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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/1/2026 and 9/12/2024 was considered by the examiner.
Allowable Subject Matter
Claim 72 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 72 is considered allowable as administration of apixaban is counter-indicated prior to surgery due to increased risk of bleeding (see Thrombosis Canada).
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 56-71 and 73-76 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2020/00338012; of record) in view of Gabriele et al. (US 2019/0142738).
Lee teaches transdermal apixaban delivery systems.
Lee’s delivery system comprises apixaban in an amount of between 2-15% (see [0034]; see instant claims 56, 62, 63, 65, 70), permeation enhancers, such as lactic acid and linoleic acid (a C-20 fatty acid), in an amount of 5-10% (see [0162, 0173, 0219] and Example 6.3; see instant claims 56, 60, 62, 63, 65, 66, 70), a flux improving agent such as crosslinked polvinylpyrrolidone (crosspovidone) in an amount of 20% (see [0193, 0194]; see instant claims 57 and 58), preservatives such as phenoxyethanol (i.e. 2-phenoxyethanol, a ‘glycol ether’) (see [0280]; see instant claims 56, 61), an adhesive comprising a mixture of acrylate-based adhesives and silicone in a ratio of 5:1 to 1:5 wherein the adhesive is present in amount of 20-25% (or more) (see [0153]; see instant claims 56, 62-64, 67, 70). The composition may additionally comprise an antioxidant (see [0053; see instant claim 64).
Although Lee does not teach their % values being “after the removal of any volatiles”, this is considered a property of Lee as Lee’s composition is generally silent to any volatiles and so as Lee’s compositions is not taught as containing volatiles, or large quantities thereof, and so it would be reasonable to conclude that the % values in Lee’s teaching would overlap with those presently claimed.
The transdermal system is to comprise a backing layer (see [0009, 0013]; see instant claims 68 and 69).
Methods of using the apixaban transdermal delivery system includes treating and/or reducing the risk of deep vein thrombosis and embolism (e.g. thromboembolism) wherein the patient population is afflicted with atrial fibrillation (see [0089]; see instant claims 71, 73, 75). In some embodiments, the patient has undergone surgery (see [0089]; see instant claim 74). The type of surgery is not considered critical absent some showing evidence otherwise. Oral administration concurrent with the use of the transdermal system is contemplated (see [0262]; see instant claim 76). The method is to provide blood concentration levels which provide systemic drug effect (see [0249]).
Lee fails to teach glycol ether (2-phenoxyethanol) as being present in an amount of 5-35 wt%.
Gabriele is directed to transdermal formulations in the form of a patch. The transdermal composition is to contain a preservative such as phenoxyethanol wherein the preservative is present in an amount of 5% (see [0108, 0110]; see instant claims 56, 61-64 and 70). It would have been obvious to modify Lee’s composition and method to include a preservative like phenoxyethanol in an amount of 5% as such an amount is known to prevent unwanted microbial growth in the transdermal delivery systems. See MPEP 2143(I)(A).
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/KYLE A PURDY/Primary Examiner, Art Unit 1611
Prosecution Insights