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 .
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 2-6 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Atkinson (US2009/0203727).
Atkinson discloses a pharmaceutical composition comprising EDTA and magnesium stearate (claim 9).
Note, with regards to claim 3, where the composition disclosed in the prior art meets the components instantly claimed, the functional property of the composition would be inherent based on the activity of the components, whether recognized at the time or not. MPEP 2112(I) and (II).
Claims 2-5, 7, and 8 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Koller (US 8,980,243).
Koller discloses a composition of EDTA and benzalkonium chloride (synonym for benzyldimethyltetradecylammonium chloride) (claim 1).
Note, with regards to claim 3, where the composition disclosed in the prior art meets the components instantly claimed, the functional property of the composition would be inherent based on the activity of the components, whether recognized at the time or not. MPEP 2112(I) and (II).
Claims 2-5, 7, and 9 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Marc (US20090215052).
Marc discloses a pharmaceutical composition comprising EDTA and PEI (claim 1).
Note, with regards to claim 3, where the composition disclosed in the prior art meets the components instantly claimed, the functional property of the composition would be inherent based on the activity of the components, whether recognized at the time or not. MPEP 2112(I) and (II).
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 2-5 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Banfi et al (Clin Chem Lab Med 2007;45(5):565–576) in view of Weitz et al (N Engl J Med 2021;385:2161-2172).
Banfi et al teaches the use of EDTA for treatment of venous and arterial thromboembolism.
Weitz et al teaches factor Xia inhibitors, such as milvexian, are used for prevention and treatment of venous and arterial thromboembolism (abstract).
It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. MPEP 2144.06. Here, the actives are all taught to treat thromboembolism, therefore it would have been obvious to combine them to produce a combined formulation.
Note, with regards to claim 3, where the composition disclosed in the prior art meets the components instantly claimed, the functional property of the composition would be inherent based on the activity of the components, whether recognized at the time or not. MPEP 2112(I) and (II).
Claims 2-5 and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kauffmann (US 20190151851)
Kauffmann teaches compositions comprising combinations which include EDTA, argatroban, apixaban, and rivaroxaban (claim 2).
It would have been obvious to select from among the agents listed where the list includes combinations.
Note, with regards to claim 3, where the composition disclosed in the prior art meets the components instantly claimed, the functional property of the composition would be inherent based on the activity of the components, whether recognized at the time or not. MPEP 2112(I) and (II).
Claims 2-5 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Banfi et al (Clin Chem Lab Med 2007;45(5):565–576) in view of Vazquez et al (Ann Pharmacother. 2008 July ; 42(7): 1118–1123. doi:10.1345/aph.1L077).
Banfi et al teaches the use of EDTA for treatment of venous and arterial thromboembolism.
Vazquez et al teaches stents comprising sirolimus of thromboembolism (abstract).
It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. MPEP 2144.06. Here, the actives are all taught to treat thromboembolism, therefore it would have been obvious to combine them to produce a combined formulation.
Note, with regards to claim 3, where the composition disclosed in the prior art meets the components instantly claimed, the functional property of the composition would be inherent based on the activity of the components, whether recognized at the time or not. MPEP 2112(I) and (II).
Claims 2-5, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Banfi et al (Clin Chem Lab Med 2007;45(5):565–576) in view of Suri (US 20170051059)
Banfi et al teaches the use of EDTA for treatment of venous and arterial thromboembolism.
Suri teaches conventional therapy for thromboembolism. includes administration of mycophenolate (¶ 8 and claim 18).
It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. MPEP 2144.06. Here, the actives are all taught to treat thromboembolism, therefore it would have been obvious to combine them to produce a combined formulation.
Note, with regards to claim 3, where the composition disclosed in the prior art meets the components instantly claimed, the functional property of the composition would be inherent based on the activity of the components, whether recognized at the time or not. MPEP 2112(I) and (II).
Claims 2-36 are rejected under 35 U.S.C. 103 as being unpatentable over (US2009/0203727) in view of Banfi et al (Clin Chem Lab Med 2007;45(5):565–576) in view of (US20090215052), Weitz et al (N Engl J Med 2021;385:2161-2172), (US 20190151851), Vazquez et al (Ann Pharmacother. 2008 July ; 42(7): 1118–1123. doi:10.1345/aph.1L077), and (US 20170051059).
The references are all discussed above, but do not teach combining all the actives, vary the rate of anticoagulant to chelating agent, of applying the agents onto an implantable scaffold for the vascular lumen.
It would have been obvious to combine the actives of the various references for treatment of thromboembolism.
Further, when combining the actives, it would have been obvious to optimize the release rate of the actives in order to provide the desired pharmacokinetic properties of the administration.
Finally, it would have been obvious use an implantable scaffold for the composition given the need to treat thromboembolism occurs in the vascular system and a stent is a common means for delivering actives to the vascular system.
Note, with regards to claim 3, where the composition disclosed in the prior art meets the components instantly claimed, the functional property of the composition would be inherent based on the activity of the components, whether recognized at the time or not. MPEP 2112(I) and (II).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri (9am-6pm + mid-day flex).
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612