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 .
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.
DETAILED ACTION
Status of claims
The amendment filed on 11/21/2025 is acknowledged. Claims 5, 15, 29, and 30 have been canceled, claims 16-23 have been withdrawn, and new claim 36 has been added. Claims 1-4, 6-14, 24-28, and 31-36 are under examination in the instant office action.
Rejections withdrawn
Applicant’s amendments and arguments filed on 11/21/2025 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn. Applicant’s amendments have overcome the 35 U.S.C. 112(b) rejection of claims 1-4, 6-14, 24-28, and 31-35 from the previous Office Action. 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.
Rejections maintained
The following rejections of the claims are remained for reasons of record and the following. In addition, new claims are hereby included in the rejections and the rejections are modified based on the amendments.
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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(a) 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 1-4, 6-14, 27, 28, and 31-36 are rejected under 35 U.S.C. 103(a) as being unpatentable over Laux et al. (US 2016/0220800 A1) in view of Mao et al. (US 2013/0123719 A1), Reynolds et al. (WO 2013/142339 A1), and Farr et al. (US 2008/0026040 A1).
Laux et al. teach transdermal therapeutic systems for delivering active agent over long period of time (paragraph 2) comprising
self-powder RFID transponder chip (paragraph 12 and claims 3 and 5) electronic components being bonded with an adhesive (paragraph 2, 20, 39, and 40) on a laminate comprising a backing layer (the claimed film in the instant claims 1-3, 9, and 10) (paragraph 38 and figure 1),
at least one active agent-containing (including antimycotics, the instant claim 14) reservoir of pressure-sensitive polymer matrix adhesive (either suspended or dissolved, the instant claims 11 and 12) (paragraph 3 and 4), and
a detachable protective layer (abstract and paragraph 5 and 38 and claim 7);
wherein there is a separate pressure-sensitive adhesive layer which is applied to at least a portion of the skin-side surface of the active agent reservoir (the instant claims 1, 13, and 28) (paragraph 3);
wherein the electronic components for display reading information (the claimed visual indicator in the instant claims 1, 6, 7, 31, and 35) for therapy optimization and/or therapy monitoring the timing of application of the transdermal therapeutic system with the timing information being generated by the activation (the claimed timing device comprising a display and activation device in the instant claims 1, 31, and 35) (paragraph 14); and
wherein the thickness of the electronic component (the claimed timing device) is 10-1500 µm (paragraph 15) and the thickness of the adhesive layer 2 in a prefabricated electronic component is 30 µm (paragraph 22-29, 31, and 47).
The limitation of claim 27 is a further limitation of alternative actives.
Laux et al. teach the radio tag may be transponders (paragraph 12), i.e., radio tag may not be transponders and thus antenna in transponder is not a must have component (the instant claim 33).
Laux et al. do not specify the long period of delivery time being 1 hour to 1 week (1-168 hour) 48 hour to 1 week (48-168 hour) claimed in the instant claims 1, 8, 31, and 35, the thickness of the transdermal therapeutic system in the instant clams 1 and 30, the area of the electronic component relative to the area of the transdermal therapeutic system in the instant claims 4, 31, and 32, and position of activation switch in the instant claim 34.
This deficiency is cured by Reynolds et al. who teach a transdermal therapeutic patch to be adhered to patient’s skin (page 7, line 3-9) for controlled delivering of any active for 72 hours (page 8, line 19-27 and page 10, line 4-33), a thickness of patch being 0.25 mm (page 9, line 8-14), and diameters of patch 100 and eLabel in figure 4b being measured to be 6.40 mm and 5.45 mm, respectively, and activation switch 410 between the battery 408 and printed circuit board 406 (figure 4b). The area of eLabel over patch is calculated to be 72.5% (5.452/6.402=0.725).
It would have been prima facie obvious at the time of the invention to a person of ordinary skill in the art to combine the teachings in Laux et al. and Reynolds et al. to specify the long period of delivery time being for 72 hours, the transdermal therapeutic systems taught by Laux et al. having the timing device covering 72.5% of the backing layer surface area, and the patch (the transdermal therapeutic system without the electronic component) having a thickness of 0.25 mm, i.e., total thickness of the transdermal therapeutic system without the electronic component being 280 µm (30+250=280) and the transdermal therapeutic system with the electronic component being 290-1780 µm (280+10=290, 280+1500=1780). Transdermal therapeutic systems having the timing device covering 72.5% of the backing layer surface area and having length of pre-programmed administrative time of 72 hours, and total thickness of the transdermal therapeutic system without the electronic component being 280 µm (30+250=280) and the transdermal therapeutic system with the electronic component being 290-1780 µm were well known to a person of ordinary skill in the art at the time of the invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
A prima facie case of obviousness typically exists when the range of a claimed composition lies inside the range disclosed in the prior art, such as in the instant rejection. The claimed range of the thickness of the timing device is 25-1000 µm and the range of electronic component taught in the prior art is 10-1500 µm and therefor, includes the claimed range.
With the thickness of the timing device being 10-1500 µm and the thickness of transdermal therapeutic system being 280 µm, the thickness of the timing device is thinner than the thickness of transdermal therapeutic system when the thickness of the timing device being from 10 µm to less than 280 µm. Please refer to MPEP 2144.04.IV.A:
where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Laux et al. in view of Reynolds et al. do not teach the same area of the electronic component relative to the area of the transdermal therapeutic system (72.5% taught by Reynolds et al. vs the claimed 5-50% and 5-20%); however, when the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Please refer to MPEP 2144.04.IV.A:
where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Laux et al. in view of Reynolds et al. do not teach the same position of activation switch, however, rearrangement of parts is a common practice requires only ordinary skill in the art and hence are considered routine expedients. Please refer to MPEP 2144.04.VI.C:
In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).
Laux et al. do not specify the electronic components for display reading information being disposed on the remainder of the transdermal therapeutic systems and timing device having a light emitting diode (LED) in the new claim 36.
This deficiency is cured by Mao et al. who teach a medication patch compliance control unit system comprising user interface including a light indicator, battery, pushbutton, an expiration timer, LED, etc., (abstract, paragraph 19-25, 30, and 31, and claims 1 and 9) being disposed on a medication patch (figure 1 and paragraph 18).
It would have been prima facie obvious at the time of the invention to a person of ordinary skill in the art to combine the teachings in Laux et al. and Mao et al. to specify the electronic components for display reading information in the transdermal patch taught by Laux et al. having a light indicator, battery, pushbutton, an expiration timer, LED and being disposed on the patch. A transdermal patch having a compliance control unit having a light indicator, battery, pushbutton, an expiration timer system, LED and being disposed on it for better patient compliance was well known to a person of ordinary skill in the art at the time of the invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for better patient compliance of the patch.
Laux et al. do not specify the transdermal patch comprising a barcode (the instant claims 1 and 31).
This deficiency is cured by Farr et al. who teach transdermal patch (paragraph 15) having barcode printed on the patch (paragraph 36).
It would have been prima facie obvious at the time of the invention to a person of ordinary skill in the art to combine the teachings in Laux et al. and Farr et al. to specify the transdermal patch taught by Laux et al. further comprising a barcode. A transdermal patch comprising a barcode was well known to a person of ordinary skill in the art at the time of the invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose of providing information of the patch.
Response to Applicants’ arguments:
Applicant’s argument based on the new claim 36 is addressed in the modified rejection above (newly underlined).
Applicants reiterated arguments were addressed previously which applies here as well and is not persuasive for reason discussed.
Applicants argue that Mao et al. teach temperature activation sensor, not the claimed button.
However, this argument is not deemed persuasive. Mao et al. teach interface including a pushbutton in paragraph 25 while temperature sensor is for patient compliant information.
Applicants argue that the prior art do not teach the claimed invention which leads to the technical effect.
However, this argument is not deemed persuasive. The prima facie obviousness is established based on the combination of the prior art and the rationales for modifications and the technical effect resulted from the claimed patch would be inherent results of based on the combination of the prior art and the rationales for modifications.
Applicant’s argument with regard to Laux et al. teaching non-flexible electronic component is basically the same as the previous argument, thus the response discussed previously (page 13-14 in the office action dated 11/08/2024) applies here as well and is not persuasive for reason discussed. Furthermore, Laux et al. teach electronic components being non-flexible in one embodiment, not the system in that embodiment.
Applicants argue that Laux et al. do not teach a timing device disposed on TTSs that including an activation button and timing device being thinner than the remainder of the system as the claimed.
However, this argument is not deemed persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references.
All in all, it would have been prima facie obvious at the time of the invention to a person of ordinary skill in the art to combine known prior art elements is that one of ordinary skill in the art would reasonably have expected the elements to maintain their respective properties or functions after they have been combined. MPEP 2141.I:
In KSR, the Supreme Court particularly emphasized “the need for caution in granting a patent based on the combination of elements found in the prior art,” Id. at 415, 82 USPQ2d at 1395, and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 415-16, 82 USPQ2d at 1395. The Supreme Court stated that there are “[t]hree cases decided after Graham [that] illustrate this doctrine.” Id. at 416, 82 USPQ2d at 1395. (1) “In United States v. Adams, . . . [t]he Court recognized that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” Id. (2) “In Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., [t]he two [pre-existing elements] in combination did no more than they would in separate, sequential operation.” Id. at 416-17, 82 USPQ2d at 1395. (3) “[I]n Sakraida v. AG Pro, Inc., the Court derived . . . the conclusion that when 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 from such an arrangement, the combination is obvious.” Id. at 417, 82 USPQ2d at 1395-96 (Internal quotations omitted.). The principles underlining these cases are instructive when the question is whether a patent application claiming the combination of elements of prior art would have been obvious. The Supreme Court further stated that:
Claim 24 is rejected under 35 U.S.C. 103(a) as being unpatentable over Laux et al. (US 2016/0220800 A1), Mao et al. (US 2013/0123719 A1), Reynolds et al. (WO 2013/142339 A1) and Farr et al. (US 2008/0026040 A1), as applied to claims 1-4, 6-14, 27, 28, and 31-36, in view of Bröms et al. (US 2016/0095226 A1).
The teachings of Laux et al. and Reynolds et al. are discussed above and applied in the same manner.
Laux et al. do not specify the function for telling time being achieved with printed electronic device.
This deficiency is cured by Bröms et al. who teach cost-effective printed timer label for providing an output signal to be used in the field of administration of certain pharmaceuticals, etc., for indicating time (abstract, paragraph 4, 10, and 43).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Laux et al. and Bröms et al. to specify the timer taught by Laux et al. being a printed electronic device. Timers including a printed electronic device was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose for indicating time.
Response to Applicants’ arguments:
Applicant’s arguments with regard to Bröms et al. not teaching the claimed invention is basically the same as the previous rejection, thus the response discussed previously applies here as well and is not persuasive for reason discussed.
Claims 25 and 26 are rejected under 35 U.S.C. 103(a) as being unpatentable over Laux et al. (US 2016/0220800 A1), Mao et al. (US 2013/0123719 A1), Reynolds et al. (WO 2013/142339 A1) and Farr et al. (US 2008/0026040 A1), as applied to claims 1-4, 6-14, 27, 28, and 31-36, in view of Seiko World’s First EPD Watch with an Active Matrix System (https://www.europastar.com/news/1004077645-seiko-world-s-first-epd-watch-with-an-active.html).
The teachings of Laux et al. are discussed above and applied in the same manner.
Laux et al. do not specify the watch being programmable electrophoretic display.
This deficiency is cured by “Seiko World’s First EPD Watch with An Active Matrix System” which teaches programmable “E-Ink” or EPD (Electrophoretic Display) watch (the same timing device as claimed according to the instant specification page 8, line 13-29 and thus having the same claimed flexibility).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Laux et al. and “Seiko World’s First EPD Watch with An Active Matrix System” to specify the watch taught by Laux et al. being programmable EPD watch. Watch including programmable EPD watch was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose for indicating time.
Response to Applicants’ arguments:
Applicant’s argument with regard to Laux et al. teaching non-flexible electronic component is basically the same as the previous argument, thus the response discussed previously (page 13-14 in the office action dated 11/08/2024) applies here as well and is not persuasive for reason discussed.
Conclusion
No claims are 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 extension fee 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 HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 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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/HONG YU/
Primary Examiner, Art Unit 1614