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 .
Election/Restrictions
Claims 1-6, and 8-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected apparatus, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/6/2026. Applicant’s election without traverse of claims 18-25 in the reply filed on 3/6/2025 is acknowledged.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 18-21, and 23-25 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being unpatentable by Roth(US 8822535 B2).
Regarding claim 18, Roth discloses a method for treating a mammalian animal having a disease, the method comprising: inducing a controlled hypometabolic state in the animal(In particular embodiments, treatment with an active compound induces "pre-stasis," which refers to a hypometabolic state through which biological matter must transition to reach stasis. Pre-stasis is characterized by a reduction in metabolism within the biological material of a magnitude that is less than that defined as stasis. In order to achieve stasis using an active compound, the biological matter necessarily must transition through a graded hypometabolic state in which oxygen consumption and CO.sub.2 production are reduced less than two-fold in the biological matter(Summary of the Invention, paragraph 5). The present invention concerns the use of oxygen antagonists and other active compounds for inducing stasis or pre-stasis in cells, tissues, and/or organs in vivo or in an organism overall, in addition to enhancing their survivability[abstract]).
Regarding claim 19, Roth discloses the method according to claim 18, wherein the inducing a controlled hypometabolic state in the mammalian animal is carried out in such a way as to slow progression of the disease in the mammalian animal(Treatments are directed toward correcting the cause of the shock syndrome and slowing progression(Description, paragraph 217).
Regarding claim 20, Roth discloses the method according to claim 18, wherein the inducing a controlled hypometabolic state in the mammalian animal is carried out in such a way as to decrease mortality of the mammalian animal(The present invention also provides methods, compositions, and apparati for enhancing survivability of and/or reducing damage to biological matter under adverse conditions by reducing metabolic demand, oxygen requirements, temperature, or any combination thereof in the biological matter of interest. In some embodiments of the invention, survivability of biological matter is enhanced by providing it with an effective amount of a protective metabolic agent. The agent enhances survivability by preventing or reducing damage to the biological matter, preventing all or part of the matter from dying or senescing, and/or extending the lifespan of all or part of the biological matter, relative to biological matter not exposed to the agent. Alternatively, in some embodiments the agent prolongs survival of tissue and/or an organism that would otherwise not survive without the agent(Summary of the Invention, paragraph 54).
Regarding claim 21, Roth discloses the method according to claim 18, wherein the controlled hypometabolic state is a hibernation-like state(In the context of organisms, a reduction in oxygen consumption on the order of roughly 8-fold is a kind of stasis referred to as "hibernation." Moreover, it will be understood in this application that a reduction in oxygen consumption on the order of around 1000-fold can be considered "suspended animation." It will be understood that embodiments of the invention concerning stasis can be achieved at the level of hibernation or suspended animation(Summary of the Invention, paragraph 59).
Regarding claim 23, Roth discloses the method according to claim 18, of wherein the disease is a serious acute disease(Survivability includes survivability when the matter is under adverse conditions--that is, conditions under which there can be adverse and nonreversible damage or injury to biological matter. Adverse conditions can include, but are not limited to, when oxygen concentrations are reduced in the environment (hypoxia or anoxia, such as at high altitudes or under water); when the biological matter is incapable of receiving that oxygen (such as during ischemia), which can be caused by i) reduced blood flow to organs (e.g., heart, brain, and/or kidneys) as a result of blood vessel occlusion (e.g., myocardial infarction, and/or stroke), ii) extracorporeal blood shunting as occurs during heart/lung bypass surgery (e.g., "pumphead syndrome" in which heart or brain tissue is damaged as a result of cardiopulmonary bypass), or iii) as a result of blood loss due to trauma (e.g., hemorrhagic shock or surgery); hypothermia, where the biological material is subjected to sub-physiological temperatures, due to exposure to cold environment or a state of low temperature of the biological material, such that it is unable to maintain adequate oxygenation of the biological materials; hyperthermia, whereby temperatures where the biological material is subjected to supra-physiological temperatures, due to exposure to hot environment or a state of high temperature of the biological material such as by a malignant fever; conditions of excess heavy metals, such as iron disorders (genetic as well as environmental) such as hemochromatosis, acquired iron overload, sickle-cell anemia, juvenile hemochromatosis African siderosis, thalassemia, porphyria cutanea tarda, sideroblastic anemia, iron-deficiency anemia and anemia of chronic disease. It is contemplated that a protective metabolic agent is an oxygen antagonist in certain embodiments of the invention. It is also contemplated that in certain other embodiments, an oxygen antagonist is not a protective metabolic agent. In other embodiments of the invention, one or more compounds may be used to increase or enhance survivability of biological matter; reversibly inhibit the metabolism and/or activity of biological matter; reduce the oxygen requirement of biological matter; reduce or prevent damage to biological matter under adverse conditions; prevent or reduce damage or injury to biological matter; prevent aging or senescence of biological matter; and, provide a therapeutic benefit as described throughout the application with respect to oxygen antagonists. It is contemplated that embodiments relating to inducing stasis are applicable to these other embodiments as well. Therefore, any embodiment discussed with respect to stasis may be implemented with respect to these other embodiments(Summary of the Invention, paragraph 57).
Regarding claim 24, Roth discloses the method according to claim 18, wherein the method further comprises following up the animal(It is preferred that the vital signs of the subject are monitored over the course of the temperature increase. Also, in conjunction with increasing the temperature, the oxygen antagonist or other active compound is removed from the subject's environment. Both heat and oxygen antagonist (or other active compound) treatment are ceased at the appropriate endpoint, judged by the medical personnel monitoring the situation, but in any event at the time the subject's temperature and other vital signs return to a normal range. Continued monitoring following cessation of treatment is recommended for a period of at least 24 hrs(Description, paragraph 231).
Regarding claim 25, Roth discloses the method according to claim 24, wherein the following up comprises measuring a change in oxygen consumption of the animal over time(The different parameters of stasis (reduction in oxygen consumption, decrease in carbon dioxide production or decrease in motility) can be assessed by a variety of assays and techniques. For example, probably the easiest way to measure the induction of stasis in mice administered H.sub.2S is through observation of their breathing. Indeed, this encompasses all three parameters in that it is indicative of decreased oxygen consumption, carbon dioxide production and motility(Description, paragraph 550).
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.
Claim(s) 22 rejected under 35 U.S.C. 103 as being unpatentable over Roth in view of Zhang et al.(“Estrogen-sensitive medial preoptic area neurons coordinate torpor in mice”).
Regarding claim 22, Roth discloses the method according to claim 18, but fails to explicitly state wherein the inducing a controlled hypometabolic state is carried out by stimulating a QRFP neuron. However, Zhang discloses “In summary, these studies identify a neuron population that is critical for an adaptive response that minimizes energy costs and increases survival during food shortages in mice74. These findings are consistent with very recent studies showing that a hypothermic and hypometabolic state can be induced by activating POA neurons, specifically glutamatergic neurons that express pyroglutamylated RFamide peptide (Qrfp)40 or neurons expressing adenylate cyclase activating polypeptide 1 (Adcyap1)30. (Discussion, paragraph 7)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the method for enhancing survivability of organisms with the QRFP stimulation of the Zhang article. Doing so would specify the neurons stimulated in order to induce a hypometabolic state in an animal to minimize energy costs of an animal and increase survival.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CATHERINE ANTHONY whose telephone number is (703)756-4514. The examiner can normally be reached 7:30 am - 4:30 pm, EST, M-F.
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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