DETAILED ACTION
Applicant’s response, filed 9/5/2025, has been fully considered. The following rejections
and/or objections are either reiterated or newly applied. They constitute the complete set presently
being applied to the instant application.
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
Claims 1-9 are pending.
Claims 1-9 are rejected.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed with the Instant Application No. 17/367,498, filed on 9/15/2021.
Specification
Response to Amendment
In view of applicant’s amendments to the specification, previous objections to the specification are withdrawn.
Claim Objections
Claims 1 and 7 are objected to because of the following informalities: there is an extraneous comma after “wherein,” in the last clause of the claims. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Response to Amendment
In view of applicant’s amendments to the claims, previous rejections under 35 U.S.C. 112 are withdrawn.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 1-6 are directed to a kit, which is a product claim. The patentability of product claims is determined by the components of the kit itself. The limitations of claim 6 do not appear to further limit the components of the kit themselves but rather appear to be reciting limitations on the types of measurement intended to be performed with the kit. This is more an intended use of the kit rather than a limitation on the composition of the kit itself and thus does not further limit the claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
Response to Amendment
In view of applicant’s amendments to the claims, previous rejections under 35 U.S.C. 103 have been reviewed, updated, and provided below.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Regensburger et al. (US 20150051083 A1; previously cited), and Butler et al. (Journal of forensic sciences (2003) 1054-1064; newly cited) in view of the following published patents (Piepenburg et al. (US 20050112631 A1), Hall et al. (US 20100184035 A1), Dau et al. (US 20030186272 A1), Wasserstrom et al. (US 20120190023 A1), Venter et al. (US 20070037165 A1), Oeth et al. (US 20080299562 A1), Leamon et al. (US 20120295819 A1), Young et al. (US 20140278127 A1), Inoko et al. (US 20040197797 A1), Andersen et al. (US 20190002872 A1), Green et al. (US 20120070832 A1), Firestein et al. (US 20130129668 A1)).
Claim 1 is directed to a multiplex PCR kit for human genotype profile identification through the amplification of the CSF1P0, D7S820, TPOX, FGA, D2S1338, D13S317, and SE33 loci using sequences 1-8, and 11-16.
Claim 7 is directed to a method of identifying human genotype profiles by amplifying via a PCR kit, STR regions corresponding to a specific list of loci.
US 20050112631 A1 reads on sequences 1, 3 and 5 via sequences 32, 35 and 44 respectively.
US 20100184035 A1 reads on sequences 2 and via sequences 103 and 56 respectively.
US 20030186272 A1 reads on sequence 4 via sequence 17.
US 20120190023 A1 reads on sequences 7 and 11 via sequences and 30.
US 20070037165 A1 reads on sequence 8.
US 20140278127 A1 reads on sequence 12 via sequence 4.
US 20040197797 A1 reads on sequence 13 via sequence 20150.
US 20190002872 A1 reads on sequence 14 via sequence 1671.
US 20120070832 A1 reads on sequence 15 via sequence 5.
US 20130129668 A1 reads on sequence 16 via sequence 199466.
Regensburger et al. teaches in paragraph [0122] “Suitable loci that can be analyzed in accordance with the method described herein include, but are not limited to, the CSF1PO, FGA, THO1, TPOX, VWA, D3S1358, D5S818, D7S820, D8S1179, D13S317, D16S539, D18S379, D18S51, D21S11, SE33, D1S1656, D2S441, D2S1338, D6S1043, D10S1248, D12S391, D19S433, and D22S1045 loci” and in the abstract “Short Tandem Repeats are currently used by law enforcement and others, for example, for the identification of individuals by DNA matching. A method is described herein that uses WPD to classify and identify repeating sequences in nucleotide sequences from the position and frequency information contained within nucleotide sequences”.
Butler et al. teaches in the abstract “New multiplex PCR sets of commonly used short tandem repeat (STR) markers have been developed to produce PCR products that are reduced in size when compared to standard commercial STR kits. The reduction in size of these amplicons can facilitate the examination and analysis of degraded DNA evidence by improving amplification efficiency. This “miniSTR” approach will permit current forensic practitioners to use STR markers and instrumentation already present in their laboratories and to generate genotyping data that is directly comparable to reference samples and searchable through the FBI’s Combined DNA Index System (CODIS) databases”, and in Table 1 the MiniSTR size is given from a minimum of 51 to a maximum of 281, which is less than 330 and therefore reads on amplification products of STR regions located at the CSF1PO locus, the D7S820 locus, the TPOX locus, the FGA locus, the D2S1338 locus, the D13S317 locus, and the SE33 locus are less than 330 bp in a single PCR reaction.
It would have been obvious at the time of first filing to modify the teachings of Regensburger et al. for a method of identifying individuals using STRs with the teachings of Butler et al. for using smaller length amplicons to use smaller STR amplicon sizes as the latter reference points out the need for such in the field of forensic identification. Additionally, it would have been obvious at the time of first filing to combine the teachings of Regensburger et al. and Butler et al. for the identification of STR regions via an amplification kit for identifying individuals, with the corresponding known sequences found in each region, described in each of the published patents as they are known STR primers for said regions. One would have had a reasonable expectation of success given that the sequences have been described in previously published literature and used for amplification. Therefore, it would be obvious to one with ordinary skill in the art to incorporate the teachings of each and to be successful.
Claim 2 is directed to the method of claim 1 but further specifies that sequences 9 and 10 amplify the amelogenin locus for sec determination.
Claim 8 is directed to the method of claim 7 but further specifies that the male or female gender is determined via analysis of the amelogenin locus.
Regensburger et al. Butler et al. and the sequence listings teach the method of claim 1 as above. Furthermore, Leamon et al. teaches in paragraph 186 “In some embodiments, targets-specific primers such as those provided in Table 14, or target-specific primers prepared as disclosed herein, that are directed to the gene amelogenin (AMG) can be used to determine the sex of the individual providing the sample”, reading on specifically amplifies amelogenin locus for sex discrimination.
US 20080299562 A1 reads on sequence 9.
US 20120295819 A1 reads on sequence 10 via sequence 50449.
Claim 3 is directed to the method of claim 2 but further specifies that the kit comprise DNA polymerases, dNTPs, PCR buffer and markers.
Regensburger et al., and the sequence listings teach the method of claims 1 and 2 as above.
Regensburger et al. further teaches in paragraph [0169] “An enzymatic reaction was set up by adding the following materials to a test tube: ddH.sub.2O, high fidelity DNA polymerase (e.g. Taq or Pfu DNA polymerase), master mix containing buffering agent and MgCl.sub.2 and nucleotides (dNTPs), 0.5 .mu.M Primer A, 0.5 .mu.M Primer B, and 50-750 ng template gDNA” and in paragraph [0003] “markers are also useful in genetic mapping and linkage analysis”, reading on further comprising DNA polymerases, dNTPs, PCR buffer and a marker of PCR amplification product.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Regensburger et al. (US 20150051083 A1; previously cited), Butler et al. (Journal of forensic sciences (2003) 1054-1064; newly cited) the sequence listings (Piepenburg et al. (US 20050112631 A1), Hall et al. (US 20100184035 A1), Dau et al. (US 20030186272 A1), Wasserstrom et al. (US 20120190023 A1), Venter et al. (US 20070037165 A1), Oeth et al. (US 20080299562 A1), Leamon et al. (US 20120295819 A1), Young et al. (US 20140278127 A1), Inoko et al. (US 20040197797 A1), Andersen et al. (US 20190002872 A1), Green et al. (US 20120070832 A1), Firestein et al. (US 20130129668 A1)), and Weikard et al. (Molecular Reproduction and Development (2006) 1333-1337; previously cited) as applied to claims 2, 3 and 8 above, and further in view of Hilario et al. (Molecular Biotechnology (2004) 77-80; previously cited).
Claim 4 is directed to the kit of claim 3 and thus claim 2 and thereby the method of claim 1, but further specifies that the sequences be labeled on the 5’ end of the sequence primers.
Regensburger et al., the sequence listings and Weikard et al. teach the method of claims 1, 2 and 3 as above.
Regensburger et al. and Weikard et al. do not teach labeling of the 5’ end of the primer.
Hilario et al. teaches in the abstract “Labels incorporated at the 3'-end of the DNA molecule prevent any further extension or ligation to any other molecule, but this can be overcome by labeling the 5'-end of the desired DNA molecule. 5'-end labeling is performed by enzymatic methods (T4 polynucleotide kinase exchange and forward reactions), by chemical modification of sensitized oligonucleotides with phosphoroamidite, or by combined methods”, reading on wherein a first marker is labeled at both of 5' end of the primer of SEQ ID NO: 1 and 5' end of the primer of SEQ ID NO: 3, a second marker is labeled at both of 5' end of the primer of SEQ ID NO: 5 and 5' end of the primer of SEQ ID NO: 7, a third marker is labeled at 5' end of the primer of SEQ ID NO: 9, 5' end of the primer of SEQ ID NO: 11 and 5' end of the primer of SEQ ID NO: 13, and a fourth marker is labeled at 5' end of the primer of SEQ ID NO: 15.
It would have been obvious at the time of invention to combine the teachings of Regensburger et al. and Butler et al. for the identification of STR regions via an amplification kit for identifying individuals, with the teachings of labeling the 5’ ends of primers taught in Hilario et al. as the later points out, this method overcomes the issue of preventing any further extension or ligation to any other molecule. One would have had a reasonable expectation of success given that Hilario et al. is a review paper on various methods for end labeling for amplification kits, such as those described in Regensburger et al. Therefore, it would be obvious to one with ordinary skill in the art to incorporate the teachings of each and to be successful.
Claims 5, 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Regensburger et al. (US 20150051083 A1; previously cited), the sequence listings (Piepenburg et al. (US 20050112631 A1), Hall et al. (US 20100184035 A1), Dau et al. (US 20030186272 A1), Wasserstrom et al. (US 20120190023 A1), Venter et al. (US 20070037165 A1), Oeth et al. (US 20080299562 A1), Leamon et al. (US 20120295819 A1), Young et al. (US 20140278127 A1), Inoko et al. (US 20040197797 A1), Andersen et al. (US 20190002872 A1), Green et al. (US 20120070832 A1), Firestein et al. (US 20130129668 A1)), Weikard et al. (Molecular Reproduction and Development (2006) 1333-1337; previously cited), and Hilario et al. (Molecular Biotechnology (2004) 77-80; previously cited) as applied to claims 1-4, 7 and 8 above, and further in view of Friedman et al. (Biophysical Journal (2006) 1023-1031; previously cited).
Claim 5 is directed to the kit of claim 4 and thus the method of claim 1, but further specifies that the markers are fluorescent materials that are detected at different wavelengths.
Regensburger et al., the sequence listings, Weikard et al., and Hilario et al. teach the method of claims 1-4 as above.
Regensburger et al., the sequence listings, Weikard et al., and Hilario et al. do not teach markers using fluorescent materials detected at different wavelengths.
Friedman et al. teaches on page 1024, column 2, paragraph 4 “Dichroic mirrors with multiple reflection bands can be employed to adapt this design to experiments with multiple dyes that are excited and emit at different wavelengths”, on page 1025, column 2, paragraph 2 “To excite the sample at multiple wavelengths simultaneously, three laser beams of different wavelengths are combined using dichroic mirrors and focused onto the back focal plane of the objective”, and on page 1030, column 2, paragraph 3 “The small broadband mirrors allow us to employ multiple excitation wavelengths without incurring the emission losses that would accompany use of the multi-wavelength dichroic mirror required in conventional epi-illuminated TIRF microscopes to separate the excitation and emission pathways.”
It would have been obvious at the time of invention to combine the teachings of Regensburger et al. and Butler et al. for the identification of STR regions via an amplification kit for identifying individuals, with the teachings of Friedman et al. for using multiple fluorescent markers that can be identified simultaneously as each locus with its STR would register individually and distinctly forming a pseudo fingerprint. One would have had a reasonable expectation of success given that Friedman et al. has a large swath of applications in various molecular studies and fluorescent and dye labeling are quite commonplace within DNA amplification. Therefore, it would be obvious to one with ordinary skill in the art to incorporate the teachings of each and to be successful.
Claim 6 is directed to the kit of claim 5 and thus the method of claim 1 but further specifies that the fluorescent materials are detected at different wavelengths via spectopscopic techniques.
Claim 9 is directed to the method of claim 7 but further specifies that the fluorescent materials are detected at different wavelengths via spectopscopic techniques.
Regensburger et al., the sequence listings, Weikard et al., and Hilario et al. teach the method of claims 1-4 as above.
Regensburger et al., the sequence listings, Weikard et al., and Hilario et al. do not teach markers using fluorescent materials detected at different wavelengths.
Friedman et al. teaches on page 1024, column 2, paragraph 4 “Dichroic mirrors with multiple reflection bands can be employed to adapt this design to experiments with multiple dyes that are excited and emit at different wavelengths”, on page 1025, column 2, paragraph 2 “To excite the sample at multiple wavelengths simultaneously, three laser beams of different wavelengths are combined using dichroic mirrors and focused onto the back focal plane of the objective”, and on page 1030, column 2, paragraph 3 “The small broadband mirrors allow us to employ multiple excitation wavelengths without incurring the emission losses that would accompany use of the multi-wavelength dichroic mirror required in conventional epi-illuminated TIRF microscopes to separate the excitation and emission pathways.”
Response to Arguments
Applicant's arguments filed 9/5/2025 have been fully considered but they are not persuasive. Applicant asserts that the previously cited art did not read on the amendments to the claims, specifically for claims 1 and 7, and that subsequently the additional rejections for dependent claims which relied on further prior art did not cure said deficiencies. Examiner agrees that prior art did not read on those amendments and that the dependent rejections did not cite prior art which did. Therefore, examiner has performed a new round of art search and updated with new prior art that cure said deficiencies.
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.
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/K.N.A./Examiner, Art Unit 1687
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685