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
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.
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.
Claims 1-12 & 19-20 is/are rejected under 35 U.S.C. 103 as being obvious over Heriot (US 2016/0008170) in view of one having ordinary skill in the art.
The applied reference has a common inventor, i.e. Wilson J. Heriot, with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Heriot discloses;
A method of integrating or fusing at least a part of a retina and at least one of a retinal pigmented epithelium (RPE) and choroid underlying the retina and the RPE, the method comprising:
E.G. via the disclosed method off treating a detached retina by heating tissue of two or more tissues, i.e. the retina and/or RPE ([0143]-[0145])
photodehydrating at least some proximal fluid separating one or more of the retina, the RPE and the underlying choroid, with photodehydrating laser light to thereby allow direct contact between the retina and at least one or more of the RPE and choroid;
E.G. via the disclosed laser that creates irradiation of the dehydrated retina and subretinal space [0211].
drying at least some of the proximal fluid separating the retina, the RPE and the choroid with a gas flowing at a rate
E.G. via the disclosed desiccating fluid 112 that results in drying of the exposed RPE and meniscus at the junction of the retina and RPE, wherein the temperature of said fluid may be adjusted in order to create a sterile, temperature regulated thermal fluid flow to target the retina and/or RPE for thermal fusion ([0169]-[0170]).
and photocoagulating at least part of the retina and at least one of the RPE and the choroid with photocoagulating laser light to thereby integrate or fuse at least part of the retina with one or both of the RPE and choroid.
E.G. via the disclosed induced direct fusion of the retina and RPE [0170].
Heriot discloses the claimed invention having a method of integrating or fusing at least a part of a retina and at least one of a retinal pigmented epithelium (RPE) and choroid underlying the retina and the RPE, the method comprising drying at least some of the proximal fluid separating the retina, the RPE and the choroid with a thermal fluid flow at a specific rate via temperature regulated fluid flow [0169]
except wherein said fluid flow has a flow rate of up to 200 ml/min. It would have been obvious to one having ordinary skill in the art at the time the invention was made to utilize a flow rate of up to 200 ml/min, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
2.
The method of Claim 1 further comprising determining tissue temperature, optionally by conducting spectral analysis.
E.G. via the disclosed temperature regulator 126/128 connected to a thermocouple 138 that provides a reading a fluid temperature to the temperature regulator which adjusts the output of the heater [0201].
*The examiner notes that based on the broadest reasonable interpretation of the claim language it is not necessary that the prior art perform the claimed spectral analysis in order to determining the tissue since the claim language deems this part of the claim as being ‘optionally’ performed.
3.
A device for integrating or fusing at least a part of a retina and at least one of a retinal pigmented epithelium (RPE) and choroid underlying the retina and the RPE,
E.G. via the disclosed method off treating a detached retina by heating tissue of two or more tissues, i.e. the retina and/or RPE with a thermal probe ([0143]-[0145])
the device comprising: at least one source of laser light, the source of laser light providing photodehydrating laser light and photocoagulating laser light;
E.G. via the disclosed laser that creates irradiation of the dehydrated retina and subretinal space [0211].
at least one source of a gas; and a pump to impel the gas at a flow rate up to 200 ml/min.
E.G. via the disclosed desiccating fluid 112, which may comprise a gas, that results in drying of the exposed RPE and meniscus at the junction of the retina and RPE, wherein the temperature of said fluid may be adjusted in order to create a sterile, temperature regulated thermal fluid flow to target the retina and/or RPE for thermal fusion ([0070], [0169]-[0170]).
4.
A system for integrating or fusing at least a part of a retina with at least one of a retinal pigmented epithelium (RPE) and choroid underlying the retina and the RPE,
E.G. E.G. via the disclosed method off treating a detached retina by heating tissue of two or more tissues, i.e. the retina and/or RPE with a thermal probe and device 100 {[0143]-[0145] & (Fig 1)}.
the system comprising: at least one source of laser light, the source of laser light providing photodehydrating laser light and photocoagulating laser light;
E.G. via the disclosed laser that creates irradiation of the dehydrated retina and subretinal space [0211].
and at least one source of a gas; a pump to impel the gas at a flow rate up to 200 ml/min;
E.G. via the disclosed desiccating fluid 112, which may comprise a gas, that results in drying of the exposed RPE and meniscus at the junction of the retina and RPE, wherein the temperature of said fluid may be adjusted in order to create a sterile, temperature regulated thermal fluid flow to target the retina and/or RPE for thermal fusion ([0070], [0169]-[0170]).
and a handpiece to direct the gas at or near the retina, RPE and/or choroid to be fused.
E.G. {[0192] & (Fig 7)}.
5.
The device according to Claim 3, further comprising a console and/or one or more gas line connecting the pump and handpiece for delivery of the gas.
E.G. via the disclosed tubing 111 from pump 110 {[0179] & (Fig 10)}.
6.
The device according to claim 3, wherein the photodehydrating laser light and/or the photocoagulating laser light is/are provided concurrently with the gas.
E.G. via [0219].
7.
The device according to claim 3, wherein gas flow is provided at a lower rate during photocoagulation than during photodehydration.
E.G. [0219].
8.
The device according to claim 3, wherein gas flow is provided during photodehydration and no gas flow is provided during photocoagulation.
E.G. via the disclosed method of providing a gas exchange wherein dehydration of the subretinal space was ‘achieved’ prior to coagulation [0218].
9.
The device according to claim 3, wherein the photodehydrating laser light and the photocoagulating laser light are directed along a laser light path.
E.G. via the disclosed laser fibre-optic cable ([0190]).
10.
The device according to claim 9 wherein the laser light path may comprises one or more optical fiber.
E.G. via the disclosed laser fibre-optic cable ([0190]).
11.
The device according to claim 10 wherein the one or more optical fiber comprises one optical fiber line for directing both the photodehydrating laser light and the photocoagulating light.
E.G. [0190]
12.
The device according to claim 10 wherein the one or more optical fiber line comprises a photodehydrating laser light optical fiber line connected to a photodehydrating laser light source and a photocoagulating laser light optical fiber line connected to a photocoagulating laser light source.
E.G. via ([0189]-[0190]).
19.
The device according to claim 3, wherein the photocoagulating light comprises any clinically used wavelength to coagulate tissue such as, 577 nm (yellow), 595 nm (orange) 630 nm (red); 488 and/or 514.5 nm (argon blue-green), 514.5 nm (green); and/or 647 nm (krypton red).
E.G. via the disclosed induced direct fusion of the retina and RPE [0170] by way of the disclosed laser that creates irradiation of the dehydrated retina and subretinal space [0211]. The examiner notes that the disclosed laser is capable of providing any clinically used wavelength as defined by the source of the laser used in Heriot, i.e. the applicant use of the language ‘any’ makes it capable for the disclosed laser to provide the claimed limitation.
20.
The device according to claim 3, wherein the laser comprises a small footprint such as, a diameter of 1000 µm.
E.G. via the disclosed laser source further incorporating the use of an optic cable 202, in which it is known that optical fibre cables, as disclosed, have a small diameter.
Also, it would have been obvious to one having ordinary skill in the art at the time the invention was made to utilize a laser and optical fibre cable having a small-diameter of 1000 µm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 13-18 is/are rejected under 35 U.S.C. 103 as being obvious over Heriot (US 2016/0008170) in view of one having ordinary skill in the art.
Heriot discloses a laser that creates irradiation of the dehydrated retina and subretinal space [0211], in which the examiner is interpreting to be the claimed photodehydrating laser light except Heriot does not explicitly disclose the use of a laser light comprising a wavelength as defined by claims 13-16 & 18. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the laser as disclosed by Heriot with the use of the specific wavelengths and/or wavelength range(s) as claimed, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Response to Arguments
The declaration under 37 CFR 1.132 filed October 3, 2025 is sufficient to overcome the rejection of claims 1-20 based upon Heriot (US 2019/0343681).
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on the reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Please see the above office action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE F JOHNSON/ Primary Examiner, Art Unit 3796