DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. This action is in response to the papers filed April 7, 2026. Applicant’s remarks and amendments have been fully and carefully considered but are not found to be sufficient to put the application in condition for allowance. Any new grounds of rejection presented in this Office Action are necessitated by Applicant's amendments. Any rejections or objections not reiterated herein have been withdrawn. This action is made FINAL.
Claims 1-5, 10, 13, 28-31, 35, 39, 43, 85 are currently pending.
Claims 28-31, 35, 39, and 43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 22, 2025.
Claim Rejections - 35 USC § 101
3. 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 1-5, 10, 13, and 85 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claims recite a judicial exception that is not integrated into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim analysis is set forth below.
Step 1: The claims are directed to the statutory category of a process.
Step 2A, prong one: Evaluate Whether the Claim Recites a Judicial Exception
The instant claims recite abstract ideas.
The claims recite a step of “determining” whether the amount of DS cf-DNA is equal to or exceeds a threshold to assess the grade of cellular rejection (clm 1). The broadest reasonable interpretation of the “determining” step is that it may be accomplished by a mental processes. For example, one may determine whether the amount of DS cf-DNA is equal to or exceeds a threshold by reading these amounts in a laboratory and thinking about whether the amount of DS cf-DNA is greater than the threshold.
The claims recite a step of “determining” that the subject has or is at increased risk of having cellular rejection grade 1 (CR1) or grade 2 (CR2) based on the determination (clms 2 and 3). The broadest reasonable interpretation of the “determining” step is that it may be accomplished by a mental processes. For example, one may determine the cellular rejection grade by thinking about how much the amount of DS cf-DNA is greater than the threshold.
The claims recite a step of “determining” a treatment or monitoring regime for the subject based on the determination (clm 4). The “determining” step broadly encompasses a mental processes. For example, one may “determine” the treatment or monitoring regime for a subject by thinking about the amount of DS cf-DNA and the threshold.
The claims recite a step of “assigning” a cellular rejection grade to the subject based on the determination (clm 5). The broadest reasonable interpretation of the “assigning” step is that it may be accomplished by a mental processes. For example, one may “assign” the cellular grade by thinking about the amount of DS cf-DNA and the threshold.
The claims recite a step of “selecting or suggesting” a treatment for the subject (clm 85). The broadest reasonable interpretation of the “selecting or suggesting” step is that it may be accomplished by a mental processes. For example, one may “select” a treatment by thinking about the amount of DS cf-DNA. Further suggesting can be done verbally.
The instant claims recite a law of nature.
The claims recite a correlation between the amount of DS cfDNA and cellular rejection grade. This type of correlation is a consequence of natural processes, similar to the naturally occurring correlation found to be a law of nature by the Supreme Court in Mayo.
Step 2A, prong two: Evaluate Whether the Judicial Exception Is Integrated Into a Practical Application
The claims do NOT recite additional steps or elements that integrate the recited judicial exceptions into a practical application of the exception(s). For example, the claims do not practically apply the judicial exception by including one or more additional elements that the courts have stated integrate the exception into a practical application:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
An additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
An additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
An additional element effects a transformation or reduction of a particular article to a different state or thing; and
An additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological
environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
In addition to the judicial exceptions claim 1 recites extracting cf-DNA from the sample; (b) preparing a preparation of amplified DNA by performing PCR amplification on the cf-DNA obtained in (a); and (c) quantifying an amount of donor-specific cell-free DNA (DS cf- DNA) in the preparation. These steps are NOT considered to integrate the judicial exceptions into a practical application because they merely add insignificant extra-solution activity (data gathering) to the judicial exception.
In addition to the judicial exceptions claim 85 recites a step of “treating” the subject. It is noted that a claim limitation can integrate a judicial exception by applying or using the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. However the treatment or prophylaxis limitation must be “particular”, i.e., specifically identified so that it does not encompass all applications of the judicial exceptions. Here the administration step is not particular, and is instead merely instructions to “apply” the exception in a generic way. Thus, the administration step does not integrate the judicial exceptions into a practical application.
Step 2B: Evaluate Whether the Claim Provides an Inventive Concept
In addition to the judicial exceptions claim 1 recites extracting cf-DNA from the sample; (b) preparing a preparation of amplified DNA by performing PCR amplification on the cf-DNA obtained in (a); and (c) quantifying an amount of donor-specific cell-free DNA (DS cf- DNA) in the preparation. These steps do not amount to significantly more because they simply append well understood, routine, and conventional activities previously known in the art, specified at a high level of generality, to the judicial exceptions.
For example, Grskovic (The Journal of Molecular Diagnostics Vol 18 No 6 November 2016) describes an assay to measure donor derived cell free DNA in solid organ transplant recipients. Grskovic teaches that the dd-cfDNA assay is based on targeted amplification of DNA regions harboring 266 SNPs and the measurement by NGS of each allele contribution at each SNP position. cfDNA extracted from 1.25 mL plasma or reference materials (described above, used at 3, 8, or 60 ng) was preamplified in a single multiplex reaction with 266 primer pairs for 15 cycles. Preamplified material was further amplified using 48 limited complexity multiplexes (1 to 11 targets per reaction) on the Access Array microfluidic system (Fluidigm, South San Francisco, CA). Index sequences and Illumina sequencing adapters were added to each sample DNA by PCR, and the sample was qualified and quantified by capillary electrophoresis. Up to 16 amplified samples were pooled in equimolar amounts, purified using Agencourt AMPure XP beads (Beckman Coulter, Brea, CA), and sequenced on an Illumina MiSeq instrument (page 892, col 2).
Further it is noted that the courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity.
Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017);
Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015);
Detecting DNA or enzymes in a sample, Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017);
Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs., 818 F.3d at 1377; 118 USPQ2d at 1546;
Amplifying and sequencing nucleic acid sequences, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014)
For the reasons set forth above the claims are not directed to patent eligible subject matter.
Response To Arguments
4. In the response the Applicants traversed the rejection under 35 USC 101. In the response the Applicants argue that similar to the claim found patent eligible by the Federal Circuit in Illumina v. Ariosa Diagnostics, amended claim 1 of the instant application is not directed to a patent-ineligible concept, the claim being directed to a method for assaying cell-free DNA in a sample and reciting steps such as extracting cf-DNA from a sample, performing amplification, and quantifying an amount of donor-specific (DS) cf-DNA. Accordingly, consistent with the Federal Circuit decision in Illumina v. Ariosa Diagnostics, the amended claims of the instant application are not directed to a patent-ineligible concept at step one of the Alice/Mayo test, and it is unnecessary to reach step two of the test.
This argument has been fully considered but is not persuasive. The instant claims are NOT analogous to those that were found patent eligible by the Federal Circuit in Illumina v. Ariosa Diagnostics. The instant claims recite correlations between the amount of DS cfDNA and cellular rejection grades. These correlations are a consequence of natural processes, similar to the naturally occurring correlation found to be a law of nature by the Supreme Court in Mayo. Additionally the claims recite numerous limitations that fall within the mental processes groupings of abstract ideas because they cover concepts performed in the human mind, including observations, evaluation, judgment, and opinion. It is maintained that the claims recite judicial exceptions.
The Applicants further argue that the present claims are patent-eligible because the recited elements that allegedly constitute a judicial exception to patent eligibility are integrated by patent-eligible steps into a practical application of that alleged exception.
This argument has been fully considered but is not persuasive. Each of steps a-c are nothing more than the collection of data as a predicate step to performing the judicial exception of determining whether the amount of DS cf-DNA is equal to or exceeds a threshold to assess the grade of cellular rejection. These steps are insignificant extra solution activity. Data gathering steps cannot make an otherwise nonstatutory claim statutory. It is maintained that the claims do not practically apply the judicial exceptions by including one or more additional elements that the courts have stated integrate the exception into a practical application.
Further Applicants argue that a technology is not routine and conventional merely because it had been discussed in scientific publications. They argue that it must be established that the technology was actually routinely or conventionally used by scientists at the time the invention was made and the application was filed.
This argument has been fully considered but is not persuasive. In addition to the judicial exceptions, the claims recite steps of extracting cf-DNA from a sample, preparing a preparation of amplified DNA by performing PCR, and quantifying the amount of DS cf-DNA in the preparation. The use of standard laboratory techniques to gather data used to observe a law of nature or other judicial exception has consistently been found to be well-understood, routine, and conventional activity. These steps were previously known to the industry (see Grskovic (The Journal of Molecular Diagnostics Vol 18 No 6 November 2016)) and they are specified at a high level of generality. They do not provide an inventive concept.
Claim Rejections - 35 USC § 112
5. 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 10 and 13 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 10 is rejected over the recitation of the phrase “wherein the threshold value is 0.2-0.8”. Claim 10 depends from claim 2 and claim 2 depends from claim 1. When the limitations of these claim are read together, claim 10 requires determining that a subject has or is at increased risk of having cellular rejection grade 1 when the amount of DS-cf-DNA is equal to or exceeds 0.2-0.8. This recitation is confusing because claim 13 requires determining that a subject has or is at increased risk of having cellular rejection grade 2 if the amount of DS cf-DNA is 0.8 or greater. Therefore it is unclear if a subject having an amount of DS cf-DNA that exceeds 0.8 would be considered to have cellular rejection grade 1 (as recited in claim 10) or if this subject would have cellular rejection grade 2 (as recited in claim 13).
Claim 13 is rejected over the recitation of the phrase “a cellular rejection grade of CR2 or greater is assigned to the subject if the amount of DS cf-DNA is 0.8 or greater”. This claim depends from claim 3 which requires determining that the subject has or is at increased risk of having cellular rejection grade 2. In the instant case it is unclear if the claims are limited to a method of determining cellular rejection grade 2 (as recited in claim 3) or if the claims also encompass determining cellular rejection grade 3 (as recited in claim 13). Clarification is required.
Claim Rejections - 35 USC § 103
6. 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.
Claims 1-5, 10, 13, and 85 are rejected under 35 U.S.C. 103 as being unpatentable over De Vlaminck (Science Translational Medicine June 18, 2014 Vol 6 Issue 241 pages 1-8) in view of Schutz (US 2016/0115541 Pub 4/28/2016).
Regarding Claim 1 De Vlaminck presents the results of a prospective cohort study (65 patients, 565 samples) that tested the utility of cell-free donor-derived DNA (cfdDNA) in measuring acute rejection after heart transplantation. Circulating cell-free DNA was purified from plasma and sequenced (mean depth, 1.2 giga–base pairs) to quantify the fraction of cfdDNA. Through a comparison with endomyocardial biopsy results, De Vlaminck demonstrates that cfdDNA enables diagnosis of acute rejection after heart transplantation, with an area under the receiver operating characteristic curve of 0.83 and sensitivity and specificity that are comparable to the intrinsic performance of the biopsy itself. Figures 4 shows the time-dependence of cfdDNA fraction in the absence of rejection (a), and three examples of acute rejection (b-d).
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In the first case (Fig. 4B), an elevated donor fraction was recorded at month 15 (cfdDNA = 5.75%), coinciding with a biopsy-defined 3R/3B acute rejection episode. In a second case (Fig. 4C), the donor-derived DNA fraction was quantified as >10%, coinciding with a 3R/3B rejection event (month 9). This patient required repeat heart transplantation after month 10 owing to development of severe cardiac allograft vasculopathy. After the second transplant, the donor-derived DNA signal returned to a low level. In a final example (Fig. 4D), elevated donor DNA fractions were observed in a patient with consecutive episodes of ACR (month 4, 2R/3A; month 12, 3R/3B; donor fractions, 2.0 and 9.0%, respectively) and AMR (month 4; donor fraction, 4.9%). This example illustrates the application of this technique for detection of both ACR and AMR events (page 2, col 2 to page 3 col 1). ≥2R/3A or AMR). Further De Vlaminck teaches that levels of cfdDNA were significantly less for stable transplant recipients (biopsy grade 0) than for recipients diagnosed with mild ACR (grade ≥1R/1A and <2R/3A) and recipients diagnosed with moderate or severe ACR (grade ≥2R/3A or AMR) (Fig. 5A). The cfdDNA levels were significantly higher for heart transplant recipients during acute rejection and correlated with the severity of the rejection episode as determined by biopsy (comparing biopsy grades 0 and 1R/1A and biopsy grades 0 and ≥2R/3A or AMR). A receiver operating characteristic(ROC) analysis of the performance of cfdDNA as a marker of ACR (≥2R/3Aor AMR) yielded an area under the curve(AUC) of 0.83 (sensitivity = 0.58 and specificity = 0.93 at a cfdDNA threshold level of 0.25%) (Fig. 5B).
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Thus De Vlaminck teaches a method of assaying cell free DNA in a sample from a transplant subject. De Vlaminck teaches extracting cf-DNA from the sample and quantifying an amount of donor-specific cell-free DNA (DS cf- DNA). De Vlaminck teaches determining whether the amount of DS cf-DNA is equal to or exceeds a threshold (0.25%). De Vlaminck teaches assessing the grade of cellular rejection using the amount of DS cf-DNA. The subjects of De Vlaminck are being interpreted as subjects suspected of having or at risk of having cellular rejection since all transplant subjects are at risk and should be monitored after receiving a transplant.
Regarding Claims 2-3 and 5 De Vlaminck teaches that levels of cfdDNA were significantly less for stable transplant recipients (biopsy grade 0) than for recipients diagnosed with mild ACR (grade ≥1R/1A and <2R/3A) and recipients diagnosed with moderate or severe ACR (grade ≥2R/3A or AMR) (Fig. 5A). The cfdDNA levels were significantly higher for heart transplant recipients during acute rejection and correlated with the severity of the rejection episode as determined by biopsy (comparing biopsy grades 0 and 1R/1A and biopsy grades 0 and ≥2R/3A or AMR). Thus De Vlaminck teaches that based on the determination one can assign a cellular rejection grade and determine that the subject has or is at increased risk of having cellular rejection grade 1 or 2.
Regarding Claim 4 De Vlaminck teaches that the GTD assay allows for improved modulation and tracking efficacy of anti-rejection therapies. De Vlaminck teaches that the GTD assay allows for early diagnosis of acute rejection and therefore presents an opportunity for early diagnosis and treatment (page 6 col 1-2). Thus De Vlaminck teaches a method of determining a treatment or monitoring regimen for the subject based on the determination.
Regarding Claims 10 and 13 De Vlaminck teaches that they analyzed the performance of the GTD approach for acute rejection diagnosis through a direct comparison with endomyocardial biopsy data. De Vlaminck teaches that the cfdDNA levels were significantly higher for heart transplant recipients during acute rejection and correlated with the severity of the rejection episode as determined by biopsy (comparing biopsy grades 0 and 1R/1A and biopsy grades 0 and ≥2R/3A or AMR). A receiver operating characteristic (ROC) analysis of the performance of cfdDNA as a marker of ACR (≥2R/3A or AMR) yielded an area under the curve (AUC) of 0.83 (sensitivity = 0.58 and specificity = 0.93 at a cfdDNA threshold level of 0.25%) (page 3 col 2 and Fig 5a and 5b). Thus De Vlaminck teaches that DS cf-DNA values can be compared to a threshold value that falls between 0.2-0.8. Further as shown in the Figure De Vlaminck teaches that patients with cellular rejection grade of CR2 or greater have 0.8 or greater levels of DS cf-DNA.
Regarding Claim 85 De Vlaminck teaches that that elevations of cfdDNA can occur before the development of rejection on endomyocardial biopsy, and may therefore present an opportunity for early diagnosis and treatment (page 6, col 2). Thus De Vlaminck teaches a method comprising treating the subject.
De Vlaminck does not teach a method comprising preparing an preparation of amplified DNA by performing PCR amplification on the cf-DNA obtained and quantifying an amount of DS cfDNA in the preparation (Clm 1).
However Schultz discloses a method wherein a cfDNA sample is obtained from a blood sample and is analyzed to determine the level of donor material by identifying the presence of donor SNP alleles in the cfDNA. Schultz teaches that any method can be used to evaluate the sample. In typical embodiments, digital PCR, such as a microfluidics-based digital PCR or droplet-based PCR is employed. Other methods can be based on direct hybridization of detection probes (without prior amplification) or sequencing, e.g., sequencing of an amplicon defined in Table 1. For example, the SNP region is amplified by PCR and then the percentage of the minor allele is determined by amplicon sequencing. The percentage of donor cfDNA (also referred to as graft cfDNA) in the cfDNA sample can be determined. In other embodiments, the copy number of donor cfDNA is determined (para 0057).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of De Vlaminck by first preparing a preparation of amplified DNA by performing PCR as suggested by Schultz. One of skill in the art would have been motivated to amplify the DNA prior to quantifying the amount of DS cf-DNA for the benefit of being able to expand the target DNA pool so there is enough DNA for sequencing.
Double Patenting
7. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
8. Claims 1-5, 10, 13, and 85 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 50, 57, 60, 66, 70, 74, 78, 89, and 92 of US Application 16/623,719. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claim 1 both sets of claims are drawn to a method of assaying cell-free DNA in a sample from a transplant subject. Both sets of claims require (a) extracting cf-DNA from the sample; (b) preparing a preparation of amplified DNA by performing PCR amplification on the cf-DNA obtained in (a); (c) quantifying an amount of donor-specific cell-free DNA in the preparation from the subject, wherein the subject has or is suspected of having a cellular rejection grade and determining whether the amount of DS cf-DNA is equal to or exceeds a threshold to assess the grade of cellular rejection (see clm 1 of the copending application). Regarding Claim 2 both sets of claims recite determining that the subject has, or is at increased risk of having, cellular rejection grade 1 (CR1) based on the determination (see clm 1 of the copending application). Regarding Claim 3 both sets of claims recite determining that
the subject has, or is at increased risk of having, cellular rejection grade 2 (CR2) based on the determination (see clm 1 of the copending application). Regarding Claim 4 both sets of claims further comprise determining a treatment or monitoring regimen for the subject based on the determination (see clm 4 of the copending application). Regarding Claim 5 both sets of claims recite assigning a cellular rejection grade to the subject based on the determination (see clm 1 of the copending application). Regarding Claim 10 both sets of claims recite a threshold value that
is 0.2 to 0.8 (see clm 1 of the copending application). Regarding Claim 13 both sets of claims state that a cellular rejection grade of CR2 or greater is assigned to the subject if the amount of DS cf-DNA is 0.8 or greater (see clm 1 of the copending application). Regarding Claim 85 both sets of claims state that determining a treatment regimen comprises selecting or suggesting a treatment for the subject or treating the subject (see clm 78 of the copending application).
Response To Arguments
9. In the response the Applicants traversed the double patenting rejection over copending Application 16/623,719. The response states that the claims have been amended and the rejection should be reconsidered. They argue that the Office has not established that the claims of the instant application are anticipated or rendered obvious by the claims of this application.
This argument has been fully considered but is not persuasive. The double patenting rejection has been modified to address the claims as amended. It is the claims of the copending application that anticipate the instant claims. The rejection is maintained.
10. 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA HANEY whose telephone number is (571)272-8668. The examiner can normally be reached Monday-Friday, 8:15am-4:45pm EST.
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/AMANDA HANEY/Primary Examiner, Art Unit 1682
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