DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
Applicant's amendments filed 6/24/2026 have been entered. Claims 3, 5-8, 13, 16-20, 29, 43, and 45-54 are canceled. Claims 55-60 have been added. Claims 1, 2, 4, 9-12, 14, 15, 21-28, 30-42, 44, and 55-60 remain pending and are subject to the election requirement dated 3/24/2026. References not included with this Office action can be found in a prior action.
Election/Restrictions
Applicant’s election without traverse of Group I, presently claims 1, 2, 9-12, 14, 15, 21-28, 30-42, and 55-60 in the reply filed on 6/24/2026 is acknowledged.
In view of the instant amendments, no claims are withdrawn at this time.
Claims 1, 2, 9-12, 14, 15, 21-28, 30-42, 44, and 55-60 are under consideration on the merits.
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.
Claims 1, 2, 4, 9-12, 14, 15, 21-28, 30-42, 44, 55, and 57-60 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.
The term “dynamic” in claims 1, 4, 14, 15, 33-35, and 44 and “static” in claims 2 and 21 are a relative terms which renders the claim indefinite. The terms “dynamic” and “static” are not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification and/correction is required.
Claim 10 recites “wherein the population of RPE cells is provided from an intermediate cell bank”, which blurs the metes and bounds of the claim as claim 10 depends from claim 1 and claim 1 is already limited to RPE cells differentiated from pluripotent stem cells. Claim 10 recites two mutually exclusive sources of RPE cells, and it is unclear which is controlling of scope for the claim. Correction is required.
Claim 39 recites the limitation “the mature RPE cells”, but there is insufficient antecedent basis for this limitation in the claim. Claim 39 depends from claim 1 and claim 1 does not require any mature RPE cells. Correction is required.
In so much that claims 2, 9-12, 14, 15, 21-28, 30-42, 44, 55, and 57-60 depend from claim 1 and do not resolve the point of confusion, these claims must be rejected with claim 1 as indefinite.
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.
Claims 1, 2, 4, 9, 11, 33, and 55 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cuzzani et al. (US 2020/0085882; provided in the IDS dated 1/26/2024).
Cuzzani teaches a method for the expansion of retinal pigment epithelial (RPE) cells, the method comprising: a) providing a population of RPE cells, wherein the population of RPE cells was differentiated from human pluripotent stem cells; b) inoculating a medium comprising a first suspendible cell support matrix (e.g. with a micro-carrier) with the population of RPE cells; and c) expanding the population of RPE cells on the first suspendible cell support matrix in dynamic suspension (e.g. suspension culturing) to provide an expanded population of RPE cells ([0150]-[0177]), anticipating claims 1 and 9. Cuzzani teaches wherein prior to step a) the population of RPE cells was expanded on a solid surface under static conditions (e.g. adherent culturing) or dynamic conditions (e.g. variable culture times) ([0159]-[0163]), anticipating claims 2 and 4. Cuzzani does not teach the microcarrier as being coated ([0177]), anticipating the negative limitations of claim 11 and 55. Cuzzani teaches a solid surface coated with for laminin, collagen, poly-D-lysine, or fibronectin ([0160]-[0162]), anticipating those embodiments of claim 30. Cuzzani teaches expanding the mixed population of cells comprising RPE cells differentiated from pluripotent stem cells on a solid substrate in suspension passaged at least 1 time, at least two times, and at least three times ([0175]-[0179]), anticipating claim 33.
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 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, 2, 4, 9-12, 21, 23-26, 31-36, 38-42, and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Cuzzani et al. (US 2020/0085882; provided in the IDS dated 1/26/2024).
The teachings of Cuzzani are relied upon as set forth above in rejecting claims 1, 2, 4, 9, 11, 33, and 55 as anticipated under 35 U.S.C. § 102.
Regarding the PEDF AND VEGF secretion of claims 40 and 41, these claims are read in light of the specification that RPE cells formulated as a monolayer with a TEER > 100 Ω and being greater than 95% positive for PMEL17 and CRALBP inherently yields polarized secretion of PEDF and VEGF (see Table 5 of the specification). Therefore, any teaching in the prior art of RPE cells formulated as a monolayer with a TEER > 100 Ω and being greater than 95% positive for PMEL17 and CRALBP is reasonably presumed to inherently generate the PEDF and VEGF secretion of claims 40 and 41 absent any showing to the contrary. See M.P.E.P. § 2112; "[T]he PTO can
require an applicant to prove that the prior art products do not necessarily or inherently
possess the characteristics of his [or her] claimed product. Whether the rejection is
based on 'inherency' under 35 U.S.C. 102, on 'prima facie obviousness' under 35
U.S.C. 103, jointly or alternatively, the burden of proof is the same." In re Best, 562 F.2d
1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977).
Cuzzani further teaches a cell banking medium ([0208]), reading on claim 10 in view of the indefiniteness rejections above. Cuzzani teaches following expansion, the pluripotent embryonic stem cells (ESCs) are subjected to directed differentiation on an adherent surface (without intermediate generation of spheroid or embryoid bodies) ([0142]), reading on that embodiment of claims 12 and 21. Cuzzani teaches a feeder cell-free system for embryonic stem (ES) cell culturing ([0141]), reading on claim 23. Cuzzani teaches methods of culturing embryonic stem (ES) cells on feeder cell layers ([0138]), reading on claim 24. Cuzzani teaches the differentiation reagent is nicotinamide and activin A as a species of TGFβ family growth factor ({0150]-[0151]), reading on claims 25 and 26. Cuzzani teaches greater than 30 doublings across 8-15 cell passages ([0178]-[0180]), reading in-part on claim 31. Cuzzani teaches culturing in DMEM + 20% human serum ([0175]), reading in-part on claim 32. Cuzzani teaches seeding at 25,000-100,000 human fibroblasts for the embodiment of induced pluripotent stem cells (iPSCs) ([0139]), reading in-part on claims 34 and 35. Cuzzani teaches oxygen concentrations of 1-20% ([0160]), reading in-part on claim 36. Cuzzani teaches at least 95% of the RPE cells express detectable levels of PMEL17 and CRALBP as measured by FACS ([0172] and [0196]), reading on claims 38 and 39. Cuzzani teaches an RPE monolayer having a transepithelial electrical resistance (TEER) of greater than 100 Ω ([0200]-[0202], reading on claim 40. Cuzzani teaches wherein the RPE cells are cryopreserved and formulated to be ready for administration to subjects after thawing ([0207]), reading on claim 41. Cuzzani teaches that RPE cell compositions are generally devoid on undifferentiated embryonic stem cells as quantified by less than 1:250,000 (i.e. 4 x 10-6 %) being Oct4+ and TRA-1-60+ as measured by FACS ([0182]), reading on claim 42.
Regarding claims 10, 12, 21, 24-26, 31, 32, 34-36, and 38-42, it would have been obvious to a person of ordinary skill in the art before the invention was filed to further add the alternative embodiments as set forth above to Cuzzani’s methods of differentiating and expanding RPE cells from pluripotent stem cells. A person of ordinary skill in the art would have had a reasonable expectation of success to do so and the skilled artisan would have been motivated to do so because Cuzzani expressly considers the addition(s), and so combining the prior art elements of Cuzzani according to known methods as taught by Cuzzani would predictably yield a method of differentiating and expanding RPE cells from pluripotent stem cells; see M.P.E.P. § 2142 and 2143(I)(A).
Regarding the cell passages and cell doublings of claims 31, 32, 34, and 35, the cell density of claims 34 and 35, and the oxygen concentration of claim 36, optimization within prior art conditions or through routine experimentation will generally not support patentability absent a showing of criticality of the claimed range to the contrary. See M.P.E.P. § 2144.05, particularly subsections II and III. In this case, Cuzzani clearly teaches that the number of cell passages and cell doublings, cell density, and oxygen concentration are all know variables which are effective to differentiate RPE cells from starting pluripotent stem cells. Thus, the burden is shifted back to establish criticality of the claimed parameters and ranges by objective evidence.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 14, 15, 22, 27, 28, and 57-59 are rejected under 35 U.S.C. 103 as being unpatentable over Cuzzani as applied to claims 1 and 12 above, and further in view of Falk et al. (Journal of Biomedicine and Biotechnology (2012), Article ID 278932, 8 pages; Reference U).
The teachings of Cuzzani are relied upon as set forth above. Cuzzani as cited above for a RPE monolayer reads in-part on claim 22
Regarding claims 14 and 22, Cuzzani does not teach wherein the solid surface comprises a second suspendible cell support matrix are expanded in dynamic culture (e.g. suspension culture). Regarding claim 15, Cuzzani does not teach wherein step ii comprises differentiating the expanded pluripotent stem cells on a third suspendible cell support matrix in dynamic culture (e.g. suspension culture). Regarding claims 27 and 57, Cuzzani does not teach the embodiments of polystyrene, surface-modified polystyrene, chemically modified polystyrene, and collagen (for only claim 27). Regarding claim 28, Cuzzani does not teach spherical microcarriers. Regarding claim 58, Cuzzani does not teach positively charged polystyrene. Regarding claim 59, Cuzzani does not teach wherein the first suspendible support matrix comprises positively charged polystyrene and is not coated with a biological support matrix.
Falk teaches methods of culturing human RPE cells on microcarriers (Abstract). Falk teaches microcarriers comprising spherical CultiSpher (microporous collagen), spherical ProNectinF (polystyrene coated with recombinant RGD containing protein), and spherical Hillex II (polystyrene modified with cationic trimethyl ammonium) as evidenced by Falk (subheading 2.1 and Figure 1), reading on claims 14, 15, 22, 27, 28, and 57-59. Falk teaches that the microcarriers are advantageous to generate sustained secretion of the neuroprotective factors PEDF and VEGF-A into conditioned media for two months and would be useful for achieving long-term delivery of these neuroprotective factors in treatment of Parkinson’s disease (Abstract; Figures 2 and 3), reading on claims 14, 15, 22, 27, 28, and 57-59.
Regarding claims 14, 15, 22, 27, 28, and 57-59, it would have been obvious to a person of ordinary skill in the art before the invention was filed to add the CultiSpher, ProNectinF, and/or Hillex II of Falk to the methods of Cuzzani. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Falk and Cuzzani are in-part directed towards methods of culturing human RPE cells on microcarriers. The skilled artisan would have been motivated to do so because Falk teaches that the addition of CultiSpher, ProNectinF, and/or Hillex II would be predictably advantageous to advantageous to generate sustained secretion of the neuroprotective factors PEDF and VEGF-A into conditioned media for two months and would be useful for achieving long-term delivery of these neuroprotective factors in treatment of Parkinson’s disease and would thus improve Cuzzani’s methods.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 37, 56, and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Cuzzani as applied to claims 1 and 12 above, and further in view of Baakdhah et al. (Biotechnology Progress (2019), 35:e2800, 11 pages; Reference V).
The teachings of Cuzzani are relied upon as set forth above.
Regarding claim 37, Cuzzani does not teach the method of claim 1, wherein step c) comprises initial a growth media volume starting at 50% of total system growth chamber volume, and wherein a growth media volume of 16.6% of total system growth chamber volume is added every 2-4 days. Regarding claim 56, Cuzzani does not teach wherein expanding the population of RPE cells on the first suspendible cell support matrix in dynamic suspension comprises agitation at 10-30 RPM followed by agitation at 20-50 RPM. Regarding claim 60, Cuzzani does not teach the method of claim 1, wherein expanding the population of RPE cells on the first suspendible cell support matrix comprises a fed batch feeding regime with (i) medium replacement on day 4, a first fed batch on day 7, a second fed batch on day 10, a third fed batch on day 11, and harvesting on day 13; (ii) medium replacement on day 4, a first fed batch on day
7, a second fed batch on day 10, a third fed batch on day 12, and harvesting on day 13; or (iii) medium replacement on day 4, a first fed batch on day 6, a second fed batch on day 8, a third fed batch on day 11, and harvesting on day 14.
Baakdhah teaches methods of expanding retinal stem cells (RSC) on microcarriers in a stirred bioreactor (Abstract). Baakdhah teaches the stirred bioreactor is operated as a semi-fed batch culture wherein 30% of the culture volume is added every two days (subheading 2.3), reading in-part on claims 37 and 60. Baakdhah teaches agitating the retinal stem cells with the microcarriers at 50 rpm to seed said cells on the microcarriers (subheading 2.7), reading in-part on claim 56. Baakdhah envisions differentiating the retinal stem cells into retinal pigment epithelial (RPE) cells (the 1st paragraph of the Introduction on page 1 and the single paragraph of the Conclusion spanning pages 10-11), reading on claims 37, 56, and 60. Baakdhah teaches that semi-fed batch culture methods are advantageous to ensure an adequate supply of nutrients as well as removal of any byproducts or cytokines that can negatively affect cell growth and proliferation (subheading 3.1), reading on claims 37, 56, and 60.
Regarding claims 37 and 60, it would have been obvious to a person of ordinary skill in the art before the invention was filed to add the semi-fed batch culture methods of Baakdhah to the methods of Cuzzani. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Baakdhah and Cuzzani are directed in-part towards culturing retinal cells, and because Baakdhah further envisions differentiating the retinal stem cells into retinal pigment epithelial (RPE) cells. The skilled artisan would have been motivated to do so because Baakdhah teaches that the addition of semi-fed batch culture methods would be predictably advantageous to ensure an adequate supply of nutrients as well as removal of any byproducts or cytokines that can negatively affect cell growth and proliferation and would thus improve Cuzzani’s methods.
Regarding claim 56, it would have been obvious to a person of ordinary skill in the art before the invention was filed to further mix the first suspendible cell support matrix (microcarrier) and RPE cells of Cuzzani at 50 rpm according to Baakdhah. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Baakdhah and Cuzzani are directed in-part towards culturing retinal cells, and because Baakdhah further envisions differentiating the retinal stem cells into retinal pigment epithelial (RPE) cells. The skilled artisan would have been motivated to do so because Baakdhah teaches that 50 rpm is operable to seed retinal cells on the microcarriers, and would thus predictably yield retinal cells seeded on microcarriers in the methods of Cuzzani; see M.P.E.P. § 2143(I)(A).
Regarding the specific culture conditions of claims 37 and 60 and the two separate rpm ranges of claim 56, optimization within prior art conditions or through routine experimentation will generally not support patentability absent a showing of criticality of the claimed range to the contrary. See M.P.E.P. § 2144.05, particularly subsections II and III. In this case, Cuzzani clearly teaches that the cell media volume and timing in semi-fed batch methods (for claims 37 and 60) are known result effective variables with respect to retinal cell growth and proliferation, and the rpm (claim 56) is a known result effective variables with respect to retinal cell seeding in microcarriers. Thus, the burden is shifted back to establish criticality of the claimed parameters by objective evidence.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Cuzzani as applied to claim 1 above, and further in view of Matsumodo et al. (PLoS One (2019), 14(3), e02112369, 15 pages; Reference W).
The teachings of Cuzzani are relied upon as set forth above.
Regarding claim 44, Cuzzani does not teach a single-use bioreactor.
Matsumodo teaches methods of culturing RPE cells and RPE cells derived from induced pluripotent stem cells (iPS-RPE) as sheets in an automated and closed cell culture system comprising disposable (single-use) bioreactors (Abstract; the paragraph spanning pages 2-3; and, the paragraph spanning pages 3-4), reading on claim 44. Matsumodo teaches that the closed cell culture system is advantageous over an open system with respect to good manufacturing practice because of increased sterility and safety (the paragraph spanning pages 2-3), reading on claim 44.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the unspecified bioreactor(s) of Cuzzani with the disposable (single-use) bioreactors of Matsumodo in Cuzzani’s methods. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Matsumodo and Cuzzani are in-part directed towards methods of culturing RPE cells derived from pluripotent stem cells. The skilled artisan would have been motivated to do so because Matsumodo teaches that the closed cell culture system comprising disposable (single-use) bioreactor(s) is advantageous over an open system with respect to good manufacturing practice because of increased sterility and safety and would thus improve Cuzzani’s methods.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 4, 25, 26, and 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6, and 14 of U.S. Patent No. US 11,987,810 (Reference A).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 3, and 4 of the ‘810 patent are the narrower embodiment of instant claim 1 and are both directed towards methods of differentiating pluripotent stem cells into RPE cells on an extracellular matrix in suspension culture (e.g. a first suspendible support matrix and dynamic suspension, respectively). As such, combining separate steps taught as useful in a method into a singular method must be held as prima facie obvious, as each step is taught separately useful for the same purpose. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) and so instant claim 1 must be held prima facie obvious over the combination of claims 1, 3, and 4 of the ‘810 patent.
Claim 1 of the ‘810 patent further reads on claims 25 and 26. Claim 5 of the ‘810 patent reads on instant claims 2 and 4. Claim 6 of the ‘810 patent reads on instant claim 36.
Conclusion
No claims are allowed. No claims are free of the art.
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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