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 .
Detailed Action
Restriction/Election
Applicant’s election without traverse of Group I, claims 1-2, 4-5, 13-15, 17 and 21 in the reply filed on 03/26/26 is acknowledged. Applicant’s election of the following species is also acknowledged: 1. Betrixaban as Factor Xa inhibitor, 2. Dabigatran as Factor Ila inhibitor acting as a thrombin inhibitor, 3. Atopaxar as a Factor lla inhibitor acting as a thrombin receptor antagonist, 4. Prasugrel as a P2Y12 receptor antagonist, and 5. Verapamil as the Pgp inhibitor.
Claims 8-10, 18-20 and 22-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/election, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/26/26.
Claim Rejections - 35 USC § 112, indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
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, 4-5, 14, 15 and 17 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. Regarding claims 2, 14-15 and 17, the phrase "preferably" and “in particular” render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 4-5 contains the trademark/trade name Xarelto, Lixiana, Eliquis, Exanta, Pradaxa and argatra. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe active ingredients which act as Xa inhibitor with specific IUPAC names and, accordingly, the identification/description is indefinite.
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, 4, 11 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gulba et al. (Gulba Dietrich: "Evaluation of the Results of the Interim analysis of the Proof of Principle Study: Efficacy assessment of a mixture of four different ingredients against wild born Norway rats", European Patent Register: all documents EP3154343/EP15729428.1, 1 December 2020 (2020-12-01), pages 1-3, presented in IDS).
Gulba et al. discloses a composition for controlling harmful rodents, in particular rats, comprising betrixaban maleate (factor Xa inhibitor as claimed), prasugrel (thrombocyte aggregation inhibitor), acetylsalicylic acid (thrombocyte aggregation inhibitor) and ketoconazole (P-glycoprotein inhibitor). Gulba et al. discloses a composition containing betrixaban maleate (factor Xa inhibitor), prasugrel (thrombocyte aggregation inhibitor), acetylsalicylic acid (thrombocyte aggregation inhibitor) and ketoconazole (P-glycoprotein inhibitor). It was formulated as a bait and fed to brown rats (Rattus norvegicus). A mortality rate of 30% was observed (the entire document).
Claims 1-2, 4, 11, 13, 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sinha et al. (US PG Pub. 2008/0254036 A1).
Sinha et al. discloses compositions containing betrixaban (Xa inhibitor) and acetylsalicylic acid (claims 37 and 40) (IIa inhibitor). Also disclosed are compositions containing betrixaban and verapamil, diltiazem OT amiodarone (paragraphs [0112]-[0114] and [0116]-[0118]; claims 41 and 43).
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.
Claims 1-2, 4, 13 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Gulba et al. (Gulba Dietrich: "Evaluation of the Results of the Interim analysis of the Proof of Principle Study: Efficacy assessment of a mixture of four different ingredients against wild born Norway rats", European Patent Register: all documents EP3154343/EP15729428.1, 1 December 2020 (2020-12-01), pages 1-3) in view of Greiner Christine et al. ("Teil 7: P-Glykoprotein -Bedeutung für den Arzneistoffmetabolismus", Lexikon der Pharmakologie - Interaktionslexikon: Neurotransmitter, 1 September 2010 (2010-09-01), pages 40-42, presented in IDS).
Gulba et al. discloses a composition for controlling harmful rodents, in particular rats, comprising betrixaban maleate (factor Xa inhibitor as claimed), prasugrel (thrombocyte aggregation inhibitor), acetylsalicylic acid (thrombocyte aggregation inhibitor) and ketoconazole (P-glycoprotein inhibitor). Gulba et al. discloses a composition containing betrixaban maleate (factor Xa inhibitor), prasugrel (thrombocyte aggregation inhibitor), acetylsalicylic acid (thrombocyte aggregation inhibitor) and ketoconazole (P-glycoprotein inhibitor). It was formulated as a bait and fed to brown rats (Rattus norvegicus). A mortality rate of 30% was observed (the entire document). Gulba is considered to be the prior art closest to the subject matter of claim 1. It discloses a composition for controlling harmful rodents, characterized in that the composition comprises: a) a factor Xa inhibitor and b) a P-glycoprotein inhibitor, and additionally characterized in that the composition additionally comprises thrombocyte aggregation inhibitors from the group of cyclooxygenase inhibitors and P2Y12 receptor antagonists.
Gulba et al. does not disclose a composition containing a P-glycoprotein inhibitor as claimed/elected, verapamil of claim 2.
Greiner et al. discloses P-glycoprotein inhibitors, such as amiodarone, quinidine, propafenone, verapamil, erythromycin, clarithromycin, ketoconazole, itraconazole or ritonavir (table 1). P-glycoprotein, which acts as a transport protein, is of great importance in detoxifying active pharmaceutical ingredients. P-glycoprotein can have a considerable influence on the bioavailability of active ingredients. The bioavailability of an active ingredient is increased if a P-glycoprotein inhibitor is added to it at the same time. P-glycoprotein is also of great importance for the formation of the blood-brain barrier. If a P-glycoprotein inhibitor is dosed, it is possible in particular for lipophilic active ingredients to also reach the brain (page 40, column 1, line 1 – page 41, column 1, line 19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized verapamil as taught by Greiner et al.
One of ordinary skill would have been motivated to do so because Greiner et al. teaches that P-glycoprotein, which acts as a transport protein, is of great importance in detoxifying active pharmaceutical ingredients. P-glycoprotein can have a considerable influence on the bioavailability of active ingredients. The bioavailability of an active ingredient is increased if a P-glycoprotein inhibitor is added to it at the same time. P-glycoprotein is also of great importance for the formation of the blood-brain barrier.
Claims 5, 14-15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Gulba et al. (Gulba Dietrich: "Evaluation of the Results of the Interim analysis of the Proof of Principle Study: Efficacy assessment of a mixture of four different ingredients against wild born Norway rats", European Patent Register: all documents EP3154343/EP15729428.1, 1 December 2020 (2020-12-01), pages 1-3, presented in IDS) in view of Gulba et al. (WO 2015/189331 A1, ‘331, presented in IDS)
Gulba et al. as discussed above do not teach use of at least one factor (thrombin inhibitor), Debigatran and the amounts of the components.
Gulba et al. ‘331 proposes the possibility of using compounds from the classes thrombin inhibitors, thrombin receptor antagonists, factor Xa inhibitors, plasminogen activator inhibitor inhibitors, P2Y12 receptor antagonists and GPIIb/IIIa receptor antagonists as a rodenticide. It is intended that the compounds can be combined in a bait for harmful rodents (paragraphs [0078]-[0083]; claims 1 and 9). Gulba teaches that a benzimidazole derivative with a benzamidine group according to WO 1998/37075 is dabigatran, a competitive, reversible and direct thrombin inhibitor. A prodrug, Dabigatranetexilat (Pradaxa®), which is converted into dabigatran in vivo, is described in more detail in International Patent Application WO 03/074056. Dabigatran is approved in the EU for the prevention of the formation of blood clots in the veins after elective knee or hip replacement surgery, as well as for stroke prevention in patients with atrial fibrillation and stroke risk. Its most common adverse drug reaction (side effect) in humans is gastrointestinal bleeding, see [129].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized dabigatran as taught by Gulba ‘331 into the rodenticide composition of Gulba et al. One of ordinary skill would have been motivated to do so because Gulba teaches that the possibility of using compounds from the classes thrombin inhibitors, thrombin receptor antagonists, factor Xa inhibitors, plasminogen activator inhibitor inhibitors, P2Y12 receptor antagonists and GPIIb/IIIa receptor antagonists as a rodenticide. It is intended that the compounds can be combined in a bait for harmful rodents (paragraphs [0078]-[0083]; claims 1 and 9). And Gulba characterizes Debigatran as thrombin inhibitor. Manipulation of the amounts would be within skill of an artisan by performing experimental manipulations.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SNIGDHA MAEWALL whose telephone number is (571)272-6197. The examiner can normally be reached Monday thru Friday; 8:30 AM to 5PM.
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612
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