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 .
Claims 1-17 are pending.
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 1-13 and 16-17 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.
Claims 1-13 and 16-17 are indefinite over the preamble of “processing degree in a food sample”. The claims are not clear as it is not clear what “degree” is attempting to encompass as the claims do not recite the type of degree. Furhtermore, the claims do not require any practical steps of identifying “degree”.
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 14-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to fragments of naturally occurring structure (primers) 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 found in nature. The native nucleotide sequence is a product of nature and is not patentable.
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.
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. 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).
Here, the fragments are nucleotide sequences that represent a variety of seafood species..
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.
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.
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) 1-6,10-17 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Abbadi et al. (J Sci Food Agric 2017 Vol 97 p. 512-519) in view of Dieffenbach (PCR methods and Applications (1993) volume 3, pages S30-S37), Roux et al(PCR Methods and Applications (1995) volume 4, pages s185-s194).
With regard to claim 1, Abbadi et al. teaches a method of isolating DNA (p. 513 1st column last paragraph). Abbadi et al. teaches amplifying fragments (at least 2) using primers pairs to detect the 16S region of Veneridae, Ostreidae, Pectinidae, Mytilidae (p. 513 1st column last para and p. 514-515). Therefore Abbadi et al. teaches the method of detecting the target region of 16S in the recited targets, however, Abbadi et al. does not teach the specific sequences.
With regard to claim 3, Abbadi et al. teaches a method of using 4 primer sets.
With regard to claims 5-6, Abbadi et al. teaches comparison to a reference library of the 16s regions (p. 514 1st parpaghra). Abbadi et al. does not teach the specific recited sequences.
With regard to claim 10, Abbadi et al. teaches detection of Tapes decussatus, Ruditapes philippinarum, Meretrix meretrix, Meretrix lyrate, Chamelea galina, and Venus verrucosa (Table 1).
With regard to claim 11, Abbadi et al. teaches detection of Crassostrea gigas (Table 1).
With regard to claim 12, Abbadi et al. teaches detection of Flexopecten glaber, Aeqipecten opercularis (table 1).
With regard to claim 13, Abbadi et al. teaches detection of Mytilus galloprovincialis, Mytilus edulis, and Mytilus chilensis (table 1).
With regard to claims 14-15, Abbadi et al. teaches fragments (at least 2) using primers pairs to detect the 16S region of Veneridae, Ostreidae, Pectinidae, Mytilidae (p. 513 1st column last para and p. 514-515). Therefore Abbadi et al. teaches primers that detect the target region of 16S in the recited targets, however, Abbadi et al. does not teach the specific sequences. Further, the term “library” does not provide any structure other than the primer sequences recited.
With regard to claims 1, and 15, the prior art teaches that these would be well known, Dieffenbach and Roux et al. teach constraints to designing oligonucleotides. Dieffenbach teaches parameters and principles of promoter design include primer length, terminal nucleotide, GC content, melting temperature, PCR product length, and placement of target sequence (s30-s34). Dieffenbach teaches PCR software was known (s35).
With regard to claims 2, 4, and 16-17, Dieffenbach et al. teaches the design of length and an amplification and the PCR conditions (p. S31). Although Dieffenbach does not teach the exact requirements recited in the claims, the amplification length and PCR conditions are routine optimization method steps for PCR analysis of a known target. As such these constraints are considered well within the ordinary artisans ability to modify in order to optimize detection of the targets.
Roux teaches optimization of PCR by the presence of enhancing agents, Mg2+, annealing temperature, primer design, cycle number, hot start PCR (s185-s194).
Designing oligonucleotides to hybridize to specific targets, which are equivalents to those taught in the art is routine experimentation. The prior art teaches the parameters and objectives involved in the selection of oligonucleotides that function as primers, see Dieffenbach and Roux. The prior art is replete with guidance and information necessary to permit the ordinary artisan in the field of nucleic acid detection to design primers. As discussed above, the ordinary artisan would be motivated to have designed and tested oligonucleotides from 16s region to obtain additional oligonucleotides that function to detect expression and identify oligonucleotides with improved properties for such detection of the species. Thus, for the reasons provided above, the ordinary artisan would have designed additional oligonucleotides using the teachings in the art at the time the effective filing date including oligonucleotides that comprise the primers pairs for each gene. As such the recited oligonucleotides are obvious over the cited prior art, absent secondary considerations
Claim(s) 7-9 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Abbadi et al. (J Sci Food Agric 2017 Vol 97 p. 512-519) Dieffenbach (PCR methods and Applications (1993) volume 3, pages S30-S37), Roux et al(PCR Methods and Applications (1995) volume 4, pages s185-s194) as applied to claims 1-6,10-17 and in view of Berry et al. (Ecology and Evolution 2017 Vol. 7 p. 5435).
Abbadi et al. teaches a method of isolating DNA (p. 513 1st column last paragraph). Abbadi et al. teaches amplifying fragments (at least 2) using primers pairs to detect the 16S region of Veneridae, Ostreidae, Pectinidae, Mytilidae (p. 513 1st column last para and p. 514-515). Therefore Abbadi et al. teaches the method of detecting the target region of 16S in the recited targets, and the combining of Dieffenbach and Roux teaches absent secondary considerations that the design of primers within this know target region is routine and conventional.
However Abbadi et al. does not teach further detecting the 16S regions in crustacean, cephalopod and Gastropoda.
With regard to claim 7, Berry et al teaches primers for the detection of the 16S regions of crustacean (p. 5437). Berry et al. teaches that this detection includes Panulirus cygnus (table A8).
With regard to claim 8, Berry et al teaches primers for the detection of the 16S regions of Cephalopod (p. 5437). Berry et al. teaches that this detection includes Notododarus sloanii (table A8).
With regard to claim 9, Berry et al teaches primers for the detection of the 16S regions of Gastropod (p. 5442 1st column). Berry et al. teaches that this detection includes all species that would be presence (p. 5442)
Therefore it would be prima facie obvious at the time of the effective filing date absent secondary conditions to modify the method of Abbadi et al, Dieffenbach, and Roux to screen any known 16S species of seafood including those taught by Berry et al to further screen known targets for detection of the presence in a sample.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Cheng (Winston) Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/ Primary Examiner, Art Unit 1682
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