DETAILED CORRESPONDENCE
Application Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s amendment to the claims filed on 06/15/2026 in response to the Non-Final Rejection mailed on 12/16/2025 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
3. Claims 11-12 are cancelled.
4. Claims 1-10 and 13-20 are pending.
Claims 15-20 stand withdrawn pursuant to 37 CFR 1.142(b).
5. Applicant’s remarks filed on 06/15/2026 in response to the Non-Final Rejection mailed on 12/16/2025 have been fully considered and are deemed persuasive to overcome at least one of the rejections and/or objections as previously applied.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Claim Rejections - 35 USC § 101
6. The rejection of claims 11-12 under 35 U.S.C. 101 because the claimed invention is directed to a nature-based product without significantly more is withdrawn in view of applicants’ amendment to the claims to cancel claims 11 and 12.
7. The rejection of claims 1-10 and 13-14 under 35 U.S.C. 101 because the claimed invention is directed to a nature-based product without significantly more is maintained for the reasons of record and the reasons set forth below. The rejection has been modified in order to address applicants’ amendments to the claims.
Claims 1-10 and 13-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a nature-based product without significantly more. As amended, claim(s) 1-10 recite(s) a retinal organoid model system, comprising: a retinal organoid comprising a population of human pluripotent stem cell (hPSC)-derived photoreceptor cells comprising a genetic mutation in at least one allele of a gene encoding a structural component of an interphotoreceptor matrix (IPM), wherein the gene encoding a structural component is IMPG2, wherein the genetic mutation results in a loss of function phenotype in the PR cells characterized by a lack of visible photoreceptor outer segments on a surface thereof, and wherein the PR cells are adapted to elaborate an IPM with visible outer segments on a surface thereof upon restoration of function of the gene encoding a structural component of the IPM. As amended, claim(s) 13-14 recite a retinal organoid model system comprising: a retinal organoid comprising a population of human pluripotent stem cell (hPSC)-derived photoreceptor cells comprising a genetic mutation in at least one allele of a gene encoding a structural component of an interphotoreceptor matrix (IPM), wherein the gene encoding a structural component is IMPG2, wherein the genetic mutation causes the PR cells to exhibit a loss of function phenotype characterized by a lack of visible photoreceptor outer segments, wherein the gene comprises at least one of i) a first non-functional allele comprising a first engineered genetic mutation, and/or ii) a second non-functional allele comprising a second engineered genetic mutation, and wherein restoration of function of at least one of the first and second alleles produces an IPM containing visible outer segments on a surface of the PR cells. This judicial exception is not integrated into a practical application because they read on naturally occurring human pluripotent stems cells that develop into photoreceptor cells. Although the dependent claims that recite an “induced pluripotent stem cell” carries the meaning in the art of an adult cell that has been reprogrammed to revert to its embryonic state, this is not significant enough to transform the cell into something that is markedly different from a pluripotent stem cell counterpart. Furthermore, the naturally occurring mutation recited in claim 6 encompasses natural IMPG gene mutations such as those disclosed by Bandah-Rozenfeld et al. (American Journal of Human Genetics, 2010; cited on IDS filed on 11/21/2025). Additionally, the recitation of “genetically engineered mutation” as recited in claims 6, 9, and 10 is specified at such a high degree of generality that it encompasses engineered natural mutations that would not be distinguished from its natural counterpart. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because human pluripotent stem cells derived from photoreceptor cells are naturally occurring components found in humans as evidenced by Sajurjo-Soriano et al. (WO 2020/221832 A1; cited on IDS filed 11/21/2025). Furthermore, mutations in an allele encoding an interphotoreceptor matrix such as the IPMG2 are natural mutations that occur in retinitis pigmentosa as evidenced by Bandah-Rozenfeld et al. (American Journal of Human Genetics, 2010; cited on IDS filed on 11/21/2025), which results in the degeneration of photoreceptors. The additional limitations “wherein the PR cells are adapted to elaborate an interphotoreceptor matrix with visible outer segments on a surface thereof upon restoration of function of a gene encoding a structural component of the IPM” are not sufficient to amount to significantly more than the judicial exception because the cells are not in the active process of restoration of function of a gene such as done in the methods of Sajurjo-Soriano et al. [see above]. The cells need only be capable of being modified. This language does not require steps to be performed or limit the claim to a particular structure and does not limit the scope of the claim. See MPEP 2106.C and 2111.04. Instead, the “wherein” clause merely recites a correlation between the natural pluripotent stem cell and its usefulness in being genetically modified. The dependent claims 3-5 and 14 only serve to further limit said correlation. Accordingly, the retinal organoid model systems of claims 1-14 are not patent eligible under 35 U.S.C. 101.
RESPONSE TO REMARKS: Beginning on p. 7 of applicants’ remarks, applicants in summary contend that in nature human carriers who are heterozygous for loss of function IMPG2 mutations do not exhibit a clinical diagnosis of retinitis pigmentosa and maintain a healthy retinal phenotype, wherein in contrast in the organoid model system, exhibits a complete lack of photoreceptor visible outer segments. Therefore, applicants contend that the retinal organoid system of the claims is markedly different in structure than what is found in nature.
This argument is found to be not persuasive because it is noted that the features upon which applicant relies (i.e., heterozygous) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In the instant case, the claims recite “at least one allele…”, which is also inclusive of a homozygous state. As such, the degeneracy of photoreceptors in those with clinical diagnosis of retinitis pigmentosa fall within the scope of the claims.
Claim Rejections - 35 USC § 102
8. The rejection of claims 1-5 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Sanjurjo-Soriano et al. (WO 2020/221832 A1, priority to 04/30/2019; cited on IDS filed 11/21/2025) is withdrawn in view of applicants’ amendment to the claims to recite “wherein the gene encoding a structural component is IMPG2”.
Claim Rejections - 35 USC § 103
9. The rejection of claims 6-7 and 11-14 under 35 U.S.C. 103 as being unpatentable Sanjurjo-Soriano et al. (WO 2020/221832 A1, priority to 04/30/2019; cited on IDS filed 11/21/2025) in view of Bandah-Rozenfeld et al. (American Journal of Human Genetics, 2010; cited on IDS filed on 11/21/2025) is withdrawn in favor of the new rejection set forth below and in view of applicants’ amendment to the claims to cancel claims 11-12.
10. The rejection of claims 8-10 under 35 U.S.C. 103 as being unpatentable Sanjurjo-Soriano et al. (WO 2020/221832 A1, priority to 04/30/2019; cited on IDS filed 11/21/2025) in view of Bandah-Rozenfeld et al. (American Journal of Human Genetics, 2010; cited on IDS filed on 11/21/2025) and Strulovici et al. (Molecular Therapy, 2007; cited on PTO-892 mailed on 12/16/2025) is withdrawn in favor of the new rejection set forth below.
11. Claims 1-7 and 13-14 are newly rejected under 35 U.S.C. 103 as being unpatentable Sanjurjo-Soriano et al. (WO 2020/221832 A1, priority to 04/30/2019; cited on IDS filed 11/21/2025) in view of Bandah-Rozenfeld et al. (American Journal of Human Genetics, 2010; cited on IDS filed on 11/21/2025). This new grounds of rejection is necessitated by applicants’ amendment to the claims.
12. As amended, claim(s) 1-10 recite(s) a retinal organoid model system, comprising: a retinal organoid comprising a population of human pluripotent stem cell (hPSC)-derived photoreceptor cells comprising a genetic mutation in at least one allele of a gene encoding a structural component of an interphotoreceptor matrix (IPM), wherein the gene encoding a structural component is IMPG2, wherein the genetic mutation results in a loss of function phenotype in the PR cells characterized by a lack of visible photoreceptor outer segments on a surface thereof, and wherein the PR cells are adapted to elaborate an IPM with visible outer segments on a surface thereof upon restoration of function of the gene encoding a structural component of the IPM.
As amended, claim(s) 13-14 recite a retinal organoid model system comprising: a retinal organoid comprising a population of human pluripotent stem cell (hPSC)-derived photoreceptor cells comprising a genetic mutation in at least one allele of a gene encoding a structural component of an interphotoreceptor matrix (IPM), wherein the gene encoding a structural component is IMPG2, wherein the genetic mutation causes the PR cells to exhibit a loss of function phenotype characterized by a lack of visible photoreceptor outer segments, wherein the gene comprises at least one of i) a first non-functional allele comprising a first engineered genetic mutation, and/or ii) a second non-functional allele comprising a second engineered genetic mutation, and wherein restoration of function of at least one of the first and second alleles produces an IPM containing visible outer segments on a surface of the PR cells.
13. With respect to claims 1 and 3-5, Sajurjo-Soriano et al. teach a retinal organoid model system comprising a population of human pluripotent stem cells derived photoreceptor cells genetically modified for the treatment of inherited retinal dystrophies [see Abstract; p. 4; p. 23, bottom]. The specification defines the term “elaborate” to mean “develop, express, or display”. Although Sajurjo-Soriano et al. does not explicitly teach “wherein the PR cells are adapted to elaborate an interphotoreceptor matrix (IPM) with visible outer segments on a surface thereof upon restoration of function of a gene encoding a structural component of the IPM”, the cells are not in the active process of restoration of function of a gene such as done in the methods of Sajurjo-Soriano et al. [see above]. The cells need only be capable of being modified, and it is the examiner’s position that interphotoreceptor matrix is inherent to the human pluripotent stem cells derived from photoreceptor cells taught by Sajurjo-Soriano et al. This language does not require steps to be performed or limit the claim to a particular structure and does not limit the scope of the claim. See MPEP 2106.C and 2111.04. Instead, the “wherein” clause merely recites a correlation between the natural pluripotent stem cell and its usefulness in being genetically modified. The dependent claims 3-5 only serve to further limit said correlation. Nevertheless, Sajurjo-Soriano et al. teach restoration of a genetic mutation by administration of a therapeutic comprising a viral particle and an RNA editor such as CRISPR [see Abstract; p. 2; p. 26, bottom].
With respect to claim 2, Sajurjo-Soriano et al. teach the retinal organoid model system, wherein the hPSC is a human induced pluripotent stem cell [see p. 3, top].
With respect to claims 6-7 and 13-14, Sajurjo-Soriano et al. teach a retinal organoid model system comprising a population of human pluripotent stem cells derived photoreceptor cells genetically modified for the treatment of inherited retinal dystrophies [see Abstract; p. 4; p. 23, bottom]. Sajurjo-Soriano et al. teach restoration of a genetic mutation by administration of a therapeutic comprising a viral particle and an RNA editor such as CRISPR [see Abstract; p. 2; p. 26, bottom].
With respect to claim 6, Sajurjo-Soriano et al. teach the retinal organoid system wherein the hPSC is a patient derived hiPSC comprising a naturally occurring mutation in gene [see p. 3].
With respect to claim 7, Sajurjo-Soriano et al. teach the retinal organoid system wherein the mutation is a coding mutation [see p. 3].
With respect to claim 13, Sajurjo-Soriano et al. teach wherein the gene comprises a first and second non-functional allele [see p. 7].
However, Sajurjo-Soriano et al. does not teach the retinal organoid model system of claims 1 and 13, comprising a mutation in a gene encoding a structural component of the IPMG2.
Bandah-Rozenfeld et al. teach mutation analysis of cases of autosomal recessive retinitis pigmentosa reveals four nonsense and one missense mutation affecting a highly conserved phenyalanine reside in IMPG2 that encodes the interphotoreceptor matrix proteoglycan IMPG2, a constituent of the interphotoreceptor matrix, leading to autosomal recessive retinitis pigmentosa [see Abstract; p. 201 column 2 to p. 202].
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to combine the teachings of Sajurjo-Soriano et al. and Bandah-Rozenfeld et al. to develop a retinal organoid model system for the restoration of the function of a IMPG2 of the IPM because Sajurjo-Soriano et al. teach a retinal organoid model system comprising a population of human pluripotent stem cells derived photoreceptor cells genetically modified for the treatment of inherited retinal dystrophies [see Abstract; p. 4; p. 23, bottom]. Bandah-Rozenfeld et al. teach four nonsense and one missense mutation in the IMPG2 encoding IMPG2 of the IPM of retinal cells leads to autosomal recessive retinitis pigmentosa. One of ordinary skill in the art would have had a reasonable expectation of success, a reasonable level of predictability, and would have been motivated to combine the teachings of Sajurjo-Soriano et al. and Bandah-Rozenfeld et al. because Bandah-Rozenfeld et al. acknowledges four nonsense and one missense mutation in the IMPG2 encoding IMPG2 of the IPM of retinal cells leads to autosomal recessive retinitis pigmentosa and one would have a reasonable level of predictability that the systems of Sajurjo-Soriano et al. could be modified to target and correct the IMPG2 mutations using the therapeutic system taught by Sajurjo-Soriano et al. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding the limitation “characterized by a lack of visible photoreceptor outer segments on a surface thereof”, MPEP 2145.II states “[m]ere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979) (Claims were directed to grooved carbon disc brakes wherein the grooves were provided to vent steam or vapor during a braking action. A prior art reference taught noncarbon disc brakes which were grooved for the purpose of cooling the faces of the braking members and eliminating dust. The court held the prior art references when combined would overcome the problems of dust and overheating solved by the prior art and would inherently overcome the steam or vapor cause of the problem relied upon for patentability by applicants. Granting a patent on the discovery of an unknown but inherent function (here venting steam or vapor) "would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art." 596 F.2d at 1022, 201 USPQ at 661.); In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Appellant argued that the presence of DEHP as the plasticizer in a blood collection bag unexpectedly suppressed hemolysis and therefore rebutted any prima facie showing of obviousness. However, the closest prior art utilizing a DEHP plasticized blood collection bag inherently achieved same result, although this fact was unknown in the prior art.)."The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").” In the instant case, the lack of visible photoreceptor outer segments on the cell surface is a latent property that flows from the teachings of Sajurjo-Soriano et al. and Bandah-Rozenfeld et al.
14. Claims 8-10 are newly rejected under 35 U.S.C. 103 as being unpatentable Sanjurjo-Soriano et al. (WO 2020/221832 A1, priority to 04/30/2019; cited on IDS filed 11/21/2025) in view of Bandah-Rozenfeld et al. (American Journal of Human Genetics, 2010; cited on IDS filed on 11/21/2025) as applied to claims 1-7 and 13-14, and further in view of Strulovici et al. (Molecular Therapy, 2007; cited on PTO-892 mailed on 12/16/2025). This new grounds of rejection is necessitated by applicants’ amendment to the claims.
15. The relevant teachings of Sanjurjo-Soriano et al. and Bandah-Rozenfeld et al. as applied to claims 1-7 and 13-14 are set forth above.
With respect to claims 8-10, Sajurjo-Soriano et al. teach a retinal organoid model system comprising a population of human pluripotent stem cells derived photoreceptor cells genetically modified for the treatment of inherited retinal dystrophies [see Abstract; p. 4; p. 23, bottom]. Sajurjo-Soriano et al. teach restoration of a genetic mutation by administration of a therapeutic comprising a viral particle and an RNA editor such as CRISPR [see Abstract; p. 2; p. 26, bottom]. Sajurjo-Soriano et al. teach the retinal organoid system wherein the mutation is a coding mutation [see p. 3].
With respect to claims 8-10, Bandah-Rozenfeld et al. teach mutation analysis of cases of autosomal recessive retinitis pigmentosa reveals four nonsense and one missense mutation affecting a highly conserved phenyalanine reside in IMPG2 that encodes the interphotoreceptor matrix proteoglycan IMPG2, a constituent of the interphotoreceptor matrix, leading to autosomal recessive retinitis pigmentosa [see Abstract; p. 201 column 2 to p. 202].
However, the combination of Sajurjo-Soriano et al. and Bandah-Rozenfeld et al. do not teach the retinal organoid model system of claim 8, wherein the hPSC is a hESC selected from the group consisting of H9, H1, H7, BG01, HES-3, HES-2, HSF-6, HUES9, HUES7, and I6 and the retinal organoid system of claim 9, comprising a mutation in at least one allele in the gene encoding a structural component of the IPM.
Strulovici et al. teach that hESCs represent an unlimited supply of normal differentiated cells to engineered disease tissues to regain normal function and can be useful as human therapeutics [see Abstract; p .850; Figure 1] and teach hESCs that can be genetically modified such as H9, H1, H7, and HES [see Table 4].
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to combine the teachings of Sajurjo-Soriano et al., Bandah-Rozenfeld et al., and Strulovici et al. to develop a retinal organoid model system for the restoration of the function of a IMPG2 of the IPM in hESCs because Sajurjo-Soriano et al. teach a retinal organoid model system comprising a population of human pluripotent stem cells derived photoreceptor cells genetically modified for the treatment of inherited retinal dystrophies [see Abstract; p. 4; p. 23, bottom]. Bandah-Rozenfeld et al. teach four nonsense and one missense mutation in the IMPG2 encoding IMPG2 of the IPM of retinal cells leads to autosomal recessive retinitis pigmentosa. Strulovici et al. teach that hESCs represent an unlimited supply of normal differentiated cells to engineered disease tissues to regain normal function and can be useful as human therapeutics. One of ordinary skill in the art would have had a reasonable expectation of success, a reasonable level of predictability, and would have been motivated to combine the teachings of Sajurjo-Soriano et al. and Bandah-Rozenfeld et al. because Bandah-Rozenfeld et al. acknowledges four nonsense and one missense mutation in the IMPG2 encoding IMPG2 of the IPM of retinal cells leads to autosomal recessive retinitis pigmentosa and Strulovici et al. acknowledges that hESCs represent an unlimited supply of normal differentiated cells to engineered disease tissues to regain normal function and can be useful as human therapeutics. One would have a reasonable level of predictability that the systems of Sajurjo-Soriano et al. could be modified to target and correct the IMPG2 mutations using the therapeutic system taught by Sajurjo-Soriano et al. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Response to Remarks Regarding Prior Art Rejections
16. Beginning on p. 8 of applicants’ remarks, applicants in summary contend that the the loss of function phenotype characterized by a lack of visible photoreceptor outer segments in the heterozygous state is an unexpected result that cannot be contemplated by the prior art of record. Applicants contend that a person of ordinary skill in the art would have expected that a retinal organoid with a heterozygous IMPG2 gene would exhibit a healthy phenotype, matching the natural human heterozygous state in vivo.
This argument is found to be not persuasive in view of the new rejection set forth above, which is necessitated by applicants’ amendment to the claims. Furthermore, it is noted that the features upon which applicant relies (i.e., heterozygous) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In the instant case, the claims recite “at least one allele…”, which is also inclusive of a homozygous state. As such, the degeneracy of photoreceptors in those with clinical diagnosis of retinitis pigmentosa fall within the scope of the claims.
Additionally, as stated in the rejection above, MPEP 2145.II states “[m]ere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979) (Claims were directed to grooved carbon disc brakes wherein the grooves were provided to vent steam or vapor during a braking action. A prior art reference taught noncarbon disc brakes which were grooved for the purpose of cooling the faces of the braking members and eliminating dust. The court held the prior art references when combined would overcome the problems of dust and overheating solved by the prior art and would inherently overcome the steam or vapor cause of the problem relied upon for patentability by applicants. Granting a patent on the discovery of an unknown but inherent function (here venting steam or vapor) "would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art." 596 F.2d at 1022, 201 USPQ at 661.); In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Appellant argued that the presence of DEHP as the plasticizer in a blood collection bag unexpectedly suppressed hemolysis and therefore rebutted any prima facie showing of obviousness. However, the closest prior art utilizing a DEHP plasticized blood collection bag inherently achieved same result, although this fact was unknown in the prior art.)."The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").” In the instant case, the lack of visible photoreceptor outer segments on the cell surface is a latent property that flows from the teachings of Sajurjo-Soriano et al. and Bandah-Rozenfeld et al.
Conclusion
17. Status of the claims: Claims 1-10 and 13-20 are pending.
Claims 15-20 stand withdrawn pursuant to 37 CFR 1.142(b).
Claims 1-10 and 13-14 are rejected.
No claims are in condition for an allowance.
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.
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/PAUL J HOLLAND/Primary Examiner, Art Unit 1656
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