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 .
Priority
The instant application is a Continuation of earlier application 16/345,948 filed 29 April 2019, which is a National Stage entry of International application PCT/KR2017/011961 filed 27 October 2017.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55 relating to Korean national applications 10-2017-0138990 filed 25 October 2017, and 10-2016-0143368 filed 31 October 2016 in the parent ‘948 application.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—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 4, 5, 7-9, 11, and 13 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, each of the above-referenced claims recites the inclusion of “one or two or more” of the additional percutaneous absorption formulation components recited. It is unclear from the language of these claims which term, “one,” or “two” or “more than two” controls. The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Applicants are advised that amending the claims to reflect the inclusion of, for example, “at least one of” each of the designated percutaneous absorption formulation components recited, should applicants’ disclosure as originally filed support such language, would likely serve to address the instant rejection.
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 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.
Claims 1, 10, 15, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 105232497 (of record in parent ‘948 application).
Applicants claims are directed to percutaneous absorption formulations comprising a melatonin-containing polymeric adhesive layer, a support layer, and a release layer. Dependent Claims 2-9 specify including in the polymeric adhesive layer particular additional agents, specifically defined solubilizing agents, crystallization inhibitors, absorption enhancers, and antioxidants. Claims 10-13 specify further limitations on the identity of the polymeric adhesive. Claim 14 includes defined quantities of tackifying resin and plasticizer, while Claims 15 and 16 place further limitations on the identity of the support and release layers, respectively.
The ‘497 document describes melatonin transdermal delivery systems comprising three layers; a lining, reservoir layer, and a release layer. (Pg.2). the lining, corresponding to the instantly claimed “support layer” is made from, for example, the polyethylene recited by Claim 15. (Id.). The release layer is described as being represented by a polyester film with a silica gel or fluorosilicone coating, as is recited by Claim 16. (Pg.3). The reservoir matrix is described as an acrylate based pressure sensitive adhesive as is recited by Claim 10. (Pg. 2).
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 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (U.S. 5,505,956), in view of Paul (U.S. PGPub. 2006/0173124) as evidenced by “Melatonin Product Information” (Cayman Chemical)(of record), and Wold (U.S. PGPub. 2007/0269522).
Kim describes devices for the percutaneous administration of a drug containing an oil-soluble drug, adhesive, penetration enhancer, and a liner. (Abs.). More particularly, the adhesive portion of the device combines a support, the adhesive portion, and a separate liner. (Col.4, L.53-55). The backing layer is described as including the polyethylene terephthalate of instant Claim 15. (Co.5, L.56-63). Kim indicates that the liner portion of the device may also be made from polymers such as PET, but specifies that the release portion is treated with a silicone of fluoro-type releasing agent per the requirements of Claim 16. (Col.5, L.44-47). The adhesive portion of the device is described as including rubbers and acrylic polymers including a variety of acrylate monomers, optionally functionalized monomers which incorporate any of carboxyl or hydroxyl-containing monomers, as well as portions containing vinyl acetate, addressing the limitations of Claims 10-12. (Col.5, L.48 – Col.6, L.22). Particular rubbers recited for use in the adhesive portion of the device include the polyisobutylene of Claim 13. (Col.6, L.23-32). Tackifying resins and plasticizers are also recited by Kim as optionally includable elements, addressing limitations of Claim 14. (Col.7, L1-4; 35). Penetration enhancers including the oleic acid of Claims 6-8 are recited as usefully included in the percutaneous drug delivery devices, preferably in amounts of between 1-20% by weight. (Col.7, L.5-20). Antioxidants such as the BHT, Tocopherol, and tocopherol acetate of Claim 9 are recited as components usefully includable in the devices Kim describes. (Col.7, L.35-41). Kim indicates that the dugs to be included in the devices described are oil-soluble, preferably in amounts of between 0.1-40% by weight. Polyvinylpyrrolidone recited as a crystallization inhibitor by Claim 5 is also recited as a component usefully incorporated into the adhesive in amounts of between 0-10% by weight. (Col.7, L.42-50).
Kim therefore describes percutaneous drug delivery formulations incorporating oil-soluble drugs in an adhesive reservoir containing combinations of functionalized acrylate and vinyl acetate polymers and polyisobutylene rubbers, which also contains components identified as tackifying agents, plasticizers, penetration enhancers, antioxidants, and crystallization inhibitors of the instant claims, mounted on a polyethylene backing and having a silica or fluorine-coated polymeric release liner attached. While many of the components are recited as being includable in amounts overlapping and therefore rendering obvious the concentrations recited by the instant claims, In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003), Kim is silent as to the amounts of tackifying agents, plasticizers, antioxidants, and even the adhesive agent itself includable in such compositions. However, Kim does indicate that each of these components are included in order to incorporate into these compositions the properties each is described as contributing to the composition as a whole. A person of ordinary skill in the art would reasonably have expected that the amounts of each are result-effective variables that achieve the results each of the components referred to provide. As such, it would have been routine to optimize the amounts of these components within the total composition suggested by Kim, rendering the concentrations of agents, plasticizers, antioxidants, and adhesive agent recited by Claim 3 and 14 obvious thereby, in the absence of evidence tending to establish the criticality of the ranges claimed. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where 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.).
Despite the breadth of teachings conveyed by Kim, Melatonin is not recited as an exemplary drug to be included in such percutaneous delivery devices, nor is a solubilizing agent as recited by Claim 4 described.
These shortcomings are addressed by the teachings of Paul and Wold.
Paul also describes percutaneous drug delivery devices utilizing acrylate copolymers as pressure-sensitive adhesives (PSA). [0002; 0006; 0008]. These PSA compositions are also described as advantageously including any of a variety of additional components; tackifiers in amounts of more than 30% [0029-30], plasticizers in amounts of up to 50% [0032], antioxidants in amounts of up to 3% [0035], and drugs including melatonin [0052], which a skilled artisan would understand is an oil-soluble drug fitting into the category of drugs includable in the compositions of Kim. See “Melatonin Product Information” (“melatonin is soluble in organic solvents…[and] sparingly soluble in aqueous buffers…).
Wold indicates that the propylene glycol of Claim 4 is understood to behave as a permeation enhancing agent when included in transdermal drug delivery devices. [0020].
It would have been prima facie obvious to have combined acrylate or acrylate/vinyl acetate and polyisobutylene rubber adhesives with melatonin, propylene glycol, PVP, oleic acid, BHT, tackifying resin, and a plasticizer, mounted such a composition on a polyethylene backing sheet, and applied a silica- or fluorosilica coated polymer release liner to provide the percutaneous formulations of the instant claims. One having ordinary skill in the art would have been motivated to do so because the art teaches that each of the claimed elements is independently understood to provide utility in formulating transdermal drug delivery devices. KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)) (“[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.”). Here, the record fails to demonstrate anything unexpected is obtained by combining the components individually taught by the art as usefully incorporated into transdermal drug delivery systems, and the claims are obvious as a result.
Conclusion
No Claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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