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 .
Applicant’s amendment filed on November 12, 2025 is acknowledged and has been entered. Claim 1 and 16 have been canceled. Claims 2 and 17 have been amended. Claims 2-15 and 17-23 are pending.
Claims 2-15 and 17-23 are discussed in this Office action.
All of the amendments and arguments have been thoroughly reviewed and considered but are not found persuasive for the reasons discussed below. Any rejection not reiterated in this action has been withdrawn as being obviated by the amendment of the claims. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This action is made NON-FINAL to address New Ground of Rejection.
New Grounds of Rejection
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 22, 2025 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 61395850 (‘850 application), 61398159 (‘159 application), 61426208 (‘208 application) and 61462972 (‘972 application), fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. In the ‘850 application, while the disclosure teaches amplification of cell free nucleic acids via PCR, the tagging and detection from one individual from another, particularly where one of the individuals includes a transplant patient was not supported in the disclosure. In the ‘159 and the ‘208 applications, while the applications provide support for amplification of cell free nucleic acids and including mutations and sequencing, the disclosures do not provide support for tagging, barcodes or distinguishing individuals in a mixture. While the ‘972 application provides support for cell free nucleic acids, multiplex amplification and sequencing, the application does not provide support for barcoding or enrichment.
Further, to consider the amendment to the claims, the disclosure of the prior-filed application, Application No. 61448547 (‘547 application), 61516996 (‘996 application), 13110685 (‘685 application), 61571248 (‘248 application), 61542508 (‘508 Application), 13300235 (‘235 application) and 61634431 (‘431 application) fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. While these applications teach amplification of cell free nucleic acids via PCR, the tagging and detection from one individual from another and other aspects of the method, as claimed, none of these applications have support for the inclusion of non-naturally occurring composition within the method, as now amended.
Therefore, the claims are entitled to an earliest priority date of July 24, 2012 as recited in the 61675020 application.
Previous Grounds of Rejection - adjusted to address amendment to the claims
Claim Rejections - 35 USC § 103
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.
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) 2-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rava et al. (US PgPub 20120010085; January 2012), May et al. (US PGPub 20140227691; August 2014) in view of Quake et al. (US Patent 8,703,652; April 2014).
With regard to claim 2, Rava teaches a method for preparing a biological sample useful for measuring an amount of DNA from a first individual in the biological sample of a second individual, comprising:
pre-amplifying polymorphic loci from cell-free DNA in a single reaction volume pre-amplified DNA of mixed origin, wherein the cell-free DNA is extracted from the biological sample and comprises DNA from the first individual and DNA from the second individual (paragraph 141 where multiplex amplification of SNP loci of 40 or more sets of PCR primers are included in amplification; paragraph 231 and 233, where preamplification of cell free DNA is described);
performing targeted amplification on the pre-amplified DNA at the polymorphic loci using primers to obtain amplified DNA; and to obtain a sequencing library of the amplified DNA to prepare the amplified DNA for high-throughput sequencing (paragraph 142, where amplified polymorphic sequences are used to prepare a sequencing library; see also paragraph 141 where multiplex amplification of specific primers are described) and
wherein the method is performed without prior knowledge of genotypes of the first and second individuals (paragraph 132, where the method can be used to determine genotype of fetal alleles, for example).
With regard to claim 4, Rava teaches a method of claim 2, wherein the biological sample is a blood, serum, plasma, or urine sample (paragraph 10, where the source sample can include blood, plasma, serum, saliva).
With regard to claim 5, Rava teaches a method of claim 2, wherein the pre-amplifying step comprises 10-30 PCR cycles (paragraph 170 where nucleic acid can be amplified using 1 to 40 cycles).
With regard to claim 6, Rava teaches a method of claim 2, wherein the pre-amplifying step comprises 15 PCR cycles (paragraph 170 where nucleic acid can be amplified using 1 to 40 cycles).
With regard to claim 11, Rava teaches a method of claim 2, wherein the polymorphic loci are SNP loci (paragraph 14-15, 18-20 where SNP loci are amplified).
With regard to claim 15, Rava teaches a method of claim 2, wherein the sequencing is sequencing-by-synthesis (paragraph 215, where sequencing by synthesis is used for sequencing).
With regard to claim 17, Rava teaches a method for preparing a biological sample useful for measuring an amount of DNA from a first individual in the biological sample of a second individual, comprising:
pre-amplifying SNP loci from cell-free DNA in a single reaction volume to obtain pre-amplified DNA of mixed origin, wherein the cell-free DNA is extracted from the biological sample and comprises DNA from the first individual and DNA from the second individual, (paragraph 141 where multiplex amplification of SNP loci of 40 or more sets of PCR primers are included in amplification; paragraph 231 and 233, where preamplification of cell free DNA is described);
performing targeted amplification on the pre-amplified DNA at the at least 50 SNP using at least 50 PCR primers to obtain amplified DNA; performing a barcoding PCR on the amplified DNA to obtain a barcoded sequencing library such that multiple samples can be sequenced together in a single sequencing lane by high-throughput sequencing (paragraph 142, where amplified polymorphic sequences are used to prepare a sequencing library; see also paragraph 141 where multiplex amplification of specific primers are described) and
wherein the method is performed without prior knowledge of genotypes of the first and second individuals (paragraph 132, where the method can be used to determine genotype of fetal alleles, for example).
With regard to claim 22, Rava teaches a method of claim 1, wherein pre-amplifying the polymorphic loci is performed by universal PCR (Example 3, paragraph 191-192 where universal amplification is used).
With regard to claim 23, Rava teaches a method of claim 1, wherein pre-amplifying the polymorphic loci is performed by targeted PCR (paragraph 142, where amplified polymorphic sequences are used to prepare a sequencing library; see also paragraph 141 where multiplex amplification of specific primers are described).
Regarding claims 2-3, 7-10, 12-14 and 17-23, while Rava teaches methods that include pre-amplification of polymorphic loci of mixed origin to obtain pre-amplified DNA of mixed origin, Rava does not specifically teach preamplification of at least 50 polymorphic loci. Further, while Rava teaches methods that include pre-amplification and multiplex amplification, Rava does not specifically teach the inclusion of or preparing a non-naturally occurring composition.
With regard to claim 2, May teaches a method for preparing a non-naturally occurring composition from a biological sample and
pre-amplifying at least 50 polymorphic loci from cell-free DNA in a single reaction volume to obtain a non-naturally occurring composition of, wherein the cell-free DNA is extracted from the biological sample and comprises DNA from the first individual and DNA from the second individual, wherein the DNA from the first individual comprises DNA from a transplant (see paragraph 29, where the nucleic acid can include non-natural linkages and composition components; paragraph 199 where up to 1000 loci are amplified via multiplex; paragraph 71, 198, 110 where the method of amplification includes pre-amplification steps before multiplex amplification; see paragraph 76, where cell free nucleic acid is amplified using steps of pre-amplification and multiplex amplification);
performing targeted amplification on the pre-amplified DNA at the at least 50 polymorphic loci using at least 50 PCR primers to obtain amplified DNA; and barcoding the amplified DNA to obtain a barcoded sequencing library of the amplified DNA to prepare the amplified DNA for high-throughput sequencing (paragraph 199 where up to 1000 loci are amplified via multiplex; paragraph 71, 198, 110 where the method of amplification includes pre-amplification steps before multiplex amplification; see paragraph 76, where cell free nucleic acid is amplified using steps of pre-amplification and multiplex amplification).
With regard to claim 3, May teaches a method of claim 2, wherein the targeted amplification comprises dividing the pre-amplified DNA into multiple aliquots; amplifying subpools of the polymorphic loci in parallel in individual reaction volumes to obtain amplified DNA, wherein each reaction volume comprises at least one aliquot of the pre-amplified DNA; and pooling the amplified DNA into one pool (paragraph 199 where up to 1000 loci are amplified via multiplex; paragraph 71, 198, 110 where the method of amplification includes pre-amplification steps before multiplex amplification; see paragraph 76, where cell free nucleic acid is amplified using steps of pre-amplification and multiplex amplification).
With regard to claim 7, May teaches a method of claim 2, wherein 50-5,000 polymorphic loci are pre-amplified in a single reaction volume (paragraph 199 where up to 1000 loci are amplified via multiplex; paragraph 71, 198, 110 where the method of amplification includes pre-amplification steps before multiplex amplification; see paragraph 76, where cell free nucleic acid is amplified using steps of pre-amplification and multiplex amplification).
With regard to claim 8, May teaches a method of claim 2, wherein 50-500 polymorphic loci are pre- amplified in a single reaction volume (paragraph 199 where up to 1000 loci are amplified via multiplex; paragraph 71, 198, 110 where the method of amplification includes pre-amplification steps before multiplex amplification; see paragraph 76, where cell free nucleic acid is amplified using steps of pre-amplification and multiplex amplification).
With regard to claim 9, May teaches a method of claim 2, wherein more than 100 polymorphic loci are pre-amplified in a single reaction volume (paragraph 199 where up to 1000 loci are amplified via multiplex; paragraph 71, 198, 110 where the method of amplification includes pre-amplification steps before multiplex amplification; see paragraph 76, where cell free nucleic acid is amplified using steps of pre-amplification and multiplex amplification).
With regard to claim 10, May teaches a method of claim 2, wherein more than 200 polymorphic loci are pre-amplified in a single reaction volume (paragraph 199 where up to 1000 loci are amplified via multiplex; paragraph 71, 198, 110 where the method of amplification includes pre-amplification steps before multiplex amplification; see paragraph 76, where cell free nucleic acid is amplified using steps of pre-amplification and multiplex amplification).
With regard to claim 12, May teaches a method of claim 2, wherein the polymorphic loci comprise SNP loci on chromosome 1 (paragraph 78, 98, 109 where multiple chromosomes are analyzed; including mention of tagging each chromosome).
With regard to claim 13, May teaches a method of claim 2, wherein the polymorphic loci comprise SNP loci on chromosome 2 (paragraph 78, 98, 109 where multiple chromosomes are analyzed; including mention of tagging each chromosome).
With regard to claim 14, May teaches a method of claim 2, wherein the polymorphic loci comprise SNP loci on chromosome 3 (paragraph 78, 98, 109 where multiple chromosomes are analyzed; including mention of tagging each chromosome).
With regard to claim 17, May teaches a method for preparing a non-naturally occurring composition from a biological sample useful for measuring an amount of DNA from a first individual in the biological sample of a second individual, comprising:
pre-amplifying at least 50 SNP loci from cell-free DNA in a single reaction volume to obtain a non-naturally occurring composition of pre-amplified DNA of mixed origin, wherein the cell-free DNA is extracted from the biological sample and comprises DNA from the first individual and DNA from the second individual, wherein the DNA from the first individual comprises DNA from a transplant (see paragraph 29, where the nucleic acid can include non-natural linkages and composition components; paragraph 199 where up to 1000 loci are amplified via multiplex; paragraph 71, 198, 110 where the method of amplification includes pre-amplification steps before multiplex amplification; see paragraph 76, where cell free nucleic acid is amplified using steps of pre-amplification and multiplex amplification).
With regard to claim 18, May teaches a method of claim 2, wherein the cell-free DNA of mixed origin comprises non-human nucleic acids (paragraph 106, where non-human nucleic acids can be included in the mixture).
With regard to claim 19, May teaches a method of claim 2, wherein one or more PCR primers target non-human target loci (paragraph 106, where non-human nucleic acids can be included in the mixture).
With regard to claim 20, May teaches a method of claim 17, wherein the cell-free DNA of mixed origin comprises non-human nucleic acids (paragraph 106, where non-human nucleic acids can be included in the mixture).
With regard to claim 21, May teaches a method of claim 17, wherein one or more PCR primers target non-human target loci (paragraph 106, where non-human nucleic acids can be included in the mixture).
With regard to claim 22, May teaches a method of claim 1, wherein pre-amplifying the at least 50 polymorphic loci is performed by universal PCR (paragraph 78, where common or universal primers are included).
With regard to claim 23, May teaches a method of claim 1, wherein pre-amplifying the at least 50 polymorphic loci is performed by targeted PCR (paragraph 78, where common or universal primers are included).
Regarding claims 2 and 17, while May teaches methods of amplification and sequencing that include steps of preamplification, May does not specifically address DNA from transplantation.
With regard to claim 1 and 17, Quake teaches wherein the DNA from the first individual comprises DNA from a transplant (Abstract, Figure 3 and Figure 4, where donor DNA is detected in transplantation patient samples; also Figure 5, where the method of monitoring transplant patients is described; see also Examples 1 and 2, especially Example 2 where transplant donor and recipient were detected and genotyped using sequencing techniques).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have adjusted the teachings of Rava to include the methods of multiplex amplification as described by May to arrive at the claimed invention with a reasonable expectation for success. Rava teaches “there is a need for additional methods that would enable the determination of the fraction of fetal nucleic acid in both male and female pregnancies” (paragraph 007). Rava also teaches “the means to determine fetal fraction that is independent of the gender of the fetus. The method can be applied for determining simultaneously the presence or absence of a chromosomal aneuploidy or other copy number variation, and may be used in conjunction with nay known methods that are used to determine aneuploidies in maternal sample” (paragraph 008). While both Rava and May teach preamplification of cell free nucleic acids, Rava is focused on amplification of the whole sample, which includes a mix of nucleic acids, as claimed. Further, May teaches methods that include steps of pre-amplification that are focused on “methods for selectively enriching a biological sample for short nucleic acids, such as fetal DNA in a maternal sample or apoptic DNA in a biological sample from a cancer patient and for subsequently analyzing the short nucleic acids for genotype, mutation, and/or aneuploidy” (paragraph 22). Therefore, one of ordinary skill in the art at the time the invention was made would have adjusted the teachings of Rava to include the methods of multiplex amplification as described by May to arrive at the claimed invention with a reasonable expectation for success.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have adjusted the method of amplification and sequencing as taught by May to include the specific detection and monitoring of transplant recipients using cell free nucleic acids as claimed to arrive at the claimed invention with a reasonable expectation for success. May teaches methods that include steps of pre-amplification that are focused on “methods for selectively enriching a biological sample for short nucleic acids, such as fetal DNA in a maternal sample or apoptic DNA in a biological sample from a cancer patient and for subsequently analyzing the short nucleic acids for genotype, mutation, and/or aneuploidy” (paragraph 22). Quake teaches methods for monitoring transplantation and note “invention describes sensitive and non-invasive methods, devices, compositions and kits for monitoring organ transplant patients, and/or for diagnosing or predicting transplant status or outcome (e.g. transplant rejection). In some embodiments, the methods, devices, compositions and kits are used to establish a genotype for both the donor and the recipient before transplantation to enable the detection of donor-specific nucleic acids such as DNA or RNA in bodily fluids such as blood or urine from the organ recipient after transplantation.” (col. 3, lines 52-61). Quake also teaches “In some embodiments, the invention provides non-invasive diagnostics exists for organ transplant patients where sequences from the organ donor, otherwise "foreign" to the patient, can be quantitated specifically. Without intending to be limited to any theory, as cell-free DNA or RNA often arises from apoptotic cells, the relative amount of donor-specific sequences in circulating nucleic acids should provide a predictive measure of on-coming organ failure in transplant patients for many types of solid organ transplantation including, but not limited to, heart, lung, liver, and kidney” (col. 7, lines 37-46) and finally that “the invention provides methods, devices, compositions and kits for detection and/or quantitating circulating nucleic acids, either free in plasma or from circulating cells, for the diagnosis, prognosis, detection and/or treatment of a transplant status or outcome. There have been claims of detection of donor-DNA in sex-mismatched liver and kidney transplant patients; conventional PCR was used to search for Y chromosome sequences from male donors in the blood of female patients. (Lo, Y. M., et al., Lancet, 351, 1329-1330 (1998) (col. 7, lines 48-52). Both May and Quake describe non-invasive methods to improve isolation and detection of nucleic acids and where Quake uses the circulating nucleic acids for monitoring transplant patients. Therefore, one of ordinary skill in the art at the time the invention was made would have adjusted the method of amplification and sequencing as taught by May to include the specific detection and monitoring of transplant recipients using cell free nucleic acids as claimed to achieve non-invasive and sensitive methods for amplification as claimed.
Response to Arguments
Applicant's arguments filed November 12, 2025 have been fully considered but they are not persuasive.
Applicant traverses the rejection over a combination of Rava, May and Quake. Applicant argues "Neither of the references, either alone or in combination teach or suggest "pre-amplifying at least 50 SNP loci from cell-free DNA in a single reaction volume to obtain pre-amplified DNA of mixed origin..." (p 7 of remarks)
Applicant argues "The methods disclosed in May first enrich fetal DNA from the sample, for example, using exonuclease digestion of maternal DNA" and that "Therefore, the amplified DNA produced in the methods of May, comes from a single origin, i.e., fetal origin." (p 7 of remarks).
Applicant concludes "Enrichment, particularly using the methods disclosed in May, is not equivalent to amplification or preamplification. Accordingly, May does not teach or suggest "pre-amplifying at least 50 SNP loci from cell-free”
Next, Applicant argues "The combination of references fails to teach or suggest targeted multiplex PCR amplification on the pre-amplified DNA at the at least 50 polymorphic loci using at least 50 PCR primers" (p 8 of remarks)
Regarding Rava Applicant argues "Rava teaches selecting 28 SNPs and designing primers to amplify the SNPs, only 13 of these SNPs were ultimately selected for multiplex amplification. See, Rava par. [0192] and Table 1. Accordingly Rava does not disclose multiple amplification of 50 polymorphic loci using 50 PCR primers" (p 8 of remarks)
Applicant argues May "utilize microfluidic devices, which "can allow the simultaneous pair-wise combination of a plurality of different amplification primers and samples. In certain
embodiments, the device is configured to contain a different combination of primers and samples
in each of the different chambers" (p 8 of remarks)
Applicant argues Quake does not teach performing multiplex PCR. Applicant also argues "neither example teaches or suggests how to quantify transplant derived cfDNA without a predetermined marker profile or prior knowledge of genotypes of the transplant" (p 10 of remarks)
First, regarding May, Applicant argues May does not teach amplification of a mixture because the method of May includes enrichment. It is noted in response that within the rejection, the mixture of nucleic acids as claimed is described primarily by Rava, not by May. It is also noted that the need for enrichment or an enrichment step does not teach away from the original sample including a mixed sample or a sample which includes a mixed origin. The prior art, regarding the steps or need for preamplification often note the preamplification step provides enrichment of nucleic acids prior to further processing and analysis. If the premise of Applicant’s remarks were true, that the need to enrich a sample prior to analysis, for example through pre-amplification steps, this position would indicate the original sample of the claimed method also does not include a sample of mixed origin or that the method would be rendered non-functional. This line of argument is wholly unpersuasive.
Applicant also argues the combination of references does not teach or suggest "pre-amplifying at least 50 SNP loci from cell-free DNA in a single reaction volume to obtain pre-amplified DNA of mixed origin...". Except, May very clearly teaches across paragraphs 71-76 the details of preamplification of samples and the importance of preamplification. Within those passages, May also teaches from 2 to 1000 or more target sequences are analyzed and amplified. These teachings are reinforced by the passage at paragraph 199, as cited within the rejection, where further multiplex is described. Even if May does not specifically describe the multiplex approach as including the pre-amplification steps, the disclosure does in the passages cited. Therefore, while Applicant’s remarks regarding the number of loci pre-amplified within Rava is noted, the loci pre-amplified within May combined with the teachings of May absolutely renders pre-amplification of at least 50 loci or SNPs obvious.
Regarding Applicant’s arguments that May effectively teaches away from simultaneous amplification and only teaches single amplification in plural individual receptacles ignores the overall sum of the teachings of May. While May does teach a microfluidic device, that array-based device is described as useful for pairwise combinations of samples, the device can also be used for digital array amplification (paragraph 193), a method which isolates particular targets or primers, by design. However, May also teaches multiplex amplification in multiple places throughout the disclosure. For example, at paragraph 109, May teaches the tagging of “a large number of different sequences” including “2 or more, 3 or more, 5 or more, 10 or more, 15 or more, 20 or more, 50 or more, 100 or more per chromosome or other template(s)), can be tagged. Moreover using various tagging strategies, different amplification produces are readily discriminated thereby permitting the methods to be highly multiplexed”. It is also noted, while the citation in paragraph 199, as cited in the rejection mentions both multiplex detection and individual reaction chambers, the passage states “In various embodiments, up to 2, 3, 4, 5, 6, 7, 8, 9, 10, 50, 100, 500, 1000, 5000, 10000 or more amplification reactions are carried out in each individual reaction chamber”. Finally, it is noted that their method of multiplex detection “facilitates multiplex detection wherein two or more different amplification products can be detected in a given amplification mixture or aliquot thereof”. These teachings taken together implies these reactions are carried out together in the chambers, as described.
Therefore, while Applicant’s arguments are noted, they are not persuasive because May teaches and suggests high level multiplex amplification, as claimed.
Finally, regarding Quake, while Applicant argues Quake does not teach multiplex and that the transplantation detection within Quake cannot be practiced without prior knowledge of genotype. In response it is noted, Quake is not relied upon for teaching multiplex amplification. It is also noted that while Quake does describe techniques where the donor and recipient are genotyped prior to transplantation, Quake also teaches scenarios where the donor and recipient can be genotyped and sequenced after transplantation. See for example col. 15, lines 1-21 and col. 17 line 41 and col. 18 line 40. Therefore, while Applicant’s arguments are considered, they are not persuasive. The rejections are maintained.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Forshew et al. (Sci Translat Med, 2012, 4 (136):1-8 and additional supplementary materials) and Sieuwerts et al. (Clin Cancer Res, 2011, 17 (11):3600-3618) teach methods that include preamplification and multiplex amplification.
Li Y, Biochemical and Clinical Diagnostic Aspects of Circulating Nucleic Acids. Sweden. University of Basel. PhD Thesis. 2005 discusses the usefulness of a circulating nucleic acids in a variety of questions, yet also focuses on the detection of urinary DNA as a marker for renal transplantation. Puszyk, William Matthew. Epigenetics of cell-free plasma DNA for non-invasive prenatal diagnosis of fetal aneuploidies. Diss. University of Warwick, 2008 where Puszyk includes detection of cell-free nucleic acid present in plasma of transplantation patients.
Conclusion
No claims are allowed. All claims stand rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE KANE MUMMERT whose telephone number is (571)272-8503. The examiner can normally be reached M-F 9:00-5:30.
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/STEPHANIE K MUMMERT/Primary Examiner, Art Unit 1637