DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, provisional application Nos. 60/530,042 (‘042) and 60/525,612 (‘612), fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claim 10-16 recite directly or by dependency “an exogenously introduced polynucleotide encoding Sox2 or Nanog” that is not expressly or implicitly described by ‘042 or ‘612. As such, claims 10-16 are not granted priority to their effective filing date. As such, the effective filing date of claims 10-16 is 11/24/2004.
Claim Objections
Claim 1 is objected to because of the following informalities: line 1 recites, “transfecting a cDNA library prepared from a pluripotent cell to a somatic cell”. This is grammatically incorrect and awkward. Amending the recitation to state “transfecting a somatic cell with a cDNA prepared from a pluripotent cell”, would be remedial. Appropriate correction is required.
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 1-16 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.
Claim 1 recites, “(ii) selecting cells that express a selectable marker”. The claims recites multiple cells (i.e. somatic cells; pluripotent cells)”. As such, this recitation lacks sufficient antecedent basis and is indefinite because it is not apparent to which cells this step refers.
Further, claim 1 recites, “(iii) assessing expression of an endogenous pluripotency gene”. However, the recitation does specify what is specifically being assessed. Expression in somatic cells, pluripotent cells, something else? As such, this recitation also is indefinite because it does not distinctly define the entity being assessed.
Further, claim 1 recites, “the cDNA encodes a protein whose expression in the cell”. This recitation also lacks sufficient antecedent basis. First, “the cDNA” lacks sufficient antecedent basis and is indefinite because the prior recitation is to “a cDNA library”. A cDNA library is has many cDNAs present. As such, which cDNA in the library is “the cDNA” as recited. Also “the cell” lacks antecedent basis and is indefinite because which of the multiple cells recited in the claim is “the cell”.
For purposes of identifying relevant prior art, claim 1 will be interpreted as “A method for identifying a gene that causes expression of at least one endogenous pluripotency gene in somatic cells comprising: (i) preparing a cDNA library from a pluripotent cell; (ii) transfecting somatic cells with the cDNA library to produce transfected somatic cells, wherein the somatic cells comprises a nucleic acid encoding selectable marker operably linked to an endogenous pluripotency gene; (iii) selecting the transfected somatic cells expressing the selectable marker to produce selected somatic cells expressing the selectable marker; and (iv) assessing expression of the endogenous pluripotency gene in the selected somatic cells, wherein expression of the endogenous pluripotency gene in the selected somatic cells indicates at least one of the cDNAs present in the cDNA library causes expression of the endogenous pluripotency gene in the selected somatic cells.
Claims 2-16 dependent upon independent claim 1 and therefore also comprises the above discussed indefinite subject matter.
Claim 5 recites, “the somatic cell does not comprise a selectable marker”. However its base claim recites in (ii) “selecting cells that express a selectable marker”. How can a cell be selected by its expression of a selectable marker and not comprise a selectable marker at the same time? Thus, claim 5 is indefinite because the intended meaning is not apparent.
Relevant Prior Art
The closest prior art is Nakatsuji (US2005/0130144 A1 effective filing date: 9/21/2001). Nakatsuji teaches a method for screening for an agent which reprograms somatic cell nuclei (i.e. a method that causes the expression of at least one endogenous pluripotent gene in somatic cells). The method can be achieved by exposing appropriate somatic cells to a component derived from ES cells (i.e. a component derived from a pluripotent cell and contacting a somatic cell with said component), detecting an activity of the component which reprograms the somatic cells and selecting the component which reprograms the somatic cells ([0022]). A reprogramming agent can be screened as follows. Components derived from ES cells are caused to act on somatic cells by means of contact, injection, or the like. The action is detected based on the expression of a Oct-GFP marker gene (i.e.- selecting cells that express a selectable marker), the activation of the X chromosome, or the as an indicator for reprogramming. A component having reprogramming activity is selected ([0024]). Nakatsuji does not teach that the method is identifying a gene that causes expression of at least one endogenous pluripotency gene specifically and does not teach that the component is specifically a cDNA library derived from a pluripotent cell that is specifically transfected into a somatic cell and specifically assessing expression an endogenous pluripotency gene caused by said transfection. As such, the claims are free of the prior art.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA STEPHENS NOBLE whose telephone number is (571)272-5545. The examiner can normally be reached M-F 9-5:30.
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MARCIA S. NOBLE
Primary Examiner
Art Unit 1632
/MARCIA S NOBLE/Primary Examiner, Art Unit 1632
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