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.
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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heriot et al. (US 2016/0008170) in view of Heriot et al. (WO 2014/110624).
Heriot ‘170 teaches a method for integrating or fusing at least a portion of a retina with the retinal pigment epithelium (RPE) including:
directing sterile desiccating fluid toward a retinal defect or tear margin to remove the meniscus and dry tissue adjacent the retina and RPE ([0169], [0172]);
drying proximal fluid separating the retina and RPE to permit direct tissue contact and fusion ([0169], [0172]);
directing the desiccating fluid through an intraocular probe toward the retina and/or RPE ([0169], [0173]);
thermally fusing the retina and RPE using a temperature-regulated thermal fluid and/or laser handpiece ([0170]-[0173], [0207]-[0211]);
producing direct retina/RPE fusion ([0151]-[0152]).
Heriot ‘624 further teaches:
dehydration of the subretinal space an retinal tear margin before laser treatment [0206].
dehydration of the retinal tear margin with a directed air stream [0207].
Irradiation of the dehydrated retina and subretinal space with laser light [0211].
direct fusion of the retina and RPE following dehydration and laser treatment ([0205]-[0211]).
Regarding the additionally recited limitations:
Heriot ‘624 and Heriot ‘170 collectively teaches photodehydration and drying tissue prior to retinal fusion by removing subretinal fluid before laser irradiation {(‘624, [0205]-[0211]) & (‘170 [0169]-[0172])}.
Heriot ‘624 and Heriot ‘170 teaches directing gas/desiccating fluid at or near the retina and RPE to facilitate fusion {(‘624, [0207]) & (‘170 [0169])}.
Heriot ‘170 teaches regulating the desiccating/thermal fluid as a controlled treatment parameter through the treatment system (‘170 [0173]-[0174]).
Regarding the limitation:
…gas flowing at a rate of up to 200 ml/min…
Heriot ‘170 teaches controlled desiccating fluid flow for achieving sufficient dehydration while avoiding undesirable tissue effects ([0169]-[0174]). Although Heriot ‘170 does not expressly disclose the numerical upper limit of 200 ml/min, the flow rate constitutes a recognized result-effective variable affecting the degree of dehydration and tissue safety. It would have been obvious to one having ordinary skill in the art to optimize the flow rate, including selecting a flow rate of up to 200 mil/min, through routine experimentation to achieve effective dehydration while minimizing collateral tissue injury. Discovering an optimum or workable value of a recognized result-effective variable is ordinarily within the level of ordinary skill in the art. In re Aller, 220 F.3d 454 (CCPA 1955).
It also would have been obvious to incorporate the more detailed dehydration and laser irradiation sequence described in Heriot ‘624 into the retinal thermofusion method of Heriot ‘170 because both references are directed to the identical objective of repairing retinal tears by removing subretinal fluid prior to fusion. Such a modification merely applies a known technique to improve the same procedure and predictably improves tissue apposition before retinal fusion in accordance with KSR.
Claim 2.
The rejection of claim 1 is incorporated herein by reference.
Heriot ‘170 teaches determining tissue temperature using regulated thermal treatment and temperature-controlled treatment parameters ([0170, [0173]-[0174]).
Claim 3.
The rationale of claim 1 is incorporated herein by reference
Regarding the additionally recited apparatus limitations:
Heriot ‘170 and Heriot ‘624 teaches at least one laser source providing laser energy for retinal fusion {( ‘170, [0207]-[0211]) & (‘624 [0211])}.
Heriot ‘170 teaches a source of desiccating gas/fluid [0169].
Heriot ‘170 teaches a pump supplying sterile temperature-regulated desiccating fluid [0173].
Heriot ‘170 teaches a handpiece/intraocular probe directing the desiccating gas toward the retina and RPE [0169].
Regarding the recited pump flow rate of up to 200 ml/min, optimization of the controlled gas flow constitutes routine optimization of a recognized result-effective variable (In re Aller).
Regarding the handpiece comprising a control to regulate gas flow, Heriot ‘170 teaches regulation of the desiccating fluid through the treatment delivery system, including regulators associated with the probe and pump ([0173]-[0174]), rendering such control obvious.
Claim 4.
The rejection of claim 3 is incorporated herein by reference.
Heriot ‘170 teaches a complete retinal fusion system including a laser source, gas source, pump, probe, and associated control components ([0173]-[0211]).
Claim 5.
The rejection of claim 3 is incorporated herein by reference.
Heriot ‘170 teaches a console, pump and fluid delivery line connecting the pump to the intraocular probe ([0173]-[0174]).
Claims 6-8.
The rejection of claim 3 is incorporated herein by reference.
Heriot ‘170 and Heriot ‘624 teaches concurrent and sequential use of desiccating fluid and laser treatment during retinal repair {(‘170 [0169]-[0172], [0207]-[0211]) & (‘624 [0206]-[0211]). Varying or terminating gas flow during different stages of treatment represents an obvious matter of treatment protocol optimization.
Claims 9-12
The rejection of claim 3 is incorporated herein by reference.
Heriot ‘170 teaches laser delivery through an optical fiber/laser probe ([0145], [0207]-[0211]).
Utilizing one or multiple optical fibers for delivery of one or more laser wavelengths would have been obvious design choice depending on the desired optical configuration.
Claims 13-20
The rejection of claim 3 is incorporated herein by reference.
Heriot ‘170 teaches laser sources operating with temperature-producing therapeutic ranges for retinal thermofusion ([0170]-[0171] & [0207]-[0211]).
Selecting particular laser wavelengths (including those recited) for tissue dehydration or photocoagulation represents optimization of known laser treatment parameters routinely selected according to tissue absorption characteristics and desired therapeutic effect.
Response to Arguments
Applicant's arguments filed June 5, 2026 have been fully considered but they are not persuasive:
Applicant principally argues that the primary reference, Heriot ‘170, fails to disclose (1) photodehydrating proximal fluid with laser light (2) drying proximal fluid separating the retina, retinal pigment epithelium (RPE), and choroid using a gas flow regulated through a handpiece at a flow rate of up to 200 ml/min, and (3) directing gas at or near the retina, RPE and/or choroid prior to photocoagulation. However, the rejection is based on the combined teaches of Heriot et al. (US 2016/0008170) and Heriot et al. (WO 2014/110624), rather than Heriot ‘170 alone.
Heriot ‘170 teaches directing sterile desiccating fluid toward the retinal defect or tear margin to remove the fluid meniscus separating the retina and RPE, thereby promoting direct tissue contact and retinal fusion ([0169]-[0173]). Heriot ‘170 further teaches controlled delivery of desiccating and thermal treatment fluids through the retinal treatment system and subsequent thermal fusion of the retina and RPE ([0170]-[0174] & [0207]-[0211]).
The secondary reference, Heriot ‘624 further teaches dehydration of the subretinal space and retinal tear margin using a directed gas stream prior to laser treatment, followed by irradiation of the dehydrated retina and subretinal space with laser light to produce retinal fusion ([0205]-[0211]).
Accordingly, the combined references teach or at least suggest the claimed sequences of dehydration, laser irradiation, and tissue fusion directed to the same therapeutic objective of improving retinal reattachment.
Applicant additionally argues that Heriot ‘170 does not disclose regulating gas flow at a rate of up to 200 ml/min through a handpiece control. Although the references do not expressly disclose the numerical upper limit of 200 ml/min, Heriot ‘170 recognizes that desiccating fluid delivery is a controlled treatment parameter used to achieve sufficient dehydration while avoiding undesirable tissue effects. The selection of an appropriate flow rate constitutes optimization of a recognized result-effective variable. Discovering an optimum or workable value through routine experimentation would have been well within the level of ordinary skill in the art. In re Aller, 220 F.2d 454, 456 (CCPA 1955). Applicant has not provided objective evidence demonstrating that the claimed upper limit yields results that are unexpected relative to the teachings of the applied prior art.
Applicant’s arguments that the applied references teach away from the claimed invention are likewise unpersuasive. Both Heriot et al. references are directed to the same field of retinal thermofusion and seek to improve retinal repair by removing subretinal fluid prior to laser-induced tissue fusion. Incorporating the more detailed dehydration and laser irradiation techniques disclosed in Heriot ‘624 into the retinal fusion system of Heriot ‘170 merely represents the predictable use of known techniques to improve the same procedure and would have been obvious to one of ordinary skill in the art. KSR Int’l Co. v. Teleflex Inc, 550 U.S. 398 (2007).
Accordingly, for the reasons set forth above, Applicant’s arguments are not persuasive, and the rejection under 35 U.S.C §103 is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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