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 .
Status of the Claims
Claims 1-31 are pending.
Applicants’ arguments filed on 08/21/2026, 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 Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn.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 of rejections and/or objections presently being applied to the instant application.
Applicants’ amendments, filed on 08/21/2026, have each been entered into the record. Applicants have amended claim 24. Claims 1-23 and 25-31 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected species. Therefore, claim 24 is a subject of the Office action below.
Claim Rejections - 35 USC § 112
Maintained/New Grounds of Rejection, Necessitated by Applicant’s 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.
Claim 24 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.
As per MPEP 2173.02, “[d]uring prosecution, applicant has an opportunity and a duty to amend ambiguous claims to clearly and precisely define the metes and bounds of the claimed invention. The claim places the public on notice of the scope of the patentee’s right to exclude (emphasis added). See, e.g., Johnson & Johnston Assoc. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052, 62 USPQ2d 1225, 1228 (Fed. Cir. 2002) (en banc).”
If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is appropriate (emphasis added). See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
Claim 24 recites the limitation of “an effective amount” and “an amount sufficient to inhibit an O6-methylguanine DNA methyltransferase in medulloblastoma and glioblastoma cells” (MGMT), however, a person of the ordinary skill in the art cannot reasonably determine the meets and bounds of the recited limitation in claim 24. This is because, each of the recited “an effective amount” and “an amount sufficient”, is a relative term in that the recited “an effective amount” or “an amount sufficient” is not defined by the claim or the specification to any specific dosage or dosage range, for the recited active ingredient. The specification does not provide a standard for ascertaining the requisite degree. For example, it is unclear from claim 24 or the specification as to:
a) what amount of bis[N,N-diethyldithiocarbamato]copper(II) would be considered as “an effective amount”;
b) what amount of bis[N,N-diethyldithiocarbamato]copper(II) would be considered as “an amount sufficient”;
c) what amount of bis[N,N-diethyldithiocarbamato]copper(II) would not be considered as “an effective amount”; and
d) what amount of bis[N,N-diethyldithiocarbamato]copper(II) would not be considered as “an amount sufficient”.
Thus, a person skilled in the art would not be able to draw a clear boundary between what is and is not covered by the claim.
The specification (see, e.g., ¶s 0120-0122 and 0126), provides working example of treating: i) human cancer cell lines; and ii) model of tumor bearing mice with bis[N,N-diethyldithiocarbamato]copper(II). However, the basis of the Applicants’ results in cell cultures and the model of tumor-bearing mice are not explained as real-world amounts, but only with “relative results”.
The phrase “an effective amount” has been held to be indefinite when the claim fails to state the function which is to be achieved and more than one effect can be implied from the specification or the relevant art. Please see MPEP § 2173.059c)(III).
In the instant case, the more than one effect that can implied from the specification are: i) treating a cancer tumor; and ii) inhibiting MGMT. The specification does not appear to provide guidelines that are elaborate enough for determining “an effective amount” and “an amount sufficient”, for bis[N,N-diethyldithiocarbamato]copper(II) recited in amended claim 24, which would: i) treat a cancer tumor cancer; and ii) inhibit MGMT. The artisan of the ordinary skill cannot tell from the specification, what is “an effective amount” and “an amount sufficient”, for the bis[N,N-diethyldithiocarbamato]copper(II) of claim 24, from what is not “an effective amount” and “an amount sufficient”, for the bis[N,N-diethyldithiocarbamato]copper(II) of claim 24.
Accordingly, without guidelines that are elaborate enough for determining “an effective amount” and “an amount sufficient”, in the specification, the skilled artisan cannot reasonably determine from the specification, what amount constitutes “an effective amount” and “an amount sufficient”, from an amount that does not constitutes “an effective amount” and “an amount sufficient”. Therefore, for the purpose of examination, an amount of Cu-DDC in a composition comprising Cu-DDC, is included in the interpretation of “an effective amount” and “an amount sufficient”. Appropriate correction is required.
Claim 24 is directed to a product (a chemotherapy composition), but, claim 24 also recites “to inhibit an O6-methylguanine DNA methyltransferase in medulloblastoma and glioblastoma cell”, which appears to indicate a process of using the chemotherapy composition. It is unclear to one skilled in the art as to whether the phrase “to inhibit an O6-methylguanine DNA methyltransferase in medulloblastoma and glioblastoma cell”, is referring to a process step, because claim 24 recites a product. A person skilled in the art cannot reasonably determine whether claim 24 is a composition or a process claim. This is indefinite because the claim recites both a product (a chemotherapy composition) and a process of using the product (“to inhibit an O6-methylguanine DNA methyltransferase in medulloblastoma and glioblastoma cell”,). Please see MPEP § 2713.05(p)(II). Accordingly, for the purpose of examination, claim 24 is being interpreted as a product, i.e., “A chemotherapy composition comprising an effective amount of bis[N,N-diethyldithiocarbamato]copper(II)”.
It is recommended that Applicants amend claim 24 to recite “A chemotherapy composition comprising an effective amount of bis[N,N-diethyldithiocarbamato]copper(II)”, in order to overcome the rejection. Appropriate correction is required.
A patent must be precise enough to afford clear notice of what is claimed, thereby "'appris[ing] the public of what is still open to them.'" Markman v. Westview Instruments, Inc., 517 U.S. 370, 373 (quoting McClain v. Ortmayer, 141 U.S. 419, 424 (1891)). Otherwise there would be "[a] zone of uncertainty which enterprise and experimentation may enter only at the risk of infringement claims." United Carbon Co. v. Binney & Smith Co., 317 U.S. 228, 236 (1942). A claim fails to satisfy this statutory requirement and is thus invalid for indefiniteness if its language, when read in light of the specification and the prosecution history, "fail[s] to inform, with reasonable certainty, those skilled in the art about the scope of the invention." Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120, 2124 (2014).
This lack of clarity makes it impossible to ascertain with reasonable precision when that claim is infringed and when it is not. Lacking such clarity, the skilled artisan would not be reasonably apprised of the metes and bounds of the subject matter for which Applicants seek patent protection. Rather, a subjective interpretation of the claimed language would be required. However, as such is deemed inconsistent with the tenor and express language of 35 U.S.C. § 112, second paragraph, the claims are deemed properly rejected.
Response to the Applicants’ Arguments
The Applicants argue alleging that the rejection is overcome by the amendment of claim 24 to recite the limitation of bis[N,N-diethyldithiocarbamato]copper(II) as the active ingredient (see page 10 of Remarks).
Response:
Applicants’ arguments have been fully considered but they are not found to be persuasive, because Applicants did not address the specific grounds of rejection set forth in the previous Office action and reiterated above. For example,
a) what amount of bis[N,N-diethyldithiocarbamato]copper(II) would be considered as “an effective amount”;
b) what amount of bis[N,N-diethyldithiocarbamato]copper(II) would be considered as “an amount sufficient”;
c) what amount of bis[N,N-diethyldithiocarbamato]copper(II) would not be considered as “an effective amount”; and
d) what amount of bis[N,N-diethyldithiocarbamato]copper(II) would not be considered as “an amount sufficient”.
The lack of clarity regarding, for example, what amount of bis[N,N-diethyldithiocarbamato]copper(II) would be considered as “an effective amount”, makes it impossible to ascertain with reasonable precision when that claim is infringed and when it is not. Lacking such clarity, the skilled artisan would not be reasonably apprised of the metes and bounds of the subject matter for which Applicants seek patent protection. Rather, a subjective interpretation of the claimed language would be required. However, as such is deemed inconsistent with the tenor and express language of 35 U.S.C. § 112, second paragraph, the claims are deemed properly rejected. Appropriate correction is required.
For the reasons above, and those made of record in the previous Office action, the rejections are maintained.
Claim Rejections - 35 USC § 102
Maintained/New Grounds of Rejection, Necessitated by Applicant’s Amendments
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.
The rejection of claim 24 under 35 U.S.C. 102(a)(1) as being anticipated by Kennedy of record (WO2009117333A1), is maintained for the reasons of record set forth in the previous Office action, of which said reasons are herein reiterated.
By way of a background, Applicants’ invention (see, e.g., ¶ 00009 of the specification), is drawn to a pharmaceutical comprising active agents selected from a group that includes bis[N,N-diethyldithiocarbamato]copper(II), i.e., cupric diethyldithiocarbamate (CuDETC, i.e., Cu-DDC), that can be employed as a treatment option for cancer tumors. The specification (see, e.g., ¶s 0120-0122), provides working example of the activity of Cu-DDC against human cancer cell lines.
Because of the ambiguity associated with claim 24 (see above rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph), claim 24 is being interpreted as a chemotherapy composition comprising an effective amount of Cu-DDC.
Regarding claim 24, Kennedy (see Examples 1-2 and 5-7), teaches a chemotherapy composition comprising cupric diethyldithiocarbamate (CuDETC, i.e., Cu-DDC) and a pharmaceutically acceptable carrier. Therefore, claim 24 is anticipated by Kennedy.
Response to the Applicants’ Arguments
The Applicants argue alleging that Kennedy fails to teach bis[N,N-diethyldithiocarbamato]copper(II) as the active ingredient (see page 11 of Remarks).
Response:
Applicants’ arguments have been fully considered but they are not found to be persuasive. This is because a person skilled in the art would have readily understood that the “cupric” in cupric diethyldithiocarbamate (CuDETC, i.e., Cu-DDC), is referring to copper (II). Kennedy teaches synthesis of CuDETC from copper (II) gluconate and sodium salt of diethyldithiocarbamate (see Example 1). The chemical structure of CuDETC is:
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, and Cas Registry Number for CuDETC (Cu-DDC) is 13681-87-3 (see attached CRN13681-87-3, cited in response to the Applicants’ allegations).
For the reasons above, and those made of record in the previous Office action, the rejection is maintained.
Conclusion
No claim is allowable.
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.
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Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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