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 .
Application Status
The preliminary amendment filed on 7/15/2024 is acknowledged. Claims 1-10, 12, 14-21, 24 and 26-32 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statements filed on 6/28/2024 and 3/18/2025 are acknowledged and have been considered except where lined through.
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)(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.
Claim(s) 1-4, 15-21 and 24 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO2022/093652 to Yellowbrick Bio (2022-05-05, IDS) .
The applied reference has a common inventor 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. 102(a)(2) 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) if the same invention is not being claimed; 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 in the reference 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.
Yellowbrick teaches a pharmaceutical composition comprising an azobenzene photoswitch and an alkylated cyclodextrin, wherein the compositions are administered to the eye to treat a variety of retina disorders (abstract). With regards to the retina disorders, Yellowbrick teaches that the retina disorders include, but are not limited to, age-related macular degeneration, retinitis pigmentosa and inherited retinal degenerations (paragraph 0141). With regards to the compositions, Yellowbrick teaches that the compositions contain an alkylated cyclodextrin and azobenzene compound in a molar ratio of 1:1 to 100:1, wherein the concentration of azobenzene is from 50mM to 200mM (paragraphs 0108 and 0130). Moreover, Yellowbrick teaches that the compositions can be administered to a subject by intravitreal injection to treat various disorders of the eye (paragraph 0025). With regards to the azobenzene photoswitch, Yellowbrick teaches that azobenzene photoswitch compounds include, but are not limited to, has the structure
PNG
media_image1.png
141
353
media_image1.png
Greyscale
referred to as compound 1 (paragraph 0038) and specifically uses compound 1 in the various experiments (see for example, paragraph 0038 and 00145). For example, Yellowbrick discovered that a single in vivo injection of compound 1 (100mM) and SBE-CD (1200mM) prolongs photosensitization of retinal ganglion cells (RGCs) (paragraph 0150). Regarding the limitations of claims 15-19, the claimed limitations appear to be results which occur by administering the claimed compounds to the claimed patient population in an effective amount. Accordingly, since the prior appears to teach administration of the same compound to the same patient population in an amount which falls within those claimed, the claimed results would appear to necessarily occur. The examiner reminds Applicants that the Office does not have the facilities and resources to determine whether such results occur. The burden is on Applicant to determine such difference. See MPEP 2112.01.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6-8, 10, 12, 14, 26, 28, 31 and 32 is/are rejected under 35 U.S.C. 103 as being obvious over WO2022/093652 to Yellowbrick Bio (2022-05-05, IDS), as applied above to 1-4, 15-21 and 24.
The applied reference has a common inventor 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.
Yellowbrick teaches a pharmaceutical composition comprising an azobenzene photoswitch and an alkylated cyclodextrin, wherein the compositions are administered to the eye to treat a variety of retina disorders (abstract). With regards to the retina disorders, Yellowbrick teaches that the retina disorders include, but are not limited to, age-related macular degeneration, retinitis pigmentosa and inherited retinal degenerations (paragraph 0141). With regards to the compositions, Yellowbrick teaches that the compositions contains an alkylated cyclodextrin and azobenzene compound in a molar ratio of 1:1 to 100:1, wherein the concentration of azobenzene is from 50mM to 200mM (paragraphs 0108 and 0130). Moreover, Yellowbrick teaches that the compositions can be administered to a subject by intravitreal injection to treat various disorder of the eye (paragraph 0025). With regards to the azobenzene photoswitch, Yellowbrick teaches that azobenzene photoswitch compounds include, but are not limited to, has the structure
PNG
media_image1.png
141
353
media_image1.png
Greyscale
referred to as compound 1 (paragraph 0038) and specifically uses compound 1 in the various experiments (see for example, paragraph 0038 and 00145). For example, Yellowbrick discovered that a single in vivo injection of compound 1 (100mM) and SBE-CD (1200mM) prolongs photosensitization of retinal ganglion cells (RGCs) (paragraph 0150).
Yellowbrick differs from the instant claims in that it does not explicitly teach that the compound was administered to one or both eyes, wherein the one eye comprised two administrations at varying weeks. Moreover, Yellowbrick does not specifically teach an amount of 1mg to 100mg to a single eye.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by Yellowbrick so as to optimize the amount of compound 1, which eye and the dosing schedule dependent on the retinal disease. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Yellowbrick teaches that the composition comprising compound 1 is effective for treating a variety of retinal disorders and provides a range of concentration, for example 100 mM, of compound 1 within the composition, wherein 100 mM prolongs photosensitization of retinal ganglion cells in mice.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In the instant case, the Examiner has reviewed the specification, specifically Example 1, and cannot find anything unexpected or critical regarding the amount or dosing protocol.
Claims 29-30 is/are rejected under 35 U.S.C. 103 as being obvious over WO2022/093652 to Yellowbrick Bio (2022-05-05, IDS), as applied above to 1-4, 6-8, 10, 12, 14-21, 24, 26, 28, 31 and 32, in further view of Bennett et al. (Science translational medicine 4.120(2012).
The applied reference has a common inventor 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.
Yellowbrick teaches a pharmaceutical composition comprising an azobenzene photoswitch and an alkylated cyclodextrin, wherein the compositions are administered to the eye to treat a variety of retina disorders (abstract). With regards to the retina disorders, Yellowbrick teaches that the retina disorders include, but are not limited to, age-related macular degeneration, retinitis pigmentosa and inherited retinal degenerations (paragraph 0141). With regards to the compositions, Yellowbrick teaches that the compositions contains an alkylated cyclodextrin and azobenzene compound in a molar ratio of 1:1 to 100:1, wherein the concentration of azobenzene is from 50mM to 200mM (paragraphs 0108 and 0130). Moreover, Yellowbrick teaches that the compositions can be administered to a subject by intravitreal injection to treat various disorder of the eye (paragraph 0025). With regards to the azobenzene photoswitch, Yellowbrick teaches that azobenzene photoswitch compounds include, but are not limited to, has the structure
PNG
media_image1.png
141
353
media_image1.png
Greyscale
referred to as compound 1 (paragraph 0038) and specifically uses compound 1 in the various experiments (see for example, paragraph 0038 and 00145). For example, Yellowbrick discovered that a single in vivo injection of compound 1 (100mM) and SBE-CD (1200mM) prolongs photosensitization of retinal ganglion cells (RGCs) (paragraph 0150).
Yellowbrick differs from the instant claims in that it does not explicitly teach that the compound was additionally administered to the contralateral eye.
Bennett et al. teach that the demonstration of safe and stable reversal of blindness after a single unilateral subretinal injection of a recombinant adeno-associated virus (AAV) carrying the RPE65 gene prompted us to determine whether it was possible to obtain additional benefit through a second administration of the AAV vector to the contralateral eye (Abstract). In summary, Bennett et al. found that the study provides the first demonstration of improved retinal and visual function after therapy readministration in a genetic disease and also the first demonstration of efficacy after readministration to the contralateral eye (page 8, 2nd column, 1st full paragraph).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by Yellowbrick so to administer the compound to the contralateral eye in addition to the impacted eye in view of the teachings of Bennett et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Bennett et al found that readministration of the therapy improved retinal and visual function and showed efficacy after readministration to the contralateral eye.
Claims 5 is/are rejected under 35 U.S.C. 103 as being obvious over WO2022/093652 to Yellowbrick Bio (2022-05-05, IDS), as applied above to 1-4, 6-8, 10, 12, 14-21, 24, 26, 28, 31 and 32, in view of Tolmachova et al. (J. Clin. Invest. 2006; 116(2):386-394).
The applied reference has a common inventor 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.
Yellowbrick teaches a pharmaceutical composition comprising an azobenzene photoswitch and an alkylated cyclodextrin, wherein the compositions are administered to the eye to treat a variety of retina disorders (abstract). With regards to the retina disorders, Yellowbrick teaches that the retina disorders include, but are not limited to, age-related macular degeneration, retinitis pigmentosa and inherited retinal degenerations (paragraph 0141). Yellowbrick further teaches that the compositions can confer light sensitivity to retinal pigment epithelial cells and photoreceptor cells (paragraph 0140). With regards to the compositions, Yellowbrick teaches that the compositions contains an alkylated cyclodextrin and azobenzene compound in a molar ratio of 1:1 to 100:1, wherein the concentration of azobenzene is from 50mM to 200mM (paragraphs 0108 and 0130). Moreover, Yellowbrick teaches that the compositions can be administered to a subject by intravitreal injection to treat various disorder of the eye (paragraph 0025). With regards to the azobenzene photoswitch, Yellowbrick teaches that azobenzene photoswitch compounds include, but are not limited to, has the structure
PNG
media_image1.png
141
353
media_image1.png
Greyscale
referred to as compound 1 (paragraph 0038) and specifically uses compound 1 in the various experiments (see for example, paragraph 0038 and 00145). For example, Yellowbrick discovered that a single in vivo injection of compound 1 (100mM) and SBE-CD (1200mM) prolongs photosensitization of retinal ganglion cells (RGCs) (paragraph 0150).
Yellowbrick differs from the instant claims in that it does not explicitly teach that retinal disorder is choroideremia.
Tolmachova et al. teaches that Choroideremia is an inherited retinal degeneration characterized as an X-linked degeneration of the retinal pigment epithelium (RPE), photoceptors and choroid (abstract).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by Yellowbrick so to administer the compound to a patient suffering from Choroideremia in view of the teachings of Tolmachova et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Yellowbrick teaches that the compound I is useful for treating a variety of the retina disorders include, but are not limited to, age-related macular degeneration, retinitis pigmentosa and inherited retinal degenerations, wherein the compositions can confer light sensitivity to retinal pigment epithelial cells and photoreceptor cells; and
Tolmachova et al. teach that Choroideremia is an inherited retinal degeneration characterized as an X-linked degeneration of the retinal pigment epithelium (RPE), photoceptors and choroid.
Claims 1-4, 6-8, 10, 12, 14-19, 24, 26, 28, 31 and 32 is/are rejected under 35 U.S.C. 103 as being obvious over WO2010051343 to The Reagents of the University of California (2010-05-06) referred to herein as California, in view of Tochitsky et al. (Scientific Reports 2017; 7: 45487, IDS).
California teaches synthetic regular of polypeptide function having the formula
PNG
media_image2.png
127
299
media_image2.png
Greyscale
(paragraph 00153). Specifically, California teaches synthetic regular compounds including, but not limited to,
PNG
media_image3.png
152
353
media_image3.png
Greyscale
page 38). Moreover, California teaches methods of treating disorders in a subject in need comprising administering a composition comprising said synthetic regulator, wherein the composition is administered intravitreally and the disorders include, but are not limited to, retinal disorders such as macular degermation, retinitis pigmentosa and inherited retinal degenerations (paragraph 00220 and 00316-00317). Moreover, California teaches that the synthetic regulators confer light sensitivity to retinal pigment epithelial cells and photoreceptor cells (paragraph 00312).
California differs from the instant claims in that it does not explicitly select a compound having the formula
PNG
media_image3.png
152
353
media_image3.png
Greyscale
or that the compound was administered to one or both eyes, wherein the one eye comprised two administrations at varying weeks. Moreover, California does not specifically teach an amount to a single eye as claimed.
Tochitsky et al. teach restoring visual function to the blind retina with a potent, safe and long-last photoswitch (title). With regards to the photoswitch, Tochitsky et al. teach that BENAQ having the structure
PNG
media_image4.png
71
144
media_image4.png
Greyscale
restores fast, spatially precise light responses to the blind mouse retina (page 1, Results). Specifically, Tochitsky et al. teach that mice received, via intravitreal injections, 2 mL of BENAQ (2mL of a 20 mM BENAQ solution) (see page 7, Intravitreal Injections). Moreover, Tochitsky et al. teach that BENAQ persists in restoring visual responses to the retina for almost 1 month after a single intraocular injection and is non-toxic at concentrations 10 fold-higher than required to impact light sensitivity (Abstract).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to specifically select a compound having the structure
PNG
media_image3.png
152
353
media_image3.png
Greyscale
as taught by California for the use in its described method in view of the teachings of Tochitsky et al.. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
- Tochitsky et al. teach that BENAQ having the structure
PNG
media_image4.png
71
144
media_image4.png
Greyscale
restores fast, spatially precise light responses to the blind mouse retina.
Moreover, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by California so as to optimize the amount of the compound, which eye and the dosing schedule dependent on the retinal disease in view of the teachings of Tochitsky et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Tochitsky et al. teach that 2 mL of BENAQ, from a 20 mM BENAQ solution, persists in restoring visual responses to the retina for almost 1 month after a single intraocular injection and is non-toxic at concentrations 10 fold-higher than required to impact light sensitivity.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In the instant case, the Examiner has reviewed the specification, specifically Example 1, and cannot find anything unexpected or critical regarding the amount or dosing protocol.
Claims 20-21 is/are rejected under 35 U.S.C. 103 as being obvious over WO2010051343 to The Reagents of the University of California (2010-05-06) referred to herein as California in view of Tochitsky et al. (Scientific Reports 2017; 7: 45487, IDS), as applied above to claims 1-4, 6-8, 10, 12, 14-19, 24, 26, 28, 31 and 32, in further view of Cao et al. (Adv. Therap. 2021, 4, 2100127, IDS).
The combination of California and Tochitsky et al. have been described above an incorporated herein.
The combination differs from the instant claims in that the combination does not teach that the composition further comprises cyclodextrin in a ratio of 20:1 to 1:1.
Cao et al. teach using cyclodextrins to encapsulate BENAQ to increase solubility and improve retinal delivery (abstract). Cao et al teach while a low ratio (3:1) of SBE-CD to BENAQ is optimal for short-term photosensitization, a higher ratio (12:1) works best for long-term photosensitization (paragraph bridging pages 5 and 6). In conclusion, Cao et al. teach that the host-guest interaction between SBE-CD and BENAQ overcomes limitations of intraocular delivery, guiding how photoswitches may be formulated as possible treatment of human blindness (abstract).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the composition taught by the combination to include cyclodextrin in view of the teachings of Cao et al. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- The combination teaches treating retinal disorders comprising administering BENAQ having the structure
PNG
media_image4.png
71
144
media_image4.png
Greyscale
which restores spatially precise light responses to the blind mouse retina.
- Cao et al. teach encapsulating BENAQ in to increase solubility and improve retinal delivery.
Claims 29-30 is/are rejected under 35 U.S.C. 103 as being obvious over WO2010051343 to The Reagents of the University of California (2010-05-06) referred to herein as California in view of Tochitsky et al. (Scientific Reports 2017; 7: 45487, IDS), as applied above to claims 1-4, 6-8, 10, 12, 14-19, 24, 26, 28, 31 and 32, in further view of Bennett et al. (Science translational medicine 4.120(2012).
The combination of California and Tochitsky et al. have been described above and incorporated herein.
The combination differs from the instant claims in that it does not explicitly teach that the compound was additionally administered to the contralateral eye.
Bennett et al. teach that the demonstration of safe and stable reversal of blindness after a single unilateral subretinal injection of a recombinant adeno-associated virus (AAV) carrying the RPE65 gene prompted us to determine whether it was possible to obtain additional benefit through a second administration of the AAV vector to the contralateral eye (Abstract). In summary, Bennett et al. found that the study provides the first demonstration of improved retinal and visual function after therapy readministration in a genetic disease and the first demonstration of efficacy after readministration to the contralateral eye (page 8, 2nd column, 1st full paragraph).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by the combination so to administer the compound to the contralateral eye in addition to the impacted eye in view of the teachings of Bennett et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Bennett et al found that readministration of the therapy improved retinal and visual function and showed efficacy after readministration to the contralateral eye.
Claims 5 is/are rejected under 35 U.S.C. 103 as being obvious over WO2010051343 to The Reagents of the University of California (2010-05-06) referred to herein as California in view of Tochitsky et al. (Scientific Reports 2017; 7: 45487, IDS), as applied above to claims 1-4, 6-8, 10, 12, 14-19, 24, 26, 28, 31 and 32, in further view of Tolmachova et al. (J. Clin. Invest. 2006; 116(2):386-394).
The combination of California and Tochitsky et al. have been described above an incorporated herein.
The combination differs from the instant claims in that it does not explicitly teach that retinal disorder is choroideremia.
Tolmachova et al. teaches that Choroideremia is an inherited retinal degeneration characterized as an X-linked degeneration of the retinal pigment epithelium (RPE), photoceptors and choroid (abstract).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by the combination so to administer the compound to a patient suffering from Choroideremia in view of the teachings of Tolmachova et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- California teaches that the azobenzene compounds are useful for treating a variety of the retina disorders include, but are not limited to, age-related macular degeneration, retinitis pigmentosa and inherited retinal degenerations, wherein the compositions can confer light sensitivity to retinal pigment epithelial cells and photoreceptor cells; and
Tolmachova et al. teach that Choroideremia is an inherited retinal degeneration characterized as an X-linked degeneration of the retinal pigment epithelium (RPE), photoceptors and choroid.
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, 15-21 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1, 9-10, 12-13, 15, 35 and 40-41 of copending Application No. 18/250,494 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims a composition comprising a cyclodextrin in combination with a compound having the structure
PNG
media_image5.png
132
355
media_image5.png
Greyscale
, wherein the molar ratio of cyclodextrin to the compound is 3:1 to 15:1, the concentration of the compound is about 100 mM and a method of treating a retinal disorder, comprising injecting the composition into the vitreous of a subject having a retinal disorder.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. NOTE: A notice of Allowance was sent out in the above application on 6/24/2026.
Claims 2-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1, 9-10, 12-13, 15, 35 and 40-41 of copending Application No. 18/250,494 (reference application), as applied above to claims 1, 15-21 and 24, in view of WO2010051343 to The Reagents of the University of California (2010-05-06) referred to herein as California.
The reference application claims a composition comprising a cyclodextrin in combination with a compound having the structure
PNG
media_image5.png
132
355
media_image5.png
Greyscale
, wherein the molar ratio of cyclodextrin to the compound is 3:1 to 15:1, the concentration of the compound is about 100 mM and a method of treating a retinal disorder, comprising injecting the composition into the vitreous of a subject having a retinal disorder.
The reference application does not specifically claim that the retinal disorder is a genetic eye disease, retinitis pigmentosa or age-related macular degeneration.
California teaches synthetic regular of polypeptide function having the formula
PNG
media_image2.png
127
299
media_image2.png
Greyscale
(paragraph 00153). Specifically, California teaches synthetic regular compounds including, but not limited to,
PNG
media_image3.png
152
353
media_image3.png
Greyscale
page 38). Moreover, California teaches method of treating disorders in a subject in need comprising administering a composition comprising said synthetic regulator, wherein the composition is administered intravitreally and the disorders include, but are not limited to, retinal disorders such as macular degermation, retinitis pigmentosa and inherited retinal degenerations (paragraph 00220 and 00316-00317). Moreover, California teaches that the synthetic regulators confer light sensitivity to retinal pigment epithelial cells and photoreceptor cells (paragraph 00312).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by the reference application so as to treat a genetic eye disease, retinitis pigmentosa or age-related macular degeneration in view of the teachings of California . One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-California teaches that azobenzene compounds are useful for treating retinal disorders including, but not limited to, genetic eye disease, retinitis pigmentosa or age-related macular degeneration.
Claims 6-8, 10, 12, 14, 26, 28, 31 and 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1, 9-10, 12-13, 15, 35 and 40-41 of copending Application No. 18/250,494 (reference application), as applied above to claims 1, 15-21 and 24.
The reference application claims a composition comprising a cyclodextrin in combination with a compound having the structure
PNG
media_image5.png
132
355
media_image5.png
Greyscale
, wherein the molar ratio of cyclodextrin to the compound is 3:1 to 15:1, the concentration of the compound is about 100 mM and a method of treating a retinal disorder, comprising injecting the composition into the vitreous of a subject having a retinal disorder.
The reference application differs from the instant claims in that it does not explicitly claim that the compound was administered to one or both eyes, wherein the one eye comprised two administrations at varying weeks.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method claimed by the reference application so as to optimize the amount of compound 1, which eye and the dosing schedule dependent on the retinal disease. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-The reference application claims a method of treating retinal disorder and that the concentration of the compound is about 100 mM.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 29-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1, 9-10, 12-13, 15, 35 and 40-41 of copending Application No. 18/250,494 (reference application), as applied above to claims 1, 6-8, 10, 12, 14-21, 24, 26, 28, 31 and 32, in further view of Bennett et al. (Science translational medicine 4.120(2012)
The reference application claims a composition comprising a cyclodextrin in combination with a compound having the structure
PNG
media_image5.png
132
355
media_image5.png
Greyscale
, wherein the molar ratio of cyclodextrin to the compound is 3:1 to 15:1, the concentration of the compound is about 100 mM and a method of treating a retinal disorder, comprising injecting the composition into the vitreous of a subject having a retinal disorder.
The reference application differs from the instant claims in that it does not explicitly claim that the compound was additionally administered to the contralateral eye.
Bennett et al. teach that the demonstration of safe and stable reversal of blindness after a single unilateral subretinal injection of a recombinant adeno-associated virus (AAV) carrying the RPE65 gene prompted us to determine whether it was possible to obtain additional benefit through a second administration of the AAV vector to the contralateral eye (Abstract). In summary, Bennett et al. found that the study provides the first demonstration of improved retinal and visual function after therapy readministration in a genetic disease and also the first demonstration of efficacy after readministration to the contralateral eye (page 8, 2nd column, 1st full paragraph).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method claimed by the reference application so to administer the compound to the contralateral eye in addition to the impacted eye in view of the teachings of Bennett et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Bennett et al found that readministration of the therapy improved retinal and visual function and showed efficacy after readministration to the contralateral eye.
Claims 5 is/are rejected under 35 U.S.C. 103 as being obvious over WO2022/093652 to Yellowbrick Bio (2022-05-05, IDS), as applied above to 1-4, 6-8, 10, 12, 14-21, 24, 26, 28, 31 and 32, in view of Tolmachova et al. (J. Clin. Invest. 2006; 116(2):386-394).
Claims 5 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1, 9-10, 12-13, 15, 35 and 40-41 of copending Application No. 18/250,494 (reference application) in view of WO2010051343 to The Reagents of the University of California (2010-05-06) referred to herein as California, , as applied above to claims 1-4, 15-21 and 24, in further view of Tolmachova et al. (J. Clin. Invest. 2006; 116(2):386-394).
The combination of the reference application and California has been described above and incorporated herein.
The combination differs from the instant claims in that it does not explicitly claim that retinal disorder is choroideremia.
Tolmachova et al. teaches that Choroideremia is an inherited retinal degeneration characterized as an X-linked degeneration of the retinal pigment epithelium (RPE), photoceptors and choroid (abstract).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method claimed by the combination so to administer the compound to a patient suffering from Choroideremia in view of the teachings of Tolmachova et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- California teaches that the azobenzene compounds are useful for treating a variety of the retina disorders include, but are not limited to, age-related macular degeneration, retinitis pigmentosa and inherited retinal degenerations, wherein the compositions can confer light sensitivity to retinal pigment epithelial cells and photoreceptor cells; and
Tolmachova et al. teach that Choroideremia is an inherited retinal degeneration characterized as an X-linked degeneration of the retinal pigment epithelium (RPE), photoceptors and choroid.
Conclusion
Therefore, No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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 S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/ Primary Examiner, Art Unit 1626
Prosecution Insights