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 .
DETAILED ACTION
RESPONSE TO AMENDMENT
Status of Application/Amendments/claims
2. Applicant’s amendment filed January 26, 2026 is acknowledged. Claims 1-87, 89, 95-97 and 106-115 are canceled. Claims 88 and 117 are amended. Claims 88, 90-94, 98-105 and 116-122 are pending in this application. Election was made without traverse in the reply filed on December 8, 2021.
3. Claims 88, 90-94, 98-105 and 116-122 are under examination with respect to dry AMD/macular degeneration in this office action.
4. Applicant’s arguments filed on January 26, 2026 have been fully considered but they are not deemed to be persuasive for the reasons set forth below.
Claim Rejections/Objections Withdrawn
5. The provisional rejection of claims 89, 108 and 115 on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 13-30 and 35-37 of copending Application No. 18/058425 in view of Gay et al. (US2013/0195806) and Banin et al. (US2018/0008458) is moot because the claims are canceled.
The rejection of claims 117-122 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in response to Applicant’s amendment to the claims.
The rejection of claim 108 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form is moot because the claim is canceled.
The rejection of claims 89, 108 and 115 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement due to new matter is moot because the claims are canceled.
Claim Rejections/Objections Maintained
In view of the amendment filed on January 26, 2026, the following rejections are maintained.
Double Patenting
6. 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 88-94, 98-105, 108 and 115-122 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 13-30 and 35-37 of copending Application No. 18/058425 in view of Gay et al. (US2013/0195806) and Banin et al. (US2018/0008458). The rejection is maintained for the reasons of record and the reasons set forth below.
Response to Argument
On p.5 of the response, Applicant requests withdrawal of the double patenting rejection because the cited Application has a later effective filing date, and the present claims are allowable.
In response, contrary to Applicant’s arguments, the instant claims are still rejected for the reasons set forth below. Applicant’s request of withdrawal of the rejection is moot. The rejection is maintained for the reasons of record until a terminal disclaimer is filed.
Claim Rejections - 35 USC § 112
7. The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 88, 90-94, 98-105 and 116-122 stand rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claims 88-94, 98-105, 108 and 115-116 as amended are directed to a method of treating or slowing the progression of a retinal disease or disorder, the method comprising, administering to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising retinal pigment epithelium (RPE) cells to a geographic atrophy (GA) lesion.
Claims 117-122 as amended are directed to a method of treating or slowing the progression of a retinal disease or disorder, comprising administering to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising RPE cells at a geographic atrophy (GA) lesion.
Response to Arguments
On p. 6-7 of the response, Applicant argues that the specification provides support for the limitation “administering….to a geographic atrophy (GA) lesion” and “administering…at a geographic atrophy (GA) lesion” because the specification discloses “implanting….covering a GA lesion….covering portions or all of the transitional zone bordering the GA lesion” (p.6 lines 19-21); “covering the entire GA lesion with a bleb” (p. 6, lines 27-28); “administered over a GA lesion….administering over the GA lesion…” (p. 13, lines 12-14) and cites MPEP2163(I)(B) in support of the arguments.
Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant's arguments, the examiner asserts that based on MPEP §2163, MPEP §§2163.01-2163.03, the specification fails to provide sufficient support for the limitations “to a geographic atrophy (GA) lesion” and “at a geographic atrophy (GA) lesion” recited in claims 88 and 117.
Based on Applicant’s arguments on p. 7-14 of the response filed 11/21/2024 and paragraphs 13-17 of Applicant’s declaration filed 11/21/2024, the recited “administration to the GA lesion” is different from the limitation “covering the GA lesion in the macula and fovea via the subretinal space in the macular area or delivering RPE cells to the area that covers the GA lesion, superiorly or superotemporally over the GA lesion, and over the entire GA lesion via the subretinal space” disclosed by Gay (US2013/0195806), which was cited in the 102 rejection in a prior office action. The rejection based on Gay (US2013/0195806) was withdrawn in response to Applicant’s declaration and assertion that administration to the GA lesion recited in instant claims is different from covering the GA lesion achieved by the Gay’s method.
Based on Applicant’s own assertion that administration to the GA lesion recited in instant claims is different from covering the GA lesion achieved by the Gay’s method in Applicant’s arguments on p. 7-14 of the response filed 11/21/2024 and paragraphs 13-17 of Applicant’s declaration filed 11/21/2024, the cited passages in the specification provides no support for the limitations “administering…..to a geographic atrophy (GA) lesion” and “administering…..at a geographic atrophy (GA) lesion” recited in claims 88 and 117.
Accordingly, the rejection of claims 88, 90-94, 98-105 and 116-122 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement due to new matter is maintained.
Conclusion
8. NO CLAIM IS ALLOWED.
9. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Banin et al. (US2018/0088458) teaches a method of treating a subject with a retinal disease or condition including dry-form AMD, the method comprising administering into the subretina of the subject a therapeutically effective amount of a pharmaceutical composition comprising human retinal pigment epithelium (RPE) cells in the macular area via a cannula through a small retinotomy to form a small bleb in the macular area along the border between areas of GA and better preserved extra-foveal retinal and RPE layer, wherein the human RPE cells including RPE cells derived from human embryonic stem cell (hESC-RPE cells) or induced pluripotent stem cell derived RPE cells (hiPSC-RPE cells), wherein at least 95% of the human RPE cells express PMEL17 and CRALBP, and wherein the therapeutically effective amount includes 50,000-5,000,000 or 50,000-1000,000 or 50,000, 200,000 or 500,000 cells per administration; and wherein the subject with dry AMD is with geographic atrophy in the macula and above 0.5 disc area in at least one eye and wherein the subject has BCVA of less than 20/200 or less than 20/100 (see abstract; paragraphs [0007]-[0034]; [0084]-[0092]; [0234]-[0308], Example 2; p. 16-17, claims 1-3, 5, 6, 10,15-16, 18; 25-26, 29, 31-34, 36, 38-40). Banin teaches that the RPE cells are delivered into the subretinal space in the macular area via a cannula through a small retinotomy to form a small bleb and a total volume of up to 50-150 μl cell suspension will be injected in areas at risk for GA expansion or in the macular area along the border between areas of GA and better preserved extra-foveal retinal and RPE layer (see paragraphs [0005]; [0234]-[0235]; [0285]-[0288]). Patients with dry AMD has geographic atrophy (GA) with degeneration of RPE cells and photoreceptors over large areas of the macula (the center of macula, which is the fovea) (see paragraph [0004]). The transplantation of RPE cells to the subretinal space in the macular area of patients with dry AMD using a cannula through a small retinotomy to form a small bleb in the macular covers a geography atrophy (GA) lesion (see paragraphs [0092]-[0102]; [0005]; [0234]-[0235]; [0285]-[0288]), which described in instant specification (see paragraphs [0284], [0298] and [0304] of the published specification). Banin teaches that administration of RPE cells results in an increase in pigmentation that remains at least about 6-12 months or 90 days-24 months as in claim 90 (see paragraphs [0234]-[0308], Example 2), a therapeutically effective amount of RPE cells is between 50,000-5,000,000 cells per administration, or 50,000-1000,000 or 50,000, 200,000 or 500,000 cells per administration (see paragraphs [0016]-[0020]; [0085]), wherein the RPE cell composition comprises at least 95% of RPE cells co-expressing PMEL17 and CRALBP (see abstract; paragraphs [0007]-[0036]; [0068]-[0074], p. 16-17, claims 1-3, 5, 6, 10,15-16, 18; 25-26, 29, 31-34, 36, 38-40). Banin also teaches that the RPE cells are generated by ex-vivo differentiation of pluripotent stem cells including human embryonic stem cells (hESCs) or generated by (a) culturing hESCs or induced pluripotent stem cells (iPSCs) in a medium comprising nicotinamide to generate differentiating cells; (b) culturing the differentiating cells in a medium comprising nicotinamide and activin A to generate cells further differentiated towards the RPE lineage; and (c) culturing the cells further differentiated towards the RPE lineage in a medium comprising nicotinamide in the absence of activin A under adherent conditions as in claims 94, 98 and 100 and also teaches that the ESCs/iPSCs are propagated in a medium comprising bFGF and TGFb under non-adherent conditions as in claim 99 (see paragraphs [0035]-[0054]; p. 16-17, claims 34, 39-40).
Banin teaches different administration methods including a single administration, into the subretinal space, by cannula as in claims 101-103 (see paragraphs [0014]-[0015];[0032]; [0086];). Banin teaches administering immunosuppression to the subject for one day, weeks, 6 weeks, months or years, which meets the limitation “for one day to three months after the administration of RPE cells” as in claim 104 (see paragraphs [0105]-[0108]; [0236]-[0266]). Banin teaches different retinal diseases including dry AMD, retinitis pigmentosa, retinal detachment, retinal dysplasia, retinal atrophy, retinopathy, macular dystrophy, cone dystrophy, cone-rod dystrophy, Malattia Leventinese, Doyne honeycomb dystrophy, Sorsby's dystrophy, pattern/butterfly dystrophies, Best vitelliform dystrophy, North Carolina dystrophy, central areolar choroidal dystrophy, angioid streaks, toxic maculopathy, Stargardt disease, pathologic myopia, retinitis pigmentosa, and macular degeneration as in claim 105 (see paragraphs [0021]; p. 16, claims 1-3, 5, 6, 10,15-16, 18; 25-26, 29, 31-34, 36, 38-39).
Gay et al. (US2013/0195806) teaches a method of treating a subject with a retinal degenerative disease or condition including Stargardt macular dystrophy (SMD) and dry-form AMD, the method comprising transplanting a therapeutically effective amount of a pharmaceutical composition comprising human retinal pigment epithelium (RPE) cells including ARPE19 cell lines to the subretinal space in the macular area via a cannula through a small retinotomy to form a small bleb in a temporal foveal position, wherein the human RPE cells including ARPE19 cell lines, RPE cells derived from human embryonic stem cell (hESC-RPE cells) or induced pluripotent stem cell derived RPE cells (hiPSC-RPE cells) or other stem cells including adult stem cells, mesenchymal stem cells (MSC-RPE cells), multipotent stem cells etc., wherein the composition comprising at least 95% human RPE cells that express one or more RPE cell markers including CRALBP, and wherein the therapeutically effective amount includes 20,000-200,000 or 20,000-500,000 cells per administration; and wherein the subject with dry AMD is with >250 microns (0.25mm) of geographic atrophy (GA) involving the central fovea (the macula) and above 0.5 disc area in at least one eye and the BCVA no better than 20/400 (see paragraphs [0401]-[0406], Example 6; [0093]-[0094]; [0275]; table 7). The subject with dry AMD disclosed by Gay is with >250 microns (0.25mm) of geographic atrophy (GA) involving the central fovea (the macula) and the BCVA no better than 20/400 (see paragraphs [0401]-[0406], Example 6; [0093]-[0094]; [0275]; table 7). The GA of >250 microns (0.25mm) involving the central fovea (the macula) disclosed by Gay is within or overlapping with the claimed range of 0.1-50mm2, 0.5-30mm2, 0.5-15mm2, 0.1-10mm2, 0.25-5mm2 or any point between two points recited in claim 116. The BCVA of no better than 20/400 disclosed by Gay is within the limitation “a BCVA of 20/64 or less; 20/70 or less; or from between about 20/64 and about 20/400” as in claim 89 (see table 7). The RPE cell composition disclosed by Gay comprises at least 95% of RPE cells co-expressing PMEL17 and CRALBP as in claim 93 (see paragraphs [0032]; [0066]; [0116]; [0157]; [0179]-[0181], table 18) and also evidenced by Banin et al. (see abstract; paragraphs [0007]-[0036]; [0068]-[0074], p. 16-17, claims 1-3, 5, 6, 10,15-16, 18; 25-26, 29, 31-34, 36, 38-40 in US2018/0088458). The RPE cells disclosed by Gay also include ARPE19 which express PMEL17 and CRALBP as in claim 93 as evidenced by Samuel et al. (see p. 61, 1st col, 2nd paragraph; p. 65, 2nd col.; p. figure 2; p. 68, 2nd col.; p. 83; 2nd col. 2nd paragraph; Samuel et al., Mol. Vis, 2017; 23:60-89). Gay teaches that administration of RPE cells results in an increase in pigmentation that remains at least about 6-12 months or 90 days-24 months as in claim 90 (see paragraphs [0091], [0425]-[0429], Example 10). Gay teaches a therapeutically effective amount of RPE cells at between 25,000-200,000 per dose or 50, 000 cells, 100,000 cells, 150,000 cells or 200,000 cells in 150ul per administration, which is either within or overlapping with the claimed range of about 50,000-5,000,000 cells per administration in claim 91. Gay also teaches 444 or 2000 cells/ul, which is within the claimed range of about 500-10,000 cells per ul in claim 92 (see paragraphs [0072]; [0318]-[0319]; [0357]-[0380], Example 3; [405]-[406]; tables 20, Example 9). Gay teaches that the RPE cells are generated by ex-vivo differentiation of pluripotent stem cells including human embryonic stem cells (hESCs) or generated by (a) culturing hESCs or induced pluripotent stem cells (iPSCs) in a medium comprising nicotinamide to generate differentiating cells; (b) culturing the differentiating cells in a medium comprising nicotinamide and activin A to generate cells further differentiated towards the RPE lineage; and (c) culturing the cells further differentiated towards the RPE lineage in a medium comprising nicotinamide in the absence of activin A under adherent conditions as in claims 94, 98 and 100 and also teaches that the ESCs/iPSCs are propagated in a medium comprising bFGF and TGFb under non-adherent conditions as in claim 99 (see paragraphs [0114]-[0119]; [0177]-[0246]; [0194];[0236]-[0246], table 1; [0179]; [0229]; [0381]-[0400]; Examples 4-5).
Gay teaches different administration methods including a single administration, into the subretinal space, by cannula as in claims 101-103 (see paragraphs [0267]; [0071]; [0319];[0401]-[0406], Example 6; [0093]-[0094]; [0275]), administering immunosuppression to the subject for one day, weeks, 6 weeks, months or years, which meets the limitation “for one day to three months after the administration of RPE cells” as in claim 104 (see paragraphs [0266]; [0073]-[0074];[0152]; [0154]; [0324]) and different retinal diseases including dry AMD, macular degeneration, retinitis pigmentosa, retinal atrophy, retinopathy, Stargardt disease as in claim 105 (see paragraphs [0071]; [0076];[0102]; [0113];[0248];[0003]-[0004]).
10. 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.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANG-YU WANG whose telephone number is (571)272-4521. The examiner can normally be reached Monday-Thursday, 7:00am-5:00pm EST.
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, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Chang-Yu Wang
April 3, 2026
/CHANG-YU WANG/Primary Examiner, Art Unit 1675
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