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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites:
the broad recitation “performing anesthesia”, and the claim also recites “performing anesthesia by retrobulbar anesthesia” which is the narrower statement of the range/limitation.
the broad recitation “fixing an eyeball”, and the claim also recites “pulling a superior rectus by using a 5-0 silk suture, and for a patient with a larger diameter of cornea, suspending a corneal limbus by using a 6-0 absorbable suture” – which is the narrower statement of the range/limitation.
the broad recitation “creating a conjunctival flap”, and the claim also recites “forming a conjunctival flap with a fornix as a base, cutting a full layer of a bulbar conjunctiva and a subconjunctival tissue at the corneal limbus along the corneal limbus, performing a blunt dissection by closely attaching the surface of a sclera under a fascia Tenon capsule to expose a surgical field, and performing a blunt dissection from an incision to a conjunctival fornix” – which is the narrower statement of the range/limitation.
the broad recitation “performing hemostasis in a surgical area”, and the claim also recites “performing hemostasis on the sclera surface of the intended scleral flap by using an underwater electrocoagulation method to avoid excessive electrocoagulation” – which is the narrower statement of the range/limitation.
the broad recitation “creating a superficial scleral flap”, and the claim also recites “creating a superficial scleral flap based at the corneal limbus, measuring 4 mmx3 mm and approximately half the thickness of the sclera; and dissecting forward to the transparent corneal limbus, performing hemostasis in the scleral flap area again and placing mitomycin under the conjunctiva and the scleral flap” – which is the narrower statement of the range/limitation.
the broad recitation “puncturing an anterior chamber” , and the claim also recites “ making an auxiliary incision in the transparent cornea within the corneal limbus in the upper nasal or upper temporal area by using a puncture knife to keep an intraocular pressure at slightly lower than a normal level, and injecting a miotic and a small amount of a viscoelastic agent into the anterior chamber to reduce the risk and degree of outward bulging of the inner wall of Schlemm's canal” – which is the narrower statement of the range/limitation.
the broad recitation “making a deep scleral flap”, and the claim also recites “making a deep scleral flap in the central area of a scleral bed beneath the superficial scleral flap and gradually dissecting forward; when ring-like fibers appear in the scleral bed, continuing the dissection until the outer wall of Schlemm's canal is incised, exposing the gray-brown inner wall of Schlemm's canal” - which is the narrower statement of the range/limitation.
the broad recitation “penetrating the Schlemm’s canal”, and the claim also recites “connecting a microcatheter with an illumination indicator to a viscoelastic injector and rotating the injector until the viscoelastic agents emerge from the tip of the microcatheter; dimming the microscope light, gently clamping the microcatheter by a pair of microscopic forceps, inserting the microcatheter into an opening of the Schlemm's canal, slowly advancing the microcatheter along the corneal limbus, and monitoring the position of indicator lamp at the tip of the microcatheter to ensure it remains within the lumen of Schlemm's canal until the microcatheter exits from the opposite end” – which is the narrower statement of the range/limitation.
the broad recitation “3600 cutting the Schlemm’s canal”, and the claim also recites “pulling both ends of an optical fiber and 3600 cutting the inner wall of the Schlemm’s canal, wherein anterior chamber bleeding can generally seen” – which is the narrower statement of the range/limitation.
the broad recitation “suturing the deep scleral flap”, and the claim also recites “suturing the deep scleral flap with a 10-0 nylon suture to prevent excessive filtration during and after surgery, which leads to complications of low intraocular pressure and a shallow anterior chamber” – which is the narrower statement of the range/limitation.
the broad recitation “excising a trabecular tissue”, and the claim also recites “puncturing into the anterior chamber from the anterior edge of the Schlemm's canal under the superficial scleral flap by using a puncture knife and then completely excising corneal and scleral tissues in parallel to the corneal limbus” – which is the narrower statement of the range/limitation.
the broad recitation “excising a peripheral iris”, and the claim also recites “making a wide base peripheral iris excision parallel to the corneal limbus, wherein an excision area is larger than a trabecular incision” – which is the narrower statement of the range/limitation.
the broad recitation “suturing the scleral flap and the conjunctival flap”, and the claim also recites “tightly suturing the anterior edge of the scleral flap with a 10-0 nylon suture, injecting a balanced salt solution or sterile normal saline into the anterior chamber from the corneal auxiliary puncture site to reform the anterior chamber and checking for fluid leakage condition at the scleral flap by using a sponge stick or a cotton swab; and suturing the conjunctival incision by using a 10-0 nylon suture in a horizontal mattress manner” – which is the narrower statement of the range/limitation.
the broad recitation “completing the surgery”, and the claim also recites “removing the superior rectus traction suture or the corneoscleral limbus suspension suture, removing an eyelid speculum, applying an eye antibiotic and glucocorticoid-containing ointment in a conjunctival sac, covering the operated eye with a dressing, and completing the procedure” – which is the narrower statement of the range/limitation.
Claim 3 recites the broad recitation “between 6-9 mm”, and the claim also recites “preferably 8 mm” which is the narrower statement of the range/limitation.
Claim 5 recites the broad recitation “approximately 0.5 -2 mm”, and the claim also recites “preferably 1 mm”, which is the narrower statement of the range/limitation; the broad recitation “for 1-4 minutes”, and the claim also recites “preferably 2 minutes”, which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the details as described in the Brief Description Of The Drawings for the Figures 1-16. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Allowable Subject Matter
Claims 1-10 contains allowable subject matter.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
The following is a statement of reasons for the indication of allowable subject matter. The examiner considers the closest prior art to be Euteneuer et al. USPN 11,504,275; Ianchulev et al. WO 2023/039133; and Riva, I., Brusini, P., Oddone, F. et al. “Canaloplasty in the Treatment of Open-Angle Glaucoma: A Review of Patient Selection and Outcomes”. However, none of the aforementioned references teach the method steps presented in the present invention.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE F STEPHENS whose telephone number is (571)272-4937. The examiner can normally be reached 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781
