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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/28/2026 has been entered.
Response to Arguments
Applicant’s amendment filed 01/28/2026 is accepted and entered.
Applicant's arguments filed 01/28/2026 have been fully considered but they are not persuasive.
Applicant argues that Wong/Barken does not disclose the one or more barriers comprise a thermally conductive metal portion that is configured to contact the surface of the eye. However, Wong does disclose that the shell of the device can be formed by an inner layer that can be made of steel or lead (¶ [0086-0088]), both of which are metals that have at least some thermal conductivity. Therefore, Wong/Barken discloses the claimed subject matter, as set forth below.
Applicant did not specifically argue the dependent claims.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6, 8, 11, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wong et al (US 2007/0282282) in view of Barken (US 2021/0145500).
Regarding Claim 1, Wong discloses a device (6, Figs. 2-4, 7, 10) for providing a therapeutic effect to an eye (1, Fig. 4) of a subject, the device (6, Figs. 2-4, 7, 10) comprising:
a container (the walls of the shell 6 form a container that allows fluid to circulate through the shell between the fluid inlet 8 and the fluid outlet 9, Figs. 2-4, 7, 10) that is configured to contain a cold fluid (¶ [0086-0088, 0122-0125]); and
one or more barriers (inner layer 20 that forms inner wall of shell 6, Figs. 2-4, 7, 10) that prevent the cold fluid from directly contacting the ocular surface (¶ [0086-0088, 0122-0125]),
wherein the one or more barriers (inner layer 20 that forms inner wall of shell 6, Figs. 2-4, 7, 10) comprise a thermally conductive metal portion that is (¶ [0086-0088, 0125]; the inner layer of the cavity can be lead or steel) configured to contact the surface of the eye (1, Figs. 2-4, 7, 10; ¶ [0086-0088, 0122-0125]), to cool one or more areas of therapeutic effect for a period of time by the transfer of heat energy from the eye (1, Figs. 2-4, 7, 10) to the cold fluid and provide the therapeutic effect (¶ [0086-0088, 0122-0125]).
Wong is silent whether the cold fluid is a cold slurry.
Barken discloses a cryosurgery system, thus being in the same field of endeavor of medical cooling devices, where the cooling fluid can be a cold slurry (¶ [0044, 0050]).
Therefore, 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 generic cold fluid of Wong to be a cold slurry, as taught by Barken. As Barken indicates that cooling fluids can be liquids, gasses, or slurries, one of ordinary skill in the art would find it obvious that a cold slurry could be utilized as the cooling fluid of Wong. Additionally, it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07).
Regarding Claim 2, Wong further discloses the one or more areas of therapeutic effect comprise a region adjacent to a corneal limbus of the eye (¶ [0123]).
Regarding Claim 3, Wong further discloses the one or more barriers (inner layer 20 that forms inner wall of shell 6, Figs. 2-4, 7, 10) are further configured to prevent contact with a cornea of the eye (1, Figs. 2-4, 7, 10; central opening 7 prevents contact with the cornea; ¶ [0123]).
Regarding Claim 4, Wong further discloses the one or more areas of therapeutic effect comprises a bulbar conjunctiva and/or a sclera (¶ [0104, 0122]).
Regarding Claim 5, Wong further discloses the container (the walls of the shell 6 form a container that allows fluid to circulate through the shell between the fluid inlet 8 and the fluid outlet 9, Figs. 2-4, 7, 10) and one or more barriers (walls that form shell 6, Figs. 2-4, 7, 10) are in the shape of a ring (as seen in Figs. 2-4, 7, 10).
Regarding Claim 6, the combination of Wong/Barken discloses the claimed invention substantially as claimed as set forth above for Claim 1.
Wong/Barken further discloses the device is further configured to be operable with a protective device comprising a thermally non-conductive material (the device of Wong/Barken is fully capable of being utilized along with a protective device comprising a thermally non-conductive material).
Regarding Claim 8, the combination of Wong/Barken discloses the claimed invention substantially as claimed as set forth above for Claim 1.
Wong/Barken further discloses the device is configured to contact the eye at the one or more areas of therapeutic effect and cool the areas of therapeutic effect for about 2 minutes to about 10 minutes (the device is fully capable of cooling one or more areas of therapeutic effect of an eye of a subject for a period of time including for between 2 minutes and 10 minutes).
Regarding Claim 11, the combination of Wong/Barken discloses the claimed invention substantially as claimed as set forth above for Claim 1.
Wong/Barken discloses the device is configured to contact the eye at the one or more areas of therapeutic effect and cool the areas of therapeutic effect for about 4 minutes to about 15 minutes (the device is fully capable of cooling one or more areas of therapeutic effect of an eye of a subject for a period of time including for between 4 minutes and 15 minutes).
Regarding Claim 12, the combination of Wong/Barken discloses the claimed invention substantially as claimed as set forth above for Claim 1.
Wong/Barken discloses the device is configured to contact the eye at the one or more areas of therapeutic effect and cool the areas of therapeutic effect to a temperature of between -6 degrees C and about 4 degrees C (Wong ¶ [0093] indicates a temperature control can be used to select the temperature of the fluid and therefore the device of Wong/Barken is fully capable of selecting the temperature of the cooling fluid).
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Wong et al (US 2007/0282282) in view of Barken (US 2021/0145500) further in view of Stark (US 5953097).
Regarding Claim 7, Wong/Barken is silent whether the protective device is configured to protect a cornea of the eye.
Stark teaches a contact lens for use with ophthalmic monitoring systems, thus being in the same field of endeavor of devices that can be utilized during ocular surgery, where the contact lens is configured to protect a cornea of the eye (Col. 4 lines 17-19, Fig. 3 describe a contact lens designed to cover only the patient’s cornea), where the protective device comprises a thermally non-conductive material (Col. 4 lines 27-40; polymer materials are known in the art to be thermally non-conductive). The contact lens can protect the eye/cornea during ophthalmic procedures (Col. 2 lines 22-33).
Therefore, it would have been obvious to modify the device of Wong/Barken to be configured to be operable with a protective device comprising a thermally non-conductive material, wherein the protective device is configured to protect a cornea of the eye, as taught by Stark, to protect the eye/cornea during ophthalmic procedures such as the cryotherapy procedure of Wong/Barken (as motivated by Stark Col. 2 lines 22-33).
Claim(s) 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Wong et al (US 2007/0282282) in view of Barken (US 2021/0145500) further in view of Krolman (US 8257256).
Regarding Claims 9 and 10, Wong/Barken is silent whether the protective device is configured to protect one or more eyelids of the eye, wherein the protective device is a speculum.
Krolman teaches an eyelid speculum, thus being in the same field of endeavor of optical surgical instruments, where the eyelid speculum protects the eyelids of the eye and is made of a plastic material (Col. 2 lines 1-34; the speculum protects the eyelids by providing a physical barrier between anything applied to the eye and the eyelid by being inserted under the eyelid, and plastic materials are known in the art to be thermally non-conductive). Using an eyelid speculum holds the eyes open for surgical procedures and helps prevent eyelashes from coming in contact with the eye during the procedure (Col. 2 lines 30-34).
Therefore, it would have been obvious to modify the device of Wong/Barken to be configured to be operable with a protective device comprising a thermally non-conductive material, where the protective device is configured to protect one or more eyelids of the eye, and wherein the protective device is a speculum, as taught by Krolman. Using an eyelid speculum holds the eyes open for surgical procedures and helps prevent eyelashes from coming in contact with the eye during the procedure (as motivated by Krolman Col. 2 lines 30-34).
Conclusion
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781