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
In view of applicants’ arguments regarding the teachings of the Chen et al. and Hexner and the amendment of the product claims to include that the cell is immortalized, the restriction requirement as set forth in the Office action mailed on Nov. 12, 2025 is hereby withdrawn.
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 1-4, 6-8, 10-12, and 19-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The claim(s) recite(s) a human erythroid progenitor cell lines, with at least 90% of cells that are CD36+ CD44- CD71+ and they express the GM-CSF-R gene at lower level than the cells of the human UT-7/EPO-S1 cell line; they express the gene encoding the EPO-R gene and the cell line is immortalized. This judicial exception is not integrated into a practical application because the claim only includes a cell line (“cell line” is defined as a population of cells with a theoretically unlimited capacity for division – specification, pg. 6, ll. 20), therefore, at least 2 cells that meet the claimed limitations.
The cell line is not substantially different from its naturally-occurring counterpart. The claimed cell line is derived from a naturally occurring product – a human leukemic cell. The cell line applicants have developed is a subset of the UT-7/GM cell line. While it appears that the inventors have pulled out a cell population/cell line that was not previously recognized by the art in its claimed format (e.g. applicants have isolated a subset that does not appear to have been previously isolated), that isolation does not distinguish the cell line from its naturally occurring counterpart. As explained by Komatsu (Blood, 1993), UT-7/Epo was a cell line formed from a subset of UT-7 cells. (whole doc, abstract). Furthermore, as taught by de Jong et al. (Stem Cells, 1997) erythropoietin reception and GM-CSF receptors are expressed in hemopoietic cells (erythroid precursors) as these progenitor cells mature and delineate toward their eventual differentiated state. (whole doc, abstract)
Although the claim recites “a cell line,” this limitation is not enough to distinguish the at least two cells that would express the claimed parameters. even though the claimed “cell line” does not occur in nature, this is not enough to distinguish the claimed cell population from its naturally occurring counterpart. This is analogous to the contention rejected by the Supreme Court in Funk Bros. Seed Co. v. Kalo Inoculant Co.. 333 U.S. 127, 131 (1948), where the court held that even though the combination of bacteria did not occur in nature, the combination [of bacteria] did not provide a different structural or functional characteristic than each bacteria possessed on its own.
"It is no more than the discovery of some of the handiwork of nature and hence is not patentable. The aggregation of select strains of the several species into one product is an application of that newly-discovered natural principle....Each species has the same effect it always had. The bacteria perform in their natural way.” Id.). In the instant situation if "bacteria" is replaced with “cell,” the same reasoning applies. In selecting a subpopulation from the UT-7/EPO-S1 cell line (a human leukemic cell line), applicants have selected a subpopulation of cells within a naturally occurring cell population. While this subpopulation of cells may work as a therapeutic product, it does not overcome the assertion that the claimed product is not markedly different from what is found in nature.
In the cell line, each cell functions the same as it would when not aggregated – each cells’ function (and structure) is the same in the aggregate as it is singly. As such, the aggregation is analogous to the naturally-occurring bacterial group in Funk Bros., which the Supreme Court found to be patent ineligible subject matter.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because only the “cell line” is claimed – the rejected dependent claims merely recite additional limitations that further define the cells, not add additional elements. It is further noted that cell cycle markers (claim 8 can be naturally occurring).
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 13-16 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. The claims recite “methods for producing parvovirus B19” (claims 13 and 14), “method for detecting infectious parvovirus B19” (claims 15 and 16), but fail to recite any method steps. Rather they recite “using the cell line of claim 1”. It is unclear, in each of these cases, what the “use” would entail, which renders the claims indefinite. Method claims must recite actual steps that can be undertaken. Could the cells be “used” merely by being cultured as cells? What concrete steps must be undertaken with the cells to meet the preamble’s stated therapeutic purpose? Applicants are encouraged to re-write these claims to clarify specific steps that enable the “use” of the cells to achieve this.
Conclusion
Claims 9, 20 and 21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, as each of these claims require a non-naturally occurring cell cycle indicator.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA E KNIGHT whose telephone number is (571)272-2840. The examiner can normally be reached Monday-Friday 9-4.
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/TERESA E KNIGHT/ Primary Examiner, Art Unit 1634