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 .
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Takehara US Patent Application Publication 2019/0015296.
As to claim 1, Takehara teaches a method for promoting physiological action, the method releasing air containing high- concentration hydrogen to a periphery of an eye – where Takehara teaches supplying hydrogen to the areas around both eyes and the eyeballs while warming the eyelids (Figs. 1-2A; Abstract, paras. 0001, 0005, 0011, 0012, 0054). Takehara teaches the method promotes circulation of blood flow around the eyes (para. 0058). However, Takehara does not teach percutaneous absorption of hydrogen. In Takehara, the hydrogen gas is formed by a reaction between aluminum hydride powder and reaction water that is stored in a supply pack 11 in a storage pocket 7 in the eye mask main body 1 (Figs. 3A-5A; para. 0027-0028). The hydrogen gas reaches tears covering the surfaces of the eyeballs of both eyes of the user, and slowly penetrates the tears, whereby the tears are saturated with the hydrogen gas. The tears are changed into a fluid approximating hydrogen water and having high hydrogen density, similar to the administration of eye drops. The hydrogen molecules catch malignant active oxygen present in the area surrounding the retinas and discharge the active oxygen from the body of the user (para. 0011). The supply pack 11 contains an absorptive polymer to absorb fluids from the eye. The therapeutic effect is achieved as the hydrogen gas is slowly transferred from the eye mask-type hydrogen supply device to the eyelids of the user in order to warm the area surrounding both eyes and the eyeballs of the user. As a result, the circulation of the blood in the area surrounding both eyes and the eyeballs of the user is accelerated (para. 0054). Thus, although Takehara does not specifically teach percutaneous absorption of the hydrogen gas in the eyelids, Takehara does teach the hydrogen gas is directed to the eyelids and areas surrounding the eyes with the same therapeutic effect, promoting orbicularis oculi blood flow, as the present invention. It would have been obvious to one having ordinary skill in the art before the invention was originally filed to have the hydrogen gas released to periphery of an eye, particularly the lower eyelid for percutaneous absorption of the hydrogen to promote orbicularis oculi blood flow.
Claims 2-5, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Takehara US Patent Application Publication 2019/0015296 in view of Free Radical Research “The preventive and therapeutic effects of molecular hydrogen in ocular diseases and injuries where oxidative stress is involved”(March 19, 2019).
With respect to claims 2-5, 9, and 10, Takehara does not teach the hydrogen gas therapy reduces brain fatigue, enhance brain functions (improve age), or promote oxytocin secretion. Free Radical Research teaches the use of molecular hydrogen (H2) for therapy in ocular diseases. Free Radical Research teaches apart from its antioxidant effects, H2 also displays anti-inflammatory, antiapoptotic, cytoprotective and mitohormetic properties. Free Radical Research teaches studies have shown that the suppression of oxidative stress by H2 treatment leads to the prevention or improvement of ocular diseases. In severe degenerative diseases, H2 slows disease progression (Abstract, Free Radical Research). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to use hydrogen gas therapy for the claimed benefits since hydrogen therapy is known for treating ocular diseases as taught in the cited Free Radical Research article.
As to claim 2, the method for promoting physiological action according to claim 1, wherein the air containing high-concentration hydrogen is released to a lower eyelid part - where Takehara teaches the hydrogen supply device is brought into direct contact with the region between the eyebrows of the user and the area surrounding both eyes of the user which includes the lower eyelid part (Figs. 1-2A; paras. 0001, 0005, 0011, 0012, 0054). Takehara teaches the method promotes circulation of blood flow around the eyes (para. 0058).
As to claims 3-5, 9, and 10, Takehara teaches the method for promoting physiological action according to claim 1, wherein the air containing high-concentration hydrogen is released to the periphery of the eye where Takehara teaches supplying hydrogen to the areas around both eyes and the eyeballs while warming the eyelids (Abstract, paras. 0001, 0005, 0011, 0012).
Claim 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Skiba et al. US Patent Application Publication 2002/0124843.
As to claim 6, Skiba teaches goggles 100/500 for supplying a medicine-carrying fog (Abstract), comprising:
a goggle body for integrally covering and sealing a periphery of both eyes including at least a lower eyelid part of a user (Figs. 1-5; para. 0038)
a temple member 502 coupled with both side parts of the goggle body, to be hooked on both ears of the user (para. 0048); and
a hydrogen releasing part 508 arranged at positions near both lower eyelid parts of the user inside the goggle body (Fig. 5; para. 0048), having a pair of hydrogen releasing openings 508 directed to each of the both lower eyelid parts, which are fluidly coupled with a discharging side end part of a tubular tube member 510 connected to an external apparatus 512. Skiba further teaches the mask face frame 506 may also be hollow such that hollow ear support members 502 are in fluid communication with frame 506. Frame 506 may be perforated intermittently along the surface of the frame 506 proximate a patient’s eyes to provide fog outlets 508 (para. 0048).
Skiba does not teach the nebulizer 512 is hydrogen generating. However, Skiba teaches nebulizing unit 512 may include one or more medication chambers, one or more liquid atomizer such an ultrasonic atomizer or a nozzle, and a propellant source such as a pump or a compressed gas canister (Fig. 5; para. 0049). It would have been obvious to one having ordinary skill in the art to provide a hydrogen gas in the medication chamber of Skiba since the medicine-carrying fog mask of Skiba is from the same field of endeavor and solves the same problem of treating ocular disease by administering a medicament to a patient’s eyes by a gas.
As to claim 8, Skiba teaches the goggles for supplying hydrogen according to claim 6, wherein the goggle body comprises an edge part 506 which contacts a periphery of an eye of the user, and seals an inside and an outside of the goggle body (para. ), while providing a space between a front lens part 504 and the periphery of the eye, the hydrogen releasing part 508, which is adjustable to a position corresponding to each of the both lower eyelid parts, is arranged on a goggle body lower part side of the edge part (Fig. 5), and each hydrogen releasing part is fluidly connectable using a detachable short tube member 510, and either of the hydrogen releasing openings is fluidly connectable with a through hole – ear supports 502, using another detachable short tube member – where each ear support 502 has a detachable short tube member 510 (Fig. 5). Skiba teaches the fog outlets 508 are provided in the periphery of the eye corresponding to the lower eyelid (Fig. 5 ; para. 0048). Skiba teaches the perforated mask frame 506 is in fluid communication with the hollow ear support members 504, which are in fluid communication with the nebulizing unit 512, which transmits medication-carrying fog to ear supports 502 (para. 0048). Skiba does not teach the medication is a high-concentration hydrogen. It would have been obvious to one having ordinary skill in the art to provide a hydrogen gas in the medication chamber of Skiba since the medicine-carrying fog mask of Skiba is from the same field of endeavor and solves the same problem of treating ocular disease by administering a medicament to a patient’s eyes by a gas.
Allowable Subject Matter
Claims 7 and 12 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.
The following is a statement of reasons for the indication of allowable subject matter: As to claim 7, the prior art, Skiba does not teach the structure recited in the claim, specifically the temple member being coupled by a coupling of a tip of each temple member with the coupling member and a pedestal part as claimed. Claim 12 depends from claim 7.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Schwenk et al. US 2022/0152369 is cited to show a wearable system and method for gas delivery to an exterior of an eye. Berdahl et al. US 2021/0153741 is cited to show an apparatus to treat, inhibit, or prevent an eye condition where the apparatus includes a cavity and a pressure source and is configured to vary non-ambient pressure applied to the cavity to affect a targeted pressure relationship between an indication of a first physiological pressure level and a second physiological pressure level associated with the eye of the patient.
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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781
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