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.
Election of Invention
Applicants’ election of following species with traverse (see page 10 of reply filed on 0/16/2026), is acknowledged and entered:
a) a composition of claim 24, as the elected species of a pharmaceutical composition;
b) GNQ-9:
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as the elected active ingredient in the elected composition of claim 24.
However, because Applicants did not distinctly and specifically point out the supposed errors in the restriction requirement, the election of invention has been treated as an election of invention without traverse (MPEP § 818.01(a)).
Claims 1-23 and 25-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected species.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.
Please note that:
1) Applicants’ presentation of GNQ-9 as allegedly representing a prodrug of diethyldithiocarbamate (DDC or DDTC):
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, is incorrect because a prodrug is a bioreversible derivative of a drug that can be converted to DDC. For example, Lee et al (J. Med. Chem., 1994, 37, 3154-3162) teaches a DDC prodrug (sugar-linked DDTC) that can be hydrolysed to release DDTC (see abstract, page 3155 and Table 1). In the instant case, compound GNQ-9 does not appear to qualify as a prodrug of DDC, because it is unclear to one skilled in the art as to how compound GNQ-9 can be bioreversibly converted to DDC. Accordingly, for the purpose of examination, Applicants’ elected compound GNQ-9 is being interpretated as an active ingredient in the elected composition of claim 24.
2) it is unclear as to the purpose of the Applicants’ election of compound Lys-DDC:
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, since there no claim depending from claim 24 (Applicants’ elected composition, see discussions above), which recite Lys-DDC.
Furthermore, the presentation of Lys-DDC, as allegedly representing N-acetyl lysine-linked DDC (see page 10 of Remarks), is incorrect because the structure of N-acetyl lysine is:
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, which different from the structure of the moiety linked to DDC moiety in the Lys-DDC above. Furthermore, there is no support for the recited structure of Lys-DDC in the specification.
Priority
This application filed on 01/19/2024, is a CON of U.S. application No. 16/864,955, filed on 05/01/2020 (ABN), which is a CON of U.S. application No. 15/246,346, filed on 08/24/2016 (ABN), which claims benefit of U.S. provisional application No. 62/209,090, filed on 08/24/2015.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/05/2024 and 11/05/2024, were in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS documents were considered. A signed copy of Form PTO-1449 is enclosed herewith.
Claim Rejections - 35 USC § 112
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” (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.
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 Cu-DDC. 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 term “an amount sufficient”, is a relative term in that it is not defined by the claim or the specification to any specific dosage or dosage range, for any of the recited active ingredients. The specification does not provide a standard for ascertaining the requisite degree. 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 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 to inhibit an O6-methylguanine DNA methyltransferase”, for any of the active agents 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 to inhibit an O6-methylguanine DNA methyltransferase”, for any of the active agents recited in amended claim 24, from what is not “an effective amount” and “an amount sufficient to inhibit an O6-methylguanine DNA methyltransferase”, for any of the active agents recited in amended claim 24.
Accordingly, without guidelines that are elaborate enough for determining “an effective amount” and “an amount sufficient to inhibit an O6-methylguanine DNA methyltransferase”, in the specification, the skilled artisan cannot reasonably determine from the specification, what amount constitutes “an effective amount” and “an amount sufficient to inhibit an O6-methylguanine DNA methyltransferase”, from an amount that does not constitutes “an effective amount” and “an amount sufficient to inhibit an O6-methylguanine DNA methyltransferase”. Appropriate correction is required.
Claim 24 recites the limitation of “a Cu-DDC prodrug”, however, a person skilled in the art cannot reasonably determine the meets and bounds of this limitation in the claim. The phrase “prodrug”, includes an unlimited number of compounds obtainable from Cu-DDC, by some undetermined chemical modification (including compounds which are structurally remote from the starting Cu-DDC). The phrase “prodrug” is a relative term which renders the claim indefinite because it is unclear to one skilled in the art as to the type of compound(s) of Cu-DDC set forth in claim 24, that are “Cu-DDC prodrug” and the type of compound(s) of Cu-DDC set forth in claim 24, that are not “Cu-DDC prodrug”.
There is no definition in the specification as to which extent Cu-DDC according to claim 24, may be modified while still being regarded as “a Cu-DDC prodrug”. The specification does not make it clear exactly what variations of Cu-DDC would fall within the meets and bounds of a “Cu-DDC prodrug” in instant claim 24.
Thus, one of ordinary skill in the art would not be able to draw a clear boundary between what is and is not covered by the claim. Appropriate correction is required.
Claim 24 recites the limitation “pro-GNQ”, and is also rejected for the same reasons set forth above. 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.
Claim Rejections - 35 USC § 102
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.
Claim 24 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kennedy et al (hereinafter “Kennedy”, WO2009117333A1, published 09/24/2009).
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 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.
Under the broadest reasonable interpretation (BRI), consistent with the specification, claim 24 is being interpretated as a chemotherapeutic composition comprising an effective amount of an active agent selected from the group consisting of the list disclosed therein, in an amount sufficient to inhibit MGMT.
Each of the term “an effective amount” and “an amount sufficient to inhibit MGMT”, is not defined by the claims or the specification to any specific amount or range of amount. Accordingly, for the purpose of examination, an amount of an active agent of claim 24 required to produce a desired therapeutic effect, is included in the interpretation of “an effective amount” and “an amount sufficient to inhibit MGMT”.
Regarding claim 24, Kennedy (see Examples 1-2 and 5-7), teaches a composition comprising cupric diethyldithiocarbamate (CuDETC, i.e., Cu-DDC) and a method for treating: i0 cancer cell lines; and ii) mice model of tumors. Therefore, claim 24 is anticipated by Kennedy.
Conclusions
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
1) Cvec et al (J. Med. Chem., 2008, 51, 6256-6258), teaches composition comprising Cu-DDC and Cu-DDC activity against breast cancer cells (see, e.g., abstract and Table 1).
2) Skrott et al (Mini-Reviews. Med. Chem., 2012, 12(12), 1184-1192), teaches composition comprising Cu-DDC and Cu-DDC activity against cancer cells (see, e.g., abstract and Figure 1).
No claim is allowable.
If Applicants should amend the claims, a complete and responsive reply will clearly identify where support can be found in the disclosure for each amendment. Applicants should point to the page and line numbers of the application corresponding to each amendment, and provide any statements that might help to identify support for the claimed invention (e.g., if the amendment is not supported in ipsis verbis, clarification on the record may be helpful). Should the Applicants present new claims, Applicants should clearly identify where support can be found in the disclosure.
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
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
Prosecution Insights