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 .
Applicants' arguments, filed 8/29/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103—Previous
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.
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.
Claim(s) 1 and 6-8 remain rejected under 35 U.S.C. 103 as being unpatentable over Nink et al., (WO 2012/084969, cited in IDS).
Nink et al. teaches a transdermal therapeutic system comprising rotigotine and an adhesive composition.
“The present invention relates to an adhesive composition containing a pressure sensitive adhesive (PSA) selected form the group consisting of styrene polymer, a polyisobutylene, or mixtures thereof, rotigotine or a pharmaceutically acceptable salt thereof as the active . . . and at least one crosslinked polyvinyl pyrrolidone or at least one copolymer of viny pyrrolidone and vinyl acetate, or a mixture thereof” (Abstract).
The object of the transdermal therapeutic system (TTS) of Nink et al. is “to provide an adhesive composition and a transdermal system containing the adhesive composition which has a high adhesive strength against patient’s skin” and “to increase the skin permeation rate of the active ingredient in order to improve systemic availability and, consequently, the effectiveness and safety of the TTS” (p. 3, lines 20-28).
The transdermal therapeutic system comprises “at least one adhesive layer made of the adhesive composition”, and “a backing layer” (p. 4, lines 30-34).
The adhesive composition further comprises “one or more penetration and/or permeation enhancer(s)” (p. 14, lines 31-32), including “lauryl alcohol” (aliphatic alcohol) (p. 15, line 18), which may be present “in an amount of 1 to 15% by weight” (p. 16, lines 1-5), as per claim 2, and “one or more tackifier” (p. 17, lines 10-11), including “alicyclic petroleum hydrocarbon resins and the hydrogenated derivatives thereof” (p. 17, lines 30-31), which may be present “in an amount of 10 to 70% by weight” (p. 18, lines 13-16), as per claim 4.
“Preferred penetration/permeation enhancers are alkyl fatty acid esters of saturated and/or unsaturated fatty acids, each containing from 8-18 carbon atoms or long chain (C10 to C30) aliphatic alcohols. Particularly preferred is octyldodecanol, most preferred 2-ecyldodecanol” (p. 15, lines 32-34).
The reference teaches a specific embodiment comprising 9% Rotigotine, 20% Crospovidone, 5% Octyldodecanol, 0.05% alpha Tocopherol, 0.001% sodium metabisufite, 0.02% Ascorbylpalmitate, 65.93% Durotak® 87-608 (PSA) (p. 29, Example 3). Here, the prior art anticipates the combination of Rotigotine and octyldodecanol in a transdermal patch.
Accordingly, it would have been obvious for the transdermal therapeutic system of Nink et al. to comprise a backing layer and an adhesive layer comprising rotigotine, an alicyclic saturated hydrocarbon resin, and an aliphatic alcohol such as octyldodecanol or lauryl alcohol, as claimed.
The rotigotine of Nink et al. may be present “in an amount of 1 to 30 % by weight” (p. 7, lines 15-18), as per claim 3.
The styrene polymer includes A-B-A triblock copolymers selected from “styrene-isoprene-styrene (SIS)” (styrene-based thermoplastic elastomer) (p.9, lines 32-34), which may be present “from 1 to 95 wt%” (p. 10, lines 10-12), as per claims 1 and 6.
The compositions further comprise a “plasticizer” (p. 16, lines 9-11), which may be present “in an amount of less than 60 wt.%, preferably 15 to 50 % by weight” (p. 17, lines 4-6), as per claims 7-8.
The prior art is not anticipatory insofar as it does not require the combination of aliphatic alcohol with the alicyclic saturated hydrocarbon resin; however, their selection would have been obvious given their plain enumeration in the prior art.
Response to Arguments
Applicant argues, “the addition of terpene-based resin and hydrogenated rosin ester instead of the alicyclic saturated hydrocarbon resin resulted in lower skin permeation of rotigotine” while “Nink merely exemplifies a large number of components including the tackifier and the penetration/permeation enhancers as examples of additives that the adhesive composition may further contain” (p. 5, sec. 3). Applicant further argues, “Nink does not teach or suggest selecting the alicyclic saturated hydrocarbon resin from among the numerous compounds and the effects thereof” (Id.); consequently, “the Examiner’s position is based on improper hindsight reasoning” (Id. at p. 6).
However, it is well settled that it is obvious for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as the prior art teaches that the selection will result in the disclosed effect. See Merck & Co., v. Biocrafi Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) ("That the '813 patent discloses a multitude of effective combinations does not render any particular formulation less obvious."); See also In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985) (affirming obviousness rejection of claims in light of prior art teaching that "hydrated zeolites will work" in detergent formulations, even though "the inventors selected the zeolites of the claims from among 'thousands' of compounds").
In this case, applicant has claimed a combination of components, disclosed in Nink et al., for the purpose of transdermal administration of rotigotine to a patient. In disclosing the claimed components, Nink et al. intended to provide a combination that also transdermally administers rotigotine to a patient. Again, the object of the transdermal therapeutic system (TTS) of Nink et al. is “to provide an adhesive composition and a transdermal system containing the adhesive composition which has a high adhesive strength against patient’s skin” and “to increase the skin permeation rate of the active ingredient in order to improve systemic availability and, consequently, the effectiveness and safety of the TTS” (p. 3, lines 20-28).
Applicant utilizes the same compounds in the same context for the same reason.
It is well settled, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect. . . . the combination is obvious" (MPEP 2141). KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Skraida v. A.G.Pro, 425 U.S. 273, 283 (1976)).
It was within the scope of the Nink et al. to provide styrene block copolymer at a concentration of 15.4%, as shown in Table 1, insofar as Nink et al. teaches a concentration range of “from 1 to 95 wt%, preferably 5 to 55 wt.%” (p. 10, lines 10-12), for styrene block copolymers. It was also within the scope of Nink et al. to provide rotigatone patches with a strong adhesive force insofar as Nink et al. teaches, “an adhesive composition and a transdermal system containing the adhesive composition which has a high adhesive strength against patient’s skin” (p. 3, lines 20-28).
Established precedent holds, “[W]here 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" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)). see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.");
It would have been obvious for the artisan to determine where in a disclosed set of percentage ranges of adhesive is optimal for providing a high adhesive strength against a patient’s skin.
Applicant’s discovery of limiting the styrene-based thermoplastic elastomer to a content of 5 to 30%, which is close to the prior art preferred range of 5 to 55 wt.%, is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Again, improving permeation of rotigotine is within the scope of Nink et al. and deemed merely a matter of judicious selection and routine optimization insofar as Nink et al. teaches alicyclic saturated hydrocarbon resins and an objective “to increase the skin permeation rate of the active ingredient in order to improve systemic availability and, consequently, the effectiveness and safety of the TTS” (p. 3, lines 20-28).
Technological Background
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure Wang et al., (AAPS PharmSciTech 2012). Wang et al. is pertinent for teaching the use of styrene-isoprene-styrene (SIS) thermoplastic elastomer in pressure-sensitive (PSA) patches (abstract).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Frederick F. Krass can be reached (571) 272-0580. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/WALTER E WEBB/ Primary Examiner, Art Unit 1612