Prosecution Insights
Last updated: April 19, 2026
Application No. 18/286,297

DERIVATIZED C60 MOLECULES AND METHODS AND MATERIALS FOR USING DERIVATIZED C60 MOLECULES TO REDUCE RADIATION INJURY

Non-Final OA §102§103§112
Filed
Oct 10, 2023
Examiner
KELLY-O'NEILL, YOLANDA LYNNETTE
Art Unit
1692
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Agni Medical LLC
OA Round
1 (Non-Final)
27%
Grant Probability
At Risk
1-2
OA Rounds
3y 5m
To Grant
70%
With Interview

Examiner Intelligence

Grants only 27% of cases
27%
Career Allow Rate
6 granted / 22 resolved
-32.7% vs TC avg
Strong +42% interview lift
Without
With
+42.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
70 currently pending
Career history
92
Total Applications
across all art units

Statute-Specific Performance

§101
1.0%
-39.0% vs TC avg
§103
40.9%
+0.9% vs TC avg
§102
11.7%
-28.3% vs TC avg
§112
24.7%
-15.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 22 resolved cases

Office Action

§102 §103 §112
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. Priority This application is a 371 of PCT/US2022/034917 which claims the benefit of US Provisional Application 63/215,967 with an effective filing date of 28 June 2021 as reflected in the filing receipt mailed on 07 March 2024 . Information Disclosure Statement The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement ha s been considered by the examiner. Status of the Claims Claims 1-3, 9-11, 17-19, 25-27, 33-35, 44, 45, 47, 48, and 50 are pending. Claims 4-8, 12-16, 20-24, 28-32, 36-43, 46, 49, and 51 are cancelled. 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. Claims 33-35 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claim 33 recites the limitation “the number of reactive oxygen species” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The limitation is interpreted as “ the a number of reactive oxygen species”. Claims 34 and 35 depend from base claim 33 and are included in this rejection as they do not correct the informalities identified in base claim 33 . 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. Claim s 44 and 45 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Mackeyev et al. (“Toward Pacitaxel -[ 60]Fullerene immunoconjugates as a targeted produg against cancer”, published 2014, Nanosystems : Physics, Chemistry, Mathematics, Vol. 5, No. 1, Pgs. 67-75, hereinafter Mackeyev ). Mackeyev is in the known prior art field of “water-soluble conjugates of Paclitaxel with malonodiserinolamide -derivatized [ 60]fullerene (C60-ser) undergo hydrolysis and release their medical payload under biological conditions”, where serinol and paclitaxel are bound to a C60 fullerene, see Abstract; Pgs. 68-71, 2.1. Synthesis and characterization of C60-Paclitaxel conjugates; Fig. 1. Regarding instant application claims 44 and 45, Mackeyev discloses in vivo test are performed by injecting mice with “C60-ser alone” or with compound 3 alone, where serinol and paclitaxel are bound to a C60 fullerene, each in a chemical drug composition of “100 µL sterile PBS dilution”, see specifically Pgs. 72-73, 2.4. In vivo cytoxic activity of 3; Figs. 4-5; see also Abstract; Pgs. 68-71, 2.1. Synthesis and characterization of C60-Paclitaxel conjugates; Fig. 1, meeting: The composition in instant application claim 44 ; and, The sterile injection solution in instant application claim 45 . 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 . 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. Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Alvarez et al. (US20120189492, published 26 July 2012, hereinafter Alvarez) in view of Zaibaq et al. (“Evaluation of the Biodistribution of Serinolamide -Derivatized C60 Fullerene, published 13 January 2020, Nanomaterials, Vol. 10, No. 143, Pgs. 1-17, hereinafter Zaibaq ). Alvarez is in the known prior art field of the use of Bingel reactions to produce C60 fullerene derivatives, such as compound 3 C60-serinol, see below, for biomedical therapeutic applications, such as for the inactivation and destruction of chemical pollutants, by reducing the number of reactive oxygen species by reacting with the contaminant, see Abstract; Paras. [0004] -[ 0010];[0067];[0079]; Fig. 2C. , where “trace organic contaminants such as, for example, pharmaceutical and petrochemical contaminants may be reacted with the reactive oxygen species to degrade the organic contaminants completely or partially into a more easily processed form”, see Para. [0062]. Regarding instant application claim 47, Alvarez teaches a method of making compound 3, C60-serinol, see Fig. 2C; Para. [0079], by a Bingel reaction, comprising reacting compound E1, serinol malonate tetraacetate, with compound 9, [ 60]fullerene , in the presence of 1,8-diazabicyclo[5.4.0]undec-7-ene, DBU, and perbromomethane , CBR4, in toluene to yield compound 12, C60-serinol acetate; and hydrolyzing to yield compound 3, C60-serinol, see Fig. 2C; Para. [0079], meeting the method of making C60-serinol, step (a) reacting to yield C60-serinol acetate and step (b) yielding C60-serinol in instant application claim 47 . Alvarez does not teach the instant application claim 47 step (b) limitation of reacting C60-serinol acetate with HCL and aqueous dioxane. Zaibaq is in the known prior art field of the derivation of C60-serinol by “ Bingel -Hirsch chemistry”, where C60-serinol is a known to have “the potential to meliorate the negative side effects of chemotherapy”, see Abstract; Pgs. 1-2; Fig. 1. Regarding instant application claim 47, Zaibaq teaches the hydrolysis of C60 fullerene bonded serinol acetate to serinol by reacting C60-serinol acetate with an aqueous/water solution of hydrochloric acid and dioxane until “the acetate protecting groups on the serinolamide moieties had been completely hydrolyzed” to yield C60-serinol, see Pg. 4, Synthesis of Compound 6 (C60-NOTA conjugate); Pg. 7, Fig. 2 , meeting the hydrolysis with aqueous dioxane and HCl in instant application claim 47 . It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the hydrolysis of Alvarez to use the aqueous acid and dioxane hydrolysis as taught by Zaibaq with a reasonable predictability of success for the purpose of efficiently producing C60-serinol by completely hydrolyzing the acetate protecting groups on the se r inolamide moieties, see Zaibaq , Pg. 4, Synthesis of Compound 6 (C60-NOTA conjugate); Pg. 7, Fig. 2. The rationale to support a conclusion that the claim would have been obvious is that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been capable of modifying the hydrolysis of Alvarez by applying the known technique of the aqueous acid and dioxane hydrolysis as taught by Zaibaq with a reasonable predictability of success for the purpose of efficiently producing C60-serinol by completely hydrolyzing the acetate protecting groups on the se r inolamide moieties, see Zaibaq , Pg. 4, Synthesis of Compound 6 (C60-NOTA conjugate); Pg. 7, Fig. 2; and, MPEP 2143 I. B-D. The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense”, see MPEP 2143 I.E. Since patents are part of the literature of the prior art relevant for all they contain, see MPEP 2123, and Alvarez and Zaibaq both teach the Bingel reaction synthesis of C60-serinol by hydrolysis of a C60-serinoal acetate , a person of ordinary skill in the art has good reason to modify Al v arez by relying upon Zaibaq before the effective filing date of the claimed invention for knowledge generally available within the hydrolysis art , see MPEP 2143 B & G and 2141, for the benefit of efficiently producing C60-serinol by completely hydrolyzing the acetate protecting groups on the se r inolamide moieties, see Zaibaq , Pg. 4, Synthesis of Compound 6 (C60-NOTA conjugate); Pg. 7, Fig. 2; and, MPEP 2141 and 2143 I. B-D. As stated in Sakraida v. Ag Pro, Inc. , 425 U.S. 273, 189 USPQ 449, reh’g denied, 426 U.S. 955 (1976), “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill”, see MPEP 2141. Selection of a known material, such as hydrolysis with aqueous HCL and dioxane, based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp. , 325 U.S. 327, 65 USPQ 297 (1945), see MPEP 2144.07. In addition, “[ i ]t is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means,” such as the selection of aqueous HCl and dioxane for the hydrolysis, “is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions. In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929)”, see MPEP 2144.05. Claim s 47 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Alvarez et al. (US20120189492, published 26 July 2012, hereinafter Alvarez) in view of Zaibaq et al. (“Evaluation of the Biodistribution of Serinolamide -Derivatized C60 Fullerene, published 13 January 2020, Nanomaterials, Vol. 10, No. 143, Pgs. 1-17, hereinafter Zaibaq ), as applied to claim 47 in the 35 USC 103 rejection above, in further view of Mackeyev et al. (“Toward Pacitaxel -[60]Fullerene immunoconjugates as a targeted produg against cancer”, published 2014, Nanosystems : Physics, Chemistry, Mathematics, Vol. 5, No. 1, Pgs. 67-75, hereinafter Mackeyev ), as evidenced by Wharton et al. (“Highly-Iodinated Fullerene as a Contract Agent For X-ray Imaging”, published 2002, Bioorganic & Medicinal Chemistry, Vol. 10, Pgs. 3545-3554, hereinafter Wharton ‘NPL). Alverez does not teach the limitations of claim 48. Mackeyev is in the known prior art field of “water-soluble conjugates of Paclitaxel with malonodiserinolamide -derivatized [ 60]fullerene (C60-ser) undergo hydrolysis and release their medical payload under biological conditions”, where serinol and paclitaxel are bound to a C60 fullerene, see Abstract; Pgs. 68-71, 2.1. Synthesis and characterization of C60-Paclitaxel conjugates; Fig. 1. Regarding instant application claim 48, Mackeyev teaches in the preparation of compound 5, 111 mg of compound 4 containing the C60 fullerene is mixed with 837 mg of ““ serinol malonate”, prepared according to [18]”, see Pgs. 69-70; Fig. 1, where the serinol malonate of reference “[18]” is the Wharton ‘NPL preparation of serinol malonate tetraacetate, see Pg. 2548, Schemes 3 and 4; Pg. 3552, Col. 1, N,N’-Bis[2-(acetyloxy)-1-[(acetyloxy)methyl]ethyl]- malonamide (9), as calculated by the examiner a ratio of serinol malonate tetraacetate/fullerene of about 7.5:1, meeting within the range in instant application claim 48 . In reference to the above claims, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the molar ratio of the serinol malonate tetraacetate:fullerene in the synthesis of Alvarez by applying the molar ratio as taught by Mackeyev with a reasonable predictability of success for the purpose of efficiently conjugating the serinol moiety to the C60 fullerene for optimal malonodiserinolamide -derivatization of the C60 fullerene in order for the C60-serinol to “accumulate in the nucleus of the cell through the nuclear pore complex” in therapeutic applications, see Mackeyev , Pgs. 68-69, Introduction; Pgs. 72-73, 2.4. In vivo cytoxic activity of 3; Figs. 4-5. The rationale to support a conclusion that the claim would have been obvious is that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been capable of produced the C60-serinol of Alvarez by applying the known technique of varying the ratio of the reactants as taught by Mackeyev with a reasonable predictability of success for the purpose of efficiently conjugating the serinol moiety to the C60 fullerene for optimal malonodiserinolamide -derivatization of the C60 fullerene in order for the C60-serinol to “accumulate in the nucleus of the cell through the nuclear pore complex” in therapeutic applications, see Mackeyev , Pgs. 68-69, Introduction; Pgs. 72-73, 2.4. In vivo cytoxic activity of 3; Figs. 4-5; and, MPEP 2143 I. B-D. The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense”, see MPEP 2143 I.E. Since patents are part of the literature of the prior art relevant for all they contain, see MPEP 2123, and Alvarez and Mackeyev both teach the synthesis of C60-serinol by reacting serinol malonate tetraacetate and C60 fullerene , a person of ordinary skill in the art has good reason to modify Al v arez by relying upon Mackeyev before the effective filing date of the claimed invention for knowledge generally available within the protecting group and C60 fullerene derivative art , see MPEP 2143 B & G and 2141, for the benefit of efficiently conjugating the serinol moiety to the C60 fullerene for optimal malonodiserinolamide -derivatization of the C60 fullerene in order for the C60-serinol to “accumulate in the nucleus of the cell through the nuclear pore complex” in therapeutic applications, see Mackeyev , Pgs. 68-69, Introduction; Pgs. 72-73, 2.4. In vivo cytoxic activity of 3; Figs. 4-5; and, MPEP 2141 and 2143 I. B-D. As stated in Sakraida v. Ag Pro, Inc. , 425 U.S. 273, 189 USPQ 449, reh’g denied, 426 U.S. 955 (1976), “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill”, see MPEP 2141. In addition, “[ i ]t is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions,” such as the molar ratios of the reactants , “or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions. In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929)”, see MPEP 2144.05. Claim s 47 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Alvarez et al. (US20120189492, published 26 July 2012, hereinafter Alvarez) in view of Zaibaq et al. (“Evaluation of the Biodistribution of Serinolamide -Derivatized C60 Fullerene, published 13 January 2020, Nanomaterials, Vol. 10, No. 143, Pgs. 1-17, hereinafter Zaibaq ), as applied to claim 47 in the 35 USC 103 rejection above, in further view of Wharton et al. (“Highly-Iodinated Fullerene as a Contract Agent For X-ray Imaging”, published 2002, Bioorganic & Medicinal Chemistry, Vol. 10, Pgs. 3545-3554, hereinafter Wharton ‘NPL). Alvarez does not teach the limitations of claim 50. Wharton ‘NPL is in the known prior art field of functionalized derivatives of C60 fullerenes by “ Bingel -type reaction” for use in the fields of biology and medicine, such as the C60-serinol derivative compound 12, see Abstract; Pg. 3545-3546, Introduction; Fig. 2; Pg. 3548, Schemes 3 and 4. Regarding instant application claim 50, Wharton ‘NPL teaches synthesis of compound 11, a C60-serinol acetate, and compound 12, a C60-serinol, where serinol malonate tetraacetate is produced in a two stage reaction with reaction i producing serinol malonate residue that is further treated in reaction ii with acetic anhydride to yield serinol malonate tetraacetate, see Pg. 2548, Schemes 3 and 4; Pg. 3552, Col. 1, N,N’-Bis[2-(acetyloxy)-1-[(acetyloxy)methyl]ethyl]- malonamide (9), meeting the reacting in instant application claim 50 . In reference to the above claims, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have produced the serinol malonate tetraacetate of Alvarez by applying the synthesis of serinol malonate tetraacetate as taught by Wharton ‘NPL with a reasonable predictability of success for the purpose of efficiently producing a serinol derivative with the desired protecting groups in order to achieve the desired attachment of the serinol to the C60 fullerene for the optimal aqueous solubility of the C 60-serinol, see Wharton ‘NPL, Abstract; Schemes 3 and 4; Pg. 3548, Col. 1, Last Two Lines-Pg. 3549, Conclusion. The rationale to support a conclusion that the claim would have been obvious is that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been capable of produc ing the serinol malonate tetraacetate of Alvarez by applying the known technique of the synthesis of serinol malonate tetraacetate as taught by Wharton ‘NPL with a reasonable predictability of success for the purpose of efficiently producing a serinol derivative with the desired protecting groups in order to achieve the desired attachment of the serinol to the C60 fullerene for the optimal aqueous solubility of the C 60-serinol, see Wharton ‘NPL, Abstract; Schemes 3 and 4; Pg. 3548, Col. 1, Last Two Lines-Pg. 3549, Conclusion; and, MPEP 2143 I. B-D. The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense”, see MPEP 2143 I.E. Since patents are part of the literature of the prior art relevant for all they contain, see MPEP 2123, and Alvarez and Wharton ‘NPL both teach the Bingel reaction synthesis of C60-serinol by use of an acetate protecting group , a person of ordinary skill in the art has good reason to modify Al v arez by relying upon Wharton ‘NPL before the effective filing date of the claimed invention for knowledge generally available within the protecting group art , see MPEP 2143 B & G and 2141, for the benefit of efficiently producing a serinol derivative with the desired protecting groups in order to achieve the desired attachment of the serinol to the C60 fullerene for the optimal aqueous solubility of the C 60-serinol, see Wharton ‘NPL, Abstract; Schemes 3 and 4; Pg. 3548, Col. 1, Last Two Lines-Pg. 3549, Conclusion; and, MPEP 2141 and 2143 I. B-D. As stated in Sakraida v. Ag Pro, Inc. , 425 U.S. 273, 189 USPQ 449, reh’g denied, 426 U.S. 955 (1976), “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill”, see MPEP 2141. Claim s 1-3, 9-11, 17-19, 25-27, 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Tour et al. (US20100197783, published 05 August 2010, hereinafter Tour) in view of Alvarez et al. (US20120189492, published 26 July 2012, hereinafter Alvarez). Tour is in the known prior art field of methods “of reducing side effects of damage in a human subject exposed to radiation” by “administering to the human subject carbon nanotubes in a pharmaceutically acceptable carrier after or prior to exposure to radiation”, see Abstract, where the carbon nanotube is a fullerene derivative , see Paras. [0011];[0029];[0031], and “[o] xidative stress is caused by an imbalance between the production of reactive oxygen and a biological system's ability to detoxify the reactive intermediates or easily repair the resulting damage”, where “[d] isturbances in this normal redox state can cause toxic effects through the production of peroxides and free radicals that damage all components of the cell, including proteins, lipids, and DNA” and “[e] xternal environmental conditions may also be responsible for the formation of damaging radical species, such as exposure to radiation”, see Paras. [0002] -[ 0003], i.e., exposure to radiation leads to an increase in reactive oxygen species. Regarding instant application claims 1-3, Tour teaches prolonging the survival of a human aka a mammal exposed to levels of radiation exceeding 2 Gy to “8-10 Gy at relatively high dose rates at or near 1 Gy /min” to 25 Gy by administering a fullerene derivative compound, where the administration of the compound “had a significantly higher rate of survival in both protection and mitigation tests when compared to the controls” not administered the compound, see Paras. [0012 ];[ 0019];[0021];[0024];[0066]-[0067];[0072]-[0074]; Figs. 4 and 10, meeting: The method for prolonging survival, administering a compound, and the longer survival if treated with the compound in instant application claim 1 ; The human mammal in instant application claim 2 ; and, Within the Gy range in instant application claim 3 . Regarding instant application claims 9-11, Tour teaches prolonging the survival of a human aka a mammal expected to be exposed to levels of radiation exceeding 2 Gy to “8-10 Gy at relatively high dose rates at or near 1 Gy /min” to 25 Gy by administering a fullerene derivative compound before exposure, where the administration of the compound “had a significantly higher rate of survival in both protection and mitigation tests when compared to the controls” not administered the compound, see Paras. [0012 ];[ 0019];[0021];[0024];[0066]-[0067];[0072]-[0074]; Figs. 4 and 10. The “carbon nanotubes and various derivatives show an unusually high radical scavenging ability, which may prove efficacious in protecting living systems from radical-induced decay whether administered before (protection) or after (mitigation) radiation exposure”, see Para. [0024], meeting: The method for prolonging survival before exposure, administering a compound before exposure, and the longer survival if treated with the compound in instant application claim 9 ; The human mammal in instant application claim 10 ; and, Within the Gy range in instant application claim 11 . Regarding instant application claims 17-19, Tour teaches “a method of reducing side effects of radical damage in a human subject exposed to radiation includes administering to the human subject a carbon nanotube in a pharmaceutically acceptable carrier prior to radiation exposure (termed here as protection)”, see Para. [0024]. The method includes prolonging the survival of a human aka a mammal exposed to levels of radiation exceeding 2 Gy to “8-10 Gy at relatively high dose rates at or near 1 Gy /min” to 25 Gy by administering a carbon nanotube fullerene derivative compound, where the administration of the compound “had a significantly higher rate of survival in both protection and mitigation tests when compared to the controls” not administered the compound, see Paras. [0012 ];[ 0019];[0021];[0024];[0066]-[0067];[0072]-[0074]; Figs. 4 and 10, meeting: The method of reducing the severity, administering a compound after exposure, and the reduction in the severity if treated with the compound in instant application claim 17 ; The human mammal in instant application claim 18 ; and, Within the Gy range in instant application claim 19 . Regarding instant application claims 25-27, Tour teaches “a method of reducing side effects of radical damage in a human subject exposed to radiation includes administering to the human subject a carbon nanotube in a pharmaceutically acceptable carrier”, where the compound “carbon nanotubes and various derivatives show an unusually high radical scavenging ability, which may prove efficacious in protecting living systems from radical-induced decay whether administered before (protection) or after (mitigation) radiation exposure”, see Para. [0024]. The method includes prolonging the survival of a human aka a mammal exposed to levels of radiation exceeding 2 Gy to “8-10 Gy at relatively high dose rates at or near 1 Gy /min” to 25 Gy by administering a carbon nanotube fullerene derivative compound, where the administration of the compound “had a significantly higher rate of survival in both protection and mitigation tests when compared to the controls” not administered the compound, see Paras. [0012 ];[ 0019];[0021];[0024];[0066]-[0067];[0072]-[0074]; Figs. 4 and 10, meeting: The method of reducing the severity, administering a compound after exposure, and the reduction in the severity if treated with the compound in instant application claim 25 ; The human mammal in instant application claim 26 ; and, Within the Gy range in instant application claim 27 . Regarding instant application claims 33-35, Tour teaches “[o] xidative stress is caused by an imbalance between the production of reactive oxygen and a biological system's ability to detoxify the reactive intermediates or easily repair the resulting damage”, where “[d] isturbances in this normal redox state can cause toxic effects through the production of peroxides and free radicals that damage all components of the cell, including proteins, lipids, and DNA” and “[e] xternal environmental conditions may also be responsible for the formation of damaging radical species, such as exposure to radiation”, see Paras. [0002] -[ 0003], i.e., exposure to radiation leads to an increase in reactive oxygen species. Reactive oxygen species are reduced by “a method of reducing side effects of radical damage in a human subject exposed to radiation includes administering to the human subject a carbon nanotube in a pharmaceutically acceptable carrier”, where the compound “carbon nanotubes and various derivatives show an unusually high radical scavenging ability, which may prove efficacious in protecting living systems from radical-induced decay whether administered before (protection) or after (mitigation) radiation exposure”, see Para. [0024]. The method includes prolonging the survival of a human aka a mammal exposed to levels of radiation exceeding 2 Gy to “8-10 Gy at relatively high dose rates at or near 1 Gy /min” to 25 Gy by administering a carbon nanotube fullerene derivative compound, where the administration of the compound “had a significantly higher rate of survival in both protection and mitigation tests when compared to the controls” not administered the compound, see Paras. [0012 ];[ 0019];[0021];[0024];[0066]-[0067];[0072]-[0074]; Figs. 4 and 10. The carbon nanotube fullerene compound reduces radical damage “with a radical trapping agent appended to the carbon nanotube forming a radical scavenger-carbon nanotube conjugate” thus “quenching free radicals in biological systems”, see Abstract; Paras. [0005] -[ 0006];[0010];[0022]-[0024]; Fig. 2, meeting: The method of reducing the number of reactive oxygen species, administering a compound before and after exposure, exposing the mammal, and the reduction in the reactive oxygen species if treated with the compound in instant application claim 33 ; The human mammal in instant application claim 34 ; and, Within the Gy range in instant application claim 35 . Tour does not teach the instant application claims 1, 9, 17, 25, and 33 limitations of C60-serinol is the fullerene derivative compound. Alvarez is in the known prior art field of C60 fullerene derivatives, such as compound 3 C60-serinol, see below, for biomedical therapeutic applications, such as for the inactivation and destruction of chemical pollutants, by reducing the number of reactive oxygen species by reacting with the contaminant, see Abstract; Paras. [0004] -[ 0010];[0067];[0079]; Fig. 2C . , where “trace organic contaminants such as, for example, pharmaceutical and petrochemical contaminants may be reacted with the reactive oxygen species to degrade the organic contaminants completely or partially into a more easily processed form”, see Para. [0062]. Regarding instant application claims 1, 9, 17, 25, and 33, Alvarez teaches C60 fullerene derivatives, such as compound 3 C60-serinol, see above, for biomedical therapeutic applications, such as for the inactivation and destruction of chemical pollutants by reducing the number of reactive oxygen species by reacting with the contaminant to remove and reduce it, see Paras. [0004] -[ 0010];[0040];[0062];[0067]-[0071];[0077];[0079]; Fig. 2C, meeting the C60-serinol is the fullerene derivative compound in instant application claim 1, in instant application claim 9, in instant application claim 17, in instant application claim 25, and in instant application claim 33 . In reference to the above claims, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the general fullerene derivative compound of Tour to use the specific C60-serinol fullerene derivative as taught by Alvarez with a reasonable predictability of success for the purpose of the efficiently detoxifying harmful contaminant reactive oxygen species from a biomedical environment susceptible or exposed to reactive oxygen species contamination, see Alvarez, Abstract; Paras. [0004] -[ 0006];[0009]-[0011];[0040];[0045];[0069]-[0070];[0079]; Fig. 2C. The rationale to support a conclusion that the claim would have been obvious is that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been capable of selecting a specific fullerene derivative compound for use in Tour by selecting the known specific C60-serinol fullerene derivative as taught by Alvarez with a reasonable predictability of success for the purpose of efficiently detoxifying harmful contaminant reactive oxygen species from a biomedical environment susceptible or exposed to reactive oxygen species contamination, see Alvarez, Abstract; Paras. [0004] -[ 0006];[0009]-[0011];[0040];[0045];[0069]-[0070];[0079]; Fig. 2C; and, MPEP 2143 I. B-D. The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense”, see MPEP 2143 I.E. Since patents are part of the literature of the prior art relevant for all they contain, see MPEP 2123, and Tour and Alvarez both teach detoxifying harmful contaminant reactive oxygen species , a person of ordinary skill in the art has good reason to modify Tour by relying upon Alvarez before the effective filing date of the claimed invention for knowledge generally available within the detoxifying harmful contaminant reactive oxygen species art , see MPEP 2143 B & G and 2141, for the benefit of efficiently detoxifying harmful contaminant reactive oxygen species from a biomedical environment susceptible or exposed to reactive oxygen species contamination, see Alvarez, Abstract; Paras. [0004] -[ 0006];[0009]-[0011];[0040];[0045];[0069]-[0070];[0079]; Fig. 2C; and, MPEP 2141 and 2143 I. B-D. As stated in Sakraida v. Ag Pro, Inc. , 425 U.S. 273, 189 USPQ 449, reh’g denied, 426 U.S. 955 (1976), “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill”, see MPEP 2141. Selection of a known material, such as the C60-serinol fullerene derivative , based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp. , 325 U.S. 327, 65 USPQ 297 (1945), see MPEP 2144.07. Relevant Prior Art Wharton et al. (US20100184818, published 22 July 2010) teaches C60-serinol synthesis by the below reaction scheme, see below and Paras. [0180] -[ 0185]. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Y. Lynnette Kelly-O'Neill whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3456 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Tuesday-Friday, 8:30 a.m. - 6:30 p.m., EST, with Flex Time . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Scarlett Yen-Ye Goon can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 270-5241 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /YO/ Examiner, Art Unit 1692 /FEREYDOUN G SAJJADI/ Supervisory Patent Examiner, Art Unit 1699
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Prosecution Timeline

Oct 10, 2023
Application Filed
Mar 25, 2026
Non-Final Rejection — §102, §103, §112 (current)

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Expected OA Rounds
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Grant Probability
70%
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3y 5m
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Low
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