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 .
Withdrawn Rejections:
Applicant's amendments and arguments filed on 03/18/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claims 38, 40-45, 47-49, 58-60, 63-69 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/18/2026 is being considered by the examiner.
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 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.
Claims 38, 40-41, 45, 47-49 and 60 and 63-69 are rejected under 35 U.S.C. 103 as being unpatentable over Wright (US20040081685).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Wright teaches a titratable dosage transdermal delivery system for systemic delivery of a therapeutic agent or drug. The system comprises a plurality of patch units that are connected along one or more borders. The plurality of patch units are divisible into units along the one or more borders having one or more lines of separation. Each patch unit is surrounded by a border. The therapeutic patch has at least a backing layer and a therapeutic agent comprising layer (abstract). The system includes matrix type comprising backing layer, drug layer, adhesive layer; drug-reservoir type and drug-in-adhesive layer type ([0008-0017, 0028]). In another embodiment, the transdermal delivery system comprises a plurality of patch units connected along one or more borders. Each patch unit comprises: a backing layer having a top surface and a bottom surface; a drug and adhesive layer disposed on the top surface of the backing layer; and a cover layer disposed on the adhesive layer, wherein each patch unit is defined by one or more lines of separation on the border ([0011]). Furthermore, it is an object of the present invention to provide a method of making the transdermal delivery system which delivers a titratable dosage of drugs to a patient. The method comprises forming a backing layer with top and bottom surfaces, which backing layer is divided into more than one units at one or more lines of separation. A drug-in-adhesive layer is disposed on the top surface of each unit of the backing layer, leaving a border on all sides of the backing layer. A cover layer is disposed on top of the adhesive layer ([0015]). As seen from Fig. 1, the separation line extends through the backing layer (Fig. 1, [0025]).
The line of Separation may be formed by perforations or weaknesses created in the backing layer ([0030]). The adhesive includes acrylic adhesive and silicone pressure-sensitive adhesive ([0038]). The monolithic drug-in-adhesive patch design is characterized by the inclusion of the therapeutic agent formulation in the skin contacting adhesive layer forming the drug-in-adhesive layer 100, a backing layer 60 and preferably, a release liner (not shown). The adhesive releases the therapeutic agent and also adheres the patch to the skin. The drug-in-adhesive system does not require a separate adhesive layer and thus the patch thickness is minimized (e.g., U.S. Pat. No. 4,751,087). Therefore, drug-in-adhesive type patches are thin and comfortable. As illustrated in FIGS. 1 and 2, each unit of the transdermal system comprises one or more borders made of the backing layer surrounding a drug delivery zone 40. The drug-in-adhesive layer 100 does not cover the entire area of the unit of the patch but are confined at the drug delivery zone 40 as shown in FIGS. 1 and 2, leaving a border 30 surrounding the drug delivery zone 40. The border 30 is covered with an adhesive to further secure the unit of the therapeutic patch onto the skin. As in any patch designs, the plurality of therapeutic patches are divisible along the border. The border may be perforated to form a line of separation 50 which facilitates division of the therapeutic patches into one or more patch units comprising one or more doses of therapeutic agent or drug respectively ([0046]). Reservoir Type Transdermal System, in one embodiment, the drug delivery zone 40 is rectangular. Alternatively, the drug delivery zone 40 may be a variety of shapes, such as, but not limited to, oval, circular, elliptical, triangular, rectangular, hexagonal. In a preferred embodiment, the drug delivery zone 40 has the same shape and therefore concentric to a patch unit of the transdermal system ([0042-0043]). The applicable therapeutic agents which can be placed on the transdermal patch can be any therapeutic substances or drugs ([0050]). Additionally, in practicing this invention one can employ a wide variety of topically active drugs consistent with their known dosages and uses ([0052]). The lines of Separation may also be a weakness of the backing or a printed line of division So that a patient may tear along or use Scissors to cut along the line. A preferred line of Separation is a line of perforations. The weakness of the backing may be a thinning of the backing that is molded or formed in the backing. In Some instances, it may be desirable to combine a line of weakness with perforations to ensure clean Separation of the transdermal delivery System into a desired number of units for optimal dosage application ([0073]). A drug-in-matrix layer is formed by dissolving or suspending a therapeutic agent in a polymer matrix through which the active agent diffuses to the skin. Methods of forming a drug-in-matrix layer are disclosed in U.S. Pat. Nos. 4,839,174, 4,840,796, 4,908,213, and 4,943,435. When a drug-in-matrix layer is disposed on the top surface of each unit of the backing layer, the drug-in-matrix layer is not coextensive with the entire unit of the backing layer. A border is left on all sides so that the backing layer is not entirely covered by the drug-in-matrix layer. This is to prevent the drug from seeping through the lines of separation. Various methods may be used to place a drug on the transdermal delivery system as discussed infra. An adhesive layer is then disposed on the drug-in-matrix layer, the adhesive layer also covers the border of the backing layer. The border is preferably uniform in width and can range from about 0 (zero) cm to about 2.0 cm. A cover layer is disposed on the adhesive layer so that each patch unit of the transdermal delivery system is protected separately. A notch is formed on the cover layer so as to facilitate separation of the cover layer from the adhesive layer when the transdermal patch is ready for use ([0074]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Wright is that Wright is not specific enough for anticipation.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce the instant invention.
Regarding the shape of patch segment, Wright teaches patch unit (segments) with hexagonal shape in drug reservoir type system, since drug-in-adhesive is alternative to drug reservoir type system, it is obvious for one of ordinary skill in the art to have patch unit (segment) in hexagonal shape with drug-in-adhesive and produce instant claimed invention with reasonable expectation of success.
Regarding claims 38, 40-41, Wright teaches a patch system comprising a backing layer with plurality of patch units (segments) as hexagonal shape on the backing layer surface, each patch unit are separated by separation line, drug in adhesive in each patch units, and the separation line extends through backing layer, adhesive composition and the cover layer (reads on release liner).
Regarding claim 45, Wright teaches silicone adhesive.
Regarding claims 47-48, Wright teaches hexagonal shape of unit, that reads on regular hexagonal shape.
Regarding claim 49, it is matter of choice for one artisan in the art to have combination of different shape of unit including hexagonal.
Regarding claim 60, Wright teaches patch unit size of 2cm of width and length, and the area is 20mm x 20mm=400mm2.
Regarding claim 63, since the patch includes all the array of segments without gap, the area of the backing layer is equal to the area of the array of patch segments.
Regarding claim 64-67, Wright teaches line of Separation is a line of perforations or weakness (thinning portion) as well as combination of perforation and weakness (thinning portion), a tie (uncut portion) between two perforation is just style of choice within skill of one artisan. Two perforations connected by a weakness (thinning portion) is also encompassed by teaching of combination of perforation and weakness (thinning portion), since weakness (thinning portion) is uncut portion, it also meets the limitation of tie portion. Since tie portion and perforation is part of separation line, and since Wright teaches border line is from about 0 (zero) cm to about 2.0 cm, it is obvious to have length of tie or perforation between 0 to about 2.0 cm, encompassing claimed range of 0.125 mm to 1 mm or 0.25 mm to 1.5 mm. Furthermore, all claimed range can be obtained by optimization through routing experimentation. MPEP 2144.05.
Regarding claims 68-69, Wright teaches topical transdermal patch.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 42-44 and 58-59 are rejected under 35 U.S.C. 103 as being unpatentable over Wright (US20040081685), as applied for the above 103 rejection for claims 38, 40-41, 45, 47-49 and 60 and 63-69, in view of Ramjit et al. (US20190350873), Heinecke et al. (US20010027285), Knutson (US20180369023), Bott et al. (US20030180281) and Zurdo Schroeder et al. (US9393218).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Wright teaching has already been discussed in the above 103 rejection and is incorporated herein by reference.
Ramjit et al. teaches An adhesive patch is described that contains an improved release liner for the treatment of various skin conditions (abstract). In an exemplary embodiment, the release liner covering the therapeutic adhesive composition contains a perforated pattern or a slit that allows for facile separation (peeling away) of the liner (in two portions) from the therapeutic adhesive composition ([0072]).
Heinecke et al. teaches A wound dressing and delivery system in the form of absorbent pad comprising slits having a substantially sinusoidal curve. (claims 1,4, 8 and 12-13).
Knutson teaches patches (abstract). The release liner has silt ([0060-0061]). A leading edge 324 of each tab 352 is cut, and the partially-cut tabs 352 remain partially-cut and attached to the release liner 334 (of the first web 348) by one or more tie points (or uncut points) 355 ([0105]).
Bott et al. teaches topical preparation (abstract). Finally, the silicone matrix may be comprised of a silicone pressure sensitive adhesive (silicone PSA), such as a silicate resin in silicone polymers, which can be solvent based or hot-melt, such as those described in U.S. Pat. Nos. 2,736,721, 2,814,601, 2,857,356, 3,528,940, and 6,337,086, the disclosures of which are hereby incorporated herein by reference for their teaching of silicone PSAs for use with the present invention. For example, Dow Corning® PSA 7-4402 (available from Dow Corning Corporation, Midland, Mich.) may be used ([0041]).
Zurdo Schroeder et al. teaches parch composition comprising active ingredients such as clobetasol propionate (claims 1,4 and 10-11).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Wright is that Wright do not expressly teach slit, clobetasol propionate, silicate resin and silicone polymer. This deficiency in Wright is cured by the teachings of Ramjit et al., Heinecke et al., Knutson, Bott et al. and Zurdo Schroeder et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wright, as suggested by Ramjit et al., Heinecke et al., Knutson, Bott et al. and Zurdo Schroeder et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to have silt in the cover layer (release liner) because slit allows for facile separation (peeling away) of the liner (in two portions) from the therapeutic adhesive composition as suggested by Ramjit et al. Since it is advantage to have easy separation, it is obvious for one of ordinary skill in the art to have silt in the cover layer (release liner) and produce instant claimed invention with reasonable expectation of success.
One of ordinary skill in the art would have been motivated to have clobetasol propionate as active agent and blend of silicate resin and silicone polymer as adhesive because clobetasol propionate is a known active in patch; and blend of silicate resin and silicone polymer is known adhesive for patch. MPEP 2144.07. Under guidance from Zurdo Schroeder et al. teaching parch composition comprising active ingredients such as clobetasol propionate; Bott et al. teaching a silicone pressure sensitive adhesive (silicone PSA) comprising a silicate resin in silicone polymers, it is obvious for one of ordinary skill in the art to have clobetasol propionate as active agent and blend of silicate resin and silicone polymer as adhesive and produce instant claimed invention with reasonable expectation of success.
Regarding claims 43 and 58, as suggested by Heinecke et al. teaching slits having a substantially sinusoidal curve; Knutson teaching the release liner having one or more tie points (or uncut points); it is obvious to have slits having a substantially sinusoidal curve and tie portion because they are regular and common for silt in the art.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Argument:
Applicants argue that separation line does not extend through the backing line in prior art.
In response to this argument: this is not persuasive. It appears that applicants simple misinterpreted prior art teaching. Wright teaches clearly in Fig. 1, the separation line extends through the backing layer, which is also indicated in [0042] that a line of separation 50 extends throughout the raised walls 100 that are formed by the backing layer 60. Therefore, the 103 rejection is still proper.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after weighing all the evidence, the Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts which is more convincing than the evidence which has been offered in opposition to it.
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JIANFENG SONG/Primary Examiner, Art Unit 1613
Prosecution Insights