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 .
Response to Amendment
The amendment filed 04/27/2026 overcomes all rejections made in the Office action mailed 04/27/2026. Claims 1-4, 6-14, 16-17, 19-24, 28, 32, 45-50 are in condition for allowance. However, upon further consideration, claim 39 is rejected on new grounds as set forth below. Because this rejection could have been made prior to the amendment, it is not necessitated by the amendment and this action is therefore NON-FINAL.
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.
Claim 39 is 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) primers, which broadly encompass fragments of naturally occurring polynucleotides. As discussed at MPEP 2106.04(b)(I), “primers” that include fragments of naturally occurring polynucleotides are not patent-eligible unless they are “markedly different” than their nature-based counterparts; see University of Utah Research Foundation v. Ambry Genetics Corp., 774 F.3d 755, 761, 113 USPQ2d 1241, 1244 (Fed. Cir. 2014). This judicial exception is not integrated into a practical application because there are no additional elements recited in the claim other than the primers. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as just explained, there are no additional elements recited in the claim other than the primers.
The claimed kit comprises a first, second, and third RT primer sets, each of which can consist of one primer. As these primers are not limited in sequence, there are countless fragments of natural polynucleotides that could be used as an “RT primer”. Even if the RT primers were limited to those suitable for reverse transcribing TCR mRNA, there are many possible subsequences of natural TCR-encoding sequences that could function as “RT primers”. Therefore, these claimed primers encompass fragments of naturally-occurring polynucleotides.
The kit also comprises a set of TCR alpha chain amplification primers and a set of TCR beta chain amplification primers comprising SEQ ID NO 97 and 98, respectively. Each of these sets can consist of a single primer. SEQ ID NOs 97 and 98 are fragments of the natural TCR alpha and beta encoding genes, respectively, as evidenced by the following sequence alignments:
SEQ ID NO 97:
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228
1582
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Greyscale
SEQ ID NO 98:
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218
1576
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Greyscale
Finally, the claimed kit comprises “a first set of TCR amplification primers” (which can consist of a single primer) comprising SEQ ID NO 96. However, in the context of the present invention, the language “TCR amplification primers” does not mean the primer is specific for or derived from the TCR genes. Instead, it is simply a primer designed to be identical to all or a portion of a “template switch oligonucleotide”, or TSO, used in synthesizing first strand cDNA. Any arbitrary sequence can be used as a TSO, and a primer comprised of all or a portion of such TSO would function as the claimed “first set of TCR amplification primers”. Therefore, if SEQ ID NO 96 is found within a naturally occurring polynucleotide, this claim element would also encompass a nature-based product and be patent-ineligible. Indeed, SEQ ID NO 96 is found within a naturally occurring polynucleotide, in at least the genome of Apteryx mantelli:
SEQ ID NO 96:
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252
1578
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Greyscale
Consequently, all recited elements of the claimed kit encompass fragments of naturally-occurring polynucleotide and are therefore patent-ineligible subject matter under 35 USC 101.
Conclusion
Claims 1-4, 6-14, 16-17, 19-24, 28, 32, 45-50 are allowed. Claim 39 is rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C WOOLWINE whose telephone number is (571)272-1144. The examiner can normally be reached 9am-5:30pm.
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/SAMUEL C WOOLWINE/ Primary Examiner, Art Unit 1681
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