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 .
Status of Claims
Claims 1-14 and 16-19 are pending and currently under consideration for patentability.
Claims 1, 2, 4, 6, and 8-14 have been amended for clarification purposes.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/20/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-14 and 16-19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claim(s) 1-9, 11-12, and 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fares (WO 2013164016 A1) in view of Laghi (US 20210100934 A1).
Regarding Claim 1, Fares teaches a method of impregnating a film, wherein the impregnation of the film comprises the following steps:
- feeding the film (film layer, 2) to be impregnated (page 17, lines 1-30);
- immersing the film (film layer, 2) into an impregnating agent (an antimicrobial agent 4), preferably arranged in an immersion basin (page 14, lines 4-15); and
- partially separating, the impregnating agent from the film in order to achieve a predefined loading of the film with impregnating agent (page 18, lines 18-24),
Fares fails to teach a method for manufacturing a transdermal therapeutic system (TTS) and adding an active ingredient into and/or onto the film. Laghi teaches a method for manufacturing a transdermal therapeutic system (TTS) and adding an active ingredient into and/or onto the film (paragraph [0011]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify Fares to use a transdermal therapeutic system (TTS) and adding an active ingredient into and/or onto the film to create a therapeutic material and to modulate the rate of transdermal delivery of active ingredients (motivated by Laghi, [0086]).
Regarding Claim 2, Fares teaches a device for impregnating a film, wherein the device comprises:
an immersion basin filled with impregnating agent (page 17, lines 1-30);
a film guiding for feeding a film to be impregnated, immersing the film into the immersion basin, and feeding the film out (page 14, lines 4-15); and
a separating device for separating the impregnating agent from the film in order to achieve a predefined loading of the film with impregnating agent (page 18, lines 18-24).
Fares fails to teach a system for manufacturing a transdermal therapeutic system (TTS), comprising a device and an active ingredient supply device for adding an active ingredient into and/or onto the impregnated film. Laghi teaches a method for manufacturing a transdermal therapeutic system (TTS) and adding an active ingredient into and/or onto the film (paragraph [0011]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify Fares to use a transdermal therapeutic system (TTS) and adding an active ingredient into and/or onto the film to create a therapeutic material and to modulate the rate of transdermal delivery of active ingredients (motivated by Laghi, [0086]).
Regarding Claim 3, Fares in view of Laghi teaches the method according to claim 1. Fares further teaches the separation of the impregnating agent is effected by means of a separating device (page 18, lines 18-24).
Regarding Claim 4, Fares in view of Laghi teaches the method according to claim 3. Fares further teaches the wherein the separating device comprises at least one wiper, coated with silicone (page 18, lines 18-24).
Regarding Claim 5, Fares in view of Laghi teaches the method according to claim 4. Fares teaches wherein the wiper comprises at least one edge and/or at least one roller (page 18, lines 18-24).
Regarding Claim 6, Fares in view of Laghi teaches the method according to claim 4. Fares teaches wherein the pressurized wiper (squeezing rollers) is arranged on both sides of the film loaded with impregnating agent (page 18, lines 18-24).
Regarding Claim 7, Fares in view of Laghi teaches the method according to claim 3. Fares teaches wherein the separating device is configured to be variably adjustable so that the predefined loading be achieved by separating the impregnating agent (page 18, lines 18-24).
Regarding Claim 8, Fares in view of Laghi teaches the method according to claim 7, wherein the separating device comprises at least one adjusting device for adjusting a pressure and/or a distance, in particular of the wiper, the adjusting device preferably comprising a pneumatic device, a hydraulic device, a spring device, an elastomer, and a pressure screw and a fine adjustment thread.
Regarding Claim 9, Fares in view of Laghi teaches the method according to claim 3. Fares further teaches wherein the separating device is arranged such that the separated impregnating agent is returned to the immersion basin(page 14, lines 4-15).
Regarding Claim 11, Fares in view of Laghi teaches the method according to claim 1. Fares further teaches wherein the impregnating agent comprises oil (page 7, line 34- page 8 line 11).
Regarding Claim 12, Fares in view of Laghi teaches the method according to claim 1. Fares further wherein the film is a porous film (page 10, lines 4-26).
Regarding Claim 16, Fares in view of Laghi teaches the method according to claim 1. Laghi further teaches wherein when the active ingredient is added, the film is coated with an active ingredient, and/or the film is bonded to one or more active ingredient containing films to form a composite film (paragraph [0085-0086].
Regarding Claim 17, Fares in view of Laghi teaches the method according to claim 9. Fares further teaches wherein the separated impregnating agent falls into the immersion basin (page 3, lines 20-35).
Regarding Claim 18, Fares in view of Laghi teaches the method according to claim 10. Laghi further teaches wherein the impregnating agent comprises mineral oil (paragraph [0015]).
Regarding Claim 19, Fares in view of Laghi teaches the method according to claim 12. Fares further teaches wherein the porous film comprises polypropylene (page 10, lines 4-26).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fares (WO 2013164016 A1) in view of Laghi (US 20210100934 A1) in view of Barberan (US 20210213483 A1).
Regarding Claim 10, Fares in view of Laghi teaches the method according to claim 1. Fares fails to teach wherein a collecting tray, connected to the immersion basin, for collecting the separated impregnating agent . Barberan teaches a roller applicator wherein a collecting tray, preferably connected to the immersion basin, for collecting the separated impregnating agent (paragraph [0063]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify Fares to have a collecting tray, similar to Barberan so the agent may be collected (as motivated by Barberan, paragraph [0063]).
Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fares (WO 2013164016 A1) in view of Laghi (US 20210100934 A1) in view of Shim (US 20180222807 A1).
Regarding Claim 13, Fares in view of Laghi teaches the method according to claim 1. Fares further teaches wherein the method comprises the following further step control for testing the film loaded with impregnating agent (page 8, lines 5-11). However fails to specify that the performing an optical and/or weight-recording process control for testing the film loaded with impregnating agent. Shim teaches a method of creating a film, wherein the step for controlling the agent within the films involves measuring the molecular weight of the agent (paragraph [0064-0065]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify Fares to control the wight of the impregnating agent, similar to Shim, in order to create an ideal material and viscosity.
Regarding Claim 14, Fares in view of Laghi teaches the method according to claim 1, Fares further teaches wherein the method comprises the following further step control for testing the film loaded with impregnating agent (page 8, lines 5-11). However fails to explicitly teach wherein a testing device, in particular comprising a scale and/or an optical control device, for testing the film loaded with impregnating agent. Shim teaches a method of creating a film, wherein the step for controlling the agent within the films involves measuring the molecular weight of the agent (paragraph [0064-0065]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify Fares to control the wight of the impregnating agent, similar to Shim, in order to create an ideal material and viscosity.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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, Rebecca Eisenberg can be reached on (571)-270-5879. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-5879.
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/KATE ELIZABETH STRACHAN/ Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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