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 .
Claim status
In the reply filed 24 January 2026, Applicant has amended claim 1. Claims 12-16 and 20-23 have previously been cancelled and added new claims 30 and 31.
Therefore, 1-11, 17-19, and 24-31 are herein pending.
Priority
This application was filed 08/11/2022 and is a 371 application of PCT/US21/17535 filed on 02/11/2021, which claims benefit to the Provisional Application 62972944 filed on 02/11/2020. Thus, the earliest possible priority for the hinstant application is 02/11/2020.
Information Disclosure Statement
No information disclosure statement (IDS) has been submitted.
Applicant is reminded that the listing of references in the specification (see p. 76 of instant SPEC) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Withdrawn Objections
In the reply filed 24 January 2026 Applicant has submitted an amended abstract. Therefore, objection to abstract is withdrawn.
Furthermore, Applicant submits an amendment to the specification and therefore, specification fully consider according to MPEP § 608.01. Accordingly, objection to specification is withdrawn
Withdrawn the Rejections
The prior rejection of Claims 5, and 10 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn. In the remark, applicant disclose that the phrase "an activating or inhibiting small molecule dependent functional higher order structure" are exemplary well described in paragraph [0058] of the application and thus claims 5 and 10 have been fully considered.
The prior rejection of Claims 1-3, 17-24, and 26-29 under 35 U.S.C. 103 as being unpatentable over Carmona et al., (WO2019067766; published on 04 April 2019; cited in PTO892; hereinafter “Carmona”), in view of Dong et al., (US20070166366A; published on Jul. 19, 2007; cited in PTO892; hereinafter “Dong”) and Barclay et al., (Molecular Endocrinology, 2007, 21(10):2503–2515; cited in PTO892; hereinafter “Barclay”) is withdrawn. The withdrawn is in light of Applicant’s amendment of claim 1 and to exclusively include the limitation of " wherein the cell is a retinal pigmented epithelial (RPE) cell," which was not taught by Carmona.
The prior rejection of dependent Claims 4-5 under 35 U.S.C. 103 as being unpatentable over Carmona et al., (WO2019067766), in view of Dong et al., (US20070166366A1) and Barclay et al., (Molecular Endocrinology, 2007, 21(10):2503–2515) as applied to claims 1-3, 17-24, and 26-29 above, and further in view of Avalos et al., (US20160326535A1; published on Nov. 10, 2016) is withdrawn.
The prior rejection of dependent Claim 6 under 35 U.S.C. 103 as being unpatentable over Carmona et al., (WO2019067766), in view of Dong et al., (US20070166366A1) and Barclay et al., (Molecular Endocrinology, 2007, 21(10):2503–2515) as applied to claims 1-5, 17-24, and 26-29 above, and further in view of Chung et al., (Nat Chem Biol. 2015 September; 11(9): 713–720) is withdrawn.
The prior rejection of dependent Claims 7, and 9-11 under 35 U.S.C. 103 as being unpatentable over Carmona et al., (WO2019067766), in view of Dong et al., (US20070166366A1) and Barclay et al., (Molecular Endocrinology, 2007, 21(10):2503–2515) as applied to claims 1-6, 17-24, and 26-29 above, and further in view of Machens et al., (Frontiers in bioengineering and biotechnology, 2017, 5, p.63).
The prior rejection of dependent Claim 8 under 35 U.S.C. 103 as being unpatentable over Carmona et al., (WO2019067766), in view of Dong et al., (US20070166366A1) and Barclay et al., (Molecular Endocrinology, 2007, 21(10):2503–2515) as applied to claims 1-7, 9-11, 17-24, and 26-29 above, and further in view of Piatek et al., (Plant biotechnology journal, 2015, 13(4), pp.578-589).
The prior rejection of dependent Claim 25 under 35 U.S.C. 103 as being unpatentable over Carmona et al., (WO2019067766), in view of Dong et al., (US20070166366A1) and Barclay et al., (Molecular Endocrinology, 2007, 21(10):2503–2515) as applied to claims 1-11, 17-24, and 26-29 above, and further in view of Merenick et al. US20180126007A1; Pub. Date: May 10, 2018).
New/maintained Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 17 and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
(New) Regarding claims 17 and 18, the limitation “the therapeutic protein”. In the reply filed 24 January 2026, applicant has amended the claim 1 and cancelled the limitation of “a therapeutic protein.” Therefore, the therapeutic protein is insufficient antecedent basis in the claims 17-18.
(Maintained) Regarding claim 18 the term “substantially non-pulsatile release” in line 2. It is a term of degree and the claim is not indefinite if the specification provides examples or teachings that can be used to measure a degree even without a precise numerical measurement. However, instant specification is not specifically defined the substantial. Therefore, a skilled person in the art (POSITA) at the time of the invention would not know how much is considered for substantial release. See MPEP 2173.05(b).
New 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Anticipated by Tao et al.
Claims 1-3, 19, 24, 26-29, 31 are newly rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tao et al. (US20070071734A1; Pub. Date: Mar. 29, 2007; cited in PTO892, hereinafter “Tao”). The new rejection is necessitated by applicant’s claim amendments.
Regarding claims 1 and 31, Tao discloses an engineered retinal pigmented epithelial (RPE) cells (i.e., APRE-19 cell [0013], abstract) comprises an exogenous nucleic acid having a cytokine coding sequence (IL-2) [0088] as well as compositions, pharmaceutical products, and implantable elements encapsulated within a semipermeable membrane [0066], [0067] which allows diffusion of the growth factor (i.e., IL-2). The document further discloses a method to make engineering APRE-19 cells [0088], wherein IL-2 is under control of the CMV promoter (i.e., repressible promoter) including a rabbit beta globin intron followed by a polyA sequence and a hygromycin gene for selection [0088]. Tao further disclose that the genetically modified ARPE-19 cells can produce a desired factor [0026], [0075]. Therefore, this discloses anticipates the engineered cell comprises an exogenous nucleic acid having a cytokine coding sequence, wherein the cytokine coding sequence is operably linked to a repressible promoter. Accordingly, Tao also anticipates the cytokine coding sequence is operably linked to a repressible promoter to a promoter that is activated as a result of signaling through the cytokine's receptor.
Regarding claim 2, Tao discloses that the exogenous nucleic acid is integrated in the genome (i.e., chromosome) of the engineered cell [0076].
Regarding claim 3, Tao discloses that the engineered cell further comprises at least one coding sequence encoding a selection marker [0075].
Regarding claims 19 and 28, Tao discloses that the implantable element comprising the engineered cell is comprising a polymeric hydrogel (e.g., cellulose) [0067], [0068].
Regarding claim 24, Tao discloses that the implantable element comprises at least about 103 and 108 engineered ARPE-19 cells [0070].
Regarding claim 26, Tao discloses a preparation of implantable elements comprising a plurality of implantable elements of engineered ARPE-19 cells ([0070]- [0073], claim 42).
Regarding claim 27, Tao discloses a method of providing an implantable element to a patient comprising implanting into the subject with the implantable element of engineered ARPE-19 cells ([0113], claim 31).
Regarding claim 29, Tao discloses a pharmaceutical composition comprising the engineered cell [0083], [0088].
Accordingly, Tao anticipates instant claims 1-3, 19, 24, 26-29, 31.
Anticipated by Sewell et al.
Claims 1-3, 18-19, 24, 26-29, 31 are newly rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sewell et al. (WO2019067766; published on 04 April 2019; cited in PTO892, hereinafter “Sewell”). The new rejection is necessitated by applicant’s claim amendments.
Regarding claims 1 and 31, Sewell discloses an engineered cell or an implantable element comprising the engineered cell, wherein the engineered cell is an RPE cell comprising an exogenous nucleic acid encoding a polypeptide, wherein the polypeptide is IL-2 (claim 1) operably linked to a repressible promoter (p.2 line 3-10).
Wherein the engineered cell further comprises at least one coding sequence encoding a transcriptional repressor that can bind to the repressible promoter, and wherein the transcriptional repressor coding sequence is operably linked to a promoter that is activated as a result of signaling through the cytokine's receptor (Fig. 9, p. 17 lns 20-25, p. 36 lns 27-31).
Regarding claim 2, Sewell discloses that the exogenous nucleic acid is integrated into a chromosome of the engineered cell.
Regarding claim 3, Sewell discloses that the engineered cell further comprises at least one coding sequence encoding a selection marker (e.g., TNF-a, IL-13, IL-6, GCSF, GM-CSF, IL-4, CCL2, or CCL4) (p. 80 lns 14-19).
Regarding claim 18, Sewell discloses the polypeptide is selected from the group consisting of therapeutic protein (i.e., an antibody) (Claim 23), therefore, POSITA would anticipate that the implantable construct provides substantially non-pulsatile release of the therapeutic protein.
Regarding claims 19, 24, and 28, Sewell discloses the implantable element comprising an alginate hydrogel capsule that encapsulating at least about 10,000, 15,000 or 20,000 engineered ARPE-19 cells (claims 33, 34).
Regarding claim 26, Sewell discloses a preparation of implantable elements comprising a plurality of implantable (p. 5 lns 9-13; p. 112 lns 7-9).
Regarding claims 27 and 29, Sewell discloses a method of providing an implantable element to a patient, the method comprising a pharmaceutical composition comprising implantable elements thereby treating the subject (claim 36).
Accordingly, Sewell anticipates instant claims 1-3, 18-19, 24, 26-29, 31.
New Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-3, 4, 5, 19, 24, 26-29, 31 are rejected under 35 U.S.C. 103 as being unpatentable over Tao et al. (US20070071734A1; Pub. Date: Mar. 29, 2007; cited in PTO892, hereinafter “Tao”), in view of Avalos et al., (US20160326535A1; published on Nov. 10, 2016; cited in PTO892; hereinafter “Avalos”). The new rejection is necessitated by applicant’s claim amendments.
As indicated above, regarding claim 1, Tao makes obvious the implantable element comprising the engineered retinal pigmented epithelial (RPE) cells (i.e., APRE-19 cell [0013], abstract of Tao) comprises an exogenous nucleic acid having a cytokine coding sequence (IL-2) ([0088] of Tao).
However, with respect to claim 4, Tao does not teach the cytokine coding sequence is operably linked to a small molecule-activated promoter.
Regarding claims 4-5, Avalos teaches that the promoter regulated by small molecule ([0098], [0105] of Avalos). Therefore, the activation or inhibition of protein regulates by the small-molecule regulator and nuclear receptor-like transcription factor ([0103], [0104] of Avalos). Therefore, the activation or inhibition is dependents on small molecule by changing the conformation of protein or function of higher-order structure.
Accordingly, it would have been obvious to practice the implantable element comprising the engineered RPE cells of Tao and include small molecule-mediated regulation of promoters as taught by Avalos with a reasonable expectation of success. The POSITA would have been motivated at the time of filing to do so since Avalos teaches small molecule-mediated regulation of promoters, it would have been obvious to POSITA to have applied combined the engineered RPE cells of Tao to the method taught by Avalos in which cytokine coding sequence is operably linked to a small molecule-activated promoter, in order to drive the expression of the cytokine that would allow for external regulation of the cytokine production by the administration of the small molecule ([0026-0027] of Avalos). Therefore, the products and method as taught by Tao et al. in view of Avalos et al. would have been prima facie obvious over the product and method of the instant application. In regard to the reasonable expectation of success in doing so, include the small molecule-activated Promoter of Avalos had a reasonable expectation of success since the steps thereof required no more than recombinant DNA and cell culture technology.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tao et al. (US20070071734A1; Pub. Date: Mar. 29, 2007; cited in PTO892, hereinafter “Tao”), in view of Avalos et al., (US20160326535A1; published on Nov. 10, 2016; cited in PTO892; hereinafter “Avalos”) as applied to claims 1-5, 19, 24, 26-29, and 31 above, and further in view of Chung et al., (Nat Chem Biol. 2015 September; 11(9): 713–720; cited in PTO892; hereinafter “Chung”). The new rejection is necessitated by applicant’s claim amendments.
As indicated above, regarding claim 1, Tao makes obvious the implantable element comprising the engineered retinal pigmented epithelial (RPE) cells (i.e., APRE-19 cell [0013], abstract of Tao) comprises an exogenous nucleic acid having a cytokine coding sequence (IL-2) ([0088] of Tao).
With respect to claim 6, Tao is silent to the cytokine coding sequence comprises a small molecule-assisted shutoff system sequence. However, such was known in the prior art.
Chung teaches small molecule-assisted shutoff system (SMASh) for targeted degradation of a protein of interest that allows for direct chemical control over the production of a specific protein (p. 713, abstract; p. 713, col 2, para 1 of Chung).
Accordingly, it would have been obvious to practice the implantable element comprising the engineered RPE cells of Tao and include small molecule-assisted shutoff system as taught by Chung with a reasonable expectation of success. The POSITA would have been motivated at the time of filing to do so since Chung teaches the small molecule-assisted shutoff system for targeted degradation of proteins allows for reversible, chemically controlled shut off for the production of a specific protein (abstract of Chung), it would have been obvious to one of ordinary skill in the art to have applied combined the engineered RPE cells of Tao with SMASh system for targeted degradation of the cytokine as taught by Chung, in order to have an additional level of control of cytokine production at the translation (protein production) level. Therefore, the products and method as taught by Tao et al. in view of Chung et al. would have been prima facie obvious over the product and method of the instant application. In regard to the reasonable expectation of success in doing so, include small molecule-assisted shutoff system of Chung had a reasonable expectation of success since the steps thereof required no more than recombinant DNA and cell culture technology.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Claims 7, and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Tao et al. (US20070071734A1; Pub. Date: Mar. 29, 2007; cited in PTO892, hereinafter “Tao”), in view of Avalos et al., (US20160326535A1; published on Nov. 10, 2016; cited in PTO892; hereinafter “Avalos”) as applied to claims 1-6, 19, 24, 26-29, and 31 above, and further in view of Machens et al., (Frontiers in bioengineering and biotechnology, 2017, 5, p.63; cited in PTO892; hereinafter “Machens”).
As indicated above, regarding claim 1, Tao makes obvious the implantable element comprising the engineered retinal pigmented epithelial (RPE) cells (i.e., APRE-19 cell [0013], abstract of Tao) comprises an exogenous nucleic acid having a cytokine coding sequence (IL-2) ([0088] of Tao).
With respect to claim 7, Tao is silent to the cytokine coding sequence is operably linked to a synthetic promoter that is activated by a synthetic transcription factor. However, such was known in the prior art.
Machens teaches the activation of synthetic promoters by synthetic transcription factors (p. 1, abstract; p. 2, col 2, para 2 of Machens).
Accordingly, it would have been obvious to practice the implantable element comprising the engineered RPE cells of Tao and include synthetic promoters as taught by Machens with a reasonable expectation of success. The POSITA would have been motivated at the time of filing to do so Since Machens teaches activation of synthetic promoters by synthetic transcription factors and Tao teach an engineered RPE cells with cytokine coding sequence operably linked to promoters, it would have been obvious to POSITA to have applied combined teachings the engineered RPE cells of Tao to the method taught by Machens, in order to activate transcription of the cytokine gene (p. 1, abstract; p. 2, col 2, para 2 of Machens). Therefore, the products and method as taught by Tao et al. in view of Machens et al. would have been prima facie obvious over the product and method of the instant application. In regard to the reasonable expectation of success in doing so, include synthetic promoters of Machens had a reasonable expectation of success since the steps thereof required no more than recombinant DNA and cell culture technology.
Regarding claims 9 and 10, Tao and Machens make obvious the engineered cell or implantable element comprising the engineered RPE cell of claim 7, and Avalos teaches promoter regulation by small molecule regulators [0098] and activating or inhibiting small molecule dependent protein by changing the conformation of protein or functional higher-order structure of protein ([0103], [0104] of Avalos).
Since Avalos teaches small molecule mediated regulation of promoters, it would have been obvious to POSITA to have applied combined teachings the engineered RPE cell of Tao to the method taught by Avalos in which cytokine coding sequence is operably linked to a small molecule activated promoter, in order to drive the expression of the cytokine that would allow for external regulation of the cytokine production by the administration of the small molecule in order to have an additional level of post-transcriptional control of cytokine expression.
Regarding claim 11, Tao, and Machens make obvious the engineered cell or implantable element comprising the engineered cell of claim 7, and Chung teaches a coding sequence comprises a small molecule assisted shutoff system sequence (p. 713, abstract; p. 713, col 2, para 1 of Chung).
Since Chung teaches the small molecule-assisted shutoff system for targeted degradation of proteins allows for reversible, chemically controlled shut off for the production of a specific protein (abstract). it would have been obvious lo one of ordinary skill in the art to have applied combined teachings the engineered RPE cells of Tao with SMASh system for targeted degradation of the cytokine as taught by Chung, in order to have an additional level of control of cytokine production at the translation (protein production) level.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Tao et al. (US20070071734A1; Pub. Date: Mar. 29, 2007; cited in PTO892, hereinafter “Tao”), in view of Avalos et al., (US20160326535A1; published on Nov. 10, 2016; cited in PTO892; hereinafter “Avalos”) as applied to claims 1-7, 9-11, 19, 24, 26-29, and 31 above, and further in view of Piatek et al., (Plant biotechnology journal, 2015, 13(4), pp.578-589; cited in PTO892; hereinafter “Piatek”).
As indicated above, regarding claim 1, Tao makes obvious the implantable element comprising the engineered retinal pigmented epithelial (RPE) cells (i.e., APRE-19 cell [0013], abstract of Tao) comprises an exogenous nucleic acid having a cytokine coding sequence (IL-2) ([0088] of Tao).
With respect to claim 8, Tao is silent the synthetic transcription factor comprises a catalytically inactive Cas9 (dCas9) fused to transcriptional activation domains. However, such was known in the prior art.
Piatek teaches synthetic transcription repressors and activators fused to catalytically inactive dCas9 (p. 578, abstract). Piatek indicates that the CRISPR/dCas9 DNA-targeting platform can be used in plants as a functional genomics tool and for biotechnological applications (p. 579-580, col2, para 3 of Piatek).
Accordingly, it would have been obvious to practice the implantable element comprising the engineered RPE cells of Tao and include synthetic promoters as taught by Machens with a reasonable expectation of success. The POSITA would have been motivated at the time of filing to do so since Tao teach an engineered RPE cell with cytokine coding sequence operably linked to promoters and Piatek teaches transcriptional activators fused to catalytically inactive dCas9, it would have been obvious to one of ordinary skill in the art to have applied combined teachings of the engineered RPE cells of Tao to the method taught by Piatek in which dCas9 when co-expressed with a guide RNA (gRNA) will localize the complex to the synthetic promoter with complementarity to the gRNA, in order to activate transcription of the cytokine gene (abstract of Piatek). Therefore, the products and method as taught by Tao et al. in view of Piatek et al. would have been prima facie obvious over the product and method of the instant application. In regard to the reasonable expectation of success in doing so, include synthetic transcription factor comprises a catalytically inactive Cas9 (dCas9) of Piatek had a reasonable expectation of success since the steps thereof required no more than recombinant DNA and cell culture technology.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Tao et al. (US20070071734A1; Pub. Date: Mar. 29, 2007; cited in PTO892, hereinafter “Tao”), in view of Avalos et al., (US20160326535A1; published on Nov. 10, 2016; cited in PTO892; hereinafter “Avalos”) as applied to claims 1-11, 19, 24, 26-29, and 31 above, and further in view of Merenick et al. US20180126007A1; Pub. Date: May 10, 2018; cited in PTO892; hereinafter “Merenick”).
As indicated above, regarding claim 1, Tao makes obvious the implantable element comprising the engineered retinal pigmented epithelial (RPE) cells (i.e., APRE-19 cell [0013], abstract of Tao) comprises an exogenous nucleic acid having a cytokine coding sequence (IL-2) ([0088] of Tao).
However, with respect to claim 25, Tao is silent to a bioreactor comprising the engineered cell.
Regarding claim 25, Merenick teaches a bioreactor consisting of engineered cells ([0003] of Merenick), to improve the safety and clinical application of direct or cell-mediated bioreactor therapeutic protein delivery it would be advantageous to be able to tum off the protein production or regulate the rate at which protein production occurs ([0004] of Merenick).
Accordingly, it would have been obvious to practice the implantable element comprising the engineered cell of Tao and include bioreactor as taught by Merenick with a reasonable expectation of success. The POSITA would have been motivated at the time of filing to do so since Tao teach an engineered cell with cytokine coding sequence operably linked to promoters and Merenick teaches a bioreactor with an engineered cell that secrete therapeutic protein, it would have been obvious to one of ordinary skill in the art to have applied combined teachings of Tao to the method taught by Merenick, in order to stably produce a therapeutic protein of interest. Therefore, the products and method as taught by Tao et al. in view of Merenick et al. would have been prima facie obvious over the product and method of the instant application. In regard to the reasonable expectation of success in doing so, include bioreactor of Merenick had a reasonable expectation of success since the steps thereof required no more than cell culture technology.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 24 January 2026 are acknowledged.
Applicant argues that the subject-matter of amended claim 1 differs from the cell disclosed in Carmona in that the cytokine gene is not under control of a transcriptional repressor nor that the cell further comprises a coding sequence for the repressor nor that the repressor is under control of a promoter which is responsive to the cytokine. The effect associated with this difference is that a controlled level of the cytokine is being produced, thereby providing a cell or implantable element producing a cytokine in a non-toxic level. See remark p. 10 4th ¶.
Applicant's arguments have been fully considered but they are not persuasive because the new ground of rejection relies on amendment claims and references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In the new rejection, Tao et al. address the implantable element comprising the engineered retinal pigmented epithelial (RPE) cells (i.e., APRE-19 cell [0013], abstract of Tao) comprises an exogenous nucleic acid having a cytokine coding sequence (IL-2) ([0088] of Tao).
SUBJECT MATTER FREE OF ART
Claim 30 is objected because art does not teach or reasonably suggest the engineered retinal pigmented epithelial (RPE) cells comprises an exogenous nucleic acid having a cytokine coding sequence, wherein the transcriptional repressor coding sequence is operably linked to a STAT-responsive promoter. Since claim 30 depends from rejected base independent claim 1, therefore, claim 30 is objected.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 date of this final action.
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is (571)272-0196. The examiner can normally be reached M-F 8-5 (EST).
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/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684