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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/05/2023 and 06/01/2026 have been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 06/01/2026 is acknowledged.
Claim Rejections - 35 USC § 103
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 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 1-7, 10-19 and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Huang (US 2016/0284103; already of record) in view of Binette (WO 2021/242788).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claim 1, Huang discloses, a method for assessing the progression of an area of retinal atrophy in a retina of a subject (Figs. 1-6C), comprising
a) defining an area of geographic atrophy (GA) or complete RPE and outer retinal atrophy (cRORA) (Para. 0007 and 0077; note, discloses measuring, monitoring and treating geographic atrophy) within an external limiting membrane (ELM) border of the retina at a first time point (Para. 0007 and 0077; note, discloses measuring, monitoring and treating geographic atrophy over time to track progression of the geographic atrophy);
b) marking and measuring an ELM border or ELM border descend using optical coherence tomography (OCT) (Para. 0007, 0120 and see Figs. 6B-C; note, Fig. 6C shows the ELM border circumscribed in white on left image of Fig 6C), wherein the ELM border is the boundary of the atrophy and the ELM border descend is the delimitation of the area with near-total photoreceptor depletion by histology (Para. 0007, 0120 and see Figs. 6B-C; note, Fig. 6C shows the ELM border circumscribed in white on left image of Fig 6C that is monitored over time);
c) calculating an area included inside the ELM border to define a first calculated area (Para. 0007, 0077 and Figs. 6B-C); and
d) defining the rate of progression of the atrophy (Para. 0007, 0120 and see Figs. 6B-C; note, Fig. 6C shows the ELM border circumscribed in white on left image of Fig 6C that is monitored over time).
Huang does not disclose defining an area of geographic atrophy (GA) or complete RPE and outer retinal atrophy (cRORA) within an external limiting membrane (ELM) border of the retina at a first time point following transplantation of retinal pigment epithelium (RPE) cells to the subject.
Binette teaches, from the same field of endeavor that in a method for assessing the progression of an area of retinal atrophy (Figs. 1-2, 11-12, 35-52) that it would have been desirable to include defining an area of geographic atrophy (GA) or complete RPE and outer retinal atrophy (cRORA) within an external limiting membrane (ELM) border of the retina at a first time point following transplantation of retinal pigment epithelium (RPE) cells to the subject (Para. 0035-0036, 0050-0053 and Figs. 11-12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include defining an area of geographic atrophy (GA) or complete RPE and outer retinal atrophy (cRORA) within an external limiting membrane (ELM) border of the retina at a first time point following transplantation of retinal pigment epithelium (RPE) cells to the subject as taught by the method for assessing the progression of an area of retinal atrophy of Binette in the method for assessing the progression of an area of retinal atrophy of Huang since Binette teaches it is known to include these features in a method for assessing the progression of an area of retinal atrophy for the purpose of providing a reliable and accurate method for assessing the progression of an area of retinal atrophy that effectively treats retinal atrophy.
Regarding claim 2, Huang in view of Binette discloses and teaches as set forth above, and Binette further teaches, from the same field of endeavor that in a method for assessing the progression of an area of retinal atrophy that it would have been desirable to include repeating steps a) through c) at a second time point to determine a SQRT of a second calculated area, wherein the control is the SQRT of the second calculated area (Para. 0035-0036, 0050-0053 and Figs. 11-12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the method for assessing the progression of an area of retinal atrophy of Binette in the method for assessing the progression of an area of retinal atrophy of Huang since Binette teaches it is known to include these features in a method for assessing the progression of an area of retinal atrophy for the purpose of providing a reliable and accurate method for assessing the progression of an area of retinal atrophy that effectively treats retinal atrophy.
Regarding claim 3, Huang in view of Binette discloses and teaches as set forth above, and Huang further discloses, the control is a historical rate of progression for the retina (Para. 0007 and 0105; note, the Examiner interprets the method of Huang is used to monitor geographic atrophy over time the initial geography that was used as the starting point of the monitoring is the control of the historical rate).
Regarding claim 4, Huang in view of Binette discloses and teaches as set forth above, and Huang further discloses, the control is a rate of progression for a control retina (Para. 0007 and 0105; note, the Examiner interprets the method of Huang is used to monitor geographic atrophy over time the initial geography that was used as the starting point of the monitoring is the control of the historical rate).
Regarding claim 5, Huang in view of Binette discloses and teaches as set forth above, and Huang further discloses, the control retina is an untreated retina of the subject (Para. 0007 and 0105; note, the Examiner interprets the method of Huang is used to monitor geographic atrophy over time the initial geography that was used as the starting point of the monitoring is the control of the historical rate).
Regarding claim 6, Huang in view of Binette discloses and teaches as set forth above, and Binette further teaches, from the same field of endeavor that in a method for assessing the progression of an area of retinal atrophy that it would have been desirable to make the measurement of the ELM border and calculation of the first calculated area is performed manually (Para. 0035-0036, 0050-0053 and Figs. 11-12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the method for assessing the progression of an area of retinal atrophy of Binette in the method for assessing the progression of an area of retinal atrophy of Huang since Binette teaches it is known to include these features in a method for assessing the progression of an area of retinal atrophy for the purpose of providing a reliable and accurate method for assessing the progression of an area of retinal atrophy that effectively treats retinal atrophy.
Regarding claim 7, Huang in view of Binette discloses and teaches as set forth above, and Binette further teaches, from the same field of endeavor that in a method for assessing the progression of an area of retinal atrophy that it would have been desirable to make the measurement of the ELM border is performed automatically by the OCT apparatus, by a standalone algorithm (Para. 0035-0036, 0050-0053 and Figs. 11-12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the method for assessing the progression of an area of retinal atrophy of Binette in the method for assessing the progression of an area of retinal atrophy of Huang since Binette teaches it is known to include these features in a method for assessing the progression of an area of retinal atrophy for the purpose of providing a reliable and accurate method for assessing the progression of an area of retinal atrophy that effectively treats retinal atrophy.
Regarding claim 10, Huang in view of Binette discloses and teaches as set forth above, and Binette further teaches, from the same field of endeavor that in a method for assessing the progression of an area of retinal atrophy that it would have been desirable to make progression of an area of retinal atrophy are measured both in mm2 and by square root transformation SQRT (Para. 0035-0036, 0050-0053 and Figs. 11-12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the method for assessing the progression of an area of retinal atrophy of Binette in the method for assessing the progression of an area of retinal atrophy of Huang since Binette teaches it is known to include these features in a method for assessing the progression of an area of retinal atrophy for the purpose of providing a reliable and accurate method for assessing the progression of an area of retinal atrophy that effectively treats retinal atrophy.
Regarding claim 11, Huang in view of Binette discloses and teaches as set forth above, and Binette further teaches, from the same field of endeavor that in a method for assessing the progression of an area of retinal atrophy that it would have been desirable to make steps a) through c) are performed at a third time point (Para. 0035-0036, 0050-0053 and Figs. 11-12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the method for assessing the progression of an area of retinal atrophy of Binette in the method for assessing the progression of an area of retinal atrophy of Huang since Binette teaches it is known to include these features in a method for assessing the progression of an area of retinal atrophy for the purpose of providing a reliable and accurate method for assessing the progression of an area of retinal atrophy that effectively treats retinal atrophy.
Regarding claim 12, Huang in view of Binette discloses and teaches as set forth above, and Binette further teaches, from the same field of endeavor that in a method for assessing the progression of an area of retinal atrophy that it would have been desirable to make second time point and third time point are about 12 months and about 24 months after transplantation, respectively (Para. 0035-0036, 0050-0053 and Figs. 11-12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the method for assessing the progression of an area of retinal atrophy of Binette in the method for assessing the progression of an area of retinal atrophy of Huang since Binette teaches it is known to include these features in a method for assessing the progression of an area of retinal atrophy for the purpose of providing a reliable and accurate method for assessing the progression of an area of retinal atrophy that effectively treats retinal atrophy.
Regarding claim 13, Huang in view of Binette discloses and teaches as set forth above, and Binette further teaches, from the same field of endeavor that in a method for assessing the progression of an area of retinal atrophy that it would have been desirable to make the historical rate of progression is predicted growth according to historical data on area of atrophy and using a SQRT lineal growth calculation to predict the theoretical size of the area of atrophy at any future time point (Para. 0035-0036, 0050-0053 and Figs. 11-12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the method for assessing the progression of an area of retinal atrophy of Binette in the method for assessing the progression of an area of retinal atrophy of Huang since Binette teaches it is known to include these features in a method for assessing the progression of an area of retinal atrophy for the purpose of providing a reliable and accurate method for assessing the progression of an area of retinal atrophy that effectively treats retinal atrophy.
Regarding claim 14, Huang in view of Binette discloses and teaches as set forth above, and Binette further teaches, from the same field of endeavor that in a method for assessing the progression of an area of retinal atrophy that it would have been desirable to make the control is the theoretical prediction of growth of the same eye (Para. 0035-0036, 0050-0053 and Figs. 11-12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the method for assessing the progression of an area of retinal atrophy of Binette in the method for assessing the progression of an area of retinal atrophy of Huang since Binette teaches it is known to include these features in a method for assessing the progression of an area of retinal atrophy for the purpose of providing a reliable and accurate method for assessing the progression of an area of retinal atrophy that effectively treats retinal atrophy.
Regarding claim 15, Huang in view of Binette discloses and teaches as set forth above, and Binette further teaches, from the same field of endeavor that in a method for assessing the progression of an area of retinal atrophy that it would have been desirable to make the comparison of atrophy area is performed between a treated eye and a fellow eye of the subject, using both mm2 and SQRT (Para. 0035-0036, 0050-0053 and Figs. 11-12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the method for assessing the progression of an area of retinal atrophy of Binette in the method for assessing the progression of an area of retinal atrophy of Huang since Binette teaches it is known to include these features in a method for assessing the progression of an area of retinal atrophy for the purpose of providing a reliable and accurate method for assessing the progression of an area of retinal atrophy that effectively treats retinal atrophy.
Regarding claim 16, Huang in view of Binette discloses and teaches as set forth above, and Binette further teaches, from the same field of endeavor that in a method for assessing the progression of an area of retinal atrophy that it would have been desirable to make calculating is performed in mm2 (Para. 0035-0036, 0050-0053 and Figs. 11-12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the method for assessing the progression of an area of retinal atrophy of Binette in the method for assessing the progression of an area of retinal atrophy of Huang since Binette teaches it is known to include these features in a method for assessing the progression of an area of retinal atrophy for the purpose of providing a reliable and accurate method for assessing the progression of an area of retinal atrophy that effectively treats retinal atrophy.
Regarding claim 17, Huang in view of Binette discloses and teaches as set forth above, and Binette further teaches, from the same field of endeavor that in a method for assessing the progression of an area of retinal atrophy that it would have been desirable to make the comparison of atrophy areas is performed on a plurality of eyes (Para. 0035-0036, 0050-0053 and Figs. 11-12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the method for assessing the progression of an area of retinal atrophy of Binette in the method for assessing the progression of an area of retinal atrophy of Huang since Binette teaches it is known to include these features in a method for assessing the progression of an area of retinal atrophy for the purpose of providing a reliable and accurate method for assessing the progression of an area of retinal atrophy that effectively treats retinal atrophy.
Regarding claim 18, Huang in view of Binette discloses and teaches as set forth above, and Huang further discloses, the first time point is before transplantation of RPE cells (Para. 0007 and 0077).
Regarding claim 19, Huang in view of Binette discloses and teaches as set forth above, and Binette further teaches, from the same field of endeavor that in a method for assessing the progression of an area of retinal atrophy that it would have been desirable to make the first time point is at the time of transplantation of RPE cells (Para. 0035-0036, 0050-0053 and Figs. 11-12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the method for assessing the progression of an area of retinal atrophy of Binette in the method for assessing the progression of an area of retinal atrophy of Huang since Binette teaches it is known to include these features in a method for assessing the progression of an area of retinal atrophy for the purpose of providing a reliable and accurate method for assessing the progression of an area of retinal atrophy that effectively treats retinal atrophy.
Regarding claim 36, Huang in view of Binette discloses and teaches as set forth above, and Huang further discloses, the area of retinal atrophy is advanced stage geographic atrophy, early-stage geographic atrophy, high-risk AMD, or late intermediate AMD (Para. 0007 and 0077).
Regarding claim 37, Huang in view of Binette discloses and teaches as set forth above, Huang in view of Binette discloses and teaches as set forth above, and Binette further teaches, from the same field of endeavor that in a method for assessing the progression of an area of retinal atrophy that it would have been desirable to make RPE cells resulting from the transplantation are present within the boundaries of the GA within the ELM (Para. 0035-0036, 0050-0053 and Figs. 11-12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the method for assessing the progression of an area of retinal atrophy of Binette in the method for assessing the progression of an area of retinal atrophy of Huang since Binette teaches it is known to include these features in a method for assessing the progression of an area of retinal atrophy for the purpose of providing a reliable and accurate method for assessing the progression of an area of retinal atrophy that effectively treats retinal atrophy.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Huang (US 2016/0284103; already of record) in view of Binette (WO 2021/242788) as applied to claims 1 and 7 above, and further in view of Wang (WO 2022/232555).
Huang in view of Binette remains as applied to claims 1 and 7 above.
Huang in view of Binette does not disclose the measurement and calculation of ELM border is performed using artificial intelligence for automatic detection, areas and volume detection by specific layers and predictions of growth.
Wang teaches, from the same field of endeavor that in a method for assessing the progression of an area of retinal atrophy that it would have been desirable to make the measurement and calculation of ELM border is performed using artificial intelligence for automatic detection, areas and volume detection by specific layers and predictions of growth (Para. 0027, 0043 and 0068).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the measurement and calculation of ELM border is performed using artificial intelligence for automatic detection, areas and volume detection by specific layers and predictions of growth as taught by the method for assessing the progression of an area of retinal atrophy of Wang in the combination of Huang in view of Binette since Wang teaches it is known to include these features in a method for assessing the progression of an area of retinal atrophy for the purpose of providing an accurate, reliable and high-speed method for assessing the progression of an area of retinal atrophy.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kerr et al. (US 2018/0318302) and Boyd (US 9,662,407) disclose a method for assessing the progression of an area of retinal atrophy that includes a) defining an area of geographic atrophy (GA) or complete RPE and outer retinal atrophy (cRORA) within an external limiting membrane (ELM) border of the retina at a first time point following transplantation of retinal pigment epithelium (RPE) cells to the subject; b) marking and measuring an ELM border or ELM border descend using optical coherence tomography (OCT), wherein the ELM border is the boundary of the atrophy and the ELM border descend is the delimitation of the area with near-total photoreceptor depletion by histology; c) calculating an area included inside the ELM border to define a first calculated area.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWAYNE A PINKNEY whose telephone number is (571)270-1305. The examiner can normally be reached M-F 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pinping Sun can be reached at 571-270-1284. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAWAYNE PINKNEY/Primary Examiner, Art Unit 2872 08/18/2026
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