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
Claims 1, 5, 7, 15, and 22 are objected to because of the following informalities:
In claim 1, line 3, ‘computing’ should be ‘computer’. In line 4, the first ‘a’ should be ‘the’. In line 7, ‘extend’ should be ‘extent’.
In claim 5, line 6, ‘the’ should be placed after ‘when’ and ‘equals or’ should be placed after ‘values’.
In claim 7, line 3, the second ‘the’ should be ‘a’.
In claim 15, line 9, ‘sub retinal’ should be ‘sub-retinal’.
In claim 22, line 13, ‘the’ should be placed after ‘of’. In line 15, ‘the’ should be placed after the second ‘of’.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7, 18, and 20 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Scheibler et al (US Pub 2020/0196858 -cited by applicant).
Re claim 1: Scheibler discloses a method for tracking progress of a retinal disease of an eye of a subject [0078; see the measurement of RT and RLT to track progress of glaucoma or macular edema], the method comprising:
receiving, by a computer, OCT image data of a retina of a subject for each of a series of OCT imaging sessions of the retina having an imaging frequency of 2 weeks or less [0079, 0185; see the OCT device to measure RT and RLT for a plurality of days from about 5-20 days wherein the results are communicated to a computer];
processing, by the computer, the OCT image data of the retina to determine a series of measured fluid extent values, wherein each of the series of measured fluid extent values is indicative of a respective extent of the retinal disease [0077, 0078, 0080, 0206; see the program instructions to extract a RT and RLT measurements at multiple points in time wherein the results are output when the RT or RLT deviate from previous measurements, wherein the measurements are fluid extent values because the thickness of the retina is an indication of buildup of fluid in the retina]; and
outputting, by the computer, an output indicative of the series of measured fluid extent values [0077, 0078, 0080, 0206; see the program instructions to extract a RT and RLT measurements at multiple points in time wherein the results are output when the RT or RLT deviate from previous measurements].
Re claims 2, 3: The series of OCT imaging sessions has an imaging frequency of at least one every 3 days and is conducted over a month [0185; the measurements are made each day from about 5-20 days or longer].
Re claim 4: At least one of the series of measured fluid extent values is indicative of at least one of a length of an intra-retinal fluid volume detected via the series of OCT imaging sessions of the retina, a depth of an intra-retinal fluid volume detected via the series of OCT imaging sessions of the retina, a volume of an intra-retinal fluid volume detected via the series of OCT imaging sessions of the retina, a length of a sub-retinal fluid volume detected via the series of OCT imaging sessions of the retina, a depth of a sub-retinal fluid volume detected via the series of OCT imaging sessions of the retina, or a volume of a sub-retinal fluid volume detected via the series of OCT imaging sessions of the retina [0077, 0240; see that the RT or RLT thickness is a length or depth and the measurements indicates a buildup of fluid in the retina].
Re claims 5, 6: The computer is further caused to: compare at least one of the series of measured fluid extent values with a respective threshold extent value; and in response to at least one of the series of measured fluid extent values equaling or exceeding the respective threshold extent value, transmit a communication to a treating professional when at least one of the series of measured fluid extent values exceeds the respective threshold extent value and induce remote treatment of the retinal disease via operation of an implanted pump to inject a therapeutic compound into the eye. [0077, 0091; see the healthy range comprising a threshold wherein if the measurement equals or exceeds the value an alert communication is sent to the physician, wherein the alert induces (interpreted as meaning to lead to or bring about something) remote treatment because the physician may decide to begin remote treatment based on the alert].
Re claim 7: The computer further to transmit at least one of the series of measured fluid extent values to a treating professional to enable tracking of the progress of the retinal disease by the treating professional [0078, 0091, 0183; see the alert received by a physician that the measurement is outside a normal range and see a display 166 showing the most recent measurements].
Re claims 18, 20: The OCT imaging data comprises imaging date data indicative of a date of occurrence of each of the OCT imaging sessions of the retina; and computer further to: process the imaging date data to monitor for non-compliance by the subject with a specified schedule for conducting the OCT imaging sessions of the retina, in response to detecting non-compliance by the subject with the specified schedule for conducting the OCT imaging sessions of the retina, transmit a reminder to the subject to comply with the specified schedule for conducting the OCT imaging sessions of the retina, and generate a recommendation of at least one of a date, volume, or composition of a therapeutic compound for a treatment of the retinal disease based on the OCT imaging data [0072, 0093; see the reminder/recommendation (i.e. to take medication, change medication, change dosage of a therapeutic compound) of corrective action and see the indication of patient compliance with the treatment course, both based on the measurements on specified dates].
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 8-17 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Scheibler, as applied to claim 1, in view of Jia et al (US Pub 2018/0263490 -cited by applicant).
Re claims 8-17, 22: Scheibler discloses the computer is caused to: store a first date of treatment for a first treatment of the retinal disease; store a second date of treatment for a second treatment of the retinal disease, wherein the second treatment of the retinal disease is subsequent to and consecutive with the first treatment of the retinal disease, and wherein a treatment interval extends from the first date of treatment to the second date of treatment [0078, 0093; see the RT or RLT measured at multiple time points wherein stored data includes a history of treatment which indicates a data of treatment, wherein the treatment interval extends from a first date to a second date]. Scheibler does not disclose calculating a fluid present interval, fluid absence interval, fluid regression interval, fluid increase interval, max thickness, and max volume, within the treatment interval, during which an intra-retinal fluid volume or sub-retinal fluid volume is detected or not detected via each of the OCT imaging sessions of the retina accomplished within the fluid present interval. However, Jia teaches of a system for automated segmentation of retinal fluid in OCT including calculating a fluid present interval, fluid absence interval, fluid regression interval, fluid increase interval, max thickness, and max volume, within the treatment interval, during which an intra-retinal fluid volume or sub-retinal fluid volume is detected or not detected via each of the OCT imaging sessions of the retina accomplished within the fluid present interval [0040, 0047, 0075; see the volume of intraretinal fluid IRF calculated, wherein a fluid absence interval is inherently calculated when the IRF is not detected, wherein a fluid regression and increase intervals are determined when the IRF is either decreasing or increasing, wherein a volume of IRF is calculated using a depth in the z direction to determine thickness/volume; wherein the same calculations are made of subretinal fluid SRF]. It would have been obvious to the skilled artisan to modify Scheibler, as taught by Jia, in order to provide for a more robust and accurate biomarker of disease activity [0006 of Jia].
Re claim 22: Scheibler discloses a system for tracking progress of a retinal disease of an eye of a subject [0078; see the measurement of RT and RLT to track progress of glaucoma or macular edema], the system comprising:
at least one processor [0080; see the hardware and software]; and
a tangible storage device storing non-transitory instructions [0080; see the software] that are executable by the at least one processor to cause the at least one processor to:
receive optical coherence tomography (OCT) image data of a retina of the subject for each of a series of OCT imaging sessions of the retina having an imaging frequency of 2 weeks or less [0079, 0185; see the OCT device to measure RT and RLT for a plurality of days from about 5-20 days wherein the results are communicated to a computer];
for each of the series of OCT imaging sessions of the retina, process the OCT image data of the retina to: check for presence of one or more measured fluid extent values; and determine one or more measured extents that are present in the retina [0077, 0078, 0080, 0206; see the program instructions to extract a RT and RLT measurements at multiple points in time wherein the results are output when the RT or RLT deviate from previous measurements, wherein the measurements are fluid extent values because the thickness of the retina is an indication of buildup of fluid in the retina];
form a series of the one or more measured extents that are present in the retina over the series of OCT imaging sessions of the retina [0077, 0078, 0080, 0206; see the RT and RLT measurements at multiple points in time where, when processed, form a series of extents];
store a first date of treatment for a first treatment of the retinal disease; store a second date of treatment for a second treatment of the retinal disease, wherein the second treatment of the retinal disease is subsequent to and consecutive with the first treatment of the retinal disease, and wherein a treatment interval extends from the first date of treatment to the second date of treatment [0078, 0093; see the RT or RLT measured at multiple time points wherein stored data includes a history of treatment which indicates a date of treatment, wherein the treatment interval extends from a first date to a second date];
process the series of the one or more measured extents that are present in the retina to identify at least one retinal fluid present interval, within the treatment interval, during which a measured extent is identified in each of two or more consecutive OCT imaging sessions of the series of OCT imaging sessions of the retina accomplished within the treatment interval; and generate an output that designates the at least one retinal fluid present interval [0077, 0078, 0080, 0206; see the RT and RLT measurement results that are output and processed to determine deviation from previous measurements, wherein the extent is identified in each of the imaging sessions which includes two or more consecutive sessions].
Scheibler does not disclose that the measured extents are from one or more identified and measured intra-retinal fluid volumes and/or sub-retinal fluid volumes to identify the fluid present interval. However, Jia teaches of a system for automated segmentation of retinal fluid in OCT including characterizing fluid accumulation in the retina using OCT imaging and calculating a fluid present interval from intra-retinal fluid volumes and/or sub-retinal fluid volumes [0040, 0047, 0075; see the volume of intraretinal fluid IRF and subretinal fluid SRF are calculated to identify fluid presence]. It would have been obvious to the skilled artisan to modify Scheibler, as taught by Jia, in order to provide for a more robust and accurate biomarker of disease activity [0006 of Jia].
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Scheibler, as applied to claim 1, in view of Huang (US Pub 2020/0075155 -cited by applicant).
Re claim 19: Scheibler discloses all features except to generate a severity score indicative of a severity of the retinal disease based on the OCT imaging data. However, Huang teaches of a system for automated analysis of OCT retinal scans including generation of a severity score indicative of a severity of the retinal disease based on the OCT imaging data [0020; see the OCT imaging for staging a severity of a retinal disease]. It would have been obvious to the skilled to modify Scheibler, as taught by Huang, in order to allow for the determination of an appropriate course of treatment based on severity.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Scheibler, as applied to claim 1, in view of Toth et al (US Pub 2007/0115481 -cited by applicant).
Re claim 21: Scheibler discloses all features except that the retinal disease comprises at least one of pigment epithelium detachment, Drusen, or a Macular hole. However, Toth teaches of a system for registering OCT with clinical tests wherein the retinal disease is pigment epithelium detachment, Drusen, or a Macular hole [0033, 0048; see the detachment disease]. It would have been obvious to modify Scheibler, as taught by Toth, in order to identify a disease and improve the course of treatment [0055 of Toth].
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 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 12,458,284. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘284 features a system for tracking progress of a retinal disease of an eye of a subject, the system comprising: at least one processor; and a tangible storage device storing non-transitory instructions that are executable by the at least one processor to cause the at least one processor to: receive optical coherence tomography (OCT) image data of a retina of the subject for each of a series of OCT imaging sessions of the retina having an imaging frequency of 2 weeks or less; for each of the series of OCT imaging sessions of the retina, process the OCT image data of the retina to: check for presence of one or more intra-retinal fluid volumes and/or one or more sub-retinal fluid volumes in the retina; and determine one or more measured extents of one or more intra-retinal fluid volumes and/or one or more sub-retinal fluid volumes that are present in the retina; form a series of the one or more measured extents of one or more intra-retinal fluid volumes and/or one or more sub-retinal fluid volumes that are present in the retina over the series of OCT imaging sessions of the retina; store first and second date data of a first and second treatment, and to identify various intervals including a fluid present interval. While the claims of ‘284 are different such as including the monitoring of thresholds, it would have been obvious to conclude that the instant claims are an obvious variant.
Conclusion
This is a CON of applicant's earlier Application No. 18/132,567. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). 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.
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797
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