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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/17/2025 has been entered.
The amended claims dated 12/17/2025 are under consideration.
The amendments and arguments presented in the papers filed 12/17/2025 ("Remarks”) have been thoroughly considered. The issues raised in the Office action dated 9/3/2025 listed below have been reconsidered as indicated.
a) The objection to the drawings is withdrawn in view of the petition for color drawings granted on 1/26/2026.
b) The amendments to the specification addressing nucleotide sequence disclosure requirements is acknowledged.
The Examiner’s responses to the Remarks regarding issues not listed above are detailed below in this Office action.
Modified grounds of rejection necessitated by amendment are detailed below and this action is made FINAL.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892 or cited on a submitted IDS, they have not been considered.
Claim Rejections - 35 USC § 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 6-9, 12-14 and 29-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mitra (US 2015/0197788 A1; previously cited), Markowitz (WO 2018/009535 A1; previously cited), Brown (US 2018/0237950 A1; previously cited) and Eltoukhy (US 2017/0260590 A1; previously cited).
The following rejections have been maintained.
Regarding claims 1 and 6, Mitra teaches methods of sequencing nucleic acids for methylation analysis.
Mitra teaches digesting genomic DNA of a sample with the methyl-insensitive restriction enzyme AluI (Fig. 4 and 7; para. 17, 20 and 152). The digestion of genomic DNA results in creating target polynucleotides comprising a plurality of cytosine residues, including methylated cytosine residues.
Mitra teaches ligating one end of the target polynucleotide to a polynucleotide in the form of an upstream universal primer and the other end to a protective polynucleotides in the form of a downstream universal primer that has an exonuclease resistant 3’ modification or “moiety” (Fig. 4 and 7; para. 17, 20 and 152). The universal primer sequences of the polynucleotides do not contain cytosine so that the sequence remains unchanged (para. 168) and are designed for GC pair content (para. 67). One would recognize that if the universal primer has GC content and is not to be changed, for example during, bisulfite treatment, that the GC content needs to include methylated cytosine.
Mitra teaches degrading polynucleotides without the exonuclease resistant 3’ modification using an exonuclease (Fig. 4 and 7; para. 17, 20 and 152).
Mitra teaches converting polynucleotides by chemically converting each unmethylated cytosine using bisulfite (Fig. 4 and 7; para. 17, 20 and 152).
Mitra teaches PCR amplifying the converted polynucleotides to produce amplicons using universal primers tailed with DNA barcodes (Fig. 4 and 7; para. 17, 20 and 152) having a five base pair combination (para. 189). It is noted that the barcodes of Mitra are structurally indistinguishable from those of the claim having “a first randomly generated UMI polynucleotide sequence”.
Mitra teaches sequencing the plurality of amplicons to produce amplicon sequence reads that correspond to one of the plurality of amplicon polynucleotides and includes the barcode (Fig. 4 and 7; para. 17, 20 and 152). Because the amplicons are of converted polynucleotides, they include a thymine at each nucleotide position corresponding to a reduced unmethylated cytosine and a cytosine at each methylated cytosine. One would appreciate that the system is not perfect and as a consequence errors in sequences may be introduced from incomplete bisulfite conversion, amplification errors, sequencing errors, etc.
Mitra teaches aligning sequence reads with reference sequences (para. 169).
Mitra teaches comparing reads to reference sequences and identifying C positions (para. 103 and 190).
Mitra further teaches using information to find a threshold to classify a locus as methylated or unmethylated in each sample. Mitra teaches optimization queries many CpGs for each locus with the bisulfite sequencing data. Mitra teaches the information was used to optimize a classifier for designating a sequence as methylated or unmethylated. For example, for Mitra an optimal classifier for classifying a sample as “methylated” was if more than 20% of CpG positions per molecule were methylated in more than 35% of molecules (para. 191), which distinguishes their tumor samples from normal samples.
Markowitz teaches that in the context of other samples different thresholds can be reached. For example, using bisulfite sequencing data, Markowitz counted the number of CpGs that were methylated between the amplification primers, and the read was classified as methylated or unmethyled using cutoffs for a required number of methylated CpGs on the amplicon (p. 85, line 29 to p. 86, line 18). For Markowitz, at least 14 CpGs out of 16 CpGs must be methylated in order to call a SqBE read methylated (p. 86, lines 2-5) or for VIM at least 8 of 10 CpGs must be methylated to call the read methylated (p. 90, lines 19-25).
Thus, it is routine to optimize the thresholds based on the samples and the individual genes being analyzed as described by Mitra. Markowitz demonstrates further that selecting thresholds of at least 75% was achieved through optimization. Thus, the present threshold of the amended claim is an obvious variant of the approach of Mitra and Markowitz that is achievable through routine optimization.
Regarding claim 2, Mitra teaches calculating the fraction of methylated target polynucleotides within the total target polynucleotides of the samples (para. 191 and para. 23 and 173).
Regarding claim 3, Mitra teaches the exonuclease resistant modification is a phosphorothioate modification (para. 67).
Regarding claim 4, Mitra teaches the use of “patch” oligonucleotides that hybridize to target polynucleotides and one of either the upstream universal primer or the downstream universal primer, in order to ligate the universal primers to the target polynucleotide (Fig. 4 and 7; paras. 17 and 20).
Regarding claims 7-9, Mitra teaches the target polynucleotide is known to have a specific methylation pattern in colon tumors or breast tumors (para. 24 and 167).
Regarding claim 12, Mitra teaches the target nucleotide sequence includes multiple 5’-C-G-3’ nucleotide pairs (Fig. 11).
Regarding claim 13, Mitra teaches the methylation of cytosines in a plurality of target polynucleotide sequences or “loci” are detected for a sample (Fig. 11).
Regarding claim 14, Mitra teaches detecting the methylation of cytosines in 94 targeted promoters (para. 160).
Regarding claims 29 and 30, Mitra teaches the above elements relevant to claim 1 and using “hypermethylated loci” for diagnosis of breast or colon cancer (para. 178).
Regarding claim 31, Mitra teaches personalized treatment of cancers (para. 163), which the ordinary artisan would recognize as encompassing well-known treatments such as chemotherapy, radiation, surgery, etc.
While Mitra teaches that barcodes are added via a primer as described above in the analysis of claim 1, Mitra does not specifically teach the ligated polynucleotides contains a barcode.
However, Brown teaches it was known that barcodes can be added to polynucleotides via primers such as the tailed primer elongation approach of Mitra or by ligation such as ligation of sequences to a molecule (para. 97).
It would have been prima facie obvious to the ordinary artisan at the time of filing that an obvious variant of attaching barcodes to a polynucleotide using primer of Mitra would be to attach them through ligation as demonstrated by Brown. The modification of simply substituting primer based barcoding for the ligation based barcoding of Brown has a reasonable expectation of success as Brown demonstrates the two are functionally equivalent ways to barcode a polynucleotide.
While Mitra teaches aligning and analyzing sequences, Mitra does not teach generating a consensus sequence for the sequencing reads.
However, Eltoukhy teaches how to determine a consensus sequence.
Eltoukhy teaches sequence reads are grouped into families with about 10 sequence reads in each family. Families are collapsed into consensus sequences by voting (e.g., biased voting) each position in a family. A base is called for consensus sequence if 8 or 9 members agree and a base is not called for consensus sequence if no more than 60% of the members agree. See para. 232.
It would have been prima facie obvious to the ordinary artisan at the time of filing to have modified the method of Mitra to incorporate the base calling and consensus sequence determination approach of Eltoukhy. The consensus sequences may be used to more accurately determine methylation profiles in a manner analogous to that described by Eltoukhy (para. 233) as well as for being useful for evaluating a sequence over time (para. 164). Eltoukhy teaches the general parameters for consensus sequence generation, thus rendering obvious the elements of the claims.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mitra (US 2015/0197788 A1), Markowitz (WO 2018/009535 A1), Brown (US 2018/0237950 A1) and Eltoukhy (US 2017/0260590 A1) as applied to claim 1 above, and in further view of Vaisvila (WO 2017/075436 A1).
The following rejections have been maintained.
Mitra teaches bisulfite treatment as noted above and does not teach converting unmethylated cytosine with TET2 and APOBEC.
However, Vaisvila teaches TET/APOBEC3A treatment does not damage ssDNA (p. 6, lines 9-11; p. 19, lines 21-24; p. 24, Example 2; and Fig. 3).
It would have been prima facie obvious to the ordinary artisan at the time of filing to have substituted the bisulfite of Mitra with the TET/APOBEC method of Vaisvila. One would have been motivated to make such a modification because TET/APOBEC3A treatment does not damage ssDNA as taught by Vaisvila. The modification has a reasonable expectation of success as both bisulfite and TET/APOBEC3A treatments are known in the art for the analysis of methylation and thus are functionally equivalent and the modification results in a simple substitution.
Claim(s) 15-23 and 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mitra (US 2015/0197788 A1; previously cited), Markowitz (WO 2018/009535 A1; previously cited), Brown (US 2018/0237950 A1; previously cited), Eltoukhy (US 2017/0260590 A1; previously cited) and Song (US 2020/0370114 A1; previously cited).
The following rejections have been maintained.
Regarding claims 15 and 20, Mitra teaches methods of sequencing nucleic acids for methylation analysis.
Mitra teaches digesting genomic DNA of a sample with the methyl-insensitive restriction enzyme AluI (Fig. 4; para. 17 and 152). The digestion of genomic DNA results in creating target polynucleotides comprising a plurality of cytosine residues, including methylated cytosine residues.
Mitra teaches ligating one end of the target polynucleotide to a polynucleotide in the form of an upstream universal primer and the other end to a protective polynucleotide in the form of a downstream universal primer that has an exonuclease resistant 3’ modification or “moiety” (Fig. 4; para. 17 and 152). The universal primer sequences of the polynucleotides do not contain cytosine so that the sequence remains unchanged (para. 168) and are designed for GC pair content (para. 67). One would recognize that if the universal primer has GC content and is not to be changed, for example during, bisulfite treatment, that the GC content needs to include methylated cytosine.
Mitra teaches degrading polynucleotides without the exonuclease resistant 3’ modification using an exonuclease (Fig. 7; and para. 20).
Mitra teaches converting polynucleotides by chemically converting each unmethylated cytosine using bisulfite (Fig. 7; and para. 20).
Mitra teaches PCR amplifying the converted polynucleotides to produce amplicons using universal primers tailed with DNA barcodes (Fig. 7; and para. 20), that have a five base pair combination (para. 189). It is noted that the barcodes of Mitra are structurally indistinguishable from those of the claim having “a first randomly generated UMI polynucleotide sequence”.
Mitra teaches sequencing the plurality of amplicons to produce amplicon sequence reads that correspond to one of the plurality of amplicon polynucleotides and includes the barcode (Fig. 7; and para. 20). Because the amplicons are of converted polynucleotides, they include a thymine at each nucleotide position corresponding to a reduced unmethylated cytosine and a cytosine at each methylated cytosine. One would appreciate that the system is not perfect and as a consequence errors may be introduced from incomplete bisulfite conversion, amplification errors, sequencing errors, etc.
Mitra teaches aligning sequence reads with reference sequences (para. 169).
Mitra teaches comparing reads to reference sequences and identifying C positions (para. 103 and 190).
Mitra further teaches using information to find a threshold to classify a locus as methylated or unmethylated in each sample. Mitra teaches optimization queries many CpGs for each locus with the bisulfite sequencing data. Mitra teaches the information was used to optimize a classifier for designating a sequence as methylated or unmethylated. For example, for Mitra an optimal classifier for classifying a sample as “methylated” was if more than 20% of CpG positions per molecule were methylated in more than 35% of molecules (para. 191), which distinguishes their tumor samples from normal samples.
Markowitz teaches that in the context of other samples different thresholds can be reached. For example, using bisulfite sequencing data, Markowitz counted the number of CpGs that were methylated between the amplification primers, and the read was classified as methylated or unmethyled using cutoffs for a required number of methylated CpGs on the amplicon (p. 85, line 29 to p. 86, line 18). For Markowitz, at least 14 CpGs out of 16 CpGs must be methylated in order to call a SqBE read methylated (p. 86, lines 2-5) or for VIM at least 8 of 10 CpGs must be methylated to call the read methylated (p. 90, lines 19-25).
Thus, it is routine to optimize the thresholds based on the samples and the individual genes being analyzed as described by Mitra. Markowitz demonstrates further that selecting thresholds of at least 75% was achieved through optimization. Thus, the present threshold of the amended claim is an obvious variant of the approach of Mitra and Markowitz that is achievable through routine optimization.
Regarding claim 16, Mitra teaches calculating the fraction of methylated target polynucleotides within the total target polynucleotides of the samples (para. 191 and para. 23 and 173).
Regarding claim 17, Mitra teaches the exonuclease resistant modification is a phosphorothioate modification (para. 67).
Regarding claim 18, Mitra teaches the use of “patch” oligonucleotides that hybridize to target polynucleotides and one of either the upstream universal primer or the downstream universal primer, in order to ligate the universal primers to the target polynucleotide (Fig. 4 and 7; paras. 17 and 20).
Regarding claims 21-23, Mitra teaches the target polynucleotide is known to have a specific methylation pattern in colon tumors or breast tumors (para. 24 and 167).
Regarding claim 26, Mitra teaches the target nucleotide sequence includes multiple 5’-C-G-3’ nucleotide pairs (Fig. 11).
Regarding claim 27, Mitra teaches the methylation of cytosines in a plurality of target polynucleotide sequences or “loci” are detected for a sample (Fig. 11).
Regarding claim 28, Mitra teaches detecting the methylation of cytosines in 94 targeted promoters (para. 160).
While Mitra teaches that barcodes are added via a primer, Mitra does not specifically teach the ligated polynucleotides contains a barcode.
However, Brown teaches it was known that barcodes can be added to polynucleotides via primers such as the tailed primer elongation approach of Mitra or by ligation such as ligation of sequences to a molecule (para. 97).
It would have been prima facie obvious to the ordinary artisan at the time of filing that an obvious variant of attaching barcodes to a polynucleotide using the primer of Mitra would be to attach them through ligation as demonstrated by Brown. The modification of simply substituting primer based barcoding for the ligation based barcoding of Brown has a reasonable expectation of success as Brown demonstrates the two are functionally equivalent ways to barcode a polynucleotide.
While Mitra teaches aligning and analyzing sequences, Mitra does not teach generating a consensus sequence for the sequencing reads.
However, Eltoukhy teaches how to determine a consensus sequence.
Eltoukhy teaches sequence reads are grouped into families, with about 10 sequence reads in each family. Families are collapsed into consensus sequences by voting (e.g., biased voting) each position in a family. A base is called for consensus sequence if 8 or 9 members agree and a base is not called for consensus sequence if no more than 60% of the members agree. See para. 232.
It would have been prima facie obvious to the ordinary artisan at the time of filing to have modified the method of Mitra to incorporate the base calling and consensus sequence determination approach of Eltoukhy. The consensus sequences may be used to more accurately determine methylation profiles in a manner analogous to that described by Eltoukhy (para. 233) as well as for being useful for observing sequences over time (para. 164). Eltoukhy teaches the general parameters for consensus sequence generation, thus rendering obvious the elements of the claims.
Mitra teaches bisulfite treatment as noted above and does not teach converting methylated cytosine to dihydrouracil (claim 15) or the use of TET (claim 19).
However, Song teaches TAPS or “TET Assisted Pyridine borane Sequencing” is a known method that detects nucleic acid modifications directly with high sensitivity and specificity, without affecting unmodified cytosines, and can be adopted to detect other cytosine modifications. Song teaches that TAPS is non-destructive, preserving RNA and DNA up to 10 kbs long. Song further teaches that compared with bisulfite sequencing, TAPS results in higher mapping rates, more even coverage and lower sequencing costs, enabling higher quality, more comprehensive and cheaper methylome analyses.
It would have been prima facie obvious at the time of filing to have modified the method of Mitra by incorporating the TAPS method of Song. One would have been motivated to make the modification because TAPS is less destructive than bisulfite treatment and TAPS results in higher mapping rates, more even coverage and lower sequencing costs, enabling higher quality, more comprehensive and cheaper methylome analyses. Furthermore, because Mitra does not want the sequences of the ligated primers to change, one would have been motivated to use cytosine in the GC content of the primers such that they are not altered during the TAPS method.
Response to the traversal of the 103 rejections
The Remarks argue the cited combination of references would not have taught or suggested the claimed methods without any reasonable expectation of success (p. 13). The Remarks, referring to the declaration by Dr. Varley, summarizes features of the invention (p. 13). The Remarks argue Fig. 7 of the application illustrates an exemplary workflow of the claimed method that includes the use of distinct UMIs ligated to one end of two independent template molecules and the use of UMIs allows the method to uniquely identify the individual template molecules and provide error correction to reduce false-positive methylation calls (p. 14). The Remarks argue each UMI that has at least 5 sequencing reads is analyzed to calculate a consensus call for each CG in the molecule (p. 14). The Remarks then summarize the thresholds for making calls regarding a consensus sequence and methylation status of the template molecule (p. 14-15). The Remarks argue the UMI error correction followed by counting molecules that were methylated across multiple CGs was the most effective strategy for quantifying low levels of methylated DNA (p. 15).
The arguments have been full considered but are not persuasive. The arguments and the declaration rely on elements that are not required by the present claims. For example, sequence reads are aligned to a “target polynucleotide reference sequence” only. Nowhere in the claim are sequence reads aligned or sorted by common or shared UMI sequences. Furthermore, there is no limitation that independent template molecules have unique UMI sequences. The claims read on not only a plurality of “target polynucleotides” being processed and sequenced, the claim also embraces a single “target polynucleotide”. Thus, the arguments are not commensurate in scope with the invention as currently claimed and rely upon features that are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The Remarks argue the cited references fail to teach or suggest methods that allow for such accurate quantification of extremely rare/low level methylation events (p. 15).
The arguments have been full considered but are not persuasive. The arguments rely upon features, i.e., extremely rare/low level methylated target polynucleotides or quantifying any type of molecule, that are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The Remarks argue Mitra focuses on genomic DNA loci rather than individual target nucleotide molecules (p. 15) and does not determine which original template molecules the sequencing reads are from (p. 15-16). The Remarks similarly argue this in regards to the Markowitz reference (p. 16).
The arguments have been full considered but are not persuasive. The claims are not limited to “individual target nucleotide molecules” as the UMIs are not limited to uniquely identifying an independent template molecule or aligning/sorting reads based upon UMI sequences. At best, the sequences are only identified by aligning them to a “target polynucleotide reference sequence” with no requirement of relying on the UMI sequence in doing so.
The Remarks argue the barcodes of Mitra are different than those of the claims and are not randomly generated (p. 16).
The arguments have been full considered but are not persuasive. The UMI polynucleotide is claimed as being ligated to a target polynucleotide. The claim does not require the use of a pool or plurality of UMI polynucleotides, each having a unique random sequence. The claim reads on a single UMI polynucleotide ligated to a single target polynucleotide. The claim further does not require a step of randomly generating the UMI polynucleotide, e.g., a random sequence of 12 bases composed of 5-methyl-C, G, A or T that uniquely identify individual template molecules. In short, the claim describes how a UMI was made but does not require making it or using a plurality of UMI. The claim also does not require sorting molecules based on the UMI sequence. The structure of the singular UMI used in isolation is not structurally different than any other barcode sequence added to a nucleic acid molecule. For example, the structure of a nucleic acid sequence, such as ATCGATCGATCG, does not identify whether the sequence as designed or randomly generated. Furthermore, a set of randomly generated 10-mers is not structurally different from a set designed to include all possible 10-mer sequences.
The Remarks argue if the ordinary artisan were to perform the methods described by Mitra or Markowitz, each of which fails to teach or suggest the claimed UMI-based error correction, it would result in significantly higher rate of false positive methylation detection (p. 16).
The arguments have been full considered but are not persuasive. The arguments are not commensurate in scope with the claimed methods as UMI-based error correction is not required. The only use of the UMI as presently claimed is to be ligated to a target polynucleotide. The remainder of the claim is absent of any use of the UMI or its sequence.
The Remarks argue Eltoukhy does not describe a consensus approach or threshold for methylation detection after chemical or enzymatic conversion, nor does Eltoukhy employ a cis-CG threshold to determine whether the consensus polynucleotide. The Remarks further argue the method of Eltoukhy results in a higher false positive methylation detection. See p. 16-17.
The arguments have been full considered but are not persuasive. The elements alleged to be missing from Eltoukhy are provided in the other references relied upon. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The Remarks argue Vaisvila does not cure the deficiencies of Mitra, Markowitz, Brown and Elthoukhy as Vaisvila is only relied upon for the elements of dependent claim 5 (p. 17).
The arguments have been full considered but are not persuasive. The combination renders obvious the claims in view of their broadest reasonable interpretation. The arguments and the declaration are not commensurate in scope with the claimed methods, which do not rely on the UMI or its sequence in any of the analysis resulting in a consensus sequence or cis-CG analysis.
The Remarks argue claim 15 is similar to claim 1 and the deficiencies of Mitra, Markowitz, Brown and Eltoukhy are not cured by the Song reference (p. 18).
The arguments have been full considered but are not persuasive. The combination renders obvious the claims in view of their broadest reasonable interpretation. The arguments and the declaration are not commensurate in scope with the claimed methods, which do not rely on the UMI or its sequence in any of the analysis resulting in a consensus sequence or cis-CG analysis.
Conclusion
No claims allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 JOSEPH G DAUNER whose telephone number is (571)270-3574. The examiner can normally be reached 7 am EST to 4:30 EST with second Fridays Off.
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/JOSEPH G. DAUNER/ Primary Examiner, Art Unit 1682
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