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 .
1. The applicant’s amendment filed on 02/26/2026 was received. Claims 1 and 5 were amended.
The text of those sections of Title 35, U.S. Code not included in this action can be found in the prior Office Action mailed on 12/19/2025.
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on 05/26/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
3. Claim 1 is directed to a patch manufacturing apparatus not to a multi-layer patch. The multi-layer patch is not part of the apparatus and any limitation/features of the multi-layer patch is irrelevant as the multi-layer patch is the article being worked upon. Additionally, the apparatus is not only limited to make a specific patch that is only disclosed by the applicant. Such apparatuses can also be used to make patches with different functional material such as oral edible patches with edible functional material on it, patches with medicine as functional material, ceramic films with coating, bandages etc. Claim is 1 is directed to an apparatus and because parts of claim 1 recite limitations of the multi-layer patch film, therefore the patch related limitations described in claim 1 not given patentable weight. (See In Re Young, 927 and MPEP 2115). It also applies to claim 2, 3, 5, and 6 as those claims are dependent on claim 1 as well as they add limitation to the multi-layer patch. For the sake of compact prosecution, the multi-layer patch film would be considered as a general multi-layer patch film without considering any additional limitations.
Claim Rejections - 35 USC § 103
4. Claims 1-7 and 9-10 remain rejected under 35 U.S.C. 103 as being unpatentable over Hiroaki et al. (JP2011012010A) in view of Hanayo et al. (JP2010207613A). The rejections are stated below to address the amendment.
Regarding Claim 1: Hiroaki et al. disclose a patch manufacturing method and a patch manufacturing device. The patch manufacturing device includes a roller (21) (main roller, part of dispensing section) on which base sheet (90) (base patch) is wounded and with support (92), the base sheet is unwound from the roller (21). [para 0045, fig 1].
The patch manufacturing device also includes a coating unit (10) (dispenser) which has multiple application heads (11) with multiple nozzles to apply solution (functional material) to base sheet (90) [para 0047; fig 2, 4]
The patch manufacturing device further includes a chemical solution supply unit (30) (functional material supply device) that supplies chemical solution (functional material) to the coating unit (10). A chemical solution tank (31) is also included in the chemical supply unit. The chemical tank (31) is connected application head (11) of the coating unit (10) via a supply pipe (32). [para 55; fig 1]. The coating head has 128 nozzles (12) (n number of nozzles).
Hiroaki further teaches that the coating application of all coating head 11 with nozzles 12 is controlled by a control unit 40. There is also a position sensor 70 that detects the position of the substrate 90 and based on the positioning of substrate, the control unit 40 adjusts the positioning of coating head 11 so that proper coating can be applied. Such way of positioning would correspond to the coating heads 11 on top of substrate with claimed guide holes [see paragraph 65].
Additionally, coating pattern 82 describes a pattern of the area where chemical solution is going to be applied. Also, para 75 clearly states "Furthermore, patterning can be freely adjusted by changing the settings of the coating pattern 82. Furthermore, the size of the coating area can be freely adjusted by changing the size of the coating pattern 82."
It means that a coating pattern as shown below can be achieved where there would be circular structures on a substrate and each circle would have a corresponding nozzle on top and a coating pattern can be achieved.
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The pattern 82 is capable of making patterns similar to configuration of the 'guide holes' and perform coating application. Hiroaki et al. further teaches the control unit controls the on/off timing of all the nozzles 12 provided on the application heads 11. Thus, when all the nozzles are on, it indicates that a plurality of nozzles are programmed to simultaneously apply the coating material. [para 73-75]
Furthermore, the patch manufacturing device also comprises of a control unit (40) (controller), which is a CPU, that controls the chemical solution ejection position of application head (11) so that droplets of chemical solution are sprayed accurately on base sheet (90). The control unit is further configured to control the whole drug application process including supplying and applying the drug to the base sheet. [para 66-67, 71-73; fig 1,5]
The patch manufacturing device further comprised of a drying unit (50) (drying section) for drying the base sheet with applied chemical solution. The dryer uses dry air or heated air. The dryer could also be an infrared dryer. [para 64; fig 1]
Hiroaki et al. does not teach a separation roller, collection roller (both parts of dispensing section), and a recovery section with a recovery roller to for recovering the patch with dried functional material. Hiroaki further do not teach a multi-layer patch with a cover film. However, Hanayo et al. disclose an apparatus of producing edible oral administered laminated film which is made by a device comprised of a peeling roll (17) (separation roller) and a collecting roller shaft (18) (collection roller) for collecting the peeled layer 16a (parts of dispensing section). The film prior to being peeled corresponds to the claimed multi layered patch [para 53]. It would have been obvious for one of ordinary skill in the art before the effective filling date of the claimed invention to include a peeling roll and a collection roll like that of Hanayo et al., into the invention of Hiroaki et al., positioned between the roller and the drying unit(shown in the diagrams below), because Hiroaki et al. teach that desired resin film layer can be removed and obtained from a multi-layered feed patch (resin film with layer 16a and 16b) using peeling roll and roller shaft respectively. [see para 0053 Hanayo et al.].
Hanayo et al. also teaches a reel (33a, 33b) (recovery roller) for collecting a film product (recover section) [para 80-81] [fig 1, 4, 5]. The reels 33a, 33b serves the purpose of collecting a film where resin film 16a (cover film) of film 16 was removed prior being collected in reels 33a, 33b. It would have been also obvious to include a reel (recovery roller) like that of Hanayo et al., into the invention of Hiroaki et al. which can be positioned in a way as shown in diagram-1 below; diragram-2 for reference because Hanayo teaches that desired film can be wounded for collection as a final product as shown below. [see para 80 Hanayo et al.].
Hanayo et al. teaches that resin film (cover film) is used to cover edible layer, the layer where an oral agent (functional material) is applied [para 43]. One having ordinary skill in the art would understand such resin films and the claimed cover film serve a similar purpose of keeping a layer (application layer) smooth or having less exposure. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filling date of the claimed invention to substitute a base sheet of Hiroaki with a base sheet having a cover resin film of Hanayo because Hanayo teaches that resin film assists in covering an edible layer (application layer) which leads to less exposure and stays smooth where a functional material is applied. [para 0043 Hanayo et al.] (Ex parte Smith, 83 USPQ2d 1509 (Bd. Pat. App. & Int. 2007), MPEP 2143). The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
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Diagram 1
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Diagram 2
Regarding Claim 2: Hiroaki et al. disclose a patch manufacturing method and a patch manufacturing device. The device uses a base sheet (90) (base patch) where a functional material is applied. As disclosed in diagram-3 below that base sheet is includes an adhesive layer (91) and chemical solution is applied on the adhesive layer creating a drug layer. [para 71, 108] Claim 2 also recites limitation to the multi-layer patch rather than adding limitation to the structure, therefore constitutes intended use and lack patentable weight.
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Diagram 3
Regarding Claim 3: Claim 3 recites a limitation to a part of the multi-layer patch of claim 1 which is not part of the apparatus rather it’s an article being worked upon. This limitation reflects an intended use and lacks patentable weight. As held in In re Young, limitations directed to the intended use of an apparatus missing a corresponding structural change or limitation do not have a patentable weight.
Regarding Claim 4: Claim 4 recites a limitation of a composition of material being used rather than reciting any structural limitation on the apparatus. The “85 to 97% by weight of hyaluronic acid” reflects an intended composition suitable for producing a particular product and does not require any further structural modification of the claimed apparatus. The same apparatus is equally capable of processing different compositions as well. As held in In re Young, limitations directed to the intended use of an apparatus missing a corresponding structural change or limitation do not have a patentable weight.
Regarding Claim 5: Claim 5 recites a limitation to a part of the multi-layer patch of claim 1 which is not part of the apparatus rather it’s an article being worked upon. This limitation reflects an intended use and lack patentable weight.
Hiroaki et al. disclose a patch manufacturing method and a patch manufacturing device which is comprised of a coating unit (10) (dispenser) which has multiple coating application heads (11) with multiple nozzles (12) to apply liquid to base sheet (90) and the coating heads are properly guided by a control unit (40) depending on the position of the sheet. [para 0047, 0065, 0073; fig 2 and 4].
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Diagram 4
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Diagram 5
Regarding Claim 6: Claim 6 recites a limitation to a part of the multi-layer patch of claim 1 which is not part of the apparatus rather it’s an article being worked upon. This limitation reflects an intended use and lacks patentable weight.
Regarding Claim 7: Hiroaki et al. disclose a patch manufacturing method and a patch manufacturing device which is comprised of a control unit (40) (controller) that reads a pattern and controls the on/off timing (interval) of all the nozzles (12) provided on the (12) application heads (11) for applying chemical solution (functional material) to the sheet (90). [para 73] [fig 1 and 5]
Regarding Claims 9 and 10: Hiroaki et al. disclose a patch manufacturing method and a patch manufacturing device comprised of a drying unit (50) (heat supply unit) for drying the base sheet with applied chemical solution (functional material). The drying unit uses dry air or heated air for heating/drying. The drying unit could also be an infrared dryer. [para64]
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Diagram 6
4. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hiroaki et al. (JP2011012010A) in view of Hanayo et al. (JP2010207613A) as applied to claim 1 and 6 above, and further in view of Lee et al. (KR20130125954A).
Regarding Claim 8: Hiroaki et al. disclose a patch manufacturing device comprised of a control unit (40) (controller), which is a CPU, that controls the chemical solution ejection position of application head (11) so that droplets of chemical solution (functional material) are sprayed accurately on base sheet (90) as described in paragraph 3 above. Hiroaki et al. and Hanayo et al. do not specifically disclose a sensor to measure thickness of films.
However, Lee et al. teach a thickness measuring device (100) and it is comprised of a sensor (thickness sensor) (120) that can measure thickness of film (131) in real time simultaneously with the drying of the applied film. The sensor can further be connected to the control unit like that of Hiroaki et al. through a bus line [para 0067 Hiroaki et al] so that the controller unit works as a memory device to store information given by the sensor [para 0030 Lee et al.]. It would have been obvious for one of ordinary skill in the art before the effective filling date of the claimed invention to include a sensor like that of Lee et al. to measure thickness of film in real time simultaneously with the drying of the applied film and include it into the invention of Hiroaki et al, as mentioned above, because Lee et al. teach that the use of a sensor determines the uniformity of the film in real time, and optimal drying conditions can be set based on the measurement of the film uniformity.[see para 0039 Lee et al.].
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Diagram 7
Response to Arguments
5. Applicant's arguments filed on 02/24/2026 have been fully considered but they are not persuasive. Applicant argues:
Independent claim 1 teaches a multi-layer patch film and its features. The limitations directed to the multi-layer patch film should be considered. Without the patch the physical configuration of the dispenser itself cannot be established
The combination of Hiroaki and Hanayo fail to teach the limitations in amended claim 1 filed on 02/24/2026
Applicant's Claim 1 is fundamentally different from the invention of Hiroaki because claim 1 teach a dispenser-based application while Hiroaki teach a droplet jetting application
Hiroaki do not suggest or disclose a one-to-one structural correspondence between nozzles and guide holes.
The apparatus of claim 1 performs application operation on a mechanically aligned guide hole and Hiroaki performs a software-based pattern-controlled application
Hanayo does not teach a cover film and resin film removed by Hanayo is not cover film
Hanayo does not teach an application process and the Hanayo reference does not have any technical motivation -absent impermissible hindsight reasoning- to apply peeling roll and winding shaft of Hanayo into the pre-application stage of hiroaki.
In Response:
a: Any feature of the multi-layered patch does not define any limitation of the apparatus. The multi-layered patch is a pre-product and once a functional material is added by an apparatus then the multi-layered patch becomes a product. The base film, guide films, cover films-are all limitation of a pre-product not the apparatus. MPEP 2114 and 2115
Additionally, statement with regard to the limitations of multi-layer patch are directed to intended use and is not further limiting in so far as the structure of the apparatus is concerned. In apparatus claims, a claimed intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. MPEP § 2111.02.
b, d, and e: Hiroaki do not specifically mention “simultaneous application” but the device can perform simultaneous application of coating. Paragraph 73 teaches the control unit controls the on/off timing of all the nozzles 12 provided on the application heads 11 which means the nozzles can be used for application at the same time. Therefore, the apparatus can perform simultaneous application of a coating material. [see paragraphs 73-75]
The coating application of all coating head 11 with nozzles 12 is controlled by a control unit 40. There is also a position sensor 70 that detects the position of the substrate 90 and based on the positioning of substrate, the control unit 40 adjusts the positioning of coating head 11 so that proper coating can be applied. Such way of positioning corresponds to the positioning of coating heads 11 on top of substrate with claimed guide holes [see paragraph 65 of hiroaki].
Additionally, coating pattern 82 describes a pattern of the area where chemical solution is going to be applied. Also, the patterning can be freely adjusted by changing the settings of the coating pattern 82. Furthermore, the size of the coating area can be freely adjusted by changing the size of the coating pattern 82 [para 75].
It means that a coating pattern as shown below can be achieved where there would be circular structures on a substrate and each circle would have a corresponding nozzle on top and a coating pattern can be achieved. Coating head 11 with nozzles 12 can apply a coating material to the corresponding circles at the same time as Hiroaki teaches that control unit controls application process of all nozzles 12 and can apply material at the same time to each circle.
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The pattern 82 can make patterns similar to configuration of the 'guide holes' and perform coating application.
Mechanically aligned guide holes is a limitation of the patch and Hiroaki's apparatus can coat a substrate that are mechanically aligned. The coating can be done by setting a pre-determined pattern on pattern 82.
c: Hiroaki teach a jetting application in an embodiment. However, the apparatus can also perform dispenser-based application as taught in a different embodiment (check para 105 Hiroaki)
f: Hanayo teaches peeling roller 17 that removes a resin film 16a on top of substrate 16. The resin film 16a is separated from substrate 16. Afterwards, shaft 18 winds the resin film 16a. This is structurally and functionally identical to the claimed separation roller, which removes a cover film from a patch and collects the cover film in a roller. The rejection is directed to the device, not directed to the particular article being processed or the purpose of the removal. The device is directed specifically to a roller mechanism that peels and collect a film. (MPEP 2114 and 2115)
The distinction of Hanayo’s invention on the basis that Hanayo’s roller removes a cover film prior to an ‘application process’ to reduce exposure is not persuasive to the claimed structure. Whether the film is an ‘unnecessary support film’ or removed after lamination does not change the underlying mechanical operation of the device. Hanayo’s peeling roller 17 and shaft 18 performs the same function of peeling and collecting as the claimed separation roller and collection roller.
g: The argument that Hanayo does not teach an application process and the Hanayo reference does not have any technical motivation -absent impermissible hindsight reasoning- to apply peeling roll and winding shaft of Hanayo into the pre-application stage of Hiroaki is not persuasive.
The rejection does not rely on hindsight reasoning. The motivation to incorporate Hanayo’s roller 17 and shaft 18 into Hiroaki’s invention was done so that a film can be removed and collected as explicitly taught by Hanayo [see paragraph 53 of Hanayo for motivation]. A person having ordinary skill in the art (PHOSITA) studying Hiroaki’s device, which applies a coating to base sheet but does not address the mechanism for removing a film and collecting the film prior to a coating application process would have recognized an obvious structural gap. A PHOSITA would have been motivated to look into the mechanical function of Hanayo’s peeling roll and winding shaft as a known proven solution for fulfilling the peeling and winding a film and incorporated those structures. Placing a known film removal and collection mechanism before a coating application rather than after coating application is a predictable modification.
A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
Additionally, in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
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 Wasiqul Haq whose telephone number is (571)272-9973. The examiner can normally be reached Monday-Friday, 9am-5pm ET.
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/WASIQUL HAQ/Examiner, Art Unit 1717
/Dah-Wei D. Yuan/Supervisory Patent Examiner, Art Unit 1717
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