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 .
Double Patenting
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 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,070,420. Although the claims at issue are not identical, they are not patentably distinct from each other because they encompass the same essential invention. The wedge and oblique nature of the irradiation of the presently claimed invention because the wedge and the obliqueness provide a change of shape for the system and there is case law making obvious a change of shape.
Claim Rejections - 35 USC § 102
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 following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6 and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gertner et al. (U.S. Patent Application Publication 2009/0161827).
Regarding claim 1, Gertner et al. disclose a system (“system 10,” see [0159], and figure 1A) comprising:
a wedge (wedge-shaped element 416 the XYZ stage, see [0225] and figure 5);
an optical unit (“one or more X-ray tubes 112,” see [0160] and figures 1-5) mounted on the wedge such that the optical unit is directed obliquely upward, the optical unit comprising a radiation source (the collection of radiation sources 112 and pointer 403, see figures 1A-3A); and
a controller (processor, processing unit, computer processor and/or the like, [0047]-[0048], [0058], and [0153]) configured to treat an eye of a patient by causing the radiation source to irradiate respective target regions of the eye with one or more treatment beams while the eye gazes obliquely downward toward the optical unit (see [0006], [0673], [0676]-[0677]).
Regarding claim 2, Gertner et al. disclose the claimed invention including the wedge has an angle selected so that while the eye gazes obliquely downward, a target region in an upper portion of a sclera or limbus of the eye is exposed to the radiation source (see figure 3A wherein an upper portion of the sclera is defined as upper 2/3 of the sclera wherein the halfway point is denoted by the central optical axis of the eye).
Regarding claim 3, Gertner et al. disclose the claimed invention including the wedge is
mounted on the motion stage (comprising “an automated positioning system (APS) 115 for moving and aiming the X-ray source assembly 420 (including X-ray tube 112 and collimator 118) to direct a treatment beam to a target from one or more selected directions,” see [0162] and figure 5).
Regarding claim 4, Gertner et al. disclose the claimed invention including the controller is configured to control the motion stage so as to align the eye with the radiation source “an automated positioning system (APS) 115 for moving and aiming the X-ray source assembly 420 (including X-ray tube 112 and collimator 118) to direct a treatment beam to a target from one or more selected directions,” see [0162] and figure 5 and given the fact that the controller/processor is responsible for the automated control).
Regarding claim 5, Gertner et al. disclose the claimed invention including comprising a headrest (“chin-head restraint assembly 160 may include a right-left pair of hand grips 163 for the patient to hold, helping to maintain the patient's torso and shoulders in perpendicular alignment to eye-guide 110,” see [0167] and figures 2A-2B, and “a head support or support 170 for stabilizing the head of subject, and includes a chin rest 172,” see [0171] and figure 16), which is configured to hold a head of the patient stationary while the eye gazes obliquely downward.
Regarding claim 6, Gertner et al. disclose the claimed invention including the headrest comprises a sensor configured to generate an output indicating whether the head is properly positioned on the headrest (“sensor,” see [0167]).
Regarding claim 12, Gertner et al. disclose the claimed invention including:
a focusing lens (lens 120; and
one or more beam-directing elements (“beam splitters,” see [0181] and figure 3A),
wherein the controller is configured to cause the radiation source to irradiate the eye with the treatment beams by firing the treatment beams at the beam-directing elements through the focusing lens, such that the beams are focused by the focusing lens prior to being directed, by the beam-directing elements, toward the respective target regions (see [0727]-[0741]).
Regarding claim 13, Gertner et al. disclose the claimed invention including at least part of each of the target regions is located within 1 mm of a limbus of the eye (see [0033] and [0213]).
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: although all of the presently pending claims are rejected and Applicant may choose to argue only (opposed to amend the claims and argue), the examiner can imagine Applicant amending independent claim 1 with all the subject matter of claim 7 and filing a proper terminal disclaimer in order to overcome both the prior art rejections and the obvious double patenting rejections and placing the application in condition for allowance.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm.
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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.
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/AARON F ROANE/Primary Examiner, Art Unit 3792
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