DETAILED ACTION
Status of the Claims
Claims 1-15 are currently pending and are examined herein.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Please note that the new examiner of record is Jeremy C. Flinders.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 11/18/2022 and 05/06/2024 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner.
Restriction Requirement
The requirement for species elections of 11/13/2025 is withdrawn.
Claim Interpretation
As per MPEP § 2111 and § 2111.01, during patent examination, the pending claims must be interpreted as broadly as their terms reasonably allow while being consistent with the specification. The words of a claim must be given their ‘plain meaning’ unless such meaning is inconsistent with the specification, wherein ‘plain meaning’ of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the relevant time. The ordinary and customary meaning of a term may be evidenced by a variety of sources, including the words of the claims themselves, the specification, drawings, and prior art. Because applicant has the opportunity to amend the claims during prosecution, giving a claim its broadest reasonable interpretation will reduce the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Yamamoto, 740 F.2d 1569, 1571 (Fed. Cir. 1984)
Below are notes made by the examiner regarding claim interpretation of the most recent set of claims. Applicant is respectfully invited to comment on or dispute any of these statements.
Claim 1 has been amended to comprise an endonuclease and that “the endonuclease comprises DNaseI or SAN” and also recites that “the final concentration of the DNaseI in the enzyme reaction solution is 0.005 to 0.01 U/μL” and that “the final concentration of the SAN in the enzyme reaction solution is 0.005 to 0.01 U/μL”. Therefore, the claim is being interpreted to require both DNaseI and SAN. By similar reasoning, the claim is also being interpreted to also require each of Taq DNA polymerase, T4 DNA polymerase, E. coli DNA polymerase I, T4 polynucleotide kinase (T4 PNK), Bovine serum albumin (BSA), and T4 bacteriophage single-stranded DNA binding protein (Gp32 SSB). Claims 2-15 depend from claim 1 and therefore also require these limitations.
Also, it is noted that claim 1 recites “the final concentration of the dNTPs in the enzyme reaction solution is 0.05-0.5 mM; the final concentration of the dATP in the enzyme reaction solution is 0.1-1 mM”. In the context of the claim, dATP is being interpreted as one of the dNTPs, however, it is noted that the concentration ranges allow for the concentration of dATP to be greater than the concentration of the total dNTPs, which is not reasonably possible.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “the final concentration of the Na2+ in the enzyme reaction solution is 5-25 mM”, however, sodium ion is monovalent and should be Na+.
Appropriate correction is required.
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 1-11 and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more.
Claim 1 recites an enzyme reaction solution defined by the presence of several proteins, salts, and buffers, with given concentration ranges. Specifically, the claim requires all of the following proteins:
DNase I endonuclease
Salt Activated Nuclease (SAN) endonuclease
Taq DNA polymerase
T4 DNA polymerase
E. coli DNA polymerase I
T4 polynucleotide kinase (T4 PNK)
Bovine serum albumin (BSA), and
T4 bacteriophage single-stranded DNA binding protein (Gp32 SSB)
Note that each of these protein names encompass proteins that are naturally occurring, and therefore the claim recites “products of nature”, which is a judicial exception, as per MPEP 2106.04(b).
Next, any combination of these proteins in the claims must be analyzed in Prong One of Step 2A for any markedly different characteristics arise from mixing them. In the present claim, there is no reasonably expected markedly different characteristic that inherently results in claiming the proteins together, nor do the recited concentration ranges reasonably introduce any markedly different characteristics, at least because the proteins are all expected to have similar or essentially the same structure and functionality as compared to their counterparts in nature, absent factual evidence to the contrary. Nor does the presence of the naturally occurring, recited salts and NTPs at their recited concentrations reasonably impose any markedly different characteristics to the proteins, noting that such salts and NTPs are often added specifically to enable biomolecules to have similar or essentially the same structure and function as found in nature. This is analogous to the court’s decision in Funk Bros., 333 U.S. at 130-31, 76 USPQ2d at 281-82, cited in MPEP 2106.04(b) and 2106.04(c), wherein a mixture of natural products (e.g. differing bacterial species), whose mixture is not known to exist in nature, is still deemed not patent eligible since there are no markedly different characteristics of the species in the mixture as compared to the individual species in isolation. The same analysis leads to a similar conclusion here, since the mere claiming together of the present composition does not reasonably and necessarily impart markedly different characteristics to the components of the system when they are claimed together.
Note that the claim also recites Tris and HEPES buffers at specific concentration ranges, however, while not being naturally occurring, they do not make the claim patent eligible. See MPEP 2106.04(c)(I)(A), which states:
Where the claim is to a nature-based product in combination with non-nature based elements (e.g., a claim to "a yogurt starter kit comprising Lactobacillus in a container with instructions for culturing Lactobacillus with milk to produce yogurt"), the markedly different characteristics analysis should be applied only to the nature-based product limitation. For instance, for the yogurt starter kit example, the Lactobacillus would be analyzed for markedly different characteristics. The container and instructions would not be subject to the markedly different characteristics analysis as they are not nature-based products, but would be evaluated as additional elements in Prong Two (and Step 2B if needed) if it is determined that the Lactobacillus does not have markedly different characteristics from any naturally occurring counterpart and thus is a product of nature exception.
The presently recited buffers correspond to the instructions and container of this example, and only need be considered as potential “additional elements”, as below.
Therefore, it can be reasonably concluded that the analysis for patent eligibility fails Prong One of Step 2A, and the claim must be further analyzed in Step 2A Prong Two and Step 2B to determine whether the claim as a whole integrates the exception into a practical application or there are additional elements that amount to significantly more than the judicial exception. Relevant considerations for evaluating whether additional elements integrate a judicial exception into a practical application, based on the Supreme Court and Federal Circuit, are discussed at length in MPEP 2106.04(d) and in the Federal Register (Vol. 84, No. 4, from January 7, 2019). In the present case, the only “additional elements” present in the claim are Tris and HEPES buffers, neither of which are naturally occurring, however, they are constitute routine, conventional, and well-understood elements and are designed to enable biomolecules to exist in similar or essentially the same structure and function as in nature, such that they cannot transform the claim into something patent eligible, even when considered in combination with the proteins and salts recited, absent factual evidence to the contrary. See MPEP 2106.04(d).
Claims 2-11 merely recite combinations of these proteins, salts, NTPs, and buffers at various concentrations, along with glycerol. Note that glycerol is naturally occurring and its inclusion in the mixtures would not reasonably affect any of the other components so as to introduce any markedly different characteristics. Therefore, these claims are also patent ineligible.
Claim 15 recites a kit comprising the components of claim 1 and “any one or a combination of at least two of a sequencing adaptor, a ligation reaction reagent or a PCR reagent.” Note that a common PCR reagent includes potassium, for example, in the form of KCl, which like the other salts of claim 1 would not make the subject matter be patent eligible.
For further information, please see the latest revision of MPEP § 2104-2106 {Patent Subject Matter Eligibility Under 35 U.S.C. 101}, including MPEP § 2106.04 {Eligibility Step 2A: Whether a Claim is Directed to a Judicial Exception} and 2106.05 {Eligibility Step 2B: Whether a Claim Amounts to Significantly More}, as well as any additional guidance on Subject Matter Eligibility, provided on the USPTO website at
https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEREMY FLINDERS whose telephone number is (571)270-1022. The examiner can normally be reached M-F 10-6:00 EST.
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/JEREMY C FLINDERS/
Primary Examiner, Art Unit 1684
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