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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-3, 7-9 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Shadduck, Pub. No. US 2003/0109907 (hereinafter “Shadduck”) in view of Baer Velde al., Pub. NO. 2002/0111608 (hereinafter “Baer veldt”).
Regarding amended claim 1, Shadduck discloses a laser system suitable for changing an intraocular pressure (IOP) of an eye (see the abstract, par. 0005 and Fig. 5), the laser system comprising: a laser source 25; a feedback controller 55 configured to regulate a dosimetry of the laser source to produce spatially and/or temporally modulated laser light (par. 0020 [“the invention includes an optional dosimetry control system for terminating or controlling energy delivery based on feedback signal from a temperature sensor array”]), see pars. 0024 and 0068;
a first optical delivery element/optical fibers 40 configured to guide the spatially and/or temporally modulated laser light to irradiate a first area on the eye (Fig. 7, par. 0051); and
a detecting element configured to detect one or more physical, chemical, mechanical and/or structural characteristics in a second area on the eye in a real-time during the change of the IOP (sensors 57, see Figs. 6, 8, and par. 0056); wherein the feedback controller is configured to regulate the dosimetry of the laser source in a real-time based on the real-time detected information pertaining to the one or more physical, chemical, mechanical and/or structural characteristics in the second area (par. 0068, note that the sensors 57 measure temperature at locations not coinciding with the locations delivered to laser radiation). However, Shadduck does not teach the feedback controller is configured to calculate a flow rate of fluid through the porous structure on the sclera as claimed. Baerveldt discloses a minimally invasive glaucoma surgical instrument and method, the system comprising a software and feedback to a controller, which result in full process control configured to determine fluid flow rate and pressure during the treatment [Par. 0178] to determine when ablation is completed through time, temperature and/or impedance.) Thus, it would have been obvious to one of ordinary skill in the art the time applicant’s invention was filed to use a fluid flow system configured to monitor/calculate a fluid flow rate during the surgical treatment to determine when ablation is completed. Furthermore, Surgical techniques to lower intraocular pressure is known in the art, when medication fails to decrease fluid flow into the eye or to increase fluid outflow, include procedures that permit fluid to drain from within the eye to extraocular sites by creating a fluid passageway between the anterior chamber of the eye and the potential supra-scleral/sub-Tenon's space, or, alternatively, into or through the Canal of Schlemm (see, e.g., U.S. Pat. No. 4,846,172).
Regarding claim 2, the first area comprises a part on the sclera of the eye (abstract [“The apparatus includes; (i) a working end geometry for contacting the anterior surface of the sclera and cornea to insure that a laser emission reaches the trabecular meshwork from a particular location on the anterior surface of the sclera”]), wherein the laser source provides a wavelength appropriate for absorption beneath the anterior scleral surface to the depth of the trabecular plates to modify the porous structure on the sclera.
Regarding claims 3 and 7-9, the recited claims language are directed to intended use/expected results. claim 7 recites the laser source is regulated to activate one or more cells on the ciliary body. However it does not teach a specific laser light (e.g., regulated dosimetry/ dose of the laser source to activate one or more cells on the ciliary body) /parameters to activate one or more cells on the ciliary body. Intended use claim language is generally given a limited patentability weight.
Furthermore, Shadduck teaches the modulated laser light is suitable for achieving and/or maintaining a first temperature range and/or a second temperature range in the first area as claimed (par. 0022 [“For the proposed method of trabecular bio-stimulation, the targeted region is elevated in temperature to a range between about 40.degree. C. to 55.degree. C. for a period of time ranging from about 1 second to 120 seconds or more. More precisely, the desired range would be between about 40.degree. C. to 50.degree. C. for such time periods.”]), wherein the modulate laser light (pars. 0014, 0022,0057) suitable for generating thermomechanical wave, which can propagate to a third are outside the first area as broadly as claimed.
Regarding claim 12, Shadduck teaches the controller of the system includes dosimetry control system 55 and optional beam sequence controller 59, which computer controllers adapted to operate in cooperation to control the power of the laser energy (par. 0057).
Allowable Subject Matter
Claims 5, 6, and 10-13 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.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AHMED M FARAH whose telephone number is (571)272-4765. The examiner can normally be reached Mon - Fri. 9:30AM -10:30 PM.
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, Niketa Patel can be reached at 571-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AHMED M FARAH/Primary Examiner, Art Unit 3792