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 CON of 16/938,114 filed 07/24/2020, now Patent number 11660324. 16/938,114 has a PRO 62/878,581 filed 07/25/2019.
Claim Status
Claims 1-2, 5-11 are pending. Claims 1-2, 5-6, 8, and 10 are amended. Claims 3-4, and 12-21 are canceled. Claims 1-2, 5-11 are being examined on the merits in this office action.
Claim Objections - Maintained
Claim 1 remains objected to because of the following informalities:
Claim 1 contains the acronym “CuPTSM”, and an acronym in the first instance of claims should be expanded upon/spelled out with the acronym indicated in parentheses, i.e., Copper pyruvaldehyde bis(N4-methylthiosemicarbazon (CuPTSM). The abbreviations can be used thereafter.
Appropriate correction is required.
Claim Rejections - Withdrawn
The rejection of claims 1-2, 5-11 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in view of the claim amendments.
The rejection of claims 16-17 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the claim amendments.
The rejection of claims 12-21 under 35 U.S.C. 102(a)(1) as being anticipated by Kutsch et al. (US 2013/0324598A1 hereinafter “Kutsch”) is withdrawn in view of the canceled claims.
Claim Rejections - 35 USC § 112 - New
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 2 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 2 recites the limitation "neurodegenerative disease" in line 1. There is insufficient antecedent basis for this limitation in the claim because the claim depends on claim 1 and claim 1 does not recite neurodegenerative disease.
Claim Rejections - 35 USC § 103 – Maintained and updated
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 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.
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.
Claims 1-4, are rejected under 35 U.S.C. 103 as being unpatentable over Warner et al. (WO 2015070177 A2 hereinafter “Warner”)*.
Warner teaches metal complexes compounds of Formula I below
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wherein M is a metal including Cu;
R1 and R2 are each independently selected from the group consisting of H, substituted or unsubstituted C1-C6 alkyl;
R5 and R6 are each independently selected from the group consisting of H, substituted or unsubstituted C1-C6 alkyl; R3 and R4 are each independently H, substituted or unsubstituted C1-C6 alkyl (Claim 1). The disclosures of Warner with the taught variables disclose the instant CuPTSM. Furthermore, Warner teaches various forms of CuPTSM and methods of making the CuPTSM [00111, 00128, 00144, 00145 and 00186]. Warner further teaches methods for treatment comprising administering to the mammal a therapeutically effective amount of the compounds for treating neurodegenerative diseases including Alzheimer's disease (AD); amyotrophic lateral sclerosis (ALS), dementia, Parkinson's disease, Huntington Disease (claims 13-16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use and administer the compounds taught by Warner such as CuPTSM and treat neurodegenerative diseases such Alzheimer's disease (AD) since Warner teaches that the compounds were used for treatment of neurodegenerative diseases such as Alzheimer's disease (AD), and amyotrophic lateral sclerosis (ALS) [0036]. One of ordinary skill in the art would have had a reasonable expectation of success in modifying and using the method of Warner to treat neurodegenerative diseases with CuPTSM because Warner teaches that the method was effective for treating neurodegenerative diseases including Alzheimer's disease (AD); amyotrophic lateral sclerosis (ALS), dementia, Parkinson's disease, Huntington Disease (claims 13-16; [0036). The disclosures render obvious claim 1.
Regarding claim 2, Warner teaches methods for treatment comprising administering to the mammal a therapeutically effective amount of the compounds for treating neurodegenerative diseases including Alzheimer's disease (AD); amyotrophic lateral sclerosis (ALS), dementia, Parkinson's disease, Huntington Disease (claims 13-16).
Claims 1-2, and 5-11 are rejected under 35 U.S.C. 103 as being unpatentable over Warner et al. (WO 2015/070177 A2 hereinafter “Warner”) in view of Beaudry et al. (WO 2019/046761A1 hereinafter “Beaudry”)*.
Warner teaches metal complexes compounds of Formula I below
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wherein M is a metal including Cu;
R1 and R2 are each independently selected from the group consisting of H, substituted or unsubstituted C1-C6 alkyl;
R5 and R6 are each independently selected from the group consisting of H, substituted or unsubstituted C1-C6 alkyl; R3 and R4 are each independently H, substituted or unsubstituted C1-C6 alkyl (Claim 1). The disclosures of Warner with the taught variables disclose the instant CuPTSM. Furthermore, Warner teaches various forms of CuPTSM and methods of making the CuPTSM [00111, 00128, 00144, 00145 and 00186]. Warner further teaches methods for treatment comprising administering to the mammal a therapeutically effective amount of the compounds for treating neurodegenerative diseases including Alzheimer's disease (AD); amyotrophic lateral sclerosis (ALS), dementia, Parkinson's disease, Huntington Disease (claims 13-16).
Warner does not teach that the ALS comprises a mutation in the SOD gene as recited in claim 9.
Beaudry teaches compounds, wherein the metal component of the compound is an isotope of the metal such as Cu (page 2, line 13-15). Beaudry further teaches methods, comprising administering to a subject or a sample a therapeutic amount of the compound for treating a motor neuron disease such as ALS (page 2, line 7-12) and that the compounds can reproducibly treat ALS and other neurological and/or copper deficiency-related diseases (page 1, line 28-29). Beaudry teaches that the models of ALS are produced the overexpression of mutant SOD (see page 43, line 10-20; claim 22) and that the compounds deliver Cu into the CNS more rapidly and effectively stabilize SOD, thereby preventing the toxicity from mutations of this protein typically present in subjects disposed to developing ALS (page 42, line 29-33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Warner and Beaudry and use the compound of Warner to treat ALS that is associated with the genetic mutation because Beaudry teaches that such Cu compounds deliver Cu into the CNS more rapidly and effectively stabilize SOD, thereby preventing the toxicity from mutations (page 42, line 29-33). One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in using the compound of Warner to treat genetic mutation associated ALS because Warner teaches that the compound was successful for treating neurodegenerative diseases including Alzheimer's disease (AD); amyotrophic lateral sclerosis (ALS), dementia, Parkinson's disease, Huntington Disease (claims 13-16). The disclosures render obvious claim 1.
Regarding claim 2, Warner teaches methods for treatment comprising administering to the mammal a therapeutically effective amount of the compounds for treating neurodegenerative diseases including Alzheimer's disease (AD); amyotrophic lateral sclerosis (ALS), dementia, Parkinson's disease, Huntington Disease (claims 13-16).
Regarding claims 5, 6 and 10, Beaudry teaches that the compounds may be used alone, in combination with one or more additional compounds, or as an adjunct to, or in combination with, an established therapy and that the compounds may be used in combination with other therapeutic agents useful for the disorder or condition being treated (page 44, line35-39). Further, Warner teaches untreated subjects [00190] which reads on naïve subjects. It would have been obvious to treat a neurodegenerative disorder using the compound of Warner in naïve or previously treated subjects.
Regarding claim 7, Beaudry teaches that the pharmaceutical compositions of the Cu comprising compounds dosages ranges from 0.1 mg/kg/day to 30 mg/kg/day (page 47, line 1-14). One of ordinary skill in the art would be motivated to try the compound if Warner at similar dosages and obtain a reasonable expectation of success.
Regarding claims 8 and 9, Beaudry teaches that the models of ALS are produced by the overexpression of mutant SOD (see page 43, line 10-20; claim 22) and that the subject further comprises humans (page 9, line 22-24). It would have been obvious to practice the method of Warner in the ALS subjects taught by Beaudry.
Regarding claim 11, Warner teaches Cmax values including 36.5 ng/ml, 14.5 ng/ml, 29 ng/ml [00196, 00197]. Further, MPEP 2111.04 states: claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. In the instant case, the limitation expresses the intended result of the method step of claim 1 and is given little patentable weight.
Response to Arguments
Applicant's arguments filed 11/13/2025 have been fully considered but they are not persuasive.
Applicant Arguments
Applicant argues that Warner teaches a non-covalent derivative (NCD) of a compound of Formula I with a ligand.
Applicant further argues that Beaudry is focused on unique derivatives of the PTSM core, in which the northern and southern portions of the core are derivatized with various functional groups and that Beaudry does not provide and teaching, suggestion, or motivation that would lead one of ordinary skill in the art to use CuPTSM. Applicant argues that specifically excluding CuPTSM as a suitable compound, Beaudry teaches away from using CuPTSM in the disclosed method.
Examiner’s Response
The arguments disclosed above have been fully considered but are unpersuasive. Examiner notes that the instant claims recite the transitional phrase “having” which is open ended and thus do not limit the CuPTSM without anything added to it. Further, Examiner notes that Warner defines ligand as a) an amino acid, b) an ester of an amino acid, c) a dipeptide, d) an organic carboxylic acid, dicarboxylic acid, or polycarboxylic acid, e) a monosaccharaide or disaccharide, and f) an organic compound. Warner discloses that the organic carboxylic acid includes stearic acid, oleic acid, citric acid etc., which the instant invention discloses as pharmaceutical diluents that can be included in the composition comprising CuPTSM (See [0087-0088] of the published application). Examiner notes the teachings of Warner are not different from the instant invention since they contain the same ligands or excipients, and further, the active ingredient is the CuPTSM which is responsible for the treatment of the medical condition. Thus, Applicants assertion that the instant invention is distinguished from the Warner prior art is unpersuasive. Both the instant invention and Warner teach that the active ingredient in treating the neurodegenerative diseases is CuPTSM and Warner teaches that the CuPTSM was successful in treating neurodegenerative diseases including Alzheimer's disease (AD); amyotrophic lateral sclerosis (ALS), dementia, Parkinson's disease, Huntington Disease. Obviousness does not require absolute predictability, only a reasonable expectation of success, i.e., a reasonable expectation of obtaining similar properties. See, e.g., In re O’Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988). (MPEP 2144.08 (II).
Regarding the arguments made on the Beaudry reference, Examiner notes that Beaudry teaches similar metal complex compounds for treating neurodegenerative diseases. Examiner used the Beaudry reference to teach that the ALS comprises a mutation in the SOD gene as recited in claim 9. Examiner notes that all the limitations of the instant invention are taught by Warner. Examiner disagrees that Beaudry teaches away because the references teaches similar compounds for treating the instant conditions and teaches that ALS comprises a mutation in the SOD gene. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure of non-preferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." See MPEP 2123 (II). The arguments are unpersuasive and the rejection is maintained.
Double Patenting – Maintained
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, 5-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11660324 in view of Warner et al. (WO 2015070177 A2 hereinafter “Warner”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite a method of treating amyotrophic lateral sclerosis (ALS) in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of CuPTSM, having the formula:
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(claim 1).
The instant claims recite a method of treating or preventing a neurodegenerative disease in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of CuPTSM (claim 1), wherein the neurodegenerative disease is amyotrophic lateral sclerosis (ALS), frontal temporal dementia (FTD), Parkinson's disease, Huntington's disease, and Alzheimer's disease (claim 2), and wherein the neurodegenerative disease is ALS (claim 3).
The claims of the patent do not recite the method of treating Alzheimer or Parkinson’s disease. Examiner notes that the patent lists Alzheimer or Parkinson’s disease as some of the diseases being treated. Further, Warner teaches the use of the instant compound and further teaches methods for treatment comprising administering to the mammal a therapeutically effective amount of the compounds for treating neurodegenerative diseases including Alzheimer's disease (AD); amyotrophic lateral sclerosis (ALS), dementia, Parkinson's disease, Huntington Disease (claims 13-16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the compound of the patent for treating neurodegenerative diseases including Alzheimer's disease (AD); amyotrophic lateral sclerosis (ALS), dementia, Parkinson's disease, Huntington Disease since all these diseases are neurodegenerative diseases. The claims of the patent render obvious the instant claims.
Regarding claim 2, Warner teaches the use of the instant compound and further teaches methods for treatment comprising administering to the mammal a therapeutically effective amount of the compounds for treating neurodegenerative diseases including Alzheimer's disease (AD); amyotrophic lateral sclerosis (ALS), dementia, Parkinson's disease, Huntington Disease (claims 13-16). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the compound of the patent for treating neurodegenerative diseases including Alzheimer's disease (AD); amyotrophic lateral sclerosis (ALS), dementia, Parkinson's disease, Huntington Disease since all these diseases are neurodegenerative diseases.
Regarding claims 5-9, the claims of the patent recite, wherein the ALS is familial or sporadic (claim 2), wherein the subject in need thereof is treatment naïve (claim 3), wherein the subject in need thereof has received previous treatment for ALS (claim 4), wherein the therapeutically effective dose of CuPTSM is 0.01 mg/kg/day-12 mg/kg/day (claim 5), wherein the subject in need thereof is human, and the human has a genetic mutation associated with ALS (claim 6), wherein the genetic mutation associated with ALS comprises a mutation in the SOD1 gene (claim 7).
Regarding claims 10-11, the claims of the patent recite, wherein the CuPTSM is administered to the subject in combination with an additional ALS treatment therapy (claim 8), wherein the CuPTSM is administered at a dose that achieves a plasma Cmax of about 50-640 ng/mL in the subject (claim 9).
Response to Arguments
Applicant should submit an argument under the heading “Remarks” pointing out disagreements with the examiner’s contentions. Applicant must also discuss the references applied against the claims, explaining how the claims avoid the references or distinguish from them. This rejection is thus being maintained.
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 Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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, Lianko G. Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MERCY H SABILA/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654