DETAILED ACTION
Notice of Pre-AIA or AIA Status
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 present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/17/2026 has been entered.
Claim Status
Applicant’s amendment of 02/17/2026 is acknowledged. Claims 1, 3, 9, and 11 are amended; claims 10 and 15-16 are cancelled; and claims 20-21 are new. Claims 1-9, 11-14, and 17-21 are currently pending and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/JP2021/003233 filed on 01/29/2021 and claims foreign priority to JP2020-069396 filed on 04/07/2020 as reflected in the filing receipt dated on 03/31/2023. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Withdrawn Objections and Rejections
Applicant’s amendments to the claims have overcome/rendered moot the previous 112(b) rejections. Thus, the rejections are hereby withdrawn.
The grounds of rejection presented herein under 103 are new/revised in accordance with Applicant’s amendment and introduction of new claims. Applicant’s arguments insofar as they pertain to the revised grounds of rejection are addressed herein.
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.
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.
Claims 1-3, 5-9, 11-14, and 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Mori et al. 2006 (JP2006028158A; IDS of 10/06/2022) in view of Tsuru et al. 2018 (US20180036255A1; PTO-892 of 04/16/2025), Mori et al. 2010 (JP2010202609A; IDS of 10/06/2022; Translation relied upon for the following rejection is cited in PTO-892 of instant action), Ishii et al. 2007 (JP2007269712A; IDS of 10/06/2022; Translation relied upon for the following rejection is cited in PTO-892 of 04/16/2025), and Sandolo et al. (Food Hydrocolloids, 23, p. 210–220; published: 01/11/2008; PTO-892 of 11/17/2025).
Mori 2006 discloses a body patch sheet, in which a sheet obtained by laminating a carbon dioxide-impermeable film and a nonwoven fabric, wherein the non-woven fabric retains a liquid or gel containing carbon dioxide and moisture, is enclosed in a carbon dioxide-impermeable container [0008]. Crosslinked hydrous gels can be composed of water-soluble polymers and a crosslinking agent [0023], which read on components (A) and (B), respectively, of the hydrogel recited in claim 1. The water the water content of gel is preferably 60% to 99.5% by mass [0017], which reads on component (C) of the hydrogel recited in claim 1 and overlaps the range recited in claim 19. The body patch sheet has preventive and therapeutic effect for skin diseases and a cosmetic effect by applying carbon dioxide to the skin to promote blood circulation [0001].
In an exemplary embodiment [0031-0032, example 3], a sheet is obtained by forming a gel layer on a nonwoven fabric. Sodium polyacrylate, which is a water-soluble anionic polymer, crosslinked polyacrylic acid, and methylparaben were added to concentrated glycerin and after stirring and suspending, water, plant extract, and aluminum hydroxide were blended to form a gel-like acrylic acid polymer, which reads on the mixing step recited in claim 6. Aluminum hydroxide, which is a hydroxide metal ion compound including aluminum, reads on the crosslinking agent of 3, 17, and 18. The gel composition is then spread on the nonwoven fabric surface to form a gel sheet [0031], which reads on instant step (1) preparing an article including a hydrogel, comprising applying the hydrogel onto a support as recited claims 1 and 12.
Then, the sheet was place in an aluminum pillow, which reads instant step (2) of housing the article including the hydrogel inside a package recited in claim 8 [0033]. Subsequently, carbon dioxide was injected into the pillow, which reads on the supplying a carbon-dioxide containing gas limitation of claim 8, and then the pillow was sealed, which reads on the package sealing limitation of instant step (2) recited in claims 1 and 8 [0033]. Lastly, the sheet was aged in a pillow for one week, also written as 168 hours [0033].
Regarding the amount of water recited in claim 19, it would have been obvious to one of ordinary skill in the art before the effective filing date of claimed invention to adjust the amount of water within the range disclosed by Mori 2006 because the reference teaches than any amount between 60% to 99.5% by mass is preferable for forming crosslinked hydrogels. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
However, Mori 2006 does not explicitly teach the loss tangent of the hydrogel recited in (1) and (2) of claims 1, 5, and 7; adjusting the carbon dioxide gas concentration in the ambient atmosphere of the hydrogel as recited in (2) of claims 1 and 7; or that the crosslinking of the hydrogel proceeds for 96 to 366 hours at atmospheric temperature until the loss tangent falls in the ranges recited (3) of claims 1, 9, and 11. Further, Miro does not expressly teach the species of water-soluble polymer recited in claims 1, 20, and 21, the limitations regarding carbon dioxide gas-containing bubbles recited in claim 1, that (3) is performed at atmospheric temperature for 96 to 366 hours as recited in claim 1, that (2) is performed at atmospheric temperature and pressure as recite din claim 2, that the mixing step of (1) is performed at atmospheric pressure as recited in claim 6, or the time and speed recited in claims 13 and 14, respectively.
Tsuru teaches a method for producing a gel patch comprising applying a composition comprising a water-soluble polymer, glycerin, and water to a backing fabric to form an adhesive mass layer, wherein a loss tangent of the composition in dynamic viscoelasticity measurement at 1 Hz at the time of application to the backing fabric is 0.75 to 1 [0009].
Mori 2010 teaches preparation of a bubble-containing gel sheet A for supplying gas to the skin, wherein gel components are mixed and stirred for 7 minutes, then magnesium aluminometasilicate, which is a crosslinking agent as evidenced by the instant specification para. 0048, was added and stirred for an additional 30 seconds to create a bubble-containing gel [0001-0002; 0040]. Mori 2010 specifies that ingredients of a different gel, sheet C, are mixed under reduced pressure of -0.09 MPa and then returned to normal pressure [0043], suggesting that the ingredients of sheet A are indeed mixed under normal pressure. The gel was placed on a nonwoven fabric surface and allowed to stand at room temperature for 2 days to crosslink and gel, forming a film [0040]. Then, sheet A was enclosed in an aluminum pillow together with 100% carbon dioxide, closed with an impulse sealer, and left at room temperature [0044]. While the unit of measurement of the concentration of carbon dioxide is not specified, one of ordinary skill in the art would interpret the concentration of a gas to be percent volume unless otherwise specified.
Ishii teaches a peelable pack cosmetic comprising a film-forming temperature-sensitive polymer, a water-soluble polymer with gelling ability, glycerin, an oil, and water, which form a film-like gel that retains sufficient moisture on skin [0012]. Ishii further teaches that is preferable to adjust the contents of the components of the peelable gel such that the loss tangent (tan δ) at 45°C is 0.2 or less to ensure that stability and strength during storage at low temperature is high. Ishii further teaches that the dynamic viscoelasticity is measured using a rotational rheometer at an observation frequency of 1 Hz [0014-0015]. According to Figure 1 (original figure found on Page 30 of the corresponding file uploaded in the IDS of 10/06/2022), when Examples 1 and 2 of Ishii are at 45°C and have a loss tangent of less than 0.2, the same samples have a loss tangent of between 0.2 to 0.4 at 25°C. While a translation of Figure 1 was not provided in the IDS of 10/06/2022, a copy of the translated figure has been added to the end of the document and cited in the PTO-892 for clarity of the record.
Sandolo evaluates parameters affecting the viscoelastic properties of a water-soluble polymer-based hydrogel, such as time needed to reach the sol-gel transition, which could allow the preparation of different kinds of hydrogels by controlling different experimental conditions [pg. 210-211, introduction]. The work of Sandolo supports that at a constant temperature of 25°C, the loss tangent, tan δ, is a result-effective variable that decreases gradually with time, indicating that a hydrogel system has transformed towards the viscoelastic solid state [pg. 216, r. col.; fig. 7a].
Regarding the loss tangent of the hydrogel recited in (1) and (2) of claims 1, 5, and 7, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to manipulate the hydrogel in the method taught by Mori 2006 such that the loss tangent at 1 Hz in dynamic viscoelasticity of the hydrogel is between 0.75 to 1, as taught by Tsuru, because the reference teaches that a hydrogel with loss tangent within this range prevents oozing of the hydrogel components during production of a gel patch [Tsuru, 0010]. The loss tangent range of Tsuru lies within the ranges recited in instant claims 1 and 7 and overlaps the range recited in instant claim 5. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05. One of ordinary skill in the art would have a reasonable expectation of success because, like the hydrogel article of Mori 2006, the gel patch of Tsuru comprises a water-soluble polymer, glycerin, water, and a backing fabric.
Regarding the carbon dioxide concentration recited in (2) of claims 1 and 7, it would have been obvious to one of ordinary skill in the art to adjust the ambient atmosphere of the gel sheet during the injection and sealing step in the prior art method by increasing the carbon dioxide gas concentration to 100% volume as taught by Mori 2010, which lies within and thus renders obvious the instantly claimed ranges, because the reference teaches that concentration of carbon dioxide is suitable for producing a sealed package containing a gel sheet with carbon dioxide bubbles.
Regarding the crosslinking duration and loss tangent of the hydrogel recited in (3) of claims 1, 9, and 11, it would have been obvious to one of ordinary skill in the art to one of ordinary skill in the art to perform the crosslinking step at room temperature and manipulate the crosslinking time of the hydrogel in the prior art method through routine optimization to ensure that the loss tangent at 1 Hz in dynamic viscoelasticity of the hydrogel is between 0.2 to 0.4 because the Ishii teaches that a loss tangent in this range ensures stability and strength during storage. The teachings of Sandolo clearly recognize that crosslinking duration is a result-effective variable used to achieve a desired viscoelastic state. While the exact time required to reach a desired loss tangent is unique to the specific composition of the hydrogel system, it would have been customary for an artisan of ordinary skill to determine the optimal crosslinking time using conventional methods in the field. The loss tangent range of Ishii lies within the ranges recited in claims 1 and 11 and overlaps the range recited in claim 9, thus rendering obvious these limitations. Regarding the temperature recited in claim 1, “room temperature” reasonably corresponds to 25°C as evidenced by the instant specification para. 0055, which lies within the range corresponding to “atmospheric temperature” of 10°C to 35°C as evidenced by the instant specification para. 0011 and thus renders obvious the limitation.
Regarding the water-soluble polymer of claims 1, 20, and 21, Mori 2010 further teaches a limited list of water-soluble polymers suitable for forming aqueous gels, including polyacrylic acids, polymethacrylic acids, carboxymethylcellulose, etc. [0019]. Mori 2006 teaches sodium polyacrylate as a suitable form of polyacrylic acid used to make its example 3 gel [0023; 0031]. It would have been prima facie obvious to one of ordinary skill in the art to substitute the sodium polyacrylate in the hydrogel of the prior art method with either carboxymethylcellulose or polymethacrylic acid, depending on the desired chemical and mechanical properties of the hydrogel, because these anionic water-soluble polymers are art-recognized as suitable alternatives for forming hydrogels used for the same purpose, i.e., delivering carbon dioxide gas to the skin.
The Examiner notes that while the translation of Mori 2010 filed with the IDS of 10/06/2022 does not appear to teach the above cited “carboxymethylcellose” feature, a copy of the translated document (also retrieved from Espacenet), which clearly names carboxymethylcellulose as an exemplary water-soluble polymer in paragraph 0019, has been cited in the PTO-892 for clarity of the record.
Regarding carbon dioxide bubbles recited in claim 1, the method taught by the prior art combination is silent as to the total area of carbon dioxide bubbles having virtual diameters of 5 mm or greater relative to the hydrogel’s surface. However, Mori 2010 further teaches that from the standpoint of gas retention, sheet strength and flexibility, and usability such as fit and conformability, it is preferable that the size of the gas bubbles in the gel are in the range of 0.01 to 2 mm [0013]. Thus, it would have been obvious to one of ordinary skill in the art to manipulate the sizes of the carbon dioxide bubbles in the prior art method to ensure that they have diameters within the range of 0.01 to 2 mm in order to achieve adequate gas retention, gel strength and flexibility, and usability. As such, the total area relative to the hydrogel’s surface of carbon dioxide gas-containing bubbles having virtual diameters of 5 mm or greater would be zero, which lies within the instantly claimed area of 10% or less.
Regarding claim 2, Mori 2010 further teaches that the pressure of the gas filled in the packaging pillow, or the container internal pressure during storage, is preferably 0.09 to 0.12 MPa at 25°C [0031]. It would have been obvious to one of ordinary skill in the art to perform both the injection and sealing step of the prior art method at the temperature and pressure taught by Mori 2010 because the reference teaches such conditions are preferable for forming a gas-filled package comprising a gel sheet (e.g., a hydrogel article). The ranges of Mori 2010 respectively overlap the value corresponding to atmospheric pressure of 0.1 MPa and lie within the range corresponding to atmospheric temperature of 10°C to 35°C, as evidenced by the instant specification para. 0011. As discussed above, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists.
Regarding claims 6 and 13, it would have been obvious to one of ordinary skill in the art to modify the mixing step of the prior art method by using a mixing time of 30 seconds at normal, i.e., atmospheric, pressure as taught by Mori 2010 (gel sheet A), which closely approaches the time range recited in claim 13, as a starting point for routine optimization when mixing the water-soluble polymer, the cross-linking agent, and the water because the reference teaches that time and pressure is suitable for producing a gel containing a particular bubble content. A prima facie case of obviousness exists where the claimed ranges or amounts “do not overlap with the prior art but are merely close” such that “one skilled in the art would have expected them to have the same properties”. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Note: MPEP 2144.05(I).
Regarding claim 14, while the prior art combination is silent as to the speed used to mix the water-soluble polymer, the cross-linking agent, and the water, it would have been obvious to one of ordinary skill in the art to determine the optimal stirring speed through routine methods. One of ordinary skill in the art would have been motivated to manipulate the stirring speed to achieve an optimal bubble ratio as taught by Mori 2010. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Absent of a demonstration of criticality of the claimed speed for mixing, differences in speed of mixing will not support the patentability of subject matter encompassed in the prior art. Note MPEP 2144.05(II)(A).
Claims 1-9, 11-14, and 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Mori et al. 2006 (JP2006028158A; IDS of 10/06/2022) in view of Tsuru et al. 2018 (US20180036255A1; PTO-892 of 04/16/2025), Mori et al. 2010 (JP2010202609A; IDS of 10/06/2022; Translation relied upon for the following rejection is cited in PTO-892 of instant action), Ishii et al. 2007 (JP2007269712A; IDS of 10/06/2022; Translation relied upon for the following rejection is cited in PTO-892 of 04/16/2025), and Sandolo et al. (Food Hydrocolloids, 23, p. 210–220; published: 11/01/2008; PTO-892 of 11/17/2025), as applied to claims 1-3, 5-9, 11-14, and 17-21 above, and further in view of SVW Wrappings Pvt. Ltd. 2018 (PTO-892 of 04/16/2025).
The combination of Mori 2006, Tsuru, Mori 2010, Ishii, and Sandolo teach the invention(s) of claims 1-3, 5-9, 11-14, and 17-21 as discussed in detail above and further incorporated herein.
While the combination of Mori 2006, Tsuru, Mori 2010, Ishii, and Sandolo teaches arranging the gel sheet between a carbon dioxide-impermeable aluminum pillow and supplying carbon dioxide into the pillow prior to sealing, the references do not expressly teach the limitations of claim 4 drawn to the specific manner of joining the lateral and intersecting sides of the aluminum to form a continuous package which is then cut to form the package.
SVW Wrappings Pvt. Ltd. teaches a four side sealing machine, wherein the sealing style packaging appearance is flat and seals the packet from all four sides, which is mostly used in the pharmaceutical and cosmetics industry to package products such as facial masks, wet tissues, and sponge wipes, among others [pg. 4]. As shown in the dimensional drawing [pg. 4], the product moves from left to right down a feeding conveyer where it is arranged between a top first wrapping sheet and a bottom second wrapping sheet [shown more clearly in the figure on pg. 3]. In this state, the lateral sides of the top first wrapping sheet and bottom second wrapping sheet are joined by the side sealing unit, wherein the lateral sides of the sheets are extending along the transporting direction [pg. 4, dimensional drawing]. The excess wrapping at the lateral sides is trimmed at the wrapper slitting unit [pg. 4, dimensional drawing]. Finally, at the end sealing and cutting unit, the first top wrapping sheet and the bottom second wrapping sheet are joined in a direction intersecting with the transporting direction at a position where the product is not present, thereby forming a continuous package in which the product is enclosed, and the continuous package is cut in a direction intersecting with the transporting direction at a region joined by the second joining to form a package [pg. 4, dimensional drawing]. SVW Wrappings Pvt. Ltd. further discloses that the wrapping material can include heat sealable laminates containing aluminum foil [pg. 5].
Regarding claim 4, 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 method taught by the combination of Mori 2006, Tsuru, Mori 2010, Ishii, and Sandolo by utilizing the four side sealing machine taught by SVW Wrappings Pvt. Ltd. to form the carbon dioxide-impermeable aluminum pouch in which the gel sheet and carbon dioxide gas are enclosed. One of ordinary skill in the art would have been motivated to use the four side sealing machine to produce hydrogel articles efficiently because SVW Wrappings Pvt. Ltd. teaches that the machine is overall durable, practical, low maintenance, and affordable [pg. 6]. One of ordinary skill in the art would have a reasonable expectation of success because SVW Wrappings Pvt. Ltd. teaches that the machine is mostly used in the cosmetics industry to package similar cosmetic products such as facial masks, wet tissues, and sponge wipes using heat sealable laminates containing aluminum foil.
Response to Arguments
Applicant’s arguments submitted on 02/17/2026 with respect to rejections under 35 U.S.C. 103 have been fully considered in so far as they apply to the new or modified rejections of the instant Office action, but were not found to be persuasive.
Applicant argues that the cited references do not teach or suggest the features presently amended into claim 1. This argument was not found to be persuasive in view of the cited reference Mori 2010.
First, the reference clearly teaches that carboxymethylcellose and polymethacrylic acid are suitable anionic water-soluble polymer alternatives to polyacrylic acid when synthesizing carbon dioxide-containing hydrogels to be used for the same purpose. Because Mori 2006 categorizes sodium polyacrylate as a suitable form of polyacrylic acid used to make its gel [0023; 0031], substituting one art-recognized water-soluble polymer for another would be prima facie obvious depending on the desired properties of the hydrogel.
Additionally, as discussed in detail above and contrary to Applicant’s argument that Mori 2010 “merely teaches a relationship between the size of the bubbles and the replaceability of a gas filled in a container in which the sheet is enclosed” and “does not provide any consideration from the viewpoint of supplying carbon dioxide gas to the skin”, Mori 2010, whose entire invention is drawn to supplying gas to the skin through a gel sheet, provides reasonable motivation to ensure that all gas bubbles within the gel are between 0.01 to 2 mm in size, i.e., diameter, which would result in the total area relative to the hydrogel’s surface of carbon dioxide gas-containing bubbles having virtual diameters of 5 mm or greater being zero, thus meeting the instant claim limitations.
Regarding Applicant’s argument that Mori 2010 does “not describe which sizes of bubbles are contained in the sheet”, this argument was not found to be persuasive. The reference clearly teaches that “such bubbles” having sizes in the range of 0.01 to 2 mm can be formed by, for example, stirring during the formation of the gel layer [Mori 2010, 0013], clearly indicating that bubbles of the disclosed size range are in fact contained in the gel sheet and, consequently, provide adequate sheet strength and flexibility, etc. as discussed in the prior art rejections above.
In view of the foregoing, the prior art rejections of record are maintained.
Conclusion
No claim is allowed.
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/SARAH C WISTNER/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616
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