2020). Claims 49, 68, 72 and 75 were rejected under 35 U.S.C. 103(a) as being unpatentable over Ning et al. (Can Res. 2012;72(10):2600-2608) as evidenced by Oronsky et al. (EXPERT OPINION ON INVESTIGATIONAL DRUGS, 2017 (online December 21, 2016); VOL. 26 (1): 109–119). Claims 4 and 22 were rejected under 35 U.S.C. 103(a) as being unpatentable over Ning et al. (Can Res. 2012;72(10):2600-2608) as evidenced by Oronsky et al. (EXPERT OPINION ON INVESTIGATIONAL DRUGS, 2017 (online December 21, 2016); VOL. 26 (1): 109–119), as applied to claim 4, in further view of Thorsen et al. (Ann Acad Med Singap 1994;23(2):209-11; 1 page). Claims 4, 43 and 45 were rejected under 35 U.S.C. 103(a) as being unpatentable over Ning et al. (Can Res. 2012;72(10):2600-2608) as evidenced by Oronsky et al. (EXPERT OPINION ON INVESTIGATIONAL DRUGS, 2017 (online December 21, 2016); VOL. 26 (1): 109–119, as applied to claim 4, in further view of Brzezniak et al. (Case Rep Oncol. 2016;9:45-50) and Oronsky et al. (WO2013052803) and Geng et al. (Scientific Reports 2017; 7, article number:13542; page1-12). Claims 4, 43 and 45 were rejected under 35 U.S.C. 103(a) as being unpatentable over Ning et al. (Can Res. 2012;72(10):2600-2608) as evidenced by Oronsky et al. (EXPERT OPINION ON INVESTIGATIONAL DRUGS, 2017 (online December 21, 2016); VOL. 26 (1): 109–119, as applied to claim 4, in further view of Brzezniak et al. (Case Rep Oncol. 2016;9:45-50) and Oronsky et al. (WO2013052803) and Geng et al. (Scientific Reports 2017; 7, article number:13542; page1-12). Claims 4, 12 and 77-84 were rejected under 35 U.S.C. 103(a) as being unpatentable over Oronsky et al. (WO2017123593; hereinafter OronskyWO2017) and Oronsky et al. (EXPERT OPINION ON INVESTIGATIONAL DRUGS, 2017 (online December 21, 2016); VOL. 26 (1): 109–119). Claims 28-31 were rejected under 35 U.S.C. 103(a) as being unpatentable over Oronsky et al. (WO2017123593; hereinafter OronskyWO2017; reference #26 on the IDS filed 1/12/23) and Oronsky et al. (EXPERT OPINION ON INVESTIGATIONAL DRUGS, 2017 (online December 21, 2016); VOL. 26 (1): 109–119), as applied to claims 4, 12 and 77-82 above, in further view of in further view of over Reid et al. (Lancet Oncol 2015; 16: 1133–42) and Oronsky et al. (US 9511016).
Applicant’s amendments and arguments are persuasive.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim Rejections - 35 USC § 112
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.
Claim 82 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. Claim 82 depends from claim 4. Claim 4 requires that the method is not part of a radiotherapy. However, claim 82 is directed to “medical instrumentation that emits radiation”, which would be part of radiotherapy, which is excluded by claim 4. Correction is required.
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.
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.
Claims 4, 12, 66-68, 70-72, 74-75 and 77-84 is/are rejected under 35 U.S.C. 103 as being obvious over Oronsky et al. (EXPERT OPINION ON INVESTIGATIONAL DRUGS, 2017 (online December 21, 2016); VOL. 26 (1): 109–119; reference A9 on the IDS filed 10/27/2020) and Singh et al. (Health Phys. 108(6):607–630; 2015).
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.
Applicant claims, for example:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). In the present case, the ordinary artisan is a medical/pharmaceutical arts research scientist trained in radiation protection, pharmaceutical formulations and radioprotection therapies.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Regarding claims 4, 77 and 82, Oronsky et al. teach:
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(Page 109, right column 2nd paragraph). From that sentence it is clear that a method of administering RRx-001 to radioprotect an individual, hence humans, in case of a nuclear emergency, which is radiation not part of a radiotherapy but with an expectation of exposure to radiation. The RRx-001 is expected to function as a radioprotectant and be in an effective amount to reduce radiation-exposure damage to normal tissue in a human is administered.
Regarding claims 4 and 77, Singh et al. teach that: “Radioprotectors or radioprotectants are prophylactic agents that are administered before exposure to prevent radiation-induced cellular and molecular damage” (Page 608, right column 2nd paragraph). Singh et al. provide examples of administration 24 to 48 hours prior to or 2 hours after irradiation (Page 617, left column 2nd paragraph: “A single sc injection of 5‐AED 24 to 48 h prior to or 2 h after a lethal dose of TBI”; page 618, right column 3rd paragraph; “A single sc injection of genistein 24 h before irradiation provided significant radioprotection”). Singh et al. also teach oral and parenteral administration (Page 610, Table 1; Page 617, 1st paragraph)
1. The difference between the instant application and Oronsky et al. is that Oronsky et al. do not expressly teach administration of between about 0.010 mg to about 100 mg of at least one dose of RRx-001 via parenteral administration, oral administration, and topical administration, and wherein the therapeutic agent is administered systemically or locally to human military personal or first responder or civilian at least 6 hours prior to exposure to radiation or within 6 hours after exposure to the radiation has ceased or protecting isolated human cells, tissues or organs and wherein the radiation comprises cosmic radiation. This deficiency in Oronsky et al. is cured by the teachings of Singh et al.
1. It would have been obvious to one of ordinary skill in the art before to the effective filing date of the claimed invention to perform the method of Oronsky et al., with administration of between about 0.010 mg to about 100 mg of at least one dose of RRx-001 via parenteral administration, oral administration, and topical administration, and wherein the therapeutic agent is administered systemically or locally to human military personal or first responder or civilian at least 6 hours prior to exposure to radiation or within 6 hours after exposure to the radiation has ceased or protecting isolated human cells, tissues or organs and wherein the radiation comprises cosmic radiation, as suggested by Singh et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because for the following sound articulated reasoning with rational underpinning based upon the evidence. First of all, a nuclear emergency would impact both ordinary citizens and first responders, both military, federal and civilian depending upon the nature of the nuclear emergency, which could be a pending nuclear power plant disaster or a pending nuclear naval ship/submarine disaster. Thus, the claimed populations are obvious for treatment with a radioprotectant prior to exposure to radiation of the pending disaster to protect and reduce damage to the normal tissue of the human subject. Especially with the Armed Forces doing the research. Also note that it is obvious to provide a first responder to a nuclear accident with a radioprotectant prior to sending the first responder into the radiation zone of a nuclear accident. Secondly, administration of at least 6 hours or 24 hours prior to exposure or within 6 hours after the radiation has ceased is obvious in view of the teachings of Singh et al. as discussed above (Singh et al. teaching 48 or 24 hours prior to or 2 hours after irradiation). Finally, the route of administration and dosage amount is readily determined by the ordinary artisan in this art, especially when Singh et al. teach both oral and parenteral administration, as the artisan would desire an effective amount to be therapeutically protective. Since cosmic radiation is ubiquitous, then the radiation naturally comprises cosmic radiation. The ordinary artisan in this art readily understands that the radioprotectant RRx-001 protects normal tissue from radiation exposure damage and that tissue would extend to isolated human cells, tissues or organs. Consequently, exposure of isolated human cells, tissue or organs to an effective therapeutic amount RRx-001 at least 6 or at least 24 hours prior to exposure to radiation to protect the isolated human cells, tissues or organs is obvious to the ordinary artisan in this art. The ordinary artisan would do so with a reasonable expectation of success.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments:
Applicant’s arguments are directed to a withdrawn rejection. Accordingly, Applicant’s arguments are moot.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim 4, 12, 22, 28-31, 43, 45, 49, 66-68 and 70-72, 74, 75 and 77-84 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of US Patent 11510901 and NASA (NASA Protects Its Superheroes From Space Weather [online] retrieved on 2/8/23 from: https://www.nasa.gov/feature/nasa-protects-its-superheroes-from-space-weather; August 16, 2017; 3 pages). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent also teaches methods of treating a subject in need of protection from radiation/reducing radiation exposure damage/protecting biological material from damaging effects of radiation by administering an effective amount of RRx-001 (claims 1, 3, 18 and 20), such as about 0.01-500 mg (Claim 5) and dosage of about 100 mg/m2 to about 500 mg/m2 (Claim 9), wherein the radiation comprises α-rays, β-rays, x-rays, y-rays, neutron radiation, ionizing radiation, ionizing radiation from sunlight, ionizing radiation from radioactive nuclei, ionizing radiation from an explosive device, or a combination thereof (claim 19), where at least “ionizing radiation from sunlight” includes cosmic radiation which is emitted by stars including our sun, with the same duration of protection (claim 2); administered prior to or after exposure to the radiation (claim 4); in the same amounts (claim 5); administered systemically or topically (claim 6); via subcutaneous pump (claim 7); administer pain reliever agent prior to administration (claims 11-13); administering second therapeutic (claim 8); administering EGFR inhibitor (claim 16); administering inorganic nitrite (claims 16 and 17). Thus, embodiments where the method is not part of radiotherapy are taught by the patent.
The method of the patent intrinsically protects the normal tissue in subjects in need of protection against radiation.
The patent does not expressly teach at least 10 mg/kg RRx-001. However, the patent does provide a wide range of dosage amounts from about 0.01 to about 500 mg (claim 5) and it appears routine optimization to arrive at 10 mg/kg as an effective amount to reduce radiation exposure damage (Claims 1 and 3) as taught by the patent. Pharmaceutical dose has been recognized as a result-effective parameter susceptible to routine optimization. See, e.g., Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 809 (Fed. Cir. 1989).
The patent does not expressly teach administration within 6 hours after exposure to the radiation has ceased. However, the patent discloses that the dose is administered to the subject prior to or after exposure to the radiation (Claim 4) and the scope of that time is taught to be: “administered to the subject at least 1 hour, 2 hours, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours, 3 days, 4 days, 5 days, 6 days, 1 week, 2 weeks, 3 weeks, or 4 weeks prior to the subject being exposed to radiation (Specification Column 12, lines 56-61).” See MPEP 804: “The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim.”
The patent does not expressly teach “cosmic radiation”. However, NASA teaches that there is an express need to protect astronauts from high energy galactic cosmic rays, which is ionizing radiation in space, and that poses a serious risk including acute radiation sickness to astronauts as they travel to Mars (page 1, 2nd and 4th paragraphs). Accordingly, it is obvious to perform the patented method on astronauts, isolated cells, tissue and organs that are living or traveling through space because they need protection against radiation including ionizing radiation from the sun which includes cosmic radiation generated an emitted by the sun.
The patent does not expressly teach erlotinib. However, the patent does teach and suggest EGFR inhibitors which the medical artisan in this art would recognize as describing the EGFR inhibitor erlotinib.
The patent does not expressly teach treating isolated cells, tissue or organs. However, the patent teaches treating biological material from the damaging effects of radiation (claim 18), where the ordinary artisan in this art understands “biological material” to include such common biological material as isolated cells, tissues and organs.
The patent does not expressly teach first responders, military personal or civilians. However, the patent teaches treating adults (Claim 15) and radiation from radiation therapy (Claim 15), hence a medical device that emits radiation, radioactive nuclei and explosive devices (Claim 19) where first responders, military personal and civilians are likely casualties of a radioactive power plant (nuclear power source) leak/nuclear emergency or explosive device. Thus, it is simply treatment of those affected by the radioactive leak/explosive device with a reasonable expectation of success.
Therefore, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patented subject matter.
Response to Arguments: Applicant asserts: “the claims of the '901 patent fail to specifically recite this particular timeframe for administration. Accordingly, for at least this reason, the present claims are patentably distinct from the '901 patent and NASA.” Respectfully, the Examiner does not agree because the patent is broad and teaches administration to the subject prior to or after exposures to the radiation (Claims 4 and 18). As asserted by the Examiner above, “the patent discloses that the dose is administered to the subject prior to or after exposure to the radiation (Claim 4) and the scope of that time is taught to be: “administered to the subject at least 1 hour, 2 hours, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours, 3 days, 4 days, 5 days, 6 days, 1 week, 2 weeks, 3 weeks, or 4 weeks prior to the subject being exposed to radiation (Specification Column 12, lines 56-61).” While the patent may not claim the instant time frame, it is within the scope of what the patent intends for “prior”. Consequently, the claimed time frame is obvious. Respectfully, Applicant’s argument is not persuasive.
Conclusion
No claims are allowed.
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 ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Y Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613