Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the pre-AIA first to invent provisions.
Claims 1-2 are currently pending and under examination.
Information Disclosure Statement
The Information Disclosure Statements filed February 06, 2024; February 06, 2024; and February 06, 2024 have been considered.
Claim Rejections - 35 USC § 112
Claims 1 and 2 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.
Claim 1 is vague and indefinite for the following reasons:
In claim 1, the sequences listed do not indicate which nucleotides form a 5' end and which form a 3' end. Specifically, it is not clear whether a sequence KNNNKNKNK is 5' - KNNNKNKNK-3' or 3 ' - KNNNKNKNK- 5’.
Additionally, Claim 1 contains, in lines 4-5, improper Markush language. Thymidine/Uridine (T/U) and T/U which is improper since T and U are not the same, not synonyms, etc.
Claim 2 depends from claim 1 and is therefore included in this rejection.
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 and 2 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions (i.e., product of nature, a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Every claimed invention must be examined to determine whether the claimed invention complies with 35 U.S.C. 101, particularly whether the claimed invention falls within a 35 U.S.C. 101 judicial exception of non-patentable subject matter (e.g., an abstract idea, law of nature, natural phenomenon, natural product etc.). Phenomena of nature, though just discovered, natural products, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work. See MPEP 2106. As per the “2019 Revised Subject Matter Eligibility Guidance” (Federal Register Vol. 84, No. 4, available 01-07-2019), claims drawn to a process, machine, manufacture or composition of matter are further analyzed according to a two-part process to determine if A) the claim(s) is/are “directed to” a judicial exception because the claims(s) recite(s) a judicial exception (i.e. prong one) that is not integrated into a practical application (i.e. prong two) and, if so, if B) the claim(s) provide(s) an inventive concept, i.e. recite(s) additional elements that amount to significantly more than the judicial exception.
Subject Matter Eligibility Test for Products and Processes
Step 1 - Is the Claim to a Process, Machine, Manufacture or Composition of Matter? YES
Claims 1 and 2 are directed to one of the statutory classes. Claims 1and 2 are directed to a plurality of degenerate oligonucleotides comprising 9 random nucleotide sequences (product/composition of matter).
Step 2A, Prong One — Does the Claim Recite an Abstract Idea, Law of Nature, or Natural Phenomenon? YES
Claims 1 and 2 recite oligonucleotides comprising random 9 nucleotide sequences, therefore the claims are drawn to a plurality of oligonucleotides which have corresponding sequences occurring in nature. Claims directed to nothing more than abstract ideas, natural phenomena, and laws of nature are not eligible for patent protection (see MPEP 2106.04). Further, as stated in MPEP 2106.04(b) II: "When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature".
Step 2A, Prong Two — Does the Claim Recite an Additional Elements that Integrate the Judicial Exception into a Practical Application? NO.
The Supreme Court has long distinguished between principles themselves, which are not patent eligible, and the integration of those principles into practical applications, which are patent eligible. However, absent are any additional elements recited in the claim beyond the judicial exceptions which integrate the exception into a practical application of the exception. The “integration into a practical application” requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
The claim analysis continues with identifying additional elements beyond the judicial exceptions that might evidence integration of the judicial exceptions into a practical application. The judicial exception is not integrated into a practical application because the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
As stated in MPEP 2106.04(b) II: "When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". For example, 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., 133 S. Ct. 2107, 2116-17, 106 USPQ2d 1972, 1979 (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., 133 S. Ct. at 2116-17, 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"); Funk Bros. Seed Co. v. Kala Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and "phenomena of nature"). Step 2A of the Office's eligibility analysis uses the terms "law of nature" and "natural phenomenon" as inclusive of "products of nature".
The product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. See, e.g., Ambry Genetics, 774 F.3d at 760, 113 USPO2d at 1244 ("Contrary to Myriad's argument, it makes no difference that the identified gene sequences are synthetically replicated. As the Supreme Court made clear, neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible."). Thus, a synthetic, artificial, or non-naturally occurring product such as a cloned organism or a humanmade hybrid plant is not automatically eligible because it was created by human ingenuity or intervention. See, e.g., In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (cloned sheep); cf. J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int'l, Inc., 534 U.S. 130-132, 60 USPQ2d 1868-69 (2001) (hybrid plant). Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from any naturally occurring counterpart."
There are no further/additional steps which applies either the identified judicial exception into practical application. Thus, a careful evaluation of the claim as a whole fails to reveal the practical application of the judicial exception to, e.g., effect an improvement to the functioning of a computer or other technology/technical field, effect a particular treatment or prophylaxis for a disease or medical treatment, implement a particular machine that is integral to the claim, or effect a transformation or reduction of a particular article to a different state or thing, or to apply the judicial exception in another meaningful way beyond generally linking its use to a particular technological environment. Accordingly, the claims do not integrate the judicial exception(s) into a practical application and is therefore directed to a judicial exception.
Step 2B - Does the Claim Recite Additional Elements that Amount to Significantly More than the Judicial Exception? NO.
The Supreme Court has identified a number of considerations for determining whether a claim with additional elements amounts to “significantly more” than the judicial exception(s) itself. The claims as a whole are analyzed to determine whether any additional element/step, or combination of additional elements/steps, in addition to the identified judicial exception(s) is sufficient to ensure that the claim amounts to “significantly more” than the exception(s).
The eligibility analysis proceeds with identifying any additional elements or limitations, separate from the judicial exceptions, that might potentially render the claims directed to a judicial exception patent eligible. To render the claims patent- eligible, these elements must comprise meaningful limitations that add to or transform the judicial exception to the effect that it amounts to significantly more than the natural correlation or abstract idea itself - i.e. provide an “inventive concept’. This judicial exception is not integrated into a practical application because the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
As evidenced by Benson et al. (Nucl. Acids Res., vol. 35, pp. D21-D25, 2007; cited in the
IDS filed February 06, 2024), as of December 2006 GenBank had at least 1.45 x 1011 bp in sequences (page D21, third paragraph).Therefore, considering that the number of all possible 9mers is 49, or about 2.62 x 105 sequences, in 2007 GenBank already had all possible 9mers, which means that all of the sequences exist in nature. Therefore the claims recite a Law of nature without additional elements and the claims do not integrate the abstract idea into a practical application. The judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05). The claims therefore do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Accordingly, the claims do not qualify as patent-eligible subject matter.
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 the guidance on Subject Matter Eligibility, including the 2019 Guidance issued Jan. 7, 2019, and the October 2019 Update, provided on the USPTO website at https:/Awww.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter- eligibility.
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 pre-AIA 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.
Claims 1 and 2 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Grothues et al. (“PCR amplification of megabase DNA with tagged random primers (T-PCR)” Nucl. Acids Res., vol. 21, pp. 1321-1322, published March 11, 1993), cited in the IDS filed February 06, 2024.
Regarding claims 1 and 2, Grotheus teaches oligonucleotides comprising 9-15 random sequence at the 3' end and a 17 nucleotide constant sequence at the 5' end (Page 1321, second paragraph).
Grotheus teaches each and every limitation of claims 1-2, therefore Grotheus anticipates claims 1 and 2.
Claims 1 and 2 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Singer et al. (“Libraries for Genomic Selex” Nucleic Acids Research, Volume 25, Issue 4, Pages 781–786 published February 15, 1997), cited in the IDS filed February 06, 2024.
Regarding claims 1 and 2, Singer teaches a population of oligonucleotides comprising
sequences of random 9mers with 16 nucleotide non-degenerate 5’ tails that are 17 nucleotides in length (Fig. 1).
Singer teaches each and every limitation of claims 1-2, therefore Singer anticipates claims 1 and 2.
Claims 1 and 2 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Ziman et al. (U.S. Patent Application Publication US 2004/0081978 A1, published April 29, 2004), cited in the IDS filed February 06, 2024.
Regarding claims 1 and 2, Ziman teaches oligonucleotides comprising 9-15 random
nucleotides with a 5' tail of 27 non-degenerate nucleotides ([0032]-[0033]).
Ziman teaches each and every limitation of claims 1-2, therefore Ziman anticipates claims 1 and 2.
Conclusion
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/JESSICA D PARISI/Examiner, Art Unit 1684
/HEATHER CALAMITA/Supervisory Patent Examiner, Art Unit 1684
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