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
The amendments and arguments filed 15 December 2025 are acknowledged and have been fully considered. Claims 1-3 and 5-20 are currently pending. Claims 1, 5, 7, and 9 are amended; claim 4 is cancelled; claims 10-18 are withdrawn; claims 19-20 are new.
Claims 1-3, 5-9, and 19-20 are examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. In particular, the rejection of claims under 35 U.S.C. 102 is withdrawn in view of Applicant’s amendment to the claims. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
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.
Claims 1-3, 5-6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Safonov (US 2019/0308001; of record) in view of Faasse et al. (US 2021/0086933; of record) and Liu et al. (Dermatologic Therapy, 2015, Vol. 28, 373-382; of record).
Claim 1 is drawn to a device for supplying hydrogen to a body surface, said device comprising:
a dry chemical separated from a solution;
said dry chemical and said solution housed in a container;
wherein said container comprises a hydrogen impermeable top outer layer;
wherein said container comprises a hydrogen permeable bottom inner layer;
wherein a hydrogen-producing reaction is initiated by destructing at least a portion of the container such that the dry chemical and solution can be mixed;
wherein said hydrogen impermeable top outer layer is laminated or sputtered with aluminum to prevent release of hydrogen into atmosphere;
wherein said hydrogen permeable bottom layer is lubricated with an oil-containing lotion to facilitate saturation of the oil-containing lotion with hydrogen for improved diffusion into a target body tissue.
Claim 2 is drawn to the device of claim 1 wherein said container comprises a destructible separating component.
Claim 3 is drawn to the device of claim 1, wherein said solution is stored in a destructible packet.
Safonov teaches hydrogen delivery systems for the topical application of molecular hydrogen (Abstract). Safonov further teach in claim 1 the system comprising a housing enclosing a dry chemical and a liquid composition separate from the dry chemical, wherein the housing has a first surface configured to be adjacent to the skin that is hydrogen permeable, and the housing is configured to be activated to cause the liquid composition to come into contact with the dry chemical to cause a hydrogen generating reaction. Safonov further teaches in claim 12 the housing having a hydrogen impermeable side opposite the hydrogen permeable side. Safonov further teaches in Fig. 2C the liquid solution being contained within a capsule (206’) that can break to release its contents (Par. [0058]), reading on the destructible separating component and destructible packet of claims 2-3.
As such, Safonov teaches a device for supplying hydrogen to a body surface, said device comprising: a dry chemical separated from a solution; said dry chemical and said solution housed in a container; wherein said container comprises a hydrogen impermeable top outer layer; wherein said container comprises a hydrogen permeable bottom inner layer; wherein a hydrogen-producing reaction is initiated by destructing at least a portion of the container such that the dry chemical and solution can be mixed.
The device of Safonov differs from the instantly claimed device in the following ways:
Safonov does not teach the hydrogen impermeable top layer being laminated or sputtered with aluminum; and
Safonov does not teach the hydrogen permeable bottom layer being lubricated with an oil-containing lotion.
Yet, as to 1: Safonov teaches the hydrogen impermeable portion being formed from any suitable material, and more than one material being used to make the housing (Par. [0032]), indicating that any hydrogen impermeable material is suitable for forming the device.
Faasse et al. teach packaging materials for medical devices (Par. [0003]) including gas impermeable materials (Par. [0013]). Faasse et al. further teach materials comprising laminated polymers and metal foils (Pars. [0051-52]), more specifically aluminum foil (Par. [0013]).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Safonov to included the aluminum laminated polymer material of Faasse et al. for the hydrogen impermeable side. It would have been obvious to substitute one gas impermeable material suitable for use in a medical device for another, with a reasonable expectation of success.
And, as to 2: Safonov further teaches the hydrogen delivery system being used to treat psoriasis (Par. [0086]) and the skin-facing surface (i.e., the hydrogen permeable surface) being treated with a compound such as a moisturizing cream (Par. [0089]).
Liu et al. teach application of a moisturizing cream for the treatment of psoriasis (Abstract). Liu et al. further teach the moisturizer comprising safflower seed oil and rice bran oil (Pg. 375 left column last paragraph).
And as discussed in MPEP 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
In the instant case, both the hydrogen delivery system of Safonov and the oil comprising moisturizing cream of Liu et al. are taught to be suitable for treating psoriasis. Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have combined the hydrogen delivery system with the moisturizing cream to yield a device further suited for treating psoriasis, with a reasonable expectation of success.
The limitation “to facilitate saturation of the oil-containing lotion with hydrogen for improved diffusion into a target body tissue” is an intended use limitation and does not impose further structural limitation. As the hydrogen delivery system of Safonov and Draelos is capable of facilitating saturation of the oil-containing lotion with hydrogen for improved diffusion, it meets the limitation.
Based on all of the foregoing, claims 1-3 are rejected as prima facie obvious.
Claim 5 is drawn to the device of claim 1, wherein a hydrogen-producing reaction is initiated by destructing at least a portion of the container such that the dry chemical and solution can be mixed, and when said dry chemical and solution are mixed, the mixing initiates a chemical reaction to produce hydrogen gas, and wherein said impermeable top outer layer results in virtually no significant diffusion of hydrogen gas through the said impermeable top outer layer during the duration of said chemical reaction.
Claim 5 recites the effects of mixing the dry chemical and solution inside of the container, and imposes no further structural limitations on the device. And as discussed in MPEP 2112.01(I), “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).” As the device of Safonov is substantially identical in structure to the instantly claimed invention, it meets the limitations of claim 5.
Nevertheless, Safonov further teaches “The system is configured to be activated to cause the liquid composition come in contact and react with the at least one dry chemical to thereby cause generation of the molecular hydrogen that passes through the first surface and is delivered to the subject's skin” (Par. [0007]).
As such, claim 5 is rejected as prima facie obvious.
Claim 6 is drawn to the device of claim 5, wherein the hydrogen permeable bottom inner layer is in contact with body tissue, and wherein hydrogen gas diffuses through the hydrogen permeable bottom inner layer into the body tissue.
Claim 6 is an intended use claim and does not impose further structural limitations on the device. Nevertheless, Safonov further teaches “wherein the housing is configured to be activated to cause the liquid composition come in contact and react with the at least one dry chemical to thereby cause generation of the molecular hydrogen that passes through the first surface and is delivered to the subject's skin” (Claim 1.)
As such, claim 6 is rejected as prima facie obvious.
Claim 8 is drawn to the device of claim 1, further comprising an adhesive.
Safonov further teach in claim 11 the attachment element of the device comprising an adhesive.
As such, claim 8 is rejected as prima facie obvious.
Allowable Subject Matter
Claims 7, 9, and 19-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 15 December 2025 have been fully considered but they are not persuasive.
Applicant argues on pg. 7-8 of the remarks that Faasse et al. do not provide any incentive or motivation for using a top layer laminated with aluminum for the purposes of making a hydrogen impermeable layer which will direct all hydrogen downward to the permeable layer.
This argument is not persuasive. Safonov teaches in par. [0032] that the housing can be made of various suitable materials, without providing any limit, further teaching that the side with its outer surface away from the skin can be made from a material not permeable by molecular hydrogen. Faasse et al. teach the use of polymer/metal laminates (pars [0051-52]) including aluminum foil as the metal as gas impermeable material (par. [0013]), these materials being suitable for sterile medical devices and delivery systems (Abstract). And as discussed in MPEP 2141(I), "[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. As substitution of the polymer aluminum foil laminate taught by Faasse et al. as the hydrogen impermeable side for the device of Safonov is nothing more than arranging elements taught in the prior art with each performing the same function it had been known to perform, and yields nothing more than one would expect, the combination is obvious.
Applicant’s submission that “there is suggested benefit or incentive for using the aluminum as claimed” appears to be an assertion of unexpected results.
It is well settled that a showing of unexpected results is generally sufficient to overcome a prima facie case of obviousness. In re Albrecht, 514 F.2d 1389 (CCPA 1975). However, as recognized by the court in In re Schulze, 346 F.2d 600 (CCPA 1965), mere arguments are not sufficient to demonstrate unexpected results. Rather, unexpected results must be established by factual evidence by comparing the claimed invention with that of the closest prior art. In re Burckel, 592 F.2d 1175 (CCPA 1979). As discussed by the court in In re De Blauwe, 736 F.2d 699 (Fed. Cir. 1994), “the absence of tests comparing [Applicant’s claimed invention] with those of the closest prior art… constitute mere argument”.
As Applicant has not compared the claimed invention with the closest prior art (i.e., Safonov) and provided factual evidence, the assertion of unexpected results constitutes mere argument and is insufficient to overcome the prima facie case of obviousness.
Applicant argues on pg. 8 of the remarks that as Safonov already teaches the treatment of psoriasis and Liu et al. offer nothing additional or beneficial to the combination of the device of Safonov, there is no prima facie case of obviousness.
This argument is not persuasive. As discussed in MPEP 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
In the instant case, as the hydrogen generating device of Safonov and the oil containing lotion of Liu et al. are both taught in the prior art to be useful for the treatment of psoriasis, the combination of the two is prima facie obvious in order to form a third composition to be used for the same purpose, to treat psoriasis.
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.
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/PAUL HOERNER/Examiner, Art Unit 1611
/CRAIG D RICCI/Primary Examiner, Art Unit 1611
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