Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Applicant’s arguments, filed 8/5/2025, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objects are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Priority
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.
This application, filed 4/132021, is a DIV of 17/223,336, filed 04/06/2021; 17/223,336 is a DIV of 16/535,672, filed 08/08/2019, now PAT 10980832; 16/535,672 is a DIV of 15/465,092, filed 03/21/2017, now PAT 10449217; 15/465,092 is a DIV of 13/382,781, filed 12/28/2012, now PAT 9603870; 13/382,781 is a 371 of PCT/US10/41427, filed 07/08/2010; PCT/US10/41427 has PRO 61/294,690, filed 01/13/2010; PCT/US10/41427 has PRO 61/263,648, filed 11/23/2009; PCT/US10/41427 has PRO 61/249,804, filed 10/08/2009; PCT/US10/41427 has PRO 61/235,574, filed 08/20/2009; PCT/US10/41427 has PRO 61/228,250, filed 07/24/2009; PCT/US10/41427 has PRO 61/226,153, filed 07/16/2009; and PCT/US10/41427 has PRO 61/223,944, filed 07/08/2009. However, the priority documents do not provide support under 35 U.S.C. 112(a) for “a method of treating a patient with amyotrophic lateral sclerosis disease” using the method presently claimed. The phrase “amyotrophic lateral sclerosis disease” does not appear in the parent applications nor the present specification. It only first appears in the claims filed 4/13/2021. Therefore, the effective filing date of the present claims is deemed to be the filing date of the present application, 4/13/2021. If applicant disagrees, they are requested to provide analysis of where contemplation of the present method can be found in the priority documents.
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s arguments beginning at the bottom of page 2 of the reply to the top of page 12 that although treatment of Amyotrophic Lateral Sclerosis is not expressly taught in applicant’s disclosure, the presently claimed method of treating ALS is inherently supported by the application, as the application teaches treating nervous system disorders and ALS is a nervous system disorder and shares features with other nervous system disorders. The examiner’s response is that the application does not teach or contemplate treating the very difficult disease of ALS, and although ALS is as nervous system disorder, the artisan would not believe that applicant has provided an enabling disclosure of treatment for ALS. Not only is there no teaching of treating of ALS, but ALS is a progressive neurodegenerative disease that eventually leads to respiratory failure, and is very hard to treat, the difficulty stems from the disease's complexity, varied progression, and challenges in developing drugs that can effectively target the central nervous system to stop motor neuron death, making multidisciplinary supportive care crucial. There is no teaching in the application of a method of treating a patient with ALS comprising administering to a patient in need thereof an effective amount of a pharmaceutically acceptable suspension comprising:
pharmaceutical grade water, at least one processing enhancer comprising sodium bicarbonate; b.) gold nanocrystals suspended in said water forming a suspension, wherein said gold c.)
nanocrystals: i.) have surfaces that do not have organic chemical constituents adhered or attached to said surfaces; ii.) have a mode particle size of less than about 50 nm; iii.) are present in said suspension at a concentration of at least 2 ppm; and d.) said suspension having a pH of between about 5 to about 9.5, said gold nanocrystals having a zeta potential of about -20 mV or lower at a temperature of about 25°C, said zeta potential being determined by measuring the electrophoretic mobility of the gold nanocrystals in the suspension, and the suspension does not contain chloride ions.
Claim Rejections - 35 USC § 112
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.
Claims 1-2 and 7-19 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.
Claim 1 is interpreted as treatment of disease or condition in a patient with amyotropic lateral sclerosis disease.” A person with amyotropic lateral sclerosis disease can amyotrophic lateral sclerosiso have a myriad of other disease and conditions. There is no description in the application of how to treat a patient with amyotrophic lateral sclerosis disease across the scope of diseases and conditions that a person with amyotropic lateral sclerosis disease may have. Further, to the extent it is amyotrophic lateral sclerosis disease that is treated, there is no description in the application of how to treat is amyotrophic lateral sclerosis disease with the presently claimed method or any method. The term “is amyotrophic lateral sclerosis disease” nor its synonyms (such as Lou Gehrig’s Disease or Motor Neuron Disease) do not appear in the application, either expressly or through reference. This term only appears in the claims with no description in the application of how to carry out the present method of treating a patient with amyotrophic lateral sclerosis disease.”
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.
Claims 1-2 and 7-19 are 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. The disease or condition treated in claim 1, is not specified, and therefore, the artisan would not know the scope of what is an “effective amount of a pharmaceutically acceptable suspension” to treat the unspecified disease or condition. Although claim 1 recites “[a] method for treating a patient with amyotrophic lateral sclerosis disease,” there is no requirement that amyotrophic lateral sclerosis is actually treated, only that the patient has amyotrophic lateral sclerosis disease, as evidenced by the phrase “[a] method for treating a patient with amyotrophic lateral sclerosis disease.” Further, claim 10 recites “wherein said gold nanocrystals have shapes comprising faces with spatially extended low index crystal planes.” The term “low index crystal planes” is a relative term. As the term is not defined in the claim or application, The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Further, claims 14 and 17 recites “low Miller Index.” The term “low Miller index” is a relative term. As the term is not defined in the claim or application, The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Further regarding claim 17, the claim recites “said nanocrystals are shaped.” It’s unclear how the term “are shaped” limits the said nanocrystals, as all objects have a shape.
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s argument that the term “administering” is taught in the application and is therefore clear, the examiner’s response is that the disease or condition treated in claim 1, is not specified, and therefore, the artisan would not know the scope of what is an “effective amount of a pharmaceutically acceptable suspension” to treat the unspecified disease or condition. Although claim 1 recites “[a] method for treating a patient with amyotrophic lateral sclerosis disease,” there is no requirement that amyotrophic lateral sclerosis is actually treated, only that the patient has amyotrophic lateral sclerosis disease, as evidenced by the phrase “[a] method for treating a patient with amyotrophic lateral sclerosis disease.” Regarding applicant’s argument that the recitation of “low” is taught in the application and known in the art, this is not found persuasive as applicant has not recited what values are encompassed as “low” and what values are not encompassed by “low” in the present invention. The term “low index crystal planes” is a relative term. As the term is not defined in the claim or application, The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Further, claims 14 and 17 recites “low Miller Index.” The term “low Miller index” is a relative term. As the term is not defined in the claim or application, The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Further regarding claim 17, the claim recites “said nanocrystals are shaped.” It’s unclear how the term “are shaped” limits the said nanocrystals, as all objects have a shape. The examiner does not dispute applicant’s argument that the shape of a nanocrystal affects its properties. However, the claim only recites that they “are shaped,” not shaped to have a particular property, and therefore its unclear what it means to be “shaped” and the artisan would not know what shapes fall under the scope of “are shaped” and which shapes do not fall under the scope of “are shaped” as the claim does not limit the shape being claimed. Regarding applicant’s argument that “shaped” in the claims refers to polyhedral morpholgoies with at least one, for example, {111} plane, engineered to enhance biocatalytic activity for ALS treatment, this is not persuasive as there is not disclosure of a treatment of ALS nor a disclosure of “shaped” to mean polyhedral morpholgoies with at least one, for example, {111} plane, engineered to enhance biocatalytic activity for ALS treatment.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-2 and 7-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 20060068026 to Hu in view of Wang (Materials Today Bio, 2020). Hu teaches a pharmaceutically acceptable suspension comprising: a.) pharmaceutical grade water, b) at least one processing enhancer comprising sodium bicarbonate; c) gold nanocrvstals suspended in said water forming a suspension, wherein said gold nanocrystals: d} wherein the nanocrystals are naked (have surfaces that do not have organic chemical constituents adhered or attached to said surfaces); i) the diameter may be 10.8 4 nm (have a mode particle size of less than about 50 nm, less than about 30 nm, within a range of about 8-18 nm), are present in said suspension at a concentration of 90 vol/vol% (at least 2 ppm). The suspension does not comprise chloride ions. The pH is not reported, but based on it being an aqueous suspension with no strong acids or bases, the artisan would understand that the pH is at or near neutral (having a pH of between about 5 to about 9.5). Potential is a result effective parameter in the preparation of the nanocrystals (paragraph 71). The composition is administered to a patient for targeted therapy (paragraph 107). The composition may be ingested (administered orally) (paragraph 111).
Hu fails to teach treating a patient having amyotrophic lateral sclerosis comprising administering the suspension to a patient. Hu fails to teach a zeta potential of about -20 mV or lower at a temperature of about 25°C.
Wang teaches treatment of amyotrophic lateral sclerosis, a progressive neurodegenerative
disease that affects both upper and lower motor neurons, with gold nanocrystal suspensions (abstract; Section 5.3.2, Table 2; Figures 2 and 92).
It would have been obvious to one of ordinary skill at the time the invention was made to administer the composition to a patient for the express reasons given in Hu, that is, “when encapsulated with molecular self-assembly carrier systems like liposomes, the Ag liposome package could be either injected into the blood stream or inhaled into the lung for targeted therapy” (paragraph 111), and further for a patient to “ingest appropriate doses (an effective amount) of Ag nanocrystal liquid sol to maintain dietary health.” As the percentage of the human population that can benefit from dietary health is very large, it would reasonably include patients having amyotrophic lateral sclerosis, and the artisan would find it obvious to administer the composition to these patients as well as the remaining patient population in need of dietary health. The motivation for this is to maintain dietary health in patients. Further, it would have been obvious to administer the gold nanocrystals to patients that have amyotrophic lateral sclerosis for the treatment of amyotrophic lateral sclerosis. The motivation for this it was known that the disease could be treated with gold nanocrystal suspensions. It would have been further obvious to optimize the zeta potential to improve the efficacy of the suspension of Hu for treatment of disease. In this way, the artisan would find the present values through routine experimentation. Hu gives sufficient guidance to this end as it teaches that potential is a result effective parameter. “‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)” MPEP § 2144.05, II. Regarding the properties of the composition recited in the claims, a composition cannot be separated from its properties. As the suspension of modified Hu is structurally identical to the present composition, it must share the same properties as the claimed invention, including those claimed.
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s argument that Wang is based on applicant’s own extensive ALS clinical trial data, the examiner’s response is that Wang as well as Hu are prior art against the present application. Wang does not share the same authors as the present inventors. If applicant wishes to overcome the rejection by a showing that Wang is applicant’s own work, a declaration must be filed. At
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-2 and 7-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 10980832 in view of Wang (Materials Today Bio, 2020).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are directed to a method for treating a patient having multiple sclerosis, comprising administering to a patient in need thereof an effective amount of a pharmaceutically acceptable suspension comprising: a.) pharmaceutical grade water; b.) at least one processing enhancer comprising sodium bicarbonate; c.) gold amyotrophic lateral sclerosis suspended in said water forming a suspension, wherein said gold amyotrophic lateral sclerosis: i.) have surfaces that do not have organic chemical constituents adhered or attached to said surfaces; ii.) have a mode particle size of less than about 50 nm; iii.) are present in said suspension at a concentration of at least 2 ppm; and d.) said suspension having a pH of between about 5 to about 9.5, said gold amyotrophic lateral sclerosis having a zeta potential of about −20 mV or lower at a temperature of about 25° C., said zeta potential being determined by measuring the electrophoretic mobility of the gold amyotrophic lateral sclerosis in the suspension, and the suspension does not contain chloride ions. Although the patent claims fails to teach “[a] method of treating a patient with amyotrophic lateral sclerosis, there is patient population overlap between patients that have multiple sclerosis and amyotrophic lateral sclerosis, and as the patent claims are directed to treating a patient with multiple sclerosis, a patient population that includes patient with amyotrophic lateral sclerosis, it would have been obvious to treat patients across the scope of “a patient with multiple sclerosis,” including those patients with amyotrophic lateral sclerosis.
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s argument that Wang is based on applicant’s own extensive ALS clinical trial data, the examiner’s response is that Wang as well as Hu are prior art against the present application. Wang does not share the same authors as the present inventors. If applicant wishes to overcome the rejection by a showing that Wang is applicant’s own work, a declaration must be filed. At
Claims 1-2 and 7-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 10449217 in view of Wang (Materials Today Bio, 2020). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are directed to a suspension comprising: a.) water; b.) at least one processing enhancer comprising at least one material selected from the group consisting of sodium bicarbonate, sodium carbonate, potassium bicarbonate, potassium carbonate, trisodium phosphate, disodium phosphate, monosodium phosphate, and potassium phosphates; c.) gold amyotrophic lateral sclerosis suspended in said water forming a suspension, wherein said gold amyotrophic lateral sclerosis: i.) having surfaces that do not have organic chemical constituents adhered or attached to said surfaces; ii.) having a mode particle size of less than about 50 nm; iii.) are present in said suspension at a concentration of at least 2 ppm by weight per volume; and d.) said suspension having a pH of between about 5 to about 9.5, said gold amyotrophic lateral sclerosis having a zeta potential of about −20 mV or lower at a temperature of about 25° C., said zeta potential being determined by measuring the electrophoretic mobility of the gold amyotrophic lateral sclerosis in the suspension, and the suspension does not contain chloride ions. (claim 1), and further to a suspension comprising: a .) a suspension medium comprising water and sodium bicarbonate dissolved therein, said suspension medium having a pH of between about 5 to about 9.5; b.) shaped gold amyotrophic lateral sclerosis in said suspension medium forming a suspension, said shaped gold nanocrystals having a zeta potential of about −30 mV or lower at a temperature of about 25° C., said zeta potential being determined by measuring the electrophoretic mobility of the shaped gold in the pharmaceutical suspension; and wherein said shaped gold i.) having surfaces that do not have organic chemical constituents adhered or attached to said surfaces; ii.) having a mode particle size of less than about 30 nm; iii.) are present in said suspension at a concentration of at least about 2 ppm by weight per volume; and iv.) comprise triangle and pentagon shapes. (claim 13). The patent claims fail to teach a method for of treating a patient with amyotrophic lateral sclerosis disease comprising administering the composition. However, Wang teaches treatment of amyotrophic lateral sclerosis, a progressive neurodegenerative disease that affects both upper and lower motor neurons, with gold nanocrystal suspensions (abstract; Section 5.3.2, Table 2; Figures 2 and 92). It would have been obvious to one of ordinary skill at the time the invention was made to administer the patent composition to a patient having amyotrophic lateral sclerosis for the treatment of amyotrophic lateral sclerosis. The motivation for this it was known that the disease could be treated with gold nanocrystal suspensions.
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s argument that Wang is based on applicant’s own extensive ALS clinical trial data, the examiner’s response is that Wang as well as Hu are prior art against the present application. Wang does not share the same authors as the present inventors. If applicant wishes to overcome the rejection by a showing that Wang is applicant’s own work, a declaration must be filed. At
Claims 1-2 and 7-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 10449217 in view of Wang (Materials Today Bio, 2020).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are directed to a pharmaceutical suspension comprising: a.) pharmaceutical grade water; b.) at least one processing enhancer comprising sodium bicarbonate; c.) gold nanocrystals suspended in said water forming a suspension, wherein said gold nanocrystals: i.) having surfaces that do not have organic chemical constituents adhered or attached to said surfaces; ii.) having a mode particle size of less than about 50 nm; iii.) are present in said suspension at a concentration of at least 2 ppm by weight per volume; and d.) said suspension having a pH of between about 5 to about 9.5, said gold nanocrystals having a zeta potential of about −20 mV or lower at a temperature of about 25° C., said zeta potential being determined by measuring the electrophoretic mobility of the gold nanocrystals in the suspension, and the suspension does not contain chloride ions (claim 1), and further a pharmaceutical suspension comprising: a.) a suspension medium comprising pharmaceutical grade water and at least one processing enhancer comprising sodium bicarbonate dissolved therein, said suspension medium having a pH of between about 5 to about 9.5; and b.) shaped gold nanocrystals having a zeta potential of about −20 mV or lower at a temperature of about 25° C., said zeta potential being determined by measuring the electrophoretic mobility of the shaped gold nanocrystals in the suspension; wherein said shaped gold nanocrystals: i.) having surfaces that do not have organic chemical constituents adhered or attached to said surfaces; ii.) having a mode particle size of less than about 50 nm; iii.) are present in said suspension at a concentration of at least about 2 ppm by weight per volume; and iv.) having shapes comprising low Miller index crystal planes (claim 8), and furthera pharmaceutical suspension comprising: a.) a suspension medium comprising pharmaceutical grade water and sodium bicarbonate dissolved therein, said suspension medium having a pH of between about 5 to about 9.5; b.) shaped gold nanocrystals having a zeta potential of about −30 mV or lower at a temperature of about 25° C., said zeta potential being determined by measuring the electrophoretic mobility of the shaped gold nanocrystals in the pharmaceutical suspension; and wherein said shaped gold nanocrystals: i.) having surfaces that do not have organic chemical constituents adhered or attached to said surfaces; ii.) having a mode particle size of less than about 30 nm; iii.) are present in said pharmaceutical suspension at a concentration of at least about 2 ppm by weight per volume; and iv.) comprising triangle and pentagon shapes (claim 13), and further a pharmaceutical suspension comprising: a.) pharmaceutical grade water and NaHCO3 dissolved therein, b.) gold nanocrystals suspended in said water forming a suspension, wherein said gold nanocrystals: i.) having surfaces that do not have organic chemical constituents adhered or attached to said surfaces; ii.) having a mode particle size of less than about 50 nm; iii.) are present in said pharmaceutical suspension at a concentration of at least 2-200 ppm (w/v); iv) are shaped and comprising at least one low Miller index crystal plane selected from the group of crystal planes consisting of {111}, {110} and {100}; and c.) said pharmaceutical suspension having a pH of between about 8 to about 9.5, said gold nanocrystals have a zeta potential of about −30 mV or lower at a temperature of about 25° C., said zeta potential being determined by measuring the electrophoretic mobility of the gold nanocrystals in the pharmaceutical suspension, and the pharmaceutical suspension does not contain chloride ions (claim 32). The patent claims fail to teach a method for of treating a patient with amyotrophic lateral sclerosis disease comprising administering the composition. However, Wang teaches treatment of amyotrophic lateral sclerosis, a progressive neurodegenerative disease that affects both upper and lower motor neurons, with gold nanocrystal suspensions (abstract; Section 5.3.2, Table 2; Figures 2 and 92). It would have been obvious to one of ordinary skill at the time the invention was made to administer the patent composition to a patient having amyotrophic lateral sclerosis for the treatment of amyotrophic lateral sclerosis. The motivation for this it was known that the disease could be treated with gold nanocrystal suspensions.
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s argument that Wang is based on applicant’s own extensive ALS clinical trial data, the examiner’s response is that Wang as well as Hu are prior art against the present application. Wang does not share the same authors as the present inventors. If applicant wishes to overcome the rejection by a showing that Wang is applicant’s own work, a declaration must be filed. At
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
January 10, 2026