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 .
This is a Final Office Action.
Claims 2-4, 7, 12, 14, 15, 17, 18, and 20-27 are pending and under consideration.
Specification
The disclosure is objected to because of the following informalities the formulas on pages 6, 7, 23 and 24 are blurry and require replacement.
Appropriate correction is required.
Amendments were submitted to replace the formulas, but the amendments are still too blurry to see and comprehend. Thus, the amendments were not entered and the objection is maintained.
Claim Objections
The objection to claims 1-20 because of the colon after each claim number should be replaced with a period, is withdrawn based on the amendments.
The objection to claims 8 and 12 because of the “Formula II” and “Formula IV,” in claims 8, 10, and 12, are cited after the period, is withdrawn based on the amendments.
The objection to claim 10 because the period is missing at the end of claim, after “Formula III,” is withdrawn based on the amendments.
The objection to claim 16 because of the phrase “breast cancer stem,” is withdrawn based on the amendments.
Claim 12 is objected to because of the following informalities: the formulas are blurry and require replacement. Appropriate correction is required.
Claim 12 was amended but the structures are still blurry. Moreover, the two structures look the same. Thus, the objection is maintained.
Claim Rejections - 35 USC § 112
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the preamble and the term “comprising” is withdrawn based on the amendments.
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112 (pre-AIA ), second paragraph, as being indefinite for the preamble and phrase, “the carbon containing radicals” is withdrawn based on the amendments.
The rejection of claims 9, 11 and 13 under 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for the IC50 values in each claim, is withdrawn based on the amendments.
The rejection of claims 1 and 14-20 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn based on the amendments.
The rejection of claim 20 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment of lung adenocarcinoma, does not reasonably provide enablement for the treatment and prevention of lung cancer generally, is withdrawn based on the amendments.
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 2-4, 7, 12, 14, 15, 17, 18 and 20-27 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 pre-AIA the applicant regards as the invention.
Claim 2 is ambiguous due to the language used in the claim, see MPEP 2111.03
The preamble states “A dinuclear gold(I) complex having … ,” but claim 1 does not include any additional components nor does the claim state a composition. Thus, the claim is unclear whether a composition or compound is being claimed. If claim 1 is intended as a compound claim, the transition phrase “having” should be replaced with “of” since compound claims are closed-ended. If Applicant intends a composition, amend the preamble to a composition. Therefore, claims 2-4, 7, 12, 14, 15, 17, 18 and 20-27 are indefinite since it is uncertain what Applicant is attempting to claim and none of the dependent claims remedy the deficiency.
Claims 2-4, 7, 12, 14, 15, 17, 18 and 20-27 are indefinite due to the term “substantially” in claims 2 and 27. Terms of degree, such as “substantial” or “relatively” are indefinite when the specification contains no “explicit guidelines” to distinguish from things which are not so, Ex parte Oetiker, 23 USPQ2d 1651, 1655 (1990) and Ex parte Oetiker, 23 USPQ2d 1641, and Seattle Box Co. v. Industrial Crating & Packaging, Inc. 221 USPQ 568, 574. Substantially is defined in the specification with regards to numerical values, see page 4. The specification does not define said term with regards to the context of the phrase “substantially the same conditions.” Therefore, claims 2-4, 7, 12, 14, 15, 17, 18 and 20-27 are indefinite since it is uncertain what Applicant is attempting to claim and none of the dependent claims remedy the deficiency.
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 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.
Claim Rejections - 35 USC § 102
The rejection of claims 1-9 under 35 U.S.C. 102(a)(1) as being anticipated by Visbal et al. (Dalton Transactions, 2014, 43(1), 328-334), is withdrawn based on the amendments.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 2-4, 7, 12, 14, 15, 17, 18 and 20-27 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Casagrande et al. (Journal of Biological Inorganic Chemistry, 2023, 28(8), 751-766).
The reference teaches the following compounds:
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, see page 756, evaluated in lung (A549), breast (MC-F7), prostate (PC-3), osteosarcoma (MG-63) and ovarian (A2780 and A2780cis) cancer models, see the abstract, and page 458 (below). Also, note, the 112b rejection above since it’s uncertain if a compound or composition is being claimed. The compounds of formula (I) were tested in assays as a composition in DMSO, among other excipients, see page 754, Drug Samples section.
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Claims 2 and 27 are drawn to compounds and compositions, note 112(b) rejection above. The wherein clauses at the end of the claims are properties of the compounds or compositions, which would be inherent since there is nothing else in claims that would alter these properties. MPEP 2112 states, “"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
If, arguendo, the properties are based on concentration for the compositions, then this is a result-effective variable, and is obvious. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "Where 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, 105 USPQ 233, 235 (CCPA 1955). The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the solvents taught by the cited references), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
The same rationale, i.e. inherent properties and/or result-effective variables, applies to claims 17, 18 and 20-26.
Thus, said claims are anticipated by or, in the alternative, obvious over Casagrande et al.
Claim Rejections - 35 USC § 103
The rejection of claims 1-11 under AIA 35 U.S.C. 103(a) as being unpatentable over Visbal et al. (Dalton Transactions, 2014, 43(1), 328-334), is withdrawn based on the amendments.
Conclusion
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 SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 pm.
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624
