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 .
Status of the Applications, Amendments and/or Claims
This action is written in response to applicant's correspondence(s) submitted on 11/25/2025. In the paper of 11/25/2025, Applicant presents arguments. No amendments are mad to the claims.
Accordingly, claims 74-93 are pending. Claims 83 and 86 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected invention(s), without traverse in the reply filed on 02/18/2025.
Claims 74-82, 84-85, and 87-93 are still under review.
Response to Arguments
Withdrawn Rejection(s)
The rejections of claims 74-82, 84-85, and 87-93 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for reasons as stated in paragraphs 7-9 on pages 7-8 of the Non-Final office action mailed on 05/27/2025, are withdrawn based on Applicant’s argument that the specification at para [052] on page 11, provides the definition of "AT/GC ratio" as
"the ratio of (i) the sum of the concentrations of ATP, TTP, UTP, and any analogs thereof, to (ii) the sum of the concentrations of CTP, GTP, and any analogs thereof, in a given solution or mixture. US2022/0136044A1 at [0053]. The definition goes on to point out that, "[a]s noted above, an 'NTP' includes rNTPs, and dNTPs. Thus, for example, ATP includes rATP and dATP."Id.”
Maintained Rejection(s)
The rejections of claims 74-82, 84-85, and 87-93 under 35 U.S.C. 101 are maintained.
The rejection of claims 74 and 91-93 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for reasons as stated in paragraphs 7-8 and 10 on pages 7-9 of the Non-Final office action mailed on 05/27/2025, is maintained.
Argument(s)
Applicant's arguments filed 11/25/2025 have been fully considered but they are not persuasive as follows. Applicant argues that although the claims are directed to judicial exception, the judicial exception is integrated into a practical application (Remarks of 11/25/2025, pg 7, section entitled “Step 2A, prong one: Does the claim recite a law of nature, a natural phenomenon, or an abstract idea”).
This argument is not persuasive and the rejections of claims 74-82, 84-85, and 87-93 under 35 U.S.C. 101 are maintained because the instant claims are drawn to composition of matter/products, NOT methods.
Applicant arguments rely on a consideration of the intended use for the composition. There might be many more process(es) for using the claimed composition, including those not realized or recited by Applicant, or those that use only a few components from the claimed composition(s). Applicant is reminded that intended use are not read into product claims.
Pertaining to claimed compositions that are indistinguishable from judicial exceptions, these compositions of matter are construed as becoming significantly more than those judicial exceptions, when the compositions are modified structurally, or comprise additional structural features/elements that are non-naturally occurring, or found naturally. A combination of two or more items that are individually indistinguishable from their natural counterparts do not promote the combination to becoming significantly more than judicial exceptions, nor will decreasing or increasing the concentration of the items in a combination promote the combination to becoming significantly more than judicial exceptions.
Concerning Applicant’s argument that the at least two primers of the claimed kit have a definite structure because they are required to be capable of amplifying at least one DNA template as recited by claim 74, this argument is not persuasive.
The at least one DNA template that the two kit primers are intended to amplify comprise BOTH target and non-target sequences; excluding claims 87-88, none of the claims direct the target sequence of the NA template to any partial or full-length sequence recited by claim 74 (i) and/or claim 74 (ii); and finally, claim 74 does not require the instant primer(s) of the claimed kit to comprise a complement nucleotide sequence that specifically binds to a target homopolymeric segment nucleotide sequence (i) of the DNA template (i); nor do the claims require the instant primer of the claimed kit to comprise a complement nucleotide sequence that fully and specifically hybridize to the target repeating A/T segment sequence (TnA)m, (ATn)m, (TAn)m, or (AnT)m, wherein n is 2 or greater and m is such that the length of the repeating A/T-rich segment is 10 or more residues. The claimed primers may very well bind and amplify the DNA templates at the undisclosed/unspecified non-target sequence comprised within the claimed DNA template(s).
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 74-82, 84-85, and 87-93 are rejected under 35 U.S.C. 101 because the claimed inventions are directed to a judicial exception (i.e., a law of nature, a natural phenomenon, an abstract idea, or a natural product) without significantly more.
Claim 74 is broadly directed to a kit comprising NTPs in an AT/GC ratio of 8 or higher, and comprising at least two primers for hybridizing to at least one DNA template, said DNA comprising: (i) a homopolymeric segment of at least 10 consecutive A residues, or at least 10 consecutive T residues.
Claim 74 is construed as being drawn to a package comprising dNTPs in a plurality of containers and additionally comprising a plurality of containers for each one of the at least two primers/nucleic acids able to hybridize to any select nucleotide sequence within a DNA nucleic acid comprising a homopolymeric segment of at least 10 consecutive A residues, or at least 10 consecutive T residues, wherein the sum of concentrations of dATP and dTTP in said plurality of containers is eight-fold or more of the sum of concentrations of dGTP and dCTP in said plurality of containers.
The claimed primers of the kit of claim 74 are nucleic acids that appear to encompass one or more natural product(s) which falls within the law of nature exception (e.g. are partial nucleotide sequences of the naturally occurring TOMM40 gene (GenBank Accession No. AH007029.2).
The claimed dNTPs of the kit of claim 74 are structurally identical to naturally occurring dNTPs, and having no functional difference relative to their naturally occurring counterparts.
None of claims 74-82, 84-85, and 87-93 further include additional elements, sufficient to raise the claims to become significantly more than judicial exceptions.
Concerning the claimed primers of claim 74 capable of amplifying at least one DNA template comprising: (i) a homopolymeric segment of at least 10 consecutive A residues or at least 10 consecutive T residues, the unpatentability of natural products as these was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (June 13, 2013) –
“A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated”, and “Myriad’s DNA claim falls within the law of nature exception”.
The following inquiries are used to determine whether a claim is drawn to patent-eligible subject matter:
Step 1. Is the claim directed to a process, machine, article of manufacture, or composition of matter?
Yes- the claims are clearly directed to packages or containers of various nucleic acids/nucleotide sequence(s) and dNTPs which are a composition of matter.
Step 2A, prong one. Does the claim recite a law of nature, a natural phenomenon, or an abstract idea (recognized judicial exceptions)?
Yes- the claims are directed one or more partial nucleotide sequences derived within any DNA template that happens to comprise at least 10 consecutive A residues, or at least 10 consecutive T residues.
The primer molecules of claim 74 are not markedly different than their naturally occurring counterpart (the oligonucleotide of GenBank Accession No. AH007029.2) and have no functional differences relative to their naturally occurring counterparts since both the claimed and naturally occurring molecules hybridize to complementary nucleic acids.
MPEP 2106.04(b)(i) identifies nucleic acid sequence(s) having no structural or functional differences from naturally occurring nucleic acids as an example of a patent-ineligible natural product.
In addition, as discussed in MPEP 2016.04(b)(II), “[P]roduct of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart.” See Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244.
Step 2A, prong two. Does the claim as a whole integrate the recited judicial exception into a practical application of the exception?
No - This evaluation is performed by identifying whether there are any additional elements recited in the claim beyond the judicial exception, and evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application.
In the instant case, the claims do not appear to recite any additional elements beyond those that may reasonably be consider part of various naturally occurring genes e.g. TOMM40 gene.
Here it is noted the none of the claims recite elements other than standard DNA elements (e.g. fluorophore labels that are non-naturally occurring nucleotides, or non-naturally occurring elements) nor do they provide elements that have functions not possessed by naturally occurring nucleic acids.
Step 2B. Does the claim recite additional elements that amount to significantly more than the judicial exception?
No- In the instant case, as detailed above, claim 74 provide one or more primer nucleotide sequences encompassing partial or full-length sequence(s) of naturally occurring DNA sequences (e.g. GenBank Accession No. AH007029.2). This part of the eligibility analysis evaluates whether the claim as a whole amount to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05.
Concerning claims are drawn to nucleic acids that encompass a product that is naturally occurring (i.e.: the claimed primer pair/probe may be the same as a portion of a natural genome), it is noted that in Association for Molecular Pathology et al v. Myriad Genetics, Inc. et al, (569 U.S. (2013)), the Supreme Court provides: Myriad did not create or alter either the genetic information encoded in the BCRA1 and BCRA2 genes or the genetic structure of the DNA. It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry. See Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U. S. 127. Finding the location of the BRCA1 and BRCA2 genes does not render the genes patent eligible “new . . . composition[s] of matter,” §101. Myriad’s patent descriptions highlight the problem with its claims: They detail the extensive process of discovery, but extensive effort alone is insufficient to satisfy §101’s demands. Myriad’s claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together.
Further, where claim 74 is directed to a collection of primers and dNTPs, the dNTPS and the primers possess no structural or functional difference and do not have any markedly different characteristic as a collection than each NTP/primer has individually.
In view of the foregoing, claims 74-82, 84-85, and 87-93 are rejected under 35 U.S.C. 101 for being directed to ineligible subject matter.
Claim Interpretation
Prior to analysis of the art, the claims must be construed. As noted in MPEP 2111, citing Phillips v. AWH Corp., 415 F.3d l303, 75 USPQ2d l321 (Fed. Cir. 2005), "During patent examination, the pending claims must be 'given their broadest reasonable interpretation consistent with the specification.' ".
Claim 74 is drawn to a kit comprising NTPS in an AT/GC ratio of 8 or higher and at least two primers able to bind a DNA template having target and non-target sequence(s).
The limitations of “wherein the at least two primers are capable of amplifying at least one DNA template”, and “wherein the at least one DNA template further comprises target and non-target nucleic acid sequences” as claimed in claim 74, are NOT construed as requiring for the instant kit of claim 74 comprise at least one DNA template further comprises target and non-target nucleic acid sequences.
Furthermore, the nature and scope of target and non-target nucleic acid sequences as recited by claim 74 are not known.
To expedite prosecution, the Office will interprete the limitation of “target and non-target nucleic acid sequences” as referring to primer-binding target nucleotide sequences and non-primer-binding nucleotide sequences.
Claims 91-93 are NOT construed as requiring inclusion of the at least one DNA template(s) as recited by these claims, to the instant kit of claim 74.
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 74 and 91-93 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 74-82, 84-85, 89-93 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. These claims omit essential elements.
Specifically, claims 91-93 are directed to the at least one nucleic acid template of kit of claim 74. Since the kit of claim 74 is only directed to a package containing containers having NTPs in an AT/GC ratio of 8 or higher and containers with at least two primers, claims 91-93 fails to provide any meaningful structural difference to the at least two primers of claim 74 because the primers of claim 74 are not required to bind any specific nucleotide segment of the at least one nucleic acid template. The clarity and scope of the claimed at least two primers of claim 74 are unknown.
Claims 75-82, 84-85, 89-93 are further rejected as they depend from claim 74.
Conclusion
No claims are currently allowed.
THIS ACTION IS MADE FINAL. 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLAYINKA A OYEYEMI whose telephone number is (571)270-5956. The examiner can normally be reached Monday -Thursday: 9:00 am - 5:00 pm, EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, GARY Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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OLAYINKA A. OYEYEMI
Examiner
Art Unit 1681
/OLAYINKA A OYEYEMI/Examiner, Art Unit 1681
/GARY BENZION/Supervisory Patent Examiner, Art Unit 1681