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 .
Claim Status and Formal Matters
This action is in response to paper filed 9/4/2025.
Claims 1, 3-8 have been amended.
Claims 1, 3-8 are being examined.
Applicant's election with traverse of group I in the reply filed on 1/132025 is acknowledged. The traversal is on the ground(s) that the response traverses the rejection by asserting MPEP 821.04 (a) allows for rejoinder of process claims. This is not found persuasive because as the introduction of chapter 800 states, “This chapter is limited to a discussion of the subjects of restriction and double patenting under Title 35 of the United States Code and Title 37 of the Code of Federal Regulations as it relates to national applications filed under 35 U.S.C. 111(a). The discussion of unity of invention under the Patent Cooperation Treaty Articles and Rules as it is applied as an International Searching Authority, International Preliminary Examining Authority, and in applications entering the National Stage under 35 U.S.C. 371 as a Designated or Elected Office in the U.S. Patent and Trademark Office is covered in MPEP Chapter 1800.” Thus as the instant application is a 371 the unity of invention practices control .
The response traverses continues traversing the lack of unity by arguing, “ Page 12 lines 17-19 of Applicant’s specification states: “The inventors realized that adding one or more mismatches between the oligonucleotides and the molecular probes provides an additional permutation factor. The degree of mismatch or complementarity can be identified in a melting curve and matched to a database.” This argument has been thoroughly reviewed but is not considered persuasive as the response is arguing the intended use of the security marker. However the elected invention is a composition which is examined based on the structure. Thus the argument is inconsistent with the elected invention.
The response traverses the election 3 target oligonucleotides. The response traverses of number of target sequences arguing it will not change the search. This argument is confusing as searching one target oligonucleotide with a primer pair and marker region, will not inherently provide art on a different target oligonucleotide with a different primer pair and different marker region. Further searching one target oligonucleotide with a primer pair and marker region will not inherently provide art on two target oligonucleotides with a primer pair and marker region.
The representative elected the first species in claim2 in the interview of 1/17/2025.
Claims 9-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 1/13/2025.
The previous 102 rejection has been withdrawn in view of the amendment. Priority
The instant application was filed 05/26/2021 is a national stage entry of PCT/EP2019/082815 with an international filing date: 11/27/2019 and claims foreign priority to GB1819256.7, filed 11/27/2018.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/4/2025 is being considered by the examiner.
Claim Objections
Claims 1, 3-8 are objected to because of the following informalities:
Claim 1 is objected to as it recites “PCR” but does not recite the full terminology for the acronym (or abbreviation). Claims are more concise when the first time an acronym (or abbreviation) is presented the full terminology is also presented. Finally an acronym (or abbreviation) may have alternative meanings to an artisan.
Claim 5 recites, “the other set(s).” This lacks antecedent basis in the claims.
Claim 8 recites, “for the or each.” This appears to be a typographical error.
Appropriate correction is required.
Response to Arguments
This is a new grounds of objection necessitated by amendment
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 3-8 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 3 recites, “combination according to claim 1, in each of the target oligonucleotides is different from the others..” The recitation of different is a relative term, which suggests some are not different. The metes and bounds are unclear if the claim 3 is intended to require multiple target sequences which have different in sequence or if it merely requires the security marker encompass multiple copies of the same sequence, which are different as they are on different molecules.
Claim 6 recites, “security marker according to claim 1, in which the or each target oligonucleotide comprises a target identity, the target identity comprising a probe identity relating to the respective complementary probe, a primer identity relating to the respective primer region pair and a complementarity identity relating to the number of nucleotide mismatches between the respective complementary probe nucleotide sequence and the marker nucleotide sequence, the security marker comprising a security code which comprises the target identity or identities of the or all of the target oligonucleotides.” Claim 6 is confusing and unclear as it appears to be providing properties of target identity, primer identity and complementarity identity it is unclear how or if this changes the structure of the security marker of claim 1.
Claim 7 recites, “ in which the target oligonucleotide(s) comprising the security marker is/are selected from a pool comprising a plurality of the target oligonucleotides, and in which each other.” It is unclear how or if this changes the structure of the security marker of claim 1.
Claim 8 recites, “n which the or each target oligonucleotide is identified by subjecting the security marker to one PCR reaction for the or each PCR primer pair in the presence of the or all of the probes, performing a melt curve analysis to generate melting temperature curves for the or each of the primer pairs, and then analyzsing the curves to generate the security code.” The metes and bounds are unclear how this limits the structure of the claim 1.
Response to Arguments
The rejections with respect to claims 1 and 2 have been withdrawn in view of the amendment.
The response traverses the rejection alleging the claim 3 is clear. This argument has been thoroughly reviewed but is not considered persuasive as, “is different from the others..” The recitation of different is a relative term, which suggests some are not different. The metes and bounds are unclear if the claim 3 is intended to require multiple target sequences which have different in sequence or if it merely requires the security marker encompass multiple copies of the same sequence, which are different as they are on different molecules. Finally “the others” lacks antecedent basis.
Claims 4 and 5 are rejected as they depend from claim 3. However the previous issues with those claims have been withdrawn in view of the amendment.
The response traverses the rejection of claim 6 asserting, “The structure of each target oligonucleotide now requires to include a target identity, a primer identity, and a complementary identity. The structure of the security marker of claim 1 is altered in that the security marker includes a security code which comprises the target identity or identities of the or all of the target oligonucleotides.” This argument has been thoroughly reviewed but is not considered as the specification provides no limiting definition of identity such that is clear how this limits the claims.
The response traverses the rejection of claim 7 in view of the amendment. This argument is not persuasive for the reasons of record.
The response traverses the rejection of claim 8 by reproducing the claim and asserting the claim is clear. This argument is not persuasive as claim 8 appears an attempt to method steps in the product claims and thus is unclear how this limits the structure of the products.
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 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring nucleic acid sequence or security marker. This judicial exception is not integrated into a practical application because there is not limitation which requires the hand of man. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims provide no limitations which differentiate the nucleic acid from a naturally occurring sequence..
Claim analysis
The instant claim 1 is directed towards A security marker and detector combination, the combination comprising: a detector including a molecular probe, the probe including a predetermined probe nucleotide sequence, and a security marker comprising a plurality of target oligonucleotides, the target oligonucleotide comprising a pair of PCR primer regions and a marker region located between the PCR primer regions, the marker region comprising a predetermined marker nucleotide sequence which is fully or partially complementary to the probe nucleotide sequence, characterized in that: the fully complimentary marker nucleotide sequence includes no nucleotide mismatches with the probe nucleotide sequence, and the partially complementary marker nucleotide sequence includes a single nucleotide mismatch with the probe nucleotide sequence or two or more nucleotide mismatches with the probe nucleotide sequence. The security marker which comprises a marker region targeted by primer regions encompass any known naturally occurring nucleic acid, as primers can be designed to any nucleic acid sequence. The recitation of PCR primers does not require the hand of man as PCR primers can be designed to any sequence.
Dependent claims set forth further limitations which are generally vague and unclear, but do not explicitly differentiate the structure of the security marker and detector from naturally occurring nucleic acid sequences.
According to the 2019 Patent Eligibility Guidance an initial two step analysis is required for determining statutory eligibility.
Step 1. Is the claim directed to a process, machine, manufacture, or composition of matter? In the instant case the Step 1 requirement is satisfied as the claims are directed towards a composition.
Step 2A Prong one. Does the claim recite a law of nature, a natural phenomenon or an abstract idea? Yes, are drawn to a nucleic acids (detector and security marker) which encompasses naturally occurring nucleic acids. .
Step 2A prong two. Does the claim recite additional elements that integrate the judicial exception into a practical application? The answer is no as the claim provide no limitations which differentiate the nucleic acid from a naturally occurring nucleic acid.
Step 2B. Does the claim recite additional elements that are significantly more than the judicial exceptions? The answer is no as the claim provide no limitations which differentiate the nucleic acid from a naturally occurring nucleic acid.
Response to Arguments
The response travers the rejection asserting, “Applicant respectfully submits the amended claim language overcomes the rejection under 35 U.S.C. 101 because the security marker and detector combination are clearly directed to a technical innovation with clear identifiable features, such as a highly efficient and unique marker system that, when combined with a probe, can be analyzed quickly with the fully and partially complimentary sequences being identified quickly using simple analytical techniques. The invention is more than just a law of nature, a natural phenomenon, or an abstract idea. “ This argument has been thoroughly reviewed but is not considered persuasive as the amendment provides no limitations which require the hand of man to differentiate the nucleic acids of the detector and security marker.
Claim Rejections - 35 USC § 102/103
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3-8 is/are rejected under 35 U.S.C. 102(a)(a)/102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Hayward US 20090286250 A1, Diffenbach (PCR methods and Applications (1993) volume 3, pages S30-S37) and Roux et al(PCR Methods and Applications (1995) volume 4, pages s185-s194).
Claim 1 recites, “A security marker and detector combination, the combination comprising: a detector including a molecular probe, the probe including a predetermined probe nucleotide sequence, and a security marker comprising a plurality of target oligonucleotides, the target oligonucleotide comprising a pair of PCR primer regions and a marker region located between the PCR primer regions, the marker region comprising a predetermined marker nucleotide sequence which is fully or partially complementary to the probe nucleotide sequence, characterized in that: the fully complimentary marker nucleotide sequence includes no nucleotide mismatches with the probe nucleotide sequence, and the partially complementary marker nucleotide sequence includes a single nucleotide mismatch with the probe nucleotide sequence or two or more nucleotide mismatches with the probe nucleotide sequence..” The broadest reasonable interpretation is the claim requires two nucleic acid sequences; detector and security marker. The security marker encompasses any nucleic acid sequences with a sequence which can be amplified by PCR primer regions at each end with any nucleic acid sequence in between which can be considered a marker region, which is fully or partially complementary to a probe detector probe sequence. The detector probe sequence can either be full complementary to the marker region or encompass one or two or more mismatches relative to the marker regions. The two or more mismatches encompasses sequences which are completely different.
With regards to claim 1, Hayward teaches, “0055] In general, analyzing the sample comprises providing a "detection molecule" configured to the nucleic acid tag. A detection molecule includes but is not limited to a nucleic acid probe and/or primer set which is complementary to at least a portion of the sequence of the nucleic acid taggant, or a dye label or color-producing molecule configured to bind and adhere to the nucleic acid taggant. The detection of the nucleic acid taggant may further comprise amplifying the nucleic acid taggant using PCR, with the detection molecule(s) being primers which specifically bind to a certain sequence of the nucleic acid taggant. When real time PCR is utilized in the analysis of the sample, an identifiable nucleotide probe may also be provided to enhance the detection of the nucleic acid taggant as well as provide semi-quantitative or fully quantitative authentication results. With the use of real time PCR, results from the analysis of the sample can be completed within 30 minutes to two hours, including extracting or purifying the nucleic acid taggant from the collected sample. Various embodiments may utilize a wide range of detection methods besides PCR and real time PCR, such as DNA rnicroarray, fluorescent probes, or probes configured to molecules which allow for the detection of the nucleic acid tag when bound to the probe by Raman spectroscopy, Infrared spectroscopy or other spectroscopic techniques used by those skilled in the art of nucleic acid detection. The method utilized to detect the nucleic acid is dependent on the quantity of nucleic acid taggant associated with the optical reporter marker. When only a few copies of NA taggant are collected in the marker sample, high sensitivity techniques such as PCR maybe preferable over fluorescent probes.”
Thus the teachings of Hayward anticipate the claim as to amplify by PCR the taggant the taggant must be flanked by sequences which can function as PCR primers and the probe to be used in real time PCR must have a sequence that is either completely complementary or partially complementary to allow detection of the taggant nucleic acid sequence. Thus the teachings of Hayward anticipates the claim.
Alternatively, Diffenbach 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). Diffenbach teaches PCR software was known (s35).
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 and amplify, 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 primers and primer target sites, see Diffenbach 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 primer. As discussed above, the ordinary artisan would be motivated to have designed and tested new primers to obtain additional oligonucleotides that function to detect taggant and identify oligonucleotides with improved properties. Thus, for the reasons provided above, the ordinary artisan would have designed additional oligonucleotides using the teachings in the art at the time the invention was made. The claimed mutations are obvious over the cited prior art, absent secondary considerations
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claims to design primers which flank the taggant or target sequence for PCR amplification. The artisan would be motivated to design primers to flank the sequence to amplify the taggant or target sequence to allow for detection. The artisan would have a reasonable expectation of success as the artisan is using well established methods for design of primers.
With regards to claim 3, Hayward teaches, “[0079] The method of 200 further comprises mixing the nucleophilic taggant in the co-solvent, at event 220, to provide a solution which can be used in formulating a nucleophilic/cyanoacrylate security marker. In embodiments where the nucleophilic taggant is DNA, the amount of DNA added to the ketone co-solvent may range from about 0.1 fg DNA/ml co-solvent to about 10 mg DNA/ml co-solvent, more particularly from about 0.5 ug/ml co-solvent to about 1 mg DNA/ml co-solvent, and even more particularly about 1 ug/ml of co-solvent to about 500 ug/ml co-solvent. At these effective concentrations, the DNA taggant is stable at room temperature in the ketone co-solvent for days, weeks or even months at a time.” Thus there are more than one copy of the nucleic acid target and thus the nucleic acids are different.
The broadest reasonable interpretation of claim 4 is the detector encompass multiple copies of the detector probe and the security marker includes a plurality of probe sets (or copies of probe). Thus the teachings of Hayward anticipate the limitations of the claims .
The broadest reasonable interpretation of claim 5 is each target oligonucleotide comprises primer pairs which are different as they are on different molecules of the target oligonucleotide or security marker.
Claim 6 is confusing and unclear as it appears to be providing properties of target identity, primer identity and complementarity identity or an attempt to provide method steps in a product claim. These do not explicitly change the structure of the security marker or detector and thus are anticipated by Hayward.
Claim 7 is confusing and unclear as the independent claim requires the security marker comprising a target oligonucleotide which comprises a marker region.. However the instant claim requires, “in which the target oligonucleotide(s) comprising the security marker is/are selected from a pool comprising a plurality of the target oligonucleotides, and in which
Claim 8 recites, “n which the or each target oligonucleotide is identified by subjecting the security marker to one PCR reaction for the or each PCR primer pair in the presence of the or all of the probes, performing a melt curve analysis to generate melting temperature curves for the or each of the primer pairs, and then analyzsing the curves to generate the security code.” This does not appear to explicitly change the structure of the security marker and is thus anticipated by Hayward.
Response to Arguments
This is a new ground of rejection necessitated by amendment.
Summary
No claims are allowed
.Conclusion
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 STEVEN C POHNERT PhD whose telephone number is (571)272-3803. The examiner can normally be reached Monday- Friday about 6:00 AM-5:00 PM, every second Friday off.
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/Steven Pohnert/ Primary Examiner, Art Unit 1683