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 arguments, filed 04/22/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 1, and 3-10, are pending and under examination.
Claim Objections
Claim 9 is objected to because of the following informalities: in line 2, ". Appropriate correction is required.
Claim Rejections - 35 USC § 112(a) or pre-AIA 1st ¶
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, and 3-10, are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for administering a composition comprising A1-A5, in particular dosage amounts, for the treatment of depression related symptoms in a subject with depression, the specification does not reasonably provide enablement for a method of treating depression generally with any ligand bound gold cluster, in any amounts. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention, state and predictability of the art, and relative
skill level
The invention relates to the treatment of depression. The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of the art. Applicants have asserted in the prior response that the etiology of depression is currently under study and is not yet clear, suggesting that treatment can be unpredictable as the cause of depression is not clear. As an illustrative example, the examiner cites Cui et al (Signal Transduction and Targeted Therapy, 2024, 9:30, pp. 1-32), where it is taught that the pathological mechanisms of depression are complex and unclear, and additional diagnostic and therapeutic strategies for depression are still needed (abs).
2. The breadth of the claims
The claims are thus very broad insofar as they suggest that any type of depression from any etiology, comprising any ligand, any excipient, and any dosage, can be treated with ligand-bound gold clusters generally. Further, the term “treatment” is defined in the instant specification 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. The claims are broad insofar as they suggest that when someone with depression taking the claimed agent, it will not worsen; or that following its treatment, it will not recur or will cure clinical depression. While such “treatment” might be theoretically possible under strictly controlled laboratory conditions, as a practical matter it is nearly impossible to achieve or predict this outcome in the “real world” where patients live, and with unknown and varying causes of depression.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for practicing the claimed invention in its “full scope”. No reasonably specific guidance is provided concerning useful therapeutic protocols for treating depression, other than embodiments A1-A5 from the working examples, which appear to simply treat symptoms of depression, rather than the full scope of the term “treating” as defined in the instant specification, as discussed above.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed agents could be predictably used to treat depression, which has unknown and varying etiology, with any ligand-bound gold cluster, in any dosage, etc., as inferred by the claim and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the claimed invention in its “full scope” a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Claim Rejections - 35 USC § 112(b) or pre-AIA 2nd ¶
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 5-10 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.
Claims 5-10 recite a list of oligopeptides, wherein each listing is followed by a parenthetical term, and it is unclear if the parenthetical term is included to simply abbreviate the preceding term, or if the parenthetical terms are included as an example of each. For purposes of examination, the claim is interpreted without the parenthetical terms.
Response to Arguments
First, Applicants assert a more accurate English translation of “沮丧” is frustration, not depression. Applicants assert that depression is significantly different from multiple sclerosis in terms of pathogenesis, symptoms, and clinical therapies, and thus, assert Sun does not teach, suggest or motivate a person of ordinary skill in the art to practice any of Sun’s teachings for the treatment of depression.
Second, Applicants assert gold nanoclusters and gold nanoparticles are completely different, each having different physical properties, sizes, characteristics, etc. Applicants assert that due to these differences, there are significant physicochemical properties and biological activities between gold clusters and gold nanoparticles. Applicants assert all of the gold cluster drugs (A1-A5) had significant therapeutic effects on depression, while gold nanoparticles (B1) showed no significant change compared to the control group.
First, this argument is persuasive. Upon further review, and upon receiving a human translation from STIC, it does appear that the “沮丧” is more accurately translated to frustration, rather than depression in the medical sense. Thus, based on the teachings of Sun, it does not appear that the skilled artisan would have reasonably applied the method of Sun, which teaches the treatment of multiple sclerosis, for the treatment of depression related symptoms with a reasonable expectation of success.
Second, this argument is persuasive. The examiner agrees that A1-A5 appear to have significant effects on depression related symptoms, while ligand bound gold nanoparticles (B1) performed similarly to control. Accordingly, based on the teachings of Yang or Rodrigues, it does not appear that the skilled artisan could have reasonably expected that the gold clusters of A1-A5 would have an improved effect on treating depression related symptoms, compared to gold nanoparticles, which performed similar to control.
Status of the Art
The closest prior art appears to be Sun (CN 111035653 A), and while disclosing 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, for the treatment of multiple sclerosis, with symptoms including mood changes and frustration, there does not appear to be any teachings or suggestions that the ligand-bound gold clusters would treat depression related symptoms when administered to a subject with depression. While it was known from Yang et al (US 20160015742 A1, hereinafter “Yang”) and Rodrigues et al (Colloids and Surfaces B: Biointerfaces, 2021, 201, 111608, pp. 1-11, hereinafter “Rodrigues”) that gold nanoparticles were known to be used to treat depression and multiple sclerosis, Applicants appear to have shown that compared to the ligand-bound gold clusters of A1-A5, ligand bound gold nanoparticles performed similar to control on depression related symptoms. Accordingly, from the teaching of the prior art, it does not appear that the skilled artisan would have reasonably expected that the ligand-bound gold clusters of A1-A5 would have resulted in improved performance on depression related symptoms compared to gold nanoparticles, or ligand bound gold nanoparticles specifically.
Double Patenting - Withdrawn
The nonstatutory double patenting rejections over the claims of copending application no. 18/725,231, 17/755,672, 17/222,310, 17/222,229, 19/185,327, 18/249,530, 18/249,253, 17/995,581, 17/758,308, and U.S. Patent no. 11058717 B, 12377167 B2, 11413355 B2, 11969477 B2, 11000543 B2, 12310985 B2, 10729718 B2, are withdrawn, as none of the copending applications nor U.S. patents disclose a method of treating depression related symptoms in a subject with depression, and there appears to be no teachings or suggestions in the prior art that would suggest administering ligand bound gold nanoparticles to a subject with depression, with the reasonable expectation that depression related symptoms would be treated, for the same reasons discussed above.
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
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