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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 22 October 2025 has been entered.
DETAILED OFFICE ACTION
This Office Action is in response to the papers filed on 22 October 2025.
CLAIMS UNDER EXAMINATION
Claims 1, 6, 8, 12-15, 18-24, 33-34 and 36-38 are pending and have been examined on their merits.
PRIORITY
Provisional Application 62/737,359 filed on 27 September 2018 is acknowledged.
WITHDRAWN REJECTIONS
The previous rejections have been withdrawn due to claim amendment.
REJECTIONS
New grounds of rejection have been necessitated by claim amendment.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 6, 8, 12-15, 18-24, 33-34 and 36-38 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to nonstatutory subject matter as evidenced by Liu et al. (Towards Stem/Progenitor Cell-Based Therapies for Retinal Degeneration. Stem Cell Reviews and Reports (2024) 20:1459–1479) and Klassen et al. (cited in the rejections below).
Based on the claims as a whole, claims 1, 6, 8, 12-15, 18-24, 33-34 and 36-38 are determined to be directed to a law of nature/natural principle. The rationale for the determination is explained below.
Question 1: Is the claim to a process, machine manufacture or composition of matter? Yes, the invention recited in claim 1 is a process.
Question 2A Prong 1: Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions) ? Yes, claim 1 is directed to a law of nature and an abstract idea.
(a) The limitations in the claim that set forth the law of nature are:
The 2019 PEG explains that the abstract idea exception includes the following groupings of subject matter:
Mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations;
Certain methods of organizing human activity – fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions); and
Mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion).
Claim 1 is directed to an abstract idea and a natural phenomenon.
The natural phenomenon is a correlation between viability of retinoblastoma (RB) cells and a cell-based therapy or treatment comprising retinal progenitor cells (RPC). The claims encompass human progenitor cells and human retinoblastoma cells. As evidenced by the published specification, active conditioned media that comprises the media used to culture an active cell-based therapy or treatment is a conditioned media that is known to be active, will protect a plurality of cells from the deleterious effects of the toxic compound ([0061]). Therefore there is a natural correlation between the media from the claimed active cells and the viability of the claimed retinoblastoma cells.
The abstract ideas are:
Determining cell viability. The specification does not recite an explicit definition for determining. Therefore visually counting live cells is broadly interpreted to read on the claim. Counting is a mental process (a judicial exception).
Determining potency of the cell-based therapy or treatment by comparing cell viability of the first and second plurality of RB cells. Comparison is a mental process that can be performed by looking at two data points. This is a judicial exception.
The claim recites a ratio of the viability of the first and second plurality of RB cells. A ratio is a mathematical equation (a judicial exception).
Comparing potency of cell based therapy/treatment to a predetermined cutoff is a mental comparison of data points. This is a judicial exception.
Determining the potency is greater than the predetermined cutoff can be performed mentally by looking at data points. This is a judicial exception.
Claim 1 recites the conditioned media comprises “a media used to culture a population of hRPCs”. The claim recites administering the population of hRPCs to the subject. The claims do not require a specific order of step (MPEP 2111.01 II). Given its broadest reasonable interpretation, the claim does not require administration in response to the judicial exceptions.
The treatment step is also recited at a high level of generality that does not add significantly more to the judicial exceptions. Liu et al. (Long-term safety of human retinal progenitor cell transplantation in retinitis pigmentosa patients. Stem Cell Research & Therapy, 8,(1) injected fetal-derived RPCs into the subretinal space of Royal College of Surgeons (RCS) rats. Six weeks after transplantation, RPCs were found to be concentrated in the outer nuclear layer (ONL), leading to its thickening. Results from electroretinography (ERG) b-wave amplitudes indicated a significant improvement in retinal function in RCS rats’ post-transplantation (see page 1463, left column, third paragraph).
Klassen (cited below) teaches compositions and methods for treating, ameliorating or preventing a retinal disease or condition by administration of retinal progenitor cells (RPCs) (Abstract). Klassen teaches treating retinitis pigmentosa (column 1, line 31; column 2, line 29).
Question 2A Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application? No.
The incubation steps recited in claim 1 are insignificant extrasolution activities. Determining viability (i.e. measuring) is required to gather data for making the determination (the judicial exception). Incubation with a toxin is interpreted to be an extrasolution activity required to gather data for determining potency (the judicial exception).
Question 2B: Do the claims recite any additional elements? Yes.
With respect to Step 2B, limitations that were found to be enough to qualify as “significantly more” when recited in a claim with a judicial exception include:
Improvements to another technology or technical field.
Improvements to the functioning of the computer itself.
Applying the judicial exception with, or by use of, a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application.
Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
With respect to Step 2B, limitations that were found not to be enough to qualify as “significantly more” when recited in a claim with a judicial exception include:
Adding the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer
Simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well understood, routine and conventional activities previously known to the industry
Adding insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea
Generally linking the use of the judicial exception to a particular technological environment or field of use.
Do the additional elements result in the claim amounting to significantly more?
No.
Regarding claim 1: Claim 1 recites culturing cells in a conditioned medium and a toxic compound. This is considered an insignificant extra-solution activity because the culturing is a necessary data gathering step in order to determine potency (a judicial exception). Claim 1 recites culturing a second plurality of RB cells in a control media. The use of control conditions is well-known, routine and conventional in the art. The control is considered an insignificant extra-solution activity because the culturing is a necessary data gathering step in order to determine potency (the judicial exception).
Claim 6 recites a predetermined cutoff (a mathematical equation, a judicial exception).
Claim 8 further limits the cell-based therapy or treatment of claim 1. The treatments are recited at a high level of generality that does not add significantly more to the judicial exceptions
Claim 12-15 recite the amount of RB cells and media. The amounts of cells and media do not amount to significantly more than the recited judicial exceptions (the natural phenomenon and abstract idea).
Claims 18 -19 further limit the toxic compound recited in claim 1. The use of a toxic compound is considered an insignificant extra-solution activity because it is part of a necessary data gathering step to determine potency (the judicial exception).
Claims 20-21 recite the incubation time. Cell culture is an insignificant extra-solution activity because it is part of a necessary data gathering step to determine potency (the judicial exception).
Claims 22-24 are directed to how viability is determined. Measuring metabolic capacity (e.g. claim 22) using a fluorescence based assay (claims 23-26) is considered an insignificant extra-solution activity because it is part of a necessary data gathering step to determine potency (the judicial exception).
Claim 33 recites a natural phenomenon and an abstract idea. The natural phenomenon is the natural correlation between viability and potency as recited in claim 1. Comparing viability (a mental step) to determine potency is an abstract idea. Claim 33 also recites comparing the potency to a predetermined cutoff value (mathematical equation, an abstract idea) to identify (a mental step) the method as valid. The toxic compound and inactive conditioned media are considered insignificant extrasolution activities because they are used to make the determination and identification (judicial exceptions).
Claim 34 further limits the cell-based therapy or treatment. The treatment is recited at a high level of generality that does not add significantly more to the judicial exceptions. The claim does not require administration of the therapy of treatment in response to the judicial exceptions.
Claim 36 recites a natural phenomenon and an abstract idea. The natural phenomenon is the natural correlation between viability and potency as recited in claim 1. Comparing viability (a mental step) to determine potency is an abstract idea. Claim 36 also recites comparing the potency to a predetermined cutoff value (mathematical equation, an abstract idea) to identify (a mental step) the method as valid.
Claim 37 further limits the cell-based therapy or treatment. Claim 36 recites the conditioned media from said cells is used in the culturing step. The use of the conditioned media is considered insignificant extrasolution activity because it is used to make the determination and identification (judicial exceptions).
Regarding claim 38: The claim further limits the control media. The control is considered an insignificant extra-solution activity because the culturing is a necessary data gathering step in order to determine potency (the judicial exception).
Therefore claims 1, 6, 8, 12-15, 18-24, 33-34 and 36-38 are not eligible subject matter under 35 USC 101.
Claim Rejections - 35 USC § 103
Claims 1, 6, 8, 12-15, 18-22 and 33-38 are rejected under 35 U.S.C. 103 as being unpatentable over Klassen et al. (previously cited; Methods for isolating mammalian retinal progenitor cells. Patent US9107897 2015) in view of Rich et al. (previously cited; Cell Potency Assay. US20090298102), Ding et al. (previously cited; Human Mesenchymal Stem Cells Expressing Erythropoietin Enhance Survivability of Retinal Neurons Against Oxidative Stress: An In Vitro Study. Frontiers in Cellular Neuroscience. 30 July 2018. Vol. 12 Article 190 pages 1-10) and Karasawa et al. (Inhibition of Histone Deacetylation by Butyrate Induces Morphological Changes in Y79 Retinoblastoma Cells. Jpn J Ophthalmol 2004; 48:542-551) as evidenced by Zhou et al. (previously cited; Retinal progenitor cells release extracellular vesicles containing developmental transcription factors, microRNA and membrane proteins. Scientific REPORTS (2018) 8:2823 pages 1-15).
Klassen teaches compositions and methods for treating, ameliorating or preventing a retinal disease or condition by administration of retinal progenitor cells (RPCs) (Abstract). Klassen teaches treating retinitis pigmentosa (column 1, line 31; column 2, line 29).
Klassen teaches a basal culture medium (column 19, lines 51-53). A basal media is interpreted to be a control media. Klassen teaches a conditioned medium that is altered as compared to a basal medium (column 20, lines 12-27). A medium can be conditioned by allowing retinal progenitor cells to be expanded, differentiated or maintained in a medium of defined composition at a defined temperature for a defined number of hours (same cited section).
Claim 1 recites a conditioned media comprising the media used to culture RPCs. This is a product by process limitation. The claimed media is undefined. The specification (PG Pub) discloses the claimed media has a trophic effect ([0053]) that is protective ([0056]). Therefore the conditioned media taught by Klassen and the conditioned media recited in claim 1 appear to be identical. Any slight variation rendered by the process is considered obvious absent evidence to the contrary.
In Example 3, RPCs were resuspended in HBSS to determine cell viability and cell number. For human transplantation, 0.5×106 cells in 100 μl HBSS were used. For transplantation into rats, varying doses ranging from 4000 to 75,000 cells in 2 μl HBSS were used.
The following is also taught by Klassen:
Klassen teaches secreted genes that showed particularly high expression by hRPCs include FGF9, GDF10, IL-1A (interleukin 1 alpha), PTN, and SPP1 (osteopontin, OPN) (column 41, lines 50-53). Klassen teaches osteopontin is highly expressed by hRPCs and secreted into the surrounding media at physiologically significant concentrations (column 47, lines 57-59). Klassen teaches OPN could play a role in the neuroprotective effects of hRPCs (column 47, lines 57-59). Therefore surrounding media of the cells is interpreted to be a conditioned media. As set forth above, the art teaches it contains components that provide a neuroprotective effect. Klassen teaches the cells have a trophic effect (column 51, lines 63-64; column 52, lines 35-36 ).
The deficiencies of Klassen are:
The art does not teach incubating retinoblastoma cells (RB cells; retinal cells) with a toxic compound and either 1) a media used to culture RPCs or a control media.
The art does not teach, determining viability of RBs, or determining the potency of the cell based therapy as recited in claim 1.
Rich et al. teach cell potency assays for use with cell-based therapies (Abstract).
Rich teaches the type of assay desired to assess potency of cell populations for transplantation is a proliferation or potency assay ([0008] [0012]). The cell potency assay may be used for any cellular-based therapy ([0016]).
The standard procedure for estimating potency is to compare a dose response for a sample with that of reference standard of the same material. Rich teaches one expected result would be that the linear section of the dose response curve would be parallel to that of the reference standard. If the sample response is displaced to the left or right of the RS, the sample has a higher or lower potency, respectively. If the dose response lines are statistically parallel to each other, a horizontal line drawn anywhere from the Y-axis that bisects the dose response curve would provide the same estimation of potency when read off the X-axis. The potency ratio of the sample can then be calculated by dividing the sample X-axis value by the reference standard X-axis value ([0132]).
Rich teaches the cell potency of a specific stem cell population is calculated by dividing the slope of the cell sample dose response curve by the slope of the reference standard dose response curve. This gives the “potency ratio”. The slope of the reference standard is designated as 1. Therefore, if the potency ratio is greater than 1, the stem cell population has a greater potency than that of the reference standard, and visa versa. The steeper the slope of the stem cell dose response curve, the more primitive the stem cell population, the greater the proliferation potential, and the greater the stem cell potency. The greater the potency, the higher the probability that the stem cell product will engraft ([0139]). Said slope is broadly interpreted to be a predetermined cutoff value.
Ding teaches retinal degeneration is a prominent feature in ocular disorders (Abstract). Ding teaches successful transplantation requires not only the capacity of the transplanted cells to engraft, but also the ability of the cells to survive in the pathological microenvironment. Ding teaches an in vitro model of oxidative stress induced retinal cell degeneration by a toxin (glutamate) (page 6, right column, last paragraph). Ding analyzes cellular recovery of human retinoblastoma (Y79 cells) subjected to said toxin at a toxic dose following incubation with the supernatants of therapeutic mesenchymal stem cells that secrete a neuroprotective factor (EPO) (see page 2, left column, last paragraph).
Ding teaches Y79 cells (retinoblastoma cells) are exposed to MSC-CM (MSC conditioned medium; a control media) and MSC-EPO-CM (MSCs that constitutively expressed EPO) for 1 hour before being exposed to glutamate (a toxin) solution for 24 hours (page 3, right column, last paragraph). Y79 cells exposed to MSC-EPO-CM read on a first plurality of RB cells. Y79 cells exposed to MS-CM read on a second plurality of RB cells.
Ding analyzes cell viability (Abstract; see page 4, left column, “Statistical Analysis; see page 5, right column, last paragraph).
Ding teaches co-treating cells with MSC-CM and MSC-EPO-CM in the presence of the toxin leads to an increase of viable cells population from 46.8% to 64.0% (MSC-CM + GA) and 71.8% (MSC-EPO-CM + GA), respectively (see page 6, right column, first paragraph). Therefore Ding compares the viability of cells treated with MSC-CM and MSC-EPO-CM. Because Ding compares the viability of the first and second plurality of retinoblastoma cells, Ding determines the potency of the claimed therapy/treatment.
Karasawa et al. teaches exposure of Y79 cells to sodium butyrate induces apoptosis (page 542, “Purpose” section); page 543, left column, second paragraph).
It would have been obvious to combine the prior art by performing a cell potency assay with the cell based therapy taught by Klassen. Klassen teaches a cell based therapy, and Rich teaches performing a cell potency assay with cell based therapy. One would have been motivated to determine potency to determine the probability the stem cell product will engraft, as taught by Rich. One would have had a reasonable expectation of success since Rich teaches potency assays can be used with cell based therapies.
It would have been obvious to combine the teaching of the prior art by using the RPC conditioned media taught by Klassen in the in vitro model taught by Ding. One would have been motivated to do so since Klassen transplants stem cells to treat retinal degeneration and Ding teaches using conditioned media to determine the ability of stem cells to recover retinal cells under oxidative stress. Ding teaches successful transplantation requires the ability of the cells to survive in the pathological microenvironment. The skilled artisan would analyze the conditioned media of the RPCs in vitro to determine their ability to protect retinal cells. One would have had a reasonable expectation of success since Klassen teaches a cell conditioned media that has a neuroprotective effect. One would have expected similar results since Klassen and Ding are both directed to methods of treating a retinal disease using stem cells.
It would have been obvious to substitute sodium butyrate as the toxin used in Ding. KSR B teaches that it is rational to substitute one known, equivalent element for another to obtain predictable results. One would have had a reasonable expectation of success since Karasawa teaches sodium butyrate can induce apoptosis in Y79 retinoblastoma cells. One would have expected similar results since both references are directed to compounds that induce apoptosis in Y79 retinoblastoma cells.
It would have been obvious to determine potency by the ratio of the viability of the first and second plurality of cells. One would have been motivated to do so since Ding analyzes the efficacy of a cell based therapy and Rich teaches the potency of cell based therapies can be determined by dividing the response of a sample and a standard. It would have been obvious to determine whether a cell therapy is sufficiently potent by comparing the potency to a predetermined cutoff. One would have been motivated to do so since Rich teaches the potency is compared to the slope. Rich teaches if the potency ratio is greater than 1, the stem cell population has a greater potency than that of the reference standard and has a higher chance of engraftment. It would have been obvious to administer treatment after determining the potency is greater than a predetermined cutoff. One would have been motivated to do so since Rich teaches a potency greater than 1 means the cell population has a greater potency and a higher probability that the stem cell product will engraft. One would have had a reasonable expectation of success since Rich teaches cell potency can be determined using a potency ratio. One would have expected similar results since Klassen, Ding and Rich are based directed to cell based therapies. Therefore claim 1 is rendered obvious.
Rich teaches the slope can be steeper than 1 (supra). The slope of the curve indicates the “primitiveness” or “stemness” of the population and, therefore, its proliferation potential ([0050]). One would choose a steeper slope (a higher predetermined cutoff) for cells with greater stemness since Rich teaches these cells have a higher engraftment potential. Therefore claim 6 is included in this rejection.
Klassen administers retinal progenitor cells in a media (supra). As evidenced by Zhou, retinal progenitor cells release extracellular vesicles (see page10, last paragraph). Therefore the media would inherently comprise exosomes. Therefore claim 8 is included in this rejection.
Ding teaches 50,000 cells/well for each treatment condition in 50 µl of MSC-CM and MSC-EPO-CM (see page 3, right column, last paragraph). Therefore claim 12 is rejected.
Ding teaches 50,000 cells/well (at least about 25,000 RB cells) for each treatment condition in 50 µl of MSC-CM and MSC-EPO-CM (in at least about 25 ul) (see page 3, right column, last paragraph). Therefore claim 13 is rejected.
Ding teaches 50,000 cells/well (at least about 25,000 RB cells) for each treatment condition in 50 µl of MSC-CM and MSC-EPO-CM (in at least about 50 µl) (see page 3, right column, last paragraph). Therefore claim 14 is rejected.
Ding teaches 50 µl of MSC-CM and MSC-EPO-CM is added (supra). This is interpreted to be at least about 75 µl. Therefore claim 15 is included in this rejection.
The specification states “ ‘about’ is understood as within a range of normal tolerance in the art, for example within 2 standard deviations of the mean”. The specification does not explicitly define the term “about”. Karasawa uses 5 mM sodium butyrate (see Table 1). This is interpreted to read on about 2mM to about 32 mM. Claim 18 is rejected.
Karasawa uses 5 mM sodium butyrate (see Table 1). This is interpreted to read on about 16 mM. The skilled artisan would optimize the amount since Karasawa teaches the effect of sodium butyrate is dose-dependent. MPEP 2133.03. MPEP 2144.05.
Claim 19 is rejected
Ding teaches cells are incubated for 1 hour with MSC-CM or MSC-EPO-CM before being exposed to glutamate solution for 24 hours (supra). Therefore claims 20-21 are included in this rejection.
Ding teaches twenty microliters of 300 µg/ml MTS (3-(4,5-dimethylthiazol-2-yl)-5-(3-carboxymethoxyphenyl)-2- (4-sulfophenyl)-2H-tetrazolium) solution was added to 100 µl culture, for 3 h, at 37°C in 5% CO2. The quantity of formazan product formed at absorbance value of 490 nm was recorded by colorimetric microplate reader (same cited section). Ding analyzes cell viability (Abstract; see page 4, left column, “Statistical Analysis; see page 5, right column, last paragraph). This is interpreted to measure the metabolic activity of the cells. Therefore claim 22 is included in this rejection.
Claim 33 recites an inactive conditioned media. The components of the media are undefined. Ding teaches “culture media only” can be used as a control (see page 3, right column, second paragraph). The claimed inactive conditioned media is indistinguishable from the media taught by Ding. It would have been obvious to determine whether a cell therapy is valid by comparing the potency to a predetermined cutoff. One would have been motivated to do so since Rich teaches the potency is compared to the slope. Rich teaches if the potency ratio is greater than 1, the stem cell population has a greater potency than that of the reference standard and has a higher chance of engraftment. Therefore claim 33 is included in this rejection.
Claim 36 recites an active conditioned media. The components of the media are undefined. The components of the media are undefined. Ding teaches “culture media only” can be used as a control (see page 3, right column, second paragraph). The claimed inactive conditioned media is indistinguishable from the media taught by Ding. It would have been obvious to determine whether a cell therapy is valid by comparing the potency to a predetermined cutoff. One would have been motivated to do so since Rich teaches the potency is compared to the slope. Rich teaches if the potency ratio is greater than 1, the stem cell population has a greater potency than that of the reference standard and has a higher chance of engraftment. Therefore claim 36 is included in this rejection.
Because the claimed method steps are rendered obvious, it would be able to determine the potency of a cell-based therapy or treatment comprising the components recited in claims 34 and 37. Therefore claims 34 and 37 are included in this rejection.
Klassen teaches the use if a basal media (supra). Therefore claim 38 is included in this rejection.
Therefore Applicant’s invention is rendered obvious as claimed.
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Klassen in view of Rich, Ding and Karasawa as applied to claim 22 above, and further in view of Moravec et al. (previously cited; The Cell Titer-Blue Cell Viability Assay: Monitoring Cell Viability Using A Fluorescence Redox Indicator Dye. Cell Notes 2003 pages 12-14).
Claim 22 is rejected on the grounds set forth above. The teachings of Klassen, Ding and Rich are reiterated. Ding teaches a color based assay that measures metabolic capacity.
The art does not teach a fluorescence based assay comprising resazurin.
Moravec discloses a fluorescent assay that monitors the ability of viable cells to metabolize resazurin to resofurin (page 12, right column, second paragraph).
It would have been obvious to use the fluorescent assay taught by Moravec to analyze cell viability in Ding. One would have been motivated to do so since Ding teaches measures cell viability using a color based assay and Moravec teaches using a fluorescent assay to measure cell viability. One would have had a reasonable expectation of success since Moravec teaches cell viability can be measured using the disclosed fluorescent assay. Therefore claim 23 is included in this rejection.
Moravec teaches incubating cells with resazurin (see page 12, left column, second paragraph; first paragraph of “Simple Protocol” section on page 12 at right column). Moravec teaches incubation for 1-4 hours and recording fluorescence (same cited section). Therefore claim 24 is rendered obvious.
Therefore Applicant’s Invention is rendered obvious as claimed.
RESPONSE TO APPLICANT’S ARGUMENTS
The arguments made in the response filed on 22 October 2025 are acknowledged. New grounds of rejection have been made above to address, the amended claims.
The Applicant argues using sodium butyrate for glutamate would make Ding inoperable because Ding is directed to oxidative stress. The arguments cite Xu et al., and argues sodium butyrate protects neuronal cells against oxidative stress. In response: Ding is directed to a method of rescuing retinoblastoma cells from toxin-induced apoptosis. Ding does not teach butyrate would be inoperable. The Applicant provides arguments, but no evidence the use of sodium butyrate would make Ding inoperable. The Xu reference is directed to diabetic inflammation, not treating retinitis pigmentosa. Xu teaches colon cells. Xu uses butyrate to lower glucose in diabetic subjects. Xu does not provide evidence the use of sodium butyrate would make Ding inoperable. Examiner emphasizes Karasawa teaches sodium butyrate can be used to induce apoptosis in retinoblastoma cells. The Applicant has not provided evidence sodium butyrate protects retinoblastoma cells against apoptosis. Therefore the arguments are not persuasive.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is (571) 270-8439.
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/NATALIE M MOSS/ Examiner, Art Unit 1653