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 .
Election/Restrictions
Newly submitted claim 20 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the originally searched, examined, and rejected claims were directed to a system while newly added claim 20 is directed to a method.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 20 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Accordingly, the examiner will search and examine claims 1-19.
Response to Arguments
Applicant's arguments filed 06/18/2026 have been fully considered but they are not persuasive.
On page 7 of 8, the last sentence of the 1st full paragraph, Applicant asserts “Gertner does not disclose, teach, or suggest treatment beams having wavelengths between 515 and 545 nanometers, such as recited by amended independent claim 1.” The examiner disagrees since Gertner et al. disclose a laser wavelength of 532 nm in [0741], see the rejection of claim 1 below.
Accordingly this action is made FINAL.
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 and 14-19 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 12-19 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 [0 160] and figures 1-5) mounted on the wedge such that the optical unit is directed obliquely upward, the optical unit comprising a radiation source (comprising: the collection of radiation sources 112 and pointer 403, see figures 1A-3A and “multiple laser diode light sources S of differing wavelengths (e.g., 532, 670, 780, 830, and/or 905 nm),” see [0741]) configured to generate one or more treatment beams having corresponding wavelengths between 515 and 545 nanometers (laser diode light source S emitting laser radiation at 532 nm, see [0741]); 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 the 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 limb us 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 11 0," see [0 167] and figures 2A-2B, and "a head
support or support 170 for stabilizing the head of subject, and includes a chin rest 172 ,"
see [0 171] 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 ]).
Regarding claim 14, Gertner et al. disclose the optical unit is indirectly mounted (coupled to) on an angled portion of the wedge such that the wedge causes the optical unit to be directed obliquely upward (see figures 1A-5).
Regarding claim 15, Gertner et al. disclose the claimed invention since claim 15 recites intended use and subject matter, namely, “trabecular meshwork of the eye disposed toward a peripheral front portion of the eye corresponding to a limbus of the eye” which is normal for most/all eyes.
Regarding claim 16, Gertner et al. disclose a system ("system 10," see [0159], and figure 1A) comprising:
an optical unit (comprising: the collection of radiation sources 112 and pointer 403, see figures 1A-3A and “multiple laser diode light sources S of differing wavelengths (e.g., 532, 670, 780, 830, and/or 905 nm),” see [0741]) disposed with respect to an eye of a patient such that the optical unit is configured to direct one or more beams used as part of treatment of one or more target regions of the eye at an oblique angle with respect to the eye (see figures 1A-16 for example), the one or more target regions being disposed toward a front portion of the eye (see figures 1A-16 for example); and
a controller (processor, processing unit, computer processor and/or the like, [0047]-[0048], [0058], and [0153]) configured to cause the optical unit to irradiate the one or more target regions of the eye using the one or more beams with the optical unit disposed such that the one or more beams impinge the eye at the oblique angle (see [0006], [0673], [0676]-[0677] and figures 1A-16).
Regarding claim 17, Gertner et al. disclose a wedge (wedge-shaped element 416 the XYZ stage, see [0225] and figure 5) on which the optical unit is mounted (indirectly) and configured to cause the optical unit to be at the oblique angle with respect to the eye (see figures 1A-16).
Regarding claim 18, Gertner et al. disclose the one or more beams have corresponding wavelengths between 515 nanometers and 650 nanometers (see the 532 nm laser source in [0741]).
Regarding claim 19, Gertner et al. disclose the front portion corresponds to
a limbus of the eye (since the eye disclosed has a limbus that is in the front portion of the eye. Also see [0759]).
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.
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 AARON F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm.
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.
/AARON F ROANE/Primary Examiner, Art Unit 3792
Prosecution Insights