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 .
Status of Claims
Currently, claims 8, 12-13, 15, 17-20 and 22-23 are pending and under consideration at this time. The amendments and arguments have been thoroughly reviewed but do not place the present application in condition for allowance. The following rejections are reiterated and present the complete set being applied to the instant claims. Any rejection not reiterated is withdrawn in view of the amendments to the claims. Response to applicant’s arguments follows. This action is FINAL.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 101
Claims 8, 12-13, 15, 18-20, and 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural correlation/law of nature and an abstract idea without significantly more. The claim(s) recite(s) the natural law/correlation between an individual being SARS-CoV2 positive or negative based on testing a sample from an individual for SARS-CoV2 material, as well as the abstract mental concept of making a determination (qualifying). This judicial exception is not integrated into a practical application nor do the claims include additional elements that are sufficient to amount to significantly more than the judicial exceptions for the reasons set forth below.
35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106. Regarding judicial exceptions, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106.
The unpatentability of abstract ideas was confirmed by the U.S. Supreme court in Bilski v. Kappos, 561 U.S. 593, 601 (June 28, 2010) and Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014). See also Myriad v Ambry, CAFC 2014-1361, -1366, December 17, 2014. The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66, 71 (2012). “[L]aws of nature, natural phenomena, and abstract ideas” are not patentable. Dia-mond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S. at 601 (2010).
In Alice Corp, the Supreme Court reiterated the two step test devised in Mayo to determine patent eligibility for claims. “First, we determine whether the claims at issue are directed to one of those patent-ineligible concepts. If so, we then ask, ‘[w]hat else is there in the claims before us?’ To answer that question, we consider the elements of each claim both individually and ‘as an ordered combination’ to determine whether the additional elements ‘transform the nature of the claim’ into a patent-eligible application.” 134 S. Ct. at 2355 (citing and quoting 566 U.S. at 72-73, 76-78).
Claims Analysis:
As set forth in MPEP 2106, the claims have been analyzed to determine whether they are directed to one of the four statutory categories (STEP 1). The claims were then analyzed to determine if they recite a judicial exception (JE) (STEP 2A, prong 1) [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)]. The claims were then analyzed to determine whether they recite an element or step that integrates the JE into a practical application (STEP 2A, prong 2) [Vanda Pharmaceuticals Inc., v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018)]. In the absence of a step(s) or element(s) that integrate the JE into a practical application, the additional elements/steps have been considered to determine whether they add significantly more to the JE (STEP 2B) [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)]. It was found that the present claims fail to meet the elements required for patent eligibility.
The instant claims are directed to diagnostic methods and therefore are directed to one of the four statutory categories of invention.
The claimed invention recites qualifying said first living being and said at least second living being as SARS-CoV2 negative when no SARS-CoV2 or SARS-CoV2 derived material is detected in the pooled sample which is a natural correlation/law between the presence or absence of SARS-CoV2 or SARS-CoV2 derived material and being SARS-CoV2 positive or negative. With regard to the natural correlation, as in Mayo, the relationship is itself a natural process that exists apart from any human action. The qualifying limitation is also a recitation of an abstract idea because this is directed to a conclusion/determination which can occur entirely within the mind. It is therefore determined that the claims are directed to judicial exceptions.
In the instant situation, the additional elements/steps of pooling and testing a pooled sample for SARS-CoV2 or SARS-CoV2 nucleic acid does not integrate the JE into a practical application because it is a mere data gathering step to use the correlation and does not add a meaningful limitation to the method.
The next step involves determining whether the remaining elements, either individually or as an ordered combination, are sufficient to “’transform the nature of the claim’ into a patent eligible application” Alice, 134 S. Ct. at 2355 (quoting Mayo, 132 S. Ct. at 1297). In the instant situation, the testing steps are generally recited and do not provide any particular reagents that might be considered elements that transform the nature of the claims into a patent eligible application because no specific elements/steps are recited. This is true for dependent claims directed to nucleic acid amplification as well. These elements are not only mere data gathering, but the general recitation of detection of nucleic acids is well understood, routine, and conventional activity. MPEP 2106.05(d)(II) sets forth laboratory techniques that the courts have recognized as well-understood, routine, conventional activity in the life sciences when they are claimed at a high level of generality. These include:
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);
Additionally, pooling biological samples for testing for the presence of infections, including respiratory infections was also well understood, routine and conventional in the prior art as evidenced by Westreich (Westreich et al; 2008, citation below) which provides a review of biological specimen pooling strategies and applications.
Applicant is reminded that in Mayo, the Court found that “[i]f a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself." Further "conventional or obvious" "[pre]solution activity" is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law”. Flook, 437 U. S., at 590; see also Bilski, 561 U. S., at ___ (slip op., at 14) (“[T]he prohibition against patenting abstract ideas ‘cannot be circumvented by’ . . . adding ‘insignificant post-solution activity’” (quoting Diehr, supra, at 191–192)). The Court also summarized their holding by stating “[t]o put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.” No novel technique or inventive concept is added by these claims. Therefore these limitations/steps do not “‘transform the nature of the claim’ into a patent-eligible application.’” Alice, 134 S. Ct. at 2355 (quoting Mayo, 132 S. Ct. at 1297).
The Supreme Court does acknowledge that it is possible to transform an unpatentable law of nature, but one must do more than simply state the law of nature while adding the words "apply it.” CLS BankInt’l, 134 S.Ct. at 2358; Prometheus, 132 S. Cl, at 1294.
When viewed as an ordered combination, the claimed limitations are directed to nothing more than the determination that a natural correlation/phenomena exists. Any additional element consists of using well understood, routine and conventional activity, and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.
Accordingly, it is determined that the instant claims are not directed to patent eligible subject matter.
Response to Arguments
The response traverses the rejection and asserts that any possible recited judicial exception is integrated into a practical application of improving techniques for the detection of SARS-CoV2. The response asserts that the claim recites specific and concrete steps that lead to an inventive concept of detection of SARS-CoV2 using pooled samples without losing sensitivity. This argument has been thoroughly reviewed but was not found persuasive because the teachings of Killian and FAD PReP exemplify the routine nature of pooling samples, from up to 11 individual swabs, in a single tube, for virus detection. Accordingly, the rejection is maintained for claims 8, 12-13, 15, 18-20, and 22.
Claim Rejections - 35 USC § 103
Claims 8, 12, 15, 18-20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Corman (Corman et al; Euro Surveill; 25(3); January 23, 2020, pages 1-8) in view of Killian (Killian, Mary Lea; Avian Influenza Virus 2nd ed., chapter 8, 2014, pages 83-91), FAD PReP (Foreign Animal Disease Preparedness and Response Plan, United States Department of Agriculture, August 2013; 31 pages provided, including 1-1 to 1-14), Westreich (Westreich et al; J Clin Microbiol, vol 46, pages 1785-1792; May 2008),Van (Van et al; J Clin Microbiol, vol 50, March 2012, pages 891-896) Hannoun (Hannoun et al; European Journal of Epidemiology, vol 16, pages 217-222, 2000), and Hong (Hong et al; Family Practice; vol 21, pages 317-323, 2004).
With regard to claim 8, Corman teaches detection of 2019-nCoV (SARS-CoV-2) in humans. Corman teaches obtaining biological samples from nose and throat swabs (claim 15) of different individuals (see page 2, para bridging columns 1 and 2). Corman therefore necessarily teaches obtaining a biological sample on a swab from a first living being and at least a second living being. Corman teaches testing the samples for the presence of SARS-CoV-2 nucleic acid using real time reverse transcription PCR (claim 16) (see page 2, col 2, last para). Corman teaches that the detection method can be used in public health emergencies (page 6, col 2, last para).
With regard to claim 8, Corman does not teach providing 2n biological samples, placing the first of 2n biological samples in an individual buffer solution, pooling the second of the 2n biological sample by placing them in a common buffer solution and incubating them for a time span allowing displacement of the nucleic acid to obtain a pool sample, and testing the pooled sample. However, the practice of pooling samples from different individuals in viral disease detection was well known and used in the art prior to the effective filing date:
A) Killian teaches detection of avian influenza virus and handling of samples. Killian teaches swab specimens can be used for virus isolation, nucleic acid based assays, and antigen immunoassays. Killian teaches obtaining swabs for flock surveillance (page 86, 3.1). Killian teaches obtaining swab specimens from a single flock, where up to 11 oropharyngeal swabs may be pooled in the same tube (claims 17-18). Killian teaches that for sample screening by rRT-PCR, swab material from each sample can be pooled and tested as a single sample to conserve resources. Killian teaches that if a pooled sample tests positive, the specimens should be tested individually. With regard to claim 12, Killian teaches placing the swab into viral transport media (buffer) and swirling vigorously to dispel the contents of the swab into the media. Killian teaches to lift the swab out of the media and press the swab firmly against the side of the tube to express any remaining liquid from the swab. Therefore, Killian teaches pooling the biological sample swabs from different individuals by placing them in a common buffer solution and incubating them for a time span allowing displacement of the nucleic acid to obtain a pool sample, and testing the pooled sample. In teaching to test specimens from a positive pool, individually, Killian suggests obtaining 2n samples for each individual, pooling one of the 2n samples, and archiving one of the 2n samples for possible future testing. One advantage of sample pooling taught by Killian includes conserving resources.
B) FAD PReP also teaches surveillance of poultry for avian influenza to secure egg supply. Like Killian, FAD PReP teaches monitoring by testing chickens from each house by rRT-PCR (p 1-11). FAD PReP also teaches pooling up to 11 oropharyngeal swabs from 11 chickens in the same tube (claims 17-18), and performing sample pooling per house. FAD PReP teaches that each swab is added to the tube, swirled in the media, and squeezed out to dispel the contents from the swab (claim 12). Therefore, FAD PReP also teaches pooling the biological sample swabs from different individuals by placing them in a common buffer solution and incubating them for a time span allowing displacement of the nucleic acid to obtain a pool sample, and testing the pooled sample.
C) Westreich also provides motivation for testing pooled samples from different individuals. Westreich discusses the optimization of screening for viral infections in the public health setting, and exemplifies screening for HIV using nucleic acid amplification techniques. Westreich teaches that the cost of these techniques can be prohibitively expensive in certain settings, and teaches a pooling algorithm can be constructed for optimizing screening of HIV using pooled nucleic acid tests (see abstract). For example, Westreich teaches creating a master pool from samples obtained from 10 specimens (claims 17-19) (see figure 1a), testing the master pool first (page 1786, col 1), and if the master pool tests positive, all component individual specimens are tested, whereas if the pool tests negative, all specimens in the pool are declared negative (page 1785, col 1). Therefore, Westreich teaches a testing strategy that produces an archived sample for each individual in a pool of individuals as well as producing a pool of material for all individuals in the pool, and testing the pooled sample first. Advantages of performing testing on pooled samples are taught by Westreich. These include a decrease in the average number of tests required per specimen compared to individual testing, and an increase in the efficiency of case detection as well as leading to higher specificity in a screening setting (page 1785,col 1).
D) Further, Van teaches using specimen pooling strategies for samples obtained from NP/throat swabs in testing for influenza. Van teaches the ability to successfully identify positive and negative results, both in testing pooled material as well as individual samples (see abstract; results). Van provides a reasonable expectation of success that respiratory viruses can be detected in a pooled sample from material obtained via NP/throat swabs.
Therefore, it would have been prima facie obvious to the ordinary artisan prior to the effective filing date, to employ the pooling strategy taught by Killian and FAD PReP for the method of detecting SARS-CoV-2 in different individuals as taught by Corman. Killian and Westreich teach the benefits of sample pooling, including conserving resources, decreasing the average number of tests required compared to individual testing, and higher specificity in a screening setting as in the public health emergency taught by Corman. The ordinary artisan would have had a reasonable expectation of success that using pooled samples would be capable of detecting respiratory virus material, including nucleic acids, obtained from swab samples given the teachings of Killian, FAD PReP, and Van.
Corman, Killian, FAD Prep, Westreich, and Van do not explicitly teach obtaining 2 swab samples for each individual, however the practice of obtaining two swab samples was also exemplified in the relevant art prior to the effective filing date:
E) Hannoun teaches influenza laboratory diagnostic and surveillance methods. Hannoun teaches obtaining double swab samples (page 218, col 1, last para) is beneficial. Hannoun states that a double sample is often collected in the same vial, which necessarily suggests that each sample of the double sample can be collected in a single vial, or in different vials.
F) Additionally, Hong, in reference to throat swabs, teaches that two or more throat swabs would increase yield (see page 322, col 1).
Therefore, it would have been prima facie obvious to the ordinary artisan prior to the effective filing date to obtain a 2 swab samples (double sample) for each individual in the method of Corman, Killian, FAD PReP, Westreich, and Van, as taught by Hannoun and Hong. The ordinary artisan would have been motivated to obtain two swabs for each individual as a double sample for ease of use in having a swab for an archived sample and a swab for the pooled sample as suggested by Killian and Westreich.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Corman in view of Killian, FAD PReP, Westreich, Van, Hannoun and Hong as applied to claims 8, 12, and 15, 18-20 and 22 above, and further in view of Li (Li et al; International Journal of Infectious Diseases, vol 85, 2019, pages 167-174).
The teachings of Corman, Killian, FAD PReP, Westreich, Van, Hannoun, and Hong are set forth above and fully incorporated herein. Corman, Killian, FAD PReP, Westreich, Van, Hannoun, and Hong do not state that the PCR medium is conventional, however Li teaches that rapid diagnosis of the ZIKV RNA virus is the only option to monitor and control disease spread (page 167). Li teaches testing and optimizing direct quantitative RT-PCR in different types of samples, including throat swabs, to simplify the operating process, reduce time for sample to answer detection, reduce the risk of exposure to infectious substances, and to reduce the sample volume required from the milliliter level to the as low as the sub microliter level. Li teaches optimizing the reaction conditions for each assay, including the type of polymerase used, Buffer components including MgCl2, dNTPs, KCL, Triton X-100, RNase inhibitor, primer pair, probe, etc (pages 168-169; page 173. Therefore, it would have been prima facie obvious to the ordinary artisan prior to the effective filing date, to perform direct detection of SARS-CoV-2 as taught by Corman, in the samples, including pooled swab samples as taught by the state of the art of Killian, FAD PReP, Westreich, Van, Hannoun, and Hong, with a reasonable expectation of success. Li exemplifies the routine nature of optimizing reagents and reaction conditions for analysis of different types of samples used for viral disease diagnosis.
Claims 17 and newly added claim 23 are rejected under 35 U.S.C. 103 as being unpatentable over Corman in view of Killian, FAD PReP, Westreich, Van, Hannoun, and Hong as applied to claims 8, 12, 15, 18-20, and 22 above, and further in view of Muniesa (Muniesa et al; PLoS ONE 9(4): e934941; pages 1-5; 2014).
The teachings of Corman, Killian, FAD PReP, Westreich, Van, Hannoun, and Hong are set forth above and fully incorporated herein. Corman, Killian, FAD PReP, Westreich, Van, Hannoun, and Hong do not teach pooling n biological samples where n is 50-500 or 50-100, however Muniesa teaches algorithms for optimizing pooled samples and teaches that the use of pooled samples could be a good strategy in order to reduce analytical cost in surveillance programs and that the sensitivity depends on the prevalence and quantity of pathogen load. Therefore, it would have been prima facie obvious to one of ordinary skill in the art, to optimize the number of pooled samples in the method of Corman, Killian, FAD PReP, Westreich, Van, Hannoun, and Hong, as taught by Muniesa, for the obvious benefits of conserving resources and decreasing the average number of tests required compared to individual testing as taught by Killian and Westreich, in the screening setting of the public health emergency taught by Corman. Absent secondary considerations, the number of pooled samples of 50-500 is considered routine optimization and obvious in view of the prior art cited.
Response to Arguments
The response dated 10/21/2025 traverses the rejections under 35 USC 103.
A) The response first references the Declaration of Prof. Michael Schmidt to “show that the diagnostic nucleic acid technology (NAT) high sensitivity comparable to a single sample was maintained even at large pool sizes up to 100 swabs”. The response asserts that nothing in the cited references teaches or suggests these advantageous results, which should be considered unexpected because they could not be predicted by those having ordinary skill in the art. This argument as well as the declaration under 37 CFR 1.132 by Prof Michael Schmidt have been thoroughly reviewed. However, the declaration is not sufficient to overcome the rejections because of the following:
i) with regard to claims 8, 12-13, 15, 18, 19, 20 and 22, these claims encompass pooling up to 11 swab samples in a single tube which is taught by the prior art of FAD PReP and Killian whereas the declaration does not provide any evidence that the teachings of FAD PReP or Killian are incorrect or inoperable.
ii) With regard to claims 17 and 23 which encompass pooling 50-100 or 50-500 swabs, the assay conditions set forth in the declaration are unclear. Applicants responses have continued to argue that it is known that as more negative samples are collected, the concentration of virus becomes lower. For example, at section 6, the declaration asserts “this result is unexpected because ordinarily such large pool sizes dilute the individual samples”. However, the pooled samples in the declaration do not appear to include negative samples such that the reference to diluting individual samples is unclear. At section 4, the declaration asserts “individual samples as well as pooled samples (10-100 swabs) with a SARS-CoV-2 concentration of 1,000 copies/ml were tested via ORF-PCR and E-gene PCR…”. Therefore, it appears that the concentration of SARS-CoV-2 was either the same in all of the pooled samples (1,000 copies/ml), or that each of the pooled swabs contained specimen from individual samples that each contained 1,000 copies/ml of SARS-CoV2, rather than to a situation where testing of a single positive swab sample was as sensitive as a pooled sample from, for example, 1 or 2 positive swab samples and 98 or 99 negative swab samples. It is unclear, therefore, what is being “diluted” and why it would be unexpected that the sensitivity of a pooled sample of 10 or 20 or 50 or 100 individual positive samples would be comparable to a single positive sample. In other words, if the tested pool is comprised of only positive samples, one would expect that it would yield a positive result. Additionally, if in fact the assay conditions in the declaration are such that that the concentration of SARS-CoV-2 was either the same in all of the pooled samples (1,000 copies/ml), or that each of the pooled swabs contained specimen from individual samples each with 1,000 copies/ml of SARS-CoV2, these conditions are not commensurate in scope with the claimed invention which does not require that all of the n swab samples be from SARS-CoV-2 positive living beings. See MPEP 716.01(b) for the requirement of nexus between the scope of the claimed invention with regard to the showing of unexpected results.
B) The response then argues that although Killian and FAD PreP disclose pooling up to 11 swab samples “as alleged by the Examiner”, the cited references do not suggest that the diagnostic NAT sensitivity can be maintained at a high level when many samples, such as the ‘up to 11” as “referred to by the Examiner” are pooled together. First, it should be noted that the response appears to question the teachings of the reference vs what is stated in the office action. The response asserts that the number of pooled samples taught is “alleged by the Examiner”. However this is not an allegation, but rather a fact that is expressly taught by the references. At page 86, section 3.1, Killian expressly states “Up to 11 oropharyngeal swabs may be pooled in the same tube…” while FAD Prep teaches “… 11 oropharyngeal swabs from 11 chickens are pooled in a tube…” (page 1-11, last para). Secondly, since the references teach to pool 11 swabs per tube, the artisan of ordinary skill would expect that the 11 swab pools would yield the necessary results from testing. Applicants have not provided any evidence that refutes or disproves the teachings of these references. The response then asserts that the Killian, FAD PreP, and Van references are all related to influenza virus rather than SARS-CoV-2, and that it is “well known” in the industry relating to the present invention that pooling samples from many people in one container will reduce sensitivity because of 1) dilution of influenza RNA by negative samples, 2) influenza viral shedding can be shorter and more variable than other viruses, like SARS-CoV-2, and 3) influenza RNA is less stable than other viral genomes. These arguments were presented in the previous responses, however as already indicated in previous office actions these arguments cannot take the place of evidence on the record. See MPEP 716.01(c)(II): “Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). Examples of statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor.”. As already addressed in section A above, the samples tested in the declaration appear to be a pooled sample of SARS-CoV-2 positive swabs, and therefore do not appear to have been diluted by negative swab samples. Furthermore, the instant claims are not directed to methods of pooling swab samples to detect influenza virus, therefore the relevance of the arguments are not clear. Again, Applicants have not provided any evidence that refutes or disproves the teachings of FAD PReP or Killian. Additionally, since the art already teaches that virus dilution and sample handling can affect results in pooled testing, the ordinary artisan would have been motivated to adopt proper handling techniques, and would have a reasonable expectation of success that pooling at least 11 swabs would be possible given the teachings of Killian and FAD PReP because Killian and FAD PReP expressly teach to pool 11 swab samples for influenza virus. Furthermore, given the teachings of Muniesa, the ordinary artisan would have been motivated to pool as many samples as possible without affecting sensitivity for the obvious benefits of conserving resources and decreasing the average number of tests required compared to individual testing as taught by Killian and Westreich, in the screening setting of the public health emergency taught by Corman.
For these reasons and the reasons already made of record, the rejections are maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JEHANNE S SITTON/Primary Examiner, Art Unit 1682