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 .
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.
Application Status
Receipt is acknowledged of amendment, filed 04/04/2025. Claims 8-10, 14, 15, 17, 18 and 20 are currently pending.
Information Disclosure Statement
Receipt of acknowledgment of the information disclosure statements filed on 11/07/2024 and 05/01/2023 have been received and all references have been considered.
Drawings
The drawings are objected to for the following reasons:
37 CFR 1.84 (u)(1) states “View numbers must be preceded by the abbreviation "FIG."”
In the current case, the view numbers for Figures 1-7 are preceded by the word "Figure" instead of the abbreviation "FIG.".
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 8 is objected to because of the following informalities:
Claim 8 recites “wherein the pegylated anti-CS agent is an Aptamer”. It is interpreted that “anti-CS” is supposed to be “anti-C5”. It would be remedial to amend “anti-CS” to recite “anti-C5”.
Claim 8 recites the abbreviations for “iRORA” and “cRORA”. The abbreviations for the ophthalmological diseases, disorders and/or conditions should be spelled out in the first appearance of the claims and should be followed by the abbreviation in parentheses.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 8 and 14, the phrase "about" renders the claims vague and indefinite in that the metes and bounds of the phrase are unclear. The phrase is unclear in that “about” does not define what the amount of the composition would need to be administered to accomplish the desired effects. Also, the phrase “about” does not define how much variation in the dose is possible to accomplish the desired effects. It would be remedial to replace the phrase “about” with the specific dosage or range of dose required to accomplish effective treatment.
Claim 8 is vague and indefinite in that the metes and bounds of the phrase “high-risk drusen” are unclear. The phrase is unclear in that “high-risk drusen” does not define what characteristics, signs or symptoms of the specific disease, condition or disorder the subject would be required to have to be considered as having “high-risk drusen”. It would be remedial to replace the phrase “high-risk drusen” with “drusen”.
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.
(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 8-10, 14, 15, 17, 18 and 20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Patel et al (WO 2015/006734 A1) as evidenced by Guymer et al (The American Academy of Ophthalmology, Vol 127, No. 3, March 2020; Pgs. 394-409).
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].
Guymer is only cited to show 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 continues to show 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).
Regarding claims 9 and 15, Patel teaches the pegylated anti-C5 specific aptamer is a compound, ARC1905,
having the structure set forth below:
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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].
Conclusion
No claims are allowed.
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/ALEXANDRA ROSE LIPPOLIS/Examiner, Art Unit 1637
/Jennifer Dunston/Supervisory Patent Examiner, Art Unit 1637