DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/24/2025 has been entered.
Claim Status
As of the Final Office Action mailed 07/28/2025, claims 1-20 were pending.
In Applicant's Response filed on 11/24/2025, claims 1, 6, and 16 were amended, claims 5 and 20 were cancelled, and claims 21-24 were newly added.
As such, claims 1-4, 6-19, and 21-24 are pending and have been examined herein.
Withdrawn Objections/Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in this application. Any objections or rejections not specifically reiterated are hereby withdrawn.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 15 and 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Please note that the rejection has been modified based on Applicant’s amendments to the claims.
While determining whether a specification is enabling, one considered whether the claimed invention provides sufficient guidance to make and use the claimed invention, if not, whether an artisan would have required undue experimentation to make and use the claimed invention and whether working examples have been provided. When determining whether a specification meets the enablement requirement, some of the factors that need to be analyzed are: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill, the level of predictability in the art, the amount of direction provided by the inventor, the existence of working examples, and whether the quantity of any necessary experimentation to make or use the invention based on the content of the disclosure is “undue” (In re Wands, 858 F.2d at 737, 8 USPQ2d 1400, 1404 (Fed. Cir.1988)).
Furthermore, the USPTO does not have laboratory facilities to test if an invention with function as claimed when working examples are not disclosed in the specification, therefore, enablement issues are raised and discussed based on the state of knowledge pertinent to an art at the time of the invention, therefore, skepticism raised in the enablement rejection are those raised in the art by artisans of expertise.
Claims 15-16 are directed to a method for treating limbal stem cell deficiency, comprising administering an effective dose to a patient in need thereof of ABCG2- positive corneal limbal stem cells by transplantation to an ocular surface of an eye patient, wherein at least 65% of the administered cells are ABCG2-positive, whose ABCG2-positive phenotype has been maintained by the method of claim 1. Claim 16 specifies that the ABCG2- positive corneal limbal stem cells are capable of maintaining their ABCG2-positive phenotype for at least 35 days.
Claim 15 requires that the cells be administered to a “patient in need” and that the cells are given at “an effective dose.” Thus, the claims require that a patient with limbal stem cell deficiency is treated.
Nature of the invention:
A method for treating limbal stem cell deficiency, comprising administering an effective dose to a patient in need thereof of ABCG2- positive corneal limbal stem cells by transplantation to an ocular surface of an eye patient, whose ABCG2-positive phenotype has been maintained by the method of claim 1.
The state of the prior art:
The state of the prior art for treating limbal stem cell deficiency in various patients in need was unpredictable before the effective filing date of the claimed invention.
The state of the prior art for administering corneal limbal stem cells via various administration routes was unpredictable before the effective filing date of the claimed invention.
The breadth of the claims:
The claims encompass treating limbal stem cell deficiency in various patients in need by administering corneal limbal stem cells via transplantation.
The level of skill in the art:
The level of skill is high that requires a researcher with a PhD degree.
The working examples and guidance provided:
The specification discloses a working example in which human pluripotent stem cells are differentiated into corneal limbal stem cells (example 1). The specification also discloses culture conditions for preserving ABCG2 expression in hPSC-LSCs using EGF, noggin, R-spondin-1, and CHIR99021 (example 2)
The specification fails to provide any working examples in which any corneal limbal stem cells are administered/transplanted or limbal stem cell deficiency is treated using corneal limbal stem cells.
The unpredictable nature of the art:
The claims encompass administering corneal limbal stem cells to a patient in need via transplantation to treat limbal stem cell deficiency. The specification, however, is devoid of any working examples that reasonably encompass the instant claims. Please note that the method of treating as in claim 15 requires the method of maintaining the ABCG2-positive LSCs as claimed in instant claim 1. While the prior art recognizes the capability of maintaining ABCG2-positive LSCs, the art fails to recognize the ability to treat limbal stem cell deficiency with those claimed cells.
Treatment of LSCD and administration of LSCs:
Haagdorens et al (Stem Cells Int. 14 Dec 2015; 2016:9798374) teaches current treatment options for limbal stem cell deficiency. The reference teaches that severe ocular surface disease can result in limbal stem cell deficiency, which leads to decreased visual acuity, photophobia, and ocular pain (abstract). While cultivated limbal epithelial transplantation has been used to transplant autologous or allogenic limbal stem cells, there is still room for improvement as overall success rate is 70% and visual acuity remains suboptimal (same para). The reference discusses the myriad of causes of LSCD, including aniridia, multiple endocrine deficiency, as well as secondary causes such as contact lens wear, thermal or chemical burns, systemic chemotherapy, and inflammatory eye disease (Table 1). Therapeutic options for LSCD range from conservative o invasive and depends on the severity of the pathology. Conservative options include autologous serum drops, eye lubrication, corneal scraping, supportive management, and amniotic membrane patching (“Treatment of LSCD” para 1). If the patient has no remaining LSCs, then the cornea has to be reseeded with new LSCs (same para). The reference concludes that despite the successes and evolving techniques in LESC transplantation, detailed interaction and signaling pathways between LESCs, niche cells, and surrounding extracellular matrix are not fully understood related to (i) physiological LESC maintenance, (ii) in vitro and in vivo microenvironment simulation, and (iii) long-term effectiveness of LESC transplantation (“Conclusion” para 1).
Post-dated Park (Ann Eye Sci, 3 Feb 2023; 8:25; p. 1-10) teaches that except for sudden trauma, diseases causing LSCD slowly depletes LSCs (“Medical treatment of LSCD” para 1). Autologous serum, platelet-rich plasma, and amniotic membrane extract eyedrops contain various growth factors that can revitalize the limbal niche have the potential to reverse LSCD at an early stage, however, these treatments have limited efficacy for LSCD at its advanced stages. Mild degree of partial LSCD can be treated by simply removing abnormal epithelium and allowing the denuded cornea to be resurfaced with cells from the remaining intact LSCs (“Surgical procedures” para 1). However, if LSCD has progressed with invasion of the visual axis, advanced surgical treatment is required. The goal of surgery is to transfer a sufficient amount of LSCs or corneal epithelial-like cells to the diseased ocular surface to promote and maintain corneal epithelialization (same para). Although many types of limbal epithelial cell transplantation technique have been developed, none of them is universally successful (same para). The reference concludes that initial treatment of LSCD is difficult, especially for hereditary cases, cases with frequent relapses, and cases with intractable underlying etiologies and once LSCD has progressed, treatment becomes challenging.
Corneal limbal stem cells are not an “end-all, be-all” to treat limbal stem cell deficiency. Disease treatments vary widely depending on the specific condition. No example exists for the efficacy of a single product to treat LSCD. These examples show that the level of predictability in the art for using corneal limbal stem cells alone as a treatment modality for LSCD is low.
The extremely broad scope of the claims and lack of guidance in the specification exacerbates a highly unpredictable art. While the results presented in the art do not necessarily preclude Applicant’s hypothesis, they certainly fail to support it in its totality that corneal limbal stem cells can treat LSCD on its own. Applicants do not provide the details of how one of ordinary skill would reasonably administer corneal limbal stem cells to a person and assess the effect of the administered cells on LSCD nor is there a reduction to practice the instant method. Consequently, the prior and post-filling art, when combined with the lack of any disclosed direct experimental test of Applicant’s hypothesis, shows that one of ordinary skill would have no basis to reasonably predict or conclude that administration of corneal limbal stem cells to a patient with LSCD would result in tangible effects as instantly claimed. Though not controlling, the lack of working examples is, nevertheless, a factor to be considered in a case involving both physiological activity and an underdeveloped art. When a patent applicant chooses to forego exemplification and bases utility on broad terminology and general allegations, they run the risk that unless one of ordinary skill in the art would accept the allegations as obviously valid and correct, the PTO may, properly, ask for evidence to substantiate them. Ex parte Sudilosky, 21 USPQ2d 1702, 1705 (BPAI 1991); In re Novak, 134 USPA 335 (CCPA 1962); In re Fouche, 169 USPQ 429 (CCPA 1971).
In essence, the specification merely presents an idea of, and leaves it entirely up to the practitioner to determine how to carry out the claimed method. It has been established by legal decision that a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion. Tossing out the germ of an idea does not constitute an enabling disclosure. While every aspect of a generic claim need not have been carried out by an inventor or exemplified in the specification, reasonable detail must be provided in order to enable one of ordinary skill to understand and carry out the invention. It is true that a specification need not disclose what is well known in the art. However, that general, oft-repeated statement is merely a rule of supplementation, not a substitute for a basic enabling disclosure. It means that the omission of minor details does not cause a specification to fail to meet the enablement requirement under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph.
Absent specific guidance, one skilled in the art before the effective filing date of the claimed invention would not know how to practice the claimed invention and would require undue experimentation to practice over the full scope of the invention claimed.
The amount of experimentation necessary:
The specification only describes various methods in which LSCs are maintained or produced from pluripotent stem cells. While Applicant’s specification is enabling for the methods of producing and maintaining LSCs, it is not enabling for the treatment of LSCD using the maintained LSCs. It merely contains a speculative embodiment of diseases that could be treated (limbal stem cell deficiency) and leaves it entirely up to one of ordinary skill to determine which population or subpopulations of “patients in need” would be able to be treated, whether the claimed administration route (transplantation) would be appropriate given a variety of factors and unpredictable nature of effective delivery, effective dosages for LSCD to be treated in the disease populations, etc. One of ordinary skill in the art could not reasonably take the working examples and readily or immediately apply the resulting data in the claimed methods of producing and maintaining to the treatment of LSCD using transplantation as broadly embraced by the claims.
For the reasons set forth above, one skilled in the art before the effective filing date of the claimed invention would not be able to make and/or use the invention as claimed. This is particularly true given the nature of the invention, the state of the prior art, the breadth of the claims, the amount of experimentation necessary, the level of skill which is high, the working examples provided and scarcity of guidance in the specification, and the unpredictable nature of the art.
Response to Arguments
Applicant’s arguments have been fully considered but are not persuasive. On p. 8 of Remarks, Applicant argues that that narrowing the therapeutic claim to LSCD, providing that at least 65% of the administered cells are ABCG2-positive, and the specification are sufficient to provide guidance to practice the claimed invention without undue experimentation. Applicant argues that LSCD is the indication associated with LSC transplantation and transplantation to the ocular surface is routine and conventional in the art. Applicant argues that the experimental data in the Ilmarinen reference reports an in vivo LSCD mouse model was transplanted with the cells of the instantly claimed method and showed early epithelial engraftment. Applicant stipulates that the preprint supports enablement that one of ordinary skill in the art, with the specification’s guidance, would achieve the claimed functional outcome without undue experimentation.
In response, the examiner disagrees.
Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention. In this case, does the instant disclosure contain sufficient information regarding administration (via transplantation) of ABCG2-positive, CK3-negative, and CK12-negative corneal limbal stem cells maintained by culturing in EGF and WNT activator such that one of ordinary skill would recognize Applicant to be in possession and sufficiently enabled for the treatment of LSCD in various populations of “patients in need”? Applicant’s mere hypothesis is not enough to meet the enablement requirement, especially when (1) the prior and post-filling art shows that one of ordinary skill would have no basis to reasonably predict or conclude that administration of corneal limbal stem cells to a patient with a LSCD would result in tangible effects, and (2) Applicant does not provide the details of how one of ordinary skill would reasonably administer corneal limbal stem cells via transplantation to a person and assess the effect of the administered cells on LSCD nor is there a reduction to practice the instant method.
While the Ilmarinen reference (applicant’s own work) is appreciated, the examiner notes that the reference is mainly toward the utilization of a neutropenia mouse model with total LSCD for short-term in vivo proof-of-concept assessment of transplantation of ABCG2-positive hiPSC-LSCs but makes no empirical showing that the instantly claimed cells can be used to treat LSCD (i.e., “ameliorating, lessening, inhibiting, or curing the disease” as defined on p. 28 of the instant specification). One of ordinary skill would have to practice undue experimentation to utilize applicant’s instantly claimed cells in a method of treating LSCD absent this empirical evidence particularly given the sparce instant specification. Thus, Applicant’s arguments are not persuasive.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-4, 6-14, 17-19, and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Ilmarinen et al (WO2018037161A1, 24 August 2017; published 1 March 2018; Ref. 6 of Foreign Patent Documents in IDS filed 30 Sept 2021; of record) in view of Deng et al (US20160376555A1, 28 June 2016; published 29 Dec 2016; Ref. 2 of US Patent Documents in IDS filed 30 September 2021; of record), Iwata et al (WO2017188378A1; 27 April 2017; published 2 Nov 2017; of record), and as evidenced by Stasi et al (Invest Ophthalmol Vis Sci. 2014 Jan 20;55(1):375-86; of record).
Ilmarinen teaches a method for producing eye cells selected from the group consisting of corneal epithelial precursor cells comprising a) culturing pluripotent stem cells in the absence of feeder cells,
b) culturing said cells in a cell culture medium comprising a TGF-beta inhibitor and a fibroblast growth factor (FGF) followed by culturing said cells in a cell culture medium comprising bone morphogenetic protein 4 (BMP-4) thereby producing eye precursor cells, and c) culturing said eye precursor cells in a cell culture medium comprising one or more supplements selected from the group consisting of epidermal growth factor (EGF), hydrocortisone, insulin, isoproterenol, and tri-iodo- thyronine in the absence of a TGF-beta inhibitor, FGF, or BMP-4, thereby producing corneal epithelial precursor cells (see claim 1 of Ilmarinen) (“method of producing ABCG2-positive corneal limbal stem cells . . .comprising a) providing pluripotent stem cells; b) culturing said cells in a cell culture medium comprising a TGF-beta inhibitor and a fibroblast growth factor (FGF); c) withdrawing the TGF-beta inhibitor and the FGF, and culturing the cells obtained in step b) in a cell culture medium comprising bone morphogenetic protein 4 (BMP-4) thereby producing eye precursor cells; d) culturing said eye precursor cells in a corneal differentiation medium thereby producing ABCG2-positive corneal limbal stem cells” as in instant claim 6 in-part). The corneal epithelial precursor cells express markers such as p63 and ABCG2 (“Differentiation phase” para 2) (i.e., corneal limbal stem cells, which are p63 and ABCG2 positive cells, see instant specification p.2, Fig. 2E and 3A) The reference teaches that the stem cells are selected from induced pluripotent stem (iPS) cells and embryonic stem (ES) cells, with the proviso that if human embryonic stem (hESC) cells are used, the method does not include the destruction of human embryos (see claim 9 of Ilmarinen) (“wherein the pluripotent stem cells are selected from induced pluripotent stem (iPS) cells and embryonic stem (ES) cells, with the proviso that if human embryonic stem (hESC) cells are used, the method does not include the destruction of human embryos” as in instant claim 10). Step (a) comprises forming embryoid bodies from the pluripotent stem cells (see claim 10 of Ilmarinen) and the formation of embryoid bodies is carried out by physical or chemical method, such as culturing cells in the presence of attachment-preventing agents, culturing cells in hanging drops, microfabrication techniques, forced aggregation e.g. by centrifugation, and culturing cells in the presence of one or more aggregation-promoting agents such as macromolecular crowders, blebbistatin and ROCK inhibitors (see claim 11 of Ilmarinen) (“wherein said forming of embryoid bodies in step a) is carried out by a physical or chemical method selected from the group consisting of culturing cells in the presence of attachment-preventing agents, culturing cells in hanging drops, microfabrication techniques, forced aggregation, and culturing cells in the presence of one or more aggregation-promoting agents” as in instant claim 12). The reference also teaches that the culturing in step (c) is carried out on a substrate coated with at least collagen IV and Laminin (see claim 12 of Ilmarinen). The reference also teaches that the addition of laminins and collagens allow for the culturing of cells without the use of feeder cells (see p. 6 lines 30-36 and p. 7 lines 1-22) such that one of ordinary skill would readily use coated surfaces with laminin and collagen to avoid the use of feeder cells (“wherein said culturing in steps d) and e) is carried out on a substrate coated at least with collagen IV and laminin” as in instant claim 13). Finally, the reference teaches obtaining precursor cells requires culturing the cells for about 10 to about 35 days and that the expression of CK12 and CK3 is present in only matured corneal epithelium cells that result from maturing the corneal epithelial precursor cells (p. 17 lines 22-30, 34-35) (“wherein the ABCG2-positive corneal limbal stem cells do not express cytokeratin 3 or cytokeratin 12” as in instant claim 6 in-part, “thereby maintaining an ABCG2 positive, CK3 and CK12 negative phenotype when continuously cultured under said conditions for at least 35 days” as in instant claim 1 and 6).
Ilmarinen differs from the instantly claimed invention in that it does not teaches that the resulting ABCG2 expressing corneal limbal epithelial cells are maintained by culturing in a maintenance medium comprising EGF and at least one Wnt activator (related to instant claim 6 in-part).
Deng teaches a method for maintaining human limbal stem cells of the corneal epithelium in an undifferentiated limbal stem cell phenotype by culturing the cells in a culture media for human limbal stem cells and that the human limbal stem cell phenotype is characterized by observing expression of ATP-binding cassette subfamily G member 2 (ABCG2) in the human limbal stem cells (see claims 1 and 2 of Deng) (“culturing said ABCG2-positive corneal limbal stem cells in a maintenance cell culture medium” as in instant claim 6 in-part). The corneal limbal stem cells can be characterized by the presence, absence, and/or expression biomarkers such as cytokeratin (K) 1, K3, K10, K12, K14, or K15 (para 0041).
Iwata teaches a method of culturing pancreatic progenitor cells wherein the cells are cultured in 1) EGF and/or FGF and 2) a Wnt agonist (see claim 1 of Iwata translation) (“maintenance cell culture medium comprising EGF and at least one Wnt activator” as in instant claim 6 in-part). The reference teaches that culturing the cells refers to maintaining the cells (see translation, p. 4 “Detailed Description of the Invention”). The reference also teaches that the Wnt agonist is a protein belonging to the R-spondin family and / or a GSK inhibitor (see claim 2 of Iwata) (“wherein the Wnt activator is selected from the group consisting of GSK3 inhibitors and proteins of R-spondin family” as in instant claim 7). The reference teaches that substances that maintain undifferentiation and promotes proliferation can be added to the medium such as GSK-3 inhibitors like CHIR99021 and TGF-b inhibitors like LDN193189 (p. 7 of translation, para 16) (“wherein the Wnt activator is CHIR99021” as in instant claim 8 and 23; “wherein the culture medium further comprises . . . LDN-193189” as in instant claim 9). The reference also teaches that noggin, a BMP signal inhibitor, can be used in place of the TGF-b inhibitor for the same purpose (p. 6 of translation, para 3) (“wherein the culture medium further comprises noggin” as in instant claim 9). This shows that EGF and Wnt agonists can be added to mediums to maintain the undifferentiated state of stem cells.
Therefore, it would have been obvious prior to the effective filing date of the instantly claimed invention to produce ABCG2-expressing corneal limbal stem cells from pluripotent stem cells as taught by Ilmarinen, where the corneal limbal stem cells are maintained in a culture medium containing EGF and a Wnt agonist as taught by Deng and Iwata in combination, to arrive at the instantly claimed invention. Deng shows that ABCG2-positive corneal limbal stem cells can be maintained in a culture medium and Iwata shows EGF and a Wnt agonist like CHIR99021 can be put in a culture medium to maintain stem cells. One of ordinary skill would have been motivated to combine the method of producing corneal epithelial stem cells that express ABCG2 (i.e., corneal limbal stem cells) with the method of maintaining corneal limbal stem cells in a medium containing at least EGF and Wnt agonist as taught by Deng and Iwata in combination according to known methods to yield the predictable and advantageous result of obtaining ABCG-2 positive corneal limbal stem cells that maintain their undifferentiated status (e.g., maintain expression of corneal limbal stem cell markers) and are able to proliferate.
Regarding newly added claim 21, Ilmarinen teaches the medium is free of BSA and HSA (see entirety of pg. 21).
Regarding newly added claim 22, Ilmarinen teaches culturing eye precursor cells in a cell culture medium comprising one or more supplements selected from the group consisting of epidermal growth factor (EGF), hydrocortisone, insulin, isoproterenol, and tri-iodo- thyronine in the absence of a TGF-beta inhibitor, FGF, or BMP-4 (see claim 1).
Regarding newly added claim 24, Ilmarinen teaches use of laminin-521 and collagen IV (see claim 12).
Response to Arguments
Applicant’s arguments have been fully considered but are not persuasive. On p. 7-8 of Remarks, Applicant argues that the prior art does not teach or render obvious the instant invention. Applicant argues that Deng does not achieve the specific, time-bound maintenance results recited in claim 1, that Iwata has no reasonable expectation of success that EGF and WNT would maintain the ABCG2-, CK3-, CK12- phenotype of the instantly claimed cell for more than 35 days.
In response, the examiner notes that the Ilmarinen reference teaches obtaining precursor cells requires culturing the cells for about 10 to about 35 days and that the expression of CK12 and CK3 is present in only matured corneal epithelium cells that result from maturing the corneal epithelial precursor cells (as instantly claimed and argued). Deng shows that ABCG2 phenotype of limbal stem cells can be maintained in culture, and Iwata shows that maintenance of undifferentiation and promotion of proliferation can be stimulated by adding GSK-3 inhibitors like CHIR99021 and TGF-b inhibitors like LDN193189 to mediums (i.e., these are properties/functions of the medium additive irrespective of the cell type absent evidence to the contrary). This provides one of ordinary skill sufficient teachings, suggestions, and motivations as to the instantly claimed methods. Please note that the response to arguments also apply to the rejections of claims 6-13 as Ilmarinen, Deng, and Iwata teach/suggest and/or motivate one of ordinary skill to produce ABCG2-positive limbal stem cells that maintain CK3- and CK12- expression. Thus, Applicant’s arguments are not persuasive and the rejection is proper.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN C REGLAS whose telephone number is (571)270-0320. The examiner can normally be reached M-F 7-3.
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/G.R./Examiner, Art Unit 1632
/KARA D JOHNSON/Primary Examiner, Art Unit 1632