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
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/16/2026 has been entered.
Status of claims
The amendment filed on 06/16/2026 is acknowledged. Claims 5, 15,29, and 30 have been canceled, claims 16-23 have been withdrawn, and new claim 37 has been added. Claims 1-4, 6-14, 24-28, and 31-37 are under examination in the instant office action.
Rejections withdrawn
Applicant’s amendments and arguments filed on 06/16/2026 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 Any rejection and/or objection not specifically addressed below is herein withdrawn.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. 103(a) rejections of claims 1-4, 6-14, 27, 28, and 31-36 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), of claim 24 over Laux et al. (US 2016/0220800 A1), Mao et al. (US 2013/0123719 A1), Reynolds et al. (WO 2013/142339 A1), Farr et al. (US 2008/0026040 A1), and Bröms et al. (US 2016/0095226 A1), and of claims 25 and 26 over Laux et al. (US 2016/0220800 A1), Mao et al. (US 2013/0123719 A1), Reynolds et al. (WO 2013/142339 A1), Farr et al. (US 2008/0026040 A1),and 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) 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.
New ground of rejection
Upon reconsideration the following new ground of rejections are applied.
Claim Rejections - 35 USC § 112(d)
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.
Claim 8 rejected under 35 U.S.C. 112(d) 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. The limitation in claim 8 is already recited in claim1. 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 112(b)
The following is a quotation of the second paragraph 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.
Claim 10 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 10 recites the limitation “the backing layer”. There is insufficient antecedent basis for this limitation in the claim.
Claim 34 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 34 recites the limitation “activation device is disposed on an outmost surface of the timing device opposing the transdermal therapeutic system”. The activation device is part of the timing device and the timing device is part of the transdermal therapeutic system while a part of the transdermal therapeutic system can’t be opposing the same transdermal therapeutic system. Thus, it is unclear and indefinite as to how the “activation device is disposed on an outmost surface of the timing device opposing the transdermal therapeutic system”, herein is encompassed.
To expedite the prosecution “activation device is disposed on an outmost surface of the timing device opposing the transdermal therapeutic system” is given its broadest reasonable interpretations by the examiner in light of the specification in the 103 rejections as opposing the skin contacting side of the transdermal therapeutic system.
New ground of rejections necessitated by Applicant’s amendment
The amendments necessitate the following new ground of rejections.
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, 2, 6, 8-10, 12-14, 24, 26-28, 31-35, and 37 are rejected under 35 U.S.C. 103(a) as being unpatentable over DiPierro et al. (US 2012/0302942 A1) in view of Farr et al. (US 2008/0026040 A1).
DiPierro et al. teach a programmable transdermal drug delivery device in form of a wristwatch (the claimed mobile application in the instant claims 1 and 31) (paragraph 125, 601, and 602 and figure 1) comprising:
(a) an interface for coupling to the skin of a subject (claim 21);
(b) an administrative reservoir storing a quantity of a dissolved or dispersed active substance such as for Alzheimer’s treatment (the claimed (b) in the instant claims 1, 14, 31, and 35) (figure 2 and claims 21, 49, and 126);
(c) a delivery mechanism for modulating the quantity of the active substance supplied from the reservoir to the interface in response to a control signal; and
(d) an electronic programmable timing mechanism (the claimed (a) timing device in the instant claims 1, 31, and 35) to generate the control signal according to a programmed administration schedule (claim 21);
wherein the device is attached to the skin with an adhesive such as pressure sensitive adhesive (PSA) (the claimed (d) in the instant claims 1, 13, 28, and 35) (paragraph 125, 137, 139, and 623);
wherein the portable active substance delivery device is configured with a reusable portion, including the display and control components, separated from a disposable portion, including the active substance or dispensing reservoir within a housing (paragraph 38 and 124) → the layer of housing enclosing disposable portion = the claimed backing layer between the timing device and the active containing reservoir in the instant claims 2 and 31;
wherein the electronic programmable timing mechanism to obtain a status of a dosing regimen (the claimed (i) in the instant claims 1 and 31 and claims 26, 35, and 37) (figure 1 and 2 and paragraph 124-126 and 132) includes a liquid crystal display (LCD) or other display 90 (the claimed (iii) in the instant claim 1, visual indicator in the instant claims 6, 31, and 35) (figure 1 and 2 and paragraph 124-126 and 132), and input such as keyboard and button on top of the watch opposing the skin contacting side of the watch (the claimed (ii) in the instant claims 1, 31, 34, and 35) (figure 1 and 2 and paragraph 125 and 126), battery 6 (the claimed (iv) in the instant claims 1, 31, and 35) (figure 2 and paragraph 126);
wherein the control and display unit 7 can be implemented by a microprocessor 91 (the claimed microchip in the instant claim 9 and printed electronic timing device in the instant claim 24), programmed as a programmable timer, with an LCD display 90 to deliver an active substance formulation (paragraph 132) for 1-2 hours or 3 days (the claimed preprogramed an administrative time of from 1 hour to 1 week in the instant claims 1, 31, and 35) (paragraph 150 and 604);
wherein the replaceable reservoir can include a description of an administration schedule (dosing regimen) printed on or affixed to the reservoir (paragraph 151).
DiPierro et al. do not teach the device containing a body temperature monitor (the instant claims 31 and 35) and do not teach the device containing a radio frequency identification chip (the instant claim 33).
Component c in the instant claims 1, 31, and 35 is optional; the limitation in claim 10 is a further limitation of an optional component; and limitations in claim 27 are further limitations of alternative components.
DiPierro et al. do not specify the timing device being thicker than the remainder of the device (≥ ½ of the thickness of the device) in the instant claims 1 and 35 → one of the three options: thinner (the instant claims 1 and 35), same, and thicker.
The timing mechanism is a part of the device, the flexibility of the timing mechanism is already part of the flexibility of the device, the timing mechanism would not affect the flexibility of the device (the instant claim 26).
DiPierro et al. do not specify dosing regimen printed on the reservoir being in form of barcode (the instant claims 1 and 31).
This deficiency is cured by Farr et al. who teach the 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 DiPierro et al. and Farr et al. to specify dosing regimen printed on the reservoir being in form of barcode. A transdermal patch comprising a barcode for information 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. Please refer to MPEP 2145.III:
the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
DiPierro et al. do not specify the relative size (the instant claims 31 and 32).
This deficiency is cured by the rationale that it is well settled that it is an obvious matter of design choice to change the general shape or size of a known element in the absence of a disclosed non-obvious advantage associated with the change. Gardner vs. TEC Systems Inc., 725 F.2d 1338, 1349-50 (Fed. Cir. 1984); In re Kuhle, 526 F.2d 553, 555 (CCPA 1975); In re Dailey, 357 F.2d 669, 672 (CCPA 1966). MPEP 2144.04.IV.A.:
the Federal Circuit held that, 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.
Claims 1-4, 6, 8-10, 12-14, 24, 26-28, 31-35, and 37 are rejected under 35 U.S.C. 103(a) as being unpatentable over DiPierro et al. (US 2012/0302942 A1) in view of Farr et al. (US 2008/0026040 A1) and Panoz (US 4,592,753).
The teachings of DiPierro et al. are discussed above and applied in the same manner.
DiPierro et al. do not specify an adhesive for attaching the timing mechanism to the backing layer recited in the instant claims 3 and 4.
This deficiency is cured by Panoz who teaches a transdermal device formed by attaching a transdermal patch to a watch with an adhesive layer between the back of the watch and the backing layer of the patch (abstract, figure 6, and column 9, line 28-40).
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 DiPierro et al. and Panoz to specify the reservoir in the device taught by DiPierro et al. being attached to the electronic programmable timing mechanism with an adhesive layer between the electronic programmable timing mechanism and the housing enclosing the reservoir (backing layer). Attaching a transdermal patch to a watch with an adhesive layer between the back of the watch and the backing layer of the patch for forming a transdermal 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. Please refer to MPEP 2145.III discussed above.
Claims 1, 2, 6-10, 12-14, 24-28, and 31-37 are rejected under 35 U.S.C. 103(a) as being unpatentable over DiPierro et al. (US 2012/0302942 A1) in view of Farr et al. (US 2008/0026040 A1) and Jacobs (US 2008/0281244 A1).
The teachings of DiPierro et al. are discussed above and applied in the same manner.
DiPierro et al. do not specify the other display being an electrophoretic display recited in the instant claims 7, 25, and 36.
This deficiency is cured by Jacobs who teaches electronic paper (electrophoretic display) being used as a visual display on an electronic bandage (claims 1, 2, 10, 16).
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 DiPierro et al. and Jacobs to specify the other display of the electronic programmable timing mechanism taught by DiPierro et al. being electrophoretic display. An electrophoretic display being used as a visual display on an electronic bandage 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. Please refer to MPEP 2145.III discussed above.
Claims 1, 2, 6, 8-14, 24, 26-28, 31-35, and 37 are rejected under 35 U.S.C. 103(a) as being unpatentable over DiPierro et al. (US 2012/0302942 A1) in view of Farr et al. (US 2008/0026040 A1) and Horstmann (US 2007/0081977 A1).
The teachings of DiPierro et al. are discussed above and applied in the same manner.
DiPierro et al. do not specify the thickener in the reservoir being a polymer recited in the instant claim 11.
This deficiency is cured by Horstmann who teaches a reservoir in a transdermal drug delivery device being in form of a polymer matrix (paragraph 28).
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 DiPierro et al. and Horstmann to specify the administrative reservoir in the device taught by DiPierro et al. being a polymer matrix. A reservoir in a transdermal drug delivery device being in form of a polymer matrix 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. Please refer to MPEP 2145.III discussed above.
Response to Applicants’ arguments:
Applicant’s arguments, filed on 06/16/2026, have been fully considered but they are moot in view of new ground of rejections.
Correspondence
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.
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/HONG YU/
Primary Examiner, Art Unit 1614
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