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 .
This action is in response to papers filed 4/30/2026.
Claims 1, 3-4,6-7,10-13,15,40,53,56,57,60-61,74,147,156 are pending. Claims 2, 5,8-9,14,16-39,41-52,54-55,58-59,62-73,75-146,148-155,157-167 have been cancelled.
The following rejections are maintained with response to arguments following.
This action is FINAL.
Withdrawn Objection and Rejections
The objection to the claims made in the previous office action is withdrawn based upon the amendments to the claims.
The 35 USC 112b rejection made in the previous office action is withdrawn based upon cancellation of claim 2.
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, 3-4,6-7,10-13,15,40,53,56,57,60-61,74,147,156 are rejected under 35 U.S.C. 101 because the claimed invention is directed to product of nature without significantly more. The claim(s) recite(s) composition that can encompass oligonucleotides which represent fragments of naturally occurring nucleic acids. This judicial exception is not integrated into a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the structures do not include anything other than a component that is found in nature. The recitation samples encompasses fragments of products of nature.
35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106.
Regarding judicial exceptions, “[p]phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106, part II. The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2116, (2013).
The claimed invention is directed to naturally occurring fragments of a naturally occurring nucleic acids as the claims encompass fragments of the samples that are naturally occurring. These molecules are not patent eligible, whether isolated or not, pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics Inc., US (June 13, 2013). The Supreme Court has made clear "separating [DNA] from surrounding genetic material is not an act of invention" Myriad, 133 S. Ct. at 2117. This judicial exception is not integrated into a practical application because they convey the same genetic information as their naturally occurring counterparts. In Myriad v. Ambry CAFC 2014-1361,1366, December 17, 2014, the CAFC further (regarding a claim directed to a pair of primers) stated “In fact, the naturally occurring genetic sequences at issue here do not perform a significantly new function. Rather, the naturally occurring material is used to form the first step in a chain reaction—a function that is performed because the probe or primer maintains the exact same nucleotide sequence as the relevant portion of the naturally occurring sequence. One of the primary functions of DNA’s structure in nature is that complementary nucleotide sequences bind to each other. It is this same function that is exploited here—the probe hybridizes to its complementary nucleotide sequence. Thus, just as in nature, probes utilize the innate ability of DNA to bind to itself.”
Response to Arguments
The reply traverses the rejection. A summary of the arguments made in the reply is provided below with response to arguments following. The reply asserts that the stopper oligonucleotide requires to have a stem loop region which would not be present in simply fragmented DNA and therefore the mixture of materials in not found in nature (p 7). These arguments have been reviewed but have not been found persuasive.
The specification teaches that the stopper sequence is designed to comprise a hairpin with stem complementary to a region of the target (p. 13). As such there is no structure recited in the claims that would be more than the nucleotides that are represented by naturally occurring structures. A hairpin structure can be found in nature and there is no structure that limits the claimed composition to that which is found in nature. The intended use of the composition for forming a chimeric amplicon does not alter the structure in such a way that it differs from nucleic acids of nature.
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.
Claim(s) 1, 3-4,6-7,10-13,15,40,53,56,57,60-61,74,147,156 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhou et al. (WO2015/081229 June 4, 2015 cited on the IDS).
With regard to claims 1, 74, Zhou et al. teaches a common primer oligonucleotide (p 16 lines 30-45). Zhou et al. further teaches an omega primer (p 16 lines 1-5). The term “stopper” does not provide any particular structure of the oligonucleotide other than the structure is recited. Further the terms first, second loop, third and fourth do not provide any particular structure of the oligonucleotide structure. As such any nucleotides of the oligonucleotide can be described as these particular sequence. Zhou et al. teaches a sequence that includes a region with a length wherein there is a region of a first and second and a third and fourth sequence that can be hybridized to the target or to each other (figure 1). Zhou et al. further teaches a loop sequence (figure 1). Zhou there for teaches the claimed stopper sequence (see figure 1B, 4a, p. 11-p. 12 and p. 25). Zhou et al teaches length of the omega primer (stopper) that would encompass regions that are within the nucleotide lengths of the combination of the sequences (p. 13). As noted the use of first, second, loop, third and fourth do not provide any structural limitations of the entirety of the oligonucleotide.
With regard to claim 3, Zhou et al. teaches use of a target (p. 9 lines 10-15).
With regard to claim 4, Zhou et al. teaches a region that binds and that there is also a region that matches to the oligonucleotides (p. 11-12 and Figure 1).
With regard to claims 6-7, Zhou et al. teaches template dependent polymerase enzymes and reagents and buffers (p. 11 lines 1-30).
With regard to claims 10 and 12-13, Zhou et al. teaches a hairpin structure which would be considered noncomplementary (p. 11-12 and figure 1).
With regard to claim 11, the fifth, sixth sequences re only defined by positions relative to other sequences and as such a single nucleic pair could be considered the fifth and sixth sequence of the omega probe (stopper) taught by Zhou.
With regard to claim 15, Zhou et al. teaches a 3’ OH end (p. 6 lines 40-45).
With regard to claims 40 and 53, 61, Zhou et al. teaches multiple oligonucleotides (stoppers) and primers (p. 48 lines 25-35 and figure 2).
With regard to claims 56-57, 60, Zhou et al. teaches multiple primers (p. 48 lines 25-35) and these primers would have 3’ regions.
With regard to claims 147 and 156, Zhou et al. teaches methods of generating chimeric amplicons (p 1). Zhou et al. teaches a common primer oligonucleotide (p 16 lines 30-45). Zhou et al. further teaches an omega primer (p 16 lines 1-5). The term “stopper” does not provide any particular structure of the oligonucleotide other than the structure is recited. Further the terms first, second loop, third and fourth do not provide any particular structure of the oligonucleotide structure. As such any nucleotides of the oligonucleotide can be described as these particular sequence. Zhou et al. teaches a sequence that includes a region with a length wherein there is a region of a first and second and a third and fourth sequence that can be hybridized to the target or to each other (figure 1). Zhou et al. further teaches a loop sequence (figure 1). Zhou there for teaches the claimed stopper sequence (see figure 1B, 4a, p. 11-p. 12 and p. 25). Zhou et al teaches length of the omega primer (stopper) that would encompass regions that are within the nucleotide lengths of the combination of the sequences (p. 13). As noted the use of first, second, loop, third and fourth do not provide any structural limitations of the entirety of the oligonucleotide. Zhou et al. teaches a method of mixing template depending polymerase with this composition and incubating by performing a PCR (11-12).
Response to Arguments
The reply traverses the rejection. A summary of the arguments made in the reply is provided below with response to arguments following. The reply asserts that the claims require two distinct oligonucleotides of a primer and a stopper that are separate from each other and perform different roles (p. 8). The reply asserts that the stopper requires a second and third sequence that are complementary to form a stem separated by a loop whereas the primer of Zhou includes a looped structure (p. 9). The reply asserts an ordered mapping of the regions whereas Zhou does not teach the claimed spatial and functional coordination between the stopper and primer (p. 9). The reply asserts that the claimed stopper is not a primer variant (p. 9). These arguments are reviewed but have not been found persuasive.
The claims do not require two oligonucleotides but rather require a composition comprising a primer oligonucleotide and a stopper oligonucleotide. As such the claims do not limit the claims to distinct structures but rather these oligonucleotides can be encompassed on the same length of the composition. The reply provides that Zhou does not claim the spatial and functional correlation between the stopper and primer. However, the claims do not require any functionality other than the intended use of forming a chimeric amplicon of a target, which Zhou et al would be capable of. Further there is no spatial requirements of the primer and the topper other than the lengths of nucleotides which would be contingent on labeling structures of strand of nucleotide. As such the claims are maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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