Applicant is requested to note that the Examiner for this application has changed. Future correspondence should be directed to Joseph (Paul) Miano, Art Unit 1631, whose contact information can be found below.
DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 1-21 are pending.
Applicant’s election without traverse of Group I, and the species of pluripotent stem cells in the reply filed on 03/10/2026 is acknowledged.
Claims 6-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/10/2026.
Claims 1-5 have been examined on their merits.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
See paragraph [0121] and a reference to Cytoscape.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Specifically, claim 3 states that “the reprogramming factor is one or more factors selected from the group consisting of Oct4, Sox2, Klf4, and c-Myc.” However, claim 1, from which is depends requires “reprogramming factors” (explicitly plural). Therefore, the selection must be from at least two or more of the group consisting of Oct4, Sox2, Klf4, and c-Myc. Additionally, Applicant should note that the Markush group in claim 3 is closed (is “consisting of”) and therefore, does not allow for the selection of programming factors beyond Oct4, Sox2, Klf4, and c-Myc. Thus, the claim is not further limiting because it broadens the scope of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) or 35 U.S.C. 102(a)(2) as being anticipated by Hochedlinger et al. (WO2008/151058A2) as evidenced by An et al. (Stem Cell Reports, 2017) and Velychko et al. (Cell Stem Cell, 2019).
In regards to claims 1, 3, and 5, Hochedlinger discloses methods for the conversion (re-programming) of non-pluripotent stem cells (differentiated somatic cells) to induced pluripotent stem cells (iPSCs) (Claim 1). Hochedlinger discloses that this method comprises inducing these cells to express reprogramming factors (e.g., Oct4, Sox2, Klf4, or c-Myc) (Claims 1 and 2; paragraph [0010]).
In regards to whether this overexpresses desmosome-related genes or epithelial cell differentiation genes, Applicant should note that overexpression of these genes is a natural consequence of performing the method steps of claim 1. Therefore, since the claim suggests that inducing a non-pluripotent cell to express a reprogramming factors is sufficient to cause overexpression of desmosome-related genes or epithelial cell differentiation genes, and since Hochedlinger carries out these steps the iPSCs as disclosed by Hochedlinger would express these genes absent evidence to the contrary.
Indeed, as evidenced by An, Oct4 overexpression itself during reprogramming of non-pluripotent cells to pluripotent cells in fact results in increased expression of Dsp (desmoplakin) (Figure 2E, p451); while as evidenced by Velychko, Oct4, Sox2, Klf4, and c-Myc reprogramming results in overexpression of Evpl (eviplakin) (Oct4 Overexpression Diverts Cells from a Direct Route to Pluripotency, p744; Figure 6C, p747).
In regards to claims 2 and 4, Hochedlinger discloses that iPSCs can be further differentiated into other cell types (paragraphs [0071, 0099]). It is noted that Hochedlinger achieves reprogramming of non-pluripotent cells by conditional expression in the presence of doxycycline (and that during differentiation doxycycline is removed (Fig. 3; paragraph [0040]). As a result, expression of Oct4 is significantly reduced (to near 0 relative expression, and is thus restricted) in these cells (Fig. 3C, paragraph [0040]). While Hochedlinger is silent as to the expression of Sox2, Klf4, or c-Myc in the absence of doxycycline, as their expression is dependent on the presence of doxycycline, a person of ordinary skill in the art would have recognized that their expression would also be similarly reduced or eliminated in the absence of doxycycline.
In regards to “then reducing the desmosome-related genes or epithelial cell differentiation genes”, as above, this is the result of cessation of Oct4, Sox2, Klf4, or c-Myc. As evidenced by An, Dsp levels are relatively reduced compared to Dox-Oct4 stimulated cells (Figure 2E, p451), while as evidenced by Velychko, Evpl is also relatively lower without dox-induced expression of Oct4, Sox2, Klf4, or c-Myc (Oct4 Overexpression Diverts Cells from a Direct Route to Pluripotency, p744; Figure 6C, p747).
Therefore, Hochedlinger anticipates the invention as claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Maherali et al. (Cell Stem Cell, 2008).
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH (PAUL) MIANO whose telephone number is (571)272-0341. The examiner can normally be reached Mon-Fri from 8:30am to 5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Doug) Schultz can be reached at (571) 272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH PAUL MIANO/Examiner, Art Unit 1631
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