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 .
Applicant’s election of Group I, claims 1-10, and the species of ligand L-cysteine and it’s derivatives, in the reply filed on 12/30/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicants assert that all ligands can be searched and examined without undue burden, however, a search burden is not a requirement under 371 practice.
Claims 6-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/30/2025.
Claim Status
Claims 1 and 3-10 are pending.
Claims 6-10 are withdrawn.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because the recitation of “methods for treating depression” does not provide the necessary steps for the process. The examiner suggests amending the specification to provide the necessary steps for the method of treating depression, such as administering the ligand bound gold clusters to a subject with depression. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 3-5, are rejected under 35 U.S.C. 103 as being unpatentable over Sun (CN 111035653 A).
Sun discloses pharmaceutical compositions comprising a gold cluster, wherein the gold cluster comprises a gold core and a ligand bonded to the gold core, and a pharmaceutically acceptable excipient (¶¶ 9, 53). The compositions can be used for the method of treating multiple sclerosis; common symptoms of multiple sclerosis include depression (¶ 4). The diameter of the gold core is less than 3 nm, and in some implementations, the diameter of the gold core is 0.5-2.6 nm (¶ 10). In some embodiments, the ligand is selected from L-cysteine and its derivatives, D-cysteine and its derivatives, cysteine-containing oligopeptides and its derivatives, D-cysteine and its derivatives, cysteine-containing oligopeptides and their derivatives, and other thiol containing compounds, including L-cysteine, N-isobutyryl-L-cysteine (L-NIBC), and N-acetyl-L-cysteine (L-NAC) (¶¶ 11-12).
Regarding the method for treating depression of claim 1, where the compositions comprising ligand bound gold clusters and a pharmaceutical excipient of Sun are administered to a subject for the treatment of multiple sclerosis, and common symptoms of multiple sclerosis include depression, it would have been obvious to administer the ligand bound gold nanoclusters of Sun to a subject with depression, as taught by Sun.
Upon administering the ligand bound gold clusters to treat multiple sclerosis in a subject with depression, treating depression in a subject naturally flows from the treatment of multiple sclerosis, which is the cause of the depression symptoms. The examiner notes that the instant specification defines “treating” as delaying the onset of, retarding or reversing the progress of, or alleviating or preventing either the disease or condition to which the term applies, or one or more symptoms of such disease or condition. Here, any change to the symptoms of depression, the progression of, etc., appear to read on treatment, which would be expected to occur following treating a subject with multiple sclerosis and depression, where multiple sclerosis causes symptoms of depression.
Regarding the gold core diameter of claims 1 and 3, it would have been obvious to formulate the gold cores with a diameter of less than 3 nm, such as 0.5-2.6 nm, as taught by Sun.
Regarding claims 4 and 5, it would have been obvious to select L-cysteine and its derivatives as the ligand, such as L-cysteine, N-isobutyryl-L-cysteine (L-NIBC), and N-acetyl-L-cysteine (L-NAC), as taught by Sun.
Claims 1 and 3-5, are rejected under 35 U.S.C. 103 as being unpatentable over Sun (CN 111035653 A), in view of Yang et al (US 20160015742 A1, hereinafter “Yang”).
Sun is discussed above, and purely arguendo, if somehow treating a subject with multiple sclerosis and depression would not be expected to treat depression, the following applies.
Yang teaches gold nanoparticles were known to be used to treat depression and multiple sclerosis (abs, ¶¶ 9, 56).
It would have been obvious to modify the method of Sun by administering the composition to a subject for the treatment of depression, where gold nanoparticles were known from Yang to treat depression and multiple sclerosis. The skilled artisan would have reasonably expected that the gold cluster core of Sun would be capable of treating depression, where Sun and Yang are both directed to gold nanomaterials as active pharmaceutical agents.
Regarding the gold core diameter of claims 1 and 3, it would have been obvious to formulate the gold cores with a diameter of less than 3 nm, such as 0.5-2.6 nm, as taught by Sun.
Regarding claims 4 and 5, it would have been obvious to select L-cysteine and its derivatives as the ligand, such as L-cysteine, N-isobutyryl-L-cysteine (L-NIBC), and N-acetyl-L-cysteine (L-NAC), as taught by Sun.
Claims 1 and 3-5, are rejected under 35 U.S.C. 103 as being unpatentable over Sun (US 20200048105 A1, hereinafter “Sun ‘105”), in view of Rodrigues et al (Colloids and Surfaces B: Biointerfaces, 2021, 201, 111608, pp. 1-11, hereinafter “Rodrigues”).
Sun ‘105 teaches a gold cluster containing material comprising a gold cluster coated with a ligand (¶ 9). The ligand includes, but is not limited to, one or more of L-cysteine and its derivatives, D-cysteine and its derivatives, cysteine-containing oligopeptides and their derivatives, and other thiol-containing compounds (¶¶ 11, 98, table 1). The L-cysteine derivatives include L-cysteine, N-isobutyryl-L-cysteine (L-NIBC), and N-acetyl-L-cysteine (L-NAC) (¶ 12). The gold clusters are ultrafine gold nanoparticles with a gold core less than 3 nm in diameter, preferably 0.5-2.6 nm (¶¶ 7, 10). The compositions can be used for preventing or treating Alzheimer’s disease and/or Parkinson’s disease (abs).
Sun ‘105 does not teach a method of treating depression in a subject.
Rodrigues teaches gold nanoparticles were known to prevent inflammation, blood-brain barrier disruption, and behavioral changes related to neurodegenerative diseases and depression, induced by hypercholesterolemic diet intake (abs). There is evidence demonstrating antidepressant action of gold nanoparticles through modulation in the levels of excitatory neurotransmitters (pg. 8 2nd col last ¶). Depression is a common non-motor symptom commonly present in patients with Parkinson’s disease and Alzheimer’s disease and is also a comorbid (pg. 2 1st col 3rd ¶, pg. 7 last full ¶). In addition, hypercholesterolemic mice displayed an increase in the immobility time in the tail suspension test, featuring a depressive-like behavior; the gold nanoparticle treatment ameliorated the depressive-like behavior in the animals fed a hypercholesterolemic diet (pg. 5 1st col last ¶).
Regarding the method for treating depression of claim 1, where Rodrigues teaches depression is a comorbid of Parkinson’s and Alzheimer’s diseases, where both were known to be treated with gold nanoparticles via the same mechanisms, it would have been obvious to use the compositions of Sun ‘105 for the method of treating depression, with a reasonable expectation of success.
Regarding the gold core diameter of claims 1 and 3, it would have been obvious to formulate the gold cores with a diameter of less than 3 nm, preferably 0.5-2.6 nm, as taught by Sun ‘105.
Regarding claims 4 and 5, it would have been obvious to select L-cysteine and its derivatives as the ligand, such as L-cysteine, N-isobutyryl-L-cysteine (L-NIBC), and N-acetyl-L-cysteine (L-NAC), as taught by Sun ‘105.
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 and 3-5, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/725,231, hereinafter ‘231 (reference application), in view of Sun (CN 111035653 A) and Yang et al (US 20160015742 A1, hereinafter “Yang”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘231 disclose an L-N-isobutyryl cysteine (L-NIBC)-bound gold cluster comprising a gold core, and a ligand bound to the gold core. The clusters can be used for the treatment of multiple sclerosis.
The claims of ‘231 do not disclose a method for treating a subject with depression, a pharmaceutically acceptable excipient, nor the diameter of the gold core.
Sun is discussed above.
Regarding the method, it would have been obvious to treat depression in a subject with depression, where both are directed to ligand bound gold clusters for the treatment of multiple sclerosis, and where depression is a common symptom of multiple sclerosis, as taught by Sun for the same reasons discussed above and of record.
Even if not, it would have been obvious to treat depression with the gold clusters of ‘231, for the same reasons discussed above by Yang.
Regarding the pharmaceutically acceptable excipient, It would have been obvious to modify ‘231 by include a pharmaceutically acceptable excipient, which was known to be suitable for ligand bound gold clusters, as taught by Sun.
Regarding the diameter of the gold core, it would have been obvious to formulate the gold cores of ‘231 to those known to be suitable for ligand bound gold clusters, such as less than 3 nm, as taught by Sun.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The following are also rejected in view of Sun for the same reasons:
Copending application no. 17/755,672, while teaching ligand bound gold clusters for treating multiple sclerosis, the claims of ‘672 do not disclose the method of treating depression. It would have been obvious to treat depression in a subject, for the same reasons discussed above by Sun. Even if not, it would have been obvious to treat depression with the gold clusters of ‘231, for the same reasons discussed above by Yang.
Claims 1 and 3-5, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/222,310, hereinafter ‘310 (reference application), in view of Sun (US 20200048105 A1, hereinafter “Sun ‘105”) and Rodrigues et al (Colloids and Surfaces B: Biointerfaces, 2021, 201, 111608, pp. 1-11, hereinafter “Rodrigues”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘310 disclose a method of treating a subject with Alzheimer’s disease, comprising administering a composition comprising a substance containing gold clusters and a ligand coating, wherein the ligand is selected from L-cysteine, etc. The gold core has a diameter smaller than 3 nm, including 0.5-2.6 nm.
The claims of ‘310 do not disclose a method of treating depression.
Sun ‘105 and Rodrigues are discussed above.
It would have been obvious to use the composition of ‘310 for the method of treating depression, for the same reasons discussed above by Rodrigues.
It would have been obvious to further include a pharmaceutically acceptable excipient, which were known from Sun ‘105 to be suitable for ligand bound gold cluster compositions.
The following is also rejected in view of Rodrigues for the same reasons:
Copending application no. 17/222,229, while disclosing a method for treating a subject with Parkinson’s disease by administering a composition comprising ligand bound gold clusters as instantly claimed, the claims do not disclose treating depression. It would have been obvious to modify the claims of ‘229 for the method of treating depression, for the same reasons discussed above by Rodrigues. It would have been obvious to further include a pharmaceutically acceptable excipient, which were known from Sun ‘105 to be suitable for ligand bound gold cluster compositions.
Claims 1 and 3-5, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 19/185,327, hereinafter ‘327 (reference application), in view of Rodrigues et al (Colloids and Surfaces B: Biointerfaces, 2021, 201, 111608, pp. 1-11, hereinafter “Rodrigues”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘327 disclose a pharmaceutical composition comprising ligand bound gold clusters and a pharmaceutically acceptable excipient, wherein the ligand is selected from L-cysteine and its derivatives, D-cysteine and its derivatives, etc. The L-cysteine and its derivatives are selected from those instantly claimed. The gold core has a dimeter of less than 3 nm, including from 0.5-2.6 nm.
The claims of ‘327 do not disclose a method of treating depression.
It would have been obvious to modify to use the compositions of ‘327 for the method of treating depression with a reasonable expectation of success, where gold nanoparticles were known to treat depression in subjects, as taught by Rodrigues.
The following are also rejected in view of Rodrigues for the same reasons:
Copending application no. 18/249,530, while disclosing a method for treating cerebral stroke in a subject comprising administering ligand bound gold clusters as instantly claimed, the claims do not disclose a method of treating depression. It would have been obvious to modify to use the compositions of ‘530 for the method of treating depression with a reasonable expectation of success, where gold nanoparticles were known to treat depression in subjects, as taught by Rodrigues.
Copending application no. 18/249,253, while disclosing a method for treating cerebral ischemic stroke in a subject comprising administering ligand bound gold clusters as instantly claimed, the claims do not disclose a method of treating depression. It would have been obvious to modify to use the compositions of ‘253 for the method of treating depression with a reasonable expectation of success, where gold nanoparticles were known to treat depression in subjects, as taught by Rodrigues.
Copending application no. 17/995,581, while disclosing a method for treating adverse effects caused by an atypical antipsychotic in a subject comprising administering ligand bound gold clusters as instantly claimed, the claims do not disclose a method of treating depression. It would have been obvious to modify to use the compositions of ‘581 for the method of treating depression with a reasonable expectation of success, where gold nanoparticles were known to treat depression in subjects, as taught by Rodrigues.
Copending application no. 17/758,308, while disclosing a method for treating liver cirrhosis in a subject comprising administering ligand bound gold clusters as instantly claimed, the claims do not disclose a method of treating depression. It would have been obvious to modify to use the compositions of ‘308 for the method of treating depression with a reasonable expectation of success, where gold nanoparticles were known to treat depression in subjects, as taught by Rodrigues.
Claims 1 and 3-5, are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. US 11058717 B, hereinafter ‘717, in view of Rodrigues et al (Colloids and Surfaces B: Biointerfaces, 2021, 201, 111608, pp. 1-11, hereinafter “Rodrigues”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘717 disclose a method of treating a subject with Alzheimer’s disease by administering a composition comprising ligand bound gold clusters, wherein the ligand is selected from N-isobutyryl-L-cysteine (L-NIBC), and N-isobutyryl-D-cysteine (D-NIBC). The gold clusters have a core diameter of 0.5-2.6 nm. The compositions further comprise a pharmaceutically acceptable excipient.
The claims of ‘717 do not disclose a method of treating depression.
It would have been obvious to use the composition of ‘717 for the method of treating depression, for the same reasons discussed above by Rodrigues.
The following is also rejected in view of Rodrigues for the same reasons:
U.S. Patent No. 12377167 B2, while disclosing ligand bound clusters wherein the ligand is selected from L-cysteine and its derivatives, the diameter of 0.5-2.6 nm, and further comprises a pharmaceutically acceptable excipient, the claims do not disclose a method of treating depression. It would have been obvious to modify to use the compositions of ‘167 for the method of treating depression with a reasonable expectation of success, where gold nanoparticles were known to treat depression in subjects, as taught by Rodrigues.
U.S. Patent No. 11413355 B2, while disclosing ligand bound clusters for protecting against optic nerve damage comprising administering ligand bound gold clusters as instantly claimed, the claims do not disclose a method of treating depression. It would have been obvious to modify to use the compositions of ‘355 for the method of treating depression with a reasonable expectation of success, where gold nanoparticles were known to treat depression in subjects, as taught by Rodrigues
U.S. Patent No. 11969477 B2, while disclosing a method for treating a subject with glaucoma comprising administering ligand bound gold clusters as instantly claimed, the claims do not disclose a method of treating depression. It would have been obvious to modify to use the compositions of ‘477 for the method of treating depression with a reasonable expectation of success, where gold nanoparticles were known to treat depression in subjects, as taught by Rodrigues.
Claims 1 and 3-5, are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. US 11000543 B2, hereinafter ‘543, in view of Sun (US 20200048105 A1, hereinafter “Sun ‘105”) and Rodrigues et al (Colloids and Surfaces B: Biointerfaces, 2021, 201, 111608, pp. 1-11, hereinafter “Rodrigues”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘543 disclose a method of treating a subject with Parkinson’s disease by administering a composition comprising ligand bound gold clusters, the ligand being selected from N-isobutyryl-L-cysteine (L-NIBC) and N-isobutyryl-D-cysteine (D-NIBC). The gold clusters have a core diameter of 0.5-2.6 nm.
The claims of ‘543 do not disclose a method of treating depression or the inclusion of a pharmaceutically acceptable excipient.
It would have been obvious to modify the claims of ‘543 for the method of treating depression, for the same reasons discussed above by Rodrigues.
It would have been obvious to further include a pharmaceutically acceptable excipient, which were known from Sun ‘105 to be suitable for ligand bound gold cluster compositions.
The following are also rejected in view of Sun ‘105 and Rodrigues for the same reasons:
U.S. Patent No. 12310985 B2, while disclosing a method for producing ligand bound gold nanoclusters and a method of treating glaucoma with the same, the reference does not disclose a method of treating depression nor the inclusion of a pharmaceutically acceptable excipient. It would have been obvious to modify the claims of ‘985 for the method of treating depression with a reasonable expectation of success, where gold nanoparticles were known to treat depression in subjects, as taught by Rodrigues. It would have been obvious to further include a pharmaceutically acceptable excipient, which were known from Sun ’105 to be suitable for ligand bound gold cluster compositions.
U.S. Patent No. 10729718 B2, while teaching a substance containing ligand bound gold clusters as instantly claimed, the reference does not disclose a method of treating depression nor the inclusion of a pharmaceutically acceptable excipient. It would have been obvious to modify the claims of ‘718 for the method of treating depression with a reasonable expectation of success, where gold nanoparticles were known to treat depression in subjects, as taught by Rodrigues. It would have been obvious to further include a pharmaceutically acceptable excipient, which were known from Sun ’105 to be suitable for ligand bound gold cluster compositions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612