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 1-8, 10, 11, and 14-20 are pending. Acknowledgment is made of the amendment of claims 1-8, 10, 11, and 14-20, and the cancellation of claims 9, 12, and 13, in the reply filed 12/15/2025. Claims 3-6 are withdrawn as being directed to a non-elected invention.
Restriction Requirement
Applicant elected, without traverse, Group I, drawn to methods of preventing or treating addiction comprising administering imatinib with an addictive substance, in the reply filed on 05/13/2025.
Claims 3-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/13/2025.
Withdrawn Objections/Rejections
Applicant’s amendments, filed 12/15/2025, overcome the objection to the specification and claims 1, 2, 9, 10, 13, 16, 19, and 20 for minor informalities. The objection to the specification and claims 1, 2, 9, 10, 13, 16, 19, and 20 has been withdrawn.
Applicant’s amendment to the claims, filed 12/15/2025, overcomes the rejection of claims 1, 2, and 7-20 under 35 U.S.C. 112(a) for scope of enablement. The rejection of claims 1, 2, and 7-20 has been withdrawn.
Applicant’s amendment to the claims, filed 12/15/2025, overcomes the rejection of claims 1, 2, and 7-20 under 35 U.S.C. 112(b) for indefiniteness. The rejection of claims 1, 2, and 7-20 has been withdrawn.
Applicant’s amendment to the claims, filed 12/15/2025, overcomes the rejection of claims 1, 2, 7, 8, 10, and 14-20 under 35 U.S.C. 102(a)(1) and 103 as being anticipated by or unpatentable over Gutstein (WO 2009048947 A1). The prior art does not teach or suggest the ratio of imatinib to addictive analgesic agent that is required by the newly amended claims. The rejection of claims 1, 2, 7, 8, 10, and 14-20 has been withdrawn.
Applicant’s amendment to the claims, filed 12/15/2025, overcomes the rejection of claims 11-13 under 35 U.S.C. 103 as being unpatentable over Gutstein (WO 2009048947 A1) further in view of Hoffman et al. (WO 2006037418 A1). For the reasons discussed above, the prior art does not teach or suggest the limitations of the newly amended claims. The rejection of claims 11-13 has been withdrawn.
New Objections
Necessitated by Claim Amendment
Claim 1 is objected to because of the following informalities:
Claim 1 reads “…an addictive substance or an addictive analgesic agent; wherein the addictive substance comprises: cocaine, morphine, nicotine, or ethanol”. For clarity, this should read “…an addictive substance or an addictive analgesic agent; wherein the addictive substance comprises: cocaine, nicotine, or ethanol; and wherein the addictive analgesic agent comprises morphine”.
Appropriate correction is required.
New Rejections
Necessitated by Claim Amendment
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, 7, 8, 10, and 11 are rejected under 35 U.S.C. 101 because the disclosed invention is inoperative and therefore lacks utility.
Claim 1 reads “…wherein a ratio of a dose of the addictive substance in the composition to a dose of the addictive substance is 1:3 or less,…” (emphasis added). It is not possible to have a ratio of something compared to itself of “1:3 or less”. Therefore, the method is inoperable. Claims 2, 7, 8, 10, and 11 are rejected as being dependent upon claim 1 and failing to clarify this issue.
For the sake of compact prosecution, the claim will be interpreted as “…wherein a ratio of a dose of the addictive substance in the composition to a dose of imatinib or imatinib mesylate is 1:3 or less,…”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2, 8, and 17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 requires that the composition comprises imatinib or imatinib mesylate and the addictive substance. However, claim 1 requires that the composition comprises imatinib or imatinib mesylate and an addictive agent, wherein the addictive agent is cocaine, morphine, nicotine, or ethanol. Therefore, claim 2 fails to further limit the subject matter of the claim upon which it depends.
Claim 8 requires that the ratio of imatinib or imatinib mesylate to ethanol is 1:50, and the ratio of imatinib or imatinib mesylate to nicotine is 40:1. However, claim 1 requires that the ratio of a dose of imatinib or imatinib mesylate to a dose of the addictive substance is 3:1 or more (see rejection under 35 U.S.C. 101). Therefore, the ratio of imatinib or imatinib mesylate to ethanol in claim 8 is not 3:1 or more, and does not include all the limitation of the claim upon which it depends.
Claim 17 teaches that the addictive agent is selected from “morphine, codeine, pethidine, fentanyl, methadone, oxycodone, hydromorphone, nalbuphine, and marijuana”. However, claim 1 requires that the addictive substance is “cocaine, morphine, nicotine, or ethanol”. Therefore, claim 17 does not limit the scope of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1, 2, 8, 10, 14, 15, and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (CN 106074555 A), hereinafter referred to as reference ‘555.
Reference ‘555 teaches, in the Experimental Method, a method of treating morphine addiction comprising administering 100 mg/kg imatinib and 10 mg/kg morphine with an injection, as in instant claims 1, 2, 8, 10, 14, 15, and 17-20. The method is taught in claim 4 to be used to treat both morphine and cocaine addiction.
Regarding the treatment of pain taught in instant claims 14-20, "treating pain" will inevitably flow from the teachings of the prior art, since the same composition (imatinib or imatinib mesylate and morphine) is being administered to the same subjects (a subject suffering from pain and morphine addiction). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (CN 106074555 A), hereinafter referred to as reference ‘555, as applied to claims 1, 2, 8, 10, 14, 15, and 17-20 above.
Reference ‘555 fails to teach a method where imatinib is administered in 100-400 mg/day.
The prior art teaches a method of treating morphine addiction comprising administering 100 mg/kg imatinib and 10 mg/kg morphine. MPEP 2144.05 II, which discusses routine optimization, states: “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. "[W]here 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, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.")”.
Therefore, since the prior art teaches the composition and methods of the instant claims, and shows results that the methods are successful in treating morphine addiction, it would be obvious to one of ordinary skill in the art to determine, through routine experimentation, the effective dose of said composition in humans.
Conclusion
Claims 1, 2, 7, 8, 10, 11, and 14-20 are rejected.
THIS ACTION IS MADE FINAL. 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 RILLA M SAMSELL whose telephone number is (703)756-5841. The examiner can normally be reached Monday-Friday, 9-5.
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/R.M.S./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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