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 .
The examiner prosecuting this application has changed. Please direct all future correspondences to Katherine Salmon.
This action is in response to papers filed 3/24/2026.
Claims 1,6-7, 47-48, 50, 54, 56, 61-62, 66, 70-71, 74-75, 80, 83, 85, 91-92 are pending.
Claims 2-5, 8-46, 49, 51-53, 55, 57-60, 63-65, 67-69, 72-73, 76-79, 81-82, 84, 86-90 and 93-95 have been cancelled.
The following rejections are newly applied.
This action is nonfinal.
Withdrawn Objections and Rejections
The objection to the drawings made in the previous office action is withdrawn based upon the entry of the drawings of 3/24/2026.
The objection to the specification made in the previous office action is withdrawn based upon the entry of the amendment to the specification of 3/24/2026.
The rejection of the claims over 35 USC 112a, 35 USC 101, 35 USC 112b and 35 USC 103 made in the previous office action is withdrawn.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 83, 85, 92 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a support, probe, templates ligase, polymerase and a label without significantly more. The claim(s) recite(s) broad claim language that is interpreted as the same structure as a product of nature. This judicial exception is not integrated into a practical application because the claims do not require a particular structure other than structures that can be found in nature.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, the claims read on the nucleotides and components, ns and enzymes found in nature. The native nucleotide sequence, enzymes, components or compositions are products of nature and is not patentable. Further the “support surface” is considered to encompass any surface including any found in nature.
Question 1
The claimed invention is directed to a naturally occurring product.
Question 2A – Prong 1
The claims are directed towards a naturally occurring product of a structure of nucleic acids (primers, oligos), compositions, components, enzymes.
MPEP 2106.04(b)(II) discusses products of nature. The MPEP specifically discusses DNA, primers and probes. The isolated DNA of Myriad and the primers of Ambry Genetics were described as products of nature by the courts. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature exception"). The Federal Circuit in Ambry reviewed “[t]he Supreme Court held ineligible claims directed to segments as short as 15 nucleotides, suggesting that even short strands identical to those found in nature are not patent eligible.”
In the instant case, the claims include naturally occurring genes, compositions and components, and enzymes. The court in Myriad held that “[a] naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated”. The court found that while Myriad had located and sequenced an important gene, Myriad had not created anything, and that “separating that gene from its surrounding genetic material is not an act of invention” (page 2118).
Accordingly, the claims are directed to judicial exceptions.
Question 2A – Prong 2
The judicial exceptions are not integrated into practical application because the claims do not recite additional elements that integrate the judicial exceptions into practical application of the exceptions.
Accordingly, claims are directed towards judicial exceptions.
Question 2B
The claims are directed to judicial exceptions with no additional limitations.
Thus, the claims do not recite additional elements that amount to significantly more than the judicial exceptions.
For those reasons, the claims are rejected under section 101 as being directed to non-statutory subject matter..
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1,6-7,47-48,50,54,66,70,74,80,85,91,92 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barry et al. (US Patent Application Publication 2019/0284616 September 19, 2019) .
With regard to claims 1 and 6-7, Barry et al. teaches a method of contacting a sample with a probe comprising a tag, comprising DNA and RNA (para 110-113). Barray et al. teaches an anchoring reagent with a DNA sequence and a RNA duplex and contacting a support surface, using RNas, and immobilizing comprising RCA (para 110-115). Although Barry et al. does not specifically teach the combination of RCA and ECL assays, Barry et al. suggests that ECL detection can be combined with RCA methodology that is adaptable to on chip signal amplificant (para 110-115).
With regard to claim 47, Barry et al. teaches support that has been considered a capture probe (para 110-115). Barry et al. teaches that this probe can comprise a quencher which would be considered a tag (para 110). Barry et al. teaches a template (para 115). Barry et al. teaches a ligase, polymerase and a label (para 98, 110, 115).
With regard to claim 48, Barry et al. suggests a probe attached to a solid support (e.g. anchoring) and that the probe can be labelled (para 127 and 138).
With regard to claim 50, Barry et al. suggest probes (e.g. anchoring) that can be about 30 (table 3).
With regard to claim 54, Barry et al. teaches a linear amplification template that comprises 5 and 3’ terminal nucleotide sequences (para 159). With regard the wherein clause, this appears to be the intended use of the template and as such as Barry et al. teaches the required structure it would be capable of the intended use.
With regard to claim 66, Barry et al. teaches a circular amplification template (para 114-115).
With regard to claim 70, as Barry teaches detection probes for RCA (para 114-115), the probe of Barry would comprise a first sequence complementary to the 5' terminal sequence of the amplification template and an adjacent second sequence complementary
to the 3' terminal sequence of the amplification template.
With regard to claim 74, Barry et al. teaches an ECL label (para 113).
With regard to claim 80, as Barry teaches oligonucleotides immobilized on a solid phrase support, these would be considered discrete regions.
With regard to claims 85 and 91, Barry et al. teaches support that has been considered a capture probe (para 110-115). Barry et al. teaches that this probe can comprise a quencher which would be considered a tag (para 110). Barry et al. teaches a template (para 115). Barry et al. teaches a ligase, polymerase and a label (para 98, 110, 115). Barry et al. suggests a probe attached to a solid support (e.g. anchoring) and that the probe can be labelled (para 127 and 138). Barry et al. suggest probes (e.g. anchoring) that can be about 30 (table 3). Barry et al. teaches a linear amplification template that comprises 5 and 3’ terminal nucleotide sequences (para 159). With regard the wherein clause, this appears to be the intended use of the template and as such as Barry et al. teaches the required structure it would be capable of the intended use. Barry et al. teaches a circular amplification template (para 114-115). Barry teaches detection probes for RCA (para 114-115), the probe of Barry would comprise a first sequence complementary to the 5' terminal sequence of the amplification template and an adjacent second sequence complementary to the 3' terminal sequence of the amplification template. Barry et al. teaches an ECL label (para 113).
With regard to claim 92, Barry et al. further teaches dNTPs (para 198).
16. Claim(s) 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barry et al. (US Patent Application Publication 2019/0284616 September 19, 2019) as applied to claims 1,6-7,47-48,50,54,66,70,74,80,85,91,92 and in view of Sood et al. (US Patent Application Publication 20040048300 March 11, 2004). .
Barry et al. teaches support that has been considered a capture probe (para 110-115). Barry et al. teaches that this probe can comprise a quencher which would be considered a tag (para 110). Barry et al. teaches a template (para 115). Barry et al. teaches a ligase, polymerase and a label (para 98, 110, 115). Barry et al. suggests a probe attached to a solid support (e.g. anchoring) and that the probe can be labelled (para 127 and 138). Barry et al. suggest probes (e.g. anchoring) that can be about 30 (table 3). Barry et al. teaches a linear amplification template that comprises 5 and 3’ terminal nucleotide sequences (para 159). With regard the wherein clause, this appears to be the intended use of the template and as such as Barry et al. teaches the required structure it would be capable of the intended use. Barry et al. teaches a circular amplification template (para 114-115). Barry teaches detection probes for RCA (para 114-115), the probe of Barry would comprise a first sequence complementary to the 5' terminal sequence of the amplification template and an adjacent second sequence complementary to the 3' terminal sequence of the amplification template. Barry et al. teaches an ECL label (para 113).
However, Barry et al does not teach a template that comprise a 5’ terminal phosphate group.
With regard to claim 56, Sood et al. teaches terminal phosphate blockers for use in nucleic acid amplification. Sood et al. teaches adding terminal phosphates during RCA for target detection (para 37).
Therefore it would be prima facie obvious to one of ordinary skill in the art to use a further structure of a terminal phosphate group of Sood et al in the template of Barry et al. in order to increase the sequence amplification of a known target.
17. Claim(s) 62 are rejected under 35 U.S.C. 103 as being unpatentable over Barry et al. (US Patent Application Publication 2019/0284616 September 19, 2019) as applied to claims 1,6-7,47-48,50,54,66,70,74,80,85,91,92 and in view of Lindegren et al. (US Patent Application Publication 2014/0170654 June 19, 2014) .
Barry et al. teaches support that has been considered a capture probe (para 110-115). Barry et al. teaches that this probe can comprise a quencher which would be considered a tag (para 110). Barry et al. teaches a template (para 115). Barry et al. teaches a ligase, polymerase and a label (para 98, 110, 115). Barry et al. suggests a probe attached to a solid support (e.g. anchoring) and that the probe can be labelled (para 127 and 138). Barry et al. suggest probes (e.g. anchoring) that can be about 30 (table 3). Barry et al. teaches a linear amplification template that comprises 5 and 3’ terminal nucleotide sequences (para 159). With regard to the wherein clause, this appears to be the intended use of the template and as such as Barry et al. teaches the required structure it would be capable of the intended use. Barry et al. teaches a circular amplification template (para 114-115). Barry teaches detection probes for RCA (para 114-115), the probe of Barry would comprise a first sequence complementary to the 5' terminal sequence of the amplification template and an adjacent second sequence complementary to the 3' terminal sequence of the amplification template. Barry et al. teaches an ECL label (para 113).
However, Barry et al does not teach a template that comprises SEQ ID No. 1668.
With regard to claim 62, Landgren et al teaches targets that can be used in probe based assays (abstract). Lindegren et al. taches that a template can include SEQ ID No 1668 in SEQ ID no 8 (para 315).
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the method of Barry et al. to use known templates such as those taught by Landgren et al.
18. Claim(s) 61,71,75,83 are rejected under 35 U.S.C. 103 as being unpatentable over Barry et al. (US Patent Application Publication 2019/0284616 September 19, 2019) as applied to claims 1,6-7,47-48,50,54,66,70,74,80,85,91,92 and in view of Fodor US Patent 6,582,908 June 24, 2003).
Barry et al. teaches support that has been considered a capture probe (para 110-115). Barry et al. teaches that this probe can comprise a quencher which would be considered a tag (para 110). Barry et al. teaches a template (para 115). Barry et al. teaches a ligase, polymerase and a label (para 98, 110, 115). Barry et al. suggests a probe attached to a solid support (e.g. anchoring) and that the probe can be labelled (para 127 and 138). Barry et al. suggest probes (e.g. anchoring) that can be about 30 (table 3). Barry et al. teaches a linear amplification template that comprises 5 and 3’ terminal nucleotide sequences (para 159). With regard to the wherein clause, this appears to be the intended use of the template and as such as Barry et al. teaches the required structure it would be capable of the intended use. Barry et al. teaches a circular amplification template (para 114-115). Barry teaches detection probes for RCA (para 114-115), the probe of Barry would comprise a first sequence complementary to the 5' terminal sequence of the amplification template and an adjacent second sequence complementary to the 3' terminal sequence of the amplification template. Barry et al. teaches an ECL label (para 113).
However, Barry et al does not teach the recited sequences for templates or probes.
However, these structures are considered fragments of known nucleic acid structures. With regard to claims 61,71,75,83 , Fodor et al. teaches a number of oligonucleotides which may be used as probes (Abstract). Fodor et al. teaches nucleic acid sequences hybridize to other sequences which are their complement, once the sequence of a gene is known, probes can be designed to specifically target that gene (Column 13, lines 40-45). Fodor et al. teaches an n-mer array comprise a solid support to which are attached all possible nucleic acid sequences of a given length (Column 17, lines 24-27). Because Fodor et al. teaches all possible 10-mers, Fodor et al. teaches an isolated nucleic acid that that is capable of hybridizing to at least 5 consecutive nucleotides in a 5’ to 3’ and a 3’ to 5’ direction of a 16s-23s ribosomal intergenic region nucleic.
Designing probes to hybridize to specific targets, which are equivalents to those taught in the art, is routine experimentation. The prior art teaches fragments that can represent probes (Fodor) to detect targets. Thus, for the reasons provided above, the ordinary artisan would have designed additional probes and templates using the teachings in the art at the time the invention was made. The claimed fragments of SEQ ID Numbers is obvious over the cited prior art, absent secondary considerations.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682
