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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/6/26 has been entered.
Claims 20, 22-34, 37-40, 42, 44-46, and 48-53 are pending. Claims 26, 29-34, 38, 40, 42 and 52 have been withdrawn. Claims 20 and 44 have been amended. Claim 53 is new. Claims 20, 22-25, 27, 28, 37, 39, 44-46, 48-51 and 53 are under consideration
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
Election/Restrictions
Applicant’s election without traverse of the Invention of Group II, claims 20-28 drawn to a patch for delivering an agent; and the species of:
a. solubilizer cyclodextrin as a species of the one or more excipients;
b. aripiprazole as the permeant (the patch recited in Claim 20 does not require a second permeant); and
c. one thin solid tablet;
in the reply filed on 12/30/24 is acknowledged.
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.
Claim 44 is 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 44 has been amended to depend from claim 53. Therefore, claim 44 does not reference a claim previously set forth. (see MPEP 608.01(n) III).
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 § 103
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 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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 20, 22-25, 27, 28, 37, 39, 44-46, 48-51 and 53 rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. (US 2015/0080353) in view of Wick et al. (US 5,662,926).
Singh et al. teach compositions and methods useful for the in vivo delivery of substantially water-insoluble drugs (e.g. abstract). Singh et al. teach that the drug may be aripiprazole (e.g. paragraph 0076; Claim 49). As evidenced by the instant Specification ad species election, aripiprazole has a water solubility of less than 10 mg/mL. Singh et al. teach that the active agent of the present invention may be combined with pharmaceutical carriers or excipients which may serve to improve the stability and/or dispersibility of the powder including cyclodextrins, such as 2-hydroxypropyl-β-cyclodextrin (e.g. paragraph 0137).
Singh et al. teach that the formulation may be in the form of a tablet or a transdermal device for absorption through the skin or mucous membranes (e.g. claim 51), but do not teach the specifics of the transdermal device. This is made up for by the teachings of Wick et al.
Wick et al. teach devices for the controlled release of an active agent to the skin or mucosa of a host are disclosed, which devices are laminates of a backing layer, a monolithic carrier layer (i.e. thin solid tablet) of an active ingredient selected from active agent, active agent enhancers and mixtures thereof, melt-blended with a thermoplastic matrix polymer capable of controllably releasing the active ingredient, wherein the active ingredient is heat stable at the melt temperature of the matrix polymer, together with means for affixing the laminate to the skin or mucosa of the host so that the active ingredient is continuously released from the carrier layer thereto (e.g. abstract). Wick et al. exemplify a drug carrier film of 10 cm2 in area and 242.3 mg of weight, which is equivalent to a density of approximately 24.23 mg/cm2, which is slightly below the claimed range of more than 30 mg/cm2 and less than 400 mg/cm2 (e.g. Example 1). Wick et al. exemplify drug carrier films of 9.6 mil (i.e. 0.24 mm), which is within the claimed range (e.g. Example 1). However, Wick et al. more broadly teach “the rate of permeation of the active agent through the rate-controlling polymer layer depends on factors such as the affinity of the active agent for the polymer layer, molecular size of the active agent, polymeric structure of the carrier layer and the thickness of the layer. Therefore, the appropriate rate-controlling polymeric material and its thickness depend on the active agent used and the desired rate of permeation. The selection of a polymer layer and its thickness provides a means, if desired, for controlling the dosage rate to the skin or mucosa (e.g. column 20, lines 48-57). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to vary the tablet thickness and density in order to achieve the desired rate of permeation.
Regarding Claims 20, 22, 37, 39, 44-46, 48 and 53, it would have been obvious to one of ordinary skill in the art at the time of filing to select the transdermal patch of Wick et al. for use with the drug formulation of Singh et al. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success because Singh et al. suggest the form of transdermal delivery device and one would have been motivated to seek out an appropriate transdermal patch, as in Wick et al.
Regarding Claim 23, Wick et al. teach the inclusion of a backing layer and a release liner layer (e.g. Claim 1; Example 1).
Regarding Claim 24, Wick et al. further teach the inclusion of a rate-controlling polymer layer between the carrier layer and the host’s skin (e.g. column 2, lines 20-62).
Regarding Claims 25, 27, and 28, Wick et al. further teach a spacer layer between the backing layer and the release liner layer, the spacer layer being laterally adjacent to the carrier layer and configured to maintain a separation distance between the backing layer and the release liner layer (e.g. Figures 8-12), wherein the separation distance appears to be in the range of about 50% to about 150% of the thickness of the thin solid tablet.
Regarding Claims 49 and 50,. Wick et al. exemplify a drug carrier film of 10 cm2 (e.g. paragraph 0154).
Regarding Claim 51, Wick et al. exemplify a drug carrier film of 10 cm2, which is above the claimed range (e.g. Example 1). However, Wick et al. more broadly teach “the width (i.e., surface area) and thickness of the permeable adhesive layer for contact with the skin or mucosa is that width and thickness which provides sufficient permeability to the active agent or active agent enhancer and a suitable surface area to allow the dosage rate desired to the skin or mucosa. These widths and thicknesses are conventional in the art and therefore need not be discussed in detail here” (e.g. column 18, lines 10-18). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to vary the tablet size in order to achieve the desired rate of permeation and total drug delivered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 20, 22-25, 27, 28, 37, 39, 44-46, 48-51 and 53 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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/NICOLE P BABSON/Primary Examiner, Art Unit 1619