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 .
This action is in response to the amendment filed 05/06/2026, in which claims 8 and 14 were amended, claims 9, 10, 15, 17, 18 and 20 were previously presented and claims 21 and 22 are newly added. Claims 8-10, 14, 15, 17, 18 and 20-22 are currently pending.
Applicant’s arguments have been thoroughly reviewed, but are not persuasive for the
reasons that follow. Any rejection and objections not reiterated in this action have been
withdrawn. This action is FINAL.
Priority
Acknowledgment is made of applicant’s claim for priority based on a provisional application filed as 63/108,428 on 11/01/2020.
All claims are given the priority date of 11/01/2020.
Information Disclosure Statement
Receipt of acknowledgment of the information disclosure statement filed on 05/06/2026 has been received and all references have been considered.
Drawings
The previously objection to the drawings has been withdrawn in view of the new drawings filed on 05/06/2026.
Claim Objections
The previous claim objections to claim 8 have been withdrawn in view of the amendments to the claim filed on 05/06/2026.
Claim Rejections - 35 USC § 112
The previous rejection of claims 8 and 14 under 35 U.S.C. 112(b) as being indefinite has been withdrawn in view of the amendments to the claims filed on 05/06/2026.
Response to Arguments - Claim Rejections - 35 USC § 102
The rejection of claims 8-10, 14, 15, 17, 18 and 20 under 35 U.S.C. 102 has been withdrawn in view of Applicant' s amendment to the claims filed on 05/06/2026.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 8-10, 14, 15, 17, 18 and 20-22 are rejected under 35 U.S.C. 103 as being anticipated by Patel et al (WO 2015/006734 A1) in view of Guymer et al (The American Academy of Ophthalmology, Vol 127, No. 3, March 2020; Pgs. 394-409). This is a NEW rejection to address the amendment to the claims in the reply filed 05/06/2026.
Regarding claims 8 and 14, “iRORA” and “cRORA” are interpreted as atrophic stages of dry-type (non-exudative) AMD, related to geographic atrophy, named according to the affected anatomic layers on OCT (instant specification para. 0008).
Patel teaches the dry age-related macular degeneration is associated with the formation of drusen wherein the treating or preventing dry macular degeneration encompasses treating or preventing an abnormality of the retinal pigment epithelium and/or underlying vasculature, known as choriocapilaries, and wherein the examples of abnormalities of the retinal pigment epithelium include geographic atrophy, non-geographic atrophy, focal hypopigmentation, and focal hyperpigmentation [00144]. Patel teaches ocular dosages of compositions comprising anti-C5 aptamers, such as ARC 1905 and ARC 187, or a pharmaceutically acceptable salt thereof, can range from about 0.1 mg to about 3 mg/eye wherein the composition is administered intravitreally [00308]. Patel teaches the pegylated anti-C5 specific aptamer is a compound, ARC1905 [00106 and 00115-00116] or a pharmaceutically acceptable salt thereof, where Aptamer = fCmGfCfCGfCmGmGfUfCfUfCmAmGmGfCGfCfUmGmAmGfUfCfUmGmAmGfUfUfUAfCfCfUmGfCmG-3T (SEQ ID NO: 26) wherein fC and fU = 2'-fluoro nucleotides, and mG and mA = 2'-OMe nucleotides and all other nucleotides are 2'-OH and where 3T indicates and inverted deoxy thymidine wherein each 20 kDa mPEG of the above structure has a molecular weight of about 20 kDa [00117-00118]. Patel the anti-C5 agent and a VEGF antagonist is administered in an amount effective to inhibit, slow, or prevent the progression of non-exudative type AMD to geographic atrophy (GA) [00150].
Patel does not specifically teach the subject has risk factor for the progression to incomplete retinal pigment epithelial and outer retinal atrophy (iRORA), iRORA, or complete retinal pigment epithelium and outer retinal atrophy (cRORA).
Guymer teaches that the atrophic stages of AMD should be named according to the affected anatomic layers on OCT wherein the term complete RPE and outer retinal atrophy (cRORA) was proposed as an end point for geographic atrophy that occurred in the presence of drusen and was defined by the following criteria: (1) a region of hypertransmission of at least 250 mm in diameter, (2) a zone of attenuation or disruption of the RPE of at least 250 mm in diameter, and (3) evidence of overlying photoreceptor degeneration, all occurring in the absence of signs of an RPE tear (Page 397, Column 1). Guymer teaches that the term incomplete RPE and outer retinal atrophy (iRORA) was introduced to describe a stage of AMD in which these OCT signs were present but did not fulfill all the criteria for cRORA (Page 397, Column 1). Guymer teaches Geographic atrophy (GA) is a late-stage disease manifestation in nonneovascular age-related macular degeneration (AMD) that progresses to severe central vision loss (Page 394, Column 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Patel to include the subject has risk factor for the progression to incomplete retinal pigment epithelial and outer retinal atrophy (iRORA), iRORA, or complete retinal pigment epithelium and outer retinal atrophy (cRORA) as taught by Guymer because Patel teaches it is within the ordinary skill in the art to use the anti-C5 agent and a VEGF antagonist is administered in an amount effective to inhibit, slow, or prevent the progression of non-exudative type AMD to geographic atrophy (GA) and Guymer teaches the atrophic stages of AMD should be named according to the affected anatomic layers on OCT wherein the term complete RPE and outer retinal atrophy (cRORA) was proposed as an end point for geographic atrophy that occurred in the presence of drusen.
One would have been motivated to make such a modification in order to receive the expected benefit of determining the stage of AMD using OCT as taught by Guymer.
Regarding claims 9 and 15, Patel teaches the pegylated anti-C5 specific aptamer is a compound, ARC1905, having the structure set forth below:
PNG
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58
518
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[00106 and 00115-00116].
Regarding claims 10, 17, 18 and 20, “iRORA” and “cRORA” are interpreted as atrophic stages of dry-type (non-exudative) AMD, related to geographic atrophy, named according to the affected anatomic layers shown on Optical Coherence Tomography (OCT) (instant specification para. 0008).
Patel teaches the dry age-related macular degeneration is associated with the formation of drusen wherein the treating or preventing dry macular degeneration encompasses treating or preventing an abnormality of the retinal pigment epithelium and/or underlying vasculature, known as choriocapilaries, and wherein the examples of abnormalities of the retinal pigment epithelium include geographic atrophy, non-geographic atrophy, focal hypopigmentation, and focal hyperpigmentation [00144].
Regarding claims 21 and 22, “iRORA” and “cRORA” are interpreted as atrophic stages of dry-type (non-exudative) AMD, related to geographic atrophy, named according to the affected anatomic layers on OCT (instant specification para. 0008). The specification defines “risk factors” as “risk factors include, e.g, hypertension, obesity, atherosclerosis, focal deposition of acellular detritus between the RPE, family history of AMD, including a genetic risk, smoking, high body mass index, high-fat diet, low intake of antioxidants and zinc, previous cataract surgery, history of cardiovascular disease, higher plasma fibrinogen, and/or diabetes” by identifying high drusen levels using SD-OCT which is recited as “SD-OCT specifically provides a reliable and reproducible method for measuring drusen morphology over time as well as other characteristic features of AMD; Additionally, SD-OCT algorithms are available in order to quantify drusen characteristics such as drusen volume and area and morphological changes over time using cube root and square root transformations, respectively; Advancements of imaging with the use of SD-OCT and color fundus imaging has made it possible to study and measure the morphology of drusen by providing three-dimensional, geometric assessment; and SDOCT imaging has also allowed for multimodal imaging and has identified other macular features that increase the risk of vision loss, including decreased internal reflectivity of drusen (identified as calcified drusen), intraretinal hyperreflective foci, and subretinal drusenoid deposits” [0076-0078 and 0087].
Patel teaches the dry age-related macular degeneration is associated with the formation of drusen wherein the treating or preventing dry macular degeneration encompasses treating or preventing an abnormality of the retinal pigment epithelium and/or underlying vasculature, known as choriocapilaries, and wherein the examples of abnormalities of the retinal pigment epithelium include geographic atrophy, non-geographic atrophy, focal hypopigmentation, and focal hyperpigmentation [00144]. Patel teaches ocular dosages of compositions comprising anti-C5 aptamers, such as ARC 1905 and ARC 187, or a pharmaceutically acceptable salt thereof, can range from about 0.1 mg to about 3 mg/eye wherein the composition is administered intravitreally [00308]. Patel teaches the pegylated anti-C5 specific aptamer is a compound, ARC1905 [00106 and 00115-00116] or a pharmaceutically acceptable salt thereof, where Aptamer = fCmGfCfCGfCmGmGfUfCfUfCmAmGmGfCGfCfUmGmAmGfUfCfUmGmAmGfUfUfUAfCfCfUmGfCmG-3T (SEQ ID NO: 26) wherein fC and fU = 2'-fluoro nucleotides, and mG and mA = 2'-OMe nucleotides and all other nucleotides are 2'-OH and where 3T indicates and inverted deoxy thymidine wherein each 20 kDa mPEG of the above structure has a molecular weight of about 20 kDa [00117-00118]. Patel the anti-C5 agent and a VEGF antagonist is administered in an amount effective to inhibit, slow, or prevent the progression of non-exudative type AMD to geographic atrophy (GA) [00150]. Patel teaches the composition is administered to a subject having a greater risk of developing an ophthalmological disease or disorder (e.g., a diabetic patient) can receive treatment to inhibit or delay the onset of symptoms [0230].
Patel does not specifically teach the subject has risk factor for the progression to incomplete retinal pigment epithelial and outer retinal atrophy (iRORA), iRORA, or complete retinal pigment epithelium and outer retinal atrophy (cRORA).
Guymer teaches that the atrophic stages of AMD should be named according to the affected anatomic layers on OCT wherein the term complete RPE and outer retinal atrophy (cRORA) was proposed as an end point for geographic atrophy that occurred in the presence of drusen and was defined by the following criteria: (1) a region of hypertransmission of at least 250 mm in diameter, (2) a zone of attenuation or disruption of the RPE of at least 250 mm in diameter, and (3) evidence of overlying photoreceptor degeneration, all occurring in the absence of signs of an RPE tear (Page 397, Column 1). Guymer teaches that the term incomplete RPE and outer retinal atrophy (iRORA) was introduced to describe a stage of AMD in which these OCT signs were present but did not fulfill all the criteria for cRORA (Page 397, Column 1). Guymer teaches Geographic atrophy (GA) is a late-stage disease manifestation in nonneovascular age-related macular degeneration (AMD) that progresses to severe central vision loss (Page 394, Column 1). Guymer teaches multimodal imaging, including OCT, has identified other macular features that increase the risk of vision loss, including increased drusen volume, decreased internal reflectivity of drusen (identified as calcified drusen), intraretinal hyperreflective foci, and subretinal drusenoid deposits (also known as reticular pseudodrusen) (Page 395, Column 1 bridging Column 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Patel to include the subject has risk factor for the progression to incomplete retinal pigment epithelial and outer retinal atrophy (iRORA), iRORA, or complete retinal pigment epithelium and outer retinal atrophy (cRORA) as taught by Guymer because Patel teaches it is within the ordinary skill in the art to use the anti-C5 agent and a VEGF antagonist is administered in an amount effective to inhibit, slow, or prevent the progression of non-exudative type AMD to geographic atrophy (GA) and Guymer teaches the atrophic stages of AMD should be named according to the affected anatomic layers on OCT wherein the term complete RPE and outer retinal atrophy (cRORA) was proposed as an end point for geographic atrophy that occurred in the presence of drusen.
One would have been motivated to make such a modification in order to receive the expected benefit of identifying subjects with increased risk factors by using OCT as taught by Guymer.
Conclusion
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 ALEXANDRA ROSE LIPPOLIS whose telephone number is (703)756-5450. The examiner can normally be reached Monday-Friday, 8:00am to 5:00pm EST.
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/ALEXANDRA ROSE LIPPOLIS/Examiner, Art Unit 1637
/CELINE X QIAN/Primary Examiner, Art Unit 1637
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