DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendments
Applicant's amendments filed 8/21/2025 to claim 255 have been entered. Claims 1-254, 262, and 264-266 are canceled. Claims 255-261, 263, and 267-274 remain pending, and are being considered on their merits. In view of the instant amendments, no claims are withdrawn from consideration at this time. References not included with this Office action can be found in a prior action. Any rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
Affidavit/Declaration
As a starting point, the instant Declaration (i.e. the Del Priore Declaration) has been submitted verbatim as was presented during prosecution during examination of Application # 12/857,866 and was not modified to reflect the different Application #, Examiner, and Art Unit assigned to this case and was not modified to address the specific 35 U.S.C. § 101 and 103 rejections of record in this case. The claims under consideration Application # 12/857,866 were methods of treating retinal disease in humans with human pigmented cells (very likely RPE cells), whereas the instant claims are directed towards a composition comprising RPE cells reciting product-by-process limitations and are thus substantially different in scope and raise different issues under 35 U.S.C. § 101 and 103.
The Declaration under 37 CFR 1.132 filed 8/21/2025 is insufficient to overcome the rejection of claims 255-260, 262, 263, and 267-274 under 35 U.S.C. § 101 because the additional evidence of Liu et al. (2014; provided in the IDS dated 10/10/2024) and as discussed on pages 3-5 of the Declaration is not reasonably commensurate to the scope of the claims. See M.P.E.P. § 716. In this case, independent claims 255 and 267 are directed towards a composition comprising RPE cells, and the claims further recite product-by-process limitations. The product-by-process limitations are generic and are not limited towards any starting pluripotent cell type and do not recite the exact differentiation methods and starting pluripotent cells of Liu (see page 8 of Liu) to establish by a preponderance of evidence that the claimed RPE cells inherently possess a different DNA methylation profile, and the claims were not amended to require any particular DNA methylation profile. Note that unclaimed characteristics cannot contribute to eligibility, see M.P.E.P. § 2106(II)(B). Secondly, the Declaration does not present any additional evidence that the nearest natural counterpart, plainly understood as at least both fetal RPE cells and adult RPE cells, do not possess the claimed functional property of melanin content reasonably commensurate to the scope of the claims.
The Declaration under 37 CFR 1.132 filed 8/21/2025 is insufficient to overcome the rejection of claims 267, 269, 272, 273 based upon Osakada in view of Hu and Seagle and claims 255, 257-260, 262, 268, 272, and 274 based upon Osakada in view of Hu, Seagle, and Allen as set forth in the last Office action because the Declaration on pages 6-9 alleges error against prior art not applied against the claims under 35 U.S.C. § 103.
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 255-260, 263, and 267-274 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural product without significantly more.
The claims recites a composition comprising RPE cells, which are a natural product. See the Abstract of Boulton et al. (Eye (2001), 15, 384-389). At this time, there is no evidence that the claimed cells possess any markedly different characteristic than the nearest natural counterpart. Claims 255-260 and 272 are only directed towards the natural product itself and its functional properties; at this time, there is no evidence that the properties of claims and 256-259, 267 and 272 are markedly different as compared to the nearest natural counterpart. Claims 268 and 269 recite statements of intended use and so do not add any markedly different characteristic to the claimed natural product.
This judicial exception is not integrated into a practical application because the claims are only directed towards RPE cells, which are a natural product.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the following reasons.
Regarding claims 255 and 267, differentiating RPE cells from pluripotent stem cells is routine and conventional in this art. For example, see Osakada (Journal of Cell Science (2009), 122(17), 3169-3179), who teaches a composition comprising RPE cells, differentiated from embryonic stem cells (p3172, paragraph starting “Next, we examined whether…”). At this time, there is no evidence that the properties of RPE cells of claims 255 and 273 are markedly different as compared to the nearest natural counterpart. Regarding claim 274, adding Y-27632 is routine and conventional in this art over Osakada, who teaches adding Y-27632 to prevent/reduce cell death (paragraph spanning p3170-3171), reading on claim 274.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 267, 269, 272, and 273 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Osakada (Journal of Cell Science (2009), 122(17), 3169-3179) in view of Hu (Photochemistry and Photobiology (2008), 84, 645-649; provided in the IDS dated 10/10/2024), and Seagle et al. (PNAS (2005), 102(25), 8978-8983; provided in the IDS dated 10/10/2024).
Osakada teaches a composition comprising RPE cells, differentiated from embryonic stem cells (p3172, paragraph starting “Next, we examined whether…”), reading on claim 267.
Regarding claims 267 and 273, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." Also, alternate rejections under both 102 and 103 are appropriate when Applicant claims a composition in terms of a function or property and the composition of the prior art is the same as that of the claim but does not explicitly disclose the function or property. See M.P.E.P. § 2112; once a substantially identical product/composition has cited and a rationale tending to show inherency is set forth, the burden shifts to Applicant to overcome to overcome the 103 rejection by further showing that any difference in the claimed function/property is non-obvious. In this case, claims 267 and 273 are directed towards functional properties. The prior art composition of Osakada are substantially similar to the claimed composition because they are in-part made by similar methods of differentiating pluripotent stem cells in vitro into RPE cells as claimed. Therefore, the burden is shifted to Applicant to show by a preponderance of evidence that the RPE cells of Osakada could not meet the limitations of claims 267 and 273.
Regarding claim 267, Osakada does not teach an average melanin content of 1-5 pg/cell.
Hu teaches that human RPE cells culture in vitro have a melanin content of ranging from 0.0036-0.502 ng/ cell (i.e. 3.6-502 pg/cell) with the melanin content decreasing over time as a function of the number of cell passages (Table 2), reading on claim 255.
Seagle teaches that the melanin content in RPE cells positively correlates with increased photoprotection from blue light-induced apoptosis (Abstract; Table 1 and p8981, subheading “Apoptosis Assay”, and p8982, subheading “Melanin Phototoxicity and Photoprotection” and particularly the paragraph starting “On the basis of the work presented here…”), reading in-part on claims 267. Seagle teaches methods of isolating and culturing human RPE cells (p8978, 1st paragraph under “Materials and Methods”), reading on claim 267.
Regarding the melanin content of claim 267, it would have been obvious before the invention was made to further passage and culture the RPE cells of Osakada to achieve a melanin content of either 1-5 pg/ cell as taught by Hu and in view of Seagle. A person of ordinary skill in the art would have had a reasonable expectation of success in Osakada, Hu, and Seagle are all in-part directed towards the culturing of RPE cells. The skilled artisan would have been motivated to do so because Seagle teaches that the melanin content in RPE cells positively correlates with increased photoprotection from blue light-induced apoptosis, and so selecting cells with higher melanin contents would likely improve the survivability of the RPE cells of Lu as Seagle teaches a known correlation between melanin content and resistance to blue light-induced apoptosis.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill at the time the invention was made.
Claim 271 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Osakada, Hu, and Seagle as applied to claim 267 above, and further in view of further in view of Binder et al. (US 2006/0002900; provided in the IDS dated 10/10/2024).
The teachings of Osakada, Hu, and Seagle are relied upon as set forth above.
Regarding claim 271, Osakada, Hu, and Seagle do not teach do not teach the RPE cell composition formulated as a graft.
Binder teaches an RPE cell composition for implantation (Abstract). Binder teaches combining the RPE cells with an amniotic membrane to form a surgical graft for replacement of Bruch’s membrane as a substrate (Abstract, [0026]), reading on claim 271.
Regarding claim 271, It would have been obvious to a person of ordinary skill in the art before the invention was filed to further formulate the RPE cells of Osakada into a graft in view of Binder. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Binder and Osakada are directed towards RPE cell compositions. The skilled artisan would have been motivated to do so because Binder teaches combining the RPE cells with an amniotic membrane to form a surgical graft for replacement of Bruch’s membrane as a substrate, and so the further formulation would be predictably advantageous to generate a graft for treatment of subjects in need thereof as taught by Binder.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill at the time the invention was made.
Claims 255, 257-260, 268, 272, and 274 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Osakada (Journal of Cell Science (2009), 122(17), 3169-3179) in view of Hu (Photochemistry and Photobiology (2008), 84, 645-649; provided in the IDS dated 10/10/2024), Seagle et al. (PNAS (2005), 102(25), 8978-8983; provided in the IDS dated 10/10/2024), and Allen (US 2006/0147437; provided in the IDS dated 10/10/2024).
Osakada teaches a composition comprising RPE cells, differentiated from embryonic stem cells (p3172, paragraph starting “Next, we examined whether…”), reading on claims 255 and 262. Osakada teaches 79.2 ± 5.1% of the colonies are PAX6+ (paragraph spanning p3171-3172), reading on claim 257. Osakada teaches human cells (p3172, paragraph starting “Next, we examined whether…” and p3176, subheading “Human ES cell culture”), reading on claim 260. Osakada teaches adding Y-27632 to prevent/reduce cell death (paragraph spanning p3170-3171), reading on claim 274.
Regarding claims 258, 259 and 272, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." Also, alternate rejections under both 102 and 103 are appropriate when Applicant claims a composition in terms of a function or property and the composition of the prior art is the same as that of the claim but does not explicitly disclose the function or property. See M.P.E.P. § 2112; once a substantially identical product/composition has cited and a rationale tending to show inherency is set forth, the burden shifts to Applicant to overcome to overcome the 103 rejection by further showing that any difference in the claimed function/property is non-obvious. In this case, claims 258, 259, and 272 are directed towards functional properties. The prior art composition of Osakada are substantially similar to the claimed composition because they are in-part made by similar methods of differentiating pluripotent stem cells in vitro into RPE cells as disclosed (e.g. see the specification at Example 4). Therefore, the burden is shifted to Applicant to show by a preponderance of evidence that the RPE cells of Osakada could not meet the limitations of claims 258, 259, and 272.
Claim 268 has been fully considered, but only further recited an intended use of the composition of claim 255. See M.P.E.P. § 2111.02 and M.P.E.P. § 2111.04. As such, the RPE cell composition of Osakada is reasonably presumed to be capable of meeting the intended use of claims 268.
Regarding claim 255, Osakada does not teach an average melanin content of 1-5 pg/cell. Regarding claim 255, Osakada does not teach 1,000-109 viable cells.
Hu teaches that human RPE cells culture in vitro have a melanin content of ranging from 0.0036-0.502 ng/ cell (i.e. 3.6-502 pg/cell) with the melanin content decreasing over time as a function of the number of cell passages (Table 2), reading on claim 255.
Seagle teaches that the melanin content in RPE cells positively correlates with increased photoprotection from blue light-induced apoptosis (Abstract; Table 1 and p8981, subheading “Apoptosis Assay”, and p8982, subheading “Melanin Phototoxicity and Photoprotection” and particularly the paragraph starting “On the basis of the work presented here…”), reading in-part on claims 255. Seagle teaches methods of isolating and culturing human RPE cells (p8978, 1st paragraph under “Materials and Methods”), reading on claim 255.
Allen teaches that RPE cells produce the immunosuppressant protein FasL and are therefore useful for creating immunologically privileged sites to treat disease. (Paragraphs 10-11.) Allen teaches that the number of RPE cells in a composition to be administered to a subject will vary depending on the specific tissue being transplanted and the desired function of the RPE cells; Allen expressly contemplates a dose range of RPE cells between 103 and 109 cells. (Paragraphs 13 and 40.) Allen teaches that a single eye can yield 2.5x105 to 1x106 cells and that a 25cm2 culture flask holds approximately 5x106 cells and teaches compositions with 4.5x105 or 4.5x106 cells per mL (i.e., 450 or 4500 cells per μL). (Paragraphs 53-54.)
Regarding the melanin content of claim 255, it would have been obvious before the invention was made to further passage and culture the RPE cells of Osakada to achieve a melanin content of either 1-5 pg/ cell as taught by Hu and in view of Seagle. A person of ordinary skill in the art would have had a reasonable expectation of success as Osakada, Hu, and Seagle are all in-part directed towards the culturing of RPE cells. The skilled artisan would have been motivated to do so because Seagle teaches that the melanin content in RPE cells positively correlates with increased photoprotection from blue light-induced apoptosis, and so selecting cells with higher melanin contents would likely improve the survivability of the RPE cells of Lu as Seagle teaches a known correlation between melanin content and resistance to blue light-induced apoptosis.
Regarding the viable cells of claim 255, the person of ordinary skill in the art would have had a reasonable expectation of success in formulating RPE-cell compositions containing amounts 1,000-109 RPE cells because Allen contemplates compositions containing up to 109 cells and specifically suggests compositions containing 450 or 4500 cells per μL. Because Allen teaches the RPE cell concentrations in the context of therapeutic administration, the RPE cells are reasonably presumed viable. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” M.P.E.P. § 2144.05.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill at the time the invention was made.
Claim 256 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Osakada, Hu, Seagle, and Allen as applied to claim 255 above, and further in view of Idelson et al. (Cell Stem Cell (2009), 5, 396-408; provided in the IDS dated 10/10/2024).
The teachings of Osakada, Hu, Seagle, and Allen are relied upon as set forth above.
Regarding claim 256, Osakada, Hu, Seagle, and Allen are silent regarding at least 50% of the RPE cells being bestrophin+.
Idelson teaches methods of differentiating human embryonic stem cells into functional retinal epithelium (RPE) cells (Abstract). Idelson teaches that the majority of pigmented RPE cells are positive for ZO-1, bestrophin, and Pax6 (Fig. 4 and paragraph starting “To characterize the phenotype of pigmented cells…” through paragraph ending “…but rather RPE-like cells” on p400), reading in-part on claims 265 and 273.
Regarding claims 256, while Idelson does not quantify the claimed marker expression Idelson make clear that bestrophin+ expression is a predictable identifier of RPE cells. Therefore, the limitations of claim 256 are directed towards the relative purity of the claimed RPE cells and so It would have been obvious before the invention was made to further enrich Osakada’s RPE cells based on at least 50% positivity for bestrophin in view of Idelson. A person of ordinary skill in the art would have had a reasonable expectation of success in doing so because both Osakada and Idelson are directed towards methods of differentiating human embryonic stem cells (hESC) into retinal pigment epithelium (RPE) cells. The skilled artisan would have been motivated to do so because obtaining greater quantities of RPE cells based on known markers of RPE cell fate would be predictably advantageous to improve the yield for available RPE cells.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill at the time the invention was made.
Claims 261, 263 and 270 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Osakada, Hu, Seagle, and Allen as applied to claim 255 above, and further in view of Binder et al. (US 2006/0002900; provided in the IDS dated 10/10/2024).
The teachings of Osakada, Hu, Seagle, and Allen are relied upon as set forth above. Osakada further teaches mouse embryonic stem cells (p3176, subheading “Mouse ES cell culture”), reading in part on claim 261. Osakada further teaches differentiating the human ES cells into RPE cells with DMEM/F12 culture medium and at an initial concentration of 8.2 * 102 clumps/ml (p3176, subheading “Human ES cell culture”), reading in-part on claim 263.
Regarding claim 261, Osakada, Hu, Seagle, and Allen do not teach any genetically engineered RPE cell. Regarding claim 263, Osakada, Hu, Seagle, and Allen do not teach a kit further comprising a separate container for an acceptable diluent. Regarding claim 270, Osakada, Hu, Seagle, and Allen do not teach the RPE cell composition formulated as a graft.
Binder teaches an RPE cell composition for implantation (Abstract). Binder teaches non-human RPE cells bioengineered (e.g. genetically engineered) so that they become compatible with human cells ([0057]), reading on claim 261. Binder teaches a kit comprising a plurality of RPE cells and a buffer or culture medium (e.g. separate components) (claim 27), reading on claim 263. Binder teaches combining the RPE cells with an amniotic membrane to form a surgical graft for replacement of Bruch’s membrane as a substrate (Abstract, [0026]), reading on claim 270.
Regarding claim 261, it would have been obvious to a person of ordinary skill in the art before the invention was made to further genetically engineer the mouse ES cells that can differentiate into RPE cells in view of Binder. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Binder and Osakada are directed towards RPE cell compositions. The skilled artisan would have been motivated to do so because Binder teaches non-human RPE cells bioengineered (e.g. genetically engineered) so that they become compatible with human cells, so the embodiment of RPE cells differentiated from mouse ES cells of Osakada would therefore be improved in downstream methods of administering the RPE cells as taught by Binder.
Regarding claim 263, It would have been obvious to a person of ordinary skill in the art before the invention was made to further separate the RPE cells and a culture medium (e.g. diluent) of Osakada into separate containers in view of Binder. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Binder and Osakada are directed towards RPE cell compositions. The skilled artisan would have been motivated to do so because Binder teaches a kit comprising a plurality of RPE cells and a buffer or culture medium (e.g. separate components), and so the further separation would be predictably advantageous to further separate the RPE cells from an additional volume of culture medium to dilute the ES cell clumps of Osakada to a desired concentration when differentiating said ES cell clumps into RPE cells.
Regarding claim 270, It would have been obvious to a person of ordinary skill in the art before the invention was filed to further formulate the RPE cells of Osakada into a graft in view of Binder. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Binder and Osakada are directed towards RPE cell compositions. The skilled artisan would have been motivated to do so because Binder teaches combining the RPE cells with an amniotic membrane to form a surgical graft for replacement of Bruch’s membrane as a substrate, and so the further formulation would be predictably advantageous to generate a graft for treatment of subjects in need thereof as taught by Binder.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill at the time the invention was made.
Response to Arguments
Applicant's arguments on pages 8-20 of the reply have been fully considered, but not found persuasive of error for the reasons given below. Any reference to the instant Declaration is fully addressed above.
On pages 8-13 of the reply, Applicant alleges that claimed RPE cells are patent eligible under 35 U.S.C. § 101. As starting point, Applicant misinterprets the relevant case law on pages 8-9 of the reply as “not all changes in characteristics will rise to the level of a marked difference”; see M.P.E.P. § 2106(C)(2). Applicant’s arguments are not persuasive because they are not reasonably commensurate to the scope of the claims. Unclaimed characteristics cannot contribute to eligibility, see M.P.E.P. § 2106(II)(B). In this case, independent claims 255 and 267 are directed towards a composition comprising RPE cells, and the claims further recite product-by-process limitations. The product-by-process limitations are generic and are not limited towards any starting pluripotent cell type and do not recite any particular set of steps, do not recite any limitations to proliferative capacity as alleged over Schwartz, do not recite the exact differentiation methods and starting pluripotent cells of Liu (see page 8 of Liu) to establish by a preponderance of evidence that the claimed RPE cells inherently possess a different DNA methylation profile, and the claims were not amended to require any particular DNA methylation profile. Similarly, Applicant’s arguments over Strunnikova and Liao on page 11 of the reply and Patterson and Liang and Godley on page 12-13 of the reply suffers from the same deficiencies as the arguments over Schwartz and Liu, i.e. the claims were not amended to recite any particular gene expression profile that might otherwise patentably distinguish the claimed RPE cells limitations from its nearest natural counterpart. Applicant is relying entirely on unclaimed features, and 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 response to applicant’s argument on pages 13-14 of the reply that there is no teaching, suggestion, or motivation to combine the references to arrive at a prima facie case for obviousness under 35 U.S.C. § 103, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the argument is not persuasive because Applicant does address the specific motivation to combine Hu and Seagle with Osakada (for independent claim 255) and Hu, Seagle, and Allen with Osakada (for independent claim 267) articulated by the examiner in the prima facie case for obviousness of record.
Applicant’s arguments on page 15 of the reply are acknowledged, but not found persuasive as prior art is presumed operable absent any showing to the contrary and reasonably commensurate to the scope of the claims. See M.P.E.P. § 2121. At this time, there is no evidence of record to suggest that the claimed melanin concentration would otherwise be unachievable in Osakada’s RPE cell composition.
On pages 16-17 of the reply, Applicant alleges that the claimed RPE cells yield unexpected results. The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." and must be commensurate in scope with the claims which the evidence is offered to support; see M.P.E.P. § 716.02(b) and 716.02(d). In this case, the arguments are not persuasive of error as they are not reasonably commensurate to the scope of the claims. The cited portion of the specification only cites one melanin concentration for the RPE cells, 4.8 ± 0.3 SD pg/cell, and does not appear to test melanin concentrations less than 4.8 pg/cell such as to demonstrate criticality of the claimed range of an average melanin content of 1-5 pg/cell as claimed; see M.P.E.P. § 716.02(d)(II). The cited portion of the specification only tests a single human embryonic stem cell line (hESCs) as the starting pluripotent cell type but the product-by-process limitations of claims 255 and 267 are generic towards the pluripotent stem cell type. The claimed RPE cell composition does not require any absolute or relative measure of cell growth and/or survival over any period of time.
Finally, even if Applicant has allegedly shown an unexpected result, the mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention; see M.P.E.P. § 2145 (II). In this case, RCE cells prepared by the differentiation of pluripotent stem cells is known and taught by Osakada, RPE cellular melanin concentrations within the claimed range are clearly taught by Hu, and so any improvement in cell growth would inherently improve the growth of the RPE cells of Osakada.
On pages 17-20 of the reply, Applicants rely on arguments traversing the above rejection of claim 255 over Osakada, Hu, and Seagle and the rejection of claim 267 over Osakada, Hu, Seagle, and Allen to traverse the rejection of claim 271 further in view of Binder, the rejection of claim 256 further in view of Idelson, and the rejection of claims 261, 263, and 270 further in view of Binder. Therefore, the response set forth above to arguments also applies to this rejection.
Conclusion
No claims are allowed. No claims are free of the art.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Carr et al. (PLoS One (2009), 4(12), e8152, 12 pages; Reference U).
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:00am-3:30pm EDT/EST (M-F).
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, Sharmila Landau can be reached at 571-272-0614. 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.
/Sean C. Barron/Primary Examiner, Art Unit 1653