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 Objections
Claim 13 is objected to because of the following informalities: For consistency purposes line 24 should end with an “;”. Appropriate correction is required.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 12 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 10 of prior U.S. Patent No. 12,343,290. This is a statutory double patenting rejection.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11, 13-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11-17 of U.S. Patent No. 12,343,290. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent is directed to the instant application’s claims.
As to the instant application’s claim 1, the reference patent claims an ophthalmic incisional instrument for making limbal relaxing incisions (LRIs) on a patient's eye having a sclera, a cornea, and a corneal limbus (claim 1), the instrument comprising:
a docking piece (claim 1) having proximal and distal ends;
said docking piece proximal end configured for placement on the sclera of said patient's eye (claim 1);
a cutting piece (claim 1) having proximal and distal ends and a rotational axis extending between said cutting piece ends;
said cutting piece configured for insertion within said docking piece (claim 1) and for rotation relative to said docking piece about said rotational axis in an assembled configuration of the instrument (claim 1);
said cutting piece mounting two cutting blades (claim 1), each cutting blade configured for extending into said patient's eye in said assembled configuration (claim 1);
a guide template (claim 1) having proximal and distal ends;
said guide template proximal end configured for attachment to said docking piece distal end in said assembled configuration (claim 1);
said guide template distal end comprising raised stoppers configured for providing lateral, arcuate stops for said cutting piece in said assembled configuration preventing rotation of said cutting piece beyond desired LRI locations (claim 1);
said docking piece further comprising a step portion (claim 1) configured for providing a mechanical stop for said cutting piece in said assembled configuration preventing further extension of said cutting blades into said patient's eye beyond a desired LRI depth of cut (claim 1);
said docking piece further comprising a suction chamber (claim 1) open at said docking piece proximal end (claim 1);
wherein said docking piece is configured for releasable attachment to the sclera of said patient's eye via sub-atmospheric pressure in said suction chamber (claim 1); and
said cutting blades configured for forming arcuate LRIs in said patient's eye coaxial to said rotational axis (claim 1).
As to the instant application’s claim 2, see reference patent claim 1.
As to the instant application’s claim 3, see reference patent claim 1.
As to the instant application’s claim 4, see reference patent claim 3.
As to the instant application’s claim 5, see reference patent claim 4.
As to the instant application’s claim 6, see reference patent claim 5.
As to the instant application’s claim 7, see reference patent claim 6.
As to the instant application’s claim 8, see reference patent claim 1.
As to the instant application’s claim 9, see reference patent claim 7.
As to the instant application’s claim 10, see reference patent claim 8.
As to the instant application’s claim 11, see reference patent claim 9.
As to the instant application’s claim 13, the reference patent claims an method for making limbal relaxing incisions (LRIs) on a patient's eye having a sclera, a cornea, and a corneal limbus with an incisional instrument (claim 11) including a docking piece (claim 11) having proximal and distal ends, a suction chamber open (claim 11) at the docking piece proximal end, and a step portion (claim 11); a cutting piece (claim 11) having proximal and distal ends and a rotational axis extending between the cutting piece ends; the cutting piece configured for insertion within the docking piece and for rotation relative to the docking piece about the rotational axis in an assembled configuration of the instrument (claim 11); the cutting piece mounting two cutting blades (claim 11); a guide template (claim 11) having proximal and distal ends; the guide template proximal end configured for attachment to the docking piece distal end in the assembled configuration (claim 11); and the guide template distal end comprising raised stoppers(claim 11); the method comprising the steps of:
aligning said docking piece proximal end on the sclera of said patient's eye (claim 11);
applying sub-atmospheric pressure to said suction chamber, attaching said docking piece to said sclera of said patient's eye (claim 11); and
aligning said guide template with said docking piece and said patient's eye as desired and attaching said guide template to said docking piece (claim 11);
aligning said cutting piece with said docking piece, said guide template, and said patient's eye as desired;
placing said cutting piece within said docking piece in said assembled position, inserting said cutting blades into said patient's eye at desired LRI locations (claim 11);
said step portion stopping said cutting piece and preventing further extension of said cutting blades into said patient's eye beyond desired LRI depths (claim 11);
rotating said cutting piece relative to said docking piece about said rotational axis, forming arcuate LRIs in said patient's eye coaxial to said rotational axis (claim 11)
said guide template raised stoppers stopping rotation of said cutting piece beyond desired LRI locations (claim 11); and
removing said cutting piece and said docking piece from said patient's eye (claim 11).
As to the instant application’s claim 14, see reference patent claim 12.
As to the instant application’s claim 15, see reference patent claim 13.
As to the instant application’s claim 16, see reference patent claim 14.
As to the instant application’s claim 17, see reference patent claim 15,
As to the instant application’s claim 18, see reference patent claim 11.
As to the instant application’s claim 19, see reference patent claim 16.
As to the instant application’s claim 20, see reference patent claim 17
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent 5,938,674 to Terry (as cited reference 8 in the IDS filed 10/03/2025), U.S. Patent 6,613,061 to Olson (as cited reference 13 in the IDS filed 10/03/2025), U.S. Patent 7,166,117 to Hellenkamp (as cited reference 14 in the IDS filed 10/03/2025), U.S. Patent Publication 2006/0287663 to Carter, and U.S. patent Publication 2009/0287232 to Davis all disclose similar instrument and methods pertinent to the scope of the claims of record.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
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